Handbook 17JUL07

NICNAS Handbook for Notifiers
© Commonwealth of Australia 2004
ISBN 0-642-39896-8
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Table of Contents
NICNAS Handbook for Notifiers 1
Table of Contents i
Table of Amendments v
How to use this handbook 1
STEP 1 1
STEP 2 1
STEP 3 1
STAY UP TO DATE 1
HELP US HELP YOU 2
SECTION I - Overview 3
1. Your Obligations Under NICNAS 3

1.1 Why Assess Industrial Chemicals? 3
1.2 About NICNAS 3
1.3 How Does NICNAS Define an 'industrial chemical'? 4
1.4 The Australian Inventory of Chemical Substances (AICS) 4
1.5 The Five Key Obligations 6
1.6 Compliance 10
1.7 Publication and Further Notification 10
SECTION II - New Chemicals 11
2. Do You Need to Notify? 11

2.1 How to Decide 11
2.2 Is the Substance a Chemical Under the NICNAS Definition? 12
2.3 Is the Chemical an Industrial Chemical Under NICNAS Definition? 13
2.4 Is the Industrial Chemical a New Industrial Chemical? 14
2.5 Is the New Industrial Chemical Exempt from Notification Under NICNAS? 14
2.6 Exemption Categories for New Industrial Chemicals 22
2.7 What is Unreasonable Risk? 26
3. Which Notification Category 30
3.1 Determining the Appropriate Notification Category 30
i
3.2 Rebate assessments 33
3.3 Outcomes of Each Category 33
3.4 Permits 33
3.5. Summary of New Chemicals Notification Categories 36
4. General Notification Procedures 37
4.1 General Information 37
4.2 Form and Content of Notifications 38
4.3 Data Requirements 39
4.4 New Chemicals Listed on a Recognised Overseas Inventory 43
4.5 Exempt Information 43
4.6 Screening of Assessments; Submit Once - Review Once 44
4.7 Method of payment of assessment fees 45
4.8 Request for Further Information by Director 46
5. Certificate Categories 49
5.1 Confidentiality 49
5.2 Variation of Data Requirements 49
5.3 Polymers of Low Concern (PLC) Notification 50
5.4 Self Assessment: Polymer of Low Concern (PLC) 50
5.5 Limited Notifications 52
5.6 Standard Notifications 53
5.7 Electronic Draft Assessment Report Using NICNAS Template 53
5.8 Extension of Assessment Certificate 55
5.9 Self assessment: non-hazardous chemicals and non-hazardous polymers 56
5.10 Assessment Process and Reports 60
6. Permit Categories 63
6.1 Exempt Information 63
6.2 Commercial Evaluation Chemical (CEC) Permits 63
6.3 Low Volume Chemical (LVC) Permits 67
6.4 Controlled Use (Export Only) Permit (EOP) 70
6.5 Early Introduction Permits 73
6.6 Section 30 Permit 74
6.7 Renewal of CEC and LVC permits 75
7. Continuing Obligations 78
7.1 Secondary Notification 78
ii
7.2 AICS 78
8. Rebate 80
8.1 Electronic Lodgement of Notification 80
8.2 Foreign Schemes 82
SECTION III - Existing Chemicals 86
9. Priority Existing Chemical Assessments 86

9.1 An Overview of Priority Existing Chemicals 86
9.2 Nominating a Chemical as a PEC 87
9.3 How Will I Know if I Need to Supply Information? 88
9.4 Applying for Assessment of a PEC 90
9.5 The Assessment Process 92
9.6 The Assessment Report 93
9.7 Removal From AICS 99
10. Other Assessments and Notifications 100
10.1 High Volume Industrial Chemicals 100
10.2 Information Sheets 101
10.3 Secondary Notifications 101
SECTION IV - Continuing Notification and Assessment Methodologies 102
11. Secondary Notifications 102

11.1 Introduction of an Assessed Chemical 102
11.2 Secondary Notifications 102
11.3 Reporting Obligations 103
11.4 Gazetted Secondary Notification 104
11.5 Application for Secondary Notification 104
11.6 Assessment Process and Reports 104
11.7 Penalties 105
12. Assessment Methodologies 106
12.1 About NICNAS Assessments 106
12.2 Toxicological Assessment 106
12.3 Occupational Health and Safety Assessment 109
12.4 Public Health Assessment 111
iii
12.5 Environmental Assessment 113
12.6 Risk Assessment of Chemicals: Assessment of Exposure from All Sources 116
SECTION V – NICNAS Registration 119
13. NICNAS Registration 119

13.1 What are the benefits of NICNAS Registration? 119
13.2 What is an industrial chemical? 120
13.3 How are we funded? 120
13.4 How do you decide if you should register with NICNAS? 121
13.5 Registration Costs 123
13.6 How do I register with NICNAS? 124
13.7 Renewal of Registration 124
13.8 Who should submit a final statement of introduction? 125
13.9 Reconsideration and review of registration assessments 125
13.10 What are my registration obligations? 126
13.11 What happens if I do not register? 126
13.12 Can I transfer my registration? 127
13.13 Register of Industrial Chemicals Introducers 127
SECTION VI - Treaties 128
14. The Rotterdam Convention on the Prior Informed Consent Procedure for Certain
Hazardous Chemicals and Pesticides in International Trade 128
14.1 About the Rotterdam Convention 128
14.2 Which Australian Government agencies are responsible for PIC? 129
14.3 Where can I get more information about the Rotterdam Convention? 129
14.4 What is covered under the Rotterdam Convention? 129
14.5 What are the industrial chemicals subject to the PIC procedure? 130
14.6 Has Australia notified any banned or severely restricted chemicals? 130
14.7 What are import decisions? 131
14.8 What do I do if I import, manufacture and/or export PIC chemicals? 132
14.9 Compliance and enforcement 135
SECTION VII - Compliance 137
iv
15 Compliance 137
15.1 Our Compliance Style 137
15.2 Our Compliance Program 138
15.3 Discovery and Recording of Non-Compliance 139
15.4 Enforcement Provisions, Offences and Penalties 140
15.5 Transfer of Assessment Certificates and Registrations 148
15.6 Record Keeping and Annual Reporting Requirements 150
15.7 Role of NICNAS Inspectors 152
Appendices 154
1. Forms 155
2. Definitions 156
3. Abbreviations 170
4 NICNAS Fees and Charges 2006-07 172
5. The Chemical Gazette 174
6. Confidentiality 178
7. Summary of the Act 180
8. Appeals 182
9. Description of an Article 185
10. Polymers of Low Concern Guidance 187
11. How to obtain Chemical Abstracts Service Registry numbers (CAS) 199
12. Schedule of Data Requirements 203
13. AICS Online Training 231
v
Table of Amendments
VERSION DATE REASON FOR AMENDMENT

NUMBER
1 16 September 2004 Rewritten NICNAS Registration Chapter
Added a new Chapter on Treaties
New Chemicals Chapter updated to include
LRCC new categories
Compliance Chapter updated
Minor changes to PEC Chapter
Editorial changes to the rest of the document and
formatting changes
Some appendices amended to reflect the new
changes
2 7 December 2004 Self assessment amendments (Section 3.3, 3.4,
5.3.1, 5.6.3 and 8.2)
NICNAS Registration
(Section 13.5- incorporated additional text to
clarify which Tier level to register at)
Editorial corrections
Appendix 10- deleted the word ‘synthetic’ from
the title
3 24 March 2005 Amendments due to new fees (Sections 5.3.1,
5.6.3, 6.2, 6.3, 6.6 and Appendix 4)
Changes to AICS forms (Section 7.2.3 and
Appendix 1)
Minor corrections clarifying the data
requirements for biopolymers and low molecular
weight synthetic polymers (Sections 3.1, 3.4,
5.6.3)
Minor corrections miscellaneous (Sections 2.5,
3.1, 3.4, 5.7.2 and 6.3)
Revised Section 2.6
4 July 2005 Amendments due to new fees (Appendix 4)
Updating self-assessment information (Section
Sections 5.3.1 and 5.6.3)
5 January 2006 Rewritten chapter 2.5.
Minor corrections miscellaneous (Sections 5.5,
8.2, 3.1, 3.4, 5.7.2 and 6.3)
6 February 2006 Rewritten Section 6.6.
Minor corrections miscellaneous (Sections 5.5)
7 August 2006 Included a new category for Controlled Use
(Export Only) Permit and other amendments
v
Section I - Overview
How to use this handbook

This handbook aims to help manufacturers and importers of industrial chemicals
comply with their obligations under the Industrial Chemicals (Notification and
Assessment) Act 1989 (Cwlth).
STEP 1
It is recommended that all users of the handbook start by reading Chapter 1, which
outlines general information concerning the role of the National Industrial Chemicals
Notification and Assessment Scheme (NICNAS) in assessing industrial chemicals in
Australia, and provides an overview of the legal obligations applying to importers and
manufacturers.
STEP 2
Having decided which of the five key obligations outlined in Chapter 1 is relevant to
you, the table below offers guidance as to which of the remaining Sections of the
handbook you need to consult.
Consult the following Sections of the

For information about:
handbook:
1 2 3 4 5 6 7
New Chemical Assessments X X X X
Priority Existing Chemical
X X X X
Assessments
Secondary Notifications X X X
NICNAS Registration X X X
Treaties X X X
STEP 3
Complete any forms (a list of forms is available at Appendix 1) and prepare
supporting documents for submission to NICNAS. Forms can be downloaded at
http://www.nicnas.gov.au/forms/.
STAY UP TO DATE
The Handbook for Notifiers is updated from time to time with new and revised
information.
1
HELP US HELP YOU

We are interested in your feedback on this handbook. Please send your comments and
suggestions to:
National Industrial Chemicals Notification and Assessment Scheme
GPO Box 58
SYDNEY NSW 2001
Or email: info@nicnas.gov.au
2
SECTION I – Overview
1.Your Obligations Under NICNAS
This chapter provides general information about the role of the National Industrial
Chemicals Notification and Assessment Scheme (NICNAS) in assessing industrial
chemicals in Australia and offers an overview of legal obligations applying to
importers and manufacturers.
1.1 Why Assess Industrial Chemicals?

The goal of NICNAS is to aid in the protection of the Australian people and the
environment by identifying the risks to occupational health, public health and the
environment from industrial chemicals. These risks are minimised if potentially
harmful effects are identified at the earliest possible time – prior to the chemical’s
importation and/or manufacture. Appropriate safe handling methods can then be
devised and implemented.
NICNAS has established a comprehensive scientific program of international

standards for assessing industrial chemicals in Australia. The availability of NICNAS
assessment reports to State and Territory regulatory agencies, companies introducing
chemicals, people in the workplace, other government agencies and to the public has
contributed significantly to making workplaces safer and in protecting human health
and the environment.
While the use of overseas hazard assessment reports is supported and encouraged, the
actual risk posed by a chemical, and hence its management, must be determined by
taking into account Australian conditions – that is, our demographics, unique
environmental ecosystems and the patterns and conditions of the chemical’s use in
this country.
1.2 About NICNAS

In Australia, industrial chemicals are regulated by the Australian Government under
the Industrial Chemicals (Notification and Assessment) Act (1989) (the Act),
administered by NICNAS and located within the Health and Ageing portfolio.
NICNAS is the Australian Government’s regulatory body for industrial chemicals. It

was established in 1990 under the Act to aid in the protection of people at work, the
public and the environment from the harmful effects of industrial chemicals.
NICNAS aims to ensure the safe use of industrial chemicals by making risk
assessment and safety information on chemicals and their potential worker, public
health and environmental risk widely available.
NICNAS assesses industrial chemicals that are new to Australia for their health and
environmental effects before they are used and/or released to the environment.
NICNAS also assesses those chemicals that are already in use in Australia known as
3
existing chemicals on a priority basis in response to specific concerns about potential

health and/or environmental effects.
1.3 How Does NICNAS Define an ‘industrial chemical’?

Under the Act, an industrial chemical is any chemical that has an industrial use. This
includes specialty chemicals, dyes, solvents, adhesives, plastics, laboratory chemicals,
chemicals used in mineral and petroleum processing, refrigeration, printing and
photocopying, paints and coatings, as well as chemicals used in the home, such as
cleaning products, cosmetics and toiletries.
The Act specifically excludes articles (see Appendix 2 – Definitions and Appendix 9:
Description of an article), radioactive chemicals and mixtures from notification and
assessment requirements. Chemicals, which are used solely as therapeutic agents,
agricultural, and/or veterinary chemicals, and/or food or food additives are also
outside the scope of NICNAS. The definition of an industrial chemical is slightly
different for NICNAS registration purposes.
1.4 The Australian Inventory of Chemical Substances (AICS)

The Australian Inventory of Chemical Substances (AICS) is a key tool that lists the
chemicals that are available for use in Australia. Some chemicals may only be
available for specified/conditional use. It is important that you are aware of any
conditions or restrictions that may apply to chemicals you import and/or manufacture
or plan to export. Failure to comply with the conditions could lead to unsafe use.
The AICS is a listing of industrial chemicals in use in Australia between 1 January

1977 and 28 February 1990. In addition, it includes new assessed chemicals and
corrections as required.
The AICS is maintained under NICNAS and contains over 38,000 chemicals. The
AICS is a list of chemical identity data; it does not contain information on toxicity,
manufacturers or importers.
Any chemical not included in AICS or any listed chemical whose importation and/or
manufacture is subject to a condition of use, is regarded as a new industrial chemical
unless it is outside the scope of the Act. New industrial chemicals must be notified
and assessed before being manufactured or imported into Australia unless they qualify
for an exemption.
1.4.1 Compilation of AICS
The first edition of the AICS was a listing of industrial chemicals already in
commercial use in Australia over the period 1 January 1977 to 28 February 1990
(‘grandfathered chemicals’). It included approximately 36,000 non-confidential
chemicals, with a further 2,500 in the Trade Name section and another 1,000 in the
confidential section. Additional chemicals (Eligible Chemicals) were added during a
two-year amnesty from 1993 to 1995. As these chemicals were added to AICS (or
4
later taken as eligible to be on AICS) before the advent of NICNAS, the vast majority
have not been assessed in Australia for health and environmental effects.
Since 1995 any addition to AICS has been principally through the new chemical
assessment process. This accounts for about 1,200 chemicals in the AICS database.
The chemical details for some chemicals on AICS have been amended where there
has been a change to the CAS number or chemical nomenclature or where an error
occurred during the AICS compilation period.
1.4.2 Components of AICS
AICS is composed of two sections: Non-confidential and Confidential. Each section

contains the following chemical details only:
CAS Number: The CAS Number is a unique number assigned to a substance when it
is entered into the Chemical Abstracts Service (CAS) Registry database. The general
format is XXX-XX-X.
Chemical Name: Chemicals are listed under their CAS approved name.
Molecular Formula: Molecular formula for some chemicals is listed on AICS.
Associated names (if any): Chemicals are more commonly known by names other
than their CAS approved name. Some of these associated names or synonyms are also
included on AICS.
The only difference between these two sections is the availability of these sections.
The confidential section of AICS is not available to the public. Chemicals listed on
the confidential section are up for renewal every five years.
1.4.3 Listing of ‘New’ Chemicals on AICS
Five year listing
All certificate-assessed chemicals are included on AICS five years of the certificate
date. For the interim five years, chemicals are not listed on AICS.
At the end of five years, the company, which is the holder of the certificate for the
assessed chemical is given the opportunity to put the chemical on the confidential
section of AICS.
For a chemical to be listed on the confidential section, an application to NICNAS is

required. There are some minimum data requirements for the application and these are
specified in the “Guidelines for Confidential Listing”. The Director, NICNAS makes
the decision after taking into consideration the public and commercial interest.
5
Immediate listing
Under Section 13B, an assessed chemical can be listed on the non-confidential section
of AICS prior to the five year period.
If the holder of certificate makes an application within 28 days of the issue of

assessment certificate no fees apply. However if any application is made after 28 days
fees apply.
Chemicals are added to non-confidential AICS through gazetting in the Chemical

Gazette.
1.4.4 Searching of AICS
To find out if a chemical is listed on AICS, you may need to check both the
confidential and non-confidential sections. The non-confidential section of AICS is
available on the NICNAS web site (www.nicnas.gov.au/obligations/aics). Please refer
to Appendix 13 – AICS Online Training – for more information.
You can also request NICNAS to do the search for you. For searches of the non-
confidential section, please complete the AICS Search Form 4 (Appendix 1). The fees
for this service (excluding GST) are as follows:
• Administrative fee: $ 30 per search

• Chemical search fee: $ 35 per chemical
All fees are payable before the search commences. Requests from the public to search
the non-confidential section of AICS are free.
For searches of the confidential section please complete AICS Search Form 5
(Appendix 1). This service is free. A statement of bona fide intent to introduce the
chemical into Australia must accompany the search request.
1.5 The Five Key Obligations

The Act sets out five key obligations for manufacturers and importers of industrial
chemicals. These obligations relate to:
1. New chemicals assessments – the notification and assessment of chemicals

determined as ‘new industrial chemicals’
2. Existing chemicals assessments – assessment of chemicals declared ‘priority
existing chemicals’
3. Secondary Notifications – the notification and assessment of chemicals
previously assessed by NICNAS including chemicals assessed under the self
assessment category
6
4. NICNAS Registration – registration of anyone importing and/or

manufacturing relevant industrial chemicals of any value for commercial
purposes.
5. Treaties – certain regulatory requirements apply to chemicals subject to an
international agreement to which Australia is a Party.
An overview of each of these obligations follows.
1.5.1 New Chemical Assessments
All new industrial chemicals must be notified to NICNAS and assessed prior to their
import or manufacture in Australia. For detailed information about what constitutes a
‘new industrial chemical’, refer to Chapter 2 – Do You Need to Notify?. Certain new
industrial chemicals are exempt from notification provided they meet certain criteria
including use; volume; concentration and risk to human health or the environment.
For most exempt categories no further action is required prior to the introduction of
the new chemical. However, in some cases, information about exempt category
chemicals still needs to be provided to the Director justifying the exemption. All
exemption categories have an annual reporting obligation. For further information on
Exemptions, see Section 2.5 in this handbook.
It is the responsibility of the importer and/or manufacturer of the new industrial

chemical to notify NICNAS through the preparation of a notification statement. The
notification statement must contain an application for an assessment certificate or
permit and a technical dossier containing all the information required for the
assessment.
Several assessment categories exist which require different levels of assessment to be

undertaken. In general, the amount of information, which is required in the
notification statement, increases in accordance with the proposed introduction volume
of the new chemical and the associated hazards, use, handling and disposal of the
notified chemical. The volume of a chemical to be introduced and the hazards of the
chemical are considered to be significant factors in determining the risk posed to
human health and the environment.
There are fee reductions if those notifying NICNAS are able to supply an acceptable
written draft assessment report or a report of a chemical assessed under an approved
foreign scheme. In some circumstances, importers or manufacturers can apply for
permits allowing chemicals to be introduced before the assessment process has been
complete. There is also provision for companies to apply to have their names added to
assessment certificates already issued to another company importing or manufacturing
the same chemical. For further information on new chemicals assessments, refer to
Chapters 2-8 Section II of this handbook.
1.5.2 Existing Chemical Assessments
Existing chemical assessment activities have an important role to play in reducing

risks from chemicals currently in use. Whereas each new industrial chemical
undergoes an assessment before being imported or manufactured in Australia, most of
7
the 38,000 already present in Australia (i.e. existing chemicals) have never had an
independent assessment of their potential risks. Declaration as a priority existing
chemical (PEC) ensures the closer examination and detailed assessment of those
chemicals that are seen to pose a potential risk to human health and/or the
environment, enabling recommendations to be made regarding their control and risk
reduction.
An industrial chemical is declared a PEC by notice in the Chemical Gazette. Once

declared, all those who wish to continue import and/or manufacture of the chemical
must apply for assessment of the chemical. In all but exceptional cases, applicants can
continue to import and/or manufacture the chemical while it is a PEC. Relevant
available information on the human health and environmental effects of the chemical
is collected for the assessment, as well as data on human and environmental exposure
and control measures.
Any interested person can nominate a chemical of potential concern for declaration as
a PEC by completing the “Priority existing chemicals nomination form”. Nominated
chemicals are ranked according to published selection criteria. Recommendations are
then made by the Director to the Minister for Health and Ageing for the declaration of
PEC.
For detailed information about Priority Existing Chemical assessments, refer to

Chapter 9 – Priority Existing Chemical Assessments in Section III of this handbook.
The Director may publish notices in the Chemical Gazette under section 48 of the
Act, requiring information to be provided about a chemical that is being considered
for recommendation as a PEC. Persons to whom the notice is directed must respond to
the notice.
Sometimes, after consideration of information gathered on a chemical, a PEC

assessment is not considered necessary or appropriate. Other types of assessments
may be considered for a chemical. More information on existing chemical
assessments other than PEC assessments can be found in Chapter 10, in Section III.
1.5.3 Secondary Notification
The initial assessment under NICNAS of the occupational health and safety, public
health and environmental aspects of a chemical is based on information available at
the time of notification. For some chemicals, changes in circumstances may occur
which necessitate a reassessment of the chemical – that is, a secondary notification
and assessment. The onus is on the importer or manufacturer to inform the Director
when a change in circumstance occurs. The Director may then decide to initiate a
secondary notification by placing a notice in the Chemical Gazette. This may apply to
all manufacturers and importers of the chemical or only to those specified in the
notice. The notice will specify the information to be provided in the notification.
For further information about secondary notifications refer to Chapter 11 – Secondary

Notifications in Section IV of this Handbook.
8
1.5.4 NICNAS Registration
All importers and/or manufacturers of industrial chemicals for commercial purposes

must register with NICNAS regardless of the amount of industrial chemicals imported
and/or manufactured in that registration year. A registration year runs from 1
September to 31 August in the following year. The Registration Tier that applies to
you depends on the value of the industrial chemicals you import and/or manufacture.
The Register of Industrial Chemical Introducers is a maintained list of all registered

importers and/or manufacturers. The register allows NICNAS to keep its industry
clients fully informed of their obligations under the Act and any changes as they take
place.
For further information on NICNAS Registration refer to Chapter 13 of this

Handbook.
1.5.5 Treaties
Rotterdam Convention on the Prior Informed Consent Procedure for Certain

Hazardous Chemicals and Pesticides in International Trade (The Rotterdam
Convention).
The Rotterdam Convention is an international procedure that:

a) helps participating countries learn more about the characteristics of certain
potentially hazardous chemicals and certain severely hazardous pesticide
formulations that may be exported to them;
b) initiates a decision making process on the future import of these chemicals and
formulations by the countries themselves and facilitates the dissemination of
these decisions to other countries; and
c) requires exporting countries to comply with the decisions.
The Convention covers industrial chemicals and pesticides (including in specific

circumstances, severely hazardous pesticide formulations). The Convention does not
involve international bans or restrictions. Decision-making on the future import of a
chemical included in the Convention lies with each Party participating in the
Convention.
The Convention provides that, if a chemical is banned or severely restricted in a

country that exports this chemical, the exporting country must provide information to
the importing country about why the chemical is banned or severely restricted.
Annex III of the Convention lists chemicals that have been banned or severely
restricted on the basis of a risk assessment in the jurisdictions of the parties to the
Convention. To be listed on Annex III, a chemical must be nominated by two
countries from different PIC regions.
For further information on the Rotterdam Convention, refer to Chapter 14 of this

handbook.
9
1.6 Compliance
The Act provides the broad parameters or framework in which the NICNAS
compliance operates. All importers, manufacturers and exporters of industrial
chemicals must comply with the legislation.
Although there are many good business reasons to pursue regulatory compliance,
there is also the prospect that offenders will be identified and subject to significant
penalty. The Act includes extensive penalty provisions, currently as high as $165,000.
NICNAS is committed to developing and maintaining an effective compliance

strategy to ensure the safe use of industrial chemicals in Australia. Its current strategy
is to maintain the public’s trust in chemical safety through compliance actions that
ensure the integrity of the scheme. All industrial chemical manufacturers, importers
and exporters should be aware that NICNAS conducts investigations aimed at
identifying non-compliance with the legislation.
For further information, refer to Chapter 15 of this handbook.
1.7 Publication and Further Notification

Copies of the Act can be accessed through the SCALEplus website of the Australian
Attorney General’s Department at scaleplus.law.gov.au.
Information about industrial chemicals and NICNAS activities is available to the
public through NICNAS assessment reports and the Chemical Gazette (see Appendix
5: Chemical Gazette), as well as at our web site:
www.nicnas.gov.au/publications/gazette
Assessment reports are available on our web site or by contacting NICNAS on Free
Call 1800 638 528. The Chemical Gazette is published on the first Tuesday of every
month. It is available on the NICNAS web site.
Further information about NICNAS operations can be found in our annual report,
which can be obtained directly from NICNAS or from the Publications page on our
web site.
10
Section II– New Chemicals
SECTION II – New Chemicals

2. Do You Need to Notify?
This chapter aims to help you decide whether a substance you are importing or
manufacturing is subject to new chemicals assessment under NICNAS. If it is, you
will need to refer to Chapters 2-8 in Section II and Section IV later in the handbook
for more information about new chemical assessment. If after reading this chapter,
you discover your chemical is not subject to new chemical assessment, no further
action is required in most cases. However, annual reporting requirements exist for all
chemicals introduced under an exemption category and record keeping requirements
and advice prior to introduction is required for certain exempt categories. These
categories (and the procedures to follow in order to supply information) are outlined
at the end of this chapter. Any forms referred to in this chapter are located on our
website at www.nicnas.gov.au.
A list of the forms is located in Appendix 1 – Forms.
2.1 How to Decide

In general, the chemicals subject to new chemical assessment under NICNAS are
those that are not listed on the Australian Inventory of Chemical Substances (AICS)
or those whose importation and/or manufacture is subject to a condition of use. See
information in Chapter 1 on how to check AICS. Since there are certain exemptions,
NICNAS recommends you follow the decision tree below to help you decide if your
substance is subject to new chemical assessment. The following pages contain
descriptions to help you answer the questions below.
Is the substance a chemical under the NICNAS definition?
• YES
• NO*
Is the substance an industrial chemical?
• YES
• NO*
Is the industrial chemical a new industrial chemical?
• YES
• NO*
11
Is the new industrial chemical exempt from notification?
• YES1
• NO: Your chemical is subject to new chemicals assessment. Refer to Chapter
3 for more information about what to do next.
*No further action required

1
Annual reporting obligations may apply, and advice to NICNAS may be required in
some cases.
2.2 Is the Substance a Chemical Under the NICNAS Definition?

THE ANSWER IS NO (and the substance does not require notification) if it fits any
one of the following descriptions:
a. Articles, being items which, due to their use, have been manufactured into a
certain shape or design, and which do not change their chemical composition
during use. For example, steel ball bearings, compounded plastic pipe or
adhesive films would be considered to be articles (see Appendix 2 –
Definitions). For the purposes of NICNAS, articles do not include fluids or
substances that may be manufactured or imported in particulate or aggregate
form, for example, a polymer in granular from which will be further
processed. Further examples of articles are given in Appendix 9 – Description
of an article.
b. Radioactive chemicals – chemicals having a specific activity greater than 35
becquerels/g.
c. Mixtures, being physical combinations of chemicals resulting from deliberate
mixing or from chemical reactions, but not being UVCB substances. Although
a mixture itself is not notifiable, new industrial chemical components in the
mixture are notifiable unless exempt (see below).
THE ANSWER IS YES, (and the substance may require notification) if it falls under
any of the following definitions:
a. Discrete chemical elements, compounds and complexes of particular

molecular identity, either as a pure or technical grade substance, for example:
i. chemical element: lead (CAS no. 7439-92-1);
ii. chemical compound: succinic acid (CAS no. 110-15-6), polyvinyl
chloride (CAS no. 9002-86-2); and
iii. chemical complex: ferric ammonium oxalate (CAS no. 14221-47-7).
Note: the chemical name and the CAS number are the identifying
characteristics of the chemical.
b. Chemical elements, compounds and complexes which exist as components in
a physical mixture of chemicals, either by chemical reaction or deliberate
mixing of the chemicals (the mixture itself is not notifiable). Examples are:
12
i. chemical element in a mixture: oxygen (CAS no. 7782-44-7) in a

mixture of gases;
ii. chemical compound in a mixture: the plasticiser dibutyl phthalate
(CAS no. 84-74-2) in a poly(vinyl chloride) blend; and
iii. chemical complex in a mixture: an aqueous solution of ferric
ammonium oxalate (CAS no. 14221-47-7)
c. chemicals of unknown or variable composition, complex reaction products or
biological other than a whole plant or animal (UVCB substances).
These are poorly defined substances that cannot be represented by a complete
chemical structure and specific molecular formula, for example:
i. unknown or variable composition: chlorinated paraffin sodium
sulfonate (CAS no. 68910-45-2), where the degree of chlorination
varies;
ii. complex product of a chemical reaction: tall oil, reaction products with
diethanolamine (CAS no. 97489-16-2). Where the product of a
chemical reaction is in a mixture with its reactants; and
iii. biological material: geranium oil (CAS no. 8000-46-2)
d. Naturally-occurring chemicals, meaning unprocessed chemicals occurring in
nature, or chemicals occurring in nature which have been extracted from the
parent material through certain defined processes without chemical change
(see Appendix 2 – Definitions), for examples:
i. naturally-occurring biological chemicals;
ii. inorganic chemicals in the soil; and
iii. minerals extracted from ore by a physical process such as dissolution
or flotation.
2.3 Is the Chemical an Industrial Chemical Under NICNAS

Definition?
THE ANSWER IS NO, and the chemical is therefore not subject to notification, if it
is used solely as an agricultural or veterinary chemical, a therapeutic good, a food or
food additive (so-called ‘excluded uses’ as defined in subsection 7(2) of the Act).
THE ANSWER IS YES, and the chemical may be subject to notification, if it has any
industrial use, and whether or not it has both an excluded and an industrial use.
Examples of the most common industrial uses for chemicals assessed by NICNAS to
date include surface coatings, paper, fuel and oil, textile processing, photography and
cosmetics. Cosmetics that have therapeutic claims must be entered on the Australian
Register of Therapeutic Goods. If they do not have another use, they are outside the
NICNAS definition of an industrial chemical.
13
2.4 Is the Industrial Chemical a New Industrial Chemical?

THE ANSWER IS NO (and the industrial chemical does not require notification) if it
falls into any of the following categories:
a. Reaction intermediates, due to their transient existence and confinement to

their chemical reaction systems (see Appendix 2 – Definitions).
b. Incidentally-produced chemicals, produced as an impurity or by-product from
a chemical reaction (see Appendix 2 – Definitions). Incidentally-produced
chemicals must have no commercial value. Information on these chemicals
would be required if the parent chemical was subject to notification.
c. Naturally-occurring chemicals (which are regarded as being on AICS).
d. Polymers (see Appendix 2 – Definitions) that do not fulfil the criteria for a
new synthetic polymer (see (a) under YES answer below for more details).
Examples of such chemicals include:
i. an existing synthetic polymer where only a change in monomer ratios
has occurred, for example, if the ethylene-vinyl acetate ratio in an
ethylene-vinyl acetate copolymer has change from 70-30% to 40-60%;
and
ii. an existing synthetic polymer containing one ore more new
monomer(s) or reactant(s), each at less than 2% weight (see Appendix
2- Definitions).
THE ANSWER IS YES (and the industrial chemical may require notification) if it is
any of the following:
a. not listed in (AICS; or,

b. listed in AICS and its import and/or manufacture is subject to a condition of
use; or,
c. a new synthetic polymer, defined as:
o a synthetic polymer that includes a combination of monomers and
other reactive components, each representing at least 2% by weight,
being a combination not listed in AICS, or
o a synthetic polymer of whose weight at least 2% is attributable to
monomer or other reactive component that is not listed in AICS as a
component of a synthetic polymer.
2.5 Is the New Industrial Chemical Exempt from Notification Under

NICNAS?
Once AICS has been consulted and it is established that the chemical to be imported
or manufactured in Australia is a new industrial chemical, the next step is to
determine whether it falls into a category that is exempt from notification.
14
For most exempt categories no further action is required prior to the introduction of
the new chemical. However, in some cases, information about exempt category
chemicals still needs to be provided to the Director justifying the exemption. The
majority of exemption categories have an annual reporting obligation.
The following table summarises the exemptions available. For a more detailed
description of these exemptions including the exemption criteria see the text below.
Exemption Volume or Other Advice Other

concentration criteria required reporting
restriction prior to requirements
introduction
Research and Not more than 100 No No Annual
Development kg in any 12 month reporting
period
Research and N/A Yes Yes – Form 6 No
Development
(manufactured)
Transhipment N/A Yes No Annual
reporting
Non-Cosmetic Not exceeding 100 Yes No (NCE- Annual
(no unreasonable kg in a period of 12 Form 1) reporting*
risk) months
Cosmetic (<1%) Introduced at 1% or Yes No Annual
less reporting*
Cosmetic Not more than 10 Yes No Annual
(no unreasonable kg in a period of 12 reporting*
risk) months
Cosmetic but Greater than 10kg Yes Yes- Form 15 Annual
(no unreasonable but not exceeding reporting*
risk) 100kg in a period
of 12 months
* The person who introduces the chemical must keep in writing, for 5 years after the introduction,
information available to the person about occupational health and safety, public health and the
environmental effects of the chemical (refer to Chapter 15 for information on annual reporting
requirements).
2.6 Exemption Categories for New Industrial Chemicals

(a) Research and Development
Notification Requirements
The new chemical is imported or manufactured only for research, development or

analytical work in a quantity of not less than 100g and not more than 100kg in any
12 month period.
15
Obligations
1. Introducers of chemicals in this category should submit an annual report and

return it to NICNAS before or on 28 September of the following registration year.
(b) Research and Development (Manufactured)
The new chemical is manufactured in Australia, solely for the purpose of research,
development or analytical work provided it is site-limited and manufacture is in an
apparatus, which cannot operate effectively to produce smaller quantities. There is
no volume restriction on this category.
Obligations
1. Complete Form 6 and return it to NICNAS prior to manufacture of the new

chemical.
(c) Transhipment
Introduced by a person at a port or airport in Australia, remains subject to the

control of customs at the port or airport at all times and leaves Australia less
than 30 days after the day of introduction. There is no volume restriction on
this category.
Obligations

(d) Non-Cosmetic (No Unreasonable Risk)
The new chemical is introduced in quantities not exceeding 100 kg in a period of

12 months, is for non-cosmetic use, and poses no unreasonable risk to occupational
health, public health or the environment (to help you decide this, refer to "What is
an unreasonable risk" Section 2.6). A guidance form for Non-Cosmetic
Exemptions is available on the NICNAS website to assist companies in
determining No Unreasonable Risk.
16
Obligations

2. Introducers of the chemical must keep in writing, for 5 years after the
introduction, all information available to the person about occupational health and
safety, public health matters and the environmental effects of the chemical.
(e) Cosmetics (<1%)
The new chemical is a non-hazardous chemical introduced in a cosmetic product

at a concentration at 1% or less (there is no volume restriction), and meets all of
the following criteria:
i. the chemical is not a hazardous chemical;
ii. the chemical is not a dangerous good;
iii. the criteria relating to the environmental effects of the chemical as
prescribed in regulation 4J have been met;
iv. the introduction of the chemical is consistent with the reasonable
protection of occupational health and safety, public health and the
environment;
v. the chemical is not used in the cosmetic as a preservative, colouring
agent or ultraviolet filter; and
vi. the chemical is not prohibited or restricted for use in cosmetics in the
European Union under Council Directive 76/768/EEC (as amended) or
in the United States of America under the Food Drugs and Cosmetics
Act 1938 (as amended).
Obligations

(f) Cosmetic <10 kg/yr (No Unreasonable Risk)
The new chemical is introduced in quantities not exceeding 10 kg in a period of

12 months, is for cosmetic use, poses no unreasonable risk to occupational
health, public health or the environment (to help you decide this, refer to "What
is an unreasonable risk" Section 2.6) and meets all of the following criteria:
17
i. the chemical is not used in the cosmetic as a preservative, colouring agent

or ultraviolet filter; and
ii. the chemical is not prohibited or restricted for use in cosmetics in the
European Union under Council Directive 76/768/EEC (as amended) or in
the United States of America under the Food Drugs and Cosmetics Act
1938 (as amended); and
iii. if the chemical is an ingredient in a cosmetic at a concentration of 1% or
more, the person who introduces the chemical must have information
which indicates that the chemical will be safe for use by potentially high-
risk groups, consistent with the anticipated pattern of consumer exposure.
Obligations

return it to NICNAS before or on 28 September of the following registration
year.
introduction, all information available to the person about occupational health
and safety, public health matters and the environmental effects of the chemical.
(g) Cosmetic >10 kg/yr but <100 kg/yr (No Unreasonable Risk)
The new chemical is introduced in an amount that is greater than 10 kg but not
exceeding 100kg in a period of 12 months, is for cosmetic use, is not covered by
exemption (e), poses no unreasonable risk to occupational health, public health or
the environment (to help you decide this, refer to "What is an unreasonable risk"
Section 2.6), and meets all of the following criteria:
i. the chemical is not used in the cosmetic as a preservative, colouring agent
or ultraviolet filter; and
ii. the chemical is not prohibited or restricted for use in cosmetics in the
European Union under Council Directive 76/768/EEC (as amended) or in
the United States of America under the Food Drugs and Cosmetics Act
1938 (as amended); and
iii. if the chemical is an ingredient in a cosmetic at a concentration of 1% or
more, the person who introduces the chemical must have information
which indicates that the chemical will be safe for use by potentially high-
risk groups, consistent with the anticipated pattern of consumer exposure.
Obligations
1. Complete Form 15 and return it to NICNAS, together with the material safety
data sheet (MSDS) relevant to the chemical or product containing the chemical,
the label to be attached to the packaging of the chemical or product containing
the chemical and the letter advising the Director that the chemical is to be
18
introduced.
If the New Chemical you wish to import or manufacture does not fall into any of
these exemption categories then you will have to notify NICNAS. Refer to
Chapter 3 of this handbook to decide the appropriate notification category.
2.7 What is Unreasonable Risk?

In assessing the risk of a chemical, consider both the hazards of the chemical, and the
potential exposure of humans and the environment. In assessing whether a risk posed
is unreasonable, consider both the potential risk (i.e., the maximum risk a chemical
may pose), and how that potential risk might be minimised (through specific handling
techniques for instance) as outlined below. If the potential risk is high and/or cannot
be minimised, the risk posed may be considered by NICNAS to be unreasonable. If
this is the case, you will need to apply for an assessment permit or certificate as
outlined in Chapter 3. If you are in doubt, contact the NICNAS Notification and
Assessment Team on 1800 638 528 for further guidance.
In estimating risk, the emphasis should be on the risk due to the chemical being
introduced, rather than due to the hazards of other components in a product.
Occupational Health & Safety risk
In relation to occupational health, the logical first step in assessing if the risk is
unreasonable would be to determine the hazardous nature of the chemical by using the
NOHSC Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(2004)] 3rd Edition. If the chemical is imported as part of a formulated
product, the hazardous nature of the product should be determined.
If the chemical (or product) is not classified as hazardous according to these criteria,
and does not have significant physico-chemical hazards or reactivity, then given the
maximum volume of 100 kg per year of chemical introduced, it is likely that the
potential risk to occupational health and public health would be low.
Where the chemical (or product) is classified as hazardous, the level of exposure to
workers during various processes such as manufacture, formulation, end-use and
disposal should be evaluated.
Public Health risk
Public risk can be assessed similarly to occupational risk (as above). In addition,
chemicals to be used in cosmetics should be assessed critically for their suitability for
deliberate application to the human body. Form 15 lists additional criteria that
cosmetic chemicals must meet, to be eligible for the “no unreasonable risk” low
volume exemption: (see Ch 2.5 above).
19
Environmental risk
The environmental fate of the chemical should be considered for each of the possible
routes for release (e.g., during manufacture, use, disposal of waste) of the chemical
into the environment (air, soil and water). When considering environmental fate, the
parameters to evaluate would include volatility, solubility, mobility and the potential
for biodegradation and bioaccumulation.
In determining whether an unreasonable risk to the environment might exist,

consideration should be given to any known ecotoxicity of the chemical and its
behaviour in air, soil and water.
Minimising risk
In the assessment of risk, potential exposure to a chemical should be considered

(where appropriate) during manufacture and/or importation, formulation, end use and
disposal in relation to the hazards (including toxicity) of the chemical.
Efforts to minimise or eliminate exposure of workplace personnel should be taken

into account in determining if an unreasonable risk exists. The risk may be minimised
by the use of engineering controls or by the wearing of personal protective equipment
such as gloves and safety spectacles.
Similarly, environmental risk is reduced in the first instance through measures to

prevent release of the chemical to the environment (e.g., manufacture of the chemical
in a closed system). Where environmental release occurs, the environmental risk may
be minimised through treatment or conversion of the chemical to a less harmful form,
for example, on site treatment of production effluent prior to discharge into the sewer.
How to assess the risks - an example
The following example shows how to assess the risks posed by a chemical. Although
it relates to a chemical used in cosmetics (fitting description (d) and (h) in section
2.5), it provides guidance useful for consideration of risks posed by a non-cosmetic
(fitting description (g) in section 2.5).
A new chemical is to be imported for use as a component of a skin moisturiser and

comprises one per cent of the finished product. The chemical is a liquid under
ambient conditions and is not determined to be a hazardous substance according to the
NOHSC Approved Criteria for Classifying Hazardous Substances
rd
[NOHSC:1008(2004)] 3 Edition.
Occupational Health considerations
The chemical is transported in 500 mL bottles packed in impact-resistant containers.

It is dispensed directly from the bottle through an open-pour method during
manufacture of the cosmetic product. In this case, the potential for worker exposure
through scenarios such as spillage or splashing should be evaluated for all facets of
the production process - from handling of the concentrate to packaging of the final
product.
20
In this case, the chemical is not a hazardous substance and is present at a relatively
low concentration in the final product Therefore the chemical would not be
considered of high occupational health risk after formulation, even if some exposure
should occur. In general, the risks posed by the final product need to be determined
on a case-by-case basis.
In cases where finished products only are imported, occupational health

considerations are usually minimal, perhaps restricted to warehousing arrangements.
The occupational health assessment needs to extend to the end use of a cosmetic
product if it is used in workplaces such as hairdressing salons and beauty parlours.
Public Health considerations
The potential for public exposure to the cosmetic product would be high. Risk is
related in this case to the hazardous nature of the chemical, its concentration in the
finished product and its behaviour, for example, mobility, on the surface of the skin.
In this case, the chemical is not a hazardous substance and the concentration in the
moisturiser is relatively low (1%). For most individuals, the risk even of repeated use
would be low.
Environmental considerations
In this example, possible routes for release include accidental spillage of the chemical
or finished product during transport and loss during manufacture, including disposal
of waste product. As only a small volume of chemical is involved, risk to the
environment may be very low. The ecotoxicity and physico-chemical properties of the
chemical, however, would need to be assessed in relation to possible release volumes
to determine whether the impact of any local release was unacceptable.
Most of the chemical in consumer products is released to the environment through the
normal use of the product. The chemical is highly diluted when it enters the aquatic
environment through washing or showering and the pattern of release is highly
dispersed. Environmental concern is therefore extremely low in view of the amount of
chemical involved (less than 100 kg per year).
Chemicals unsuitable for exemption
Chemicals cannot be considered for exemption if:
• they are likely to be persistent or bioaccumulative, or have breakdown

products with these characteristics; or
• they are classified as carcinogenic, mutagenic or toxic to reproduction under
the NOHSC Approved Criteria for Classifying Hazardous Substances
[NOHSC:1008(2004)] 3rd Edition
The following groups of chemicals might not be suitable for exemption. If proposed
for exemption, a strong case that they do not pose an unreasonable risk in use should
be made:
21
• Chemicals containing other than the following elements:

o hydrogen, lithium, boron, carbon, nitrogen, oxygen, sodium,
magnesium, aluminium, silicon, phosphorus, sulfur, potassium,
calcium, titanium, iron, copper, zinc, gallium, germanium, selenium,
rubidium, strontium, zirconium, tin, caesium.
o chlorine, bromine and iodine, only as anions.
• Chemicals containing the following high concern reactive functional groups:
o pendant acrylates and methacrylates,aziridines, carbodiimides,
halosilanes, hydrosilanes, hydrazines, isocyanates, isothiocyanates,
alpha or beta lactones,vinyl sulfones or analogous compounds,
partially-hydrolysed acrylamides, acid halides, acid anhydrides,
aldehydes, epoxides, amines, or other reactive functional groups
identified as of high concern
o alkoxysilanes with C1 or C2 alkoxy groups
• Chemicals having or expected to have high acute or chronic ecotoxicity to any
aquatic species. This would include cationic chemicals/polymers and those
having LC50 values of less than 1 mg/L (acute) or 0.01 mg/L (chronic). For
uses where concentrated discharge is possible, more stringent ecotoxicity
limits would apply.
• Chemicals having low biodegradability.
• Chemicals suspected of having carcinogenic, mutagenic or reprotoxic effects.
An example where exemption might be justified for the groups of chemicals listed
above is if the volume is very low (substantially less than 100 kg/yr).
Data requirements
Introducers assessing whether “no unreasonable risk” applies will need data on the
hazards of the chemical, or likely hazard based on structure. While no specific
requirements are set out for hazard data, it is expected that the determination of
hazard will be on an informed basis. In most cases, this information will be available
from suppliers.
22
3. Which Notification Category?

Having established that you wish to import or manufacture a new industrial chemical
that needs to be notified (including import of a mixture containing the chemical),
reading this chapter will help you determine the most appropriate notification
category. It also outlines other kinds of applications allowing you to:
• obtain permission to introduce a chemical already notified even though the

assessment is not complete (see Permits in this chapter);
• renew an existing low volume chemical permit or commercial evaluation
permit (see Renewal of Permits in this chapter)
• have your company name added to an assessment certificate issued to another
company importing or manufacturing the same chemical (see Extension of an
Original Assessment Certificate in this chapter).
• obtain a fee reduction by providing an acceptable written draft assessment
report with your application (see Provision of a Draft Assessment Report in
this chapter)
• submit a self assessment for certain categories of chemicals.
For further information about proceeding with any application described in this
chapter, refer to Chapter 4 - General Notification Procedures, as well as the relevant
sections in Chapters 5 - Certificate Categories and Chapter 6 - Permit Categories.
3.1 Determining the Appropriate Notification Category

There are a number of categories relating to notification for a new chemical
assessment, with each category depending on the type of chemical, the amount being
introduced and the period of use required.
Commercial Evaluation Chemical (CEC), Low Volume Chemical (LVC) and

Controlled Use (Export Only) Permit (EOP), notifications are for chemicals
manufactured or imported for a specific period of time and result in the issue of a
permit. An application to renew an existing commercial evaluation, low volume
chemical permit or controlled use (export only) permit can be made in certain
circumstances. (See chapter 6.7 for details)
Polymers of Low Concern (PLC), Limited and Standard Notifications and Self
Assessments are for chemicals manufactured or imported for a longer period of time
and result in the issue of a certificate. There are different fees for each category.
In making your decision about which notification category is appropriate for you, read
the descriptions below. You may also wish to consult the table in section 3.4, which
summarises the categories including the time taken for the assessment and the
duration of the certificate or permit issued. Note that chemicals which are polymers
and do not meet the criteria for a PLC may be assessed in either the Limited or
Standard categories.
23
There are further kinds of applications that may be made subsequent (or in addition)
to applications for PLC, Limited or Standard notifications. These applications are
detailed under Other types of application later in this chapter.
Commercial Evaluation Chemical (CEC) notifications are for limited volume

chemicals to be introduced solely for the purpose of market evaluation where the
maximum quantity to be introduced is four tonnes in a maximum period of two years.
Examples of possible uses are:
• to test a new polymer in a surface coating when a large quantity is required to

fill paint lines; or
• to evaluate a new process which requires a new industrial chemical.
Low Volume Chemical (LVC) notifications are for small volume chemicals to be
introduced at a rate of up to 100 kg per year for a maximum of three years.
Controlled Use (Export Only) Permit (EOP) notifications are for introduction of a
new chemical for export purposes or for its use in formulation of products in Australia
for export of the entire quantity for a maximum of three years.
Polymers of Low Concern (PLC) notifications are for polymers for which the
following applies (refer to Appendix 10 - Polymers of Low Concern Guidance for
more detail):
a. Number-average molecular weight

Except for certain polyesters (see below), a PLC must have a number-average
molecular weight (NAMW) greater than 1000.
For polymers with NAMW between 1000 and 10000, the allowable low
molecular weight species (MW below 1000 and 500) for these polymers is
25% and 10% respectively provided that the polymer has a limited content of
reactive functional groups.
For polymers with NAMW greater than 10000, the allowable low molecular
weight species (MW below 1000 and 500) for these polymers remains at 5%
and 2% respectively. There is no restriction on the number of reactive
functional groups in the polymer.
b. Low charge density
A polymer has a low charge density if it is not a cationic polymer or is not
reasonably anticipated to become a cationic polymer in a natural aquatic
environment (4 < pH < 9). Certain solid materials and polymers with a low
content of cationic groups are allowable as PLCs.
c. Hazard Classification
A PLC must not be classified as a hazardous chemical.
d. Stability
A polymer is stable under the conditions in which it is used if it does not
readily break down by hydrolysis, thermal degradation, photodegradation,
depolymerisation or any other means.
24
e. Chemical composition
A PLC must contain as an integral part of its composition at least two of the
atomic elements carbon, hydrogen, nitrogen, oxygen, silicon and sulfur. There
are restrictions on the content of other elements.
f. Water absorbing polymers
A water absorbing polymer with NAMW 10000 and greater cannot be a PLC.
g. Polyesters
A polyester manufactured solely from one or more allowable reactants may be
a PLC, provided that the polymer meets the other criteria.
It should be noted that each batch of a particular new polymer must meet the criteria
to be eligible for notification and assessment as a PLC.
A polymer of low concern can be either a synthetic polymer or biopolymer. In

addition, the residual monomer content will no longer impact the classification of the
polymer as a low concern polymer. However, information regarding the residual
monomer content will still need to be provided.
Limited Notifications are for chemicals that fit into the following categories:
a. small volume chemicals, biopolymers and low molecular weight synthetic
polymers (NAMW < 1000), i.e. those which are to be imported or
manufactured at a rate of up to one tonne per 12 month period (but which do
not qualify for a commercial evaluation or low volume chemical permit); or
b. site-limited chemicals, biopolymers and low molecular weight synthetic
polymers (NAMW < 1000), i.e. those restricted to their manufacturing site and
manufactured at a rate of not more than 10 tonnes per 12 month period; or
c. research, development or analytical chemicals, which are manufactured or
imported in a quantity of more than 100 kg but not more than one tonne per 12
month period.
d. synthetic polymers with NAMW greater than 1000 and which do not meet the
PLC criteria.
Standard Notifications are for chemicals, biopolymers and low molecular weight
synthetic polymers imported or manufactured at greater than one tonne per year and
which do not fulfil the requirements of any other category.
Self Assessment
Following the introduction of the Industrial Chemicals (Notification and Assessment)

Amendment (Low Regulatory Concern Chemicals) Act 2004 and supporting
Regulations it is possible to submit a self assessment application for the following
categories of chemicals:
1. Polymer of Low Concern (PLC) (See Section 5.3.1 for further information)
2. Non-hazardous chemicals and non-hazardous polymers other than PLC (See

Section 5.6.3 for further information).
25
Extension of an Original Assessment Certificate
The Act allows for an extension of a current assessment certificate to cover other
companies intending to import or manufacture a notified chemical. If one or more
companies wish to import or manufacture a notified chemical, their name(s) may be
added to the assessment certificate provided that the holder of the original certificate
is in agreement and that a certain number of other criteria are met. Refer to Chapter 5
- Certificates for further information.
3.2 Rebate assessments

Electronic lodgement
A rebate of up to 15% of the assessment fee for Standard Notifications, Limited

Notifications and Polymer of Low Concern Notifications is available to applicants
who submit an acceptable written draft assessment report with their notification
statements. In practice, this is now the electronic lodgement of a notification, for
limited and standard notifications only. Applicants for the rebate must pay the full
notification fee when lodging their notification. The rebate will be returned by
NICNAS if the draft report meets criteria outlined under Provision of a Draft
Assessment Report in Chapter 5. (See Chapter 8 -Rebates for more information)
Assessment report from a national authority
A rebate of up to 40 per cent of the assessment fee for Standard or Limited

Notifications may be available to applicants who submit an assessment report
prepared under a foreign notification and assessment scheme. See Chapter 8 - Rebates
for further information.
3.3 Outcomes of Each Category

Categories 1, 2 and 3 (CEC, LVC and EOP) result in the issue of a permit allowing
the introduction of fixed quantities of the chemical for the duration of the permit.
They also result in the publication of a notice of the permit in the Chemical Gazette.
Categories 4, 5 and 6 (PLC, Limited and Standard) result in an assessment report,

the issue of an assessment certificate, publication of a summary report in the
Chemical Gazette and the addition of the assessed chemical to the AICS.
3.4 Permits
Permits allowing introduction before assessment is complete
Under certain circumstances, a chemical may be eligible for a special permit allowing
it to be introduced into Australia before its assessment is complete. There are two
kinds of early introduction permits (EIP).
26
Section 30A (EIP) Permits are for non-hazardous new industrial chemicals, while
Section 30 Permits are for new chemicals where it can be shown that their immediate
introduction is in the public interest.
30A (EIP) Permits Criteria
To be eligible for an EIP, applicants need to satisfy the Director that:
• the chemical is not a hazardous substance according to the NOHSC Approved

Criteria for Classifying Hazardous Substances;
• the chemical is not a dangerous good according to the Australian Code for the
Transport of Dangerous Goods by Road and Rail;
• the prescribed criteria relating to the environmental effects of the chemical
(see below) are met; and
• the introduction of the chemical is consistent with the reasonable protection of
occupational health, public health and the environment.
In general, a polymer that qualifies for notification and assessment as a PLC under the
current PLC criteria would satisfy the criteria for an EIP application.
Certain environmental criteria must be met when applications for a Standard or a

Limited assessment, including polymers other than PLCs have been made.
Standard Notifications:
• the chemical has a water solubility greater than 1 mg/L, or

o it dissolves in water without dissociation or association and has an n-
octanol/water partition coefficient (as log Pow) that does not exceed 3,
or
o the molecular weight (or number-average molecular weight for a
polymer) exceeds 1,000;
• the chemical is readily biodegradable; and
• the chemical has a very low aquatic toxicity to fish, aquatic invertebrates and
algae, that is, LC50 or EC50 100 mg/L or greater.
Limited Notifications:
• the chemical has a water solubility greater than 1 mg/L, or

o it dissolves in water without dissociation or association and has an n-
octanol/water partition coefficient (as log Pow) that does not exceed 3,
or
o the molecular weight (or number-average molecular weight for a
polymer) exceeds 1,000.
Section 30 Permit Criteria
27
Chemicals which do not meet the criteria for a Section 30A Permit, may be eligible
for a Section 30 Permit if the Minister is satisfied that:
• the chemical is of special benefit to the public in some way, for example, the
import of a chemical may be critical during an environmental emergency;
• it is in the public interest that the chemical be introduced immediately; and
• introduction of the chemical is consistent with the protection of occupational
health, public health and the environment.
Renewal of an existing LVC and CEC permit
Existing LVC and CEC permits can be renewed provided certain criteria are met.
Although an LVC permit can be renewed any number of times a CEC permit may be
renewed only once. Refer to Chapter 6 – Permits for further information.
28
3.5. Summary of New Chemicals Notification Categories
Categories Other kinds of Applications

Exemption CEC - LVC - EOP - PLC - Ltd - Refer Std - Refer Renewal Provision of Self Section Extension of
low volume Refer to Refer to Refer to Refer to to Chapter 5 to Chapter LVC & Electronic Assessment – 30/30A an Original
(<100kg) - Chapter Chapter Chapter 6 Chapter 5 5 CEC Template/ Draft Refer to Permits - Asst
Refer to 6 6 permits – Asst Report or Chapter 5 Refer to Certificate -
Chapter 2.5 Refer to Asst Report under Chapter 6 Refer to
Chapter 6 Foreign Scheme- Chapter 5
Refer to Chapter 5
Letter of Permit Permit Permit Certificate Certificate Certificate Permit Certificate Certificate Permit Certificate
Outcome consent
Chemical <100 kg/yr <4 <100 Unlimited Unlimited <1 tonne/yr1 >1 tonne/yr As for As for Ltd or Std As for PLC, As for PLC, As for PLC,
Amount tonnes kg/yr previous Ltd or Std Ltd or Std Ltd or Std
Introduced <10 LVC or
tonne/yr1 for CEC
site limited
chemicals
Duration of Not applicable Up to 2 36 36 months 5 years 5 years 5 years 36 months 5 years 5 years Until 5 years from
Certificate or years months (LVC) and certificate granting of
Permit up to 2 yrs issued, or original
(CEC) permit certificate
rescinded
Assessment Not applicable 14 days2 20 days3 20 days 90 days 90 days 90 days 20 days 90 days 28 days 28 days 45 days
Timeframe (LVC) and
14 days2
(CEC)
For details of current fees see Appendix 4
1 Volume restriction does not apply to synthetic polymers with NAMW > 1000.
2 While there is no legislative time frame for CEC applications, they are usually processed within 14 days.
3 While there is no legislative time frame for EOP applications, they are usually processed within 20 days.
29
4. General Notification Procedures

This chapter outlines the general form and content of applications for new chemical
assessments. For additional information about specific application categories and
other kinds of application, refer to Chapters 5 & 6. Any forms referred to are available
in Appendix 1.
4.1 General Information
4.1.1 Identification of Notifier
The following information must be provided with each notification statement, using
the standard form provided for this information:
Business name, Australian Business Number (ABN) and address:

Business phone number:
Address for correspondence:
Technical contact (name and title):
(phone number):
(fax number):
(e-mail address):
Date of submission:
For the technical contact, identify a person who can provide the Director with
additional information if required. The title or position of the contact, for example,
Development Manager or Chief Chemist, should be given.
The notifier must also indicate the class of notification or application, that is:
• type of notification, for example, New Chemical, Secondary Notification;

• for new chemicals, a Standard Notification, Limited Notification or Polymer
of Low Concern Notification;
• whether it is based on an assessment made under a foreign scheme;
• whether the application is for an extension of an assessment certificate; and
• for new chemicals, whether the application is for a permit or renewal of an
existing permit , for example, for commercial evaluation, early introduction or
low volume use.
4.1.2 Statement and Certification
Each notification must be accompanied by a statement that:
• there is full entitlement to the use of data which has not been produced in
laboratories owned or otherwise affiliated with the notifier; and
• all information notified is true and correct.
30
These declarations are included on the standard forms for each type of application and
notification.
Notifiers must also indicate whether:
• the test data have been generated in accordance with the OECD's Guidelines
for the Testing of Chemicals or other standard test methods recognised by the
Director; and
• the laboratory used to generate the test data operated under standards
equivalent to those in the OECD's Principles of Good Laboratory Practice.
4.1.3 Submission of Information
All applications and information relating to notifications should be sent to the:
Director of Chemicals Notification and Assessment

National Industrial Chemicals Notification and Assessment Scheme
GPO Box 58
SYDNEY NSW 2001
4.1.4 Joint Application
If two or more importers or manufacturers wish to apply for an assessment certificate

or a permit, a joint application may be submitted (with only a single fee).
4.1.5 Withdrawal of Notification
A notifier may withdraw an application for an assessment certificate at any time

before the assessment report of the chemical is published. The notifier can regain all
documents submitted in the notification, including the application for an assessment
certificate, by writing to the Director and asking for their return. The notifier may also
be eligible for a refund of part of the application fee.
Similarly, a notifier may withdraw an application for a permit.
4.2 Form and Content of Notifications

All applications, notification statements and other documents must be clearly legible
and submitted in English. Any translation into English must be accompanied by a
signed statement certifying that the translation has been carried out by a competent
person or organisation. MSDS must be clearly legible and suitable for publication.
Each notification category has a specific standard form and checklist. These can be
found in Appendix 1, along with application forms for any exempt information.
Additional forms are available from NICNAS or can be downloaded from our Internet
site www.nicnas.gov.au/forms/
The specific application forms and notification checklists should be used as far as
possible in the submission of data and information required in the notification
31
package. However, most notifications will not be restricted to the completion of these
forms and other information will be required, for example, toxicity studies, MSDS
and occupational exposure data. The requirements for each notification category are
detailed in Chapter 5 - Notification procedures for each category. Notifiers must
provide all the information available to them to enable a thorough assessment of the
chemical, and they must declare that they are entitled to use and to give the Director
all the data in the notification.
Notifiers may seek the professional assistance of consultants in the preparation of

submissions. Refer to industry associations or professional associations for guidance
in this matter.
Notification packages should be submitted in loose-leaf form rather than be bound.
If known by the notifier, the expected date of commencement of manufacture or

importation should be provided in the notification statement.
4.2.1 Number of Copies
For Standard Notifications, Limited Notifications and PLC Notifications, two copies
of the complete notification statement, including the technical dossier and other items
of information, are required.
For permits, only one copy of all the information required is sufficient, as information
submitted for permit applications is not usually sent to other agencies for
environmental assessment.
Please refer to NICNAS Matters June 2005 for further details regarding electronic
lodgement.
4.3 Data Requirements

For most notification categories, the data requirements are described in terms of the
Schedule to the Act. For Standard and Limited Notifications, there are different data
requirements depending on whether the chemical is a polymer or a non-polymer. For
CECs and LVCs, the data requirements are the same for polymers as for non-
polymers (see Table 4.3).
Schedule requirements are divided into Parts A, B, C and D.
Part A
• a statement of which parts of the Schedule are being addressed in the

notification;
• a summary of the chemical's occupational health, public health and
environmental effects;
• a summary of how the chemical meets the definition of a hazardous substance
in accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances; and
32
• a bibliography of all references used in the notification package.
Part B
• identification, composition and properties of the chemical;

• use and manufacture/import volume;
• exposure data (occupational health, public health and environmental);
• label and MSDS; and
• emergency procedures.
Part C
• results of experimental animal and in vitro toxicological and ecotoxicological

studies; and
• biodegradability and bioaccumulation data.
Part D
Specific for polymers and includes:
• molecular weight data;

• residual monomer and impurity data; and
• stability data.
Table 4.3 - Data to be submitted with applications for each notification category
Refer to Appendix 12 - Schedule of data requirements for description of individual

paragraphs.
Category Data to be Submitted

Non-Polymers Polymers
PLC N/A As per Form 1-PLC
SAPLC N/A As per Form 1 - PLC Self Assessment
CEC A* (Para 2), B* (Paras 6a, 7 ,8, 11, 12)

LVC A* (Para 2), B (Paras 1, 3, 6 ,7 ,8, 11, 12)
EOP As per Form EOP-1
LTD AB ABD
STD ABC ABCD
SANHC As per Form 1-Self-assessment Non PLC
SANHP As per Form 1-Self-assessment Non PLC
33
Key:
A. Part A of the Schedule

B. Part B of the Schedule
C. Part C of the Schedule
D. Part D of the Schedule
Polymers include both synthetic polymers and biopolymers.
The scheduled items in Table 4.3 above represent a minimum set of data
requirements. If additional data is available to the notifier, it should be provided to
NICNAS as part of the notification package. Refer to Request for Further Information
by Director later in this Chapter, for more information.
4.3.1 Submission of Test Results
The technical dossier submitted must include the full reports of all chemical testing.
The test methods should be described in sufficient detail to enable the assessor to
determine the acceptability of the method. Indicate whether a standard guideline, for
example, the OECD Guidelines for the Testing of Chemicals, was used. OECD
publications are available from:
D A Books (Australia) Pty Ltd

648 Whitehorse Road
MITCHAM VIC 3132
Tel: (03) 9873 4411
(1800) 338 863 toll free
Other techniques may be acceptable if they constitute a valid method for determining
the required information. This will be determined on a case-by-case basis.
The test method used, and the testing organisation, must be indicated for each data
item in the notification statement. For testing carried out in Australia, notifiers must
indicate whether the testing has been carried out in accordance with National
Association of Testing Authorities' (NATA) standards.
It is preferred that data submitted in support of an application should have been

obtained in accordance with currently accepted principles of good laboratory practice,
for example, the OECD Principles of Good Laboratory Practice. Tests conducted
prior to 1981 may not have been carried out in accordance with good laboratory
practice, but recently obtained tests will be expected to conform.
There are specific responsibilities regarding the observance of good laboratory

practice on both the manufacturers and importers who require tests to be carried out;
and on the managers of the laboratories where the tests are carried out. Therefore,
manufacturers and importers who arrange for tests to be carried out in a laboratory not
under their control must ensure that the manager of that laboratory is informed of his
or her obligations with respect to good laboratory practice before the testing begins.
34
A quality assurance report should also be provided with each study.
4.3.2 Variation of Data Requirements
NICNAS provides for some flexibility in the provision of data items in the
notification statement accompanying applications for an assessment certificate. Data
exemptions can be gained by written application and subsequent approval from the
Director. For example, provision of a data item may be scientifically inappropriate,
not technically possible or not economically feasible. Sufficient information must be
available to enable the Director to make an adequate assessment of the chemical.
A fee must accompany any application to omit or substitute the data items required by
the Schedule. Applications for variation must be made on Form 2 in Appendix 1,
which should be part of the notification package when applying for an assessment
certificate. For further guidance, see under the appropriate notification category in this
chapter.
When considering an application for variation of data requirements, the Director may
allow the omission of certain data items if he or she is satisfied that:
• the introduction of the chemical is not against the public interest;

• the omissions are justified; and
• an adequate assessment of the occupational health, public health and
environmental hazards of the chemical can be made without the data items.
In some cases, the Director may allow or recommend the substitution of certain data
items with alternatives.
Where the notifier considers that it would not be technically possible to carry out a
specified test, or to obtain results for the test, an application for a waiver for the test or
relevant data item may be submitted. For example, if the chemical is a gas at room
temperature, a feeding study cannot be carried out. Justification for the omission must
be included under the appropriate item heading in the notification statement.
The notifier may consider that a specified test or data item is irrelevant, unnecessary
or scientifically inappropriate in the evaluation of the potential occupational health,
public health and environmental hazards of the chemical. For example, an eye
irritation test may be unnecessary for chemicals with a pH above 11.5 or below 2 as
irritant effects may be assumed. For another example, if data shows that the chemical
is a skin sensitiser in humans, then a skin sensitisation test in animals is not required.
However, if the test has been done and is available, it should be submitted. Any
omission on such grounds must be justified, and included under the appropriate item
heading.
The notifier may consider that the generation of a particular data item required by the
Schedule is not economically feasible, and that the data item is not essential for
adequate occupational health, public health and environmental assessment of the
chemical. Such omissions on economic grounds must be fully justified by the notifier,
who must satisfy the Director that:
35
• the cost of generating the data may prohibit the introduction of the chemical;
and
• the omission will not affect the preparation of an adequate assessment.
Information to be supplied in this case must include the cost of generating each data
item that has been omitted and the cost benefit details associated with the introduction
of the chemical. For example, income from expected sales, raw material costs and
production costs should be provided. Claims for omitting data items that are based
solely on the administrative costs associated with preparing a submission will not be
considered.
Each notification that has taken advantage of the flexibility provisions of NICNAS by
omitting certain data items specified in the Schedule must include a statement which
supports the notifier's claim that sufficient data is being submitted to enable an
adequate assessment of the occupational health, public health and environmental
hazards of the chemical.
The only circumstances where the fee may be waived are when it is physically
impossible to conduct a particular test or study and surrogate data are not available or
cannot be generated. In these cases, an omission will be considered on a case-by-case
basis.
4.4 New Chemicals Listed on a Recognised Overseas Inventory

Some countries have listings or inventories of chemicals which have been introduced
in that country. The listing indicates that the chemical may have been in use at some
time in that country, and consequently there may be certain items of information
available about the chemical due to that use. The listing does not necessarily mean
that the chemical has been assessed in that country.
Unfortunately at present the provisions of information available to the notifier through

the chemical's listing on a recognised overseas inventory won’t be adequate for
granting an assessment certificate, as the foreign schemes do not contain sufficient
information to cover the schedule data requirements for NICNAS.
4.5 Exempt Information

A manufacturer or importer may consider that certain items of information required in
a notification may be harmful commercially if disclosed. For all notification
categories, including submissions of additional information, notifiers can claim
certain items of information to be exempt information. This means that these items
would not be published in the publicly available versions of the assessment report of
the chemical.
Notifiers should clearly indicate those pieces of information in the notification

statement and other documents that they wish to claim as exempt information, and
give reasons to substantiate each claim. Form 3 should be submitted with these
claims. Further guidelines on confidentiality are detailed in Appendix 6 -
Confidentiality.
36
Exemption cannot be granted for certain items of information described in the Act as
'basic information' [subsection 75(1) of the Act]. Publication of these items is deemed
to be in the public interest. Information considered to be basic information is listed in
Appendix 2 - Definitions.
In applications for exempt information, the Director weighs the public interest in
publishing the information against the potential commercial harm to the notifier.
4.5.1 Submission of Information by Persons Other Than the Applicant
There are instances where information may be submitted by persons other than the
applicant. For instance, an overseas manufacturer of a chemical may not release
confidential information to the importer (who requires it for the preparation of a
notification or application). Alternatively, an Australian company (or subsidiary
company) may not release confidential information to the import agent. In these
instances, the company holding the information may supply it directly to NICNAS on
behalf of the applicant. NICNAS will endeavour to hold the information in
confidence. However, the onus is on the third party to clearly specify in their
submission which information is not to be disclosed to the other party.
Such information must be forwarded to the Director with a covering letter clearly
cross-referencing the data. The letter should state that the information is being
supplied by party A:
• on behalf of the applicant (party B);

• in relation to party B's application for (assessment certificate or type of
permit);
• citing NICNAS reference number (for example, CEC... or STD/...); and
• for chemical (name used by the notifier).
Submitted data should be numbered according to the appropriate notification

checklist. Party A should clearly indicate which information is not to be disclosed to
the applicant (party B).
Each page should be clearly identified as having been submitted by the third party
(party A) in confidence so that an assessor can easily and unequivocally identify its
status during assessment.
Information submitted by this means would need to be eligible for exemption (see
Appendix 6 - Confidentiality). The party(ies) may seek clarification on this matter
when or before the data is submitted. The information will not be included in the
publicly available versions of the assessment report or other documentation sent to the
applicant.
4.6 Screening of Assessments; Submit Once - Review Once

Amendments to the Regulations in 1997 provide for a Submit Once - Review Once
System of Pre-screening (known as SORO) for Standard Notifications and Limited
37
Notifications [Regulation 14]. This helps to prevent the assessment system being
slowed up by notifications of poor quality, as assessments are not started until
sufficient information is provided.
Under this system, the notification fee for Standard Notifications and Limited
Notifications is paid in two parts.
• an initial lodgement fee of $500, which must be paid when the notification is
first submitted; and
• the remainder of the notification fee, which is payable within seven days after
the Director advises that the notification package is complete.
A complete submission is one that meets the Schedule of Data Requirements

contained in the Act, detailed in Appendix 12. Also, the notification must be in the
approved format, contain all the relevant data (or variations) and meet the required
standards in terms of level of detail.
If the submission is not complete, the applicant will be advised of the outstanding data
items required for the assessment, and also that the assessment has not commenced. If
the submission is grossly deficient, it will be returned to the notifier with an
explanation of the deficiencies. In any event, the assessment will not commence until
the notification is considered complete.
The Submit Once - Review Once system does not prevent the Director from
requesting additional information at a later time. However, SORO aims to increase
efficiency by limiting the need to request additional information during the
assessment process.
4.7 Method of payment of assessment fees

Payment Options
1. CHEQUE PAYMENTS
Cheques are to be made payable to National Industrial Chemicals Notification and

Assessment Scheme (NICNAS) in $AUD. Payments marked Attn New Chemicals
Admin are to be mailed to:
NICNAS
GPO Box 58
SYDNEY NSW 2001
AUSTRALIA
2. ELECTRONIC FUNDS TRANSFER
Electronic Funds Transfers can only be made if you have an invoice number and or a
notification number. Please contact New Chemicals Admin on 02 8577 8800 if you
require an invoice number.
38
If payment is being made from a foreign bank, all bank charges/fees in getting the
exact $AUD to NICNAS is payable by the payee.
The details for EFT payments have recently changed and are as follows:
Reserve Bank of Australia BSB Number: 092-009
London Circuit Account Number: 11608-5
Canberra ACT 2600 Account Name: Dept of Health and Ageing Official
Departmental NICNAS Special Account
Please quote your Invoice Number and/or Notification number when making the
payment.
Please Fax Remittance Confirmation from your bank to NICNAS on: 02 8577 8888
3. CREDIT CARD PAYMENTS
Invoice or Notification number:
MasterCard Visa
Expiry Date: Amount:

__ __ / __ __ / __ __ $
Credit Card number:
Authorised Signature: Print Name:
• For further information, please contact NICNAS on:

• Free call: 1800 638 528
• Phone: (02) 8577 8800
• Fax: (02) 8577 8888
• Email: info@nicnas.gov.au
• or visit our website at www.nicnas.gov.au
4.8 Request for Further Information by Director

In certain cases, it may become apparent that the notification statement does not
contain all the information required by the Schedule. There may also be a need to
39
obtain clarification about certain pieces of information submitted in the initial

notification. For example, ambiguities or inconsistencies in data may need to be
resolved, or interpretation of unqualified test data may need to be carried out. In these
cases, the Director can ask the notifier to provide more information.
Secondly, the Director might consider that certain information additional to that
required under the Schedule is necessary for the proper assessment of the chemical. In
these cases, the Director will ask the notifier to provide specific additional test data or
information. For example, where long-term exposure to the chemical is likely and
short-term or screening toxicity tests indicate possible longer- term effects, chronic
toxicity test results may be requested. Another example is the case of CFC
replacements, where ozone depleting potential and global warming potential data are
normally required.
Also, for chemicals which may be persistent in the environment or bioaccumulate,

additional information may be requested. This is to satisfy the requirements of the
Stockholm Convention on Persistent Organic Pollutants (POPS), which Australia
ratified and came into force on 18th August 2004 (refer to January 2004 Chemical
Gazette).
The written request by the Director for further information will specify a time period
of not less than 28 days for compliance. In cases where further information is to be
submitted, the timeframe to complete the assessment begins from the receipt of the
complete notification statement.
In order to minimise delays and requests for further information by the Director, it is
in the best interest of notifiers to ensure that a complete notification statement is
submitted and that the statement is unambiguous. Checklists are provided for each
notification category in this handbook to assist notifiers in this matter.
Provision of New Information During Assessment
During the assessment process, the notifier might become aware of new information
relevant to the assessment of the chemical. Such information could include:
• references to the chemical in the scientific literature;

• results of further testing carried out in Australia or in a foreign country;
• new information on occupational, public or environmental exposure;
• new uses of the chemical;
• information available from within the company or from the parent company or
supplier;
• information presented at conferences; and
• information from patent specifications.
Any new assessment information, in the form of a separate technical dossier, must be
submitted to the Director as soon as practicable. The dossier should make reference to
40
the relevant parts of the Schedule and conform to the general requirements for
notification statements as far as possible.
The requirement to provide new information puts the onus on notifiers to regularly
monitor the scientific literature and other known information sources with respect to
the notified chemical.
The provision of new information as described in this subsection is dependent on the

notifiers skills, experience and resources, and any other factors which might affect the
notifiers awareness of new information. For example, the notifier's links with parent
or associated companies, years in the business and information systems may be taken
into account in deciding whether a notifier should have known about the new
information.
Failure to provide additional new information on a chemical during its assessment can
lead to the suspension of the assessment process until the information is received.
41
5. Certificate Categories
This chapter provides specific information aimed at helping you to compile the
necessary forms and additional documents for each of the certificate assessment
categories namely: (PLC, Limited or Standard) and other types of applications
(Extension of an Original Certificate and Provision of a Draft Assessment Report)
outlined in Chapter 3. Joint applications may be submitted with the fee shared
between the applicants.
Any forms and checklists referred to are in Appendix 1.
5.1 Confidentiality
Exemption provisions apply to the following certificate notifications, Polymers of
Low Concern (PLC) notifications, Limited Notifications, Standard Notifications and
Extension of an Original Assessment Certificate.
The notifier can claim for certain items of information to be exempt from publication.
If justified, these items would not be published in the publicly available versions of
the assessment report of the chemical. Applicants should clearly indicate those pieces
of information in the notification statement and other documents that they wish to
claim as exempt information, and give reasons to substantiate each claim. Reasons
should address why any prejudice to the commercial interests of the applicant
resulting from publication would outweigh the public interest.
An application for exempt information can be made by filling out Form 3 and paying
the fee. Notifiers should also indicate the relevant data items on the appropriate
Checklist. Further guidelines on confidentiality are detailed in Appendix 6 -
Confidentiality.
If the Director decides that a claim that certain items of information be exempt from
publication is justified, then those items will not be published in the full public report
or summary report. However, the items are included in the assessment report. On the
other hand, if the claim is rejected, then the Director notifies the applicant, who may
appeal to the Administrative Appeals Tribunal for a review of the decision. In all
cases, the applicant receives written notice from the Director.
5.2 Variation of Data Requirements

NICNAS provides for flexibility of data requirements in a notification. However, the
Director needs to be satisfied that the chemical can be adequately assessed without the
specific data or by substituting with other data, for example, data for a similar
chemical (analogue).
Notifiers need to provide scientific reasoning to justify omission of any item of

information required by the Schedule. An application to vary data requirements can
be made by filling out Form 2 and paying the fee. Notifiers should also indicate the
relevant data items on the appropriate certificate Checklist. Further guidelines on
Variation of Data Requirements are detailed in Chapter 4.
42
5.3 Polymers of Low Concern (PLC) Notification

Each notification for a PLC (non self assessed) must consist of:
• the application for an assessment certificate, using Form 1-PLC

• the information about the polymer, comprising the data items listed on Form
1-PLC
• any other information available to the notifier which may assist in the proper
assessment of the polymer, for example, additional information on its use
• any application for variation of Schedule requirements (Form 2), with the
appropriate fee
• any application for exempt information (Form 3), with the appropriate fee.
• the PLC Notification checklist, indicating which items on the form have been
completed, items for which an application for variation has been made, and
items for which an application for exempt information has been made
• a statement that the notifier is entitled to use and to give the Director all the
data in the notification statement (included on Form 1-PLC)
• a declaration that all available information has been submitted (included on
Form 1-PLC); and
• the appropriate fee
The necessary standard forms for a PLC Notification are included in Appendix 1.
Two copies of each technical dossier are required.
5.4. Self Assessment: Polymer of Low Concern (PLC)

Notification procedure
The self-assessment submission need consist only of an electronic copy of the signed
notification form with attached self-assessment report (Form 1-PLC Self Assessment
(WORD 460Kb) Large file warning), the relevant fee, and a copy of the MSDS for
the notified polymer. Other than the MSDS, no supporting data such as
physicochemical and toxicological studies should be sent with the application. If
supporting data is submitted with the application then this application would not be
considered a self-assessed application (see Chemical Gazette 5th July 2005 – Audited
Self-Assessment - Frequently Asked Questions). Supporting data must be retained for
5 years from the date the certificate is issued and may be subject to audit. In addition,
there may be requirements for information to be held confidential, in which case Form
3 - Exempt Information (WORD 72Kb) and the relevant fee should also be submitted
Third party applications where data is exempt from the notifier cannot be accepted as
self-assessment. In addition, joint notification applications are not accepted as self-
assessments.
43
To assist in filling out the self-assessment template, there is guidance material within
the template in the form of highlighted headings, and a separate Guidance Document
(WORD 450Kb) Large file warning which includes suggestions on how to report on
the risk posed by the polymer at the appropriate level of detail. The suggested text
may be used where appropriate, or more relevant text may be devised by the notifier
on a case by case basis. An Example Notification (WORD 460Kb) Large file warning
(not a real case) has been prepared by NICNAS and is also available to illustrate the
use of the template.
On receipt of a self-assessment submission, NICNAS will screen the notification for

three issues:
1. Correct application of the PLC criteria

2. Whether the polymer poses any residual concern; and
3. Completeness of the self-assessment
If the PLC criteria have been found to have been incorrectly applied in determining
the status of the polymer, based on the information in the self-assessment report, the
notification will be rejected and the notifier advised to re-notify in the correct
category.
There may be cases where a polymer fully meets the PLC criteria, but some residual
concern remains, primarily in cases where exposure is high such as where polymers
with significant water solubility are released directly to the environment (eg cosmetic
or water treatment applications) or where polymers are constituents of products
deliberately applied to the body (eg cosmetics) or in food contact applications. In
addition, if effects are observed during toxicological or ecotoxicological studies and
these are relevant to exposure conditions, residual concern may be invoked. NICNAS
may request some additional information to enable assessment of the specific concern.
The notifier will be informed of the circumstances, including any intent to request
additional information, at 14 days after receipt of the notification. If a significant
health or environmental concern is identified by NICNAS during the screening
period, the self-assessment process will lapse, with the assessment reverting to the
normal 90-day timeframe.
The self-assessment report will be the only document received by NICNAS and as
such is required to be a complete record of risk assessment for the polymer. If there
are gaps or inconsistencies in the risk assessment document, the notifier will be
requested to revise the document and re-submit it. The assessment clock will not be
started until NICNAS has accepted that the report is complete.
NICNAS will prepare the Self-Assessment Report, Full Public Report, Summary
Report and certificate for the notifier and will forward these by Day 28 of the
assessment clock. The report may contain information prepared by NICNAS on other
matters where these have been flagged in a request for additional information. On
receipt of the report, the notifier will have the opportunity to advise NICNAS of
confidentiality concerns within 14 days, after which time, the Full Public Report and
Summary Report of the assessment will be published on the NICNAS website.
44
Obligations
Under the Act, a person who is issued a self-assessed assessment certificate must keep
records to support any statement made in or in connection with the application for the
certificate for 5 years from the date the certificate is issued and also must provide a
report to the Director before or on 28 September of the following registration year.
This report must state the following:
(a) the name of the chemical in respect of which the permit or certificate is
issued; and
(b) the volume of the chemical that was introduced during the year; and
(c) any adverse effect of the chemical on occupational health and safety,
public health or the environment of which the person has become aware
during the year.
5.5 Limited Notifications

A Limited Notification occurs when a full assessment of the occupational health,
public health and environmental effects of the chemical is not required. In this case,
data items for Part C of the Schedule do not need to be submitted. However Part C
should be provided if available.
Each Limited Notification must consist of:
• the application for an assessment certificate, using Form 1-LTD

• the technical dossier of information about the chemical, comprising Parts A
and B of the Schedule, and Part D for a synthetic polymer or biopolymer (see
Chapter 4 and Appendix 12 for further information)
assessment of the chemical, for example, additional occupational or
environmental exposure data
appropriate fee
• any application for exempt information (Form 3), with the appropriate fee.
• the Limited Notification checklist, indicating which items in the Schedule
have been submitted, items for which an application for variation has been
made, and items for which an application for exempt information has been
made
data in the notification statement (included on Form 1-LTD)
Form 1-LTD); and
• the appropriate fee (this can be paid in two parts for SORO)
45
The necessary standard forms for a Limited Notification are included in Appendix 1.
Two copies of the technical dossier are required.
5.6 Standard Notifications

Each Standard Notification must consist of:
• the application for an assessment certificate, using Form 1-STD

• the technical dossier of information about the chemical, comprising Parts A, B
and C of the Schedule, and Part D for synthetic polymer or biopolymer (see
Chapter 4 and Appendix 12 for further information)
assessment of the chemical, for example, additional toxicity data
appropriate fee
• any application for exempt information (Form 3), with the appropriate fee
• the Standard Notification checklist, indicating which items in the Schedule
made
data in the notification statement (included on Form 1-STD)
Form 1-STD); and
• the appropriate fee (this can be paid in two parts for SORO).
The necessary standard forms for a Standard Notification are included in Appendix 1.
For all Standard Notifications, the technical dossier of information submitted must
include the full reports of all testing, for example, for the physico-chemical properties.
Methods should be fully described to enable the assessor to identify the methods used
and the protocols followed.
Toxicity results must include the observations and results obtained for individual
animals. Summaries and summary tables of mean score observations alone are not
acceptable. A statement should be included specifying whether the laboratory
practices followed in obtaining data were in accordance with the currently accepted
principles of good laboratory practice.
Two copies of the technical dossier are required.
5.7 Electronic Draft Assessment Report Using NICNAS Template

A rebate of up to 15% of the assessment fee for Standard Notifications, Limited
Notifications and Polymer of Low Concern Notifications is available to applicants
46
who submit an acceptable written draft assessment report with their notification
statements. In practice, this applies principally to the electronic lodgement of
notification, for limited and standard notifications only, using the template on the
website.
Applicants for the rebate must pay the full notification fee when lodging their
notification. The rebate will be returned by NICNAS if the draft report meets the
criteria outlined below.
The criteria defining an acceptable written draft assessment report fall into three broad
areas:
• approved format;
• level of detail required for each section; and
• completeness of the submission.
For further information see Rebates in Chapter 8 of this handbook.
Approved Format
The format must be consistent with the current requirements under the Schedule. The
certificate notification template has been designed to provide information about the
chemical in a standardised format and also to comply with the notification
requirements of the Act. The permit notification template is also available and use of
the template generally simplifies the permit application process. However, there are
no rebates associated with their use. Reports are available electronically from the
NICNAS website
Level of Detail
Sufficient information is required to enable an assessment of the occupational health,

public health and environmental effects and exposure. The report should include
details of tests performed and a summary of any toxicity and ecotoxicity data,
together with copies of the full supporting study reports.
Completeness
Notifiers should provide a detailed explanation of the manufacturing and/or import

process. Notifiers should also describe the likely occupational health, public health
and environmental hazards of the notified chemical and the potential for occupational,
public and environmental exposure. In considering this information, the notifier must
determine the risk of any adverse occupational health, public health or environmental
effects and consider the practical options to control such risks. The draft assessment
report must include recommendations for the safe use, handling and disposal of the
chemical.
Notifiers applying for the rebate in assessment fees should provide the following:
47
• the normal application for an assessment certificate, using Form 1-STD for a
Standard Notification, Form 1-LTD for a Limited Notification and Form 1-
PLC for a PLC Notification;
• an application for the rebate on Form 13;
• the draft assessment report, preferably on computer disk, according to the
criteria outlined above;
• any other information available to the notifier which may assist in the
comprehensive assessment of the chemical, for example, additional
occupational exposure data;
appropriate fee
• the appropriate notification checklist, indicating which items in the Schedule
made; and
• the appropriate fee for the type of notification.
The necessary standard forms are in Appendix 1.
5.8 Extension of Assessment Certificate

Each application should consist of:
• the application for an extension of the original assessment certificate, using

Form 1-EXT;
• the technical dossier of information (see Chapter 4 and Appendix 12),
comprising:
o for a PLC, the data items listed on Form 1-PLC [Regulation 4A]; or
o for any other chemical or polymer other than PLC, paragraphs 1, 2, 3,
5, 11 and 12 of Part B of the Schedule, that is, the identity and
composition of the chemical, its use and volume of use, and a label and
MSDS;
• supplementary information on matters affecting occupational, public and
environmental exposure if the application contains any significant differences
from the original application;
• any new health and environmental effects information that is available about
the notified chemical;
• confirmation that the applicant has access to the full public assessment report
for the notified chemical;
• the written agreement of the holder of the original assessment certificate to the
application for extension, using Form 14;
48
• a statement that the applicant is entitled to use and give the Director all the
data in the notification (included on Form 1-EXT);
Form 1-EXT); and
• the appropriate fee
The necessary standard forms are included in Appendix 1.
Note: Information provided in an application for extension is not provided to the

original notifier.
Assessment Process And Reports
Under the Extension of an Original Assessment Certificate Notification, the original

assessment report is modified within 45 days after application or after additional
information was submitted.
The following reports are prepared:
• a list of the modifications to the assessment report, which may contain exempt
information;
• a list of the modifications to the assessment report without the exempt
information;
• a modified assessment report (the version containing exempt information);
• a modified full public report (modified assessment report without the exempt
information);
• a list of modifications to the summary report and
• modified summary report.
Following the assessment of information and preparation of reports, a copy of the

modifications to the original assessment report is sent to the holder of the original
assessment certificate and the applicant for extension. The copy of modifications sent
to the holder of the original assessment certificate must not contain exempt
information.
5.9 Self assessment: non-hazardous chemicals and non-hazardous

polymers
To establish that a chemical or polymer is non-hazardous, certain data is required to
be held by the notifier. The data needed is detailed below.
Health Criteria
To establish that a chemical other than a polymer is a non-hazardous chemical with

respect to mammalian toxicity for purposes of self-assessment, the data listed in Table
49
1 must be available to the notifier regardless of import volume. This means that whilst
full toxicological data may not be required for current limited category notifications,
these data are required for audited self-assessment purposes for the limited assessment
category. For each test, the result must lead to the chemical not being classified as
hazardous in accordance with the NOHSC Approved Criteria for Classifying
Hazardous Substances. Indicative results are listed in Table 1. For genotoxicity
testing, the results of the two genotoxicity tests should both independently be
negative. The relevant Test Guidelines (normally OECD) are also provided for
information.
Endpoint Indicative Result Test Guideline

1. Rat, acute oral LD50 > 2000 mg/kg bw OECD TG 401
OECD TG 423
2. Rat, acute dermal LD50 > 2000 mg/kg bw OECD TG 402
3. Rat, acute inhalation OECD TG 403
(aerosols or particulates) LC50 > 5 mg/L/4 hour
(gases or vapours) LC50 > 20 mg/L/4 hour
4. Rabbit, skin irritation slightly to non-irritating OECD TG 404
5. Rabbit, eye irritation slightly to non-irritating OECD TG 405
6. Skin sensitisation no evidence of OECD TG 406 (Buehler
sensitisation. and Maximisation tests)
OECD TG 429 (LLNA)
7. Rat, repeat dose toxicity – ≥
10 days.* Oral NOAEL >50 mg/kg OECD TG 407 – 409,
bw/day 422
Dermal NOAEL > 100 OECD TG 410 – 411
mg/kg bw/day
Inhalation NOAEL > OECD TG 412 – 413
0.25 mg/L, 6h/day
8. Genotoxicity - bacterial non mutagenic OECD TG 471 – 472
reverse mutation
9. Genotoxicity – in vitro non genotoxic OECD TG 473, 476.
479 – 482
Table 1. Data requirements for non-polymers under the self-assessment scheme
* Data from only one repeated-dose mammalian toxicity test required.
If data beyond that specified in Table 1 is available, this must also be reported, and
any classification as a hazardous substance based on this additional data will also
preclude the chemical being accepted for purposes of self-assessment.
Waivers of test requirements or substitution of analogue or product results are not

possible for the self assessment scheme as case by case NICNAS assessment is
required for any variations to these requirements. However Acute Inhalation Toxicity
results are not required if:
a) The chemical has a vapour pressure less than 1.5 kPa; and
b) The chemical as introduced has less than 25% of particles having less than 10
μm diameter; and
c) The chemical is not purposely aerosolised during use (except where this
constitutes a “controlled use”).
50
The results of the toxicity testing must be listed in the report template, along with
discussion of any observed results below classification thresholds. NICNAS may ask
that the notification be changed to a non-self assessed category if the information
indicates that there are any concerns requiring further assessment. “Slightly irritating”
refers to irritation test results where effects are observed but these are below
classification thresholds. “Non mutagenic” and “non genotoxic” refer to negative
results as defined for the individual test guidelines.
For a polymer, the above requirements hold for biopolymers and low molecular
weight synthetic polymers (NAMW < 1000). For synthetic polymers with NAMW ≥
1000, only data items 1, 4 and 8 (in Table 1) are normally required to be available to
the notifier. However, where the polymer contains one or more High Concern
Reactive Functional Groups with FGEW < 5000, as defined in the PLC criteria
(except unsubstituted positions ortho and para to phenolic hydroxyl or partially-
hydrolysed acrylamides), item 6 is also required to be available.
Environmental criteria
Environmental criteria are identical to those required to obtain an Early Introduction

Permit for a chemical or polymer in the relevant category. Chemicals meeting criteria
for persistence and/or bioaccumulation will not be accepted for purposes of self-
assessment. All relevant environmental data and a full set of physical and chemical
data are also required to be presented in the self-assessment report.
Notification procedure
The self-assessment submission need consist only of an electronic copy of the signed
notification form with attached self-assessment report (Form 1-Self Assessment non
PLC) the relevant fee, and a copy of the MSDS for the notified chemical/polymer.
Other than the MSDS, no supporting data such as physicochemical and toxicological
studies should be sent with the application. If supporting data is submitted with the
application then this application would not be considered a self-assessed application
(see Chemical Gazette 5th July 2005 – Audited Self-Assessment - Frequently Asked
Questions). Supporting data must be retained for 5 years from the date the certificate
is issued and may be subject to audit. In addition, there may be requirements for
information to be held confidential, in which case Form 3 - Exempt Information
(WORD 72Kb) and the relevant fee should also be submitted. Third party
applications where data is exempt from the notifier cannot be accepted as self-
assessment. In addition, joint notification applications are not accepted as self-
assessments.
To assist in filling out the self-assessment template, there is guidance material within
the template in the form of highlighted headings. A separate guidance document
which includes suggestions as to how to report on the risk posed by the chemical at
the appropriate level of detail is also available.
On receipt of a self-assessment submission, NICNAS will screen the notification for

three issues:
1. Correct application of the non-hazardous criteria
51
2. Whether the chemical/polymer poses any residual concern; and

3. Completeness of the self-assessment
If the non-hazardous criteria have been found to have been incorrectly applied in
determining the status of the chemical/polymer, based on the information in the self-
assessment report, the notification will be rejected and the notifier advised to re-notify
in the correct category.
There may be cases where a chemical/polymer fully meets the non-hazardous criteria,
but some residual concern remains, NICNAS may request some additional
information to enable assessment of the specific concern. The notifier will be
informed of the circumstances, including any intent to request additional information,
at 14 days after receipt of the notification. If a significant health or environmental
concern is identified by NICNAS during the screening period, the self-assessment
process will lapse, with the assessment reverting to the normal 90-day timeframe.
The self-assessment report will be the only document received by NICNAS and as
such is required to be a complete record of risk assessment for the chemical/polymer.
If there are gaps or inconsistencies in the risk assessment document, the notifier will
be requested to revise the document and re-submit it. The assessment clock will not
be started until NICNAS have accepted that the report is complete.
NICNAS will prepare the Self-Assessment Report, Full Public Report, Summary
Report and certificate for the notifier and will forward these by Day 28 of the
assessment clock. The report may contain information prepared by NICNAS on other
matters where these have been flagged in a request for additional information. On
receipt of the report, the notifier will have the opportunity to advise NICNAS of
confidentiality concerns within 14 days, after which time, the Full Public Report and
Summary Report of the assessment will be published on the NICNAS website.
Obligations
Under the Act, a person who is issued a self-assessed assessment certificate must keep
records to support any statement made in or in connection with the application for the
certificate for 5 years from the date the certificate is issued and also must provide a
report to the Director before or on 28 September of the following registration year.
This report must state the following:
(a) the name of the chemical in respect of which the permit or certificate is
issued; and
(b) the volume of the chemical that was introduced during the year; and
(c) any adverse effect of the chemical on occupational health and safety,
public health or the environment of which the person has become aware
during the year.
52
5.10 Assessment Process and Reports

In normal circumstances, an assessment for a new industrial chemical is completed
within 90 days from the date of acceptance of an application for an assessment
certificate, that is, the date of receipt of the complete notification package. Following
provision of the assessment report to the applicant, there is a two-week period for the
applicant to apply for variation to the report. Therefore, notification of a new
industrial chemical must be made at a very minimum of 104 days prior to the intended
date of manufacture or importation (unless chemical is eligible for an EIP).
In certain circumstances, the time for an assessment will exceed 90 days, that is:
• when additional information has been requested by the Director, the period of
90 days will begin from the date of receipt of the additional information; or
• when an unusually detailed or complex assessment is necessary, an additional
90 days may be granted, with the applicant being advised as soon as
practicable.
Following the assessment of a notified chemical under the Standard Notification,

Limited Notification and PLC notification categories, the following reports will be
written and sent to the notifier:
• assessment report (composed of the full public report and any exempt
information); and
• full public report (which does not include exempt information); and
• summary report (condensed version of the full public report for publication in
the Chemical Gazette).
If information has been supplied by a third party on behalf of the notifier, then this
confidential information will be deleted from the assessment report before it is sent to
the notifier, provided that the information is justifiably exempt from publication.
Further guidelines on confidentiality are detailed in Appendix 6 - Confidentiality.
When the reports are sent to the notifier, advice will be given regarding publication of
the reports and possible variation of the assessment report before publication (see
sections below).
5.10.1 Requests for Variation of Assessment Reports
Within 14 days of receipt of an assessment report (non self assessed), the notifier may
ask the Director to make changes to it, stating the reasons for the request. For
example, the notifier may disagree with the conclusions and/or recommendations on
scientific grounds and request a change (or variation) to the report.
To request a variation of the assessment report, notifiers should complete Form 4 and
attach the appropriate fee. Notifiers should ensure that the reasons for the request to
vary the report are clearly stated. Supporting documentation may be necessary.
53
The Director may either agree to the changes or refuse to change (vary) the report.
This must be done within 14 days. Whichever way the Director decides, the notifier
will be given notice in writing of the decision.
The notifier may then:
• give written consent for the publication of the reports;

• appeal against the decision (see Appendix 8 - Appeals); or
• withdraw the notification.
Applications to vary assessment reports after publication can also be made (see
below).
5.10.2 Publication of Assessment Reports
If the Director has not received any request for changes to an assessment report from
the notifier within 28 days of first forwarding the report, then it may be published.
Under the Act, the assessment report is published by:
a. publishing the summary report of the notified chemical in the Chemical

Gazette;
b. giving a copy of the assessment report to Department of the Environment and
Heritage and
c. giving a copy of the full public report to any person that the Minister directs.
Under the Extension of an Original Assessment Certificate Notification, the modified

summary report is published in the Chemical Gazette.
5.10.3 Variation of Assessment Reports after publication
Notifiers may apply to the Director for variation of the full public report after the
summary report has been published in the Chemical Gazette. As for applications for
variation before publication, notifiers should complete Form 4 and attach the
appropriate fee. Notifiers will be given notice in writing of the Director's decision
within 14 days of the request. Under this provision of the Act, third parties, such as
members of the public, can similarly apply to the Director for variation of the report
after publication.
54
5.10.4 Assessment Certificates
The assessment certificate for a new chemical is given to the notifier, within 7 days of
consent to publish, or at some time after 28 days if no consent is provided. The
chemical will be added to the AICS five years after the assessment certificate is given.
Assessment certificates can be transferred only in special circumstances [section 73 of

the Act], that is:
• upon the death of the holder of the assessment certificate;

• upon bankruptcy;
• upon liquidation; or
• upon disposal of the business.
Any new holder of an assessment certificate must advise the Director as soon as
possible.
55
6. Permit Categories
This chapter includes information on how to compile the necessary forms and
additional documents for each of the permit assessment categories (CEC and LVC)
and other types of applications (Section 30A and Section 30 Permits and renewal of
existing LVC and CEC permits) outlined in Chapter 3.
Any forms and checklists referred to are in Appendix 1.
6.1 Exempt Information

Exemption provisions apply to the following permits notifications: Commercial
Evaluation Chemical (CEC) permits; Low Volume Chemical (LVC) permits;
Controlled Use (Export Only) Permit (EOP), Section 30A (Early Introduction Permit -
EIP) and Section 30 Permits.
In these cases, no assessment reports are published. A notice is placed in the Chemical
Gazette (see Appendix 5). If the applicant does not want the chemical identity or
specific use published, an application for this information to be exempt from
publication in the Chemical Gazette can be made, with reasons to substantiate each
claim. Reasons should address why any prejudice to the commercial interests of the
applicant resulting from publication would outweigh the public interest.
An application for exempt information can be made by filling out Form 3 and paying
the fee. Notifiers should also indicate the relevant data items on the appropriate permit
Checklist. Further guidelines on confidentiality are detailed in Appendix 6 -
Confidentiality.
6.2 Commercial Evaluation Chemical (CEC) Permits

The Commercial Evaluation Permit allows the introduction of a chemical without a
detailed notification package, or full assessment, to provide a cost effective way for
industry to extend existing markets or create new markets. It allows the manufacture
or import of up to four tonnes of a chemical for a period of up to two years for the
purposes of commercial evaluation of that chemical.
If the product to be evaluated is a mixture of chemicals, then each new chemical

constituent of the mixture requires an individual permit.
Commercial Evaluation
The commercial evaluation permit allows the chemical to be used only for the
specified purpose of commercial evaluation, for example, to test a new polymer in a
surface coating when a large quantity is required to fill paint lines, or to evaluate a
new process that requires a new industrial chemical. The use of the chemical is
specified in the permit, together with the period of introduction and the maximum
quantity permitted.
56
Applications for Commercial Evaluation Permits will be refused if there is

insufficient evidence that the chemical is for commercial evaluation only. It is
unlikely that a company could obtain a series of Commercial Evaluation Permits to
cover importation over a period of years.
Volume
Although the maximum introduction volume allowed is four tonnes, notifiers should
only apply for quantities that reasonably reflect the needs for commercial evaluation
of the chemical. Notifiers will need to provide sufficient justification for their claims.
Duration
The maximum duration introduction of a permit is 2 years. Use of the chemical under
the permit may continue beyond the period of introduction, providing the chemical is
used for the purposes of commercial evaluation.
If the period of a commercial evaluation will exceed the period of introduction under
the Permit, the applicant can request permission from the Director for extra use time
beyond the allowed period of introduction before the Permit expires and explain why
the extended use period is needed.
User Agreements
To ensure adequate safeguards, under subsection 21D(2) of the Act, User Agreements
between the applicant and all users conducting the evaluation of the chemical need to
be provided to NICNAS. Only those proposed users who have completed a User
Agreement can use the chemical. Under the agreement, users agree to be bound by the
conditions of the permit until the end of the evaluation and to provide NICNAS with a
final report on permit expiry. The report must include any health or environmental
effects observed during use. User Agreements (Form 8) can be submitted to NICNAS
after the initial application.
In some instances, applicants may wish to have permits issued before agreements are
made. These applications will be considered on a case-by-case basis. However, a
likely scenario is that the Director may need to impose a further permit condition, for
example, that the chemical could not be passed on to, or used by, another person
without an agreement being first forwarded to NICNAS. If no agreement is submitted
with an application for a Commercial Evaluation Permit, applicants need to explain
their customer arrangements.
The commercial evaluation permit system is not available without a User Agreement.
That is, a CEC permit cannot be issued for chemicals to be evaluated through retail
sale where a user agreement cannot be obtained, for example, end-use consumer
products such as cosmetics and domestic cleaners.
Assessment Process and Permit Conditions
There is no statutory deadline for issuing Commercial Evaluation Permits. The

process is usually completed within 14 days.
57
Commercial Evaluation Permits include the following standard conditions plus any
additional chemical-specific recommendations:
• The maximum quantity of chemical that can be introduced and the

introduction period for the purpose of commercial evaluation;
• The applicant must advise NICNAS in writing before the permit expires, if the
period of commercial evaluation is to extend beyond the duration of the
permit;
• The Applicant must forward any outstanding User Agreement forms to the
Director, prior to the chemical being distributed to or used by the user;
• Use of the chemical under this permit must be in accordance with all relevant
State or Territory OHS, environmental and poisons legislation;
• Where a suitable and sufficient workplace risk assessment indicates that
control measures are necessary, these should be implemented to prevent, or
where this is not practicable, minimize the risks to human health. Adequate
control of exposure to workers should be in accordance with the hierarchy of
controls;
• Workers exposed to the chemical and products containing it must be informed
that it is being introduced into Australia under a permit;
• The MSDS is to be made available at all sites where the chemical is used;
• The MSDS for the chemical and products containing it must carry advice that
the chemical is being manufactured or imported under a Commercial
Evaluation Permit granted under section 21G of the Industrial Chemicals
(Notification and Assessment) Act 1989. Suggested wording is: '……….. is
being introduced under a Commercial Evaluation Permit granted under section
21G of the Industrial Chemicals (Notification and Assessment) Act 1989.' ;
• Disposal of waste should be in accordance with Local, State and federal
government regulations;
• Records are to be kept at the site(s) of use of the quantity used, any adverse
occupational health and safety, public health and environmental effects
resulting from use; and
• At the end of the evaluation, the notifier must advise the Director of:
1. quantities used,
2. means of disposal of any excess quantity,
3. any adverse occupational health and safety, public health and
environmental effects during permit use, and
4. the outcome of this commercial evaluation.
Under the Act, there is a penalty if the holder of a CEC permit contravenes any permit
condition without a good reason. Chemicals that are the subject of a CEC permit are
not eligible for listing on the AICS.
If a Commercial Evaluation Permit is in force, a second permit for the chemical

cannot be issued to the same notifier or customer (proposed user of the chemical).
58
If the commercial evaluation of the chemical proves satisfactory and the notifier
wishes to continue importing the chemical for full-scale commercial use, the notifier
should allow sufficient time to obtain an assessment certificate. Joint applications may
be submitted with the fee shared between the applicants.
Publication
Notice of the granting of a Commercial Evaluation Permit will be published in the

Chemical Gazette. Details published are as follows:
• name of the chemical or trade name;

• name of the company to which the permit is issued;
• volume of chemical which may be introduced;
• date of issue of the permit;
• duration of the permit (maximum two years); and
• general use of the chemical.
Final Report
At the end of the commercial evaluation process each Permit holder must provide a
Final Report to the Director. NICNAS will write to CEC Permit holders three months
before the permit expiry date with a reminder that a final Report must be provided.
CEC Overview
Each notification for a CEC permit must consist of:
• the application for a CEC permit, using Form 1-CEC;

• the total quantity of chemical to be introduced, including a written explanation
justifying the quantity (this should relate to the chemical entity);
• the total time period for introduction;
• the use of the chemical, clearly indicating the purpose for which the chemical
is being evaluated. Description of distribution arrangements should be
included and all users, including end-users, clearly identified;
• details of any previous or current permits (if the applicant has knowledge of
any permits which have been previously issued in Australia for the chemical
under any legislation, including this Act, particulars should be provided);
• User Agreements .The applicant and each proposed user of the chemical must
sign an agreement to comply with the conditions of the permit. This agreement
must be included with the application.
environmental effects (as in Paragraph 2 of Part A of the Schedule);
• information about the chemical, comprising the data items listed in paragraphs
6(a)(i) to 6(iv), 7, 8, 11 and 12 of Part B of the Schedule (see Appendix 12);
59
• any application for exempt information [Form 3], with the appropriate fee
• the CEC checklist, indicating which items on Form 1-CEC have been
completed and items for which an application for exempt information have
been made;
data in the notification statement (included on Form 1-CEC);
o a declaration that all available information has been submitted
(included on Form 1-CEC); and
o the appropriate fee
The necessary standard forms for a CEC Notification including the "Template for
preparation of CEC submission with guidance material", are included in Appendix 1.
Renewal of CEC permit
Following introduction of the Industrial Chemicals (Notification and Assessment)

Amendment (Low Regulatory Concern Chemicals) Act 2004, Existing CEC permits
can be renewed provided certain criteria are met (see section 6.7 for further
information). A CEC permit can be renewed only once (NEW CHEMICALS-
RENEWAL OF PERMITS-FAQ).
6.3 Low Volume Chemical (LVC) Permits

A LVC permit allows a chemical to be introduced at a maximum quantity of 100kg
per year for a maximum period of three years. Should further quantities of the
chemical be required during this period, the applicant must apply for either another
permit type or an assessment certificate. There is no longer a limit on the maximum
total amount of a LVC that can be introduced by all companies nationwide i.e. more
than one company can hold a LVC permit for the same chemical allowing the
introduction of 100kg per year. However, if two or more companies submit a joint
application the maximum quantity would be shared among the applicants.
Each notification for a LVC Permit must consist of:
• the application for a LVC Permit, using Form 1-LVC;

• the purpose for which the chemical is to be manufactured or imported,
including detailed information about its proposed use;
• the total quantity of chemical to be introduced for each year of the permit (this
should relate to the chemical entity);
• the total time period for introduction (maximum three years);
environmental effects (as in paragraph 2 of Part A of the Schedule);
• information about the chemical, comprising the data items listed in paragraphs
1, 3, 6, 7, 8, 11 and 12 of Part B of the Schedule (see Appendix 12);
• any application for exempt information (Form 3), with the appropriate fee;
60
• the LVC checklist, indicating which items on the form have been completed
and items for which an application for exempt information have been made;
data in the notification statement (included on Form 1-LVC);
Form 1-LVC) and the appropriate fee.
The necessary standard forms for a Low Volume Chemical Permit Notification
including the "Template for preparation of LVC submission with guidance material",
are included in Appendix 1.
LVC Permits are issued within 20 days of receipt of a complete notification, provided
the Director is satisfied that the requirements of the Act are fulfilled.
A permit is granted on the condition that the holder of the permit notify the Director
if:
• the function or use of the chemical has changed, or is likely to change,

significantly;
• the amount of the chemical being manufactured or imported has exceeded, or
is likely to exceed, the limit of 100 kg per year;
• a chemical subject to a LVC Permit for import only has begun to be
manufactured in Australia;
• the method of manufacture has changed, or will be changed, resulting in a
possible increased risk of adverse occupational health, public health or
environmental effects; or
• the holder of the permit has become aware of additional information relating
to adverse occupational health, public health or environmental effects of the
chemical.
The holder of the permit must notify the Director within 28 days of becoming aware
of any of these changes or circumstances.
LVC Permits include the following standard conditions in addition to

recommendations specific to individual chemicals:
• The total quantity of chemical that can be introduced per annum;

• The length of time the permit will remain in force;
61

controls;
• The MSDS for the chemical and products containing it must carry advice that
the chemical is being manufactured or imported under a Low Volume
Chemical Permit granted under section 21U of the Industrial Chemicals
(Notification and Assessment) Act 1989. Suggested wording is:
'……… is being introduced under a Low Volume Chemical Permit granted
under section 21U(2) of the Industrial Chemicals (Notification and
Assessment) Act 1989.' ; and
• Disposal of waste should be in accordance with Local, State and Federal
government regulations.
The permit may also specify other events of which the Director is to be advised.
Chemicals that are the subject of a LVC Permit, are not eligible for listing in the
AICS.
Publication
Notice of the granting of a LVC Permit is published in the Chemical Gazette. Details
published include:

• duration of the permit (maximum three years); and
Renewal of LVC permit
Existing LVC permits can be renewed provided certain criteria are met (see section
6.7 for further information). A manufacturer or importer may apply for a LVC permit
to be renewed any number of times (NEW CHEMICALS-RENEWAL OF PERMITS-
FAQ).
Annual reporting and record keeping
Holders of a low volume permit must keep records to support any statement made in
or in connection with their application for the permit, or any application for a renewal
of the permit, for 5 years from the date the permit is issued. Holders must also make
an annual report to the Director stating the name and volume of the chemical, together
with any adverse effect of the chemical on occupational health and safety, public
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health or the environment. The annual report must be provided on or by 28

September of each year. This gives introducers 28 days from the end of the
registration year on 31 August to provide the annual report.
6.4 Controlled Use (Export Only) Permit (EOP)

Industrial chemicals introduced under the following scenarios will be eligible for the
Controlled Use (Export Only) Permit, known as EOP:
• importation of a new chemical into Australia for export of entire quantity;
• importation of a new chemical into Australia for use in formulation of

products for export of entire quantity;
• manufacture of a new chemical in Australia for export of entire quantity; and
• manufacture of a new chemical in Australia for use in formulation of products

for export of entire quantity.
The EOP will be available for chemicals where low risk can be demonstrated. In
particular, sufficient control measures must be in place to satisfy the criterion of
‘highly controlled’ (section 22A of the Act). Sufficient control measures must be in
place to prevent exposure to workers and the public and release to the environment.
The duration of the EOP will be a maximum of three years (section 22G of the Act).
Renewal of the permit may be allowed provided there is no significant change in
circumstances (section 22B of the Act).
Chemicals prohibited or severely restricted under Australia’s international obligations

will not be eligible for an EOP. For example, new chemicals with persistent organic
pollutant (POPS) characteristics, which include persistence and bioaccumulation, will
not be eligible.
Information to accompany the application
The basic information required by NICNAS with an application for an EOP is listed
in subsection 22C(2) of the Act, namely:
• uses of the chemical;
• a summary of the chemical’s effects on occupational health and safety, public

health and the environment;
• the volume to be introduced over a 3-year period.
The summary of health and environmental effects requires consideration of the

chemical’s health and environmental hazards and an estimate of the impact of the
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chemical on workers, the public and the environment. A legislative condition of the
permit is that there be low risk to occupational health and safety, public health and the
environment.
Paragraph 22C(2)(e) allows for further data requirements in the regulations and, for
an application for an EOP, the following items will be required (listed in Regulation
6B):
• information on chemical identity, as in Part B.1 of the Schedule to the Act (for
polymers, typical molecular weight data would be required);
• summary of how the chemical meets the definition of hazardous chemical in

the Act;
• details of any notification of the chemical in another country;
• concentration of the chemical in products, if the chemical is an ingredient in

products;
• detailed information on how the chemical is controlled, for example, methods

of control to prevent release into the workplace, community and the
environment (the EOP is only for chemicals which are ‘highly controlled’, so
this must be demonstrated by the applicant);
• precautions taken for safe storage and transport;
• information on emergency procedures, as in Part B.13 of the Schedule;
• country, or countries, to which the chemical is to be exported; and
• label and MSDS for the chemical and products containing the chemical.
For introduction volumes exceeding 10 tonnes per year, all available toxicological and
ecotoxicological data must be provided with the application. Toxicological and
ecotoxicological information may be requested in other cases.
Form of Application
An electronic template is available on the website for applications (Form 1-EOP). It

must be submitted to NICNAS with the fee and the required information for
assessment.
Joint applications can be made by manufacturers and/or importers of a new industrial

chemical for EOP.
An application can be accompanied by an application (Form 3) claiming certain

information to be treated as exempt from publication (see Section 6.1).
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Assessment process
There is no statutory deadline for issuing EOP. However, the process is expected to be
completed within 20 days of receipt of a complete notification, provided the Director
is satisfied that the requirements of the Act are fulfilled.
The holder of the permit is bound by the permit conditions – a permit is granted on
the condition that the holder of the permit notify the Director if:
• the function or use of the chemical has changed, or is likely to change,

significantly; or
• a chemical subject to an EOP permit for import has begun to be manufactured;
or
• the method of manufacture has changed, or will be changed, resulting in a
possible increased risk of adverse occupational health, public health or
environmental effects; or
• the holder of the permits become aware of additional information relating to
adverse occupational health, public health or environmental effects of the
chemical.
The holder of the permit must notify the Director within 28 days of becoming aware
of any these changes or circumstances.
Publication
Notice of granting of an EOP Permit will be published in the Chemical Gazette.

Details of the notice include:

• duration of the permit (maximum three years); and
Annual reporting and record keeping
Holders of an EOP must keep records to support any statement made in or in

connection with their application for the permit, or any application for a renewal of
the permit, for 5 years from the date the permit is issued. Holders must also make an
annual report to the Director stating the name and volume of the chemical, together
with any adverse effect of the chemical on occupational health and safety, public
health or the environment. The annual report must be provided on or by 28
September of each year. This gives introducers 28 days from the end of the
registration year on 31 August to provide the annual report.
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6.5 Early Introduction Permits

An application for an EIP can be made at the same time as a Standard Notification,
Limited Notification or PLC Notification, or it can be made later, but before the
assessment is completed. An application can be made by filling out Form 1 - EIP and
forwarding it to NICNAS with the appropriate fee. This amount is additional to the
normal notification and assessment fee. Joint applications may be submitted with the
fee shared between the applicants.
In deciding whether to grant the EIP, the Director will take into account a number of
matters, including the proposed use of the chemical and information about its
occupational health, public health and environmental effects.
The Director must also take into account the likelihood of release of the chemical to
the aquatic environment. For Standard Notifications, direct release in to a natural
waterway must be considered. For Limited Notifications, there are two considerations
that must be taken into account:
• direct release into a natural waterway; or

• release into a water treatment works at a rate more than 10 kg per year from an
individual source or 50 kg in total (this matter does not apply if the chemical is
readily biodegradable and has a very low aquatic toxicity to fish, aquatic
invertebrates and algae).
In taking into account the likelihood of the chemical being released to water, the
Director will only consider releases that result from normal use practices rather than
from spills, etc. Qualitative or semi-quantitative estimates of release to water rather
than detailed calculations will normally be sufficient.
Under normal circumstances, an application for an EIP will be decided within 28

days.
EIPs include the following standard conditions in addition to recommendations

specific to individual chemicals:
• The EIP is in force only until the assessment certificate is obtained;

• If the application for an assessment certificate is withdrawn, the permit lapses;
• If full assessment of the chemical cannot commence or is stopped due to
outstanding data for a specified period, the permit lapses;
controls;
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• Disposal of waste should be in accordance with Local, State and Federal
government regulations;
• records are to be kept at the site(s) of use; and
• At the end of the period for which this permit is issued, the applicant must
report to the Director any adverse occupational health and safety, public health
and environmental effects, reported from the use of this chemical.
Publication
Under the Act, the Director must decide an application for an EIP within 28 days of
receipt of the application. EIPs granted are published in the Chemical Gazette.
Details published include:

• date of issue of the permit; and
6.6 Section 30 Permit

A Section 30 Permit application must accompany or follow an application for an
assessment certificate. Joint applications may be submitted with the fee shared
between the applicants. Section 30 permits are issued only under exceptional
circumstances.
The notifier must write to the Minister outlining the reasons for the application, in
particular:
• the reasons why the introduction of the chemical is in the public interest;
• why the introduction must be without delay; and
• how introduction of the chemical will impact on occupational health, public
health and the environment.
The amount required for introduction should be justified in the application. All other
supporting information must be submitted. The appropriate fee should be sent with
the application.
In deciding whether to grant a Section 30 Permit, the Minister would usually seek
advice from the Director, taking into account a number of matters, including the
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proposed use of the chemical, information about its health and environmental effects
and the volume of chemical required.
Section 30 Permits are subject to conditions stated in the permit. There is no set limit
on the amount of chemical for which a Section 30 Permit may be granted, however,
the permit will specify limits on amount and time. Conditions specified in the permit
must be consistent with the reasonable protection of occupational health, public health
and the environment.
If the application for an assessment certificate is withdrawn, the permit lapses.
Publication
In granting a permit, the Minister will give notice in the Chemical Gazette as early as
possible. The notice will contain the following items of information unless the
Minister is satisfied that any items should be withheld in the public interest:
• name of the applicant;

• name(s) of the chemical, as shown to the public; and
• terms of the permit, including period in force.
Applicants may appeal to the Administrative Appeals Tribunal against a decision to

publish information against their wishes.
6.7 Renewal of CEC and LVC permits

Existing LVC and CEC permits can be renewed provided certain criteria are met.
Although an LVC permit can be renewed any number of times, a CEC permit maybe
renewed only once.
CEC permit renewal
Each application for a renewal of a CEC Permit must consist of:
• the application for a CEC permit renewal, using Form CEC-1R including
evidence that the criteria listed below have been met;
• a copy of the current permit including conditions;
• new user agreements forms. [Form 8] The applicant and each proposed user of
the chemical must sign an agreement to comply with the conditions of the
permit. This agreement must be included with the application;
• any application for exempt information (Form 3), with the appropriate fee for
information that was not claimed as exempt in the original application. Form 3
– Exempt Information needs not to be resubmitted if it was in the original
permit submission;
data in the notification statement (included on Form CEC-1R);
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Form CEC-1R); and the appropriate fee.
The necessary standard form for a CEC permit renewal Notification is included in
Appendix 1.
Criteria for CEC renewal
• the existing permit must still be current.

• the permit has not previously be renewed
• the function or use of the chemical has not changed, and is not likely to
change, significantly;
• the amount of the chemical being introduced has not increased, and is not
likely to increase, significantly;
• in the case of a chemical that was not manufactured or proposed to be
manufactured in Australia at the time the permit was issued, it continues not
to be manufactured in Australia;
• the method of manufacture of the chemical in Australia has not changed, and
is not likely to change, in a way that may result in an increased risk of an
adverse effect on occupational health and safety, public health or the
environment;
• no additional information has become available to the manufacturer or
importer as to any adverse effects of the chemical on occupational health and
safety, public health or the environment;
• all conditions of the current permit were complied with during the period of
the current permit;
• no changes are required to any conditions of the permit.
LVC Permit Renewal
Each application for a renewal of a LVC Permit must consist of:

• the application for a LVC Permit renewal, using Form LVC-1R including
evidence that the criteria listed below have been met;
• a copy of the current permit including conditions;
• any application for exempt information (Form 3), with the appropriate fee for
information that was not claimed as exempt in the original application. Form 3
– Exempt Information needs not to be resubmitted if it was in the original
permit submission;
data in the notification statement (included on Form LVC-1R);
Form LVC-1R) and the appropriate fee.
The necessary standard form for a LVC permit renewal Notification is included in
Appendix 1.
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Criteria for LVC renewal
• the existing permit must still be current.

• the function or use of the chemical has not changed, and is not likely to
change, significantly;
• the amount of the chemical being introduced has not increased, and is not
likely to increase, significantly;
• in the case of a chemical that was not manufactured, or proposed to be
manufactured, in Australia at the time the permit was last issued—it continues
not to be manufactured in Australia;
• the method of manufacture of the chemical in Australia has not changed, and
is not likely to change, in a way that may result in an increased risk of an
adverse effect on occupational health and safety, public health or the
environment;
• no additional information has become available to the manufacturer or
importer as to any adverse effects of the chemical on occupational health and
safety, public health or the environment;
• all conditions of the current permit were complied with during the period of
the current permit;
• no changes are required to any conditions of the permit.
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7. Continuing Obligations
This chapter provides information on your obligations to NICNAS when relevant
changes occur in circumstances associated with a chemical that has been previously
assessed. It also outlines the processes of listing a new chemical on the confidential
section of the Australian Inventory of Chemical Substances (AICS).
7.1 Secondary Notification

A secondary notification may be required when circumstances arise that were set out
in the initial assessment report as requiring secondary notification, or when an
introducer (which may or may not be the original applicant) of an assessed chemical,
or the Director, becomes aware of a significant change in circumstances.
For further information on Secondary Notifications, including how to apply, see

Section IV - Continuing Notifications and Assessment Methodologies.
7.2 AICS
7.2.1 Applying to Have a Chemical Listed in the Confidential Section of

AICS
The director is obliged by law to give a holder of an assessment certificate at least 18

days written notice of an intention to add the chemical to the non-confidential section
of the AICS. The holder of the certificate may then apply to the Director for the
chemical to be included in the confidential section of the AICS. A fee applies.
Applicants must use Form AICS-1, which lists the criteria to be addressed in the
claim. The Director will give the applicant written notice of the decision.
If the Director is satisfied that publication of some or all of the chemical's particulars
could reasonably be expected to prejudice the commercial interests of the applicant,
and the prejudice outweighs the public interest in the publication of those particulars,
then the Director must include the chemical in the confidential section. Otherwise the
chemical must be listed in the non-confidential section.
7.2.2 Holder of a Confidence
A person who applies to have a chemical listed in the confidential section of the AICS
will be treated as the 'holder of a confidence' in relation to that listing. The holder of a
confidence will be advised of any intention to remove the chemical from the
confidential section. He or she may then give the Director reasons why the chemical
should not be transferred and appeal against any such decision to transfer the
chemical.
Those who buy a business that has had a chemical in the confidential section of the
AICS may apply to become the holder of a confidence in relation to these chemicals.
Applications must be made by use of Form AICS-3. A fee applies.
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7.2.3 Transfer From the Confidential Section to the Non-Confidential

Section
A new chemical, which has been listed in the confidential section of the AICS
following assessment, will be transferred to the non-confidential section five years
after the confidential listing unless:
• an application against the transfer is made by the holder of a confidence using

Form AICS-1, with full justification for retaining the confidential listing (a fee
applies); and
• the Director is satisfied that the reasons given by the holder of a confidence
warrant the retention of the chemical in the confidential section.
Where such an application is successful, the chemical will remain in the confidential
section for a further five years before the next review for transferral to non-
confidential section.
The holder of a confidence will receive advice of any proposal to transfer a chemical
at least three months before the fifth anniversary of the relevant inclusion or re-
inclusion date of the chemical.
7.2.4 Appeals Relating to Listing on the Confidential Section
If the request for reconsideration of the decision by the Director not to list the new
chemical in the confidential section of the AICS or to transfer the chemical to the
non-confidential section is rejected, an appeal can be made to the Administrative
Appeals Tribunal.
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8. Rebate
You may be granted a reduction in the fee for a notification assessment if you submit
an electronic copy of the notification submission prepared using the approved
NICNAS electronic Template for a Standard or Limited notification category. A
reduction in the fee may also be granted for a Standard or Limited notification
category if you submit an assessment report of a chemical assessed under an
assessment scheme from any OECD country.
This chapter outlines the procedures to follow to make an electronic lodgement of

notification, the factors you should consider in submitting a foreign assessment report
and the process to follow should you wish to nominate a foreign scheme for approval
by NICNAS. Any forms referred to are in Appendix 1.
8.1 Electronic Lodgement of Notification

In an effort to reduce the cost and time of assessment of new chemicals, NICNAS
aims to streamline the assessment process by providing a Template to enable
applicants to submit information about a chemical in a standardised format and also to
comply with the notification requirements of the Act. The information provided in the
Template must be comprehensive to enable NICNAS to conduct its assessment of the
chemical.
Eligibility for the 15% Rebate in Notification Fee
Applicants for the rebate must pay the full notification fee when lodging their
notification. The rebate will be sent by NICNAS if the notification meets the criteria
outlined below. A rebate of up to 15% of the assessment fee for Standard and Limited
notifications may be provided to applicants who submit an acceptable electronic
notification with their notification statement.
The criteria defining an acceptable notification fall into 3 broad areas:
• approved format.
• level of detail required for each section.
• completeness of the submission.
Approved Format
The Approved Format comprises the required Schedule Attachments. The Template
comprises six documents: (i) the notification form for electronic submission (ii)
Schedule Part A - Summary of Notification (iii) Schedule Part B - Identity, Properties
and Uses (iv) Schedule Part C1 - Toxicology Information (v) Schedule Part C2 -
Environment (vi) Schedule Part D - Polymer Information. If data which is outside the
required Schedule parts for the notification category is available to you, the
appropriate Schedule Attachment should also be completed to the extent required to
cover this data; for example, if mammalian toxicology or genotoxicity data is
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available for a notification submitted as a Limited notification, the appropriate

sections of Schedule Attachment C1 should be completed. For toxicology,
ecotoxicology and physico-chemical properties data, there are additional sections that
correspond to test data, which is not on the schedule but may be available to you.
These additional tests sections should be filled out to the extent required to cover all
of the data available to you.
Level of Detail
Sufficient information is required to enable the assessment to be made from an

occupational, public health and environmental perspective. This includes details of
tests performed and where toxicity data are available a summary of the data is
required with supporting study reports. Although provision of toxicity data is not a
scheduled requirement for Limited notifications, the Act does stipulate that if these
data are available to the applicant they should be provided with the submission.
Completeness
The schedule in the table below indicates the information required for an acceptable
submission.
Assessment Report Applicant to

Assessment Report Applicant to
Template Section Complete for
Template Section Title Complete
Number 15% Rebate
1 APPLICANT & Yes Yes
NOTIFICATION DETAILS
2 IDENTITY OF Yes Yes
CHEMICAL
3 COMPOSITION Yes Yes
4 INTRODUCTION & USE Yes Yes
INFORMATION
5 PROCESS AND RELEASE Yes Yes
INFORMATION
6 PHYSICOCHEMICAL optional Yes
PROPERTIES
7 TOXICOLOGICAL optional Yes
INVESTIGATIONS
8 ENVIRONMENT optional Yes
13 BIBLIOGRAPHY Yes Yes
Attach completed copies of Schedule Attachments Parts A and B, and Parts C1, C2
and D as required.
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Guidance for applicants covering content and completeness required to further define
the criteria for an acceptable submission can be found in Chapter 5 - Certificate
Category.
8.2 Foreign Schemes

The Transitional Arrangements Towards Recognition of Approved Foreign Schemes
(Transitional Arrangements) were first published in the Chemical Gazette No. C 4, 7
April 1998. Updated arrangements were later published in the November 2001 issue
of the Chemical Gazette (No. C11).
Rebates are available to applicants for assessment certificates if assessment reports

can be obtained from approved foreign schemes. In practice, assessment reports can
be obtained from European Union member states and Canada. In particular, Australia
and Canada signed a Bilateral Arrangement in 2002, which facilitates the exchange of
reports and information between the two countries.
In addition, Canada and Australia share similar criteria for defining a Polymer of Low
Concern (PLC), so NICNAS can introduce resource savings for both industry and
NICNAS where the applicant provides evidence to NICNAS that a polymer has been
notified and assessed in Canada under the Canadian Environment Protection Act
(CEPA) as a Low Concern Polymer. In this circumstance, NICNAS can waive the
application fee for an Early Introduction Permit (EIP).
The following options are available to applicants notifying new industrial chemicals
to NICNAS in the standard, Limited or PLC categories.
Option 1 For Standard or Limited categories
Up to 40% Rebate in Notification Fee for Provision of an Acceptable Assessment

Report issued by a National Authority
Option 1 applies to chemicals or polymers for notification under subsections 23(4) to

23(9) of the Act, that is, notification under the Standard or Limited Notification
category.
Criteria for an Acceptable Assessment Report
The assessment report must:
• date from post-1994. Preferably, the report should be in English, however,

authorised translations are acceptable. Electronic reports are also acceptable;
• originate from the national authority of an OECD Member country, preferably
Canada or any European Union Member State;
• include confidential information, for example, chemical identity. Sanitised
documents are not acceptable;
• include a summary and assessment of physicochemical properties;
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• include a summary and assessment of toxicological and environmental effects

data, as appropriate;
• include a health and environmental risk assessment; and
• be accompanied by a letter of validation from the overseas authority that the
report is the full and final report issued for that chemical.
Conditions
In all instances, acceptance of an assessment report is subject to approval by the

Director.
Applicants are still required to follow the notification procedures as described in

Section 23 of the Act and submit a notification statement about the chemical or
polymer that contains the information required as per the Schedule. Where not already
covered by the notification requirements of section 23, the following information
should also be submitted to the Director.
• Details of the overseas authority, that is, when and where notified;
• A copy of all the particulars about the chemical that were given under the
foreign scheme and are available to the applicant; and
• Any other information about the chemical available to the applicant, that is,
assessment information or information given under another foreign scheme.
NICNAS statutory timeframes for assessment remain unchanged.
Rebate
NICNAS will decide the level of rebate on a case-by-case basis. The maximum rebate
is 40% of the notification fee, however the fee rebate will be less than 40% if data on
toxicological and environmental effects are absent or incomplete. Delays in provision
of the overseas assessment report, while possibly outside the control of the applicant,
will also affect the level of rebate.
Method of Application and Fees
Applications for Assessment Certificates under the New Transitional Arrangements

are to be made on the usual Form 1-STD or Form 1-LTD. Notification fees must be
paid in full. The rebate is determined at the end of the assessment period.
Obtaining Assessment Reports from the Canadian Authority
Applicants should first contact NICNAS to obtain a proforma authorising

Environment Canada to transmit the Canadian assessment report to NICNAS. This
will expedite the process of obtaining the Canadian assessment report and reduce the
likelihood of a reduced rebate due to late arrival of the Canadian report. It is advisable
to start this process as early as possible, and preferably before the notification is made
to NICNAS.
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Option 2: For polymers of Low Concern
A Free Early Introduction Permit (EIP) for Polymers of Low Concern (PLC) Assessed
as Low Concern Polymers in Canada
Option 2 applies to polymers notified and assessed as a Low Concern Polymer under
CEPA. This option is not necessary for the self-assessment of PLCs as these are
processed within 28 days of an accepted self-assessment report.
Eligibility Criteria
The polymer has been assessed as a Low Concern Polymer under CEPA. The PLC
notification statement and EIP application to NICNAS includes a Validation Letter
from Environment Canada to this effect.
The PLC notified to NICNAS meets the requisite criteria for early introduction
described under section 30A of the Act.
Conditions
In all instances, recognition of the Validation Letter from Environment Canada is

subject to the approval of the Director. NICNAS and Environment Canada will
assume that the presence of a copy of the letter indicates that the applicant is entitled
to use it.
In all instances, the granting of an EIP is subject to the approval of the Director.
Polymers which have had conditions or restrictions imposed by CEPA are ineligible
for this option.
NICNAS statutory timeframes for both assessment of the EIP application and PLC
assessment certificate remain unchanged.
Method of Application and Fees
An application for an EIP under the Transitional Arrangements is to be made on Form

1-EIP. The fee need not be provided, as long as the Eligibility Criteria and Conditions
are met.
Accessing the CEPA 'No Suspicion of Toxic' Validation Letter
Applicants need to contact the Canadian company applicant to obtain a copy of the
Environment Canada Validation Letter. This letter states that:
• the Schedule VI information on the polymer completes the applicant's

obligations under the CEPA New Substances Notification Regulations (that is,
meets Low Concern Polymer criteria);
• the assessment outcome is 'Not suspected to be Toxic'; and
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• depending on trigger threshold volumes, the polymer is eligible for addition to

the Domestic Substances List.
It should be noted that, as a general rule, assessment reports prepared under a foreign
notification and assessment scheme should be of at least the same standard as the
reports produced by NICNAS.
For further details on the Transitional Arrangements please contact NICNAS New
Chemicals on freecall 1800 638 528.
8.2.1 Nomination of Foreign Schemes
Approved State and Territory Notification Procedures
Some States and Territories may introduce their own legislation regarding the
notification of new chemicals to be manufactured in Australia. For the purposes of
NICNAS, the Minister may approve, by notice in the Chemical Gazette, a notification
law in a State and Territory if:
• the notification requirements under the State and Territory law are at least
equal to that required under the Commonwealth Act; and
• there are arrangements in place between the State and Territory and the
Commonwealth which would enable a copy of the notification statement to be
sent to the Director promptly [section 41 of the Act].
At the time of publishing this Handbook for Notifiers, there was no intention by any
of the States or Territories to introduce their own notification laws.
8.2.2 Further Information
For a notification based on an assessment under an approved foreign scheme, the

Director may request further information relating to the use, volume or method of
manufacture of the chemical. The Director may also request the clarification of
certain data items submitted in the notification.
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Section III– Existing Chemicals
SECTION III - Existing Chemicals

This section deals with the information required from importers and manufacturers
when chemicals already in existence in Australia are assessed by priority for risks to
health and safety and the environment.
9. Priority Existing Chemical Assessments

This chapter outlines what a Priority Existing Chemical (PEC) is, how it is declared,
and the obligations you may have relating to a chemical that is declared (or is being
considered for declaration) as a PEC.
The chapter also includes background information on how a PEC is selected and
assessed, and issues relating to the publication of PEC assessment reports. All forms
referred to in this chapter can be found in Appendix 1.
9.1 An Overview of Priority Existing Chemicals

A Priority Existing Chemical (PEC) is an industrial chemical has been selected for
assessment because there are reasonable grounds to believe that the manufacture,
handling, storage, use or disposal of the chemical gives rise, or may give rise, to a risk
of adverse health and/or environmental effects. For example, formaldehyde was
declared a PEC in March 2002 because of concerns over its wide occupational and
public exposure and potential adverse health effects.
PECs are declared by the Minister for Health and Ageing, following a
recommendation from the Director of NICNAS. The declaration is publicised through
a notice in the Chemical Gazette and through notices mailed to relevant people.
Once a chemical has been declared a PEC, those who wish to import or manufacture it
while it is a PEC must lodge an application for assessment of the chemical with
NICNAS. Importers of mixtures or formulations containing the chemical must also
apply for its assessment.
Even if you are not currently importing or manufacturing the chemical, you may still
be required to supply information as a past importer or manufacturer. You may also
be asked to supply information when a chemical is being considered for declaration as
a PEC. Notices in the Chemical Gazette will state who should supply information.
Copies of any notices published in the Gazette are also mailed to persons expected to
fall into the category of people who should supply information. (In the remainder of
this chapter, the term "notifier" refers to any supplier of information).
There are no application fees for the assessment of PECs, but there are financial
penalties for failing to supply information (see section 15.4.2 of this Handbook).
In all but exceptional circumstances, those persons who have applied for the chemical
to be assessed may continue to import or manufacture the chemical during the
assessment period.
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9.1.1 What Kind of Chemical can be declared?
A PEC can be:
i. any chemical listed in the AICS;

ii. any naturally-occurring chemical, which is deemed to be listed in the AICS; or
iii. a new industrial chemical which is:
o manufactured in a fixed apparatus, solely for the purpose of research,
development or analytical work; or
o introduced under a <100kg exemption for cosmetic and non-cosmetic
chemicals which pose no unreasonable risk to occupational health,
public health or the environment; or
o introduced solely for the purpose of research, development or analysis,
and in a quantity of not more than 100 kg in any 12 month period; or
o introduced by a person at a port or airport in Australia, remains subject
to the control of customs at the port or airport at all times and leaves
Australia less than 30 days after the day of introduction; or
o covered by a Commercial Evaluation Permit.
The declaration may apply to all aspects of the chemical; or only to specific uses. For
example, the assessment of 2-butoxyethanol was for its use in cleaning products only.
The declaration may also apply only when the chemical is manufactured, handled,
stored or used at specific sites or in specific circumstances, for example, when stored
in large quantities at specific locations.
9.2 Nominating a Chemical as a PEC

As well as a direct recommendation by the Director, members of the public (for
example, a company, union, individual or government department) may nominate any
of the 40,000 or so existing industrial chemicals in use for assessment as a PEC.
Public nominations are invited periodically and are prioritised in accordance with
selection criteria based on volume of use, potential exposure and severity of health
and environmental effects. Following consultation with industry, unions, the public,
and government departments, a candidate list of chemicals is drawn up for
consideration as possible PECs.
A direct recommendation by the Director may also result from an immediate threat to
the environment or to the health of workers and the public.
1,3,5-triglycidyl isocyanurate (TGIC) and Savinase (proteinases) were declared PECs

after direct recommendation by the Director. Others, such as sodium ethyl xanthate,
N-vinyl-2-pyrrolidone, glycolic acid and glutaraldehyde, were nominated during the
public nomination phase.
Nomination results in the publication of a notice in the Chemical Gazette under

section 48 of the Act (a section 48 Notice) calling for information. For each chemical
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or group of chemicals, a summary of the information provided under section 48 is

then prepared and made available. Summaries are usually published in the Chemical
Gazette and on the NICNAS website (www.nicnas.gov.au) and are also obtainable
from NICNAS. Sometimes the summary is not published in the Chemical Gazette. In
this case a notice will appear in the Chemical Gazette stating where copies can be
obtained. Summaries do not contain exempt information.
Once the Director has considered all the information available and has consulted with
interested parties, he or she decides if there are reasonable grounds for believing that
the manufacture, handling, storage, use or disposal of the chemical(s) might give rise
to adverse health or environmental effects. If there are such grounds, the
recommendation is made to the Minister to declare the chemical a PEC.
9.2.1 What Kind of Assessment is Required?
There are two categories of PEC assessment:
• Full assessment - undertaken to determine the risk of adverse health or

environmental effects that could be caused by the import, manufacture, use,
storage or disposal of the chemical.
• Preliminary assessment - undertaken to determine either the significance of
the chemical properties, the intended use, adverse health or environmental
effects and/or the extent of exposure. For example, a chemical may be a well-
known carcinogen, but the extent of human exposure in Australia may be
unknown. A preliminary assessment would allow an investigation into the
extent of worker and public exposure. If exposure is widespread or high, then
the preliminary assessment would identify the concerns and further assessment
may be necessary.
Chemicals can be declared and assessed as a group to increase efficiencies in the

assessment process. For example, the persulfates of ammonia, potassium and sodium
were declared in April 1998 for assessment together.
9.3 How Will I Know if I Need to Supply Information?

You may be required to supply information at any of three stages during the
declaration of a PEC. The request is made in the form of a notice published in the
Chemical Gazette or mailed to you. These notices, which refer to sections of the Act,
are:
1. A Section 48 Notice calling for more information about a chemical (which you
may or may not be importing or manufacturing) that is being considered for
declaration as a PEC.
2. A Section 51 Notice calling for an assessment application for a chemical you
are importing or manufacturing, which has been declared a PEC.
3. A Section 58 Notice calling for information about a chemical you may or may
not be importing or manufacturing, which has been declared a PEC. A Section
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58 Notice may also be published after assessment commences if the need for
further information has been identified.
9.3.1 The Section 48 Notice
When deciding whether to make a recommendation for the declaration of a chemical

as a PEC, the Director may require additional information. This may include:
• specified information about a particular chemical, such as use and health

and/or environmental effects;
• the quantities of the chemical used for a specified purpose in a specified
period, for example, use in cosmetics over the past three years; and
• the quantities of the chemical manufactured or imported in a specified period.
The notice will include the persons who are required to provide the information and
the period in which the information is to be provided (at least 28 days).
The notice might specify particular companies or associations who should provide
information, or it might be a more general notice requesting information from all
introducers or users of the chemical.
Those to whom the notice is directed must comply with the request within the time
specified in the notice unless there is a reason that satisfies the Director. There is a
penalty for non-compliance.
The information must be sent to the Director, be in English, and be as complete as

possible to assist the Director in deciding whether to recommend declaration of the
chemical or not.
Providers of information may claim certain items of information as exempt from

publication, with justification of each claim. Claims for exempt information must be
made on Form 3, which is sent with a nominated fee to the Director. Form 3 should
accompany the main body of information being submitted.
Further guidance on exempt information is detailed in Appendix 6 - Confidentiality.
9.3.2 The Section 51 (Declaration) Notice
The declaration notice generally contains four main sections:
• the declaration statement listing the chemical with its name and CAS number,
whether the assessment is a preliminary or full assessment, and whether the
declaration is to apply to the chemical generally or whether it is to apply to a
specific use, geographical area or circumstance;
• the requirement to apply for assessment, specifying who must apply, how to
apply and when to apply;
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• the list of matters to be taken into account when carrying out the assessment,
for example, the likely uses of the chemical and its risk to human health and
the environment; and
• the list of information, which should accompany any application for
assessment and how it should be provided.
If appropriate, the notice will also mention whether the chemical is to be assessed
together with another chemical or as a class of chemicals.
Persons who are not manufacturers and importers of the chemical or mixtures
containing the chemical may also apply for assessment, for example, industry
associations, unions or members of the public with health and/or environmental
concerns about the chemical.
Joint applications are allowed under the Act. Two or more manufacturers and
importers may come to an arrangement to submit a joint application for assessment.
This may involve sharing of information to be provided or in some cases a
coordination point for liaison with NICNAS.
Detailed information about responding to a Section 51 Notice is included below under

Applying for Assessment of a PEC.
9.3.3 The Section 58 Notice
The Section 58 Notice may specify persons such as past manufacturers, those
expecting to introduce the chemical in the near future, formulators and industry
associations and ask them to supply information. The list of information to be
provided is usually the same as that listed for applicants for assessment (i.e.
respondents to the Section 51 Notice), but there may be instances where specific
information is requested from a particular notifier, for example, a particular company
may have specific environmental exposure data
9.4 Applying for Assessment of a PEC

All applications for the assessment of a PEC must be on the Form 1-PEC form. The
form can be found in Appendix 1, on the NICNAS website
(www.nicnas.gov.au/forms) or by contacting NICNAS on 1800 638 528.
For any queries, the NICNAS officer nominated in the notice in the Chemical Gazette
should be contacted.
Any of the following information may need to be submitted:
• the physical and chemical properties of the chemical, as listed in paragraph 9

of Part B of the Schedule in the Act;
• the health and environmental effects of the chemical, including known human
and environmental effects, and the items listed in Part C of the Schedule;
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• the quantity, or proposed quantity, imported or manufactured, as listed in

paragraph 5 of Part B of the Schedule;
• uses or potential uses of the chemical, as listed in paragraph 3 of Part B of the
Schedule;
• the names of customers to whom the applicant or notifier has supplied or
intends to supply the chemical;
• information on the manufacturing procedures, handling (including
transportation) and storage of the chemical;
• information about occupational health and safety, public health and
environmental matters, particularly exposure matters, as in paragraphs 6 to 8
of Part B of the Schedule;
• copies of labels and MSDSs of the chemical and products containing the
chemical; and
• a description of procedures in place to deal with emergencies involving the
chemical.
The information required for PECs will generally vary from chemical to chemical.
For example, more information will usually be required for PECs for full assessment
than for PECs for preliminary assessment. Also, there may be no environmental
assessment for a particular PEC, so no information relating to environmental matters
would need to be submitted. Also, more specific data on particular aspects of
toxicology and ecotoxicity (than mentioned in the Schedule) may be required,
depending on the chemical and its hazards.
All test data must be supported by methodology. Compliance with currently accepted
principles of good laboratory practice is preferred and should be stated if it applies.
All potential notifiers are encouraged to discuss data requirements with the nominated
NICNAS contact officer.
9.4.1 Joint Submission of Information
Notifiers may submit a joint notification for some items of information specified in
the notice, for example, common toxicity data need only be supplied once. On the
other hand, some items of information, such as information on use, worker exposure
and handling procedures of the chemical should be submitted on an individual basis
by each notifier so that a good cross-section of information can be obtained to enable
a proper assessment of the PEC.
9.4.2 Exempt Information
You may request that certain items of information be regarded as exempt from
publication. Justification for these claims must be included in the notification. Claims
for exempt information must be made on Form 3, which is sent with a nominated fee
to the Director. Form 3 should accompany the main body of information being
submitted. Further guidance on exempt information is detailed in Appendix 6 -
Confidentiality.
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9.5 The Assessment Process

Figures 9.1 and 9.2 summarise the procedures following declaration of a chemical as
a PEC, through to preparation of a draft report and finalisation of the report.
In assessing PECs, detailed information is collected on health and environmental

effects as well as data on human and environmental exposure to the chemical. Most of
the information is provided directly by applicants and notifiers, overseas organisations
and the published literature. Wherever possible, international reviews and reports are
used to improve efficiency and minimise duplication. For example, reports from
international organisations and departments such as World Health Organisation
(Environmental Health Criteria Reports), Organisation for Economic Co-Operation
and Development, International Agency for Research on Cancer and the United
States' Department of Health and Human Services (Agency for Toxic Substances and
Disease Registry Reports) are used wherever possible.
In most cases, informal site visits by NICNAS officers are carried out to obtain
further information for the assessment, and to ensure the recommendations in the
assessment report are both practicable and relevant.
NICNAS officers coordinate the overall assessment and perform the primary
toxicology, occupational health assessment and public health assessment. Under an
agreement with NICNAS, Environment Australia (Department of the Environment
and Heritage) undertakes the environmental assessment.
The scope of the assessment is set by the 'matters to be taken into account', which are
listed in the declaration notice in the Chemical Gazette. This is largely dependent on
whether the assessment is to be a full or preliminary assessment and whether the
assessment will focus on occupational health, public health or the environment, or
whether all aspects will be covered.
In full PEC assessments, a risk assessment is conducted to give a measure of the risks
to occupational health and safety, public health and the environment resulting from
exposure to the chemical. The risk assessment is based on an assessment of exposure
and health and environmental hazards using international standards and guidelines.
The most up-to-date methods of exposure, hazard and risk assessment are used, with
assessors keeping abreast of new developments in the field internationally. In
preliminary PEC assessments, the assessment is confined to an assessment of
exposure and/or hazard.
It is of benefit to the overall assessment that an interactive process exists between

NICNAS, PEC applicants, notifiers and other interested persons. Regular progress
meetings are conducted at key points in the assessment to make the process as
transparent as possible.
The draft assessment report should be completed within six months of the Director
receiving all the required information, unless there are good reasons for extending the
assessment period. For example, there may be important matters to resolve between
NICNAS and the applicants, which require more than the usual amount of
consultation, or new critical data may become available.
85
In all but exceptional circumstances, those persons who have applied for the chemical
to be assessed may continue to import or manufacture the chemical during the
assessment period. Certain activities (for example, the method of manufacture, or a
particular use of the chemical) may be prohibited while it is a PEC on the grounds that
the activity may give rise to an unacceptable health or environmental risk. In such
cases, the Minister announces the prohibition by notice in the Chemical Gazette. A
copy of such a notice would be sent to importers and manufacturers of the chemical.
9.6 The Assessment Report
9.6.1 Contents of the Assessment Report
The procedures for finalising the PEC assessment report are summarised in Figure
9.2.
Under the Act, the assessment report must include a summary of the health, safety and
environmental matters considered in the assessment and a list of recommendations
about certain matters specified in the Act.
Recommendations may be made on matters such as:
• the uses of the chemical, for example, whether any restriction on use is
warranted;
• control measures, including regulatory controls, that need to be implemented
during the manufacture, importation, handling, storage, use and disposal of the
chemical so that the health of persons who are exposed to the chemical is
ensured;
• control measures, including regulatory controls, that need to be implemented
to protect the environment;
• the packaging and labelling of the chemical and products containing the
chemical;
• the content of the MSDS of the chemical and products containing the
chemical;
• the means of disposal of the chemical;
• the procedures to protect people and the environment in the event of any
emergencies associated with the chemical; and
• in the case of a preliminary assessment, whether further assessment is
required.
Regulatory controls may include such matters as hazard classification, exposure

standard, poisons scheduling and health surveillance. Other controls may include
measures such as substitution, ventilation, safe work practices and emission control
systems.
PEC assessment reports do not contain exempt information.
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All PEC assessment reports are different depending on the scope and the matters that
need to be taken into account in the assessment. To date, the following format has
been used for most reports:
• Introduction and background, where details such as the scope and purpose of
the assessment are discussed.
• The identity and physical and chemical properties of the chemical, and
methods of detection and analysis.
• Uses of the chemical and products containing the chemical, including details
about import, manufacture and formulation (focussing on uses in Australia).
• Occupational exposure assessment, including exposure during the various end-
uses and during manufacture and/or formulation. This section will usually
include monitoring results and details of any surveys conducted.
• Assessment of the health effects of the chemical, including toxicokinetics and
metabolism, effects in animals and in vitro test systems, and human health
effects. This section will include an assessment of toxicological studies
submitted by applicants and studies and reports in the open literature. Where
possible, international reports are used in this part of the assessment.
• Health hazard classification based on the assessment of health effects against
the NOHSC Approved Criteria for Classifying Hazardous Substances.
• Public health assessment, which integrates public exposure with the results of
the health hazard assessment.
• Characterisation of the occupational risk resulting from potential exposure to
the chemical. This section brings together the results of the health hazard
assessment and the occupational exposure assessment to give a measure of
risk to workers in terms of a margin of exposure estimated for each of the
various occupational scenarios.
• An assessment of current risk management strategies used to control exposure,
particularly occupational exposure. This section often includes an assessment
of current labels and MSDS of the chemical and products containing the
chemical. The section also includes details of current regulatory controls such
as exposure standards and health surveillance.
• Environmental assessment, which includes an estimate of environmental
release and fate of the chemical and an assessment of its environmental
effects, for example, effects on aquatic species. This is followed by an
assessment of environmental hazard or risk. International reports can be used
in this part of the assessment.
• Recommendations.
• The circumstances in which any secondary notification may be required, for
example, any new information about the health effects of the chemical.
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FIGURE 9.1 - PROCEDURES FOLLOWING DECLARATION OF A CHEMICAL TO

PREPARATION OF DRAFT REPORT
Chemical* is declared a PEC by notice in the

Chemical Gazette
DECLARATION
28 days
Introducers of the chemical lodge applications for

assessment. Information to assist the
No applications are assessment that is specified in the declaration
lodged notice must accompany an application.
INFORMATION Director may require persons

to provide information for the
GATHERING
purposes of assessment by
publication of a ‘Section 58’
28 days notice in the Chemical
minimum to Gazette.
comply with
notice
12
months All information required for the
assessment is collected. Assessment
begins.
ASSESSMENT 6 months** A Section 58 notice

may also be published
after assessment
commences if the
need for further
information is
Draft assessment report is identified
Director may cause prepared
an assessment
report to be
prepared.
* The notice specifies whether the declaration applies to the chemical generally or only when it is used for particular
purposes or in particular circumstances. If more than one chemical is declared, the notice will specify if they are to be
assessed together.
** Assessment timeframe of six months may be extended by the Minister
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FIGURE 9.2 - PROCEDURES FOR FINALISATION OF PEC ASSESSMENT

REPORT
CHECKING Draft report sent to applicants
DRAFT 28 days for applicants to check

for errors
REPORT
Applicants notify Director of any errors
for
28 days for Director to
correct errors
ERRORS
Draft report sent to applicants and notifiers (i.e. those

who provided information in response to s58)
Notice published in the Chemical Gazette indicating

that the draft report is publicly available
28 days for persons to

VARIATION consider draft report
of Persons submit requests No requests for variation

for variation received
DRAFT
28 days for Director
REPORT to consider requests
Director makes a decision regarding requests for

variation. A copy of each decision is sent to each
applicant and the person who made the request.
A Notice that a copy of all decisions is available is
published in the Chemical Gazette.
28 days for persons to consider

Director’s response to
requests for variation
PUBLICATION Persons lodge application with No application

AAT for review of Director’s made to AAT for
of decision(s) review of decision
FINAL
Final report cannot be
REPORT prepared or published until FINAL REPORT
AAT review finalised PUBLISHED
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9.6.2 Correcting Errors in the Draft Assessment Report
On completion of the draft assessment report, a copy is sent to each applicant with a
letter asking them to correct any errors in the report. These errors may include factual
errors, for example, volumes of chemical imported, calculation errors and editorial
errors.
If the applicant finds errors in the draft assessment report, then the Director must be
notified within 28 days of notice being sent. Notification of errors must be in writing
and clearly state the location of the error in the report, the correction to be made and,
if necessary, a reference to support the correction. Notified errors are then verified by
NICNAS and the draft report amended accordingly. Under the Act, errors must be
corrected by NICNAS within 56 days of notice being sent to applicants.
It is not intended that this phase of the assessment process address formal variations to
the report based on matters such as scientific methodology and expert judgment.
These types of request for change to the assessment report are handled later in the
process. However, the applicant may foreshadow that applications for this type of
change are likely to be submitted later (in the formal variation period).
9.6.3 Variation of the (Corrected) Draft Assessment Report
Persons and organisations have the opportunity to request changes, or variations, to

the draft assessment report. There are no fees required for these requests. In effect, the
draft report is available for public comment.
Report Sent to Applicants and Notifiers
On correction of errors in the draft assessment report, a copy of the report is sent to
each applicant and to each person who provided information for the assessment in
response to the Section 58 Notice in the Chemical Gazette. This must be done within
56 days of the (uncorrected) draft report and notice being sent to applicants.
Notice in the Chemical Gazette
Also within 56 days, a notice will be placed in the Chemical Gazette describing how a
person may obtain a copy of the (corrected) draft report and how to make a request to
vary the report. Copies of the (corrected) draft report are available from NICNAS.
Request to Vary Assessment Report
Within 28 days of the above notice in the Chemical Gazette, any person or
organisation may ask the Director to vary the draft assessment report. For example, a
person may disagree with the conclusions or recommendations in the report on
scientific grounds and make a request that the report be altered. Requests for variation
must be made on a standard form (Form 4a), which is sent to the Director. All
applications for variations must identify the exact words, sentence or paragraph in the
report to be varied and then state replacement words, sentences or paragraphs. The
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rationale behind any request for variation must be clearly explained, with references,
so that the Director can decide whether it would be correct to alter the report.
Variation of the Draft Assessment Report
The Director may accept or refuse any request to vary the report.
In all cases, the decision is based on sound scientific judgment and advice, and the
reasons are clearly stated. Also, the decision must be made within 56 days of the
notice in the Chemical Gazette inviting applications for variation. A copy of each
decision made during this process is sent to each applicant for assessment and each
applicant for variation, together with the reasoning behind each decision. Copies of
each decision are publicly available (see below).
If the Director refuses to vary the report, then publication of the report is delayed, to
allow any appeal to the Administrative Appeals Tribunal by the applicant. Otherwise
the Director changes the report and proceeds towards publication.
After making a decision concerning a request for variation, the Director:
• publishes a notice in the Chemical Gazette stating the decision made on the
request and how any person or organisation can obtain a copy of the decision;
and
• gives a copy of the decision and a copy of the notice to each applicant for
assessment and each applicant for variation.
Once the draft assessment report is changed in accordance with the variation process,
it becomes the final assessment report for the PEC.
9.6.4 Summary Report
Before the final assessment report is published, a summary report for the PEC is
prepared. This must include the names by which the chemical is known (including
trade names), the name of each applicant for assessment, the address where copies of
the final assessment report can be obtained, and any other prescribed information.
While there are no regulations governing additional material in the summary report, it
usually contains an abstract outlining the health and environmental effects of the
chemical, its uses, and a list of recommendations. As in draft and final PEC
assessment reports, summary reports for a PEC do not contain exempt information.
The summary report is published in the Chemical Gazette.
9.6.5 Final Report
The final assessment report is issued to each applicant and each respondent to the
Section 58 Notice as well as to the Commonwealth departments responsible for public
health and the environment. In addition, copies are usually given to the relevant
authorities in each State and Territory, who may adopt some of the recommendations.
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Once a final assessment report is published, the chemical is no longer a PEC.
9.7 Removal From AICS

Where a chemical has been declared a PEC, and no application for the assessment of
the chemical is received within the 12 months after declaration, and the chemical has
not been assessed under the Director's instruction, the Director must remove the
chemical from the AICS.
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10. Other Assessments and Notifications

This chapter describes assessments and information resources other than Priority
Existing Chemical assessments that are produced under the Existing Chemicals
Program. It also refers to obligations of introducers of industrial chemicals in regard
to secondary notification of chemicals that have previously been assessed as Priority
Existing Chemicals.
10.1 High Volume Industrial Chemicals

NICNAS maintains a list of industrial chemicals manufactured or imported into
Australia at quantities greater than or equal to 1000 tonnes/year. The Australian High
Volume Industrial Chemical List was first established in 2002 from information
supplied by importers and manufacturers of industrial chemicals during 2000-2001.
Companies importing industrial chemicals in volumes ³ 100 metric tonnes per year
between 1999 and 2001 were required to submit information regarding chemical
identity, the volumes imported and general uses of the chemicals, under section 48
Subdivision 5B of the Act. The High Volume Industrial Chemical List contains
aggregate quantities of reportable chemicals in bands defined by orders of magnitude,
namely, 1000-9999 tonnes, 10,000-99,999 tonnes, 100,000-999,999 tonnes, and
1,000,000 tonnes and above. It contains information on chemical identity (chemical
name and CAS number), uses of the chemical and industries that use the chemical.
The HVICL serves the following functions:
• As an OECD member country, Australia must contribute to assessment of

industrial chemicals carried out under the OECD's High Production Volume
(HPV) Chemicals Programme. From June 1999, determination of individual
country contributions to the Programme is based on national production of
high volume chemicals.
• Information on the pattern of introduction and use of industrial chemicals in
Australia enables NICNAS to support or selectively sponsor the international
assessment of chemicals of particular importance to the Australian people and
environment.
• The information assists NICNAS in the screening of existing chemicals for
national assessment under the Priority Existing Chemicals program.
• Inclusion of a compilation of the information in a publicly available Australian
High Volume Industrial Chemicals List (AHVICL) addresses the increasing
public demand for easily accessible information on potential chemical hazards
to human health and the environment, that is, the community's 'right to know'.
From time to time information is sought on chemicals on the HVIC List by a notice in
the Chemical Gazette under section 48, Subdivision 5B of the Act, to assist in
decisions on whether assessments might be warranted and if so, the type of
assessment. HVICL chemicals may be selected for recommendation as PECs, or may
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be the subject of a shorter assessment such as for an Existing Chemical Information

Sheet.
10.2 Information Sheets

Existing chemicals that are considered of concern for one reason or another may be
subject of calls for information under Section 48 Subdivision 5B of the Act, but may
not always be considered suitable for assessment as a Priority Existing Chemical. In
this case, it may be considered that a smaller type of assessment will fulfil a perceived
requirement for information on the chemical. Existing Chemical Info Sheets contain
summaries of available data on one or more aspects of a chemical that has not been
declared a PEC. Other non-PEC assessments and information products produced
under the Existing Chemicals Program include:
Safety Info Sheets provide a concise plain English summary of the major findings of
PEC assessment, and are suitable for display in the workplace.
NICNAS Alerts highlight and provide information on topical activities.
Screening Assessments provide a summary of information collected in chemicals that

have been nominated for assessment as PECs, screened to see if they fit the criteria
for assessment, and not selected for assessment. These assessments provide an
explanation of why the chemical or chemical group was not selected.
Chemical Info Sheets provide information on general chemical subjects.
The above products are available on the NICNAS web site at www.nicnas.gov.au
10.3 Secondary Notifications

Under Section 64, Division 6, of the Act, the secondary notification of a chemical that
has previously been assessed as a Priority Existing Chemical may be required where a
person who introduces the chemical or the Director becomes aware of circumstances
that may warrant a reassessment of its hazards and risks. For guidance on the types of
circumstances that may obligate a secondary notification and the procedure for
Secondary Notification, refer to Section 4 of this Handbook.
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Section IV – Continuing Notification and Assessment Methodologies
SECTION IV - Continuing Notification and

Assessment Methodologies
11. Secondary Notifications
This chapter provides information on your obligations to NICNAS after a new
chemical has been assessed and given approval to be introduced by manufacture or
import. The chapter also outlines the relevant changes in circumstances associated
with a chemical that has been previously assessed, which may lead to a secondary
notification.
11.1 Introduction of an Assessed Chemical

For chemicals introduced under a commercial evaluation category and early
introduction permit category, the permit holder must notify the Director at the end of
the period for which the commercial evaluation or the early introduction permit is
issued, any health effects reported, the amount of chemical used and the means of
disposal of any surplus.
For chemicals introduced under a low volume chemical category, the permit holder
must notify the Director in writing within 28 days of becoming aware of any of the
following circumstances: (a) the function or use of the chemical has changed or is
likely to change significantly; (b) the amount of the chemical being introduced has
exceeded or is likely to exceed the limit allowed to be introduced per annum; (c) the
chemical has begun to be manufactured in Australia; and (d) the permit holder has
become aware of additional information relating to adverse effects of the chemical.
11.2 Secondary Notifications

Where a chemical has been assessed by NICNAS, there may be changes in
circumstances that would necessitate a reassessment of particular aspects of the
chemical, that is, a secondary notification and assessment.
Secondary notification may be required, for example, when:
• circumstances foreshadowed in the final assessment report have occurred, for

example, a new use of the chemical;
• significant new information about the health or environmental effects of the
chemical become available; or
• the Director becomes aware of a significant change in circumstances, for
example, a significant increase in the number of people exposed to the
chemical.
If it has been less than 5 years since the original assessment certificate was granted,
the secondary notification is assessed as a New Chemical and a fee of up to $7,057
applies.
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If it has been longer than 5 years since the original assessment certificate was granted,
the secondary notification is assessed as an Existing Chemical and no fee applies.
When the Director is notified that NICNAS has received a secondary notification, the
decision regarding whether or not to proceed with the assessment rests on the
Directors discretion.
11.3 Reporting Obligations
The Introducer Becomes Aware of a Significant Change in Circumstances
When there is a change of circumstances associated with a chemical that has been
previously assessed, the onus is on the importer or manufacturer to inform the
Director of Chemicals Notification and Assessment (the Director) within 28 days of
becoming aware that circumstances have changed.
Relevant circumstances requiring a secondary notification are those which may result
in an increased occupational health and safety, public health or environmental risk.
These being:
• A significant new use of the chemical which may:

i. increase the potential for human exposure,
ii. increase the environmental exposure, or
iii. change the type of exposure, for example, from dermal exposure to
inhalation.
For example, a chemical initially used as a catalyst in a chemical reaction may
later be used as a metal cleaning agent.
• A significant increase in the quantity of chemical imported or manufactured.
For example, a tonnage increase from 1 to 10 tonnes per year or from 50 to
500 tonnes per year. Apart from the potentially increased exposure, a
significant increase in quantity may lead to a change in the type of exposure;
for example, the means of disposing of large quantities may be different from
the methods used to dispose of small quantities.
• Production in Australia may have begun for a chemical initially assessed as an
imported chemical.
• A change from less than 1 tonne to more than 1 tonne for a chemical originally
notified as Limited Notification Polymer of Low Concern.
• A change in the method of manufacture which may lead to an increased risk
by:
i. changing from a closed process to an open system,
ii. using different raw materials,
iii. using different processing conditions,
iv. increasing the number of workers required,
v. changing the type of exposure,
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vi. changing the method of waste disposal, or

vii. increasing the environmental exposure.
• New information on potentially hazardous properties of the chemical may
have been identified since the initial assessment. For example, it may become
known at a later stage that the chemical is carcinogenic.
The Director Becomes Aware of a Significant Change in Circumstances
If the Director becomes aware, for example, from a third party, of changes or likely
changes in circumstances, and has not been informed by the manufacturer or importer,
then he or she has the right to call for a secondary notification independently. Based
on the type of information available, the Director will decide whether or not
secondary notification of the chemical is required.
11.4 Gazetted Secondary Notification
Where the Director has decided that secondary notification of a chemical is required,
a notice will be placed in the Chemical Gazette and will be addressed to a specific
notifier or to all persons who import or manufacture the chemical.
The Director may also contact persons who may hold information that may assist in
the secondary assessment. In these cases, the Director will give notice in the Chemical
Gazette to other selected importers and manufacturers of the chemical to submit
information relevant to the change in circumstances that prompted the secondary
notification.
By taking into account the change in circumstances and the impact that the change
will have on occupational health, public health and the environment, the notice will
specify those data items in the Schedule where information must be provided. For
example, a significant new use of the chemical may lead to revised occupational
health and safety information and revised emergency procedures. Another example,
where information on occupational exposure may be specified in the case of a
significant increase in the number of workers exposed has prompted a secondary
notification.
For further information about the Schedule of data requirements and assessment
methodologies, refer to Chapters 11 and 12 in Section IV of this handbook.
11.5 Application for Secondary Notification
An application for a secondary notification should be made on Form 1-SN in

Appendix 1. Secondary notification statements must include all available information
according to those specified in the notice by the Director in the Chemical Gazette. All
documents sent to the Director in support of a secondary notification must be in
English. The notifier may request that certain items of information remain exempt
from publication, with justification of each claim to be included in the notification.
Further guidance on confidentiality is detailed in Appendix 6 - Confidentiality.
11.6 Assessment Process and Reports
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In normal circumstances, a secondary notification assessment is completed within 90

days from the date of acceptance of an application for a secondary notification
assessment, that is, the date of receipt of the complete notification package.
Following the assessment of a notified chemical under a Secondary Notification

category, the original assessment report is modified within 90 days. The following
reports are prepared and sent to the applicant:
• assessment report (the version containing exempt information);

• full public report (assessment report without the exempt information); and
• summary report.
11.7 Penalties
There may be penalties for failing to notify the Director of a change in circumstances.
When deciding whether a notifier should have been aware of a change in
circumstances, the Director will take into account the notifier's knowledge, skills and
experience as well as the nature of the change in circumstances - for example, the
impact of the change on the health and safety of workers, the public at large and the
environment. Manufacturers and importers in doubt as to whether a secondary
notification is required should contact the Director for advice.
For new chemicals where a failure to make a secondary notification has occurred, the
Minister may suspend any assessment certificate or permit which the notifier may
have for that chemical. If the chemical is already imported or manufactured in
Australia, non-compliance may lead to importation and/or manufacture being
prohibited.
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12. Assessment Methodologies

This Chapter outlines in detail how the various aspects of a chemical's toxicology, and
its effects on occupational health and safety, public health and the environment, are
considered in the processing of assessing a new or existing chemical. The material
should be used as further guidance when you are compiling your application.
12.1 About NICNAS Assessments

NICNAS officers within the Office of Chemical Safety (OCS) of the Therapeutic
Goods Administration carry out toxicological, public health and occupational health
and safety assessments. The Risk Assessment and Policy Section of Environment
Australia conduct the environmental assessment for NICNAS under a service
agreement. The type and degree of assessment varies depending on the type of
notification. For example, a quantitative risk assessment may be conducted for a
priority existing chemical, whereas a qualitative assessment usually occurs for a new
chemical. The risk assessment entails some or all of the following elements:
• hazard identification;
• hazard assessment, incorporating the dose-response relationship;
• exposure assessment; and
• risk characterisation, where the hazard and exposure assessments are
integrated.
For some priority existing chemicals, the assessment may be limited to a hazard
and/or exposure assessment only.
Assessments are conducted on a case-by-case basis and will be based on a weight of

evidence approach, taking into account scientific judgment, knowledge of the
mechanism of action of effects, and recognition of the inherent uncertainty in
extrapolating animal data to humans. From the risk assessment, recommendations are
formulated to manage the risk, taking into account existing risk management
strategies.
12.2 Toxicological Assessment

The toxicological assessment establishes the toxicity of the chemical and identifies
the set of inherent properties that make it capable of causing adverse effects. For
chemicals with unknown toxicity, for example, new chemicals, this would involve a
series of animal studies, which investigate the major biological systems. These would
include studies for acute toxicity, reproductive toxicity, genotoxicity and perhaps
other specific endpoints such as neurotoxicity. For existing chemicals, human health
effects data may be available.
Both human and experimental animal data are assessed in accordance with
international guidelines to identify the critical health effects of the chemical and to
determine the dose-response relationship, with no observed adverse effect levels
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(NOAELs) established wherever possible. Good quality human data is given

preference for the risk assessment. The health hazards of the chemical are classified in
accordance with the NOHSC Approved Criteria for Classifying Hazardous
Substances.
The toxicological database may consist of studies that have been performed with a
structural analogue of the notified chemical, or with a formulation.
Adequacy and applicability of the data will be taken into account when performing
the assessment. Where data gaps exist, or the notification does not require toxicology
data, as with some classes of polymer, the evaluator may be able to predict the
toxicological hazard from the chemical's physical properties or the characteristics of
structurally related chemicals, given that factors such as volatility, solubility and
molecular weight can indicate the likely extent of absorption across biological
membranes.
Whole animal studies are the mainstay of toxicological testing. However, laboratories
are being encouraged worldwide to develop alternative in vitro test systems that will
be predictive of toxicity in vivo.
12.2.1 Quality of Data
To ensure that data is of sufficient quality for use in risk assessment, all new testing
should be conducted according to internationally recognised methods, for example,
the OECD's Test Guidelines, and Good Laboratory Practice (GLP) standards. For
many existing chemicals, the data available will have been generated prior to GLP
and OECD standard methodology. This data can still be used for the assessment if
valid conclusions can be drawn. The evaluation requires the use of expert judgment,
with the determination of validity to be both justified and transparent. In determining
the quality and validity of data, matters such as completeness and scientific detail in
the test report need to be considered.
12.2.2 Relevance of Data
The relevance of test data is considered in the assessment. For example, it is necessary
to judge whether the appropriate route of exposure has been used, whether the most
suitable species has been studied, and whether the substance tested is representative of
the chemical being assessed.
The relevance of animal and in vitro test data for humans is also considered. The
evaluation is aided by use of toxicokinetic and metabolism data for the chemical, in
both animal and humans if possible. Generally, effects observed in animals are
assumed to occur in humans unless there is clear well-documented evidence for a
species-specific effect to justify a conclusion that the effect either could not occur in
humans or is of little relevance. In vitro data alone are generally not directly
predictive for effects on humans.
However, highly electrophilic substances, which give positive results in genotoxicity

studies in vitro, may be of concern regarding their potential to be mutagenic in
humans at the initial site of contact, for example, the skin or respiratory tract.
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12.2.3 Evaluation of Human Data
The evaluation of human data generally requires a more critical appraisal of the
validity of the data than animal data. The main types of human data are
epidemiological studies, controlled studies in volunteers and case reports.
The strength of epidemiological evidence for specific health effects depends on

matters such as the type of analysis and the magnitude and specificity of the response.
Confidence in the findings is increased when comparable results are obtained in at
least two independent studies on populations exposed to the same chemical under
different conditions. Criteria for assessing the adequacy of epidemiological studies
include the proper selection and characterisation of the exposed and control groups,
adequate characterisation of effect and exposure, sufficient length of follow-up for
disease occurrence, and proper statistical analysis.
Controlled human studies are often useful in determining exposure levels associated
with acute effects such as skin irritation. Human patch tests for skin sensitising effects
can also be conducted. Criteria for a well-designed study include the use of a double-
blind study design, inclusion of a matched control group and a sufficient number of
subjects to detect an effect. Epidemiological studies with negative results cannot
prove the absence of a particular toxic effect of the chemical in humans, but good
quality controlled human studies which are negative may be useful in the risk
assessment.
12.2.4 Evaluation of Animal and In Vitro Data
Most of the health effects information required for the risk assessment will be derived
from controlled studies in experimental animals and in vitro test systems.
The assessor needs to identify the adverse effects of the chemical in the study, and
make a judgment about how well the study identifies that particular effect.
Generally, the assessor needs to judge whether the study establishes a dose or
exposure level at which the critical effect is not observed. For repeated dose studies, a
NOAEL should be established or, where this is not possible, a LOAEL stated.
For each study, it is important to evaluate the study design and how the study was
carried out. Matters such as the frequency and duration of exposure, appropriateness
of the species and strain of animals used, and the choice of doses need to be
considered. Matters that need to be considered in the evaluation of data in each study
include the assessment of effects on control animals, causes of mortality, clinical
observations during the exposure period, organ and body weight changes and
biochemical changes.
12.2.5 Dose Response Assessment
It is generally agreed that there is a threshold dose or concentration for many of the
adverse health effects caused by chemicals. The threshold dose may vary considerably
for various routes of exposure and for different species because of differences in
toxicokinetics and possibly also mechanisms of action. The observed threshold dose
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in a toxicity test will be influenced by the sensitivity of the test system, that is, it will
depend on the exposure concentrations used in the study.
Unless a threshold mechanism is demonstrated, it is generally taken that thresholds

cannot be identified in mutagenicity in vivo and genotoxicity, although a dose-
response relationship may be demonstrated under experimental conditions.
When a reliable dose-response relationship has been identified, then the slope of the
curve is taken into account. For a steep curve, the NOAEL is more reliable, as the
greater the slope, the greater the reduction in response to reduced doses.
For a shallow curve, the uncertainty in the NOAEL may be higher and must be
allowed for in the risk characterisation.
12.3 Occupational Health and Safety Assessment

In general, the aim is to determine the potential risk to the health and safety of
workers. This is achieved by assessing the health and physico-chemical effects of the
chemical, estimating the exposure to workers, and then characterising the risk.
However, in some cases, a hazard assessment only is conducted. For new industrial
chemicals, the occupational health and safety assessment is normally a hazard
assessment as exposure data is limited. For some types of priority existing chemical
assessments (preliminary assessments), a characterisation of use or an assessment of
exposure only may be required. Where possible, peer-reviewed international reviews
are utilised in the assessment.
12.3.1 Exposure Assessment
The exposure assessment is conducted by establishing the use pattern of the chemical
and identifying the sources of occupational exposure. Exposure is then estimated by
taking into account the routes of exposure, the frequency and duration of exposure,
and measured worker data, for example, atmospheric and/or biological monitoring
results. Information is needed for each of the scenarios where workers are potentially
exposed to the chemical. The reliability of the measured data, and its ability to be
representative, are considered in the assessment. If insufficient measured data are
available, then model calculations are used to estimate typical and 'reasonable worst-
case' exposure levels. Where necessary, default values are used for certain input
parameters in the model calculations, for example, inhalation rate, body weight and
skin surface area.
Internationally accepted methods are used in the assessment, for example, a

modification of the United Kingdom EASE (Estimation and Assessment of Substance
Exposure) model is used for estimating exposure. Where exposure levels have been
determined from both measured and modelled data, preference is usually given to
measured data provided it is both reliable and representative of the scenarios being
considered in the assessment.
For new chemicals, the occupational exposure assessment is usually qualitative, as

measured data is unlikely to be available and there is insufficient information
available to predict reliable quantitative estimates.
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12.3.2 Risk Characterisation
The health risk to workers is characterised by integrating the exposure and effects
assessments. For brief or short-term exposures, human data and information from
acute toxicity studies in animals are taken into account to determine the risk of
adverse health effects, such as acute respiratory effects and skin irritation.
For longer term and repeated exposures, the health risk to workers is characterised by
firstly comparing exposure estimates with NOAELs to give a margin of exposure
(MOE), and then deciding whether there is cause for concern.
Matters taken into account when characterising the risk include the uncertainty arising
from the variability in the experimental data and inter- and intra-species variation, the
nature and severity of the health effect and its relevance to humans, and the reliability
of the exposure database.
Where an exposure estimate is higher than or equal to the NOAEL, the chemical is of
concern with regard to the exposure of the human population considered. Where the
exposure estimate is lower than the NOAEL, matters such as those mentioned above
are taken into account before deciding whether the chemical is of concern. For
example, the MOE may be based on a human NOAEL, leading to greater certainty in
the characterisation of risk. Conversely, if a LOAEL is used in the absence of a
NOAEL, the degree of uncertainty would be higher and a higher MOE would be
required. Expert judgment is required to weigh these individual parameters on a case-
by-case basis, with the approach to be both transparent and justifiable.
Where it is not possible to determine a NOAEL or LOAEL - for example, where there
is a lack of suitable data - the risk is evaluated on the basis of qualitative or
quantitative exposure relevant to the human population under consideration.
For certain types of health effects, for example, developmental toxicity, the risk to
sensitive sub-populations, for example, pregnant women, is taken into account.
For new chemicals, a more qualitative characterisation takes place as exposures are
often unknown or more difficult to predict.
12.3.3 Risk Management
In the assessment, current risk-reduction strategies are appraised and, if the risk
characterisation has shown that there is cause for concern, then further control
measures are recommended where necessary. Both regulatory and non-regulatory
controls may be recommended.
The hierarchy of controls is used to formulate measures, which can be applied directly
to the workplace to reduce the risk of adverse health effects. Where regulatory
controls may be required, current controls, for example, exposure standards, are
appraised for adequacy.
The standard of hazard communication is often addressed when considering risk

management strategies. MSDS and labels are assessed against the respective codes of
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practice, and programs for the training and education of workers may be
recommended.
12.4 Public Health Assessment

In broad terms, the assessment aims to establish whether there is any potential for the
chemical to adversely affect the health of members of the public. This will be
influenced by two main factors: the nature and extent of any public exposure to the
chemical; and the toxicological properties of the chemical.
When performing an assessment, the evaluator will begin by identifying the chemical,
together with its estimated production or import volume and proposed use, examine
the entire life history of the chemical and consider the potential for the public to
become exposed at each phase of its lifecycle. This would begin with importation or
synthesis and transport within the country, proceed through to reformulation or use in
industrial processes and possible use in consumer or industrial goods, and finish with
the eventual disposal of the chemical (or products containing it).
Public exposure to notified chemicals most often occurs when they are sold in
consumer products, or when products containing them enter the public domain.
The extent of public exposure will depend on the concentration of the chemical in
products, the sales volume and use pattern of the products, and other factors including
the physical state of the notified chemical. The evaluator will differentiate between
the number of people likely to be exposed and the likely dose (amount of chemical
exposure) to each individual resulting from the product's intended use. Most members
of the public will be exposed to a chemical constituent of a widely used product, for
example, an additive to motor oil, but the amount of exposure may be minimised by a
brief duration and/or low frequency of contact. Conversely, small numbers of people,
for example, users of a photo-developing solution, may be exposed to comparatively
greater amounts of a chemical, with exposure being increased by prolonged or
frequent contact.
Some products, such as ink cartridges, will be packaged so as to reduce the

opportunity for contact with the notified chemical during normal handling.
Other products may come into contact with members of the public without causing
exposure to the notified chemical. For example, polymers or dyes used in plastic or
fibre may enter the public domain in an encapsulated, bonded or cured state from
which they cannot be absorbed or otherwise become bioavailable. Here, even
extensive or prolonged contact would lead to negligible exposure.
The evaluator must take into account the possibility of public exposure arising from
release into the environment during transport, manufacturing or end-use.
Among the most important factors here will be the amount of chemical which may be
released, the location of possible discharges or spills, and the chemical's physical state
when it enters the environment. These will influence the probability of public contact
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with the chemical at the release site, or the chemical exhibiting mobility in the air, soil
or water, which will in turn determine whether it may be inhaled or enter the potable
water supply or food chain. Emergency containment, cleanup and disposal procedures
given in the MSDS could play a significant part in mitigating the effects of an
accidental release, and will be noted. Similarly, the notified chemical may enter the
environment following its disposal, or disposal of products containing it, and the
assessment report will include consideration of the likelihood of public exposure
arising from this means.
12.4.2 Assessment of Toxicological Assessment
Where toxicology data have been provided, the evaluator will consult the toxicology
assessment to determine the nature and severity of any hazards posed by the chemical.
Irrespective of the class of notification, the identity and concentration of hazardous
impurities or residual monomers will be examined, and the evaluator will comment on
their likely toxicological significance at the levels present in products entering the
public domain.
12.4.3 Implications for Public Health
Utilising the above information, the evaluator will then assess whether the chemical is
likely to pose any significant risks to the public. The use, concentration and physical
state of the chemical when it reaches the public domain will have an important
bearing on this part of the assessment. Many notified chemicals will have no adverse
effect on public health, due to low potential for exposure and/or low toxicological
hazard at the levels present in products. However, where frequent or prolonged public
exposure to the chemical is anticipated due to its presence in consumer goods, for
example, take away food containers, laundry detergents and personal care products,
the evaluator may make a quantitative estimate of the user's exposure/intake of the
chemical. Some notifiers may supply this information but, alternatively, the evaluator
may apply an algorithm based on those described in the European Commission's Risk
Assessment of Existing Substances - Technical Guidance Document (1994). The
exposure estimate is then related to the results of toxicological studies to determine
the margin of exposure between the anticipated consumer exposure/intake and doses
causing toxicologically significant effects in animals. Finally, the evaluator will
recommend whether any special conditions are required to protect public health, such
as warning statements to appear on the label or an upper limit to the concentration at
which the notified chemical may be used in certain product types.
12.4.4 Priority Existing Chemicals
Public health assessment methods for priority existing chemicals (PECs) are similar to
those for new chemical notifications, although the size and complexity of the
assessment report may be increased, depending on the amount of information
available on use, and the extent of animal and human toxicological data. If a survey of
the PEC's use in industrial and consumer products has been performed, its results will
be incorporated into the assessment. Where a PEC has been subjected to Poisons
Scheduling, consumer product labels will be examined to verify compliance with the
requirements of the Poisons Schedule with regard to signal headings, first aid
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instructions and safety directions. Otherwise, the evaluator will comment on the
general suitability of label directions for use and other statements.
If there is any indication of potentially significant public exposure to the PEC, either
from environmental sources or its use in, or contamination of, consumer products, the
evaluator will assess the level of risk to the public. The approach taken will vary with
the extent of data on exposure levels and toxicology, and with the nature of any
hazard posed by the chemical. As with new chemicals, the evaluator may calculate a
margin of exposure. Alternatively, the level of risk to the public may be inferred from
the extent of public exposure and epidemiological evidence of health effects in
persons exposed occupationally.
Whenever there appears to be significant risk to public health, recommendations are

made with a view to reducing public exposure to the PEC. Where public exposure
arises from environmental contamination, the evaluator may recommend that
measures be taken to reduce emissions of the PEC. If the primary source of public
exposure is from consumer products, the evaluator may recommend review of the
poisons scheduling status of the PEC, or revision of label instructions for use, first aid
instructions and/or safety directions. In cases where the nature of the hazard or the
level of risk require it, the evaluator may recommend an upper limit to the
concentration of the PEC in consumer products, or even that use of the PEC in
consumer products should cease. Where there are grounds for concern based on
toxicological findings, but there is insufficient information upon which to base
realistic estimates of public exposure and risk, the evaluator may also recommend that
further data be obtained to enable an adequate assessment of the implications for
public health.
12.5 Environmental Assessment

In conducting an environmental assessment, Environment Australia estimates the
extent of the potential environmental exposure based on information supplied by the
notifier along with local and literature sources. The environmental effects of the
chemical are also measured by the degree of toxicity to aquatic organisms.
The potential hazard of the chemical to the environment and its fate are then
evaluated. Schedule information required for an assessment of the potential
environmental impact includes chemical identification data (paragraph 1 of Section B
of the Schedule), certain physical and chemical data (paragraph 9 of Section B of the
Schedule, including water solubility, hydrolysis, partition coefficient, dissociation and
adsorption/desorption), volume of import and/or manufacture (paragraph 5 of Section
B of the Schedule), environmental release (paragraph 7 of Part B of the Schedule),
environmental fate (biodegradability and bioaccumulation potential (paragraphs (q)
and (r) of Part C of the Schedule), and the toxicity to aquatic organisms (paragraphs
(m) to (p) of Part C of the Schedule). Note that the fate and toxicity information are
only required for Standard Notifications, though these should be provided if available
for the other categories.
12.5.1 New Chemicals
Exposure
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To determine environmental exposure, a cradle-to-grave approach is adopted.

Information on all stages of the life cycle of the notified chemical while in Australia is
required to determine the amount of chemical released to the environment. This
includes releases (if relevant) of the chemical during the manufacture, processing,
distribution, application, use and disposal stages (paragraph 7 of Part B of the
Schedule). It is emphasised that much, if not all, of this information should be
obtained locally, rather than from overseas sources. If low environmental exposure
can be demonstrated, consideration to waiving certain elements of the environmental
fate and toxicity data requirements for Standard Notifications can be given.
Fate
The fate of the chemical in all of the environmental compartments, including

wastewater treatment systems and landfills, is established based on the physical and
chemical properties of the chemical. For standard notifications, stability in water
(hydrolysis), biodegradation and bioaccumulation are Schedule requirements.
However, additional data may be considered if relevant, for example, stability in air,
ozone depletion and atmospheric half-life if volatile, transport and distribution
between environmental compartments. The level of detail will vary between
assessments depending on the available data and the type of assessment, for example,
Standard Notifications, Limited Notifications or Polymers of Low Concern
Notifications. Monitoring data and levels in the environmental media may also be
considered, although this is more common for existing chemical assessments.
Effects
The environmental effects are determined based on ecotoxicological data as outlined

in paragraphs (m) to (p) of Part C of the Schedule. Aquatic organisms are used as an
indication of the environmental effects as industrial chemicals are often directly
released to the aquatic compartment as waste products in effluent.
Tests on three different aquatic species at increasing trophic levels, that is algae,
aquatic invertebrates and fish, are essential to gain a sound indication of the
ecotoxicological profile, given the potential differences in toxicity to these organisms.
The provision of ecotoxicological data is only required for Standard Notifications.
However, data should be provided if available for other classes (Limited Notifications
or Polymers of Low Concern Notifications), particularly where the use pattern would
result in release to the aquatic compartment and if the substance belongs to a class
known to exhibit aquatic toxicity.
Hazard
The exposure, fate and effects data are used to determine the potential environmental
hazard. Likely and worst-case exposure patterns are compared to the chemical's
ecotoxicological profile to ascertain which living organisms, if any, are likely to be
affected by the chemical's proposed use (as detailed in points 2 and 3 of the hazard
section for PECs immediately below). If the hazard is unacceptably high, measures
will be recommended to reduce the environmental exposure or mitigate the
environmental effects.
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It is usually difficult to perform a formal hazard assessment for Limited Notifications

and Polymers of Low Concern Notifications, as fate and effects data are not Schedule
requirements. In these cases, attention is focused on the extent of environmental
exposure, particularly to the aquatic compartment, taking into account available
ecotoxicity information.
12.5.2 Priority Existing Chemcials (PEC’s)
Exposure
Priority existing chemicals often require more in-depth analysis of releases to the
environment, as these chemicals are usually high-production volume or high-use
substances, so are widespread in use around the country. Surveys are usually
conducted by NICNAS to determine import quantities, manufacturers, formulators
and end-users. Environment Australia uses this information to predict highest
exposures.
Fate
For PECs, the fate of the chemical in all of the environmental compartments is also
established, based on the physical and chemical properties of the chemical.
Specifically considered are stability in soil, water (hydrolysis) and air (photolysis and
photodegradation), transport and distribution between environmental compartments,
including predicted environmental concentrations and distribution pathways, mode of
degradation in actual use, biodegradation and bioaccumulation. Additionally, for PEC
assessments, monitoring data and levels in the environmental media may also be
considered.
Effects
In a similar manner to new chemicals, the environmental effects are determined based
on ecotoxicological data as outlined in sections (m) to (p) of Part C of the Schedule.
However, as a result of their wider exposure, the toxicity to terrestrial organisms, soil
dwelling organisms, terrestrial plants and birds may also be considered during a PEC
assessment. The type of organisms that are considered is dependent on the
expected/predicted exposure patterns. For example, for chemicals released to soil, the
toxicity to soil dwelling organisms may be necessary to determine the potential hazard
to these organisms during the calculation of the environmental hazard.
Hazard
The environmental hazard in existing chemical assessments is determined using the

following procedures:
1. An estimate of the concentration in respective media (water, soil and air) is

made based on release estimates determined above, assuming worst-case
conditions. Often, as is the case for new chemicals, the aquatic compartment is
the main focus.
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2. This estimated environmental concentration is compared to the known

environmental effects levels. In order to determine the potential hazard, the
lowest toxic effect for the environmental compartment, for example, the LC50
result for Daphnia, is considered. The ratio of the estimated environmental
concentration to this toxic effect result is determined.
3. If test results are limited, for example, one acute test for two trophic levels,
then a ratio of less than 0.001 indicates the potential environmental hazard is
low. If there is a large range of tests, for example, several acute and some
chronic for all trophic levels, then a ratio of 0.01 or 0.1 may be justified in
determining the potential environmental hazard. Where ratios are larger than
acceptable, there is an indication that restrictions on use need to be
implemented to reduce the environmental hazard.
12.6 Risk Assessment of Chemicals: Assessment of Exposure from All

Sources
A key objective of the Industrial Chemicals (Notification and Assessment) Act 1989
(the Act) (Section 3) is to provide a national system of notification and assessment of
industrial chemicals for the purposes of aiding in the protection of the Australian
people and the environment by finding out the risks to occupational health and safety,
to public health and to the environment that could be associated with the importation,
manufacture or use of the chemicals.
Thus, NICNAS is a risk based regulatory system.
NICNAS assesses the risks to occupational health and safety, public health and the
environment using well established, internationally accepted methodology
(International Programme on Chemical Safety, 1999; European Commission, 2003).
Risk assessment, when applied to chemicals generally, is the overall process of
decision making, taking into account:
o Hazard assessment (including hazard classification and establishment of

dose-response relationships);
o Exposure assessment;
o Risk characterisation; and
o Risk management.
Chemical Risk Assessment: Our Approach
12.6.1 Hazard Assessment

Hazard assessment establishes the toxicity of a chemical and identifies the set of
inherent properties that makes it capable of causing adverse effects. Thus, the hazard
assessment step identifies the type of hazard that might occur given the appropriate
circumstances.
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The other major variable in the risk characterisation equation is the estimate of
exposure. The purpose of exposure evaluation is to identify the magnitude of
exposure to a particular chemical and to determine the frequency and duration of that
exposure and all the routes by which exposure occurs over the chemical life cycle.
For the majority of chemicals, exposure assessment is probably the most variable
aspect of the risk assessment paradigm. This reflects a variety of contributing factors
such as differing and/or unique exposure and use patterns of chemicals across a range
of industrial uses, the unique nature of ecosystems, fauna and flora, together with
differing methodologies for exposure assessment as well as differences in dose-
response extrapolation methodology.
The exposure assessment is a critical element of the risk assessment and can comprise
both direct exposure (ie. workers carrying out manufacture; consumer use of
household products etc.) as well as indirect exposure via the environment.
The assessment of both direct and indirect exposures via the environment are
important considerations for the risk assessment, particularly for the public health and
environmental assessments where exposure to a chemical may arise from several
sources such as contact with the raw chemical itself, a preparation or mixture, finished
goods containing the chemical (eg. treated fabrics and carpet) or via contamination of
the environment (eg. lead and other chemicals in household dust and ambient air).
Where exposure of the population to a chemical is likely or suspected (ie. through

biomonitoring data or known chemical properties such as leaching) the risk
assessment consideration is extended to include all the sources of the exposure. The
release of chemicals into the environment, for example, from articles via leaching,
exudation and/or surface abrasion, may occur at any time in the life cycle of the
article, including during use, handling, disposal or storage. Hence, NICNAS’s risk
assessment, whilst focussing on regulating chemical use, may also need to consider
the use of a chemical in the production of and release from a finished article.
Therefore, information about the possible release of a chemical from an article may be
required as part of the exposure information to facilitate the risk assessment of an
industrial chemical.
12.6.3 Risk Characterisation

The risk characterisation process involves integrating hazard identification, hazard
characterisation and exposure assessment outcomes.
The process of interpreting and integrating the information on hazard and exposure to
provide a practical estimate of risk is complex and may involve determining what is
an acceptable risk and how risk should be managed.
12.6.4 Risk Management

Risk characterisation is only part of the risk analysis process. The second major aspect
of risk analysis is risk management. Risk management involves risk evaluation, which
addresses the fundamental socio-economic problem of determining the optimal level
of risk in society based on a trade off between risk, cost and benefit.
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The economic and social benefits of any risk reduction action(s) must be balanced
with the economic, political and social costs of implementing the risk reduction
strategy(ies). Risk management also involves monitoring, evaluating and reviewing
the strategies implemented.
References
European Commission (2003) Technical Guidance Document on Risk Assessment.
Part 1. Institute for Health and Consumer Protection, European Chemicals Bureau.
EUR 20418 EN/1.
Industrial Chemicals (Notification and Assessment) Act 1989. Australian
Government, Canberra.
International Programme on Chemical Safety (1999) Environmental Health Criteria
210. Principles for the Assessment of Risks to Human Health from Exposure to
Chemicals. World Health Organization, Geneva.
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Section V – NICNAS Registration
SECTION V – NICNAS Registration

13. NICNAS Registration
All importers and/or manufacturers of industrial chemicals for commercial purposes
must register with NICNAS. Registration for 2004-05 involves an annual
registration fee (refer to NICNAS registration brochure for details), regardless of the
amount of industrial chemicals imported and/or manufactured in that registration year.
A registration year runs from 1 September to 31 August in the following year.
The relevant provisions for NICNAS registration obligations appear in section 80 of

the Act and can be accessed at the SCALEplus website of the Australian Attorney
General's Department at scaleplus.law.gov.au.
NICNAS Registration is not linked to the toxicity or hazardous nature of your

chemicals. It is not the registration of chemicals or products, but is the
registration of your business. The Registration Tier that applies to you depends on
the value of the industrial chemicals you import and/or manufacture.
13.1 What are the benefits of NICNAS Registration?

NICNAS Registration was introduced to improve industry knowledge of NICNAS
and the regulation of industrial chemicals in Australia, thereby enhancing community
confidence in the chemical industry. It will also help to ensure that information and
education on the safe use of chemicals becomes more widely available. The aim of
NICNAS registration is to deliver our goal of 'safe and sustainable use of industrial
chemicals' through effective partnership between the regulator and the industry. By
registering all those in the chemical industry NICNAS will be able to assist and serve
industry more efficiently.
Under NICNAS Registration, a Register of Industrial Chemical Introducers is

maintained www.nicnas.gov.au/obligations/registration/register.htm.
This means NICNAS is able to build up a comprehensive client base, which allows us
to keep you, our industry clients, fully informed of your obligations under the Act. By
engaging with you, we can better target our education and compliance activities to
meet the needs of your industry sector.
Once registered, you will receive the Chemical Gazette over the Internet. The
Chemical Gazette is the formal NICNAS publication for advising important matters,
regulatory issues and requirements for chemical introduction. You will also be
provided with frequent updates through the NICNAS newsletter, NICNAS matters. In
this way you will be kept in the information loop concerning chemical safety.
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Registration fees will be used to fund compliance activities, as well as education and
training, especially targeting small and medium sized enterprises.
13.2 What is an industrial chemical?

Under the Act, industrial chemicals encompass many things and include cosmetics,
solvents, adhesives, plastics, inks in pens and biros, laboratory chemicals, chemicals
used in mineral and petroleum processing, refrigeration, printing and photocopying,
paints and coatings, household cleaning products and toiletries, to name just a few.
The Act specifically excludes articles (such as plastic chairs, glow sticks,
photographic film, etc.) and radioactive chemicals. Chemicals used solely as
medicines, pesticides, veterinary chemicals, and/or food or food additives are also
outside the scope of NICNAS.
13.3 How are we funded?

Our activities have been fully cost recovered since 1997 through NICNAS
Registration fees and charges, fees and administrative charges for new chemical
assessments. NICNAS Registration monies fund the administration of NICNAS
Registration, the assessment of existing chemicals, our education and awareness
activities, and most of our compliance activities. The fees and charges obtained from
new chemical assessments fund the New Chemicals program.
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13.4 How do you decide if you should register with NICNAS?

To help you make this decision, please follow the decision tree below.
Decision Tree for NICNAS Registration
Do you plan to import and/or

manufacture chemicals over the
next year?
NO YES Step 1
NO Is the chemical(s) used for

commercial purposes?
YES Step 2
Is the chemical(s) used for

purposes other than a:
Registration is NO - Pesticide
not required - Veterinary chemical
- Medicine
- Food/food additive?
YES Step 3
Is the chemical(s) other than:

NO - A biological material
- An unprocessed, naturally
occurring chemical?
YES
Step 4
Then you are an importer and/or
manufacturer of industrial
chemical(s) and registration of
your business is required.
Please complete form

Step
NR-1A and return it to 5
NICNAS.
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STEP 1 ‘Chemicals’ is a very broad term: it includes lipsticks,

shampoos, cosmetics (even ones containing naturally-occurring
ingredients), inks in pens/biros, solvents, adhesives, plastics, paints
and toner/inks in printer cartridges. However, it does not include
articles (such as plastic chairs, glow sticks, paper, etc.) and
radioactive materials. The chemical can be an element, compound
or ingredient in a mixture.
STEP 2 Examples of commercial purpose include on selling or use in your

business. Non-commercial purpose includes personal use, teaching purposes, non-
profit research and charity.
STEP 3 Your registration is based on whether you introduce industrial chemicals.

The definition of an industrial chemical is associated with the end use of the
chemical.
Examples to give you an idea on how an industrial chemical is defined by its end
use:
a) Glue for wood binding. This is considered to be an industrial chemical.
b) Chemical for the purposes of pest control. This would be a pesticide and thus
not considered an industrial chemical.
c) Chemical to be used both as a solvent in paint and as a pool chemical used to
kill algae. The proportion imported for use in paint would be considered an
industrial chemical, and thus requires the registration of your business.
It also must be noted that all cosmetics are industrial chemicals, except if they are
used for medical-related purposes (such as anti-dandruff shampoos) and are
registered with the Therapeutics Goods Administration (TGA).
Therefore, if you only import/manufacture chemicals that are solely for use as a
pesticide, veterinary chemical, medicine, food/food additive, then they are not
industrial chemicals, and hence registration of your business is not required.
STEP 4 ‘Naturally-occurring’ chemicals and biological materials (eg. blood),

while industrial chemicals are exempt from NICNAS Registration requirements.
A ‘naturally-occurring’ chemical is very narrowly defined under the Act. Many
substances do come from natural origins, but this does not mean they meet the
definition of ‘naturally-occurring’.
What has to be considered is the process involved in deriving or extracting these
substances. Under the Act, only mechanical processes (eg. dissolution in water,
cold-pressing, etc.) are allowed if substances are to retain their ‘naturally-
occurring’ status. If a chemical process (eg, fractional precipitation) were used,
then the substance derived would no longer qualify as ‘naturally-occurring’.
Examples of biological material would include blood, human or animal tissue, etc.
For more information on which chemicals are within the scope of NICNAS
registration refer to the Fact Sheet on Relevant Industrial Chemicals
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STEP 5 Now that you have determined that you need to register your business
with NICNAS, the next step is to decide which tier you should register under. You
must then complete the form NR-1A and return it to NICNAS.
13.5 Registration Costs

There are three levels of registration. Your registration level, and hence
registration cost, is based on the total value of industrial chemicals imported
and/or manufactured each year. See Appendix 4 for fees and charges.
How do I estimate the value of the chemicals I introduce?

To determine which Tier you should register at, the total value of the industrial
chemicals you import and/or manufacture must first be estimated. NICNAS
Registration is not intended to add unduly to your accounting or record keeping
requirements. You can base your registration level on reasonably justifiable
estimates.
It may be helpful to use relevant commercial documents such as commercial

invoices, order/confirmation bill of lading/airway bill, insurance certificates or
receipts for purchase of goods.
To make this estimation, there are four options:
Option A – You import only:

Annual value of all
= Customs value + Insurance + Freight + Customs Duty
industrial chemicals (in AUS dollars)
Option B – You manufacture only (and buy ingredients from local suppliers):
The total value of industrial chemicals manufactured is
the cost of labour and materials (including all
ingredients) involved in the manufacture, plus the
factory overhead expenses.
Option C – You import AND manufacture, but your

imports are not used in your manufactures:
You would apply Option A to your imports, Option B
for your manufactures and add the two values together.
Option D – You import AND manufacture, but some or

all of your imports are used in your manufactures:
In this case, the total value is estimated in the same way
as in Option C. However, make sure that the value of
the imported chemicals (used to manufacture another
chemical/s) is only counted once when calculating your
total value of introductions.
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13.6 How do I register with NICNAS?

Applications for registration must be made on the approved form NR-1A.
Applications are to:
• contain an approved form completed in full;
• be accompanied by the required payment, and
• be lodged with NICNAS no later than 31 August before the start of the
registration year.
Once the application has been processed, the registrant will be allocated a registration
number and issued with a certificate. The importer and/or manufacturer’s name will
then be placed in the Register of Industrial Chemical Introducers.
Applications for registration will be considered as soon as practicable within 30 days

of their receipt.
Registration is in force the whole of the registration year to which it relates (1

September to 31 August), or for the remainder of that year in the case of part year
registrations. There is no reduction in fee/charge for part year registrations.
13.7 Renewal of Registration

Registrations are renewed on an annual basis. Early in August each year, NICNAS
will send you an invoice and renewal form. Simply complete the Application for
Renewal of Registration/Notice of Non Renewal (NR-2) and return it to NICNAS
with the necessary payment. You have until 31 August to renew your registration.
Renewals received by NICNAS after the renewal deadline of 31 August are subject to
a mandatory late renewal penalty (an additional 15% of the total registration cost).
Which Tier level should I renew my registration at?
All importers and/or manufacturers of relevant industrial chemicals for commercial

purposes are required to pay the registration fee. Some registrants are also required to
pay the registration charge:
• Register as Tier 1 if you intend to import and/or manufacture relevant
industrial chemicals in a registration year below $500,000. Tier 1 registrants
only pay the registration fee; but,
If last financial year, you have imported and/or manufactured relevant industrial
chemical at a value that equalled or exceeded $500,000, you will be required to pay
the annual registration charge as well and register as either Tier 2 or 3. Tier 2 and 3
registrants pay the registration fee and charge.
• Register as Tier 2, if you intend to import and/or manufacture relevant
industrial chemicals at or above $500,000 in a registration year.
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• Register as Tier 3, if you intend to import and/or manufacture relevant

industrial chemicals at or above $5000,000 in a registration year.
You could be entitled to a refund at the end of the registration year depending on the
value of relevant industrial chemicals actually imported and/or manufactured.
Notice of intent not to renew registration
At the end of the registration year, if you are no longer required to be registered in the
following year, you must submit a statement of your intent not to renew your
registration before the start of the next registration year (i.e., by 31 August). This
statement is to be provided to the Director, giving reasons why registration is no
longer required. For example, you have decided to source your industrial chemicals
locally rather than import them, or your business stopped trading in industrial
chemicals. The renewal/non-renewal form, NR-2, can be used for submitting this
notice.
13.8 Who should submit a final statement of introduction?

If you are registered at the Tier 2 level, you must submit a final statement of
introduction (NR-3) to NICNAS no later than 31 October following the end of your
registration year. This statement is to indicate the value of industrial chemicals
actually introduced in that year.
On the basis of the statement, the Director will issue a written assessment confirming
one of the following:
• that registration was at the correct level and that the correct registration charge
was paid;
• that the total value of industrial chemicals imported and/or manufactured by
you was below the $500,000 threshold in the year for which they were
registered, in which case the registration charge will be refunded; or,
• that the total value of industrial chemicals imported and/or was equal to or
exceeded $5,000,000 for the registration year; therefore, the registration
charge should be adjusted to the higher level, and the notice will indicate the
date by which the additional charge is to be paid (this date will be at least 28
days after the notice is given).
13.9 Reconsideration and review of registration assessments

Within 21 days of receiving your assessment of registration, you may request
reconsideration of the assessment by writing to the Director, stating the reasons for
the request. The Director will reconsider the assessment on request and he or she may
confirm, revoke or vary the original assessment in any manner.
If you do not agree with the outcome of a reassessment, you may lodge an appeal with
the Administrative Appeals Tribunal within 28 days of the end of the reconsideration
process.
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13.10 What are my registration obligations?

Tier 1 level Registrants
If you are registered at the Tier 1 level, you do not have to submit a final statement
of introduction; however, if it turns out that you introduced $500,000 or more, you
will have to upgrade your registration and pay the registration charge of $1,099 (Tier
2 level) or $8,186 (Tier 3 level).

If you are registered at the Tier 2 level, you are required to:
• submit a final statement of introduction (NR-3) to NICNAS after the

registration year has ended and,
• keep for five years all records relating to industrial chemicals imported and/or
manufactured in that year that are necessary to work out whether the
registration charge is payable, and any amount of registration charge payable.
Registered importers at Tier 2 must keep all relevant commercial documents

(within the meaning of s240 of the Customs Act 1901) relating to the
industrial chemical/s for at least five years after the industrial chemical is
imported into Australia. This includes commercial documents that came into
the person's possession or control before, on, and after the entry of the
industrial chemical/s into Australia.

If you are registered at the Tier 3 level, the above requirements in relation to the
final statement do not apply to you as you are entitled to unlimited introductions.
13.11 What happens if I do not register?

If you do not have a NICNAS Registration, yet you import and/or manufacture
industrial chemicals for commercial purposes, then you are in breach of the Act. The
Act allows NICNAS to stop you from introducing industrial chemicals until you have
met the requirements of the Act. Penalties apply.
Under section 80B of the Act, it is an offence to import and/or manufacture

industrial chemicals in a registration year without a registration in force. The
associated penalty is up to $33,000 for an individual and $165,000 for a
company.
NICNAS believes in achieving compliance through information dissemination and

working cooperatively with industry. You are welcome to call our free call hotline
1800 638 528 to discuss any aspects of NICNAS Registration.
We are committed to maintaining the integrity of the program, and to ensuring the
interests of members of industry who comply with NICNAS Registration
requirements are protected against those who do not. You may be subject to audits
119
from time to time, and may be required to justify the basis for determining the total
value of industrial chemicals imported and/or manufactured.
13.12 Can I transfer my registration?

The registration of an importer or manufacturer under the Registration of Introducers
of Industrial Chemicals provisions in Part 3A of the Act is not transferable except
under the following circumstances:
• if a registered person dies, the legal personal representative of the person's
estate becomes the registered person;
• if a registered person becomes bankrupt, the trustee of the estate of the
bankrupt becomes the registered person; and/or
• if a body corporate that is registered is being wound up, the person appointed
to be the liquidator of the body corporate becomes the registered person.
When to notify the Director of changes to your circumstances
Under s80R(5) of the Act, the Director must be notified in writing as soon as
practicable, if any of the above circumstances occur, so that the Register of Industrial
Chemical Introducers can be updated.
If a registered body corporate is taken over by another person (whether registered or

not) and as a result of the takeover the body corporate ceases to exist, the Director
must be notified of the particulars of the take over within seven days after the
takeover takes effect.
Also, if a registered body corporate merges with another (whether registered or not) to
form a new body corporate, the Director must be notified of the merger by the new
corporate within seven days of the merger taking effect.
13.13 Register of Industrial Chemicals Introducers

The Register of Industrial Chemical Introducers contains a maintained list of
registrants and their registration numbers. This provides NICNAS with current details
of its client base, enabling it to keep its industry clients fully informed of their
obligations under the Act and any changes as they take place.
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Section VI – TREATIES
SECTION VI - Treaties
14. The Rotterdam Convention on the Prior Informed
Consent Procedure for Certain Hazardous Chemicals
and Pesticides in International Trade
The information presented is intended to provide plain English guidance on
Australia’s rights and obligations for industrial chemicals under the Rotterdam
Convention on the Prior Informed Consent Procedure for Certain Hazardous
Chemicals and Pesticides in International Trade (the Rotterdam Convention; also
known as PIC) and industry requirements for meeting out these obligations.
However, persons should refer to text of the Rotterdam Convention, which sets out the
provisions and obligations that apply to all Parties. The PIC site is at www.pic.int.
14.1 About the Rotterdam Convention

The Rotterdam Convention puts obligations on the import and export of
certain hazardous chemicals. This means that countries that are signatories of
the Rotterdam Convention are given the power to make informed decisions on
which chemicals they want to receive and to exclude those they cannot
manage safely.
Under the Rotterdam Convention, countries nominate chemicals that have

been severely restricted or banned in their country, and once approved for
inclusion in the Prior Informed Consent (PIC) procedure, these chemicals will
be subject to controls in international trade. In addition, a country seeking to
export a chemical subject to a ban or severe restriction in its own territory
must inform the importing country at the time of first export, and then
annually. In such a way, the Rotterdam Convention is about exporting and
importing countries sharing responsibility for notification and monitoring to
safeguard human health and the environment from the harmful effects of
certain hazardous chemicals.
The PIC procedure does not mean globally banning or severely restricting
certain chemicals, nor does it mean that an individual country should
automatically prohibit its import. It does mean that chemicals listed in the
Rotterdam Convention are subject to extensive information exchange, priority
attention for national decisions on imports, and obligations related to export
controls.
As a Party to the Rotterdam Convention, Australia must ensure that chemicals

listed in the Convention are not exported to countries that do not wish to
receive them.
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14.2 Which Australian Government agencies are responsible for PIC?

The Australian Government Department of the Environment and Heritage
(DEH) is the lead agency for the Rotterdam Convention. In addition, for
industrial chemicals, DEH is the Designated National Authority (DNA)
responsible for international liaison and communication with the PIC
Secretariat (the United Nations Environment Programme (UNEP) and the
Food and Agriculture Organisation of the United Nations (FAO)).
The National Industrial Chemicals Notification and Assessment Scheme

(NICNAS) is the Australian Government regulator of industrial chemicals and
is responsible for implementing the obligations of the Rotterdam Convention
domestically regarding industrial chemicals.
For pesticides, the Australian Government Department of Agriculture,

Fisheries and Forestry is the DNA and is also responsible for implementing
Australia’s obligations under the Rotterdam Convention for chemicals with an
agricultural or veterinary application.
14.3 Where can I get more information about the Rotterdam

Convention?
The text of the Rotterdam Convention sets out the provisions and obligations
that apply to all Parties.
The international site dedicated to PIC can be accessed at www.pic.int.
14.4 What is covered under the Rotterdam Convention?

The Rotterdam Convention applies to banned or severely restricted chemicals
and to severely hazardous pesticide formulations.
Chemicals are subject to the PIC procedure if they are included in Annex III of
the Rotterdam Convention.
The term “chemical” is defined in Article 2 of the Rotterdam Convention, and

includes substances that are pure, as well as mixtures with other substances.
Chemicals can be listed in use categories as either “industrial” or “pesticide”,
or in both categories. The category specified in Annex III is the regulated use
under the Rotterdam Convention. For example importers or exporters of a
listed chemical under the industrial category are required to comply with the
import decisions for the industrial use only.
The Rotterdam Convention does not apply to:

• narcotic drugs and psychotropic substances;
• articles;
• radioactive materials;
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• wastes;
• pharmaceuticals;
• chemical weapons
• chemicals used as food additives;
• food;
• chemicals imported in quantities not likely to involve a risk provided
they are imported for the purpose of research or analysis or by an
individual for his or own personal use.
14.5 What are the industrial chemicals subject to the PIC procedure?
The list of chemicals subject to the PIC procedure includes five industrial
chemicals (listed in Annex III). Additions to the list depend on a decision by
the Conference of the Parties meeting. The first meeting (COP-1) will be held
in September 2004.
Industrial Chemical CAS Numbers
Crocidolite asbestos* 12001-28-4
Polybrominated biphenyls (PBBs):

Hexabromobiphenyl 36355-01-8
Octabromobiphenyl 27858-07-7
Decabromobiphenyl 13654-09-6
Polychlorinated biphenyls (PCBs) 1336-36-3
Polychlorinated terphenyls (PCTs) 61788-33-8
Tris (2,3-dibromopropyl) phosphate 126-72-7

(Tris)
* The ambhibole forms of asbestos actinolite, anthophyllite, tremolite and amosite are
currently being considered by the Rotterdam Convention for PIC listing.
The PIC website publishes Decision Guidance Documents (DGDs) for each
chemical listed in the Rotterdam Convention. The DGDs detail the scope of
the chemicals subject to PIC, and provide basic information about the
chemical’s characteristics and a summary of the reasons why the chemicals
were either banned or severely restricted. Copies of DGDs are available at
www.pic.int/en/Table7.htm.
14.6 Has Australia notified any banned or severely restricted

chemicals?
Under Article 5 of the Rotterdam Convention, a notification of a chemical is
made by an individual Party that has made an explicit national hazard/risk
based decision to ban or severely restrict the chemical in order to protect
human health or the environment within its jurisdiction.
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Australia has notified chrysotile asbestos and the amphibole forms of asbestos
and as such must meet certain obligations. This includes the provision of
Export Notification before the first export in any calendar year to the
Designated National Authority of the importing Party. Annex V of the
Rotterdam Convention sets out the information to be included in the Export
Notification. These obligations cease if the chemical is added to Annex III.
14.7 What are import decisions?

The import decision of a participating country informs whether it consents to
the import of the chemicals listed in the Rotterdam Convention.
A final decision may include:

• consent to future importation of the chemical;
• not consent to future importation of the chemical; or,
• consent to future importation of the chemical but subject to
specified conditions
An interim response may include:

• an interim decision consenting to import with or without specified
conditions; or not consenting to import during the interim period
until a final decision;
• a statement that a final decision is under consideration; or,
• a request for further information or assistance in evaluating the
chemical.
PIC Circular
Every 6 months, import decisions are formally notified to all Parties in the
form of a document called the PIC Circular which can be accessed at
http://www.pic.int/en/ViewPage.asp?id=266.
The key documents relevant to the PIC procedure are Appendices III and IV.
Appendix III contains a current list of the chemical subject to the Rotterdam
Convention. Appendix IV contains all the import decisions for chemicals
subject to the Rotterdam Convention that have been submitted by parties, as
well as a list of those Parties that failed to provide import response. Appendix
IV is the official reference for exporters of chemicals that are subject to the
Rotterdam Convention.
The PIC website also provides a country-specific import response database in

advance of the Circular for information and convenience purposes.
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14.8 What do I do if I import, manufacture and/or export PIC

chemicals?
Regulatory obligations for importers and/or manufacturers under PIC
Australia’s import decision for industrial chemicals listed in Annex III reflects
the current regulatory status of that chemical in Australia. There are no
additional requirements to the existing import controls.
Initial enquiries for industrial chemicals should be directed to:

Director, Chemicals Policy
Australian Government Department of the
Environment and Heritage
Environment Protection Branch
GPO Box 787, Canberra ACT, Australia 2601
Tel: +61 2 6274 1841

Fax: +61 2 6274 2060
Industrial Chemical Australia’s Import Decision
Consent to import subject to specific conditions:
Polychlorinated Importation is prohibited under Regulation 4AB of the

biphenyls Customs (Prohibited Imports) Regulations 1956, unless the
importer is granted permission from the Minister for Justice
Polychlorinated and Customs.
terphenyls
Further information on the administration of this control can
be found at the “Industrial Chemicals” link on the Customs
website at:
www.customs.gov.au/site/page.cfm?area_id=5&nav_
id=1340#
Consent to import subject to specific conditions:
Crocidolite asbestos* Crocidolite is severely restricted in Australia. There is no

mining and future mining would not be approved.
The import of asbestos and goods containing asbestos is

regulated under Regulation 4C of the Customs (Prohibited
*Amphibole asbestos Imports) Regulations 1956. The import of chrysotile
(actinolite, asbestos is prohibited unless subject to an exemption, or a
anthophyllite, amosite permission has been granted by the Minister of Employment
and tremolite asbestos) and Workplace Relations.
is being considered for
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PIC listing Further information on the administration of this control can

be found at:
customs.gov.au/site/page.cfm?area_id=5&nav_id=13
40#Asbestos
Interim Decision on import: Consenting to import

with specified conditions
Polybrominated
biphenyls: Hexabromobiphenyl is not listed on the Australian
Inventory of Chemical Substances (AICS). Importation
Hexabromobiphenyls and/or manufacture of hexabromobiphenyl, or
formulations containing this chemical, are not allowed
without a valid assessment certificate/permit from
Octabromobiphenyls NICNAS.
Decabromobiphenyls Octabromobiphenyl and decabromobiphenyl were

declared as Priority Existing Chemicals (PEC) on 6 July
2004. All manufacturers and/or importers of these
chemicals, or formulations containing these chemicals,
must apply for assessment to NICNAS.
To see particulars of the PEC Notice see July 2004

Chemical Gazette
www.nicnas.gov.au/publications/gazette/chemgazettejul20
04.htm
Interim Decision on import: Consenting to import

Tris-(2,3- with specified conditions
dibromopropyl)
phosphate This chemical was declared as a Priority Existing
Chemical on 6 July 2004. Manufacturers/and or importers
must apply for assessment before introducing this
chemical or products containing this chemical.
To see particulars of the PEC Notice see July 2004

Chemical Gazette
www.nicnas.gov.au/publications/gazette/chemgazettejul20
04.htm
Regulatory obligations for exporters under PIC

Exporters should remain informed as to which chemicals are on Annex III
(chemicals subject to the Prior Informed Consent Procedure) and the import
decisions (published in the PIC Circular) for these chemicals to ensure that
they do not export a chemical to a country that does not wish to receive it.
Initial enquiries for industrial chemicals should be directed to:

Director, Chemicals Policy
Department of the Environment and Heritage
Environment Protection Branch
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GPO Box 787, Canberra ACT, Australia 2601
Tel: +61 2 6274 1841

Fax: +61 2 6274 2060
Industrial Information to exporters

Chemical
New regulations will be in force on 18 August 2004 under
Polychlorinated the Industrial Chemicals (Notification and Assessment)
biphenyls Regulations (1990) requiring exporters of these chemicals to
obtain written authorisation from NICNAS.
Polychlorinated
terphenyls
Polybrominated Exporters are required to complete an export authorisation

biphenyls: application form (Form EXP-1).
Hexabromobiphenyl,
Decabromobiphenyl
Octabromobipheny
Tris-(2,3-
dibromopropyl)
phosphate
Asbestos and goods containing asbestos are currently

Crocidolite asbestos regulated under Regulation 4 of the Customs (Prohibited
Exports) Regulations 1958.
Further information on the administration of this control

can be found at the “Asbestos” link on the Customs
website at:
http://www.customs.gov.au/site/index.cfm?area_id=5&na
v_id=1338
Information to accompany exports of PIC chemicals
Article 13 of the Rotterdam Convention outlines the information required to

accompany exports of chemicals included in Annex III as well as chemicals
that are banned or severely restricted in the exporting country:
• Ensure adequate labelling of the chemical: include information on the

hazards and risks posed by the chemical on human health or the
environment;
• Provide the importer with a copy of an up-to date safety data sheet in
an internationally approved format;
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• The information provided should be in the official language of the

importing country, as far as is practicable;
• Shipping documents should bear any harmonised system custom code

assigned by the World Customs Organisation, where available.
14.9 Compliance and enforcement

The obligations of the Rotterdam Convention for industrial chemicals are
implemented under the Act administered by the National Industrial Chemicals
Notification and Assessment Scheme (NICNAS).
The Act provides for Australia to comply with obligations under international
agreements. Regulations were also made recently for the purposes of Section
106(1) of the Act, to prohibit the export of certain industrial chemicals without
the prior authorisation of the Director, NICNAS. These chemicals are listed in
Annex III of the Rotterdam Convention:
• Polychlorinated biphenyl (PCB)

• Polychlorinated terphenyl (PCT)
• Polybrominated biphenyl (PBB):
hexabromobiphenyl, decabromobiphenyl, octabromobiphenyl
• Tris (2,3-dibromopropyl) phosphate (Tris)
Pursuant to paragraph 5 of section 106 of the Act, it is an offence to import,

manufacture or export industrial chemicals in contravention of an international
agreement to which Australia is a Party. The associated penalty is up to $33,000
for an individual and $165,000 for a company.
Compliance programs
NICNAS’s Innovation and Compliance Team is responsible for processing

export authorisation applications and conducting audits of importers,
manufacturers and exporters of industrial chemicals.
Exporters, importers and manufacturers are responsible for keeping relevant

commercial documents relating to industrial chemicals for at least five years.
Relevant commercial documents could include a commercial invoice providing

a description of the goods, orders/confirmations, bills of lading / airway bills,
insurance certificate, receipt of purchase of goods, illustrated descriptive
material and other records provided to Customs.
Subsection 100G(1) of the Act allows the Director to obtain any information or
document from a person, if on reasonable grounds that information or document
is believed to be necessary to allow Australia to comply with the Rotterdam
Convention’s obligations.
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The Director’s request will specify the information that is required and how it is
to be provided. It will also specify the final date that the information must be
provided, giving at least 14 days notice of this. Failure to provide the requested
information to the Director is an offence. The associated penalty is up to $6,600
for an individual and $33,000 for a company.
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Section VII- Compliance
SECTION VII - Compliance

This section covers Compliance with the Act. The Act provides a legislative basis for
enforcement and inspections involving industrial chemicals. This Section provides an
overview of the compliance program and the enforcement requirements under the Act.
15 Compliance
15.1 Our Compliance Style
NICNAS is strongly committed to developing and maintaining an effective and
proactive compliance strategy to ensure the safe use of industrial chemicals in
Australia.
Under the Act, NICNAS scientifically assesses industrial chemicals for their health
and environmental effects and makes recommendations for safe use. The Act sets out
regulatory obligations on importers, manufacturers and exporters of industrial
chemicals, which in essence, form the focus of the compliance program.
The compliance team is responsible for a number of NICNAS programs aimed at

ensuring that manufacturers, importers and exporters of industrial chemicals are
aware of and exercise their responsibilities under the Act.
NICNAS is committed to developing and maintaining an effective compliance

strategy to ensure the safe use of industrial chemicals in Australia. Our strategy is to
maintain the public’s trust in chemical safety through compliance actions that ensure
the integrity of the scheme. All industrial chemical manufacturers, importers and
exporters should be aware that NICNAS conducts audits, inspections and
investigations aimed at identifying non-compliance with the legislation.
NICNAS has adopted a conciliatory approach to compliance through partnerships

with the Australian chemical industry and the public by maintaining a strong focus on
education and raising awareness. We will protect the business interests of compliant
importers, manufacturers and exporters by ensuring high levels of transparency,
competence and professionalism in our approach to compliance.
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Criminal Prosecution
Injunctions
(Court orders)
Directional Compliance
(Warning letters, late penalty, variation of
permit conditions, revoke permit/certificate)
Inspections and audits
Cooperative Compliance
(Education, persuasion, seminars, website and negotiation)
The above pyramid features NICNAS hierarchal enforcement strategy, starting with a
persuasive approach, which employs no sanctions, and gradually progressing to more
severe sanctions.
15.2 Our Compliance Program

Under the Act, NICNAS scientifically assesses industrial chemicals for their health
and environmental effects and makes recommendations for safe use. The Act sets out
regulatory obligations on importers, manufacturers and exporters of industrial
chemicals.
The aim of the program is to increase compliance by implementing the following

strategies:
• Identify, assess and rectify non-compliance;
• Raise awareness of NICNAS obligations;
• Obtain feedback from industry and the public to assist NICNAS in developing
and evaluating its education and compliance strategies;
• Assess the levels of compliance and industry awareness of the regulatory

requirements;
• Develop and nurture relationships with industry and community contacts; and
• Maintain a visible presence in the chemical industry and show that NICNAS is
proactive about compliance.
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15.3 Discovery and Recording of Non-Compliance

Compliance casework is generated from self-reporting, third party allegations, audits
and internal checks.
15.3.1 Self Reporting of Non-Compliance
These cases arise when importers and/or manufacturers or exporters formally advise
NICNAS of non compliance with the legislation. Such notification would normally
include information that demonstrated, or otherwise makes a claim, that non
compliance was inadvertent.
Self-reporting is seen as the first step in taking action to come within NICNAS
compliance activity. NICNAS has discretion in applying sanctions to an introducer
(ie, importer and/or manufacturer) or exporter that self-reports a breach where:
a) The reason for the non-compliance is explained and was inadvertent;
b) The non-compliance was due, or partially due, to a systemic flaw and the
offender has initiated or has expressed a willingness to remedy the flaw and
check for further instances of non-compliance that may have resulted from
that flaw; and,
c) The offender is committed to taking action to remedy the breach within agreed
timeframes.
If you inform NICNAS of any inadvertent breach occurring, our approach is to meet
with you to draw up a timetable of actions to remedy the breach.
15.3.2 Third Party Allegations
A ‘Report of non-compliance with NICNAS Requirements’ form has been developed

for those who wish to report suspected non-compliant activities. NICNAS values and
encourages the community, industry and other government agencies and industry
associations to provide information on any breaches of the industrial chemicals
legislation. As a matter of policy all formal third party reports are investigated.
Complete confidentiality is ensured in all cases.
If you wish to bring a compliance matter to our attention, you can:
• Email the compliance team at comply at comply@nicnas.gov.au;

• Telephone the compliance team on 1800 638 528;
• Fax details to the compliance team on 02 8577 8888;
• Write to the compliance team using our postal address; or,
• Arrange to come in and meet with us.
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15.4 Enforcement Provisions, Offences and Penalties

This Section provides a guide to industry on the existing and new enforcement
provisions that were created as part of the new Australian Government Low
Regulatory Concern Chemicals initiative.
The information presented should be used as a guide only and should not be relied
upon for legal advice. Persons should refer to the Industrial Chemicals (Notification
and Assessment) Act 1989 and the Industrial Chemicals (Notification and Assessment)
Regulations 1990 which can be accessed via the SCALEplus website of the Australian
Attorney-General’s Department at http://scaleplus.law.gov.au.
Offences committed under the Industrial Chemicals (Notification and Assessment)

Act 1989 are punishable by prosecution in accordance with the Crimes Act 1914.
Those who are prosecuted and found to be in breach of the Act will be liable for fines
of up to $33,000 for an individual and $165,000 for a company. The specific penalties
for each offence under the Act are listed in the tables below.
15.4.1 New Industrial Chemicals
A new industrial chemical is defined as an industrial chemical that is not listed on the
Australian Inventory of Chemical Substances or if its importation and/or manufacture
is subject to a condition of use. Certain chemicals, however, are exempt from
notification requirements but have annual reporting obligations.
The following are some measures NICNAS has adopted to ensure the safety of
workers, the public and the environment:
• The NICNAS compliance team conducts inspections and audits to monitor

compliance with the Act;
• For all new industrial chemicals that are assessed by NICNAS, the chemical or
trade name, use, hazardous status and applicant details are published in the
Chemical Gazette; and
• A summary report of occupational health, public health and environmental
effects are published in the Chemical Gazette for all chemicals assessed under
a certificate category.
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Table 15.4.1 Summary of New Chemicals offences and Penalties under the Act
Section Guidance Maximum
Offence Penalty
Individuals
(corporation)
New provision:
s15A The Director may include in the AICS certain $13,200
Failing to comply with conditions associated with the mode of use or ($66,000)
conditions of use of an introduction of the chemical. The person importing or
AICS listed chemical manufacturing the chemical must comply with those
(Fault based offence) conditions.
s21 A new industrial chemical is defined as one that is not $33,000

Introducing a new industrial listed on the Australian Inventory of Chemical (165,000)
chemical (without a valid Substances, or is listed but whose importation and/or
certificate/permit and not manufacture is subject to certain conditions. All new
exempt) industrial chemicals must be notified to NICNAS, and
(Fault based offence) an assessment certificate or permit obtained before
they can be imported/manufactured in Australia.
This does not apply if the new industrial chemical is

considered exempt from notifying to NICNAS
New provision:
s21AA(4) Persons introducing a new industrial chemical under $1,100 per day
Failing to provide annual an exemption must provide a report to the director to a maximum of
report. before or on 28 September of the following $13,200
(Fault based offence) registration year.
($5,500 per day
to a maximum of
$66,000)
s21L(4) Commercial Evaluation Chemical (CEC) permits are Director can
Contravening any of the subject to stipulated conditions to safeguard public cancel permit
conditions imposed on the and occupational health, and the environment. All (s21N) AND
commercial evaluation permit conditions specified on the permit must be adhered to $33,000
(Fault based offence) by the importer or manufacturer and agreed user/s. ($165,000)
s21W(5) Low Volume Chemical (LVC) permits are subject to Director can
Contravening any of the stipulated conditions to safeguard public and cancel permit
conditions imposed on the occupational health and the environment. The holder (s21W(6)) AND
low volume permit of the permit (importer or manufacturer) must follow $33,000
(Fault based offence) all the conditions on the permit. ($165,000)
New provision:
s22I Controlled Use permits are granted subject to $33,000
Contravening any of the conditions that the chemical is imported or ($165,000)
conditions imposed on the manufactured only for the use stated on the permit.
controlled use permit Conditions designed to safeguard public and
(Fault based offence) occupational health and the environment also apply.
The holder of the permit (importer or manufacturer)
must follow all the conditions on the permit.
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s30C In certain circumstances, the Director may revoke an $33,000

Using a chemical after Early Introduction Permit (EIP). The holder of the ($165,000)
receiving a revocation notice permit must stop importing/manufacturing the
from Director (regarding chemical as soon as revocation notice is received.
Early Introduction Permit)
(Fault based offence)
New provision:
s40K(3) A person issued a Low Volume permit, Controlled $13,200
Failing to keep supporting Use permit, or a self-assessed assessment certificate is ($66,000)
records for required to keep records in support of information
permits/certificates. associated with their application for the certificate and
(Fault based offence) keep these records for 5 years.
New provision:
s40L(3) A person must provide information to the Director if $6,600
Failing to supply the Director requests information relating to a Low ($33,000)
requested information on Volume permit, a Controlled Use permit, or a self-
permits/certificates to the assessed assessment certificate.
Director.
New provision:
Persons introducing a new industrial chemical under a $1,100 per day
S40N(4) Commercial Evaluation permit, Low Volume permit, to a maximum of
Failure to provide annual Controlled Use permit, or a self-assessed assessment $13,200
report for permits/certificates certificate, must provide a report to the Director
(Fault based offence) before or on 28 September of the following ($5,500 per day
registration year. to a maximum of
$66,000)
For further information on New Chemicals Assessments see Section II in this
handbook.
15.4.2 Priority Existing Chemicals
Chemicals of concern may be declared a PEC by the Minister (Health and Ageing)
under section 51(1) of the Act, subsequent to the recommendation of the Director,
NICNAS. The Director is required under section 54 of the Act to maintain a list of
declared PECs.
A PEC declaration creates obligations for those importing or manufacturing the

chemical to apply for assessment (within 28 days of the declaration) and provide
information on the chemical.
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Table 15.4.2 Summary of Priority Existing Chemicals offences and Penalties

under the Act
Offence penalty
Individual
(Corporation)
s48(7) $6,600
The Director may place a notice in the Chemical
Contravening a notice ($33,000)
Gazette calling for information about an existing
requesting information about
chemical that is being considered for declaration as
potential Priority Existing
a PEC. The Chemical Gazette notice will include
Chemicals (PEC)
details of the person/s required to provide the
information and the period in which the information
is to be provided (the time frame specified must be
at least 28 days).
s56 Importing and/or manufacturing a PEC is prohibited $33,000

Introducing a PEC (without without submitting an application for the assessment ($165,000)
applying for assessment under of the chemical.
s55)
s58(8) For the purpose of assessing a PEC, the Director $6,600

Contravention of a call for may, by notice in the Chemical Gazette, require a ($33,000)
information about a PEC person to provide information about the chemical.
(Fault based offence) All persons specified in the Gazette notice must
provide the required information to the Director
within the timeframe specified.
s61(4) If the Minister believes that an activity involving a $33,000

Failure of an importer or PEC gives rise to an unacceptable risk of adverse ($165,000)
manufacturer to comply with a health or environmental effects, he/she may prohibit
notice prohibiting an activity that activity by a notice in the Chemical Gazette. An
while the chemical remains a importer or manufacturer must comply with the
PEC notice.
s61(5) If the Minister believes that an activity involving a $26,400

Failure of a person other than PEC gives rise to an unacceptable risk of adverse ($132,000)
an importer or manufacturer to health or environmental effects, he/she may prohibit
comply with a notice that activity by a notice in the Chemical Gazette. A
prohibiting an activity while the person, other than an importer or manufacturer of
chemical remains a PEC the chemical must comply with the notice.
For further information on Priority Existing Chemicals see Section III in this
Handbook.
15.4.3 Secondary Notification After Assessment
All chemicals that have been assessed by NICNAS (both new and existing
chemicals), including self-assessed chemicals, may be subject to secondary
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notification. Once a chemical is assessed, the assessment report may recommend the
secondary notification of the chemical in certain circumstances specified in the report.
Under s64(1), if a person becomes aware of these particular circumstances, or any of
the other circumstances that are specified in s64(2) of the Act (listed below), that
person will be required to notify the Director within 28 days of becoming aware of
these circumstances.
The Director may decide to require the secondary notification of the chemical under
s65 of the Act, by notice in the Chemical Gazette, which must specify the information
about the chemical that is to be given by way of secondary notification.
Table 15.4.3 Summary of Secondary Notification offences and penalties under the Act
Section Guidance Maximum penalty
Offence Individual
(Corporation)
s64(1)(2) Where a person who introduces an industrial $13,200
Failure to notify the chemical that has been assessed by NICNAS ($66,000)
Director within 28 days becomes aware that:
of certain specified • the function or use of the chemical has or
circumstances occurring is likely to change;
giving rise to the • the amount of chemical introduced has, or
obligation of secondary is likely to increase;
notification • in the case of an imported chemical, it has
(Fault based offence) begun to be manufactured;
• the method of manufacture has, or is
likely to, change;
• additional information is available on the
adverse health or environmental effects of
the chemical; and/or,
• other circumstances recommended on the
assessment report for the chemical have
occurred;
the person must notify the Director of the
change in circumstances within 28 days.
s67 The Director may, by notice in the Chemical In the case of a new
Failure to comply with Gazette, require the secondary notification of industrial chemical: the
secondary notification a chemical by person/s to whom the notice Minister may suspend any
requirements applies within a period of not less than 28 assessment certificate or
(Fault based offence) days. introduction permit held by
the person for that chemical
Person/s to whom the notice applies must AND $13,200 ($66,000)
provide information about the chemical that is
to be given by way of secondary notification In any other case: the
within a period of not less than 28 days. Minister may prohibit the
importation and
manufacture of the
chemical by that person.
AND $13,200 ($66,000)
s69 The Director may, for the purpose of $6,600
Contravention of a notice assessing a new or existing industrial ($33,000)
by the Director in the chemical requiring secondary notification,
Chemical Gazette requiring require through a notice in the Chemical
137
information for the Gazette:

purposes of assessment of • all persons who introduce the chemical; or
chemicals (existing/new) • specified persons who introduce the
requiring secondary chemical; or
notification • specified persons who may have relevant
(Fault based offence) information on the chemical;
but who are not required to give secondary
notification, to provide the Director the
information specified on the notice.
For further information on secondary notifications see Chapter 11 in Section IV of

this Handbook.
15.4.4 Registration of Chemical Introducers
NICNAS is committed to ensuring that the interests of members of industry who

comply with the introducer registration requirements are protected against those who
do not. NICNAS allocates considerable resources to identifying importers and
manufacturers that have not registered.
The following are some measures NICNAS has adopted as part of its compliance
program in relation to NICNAS registration matters:
• a list of registrants is published quarterly in the Chemical Gazette;
• registered importers and manufacturers may be audited, and will be required to

justify the basis for determining their estimated value of relevant industrial
chemicals manufactured and/or imported; and
• NICNAS makes use of other available information about industrial chemical

importers and manufacturers; for example, import data, to monitor compliance
with the legislation.
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Table 15.4.4 Summary of NICNAS Registration offences and penalties.

Offence penalty
Individuals
(Corporation)
s80B You must be registered with NICNAS if you $33,000

Introducing relevant industrial introduce (import and/or manufacture) relevant ($165,000)
chemicals without a registration industrial chemicals in a registration year. A
in force registration year runs from 1 September to 31
(Strict liability offence) August in the following year.
s80Q If you have been registered with NICNAS for a $3,300

Failure to provide the Director particular registration year, you must, within two ($16,500)
with a written statement months of the end of that registration year,
indicating the total value of provide the Director with a written statement of
relevant industrial chemicals the total value of relevant industrial chemicals
actually introduced in a actually introduced in that registration year.
registration year by 31 October
(Strict liability offence)
s80QD If you are registered for a particular registration $3,300

Failure to retain records for five year, you must keep all records to prove your ($16,500)
years introduction value for that year. These records
(Strict liability offence) have to be kept for a period of five years.
s80W(3) If the Director believes that you should have $3,300

Failure to comply with notice been registered in a particular registration year, ($16,500)
requiring information relating to he/she may require you to supply information
the introduction of relevant relating to your introductions of relevant
industrial chemicals in a relevant industrial chemicals for that registration year.
registration year
For further information on registration of chemical introducers, see Section V -
NICNAS Registration.
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15.4.5 Annual Reporting and Record Keeping
Table 15.4.5 Summary of annual reporting and record keeping offences and penalties
under the Act
Offence Penalty
Individuals
(corporation)
New provision:
s21AA(4) Persons introducing a new industrial chemical under $1,100 per day
Failing to provide annual an exemption must provide a report to the director to a maximum of
report. before or on 28 September of the following $13,200
(Fault based offence) registration year.
($5,500 per day
to a maximum of
$66,000)
New provision:
s40K(3) A person issued a Low Volume permit, Controlled $13,200
Failing to keep supporting Use permit, or a self-assessed assessment certificate is ($66,000)
records for required to keep records in support of information
permits/certificates. associated with their application for the certificate and
(Fault based offence) keep these records for 5 years.
New provision:
s40L(3) A person must provide information to the Director if $6,600
Failing to supply the Director requests information relating to a Low ($33,000)
requested information on Volume permit, a Controlled Use permit, or a self-
permits/certificates to the assessed assessment certificate.
Director.
New provision:
S40N(4) Persons introducing a new industrial chemical under a $1,100 per day
Failure to provide annual Commercial Evaluation permit, Low Volume permit, to a maximum of
report for permits/certificates Controlled Use permit, or a self-assessed assessment $13,200
(Fault based offence) certificate, must provide a report to the Director
before or on 28 September of the following ($5,500 per day
registration year. to a maximum of
$66,000)
s80QD If you are registered for a particular registration year, $3,300

Failure to retain records for you must keep all records to prove your introduction ($16,500)
five years value for that year. These records have to be kept for a
(Strict liability offence) period of five years.
For further information on record keeping and reporting requirements, see 15.6
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15.4.6 Other Offences
Table 15.4.6 Summary of miscellaneous offences and penalties under the Act
Section Guidance Maximum penalty
Offence Individuals
(Corporation)
s106(5) You cannot introduce (import and/or $33,000

Introduction or export of manufacture) or export an industrial ($165,000)
chemical in contravention of a chemical that has been prohibited through
Regulation made under s106 an international agreement.
(i.e., a Regulation that bans or
restricts a chemical that is the
subject of an international
agreement)
New provision:
The Director's request will specify the $6,600
S100G information that is required and how it is ($33,000)
A person commits an offence if to be provided. It will also specify the
the person fails to comply with final date that the information must be
the Director’s request to provide provided, giving at least 14 days notice of
information in relation to this.
Australia’s obligations under the
Rotterdam Convention
s88(3)
Refusal to answer questions or You must produce documents and $3,300
produce documents requested requested information to a NICNAS ($16,500)
during an inspection inspector to ascertain whether the Act or
regulations have been complied with.
15.5 Transfer of Assessment Certificates and Registrations

This Section deals with the circumstances specified in the Act under which transfer of
assessment certificates and registrations may occur.
15.5.1 Assessment Certificate
Under section 73 of the Act, in certain circumstances a business may arrange to

transfer any assessment certificates that it may hold where:
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• the holder of the assessment certificate dies, the legal personal

representative of his or her estate becomes the holder of that
certificate;
• the holder of the assessment certificate becomes bankrupt, the person

who becomes the trustee in bankruptcy of the estate of the bankrupt
becomes the holder of the certificate; and/or
• a corporate body that is being wound up, the liquidator of the body
corporate becomes the holder of the certificate; and/or,
• disposes of the business to which the certificate relates and it is a term

of the agreement for the disposal of the business that the person who
acquires the business becomes holder of the certificate, then that
person will become the holder of the certificate.
It is important for those acquiring a business to make sure that there is a specific term
in the acquisition agreement that specifies transfer of NICNAS assessment certificates
with the acquisition. Permits are issued for limited periods and are not eligible for
transfer.
When to notify the Director of changes to your circumstances?
Under s73 of the Act, the new holder must give notice to the Director of the transfer
as soon as practicable. The Director may revoke a certificate if a person fails to
provide notice of a transfer.
15.5.2 Registration
The registration of an importer or manufacturer under the Registration of Introducers

of Industrial Chemicals provisions in Part 3A of the Act is not transferable except
under the following circumstances:
if a registered person dies, the legal personal representative of the person’s estate
becomes the registered person;
if a registered person becomes bankrupt, the trustee of the estate of the bankrupt
becomes the registered person; and/or
if a body corporate that is registered is being wound up, the person appointed to be the
liquidator of the body corporate becomes the registered person.
When to notify the Director of changes to your circumstances?
Under s80R(5) of the Act, the Director must be notified in writing as soon as
practicable if any of the above circumstances occur so that the Register of Industrial
Chemical Introducers can be updated.
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If a registered body corporate is taken over by another person (whether registered or

not) and, as a result of the takeover, the body corporate ceases to exist, the Director
must be notified of the particulars of the takeover within seven days after the takeover
takes effect.
Also, if a registered body corporate merges with another body corporate (whether
registered or not) to form a new body corporate, the Director must be notified of the
merger by the new corporate within seven days of the merger taking effect.
15.6 Record Keeping and Annual Reporting Requirements
15.6.1 General Requirements
Under Regulation 7A of the Industrial Chemicals (Notification and Assessment)

Regulations 1990, the importer of a chemical must keep:
2. A written statement specifying:
• whether the chemical is, or contains, an industrial chemical;
• in the case of an industrial chemical – whether a submission for the

inclusion of the chemical in the AICS is being dealt with;
• whether the chemical is a new industrial chemical;
• whether there is an assessment certificate in force in relation to the

chemical; and
• whether there is a permit in force in relation to the chemical.
2. All relevant commercial documents (within the meaning of s240 of the

Customs Act 1901) relating to the industrial chemical(s) for at least five years
after the industrial chemical is imported into Australia. This includes
commercial documents that came into the person’s possession or control
before, on, and after the entry of the industrial chemical(s) into Australia.
Relevant commercial documents could include a commercial invoice providing a

description of the goods, orders/confirmations, bills of lading/airway bills, insurance
certificates, receipts for purchase of goods, illustrated descriptive material and other
records provided to Customs.
15.6.2 Annual reporting and record keeping obligations for exemption

categories
Section 21AA of the Act details annual reporting obligations for introducers under the
exemption categories in subsections 21(4) and 21(6). Introducers have 28 days from
the end of the registration year on 31 August to provide their annual report. This
143
means that a person who introduced industrial chemicals under the exemption
categories, namely:
• chemicals introduced solely for the purpose of research, development

or analysis in quantities of not more than 100 kg per annum, or
• chemicals introduced at a port or airport that remain subject to the

control of Customs at the port or airport at all times and leave Australia
less than 30 days after the day of introduction, or
• chemicals that are used for non-cosmetic purposes and introduced in

quantities of less than 100 kg per annum, provided that they pose no
unreasonable risk to human health and the environment, or
• similar chemicals in quantities of less than 100 kg for cosmetic

purposes provided prescribed requirements such as packaging and
labelling are met, or
• non-hazardous chemicals introduced in a cosmetic at a concentration

of less than 1%,
will be required to make an annual report for chemicals introduced in the 12-month
period from 1 September – 31 August, and submit it in the approved form by 28
September each year.
Introducers are required to provide an annual report to the Director, NICNAS, stating
the name and volume of chemical introduced during the year.
Record keeping requirements are effective immediately, and annual reporting is

required for the period 1 September 2004 to 31 August 2005 with the report due on 28
September 2005.
15.6.3 Annual reporting and record keeping obligations for low volume
permits, controlled use permits and self-assessment certificates
Under section 40K, all holders of low volume and controlled use permits and self-
assessment certificates are required to keep records for five years for audit purposes.
Section 40L gives the Director the power to require all holders of these particular
permits and certificates to provide information in or in connection with their
application for, or application for renewal of, the permit or certificate that they hold,
to the Director on request.
Section 40N requires all holders of these permits and certificates to make an annual
report to the Director stating the name and volume of the chemical, together with any
adverse effect of the chemical on occupational health and safety, public health or the
environment.
The annual report must be provided on or by 28 September of each year, with the first
report required under these new arrangements due on 28 September 2005. This gives
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introducers 28 days from the end of the registration year on 31 August to provide the
annual report.
15.7 Role of NICNAS Inspectors

NICNAS inspectors are appointed by the Director of NICNAS. They are usually
NICNAS staff, but the Director also has the authority under the Act to make
arrangements for certain State and Territory public servants to exercise inspectorate
powers for NICNAS.
NICNAS inspectors conduct:
(i) site visits to monitor compliance with the Act; and

(ii) investigations into suspected and/or reported breaches of the Act.
Section 86(5) of the Act provides that searches to monitor compliance with the Act
can be conducted where there are reasonable grounds for suspecting that:
(a) an industrial chemical is being manufactured;

(b) an industrial chemical, whether imported into Australia or
manufactured in Australia, is being stored, processed or used; or
(c) records relating to the importation, manufacturing, handling, storage,
use or disposal of an industrial chemical are kept.
An inspector may enter premises for the purposes of ascertaining compliance with the
Act if the inspector has the consent of the occupier of the premises. If the consent is
not given, the inspector may apply to a Court for a warrant to enter the premises.
15.7.1 Conducting an Inspection
During an inspection, the Inspector(s) may, to the extent that it is reasonably

necessary for ascertaining compliance or non-compliance with the Act:
(a) search the premises;
(b) take photographs (or make sketches) of the premises or any substance or thing
at the premises;
(c) take and keep samples of any substance at the premises;
(d) inspect any record or document kept at the premises; and/or
(e) remove, or make copies of, any such record or statement.
15.7.2 Search and Seizure Provisions
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Where the inspector has reasonable grounds for suspecting that there may be evidence
on the premises of a breach of the Act, the Inspector may:
(a) with the consent of the occupier of the premises, search the premises and
seize the evidence; or
(b) without the consent of the occupier, obtain a warrant and then search the
premises and seize the evidence.
Where the Inspector seizes any ‘thing’ under the search and seizure provisions of the
Act, (a ‘thing’ could include samples, records and other documents), the Inspector
may keep the thing until the conclusion of the proceedings.
15.7.3 Prosecutions
Where NICNAS has determined that an offence has been committed under the Act,
the relevant Inspector(s) will prepare evidence briefs that are used by the Deputy
Director of Prosecutions for the prosecution of the relevant person/company.
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Appendices
Appendices
147
Appendix 1 – Forms
1. Forms
See the NICNAS web site, http://www.nicnas.gov.au/forms/ for the latest versions.
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Appendix 2 – Definitions
2. Definitions
Definitions in this publication are consistent with those in the Act and relevant
NOHSC documents.
The Act
The Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth).
Administrative Appeals Tribunal
The tribunal created by the Administrative Appeals Tribunal Act 1975 (Cwlth).
agricultural chemical
A substance or mixture of substances that is a means of directly or indirectly:
a. destroying, stupefying, inhibiting, attracting or repelling a pest in relation to a

plant, a place or a thing; or
b. destroying a plant; or
c. modifying the physiology of a plant so as to alter its natural development,
productivity or reproductive capacity; or
d. modifying the effect of another agricultural chemical product;
but does not include:
e. a veterinary chemical product; or
f. a substance or mixture of substances of a kind that is declared by the
Regulations not to be an agricultural chemical product for the purposes of the
Agricultural and Veterinary Chemicals Code Act 1994 (Cwlth).
article
An object that:
a. is manufactured for use for a particular purpose, being a purpose that requires
that the object have a particular shape, surface or design; and
b. is formed to that shape, surface or design during manufacture; and
c. undergoes no change of chemical composition when used for that purpose
except as an intrinsic aspect of that use,
but does not include a particle or a fluid (see Appendix 9 - Description of an Article).
Australian Inventory of Chemical Substances (AICS)
AICS is a key tool that lists the chemicals that are available for use in Australia. Some
chemicals may only be available for specified/conditional use.
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basic information
In relation to a chemical, means all the following information:
a. the name or names by which the chemical is known to the public or is

intended by its importer or manufacturer to be so known; and
b. the chemical's general uses; and
c. the precautions and restrictions to be observed in the manufacture, handling,
storage, use and disposal of the chemical; and
d. recommendations arising from the assessment of the chemical under this Act
that relate to disposing of the chemical and rendering it harmless; and
e. the procedures to be followed in the event of an emergency involving the
chemical; and
f. prescribed physical and chemical data about the chemical, not being data that
would reveal the chemical's composition (see Regulation 3); and
g. prescribed data relating to the health effects or the environmental effects of the
chemical (see Regulation 4).
biopolymer
Means:
a. a polymer directly produced by living or once-living cells or cellular

components; or
b. a synthetic equivalent of a polymer referred to in paragraph ; or
c. a derivative or modification of a polymer referred to in paragraph in which the
original polymer remains substantially intact.
chargeable person (Tier 2 and Tier 3 registrants)
In relation to a registration year, means:
a. a person who proposes to introduce relevant industrial chemicals in

that registration year of a value that equals or exceeds the threshold
value if that person:
i. did not introduce relevant industrial chemicals in the previous
financial year; or
ii. introduced relevant industrial chemicals in the previous financial
year of a value less than the threshold value; or
b. a person who proposes to introduce relevant industrial chemicals in

that registration year of any value if that person introduced relevant
industrial chemicals in the previous financial year of a value that
equalled or exceeded the threshold value.
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chemical
Includes:
a. a chemical element, including a chemical element contained in a mixture; or

b. a compound or complex of a chemical element, including such a compound or
complex contained in a mixture; or
c. a UVCB substance; or
d. a naturally-occurring chemical,
but does not include:
e. an article; or
f. a radioactive chemical; or
g. a mixture.
commercial evaluation
In relation to an industrial chemical, means testing the chemical with a view to

ascertaining its potential for commercial application.
commercial evaluation permit
A permit that allows the importation and/or manufacture of a limited, specified

amount of a chemical over a specified time for the purpose of commercial evaluation.
cosmetic
has the same meaning as cosmetic product has in the Trade Practices (Consumer
Product Information Standards) (Cosmetics) Regulations 1991.
The Trade Practices Consumer Product information Standards (Cosmetics)

Regulations (1991) defines a cosmetic product as ‘A substance or preparation
intended for placement in contact with any external part of the human body,
including: the mucous membranes of the oral cavity and the teeth; with a view to:
altering the odours of the body; or changing its appearance; or cleansing it; or
maintaining it in good condition; or perfuming it; or protecting it.’
NICNAS registration
The application by importers and/or manufacturers in Australia to import relevant

industrial chemicals for commercial purposes.
Director
The Director of NICNAS as appointed under section 90 of the Act.
disposal
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In relation to a chemical, includes disposal of waste resulting from the manufacture or

use of the chemical.
eligible chemical
An industrial chemical that was eligible to be submitted for inclusion on the AICS at a
time during the period that began on 1 January 1977 and ended on 16 July 1990.
environment
Includes all aspects of the surroundings of humans, whether affecting them as

individuals or in social groupings.
environmental effect
In relation to an industrial chemical, the effect on the environment of the importation,

manufacture, handling, storage, use or disposal of the chemical.
excluded use
In relation to a chemical, means:
a. use as an agricultural chemical or a constituent of an agricultural chemical; or

b. use as a veterinary chemical or a constituent of a veterinary chemical; or
c. therapeutic use or use as an ingredient or component in the preparation or
manufacture of goods for therapeutic use; or
d. use as food intended for consumption by humans or animals or a constituent of
such food; or
e. use as a food additive in food referred to in paragraph .
exempt information
Information about which the Director has given a notification under section 75 of the
Act, and includes information for which an application for treatment as exempt
information has been made under the Act, but not finalised.
existing chemical
An industrial chemical not defined as a new chemical. This includes naturally

occurring chemicals.
factory cost
In relation to the industrial chemicals manufactured by a person, means the total of:
a. the cost of labour involved in the manufacture; and

b. the cost of materials involved in the manufacture other than the cost of any
relevant industrial chemical:
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i. that is used as an ingredient in the manufacturing, and

ii. in respect of which an amount of registration charge has been paid; and
c. the factory overhead expenses
incurred by the person in respect of the manufacture of the first-mentioned chemicals.
food additive
A chemical whose inclusion in food as a food additive is permitted by the Food

Standards Code [as defined for the purposes of the Australia New Zealand Food
Authority Act 1991 (Cwlth)].
foreign scheme
A chemicals notification and assessment scheme operating in a foreign country.
full assessment
The assessment of a priority existing chemical that requires that at least one of the
matters in paragraphs 51(3) to 51(3)(h) of the Act be taken into account in preparing
an assessment report on the chemical.
handling
In relation to a chemical, includes transporting the chemical.
hazardous chemical
a. a chemical that is included in the List of Designated Substances [NOHSC:

10005] published in April 1999 by the National Occupational Health and
Safety Commission; or
b. a chemical that is classified as a hazardous substance in accordance with the
Approved Criteria for Classifying Hazardous Substances [NOHSC: 1008]
published in April 1999 by the National Occupational Health and Safety
Commission.
health effect
In relation to an industrial chemical, the effect on occupational health and safety or on

public health of the importation, manufacture, handling, storage, use or disposal of the
chemical.
holder
In relation to a permit or an assessment certificate, means a person in respect of whom

the permit or certificate is issued.
holder of a confidence
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In relation to an industrial chemical, a person who under section 17 of the Act is to be

treated as the holder of a confidence about the chemical.
import
In relation to an industrial chemical, means to do an act which constitutes importation

of the chemical for the purposes of the Customs Act 1901 (Cwlth), or would constitute
such importation if that Act extended to the external Territories.
importer
In relation to an industrial chemical, a person who imports or proposes to import the

chemical.
incidentally-produced chemical
A chemical that is produced as a result of:
a. the exposure of another chemical to light, heat or other environmental

conditions in the course of handling or storage; or
b. the occurrence of a chemical reaction during the manufacture or use of another
chemical,
but not a chemical whose production has commercial value for a person
manufacturing, handling, storing or using that other chemical.
industrial chemical
A chemical that has an industrial use, whether or not it also has an excluded use.
Interim Notification Scheme
The voluntary notification and assessment scheme for new industrial chemicals
conducted by the former Department of the Arts, Sports, the Environment, Tourism
and Territories before the commencement of NICNAS.
introduction
In relation to an industrial chemical, the importation or manufacture in Australia of

the chemical.
introduction permit
A permit which allows the introduction of a new industrial chemical under section 30
of the Act before the assessment report is completed.
label
A set of information, on a container, which identifies a substance together with

sufficient information so that it can be used safely. A label should contain the
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minimum information described in the NOHSC National Code of Practice for the
Labelling of Workplace Substances, Australian Government Publishing Service,
Canberra, 1994.
listed industrial chemical
An industrial chemical whose particulars are included in the AICS.
low volume chemical
An industrial chemical which is imported and/or manufactured in quantities which do

not exceed 100 kg/year and for which a low volume permit is in force.
low volume permit
A permit which allows the importation and/or manufacture of an industrial chemical

in volumes not exceeding 100 kg/year nationwide, under specified conditions.
manufacturer
In relation to an industrial chemical, a person who manufactures or proposes to

manufacture the chemical in Australia.
Material Safety Data Sheet (MSDS)
In relation to a chemical or to a product or substance containing a chemical, a

document that is prepared in accordance with the NOHSC National Code of Practice
for the Preparation of Material Safety Data Sheets, Australian Government
Publishing Service, Canberra, 1994.
matters to be taken into account
Matters that may be considered when assessing a priority existing chemical

[subsection 51(3) of the Act]. They are:
a. the properties of the chemical;

b. any use to which the chemical is intended to be, or is reasonably likely to be,
put;
c. any adverse effects on the environment or persons which the chemical has the
intrinsic capacity to cause;
d. the extent to which the environment, persons in a particular occupation or the
public will be exposed to the chemical;
e. any risk to the health or safety of persons who, because of their occupation,
are engaged, or likely to be engaged, in the manufacture, handling, storage,
use or disposal of the chemical;
f. any risk to the health or safety of likely consumers handling or using the
chemical or any product containing the chemical;
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g. any risk to the environment arising from the use of the chemical or from the
discharge of waste products resulting from the manufacture or use of the
chemical;
h. the extent to which any risk referred to in is capable of being reduced by
compliance with:
i. appropriate procedures relating to the manufacture, handling, storage,
use or disposal of the chemical, or
ii. special requirements in the packaging or labelling of the chemical; or
iii. procedures relating to the control of, or the discharge into the
environment of, the chemical or waste products resulting from the
manufacture or use of the chemical; and
i. any other relevant information available to the Director.
Minister
The Minister for Health and Ageing
mixture
A physical combination of chemicals resulting from deliberate mixing of those

chemicals or from a chemical reaction, but not including a UVCB substance.
monomer
A chemical, the molecules of which are, capable of forming covalent bonds with two
or more like or unlike molecules under the conditions of the relevant polymer-forming
reactions used for a particular process of polymer formation.
naturally-occurring chemical
a. an unprocessed chemical occurring in a natural environment; or

b. a chemical occurring in a natural environment, being a substance that is
extracted by:
i. manual, mechanical or gravitational means, or
ii. dissolution in water, or
iii. flotation, or
iv. a process of heating for the sole purpose of removing uncombined
water,
without chemical change in the substance.
new industrial chemical
(a) either:
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(i) if the chemical is a listed industrial chemical whose introduction is

subject to a condition of use under section 13—the chemical but only
to the extent that the manufacturer or importer of the chemical
introduces, or proposes to introduce, the chemical for any other use; or
(ii) otherwise—an industrial chemical that is not a listed industrial
chemical; and
(b) in the case of a synthetic polymer—a chemical that is a new synthetic

polymer;
but does not include the following:
(c) a reaction intermediate;

(d) an incidentally-produced chemical.
new monomer
A monomer not listed in the monomer section of the AICS.
new synthetic polymer
Means:
a. a polymer that includes a combination of monomers and other reactive

components, each representing at least 2% by weight, being a combination not
listed in the AICS; or
b. a polymer of whose weight at least 2% is attributable to a monomer or other
reactive component that is not listed in the AICS as a component of a synthetic
polymer.
non-hazardous chemical
a chemical in respect of which the following conditions are met:
(a) the chemical is not a hazardous chemical;

(b) the chemical is not a dangerous good;
(c) the prescribed criteria relating to the environmental effect of the chemical
have been met;
(d) any other prescribed conditions have been met;
(e) the introduction of the chemical is consistent with the reasonable protection of
occupational health and safety, public health and the environment.
The Director must take account of the following matters in deciding whether he or she
is satisfied that the condition referred to in paragraph (e) of the definition of non-
hazardous chemical is met:
(a) the proposed nature of the use of the chemical;

(b) the extent of the proposed use of the chemical;
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(c) the effect of the chemical on the environment;

(d) the effect of the chemical on occupational health and safety and public health;
(e) the structure and activity of the chemical;
(f) whether, in Australia or overseas, the chemical is the subject of:
(i) investigations initiated by a person because of concerns about a
possible adverse effect on occupational health and safety, public health
or the environment; or
(ii) action taken by a person to control the use of, or access to, the
chemical;
(g) any other prescribed matter.
Poisons scheduling
Chemicals that are likely to be hazardous to the public may be referred to the National
Drugs and Poisons Scheduling Committee (NDPSC) for consideration. If a chemical
is listed in a schedule of the Standard for the Uniform Scheduling of Drugs and
Poisons (SUSDP), certain signal headings, warning statements and/or safety
directions must be placed on the product label.
polymer
A chemical:
a. consisting of molecules that are:

i. characterised by the sequence of one or more types of monomer units,
and
ii. distributed over a range of molecular weights whose differences in the
molecular weight are primarily attributable to differences in the
number of monomer units; and
b. comprising a simple weight majority of molecules containing at least three
monomer units which are covalently bound to at least one other monomer unit
or other reactant; and
c. comprising less than a simple weight majority of molecules of the same
molecular weight.
polymer of low concern (PLC)
a polymer that:
(a) either:
(i) has a number average molecular weight, as defined by the regulations,

that is greater than 1,000; or
(ii) has a number average molecular weight, as defined by the regulations,
that is less than or equal to 1,000, and has such other characteristics as
are prescribed by the regulations; and
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(b) has a low charge density, as so defined; and

(c) is not a hazardous chemical; and
(d) does not dissociate readily, as so defined; and
(e) under the conditions in which it is used is stable, as so defined; and
(f) has such other characteristics as are prescribed by the regulations.
preliminary assessment
The assessment of a priority existing chemical that requires that at least one of the
matters in paragraphs 51(3) to 51(3) of the Act be taken into account in preparing an
assessment report on the chemical.
priority existing chemical (PEC)
An industrial chemical in respect of which a declaration under section 51 of the Act is

in force.
radioactive chemical
A chemical having a specific activity greater than 35 becquerels/g.
reaction intermediate
A substance that:
a. is produced in the course of a chemical reaction; and

b. has a transient existence; and
c. does not become a major component of the reaction mixture; and
d. is not removed from the reaction system.
Register
The Register of Industrial Chemical Introducers, a list of registered importers and

manufacturers of relevant industrial chemicals
registration charge
A charge imposed on the registration of a chargeable person (ie above $500,000 total
value of relevant industrial chemicals introduced):
a. so far as it is a duty of customs - by the Industrial Chemicals (Registration

Charge - Customs) Act 1997 (Cwlth); and
b. so far as it is a duty of excise - by the Industrial Chemicals (Registration
Charge - Excise ) Act 1997 (Cwlth); and
c. so far as it is neither a duty of customs nor a duty of excise - by the Industrial
Chemicals (Registration Charge - General ) Act 1997 (Cwlth).
159
registration year
Starts on 1st September and finishes on 31st August the following year.
relevant industrial chemical
For the purposes of NICNAS registration, an industrial chemical:
a. that is not intended for an excluded use; and

b. that is not:
i. a naturally-occurring chemical, or
ii. biological material, or
iii. an incidentally-produced chemical, or
iv. a reaction intermediate.
sequence
In relation to a polymer molecule, means a continuous string of monomer units within

the molecule that are covalently bound to one another and are uninterrupted by units
other than monomer units.
site-limited chemical
A chemical which is confined to its site of manufacture solely for the purposes of
further manufacture.
supplementary information statement
A statement containing, in relation to the application for an extension of an original

assessment certificate to cover other introducers:
a. if there has been a significant variation in matters affecting occupational,

environmental or public exposure as set out in the notification statement that
accompanied the application for the original certificate or as set out in any
additional information given under section 27 or section 28 of the Act in
respect of the application for the original certificate, details of the variation;
and
b. any new information available to the applicant about the health and
environmental effects of the chemical; and
c. confirmation that the person has access to a copy of the full public assessment
report about the chemical.
synthetic polymer
Any polymer other than a biopolymer.
therapeutic use
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Use in, or in connection with:
a. preventing, diagnosing, curing or alleviating diseases, ailments, defects or

injuries in humans; or
b. influencing, inhibiting or modifying physiological processes in humans; or
c. testing the susceptibility of humans to diseases or ailments,
and, without limiting this, includes use in, or in connection with, testing for
pregnancy, contraception, prosthetics or orthotics.
Cosmetics or chemicals with therapeutic claims must be entered on the Australian

Register of Therapeutic Goods, through the Therapeutic Goods Administration.
threshold value
In relation to relevant industrial chemicals introduced by a person, means $500,000.
trade name product
A chemical included in the section of the AICS known as Section VIII-AICS Trade
Names Annex.
UVCB substance
Means:
a. a chemical of unknown or variable composition; or

b. a complex product of a chemical reaction; or
c. biological material, other than a whole animal or a whole plant.
Value of relevant industrial chemicals imported
by a person during a particular period (whether a financial year or a registration year),

means the amount, worked out to the nearest whole dollar, using the formula:
a. all of those relevant industrial chemicals; plus

b. the cost of the insurance and freight relating to those chemicals; plus
c. the customs duty payable on those chemicals.
Value of relevant industrial chemicals introduced

means the sum of:
a. the value (if any) of the relevant industrial chemicals imported by that person
during that period; and
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b. the value (if any) of the relevant industrial chemicals manufactured by that
person during that period.
Value of relevant industrial chemicals manufactured

means the factory cost of manufacturing the industrial chemicals by the person during
that period.
veterinary chemical product
A substance or mixture of substances that is:
a. a means of directly or indirectly:

i. preventing, diagnosing, curing or alleviating a disease or condition in
an animal or an infestation of an animal by a pest in relation to that
animal; or
ii. curing or alleviating an injury suffered by an animal; or
iii. modifying the physiology of an animal:
so as to alter its natural development, productivity or
reproductive capacity, or
so as to make it more manageable; or
b. prepared by a pharmacist or veterinary surgeon, in the course of the practice of
his or her profession, to deal with a particular condition of a particular animal
in a particular instance; but does not include a substance or mixture of
substances of a kind that is declared by the Regulations made under
Agricultural and Veterinary Chemicals Code Act 1994 (Cwlth) not to be a
veterinary chemical product for the purposes of that Act.
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Appendix 3 – Abbreviations
3. Abbreviations
AAT Administrative Appeals Tribunal
ACS American Chemical Society
the Act Industrial Chemicals (Notification and Assessment) Act 1989
AGPS Australian Government Publishing Service
AICS Australian Inventory of Chemical Substances
CAD Chemical Assessment Division
CEC Commercial Evaluation Chemical (permit)
CFC Chlorofluorocarbon
the Director Director, Chemicals Notification and Assessment
EINECS European Inventory of Existing Chemical Substances
EIP Early Introduction Permit (for non-hazardous chemicals)
EOP Controlled Use (Export Only) Permit
GLP Good Laboratory Practice
IUPAC International Union for Pure and Applied Chemistry
Log Pow n-octanol/water partition coefficient
LC50 Median lethal concentration
LD50 Median lethal dose
LOAEL Lowest observable adverse effect level
LVC Low Volume Chemical (permit)
mg/L milligrams per litre
the Minister Minister for Health and Ageing
MOE Margin of exposure
MSDS Material Safety Data Sheet
NAMW Number-average molecular weight
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Appendix 3 – Abbreviations
NATA National Association of Testing Authorities
NCI National Chemicals Inventories
NICNAS National Industrial Chemicals Notification and Assessment Scheme
NOAEL No observable adverse effect level
NOHSC National Occupational Health and Safety Commission
OECD Organisation for Economic Cooperation and Development
PEC Priority Existing Chemical
PLC Polymer of Low Concern
ppm parts per million
SORO Submit Once - Review Once
TGA Therapeutic Goods Administration
TSCA Toxic Substances Control Act (USA)
mm micrometre
US EPA United States Environmental Protection Agency
UVCB Chemical of unknown or variable composition, complex reaction products or

biological material
164
Appendix 4 – Fees and Charges
4. NICNAS Fees and Charges 2008-09
See the NICNAS web site for a list of fees and charges.
165
Appendix 5 – The Chemical Gazette
5. The Chemical Gazette

The Chemical Gazette is a special edition of the existing periodic series of the
Commonwealth Government Gazette. It is published electronically on the first
Tuesday of each month, on the NICNAS website at
www.nicnas.gov.au/publications/#gazette
Occasionally, additional editions of the Chemical Gazette are published.
Operational information relating to NICNAS is published in the Chemical Gazette by

way of notice or declaration by the Minister or the Director. Occasionally,
information relating to other matters concerning industrial chemicals, for example,
exposure standards, is published in the Chemical Gazette (see further below).
Companies, organisations, government departments and individuals may subscribe to

an email alert for the Chemical Gazette.
Printed copies are available by contacting NICNAS on: 02 9577 8800.
The Chemical Gazette can be inspected during business hours, free of charge, at:
NICNAS
334-336 Illawarra Rd
Marrickville NSW 2204
Subscribers to the Chemical Gazette include a number of State Libraries and other
libraries where the Chemical Gazette can be inspected.
The notices and/or declarations relating to NICNAS which are important and must be
published in the Chemical Gazette.
1. Summary Assessment Report for New Chemicals
Under the Act, a summary report for a new chemical consists of:
• the name of the chemical;

• the name of each applicant;
• the address where copies of the final assessment report can be obtained by
members of the public; and
• any other prescribed information.
Regulation 8 prescribes the information to be included in the summary report as

follows:
a. a statement of the type of assessment carried out, that is, whether a Standard
Assessment, Limited or PLC Assessment;
b. the chemical names of hazardous constituents of the chemical;
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c. a summary of the occupational health and safety, public health and

environmental matters contained in the assessment report;
d. the intended use of the chemical; and
e. any recommendations contained in the assessment report in relation to the
chemical.
2. A Notice Calling for Information about an Existing Chemical
A notice will call for information about an existing chemical when the Director is
considering whether to recommend declaration of the chemical as a PEC. The
Director will request:
• specified information about a particular industrial chemical, for example,

information about its health and environmental effects; and/or
• the names and quantities of industrial chemicals used by persons for a
specified purpose in a specified period; and/or
• the names of industrial chemicals that are introduced by persons in specified
quantities in a specified period, for example, the volumes manufactured over
the previous five years.
3. Declaration of a PEC
The decision by the Minister to declare a chemical or group of chemicals as PEC(s) is

announced by publication of a notice in the Chemical Gazette. The notice will
specify, in respect of each chemical to which the notice relates:
• whether declaration applies to the chemical generally or specifically, for

example, only to specific uses of the chemical;
• whether the assessment is to be a preliminary assessment or a full assessment;
• matters to be taken into account in the assessment;
• information to accompany any application for the assessment; and
• if the notice relates to more than one chemical, whether the declared chemicals
are to be assessed together.
4. A Summary Assessment Report on a PEC
Under the Act, a summary report consists of:
• the name of the chemical;

• the name of each applicant;
• the address where copies of the final assessment report can be obtained by
members of the public; and
• any other prescribed information.
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Currently, there are no Regulations which prescribe information to be included in a

summary report of a PEC.
5. Other notices and/or declarations relating to NICNAS which must be published

in the Chemical Gazette.
Section in Notice or Declaration

the Act
14(1) Inclusion of a new chemical in the AICS five years after the giving of an
assessment certificate (other than an extension of an original certificate).
20(a) Addition of information concerning chemicals added to the AICS before
17 July 1990 or between 1 March 1993 and 17 July 1993.
20(aa) Addition of extra information about industrial chemicals already in the
AICS that was obtained under section 20AB (details of trade name
products).
20(b) Correction of an error in the AICS (except the wrong inclusion of a
chemical in the AICS).
20AA(1) Removal of a chemical that has been wrongly included in the AICS.
20AB Request for identity of chemicals making up trade name products.
21AB(2) List of chemicals introduced under an exemption.
21J Issue of commercial evaluation permit.
21Y Issue of low volume permit.
21ZA(2) List of chemicals for which a low volume permit has been issued.
30(2) Issue of a permit to import a chemical before assessment is completed.
30A Grant of a permit for early introduction of a non-hazardous chemical.
40(2) Application for variation of a full public report.
40(7) A decision on an application for variation of a full public report.
40G Publication of a summary report, incorporating modifications.
41(2) Equivalence of a State or Territory scheme.
41(4) Revocation of a State or Territory scheme equivalence.
43(2) Approval of a foreign scheme.
43(6) Foreign scheme no longer approved.
50A(4) A notice stating where a summary of information given under section 48
of the Act can be obtained.
54(3) Lists of chemicals that are PECs and chemicals that have been PECs.
58(1) A notice to seek information for assessment of a PEC.
60E(1) A notice for variation of draft PEC assessment report.
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60E(6) A notice of a decision concerning a request for variation of draft PEC

assessment report.
61(2) Prohibition of an activity involving a PEC until assessment is
completed.
65(1) A notice to require secondary notification.
68(4) by reference to 38 A summary assessment report after secondary
notification.
69(1) A notice to provide information for secondary notification.
71(3) Lists of chemicals that require secondary notification or that have
required, but no longer require, secondary notification.
72 A declaration that a chemical is no longer subject to secondary
notification.
74(2) List of chemicals for which assessment certificates are in force.
105(1) Amendment of the Schedule to the Act.
106(2) Notice requiring persons importing or exporting a particular chemical
named under a specified international agreement to give information in
the approved form about movements of the chemical into or out of
Australia.
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Appendix 6 – Confidentiality
6. Confidentiality
EXEMPT INFORMATION
For all notification categories, including submission of additional information, claims

can be made for certain data items to be regarded as exempt from publication. A
notifier may consider that certain data items required in a notification statement may
be commercially harmful if disclosed. The notifier must identify those data items
together with full reasons substantiating the claim for exemption [subsection 75(1) of
the Act].
In notification statements submitted to NICNAS, items of information subject to a

claim for exemption must be clearly identified so that it is obvious to the assessor of
the chemical.
Applications for exemption cannot be granted for information that falls within the
scope of 'basic information' [subsection 75(2) of the Act]. The definition of basic
information can be found in Appendix 2 - Definitions.
Applications for exempt information can be made for information submitted in

connection with:
a. an application for a Low Volume Chemical Permit [subsection 21ZB(1) of the

Act];
b. written notice to the Director of a change in circumstances or of new
information, as required under the conditions of the Low Volume Chemical
Permit [subsection 21ZB(2) of the Act];
c. an application for a Commercial Evaluation Permit [section 21P of the Act];
d. the notification of a new chemical (including a polymer of low concern)
[section 25 of the Act];
e. the provision of further information to assist in the assessment of a new
chemical [section 29 of the Act];
f. an application for early introduction of a non-hazardous chemical [section 30A
of the Act];
g. an application for extension of an original assessment certificate to cover other
importers or manufacturers [section 40D of the Act];
h. the notification of a new chemical which has been notified and assessed under
notification law in force in a State or Territory [section 42 of the Act];
i. the notification of a new chemical which has been notified and assessed under
an approved foreign scheme [section 45 of the Act];
j. the provision of information for a prospective Priority Existing Chemical
(PEC) [section 50 of the Act];
k. the provision of information for a PEC [section 60 of the Act];
l. the secondary notification of a chemical [section 66 of the Act]; and
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Appendix 6 – Confidentiality
m. information given to inspectors [section 89 of the Act].
Applications should be made on Form 3 and be accompanied by the required fee

($588).
In all applications for exemption from publication, the Director weighs the public
interest in publishing the information against the potential commercial harm to the
notifier.
If the Director decides that the claim is justified, then those data items will be classed
as exempt from publication. On the other hand, if the claim is rejected, then the
Director will notify the applicant, who may appeal to the Administrative Appeals
Tribunal for a review of the decision. In all cases, the applicant will receive written
notice of the Director's decision.
SECURITY OF INFORMATION DURING ASSESSMENT
The dossiers of information that comprise the notification statement or permit

application are only available to staff within the government agencies conducting the
assessment. If assessments were to be done under contract, confidentiality agreements
would be signed.
PUBLIC ACCESS TO INFORMATION
In the case of chemicals for which the summary report (or the full public report for a
polymer of low concern) has been published in the Chemical Gazette, the full public
report of the chemical is available for public inspection, from NICNAS.
DISCLOSURE OF EXEMPT INFORMATION IN SPECIAL CIRCUMSTANCES
In special circumstances, the Director may disclose certain items of exempt

information about a chemical [section 79 of the Act]. This can be done:
• with the consent of the notifier and, in the case of information given under an
approved foreign scheme, the corresponding foreign government; or
• without consent, in an emergency where the Director must be satisfied that
any delay in disclosure could endanger the occupational health and safety of a
person, public health or the environment.
In both situations, the Director must be satisfied that:
• the disclosure is to assist in the protection of occupational health and safety,

public health or the environment; and
• the public interest in disclosing the exempt information outweighs the
commercial interest of the applicant.
In all cases of disclosure of exempt information, the Director must give written notice
to the applicant and, if necessary, the relevant foreign government [section 80 of the
Act].
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Appendix 7 – Summary of the Act
7. Summary of the Act

The following table provides a summary of which sections of the Act refer to the key
kinds of application outlined in this book.
Exempt Chemical for Site-Limited R&D Paragraph 21(3)(b)

Exempt Chemical for Volume-Limited Paragraph 21(6)(a)
R&D
Exempt Small Amount Chemical Subsection 21(4)
(cosmetic and non-cosmetic)
Exempt Chemical (other) Paragraph 21(6)(b)(c)
Secondary Notification Section 65
NICNAS Registration Section 80
New chemicals assessments
Commercial Evaluation Chemical Sections 21B
Low Volume Chemical Sections 21S
Polymers of Low Concern Section 24A
Limited Notifications Subsection 23
Standard Notifications Subsection 23
Extension of Original Assessment Section 40A
Certificate
Other types of application and assessment
Provision of a Draft Assessment Report Regulation 15(5)
Self Assessment Section 23A
Section 30A Early Introduction Permit Section 30A
Section 30 Permit Section 30
Provision of an Approved Foreign Report Sections 44(5)
Variation of Schedule Requirements Section 24
Exempt Information Sections 21P, 21ZB, 25, 29, 30A, 40D,
42, 45, 60,66, 75 and 89
Variation of Assessment Report Section 37
Variation of Full Assessment Report Section 40
Variation of Draft PEC Assessment Section 60
Report
Listing on Confidential Section of the Sub-section 14(3)
AICS
172
Appendix 7 – Summary of the Act
Re-Listing on Confidential Section of the Section 19

AICS
Status of Holder of Confidence Section 17
Priority Existing Chemical Assessment Sub-section 55(1) and 55(1A)
173
Appendix 8 – Appeals
8. Appeals
Many features of NICNAS depend on decisions made by the Minister for Health and
Ageing or the by the Director.
The decisions listed below made by the Minister or Director under the Industrial
Chemicals (Notification and Assessment) Act 1989 (Cwlth) are appealable to the
Administrative Appeals Tribunal.
Decision Made Subject

Under By
Section
14(4) Director A decision to include a chemical in the confidential section of
the AICS five years after the giving of an assessment
certificate.
17(4) Director A decision on whether to treat an applicant as the holder of a
confidence about a chemical.
18A(2), Director A decision to reject a person's reasons against the
19(9) transference of a chemical from the confidential to the non-
confidential section of the AICS.
20AA(6) Director A decision to remove a chemical wrongly included in the
AICS.
20E(3) Director A decision that an application for listing an eligible chemical
should be refused.
21H(1) Director A decision to refuse the application for a Commercial
Evaluation Permit on the grounds that the quantity requested
is not reasonably needed.
21H(2) Director A decision to refuse the application for a Commercial
Evaluation Permit on the grounds that the period requested
exceeds one year.
21L Director The decision to use specified conditions in a Commercial
Evaluation Permit.
21U(3) Director A decision to refuse an application for a Low Volume
Chemical Permit.
21W(3) Director A decision to grant a Low Volume Chemical Permit subject
to specified conditions.
21W(4) Director A decision to impose further conditions on a Low Volume
Chemical Permit or to revoke or vary conditions already
imposed.
21W(6) Director A decision to cancel a Low Volume Chemical Permit.
24(1) Director A decision on waiving the requirements of the notification
statement in the case of a chemical listed on a recognised
international inventory of chemicals.
24(3) Director A decision allowing the variation of information normally
174
required by the Schedule in the notification statement.

24(4) Director A decision on waiving the requirements of the notification
statement where particular matters specified in the Schedule
are irrelevant, or unnecessary, for the assessment of the
chemical.
27(1) Director A decision to request further information about a matter
relating to a requirement in the Schedule.
27(2) Director A decision to request further information which is additional
to the requirement in the Schedule, and which is necessary to
complete an assessment.
27(4) Director A decision that a notifier has complied with a notice to give
additional information for the assessment of the chemical.
28(2) Director A decision to suspend consideration of the notification until
the notifier supplies further new information relevant to the
adequate assessment of the chemical.
30(1) Minister A decision to grant to a notifier a permit to introduce a
chemical before the assessment certificate is given.
30(3) Minister A decision that information be published relating to a
chemical which is subject to a permit.
30(5) Minister A decision on conditions specified in a permit allowing the
introduction of a chemical before an assessment certificate is
given.
30A(3) Director A decision not to grant an Early Introduction Permit.
30C(1) Director A decision to revoke an Early Introduction Permit.
31(3) Minister A decision to grant an additional 90 days in which to
complete a thorough assessment and report.
37(2)(b) Director A decision to grant an additional 90 days in which to
complete a thorough assessment and report.
40(6) Director A decision on varying a full public report as requested.
40F(3)(b) Director A decision to refuse to vary an assessment report as requested
by the notifier.
44(1)(d) Director A decision on whether the assessment under an approved
foreign scheme is relevant to Australia.
44(2)(b) Director A decision on adoption of a report, other information and
documents given under an approved foreign scheme.
44(5) Minister A decision to grant an additional 90 days to complete an
assessment report based on information provided under an
approved foreign scheme.
51(1) Minister A decision to declare a PEC.
52 Director A decision that a chemical was wrongly included in the
AICS.
57(6) Minister A decision to extend the period of six months to 12 months
175
for completion of a thorough assessment report for a PEC.

58(3) Director A decision concerning information to be given for the
assessment of a PEC.
60E(5) Director A decision to refuse to vary a draft assessment report.
61(2) Minister A decision to prohibit a particular activity involving a
declared PEC.
65(2) Director A decision to require a secondary notification.
67(1) Minister A decision to suspend an assessment certificate or
introduction permit, or to prohibit continuing introduction of
a chemical, on failure to comply with a secondary
notification requirement.
68(6) Minister A decision to grant an additional period of up to 90 days in
which to complete a thorough assessment and report for a
chemical subject to secondary notification.
69(1) Director A decision to require persons who are not required to give a
secondary notification of a chemical to supply information to
assist in the thorough assessment of that chemical.
73(6) Director A decision to revoke an assessment certificate due to not
being informed of a change in the holder of the certificate.
75(1) Director A decision to allow specific items of information to be
exempt from publication.
79(a) Director A decision to disclose exempt information in the public
interest.
80G(2) Director A decision to refuse an application for registration.
80K(5) Director A decision to refuse an application for renewal of
registration.
80QA(1) Director A decision on assessment of a registration charge.
80QC(3) Director A decision in response to a reconsideration or review of an
assessment.
To have a decision reviewed, you must write to the Administrative Appeals Tribunal
setting out the decision to be reviewed and the reasons for requesting the review. For
more information contact:
Principal Registrar
Administrative Appeals Tribunal
Level 4
Commonwealth Law Courts
Cnr Tank Street and North Quay
BRISBANE QLD 4000
Phone: (07) 3361 3000
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Appendix 9 – Description of an Article
9. Description of an Article
An item is an article [subsection 6 (2) of the Act] if it satisfies each of the following
criteria:
a. An article is a manufactured item which is deliberately formed to a specific
shape or design during manufacture.
b. An article has an end use function wholly or partly dependent on its shape or
design.
A solid substance which is manufactured or imported, formed to a particular

shape, and which undergoes only further limited processing into a finished
article, is considered to be itself an article. ‘Limited processing’ covers
cutting, bending, surface chemical reaction, etc, but excludes processes such
as pulverising, melting, pelletising, etc, where the formed shape is completely
destroyed. Other items to be regarded as articles are polymer blocks, sheets,
films and filaments.
c. An article undergoes no change of chemical composition during end use,

except as an intrinsic part of that end use (items such as photographic film in
which the chemical composition is altered as a result of use are examples of
articles where the change of chemical composition is intrinsic to the intended
use).
Fluids and particles are not normally considered to be articles regardless of shape or
design. ‘Fluids’ refers to liquids (including suspensions and solutions) and gases.
‘Particles’ refers to any solid chemical substance or mixture of substances that is in
discrete aggregations of unspecified size, which may take the form of dust, powders,
dispersions, granules, lumps and flakes. Substances in a form in which the bulk
properties and usefulness of the substance are dependent in part on the particle’s
shape are not regarded as articles.
Fluids or particles contained within a vessel serving simply to store, transport and
dispense its content are considered to be chemical substances. In general, all fluids
and particles, such as cleaners, solvents, fuels, glues, sealants, inks, paints and other
coatings, are chemical substances if they are merely contained in some form of
packaging.
The contents of containers, such as bottles, jars, cans, aerosol cans, drums, barrels,
tanks, bags, tubes and sachets are chemical substances or mixtures of chemical
substances.
However, for items where it is intended that the fluid or particulate contents remain in
their container during normal use of the item, and that they serve an intrinsic part of
the end purpose of the item, then the fluids and particles are considered to be an
integral part of the article. Thus, a motor lubricant in a bottle, drum or aerosol can is a
chemical substance (or a mixture of chemical substances) should be notified, but a
lubricant in a motor vehicle or other piece of mechanical equipment is part of an
article and should not be notified.
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Appendix 9 – Description of an Article
If a fluid or particulate substance is not considered to be an integral part of an article,

the chemical substance needs to be notified, for example, inks and toners in copier,
printer cartridges and typewriter ribbons.
In practice, it will only be for imported items containing fluids and particles that a
decision needs to be made whether the fluid or particles constitute a chemical
substance (or a constituent of a mixture or chemical substances) and therefore should
be notified, or whether the fluid or particle is to be considered as an integral part of an
article. The constituents of items that are locally manufactured will be present as
individual chemical entities prior to packaging or assembly and therefore must be
notified.
In some manufacturing processes, the chemical substance synthesised is immediately

subject to physical processing to form it into an article, for example, in a process
involving manufacture of a polymer resin followed by extrusion into a plastic bottle.
For manufacturing processes of this type carried out in Australia, the chemical
ingredients used in the manufacturing process are considered as industrial chemicals
and NICNAS should be notified. However, the final resultant product being, the
plastic bottle is considered to be an article.
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Appendix 10 –Polymers of Low Concern
10. Polymers of Low Concern Guidance

The material in this appendix offers greater detail on the criteria for nominating
polymers of low concern (PLCs) and should be read with reference to Chapter 3 –
Which notification category?
1. Reactive Functional Groups

The number of reactive functional groups (RFGs) in a polymer is important in
determining whether it meets the new criteria. RFGs must be taken into account when
considering the low molecular weight species of a polymer (see section 3 below) and
in determining whether cationic polymers are PLCs (section 4 below).
A reactive functional group is defined as an atom or associated group of atoms in a
chemical substance that is intended or can be reasonably anticipated to undergo facile
chemical reaction.
RFGs are divided into three categories, low, moderate and high concern, to reflect the
comparative reactivity of each functional group (see Table 1 below). The criterion for
categorisation is more qualitative than quantitative. It is based on the presence of
chemically or metabolically reactive or toxic (including ecotoxic) functional groups
within the polymer. RFGs in the low concern category generally lack reactivity, or
have low adverse reactivity, in a biological setting.
For human health hazard, RFGs are placed in the high concern category if there is
evidence of adverse effects in humans or there is conclusive evidence of severe
effects in animals. RFGs are placed in the moderate concern category if there is
evidence of reactivity in a biological setting but the effects are not severe enough to
place the functional group in the high concern category. Sufficient information should
be available to be confident of categorisation as moderate concern. Where the
reasoning behind categorisation is not clear, RFGs default to the high concern
category until sufficient information becomes available. Similarly, RFGs not
categorised default to the high concern category until sufficient information becomes
available.
A number of functional groups are not considered to be RFGs. These include

carboxylic esters, ethers, amides, urethanes, sulfones and the nitro group. This is
provisional on the functional group not being modified to enhance its reactivity, eg.
the dinitrophenyl ester of a carboxylic acid.
Amines are taken to be high concern RFGs. Polymers containing these RFGs are
generally considered under cationic polymers.
RFGs in their respective categories are listed in the Regulations under the Act. The
list will be updated when necessary by notice in the Chemical Gazette.
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Table 1 Reactive Functional Group Categories

Low concern Moderate concern High concern
Carboxylic acid Pendant acrylates and

methacrylates
Aliphatic hydroxyl
Aziridines
Unconjugated olefinic
considered ‘ordinary’ Carbodiimides
Butenedioic acid Halosilanes, Hydrosilanes,

Alkoxysilanes1
Conjugated olefinic groups Conjugated olefinic groups

contained in naturally not contained in naturally Hydrazines
occurring fats, oils and occurring fats, oils and
carboxylic acids carboxylic acids
Isocyanates, isothio-
cyanates
Blocked isocyanates
(including ketoxime- Alpha or beta lactones
blocked isocyanates)
Vinyl sulfones or
analogous compounds
Thiols
*Acid halides
Unconjugated nitriles *Acid anhydrides
*Aldehydes
Halogens (except reactive *Hemiacetals
halogen-containing groups *Methylolamides, -amines
such as benzylic or allylic or –ureas
halides)
*Cyanates
*Epoxides
*Unsubstituted positions
ortho and para to phenolic
hydroxyl
*Allyl ethers
*Imines (ketimines and
180
aldimines)
Partially-hydrolysed
acrylamides
Other reactive functional
groups not in the low or
moderate concern groups
1
Alkoxysilanes with alkoxy groups greater than C2 are in Moderate Concern in US
* Denotes group is in Moderate Concern category under United States Environmental
Protection Agency (US EPA) and for which information to support categorisation as
‘Moderate’ is unavailable to NICNAS. It is proposed that these reactive functional
groups default to the high concern category pending provision of data and information
by industry and/or other parties to NICNAS.
2. Functional Group Equivalent Weight (FGEW)

The concept of functional group equivalent weight (FGEW) is used to assist in
determining whether the RFGs in a polymer are substantially diluted by polymeric
material to allow the polymer to be a PLC.
The FGEW of a polymer is defined as the ratio of NAMW to the number of functional
groups in the polymer. It is the weight of polymer that contains one formula weight of
the functional group.
Low concentrations of RFGs are permissible in the polymer molecules, but the
quantity is restricted by the reactivity of the particular functional group(s) in question.
Guidance in calculating FGEW is provided at the end of this appendix.
3. Molecular Weight
Unless a new polymer is a polyester manufactured from the list of allowable reactants,
the number average molecular weight (NAMW) of a PLC must be 1000 or greater.
Under the new criteria, a PLC must also meet the low molecular weight criteria.
These are described below. (Polyesters are discussed in section 9 below.)
Low Molecular Weight Species

For the purposes of the Act, the low molecular weight species in a polymer includes
the oligomer content with NAMW less than 1000, where oligomer is defined as the
low molecular weight species derived from the polymerisation reaction.
This definition is consistent with that used by the US EPA in their polymer exemption
criteria. The definition means that residual monomers and other reactants are not
included when determining the content of low molecular weight species.
For polymers with NAMW between 1000 and 10000, the allowable low molecular
weight species (MW below 1000 and 500) has been increased from 5% and 2%
respectively to 25% and 10% provided that the polymer contains:
(h) only low concern reactive functional groups (RFGs); or
(i) moderate concern RFGs with a combined FGEW of 1000 or more (provided no
high concern groups are present); or
(j) high concern RFGs with a combined FGEW of 5000 or more (the calculated
FGEW must include moderate concern groups if present).
181
Example: Consider a polymer of NAMW 8000, 15% < MW 1000, 6% < MW 500 and
2 isocyanate groups at the ends of the polymer backbone. Is the polymer a PLC? First,
the polymer meets the MW criteria. The FGEW is 8000/2 = 4000. As the RFGs are in
the high concern category, the polymer does not meet the criterion as the FGEW is
below 5000. Therefore, the polymer is not a PLC.
For polymers with NAMW 10000 or greater, the allowable low molecular weight
species (MW below 1000 and 500) for these polymers will remain at 5% and 2%
respectively. However, the restriction on RFGs has been removed, that is, there is no
limit on the number of RFGs in a polymer with NAMW > 10000.
Example: Consider a polymer of NAMW 18000, 15% < MW 1000, 6% < MW 500
and 2 isocyanate groups at the ends of the polymer backbone. Is the polymer a PLC?
First, there is no restriction on RFGs so the number of isocyanate groups does not
matter. However, as the polymer does not satisfy the criterion for low MW species,
the polymer is not a PLC.
4. Cationic Polymers
To be eligible as a PLC, a polymer must have a low charge, or cationic, density.
Cationic polymers and polymers which are reasonably anticipated to become cationic
in a natural aquatic environment are not eligible as PLCs. The main concern is the
toxicity of cationic polymers towards aquatic organisms such as fish and algae.
For the purposes of the Act and this guidance, the following definitions apply:
• A polymer has a low charge density if it is not a cationic polymer or is not
reasonably anticipated to become a cationic polymer in a natural aquatic
environment (4<pH<9) or:
• the polymer is a solid material that is not soluble or dispersible in water and
will only be used in the solid phase, e.g. ion exchange beads; or
• the polymer is cationic (or potentially cationic) and the combined (total)
FGEW of cationic groups is 5000 or above.
Guidance in calculating FGEW is provided at the end of this appendix.
• A cationic polymer is defined as a polymer that contains a nett positively-
charged atom(s) or associated group(s) of atoms covalently linked to its polymer
molecule. Examples are the ammonium, phosphonium and sulfonium cations.
• A potentially cationic polymer is defined as a polymer containing groups that
are reasonably anticipated to become cationic. Examples are all amines
(primary, secondary, tertiary, aromatic, etc.) and all isocyanates (which
hydrolyse to form carbamic acids, then decarboxylate to form amines).
• Reasonably anticipated means that a knowledgeable person would expect a
given physical or chemical composition or characteristic to occur, based on
factors such as the nature of the precursors used to manufacture the polymer, the
type of reaction, the type of manufacturing process, the products produced in the
polymerisation, the intended uses of the substance, or associated use conditions.
Example: Consider a polyamide of NAMW 7000 manufactured from equimolar

amounts of ethanediamine and isophthalic acid. On average, the polymer will have
one unreacted amino group at one end of the polymer chain and an unreacted
182
carboxylic acid group at the other end. The amino group is potentially cationic so, as
FGEW is defined as the ratio of NAMW to the number of RFGs, the FGEW for the
amino group is 7000/1. Therefore, the polymer meets the criteria for low charge
density as the FGEW is above 5000. If the NAMW had been less than 5000 or if the
polymer had two free amine groups, then the polymer would not have been eligible as
a PLC.
5. Hazard classification
A polymer can only be a PLC if it is not classified as a hazardous chemical. Under the
Act, each of the following is a hazardous chemical:
c. a chemical that is included in the List if Designated Substances [NOHSC:
10005] published in April 1999 by the National Occupational Health and
Safety Commission;
d. a chemical that is classified as a hazardous substance in accordance with the
Approved Criteria for Classifying Hazardous Substances [NOHSC: 1008]
published in April 1999 by the National Occupational Health and Safety
Commission.
6. Elemental Criteria
A PLC must contain as an integral part of its composition at least two of the atomic
elements carbon, hydrogen, nitrogen, oxygen, silicon and sulphur. A PLC must not
contain as an integral part of its composition (other than impurities) elements other
than:
• carbon, hydrogen, nitrogen, oxygen, silicon and sulphur;
• sodium, magnesium, aluminium, potassium, calcium, chlorine, bromine and
iodine as the monatomic counter-ions Na+, Mg2+, Al3+, K+, Ca2+, Cl-, Br- or I-;
• fluorine, chlorine, bromine or iodine covalently bound to carbon; or
• less than 0.2 % (by weight) of any combination of the atomic elements lithium,
boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin and
zirconium.
No other elements are allowed, except as impurities. Specifically, the fluoride anion
F- is not allowed as it has a high acute toxicity.
It should be noted that this criterion refers to monatomic species only. For example, a
polymer containing the ammonium counter ion may be a PLC provided it meets the
other PLC criteria.
Regarding the binding of halogens to carbon, it should be noted that the perchlorate
anion ClO4- would not be allowed, as the chlorine is not covalently bound to carbon,
however, the trichloroacetate anion CCl3CO2- would be allowed.
7. Degradable or Unstable Polymers

A PLC must be a stable polymer. In other words, a polymer is not eligible to be PLC
if it is designed or reasonably anticipated to degrade, decompose or depolymerise
substantially, including those polymers that could substantially decompose after
manufacture and use, even though they are not actually intended to do so.
For the purposes of the Act and this guidance, the following definition applies:
Degradation, decomposition or depolymerisation means a type of chemical change in
which a polymeric substance breaks down into simpler, smaller weight substances as
183
the result of (for example) oxidation, hydrolysis, heat, sunlight, attack by solvents or
microbial action.
‘Reasonably anticipated’ is defined above in section 4.

‘Substantially’ is taken to mean ‘considerably’, ‘meaningfully’ or ‘to a significantly
large extent’. It is not intended to include the slow, natural biodegradation that occurs
during, say, the weathering of paint.
Examples of polymers that would not meet this criterion include:

• polymers which are designed to be pyrolysed or burnt during their normal use;
• polymers which are explosive; and
• polymers which substantially biodegrade in the environment, for example, starch.
8. Water Absorbing Polymers

Water absorbing polymers with NAMW 10000 and greater will not qualify as PLCs.
A water absorbing polymer means a polymer that is capable of absorbing its own
weight in water.
This criterion is for water absorbing polymers in particulate form only. It is directed
towards polymers known as ‘super absorbents’, for example, polymers used in
applications such as disposable nappies and paper towels. Based on rat inhalational
data for a water-absorbing polyacrylate polymer, where lung tumours were observed
in both males and females at 0.8 mg/m3, it has been assumed that lung damage may
occur from the inhalation of water absorbing polymers, as the lungs are unable to
clear the inhaled particles.
Water-soluble and water dispersible polymers are not considered to be water

absorbing polymers. Moreover, it is assumed that particles of these polymers are
adequately cleared from the lungs after inhalation.
9. Polyesters
The definition of a polyester is as follows:
Polyester means a chemical substance that meets the definition of polymer (in the
Act) and whose polymer molecules contain at least two carboxylic acid ester linkages,
at least one of which links internal monomer units together.
Polyesters manufactured from an approved list of monomers or other reactants are
eligible for notification as PLCs, provided they satisfy the other PLC criteria. This
provision is independent of NAMW. The list of approved monomers and other
reactants is in Table 2 below. The table, to be in the regulations, can be updated by
notice in the Chemical Gazette.
It should be noted that a number of reactants on the list are not on AICS. Therefore,
the manufacture of polyesters from these reactants could not be carried out in
Australia without notification and assessment of the reactant. On the other hand,
polyesters manufactured from these reactants overseas could be imported, as the
reactant itself would not be introduced.
Note that polyesters manufactured from the anhydride of an acid on the polyester list,
for example, succinic anhydride (butanedioic acid), are allowed, provided that there
are no pendant anhydrides in the polymer.
184
In summary, certain polyesters will not be eligible for notification as PLCs. These
include:
• biodegradable polyesters (they would not meet the degradation criterion);
• water-absorbing polyesters; and
• polyesters manufactured from any monomer or other reactant not on the list of
allowable reactants, including such a reactant at less than 2%.
Table 2 List of reactants from which polyester may be made
Reactant CAS no.
Monobasic Acids and Natural Oils

Benzoic acid........................................................................................ 65-85-0
Canola oil.......................................................................................... 120962-03-0
Coconut oil.......................................................................................... 8001-31-8*
Corn oil.............................................................................................. 8001-30-7*
Cottonseed oil....................................................................................... 8001-29-4*
Dodecanoic acid................................................................................. 143-07-7
Fats and glyceridic oils, anchovy....................................................... 128952-11-4*
Fats and glyceridic oils, babassu......................................................... 91078-92-1*
Fats and glyceridic oils, herring....................................................... 68153-06-0*
Fats and glyceridic oils, menhaden..................................................... 8002-50-4*
Fats and glyceridic oils, sardine......................................................... 93334-41-9*
Fats and glyceridic oils, oiticica......................................................... 8016-35-1*
Fatty acids, C16-18 and C18-unsaturated ............................................. 67701-08-0*
Fatty acids, castor-oil.......................................................................... 61789-44-4*
Fatty acids, coco................................................................................. 61788-47-4*
Fatty acids, dehydrated castor-oil....................................................... 61789-45-5*
Fatty acids, linseed oil......................................................................... 68424-45-3*
Fatty acids, safflower oil..................................................................... 93165-34-5
Fatty acids, soya............................................................................... 68308-53-2*
Fatty acids, sunflower oil.................................................................... 84625-38-7*
Fatty acids, sunflower-oil, conjugated................................................. 68953-27-5*
Fatty acids, tall-oil............................................................................... 61790-12-3*
Fatty acids, tall-oil, conjugated*...........................................................
Fatty acids, vegetable oil..................................................................... 61788-66-7*
Glycerides, C16-18 and C18-unsaturated .............................................. 67701-30-8*
Heptanoic acid.................................................................................. 111-14-8
185
Hexanoic acid...................................................................................... 142-62-1

Hexanoic acid, 3,3,5-trimethyl-........................................................... 3302-10-1
Linseed oil........................................................................................... 8001-26-1*
Linseed oil, oxidised............................................................................ 68649-95-6*
Nonanoic acid...................................................................................... 112-05-0
Oils, Cannabis*.....................................................................................
Oils, palm kernel.................................................................................. 8023-79-8*
Oils, perilla........................................................................................ 68132-21-8*
Oils, walnut....................................................................................... 8024-09-7
Safflower oil........................................................................................ 8001-23-8*
Soybean oil........................................................................................ 8001-22-7*
Sunflower oil....................................................................................... 8001-21-6*
Tung oil................................................................................................. 8001-20-5*
Di and Tri Basic Acids:.

1,2-Benzenedicarboxylic acid.............................................................. 88-99-3
1,3-Benzenedicarboxylic acid............................................................. 121-91-5
1,3-Benzenedicarboxylic acid, dimethyl ester.................................. 1459-93-4
1,4-Benzenedicarboxylic acid.............................................................. 100-21-0
1,4-Benzenedicarboxylic acid, diethyl ester………………………… 636-09-9
1,4-Benzenedicarboxylic acid, dimethyl ester..................................... 120-61-6
1,2,4-Benzenetricarboxylic acid........................................................... 528-44-9
Butanedioic acid................................................................................... 110-15-6
Butanedioic acid, diethyl ester.............................................................. 123-25-1
Butanedioic acid, dimethyl ester......................................................... 106-65-0
2-Butenedioic acid (E)-....................................................................... 110-17-8
Decanedioic acid.................................................................................. 111-20-6
Decanedioic acid, diethyl ester............................................................ 110-40-7
Decanedioic acid, dimethyl ester......................................................... 106-79-6
Dodecanedioic acid.............................................................................. 693-23-2
Fatty acids, C18-unsaturated, dimers.................................................. 61788-89-4*
Heptanedioic acid............................................................................. 111-16-0
Heptanedioic acid, dimethyl ester....................................................... 1732-08-7
Hexanedioic acid................................................................................. 124-04-9
Hexanedioic acid, dimethyl ester........................................................ 627-93-0
186
Hexanedioic acid, diethyl ester............................................................ 141-28-6

Nonanedioic acid.............................................................................. 123-99-9
Nonanedioic acid, dimethyl ester........................................................ 1732-10-1
Nonanedioic acid, diethyl ester........................................................... 624-17-9
Octanedioic acid.................................................................................. 505-48-6
Octanedioic acid, dimethyl ester........................................................ 1732-09-8
Pentanedioic acid............................................................................... 110-94-1
Pentanedioic acid, dimethyl ester......................................................... 1119-40-0
Pentanedioic acid, diethyl ester........................................................... 818-38-2
Undecanedioic acid.............................................................................. 1852-04-6
Polyols
1,3-Butanediol...................................................................................... 107-88-0
1,4-Butanediol.................................................................................... 110-63-4
1,4-Cyclohexanedimethanol............................................................... 105-08-8
1,2-Ethanediol.................................................................................... 107-21-1
Ethanol, 2,2´-oxybis-....................................................................... 111-46-6
1,6-Hexanediol................................................................................. 629-11-8
1,3-Pentanediol, 2,2,4-trimethyl-..................................................... 144-19-4
1,2-Propanediol................................................................................. 57-55-6
1,3-Propanediol, 2,2-bis(hydroxymethyl)-..........……..................... 115-77-5
1,3-Propanediol, 2,2-dimethyl-............................................…......... 126-30-7
1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)-................................... 77-99-6
1,3-Propanediol, 2-(hydroxymethyl)-2-methyl................................. 77-85-0
1,3-Propanediol, 2-methyl................................................................. 2163-42-0
1,2,3-Propanetriol.............................................................................. 56-81-5
1,2,3-Propanetriol, homopolymer.................................................... 25618-55-7
2-Propen-1-ol, polymer with ethenylbenzene.................................... 25119-62-4
Modifiers
Acetic acid, 2,2´-oxybis-.................................................................... 110-99-6
1-Butanol........................................................................................ 71-36-3**
Cyclohexanol.................................................................................... 108-93-0
Cyclohexanol, 4,4´-(1-methylethylidene) bis..................................... 80-04-6
Ethanol, 2-(2-butoxyethoxy)-............................................................ 112-34-5
1-Hexanol.......................................................................................... 111-27-3
187
Methanol, hydrolysis products with trichlorohexylsilane and 72318-84-4*

trichlorophenylsilane................
1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1- 13393-93-6
methylethyl)-……………………………………………..
Phenol, 4,4´-(1-methylethylidene)bis-, polymer with 2,2´-[(1- 25036-25-3
methylethylidene)bis(4,1-phenyleneoxymethylene)]bis[oxirane]......
Siloxanes and Silicones, dimethyl, diphenyl, polymers with phenyl 68440-65-3*
silsesquioxanes, methoxy-terminated………………………………..
Siloxanes and Silicones, dimethyl, methoxy phenyl, polymers with 68957-04-0*
phenyl silsesquioxanes, methoxy-terminated………………………
Siloxanes and Silicones, methyl phenyl, methoxy phenyl, polymers 68957-06-2*
with phenyl silsesquioxanes, methoxy- and phenyl-terminated…….
Silsesquioxanes, phenyl propyl......................................................... 68037-90-1*
*Designates chemical substance of unknown or variable composition, complex

reaction products, and biological materials (UVCB substances). The CAS Registry
Numbers for UVCB substances are not used in Chemical Abstracts and its indexes.
**These substances may not be used in a substance manufactured from fumaric or
maleic acid because of potential risks associated with esters which may be formed by
reaction of these reactants.
10. Data Requirements

The data requirements for the notification of a polymer as a PLC are stipulated on
Form 1-PLC, which can be found in Appendix 1. Only minor changes to the form
have been made a result of the revision of the criteria. These are listed below. General
guidance on PLC data requirements can be found in Appendix 12 – Schedule of data
requirements.
Environmental Impact
The following wording has been included on the PLC form:
What is the environmental impact? Provide information about the release of the
polymer likely to occur at the manufacture or reformulation site and during normal
end use (rather than from spills etc). Qualitative or semi-quantitative estimates only
are required. Where there is both a high content of low molecular weight species and
a high release to water, aquatic toxicity data for fish, daphnia and/or algae may be
required.
Public Health
The following wording has been included on the PLC form:
What is the likely public health exposure? Provide a brief description of any way in
which the polymer could be harmful or hazardous to the health of the public at large.
Where there is both a high content of low molecular weight species and the polymer
is to be used as an ingredient in a cosmetic product at 1% or more, additional
information, eg. toxicological data, may be required.
Attachment
How to Calculate Functional Group Equivalent Weight
188
Unless a functional group equivalent weight (FGEW) can be determined empirically

by recognised, scientific methodology (typically titration), a worst-case estimate must
be made for the FGEW. All moderate and high concern functional moieties must be
taken into account when calculating FGEW. Guidance for estimating FGEW with
specific methods is provided below, together with examples for each methodology.
The methods described are:
end-group analysis; and
the percent charged method.
1. End Group Analysis

FGEW can be calculated by simply counting the number of RFGs and dividing into
the NAMW, i.e.
NAMW
FGEW =
n
Equation 1
where n = the number of RFGs in the monomer.
Linear Polymers
For most condensation polymers (e.g. polyesters, polyamides), the only RFGs are at
the end of the chain because the other RFGs are used up in the condensation reaction.
For linear polymers, where there are 2 RFGs per monomer, the FGEW is half the
NAMW.
Example For a polyamide of NAMW 1500 made from ethylenediamine and

adipic acid, an amine group would be expected at each end of the polymer chain.
Therefore, FGEW = 1500/2 = 750.
Branched Polymers
For polymers where branching occurs, the RFGs at the end of each branched chain
must be counted.
Example Consider the polymerisation of pentaerythritol (4 reactive groups) with

polypropylene glycol (2 reactive groups) and an excess of isophorone diisocyanate (2
reactive groups) to give a polymer of NAMW 3000. Due to the branching of
pentaerythritol and excess diisocyanate, the resultant polymer will theoretically have
6 isocyanate end groups. Therefore, FGEW = 3000/6 = 500.
2. Percent Charged Method

Some condensation and addition reactions create polymers where not all RFGs along
the backbone of the polymer are consumed during the reaction, so an accurate FGEW
cannot be determined by use of a simple end group analysis. In many of these cases,
the calculation of FGEW may be more complex. For example, in some condensation
and addition reactions, some of the RFGs along the polymer backbone are unchanged
during polymerisation. Also, in some cases, the structural formula of the final
polymer is not accurately known.
In these cases, FGEW can be calculated using the weight % monomer in the polymer
(W) and the formula weight of the monomer (FW) as follows:
100 FW
FGEW =
Wn
Equation 2
189
Example For an acrylic polymer containing 7.5% acryloyl chloride monomer

(FW 90.5), the FGEW of acid chloride groups in the polymer is:
100 × 90.5
FGEW =
7.5 × 1
If the various RFGs in a polymer arise from multiple monomers, the following
equation can be used:
1
FGEWcomb =
1 1 1
+ + ....... +
FGEW1 GFEW2 FGEWn
Equation 3
Example Consider the reaction between ethanediamine (MW 60) (charged at

30%) and diglycidyl ether (MW 130) (70%) to give a polymer of NAMW 5000. The
epoxides in the backbone are reacted to give an aliphatic alcohol (low concern). The
amine groups remain intact, with their FGEW proportional to the charged amount of
ethanediamine. As the diglycidyl ether is in excess, it can be assumed that the
polymer is epoxide-terminated.
Using Equation 2, the FGEW for the amine group is (100 x 60)/(30 x 2) = 100. The
FGEW for the epoxide group can be calculated using end group analysis (Equation 1),
i.e. 5000/2 = 2500.
Then using Equation 3, FGEWcomb = inverse of [1/100 + 1/2500] = 96.
Example Consider a p-cresol-formaldehyde condensation polymer which is

reacted with 1.5% epichlorhydrin to give an epoxide-capped resin. As a worst-case, it
is assumed that the polymer is phenol-terminated and that epoxy rings from the
epichlorhydrin (MW 92.5, 1 epoxy group) are also present. A NAMW of 10000 is
assumed.
Using Equation 2, the FGEW for the epoxide group is (100 x 92.5)/(1.5 x 1) = 6167.
The FGEW for the phenol group can be calculated using end group analysis (Equation
1), i.e. 10000/2 = 5000.
Example Consider the addition reaction involving the polymerisation of three

acrylates, glycidyl methacrylate (10%, MW 142, 1 RFG), hydroxymethyl acrylamide
(2%, MW 101, 1 RFG) and acrylic acid (88%). In this case, it can be assumed that
each monomer is completely incorporated into the polymer, with the RFGs of concern
being the epoxide group from glycidyl methacrylate and the hydroxymethyl amide
group from the acrylamide. The carboxylic acid moiety from acrylic acid is of low
concern and need not be included in FGEW calculations.
Using Equation 2, the FGEW for the epoxide group is (100 x 142)/(10 x 1) = 1420.
Again using Equation 2, the FGEW for the hydroxymethyl amide group is (100 x
101)/(2 x 1) = 5050.
190
Appendix 11 – How to obtain CAS registry numbers
11. How to obtain Chemical Abstracts Service Registry

numbers (CAS)
INTRODUCTION
The Chemical Abstracts Service Registry Services furnishes CAS Registry numbers
to customers either by retrieving existing CAS Registry numbers and/or assigning
new CAS Registry numbers for chemical substances. This service is done by a
computer search of information provided by the customer to CAS in hard copy form
(for orders with less than 50 substances). If you have questions regarding this service,
or need information, the CAS Registry Services Coordinator is available at ISD
telephone number (1)(614) 447 3600 and ISD facsimile number (1)(614) 447 3713.
If you wish to have Chemical Abstracts Index Names or other additional substance
information, such as molecular formulae, synonyms and structure diagrams, included
with the CAS Registry number, please contact the CAS Registry Services
Coordinator. To obtain CAS Registry numbers for your substances, the general
information given below will help you determine what substance information you
should include. Order forms (see the sample at the end of this Appendix) must be
completed and returned with payment to the following address:
Chemical Abstracts Service

CAS Registry Services
PO Box 3012
Columbus, Ohio 43210
United States of America
INFORMATION REQUIREMENTS
Policy for the assignment of a new CAS registry number
CAS Registry Services will assign a new CAS registry number to a substance
provided that:
a. The existence and chemical identity of the substance are:

(i) documented by citation in a technical journal, other periodical,
handbook, chemical manufacturer's catalogue, other publication or
other information file which is readily available to the public (either
gratis or at a reasonable fee) in printed, microfiche, or computer-
readable form, or (ii) being reported to a governmental regulatory
agency.
b. Each such request must be accompanied by the complete citation or full name
of the source document/file or the name of the regulatory agency.
c. The chemical meets the chemical registration criteria established by CAS for
the CAS Chemical Registry System.
d. The requesting person (or organisation) must include a written statement that
they do not consider the existence and chemical identity of the substance itself
191
confidential, even though the interest in the substance by a specific person or

organisation may be regarded as confidential.
Information to be submitted for the retrieval of an existing CAS registry number or

the assignment of a new CAS registry number
For substances with well-defined, unique chemical structures, the following

information must be provided:
a. chemically descriptive name which includes the locants for all substituents;
b. molecular formula; and
c. complete structural diagram
Notes:
a. If the substance is a salt, the ratios must be included.

b. If there is known stereochemistry, this must be included.
For chemical substances which cannot be uniquely defined by chemical structure, or

are UVCB substances, such as complex reaction products, one of the following
descriptions is required:
a. a chemically descriptive name which includes a detailed description of the

reaction scheme including all starting reactants and the identification of the
typical chemical composition of the product;
b. if the substance is a result of a manufacturing process or stream, then a
specific description of the manufacturing process, with specific precursors,
specific process terms and typical chemical composition of the product is
necessary; and
c. if the substance is prepared from a natural product, for example, a resin or an
oil, then the substance description should include the genus and species of the
source.
CAS REGISTRY SERVICES TERMS and CONDITIONS
1. INVOICING AND PAYMENT
CAS shall mail invoice(s) for all CAS Registry Services output and related services
rendered to customers. Invoiced amounts are due on receipt of the invoice and may be
paid only in US dollars or UNESCO coupons. Invoices not paid within 30 days shall
be assessed a 5 per cent surcharge.
2. USE AND DISTRIBUTION RESTRICTIONS
CAS Registry Services is the copyright of the American Chemical Society.
When customer's CAS Registry Services output contains synonyms or connection

tables, a CAS licence is required if the customer distributes such output in computer-
192
readable form to third parties except in the following ways: (a) in copyrighted
scientific publications when search results are incidental to the publication, and (b) in
reports to a government agency which are required by law or administrative rule.
While subject to the copyright of the American Chemical Society, the following items
of information are not subject to the use and distribution restrictions specified herein,
provided that they are not made available to any third party in any electronic or
computer-readable form: CAS Registry Numbers, CA Index Names, Molecular
Formulas and Structure Diagrams.
3. LIMITATIONS AND LIABILITY.
While CAS uses its best efforts to deliver complete and accurate CAS Registry
Services output, CAS does not warrant accuracy or completeness, is not responsible
for errors and omissions, and is not liable for any direct, indirect or consequential
damages.
193
CAS REGISTRY SERVICES ORDER FORM
Chemical Abstracts Service CAS Registry Services

PO Box 3012
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Please complete this section for each substance for which you are requesting a CAS Registry
Number.
CHEMICAL SUBSTANCE NAME(S) AND CHEMICAL SUBSTANCE DESCRIPTION:

(See INFORMATION REQUIREMENTS Section 2)
If you wish the ASSIGNMENT of a new CAS Registry Number, please complete one copy of
this form and include it with your order. (See INFORMATION REQUIREMENTS Section 1)
Enter the literature citation (source document) OR governmental regulatory

agency on the following line:
_______________________________________________________________________________
The specified substance(s) are NOT confidential. I understand that the substance(s)
will reside in the CAS Chemical Registry System and will therefore be accessible to
CAS and the public.
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194
Appendix 12 – Schedule of Data Requirements
12. Schedule of Data Requirements
This Appendix provides guidance concerning the data necessary to submit with your
application for new or existing chemical assessments. Use this to help ensure you
have provided all the necessary information. The numbering in this chapter is
consistent with the numbering in the Schedule to the Act.
SCHEDULE PART A
1. Identification Of Data Requirements To Be Dealt With In The Notification
Each application must identify which data is being supplied. For new chemicals, the
data to be submitted for each category of application are outlined in Chapters 4, 5 and
6. Where doubt exists, contact the Director.
For PECs, data requirements are often described in terms of the Schedule. These
requirements are listed by notice in the Chemical Gazette.
2. Summary Of Health And Environmental Effects
A summary of the occupational health and safety, public health and environmental
effects of the chemical is required in all Standard Notifications and Limited
Notifications. Notifiers should discuss the effects and hazards of the chemical in light
of proposed recommendations for its use.
The summary should highlight the results of the tests that are used to determine the
toxic effects of the chemical, including its ecotoxicity, that is, a summary of the most
significant results of Part C of the Schedule. In tests where no adverse effects are
observed, comments on dosage levels should be made. The summary should also
highlight the physical and chemical hazards of the chemical, for example,
flammability and reactivity.
The summary should highlight the toxic effects and hazards of the chemical and its
impact on occupational health and safety, public health and the environment.
The summary should also address any information missing from the notification, and
justify the omission(s).
3. Summary Of How The Chemical Meets The Definition Of A Hazardous

Substance
Under the NOHSC Standard Control of Workplace Hazardous Substances: National

Model Regulations and National Code of Practice, a hazardous substance is defined
as:
• a substance which is listed on the NOHSC List of Designated Hazardous
Substances; or
• a substance which has been classified as a hazardous substance by the
manufacturer or importer in accordance with the NOHSC Approved Criteria
for Classifying Hazardous Substances (Approved Criteria).
195
Under the amended NICNAS legislation, a hazardous substance is defined as a

‘hazardous chemical’.
The notifier should state whether the notified chemical is a hazardous substance or
not. If the chemical is a hazardous substance, the notifier should provide a health
hazard classification of the notified chemical, carried out in accordance with the
NOHSC Approved Criteria. This should include the appropriate risk and safety
phrases and the basis of the classification (in terms of the toxicological endpoints
considered). For the purposes of notification, the health hazard classification of
products containing the notified chemical should also be provided.
As a requirement for the MSDS of the notified chemical, an appropriate statement of
hazardous nature should be provided. The wording to be used is either:
• Hazardous according to the criteria of National Occupational Health and
Safety Commission; or
• Not classified as hazardous according to the criteria of National
Occupational Health and Safety Commission.
4. Details Of Any Notification Made In Relation To The Chemical In A Country

Other Than Australia
A summary of the status of the notified chemical in countries other than Australia
should be provided. The information provided should include:
• name of each country;
• whether an assessment of the chemical was carried out in any of the
nominated countries or, alternatively, whether the chemical is listed on one or
more national inventories without being assessed;
• date of the assessment (if an assessment was carried out);
• whether a risk assessment report is available to the notifier (if an assessment
was carried out); and
• whether the notifier wishes the notification package to be considered under
the Foreign Schemes Program (see Section 8.2).
5. Bibliography
A complete listing of all publications referred to in the notification statement is

required, including:
• references for published and unpublished studies;
• references for other information obtained from the scientific literature;
• references to standards and codes of practice;
• test methods used to generate data;
• references to other notification and assessment schemes; and
• other reports on the chemical or class of chemicals.
SCHEDULE PART B
In this section, the numbering is consistent with the numbering in the Schedule to the
Act.
1. Identity Of The Substance
196
A complete and unambiguous identification of the chemical must be provided by

completing paragraphs 1(a) to 1(g) of Part B of the Schedule. For chemicals with a
Chemical Abstracts Services (CAS) number, a CAS printout should be provided. In
the case of a synthetic polymer, information listed below under paragraphs 1(a) to
1(c) should also be provided for the constituent monomer(s).
1(a) Chemical name

The chemical name(s) to be provided is that which will be used in the AICS, that is,
the Chemical Abstracts (CA) Preferred Index name(s). If this is not available, then use
the International Union for Pure and Applied Chemistry (IUPAC) name(s).
For substances that are not pure chemicals, that is, chemicals of unknown or variable
composition, a complex product of a chemical reaction, or a biological material
(UVCB), the chemical name must describe the substance as completely as possible.
An example of a chemical of unknown or variable composition is fatty acids,
cottonseed oil. An example of a complex product of a chemical reaction is
polyethoxylated C12-20 alcohols. Typical biological materials are geranium oil and
proteinase. For biopolymers, the biological source must be indicated.
1(b) Other names

Common names by which the chemical is known or identified in the scientific or
technical literature are required. For example, 2-propanone is commonly known as
acetone.
1(c) Marketing name of chemical

Names under which the chemical has been, or will be, marketed are required. This
will include trade names.
1(d) CAS number

Each new chemical has its own unique number assigned to it by the Chemical
Abstracts Service (CAS). The number, known as the CAS number, can be obtained by
reference to the procedure in Appendix 11 - How to obtain Chemical Abstracts
Service registry numbers.
If a CAS number has not been allocated to the chemical, then the notifier should state
when an application has been made.
1(e) Molecular and structural formulae

Provide a molecular formula that gives the identity and number of atoms of each
element in the molecule, for example, C6H6 for benzene, H2SO4 for sulphuric acid.
Provide a structural formula that indicates the location of atoms, ions or groups and
the nature of bonds joining them, for example, acetic acid.
For polymers, the molecular and structural formulae of the constituent monomers, and
their appropriate ratios, should be provided.
1(f) Molecular weight

The gram-molecular weight of the chemical is to be provided. For polymers, both the
number-average molecular weight and the weight average molecular weight should be
provided (see Part D in this Chapter).
1(g) Spectral data
197
Copies of spectra, for example, from infra-red spectroscopy, nuclear magnetic

resonance spectroscopy, mass spectroscopy and ultraviolet-visible spectrophotometry,
are required to confirm the structural formula. Principal wavelengths and/or other
significant data should be indicated. Analytical details, such as the solvent used or the
infrared matrix used, for example, nujol mull or potassium bromide pellet, should also
be provided.
For biological materials that are derived from plants (herbs), confirmation of the
identity of the herb is required. Due to the variability within classes and species of
herbs, an authenticated certificate of analysis should be provided. Internationally,
herbs can be identified at Kew Gardens, London, United Kingdom. In Australia, herbs
can be identified at the New South Wales Herbarium in Sydney.
Similarly, confirmation of the identity of biological materials derived from animals

and gene technology is required.
2. Composition Of The Chemical

2(a) Purity
The degree of purity of the chemical (as a weight percentage) is to be provided. For
chemicals containing water, this percentage shall be given for the dried substance,
unless water is an integral part of its composition.
2(b) Toxic or hazardous impurities

The identity and the weight percentage of all known (or reasonably anticipated)
impurities (including isomers and by-products) of a hazardous or toxic nature shall be
provided, together with details of their toxic and hazardous properties. This section
includes impurities which are classified as dangerous goods and substances listed on
the Poisons Schedule. For impurities that are classified as hazardous substances in
accordance with the NOHSC Approved Criteria, the risk phrases should be indicated.
Where possible, all impurities should be identified by their CAS number and
Chemical Abstracts Preferred Name Index name. If this is not available, then the
IUPAC name or common chemical name should be provided.
2(c) Non-hazardous impurities

For all non-hazardous impurities present at 1% by weight or more, the identity and
weight percentage is to be provided.
2(d) Additives/adjuvants
The maximum weight percentage of all chemicals incorporated into the main
chemical substance is required.
Chemical substances such as stabilisers, inhibitors and modifiers should be included.
All additives/adjuvants should be identified by their CAS number, Chemical
Abstracts Preferred Name Index name, common name and name under which the
chemical is marketed.
3. Information On Use
198
All proposed uses of the chemical are required, for example, solvent, dyestuff,
adhesive, plasticiser or detergent. For each use, the approximate percentage of total
manufacture or import should be indicated. The information should be given in
descending order of importance. The industry where the chemical is to be used should
be identified, for example, the paper and pulp industry. The fields of use and methods
of application should be described, for example, a spray-on paint stripper in the
painting industry. For all forms of the notified chemical, including final end-use
products, the concentration of notified chemical in the mixture or product must be
provided. This information is critical for the risk assessment. Information provided for
use should be as complete as possible to enable a proper assessment of the notified
chemical to be carried out.
4. precis of appearance
The appearance of the chemical shall be described in terms of colour and form, for
example, brown, viscous liquid or grey powder. Its physical state at 20°C and 101.3
kPa (ambient conditions) is required.
The odour, including odour threshold, and volatility of the substance should also be
provided. For example, toluene is a liquid of low volatility with a characteristic
aromatic odour, and an odour threshold at approximately 10 ppm v/v.
5. Estimated Manufacture Or Import Volume

Specify whether the chemical is to be manufactured in Australia or imported, and the
amount in range of tonnes per year (1-10, 10-100, 100-1000, 1000-10000 or greater
than 10000) for each of the first five years. Estimated quantities should be those of the
notified chemical, not of the product or formulation.
6. Occupational Health And Safety

6(a) Occupational exposure data
The data to be included must provide a comprehensive description of occupational
exposure factors so that an adequate occupational health and safety assessment can be
carried out. In the case of importers who do not use the chemical, the relevant items of
information should be obtained from the user. For new chemicals that have been in
use overseas, relevant occupational exposure information, for example, monitoring
data for a similar use, should be submitted if available from overseas sources. The
following is a set of information that is to be submitted. Any other information that is
relevant to occupational exposure should also be included.
6(a)(i) Number and category of workers

An estimate of the maximum total number and category of workers likely to be
exposed to the chemical or any product treated with the chemical is required, for
example, those employed in maintenance tasks associated with the chemical, or those
employed in packaging and storing the chemical. Include all workers involved from
the manufacturing process or importation onwards, and also those involved in storage,
handling, transportation and disposal of the chemical. Though some of this
information may be imprecise, for example, in the case of product development,
estimates should be provided.
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6(a)(ii) Nature of work done

To adequately assess the occupational health and safety hazards of the chemical, some
indication of the nature of the work carried out, or to be carried out, is required for
each type of worker exposed to the chemical. For each of the worker categories,
briefly describe the nature of work carried out with the chemical. State the maximum
duration of exposure for each category in hours per day and days per year and the
frequency of exposure. Include activities requiring protective clothing and equipment,
and indicate the physical form(s) of the chemical during exposure, for example, hot
liquid or fine powder.
6(a)(iii) Safety procedures to be observed when handling the chemical

Information is required on methods and procedures to minimise or prevent worker
exposure. Principles and procedures for the effective control of chemicals in the
workplace are detailed in the NOHSC standard Control of Workplace Hazardous
Substances: National Model Regulations and National Code of Practice.
While the standard has been written for the control of hazardous substances, the
principles apply just as well to chemicals not classified as hazardous.
The prevention of worker exposure to a particular chemical can be achieved by

working through the following hierarchy of control measures:
• isolation of the process or operation;
• engineering controls, including local exhaust ventilation for vapours, gases
or particulates;
• adoption of safe work practices, including changes to work methods; and
• the provision and use of suitable approved personal protective equipment
where other measures have not been effective.
A description of the isolation procedures and engineering controls used, or to be

used, in minimising worker exposure to the chemical is required. This may include:
• isolation of a hazardous operation by removal to a remote area of the
workplace;
• modifications to the working environment, for example, ventilation or fume
extraction;
• enclosure, for example, spray painting within booths; and
• preventive maintenance Schedules designed to maintain plant, equipment
and extraction systems to a high standard.
A description of the safe work practices to be observed by workers in handling the

chemical is required. These include:
• precautions during routine handling of the chemical;
• precautions during storage and transport of the chemical;
• precautions in handling spills;
• good housekeeping; and
• introduction of procedures to reduce the duration and frequency of exposure
for employees.
Specific information on protective clothing and equipment necessary during both

routine and non-routine tasks is required.
• The types of respiratory equipment required should be specified in
accordance with Australian Standards AS 1716 Respiratory Protective
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Devices and AS 1715 Selection, Use and Maintenance of Respiratory

Protective Devices or equivalent internationally acceptable standards.
• The type of protective clothing required should be stipulated, for example,
gloves, eye protection and/or footwear. This information should be specific,
for example, flame-proof cotton overalls. Impervious gloves are not sufficient,
whereas nitrile gloves would be. The relevant Australian Standards (or
equivalent) should be consulted, for example, AS 2161.2 Occupational
Protective Gloves Part 2: General Requirements, AS 1336 Eye Protection in the
Industrial Environment, and AS 3765.1 Clothing for Protection against Hazardous
Chemicals Part 1: Protection against General or Specific Chemicals.
Australian and International Standards are updated from time to time, so notifiers
should check that they consult the most recent versions of each standard.
6(a)(iv) Education and training

A brief description of the core training and education given to employees to become
proficient in safe working practices is required. This should include a section on the
training required to introduce the new chemical into the workplace. For importers
who may not use the chemical, some indication of the proposed core training and
education program should be obtained from the user. The information should include:
• instruction on health and safety hazards of the chemical, including the routes
of entry into the body;
• instruction in the correct use of all protective equipment required during
handling of the chemical;
• instruction in the correct use of relevant plant and equipment;
• instructions for emergency situations;
• information on labelling of the chemical; and
• availability of the MSDS.
The duration and frequency of training periods should be indicated.
6(a)(v) Prevalence of work-related Injuries and diseases related to

workers exposed to the chemical
For chemicals already in use, any effect on the occupational health of workers
exposed to the chemical may be known before introduction of the chemical into
Australia. The type, frequency and severity of all work-related injuries and diseases
resulting from worker exposure to the notified chemical are required, for example,
incidence of health effect or disease and total work time lost. Where available, details
on the duration, frequency and levels of exposure of workers to the chemical should
be indicated. Exposure to other chemicals or other relevant factors should also be
mentioned.
If workers exposed to the chemical have experienced adverse health effects, then
these should be fully described in the notification under paragraph 6(b) of Part B of
the Schedule, Health Conditions. Guidance for information in paragraph 6(b) of Part
B of the Schedule is detailed below.
6(a)(vi) Other occupational hazards

Other information on possible occupational hazards not referred to elsewhere in
paragraph 6(a) of Part B of the Schedule should be provided. In particular,
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information on conditions that may tend to increase the hazard of the chemical is
required. This information may include such items as:
• adverse working conditions, for example, heat or cold;
• any work in confined spaces;
• potential exposure to other hazardous substances;
• possibility of reaction, for example, with other substances or with water; and
• any other interaction, for example, interaction of chemicals and heat.
6(b) Health conditions

Information to be submitted with respect to health conditions will usually only be
available for chemicals already in use, for example, chemicals used in a foreign
country. The notification statement should include a list of any health conditions that
have been reported or are known to the notifier. The list must include health
conditions that indicate that the chemical should not be used.
This should include all health conditions such as asthma, broken skin, dermatitis, or
therapeutic or recreational drug use or abuse, for example, anti-hypertensive agents,
alcohol or tobacco.
The notification statement should report any evidence of specific health conditions
associated with the chemical that might suggest that it should not be used without
special precautions. For example, exposure to the chemical may cause severe
dermatitis.
The notification statement should list any health conditions that could reasonably be
expected to occur for the notified chemical, for example, by analogy with structurally
similar chemicals, or analogues.
Any health conditions aggravated by the chemical should be mentioned, for example,
exposure to the chemical may increase the incidence of asthma in susceptible
workers.
6(c) Occupational health monitoring

Occupational health monitoring should include details of both the atmospheric
monitoring and biological monitoring procedures to be adopted in giving some
measure of worker exposure to the chemical. For chemicals already in use,
methodology may be obtained from international sources. For new chemicals,
methodology may be developed by consideration of existing methodology for
structurally similar existing chemicals. Applicants should provide information on
existing or proposed exposure limits and any known methods of atmospheric or
biological monitoring of the notified chemical.
If no monitoring procedures are proposed, then this should be justified in terms of the
health and safety hazards of the chemical and extent of worker exposure to the
chemical.
For importers who may not use the chemical, some indication of proposed monitoring
procedures should be obtained from the user.
6(c)(i) Atmospheric monitoring
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Information is required on the type(s) of atmospheric monitoring proposed, for

example:
• personal monitoring, where the time-weighted average concentration of
actual worker exposure to the chemical is indicated;
• automatic continuous monitoring, where peak level concentrations and time-
weighted average concentrations of the chemical in the work areas are
indicated;
• fixed-point monitoring, where time-weighted average concentrations of the
chemical over a set period, for example, an eight-hour shift, are indicated for a
fixed location in the work area; and
• grab sampling, where instantaneous concentrations of the chemical are
indicated.
Details on sampling techniques and sampling equipment should be included. For

example, passive monitor badges may be used for personal monitoring. A brief
description of the analytical method(s) used should be provided, together with the
principal technique specified, for example, gas chromatographic or gravimetric
analysis. Details of the type of instrumentation used in the method should also be
included.
6(c)(ii) Biological monitoring

Biological monitoring involves the quantitative measurement of the chemical or its
metabolite in the appropriate body tissue, fluid or excretion product, for example, in
blood, urine or expired air.
Information should be provided on the test(s) to be used, the program of activities, the
relevant collection procedures and the analytical methods and instrumentation.
6(d) Observations on human exposure

Information held, or reasonably obtainable, by the notifier on studies or observations
of the effects of the chemical on humans is required. In particular, observations of
health problems or adverse symptoms in humans exposed to the chemical are
required. This may include information on specific incidents, for example, acute
exposure resulting from an accidental spillage. Information on any epidemiological
studies on workers who have been exposed to the chemical is required. Where
possible, any health conditions (either positive or negative) should be related to
exposure levels.
7. Environmental Impact
An assessment of the environmental impact of the chemical is to be provided.
Information on the following should be included in the notification statement:
• manufacturing process;
• release to the environment for each use, including that from any
manufacturing, reformulation, repackaging and end use;
• storage and transport; and
• disposal.
Information supplied in this section should be complementary to that detailed in
paragraph 13 of Part B of the Schedule. In the case of importers who may not use the
chemical, information on environmental impact should be obtained from the user.
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7(a) Manufacturing process

Information on the manufacturing process is not required for chemicals manufactured
outside Australia. However, information is required on the formulation process for
imported chemicals if they are reformulated or repackaged in Australia, for example,
into products for industrial or domestic use.
7(a)(i) Identity of the site(s) where the chemical will be manufactured or

reformulated
The location(s) of each industrial site (manufacturing, processing or other operation)
controlled by the notifier is required. The location of sites where repacking and/or
reformulation of the chemical is carried out is also required.
7(a)(ii) Process description

For each operation controlled by the notifier, the process description should include:
• a diagram of the major unit operation steps and chemical conversions;
• the identity and entry points of all feedstocks, including reactants, solvents
and catalysts; and
• the location of the points of release of the chemical to the environment.
7(a)(iii) Release of chemicals at each site

For each release point identified in the preceding subsection, the following
information is required:
• an estimate of the amount and concentration of chemical released directly to
the environment or into control technology (in kg/day);
• the media (air, soil or water) to which the chemical is released;
• a description of any control technology used to limit release; and
• the destination(s) of releases to water.
7(b) Release to the environment for each use

For each recommended specific use or application identified in paragraph 3 of
Part B of the Schedule, the information provided should include the estimated
number of sites for each use, broad process descriptions and descriptions of
situations in which environmental release of the chemical may occur,
including through equipment cleaning, for example:
• to ambient air, for example, through smoke stack emissions, car exhaust
fumes, incineration gases, aerosols and fugitive refrigerant gases;
• in water, for example, natural waterways or ground water, including release
to waste water treatment facilities; and
• to the surrounding land, for example, through overspray of paints, general
wear and tear and deposition.
The quantity, concentration and media of release for each situation are required.
7(c) Transport and storage

The safe storage requirements, for example, location, temperature or incompatibility,
should be defined for the chemical. The chemical's classification under the Australian
Code for the Transport of Dangerous Goods by Road and Rail is also required.
A description of all intended storage facilities is required, including size, type and
capacity of containers and potential for environmental exposure. A description of all
intended transport between storage facilities should be provided, including quantity to
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be transported, mode of transport and potential for environmental exposure. Technical

details on storage and transport should also be included in the MSDS(see paragraph
12 of Part B of the Schedule).
7(d) Disposal
A full description of all disposal procedures is required, including for all
contaminated packaging, including:
• route of disposal, for example, landfill or incineration;
• quantities to be disposed of by each route, including residues in
contaminated packaging (where applicable and not addressed in paragraphs
7(a) and 7(b) of Part B of the Schedule); and
• identity and hazards of any degradation products resulting from disposal.
If disposal needs to be in accordance with government regulation, this should be
stated.
8. Public Health
Exposure of the general public to industrial chemicals may occur in three ways.
Firstly, there may be exposure during industrial use as a result of contamination of air,
water or food. Secondly, there may be exposure as a result of an industrial accident.
Thirdly, there may be exposure from domestic use. The notifier must provide a
description of the potential public health implications of the chemical in the light of
the toxicological findings and the expected public health exposure.
The following information submitted in other parts of the Schedule should be taken
into account when providing the description of public health implications, with the
items listed below cross-referenced under the appropriate heading in the notification
statement:
• description of proposed uses (as specified in paragraph 3 of Part B of the
Schedule);
• identity and percentage of any impurities and their toxicological significance
(paragraph 2 of Part B of the Schedule);
• physico-chemical properties (paragraph 9 of Part B of the Schedule);
• information about the site of manufacture or reformulation in Australia and
the release of the chemical into the environment at that site (paragraph 7(a) of
Part B of the Schedule);
• for each use of the chemical, information about its release into the
environment, including the quantity, concentration and frequency of release
(paragraph 7(b) of Part B of the Schedule);
• conditions of safe storage (paragraph 7(c) of Part B of the Schedule);
• disposal procedures (paragraph 7(d) of Part B of the Schedule);
• consequences of, and emergency procedures associated with, accidental
spillage (paragraph 13(b) of Part B of the Schedule);
• the results of toxicity tests in animals (Part C of the Schedule); and
• information arising from human exposure to the chemical, including
symptoms of exposure, poisoning reports, clinical observations and
epidemiological studies (paragraph 6(d) of Part B of the Schedule).
The studies provided in a Standard Notification statement (as per items listed in the
Schedule) are generally sufficient to enable assessment of public health hazards
associated with single or infrequent human exposure, such as may occur in accidental
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situations. Unless appropriate additional information is provided, they are generally

not sufficient to allow an assessment of public health risks where widespread or long-
term exposure is likely. For example, distribution in domestic products, regular
exhausting of a chemical into the atmosphere resulting in deposition on edible plants
or water catchments, contamination of waterways by an accidental spill or release of
the chemical in a manner which may lead to incorporation in the food chain. For these
reasons, the Director may require additional information on these aspects if significant
public exposure is likely.
9. Physico-Chemical Data
In general, all physical and chemical property data should specify:
• the grade and nature of the chemical tested, including its purity (if the
chemical is in a mixture, this should be noted for all data provided);
• the testing authority or organisation providing the data (where
applicable);and
• the physical conditions used for all test data, for example, temperature or
pressure.
Where the notifier performs measurements, the OECD Guidelines for the Testing of
Chemicals may be helpful. The numbers in parenthesis after each test are the method
numbers in the guidelines, for example, TG102 in subsection 9(a) in Part B of the
Schedule refers to Test Guideline number 102. The standard of testing to obtain data
should conform to the principles of good laboratory practice. Notifiers may refer to
the OECD Principles of Good Laboratory Practice for information on this matter.
9(a) Melting point/boiling point (TG 102, TG 103 or equivalent)

The melting point or boiling point is to be provided. However, for non-pure chemicals
a temperature range may be more appropriate, or for some chemicals the freezing
point is more appropriate than the melting point.
9(b) Specific gravity/density (TG 109 or equivalent)

The density (in kg/m3) is required for all chemicals. For gases, the specific gravity
(air = 1) is also required, as this will assist in indicating any tendency of the chemical
to settle or disperse when discharged at high concentrations into the atmosphere. For
liquids, both the liquid and vapour densities should be provided.
9(c) Vapour pressure (TG 104 or equivalent)

The vapour pressure of the chemical is to be provided expressed as kilopascals (kPa)
at 25°C.
Any effect on the measurement by impurities should be stated. Vapour pressure is
important for estimating the chemical's potential for inhalation exposure and for
determining the application route(s) for toxicity testing.
Vapour pressure is environmentally relevant because it helps to estimate the
chemical's distribution between the environmental compartments, that is, the phase
transitions between soil and air, soil and water, and (with water solubility) water and
air. It can help to predict atmospheric concentrations.
9(d) Water solubility (TG 105 or equivalent, TG 120 for polymers)

The saturation mass concentration of the chemical in water is required (in g/L at
20°C). The method of measurement should be indicated. If the substance is insoluble
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in water, the detection limit of the analytical method used should be indicated, and
any water accommodated fraction of the chemical determined. Water solubility is
significant environmentally because:
• it largely determines the mobility of the chemical within and between the air,
soil and water compartments;
• it may be important in determining appropriate emergency services
responses;
• water-soluble chemicals gain ready access to humans and other living
organisms; and
• it has large effects on the potential for bioaccumulation.
9(e) Hydrolysis as a function of pH (TG 111 or equivalent)

This parameter is to be provided for water-soluble chemicals only (water solubility
greater than 10-3 mole/L). The degree of hydrolysis at 25°C is required at pH values
normally found in the environment (pH 4-9) and under more acidic conditions (pH 1-
2) for physiological purposes. Hydrolysis is one of the main modes of abiotic
degradation of substances in the environment.
9(f) Partition coefficient (n-octanol/water) (TG 107 or equivalent, TG 117)

This parameter is to be provided only for (pure) water-soluble chemicals which do not
dissociate or associate, and which are not surface-active. It is expressed as log Pow, at
20oC.
The partition coefficient of a substance between water and a lipophilic solvent (n-
octanol) can indicate its potential for skin absorption, or can be used to estimate the
chemical’s bioaccumulation potential in aquatic organisms. Relationships exist
between this parameter and bioaccumulation in fish.
9(g) Adsorption and desorption (TG 106 or equivalent)

Information on adsorption and desorption should be provided, with results expressed
in terms of the adsorption and desorption of the chemical in/from standard soils under
standard test conditions. This data is necessary for the evaluation of the tendency of
chemicals to migrate into the air, water and soil or sediment compartments of the
environment. Adsorption and desorption processes also have an effect on the transport
of chemicals and on their bioavailability.
9(h) Dissociation constant (TG 112 or equivalent)

The dissociation constant (in pKa) is required for all chemicals that dissociate in
water.
The method of determination should be stated. The extent of dissociation of a
chemical in water governs the forms that it will take in the aquatic environment.
Knowledge of the dissociation constant, together with the pH of the systems in which
a chemical is likely to be found, makes it possible to estimate the extent to which
dissociated and undissociated forms will be present.
9(i) Particle size (distribution)/fibre length (TG 110 or equivalent)

The mean particle size and particle size range of the substance is required (for solids
only). In particular, the respirable fraction (1-10 ∝m) should be indicated. For fibrous
substances, the fibre length and length range is required instead. Particle size is one
factor which influences the distribution and mass transport of insoluble and non-
volatile particles in water, air and, in some cases, the upper soil layer. Furthermore,
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the tendency of a chemical to settle and penetrate biological tissue, for example,
inhalation characteristics, depends on particle size.
9(j) Flashpoint (open cup/closed cup)

The flash point (in °C) of the chemical is required, with its method of determination
(open or closed cup method).
9(k) Flammability limits (%) (explosive limits)

The degree of flammability is required, that is:
• pyrophoric;
• highly flammable;
• flammable;
• combustible; or
• not flammable.
The upper and lower percentage limits of flammability in air are required. These
limits indicate the percentage concentrations of flammable vapour in air at which a
flame can be propagated or an explosion will occur.
The distinction between flammable and combustible should not be overlooked. For
example, sodium chloride, carbon tetrachloride and carbon dioxide are
noncombustible and non-flammable, but sugar, cellulose and ammonia are
combustible but non-flammable. Details on the nature and identity of toxic and
hazardous combustion products are required.
9(l) Auto ignition temperature

The minimum temperature (in °C) for auto ignition should be provided. Auto ignition
is the minimum temperature required to initiate or cause self-sustained combustion in
any substance in the absence of a high-temperature ignition source, such as a spark or
flame.
9(m) Explosive properties

Information on the chemical's potential to detonate as a result of heat, shock or
friction, is required. Details on the nature and identity of hazardous explosion
products should be provided.
9(n) Reactivity
Any information about the stability and reactivity of the chemical is required,
including:
• oxidising properties;
• incompatibility with other substances;
• conditions contributing to instability; and
• full information on the decomposition products and their hazards.
Use of calculated data

The provision of estimated values for physico-chemical parameters derived from
Quantitative Structure Activity Relationships (QSARs) is not encouraged and will
only be accepted as a last resort after all other efforts to obtain data, including from
the literature, have been exhausted.
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The QSAR procedures involve the use of empirical relationships between the n-
octanol/water partition coefficient (log Pow) and parameters such as water solubility
and soil absorption/desorption coefficients that have been established for certain
broad chemical classes. The use of this method, however, involves inherent statistical
undertainties and, moreover, its applicability depends on the avilability of reliable
values for log Pow. The use of QSAR estimated data is inappropriate if the unknown
compound contains cationic or anionic groups [or has the potential to become charged
in the environmental pH range (4>pH<9)], and particularly so if the material is
expected to possess surfactant properties.
The limitations of QSAR estimates and the scientific caution required in their
interpretation and use have been well documented by Kaiser et al (Kaiser K. L. E.,
Deardon J. C., Klein W. and Schulz T. W.; "A note to users of ECOSAR"; Water
Quality Research Journal of Canada, 34(1), pp 179-182, 1999). In some cases the
inherent instability of a compound may preclude accurate experimental determination
of certain properties, and in such cases QSAR
estimates may be acceptable.
10. Methods Of Detection And Determination

A listing of the analytical methods used for the detection and determination (assay) of
the chemical is required. Where standard methods are used, the appropriate
bibliographical references should be stated. Otherwise, a description of the method(s)
should be given such that a competent analytical chemist could repeat the
measurements without further aid.
11. Label
A copy of the proposed label(s) for the notified chemical and all products containing
the notified chemical shall be compiled in accordance with the NOHSC National
Code of Practice for the Labeling of Workplace Substances, and included in the
notification statement.
12. Material Safety Data Sheet

MSDS provide information needed to allow the safe handling of substances. They are
used by employers to ensure that employees have ready access to information on
substances used at work. In each notification statement, a copy of the proposed MSDS
for the chemical must be provided. MSDS are required for all chemicals notified
under NICNAS, not just hazardous chemicals. Where the chemical is available
commercially from the notifier in other products, for example, as an ingredient in a
polymer mixture, then MSDS for those products must also be submitted. Where the
chemical exists in more than one form in the notifier's workplace, for example, as an
ingredient in a solvent mixture, then MSDS for those products must also be
submitted. All MSDS should be compiled in accordance with the NOHSC National
Code of Practice for the Preparation of Material Safety Data Sheets. An original that
can serve as a camera-ready copy for publication with the full public report should be
included.
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13. Emergency Procedures

Information on emergency procedures should include the UN Number, proposed
Dangerous Goods Class(es) and the Hazchem Code. This information will be
determined using the classification in the Australian Code for the Transport of
Dangerous Goods by Road and Rail.
13(a) Occupational emergency procedures

A full description of procedures employed to render the chemical harmless in the
workplace is required. This should include environmental emergencies, for example,
spillage or release of the chemical in the workplace, and personnel emergencies, for
example, inhalation of leaking vapours by workers.
13(b) Environmental emergency procedures

A full description of procedures employed to render the chemical harmless outside the
workplace is required. This should include procedures for managing:
• workplace emergencies affecting the public at large, for example, a gas
release affecting nearby residents;
• transport emergencies; and
• emergencies at storage facilities outside the workplace.
This information should include the possibility of:
• recovery;
• containment;
• neutralisation; and
• destruction, for example, incineration.
SCHEDULE PART C
In this section, the numbering is consistent with the numbering in the Schedule to the
Act.
INTRODUCTION
Part C of the Schedule specifies the health and environmental effects data that must be
submitted as part of a Standard Notification statement. Complete study reports must
be provided. All data should specify:
• the organisation responsible for the test; and
• whether standard protocols and good laboratory practice were followed.
The numbers in parenthesis after each test are the method numbers used in the OECD
Guidelines for the Testing of Chemicals. Ideally, toxicity tests should be carried out in
accordance with these or equivalent guidelines. It should be noted that this Handbook
for Notifiers is not intended to provide detailed instructions on test procedures, and
notifiers are referred to appropriate sources for comprehensive information on test
procedures.
ACUTE TOXICITY DATA
Information on the acute toxicity of the chemical will give a measure of the toxic
effects following short term exposure of the substance, and may indicate its specific
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toxic effects and possible mode of action. The tests undertaken should be relevant to
the physical properties of the chemical and take into consideration the way in which
the chemical is to be used.
LD50 values are not mandatory requirements and procedures such as the limit test are
acceptable.
(a) Acute oral toxicity (TG 401 or equivalent)

Acute oral toxicity testing provides information on the health hazards likely to arise
from a short-term exposure by the oral route. The results may provide information on
the chemical's mode of toxic action.
The data required includes:
• some quantitative measure of toxicity with an indication of accuracy;
• test animal used, indicating number, species/strain and sex;
• the nature of the dosed material, for example, solution or suspension (details
of the vehicle used (if any) should be provided);
• method; and
• results of testing, including:
- tabulation of response data by number, sex and dose level,
- toxic effects seen, time of onset and duration,
- time of death after dosing,
- slope of dose-mortality curve, where possible, and
- effects on the organs, for example, gross findings at autopsy and histological
data.
(b) Acute dermal toxicity (TG 402 or equivalent)

Acute dermal toxicity testing provides information on the health hazards likely to
arise from a short-term exposure to the skin. The results may provide information on
dermal absorption and the chemical's mode of toxic action by this route.
• some quantitative measure of toxicity with some indication of accuracy;
· the nature of the dosed material, for example, solution or suspension (details
of the vehicle used (if any) should be provided);
· method; and
· results of testing, including:
data.
(c) Acute inhalation toxicity (TG 403 or equivalent)

The acute inhalation toxicity of the chemical, such as a gas, volatile substance or
aerosol/particulate, provides information on health hazards likely to arise from short-
term exposure by inhalation. The results may provide additional information on the
chemical's mode of toxic action.
• some quantitative measure of toxicity with some indication of accuracy;
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• nature of dosed material, with particle size if aerosol or particulate;

• method; and
data.
IRRITATION/CORROSION
Information derived from irritation testing serves to indicate the possible existence of
hazards likely to arise from exposure of the skin, eyes and mucous membranes to the
chemical. Chemicals that have predictable corrosive potential based on physico-
chemical properties, such as strong acidity or alkalinity, are often not tested in
animals for irritation.
(d) Skin irritation (TG 404 or equivalent)

A finding of dermal (skin) irritation by the chemical on the skin of mammals indicates
the existence of possible hazards likely to arise from exposure of the human skin to
the chemical.
The dermal irritation assessment should be made in conjunction with an assessment of
the nature, intensity and reversibility of the observed response. The data required
includes:
• method;
• form of the dose; and
- tabulation of response data by number, sex and dose level for each
observation time period, for example, 30-60 minutes, 24, 48 and 72 hours after
patch removal, and
- description of any lesions observed, together with the onset time and
recovery period.
(e) Eye irritation (TG 405 or equivalent)

Results of animal eye irritation studies can help to predict possible hazards likely to
arise from exposure of human eyes and associated mucous membranes. An
assessment of the severity of acute eye irritation is required. Evaluation should be
made in conjunction with an assessment of the nature and reversibility of the response
observed. The data provided should include:
• method;
• physical nature and, where applicable, concentration and pH value for the
test substance; and
- tabulation of response data by number and sex at each observation
time, for example, 1, 24, 48 and 72 hours, and
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- description of the degree and nature of irritation/corrosion on the

cornea, iris and conjunctiva, with time onset, severity and recovery
period.
SENSITISATION
(f )(i) Skin sensitisation (TG 406 or equivalent)

The potential of a chemical to provoke a skin sensitisation reaction (dermal
sensitisation or allergic contact dermatitis) can help to predict the possible hazard to a
human population that is repeatedly exposed to the chemical. In animal studies, the
two preferable methods have been the Magnusson and Kligman Guinea-Pig
Maximisation Test, which use an adjuvant, and the Buehler Test, also in guinea pigs,
but without an adjuvant. More recently, mouse models for assessing sensitisation
potential have been developed, namely the ear-swelling test and the local lymph node
assay. Both assays can detect moderate to severe sensitisers.
For animal studies, the data provided should include:
• method; and
- tabulation of response data by number, sex and age of treated and control
animals
- dose level administered at each stage, and
- whether irritation occurred during the induction stages and any histological
abnormality at the conclusion of the test.
For some chemicals, human patch tests may have been conducted. If so, the study and
results should be provided.
(f)(ii) Respiratory sensitisation

No standard OECD guidelines are available for the determination of the respiratory
sensitising potential of chemicals in animals. If non-standard studies are available,
they should be submitted. Similarly, any human evidence regarding this effect should
be provided.
(g) Repeated dose toxicity

Repeated dose toxicity data provides information on possible health hazards likely to
arise from repeated exposures over a limited period of time. The basic study used for
repeated dose toxicity is normally the 14-day or 28-day oral study (TG 407 or
equivalent). This method may provide information on neurological effects,
immunological effects and reproductive organ toxicity. Where toxicity arising from
dermal absorption has been observed in acute toxicity studies, and human skin contact
is likely during use of the chemical, a 14-day to 28-day repeated dose dermal toxicity
study (TG 410 or equivalent) should be conducted to provide information on possible
health hazards likely to arise from repeated skin contact. Similarly, where toxicity
arising from inhalation has been observed in acute toxicity studies, and inhalation by
humans is likely during use of the chemical, a 14-day to 28-day repeated dose
inhalation toxicity study (TG 412 or equivalent) should be conducted to provide
information on possible health hazards likely to arise from repeated inhalation.
Data from each study should include:

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• dosing vehicle, if any;

• route and frequency of administration;
• method;
- tabulation of toxic response data by number, sex and dose,
- description of effects observed on the animal and its organs,
including clinical biochemistry and pathology investigations (include
signs of toxicity, their time and onset of duration, whether the effects
were reversible, and necropsy and histological findings), and
- discussion of the results and conclusions of the study.
GENETIC TOXICOLOGY
The primary function of genotoxic testing is to investigate the potential of the

chemical to induce mutations in the human genome and the potential for any
mutations to be transmitted through the germ cells to future generations. The battery
of tests should include:
• a test which demonstrates the chemical's ability to induce point mutations in
established microbial systems; and
• a test that demonstrates any production by the chemical of chromosome
damage in mammalian cells grown in vitro.
There are a number of tests in each group that may be selected. Notifiers are referred
to the OECD Guidelines on Genetic Toxicology Testing and Guidance on the
Selection and Application of Assays for a listing of tests that may be used. Equivalent
or appropriate tests from other recognised protocols can also be used. The selection of
tests to be used in the battery will depend on:
• the nature of the chemical;
• the extent of its eventual distribution and use;
• data from other toxicological tests and toxicokinetic studies; and
• the available technical expertise.
(h) Induction of point mutations (TG 471, TG 472 or equivalent)

A test designed to demonstrate the induction of point mutations (base-pair change and
frame shift mutations) in established microbial test systems is required, with and
without the use of appropriate metabolic activation systems. Suggested methods
include TG 471 Salmonella typhimurium Reverse Mutation Assay and TG 472
Escherichia coli Reverse Mutation Assay.
(i) Induction of germ cell damage (TG 478 or equivalent)

A test designed to detect the induction of germ cell damage in vivo is required. A
suggested method is test method TG 478 the Dominant Lethal Test in the Rat or
Mouse.
(j) Chromosome damage (TG 473, TG 474, TG 479 or equivalent)

A test designed to demonstrate the production of chromosome damage in appropriate
mammalian cells grown in vitro is required, with and without the use of appropriate
metabolic activation systems. Suggested methods include TG 473 In vitro
Mammalian Cytogenetic Test, TG 474 Micronucleus Test and TG 479 In vitro
Chromatid Exchange Assay.
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ECOTOXICITY DATA
Information on the ecotoxicity of the chemical is required to give a measure of the

short-term toxic effects on biotic systems. The data provided should specify:
• organisation responsible for the test;
• whether standard protocols and good laboratory practice were followed; and
• number of animals or plants used.
Results calculated from measured/actual concentrations are strongly preferred over

results calculated from nominal concentrations. The use of QSAR generated data for
fish, Daphnia and algal toxicity is not encouraged and will only be accepted as a last
resort. The limitations of this approach have been documented by Kaiser et al (Kaiser,
K.L.E.: Deardon, J.C.; Klein, W.; and Schultz, T.W.; 'A Note to the Users of
ECOSAR'; Water Quality Research Journal of Canada, 34(1), pp 179-182, 1999).
(k) Fish, acute toxicity test (TG 203 or equivalent)

An assessment of the acute toxicity of the chemical to fish is made after continuous
exposure of the fish to a series of concentrations of the chemical in water over a
period of four days. Mortalities and any abnormal responses are recorded over this
period. The data required includes:
• measure of toxicity, for example, LC50 (in mg/L), with confidence limits;
• number and species of fish used;
• duration of exposure;
• no-effect level (in mg/L);
• method; and
- tabulation of mortality against concentration according to observation time,
and
- concentration-mortality curve at end of test.
(l) Daphnia, acute immobilisation test and reproduction test (TG 202 or
equivalent)
An assessment of the toxicity of the chemical to aquatic invertebrates is made by the
exposure of daphnids to a series of concentrations of the chemical in water. The test
comprises two phases:
• acute phase, which gives:
- 24 hour EC50 value,
- highest concentration causing no immobilisation, and
- lower concentration causing 100 % immobilisation; and
• reproduction phase, which gives:
- EC50 (immobilisation) values over period of 1-14 days,
- no observed effect concentration (in mg/L), and
- other information based on reproduction observations.
The data provided should include:

• number and species of Daphnia used;
• duration of exposure;
• concentrations used;
• description of the methods used; and
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• tabulation of concentration-response time results.
It should be noted that a Daphnia sp reproduction test is a Schedule item and

therefore should be provided, especially when acute toxicity and exposure to the
aquatic compartment are both high. In the absence of this part of the test, a variation
to the data requirements should be submitted along with supporting scientific
argument to fully justify the omission, for example, limited aquatic exposure.
(m) Algal growth inhibition test (TG 201 or equivalent)

An assessment of the potential effects of the chemical on the natural environment is
made by exposing algae to a series of concentrations over at least three days. Algae
growth is determined after each day, and the algae concentration per mL is calculated
for each time and concentration. An assessment can be based on the 72 hour EC50
value and the growth concentration curves.
The data provided should include:
• test organisms used, for example, origin, strain and method of cultivation;
• test conditions used, including concentrations used and duration of test; and
- EC50 value,
- no observed effect concentration,
- assessment of time-effect relationship,
- cell concentrations and concentration-effect relationship, and
- other observed effects.
BIODEGRADATION
An assessment of the potential of the chemical to biodegrade in the environment is

required. Therefore, test results for ready biodegradability should be provided. The
method used and the body responsible for the test should be indicated.
(n) Ready biodegradability (%) (TG 301A-F or equivalent)

As assessment of the ability of the chemical to rapidly biodegrade in the environment
is made by studying the biodegradation of the chemical in aqueous solutions over a
period of up to 28 days.
The data provided should include full details of the method used in the test and
tabulation of the time-effect results. For some chemicals not readily biodegradable,
the inherent and ultimate biodegradability (TG 302A-C or equivalent) of the chemical
may be required.
NOTE: Although not a scheduled item, it is increasingly common that biodegradation

data obtained under anaerobic conditions is available. If it is available, this data
should be provided in notification dossiers, particularly if the notified material is
likely to become associated with aquatic sediments. Similarly, data on biodegradation
in seawater should also be provided if available.
(o) Bioaccumulation
An assessment of the potential of the chemical to bioaccumulate in the environment,
both aquatic and terrestrial, is required. A full bioaccumulation test is not a Schedule
requirement, however, results should be provided if available.
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The assessment should take into consideration:

• partition coefficient for n-octanol/water;
• fat solubility;
• water solubility; and
• ready biodegradability.
If the chemical has a low partition coefficient and/or is readily biodegradable, then no
bioaccumulation testing is required. Notifiers are referred to the OECD Testing
Guidelines on Degradation and Accumulation for further information.
SCHEDULE PART D
Part D refers to Polymers. In this section, the numbering is consistent with the
numbering in the Schedule to the Act.
IDENTITY AND COMPOSITION OF THE POLYMER
Information given in this section must characterise the polymer as closely as possible.
The information should be complementary to that given under paragraphs 1 and 2 of
Part B of the Schedule, where details of the complete polymer mixture, that is, the
polymer and its additives/adjuvants, are provided. All monomers and other reactants
should be identified according to the guidelines in section 1 of Part B of the Schedule.
1. Weight-percentage of ingredients
The maximum weight-percentage of each monomer and all other reactants used to
manufacture the polymer is required. Include all substances used in the manufacture
of the polymer and which become part of the polymer composition. Reactants include
chain transfer and cross-linking agents, modifying groups and other end groups
incorporated into the polymer. Also include post-reacting agents used in the
manufacture of post-reacted polymers.
The weight-percentage of reactant must be based on the dry weight of polymer.
2. Number-average molecular weight of the polymer

If more than one molecular weight composition of the polymer is to be manufactured,
then the number-average molecular weight of the lowest molecular weight
composition is required. The weight average molecular weight and an indication of
the molecular weight
distribution (polydispersity) should also be provided. The method used to determine
the molecular weight, for example, size exclusion chromatography, and the
organisation conducting the test, should be stated. A report of the analysis must be
included in the notification statement.
3. Maximum weight-percentage of residual monomer(s) and all other

reactants
The maximum weight-percentages of all residual monomers and other reactants (as
listed in paragraph 1 of Part D of the Schedule) at the completion of manufacture or at
the time of importation are required. The method used to determine the concentrations
of reactants, for example, gas chromatography, and the organisation conducting the
test, should be stated. A report of the analysis should be included in the notification
statement.
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4. Low molecular weight polymer

The maximum weight percentage of the low molecular weight fraction of the polymer
is required, that is, the fraction with molecular weight below 1,000 daltons and the
fraction with the molecular weight below 500 daltons. The method used to determine
the low molecular weight fractions and the organisation conducting the test should be
stated. A report of the analysis should also be included in the notification statement.
The low molecular weight fractions are usually determined in the one analysis with
the weight-average and number-average molecular weights (see paragraph 2 of Part D
of the Schedule).
5. Degradation products
Information on all products resulting from the degradation, decomposition or
depolymerisation of the polymer is required, including identification of the products.
Details should include the conditions under which degradation, decomposition or
depolymerisation take place. The rate and mode of degradation, decomposition or
depolymerisation should be provided, together with the likely proportion of products
formed. In particular, information on all dangerous and hazardous products should be
provided.
Information on the degradation products likely to be produced during or after the
disposal of the polymer should be included.
6. Loss of monomers, other reactants, additives and impurities

Information on the natural loss of monomers, reactants, additives and impurities from
the polymer is required in order to assess health and environmental effects during use
of the polymer. This data should include:
• loss by volatility, for example, monomer;
• loss by exudation, for example, additive; and
• loss by leaching, for example, by water or oil.
The conditions under which such loss may occur should be indicated.
DATA REQUIREMENTS FOR POLYMERS OF LOW

CONCERN
Form 1-PLC specifies the information required for the notification statement for
Polymers of Low Concern (PLC) (see Appendix 1 - Forms.) It may be necessary to
attach supporting data if the space on the form is insufficient. Notifiers need not
submit raw data, such as toxicological studies with their Form1-PLC. However, such
data should be easily accessible to the notifier in case further information is required
for assessment. The information to be provided on or with Form 1-PLC is stipulated
below.
(a) Chemical name of the polymer

The exact chemical name, as described in paragraph 1(a) of Part B of the Schedule is
required. The chemical name to be provided is the Chemical Abstracts (CA) Preferred
Index name or the International Union for Pure and Applied Chemistry (IUPAC)
name of the polymer. An assessment certificate cannot be issued unless NICNAS is
informed of the identity of the polymer. If the identity is considered confidential, an
application for the Data Requirements
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(b) Marketing or other name(s)

Include all the alternative chemical names by which the polymer is known and all
trade or marketing names for the polymer.
(c) Chemical Abstracts Service (CAS) number

The CAS number, as described in paragraph 1(d) of Part B of the Schedule is
required. If a CAS number has not been assigned to the chemical, this should be
indicated on the form.
(d) Justification for 'low concern' classification

The notifier must demonstrate that the polymer meets the criteria for a PLC so, in
most circumstances, all of the Yes boxes on Form 1-PLC should be ticked. If the
notifier believes that, for example, the notified polymer does not meet one of the
criteria yet the polymer should be regarded as a PLC, then the relevant No box should
be ticked and information and data to support the application should be provided.
(e) Molecular formula

The molecular formula should be provided in the form (monomer 1)a.(monomer
2)b....(monomer m)n.
(f) Structural formula

A structural representation of the polymer indicating the location of atoms, ions or
groups and the nature of the bonds joining them must be provided. If space is
insufficient, attach a separate sheet. If the polymer is random and cannot be
represented, this should be stated, and the structure of monomer components
provided.
(g) Means of identification

A list of the spectral data available to confirm the identity and structural formula of
the notified polymer must be provided. For example, the list could include infrared,
nuclear magnetic resonance, ultraviolet-visible and/or mass spectroscopy data (see
paragraph 1(g) of Part B of the Schedule). A copy of at least one example of spectral
data should accompany Form 1-PLC.
(h) Number-average molecular weight

The number-average molecular weight must be provided, as described in paragraph 2
of Part D of the Schedule in this Chapter. A copy of the analysis should accompany
Form 1-PLC.
(i) Weight percentage of molecules with molecular weight less than 1000
daltons and less than 500 daltons
The percentages of low molecular weight species below 1000 daltons and 500 daltons
must be provided. As described in paragraph 4 of Part D of the Schedule, normally
this information can be determined from the gel permeation chromatographic
measurement of the number-average molecular weight.
(j) Charge density

The notifier must demonstrate that the polymer meets the PLC criteria for low charge
density. The questions on charge density and cationic potential on Form 1-PLC must
be answered and, if the polymer contains any charged groups, a calculation of the
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charge density must be provided. The charge density should be provided in terms of
the number of charges per 1000 daltons molecular weight, or the equivalent weight of
charged groups, which is the ratio of the number-average molecular weight to the
number of charged groups in the polymer. Comments on the potential for ionisation in
the pH range (4-9 inclusive) likely to be encountered in the environment should be
included.
(k) List of polymer constituents

The correct chemical name, CAS number and the weight percentage of each of the
polymer constituents (monomers and other reactants) must be provided. All test data
must be supported by methodology. Compliance with currently accepted principles of
good laboratory practice is preferred and should be stated if it applies. All information
submitted should be referenced wherever possible.
(l) Residual monomer content

The identity and weight percentage of all residual monomers and other reactants must
be provided. A copy of the analysis should accompany Form 1-PLC. Notifiers should
note that a PLC must satisfy the criteria for low molecular weight species. Low
molecular weight species include monomers and other reactants and low molecular
weight oligomers.
(m) Water solubility

The water solubility in mg/L must be provided. Notifiers should specify whether the
figure quoted is a test result or an estimate. For test results, a copy of the analysis
should accompany Form 1-PLC.
(n) Particle size distribution

For polymers that are solids, the mean particle size and the particle size distribution
must be provided, including the percentage of particles in the respirable and inspirable
ranges. A copy of the analysis should accompany Form 1-PLC.
(o) Stability of the polymer

Notifiers must comment on the potential for the polymer to break down by hydrolysis,
thermal degradation, photodegradation, depolymerisation or otherwise, under
processing and normal conditions of use.
(p) Residual reactive functional groups

The presence and identity of reactive functional groups that are intended to, or are
reasonably likely to, undergo further reaction must be specified. If no such groups are
present, this should be stated.
(q) Intended use(s)

As described in paragraph 3 of Part B of the Schedule, all intended uses of the
polymer must be provided. For example, the polymer may be component in a paint
mixture for outdoor use, or an industrial plastic for the preparation of components for
the automotive industry.
(r) Appearance of the polymer
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A description of the physical state and colour of the polymer at 20°C and 101.3 kPa
(ambient conditions) must be provided (as described in paragraph 4 of Part B of the
Schedule).
(s) Estimated manufacture or import volume

The approximate intended volumes of import and/or manufacture must be provided
for the polymer during each of the first five years (as described in section 5 of Part B
of the Schedule in this Chapter). The estimates should distinguish between the
notified polymer and any imported or manufactured products containing the polymer.
(t) Site of manufacture or reformulation

Notifiers must include a list of the Australian sites where the polymer or formulations
involving the polymer are to be manufactured. If the polymer is imported in a product,
notifiers should advise whether, and where, the polymer is packaged or reformulated
prior to further transport and use.
(u) Physico-chemical properties

Data on certain physico-chemical properties are required. These data items are
melting point, density, flammability limits, auto ignition temperature, explosive
properties and reactivity, for example, oxidation potential. Guidance on these
properties can be found in paragraph 9 of Part B of the Schedule.
(v) Occupational health and safety data

The information to be provided on occupational health and safety is similar to that
specified for most other categories of notification. The information can be provided in
summary form on Form 1-PLC. However, it is likely that insufficient space will be
available on the form and information will need to be appended. The submission
should address occupational health and safety issues at all stages of the polymer's
manufacture, formulation and end-use. Processes should be described in sufficient
detail for the assessor to determine the route, extent and significance of possible
exposure and the effectiveness of the proposed control measures. The information to
be provided is itemised on Form 1-PLC. However, notifiers should consult paragraph
6 of Part B of the Schedule for guidance.
(w) Environmental Impact

The information required on environmental impact can be provided in summary form
on Form 1-PLC. It is possible that insufficient space will be available on the form and
information will need to be appended. Release of the polymer to the environment is
required for all stages of the polymer's manufacture, formulation and end-use.
Processes should be described in sufficient detail for the assessor to determine the
extent and significance of possible environmental exposure. Storage and disposal of
the polymer should be considered. Where there is both a high content of low
molecular weight species as well as a high release to water, aquatic toxicity for fish,
daphnia and/or algae may be required. Notifiers should consult paragraph 7 of Part B
of the Schedule in this Chapter for further guidance.
(x) Public Health

The information to be provided on public health is similar to that required for most
other categories of notification. The information can be provided in summary form on
Form 1-PLC. However, in some cases, additional information will need to be
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appended. The submission should consider possible exposure to the public at large at
all stages of the polymer's manufacture, formulation and end-use. Where there is both
a high content of low molecular weight species and the polymer is to be used as an
ingredient in a cosmetic product at 1% or more, additional information, e.g.
toxicological data, may be required. Notifiers should consult paragraph 8 of Part B of
the Schedule for further guidance.
(y) Label
A copy of the proposed label(s) for the notified polymer and all products containing
the polymer shall be compiled in accordance with the NOHSC National Code of
Practice for the Labelling of Workplace Substances and submitted with Form 1-PLC.
(z) Material Safety Data Sheet
A copy of the proposed MSDS for the notified polymer and all products
containing the polymer shall be compiled in accordance with the NOHSC
National Code of Practice for the Preparation of Material Safety Data Sheets
[NOHSC:2011(1994)] and submitted with Form 1-PLC.
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Appendix 13 – AICS Online Training
13. AICS Online Training

Guidance for Searching AICS online
AICS online is the list of chemicals on the non-confidential section of the Australian
Inventory of Chemical Substances (AICS) that can be searched via the Internet. This
list is updated every fortnight.
Suggested strategy of Searching
AICS online can be searched using the following three chemical identifiers:
• CAS Number
This is the easiest and fastest method to search AICS online. We recommend
that you try to find the CAS number first if the chemical name you have is not
on AICS. There are several useful Internet sites to help find CAS numbers.
• Chemical Name
The second most useful method for searching AICS is by chemical name.
However chemicals are known by many names and these may not be listed on
AICS. If the chemical name you have is not found on AICS, then we
recommend that you try and find other names for the chemical. There are
several useful Internet sites to find other chemical names.
• Molecular Formula
Search by molecular formula is least effective and recommended to be used in
combination with chemical name search. Few chemicals on AICS have
molecular formulas.
Internet sites
There are several Internet sites that are helpful identifying CAS numbers or chemical
names:
• Chemical information
• Internet search engines
Search strategies for specific group of chemicals
Further guidance is provided for the following groups of chemicals:
• Polymers
• Cosmetics
Confidential AICS search
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CAS Number Search
The CAS Number is a unique number assigned to a substance when it is entered into
the Chemical Abstracts Service (CAS) REGISTRY database. More information on
CAS is available at http://www.cas.org/EO/regsys.html and
http://www.nicnas.gov.au/publications/pdf/handbook/appendix11.pdf.
Because each CAS number is a unique identifying number, in contrast to chemical or

associated names for which there may be multiple names in use for a chemical,
searching the AICS using CAS number is the easiest and least ambiguous method of
identifying whether chemicals are listed or not.
The format of CAS number is three blocks of numbers separated by dashes i.e. XXX-
XX-X. The first block can be between 2 and 6 digits. The second block has only 2
digits and the last block is always a single digit. Any preceding zeros in the first block
need to be discarded. For example, the CAS number for formaldehyde is 50-00-0.
If the entered CAS number matches a CAS number listed on AICS exactly, details of
the chemical will be displayed on the screen. The result of a search using a CAS
number is limited to only a single chemical. If CAS number entered is not the correct
format (eg. too few or many numbers), an alert message will be displayed. The CAS
number search field will not accept “wild card” searches.
As an example, to search for formaldehyde, the CAS number (50-00-0 or 50000) can
be entered into the search field and the search commenced by hitting Go. If no dashes
are included, the system will add them to the last three digits. Below are screenshots
of before and after searching for ‘50000’.
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Printable
version
button
To print the results of the chemical search, click on the printable version. This will
open the search result in a window suitable for printing (below).
AICS
update date
If there are no hits for the CAS number then a negative search screen will appear
stating “No results found”.
Chemical Name Search
Chemicals are listed under ‘Chemical Name’ with their CAS approved name.
Chemicals are more commonly known by names other than their CAS approved
name. Only some of these associated names or synonyms are also included on AICS.
Both of these names can be searched by using the “Chemical Name Search” method.
In the example above, formaldehyde has six listed associated names on AICS.
However, it has several more associated names, such as “formal” which are not listed
on AICS. Therefore, if “formal” is entered for the search, a negative result will occur
even though formaldehyde is listed.
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The search engine for chemical name search has been set up to search for name
fragments. A fragment is defined as a word, with a ‘space’ or ‘bracket’ or ‘–‘ or
‘number’ separating the next word.
Please note that the chemical names are in different formats on AICS (eg. extra
space, bracket or sequence) and a negative result may occur if the correct format is
not used. Given below are some examples for simple chemicals with different name
formats:
1. Methylethyl ketone is listed (for CAS 78-93-3) whereas ethylmethyl ketone

and methyl ethyl ketone are not listed, though they represent the same
chemical.
2. Isopropylbenzene is listed (for CAS No. 98-82-8) whereas searching on
isopropyl benzene gives no result, though the chemical is the same.
3. Sodium sulfate (7757-82-6) is more commonly known as sodium sulphate.
Sulfate is the CAS approved name format.
If you do not have the CAS number or correct chemical name, you should ensure that
you have sufficient associated names to enable a comprehensive AICS search.
Associated chemical names or synonyms can be obtained through Internet sources or
other published documents.
AICS does not list trade names or International Nomenclature of Cosmetic

Ingredients (INCI) names and so searching cannot be conducted for these names.
Chemical names and molecular formula searches can be enhanced by the use of the
wildcard”*”. This can be used in different search options.
Search results are limited to 200 hits for any search. If there are more than 200 hits,
the search engine returns a request to refine the search. Chemical name searches can
be refined using the operator phrases available as drop down menus.
There are several options for Chemical Name Search:
(a) Contains all words: The search will be conducted on all words entered on the
line. The sequence or any preceding characters (including wildcards) are ignored.
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Wildcard option, “*”, can be used at the end of words for search. This is the best
option if a chemical name is long and has many components (eg polymers). For
example, if ‘pentanoic acid’ is entered on the search field, the search engine will
break the name into two fragments, ‘pentanoic’ and ‘acid’ and search for chemical
names on AICS that contain both the fragments. There are about 82 records on AICS
that contain both the fragments.
(b) Contains any words: This will search for any word entered on the line. This
option has to be used in combination with other options as it may lead to large number
of hits. For example, if ‘pentanoic acid’ is searched using this option, too many hits
occur. This is because the search engine is trying to find if either of the fragments
‘pentanoic’ or ‘acid’ is listed in the chemical names on AICS.
(c) Contains phrase: This will search for any phrase entered. The sequence of the
phrase items is maintained during the search. This option needs to be used with
caution as it may result in a negative result if the sequence on AICS does not match
the sequence of the search phrase.
For example, if ‘pentanoic acid’ is searched using contains phrase option, 82 records
are returned, however, if the sequence is reversed and ‘acid pentanoic’ is searched for
no results are returned.
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(d) Starts with: This will search for any chemical name starting with the name
entered. Here wild card,”*”, can be used at either side of the word for searches. This
is the best option when using wildcard.
For example, if ‘pentanoic acid’ is searched, all chemicals where pentanoic acid is the
first part of the name are displayed.
(e) Equals: This search matches the exact chemical name. In this option, spaces,
brackets, commas, dashes are important and unless these are entered correctly the
chemical will not be matched. Wildcard cannot be used with this option. It is useful
when searching for individual chemical names (eg benzene, water etc)
(f) Excludes phrase: This option will exclude any phrase/word entered. It should be
noted that sequence is important in any phrase option. If you want to exclude only
individual words, use this option on separate lines. This is useful to narrow down
search results.
For example, to narrow down the search results for ‘pentanoic acid’ from 82 (using
‘contains all words’ option) to manageable numbers, excludes phrase may be used.
First identify the words/ phrases in the list that you do not want in your results by
scrolling down. Once these are identified, type the words on different search lines and
use the option ‘excludes phrase’.
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Results when exclude terms are on same line:
Results when exclude terms are on different search lines:
Any combination of the above operator phrases can be used to do the search.
Molecular Formula Search
Molecular formula information on AICS is limited to only a few chemicals. We

recommend you use this option to assist only in narrowing chemical name searches.
The search options are:
Contains: This will search for phrase entered on the line. The sequence of phrase is
maintained during the search. This option needs to be used with caution as it may
result in negative result if the sequence on AICS does not match the search phrase.
Wildcard, “*”, can be used in the search if the sequence is not known.
Starts with: This will search for molecular formula starting with the phrase entered.
Wildcard, “*”, is useful to get more hits and can be used in the start or end of phrase.
Equals: This search matches the exact molecular formula. This option is useful when
molecular formula is known. Wildcard is not useful in this option.
Excludes phrase: This option will exclude any phrase/word entered.
229
Internet sites
Chemical information databases
Given below are some links that may be useful to find chemical information. It should
be noted that information on these links may not be accurate.
• US TSCA search page http://msds.pdc.cornell.edu/tscasrch.asp
The US TSCA inventory can be searched on this site to obtain chemical

identity information that can be used to search AICS.
• EU Existing chemicals page http://ecb.jrc.it/existing-chemicals/
The EU Existing chemical inventory, EINECS, can be searched on this site by

using chemical name or EINECS numbers. This site is particularly useful to
identify CAS number when an EINECS number is available.
• EU cosmetics chemicals list

http://europa.eu.int/comm/food/fs/sc/sccp/out123cm_en.pdf
Information on cosmetic ingredients and their chemical identities are available

on this site.
• International Nomenclature for cosmetic ingredients (INCI)

http://pharmacos.eudra.org/F3/inci/index.htm
Information on cosmetic ingredients and their chemical identities are available

on this site.
• National Library of Medicine (US)

http://chem2.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
This site lists chemicals and available toxicity information. It is particularly

useful as it lists chemicals which are not on major inventories.
• MSDS-Search
http://www.msdssearch.com/BackgroundN.htm#USEFUL%20LINKS
The links on this site can be used to find other sites where the chemical
identities can be searched.
Internet search engines
Any Internet search engine (Yahoo, Ninemsm, Google etc) can also be used to find if
information on chemical name and CAS number.
230
Search results can be narrowed down using the advanced search options (contains
phrase, exactly etc). An easier way is to add additional search terms. For instance if
you are searching for a chemical name only and get more than 2000 hits, just add the
term ‘CAS number’ and redo the search. This will show the site hits where both the
‘chemical name’ and ‘CAS number’ are on the web site.
Search strategies for specific group of chemicals
Polymers
Searching for polymers by name can be difficult as the names are long and chemical
names are sometimes in different formats. Given below are a few hints on how to
search for polymers on AICS.
Clearly, because of the complexity of polymer names, searching for polymers on

AICS using the CASRN is the best option. However, if no CASRN is available, it is
best to break the chemical name into keyword fragments and search for a combination
of these fragments to find the polymer. An example of a polymer chemical name
search is below:
Example 1:
Polymer to be searched:
Phenol, 4,4'-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, polymer
with paraformaldehyde, 3-methylphenol, 2-methylphenol and 4-methylphenol
This polymer name can be broken down into the following keyword fragments:
Phenol
Methylethylidene
Chloromethyl
Oxirane
Paraformaldehyde
Methylphenol
Choose the search operator “Contains all words” and input the fragments on the same
line or different lines. Click Go to search for the polymer.
231
If there is more than one hit for the name combination, then all the search results will
be displayed. In this case only one chemical name was found on AICS and it will be
displayed as follows:
Example 2:
This example demonstrates a search sequence for a polymer where the supplied
chemical name is different to the name listed on AICS.
Polymer to be searched:
Acrylic acid, polymer with acrylonitrile, butyl acrylate and styrene
If the above polymer is searched for the keyword fragments acrylic acid, acrylonitrile,
butyl acrylate and styrene, the search will return as negative.
However, if synonyms for each keyword fragment can be identified using AICS or
other sources, these can be used for the AICS search.
Synonym for acrylic acid on AICS is:

2-propenoic acid;
232
Synonyms for butyl acrylate on AICS are:
2-Propenoic acid, butyl ester

Acrylic acid, butyl ester
Butyl 2-propenoate
n-Butyl acrylate
Synonyms for acrylonitrile on AICS are:

2-Propenenitrile
Cyanoethylene
Synonyms for styrene on AICS are:

Benzene, ethenyl-
Ethenylbenzene
Vinylbenzene
A combination of the above synonyms can be used for the search as shown below:
Several possible candidate polymers may be returned. The correct polymer can be
identified manually from the list by clicking on the CAS number (see below).
233
Clearly, it is important to consider synonyms when conducting chemical name

searches.
Cosmetics
Cosmetic chemicals are known by their more common industry trade names eg. INCI.
As most of these trade names are not on AICS, searching with these terms will
generally yield negative results. The strategies to find cosmetic ingredients are:
1. Contact your supplier to get correct chemical details or ask them to check the
chemicals.
2. Use Internet resources to find chemical information and use it to search AICS.
Please note that information on these links may not be accurate.
Example:
Stearamide DEA
If this term is searched on AICS, no results are obtained.
However from Internet searching the CAS number can be found.
234
The CAS number for this chemical is 93-82-3 and using this information AICS can be
searched.
Confidential AICS Search
If there is no match on the chemical name or CAS number, the chemical may be listed
in the confidential section of AICS. This section cannot be searched via the web. For
NICNAS to conduct a search of the confidential section of the AICS, written
submission of a bona fide intention to manufacture or import the chemical must be
submitted to NICNAS. Click here to view confidential search requirements.
235

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NICNAS Handbook for Notifiers

© Commonwealth of Australia 2004

1. Your Obligations Under NICNAS 3

SECTION II - New Chemicals 11

2. Do You Need to Notify? 11

SECTION III - Existing Chemicals 86

9. Priority Existing Chemical Assessments 86

SECTION IV - Continuing Notification and Assessment Methodologies 102

11. Secondary Notifications 102

SECTION V – NICNAS Registration 119

13. NICNAS Registration 119

SECTION VI - Treaties 128

SECTION VII - Compliance 137

VERSION DATE REASON FOR AMENDMENT

How to use this handbook

Consult the following Sections of the

HELP US HELP YOU

1.1 Why Assess Industrial Chemicals?

NICNAS has established a comprehensive scientific program of international

1.2 About NICNAS

NICNAS is the Australian Government’s regulatory body for industrial chemicals. It

existing chemicals on a priority basis in response to specific concerns about potential

1.3 How Does NICNAS Define an ‘industrial chemical’?

1.4 The Australian Inventory of Chemical Substances (AICS)

The AICS is a listing of industrial chemicals in use in Australia between 1 January

1.4.1 Compilation of AICS

1.4.2 Components of AICS

AICS is composed of two sections: Non-confidential and Confidential. Each section

Molecular Formula: Molecular formula for some chemicals is listed on AICS.

1.4.3 Listing of ‘New’ Chemicals on AICS

Five year listing

For a chemical to be listed on the confidential section, an application to NICNAS is

If the holder of certificate makes an application within 28 days of the issue of

Chemicals are added to non-confidential AICS through gazetting in the Chemical

1.4.4 Searching of AICS

• Administrative fee: $ 30 per search

1.5 The Five Key Obligations

1. New chemicals assessments – the notification and assessment of chemicals

4. NICNAS Registration – registration of anyone importing and/or

An overview of each of these obligations follows.

1.5.1 New Chemical Assessments

It is the responsibility of the importer and/or manufacturer of the new industrial

Several assessment categories exist which require different levels of assessment to be

1.5.2 Existing Chemical Assessments

Existing chemical assessment activities have an important role to play in reducing

An industrial chemical is declared a PEC by notice in the Chemical Gazette. Once

For detailed information about Priority Existing Chemical assessments, refer to

Sometimes, after consideration of information gathered on a chemical, a PEC

1.5.3 Secondary Notification

For further information about secondary notifications refer to Chapter 11 – Secondary

1.5.4 NICNAS Registration

All importers and/or manufacturers of industrial chemicals for commercial purposes

The Register of Industrial Chemical Introducers is a maintained list of all registered

For further information on NICNAS Registration refer to Chapter 13 of this

Rotterdam Convention on the Prior Informed Consent Procedure for Certain

The Rotterdam Convention is an international procedure that:

The Convention covers industrial chemicals and pesticides (including in specific

The Convention provides that, if a chemical is banned or severely restricted in a

For further information on the Rotterdam Convention, refer to Chapter 14 of this

NICNAS is committed to developing and maintaining an effective compliance

For further information, refer to Chapter 15 of this handbook.

1.7 Publication and Further Notification

SECTION II – New Chemicals

A list of the forms is located in Appendix 1 – Forms.