Guidance on national chemicals control

Risk reduction of chemicals

GUIDANCE 2

kemikalieinspektionen.se
The Swedish Chemicals Agency’s guidance series on national chemicals control
This guidance is part of a series developed by the Swedish Chemicals Agency. The guidance
documents cover a wide range of issues that are important for the establishment of a system for
preventive chemicals control. First versions of the documents were published during 2017 to 2020.

Control of chemicals placed on the market (brochure)

1. Sustainable financing of institutional capacity for chemicals control

2. Risk reduction of chemicals

3. Legislation on chemicals placed on the market

4. Enforcement of legislation on chemicals placed on the market

5. Access to Information on primary suppliers and chemicals on the market

6. Hazard and risk assessment and risk reduction of pesticides

7. Hazard and risk assessment of chemicals – an introduction

Link to the guidance documents and more information on guidance on national

chemicals control: www.kemi.se/en/guidance-on-national-chemicals-control

The Swedish Chemicals Agency is supervisory authority under the Government. We work in Sweden,
the EU and internationally to develop legislation and other incentives to promote good health and
improved environment. We monitor compliance of applicable rules on chemical products, pesticides
and substances in articles and carry out inspections. We also provide guidance regarding enforcement
and inspections to municipalities and county administrative boards. We review and authorise pesticides
before they can be used. Our environmental quality objective is A Non-toxic Environment.
© Swedish Chemicals Agency. Stockholm 2020. Article number: 511 374
Cover illustrations by Maja Modén

Document history
Version 1.0 First Edition Guidance 2/18 June 2018

Version 1.1 Change of name to Guidance 2 December 2020

Minor editorial changes.
Preface
Chemicals contribute in many ways to improving our standard of living, but some of them are
hazardous and can have serious adverse effects on human health and the environment. It is
therefore necessary to use different means to protect human health and the environment from
adverse effects emanating from exposure to hazardous chemicals.
This Guidance, developed by the Swedish Chemicals Agency, is a complement to the UNEP
Guidance on the Development of Legal and Institutional Infrastructures and Measures for
Recovering Costs of National Administration (LIRA guidance). It supplements LIRA with
further guidance related to risk reduction measures with regard to the control of chemicals
placed on the market.
The Swedish Chemicals Agency has developed this Guidance document with the financial
assistance of the Swedish International Development Cooperation Agency (Sida). The views
herein shall not be taken to reflect the official opinion of Sida.
Content
Preface............................................................................................................... 3

Content .............................................................................................................. 4

Summary ........................................................................................................... 6

Definitions and acronyms ................................................................................ 8

1. Introduction and scope ........................................................................ 9

2. Risk reduction of chemicals – a preventive approach .................... 11

3. Roles and responsibilities ................................................................. 12

3.1 The role of governments ............................................................................................... 14
3.2 The role of industry ....................................................................................................... 14

4. Risk reduction through general obligations on industry ................ 15

4.1 Dissemination of information in the supply chain .......................................................... 15
4.1.1 Implementation of GHS ................................................................................................. 18
4.2 General requirements on industry to assess and reduce risks ..................................... 18

5. Implementing international conventions and agreements.............. 20

6. Prioritisation of chemicals for introducing risk management

measures by authorities.................................................................... 20
6.1 What substances should be prioritised? ....................................................................... 21
6.1.1 Prioritisation based solely on hazard ............................................................................ 21
6.1.2 Prioritisation based on potential risk ............................................................................. 22
6.2 Sources of information supporting prioritisation. ........................................................... 23

7. The role of the authority’s risk assessment ..................................... 24

8. Risk reduction instruments ............................................................... 25

8.1 Choice of instruments ................................................................................................... 26
8.1.1 Socio-economic considerations .................................................................................... 27
8.2 Administrative instruments ............................................................................................ 28
8.2.1 Classification and labelling and safety data sheets ...................................................... 28
8.2.2 Control of access to particularly hazardous chemicals and to chemicals posing
uncontrolled risks .......................................................................................................... 28
8.3 Economic policy instruments......................................................................................... 31
8.4 Informative instruments (and general information) ....................................................... 32
8.4.1 Broad awareness raising............................................................................................... 33
8.4.2 Information from authorities aimed at solving a specific problem ................................. 35

9. Decision making ................................................................................. 37

Annex 1 – International Conventions and agreements ............................... 39

1. Strategic approach to International Chemicals Management ....................................... 39
2. Stockholm Convention .................................................................................................. 40
3. Rotterdam Convention .................................................................................................. 40
4. Minamata Convention ................................................................................................... 40
5. The Globally Harmonized System of Classification and Labelling of Chemicals - GHS
...................................................................................................................................... 41
6. The 2030 Agenda for Sustainable Development and the Sustainable Development
Goals ............................................................................................................................. 41
Summary
The aim of the present document is to give guidance to countries (governments and
authorities) in their efforts to set up an efficient system for the sound management of
chemicals with a special focus on legal and voluntary tools for risk reduction of chemical
substances on their own or when used in mixtures or in articles.
The guidance focuses on preventive chemicals control, which means measures directed
towards the placing of chemicals on the market. The risk management of chemicals covered
here makes use of information on the properties of chemicals at an early point in their life
cycle and thus contributes to preventing exposure to chemicals with adverse effects. Choosing
a preventive approach saves not only human and natural resources, but will also often have
financial benefits because the costs for preventing pollution are considerably less than the
costs for remediation of a contaminated environment.
An important part of preventive chemicals control is to make chemicals risk management an
integrated and natural part of the daily work within industry, including all companies that
handle chemicals. It is central to develop legislation that allocates responsibilities to
producers, importers, and users. The starting point is to ensure that information on the
contents of the chemical substances and mixtures that are placed on the market is
disseminated in the supply chain by those who place the substances and mixtures on the
market. A fundamental means to provide for the dissemination of information needed for
informed choices and safe handling to all actors in the supply chain is to make the
requirements for classification and labelling according to the Globally Harmonized System
(GHS) mandatory. Obligations placed on a few upstream actors will provide many
downstream actors with the information they need to assess risks, make informed choices, and
provide for safe handling. There could also be legal requirements for industry to perform risk
assessments and to apply any risk-management measures needed to control the risk.
In some cases, general requirements in the legislation, including disseminating information
according to GHS and taking necessary action as required, are not sufficient to handle specific
chemicals due to the potential risks they pose. It will then be necessary for authorities to
introduce measures towards those substances or groups of substances. Some measures are
taken at the international level through international conventions and agreements. The
implementation of international conventions and agreements, that the country is a party to, is
a matter of high priority.
Besides the implementation of decisions taken internationally, there is a need to consider the
prioritisation of chemicals that might be of concern on a national level and for which risk-
management measures might be necessary. A systematic approach would build on the
prioritisation of substances that, due to their known or assumed hazards and/or use patterns,
are likely to give rise to risks that need to be eliminated or at least reduced to an acceptable
level. For substances with inherent properties giving rise to very severe or irreversible effects,
it can be sufficient to base a decision for risk reduction on the hazard assessment. This could,
for example, be the case for substances that are persistent, bio-accumulating, and toxic (PBT)
or that are very persistent and very bio-accumulating (vPvB), carcinogenic, mutagenic, or
toxic to reproduction that meet the criteria for CMR category 1A or 1B according to the GHS
(especially those without a threshold for effects), or that give rise to other severe and
irreversible health effects.

6
For other chemicals than those mentioned above, when considering the need for restricting or
banning the use of such a chemical a risk assessment should normally be carried out. For such
a risk assessment, it is necessary to have information both on the hazard of the substance (the
inherent properties) and the potential exposure to the substance in the country because risk is a
function of hazard and exposure.
When analysing the need for further risk reduction, much support for the selection of
substances can be drawn from actions taken and priorities set in other countries. The hazard
assessment of a specific substance does not need to be repeated because the inherent
properties are always the same. There might, however, be a need to assess the national
exposure to the substance because this might vary from country to country. The exposure
parameter needs to be based on the available data, and the simplest method is to base it on the
volume of the substance on the market. Not having detailed exposure data should not prevent
authorities from making an estimate of the likelihood that the occurrence of the substance on
the market might entail risks to the environment or to human health.
Precaution should be applied in risk management when there are threats of serious or
irreversible damage to human health or the environment, which is in line with the
Precautionary principle from the 1992 Rio Declaration. In this situation, the lack of full
scientific certainty should not be used as a reason for postponing cost-effective measures to
prevent damage.
When the result of a risk assessment shows that measures already taken by industry are not
enough to reduce the risk and there is a need to further reduce the exposure to a chemical in
the environment and in humans, it is necessary for the government and/or its authorities to
introduce one or more risk reduction measures. There are a number of different instruments
that can be used. Administrative risk reduction instruments cover bans and restrictions,
authorisations, premarket approval systems, and the obligation to classify and label chemicals
and to supply safety data sheets. Economic policy instruments include fees and taxes.
Examples of informative instruments are targeted information on a specific problem,
ecolabelling, dialogues with industry, voluntary commitments as well as tools for substitution
and public procurement.
Which instrument to choose depends on the risks that need to be tackled and on the specific
situation in individual cases. When the hazard is high, as mentioned above, measures might
be taken without performing a full risk assessment. In such cases, the preferred risk reduction
measure many times can be a total ban. Also, in other cases in which the risk from the
chemicals is high, administrative risk reduction instruments might be the most appropriate.
Economic instruments could be used e.g. for moderately hazardous substances where there is
a need for a reduction in the use, but not a total phase-out, and the government wants to use
market forces to find the areas where the reduction could be made with the lowest cost. An
informative instrument is less compulsory than other types of risk reduction measures and
aims to achieve a voluntary reduction of the use of a specific substance or group of
substances. Informative instruments can be used as stand-alone measures if the risk from a
specific substance or group of substances is comparably low but still needs to be reduced.
When developing new legislation, a clear process – including possibilities for companies to
engage in the process – makes it easier for companies to comply with the legislation. It is
important that all requirements are fully understandable by the affected companies as well as
by the enforcement authorities. Decisions regarding risk management usually have to be taken
in several steps, and for each step it needs to be defined at what level and by whom a decision
can be taken, and the legislation needs to give clear mandates to these decision-makers.

7
Definitions and acronyms
Chemical products are usually defined and understood as chemical substances and
mixtures of chemical substances.

GHS uses the following definitions:

Substance means chemical elements and their compounds in the natural state or obtained by
any production process, including any additive necessary to preserve the stability of the
product and any impurities derived from the process used, but excluding any solvent, which
may be separated without affecting the stability of the substance or changing its composition
Mixture means a mixture or solution composed of two or more substances in which they do
not react
Many chemical products are incorporated in finished products, or articles, during the
production phase. Examples could be painted and lacquered furniture, polymers and metals in
electric and electronic products, dyes in textiles, flame retardants and plasticizers in plastics
etc. Articles may pose a risk due to their chemical contents. In some countries specific
substances have been regulated in specific groups of articles, but in general they are to a large
extent unregulated with regards to their chemical contents.

The following definition is used in the EU Reach regulation:

Article means an object which during production is given a special shape, surface or design
which determines its function to a greater degree than does its chemical composition.

Acronym Explanation
CLP EU Regulation on Classification and Labelling of Substances and Mixtures (No.
1272/2008)
CMR Carcinogenic, Mutagenic and Toxic to the Reproductive system
ECHA European Chemicals Agency
EU European Union
GHS Globally Harmonized System of Classification and Labelling of Chemicals
ICCM International Conference on Chemicals Management (of SAICM)
IOMC The Inter-Organization Programme for the Sound Management of Chemicals
OECD Organisation for Economic Co-operation and Development
PBT Persistent, Bioaccumulative and Toxic
REACH EU Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals
(No. 1907/2006)
SAICM Strategic Approach to International Chemicals Management
SDS Safety Data Sheet
SVHC Substances of Very High Concern
UNEP United Nations Environment Programme
WHO World Health Organisation
vPvB very Persistent and very Bioaccumulative

8
1. Introduction and scope
Chemicals form an important part of our daily life, but they may also pose risks to health and
environment depending on their intrinsic hazardous properties and how they are used.
Hazardous chemicals can be present in products that are sold to professional users and to
private consumers for use in everyday life. The use and subsequent dispersal of hazardous
substances can jeopardise the long-term utilisation of land and water resources and make
groundwater and fish, for example, unfit for human consumption. This in turn can have an
adverse impact on the development of countries. People are exposed to chemicals at work, in
their homes, and indirectly through the environment, which can lead to deaths or acute or
long-term effects on health. Measures are taken to reduce such exposure in many countries,
but there are wide differences today in the capacity of the world's countries to manage
chemicals safely.
Generally, poor people are exposed significantly more often than others to hazardous
substances. It is particularly serious when foetuses and children are exposed, as this can affect
their development and in many ways impair their prospects in life. Control over chemicals
and their use saves lives and is needed in order to achieve sustainable development.
During the last decades, international cooperation with the aim of improving the sound
management of chemicals globally has taken place. This cooperation has resulted in some
international conventions to eliminate or reduce the use of the most hazardous chemicals,
including the Stockholm Convention on Persistent Organic Pollutants and the Minamata
Convention on Mercury.
The Strategic Approach to International Chemicals Management (SAICM), an international,
non-legally binding agreement, is a policy framework to foster the sound management of
chemicals. SAICM was developed by a multi-stakeholder and multi-sectoral Preparatory
Committee and supports the achievement of the goal agreed upon at the 2002 Johannesburg
World Summit on Sustainable Development through its overall objective:
“to achieve the sound management of chemicals throughout their life cycle so that, by 2020,
chemicals are used and produced in ways that lead to the minimization of significant adverse
effects on human health and the environment.”

Substance Mixture Article

For example, citric acid or For example, a can For example, a mobile
pentachlorophenol containing paint phone or a T-shirt

Figure 1. A substance can be used as such, in a mixture or in an article. Illustrations by Maja

Modén.

The aim of the present document is to give guidance to countries (governments and
authorities) in their efforts to set up an efficient system for the sound management of

9
chemicals with special focus on legal and voluntary tools for risk reduction of chemicals.
Thereby the guidance supports work in relation to SAICM for meeting the 2020 1 goal. The
guidance is complementary to the UNEP LIRA guidance 2 and adds to the IOMC Toolbox 3.
A legal framework that defines roles and responsibilities for both industry and the
government is a fundamental starting point and is a cornerstone for the sound management of
chemicals and for achieving sustainable development. 4 5
This guidance focuses on the control of chemical substances and mixtures as well as articles
that contain chemicals when they are placed on the market. Placing chemicals on the market
includes the production and import of chemicals and making them available to third parties
for use in the supply chain, including use by the general public. It focuses on examples of
different risk reduction measures and instruments – legal as well as voluntary – that might be
introduced to reduce the risks from hazardous chemicals. Specific legislation on occupational
health, industrial accidents, emissions from production, and waste also contributes to the
overall risk reduction of chemicals, but this will only be mentioned briefly in this document.
The document will not focus on types of chemicals that are normally covered by sector-
specific legislation such as pesticides 6, pharmaceuticals, and food additives.

Figure 2. Exposure to chemicals may occur through emissions from facilities to air and
water. Workers may be exposed at the work place. These areas are normally covered by
specific legislation on occupational health and emissions from production. Exposure can also
occur from the products produced in or imported to a country. This guidance focus on
substances placed on the market as such or used in mixtures or articles. Illustrations by Maja
Modén.

1
http://www.saicm.org/StrategicApproach/Towardsnbsp2020/tabid/5499/language/en-US/Default.aspx
2
UNEP Guidance On the Development of Legal and Institutional Infrastructures and Measures for Recovering
Costs of National Administration for Sound Management of Chemicals (LIRA)
https://www.unenvironment.org/resources/report/lira-guidance
3
The Inter-Organization Programme for the Sound Management of Chemicals,
http://www.oecd.org/chemicalsafety/news-iomc-online-toolbox-may-2015.htm
4
UNEP Guidance On the Development of Legal and Institutional Infrastructures and Measures for Recovering
Costs of National Administration for Sound Management of Chemicals (LIRA). See footnote 2.
5
Swedish Chemicals Agency (2018). Guidance on national chemicals control: Legislation on chemicals placed
on the market. www.kemi.se/en/guidance-on-national-chemicals-control
6
Swedish Chemicals Agency (2020). Guidance on national chemicals control: Hazard and risk assessment and
risk reduction of pesticides). www.kemi.se/en/guidance-on-national-chemicals-control

10
 Some important international goals and strategies
for the sound management of chemicals
2020 goal
In 2002, at the UN World Summit on Sustainable Development in Johannesburg, governments and
all other relevant organisations agreed to renew as advanced in Agenda 21, to sound management
of chemicals throughout their life cycle and of hazardous wastes for sustainable development as well
as for the protection of human health and the environment, inter alia, “aiming to achieve, by 2020,
that chemicals are used and produced in ways that lead to the minimization of significant adverse
effects on human health and the environment” 7.
Strategic Approach to International Chemicals Management, SAICM
SAICM is a multiple stakeholder and multi-sectoral policy framework adopted in 2006 by the first
International Conference on Chemicals Management, ICCM, to achieve the 2020 goal 8.
Overall Orientation and Guidance for Achieving the 2020 Goal, OOG
In order to define sound management of chemicals in concrete elements, the fourth ICCM in 2015 as
a part of SAICM endorsed the OOG, with six core activity areas and 11 basic elements recognised
as critical to attaining sound management of chemicals and waste. These include legal and
institutional frameworks, industry participation and defined responsibilities across the product life
cycle, and cost recovery policies and systems 9. See also Annex 1.1 for the full text.

Sustainable Development Goals, SDGs

Seventeen Sustainable Development Goals and 169 associated targets were adopted by the Heads
of State and Government and High Representatives meeting at the United Nations Headquarters in
2015. Target 12.4 in principle reflects the 2020 goal: “By 2020, achieve the environmentally sound
management of chemicals and all wastes throughout their life cycle, in accordance with agreed
international frameworks, and significantly reduce their release to air, water and soil in order to
minimize their adverse impacts on human health and the environment” 10.

2. Risk reduction of chemicals – a preventive

approach
As described above, chemicals can have serious adverse effects on human health and the
environment, which affects people’s quality of life and can lead to substantial costs for
society. The reason/rationale for applying risk reduction measures is to protect human health
and the environment from the adverse effects of hazardous chemicals as well as to gain
financially because natural resources will be preserved and remain useable in the long run and
because there will be reduced costs for health care. In addition, trade is promoted because a
clear and consistent legal system for managing risks from chemicals allows countries to trust
products from another country, and greater trade generates greater profits.
While risk assessment to a large extent is based on science, subsequent risk-management
measures are frequently influenced or steered by political considerations. Risk management is

7
Johannesburg Plan of Implementation http://www.un-documents.net/jburgpln.htm)
8
See SAICM website. http://www.saicm.org/
9
http://www.saicm.org/Portals/12/Documents/OOG%20document%20English.pdf
10
http://www.un.org/sustainabledevelopment/;
http://www.un.org/sustainabledevelopment/sustainable-development-goals/

11
a decision making process that involves political, social, economic and technical factors as
well as a relevant risk assessment 11.
The risk management of chemicals covered here makes use of information on the properties
of chemicals at an early point in the life cycle of the chemicals and thus it contributes to
preventing exposure to chemicals with adverse effects. Traditionally, pollution control often
takes place as an end-of-pipe activity, but preventing pollution at the beginning of the supply
chain offers an opportunity to achieve additional environmental and health benefits. The
sooner action is taken to reduce adverse effects from chemicals, the cheaper it will be for
society as well for industry because taking early action is much less complicated than to direct
measures towards widespread uses. Choosing a preventive approach saves not only human
and natural resources, but will also often have financial benefits.

”Prevention is better than cure”

Bernardino Rammazzini (1633-1714)

For the vast majority of chemicals, it is sufficient to place general obligations on the actors in
the supply chain to communicate and make use of the information conveyed in accordance
with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS),
while for a number of chemicals more stringent risk reduction measures are needed.
Adopting a clear and transparent national chemicals policy supports the work of the
government as well as that of industry and other stakeholders. Such a policy will contribute to
clear and transparent information on what measures might be taken for chemicals and thus
give industry guidance on what types of substances not to choose for production and use. In
combination with relevant legislation, this will contribute to a level playing field for industry.

3. Roles and responsibilities

To provide for the sound management of chemicals, national legislation is necessary. In the
legislation there will be a number of tasks defined that someone needs to carry out. It is,
therefore, important that the legislation clarifies the division of responsibilities between trade
and industry on the one hand and the national administration on the other hand.
It is reasonable that the main responsibilities for managing risks with chemicals placed on the
market should lie with the chemical producers and importers for the risks that might emerge
from the chemicals they produce and import. It is, therefore, central to develop legislation that
allocates responsibilities to companies in order to internalise most of the costs of chemicals
management.
The approach to clearly identify the roles and responsibilities of different stakeholders,
including governments and industry, is covered by six core activities and 11 basic elements as
elaborated in the OOG (see full text in annex 1), which aims to identify approaches for all of
SAICM’s stakeholders towards the achievement of the overall 2020 goal, including some

11
WHO: Terminology from the International Programme on Chemical Safety, WHO

12
concrete elements to support the implementation of the Overarching Policy Strategy 12 of
SAICM.
The role of governments is to make industry assume their responsibility by issuing relevant
legislation and recommendations as well as carrying out enforcement of the legislation,
including, when necessary, banning or restricting the use of certain chemicals.

Table 1. Division of chemicals management activities relating to placement of chemicals on

the market between producers/importers, downstream users, and national administrations.
Examples of tasks are given.
Companies producing or Downstream users of National administration related to
importing chemicals chemicals chemicals placed on the market

Adjusting production and/or
importation to comply with
bans and restrictions
Gathering data on hazards
Pre-marketing testing (if
data are not already
available)
Assessing risks and take
measures to reduce risk if
necessary
Updating the information
base when required
Classifying and labelling
according to relevant
legislation, preferably GHS
Transferring of safety
information in the supply
chain, including labelling
and safety data sheets
Adjusting the use and
production to comply with
bans and restrictions
Taking into account the
received and otherwise
obtained information on
hazards and safety
measures of supplied
chemicals when deciding
which chemicals to use and
how they will be used
Transferring safety
information in the supply
chain for the whole life cycle
of the chemical, including
labelling and safety data
sheets for chemical mixtures
Reporting according to
existing obligations, for
example, to the national
chemicals registry or
notifying the production or
import
Obtaining and keeping information
on chemical producers/importers
Requiring information on chemicals
produced/used in the country
Prioritising substances and
assessing information from industry
and other sources about the hazards
and risks of those substances
Issuing regulations, and guidelines,
including:
a) legal requirements on
classification and labelling
b) bans and restrictions on certain
hazardous substances
c) authorizations of chemicals of high
concern, e.g. pesticides
Enforcing the legal requirements and
taking measures to ensure
compliance
Having dialogues with industry

Reporting according to Providing general information to

existing obligations, for various stakeholders in society
example, to the national
chemicals registry or Participating in international and
notifying the production or regional communication and co-
import operation

Co-operating with other authorities

Charging fees for services provided

12
The Overarching Policy Strategy is one important part of SAICM
http://www.saicm.org/About/SAICMOverview/tabid/5522/language/en-US/Default.aspx

13
3.1 The role of governments
The role of governments is to make industry, i.e. producers and importers, as well as
downstream users, assume responsibility for the products they place on the market by issuing
relevant legislation and recommendations as well as carrying out enforcement of such
legislation. It is, therefore, central to develop legislation that allocates responsibilities to
producers, importers, and users for ensuring informed choices and safe handling of chemicals.
It is estimated that more than 100,000 chemicals are available on the market 13, but the number
used in significant volumes are much fewer. The number of registered substances in the
REACH system in volumes over one tonne/year was 21 551 at 31 May 2018, which was the
final date of the 10-year period for registration of phase-in substances manufactured in and
imported to the EU-market in such volumes.
Many of the substances used today have hazardous properties to a greater or a lesser degree
and they are used in many different ways. It is not possible to have detailed legislation on the
use of each and every one of these chemicals. General provisions laying responsibility on
industry are therefore necessary.
For chemicals where unacceptable risks to human health or the environment might occur
despite this general obligation, the government should be able to introduce bans, restrictions,
and other risk-reducing measures. The government should, in order to be resource efficient,
focus its regulatory work on chemicals posing the greatest risks.
Thus, the legislator should:
• Adopt a legislative framework clarifying the roles and responsibilities of government
and authorities as well as those of industry.
• Adopt detailed legislation supporting the sound management of chemicals, e.g. how to
implement GHS 14.
• Introduce bans, restrictions, and other risk reduction measures for substances posing
risks that are not adequately controlled by industry.
• Supervise and enforce the compliance of legislation.

3.2 The role of industry

All actors in the supply chain shall apply relevant risk-management activities for the
chemicals they produce, import, place on the market, and use. Hence, the main responsibilities
for managing risks with chemicals placed on the market should lie with industry, i.e.
producers and importers of chemicals, as well as with users for the risks that could emerge
from the chemicals they produce, import, or use. They are the ones who develop and/or use
the actual substance and should therefore be responsible for having the necessary knowledge.
To achieve this, it is necessary to define clear roles and responsibilities for industry, including
that industry shall always carry the responsibility for its products. Such basic requirements
(should) include:
• To gather knowledge, and if necessary generate new knowledge on chemicals’
properties, hazards, and risks.

13
The Classification and Labelling Inventory at ECHA contained at the beginning of 2018 more than 135,000
substances. These include all substances subject to registration under REACH as well as all substances placed on
the market that are classified as hazardous. https://echa.europa.eu/regulations/clp/cl-inventory
14
The Globally Harmonized System for Classification and Labelling. See chapter 4 and annex 1 for further
details.

14
 • To classify and label their chemicals in accordance with GHS 15.
• To disseminate information on hazardous properties of chemicals and on safe
handling procedures as well as to provide safety data sheets to professional
users.
• To supply additional information about the products, when necessary, in order
to enable and facilitate the best choice of products for downstream users and to
ensure their safe handling of the products.
• To take necessary actions following the classification.
• To make informed choices about chemicals in order to avoid hazards.
• To substitute hazardous chemicals for less hazardous ones or to apply an
alternative technique when possible (the substitution principle) 16 17 18.
• To organise and assure the safe use of chemicals and their storage, transport,
and appropriate disposal.
Depending on which part in the supply chain a company operates, responsibilities differ. The
main obligations fall on the primary producers, while downstream users should choose the
safest chemical for their purpose and should use the chemical in a safe way.

4. Risk reduction through general obligations on

industry
Chemicals risk management should be an integrated and natural part of the daily work within
industry, including all companies that handle chemicals. As mentioned above, it is central to
develop legislation that allocates responsibilities to producers, importers, and users. The
starting point is to ensure that information on the contents of the chemical substances and
mixtures that are placed on the market is disseminated in the supply chain by those who place
the substances and mixtures on the market. This enables all actors who receive the
information to assess risks, make informed choices, and provide for safe handling. There
could also be legal requirements on the role of industry on performing risk assessments and
on applying the risk management measures needed to control the risk.

4.1 Dissemination of information in the supply chain

A fundamental means to provide for the dissemination of information needed for informed
choices and safe handling to all actors in the supply chain is to make the requirements for
classification and labelling according to GHS mandatory. Furthermore, this system supports
the use of standardised safety data sheets, which are a valuable source of information on the
properties of chemicals and how to handle them.
The anticipated role of GHS is that knowledge on hazards and necessary precautions shall be
gathered and conveyed by the chemicals producers and importers that are the primary actors
making chemicals available for use along the supply chains. Producers of mixtures need to

15
The Globally Harmonized System for Classification and Labelling. See chapter 4 for further details.
16
ECHA Strategy to promote substitution to safer chemicals through innovation
January 2018; https://echa.europa.eu/documents/10162/13630/250118_substitution_strategy_en.pdf/bce91d57-
9dfc-2a46-4afd-5998dbb88500;
Substituting to safer chemicals (ECHA website). https://echa.europa.eu/substitution-to-safer-chemicals
17
ECHA newsletter (2015). “The American way”, September 2015, issue 4.
https://newsletter.echa.europa.eu/home/-/newsletter/entry/4_15_substitution-in-us
18
OECD Substitution and Alternatives Assessment Toolbox. http://www.oecdsaatoolbox.org/

15
classify and label their products, based on the information that they receive from their
suppliers. The information should follow the chemicals down the supply chain, see figure 3.
Obligations placed on a few upstream actors will provide many downstream actors with the
information they need to make safe choices and to handle chemicals safely.

Figure 3. Flow of information down the supply chain. The size of the block illustrates the
number of companies in a schematic way. Illustration by Maja Modén.

As an example, the EU legislation implementing GHS, the CLP Regulation 19 20, aims to
ensure that the hazardous properties of chemicals are identified and clearly communicated to
users through labelling (all users) and safety data sheets (professional users). The obligation
to classify chemicals before making them available on the market is put on producers and
importers of substances and mixtures.
The obligation for producers and importers to classify and label chemicals, as set out in
GHS, is the primary means for handling the vast majority of chemicals and their
accompanying risks. GHS gives information, via the labels and the safety data sheets, on the
properties of the chemicals and how to handle them in a safe way. GHS should thus be
considered as a cornerstone for risk reduction measures. The GHS pictograms are shown in
figure 4.

19
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
Classification, Labelling and Packaging Of Substances And Mixtures.
20
Requirements for safety data sheets are implemented through the REACH regulation.

16
Figure 4. Pictograms to be used when a substance or a mixture fulfils the criteria for
different hazards as defined in GHS.

As mentioned, GHS also includes harmonised criteria for mixtures, but the system is not
directly aimed for use with articles. Information on the occurrence of specific substances in an
article can, however, be based on the classification of the substances according to GHS, e.g.
this article might contain a substance that is a skin sensitizer. Within the framework of
SAICM, a voluntary information system for Chemicals in Products (CiP) has been
developed 21.
The CiP system is used by companies to give information to downstream users, including
final customers, on the content of specific chemicals in products and articles. An obligation
for information on the presence of chemicals in articles could primarily address substances
that are specifically important to be aware of, i.e. those with specific hazardous properties,
and when there is a need to pay specific attention to how to handle the article during the use
phase or when it becomes waste. This should be done in order not to contaminate the
environment or to create a health risk for the consumer. Such information enables
downstream users to influence the choice of chemicals and can force the producers to find
substitutes for the most hazardous chemicals. This is also important for creating a circular
economy 22 where resources can be recycled in a safe way.
The merits behind focusing the law and consequently enforcement activities at the primary
level would be:
• Relatively few producers and importers compared to retailers and users
• Producers and importers generally have a better knowledge on their respective
products (and the contents) than their clients
• Product information (label/SDS) should be produced by producers and
importers and distributed to retailers and users

21
http://www.saicm.org/EmergingPolicyIssues/Chemicalsnbsp;innbsp;Products/tabid/5473/language/en-
US/Default.aspx
22
A circular economy is an economy where the value of products, materials and resources is maintained in the
economy for as long as possible, and the generation of waste minimised. Definition from COM(2015) 614 final,
Communication From The Commission To The European Parliament, The Council, The European Economic
And Social Committee And The Committee Of The Regions -Closing the loop - An EU action plan for the
Circular Economy

17
4.1.1 Implementation of GHS
GHS can be implemented in a couple of ways. It can be included in legislation as it is and
with all details of criteria and all other technical details included or with some adaptations in
accordance with the “Building block principle” as defined in the system. In such a case it is
important to realise that the system is updated every second year and it is therefore necessary
to be able to keep the legislation up to date in a quick and uncomplicated manner. Some
countries have chosen another way to implement the system, such as through a general text in
the legislation about the obligation to apply it and in addition referring to a national standard
or the UN publication as such. This might be a better way of implementation if updating
legislation according to the national legislative process and tradition is complicated and time-
consuming and perhaps needs to be brought to the parliament for adoption.
When introducing GHS, it is not only necessary to provide an ample transitional period in
order for industry to learn how the system works and to have time to implement it, but it is
also advisable to have a later entry-into-force date for mixtures than for substances. Those
who are obliged to classify and label mixtures need to have access to the classifications of all
substances that are ingredients in the mixture in order to be able to classify the mixture. If
they purchase the components of the mixture they produce, they need to get the information
on the properties of the substances before they are able to classify their mixtures. This means
that there needs to be quite a long time between the two entry-into-force dates in order for
those who have to classify mixtures to get access to all the necessary data. As an example the
EU CLP regulation implementing GHS required that all substances were classified and
labelled according to the new system by 1 December 2010 and all mixtures by 1 June 2015. A
similar adaptation time was used in Indonesia where GHS criteria had to be used for
substances by 24 March 2010 and for mixtures by 31 December 2016.
Countries could also consider the need for a list of harmonised classifications of a number of
substances. Such a list could contain the most hazardous chemicals and/or the most
commonly used substances, if they are hazardous. Such classifications should then be
obligatory for all companies that are placing them on the market. Because hazards depend on
the intrinsic properties of a chemical and hence are always the same, official/harmonised
classifications using the GHS criteria from other countries or regions could preferably be used
as a starting point. These are normally peer-reviewed by expert groups and thus can be
considered reliable. The advantages of having such a list are that it ensures that the whole
market is using the same classification for the same substance and it facilitates small and
medium-sized enterprises giving correct information to their downstream users. International
trade is also facilitated by using the same official classification as in other countries or
regions, which is an advantage for the national exporting industry. It is of course necessary to
make sure that the list is updated regularly and kept up to date. One disadvantage with a
national list is thus that additional administrative tasks will be put upon the government and
thus draw from the normally scarce resources in the chemicals area of the country. Using
other countries’ official lists will reduce such disadvantages.

4.2 General requirements on industry to assess and reduce risks

The chemicals legislation could require producers or importers to perform risk assessments
for the substances they produce or import and to take necessary measures to ascertain that the
chemicals can be used in an acceptable way. If at some stage of the chemical’s life cycle the

18
risk assessment shows that there is a risk 23, companies could be required to apply necessary
risk-management measures to control the risk and to supply relevant safety information to
downstream users based on the assessment that has been carried out.
Furthermore, GHS provides information that is supportive and valuable for complying with
legislation that might already exist in areas such as occupational health, industrial emissions,
preventing industrial accidents, and handling hazardous waste, see figure 5. The regulation of
the transport of hazardous chemicals uses the same symbols for the same type of hazard, but
the transport sector also has the need for further pictograms and the final pictograms differ in
colour.

Figure 5. Classification and labelling of substances and mixtures provides safety information
to support other legislation areas. Illustration by Maja Modén.

Sometimes, legislation in these areas can explicitly refer to relevant GHS criteria, and if so it
needs to be regularly updated in line with the GHS amendments. Legislation can also address

23
Swedish Chemicals Agency (2020). Guidance on national chemicals control: Hazard and risk assessment of
chemicals – an introduction.www.kemi.se/en/guidance-on-national-chemicals-control

19
specific substances (see chapter 8). However, in most cases, the legislation on emissions and
the legislation concerning workers’ protection are not so detailed in relation to single
chemicals but use parameters that are more general. In any case, making use of the
information provided by GHS as far as possible is advisable because this facilitates and
supports the managing of chemicals and the fulfilment of the obligations for industry in
various pieces of legislation either on a specific or on a more general level.

5. Implementing international conventions and

agreements
During the last decades, international cooperation in restricting or banning the production and
use of the most hazardous chemicals has taken place, and for a small number of substances
that are transported across international boundaries, international conventions on how to
handle such chemicals have been developed. For countries that have signed and ratified 24
conventions, it is an obligation to implement the agreed-upon decisions in their legislation. It
has to be taken into account that even if the first, basic requirements have been implemented,
the legislation might need to be continuously updated due to progress that is made and new
decisions that are taken as part of the convention. The implementation needs to be carried out
in a manner that is coherent with the aim of the agreement, such as introducing bans or
restrictions on the production and use of a specific chemical, as well as coherent with each
country’s own constitution, legal framework, and tradition. Examples of such international
agreements are the Stockholm Convention on Persistent Organic Pollutants, the Minamata
Convention on Mercury, and the Montreal Protocol on Substances that Deplete the Ozone
Layer. For more information, see annex 1.

6. Prioritisation of chemicals for introducing risk

management measures by authorities
In addition to the obligations of implementing a convention following its ratification, it is
necessary for a country to consider the need for introducing further risk reduction measures
for other chemicals not covered by the conventions but that nevertheless pose risks to human
health or the environment on the national level.
As pointed out above, it is essential that basic legislation requires industry to take
responsibility for the chemicals they produce, import, and use in order to reduce the risks to
human health or the environment. However, in case such requirements in the legislation,
including disseminating information according to GHS (see chapter 4) and taking necessary
action as required, are not sufficient to handle specific chemicals due to the potential risks
emanating from them, it will be necessary for authorities to introduce measures towards those
substances or groups of substances. These substances might be identified through actual cases
of pollution and poisoning, but it is advisable to try to identify potentially problematic
chemicals before any harm has occurred. A systematic approach would build on the
prioritization of substances that, due to their known or assumed hazards and/or use patterns,
are likely to give rise to risks that need to be eliminated or at least reduced to an acceptable
level.

24
Ratification means signing or giving formal consent to a treaty, contract, or agreement making it formally
valid. In many countries, this requires the adoption of a legal act by the parliament.

20
Adopting a national chemicals policy pointing to the types of substances that should be
prioritised for action could support the subsequent legislative work of the government. Such a
policy contributes to transparency, clarity, and certainty for industry and thus makes it clear
what kinds of substances are likely to be banned or restricted in order to reduce risks. A
policy could be based on the classification criteria in GHS, as far as is possible, and possibly
in combination with other priority criteria and factors. This means that chemicals meeting
chosen specific criteria could be subject to, or be candidates for, certain risk-management
measures.

6.1 What substances should be prioritised?

6.1.1 Prioritisation based solely on hazard

For substances with inherent properties giving rise to very severe or irreversible effects, it can
be sufficient to base a decision for risk reduction on the hazard assessment. This could be, for
example, the case for substances that are:
• persistent, bio-accumulating, and toxic (PBT) or very persistent and very bio-
accumulating (vPvB),
• carcinogenic, mutagenic, or toxic to reproduction meeting the criteria for CMR
category 1A or 1B (especially those without a non-threshold for effects) according to
GHS, or
• giving rise to other severe and irreversible health effects.
Such an approach is in line with the SAICM objectives for risk reduction in its Overarching
Policy Strategy which states that chemicals or chemical uses that pose an unreasonable or
otherwise unmanageable risk to human health and the environment based on a science-based
risk assessment and taking into account the costs and benefits as well as the availability of
safer substitutes and their efficacy should no longer be produced or used. Examples of groups
of chemicals, mentioned by SAICM, that might be prioritised for such assessment are PBTs;
vPvBs, chemicals that are carcinogens and mutagens or that adversely affect, among other
things, the reproductive, endocrine, or nervous system; mercury; and other chemicals of
global concern.

Substances that are vPvB accumulate in the environment and are resistant to degradation. The
levels might therefore increase in biota over time however small the emissions are.
Experience has also shown that quite a few substances with such properties have later, when
more scientific data have become available, turned out to be toxic, but at such a point it is
impossible to eliminate the substance from the environment and reduce the risk associated
with it. Substances that are carcinogenic, mutagenic, or toxic to reproduction are another
group that might be prioritised only based on hazard because these have very severe effects
and it cannot be presupposed that all possible users can handle these substances safely enough
to protect themselves and others from being exposed.
As an example, the EU REACH legislation defines chemicals that have inherently very severe
and/or irreversible properties. These are chemicals meeting the criteria for CMR category 1A
or 1B according to GHS and includes chemicals that are PBTs or vPvBs 25 and those that due
to other severe and irreversible health effects give rise to an equivalent level of concern, as
substances of very high concern (SVHC). The substances identified according to these criteria

25
Defined in the REACH legislation because GHS lacks criteria for persistence and bioaccumulation

21
are published on the so-called Candidate list 26. This list contains substances that are
candidates for authorisation (substance and company specific) for use within the EU. If
authorisation is not granted for the use of a substance, its use will prohibited.
The way that the ECHA PBT Expert group explains the concerns of the PBT/vPvB substances
is: “Substances that persist for long periods of time in the environment and have a high
potential to accumulate in biota are of specific concern since their long-term effects are rarely
predictable. After entering the environment once, the exposure to these substances is very
difficult to reverse by the cessation of emission. Protection of pristine remote areas from
PBT/vPvB substances is particularly difficult as these substances do not degrade near
emission sources but may be gradually transported into remote areas. For PBT/vPvB
substances a "safe" concentration in the environment cannot be established using the methods
currently available. A particular concern with vPvB substances is that even if no adverse
effects can be demonstrated in laboratory testing, long-term effects might be possible since
high but unpredictable levels may be reached in humans or the environment over extended
time periods” 27.

6.1.2 Prioritisation based on potential risk

Even if a general obligation is put on industry to act upon its own risk assessments, there are
cases where the authorities need to prioritise substances that are assessed by industry for
possible further action. This is, for example, necessary if there are a great number of
producers and importers and/or users because it is not reasonable for a single company to
assess and consider the total exposure from all different sources. In some instances, it might
also be necessary to consider restricting a group of substances when the structures of the
different substances in the group are very similar to each other and one can expect that the
mode of action and the end-point for effects will be the same. As in the previous case, such
consideration needs to be taken by the authorities because the substances might be produced
and imported by many different companies.
For other chemicals than those covered by 6.1.1, and when considering the need for
restricting or banning the use of a chemical, a risk assessment should normally be carried out.
When performing a risk assessment, it is necessary to have information both on the hazard of
the substance (the inherent properties) and the potential exposure to the substance in the
country because risk is a function of hazard and exposure. These parameters therefore also
form the basis for the prioritisation.
In some cases, a country might have national experience that a substance has given rise to, or
is suspected to give rise to, adverse effects in humans or pollution of the environment. In other
cases, data on the occurrence of the substance in the country are well known and give rise to
concern due to the chemical’s inherent properties.
In all these cases, the following information should be taken into account when setting the
priorities:
• Degree of severe inherent properties
• Exposure
• Volume of the substance produced and/or used, including import as a
proxy for potential exposure, and/or

26
See ECHA website: https://echa.europa.eu/candidate-list-table
27
https://echa.europa.eu/pbt-expert-group

22
 • Use pattern (e.g. whether the product is likely to be used by a vulnerable
part of the population such as children, pregnant women, illiterate persons,
etc.), and/or
• Wide-spread and/or well-known exposure from, for example, monitoring
studies or surveillance projects (this includes if there is a large number of
producers and/or users or if the chemical is available to the general public)
The exposure parameter needs to be based on available data, and the simplest method is to
base it on the volume of the substance on the market. If more refined data exist, this
information should be added or used instead. Not having detailed exposure data should not
prevent authorities from making an estimate of the likelihood that the occurrence of the
substance on the market might entail risks to the environment or human health.
Prioritisation is normally a stepwise procedure. A broader group of substance might be
prioritised based on basic information. For these, more refined data are searched for, and
when more detailed data become available the prioritisation is gradually improved to finally
target the substances with the greatest potential risks.

6.2 Sources of information supporting prioritisation.

When analysing the need for restricting chemicals, much support for the selection of
substances can be drawn from actions taken and priorities set in other countries. Thus
experiences from other countries’ work and decisions in the area of restricting the production
and use of specific chemicals can serve as a gateway or a reason for authorities in the country
to look into the need to take action in the national arena. Taking advantage as far as possible,
not only of other countries’ prioritisations, but also assessments of chemicals prioritised for
action, is valuable and resource saving. Not only is information on the risk reduction
measures in force, and the background to them, made available on websites etc. by countries
or organisations, but there is also information on priorities, considerations, and proposals for
further measures linked to specific substances. Such information will be useful for countries
that need to decide how to proceed in reducing the risks from different substances.
The assessment of the inherent properties of a specific substance (hazard assessment) does not
need to be repeated because these properties are always the same. There might, however, be a
need to assess the national exposure to the substance because this influences the extent of the
risk to be considered. If, after investigation into the occurrence, there is no indication that the
substance is produced or imported or used in any kind of product in the country, the need for
prioritising it for action for the time being is small (even if other countries have seen problems
with it), especially if resources are limited.
An important step in getting information on substances regulated in other countries is to use
information from the Rotterdam Convention. Annex III to the convention lists substances,
including pesticides and industrial chemicals that are banned or severely restricted in at least
two of the five UN regions. For all substances listed in Annex III, a Decision Guidance
Document is available that contains valuable background information on the substance and its
properties. Information on further national restrictions can be found through information 28
sent to the Rotterdam Convention Secretariat because parties to the convention have an
obligation to inform the secretariat about their national or regional bans and severe
restrictions on chemicals that are not (yet) covered by any international conventions or
agreements even though they have the potential to create problems in the national arena.

28
http://www.pic.int/Implementation/PICCircular/tabid/1168/language/en-US/Default.aspx; see annex V.

23
Some background information is also available for these substances. Such notifications give
the importing country and others valuable information about the occurrence and use of a
substance as well as the decisions of other countries to ban and restrict the substance, and it
gives them an opportunity to consider the need to introduce similar measures in their country.
Another source of information is of course the GHS classifications. Examples of substances to
look into could be CMR substances or substances with other serious hazardous properties,
even if they are not part of annex III to the Rotterdam Convention.
It is often a long process before a country introduces a restriction on the use of a substance
that poses risks to the environment or human health. Many countries publish preparatory work
and candidates for risk reduction on their websites, and such information can also be of value
for other countries. Such information quite often not only contains lists of substances, but also
valuable background information on why a substance is a candidate for risk reduction. One
example of such information is the REACH Candidate list 29 of substances that might be
subject to authorisation within the EU. On the ECHA website, information on substances
being discussed for harmonised classification and labelling and bans is also accessible for
countries outside the EU. The US EPA website 30 also publishes information on the
assessments of substances that are of concern.
Information on volumes and use areas of a candidate for restriction can be obtained from the
chemicals register, if available in the country, or by other means, e.g. surveys or
questionnaires. Guidance on how to get an overview of use areas for different chemicals is
described in the guidance on Access to information on primary suppliers and chemicals on the
market 31.
Finally, it is necessary for the government to weigh all of the above-mentioned information in
relation to each other before a decision is taken as to whether the chemical is to be prioritised
for further action or not. How much weight each factor should be given needs to be decided
nationally.

7. The role of the authority’s risk assessment

Having legal structures where inherent properties giving rise to very severe or irreversible
effects is enough for decisions on restrictions and bans enables countries to base a decision
for risk reduction on hazard assessments 32. This could be the case for substances that are
PBTs or vPvBs, as well as chemicals that are carcinogenic, mutagenic, or toxic to
reproduction or that have other severe and irreversible health effects.
For other chemicals, a risk assessment should normally be carried out when considering the
need for restricting or banning the use of a chemical. When performing a risk assessment, it is
necessary to have information both on the hazard of the substance (the inherent properties)
and the potential exposure to the substance in the country because risk is a function of hazard
and exposure. Unless the chemical undergoing risk assessment is uniquely produced in the
country, risk assessments from other countries could be used to a large extent. Normally, the
first step when carrying out a risk assessment of a substance is to assess the inherent

29
ECHA website https://echa.europa.eu/candidate-list-table
30
https://www.epa.gov/assessing-and-managing-chemicals-under-tsca
31
Swedish Chemicals Agency (2019). Guidance on national chemicals control: Access to information on
primary suppliers and chemicals on the market.
32
Swedish Chemicals Agency (2020). Guidance on national chemicals control: Hazard and risk assessment of
chemicals – an introduction.

24
properties of the substance – to make the hazard assessment. The inherent properties of any
substance are always the same and hence all such available hazard data and assessments from
other countries, organisations, and science should be used as the basis for the risk assessment.
The exposure of the environment and the population to a substance might, however, vary
from country to country. In some cases, especially when it concerns hazardous chemicals
entering the country as a constituent in a product that is also used in other countries, it might
be relevant to use full risk assessments that are internationally available in order to save
resources and time. On the other hand, if it is clear that the use pattern or the volume of the
substance differs significantly from these parameters in a country where a risk assessment has
already been made, it might be necessary to undertake a national risk assessment taking into
account the exposure in the country 33.
Precaution should be applied in risk management when there are threats of serious or
irreversible damage to human health or the environment. In this situation, the lack of full
scientific certainty should not be used as a reason for postponing cost-effective measures to
prevent damage.

The Precautionary principle

Rio Declaration 1992

Principle 15

“Where there are threats of serious or irreversible damage, lack of full

scientific certainty shall not be used as a reason for postponing cost-
effective measures to prevent environmental degradation.”

8. Risk reduction instruments

When the result of a risk assessment shows that measures already taken by industry are not
enough to reduce the risk and there is a need to further reduce the exposure to a chemical in
the environment and in humans, it is necessary for the government and/or its authorities to
introduce one or more risk reduction measures. There are a number of different instruments
that can be used. When the hazard is high, as mentioned above, measures might be taken
without doing a full risk assessment. In such cases, the preferred risk reduction measure many
times can be a total ban. A total ban might, for example, be relevant for substances that are
very persistent and very bioaccumulating, vPvBs, or substances that are carcinogenic,
mutagenic, or toxic to reproduction, CMRs, especially in products intended for use by the
general public.
When considering how to most effectively reduce the exposure and hence the risk of a
chemical, it is necessary to look into where the highest exposure occurs and what is giving
rise to this exposure. Issues to consider are if the sources are emissions from production
facilities or if emissions as well, or even primarily, are occurring during the use and waste
stages in the chemical’s life cycle. Further, based on this, it is important to assess if there are
only a few sources or many. Such considerations indicate whether there is a need to take

33
Swedish Chemicals Agency (2020). Guidance on national chemicals control: Hazard and risk assessment of
chemicals – an introduction. www.kemi.se/en/guidance-on-national-chemicals-control

25
measures on the placing the chemical on the market or if it is more efficient to reduce risk by
placing demands on, for example, emission reduction from a specific facility.
If the exposure to the environment and/or humans emanates from a point source, the most
efficient way to reduce the risk might thus be to take action at the point source. This means
that safer handling of the chemical in the production line or the elimination of releases into
the air and water at production plants could be an efficient and economical way to reduce the
risk. The same approach can be applied to reduce occupational health risks by introducing
emission restrictions in the workplace. Detailed guidance on how to apply risk reduction
instruments to eliminate or reduce point sources is, for example, available through EU 34,
OECD 35, and other organisations and includes how to use Best Available Techniques (BAT)
and Best Environmental Practices (BEP). This might be sufficient, especially if the chemical
is used by a very limited number of companies and is only intended for industrial use and is
not present in the products they produce. Examples of such chemicals could be intermediates
or chemicals used to support production, such as lubricants or cleaning agents. These areas
are not further covered in this paper where the focus is on reducing the use of the substance as
such, in mixtures, or in other types of articles in production and import where the use is more
widespread.
Because there is a very large number of chemicals on the market, many of which have
hazardous properties to a greater or a lesser degree and which are used in many different
ways, it is necessary to be able to choose from a palette of alternative risk reduction measures
in order to apply the most suitable or relevant risk reduction instrument for a specific
chemical or a specific use of a chemical. Measures for restricting the production and use can
entail a total phase-out or reduction of specific uses of the substances and can be legally
binding or voluntarily applied by industry, downstream users, and retailers in order to reduce
risks from the chemical.
In this chapter, different risk reduction instruments leading to changes in production and use
of substances that pose risks will be described. Some of these instruments have to be clearly
spelled out in the legislation in the country, while others are more of a voluntary nature. Their
advantages and disadvantages will be discussed.

8.1 Choice of instruments

When considering the introduction of any kind of risk reduction measures for a chemical, it is
advisable to work in a structured way and to start by identifying the problem. Examples of
questions that then need to be answered include:

WHAT risk reduction is to be achieved?

WHO needs to take action in order to reduce the risk?
HOW might the risk be managed?
WHEN should a specific instrument be used in relation to the use of other instruments?

The process starts with prioritisation followed by hazard and/or risk assessment for selected
chemicals (see chapters 6 and 7).
The next step in the process should be to identify the most appropriate risk reduction
instruments. In this process, industry, downstream users, and other stakeholders should be

34
See e.g. EU reference documents on BAT and BEP; https://eippcb.jrc.ec.europa.eu/reference/
35
See OECD on BAT etc. http://www.oecd.org/chemicalsafety/risk-management/best-available-techniques.htm

26
invited to contribute. The latter group might be other authorities or different non-
governmental organisations (NGOs), including environmental and consumer representatives.
Downstream users play an important role because they can have other perspectives than the
producers/importers when it comes to introducing safer alternatives. The waste sector is
another important stakeholder because waste containing hazardous substances has to be
treated in a special way. Reducing the use of hazardous substances makes it easier to handle
waste in an adequate way. It is essential to have good contacts with relevant industry groups
in order to increase their understanding for the need to introduce risk reduction measures and
to get a broad picture as a basis for assessing the most effective instrument to achieve the aim
of the measures.
Factors to take into account for the choice of the most appropriate risk reduction instrument
are:
• Degree of hazard and risk
• Efficiency
• Sustainability over time
• Costs and benefits for different actors, socioeconomic consequences
• Administrative burden
To achieve the expected result, i.e. that the risk to human health and the environment from the
chemical is eliminated or reduced, there is a need for comparing different instruments with
each other. The introduction of an administrative (legal) measure such as a total ban or a
restriction for certain uses is one option. Another way forward is to investigate whether
economic policy instruments such as taxes or fees alone or in combination with other
instruments would serve the purpose to reduce the risk. Still another way forward would be to
assess whether an informative instrument, such as dialogues between authorities and industry,
might be sufficient to reduce the risks to the required extent.

8.1.1 Socio-economic considerations

In the process of choosing policy instruments to reduce the risk from the production, import,
and use of a chemical, it is helpful to carry out an assessment of the socio-economic impacts
of different options. Such an assessment is facilitated by having good contacts with different
stakeholders, including relevant industries, in order for them to be able to investigate the
effects on their industry sector and to inform the authorities. Information can also be gathered
from other sources and actors. Furthermore, information on actual consequences in other
countries could be used.
Such an analysis for different options facilitates choosing the instrument that is most cost-
effective, that is, is connected with the lowest costs for different actors (including the
government) but at the same time reduces the risk to a sufficient extent. Even though the cost
for one type of industry might be a disadvantage, it should not prevent the introduction of the
measures if considered relevant and important for the protection of human health and the
environment. It should also be taken into account that introducing a risk reduction instrument
can be a disadvantage for one company and at the same time an advantage for another
company (e.g. a company that provides alternative solutions). These aspects should be taken
into account when considering the most relevant choice of instrument, and if all other
requirements for an efficient instrument are fulfilled, then the one with the most advantages
for society as a whole should be chosen.

27
Methods for carrying out quite extensive impact assessments have been collected by the
OECD 36. These methods are aimed at all different levels of regulation and are thus quite
complicated in nature.

8.2 Administrative instruments

8.2.1 Classification and labelling and safety data sheets

As mentioned before, a cornerstone for risk management measures is to make GHS
mandatory for all substances and mixtures. Because this is fundamental in placing general
obligations on industry, this instrument has already been dealt with in chapter 4.

8.2.2 Control of access to particularly hazardous chemicals and to chemicals

posing uncontrolled risks
Certain substances can be considered too hazardous or give rise to too great of a risk to be
freely and openly available to use. There are some different instruments to control access to
such substances, all of which are aiming at more or less far-reaching limitations on the
production, placing on the market, or use of the substance as such, in mixtures, or in articles.

8.2.2.1 Bans and restrictions

Banning the production/import and use of a chemical or restricting its use in certain
applications can be introduced at all stages of the chemical’s lifecycle. The most far-reaching
measure is of course to ban all production, import, and use of a substance, including in
mixtures and articles. This type of ban is relevant to introduce when the hazard or the risk
from the substance is high and especially if there are a number of sources giving rise to the
risk. The efficiency and sustainability of this type of ban is normally good as long as the
legislation is enforced.
When banning or restricting the use of a chemical nationally, it has to be remembered to
include the same measure for import of the substance as such, in mixtures, and in articles. The
import could otherwise reduce the efficiency of the measure and give rise to continued health
and environmental problems caused by the chemical. It would also create uneven conditions
for producers and importers.
Substances with inherent properties giving rise to very severe or irreversible effects could be
banned based on the hazard assessment of their inherent properties, as mentioned in section
6.1. This could be done for specific substances. Another risk reduction measure can be to
introduce more general restrictions on the use of substances based on the classification of the
substance meeting specific GHS criteria, e.g. CMR substances, because it could not be
considered acceptable to expose the general public or the environment to these kinds of
substances. Such restrictions can be introduced for products that are intended for consumer
use such as paints and household chemicals. Inherent properties such as persistence and
bioaccumulation can also be a reason for introducing a general ban on substances having such
serious properties.
Further, in cases where risk assessments have been carried out and these have shown that risk
reduction is necessary, different levels of bans and restrictions can be introduced. In some
cases a total ban is necessary. In other cases it might be sufficient to ban the use of the
chemical in specific areas where the use gives rise to, for example, pollution of the
36
http://www.oecd.org/gov/regulatory-policy/ria.htm

28
environment but the chemical can still be used in other applications without causing an
unacceptable risk. There might also be a need to allow a specific use of a substance that is
essential to society and for which there are no alternatives yet. This can be done by
introducing exemptions that can vary in their extent. Introducing this possibility can, in
certain cases, create a greater acceptance of the ban. Examples of how to partly ban a
substance are:
1. The ban covers only specific uses of the chemical, which means that all other uses
are permitted.
2. A ban with general exemptions for specific areas that are specified in the
legislation.
3. A ban with a possibility to issue exemptions on a case-by-case basis, following
applications from industry, for a specific use that fulfils criteria specified in the
legislation.
The first case, from the points above, is useful if the risk is reduced to an acceptable extent
with a ban for a specific use or uses. In the second and third case, the aim is eventually to
achieve a phase-out of the substance, but some specific uses are essential for society and no
substitutes are available yet. These types of bans give already from their introduction a clear
signal that the goal is to eliminate the use of the substance. Criteria for the third case need to
be specified in the legislation. Such criteria could be that the use is of critical importance for
society as a whole or an important subset of it and there is no possibility – for different
reasons and for the time being – to substitute the substance with a less hazardous alternative.
Such exemptions can be time-limited and can be combined with an obligation to investigate,
within a certain time frame, alternatives to the substance in question. This type of system can,
however, be quite resource demanding and can create a heavy administrative burden on the
part of the government that is granting exemptions for use. This type of exemption is in its
construction similar to authorisations or a premarket approval system of the use, which in a
way also allows the use on a case-by-case basis.
In some countries, additional legislation for specific products, e.g. for toys and cosmetics,
have been introduced in addition to the general chemicals legislation. Such legislation might
cover several different aspects of the product, not only in relation to its chemical content but,
as in the toy example, the size of toy’s parts to avoid choking in small children. In relation to
chemicals, product legislation often uses the GHS criteria as a basis for banning or restricting
the use of substances. The EU legislation on toys and cosmetics, for example, includes a ban
on the use of substances meeting the GHS criteria for CMR classification categories 1A and
1B and in some cases also those meeting the criteria for category 2. .
The advantages of introducing a ban that reduces or even eliminates the risk to environment
and health is that it is clear and equal to all actors in the supply chain and is easy to
communicate, it is normally sustainable, and it does not require high administrative costs to
maintain, other than for its enforcement. A disadvantage is that it might need quite a long time
before being fully effective.
If a partial ban is enough for achieving the needed reduction in exposure to eliminate the risk,
it is an advantage to design such a limited ban because the cost to industry as a whole will be
smaller. On the other hand, with a partial ban new areas of use that are not specifically
mentioned in the ban might be introduced. Therefore, it is necessary to regularly monitor the
use of the substance in order to be able to assess the effects of new use areas and take action
against them if needed.

29
A system that allows for exemptions is more administratively resource demanding than the
others and might need even more resources for effective enforcement.
Generally, there is also a need to consider what kind of action will be taken by industry when
a substance is banned or severely restricted. There could be a risk that the substance will be
replaced by a substance with similar properties such as a related salt of a metal belonging to
the same group of substances. In such cases, it might be advisable to consider the need to
introduce the same ban or restriction for the whole group of substances in order to avoid the
use of a substitute that does not give any advantages from a health or environmental
perspective.

8.2.2.2 Authorisation or premarket approval systems

A premarket approval system is not common for chemicals in general (industrial and
consumer chemicals) but can be used in certain cases. On the other hand, such a system is
generally used for specific chemicals such as pesticides, food additives, and pharmaceuticals.
This type of system might also be useful for some hazardous industrial and consumer
chemicals for which the use should be limited to the greatest possible extent, for example, the
authorisation system for substances of very high concern (SVHC) in the EU REACH
legislation. 37 The ultimate aim is, however, that all such substances shall eventually be
substituted. The reason for introducing such a system is that the use of the substances in these
groups needs to be restricted because of the risks related to them, sometimes in combination
with very widespread use. In such a system, industry has to prove that there is a need for these
substances and that they can be used in a safe way. Each use of a substance needs a specific
authorisation, which is normally time-limited. This could also be a way to encourage
companies to substitute such hazardous substances with less hazardous ones. At the same
time, the system is complicated and resource demanding both for the authorities and industry.
Hence, such a system can only be recommended for a very limited number of substances
meeting very specific criteria. Such criteria could identify substances that either have very
severe hazardous properties or could cause long-term problems if spread in society or the
environment.
An advantage of an authorisation system is that a high level of safety and risk reduction can
be achieved. It gives clear signals to industry on which substances that preferably should be
avoided. On the other hand, it is very resource demanding. To be efficient and sustainable, it
requires a long time engagement by personnel who are quite competent in relevant areas.

8.2.2.3 Transparent processes and enforcement requirements

When drafting new legislation it is essential to ensure that requirements are fully
understandable for trade and industry. The duties of affected companies must be made clear,
so that both the regulated companies and the government can readily identify what constitutes
compliance. It is best when the regulated companies not only understand what the
requirements are and how to comply with them, but also the reasons for the requirements.
Knowing the reason for requirements can help develop both the capacity and the willingness
to comply.

37
The REACH Legislation: Regulation (EC) No 1907/2006 of the European Parliament and of the Council on
the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH): Title VII Authorisation

30
A clear process for the development of new legislation including e.g. possibilities for
companies to engage in the process and relevant transition periods prior to entry into force
makes it easier for companies to comply with the legislation.
Requirements can also be phased in over a period of time, with some simpler or more critical
rules becoming effective earlier than others. The more industry and government can engage in
a dialogue when new requirements are being worked out, the better compliance can be
expected once the regulations enter into force.

Legislation Transition Entry into Enforce-

Remittance Adoption
proposal period force ment

Figure 6. General scheme presenting the legislative process

All administrative (legal) instruments need to be accompanied by efficient and effective

enforcement and sanctions if the legal requirements are not fulfilled. The goal with
enforcement is to ensure compliance with legislation. Without enforcement, even the strictest
bans are of little or no value thus .enforcement is a prerequisite for efficiency and
effectiveness. Therefore, enforcement is one of the most important instruments to actually
reduce risks from hazardous substances because

No enforcement = No law

Any country introducing new legal requirements in different areas will need to consider how
this law shall be controlled. Provisions for an inspection system should therefore be
established in legislation and effectively implemented.

8.3 Economic policy instruments

In addition to common administrative instruments, economic policy instruments or incentives
can complement these in a number of areas. The instruments could consist of taxes and fees
as well as different forms of subsidies.
An economic policy instrument could be taxes or fees that have to be paid for the use of a
specific substance that is considered to create health or environmental problems. The
application of taxes and fees as economic policy instruments must be based on legislation in
the same way as administrative risk reduction instruments. They also need the same basis for
decisions, such as hazard and/or risk assessments and socio-economic considerations. In
addition, they require a system for collection of the taxes and/or fees as well as a system for
control and enforcement.
An economic policy instrument could also be designed to cover a broader group of chemicals
according to well-defined criteria. Such an economic policy instrument could be differentiated
with respect to the toxic or hazardous properties of the substances in the group. Differentiated
fees based on different properties could create incentives to seek out less harmful alternatives.
It is normally not useful to introduce economic policy instruments if the area is already well
regulated, in which case an economic policy instrument would have little effect, and not if the
undesirable chemical is highly hazardous to health or the environment. It should not be

31
possible to pay for the right to spread a substance that is highly hazardous. In addition, an
economic policy instrument is not suitable if the undesirable substance occurs sporadically.
However, economic policy instruments might usefully complement other instruments in a
number of cases, e.g. for moderately hazardous substances where there is a need for a
reduction in the use, but not a total phase-out, and the government wants to use market forces
to find the areas where the reduction could be made with the lowest cost. When there are good
opportunities to increase the market share of alternatives that are better from the point of view
of health and/or the environment, economic policy instruments are also a suitable
complement. Environmental economic instruments consequently drive substitution and
innovation and favour environmentally sound alternatives, with the result that these reach the
market more quickly and/or increase their market shares to a greater extent than if such
instruments were not used.
A drawback of economic policy instruments is that the administrative burden increases, and
hence the costs, due to the additional administration of such instruments, both for the
authorities and for industry. It is necessary that a system for collection of taxes or fees is
available in the country, otherwise it will be very difficult to ensure the efficiency of the
instrument. This means that it is important to assess the accompanying administrative costs
before an economic policy instrument is introduced. It is also important to ensure that
compliance can be monitored and that enforcement is possible.

8.4 Informative instruments (and general information)

An informative instrument as a risk reduction measure is less compulsory than other types of
risk reduction measures and aims to achieve a voluntary reduction of the use of a specific
substance or group of substances. Informative instruments can be used as stand-alone
measures if the risk from a specific substance or group of substances is comparably low but
still needs to be reduced. Benefits for society could still be gained and the costs to industry
would not be too high because ample time could be taken for reducing the use of the
substance in question thus making it possible to find or develop suitable alternatives. A
drawback with informative instruments is that the outcome is less certain than with
administrative measures. For the risk reduction to be sustainable, it is also necessary to make
sure that the activities are followed-up continuously over a longer period of time. If not
followed up, or complemented by introducing an administrative instrument at a later stage,
the effects of these kinds of instruments might not be very sustainable.
An informative instrument can be appropriate:
• to encourage the reduction of use and the substitution of a substance or a group
of substances with unwanted properties causing a moderate risk to human
health and/or the environment.
• to speed up the elimination of a specific substance or a group of substances
before a ban or a restriction is adopted and/or enters into force.
• to inform industry at an early stage on substances that might need measures
due to the emerging weight of the evidence.
Informative instruments are, however, not suitable as stand-alone measures when there is a
severe risk or when target groups are difficult to reach.
When planning to develop and publish information about chemicals, it is important to
carefully consider what the aim of the information is and with this is mind to define the target

32
audience for the specific information. Information developed by the authorities for the
different target groups, including professionals, producers, downstream users, and the general
public, needs to be developed with the specific target group in mind because their needs will
differ to a great extent.
As a basis for informative instruments, there needs to be a general awareness of the hazards
that chemicals can pose. This also facilitates the introduction of other instruments. Therefore,
general awareness will briefly be dealt with in this chapter.
Information on administrative and economic instruments is often needed. However, this is a
measure to support the implementation of these instruments, and such information is not an
instrument in itself. Many authorities have, for example, developed websites with information
on existing legislation that is relevant for a company that is producing, importing, or using
chemicals. They might also provide information through helpdesks, seminars, and printed
material. This kind of information on the existence of other instruments will not be covered
further in this chapter.

8.4.1 Broad awareness raising

The authorities can support broad awareness-raising in general about chemicals and their
effects and how to handle them, for example, in school curricula and through general
information material, websites, etc. Broad awareness raising serves as a platform for all other
risk reduction instruments because general knowledge about chemicals and their potential
effects is necessary to achieve the intended effects of the instruments.
Many countries and organisations have developed websites and/or printed information
material to inform the public in general about chemicals and their risks. When needed,
information material, including press releases, is issued for specific issues of concern.
In figure 7 a few examples of information material and campaigns that are available on
different websites are shown.
To a certain extent, non-governmental organisations can also play an important role in
addition to the authorities in meeting these demands from consumers. In order to ensure that
coming generations of adults have a good knowledge of sustainable safe handling of
chemicals, education programmes can be developed to be included in the school curricula,
which would make a long-term contribution to sustainable consumption.
Well-informed consumers can put pressure on national as well as local politicians to issue
legislation with the aim of reducing the use of hazardous chemicals and reaching a less toxic
everyday environment.

33
Figure 7. Clockwise: Hanna’s house, information for teaching schoolchildren about
hazardous chemicals 38. Chemicals in Children's Everyday Lives, practical tips to all who care
for children 39. The European Chemicals Agency not only has information aimed at industry,
but also at consumers 40 to inform them about the use of chemicals and their possible risks, the
Keep Sweden Tidy Foundation is another example of how to work with schools 41. See also
further examples at Chemicals in the everyday environment 42 .

38
http://english.hannashus.dk/
39
https://www.kemi.se/global/broschyrer/chemicals-in-childrens-everyday-lives.pdf
40
https://echa.europa.eu/chemicals-in-our-life
41
https://hsr.se/keep-sweden-tidy-foundation
42
https://www.kemi.se/en/chemicals-in-our-everyday-lives

34
8.4.2 Information from authorities aimed at solving a specific problem

8.4.2.1 Steering the marketing of the products

8.4.2.1.1 Dialogues with industry

An important objective of dialogues between authorities and industry is to increase awareness
and knowledge about the risks of using hazardous substances as such, in mixtures, or in
articles and to encourage continuous substitution of hazardous chemicals with less hazardous
alternatives whenever possible. Further, the dialogues can be used to speed up the phase-out
of especially hazardous substances. Dialogues between the authorities and industry is long-
term work. Initially, contact needs to be to established and trust needs to be built, and it is
important to allow all actors to exchange views on difficulties and possibilities. Dialogues
also give the participating authorities a better understanding of the conditions faced by
different industries. A good dialogue hopefully gives rise to continued work within industry
towards reducing risks from the use of hazardous substances without the involvement of
authorities on any detailed level in the future.
A practical approach in carrying out dialogues might be to concentrate on a specific group of
articles, such as toys, textiles, or electronics, because they might contain a number of
chemicals that need to be reduced, and to carry out the dialogues with the sectors of industry
that are producers and importers of these type of products. It is also useful to involve the
sector-specific organisations in such dialogues because they can help reach a broader group of
companies. An important goal of the dialogues should be to increase the company’s
awareness and knowledge about the specific risks from the chemicals in these groups of
articles.
Many years can pass from identification of a chemical’s risk to health and the environment
until changes are made in legislation and these changes have entered into force. Industry-
sector dialogues can be useful to speed up the elimination of a specific substance or group of
substances before a ban or a restriction is adopted and/or enters into force. Dialogues with
prioritised industry sectors can also be very useful for reducing the use of a specific substance
or group of substances with unwanted properties causing a moderate risk to human health
and/or the environment.
A basic requirement in the legislation should be that companies are responsible for ensuring
that their products do not harm people or the environment, and one can argue that even
though the legislation does not contain detailed rules for all substances or has not yet entered
into force for a specific substance, it is an obligation for industry to avoid using hazardous
substances when better alternatives are available.
In many cases, it is possible to see faster results with these kinds of informative instruments
than with a ban or a restriction. However, one disadvantage might be that the results of such
dialogues do not last over time. This should not discourage the government or other
authorities from carrying out such activities, especially if they are combined with other more
long-lasting measures such as introducing a legally based restriction at a later stage.
8.4.2.1.2 Voluntary commitment
In some cases, discussions and dialogues with industry might result in a voluntary
commitment from industry to substitute a hazardous substance with a less hazardous
alternative substance or an alternative technique. This needs to be followed up in order to
verify that such actions are actually taken.

35
It is not recommended that the authorities commit to doing something in return in response to
the industry’s commitment (i.e. to enter into a mutual agreement). This is legally complicated,
and in some countries it is not even legally possible for authorities to sign a commitment as a
response to an industrial commitment.
8.4.2.1.3 Tools for substitution
Authorities can support choices of chemicals by providing information on which chemicals
might have unwanted properties and could become candidates for substitution. An example of
a website with a support tool for industry actors to go beyond the detailed legislation when
choosing chemicals is the Swedish Chemicals Agency’s web-based tool PRIO that can help
such actors in reducing the health and environmental risks from chemical substances 43.
The aim of PRIO is to help industry in the assessment of health and environmental risks from
chemical substances so that people who work as environmental managers, purchasers, and
product developers can identify the need for risk reduction. In order to achieve this goal,
PRIO provides a guide for decision-making that can help in setting risk reduction priorities.

8.4.2.2 Steering consumption

Steering consumption towards reduced use of a specific substance, group of substances, or
products when a specific problem has been identified can be achieved through some tools that
are presented in this section.
8.4.2.2.1 Public procurement
One example of an instrument that can provide great opportunities is chemical requirements
in public procurement. Public tenders can be an important instrument in reducing the risks in
hospitals, schools, and other public places. Municipalities and others who put out calls for
tenders should be able to set well-founded requirements in relation to chemicals in their
tenders. To support them in this, the central authorities can provide criteria and guidance.
Such criteria could, for example, contain requirements that substances or mixtures meeting
specific GHS criteria cannot be used for the purpose that the tender covers. One way to reduce
risks from hazardous substances that can be used in public procurement is to ask for eco-
labelled articles and services, or products with equivalent documentation. Demands in tenders
for public procurements might also contribute to the production of less hazardous products in
other parts of the market. The possibility to set these kinds of requirements might vary
depending on the legislation in each country. For example, since 2014 it has been possible for
EU authorities to set specific environment-related criteria in public procurement according to
the EU Procurement Directive 44.
8.4.2.2.2 Targeted information for a specific problem
Information pamphlets, websites, press releases, and other similar material can be used as a
steering instrument when there is a wish to reduce risks from a specific substance or a group
of substances. Doing this can contribute to a reduction in the use of the substance as it can
affect the demand from downstream users as well as the general public. Being aware of a
problem might trigger questions on the availability of alternatives and the avoidance of
buying products containing specific substances. In such a way, this might trigger substitution
as well.

43
https://www.kemi.se/prioguiden/english/start
44
http://ec.europa.eu/growth/single-market/public-procurement_en

36
As for producers and importers of chemicals, authorities can support choices of chemicals by
giving information to downstream users on which types of chemicals have unwanted
properties and should be candidates for substitution. It is valuable to inform downstream users
of the need or the desirability to substitute a specific type of substance for one that is less
hazardous because they many times can choose between different alternatives and can put
pressure on their suppliers to provide alternatives.
Information directly to the consumers on substances as such or when used in mixtures and
articles aimed for the general public can lead to well-informed, strong consumer groups that
refuse to buy products that contain specific hazardous chemicals. Their behaviour will put
pressure on downstream users and through them also the importers and producers to substitute
such chemicals with less hazardous ones. Specific, targeted information from authorities on a
specific problem aimed at private consumers is an informative steering instrument where the
expected result is a substitution of the targeted substance.
The aim could also be to inform about the chemicals’ effects and properties and how to use
and handle them. Consumers in many countries are increasingly asking for information and
support to enable them to make safe choices, for example, with regard to hazardous
substances in products and articles.
On a general level, authorities play an important role in giving correct and un-biased
information to the general public and public organisations on chemicals in the everyday
environment so that they can make informed choices and can handle chemicals, especially
hazardous chemicals and chemical-containing articles, in a safe manner. This also includes
how to deal with chemical-containing waste. However, more detailed information on how to
handle a specific chemical needs to be supplied by the producer or the one placing the
chemical or the article containing the chemical on the market through correct labelling and
safety information.

8.4.2.2.3 Ecolabelling
Ecolabelling has become a useful tool for governments in encouraging sound environmental
practices and for businesses in identifying and establishing domestic and sometimes
international markets for their environmentally preferable products. Commitment to clear
objectives has been critical to the success of ecolabelling programmes around the world. The
systems are voluntary third party programmes based on multiple criteria that award a license
that authorises the use of ecolabels on products. These labels indicate overall environmental
preferability within a specific product category for which specific criteria based on lifecycle
considerations have been developed. In relation to chemicals, strict requirements for their use
should, when relevant, be set that go beyond the legal requirements. The requirements for
ecolabels need to be clear, unambiguous, and objectively verifiable in order to ensure
transparency and fair competition in the procurement processes for the benefit of the
suppliers. For examples, see the EU Ecolabel programme, the German Blue Angel and the
Nordic Swan ecolabel 45.

9. Decision making
There are a number of different decision that need to be made in the process of introducing
instruments in order to eliminate or reduce the risk from hazardous chemical substances. The

45
http://ec.europa.eu/environment/ecolabel/the-ecolabel-scheme.html and https://www.blauer-engel.de/en,
http://www.nordic-ecolabel.org/the-nordic-swan-ecolabel/

37
legislation has to be clear, explicit, and consistent in terms of at what level and by whom a
decision can be taken, and it must give clear mandates to those. Decisions usually have to be
taken in several steps, and for each of them the appropriate level needs to be defined.
Examples of such decisions are the following:
• Decision on the general policy for the risk management of chemicals
• Decision on basic legislation, including defined roles and responsibilities
and mandatory requirements for using GHS
• Decision on choice of chemicals for hazard and/or risk assessment, based
on prioritization
• Decision on whether or not to continue with the development of proposals
for risk reduction based on the hazard/risk assessment
• Decision on risk reduction measures
In some countries there might be one authority that is delegated to prepare and propose
measures, while the final decision is taken at a more senior level, i.e. at the ministerial level or
even by the legislative body, which can be the parliament. A proposal for measures to be
taken could emanate from the delegated body or might come as an assignment from the
decision makers.
The delegated body should in this case carry out the assessment of the risk of the chemical as
well as assess the impact of the proposed measures and prepare the decision for adoption by
the deciding body. It should also be clear in the legislation or in the policy from the legislator
or the government (if this is not the same body) how the process is to be carried out, i.e. how
the decisions needed for the different steps are to be made and which considerations they
should be based on.
When legal instruments, including mandatory economic policy instruments, are adopted, this
normally requires decisions at more senior levels than other instruments such as different
types of informative instruments, e.g. dialogues with industry. The reasons behind the
decision to introduce risk reduction measures and the choice of instrument should be
described in a way that is understandable to both decision makers and stakeholders. In a case
where there are suspicions of severe adverse effects caused by a substance but full scientific
evidence is lacking, it should be considered to apply the precautionary principle for the
decision on risk reduction. To what extent the Precautionary Principle should be applied
should also be based on political decisions and should be documented in relevant legislation.

38
Annex 1 – International Conventions and
agreements
1. Strategic approach to International Chemicals Management
Adopted by the International Conference on Chemicals Management (ICCM) on 6 February
2006 in Dubai, United Arab Emirates, the Strategic Approach to International Chemicals
Management (SAICM) is a policy framework and hence not legally binding, to foster the
sound management of chemicals.
SAICM was developed by a multi-stakeholder and multi-sectoral Preparatory Committee and
supports the achievement of the goal agreed at the 2002 Johannesburg World Summit on
Sustainable Development of ensuring that, by the year 2020, chemicals are produced and
used in ways that minimize significant adverse impacts on the environment and human health.
SAICM comprises the Dubai Declaration on International Chemicals Management,
expressing high-level political commitment to SAICM, and an Overarching Policy Strategy
which sets out its scope, needs, objectives, financial considerations underlying principles and
approaches and implementation and review arrangements. Objectives are grouped under five
themes: risk reduction; knowledge and information; governance; capacity-building and
technical cooperation; and illegal international traffic.
In the intersessional period between ICCM 3 and ICCM 4 stakeholders have discussed and
recommended what need to be in place in a country to enable it to fulfil the 2020 goal in time.
These recommendations are presented in a document outlining an Overall Orientation and
Guidance to identify approaches for all SAICM’S stakeholders towards the achievement of
the overall objective by 2020 including some concrete elements to support the implementation
of the Overarching Policy Strategy. This recommendation was adopted at ICCM4 taking
place 27 September - 3 October 2015.
This guidance contains a set of 11 basic elements that have been recognised as critical at the
national and regional levels to the attainment of sound chemicals management they are:
• Legal frameworks that address the life cycle of chemicals and waste;
• National, sub-regional and regional enforcement and compliance mechanisms;
• Implementation of relevant international conventions;
• Strong institutional frameworks and coordination mechanisms among relevant
stakeholders;
• Collection and systems for the sharing of data and information among all relevant
stakeholders using a life-cycle approach, such as the implementation of the Globally
Harmonized System of Classification and Labelling of Chemicals;
• Industry participation and responsibility, including cost recovery policies and systems as
well as the incorporation of sound chemicals management into corporate policies and
practices;
• Inclusion of chemicals in national budgeting, processes and development plans;
• Chemical risk assessment through use of best practices;
• Strengthened capacity to deal with chemicals accidents, including poisonings;
• Monitoring and assessing the impacts of chemicals on health and the environment;
• Development and promotion of environmentally sound and safer alternatives.

39
2. Stockholm Convention
The Stockholm Convention on Persistent Organic Pollutants was adopted by the Conference
of Plenipotentiaries on 22 May 2001 in Stockholm, Sweden. The Convention entered into
force on 17 May 2004. It is a global treaty to protect human health and the environment from
chemicals that remain intact in the environment for long periods, become widely distributed
geographically, accumulate in the fatty tissue of humans and wildlife, and have harmful
impacts on human health or on the environment.
In response to this global problem, the Stockholm Convention, requires its parties to take
measures to eliminate or reduce the release of POPs into the environment. Such measures
include:
• Prohibition and/or elimination of the production and use, as well as the import and
export, of the intentionally produced POPs that are listed in Annex A to the Convention;
• Restriction of the production and use, as well as the import and export, of the
intentionally produced POPs that are listed in Annex B to the Convention;
• Reduction or elimination releases from unintentionally produced POPs that are listed in
Annex C to the Convention;
• Ensuring that stockpiles and wastes consisting of, containing or contaminated with POPs
are managed safely and in an environmentally sound manner;
• Targeting additional POPs.

3. Rotterdam Convention
The text of the Rotterdam Convention was adopted on 10 September 1998 by a Conference of
Plenipotentiaries in Rotterdam, the Netherlands. The Convention entered into force on 24
February 2004. The Convention covers pesticides and industrial chemicals that have been
banned or severely restricted for health or environmental reasons by Parties and which have
been notified by Parties for inclusion in the PIC procedure.
The Convention promotes the exchange of information on a very broad range of chemicals. It
does so through:
• the requirement for a Party to inform other Parties of each national ban or severe
restriction of a chemical;
• transition to inform other Parties that it is experiencing problems caused by a severely
hazardous pesticide formulation under conditions of use in its territory;
• the requirement for a Party that plans to export a chemical that is banned or severely
restricted for use within its territory, to inform the importing Party that such export will
take place, before the first shipment and annually thereafter and hence give the importing
country a possibility to deny the import via the so called Prior Informed Consent
procedure.

4. Minamata Convention
The Minamata Convention on Mercury is a global treaty to protect human health and the
environment from the adverse effects of mercury. The major highlights of the Convention on
Mercury include a ban on new mercury mines, the phase-out of existing ones, control
measures on air emissions, and the international regulation of the informal sector for artisanal
and small-scale gold mining. It also includes regulating the use of mercury in certain products
such as measuring devices and cosmetics.

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5. The Globally Harmonized System of Classification and Labelling of
Chemicals - GHS
The GHS system which was first adopted in 2002 provides a (non-legally binding) system for
countries for classification a labelling of chemicals, substances as well as mixtures. It was
agreed by the participating countries and stakeholders at the World Summit for Sustainable
Development in the Johannesburg Plan of Implementation 2002 that it should be implemented
by 2008. The purpose of the GHS is:
• To enhance the protection of human health and the environment by providing an
internationally comprehensible system for hazard communication,
• To provide a recognized framework for countries without an existing system
• To reduce the need for testing and evaluation of chemicals; and
• To facilitate international trade in chemicals whose hazards have been properly assessed
and identified on an n international basis.
GHS is not intended to harmonise risk assessment procedures or risk management decisions
but gives a sound basis for other pieces of legislation and according to the classification of a
substance, measures can be warranted that reduce or eliminate the risk emanating for using
the chemicals in questions.

6. The 2030 Agenda for Sustainable Development and the Sustainable

Development Goals
In “Transforming our world: the 2030 Agenda for Sustainable Development”, UN Member
States re-confirmed to
“reduce the negative impacts of urban activities and of chemicals which are hazardous for human
health and the environment, including through the environmentally sound management and safe use
of chemicals, the reduction and recycling of waste and the more efficient use of water and energy”.
This Agenda is a plan of action for people, planet and prosperity with 17 Sustainable
Development Goals (SDGs) and 169 targets. It recognises that eradicating poverty in all its
forms and dimensions, including extreme poverty, is the greatest global challenge and an
indispensable requirement for sustainable development. All countries and all stakeholders,
acting in collaborative partnership, will implement this plan.
The 17 Sustainable Development Goals and its 169 targets demonstrate the scale and
ambition of this new universal Agenda. They seek to build on the earlier Millennium
Development Goals and complete what these did not achieve. They are integrated and
indivisible and balance the three dimensions of sustainable development: the economic, social
and environmental.
However, there are eight goals and sixteen targets in Agenda 2030 that have a clear relation to
chemicals: safe food and sustainable agriculture (goal 2), good health (goal 3), clean water
(goal 6), safe working environments (goal 8), sustainable consumption and production
patterns (goal 12), as well as protection of ecosystems and biodiversity (goals 14 and 15).
Governments have the primary responsibility for follow-up and review, at the national,
regional and global levels, in relation to the progress made in implementing the Goals and
targets over the coming fifteen years. To support accountability to our citizens, there will be a
systematic follow-up and review at the various levels, as set out in this Agenda and the Addis
Ababa Action Agenda. 230 indicators have been developed to assist the follow-up and review
at the various levels.
The 17 SDGs takes into account all three dimensions of sustainable development, the
economic, social and environmental dimension.

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Explanation of goals:
1. End poverty in all its forms everywhere.
2. End hunger, achieve food security and improved nutrition and promote sustainable agriculture.
3. Ensure healthy lives and promote wellbeing for all at all ages.
4. Ensure inclusive and equitable quality education and promote lifelong learning opportunities for all.
5. Achieve gender equality and empower all women and girls.
6. Ensure availability and sustainable management of water and sanitation for all.
7. Ensure access to affordable, reliable, sustainable and modern energy for all.
8. Promote sustained, inclusive and sustainable economic growth, full and productive employment
and decent work for all.
9. Build resilient infrastructure, promote inclusive and sustainable industrialization and foster
innovation.
10. Reduce inequality within and among countries.
11. Make cities and human settlements inclusive, safe, resilient and sustainable.
12. Ensure sustainable consumption and production patterns.
13. Take urgent action to combat climate change and its impacts
14. Conserve and sustainably use the oceans, seas and marine resources for sustainable
development.
15. Protect, restore and promote sustain able use of terrestrial ecosystems sustainably manage
forests, combat desertification, and halt and reverse land degradation and halt biodiversity loss.
16. Promote peaceful and inclusive societies for sustainable development, provide access to justice
for all and build effective, accountable and inclusive institutions at all levels.
17. Strengthen the means of implementation and revitalize the Global Partnership for Sustainable
Development.

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