The Institution of Occupational Safety and

Health, Southern Branch

Chemical Risk Assessment under COSHH,

REACh, RoHS, DSEAR, CLP and GHS
– A Coordinated Approach

Monday 10th February 2014

• Presented by
• Colin Martin CChem, MRSC, AFOH, FInstCT, MIMF
• Senior Partner, ParaChem Consulting Chemists
COSHH REGULATIONS

The Control of Substances Hazardous to

Health Regulations, 2002 (as amended)

And

Approved Code of Practice and Guidance

L5 (Sixth Edition) 2013
COSHH REGULATIONS

Reg. 6 (1)“An employer shall not carry out

any work which is liable to expose any
employees to any substance hazardous to
health unless he has-
(a) made a suitable and sufficient
assessment of the risk created by that work
to the health of those employees and of the
steps that need to be taken to meet the
requirements of these Regulations…”
COSHH REGULATIONS

• Risk assessment of substances hazardous to humans

– Harmful, toxic, corrosive, irritant
• Involves consideration of
– Hazardous properties
– Method of use
– Health effects
– Exposure type, level, duration
– Amount of substance
– WELs
– Results of health surveillance
– Results of air-monitoring
– Etc.
DSEAR REGULATIONS

The Dangerous Substances and Explosive

Atmospheres Regulations, 2002

And

Approved Code of Practice and guidance

L138 (Second Edition) 2013
DSEAR REGULATION 2002

Reg. 5 (1)“Where a dangerous substance is

or is liable to be present at the workplace,
the employer shall make a suitable and
sufficient assessment of the risks to health
which arise from that substance”
 DSEAR REGULATION 2002
• Risk assessment of substances hazardous because of their
physical properties
• Flammable, highly flammable, extremely flammable,
oxidising, explosive
• Involves consideration of
– Hazardous properties – e.g. Flash point and LFL
– Method of use
– Interactions of substances
– Release type, level, duration
– Amount of substance
– Likelihood of existence / persistence of a flammable atmosphere
– Effects of a fire / explosion
– Etc.
REACH REGULATION

Regulation (EC) No. 1907/2006 of the

European Parliament and of the Council of
18 December 2006

concerning the Registration, Evaluation,

Authorisation and Restriction of Chemicals
“REACh”
REACH REGULATION AIMS

• To protect human health and the

environment from the use of chemicals.
• To force manufacturers and importers to
manage the risks associated with the use
of chemicals
• To allow free movement of substances
within the EU
REACH – WHAT’S INCLUDED?

• Legislates chemicals/substances from

“cradle to grave”

• Substances manufactured/imported into EU

at >1 tonne pa

• Individual chemical substances

• Preparations (mixtures)

• Substances in “articles”
REACH – WHAT’S NOT INCLUDED?

• Radioactive substances
• Substances under customs supervision
• Transport of substances
• Non-isolated intermediaries
• Waste
• Naturally occurring low-hazard substances

[cf COSHH – lead, asbestos, radiation]

REACH IN THE UK

• The REACh Enforcement Regulations 2008

(SI 2008/2852)
– Allocate responsibility for enforcement
to “Competent Authorities” “CA” (HSE,
HSENI, EA, SEPA, NIEA, DECC, local
authorities)
– Provision of power to CAs
– Duty of CAs to cooperate
– Setting of offences and penalties
ENFORCEMENT ACTION IN UK

• Competent Authority (HSE) reports

– Since passing into law in 2009

• >70 Notices served (Enforcement or

Prohibition)* up to today

• 3 criminal prosecutions** by local

authorities
*Source HSE Chemicals Directorate
**Source Royal Society of Chemistry
REGISTRATION – Main requirement of REACH?
• Registration / Pre-registration
– In nearly all cases applies to manufacturers / importers
of chemicals:- NOT to “downstream users”
• How does REACH affect risk assessment of
chemicals?
– HSE advice - Compile an inventory
• Include substances, preparations, substances in articles
• Obtain & Audit SDS for compliance
• Notify ECHA* if substance not registered on ECHA website
for their application
• Downstream users– check composition of chemicals for
SVHCs
*European Chemicals Agency (ECHA)
“DOWNSTREAM USER” A definition

• “Downstream users are companies or

individuals who use a chemical
substance, either on its own or in a
mixture, in the course of their industrial
or professional activities”
• Examples:- Formulators, End-users,
Producers of articles, Re-fillers, Re-
importers.
“DOWNSTREAM USER” A definition

• End-users: Use substances or mixtures but do not

supply them further downstream. Examples include
users of adhesives, coatings and inks, lubricants,
cleaning agents, solvents and chemical reagents like
bleaching products.
• Producers of articles: Incorporate substances or
mixtures into or onto materials to form an article.
Examples include textiles, industrial equipment,
household appliances and vehicles (both components
of and finished goods).
• MOST MANUFACTURING BUSINESSES ARE
DOWNSTREAM USERS !!!
DOWNSTREAM USER OBLIGATIONS

1. Registration
Producers or importers of articles shall submit a registration to
ECHA for any substance contained in those articles, if both the
following conditions are met:

1. The substance is present in those articles in quantities

totalling over one tonne per producer or importer per year.

2. The substance is intended to be released under normal or

reasonably foreseeable conditions of use.
DOWNSTREAM USER OBLIGATIONS

2. Notification
Producers and importers have to notify ECHA about substances if all the
following conditions are met:

1. The substance is present in their relevant articles above a

concentration of 0.1% weight by weight.

2. The substance is present in these relevant articles in quantities

totalling over one tonne per year.

3. The substances are included in the “Candidate List”.

SVHCS, CANDIDATE LIST, and ROADMAPS

SVHC = Substance of Very High Concern

Inclusion in Candidate List = First step towards
inclusion in Authorisation List (Annex XIV)
Authorisation = Industry is forced to reduce risks
from SVHCs by progressive replacement with
suitable alternatives
Substances in Authorisation List cannot be sold after
“Sunset date”
Effective Ban
All SVHCs to be included in the Candidate List by 2020
SVHC

• Significant properties of SVHCs

– Carcinogenic, mutagenic or reprotoxic
(CMRs)
– Persistent, bioaccumulative and toxic
(PBTs)
– Very persistent and very bioaccumulative
(vPvBs)
– Other substances where evidence of
endocrine disruption exists
EXAMPLES OF SVHCS

• 1-Methyl-2-pyrrolidone,
• Bis(2-ethylhexyl)phthalate
• Boric acid
• Cadmium compounds, various
• Chromium trioxide
• Cobalt compounds, various
• Phenolphthalein
• Sodium dichromate
• Trichloroethylene
• Triglycidyl isocyanurate (TGIC)
+ 164 more as of 16/12/2013
DOWNSTREAM USER OBLIGATIONS #4

3. Communication
• Producers and importers have to notify industrial
customers about substances if both of the following
conditions are met:

1. The substance is present in their relevant articles

above a concentration of 0.1% weight by weight.

2. The substances are included in the “Candidate List”.

ROHS REGULATION

• The Restriction of the Use of Certain

Hazardous Substances in Electrical and
Electronic Equipment Directive (2011/65/EU)
“RoHS”.
• The Restriction of the Use of Certain
Hazardous Substances in Electrical and
Electronic Equipment Regulations 2012 (SI
2012/3032)
– Became law on in UK on 2 January 2013.
ROHS – MAIN IMPACT ON INDUSTRY

• Bans the placing on the market of

new electrical and electronic
equipment containing more than
agreed levels of six substances.

• Enforcement Authority is National

Measurement Office
ROHS – MORE DETAILS

• Enforcement and penalties similar to

REACh
• Applies to manufacturers / assemblers /
importers
• Proof of compliance required before
products are placed on market
• Method of calculation for compliance is
different to REACh
ROHS - Restricted Substances

Restricted Lead Mercury Hexavalent Polybrominated Polybrominated Cadmium

biphenyls diphenyl ethers
Substance Chromium
(PBB) (PBDE)

Restricted 0.1 0.1 0.1 0.1 0.1 0.01

Limit
(% w/w)

Restricted 1000 1000 1000 1000 1000 100

Limit
(ppm)
ROHS – MAIN DIFFERENCES TO REACH

• “Homogeneous” part
– Uniform composition throughout, e.g.
plastics, glass, metals, alloys, resins and
coatings
– Electroplated metals separate to substrate
– Passivate separate to electroplated layer
• Exemptions
– Medical devices, military, telecoms, and
specific exemptions
– http://www.bis.gov.uk/nmo/enforcement/roh
s-home/rohs-exemptions
THE DODD-FRANK WALL STREET REFORM
AND CONSUMER PROTECTION ACT

• Section 1502 – “Conflict Minerals”

– Requires the identification of the origin of metals
derived from cassiterite, coltan, wolframite and the
origin of gold.
– It should be established through the supply chain
that these metals are "DRC* Conflict Free" as
appropriate.
– Inhumane mining practices
– Proceeds fund illegal militia
*Democratic Republic of Congo
THE CONTROLLED DRUGS (DRUG
PRECURSORS) REGULATIONS, 2008 (x 2)

• Controlled drug and precursor chemical

licence
– Licence may be required if a company or
individual deals in or uses chemical that
are known to be used in the
manufacture of illegal drugs
– Licences issued by Home Office Drugs
Licensing & Compliance Department
– Aim to to stop the supply of precursor
chemicals to manufacturers
CHEMICAL RISK ASSESSMENT

Chemical Identification
Names and numbers
Hazard Classification – Old and New
CHiP, GHS, CLP
Substances of Very High Concern
SVHCs, CMRs, PBTs, vPvBs
CHEMICAL IDENTITY

Ethanoic acid
C2H4O2

Methanecarboxylic
acid
Essigsaeure
CH3CO2H
Ethylic acid
Demonstrates the need for standard names….
STANDARDISED NAMING SYSTEM
Ethanoic acid - Simple example, what about more complex
chemicals…
α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-
methanol

[4-[[4-anilino-1-naphthyl][4-
(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-
ylidene] dimethylammonium chloride

1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-

(1H,3H,5H)-trione
(all correct IUPAC names)
STANDARDISED NAMING SYSTEM
• Spot the difference…

[4-[[4-anilino-1-naphthyl][4-
(dimethylamino)phenyl]methylene]cyclohexa-2,5-
dien-1-ylidene] dimethylammonium chloride

[4-[[4-anilino-1-naphthyl][4-
(dimethylamino)phenyl]methylene]cyclohexa-2,5-
dien-1-ylidene] diethylammonium chloride

• Need easier ID system???

NUMERICAL ID SYSTEMS

• 229-851-8 786-83-0 • α,α-Bis[4-(dimethylamino)phenyl]-4

(phenylamino)naphthalene-1-
methanol

• 219-943-6 2580-56-5 • [4-[[4-anilino-1-naphthyl][4-

(dimethylamino)phenyl]methylene]
cyclohexa-2,5-dien-1-ylidene]
dimethylammonium chloride

• 423-400-0 59653-74-6 • 1,3,5-tris[(2S and 2R)-2,3-

epoxypropyl]-1,3,5-triazine-2,4,6-
(1H,3H,5H)-trione
• “EC Number” “CAS Number”
EC NUMBERS

• European Commission Number EC Number

– Chemicals are assigned unique numbers and no two
substances have same number
– IUCLID Database
• http://esis.jrc.ec.europa.eu/index.php
• International Uniform ChemicaL Information Database
– Assigned to substances for regulatory purposes in the EU - >
100,000 substances
CAS NUMBERS

•Chemical Abstracts Service (CAS) CAS Number

–Division of American Chemical Society
–CAS Registry

•> 71 million substances assigned individual registry

numbers known at 1957 onwards

•> 64 million proteins and DNA sequences

•All given unique numbers and no two substances have
same number
•First Registry number “50-00-0” Formaldehyde
HAZARD CLASSIFICATION

• Chemicals classified under “CHiP” (Chemicals (Hazard

Information) in Packaging) Regs under outgoing
system
– Based on Approved Supply List (ASL)

• 2009 Onwards New System is “CLP / GHS”. Globally

Harmonised System of Classification and Labelling of
Chemicals
– Based on IUCLID

• Now until 2015 (2017 for some) – Transition period –

Both systems used
HAZARD CLASSIFICATION UNDER CHiP

• Corrosive • Harmful

• Highly
Flammable, • Irritant
Extremely
Flammable

• Toxic • Oxidising
CHiP – “RISK PHRASES”

• Risk Phrases
– State the risk associated with a substance
• R10 Flammable
• R35 Causes severe burns
• R51 Toxic to aquatic organisms
• R42/43 May cause sensitisation by inhalation and
skin contact
• R48/20/21/22 Harmful: danger of serious
damage to health by prolonged exposure
through inhalation, in contact with skin and if
swallowed
GHS AND CLP

• Classification, Labelling and Packaging of

Substances and Mixtures (CLP Regulation) from
European Union, adopts

• Globally Harmonised System of Classification

and Labelling of Chemicals (GHS)

• Classification and Labelling of Hazardous

Substances will be universal (They hope)
CHiP TO CLP – ICONS TO PICTOGRAMS
Some convert logically
CHiP TO CLP – ICONS TO PICTOGRAMS
and some don’t

This pictogram refers to less serious

health hazards such as skin
irritancy/sensitisation and applies to
many circumstances where the
CHIP symbol is applied.

This pictogram reflects serious

longer term health hazards such
as carcinogenicity and
respiratory sensitisation
CHiP TO CLP
– Risk Phrases to Hazard Statements

Risk Phrase Hazard Statement

– R35 • H314
Causes severe burns Causes severe skin
burns and eye damage

– R12 • H224
Extremely flammable
Extremely flammable
liquid and vapour
Safety Phrases and Precautionary Statements

Safety Phrase Precautionary

Statement
–S 2
Keep out of reach of
children
• P201
Keep out of reach of children
– S20
When using do not eat • P264
or drink Wash thoroughly after
handling
– S25
Avoid contact with
eyes
GHS –
EXAMPLE
LABELLING
CHEMICAL DATA AUDITING – A
COORDINATED APPROACH FOR ALL
CHEMICAL REGULATIONS
•Draw up an inventory of all chemicals on site
•Obtain Safety Data Sheets (SDS) for all
•Audit Safety Data Sheet (SDS)
–Is the SDS REACh/CLP Compliant?
–Sec. 1.2 Relevant identified uses of the substance or
mixture and uses advised against?
–Sec. 2 Classification?
–Sec. 3 Composition – Chemical Identity?
Draw up an inventory of all chemicals on site
Is the SDS REACh/CLP Compliant?
SDS AUDIT UNDER REACH

Sec 1.2 - Relevant identified Use:

Sets out application for which a chemical substance
may be used.
Producers (manufacturers) can only use a chemical in
the method described
Other methods of use will require the manufacturer to
register their method of use with ECHA.
Uses advised against:
Effective prohibit particular uses of a chemical
substance
Relevant identified Uses – ECHA Guidance
• Suppliers must indicate the relevant identified
use(s) of a substance using a brief
(understandable) description of what the substance
is intended to do. Uses advised against and
reasons why must be given if applicable

• At least the identified uses relevant for the

recipient(s) of the substance or mixture shall be
indicated. This shall be a brief description of what
the substance or mixture is intended to do, such as
“flame retardant”, “anti-oxidant”.The uses which
the supplier advises against and why shall, where
applicable, be stated. This need not be an
exhaustive list
Relevant identified Uses – Examples received

• Peelable mask, aerosol cleaner, manufacture of

printed circuits, adhesive, semiconductors,
electrical and electronic applications, additive
for paints, grease, manufacture of substances,
machine oil, uses in coatings, other consumer
uses, water treatment, “blank”, metal marking
ink, cleaner, etc. etc.
Sec. 3 Composition – Chemical Identity?
CHEMICAL INVENTORY TO “ALL
SUBSTANCES REPORT”
• “All Substances Report”
– Lists all constituents of all consumables in
factory
– CAS and EC Numbers
– % age composition of substances in
proprietary products
– Shows the chemical products they are
contained in
– Key to compliance with all Regs that require
identification of chemicals
 STRUCTURE OF “All Substances Report”
Chemical Inventory All Substances Report

Chemical X 2-Butoxyethanol
Nickel sulphate Chemical Y
Sulphuric acid Chemical Z
Boric acid Ammonium persulphate
Chemical Y Chemical Z
Sulphuric acid Boric acid
2-Butoxyethanol Chemical X
Chemical Z Nickel sulphate
Ammonium persulphate Chemical X
Sulphuric acid
2-Butoxyethanol
Sulphuric acid
Chemical X
Chemical Y
Chemical Z
ALL SUBSTANCES REPORT
ADDITIONAL DATA COLLECTION

• Need to know composition of manufactured article

– All chemicals used in factory – “All Substances
Report”
• Next Step…
– Base materials – Request to supplier
– Bought-in components - Request to supplier
– Free-issue customer parts - Request to supplier
– Surface finishes - Request to supplier
INVENTORY OF NON-CHEMICALS

• Obtain information on SVHCs present in;

– Base materials, bought-in components, free-issue
customer parts and ANYTHING ELSE THAT IS
INCLUDED IN FINISHED PRODUCT
• When to obtain information
• Needs to be recorded (and kept for 10 years)
CONSOLIDATED INVENTORY

• On completion of compilation and the inventories

of chemical and non-chemical consumables
• We have identified any SVHCs, RoHS banned
substances, Conflict Minerals and Precursor
Chemicals present
• Can now look at thresholds for disclosure
requirements where applicable
• May be able to exclude SVHCs present on
inventory, but not present in finished product,
such as…
EASY EXCLUSIONS?

• 1-Methyl-2-pyrrolidone
– CAS 872-50-4, EC 212-828-1 is SVHC

– Used in “Hermitite Gasket Remover”

– Used in maintenance department
– Not in finished product
– No duty to disclose
EASY EXCLUSIONS?

• Phenolphthalein
– CAS 77-09-8, EC 201-004-7 is SVHC

– Used in chemical analysis

– Not in finished product
– No duty to disclose
EASY INCLUSIONS?

• Chromium trioxide CAS 1333-82-0 is SVHC

– Used in chromate conversion coating on zinc

plated components
– Is in finished product – Calculation required
– (Easy non-exclusion)
EASY INCLUSIONS?

• Di-sec-octyl phthalate

– Real ID Bis(2-ethylhexyl)phthalate or DEHP

– CAS 117-81-7, EC 204-211-0

– Used in bought-in article (plastic components)

– Supplier questionnaire and possibly calculation
required.
DESIGN & PROCUREMENT CONSIDERATIONS

• Do we need to design out SVHCs, RoHS banned

substances, Conflict Minerals and Precursor
Chemicals ?
– Differences in exclusion criteria
• Do we need to seek alternative (SVHC/RoHS etc
free) materials?
Thank you for attending and listening

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