The UK Chemical Framework Dr Sara Lumley in association with - - PowerPoint PPT Presentation

in association with

insight-hr.co.uk capitallaw.co.uk

The UK Chemical Framework

Dr Sara Lumley

in association with

insight-hr.co.uk capitallaw.co.uk

The old framework

The old framework

Abbreviation CHIP 4 CoSHH Full title Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 Control of Substances Hazardous to Health Regulations 2002 Type of law UK Regulations UK Regulations Who it applies to

• Manufacturers
• Suppliers
• Users

Duties (summarised)

• Classification of

hazard

• Information:
• Labelling
• Safety data sheets
• Packaging
• Child resistant

fastenings

• Risk assessment
• control
• monitoring

To be revoked 1st July 2015 n/a

in association with

insight-hr.co.uk capitallaw.co.uk

The new framework

The new framework

Abbreviation REACH 2006 CLP 2009 CoSHH 2002 Full title Registration, Evaluation, Authorisation and Restriction of Chemical Hazards Classification, Labelling and Packaging Regulation Control of Substances Hazardous to Health Regulations Type of law EU Regulation

• Applies directly

in all 28 EU Member States EU Regulation

• Applies directly

in all 28 EU Member States UK Regulations

• Applies to the

UK only Who it applies to

• Manufacture &
• Supply
• Supply
• User

Duties (summarised)

• Register
• evaluate
• authorise
• classify
• restrict
• safety data

sheets

• Labelling
• packaging
• Risk

assessment

• control
• monitoring

REACH and CoSHH

REACH

• Substance driven
• Wide ranging
• Human health and

environment

• Only chemicals

Both have user duties! CoSHH

• Task/process driven
• Site specific
• Human health
• nly
• Chemicals, process bi

products, biological agents, waste etc.

REACH

What is a hazardous chemical?

Table 3.2 of part 3 of Annex VI of the CLP Regulation

• The list of harmonised classification and labelling of

hazardous substances (664 pages!)

Index No International Chemical Identification EC No CAS No Classification Labelling Concentration Limits Notes 001-001-00-9 hydrogen 215-605-7 1333-74-0 F+; R12 F+ R: 12 S: (2-)9-16-33 001-002-00-4 aluminium lithium hydride 240-877-9 16853-85-3 F; R15 F R: 15 S: (2-)7/8-24/25-4 3 001-003-00-X sodium hydride 231-587-3 7646-69-7 F; R15 F R: 15 S: (2-)7/8-24/25-4 3

A fundamentally new approach

REACH creates a fundamentally new approach to chemicals control by:

• moving the onus of risk assessment and the

identification of the necessary controls much higher up the supply chain e.g. manufacturers and importers

• putting duties on suppliers and ‘downstream users’
• f chemicals

– to ensure that information gained is passed down the supply chain, and effectively applied to control risks.

Aims of REACH

• ‘No data, no market’ – upstream responsibility
• more hazard information
• consumers ‘right to know’ whether the articles they

buy contain any ‘substances of very high concern’- ‘candidate list’

– to encourage companies to look for safer alternatives

• harmonise the way substances are classified
• reduce the amount and extent of animal testing

– sharing data – informing ECHA of animal testing.

REACH

15 titles covering the different issues and responsibilities under the Regulation

• each title is divided into chapters
• each chapter sub-divided into articles, which tell us

what we must do

• 17 annexes explain how to do it.

REACH

• Registration by manufacturer/supplier

– assemble and submit information for pre registration – prepare registration (dossier and substance evaluation) – submit

• Evaluation by European Chemicals Agency (ECHA)

– dossier and substance evaluation – formation of Substance Information Exchange Forum (SIEF).

From: ¡ECHA ¡– ¡Guidance ¡for ¡Downstream ¡Users ¡ ¡

REACH

Authorisation

• ‘Substances of very high concern’
• Annex XlV:

– check the ‘candidate list’ and comply with the conditions of the authorisation covering your use – e.g. trichloroethylene, arsenic acid, chromium trioxide etc.

• these substances may not be used in the EU unless

a company (and their registered users) have been authorised to do so

• this will mean that such substances are eventually

phased out of all non-essential uses.

REACH

Restriction

• Annex XVII
• check compliance with any restrictions on the

substance – e.g. asbestos, benzene, chloroethylene (vinyl chloride).

*if use has not been considered by supplier, may need to do your own CSR ** exposure scenarios required for >10 tpa REACH Registration Chemical safety report (over 10 tpa) Article communication and notification Safety data sheets, exposure scenarios Manufacture/import <1 tpa ✖ ¡ n/a n/a ✔ ¡ Manufacture/import >1 tpa ✔ ¡ ✔ ¡ n/a ✔** ¡ Manufacture >1 tpa in the EU & export outside EU ✔ ¡ ✔ ¡ n/a ✔** ¡ ¡ Buy in a REACH Registered substance and make mixtures ✖ ¡ ✖ ¡ n/a ✔** ¡ Buy in a REACH Registered substance and make articles ✖ ¡ ✖ ¡ ✔ ¡ > 0.1% on candidate list ✖ ¡ ¡ Users of chemicals bought from EU sources ✖ ¡ ✖* ¡ n/a ✔** ¡

tpa = tonne/s per annum

REACH user role

Produce a chemical inventory Use the information received from suppliers

• safety data sheet (SDS)
• extended safety data sheets and (SDS with exposure

scenarios) Ensure use of the chemical is:

• safe for human health and the environment
• in the scope of the registration
• if your use is not covered you can ask your supplier to

include your use or

• inform ECHA and do your own chemical safety report

e.g. Marine Specialty Chemicals Limited.

REACH user role

Implement risk management measures:

• If the user decides that certain risk management

measures are inappropriate, they will need to:

– demonstrate and justify their reasoning, with reference to their CoSHH assessment – document any decision not to apply REACH risk management measures in their CoSHH assessment, and reasons why – report any information on the SDS that might call into question the appropriateness of the risk management measures to the ECHA (Article 34).

REACH user role

Inform your supplier:

• of any new information on hazards
• if the risk management measures are not

appropriate for your use or

• any adverse effects occur when using the

recommended risk management measures. Ensure that you pass on:

• all relevant hazard information
• safe conditions of use and
• any risk management measures to your customers.

Safety data sheets

Safety data sheets (SDS) must

• provide information to customers

and to retailers/consumers to enable safe use of substances or preparations

• recommend appropriate measures

to control risks.

Safety data sheets (SDS)

Changes:

• once chemicals are registered, safety data sheets

will list registration numbers (s1)

• this should trigger a CoSHH assessment review
• may also include exposure scenarios (s16)
• follow the advice on risk management measures in

the exposure scenario

• if different:

– justify different risk management measures or – maximum of 12 months to comply with the exposure scenario the risk management measures.

SDS changes

• 1. Identification of

substance

• 2. Hazards
• 3. Composition
• 4. First-aid measures
• 5. Fire-fighting measures
• 6. Accidental release

measures

• 7. Handling & storage
• 8. Exposure controls & PPE

9. Physical/chemical properties

• 10. Stability & reactivity
• 11. Toxicological

information

• 12. Ecological information
• 13. Disposal considerations
• 14. Transport information
• 15. Regulatory information
• 16. Other information

‘Extended’ safety data sheets

SDS with at least one exposure scenario (ES) included in the annex

• ES will normally only be attached to SDS’s after the

relevant hazardous substance has been registered by the supplier

• it is recommended that a supplier should only provide an

extended SDS when both the registration number and the relevant exposure scenarios are ready

• in the meantime, it is recommended to include a phrase

in section 15 to explain that the ES’s are under development.

Exposure scenarios

Is your use covered?

• describe your use
• look for the ES title and associated combinations of

use descriptors that reflect your uses

• identify any ‘obvious mismatch.’

SDS

What if your use is not covered by an ES?

• notify use to the supplier & provide sufficient

information or

• look for an alternative supplier or
• carry out downstream user (DU) chemical safety

assessment (CSA) (check exemptions!) & notify to ECHA (6 months).

Classification, Labelling and Packaging (CLP) Regulation 2009

Need for harmonisation

• LD50 oral rat = 261 mg/kg
• Australia

harmful

• Canada

toxic

• China

not hazardous

• EU

harmful

• India

non-toxic

• Japan

toxic

• Malaysia

harmful

• New Zealand

hazardous

• USA

toxic Different classification and SDS!

Caffeine UN GHS: Warning, acute toxicity, cat 3.

Chemical life cycle - roles

• 1. Manufacturers and importers
• 2. Companies producing mixtures
• 3. Distributors
• 4. Industrial end-users
• 5. Professional end-users and
• 6. Consumers.

What to do!

• 1. Check product's labels

– pictograms, risk phrases, hazard statements

• 2. Check safety data sheets

– you can use the suppliers’ classification and labelling if you do not change the composition

• 3. Consult ECHA classification and labelling inventory

– to see how the substance is classified and check it has a harmonised classification

• 4. Apply the harmonised classification for substances.

Update your labels!

Pictograms e.g.

Until 1st June 2015 for Preparations (Not valid for substances since 1st Dec 2010)

Hazard statements e.g.

– H320 – causes eye irritation – H332 – harmful if inhaled

Precautionary statements e.g.

– P210 – keep away from heat – P262 – do not get on skin

Increase awareness!

• Some new hazard

pictograms are well recognised by the general public whilst

• thers are not
• very high recognition by

general public (over 80%)

• New CLP pictograms are

scarcely known or understood by the general public

• very low recognition and

understanding (20% and 12%)

Deadlines

Regulation Date Deadline

REACH 1 June 2018 PHASE 3: Registration of substances supplied at ≥ 1 tpa CLP 1 June 2015 Apply CLP to all mixtures CLP 1 June 2017 Deadline for re-labelling and re- packaging of products already in the supply chain

Serious long term health hazards

e.g. cancers & respiratory sensitisors

Less serious toxic hazards (harmful)

e.g. skin irritation/sensitisation ¡

Corrosive hazards

e.g. acids and alkalis

Severe toxic hazards

e.g. cyanide

New labelling for health hazards

Category Old CHIP label New CPL label Irritant

(Xi) Skin eye

Harmful

(Xn)

Toxic & Very Toxic

(T) (T+) Cat 1, 2, 3

Corrosive

(C)

Skin sensitisiation

(Xn)

Respiratory Sensitisation

(Xn)

Category Old CHIP label New CPL label Carcinogenic

Cat 1&2 Cat 1&1A

Carcinogenic

Cat 3 Cat 2

Mutagenic

Cat 1&2 Cat 1&1A

Mutagenic

Cat 3 Cat 2

Reproductive toxin

Cat 1&2 Cat 1&1A

Reproductive toxin

Cat 3 Cat 2

New statements

Hazard phrases Hazard statements e.g.: H240 - Heating may cause an explosion

H320 - Causes eye irritation H401 - Toxic to aquatic life

Risk phrases Precautionary statements e.g.: P102 - Keep out of reach of children

P271 - Use only outdoors or in well-ventilated area P410 - Protect from sunlight

Becomes

Thank you Questions?