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

The UK Chemical Framework Dr Sara Lumley in association with capitallaw.co.uk insight-hr.co.uk

The old framework in association with capitallaw.co.uk insight-hr.co.uk

The old framework Abbreviation CHIP 4 CoSHH Full title Chemicals (Hazard Control of Substances Information and Hazardous to Health Packaging for Supply) Regulations 2002 Regulations 2009 Type of law UK Regulations UK Regulations Who it applies to • Manufacturers • Users • Suppliers Duties • Classification of • Risk assessment (summarised) hazard • control • Information: • monitoring - Labelling - Safety data sheets - Packaging - Child resistant fastenings To be revoked 1 st July 2015 n/a

The new framework in association with capitallaw.co.uk insight-hr.co.uk

The new framework Abbreviation REACH 2006 CLP 2009 CoSHH 2002 Full title Registration, Classification, Control of Evaluation, Labelling and Substances Authorisation and Packaging Hazardous to Restriction of Regulation Health Chemical Hazards Regulations Type of law EU Regulation EU Regulation UK Regulations • Applies directly • Applies directly • Applies to the in all 28 EU in all 28 EU UK only Member States Member States Who it • Manufacture & • Supply • User applies to • Supply Duties • Register • Labelling • Risk (summarised) • evaluate • packaging assessment • authorise • control • classify • monitoring • restrict • safety data sheets

REACH and CoSHH REACH CoSHH • Substance driven • Task/process driven • Wide ranging • Site specific • Human health and • Human health environment only • Only chemicals • Chemicals, process bi products, biological agents, waste etc. Both have user duties!

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 EC No CAS No Classification Labelling Notes International Concentration Limits Chemical Identification 001-001-00-9 hydrogen 215-605-7 1333-74-0 F+; R12 F+ R: 12 S: (2-)9-16-33 001-002-00-4 240-877-9 16853-85-3 F; R15 F aluminium lithium hydride 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’ of 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 REACH Chemical Article Safety data considered by supplier, Registration safety report communication sheets, may need to do your own (over 10 and notification exposure CSR tpa) scenarios ** exposure scenarios required for >10 tpa Manufacture/import <1 tpa n/a n/a ✖ ¡ ✔ ¡ Manufacture/import >1 tpa n/a ✔ ** ¡ ✔ ¡ ✔ ¡ Manufacture >1 tpa in the n/a ✔ ** ¡ ✔ ¡ ✔ ¡ EU & export outside EU ¡ Buy in a REACH Registered ✖ ¡ ✖ ¡ n/a ✔ ** ¡ substance and make mixtures Buy in a REACH Registered ✖ ¡ ✖ ¡ ✔ ¡ ✖ ¡ substance and make > 0.1% on ¡ articles candidate list Users of chemicals bought ✖ * ¡ n/a ✔ ** ¡ ✖ ¡ from EU sources 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 9. Physical/chemical substance properties 2. Hazards 10. Stability & reactivity 3. Composition 11. Toxicological information 4. First-aid measures 12. Ecological information 5. Fire-fighting measures 13. Disposal considerations 6. Accidental release 14. Transport information measures 7. Handling & storage 15. Regulatory information 8. Exposure controls & PPE 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 l ook 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 • LD 50 oral rat = 261 mg/kg • Australia harmful Caffeine • Canada toxic • China not hazardous • EU harmful • India non-toxic • Japan toxic UN GHS: • Malaysia harmful Warning, • New Zealand hazardous acute toxicity, • USA toxic cat 3. Different classification and SDS!

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.