REACH – Introduction and overview

1. REACH – Introduction and overview Julia Laverty Institute of Metal Finishing 09 October 2007

2. Today’s presentation • General introduction to REACH • Downstream users and REACH • Overview of enforcement proposals • The REACH Competent Authority

3. UK REACH CA: Two crucial points • DEFRA has been the lead government dept for UK REACH negotiations in the EU; and still is for overall REACH implementation in the UK – choosing UK CA; establishing a UK enforcement regime etc. Defra asked HSE to deliver the UK CA role in 2006. • The REACH “regulatory orchestra” is to be conducted by the new European Chemicals Agency (ECHA), based in Helsinki, Finland. National CAs not directly involved in some processes.

4. Why REACH? • >30,000 substances on the EU market above 1 tonne per year • Limited information available on hazards and risks to human health and environment • Increasing public concern over the risks of chemicals – better evidence base required • Current systems slow to produce results and are confusing for industry and for authorities to administer • Rationalises the current EU system for regulating chemicals

5. Aims of REACH • To improve human health and the environment by providing a high level of protection from the use of chemicals • To make people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use. • To allow free movement of substances on the EU market • To promote the use of alternative methods for the assessment of hazards of substances

6. Key features of REACH • New registration requirement covering almost all substances manufactured or imported into EU market >1tonne per year – no data, no market!! • Will introduce system for “authorising” the use of some chemicals • Establishes the European Chemicals Agency (ECHA) • Covers features of the current regime i.e. SDS, increased information requirements with increased tonnage • Transfers responsibility for gathering and assessing data on hazards and risk of chemicals from authorities to industry

7. Scope of REACH • Substances manufactured or imported into the EU at 1 tonne per year or more per manufacturer/importer. • Includes substances supplied in preparations (e.g. mixtures, formulations) to the extent where they are not covered by more specific legislation • Includes substances supplied in articles in quantities totalling over 1 tonne per year (per producer/importer) if certain criteria are met

8. Scope Substances not covered • Radioactive • In transit in customs • Non-isolated intermediates • Waste (as defined in Directive 2006/12/EC) • Substances for use in defence

9. Scope Tailored provisions for substances covered by specific legislation – e.g.: • Human and veterinary medicines • Food and foodstuff additives • Plant protection products and biocides And also provisions within REACH for: • Isolated intermediates • Substances used for R&D

10. How will REACH work? • Substances are registered by dutyholders in tonnage-related tranches between 2008 and 2018 • Pre-registration period from 1 June 2008 to 30 November 2008 • Substances not pre-registered must then be registered immediately in December 2008 or cannot be supplied (legally) • Registration includes submitting a dossier of prescribed information to the European Chemicals Agency

11. Key REACH Milestones 1 June 2007REACH entered into force 1 June 2008 Pre-registration for existing substances starts Registration for new substances starts 30 November 2008Pre-registration for existing substances ends 1 December 2008 Registration for existing substances starts (those substances that were not pre-registered) 1 January 2009List of pre-registered substances published 1 June 2009 First recommendation of priority substances to be considered for authorisation published 30 November 2010Deadline for registration of substances supplied at: ≥1000 tpa; ≥100 tpa and classified under CHIP as very toxic to aquatic organisms; ≥ 1 tpa and classified under CHIP as Cat 1 or 2 carcinogens, mutagens or reproductive toxicants. 31 May 2013 Deadline for registration of substances supplied at ≥100 tpa 31st May 2018Deadline for registration of substances supplied at ≥1 tpa

12. Key issues for downstream users • Make sure that your supplier is going to pre-register to ensure continuity of supply • Ensure that you inform your supplier of how you use the substances so they include that in the Chemical Safety Report as an identified use • Use the substance in the prescribed manner • Feedback experience up the supply chain • If you do not want to your supplier to know how you use the substance supply Risk Assessment and Management Measures to the ECHA

13. Safety Data Sheets (SDS) • What are the changes? - change of heading orders - email contact address for responsible person - exposure scenarios and risk management measures where required, to be included in the Annex to the SDS

14. Safety data sheets (SDS) • When should the changes be made? • When the new information becomes available or when the SDS is next reviewed • Member states have agreed that the focus of enforcement should at the moment lie in the correctness of the contents, rather than the formalities of the formats used

15. Enforcement of REACH • Domestic enforcing regulations are required by 1 December 2008 • Likely to be introduced in the UK early 2008 • Consultative document issued by DEFRA for comment earlier this year • Currently drafting a statutory instrument • DEFRA policy is for enforcement by bodies at premises where they already enforce.

16. Enforcement proposals • Supply chain enforcement of REACH: - HSE to enforce throughout chain up to retail sale (HSENI in Northern Ireland) - Trading standards officers to enforce retail sale

17. Enforcement proposals • User aspects of REACH (Health & Safety at work aspects): - HSE and Local Authority Environmental Health Officers according to enforcing authority regulations

18. Enforcement proposals • Environmental use aspects: - Environment Agency (in England & Wales), Scottish Environment Protection Agency, the Northern Ireland Environment and Heritage Service, Local authorities as appropriate.

19. Role of the UK Competent Authority • Helpdesk • Enforce compliance with registration • Evaluate priority substances • Identify substances requiring authorisation decisions • Nominate and support candidates for EU REACH committees • Liaise with other regulators on downstream enforcement issues

20. Reactive helpdesk • Active since October 2006 • Enquiries received via email or telephone • ~ 60 enquiries per week • Wide range of topics, commonly: • Downstream user requirements • Registration/pre-registration • Scope • Articles

21. Things the helpdesk CAN do • Provide advice on interpretation of the text of REACH • Facilitation role – help dutyholders understand that they have responsibilities and how to meet them • Work with key stakeholders on communicating key messages • Part of the EU network of national helpdesks • Network with other UK helpdesk providers

22. Things the helpdesk CANNOT do • Respond to complaints about the operation of REACH at the European level (ECHA/European level) • Provide input to any assessments being conducted by industry (not like NONS or ESR) • Give views/opinions on draft assessments • Provide support on policy issues (DEFRA)

23. Regional roadshow events

24. To book events • Email: reachcameetings@hse.gsi.gov.uk • Telephone: 0845 408 9574 • Mail: UK REACH CA 2.3 Redgrave Court Bootle Merseyside L20 7HS

25. Contact details - enquiries • Email: ukreachca@hse.gsi.gov.uk • Telephone: 0845 408 9574 • Mail: UK REACH CA 2.3 Redgrave Court Bootle Merseyside L20 7HS Website: www.hse.gov.uk/reach