REACH - how it works and its proposed enforcement in the UK Dr Julian Delic UK Competent Authority

1. REACH - how it works and its proposed enforcement in the UKDr Julian DelicUK Competent Authority

2. What is REACH? • New EU Regulation that became law in the UK on 1 June 2007 • It’s big and broad in scope AND • It’s not just for the chemical sector Registration, EvaluationAuthorisation and Restriction of Chemicals

3. REACH Terminology

4. REACH Terminology : Articles

5. REACH terminology : Roles • Manufacturers (registration) • Importers (registration) • Only Representative (registers for non-EU business) • Downstream Users – not consumers (follow use directions; supply information up and down the supply chain) • Distributors - including retailers (information conduit – both ways)

6. Downstream Users • Formulator • End-User • Industrial User • Article Producer • Craftsmen, micro enterprise, professional service providers • Re-fillers • Re-importers (Importers with non-EU supplier using Only Representative)

7. Key features of REACH • Introduces new Registration requirement covering almost all substances manufactured or imported into the EU market above 1 tonne per year – no data, no market! • Information requirements increase with increasing tonnage supplied • Will introduce system for “Authorising” the use of some chemicals

8. Substances not covered Some examples: • Radioactive • Dangerous goods in transit • In customs • Waste (as defined in 2006/12/EC) • Human and veterinary medicines • Polymers

9. Registration Does your company introduce the EU to a substance by manufacture or importation at ≥1 tonne per year? - as the substance itself - within a preparation (mixture of two or more) - within an article, with intended release If so, • EChA • Helsinki PRE-REGISTRATION then REGISTRATION (via SIEF?)

10. Note – REACH applies to substances Two types of substance: “Phase-in” – largely those already around (existing) The following slides refer to these substances. “Non-phase in” – new to the EU

11. Pre-registration starts. Registration for non-phase in substances starts 1st June 2008 1st Dec 2008 Pre-registration ends – Registration of phase-in substances starts Deadline for registration of substances supplied at >1000 tpa; classified under CHIP as Very toxic to aquatic organisms at > 100 tpa; classified under CHIP as Cat 1 or 2 CMR at > 1 tpa 1st Dec 2010 Deadline for registration of substances supplied at >100 tpa 1st June 2013 1st June 2018 Deadline for registration of substances supplied at >1 tpa Registration Timeline

12. Registration • Registration involves submission of a dossier of technical information to the ECHA – through an electronic format • Includes information on: name of registrant, identity of substance, uses, physico-chemical, toxicology and ecotoxicological properties (and possibly assessments of risk and risk management measures) • It will cost to register • The cost to register will vary (e.g. tonnage, data submitted, SME)

13. Pre-registration of substances • There is a period of pre-registration 1 June 2008 – 30 November 2008 • Substances are registered in tonnage-related phases between 2008 and 2018 – but only if pre-registered • Substances not pre-registered must be registered in December 2008 or cannot be manufactured/imported (legally!) and supply has to stop until registered

14. Pre-registration • Pre-registration is free of charge • It flags up an intention to register • It allows the use of the phase-in periods • Simple - done via ECHA electronically • It means you join with others wanting to register this substance in a Substance Information Exchange Forum (SIEF)

15. Registration - Downstream Users • You do NOT need to Register or Pre-register. • Think about the chemicals you use • Standard chemicals in standard ways – nothing to worry about • Niche chemicals or chemicals in a novel way – think about talking to suppliers about registration intentions, are your uses covered?

16. Authorisation of Substances • By June ’09 ECHA will produce a list of substances for authorisation – this will be reviewed periodically and will appear in Annex XIV of REACH. • The list will be drawn off a bigger “candidate list” • Industry will then need to submit an application for authorisation to use. • There will be a cost to apply for an authorisation

17. Proposals for SVHCs CMRs: 4,4’-diaminodiphenylmethane, dibutyl phthalate, cobalt dicholride, diarsenic pentaoxide, diarsenic trioxide, sodium dichromate dihydrate, diethylhexyl phthalate, lead hydrogen arsenate, triethyl arsenate, benzyl butyl phthalate PBT/vPvB:anthracene, cyclododecane, musk xylene, hexabromocyclododecane, short chain chlorinated paraffins (UK), bis(tributyltin)oxide

18. Enforcement of REACH in the UK

19. Allocation of enforcement responsibility REACH contains many duties but these can be divided into: REGISTRATION RELATED DUTIES • HSE in its role as Competent Authority SUPPLY-CHAIN RELATED DUTIES • HSE/HSENI until retail sale (then Trading Standards) USE RELATED DUTIES • existing UK enforcement regime and enforcing authorities for health, safety and environmental legislation

20. Enforcement of use-related duties Environmental protection Health and safety England & Wales & Local Authorities & Local Authorities Scotland & District Councils Northern Ireland Offshore

21. Proposed penalties • Summary conviction, e.g. in Magistrates Courts: - Fine of up to £5,000 and/or - Up to 3 months imprisonment • Conviction on indictment, e.g. in Crown Courts: - Unlimited fine and/or - Up to 2 years imprisonment

22. Key Messages • THE CLOCK IS TICKING – YOU NEED TO BE ACTING NOW • Identify your status under REACH • Your duties will depend on this. • If you have a registration duty (Manufacturers and Importers) – Pre-registration is vital

23. Support for business • Trade Associations • Commercial helpdesks/consultants • EU guidance • http://ec.europa.eu/echa/ • CA Helpdesk • www.hse.gov.uk/reach • Telephone: 0845 408 9575 • e-mail: UKREACHCA@hse.gsi.gov.ukU • UK REACH CA e-bulletin