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

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, Evaluation Authorisation and Restriction of Chemicals

SubstancePreparation CopperBrass Alloy of copper + zinc Zinc Titanium dioxideWhite Paint [titanium dioxide + …] Ethylene glycolAntifreeze [ethylene glycol + …] Sodium dodecyl sulphateWashing detergent (sodium dodecyl sulphate + …) Ylang-ylang extractFragrance concentrate (ylang-ylang extract + …) REACH Terminology

REACH Terminology : Articles

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) REACH terminology : Roles

–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) Downstream Users

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

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

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 EChA Helsinki PRE-REGISTRATION then REGISTRATION (via SIEF?) If so,

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 Note – REACH applies to substances

Registration Timeline 1 st June 2008 Pre-registration starts. Registration for non-phase in substances starts 1 st Dec 2008Pre-registration ends – Registration of phase-in substances starts 1 st Dec 2010 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 1 st June 2013 Deadline for registration of substances supplied at >100 tpa 1 st June 2018Deadline for registration of substances supplied at >1 tpa

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) Registration

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 Pre-registration of substances

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) Pre-registration

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?

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

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

Enforcement of REACH in the UK

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 Allocation of enforcement responsibility

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

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 Proposed penalties

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 Key Messages

Support for business Trade Associations Commercial helpdesks/consultants EU guidance CA Helpdesk –Telephone: – –UK REACH CA e-bulletin