REACH Introduction and overview

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REACH Introduction and overview

• Julia Laverty
• Institute of Metal Finishing
• 09 October 2007

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Todays presentation

• General introduction to REACH
• Downstream users and REACH
• Overview of enforcement proposals
• The REACH Competent Authority

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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.

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Why REACH?

• gt30,000 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

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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

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Key features of REACH

• New registration requirement covering almost all
  substances manufactured or imported into EU
  market gt1tonne 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

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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

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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

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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 RD

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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

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Key REACH Milestones
1 June 2007 REACH entered into force 1 June
2008 Pre-registration for existing substances
starts Registration for new substances starts
30 November 2008 Pre-registration for existing
substances ends 1 December 2008 Registration for
existing substances starts (those substances
that were not pre-registered) 1 January
2009 List of pre-registered substances
published 1 June 2009 First recommendation of
priority substances to be considered for
authorisation published 30 November
2010 Deadline 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 2018 Deadline for registration of
substances supplied at 1 tpa
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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

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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

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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

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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.

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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

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Enforcement proposals

• User aspects of REACH (Health Safety at work
  aspects)
• - HSE and Local Authority Environmental Health
  Officers according to enforcing authority
  regulations

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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.

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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

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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

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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

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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)

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Regional roadshow events
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To book events

• Email reachcameetings_at_hse.gsi.gov.uk
• Telephone [phone]
• Mail UK REACH CA
• 2.3 Redgrave Court
• Bootle
• Merseyside
• L20 7HS

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Contact details - enquiries

• Email ukreachca_at_hse.gsi.gov.uk
• Telephone [phone]
• Mail UK REACH CA
• 2.3 Redgrave Court
• Bootle
• Merseyside
• L20 7HS
• Website www.hse.gov.uk/reach