REACH Key principles

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REACHKey principles

• 2-3 April 2009, Hong Macao
• Magnus Gislev European Commission
• Delegation in Beijing

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Contents

• Background
• From authority to industry responsibility
• Key elements REACH
• Registration
• Evaluation
• Autorisation
• Restriction
• Implementation timetable
• Conclusion

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Background

• Chemicals industry in EU 30,000 companies
• 1.9 million employees
• Up to 1981 100,106 existing chemicals on EU
  inventory
• Since 1981 another 4,000 new chemicals

4
Old EU legislation

• Existing substances could be used without testing
• lack of knowledge about their properties and uses
• Burden of proof was on public authorities
• Old system slow to act
• no efficient instrument to deal with problematic
  substances
• Lack of incentives for innovation
• in particular for less hazardous substitutes

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REACH Goals

• Protect health and safety
• Protect environment
• Maintaining a competitive/innovative chemicals
  industry
• To reach goals industry must provide the data

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More responsibility for industry

• Industry to demonstrate safety of chemicals
• Properties of substances
• Use of substances
• Risk assessment
• Risk management
• Why? Those who manufacture and use the
  substances have easier access to information than
  authorities

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REACH

• Regulation (EC) No 1907/2006 of the European
  Parliament and of the Council of 18 December 2006
  on the Registration, Evaluation and the
  Authorisation of Chemicals
• Scope
• manufacture, import, placing on market and use
  of substances (on their own, in preparations or
  in articles)

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Key elements of REACH

• Registration of substances 1 tonne/yr
• Evaluation of some substances
• Authorisation only for substances of very high
  concern
• Restrictions - the safety net (EU action)
• Agency to efficiently manage system

Focus on priorities Substances with high
volumes and those of greatest concern!
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Registration (1)
AIM Ensure industry adequately manages risks
from substances

• Registration
• Tonnage based
• Applies to chemicals manufactured in the EU
  and/or their importation
• Registration deadlines 2010, 2013, 2018

• Industrys responsibility

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Registration (2)
Information and Communication
Industry obtains and communicates the necessary
information to adequately control the risks

• Registration by manufacturers and importers
• Collect information up and down the supply chain
• Assess information
• If volumes gt10 tonnes, assess the risks and
  determine appropriate risk management measures
• Communicate results down the supply chain
• Registration is the documentation that the above
  obligations have been carried out.

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Pre-registration
Aim Sharing of information

• Pre-registration
• Manufacturers and importers
• 1 June 2008 until 1 December 2008
• Extended deadlines for registration
• Data sharing

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Evaluation
industry is meeting obligations Prevent
unnecessary testing
Aim Check if more information is needed

• Dossier evaluation
• By the European Chemicals Agency (ECHA)
• Examination of testing proposals
• Compliance check
• Substance evaluation
• By EU Member States competent authorities
• Rolling plans with substance prioritisation
• Follow-up suspicion of risk request more info

• Authorities responsibility

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Authorisation
Aim Ensure risks from substances of very high
concern are properly controlled

• Applies to
• Substances of very high concern (SVHC) (CMR, PBT,
  vPvB, scientific evidence of probable serious
  effects)
• Substance, substance in preparation (unless below
  concentration limit), substance incorporated into
  an article
• Substance cannot be used unless authorised
• Substances progressively authorised
• Downstream users can use suppliers authorisation

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Restrictions
Aim act as safety net

• EU-wide concern
• EU Member States and European Commission initiate
• ECHA Committees examine
• Risk
• Socio-economic aspects
• European Commission - final decision
• Carry-over of existing restrictions from previous
  legislation

• European Commissions responsibility

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Data sharing

• Data sharing mechanisms of REACH
• avoid unnecessary testing, while generating
  necessary information to identify hazards and
  manage risks of substances
• avoid animal testing, tests on vertebrate animals
  as a last resort only
• reduce costs to industry
• Inquiry and Substance Information Exchange Forums
  (SIEFs)

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REACH timeline

• June 2007 - Entry into force of REACH
• June 2008 - Agency operational
• Pre-registration until 1 December 2008
• - Registration begins
• June 2009 - First substances prioritised for
  authorisation
• June 2010 - New restrictions
• End 2010 - First registration deadline for 1000t
  CMR
• End 2018 - Last registration deadline for 1t

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Conclusions

• REACH aims for better health and safety and
  environmental protection
• Industry responsibility demonstrated at
  registration
• Key role for European Chemicals Agency and Member
  States authorities
• Governments can tack action to control dangerous
  substances

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More Information
Thank you!
http//echa.europa.euhttp//ec.europa.eu/environm
ent/chemicals http//ec.europa.eu/enterprise/chem
icals