European Unions REACH

1
European Unions REACH Registration, Evaluation,
Authorization of Chemicals
Status Expected to enter-into-force 2007

• Scope
• Existing (phase-in) and new (non phase-in)
  chemicals
• Priority high volume production chemicals
  chemicals of greatest concern
• Restrictions are provided for
• Exemptions (e.g. waste food non-isolated
  intermediates uses covered by sectoral
  legislation identified individual substances
  certain categories of substances plastics RD
  chemicals etc.)

2

• Who is affected?
• European-based manufacturers and importers (M/I)
• Downstream Users (DU)
• Businesses exporting to the EU

The Supply Chain!
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REGISTRATION
Registrant collects information, assesses risk(s)
and implement/recommend relevant control measures

• Applies to new (non phase-in chemicals)
• Substances produced/imported 1 metric ton/year
• Must pre-register intent by 18 months after
  entry in force
• Registration deadlines tiered upon basis of
  quantity of substance produced/imported per annum
• Obtain adequate risk data perform Chemical
  Safety Assessment (CSA) for substances gt 10
  metric tons p.a (to generate a Chemical Safety
  Report, CSR)
• Reporting requirements dependent on both
  quantity and nature of substance

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Registration contd

• The M/I CSR to cover all uses identified DU
• Each substance to have an Expanded (Material)
  Safety Data Sheet (SDS) with information from the
  CSR. Each Expanded SDS to be accompanied by a
  Exposure Scenario that covers the manufacture
  and each identified use of the substance over its
  life-cycle
• Forces information sharing through the supply
  chain
• NO DATA NO MARKET
• Emphasis is pre-manufacture, not pre-marketing
• Responsibility placed on industry and M/I in
  particular

5
Registration contd

• Includes Substances In Articles (SIA) that are
  intentionally released
• Requires notification of substances of very
  high concern within articles
• present above a concentration limit of 0..1
• exposure of the public or environment during any
  stage of the life cycle
• present above 1 metric ton

Notification is related to the AUTHORIZATION
process
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EVALUATION

• Dossier evaluation (registrants submitted
  information)
• Substance evaluation
• Only some substances will be evaluated
• Establish Community Rolling Plan (CRP) for
  substance evaluation
• Mechanisms to restrict chemicals of
  community-wide concern

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AUTHORIZATION
Ensures risks from substances of very high
concern (SVHC) are properly controlled and
eventually substituted

• Covers
• Carcinogens, Mutagens, and Reproductive
  Toxicants (CMRs)
• Persistent Bioaccumulative Toxics (PBTs)
• Very Persistent Very Bioaccumulative (vPvB)
• Substances of Equivalent Concern (e.g.
  endocrine disruptors)
• Criteria to grant authorization
• Demonstrate adequate control not available if
  cannot establish threshold
• Socio-economic benefits outweigh costs
• Substitutes have been analysed
• List of authorized chemicals will be made public

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SOME IMPLICATIONS

• REACH will impact chemical use and supply
  globally
• Disappearance of some substances from the supply
  chain is inevitable
• Greater information will affect liability

SOME NEXT STEPS

• Identify substances for pre-registration
  URGENT!!
• Identify products (substances, preparations, and
  articles) that may be vulnerable under REACH
• Understand your supply chain