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European Unions REACH

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Title: 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!
3
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

4
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
6
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

7
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

8
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
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