Introduction to REACH by gregoria

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									      Introduction to REACH

the new EU chemicals Regulation




Steve Bailey,
GlaxoSmithKline
March 2007
                      Overview
   Registration,      Single system to replace 40
   Evaluation,         existing sets of regulations
   Authorisation and  New and existing chemicals
   Restriction of     Occupational, environmental, and
   Chemicals           consumer risks
                       Burden of proof on industry
                       Manufacturer/importer responsible
                           testing and assessment
                           safe downstream use and disposal
                      Why REACH?
 Synthetic chemicals accumulating in
  the environment and in humans
 Public concern and demand for more
  sustainable chemical products
 Old EU legislation not working
    Lack of data on most chemicals
    Lack of knowledge about uses of chemicals
    Users unable to assess chemicals correctly
    Member State authorities have insufficient
     information and resources
    Drag on research and innovation
                  Other EU Chemicals
                Regulations and Initiatives
   Integrated Pollution Prevention and Control Directive
   Chemical Agents Directive
   Carcinogens Directive
   Solvent Emissions Directive
   Water Framework Directive
   Restriction of Hazardous Substances Directive
   Fluorinated Gases Regulation
   Ratification of Rotterdam Convention
   Ratification of Stockholm Convention
   Party to OSPAR Convention
   Environment and Health Action Plan
              How REACH Will Work
 New European Chemicals Agency
                                                             Technical Dossier
                                                 • Identify of the manufacturer/importer
                                                           • Identity of substance
 Registration above 1 tonne                       • Info - manufacture and use of the
                                                                 substance
    about 30,000 marketed substances                  • Classification and labelling
                                               • Guidance on safe use of the substance
    requires dossier of test information     • Study summaries – substance properties
    reduced requirements for intermediates            • Test proposals (if relevant)
                                                          • Exposure information

 One Substance One Registration

 Evaluation above 10 tonnes                           Chemical Safety Report
    about 10,000 substances                             • Hazard Assessment
                                                       • Exposure Assessment
    requires detailed Chemical Safety              • Risk Management Measures
                                                        • Risk Characterisation
     Assessment and Report                               • Exposure Scenarios
                Registration Timetable

 June 2007:
   entry into force in
    Member States

 June 2008:
   European Chemical
    Agency start-up

 2008 – 2018:
   phase-in for
    existing substances


                            Substance Information
                              Exchange Forums
                      Authorisation
 Authorisation of Chemicals
    required for all substances of very high concern
    estimated 1,500-2,000 substances
    will be time limited to ensure progressive substitution
 Substances of very high concern are:
      CMR (Carcinogen, Mutagen or Toxic for Reproduction Cat.1 or 2)
      PBT (Persistent & Bioaccumulative & Toxic) or
      vPvB (Very Persistent & Very Bioaccumulative & Toxic)
      substances of equivalent level of concern
 Applicants must
    demonstrate that risks are adequately controlled or that socio-
     economic benefits outweigh risks
    develop substitution plans or inform on research to find
     alternatives
 Restrictions can be applied to any substance
         Examples of Chemicals at Risk

CMRs                                PBTs & vPvBs
 Certain reagents eg.               Ingredients in consumer
  formaldehyde, epichlorhydrin,       products
  propylene oxide
                                     Packaging constituents
 Certain solvents e.g., dimethyl
  formamide, acetamide               Greenhouse gases

 Certain metal based reactants      Endocrine modulators eg.
  or catalysts e.g., tributyl tin     hormones (review after 6
                                      years)

       These may impact manufacturing processes,
                 products or packaging
             Substances in Articles

 Registration required if:
    substance is intended to be released, and
    substance is present in quantities >1 tonne

 Notification is required if:
    substance is on candidate list for authorisation
    substance is present in quantities > 1 tonne
    substance is present in concentration > 0.1% by weight
   except where there is no exposure
                       Supply Chain Complexity

      Raw materials                    Formulated Products (Tablets and Solutions)

     3 stage process      Transported
       Swiss or UK                                                             3 formulations,
                                                       2 solvents
                        Intermediate C                  1 acid
                                                                               19 excipients,
                                                                               2 other active
                         Source Swiss or UK                                    ingredients
Transported
Intermediate   A        OS Intermediate 1            OS Intermediate 2       Active
Transported
Intermediate   B                                                                 1 solvent
                                                                                  1 acid
                              Raw materials for in
                              house make (Ireland)
         Source              2 raw materials         40+ Registrations required
      USA or France          1 reagent               during supply chain to
                             1 solvent
                                                     manufacture the formulated
                                                     products
      Raw materials
                       REACH and
                   Occupational Hygiene

 Occupational hygiene is fundamental to REACH
  implementation:
      Exposure Scenarios
      Risk Management Measures
      Exposure Limits (DNELs)
      Exposure monitoring and modelling
      Data interpretation
      Risk communication
 N.B. REACH Annex 1 on Chemical Safety Reports
 Guidance still being developed
    REACH Implementation Projects (RIPs)
 Commitment to review Annex 1 within 12 months!
                Chemical Safety Assessment

 Human health
    Evaluate data (animal data,
     epidemiology)
    Decide on classification and labelling
    Establish Derived No-Effect Level
     (DNEL)

 Safety (physico-chemical)
    Explosivity, flammability, oxidising
     potential

 Environmental
    Evaluate data, including PBT and vPvB
     assessment
    Decide on classification and labelling
    Establish Predicted No-Effect
     Concentration (PNEC)
                          Exposure Scenarios

   Describe                                   How does the ES fit with a
       processes and tasks                       COSHH risk assessment?
       frequency and duration                    What if the conclusions are
                                                  different?
       operational conditions
       adequately measured: representative      What if my use isn’t covered
        exposure data or modelling data           by an ES?
       risk management measures required        How can a supplier estimate
   Cover manufacture and intended uses           the exposure levels at my
    throughout substance life cycle, incl.        site?
    waste disposal/recycling                     Should ES be generic or
   For each human population exposed             specific?
    (as workers, consumers, indirectly via       Can COSHH Essentials help?
    the environment, or a combination)
   Included as an appendix to
    Extended Safety Data Sheet
                    Risk Management Measures
 Must cover workers, consumers,             How effective are RMM? Do I
  and general public                            need to measure exposure?
 For workers, consider…                       A different mix of control
                                                options may achieve the
     Hierarchy of control                      same result; are both options
     Principles of Good Control Practice       valid?
      (COSHH)                                  Do I have to use the
     All routes of exposure (inhalation,       recommended RMM from my
      dermal, accidental ingestion)             supplier?
 Determine residual risk (after               What if different suppliers
  RMM implemented)                              give conflicting
                                                recommendations?
 Risk Characterisation – compare              Will control banding schemes
  exposure with the relevant DNEL               like COSHH Essentials help?
               BOHS and REACH

 REACH Steering Group
  reporting to Council
 REACH pages on website
 Workshops/Seminars
  planned for 2007
 Statement on value of
  OH in REACH
                      Useful websites

European Chemical Bureau             http://ecb.jrc.it/REACH/
CEFIC                        http://www.cefic.be/

DG Enterprise                http://ec.europa.eu/enterprise/reach

DG Environment
  http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm

CIA “REACH Ready”                    http://www.reachready.co.uk/

British Occupational Hygiene Society         www.bohs.org.uk/

								
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