Implementation of the GHS in the EU

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					     Implementation of the GHS
            in the EU
                       Andrew Fasey
               andrew.fasey@ptkltd.com

Innovators Roundtable
16 November 2005
Charlottesville, USA
                    Why I am here
• PTK Ltd (now - ??)
      • Senior Special Fellow for the UN on GHS Implementation
      • REACH, GHS (industry, EU governments, WHO)
• DG ENTR (2001 - 2004)
      • ongoing development of GHS: UN & OECD
      • implementation of GHS in the EU
      • author (1 of) of REACH
• UK govn: international chemicals policy (1997 –2001)
      •   author (1 of) of GHS: IOMC drafting group
      •   Head of UK delegation to the UN GHS Committees
      •   Acting Head of UK delegation to IFCS III (Bahia Declaration)
      •   policy on chemicals strategy White Paper
• DG ENV chemicals unit (1994 – 1997)
                    Summary
• As many questions as answers
• NOT to describe the GHS
• Position of the EU institutions
  – Commission
  – Council
• Issues to be addressed, options, likely
  solutions
  –   Scope & Building Blocks
  –   REACH
  –   Downstream legislation
  –   Annex 1
  –   Transport
        European Commission
• WP: GHS to be considered as part of REACH
• EM to the Directive amending 67/548/EEC, 29
  October 2003 – 2003/0257(COD)

  “it is the intention of the Commission to propose the inclusion of the
  … GHS into Community Law as soon as possible”
  & more specifically
  “the Commission will come forward with the necessary proposals for
  having it adopted at the same time as the final adoption of the
  REACH legislation”
       European Council
“invites the Commission to … analyse its
implications for Community legislation and
consider … the need to submit proposals
for its implementation”

– 7 June 2001 on the WP
– 24 June 1999 on the development of the WP
       International Context

• Rio, 1992 – Chapter 19 of UNCED Agenda 21
• Development by IOMC, to end 2001
• UN CETDG/GHS – agreed Dec 2002
• UN ECOSOC – adopted July 2003
• IFCS III - operational by 2008
• WSSD, Jo’burg – operational by 2008
               Context
• GHS is voluntary
• Options etc necessary for political
  agreement
• Increased harmonisation over time
• Reduced ‘ownership’ problems
• Living document
• Improve over time in light of experience
  EU – Implementation Issues
• Existing comprehensive C&L system
  – Substances (67/548/EEC)
  – Preparations (99/45/EEC)
  – Applies to all sectors (apart from transport)
• Downstream legislation
  – 30+ pieces affected
  – Major implications
• REACH
  – Timing, implementation period
  – Part of or stand-alone
    EU – Implementation Issues
• Non-GHS elements
    – GHSify or as now
•   Scope and building blocks
•   Annex I – harmonised C&L
•   New EU MS
•   Competence
    – Commission or MS
• Timing

    European Commission proposal
    - end 2005?
     Scope / Building Blocks
• Freedom to implement
  – options &/or
  – classes &/or
  – categories
• For example:
  – Sensitisation options
  – CMR options
  – Transport: classes
  – Acute toxicity category 5
    Scope / Building Blocks
• Choices (not mutually exclusive)
  – As close to current EU scope as possible
  – All GHS, apply to supply-side
  – Consider each BB, option, class, category on
    merit
  – All GHS, apply to each sector as needed
• International harmonisation
              Scope - Issues
• Impact on downstream legislation
  – Over 30 refer to C&L
  – e.g. Seveso Directive, Worker Protection legislation
• Comparison EU vs. GHS
  – Substances
  – Mixtures
• Labelling
  – Over-labelling
  – Risk based
  – Consumers / users
                      REACH
• Timing
  – Before
     • Ideal but politically possible?
  – After
     • Duties need to be repeated e.g. C&L
     • Change in status e.g. authorisation
  – At same time
     • Onerous but logical

  BUT IF REACH DELAYED?
      Regulatory Instrument
• Regulation
• Article 95 (internal market)
• Stand-alone
  – Relevant to many pieces of legislation incl. REACH
  – Easier to update
  – Incorporate other C&L legislation e.g. transport?
• Part of REACH
  – After 1st reading
  – Too big a change?
  – Dragged down by REACH or vice versa?
    Downstream Legislation
• 30 + pieces of legislation
• How affected
  – Impact assessment
  – Sector by sector
• Choices per sector
  – GHS classes/categories
  – Existing EU criteria
  – Introduce specific criteria
  – Assume ‘equivalence’
    Downstream Legislation
Examples
• Waste
• Prior Informed Consent (PIC: Rotterdam
  Convention)
• Detergents
• Seveso (major accident sites)
• Worker protection
          Seveso Directive
Options
1. Acute toxicity 1 & 2
2. Acute toxicity 1, 2 & 3
3. 200 mg/kg
4. Convention to harmonise with GHS
5. Acute toxicity 1, 2 & 3 and change
   qualifying quantities
6. Change aggregation criteria
        Annex 1 to 67/548/EEC
• Transfer all to GHS             • Transfer CMRs and
  Regulation                        respiratory sensitisers to
                                    GHS Regulation
   – Huge resource requirement
     to reclassify
                                     – Consistent with REACH
   – Potential to delay
                                     – Easy for CMRs
   – Against principle of self-
     classification in GHS           – Few respiratory sensitisers

   – WTO concerns                    – Rest of Annex 1 to C&L
                                       Inventory (EU format)
   – Benefits to H, S & E

   – Consistency, harmonisation
                  Transport
• Substances: differences between transport
  (UNRTDG, chap 3.2) and Annex 1 (67/548)
  – Single inventory?
• Harmonisation across supply and transport
• Implementation date by modal bodies (ADR,
  RID, IMO) – 1 Jan 2007
• Multi-lateral agreements – GHS add to the
  problem?
• Conventions e.g IMDG Code => GHS?
               Other Issues
• Weaknesses in GHS
  – guidance
• Gaps in coverage
• Language & translation (massive in EU)
• 3rd country implementation
  – Yes / No
  – Costs / benefits
  – Common date
• New EU MS
  – overload
     Implementation Period
Assuming GHS & REACH at same time
• 3 years
  – REACH requirements in advance
  – 1st registration deadline
  – C&L inventory deadline
• 11 years
  – REACH requirements in advance
  – Last (current) REACH deadline
• Mixed e.g.
  – Substances then preparations
  – To REACH requirements
  – 11 years (e.g.) for all non-REACH
    Implementation Period
• Long period
  – Spread costs
  – Enable resources to cope
  – Teething problems ironed out
• Short period
  – Less confusion over dual system
  – Benefits realised more quickly
          Ongoing Issues
• ‘Model’ Regulation?
• Continual improvement
• Competence – MS or Commission?
• EU coordination
• MS and 3rd country involvement
• Codification of hazard statements
  (essential for EU & internationally)
            Ongoing Issues
•   Sensitisation
•   Ozone Depleting Substances (ODS)
•   Terrestrial toxicity
•   Water reactive substances
•   Inhalation toxicity
•   Neurotoxicity
•   S-phrases / precautionary statements
  Ozone Depleting Substances
           (ODS)
Options
1. No label
2. EU symbol
3. GHS symbol
4. No requirements
   Structure of EU Legislation
• Keep as close to GHS as possible
• Merge C&L for substances and mixtures (as
  in GHS)
• Transport and supply kept separate as
  different legal basis
• Legal Articles – describe what, how, when
  – General issues
  – Hazard identification, evaluation and classification
  – Packaging
  – Hazard communication: labelling
    (SDS to REACH)
  – Links to REACH (in REACH or GHS?)
          Structure cont.
• Annex 1 – classification and labelling
            criteria
• Annex 2 – hierarchy
• Annex 3 – hazard statements
• Annex 4 – precautionary statements
• Annex 5 – harmonised EU C&L
            Conclusion
• EU plans to implement the GHS
• Proposal by end 2005…
• Downstream legislation = biggest
  concern
• Many questions of principle
• Many detailed questions
• First mover advantage?
• Progressive global harmonisation
      Contact
     Andrew Fasey

andrew.fasey@ptkltd.com

    www.ptkltd.com

				
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