1. Implementation of the GHS in the EU
Andrew Fasey
Innovators Roundtable
16 November 2005
Charlottesville, USA

2. Why I am here PTK Ltd (now - ??) DG ENTR (2001 - 2004)
Senior Special Fellow for the UN on GHS Implementation
REACH, GHS (industry, EU governments, WHO)
DG ENTR ( )
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)

3. 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
More detail than I can go through during the presentation and probably far more than you are interested in! I will concentrate on the issues that may affect you.

4. 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”

5. 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

6. 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
UNCED – UN conference on environment and development
IOMC – Interorganisational Prog for the safe mgmt of chemicals
WSSD – World Summit on Sustainable Development

7. 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

8. 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

9. 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?

10. Scope / Building Blocks
Freedom to implement
options &/or
classes &/or
categories
For example:
Sensitisation options
CMR options
Transport: classes
Acute toxicity category 5

11. 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

12. Scope - Issues Impact on downstream legislation Comparison EU vs. GHS
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

13. REACH Timing Before After At same time BUT IF REACH DELAYED?
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?

14. 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?

15. 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’

16. Downstream Legislation
Examples
Waste
Prior Informed Consent (PIC: Rotterdam Convention)
Detergents
Seveso (major accident sites)
Worker protection

17. Seveso Directive Acute toxicity 1 & 2 Acute toxicity 1, 2 & 3
Options
Acute toxicity 1 & 2
Acute toxicity 1, 2 & 3
200 mg/kg
Convention to harmonise with GHS
Acute toxicity 1, 2 & 3 and change qualifying quantities
Change aggregation criteria

18. Annex 1 to 67/548/EEC
Transfer all to GHS Regulation
Huge resource requirement to reclassify
Potential to delay
Against principle of self-classification in GHS
WTO concerns
Benefits to H, S & E
Consistency, harmonisation
Transfer CMRs and respiratory sensitisers to GHS Regulation
Consistent with REACH
Easy for CMRs
Few respiratory sensitisers
Rest of Annex 1 to C&L Inventory (EU format)

19. 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?
ADR – the European Agreement concerning the International Carriage of Dangerous Goods by Road (from 1957)
RID - Railways
IMO – International Maritime Organisation
IMDG – International Maritime Dangerous Goods (IMDG) Code

20. Other Issues Weaknesses in GHS Gaps in coverage
guidance
Gaps in coverage
Language & translation (massive in EU)
3rd country implementation
Yes / No
Costs / benefits
Common date
New EU MS
overload

21. Implementation Period
Assuming GHS & REACH at same time
3 years
REACH requirements in advance
1st registration deadline
C&L inventory deadline
11 years
Last (current) REACH deadline
Mixed e.g.
Substances then preparations
To REACH requirements
11 years (e.g.) for all non-REACH

22. 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

23. 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)
Codes needed for downstream legislation.
Codes needed for international agreements such as international chemicals safety cards

24. Ongoing Issues Sensitisation Ozone Depleting Substances (ODS)
Terrestrial toxicity
Water reactive substances
Inhalation toxicity
Neurotoxicity
S-phrases / precautionary statements

25. Ozone Depleting Substances (ODS)
Options
No label
EU symbol
GHS symbol
No requirements

26. 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?)

27. 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

28. 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

29. Contact
Andrew Fasey