Implementation of the GHS in the EU

Andrew Fasey [email protected]

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 1 st 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 Regulation

– Huge resource requirement to reclassify •

Transfer CMRs and respiratory sensitisers to GHS Regulation

– 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)

3 rd 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 – 1 st 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 3 rd 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 [email protected]

www.ptkltd.com