Chemicals: Commission presents proposal to modernise EU legislation, October 2003

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Series Details 17.11.03
Publication Date 17/11/2003
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On 29 October 2003, following widespread consultations on its February 2001 White Paper on a Strategy for a future Chemicals Policy, the European Commission issued a Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).

If adopted, the Regulation will establish a European Chemicals Agency and will amend existing Directives to take account of the new legislation. The European Commissioner responsible for the environment, Margot Wallström, described the REACH Regulation as 'a groundbreaking proposal. Once adopted, it will allow us to take advantage of the benefits of chemicals without exposing ourselves and the environment to risks. Thus it will create a win-win situation for industry, workers and citizens, and our ecosystem. It will give Europe's citizens the high level of protection that they have the right to expect. The EU will have one of the most progressive chemicals management systems in the world.'

The legislation will require some 30,000-100,000 chemical substances already in use to be tested, at an estimated cost to the chemicals industry of some €2.3 billion over 11 years, and of between €2.83.6 billion and €4.05.2 billion to 'downstream users'.

Background

Current EU legislation on chemicals distinguishes between those on the market in September 1981 - 'existing substances', which make up 99% of those currently available - and those introduced since that date - known as 'new substances'. These new substances are subject to Directive 67/548, which requires them to be tested and assessed for possible risks to human and environmental health. There are currently no similar requirements for existing chemical substances.

The Summary of the Royal Commission on Environmental Pollution's Twenty-fourth Report states that 'the manufacture and use of chemicals has created risks to the natural environment and human health, many of which are poorly characterised. There is a long history of serious environmental concerns associated with chemicals that were originally thought to be beneficial.'

Lack of public confidence in chemicals and the chemical industry is one of the problems identified in a report by the Lowell Center for Sustainable Production Chemicals Policy Initiative, Integrated Chemicals Policy: Seeking New Direction in Chemicals Management. Other limitations of the current system are said to include:

  • lack of toxicity information, public data, and government attention to the large majority of existing chemicals,
  • exposure to unregulated chemicals used in a wide range of consumer products
  • a risk-assessment process which requires governments to demonstrate that a substance is harmful
  • continued use of inherently dangerous chemicals

The Commission's own justification for reforming chemicals legislation is that it is necessary to:

  • protect human and environmental health
  • maintain and enhance the competitiveness of the Union's chemical industry
  • prevent the fragmentation of the internal market
  • increased transparency
  • integrate with international efforts
  • promote non-animal testing methods
  • conform with the Union's international obligations under the World Trade Organization

To address the shortcomings identified, the Commission has proposed a new system known by the acronym REACH: Registration, Evaluation, Authorisation and Restriction of Chemicals. The main element of the new legislation (published as COM(2003)644) will be a Regulation on REACH, which amongst other things will establish a European Chemicals Agency and amend Directive 1999/45/EC. An associated draft Directive will amend Directive 67/548/EEC.

The main elements of REACH are characterised by the Commission as:

  • Registration: will require industry to obtain relevant information on substances and to use it to manage them safely
  • Evaluation: will provide confidence that industry is meeting its obligations and preventing unnecessary testing
  • Risks: Authorisation will be granted to substances with properties of very high concern which are adequately controlled, or for which there are no suitable alternatives and the socio-economic benefits outweigh the risks
  • Restrictions: intended to provide a safety net for risks not adequately addressed elsewhere in the system
  • European Chemicals Agency: established to manage the technical, scientific and administrative aspects of the REACH system at EU level

Examples of substances which will be subject to authorisation are

Those which are carcinogenic, mutagenic or toxic to reproduction (CMRs - categories 1 and 2), those which are persistent, bio-accumulative and toxic (PBTs), and those which are very persistent, very bio-accumulative (vPvBs). An additional category will also be subject to the RACH authorisation requirements: those substances identified as having 'serious and irreversible effects to humans and the environment equivalent to the other three categories' (e.g. certain endocrine disrupting substances).

Existing chemical substances will be phased into the REACH system, with CMRs and chemicals produced in high volumes having to be registered first. They will have to be authorised from the third year after the Regulation enters into force; chemicals produced in quantities of 100-1,000 tonnes will have to comply from year 6; those in volumes of 1-100 tonnes, from year 11.

There will be exemptions for 'non-isolated intermediates' (chemicals used to make other chemical substances, which are never separated from the mixture of other chemicals inside a chemical system), while isolated intermediates (substances which have been separated out from other substances) will have to be registered, but with simplified information requirements. Polymers will be exempt from registration and evaluation, although registration requirements might be introduced if a practicable and cost-effective way of identifying dangerous polymers is developed.

The draft Regulation takes account of contributions to the Public Consultation on REACH received by the Commission following publication of its 2001 White Paper. The Commission's Extended Impact Assessment concludes that the proposals 'represent a balanced approach which will contribute to improved health for the citizens of the EU and greater protection of the environment; will bring added benefits to worker safety; will improve the conditions for innovation, by making it easier and cheaper to develop new and safer substances; and, also by limiting cost, will help to maintain the competitiveness of the chemicals industry.. The Commission believes that the proposal differs from the White Paper by now recognising the need for a cost-effective system based on:

  • reduced testing costs
  • lower test requirements for chemicals produced in quantities of 1-10 tonnes
  • lighter registration requirements for intermediates
  • the (initial) exclusion of polymers from registration and evaluation
  • encouraging the development, regulatory acceptance, and use of non-animal testing methods
  • the use of Safety Data Sheets rather than the previously proposed Chemical Safety Reports

The consultation process elicited over 6,000 contributions, 42% from industry and some 50% from individuals. Prior to publication of the Commission's proposal, the leaders of France, Germany and the UK wrote to Commission President Romano Prodi expressing their concerns about the new legislation (see Trilateral Letter on New EU Chemicals Strategy).

The Commission's proposal must be adopted by the European Parliament and the Council of the European Union under the co-decision procedure. At the Competitiveness Council (Internal Market, Industry and Research) meeting on 10 November, it was agreed that an ad hoc Working Party on Chemicals, empowered to 'examine the proposal in all its aspects', would be established within the Committee of Permanent Representatives (Coreper). The Italian Presidency asked Coreper to 'continue analysing this issue as a matter of priority in time for the next Competitiveness Council on 27 November 2003.. The Council meeting also heard from Enterprise Commissioner Erkki Liikanen that a conference on REACH had been organised for chemical stakeholders on 21 November 2003.

Further information within European Sources Online

European Sources Online: In Focus
12.5.03: Chemicals industry: European Commission publishes new draft EU chemicals policy, May 2003
 
European Sources Online: European Voice
08.05.03: REACH plans set for year-long delay
22.05.03: Calls for more control of 'cancer' chemicals
05.06.03: Day: Commission's chemicals reforms will foster innovation
03.07.03: Chemicals out of REACH
17.07.03: REACH policy 'could save billions of euro' across EU
24.07.03: EU chemicals policy 'will fail'
18.09.03: Chemicals policy 'threatens German jobs'
09.10.03: Demand for REACH study
23.10.03: Commission to unveil revised chemicals policy
30.10.03: Wallström and Liikanen reveal contentious chemicals proposal
13.11.03: Jury still out on Commission's REACH plan
 
European Sources Online: Financial Times
05.05.03: Brussels to unveil chemicals risk assessment plan
10.07.03: Chemical groups expected to reject EU environment law
14.07.03: Over-REACH
15.07.03: Chemicals industry attempts to water down testing proposals
15.07.03: EU chemicals plan 'could save 69bn euro in health costs'
10.09.03: Chromium maker warns EU rules will cost jobs
10.09.03: New proposals will bring 'huge bureaucratic burden'
10.09.03: Proposals spark fierce controversy
10.09.03: Time for swift action
10.09.03: Why tough regulations are good news
17.09.03: Hewitt attacks chemicals directive
23.09.03: EU chemicals row set to be trial of strength
26.09.03: Brussels to water down controls on chemicals after pressure
06.10.03: Fears for chemical industry from data initiative
09.10.03: Draft EU rules for chemicals 'still do not work'
17.10.03: Cost comes down on chemicals reforms
30.10.03: A better solution
30.10.03: Brussels chemicals plan fails to sway critics

Further information can be seen in these external links:
(long-term access cannot be guaranteed)

EU Institutions

European Commission:

29.10.03: COM(2003)644
VOLUME I
- Proposal for a Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency and amending Directive 1999/45/EC and Regulation (EC) (on Persistent Organic Pollutants)
- Proposal for a Directive amending Council Directive 67/548/EEC in order to adapt it to Regulation (EC) concerning the registration, evaluation, authorisation and restriction of chemicals

VOLUME II [not available at time of writing - try this link]
Annex I General provisions for Assessing Substances and Preparing Chemical Safety
Reports
Annex II Exemptions from obligation to register in accordance with article 6 (a)
Annex III Exemptions from the obligation to register in accordance with article 6 (b)
Annex IV Information requirements referred to in article 9
Annex V Standard information requirements for substances manufactured or imported in
quantities of 1 tonne or more
Annex VI Additional standard information requirements for substances manufactured or
imported in quantities of 10 tonnes or more
Annex VII Additional standard information requirements for substances manufactured or
imported in quantities of 100 tonnes or more
Annex VIII Additional standard information requirements for substances manufactured or
imported in quantities of 1000 tonnes or more
Annex IX General rules for adaptation of the standard testing regime set out in Annexes V to VIII

VOLUME III
Annex X part A to the Proposal for a Regulation

VOLUME IV
Annex X part B to the Proposal for a Regulation

VOLUME V
Annex X part C to the Proposal for a Regulation

VOLUME VI [not available at time of writing - try this link]
Annex XI General provisions for Downstream Users to Assess substances and prepare Chemical safety reports
Annex XII Criteria for the identification of Persistent, Bioaccumulative and Toxic Substances, and Very Persistent and Very Bioaccumulative Substances
Annex XIII List of substances subject to authorisation
Annex XIV Dossiers
Annex XV Socio-economic analysis
Annex XVI Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles
Annex XVII Persistent organic pollutants (POPs)
LEGISLATIVE FINANCIAL STATEMENT

 
DG Press and Communication
Press Releases:
  29.10.03: Chemicals: Commission presents proposal to modernise EU legislation [IP/03/1477]
 
Memos:
  16.10.03: Impact Assessment of the Chemicals proposal [MEMO/03/202]
  29.10.03: Q and A on the new Chemicals policy REACH [MEMO/03/213]
  06.11.03: Presence of persistent chemicals in the human body results of Commissioner Wallström's blood test [MEMO/03/219]
  11.11.03: Results of the Competitiveness Council of Ministers, Brussels, 10th November 2003 [MEMO/03/226]
 
Speeches:
  16.05.03: Margot Wallström: “A new European Chemicals Policy” [SPEECH/03/247]
  27.06.03: Erkki Liikanen: EU Industrial Policy and the Chemicals Strategy [SPEECH/03/332]
  29.10.03: Erkki Liikanen: “Commission's proposal on Chemicals” [SPEECH/03/502]
 
DG Enterprise
  Homepage
    Chemicals
    Extended Impact Assessment of the New Chemicals Policy
    REACH Regulation - Public Consultation
 
DG Environment:
  Homepage
    White Paper on Chemicals [links to all related documents]
 
Council of the European Union:
  Homepage
  10.11.03: Competitiveness Council (Internal Market, Industry and Research)

Governments, official bodies

German Advisory Council on the Environment:
Homepage [in German]
  On the Economic Impact of the Planned Reform of European Chemicals Policy. Statement
 
Royal Commission on Environmental Pollution:
Homepage
  Twenty-fourth Report, Chemicals in Products - Safeguarding the Environment and Human Health
  Summary
Press releases:
  26.06.03: Reducing the risks from chemicals
 
UK Department for Environment, Food and Rural Affairs:
Homepage
  UK Government response to REACH proposals
  20.09.03: Trilateral Letter on New EU Chemicals Strategy
 
United States Mission to the European Union
Homepage
  10.07.03: U.S. Comments on the EU's Draft Chemicals Regime

Industry organisations

American Chamber of Commerce to the European Union:
Homepage
Press releases:
  29.10.03: Business calls on Commission to reconfigure REACH
Position papers:
  16.10.03: Position letter on the draft proposal for REACH regulation
 
American Chemistry Council:
Homepage
  All EU REACH materials
Press releases:
  15.07.03: US chemical makers criticize European regulatory plan
  26.09.03: US chemical makers ask EU to revise new chemicals proposal
  08.10.03: American, European chemical makers object to new draft of EU chemicals regulation
  30.10.03: American chemical makers unimpressed with changes in EU chemicals regulation
 
European Chemical Industry Council (CEFIC):
Homepage
  Chemicals Policy Review
Press releases:
  01.10.03: Chemical Industry: revised REACH proposals a step in the right direction but more substantial changes still needed
  08.10.03: Revised REACH proposals: the right direction on 'scope' but no progress on 'workability'
  16.10.03: Common action for REACH needed
  29.10.03: Cefic continues to co-operate to make REACH workable
  27.06.03: Cefic President Eggert Voscherau calls for a coherent industrial policy and workable chemicals legislation in Europe
  14.07.03: Cefic says bureaucratic REACH system would collapse upfront unless fundamentally reviewed
 
Lowell Center for Sustainable Production Chemicals Policy Initiative:
Homepage
  Integrated Chemicals Policy: Seeking New Direction in Chemicals Management.
  New Directions in European Chemicals Policies: Drivers, Scope, and Status
  Chemicals Policies in Europe Set New Worldwide Standard: Registration, Evaluation and Authorization of Chemicals (REACH)
  Innovative Chemicals Policy Initiatives in Europe: Drivers of the REACH Proposal
  So What? Projected Changes in Chemicals Management under the Proposed European Chemicals Policy
 
Orgalime:
Homepage
Positions:
  09.07.03: REACH regulation: public internet consultation
  09.07.03: Orgalime position on REACH Consultation Documents
 
Risk & Policy Analysts Ltd:
Homepage

Environmental Organisations

Chemical Reaction (a joint project of the European Environmental Bureau, Friends of the Earth and Greenpeace):
Homepage
Press releases:
  29.10.03: Slimmed-down REACH needs healthy supplements
 
European Environmental Bureau:
Homepage
Press releases
  07.05.03: Delay and indecision as Prodi Commission fails to protect us from hazardous chemicals
  08.07.03: European citizens say protect us from hazardous chemicals
  14.07.03: NGOs challenge chemical industry: Be competitive!
  25.09.03: NGOs call on Commission to stop reversing on chemicals reform
  09.10.03: How can the chemical industry lose 5.5 million jobs?
  16.10.03: REACH impact assessment exposes industry scaremongering
 
Friends of the Earth Europe:
Homepage
 
Greenpeace:
Homepage
Press Releases:
  13.10.03: EU chemical regulations must protect public health
Reports:
  Hazardous Chemicals in Consumer Products
  Safer Chemicals within Reach. Using the Substitution Principle to drive Green Chemistry

Media Organisations

BBC News Online:
07.05.03: EU tightens chemical rules
29.10.03: EU launches chemicals crackdown

Eric Davies
Researcher
Compiled: 17 November 2003

Background and reporting on the week's main stories in the European Union and the wider Europe.

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