National Anti-vivisection Society


National Antivisection Society

EU chemicals testing: Council of Ministers

Next the EU Council of Ministers representing the Member States, attended an Extraordinary meeting of the Competitiveness Council in Brussels on 13 December with the aim of agreeing REACH. The UK, holder of the EU Presidency from June to December 2005, was determined to get political agreement on REACH and therefore proposed a ‘compromise text’ to achieve this.

The REACH proposal that came out of the European Parliament is summarised below, together with some of the key points that the UK put forward as the ‘compromise’ for the European Council of Ministers (Competitiveness Council) meeting:-

Authorisation: The European Parliament voted to introduce a mandatory substitution of dangerous chemicals with safer alternatives where they are available. However, the Competitiveness Council proposal written by the UK Government did not include a substitution. Instead, manufacturers would simply provide an analysis of safer alternatives – and the authorities would not be able to require a manufacturer to stop using a dangerous chemical if the manufacturer could make the case that they can ‘control’ it.

Duty of Care: The European Parliament had addressed a gap in the REACH proposals, where 70,000 substances were excluded from the ‘registration’ under REACH because they are either produced in low volumes – below 1 tonne per annum – or exempt. The Parliament dealt with this gap by adopting a legally-binding ‘duty of care’ for all chemical manufacturers and users, to ensure that they do not produce, market, import or use substances that adversely affect human health or the environment. The Council proposal does not include a Duty of Care.

Registration: Chemicals produced in volumes of 1 to 10 tonnes a year: European Parliament and Council proposals – both weaken the original EC proposal by introducing exemptions for these low-volume chemicals. As we said earlier, this means that animal testing will not be required, because data from some 20,000 chemicals will simply not be collected.

Chemicals produced in volumes of 10 to 100 tonnes a year: The Council had resisted attempts to introduce further exemptions.

The Council of Ministers commented after the meeting that: “The compromise that the Council has reached provides that authorisations should not be granted on the grounds of adequate control in the case of substances that are persistent, bioaccumulative and toxic (PBT), or very persistent, very bioaccumulative (vPvB). For substances where it is not possible for determine safe thresholds with current methods, the proposal provides for a review within 12 months after REACH comes into force. In addition, it was agreed that applications for authorisations should always include an analysis of possible alternatives by the registrant”. With regard to exemptions from Registration, the Council agreed that these should be reviewed within 12 months after REACH comes into force.

Mandatory substitution of dangerous chemicals with safer alternatives – lost: The Council wants to see a systematic analysis of the alternatives, and then review. Industry is in favour of demonstrating that they can ‘control’ chemicals and will continue to push this which maintains the status quo.

Consumer and green groups say that the Council has rejected a crucial principle adopted by the European Parliament. Chemical producers will be be required to simply ‘assess’ substitutes for a hazardous chemical. This loophole represents little change from the current, flawed system, which has failed to control the most dangerous chemicals and hinders safe, innovative products from entering the market.

It was also felt that although the Council strengthened substitution requirements for persistent and bioaccumulative chemicals, which represent only a fraction of all hazardous chemicals – they left the door open for carcinogens, chemicals that are toxic to reproduction and hormone-disrupting substances to stay on the market, even if safer alternatives exist.

Consumer and green groups say it is essential that the Parliament reaffirms its support for ‘mandatory substitution’ at the Second Reading, next year.

Data Sharing/One Substance, One Registration: The Council has chosen to provide “opt-out” clauses for mandatory data sharing, which undermines the whole concept. Mandatory data sharing is essential to prevent unnecessary duplication of animal tests.

Consumer groups and environmental groups such as Greenpeace considered that the Council voted to drastically reduce safety data that chemical producers would be obliged to supply, particularly for substances produced in low quantities. Thousands of chemicals could thus stay on the market, despite no health information being available. This, too, undermines the likelihood of identifying safer alternatives.

The Greens in the European Parliament commented that the Council had accepted most of the bad proposals from the Parliament, while it largely ignored the positive elements.

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