After two years of intense debate, the Competitiveness Council reached a political agreement on the draft regulation for the registration, evaluation, authorisation and restriction of chemicals (REACH) on 13 December.

The new EU REACH regulation will replace 40 existing legal acts and create a single integrated system for the registration, evaluation, authorisation and restriction of chemicals. REACH will ensure that the gaps in existing information on the hazardous properties of some 30,000 chemicals are filled, and that the necessary information on the safe use of substances is transmitted along the industrial supply chain leading to reduced risks for workers, for consumers, and for the environment. REACH will reverse the burden of proof so that industry, both producers and importers of substances, rather than public authorities, will have to assume responsibility for providing the necessary information and taking effective risk management measures.

The Council has backed the compromise adopted by the European Parliament on the registration procedures, which will reduce the number of chemicals needing to be tested from 30,000 to nearer 12,500. Ministers also supported the sharing of data, in order to minimise the duplication of tests, including tests on animals.

At the centre of the debate were 'authorisation' and 'substitution'. Whereas some delegations stressed the importance of providing for strong incentives or even obligations for substitution of dangerous substances, other delegations were worried by the impact on industry if excessive conditions for authorisation were to be adopted. The agreement by the Council aimed at striking a balance between these different views.

The proposal 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). On amendments regarding authorisation - the Parliament had proposed a revision within five years - the ministers said reviews should be set on a individual case-by-case basis. The ministers also said that companies seeking authorisation for dangerous substances would have to prove that the risks could be adequately controlled and provide information on possible alternatives.

The Council also approved the establishment of a new European Chemicals Agency, to be located in Helsinki, Finland. The agency will manage the registration of substances through the setting up of a database. It will also play an important role in the evaluation and authorisation of substances.

The European Commission has welcomed the Council's political agreement. Commission Vice-President Günter Verheugen, responsible for enterprise and industry, said: 'This agreement puts an end to a long period of uncertainty for industry and helps them plan for the very challenging task of meeting the new requirements. The Council's agreement is a reasonable compromise. We have succeeded in making REACH more effective and more workable. And we have succeeded in maintaining the competitiveness of EU industry and - a crucial point - reducing the burden for small and medium-sized companies.'

Environment Commissioner Stavros Dimas added: 'This agreement will represent a marked improvement in the protection of health and the environment. It will reduce chemical related disease and will allow users and consumers to make informed choices about the substances they come in contact with. It will also encourage innovation and give a strong incentive to industry to replace dangerous chemicals with safer ones.'

But not everyone is so pleased. Environmental groups are accusing the Member States of watering down the conditions for the authorisation of toxic chemicals set by European Parliament: the text approved in the first reading required the substitution of hazardous chemicals with safer alternatives whenever possible, whilst the text approved by the Council merely says companies should be encouraged to do so.

In a joint communiqué issued on 13 December, environmental, women's, health and consumer organisations expressed disappointment that EU ministers had 'failed to seize a unique opportunity to protect people and the environment from the threat of toxic chemicals'. They underline that the strengthened substitution requirements approved by the Council for PBT and vPvB represent only a fraction of all hazardous chemicals, and that other carcinogen chemicals that can harm reproduction and hormone-disrupting substances will be not affected, even though safer alternatives exist. Another point of discord concerns the proposed reduction on safety data that chemical producers would be obliged to supply, particularly for substances produced in low quantities (i.e. produced or imported in the range of one to ten tonnes). The communiqué urges the European Parliament to reaffirm its support for 'mandatory substitution' at the second reading, in 2006.

It seems that industry is also not entirely satisfied. UNICE (the European Community's Union of Industries) has welcomed an agreement which goes 'halfway towards the fully risk-based approach advocated by the industry'. And while satisfied with the reduction of information requirements for low-volume substances that will make REACH more cost-efficient for small and medium sized enterprises (SMEs), the employers' confederations represented by UNICE think that appropriate control of the use of the most dangerous substances should be a sufficient condition for unlimited authorisation.

As the agreed text differs from the proposal adopted by the European Parliament on 17 November, the formal Common Position of the Council, to be approved under the Austrian Presidency in May 2006, will have to go back to the European Parliament for a second reading under the co-decision procedure. It is expected that a final decision on REACH will be made by the European Parliament and Council in autumn 2006. The Commission expects the following Regulation to enter into force in spring 2007, and the operational requirements of REACH are expected to be applied from 2008 onwards.