Brussels, 13 December 2005
The European Commission welcomes the Council’s political agreement on a comprehensive new system aimed at ensuring greater safety in the manufacture and use of chemical substances. The new system, REACH, will establish an 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 the public authorities, will have to assume greater responsibility for providing the necessary information and taking effective risk management measures. The formal Common Position of the Council should be approved under the Austrian Presidency in May 2006, a step that will pave the way for the second reading of the proposal by the European Parliament. Parliament adopted its first reading of REACH on 17 November.
Commission Vice-President Günter Verheugen responsible for enterprise and industry policy 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.”
Commissioner Stavros Dimas responsible for environment policy said: “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. Today’s agreement presents to our citizens a chance for a healthier life and a safer environment.”
REACH stands for Registration, Evaluation and Authorisation of Chemicals. This new EU regulation will replace 40 existing legal acts and create a single system for all chemical substances. It will introduce a new European Chemicals Agency to be established in Helsinki, Finland, which will manage the registration of substances, through the setting up of a database. It will play an important role also in the evaluation and authorisation of substances.
REACH will require manufacturers and importers to gather comprehensive information on properties of their substances produced or imported in volumes over 1 tonne per year and to submit the necessary information to demonstrate their safe use in a registration dossier to the European chemicals agency. Failure to register will mean the substance cannot be manufactured or imported to the EU market.
Member States’ public authorities will examine registration dossiers and substances of concern. They will also scrutinise all proposals for animal testing to keep it to the minimum absolutely necessary. Use-specific authorisations will be required for chemicals that cause cancer, mutations or reproduction problems, or that accumulate in our bodies and in the environment. Authorisation will be granted only to companies that can show that the risks are adequately controlled or if social and economic benefits outweigh the risks and suitable alternative substances do not exist. This will encourage substitution of unsafe substances by safer ones.
Existing system not working
REACH will improve the current EU chemicals legislation, which distinguishes between so-called “existing” and “new” chemicals. All chemicals that were put on the market before 1981 are called “existing” chemicals. They amount to around 100,000. Chemicals introduced after 1981 (around 4,300) are called “new” chemicals. While new chemicals have to be tested, there are no systematic provisions for the existing substances. Consequently, in volume terms, safety information is sketchy for around 99% of these existing chemicals.
As national competent authorities are responsible for the risk assessment of new chemicals, the process is slow, cumbersome and resource-intensive. For example, since 1993, 140 high-volume chemicals have been singled out for risk assessment, of which only a very limited number have completed the process. In addition, the existing system discourages the introduction of new and possibly safer chemicals – thereby giving no incentives for innovation.
It is expected that the final decision on REACH will be reached by the European Parliament and Council in autumn 2006. The Commission expects entry into force of the Regulation for spring 2007. Thereafter it will take about a year for the REACH Agency to be operational. Accordingly the operational requirements of REACH are expected to start to be applied from 2008 onwards.