EUROPEAN REVIEW
FOLLOWING A LONG PERIOD of consultation (see issue 22 page 7) the European Commission has finalised its proposals for new laws on the regulation of chemicals. The proposed regulation would replace over forty existing Directives and Regulations. It is estimated that about 99% of currently used chemicals were discovered before 1981 and have not been adequately tested. At the core of the proposed system is REACH a single, integrated system for Registration, Evaluation and Authorisation of CHemicals. REACH would require companies that produce and import chemicals to assess the risks arising from their use and to take the necessary measures to manage any risk they identify. This would reverse the burden of proof from public authorities to industry for ensuring the safety of chemicals on the market.
The registration process would set up a central database managed by a new European chemicals agency which would receive information from the manufacturers on properties, uses and safe ways of handling the chemicals and release 'non-confidential' facts to the public. Certain substances such as polymers would be exempt and the Commission has also reacted to criticism of its previous 'volume-based' approach by making the level of information required proportionate to the risks posed by a substance as well as the amount produced. It is estimated that 80% of the chemicals registered would require no further action.
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The evaluation process would have two parts: any proposals
involving animal testing using the substance are analysed first as one
of the aims of the new law is to reduce animal testing without
increasing industry costs. The Commission hopes that the sharing of
laboratory data and using alternative sources of information will keep
tests to a minimum. Secondly 'where they had justified reasons to
suspect that there was a risk to human health or the environment' the
agency would evaluate the chemical itself. The outcome of the
evaluation could be a request for further information, authorisation or
a ban. |
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controlled. The social and economic importance of a substance and the possible use of substitutes would also be taken into account. Mindful of the need not to hamper with bureaucracy an industry worth €452 billion annually (€80 billion in the U.K.) the Commission has tried to balance 'high standards for protection of health and the environment while safeguarding the competitiveness of enterprises and improving the potential for product innovation'. Thus it proposes to concentrate its efforts on the dangerous chemicals mentioned above when used in high volumes while relaxing the rules on registration of substances used in research and requiring only essential safety information when the volume used is less than 10 tonnes per year. In this way the Commission estimates that an 82% saving has been made compared to the pre-consultation proposals and in its present form the new legislation would cost the chemicals industry €2.3 billion over 11 years. |
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Commissioner Wallström accepts a petition from groups favouring greater controls on chemicals |