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July 2003 |
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Safety in reach |  Back to contents | |
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A radical new approach to evaluate and approve chemical substances is currently taking shape within the EU. For many, particularly in the environmental and consumer field, it is not before time. The existing EU approach is seen as slow and cumbersome with the result that final risk assessments have been completed on only a small number of substances. The new approach will speed up the process of evaluation, and will involve both the manufacturers and the users of chemicals in order to try and decide once and for all which chemical substances are safe and which are not. ONGOING DEBATE Debate on a new approach to EU chemicals policy has been ongoing for some years. In January 2001, the Commission set out its thinking on the subject in a white paper which looked at the problems of the current approach and identified some key elements for a future strategy. It noted that the chemical industry is Europe's third largest manufacturing industry, employing 1.7 million people directly and with up to three million jobs being dependent on it. As the white paper stated, EU policy needed to provide incentives for technical innovation and the development of sustainable chemicals in order for its industry to remain competitive. However, it was recognised that this was being hindered by the burdens of the present notification system. At the same time, too many chemical-related health problems were being experienced within the EU and legislative action to protect citizens and the environment was proceeding too slowly. In developing a new approach, the Commission identified seven key objectives that must be met in order to achieve sustainable development in the chemicals industry within the framework of the EU's single market. These are:
Two years on and the Commission has come up with some concrete proposals for its new system. It is currently consulting on these before submitting a formal proposal to the Council. The new system will be known as Registration, Evaluation and Authorisation of Chemicals (REACH). A key difference from the current two-tier approach, which treats "new" substances differently from "existing" (ie, pre September 1981) ones, is that all substances will now come under a single regime. CENTRAL AGENCY At the heart of the new system would be a central agency which would provide technical expertise to the Commission and others and would establish and run the IT infrastructure of the system. Among other things, it would advise the Commission on priorities for setting up the authorisation procedure, on applications for authorisations for the uses of substances of very high concern and on risk reduction measures for dangerous substances. It would also establish a forum of member states to co-ordinate a network of enforcement authorities, which would promote a common approach to implementation. In addition, it would establish and maintain a classification and labelling inventory of chemical substances in the form of a publicly accessible database. All non-confidential information on substances would be made publicly available over the internet by the agency. There would be a strict procedure for determining applications by companies to keep information confidential. The proposal also lists the sort of information that would not be considered as confidential such as the results of toxicological or eco-toxicological studies, safety guidance notes and any animal testing undertaken. DUTY OF CARE AND REGISTRATION Under the REACH system all manufacturers and downstream users of chemicals would be under a duty of care to manufacture or use their substances in such a way that under reasonably foreseeable conditions, human health and the environment are not adversely affected. Manufacturers and importers who produce or bring in more than 1 tonne of chemical substances per year would be required to register their substances with the agency. This would involve performing a chemical safety assessment of their substances, a duty also imposed on downstream users. Proposals to use chemicals in a different way to that listed in the registration would have to be reported to the agency. It would check registrations for completeness and then forward them to the relevant member state. The information to be provided upon registration would consist of a technical dossier and a chemical safety report and would vary according to the volume of substances involved. It would include elements such as the intrinsic properties and hazards of each substance, its intended use and exposure scenario, an assessment of human health and environmental risks, and a statement on the management of these risks. Companies would not necessarily have to do their own testing to register. They could make use of other information available, such as studies from other countries, previous animal testing, available in vitro data, epidemiological studies etc. One of the aims of the new regime would be to keep animal testing to a minimum. For low volume chemicals (1-10 tonnes per year) it is envisaged that animal testing will as far as possible be avoided. Animal testing for larger volumes would be permitted where existing information and validated alternative methods were insufficient. However, these tests would need to be agreed with the competent authorities before experiments could start to ensure they were relevant, scientifically valid and did not duplicate other tests. All actors in the supply chain would be required to communicate appropriate information down this chain. EVALUATION AND AUTHORISATION Substances produced in volumes higher than 100 tonnes per year would have to be evaluated by the competent authorities of the member states, as would any substances of concern. There would be two levels of evaluation - standard evaluation and priority evaluation. The competent authorities would use the latter in cases where they required more information than that contained in the registration dossier or where they had reasons for concern. Those substances considered to be most hazardous would be subject to authorisation before use. Companies applying for an authorisation would have to demonstrate that they could adequately control the risks posed by the chemical substance concerned or that the social and economic benefits of the substance outweighed the risks. The possibility for substitution would also be considered. Within the proposal, hazardous substances fall under three main definitions:
Endocrine disrupting substances and other substances that give rise to similar levels of concern would be subject to authorisation on a case-by-case basis. ENFORCEMENT AND PENALTIES On the issue of enforcement, the proposal is vague, saying merely that member states must maintain a system of official controls and other activities appropriate to the circumstances in order to check that the regulation is being observed. With regard to penalties, these would have to be effective, proportionate and dissuasive. Any fines imposed must not exceed 10 per cent of the annual worldwide turnover of the offender. However, the fines must have a deterrent effect and would have to be increased where there were aggravating circumstances such as it being a repeat offence or where there was an obstruction of the investigation. Member states would have to send an annual enforcement report to the agency. Finally, the new system would include a process allowing the Commission to impose restrictions on any substance, for example, a prohibition or conditional usage. Member states would be able to suggest restrictions by submitting a dossier to the agency. Full details of the Commission's proposals can be found
at The UK government's position on the REACH system can be found on the Defra website at www.defra.gov.uk/environment/chemicals/pdf/necs-ukposition.pdf
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