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Planned European Chemical System means progress for consumer health protection
BfR, however, feels that the REACH System is in need of major improvements
Chemicals are present in many products which consumers come into contact with every day. Approximately 30,000 chemical substances are produced in volumes of more than one tonne a year. We do not always know which products these chemicals are used in. Assessment of possible health risks are only available for a small percentage of the 30,000 substances. This unsatisfactory situation, possibly involving some safety gaps, must be remedied. That's what prompted the European Commission to submit a draft regulation containing details on the components Registration, Evaluation, Authorisation and restrictions on the use of Chemicals for which the abbreviation the "REACH System" has been coined. The main thrust is the introduction of an authorisation obligation and an accelerated risk assessment procedure. At a press conference staged by the Federation of German Consumer Organisations (vzbv) on EU chemicals policy, the head of Chemicals Evaluation at the Federal Institute for Risk Assessment described the draft decision today in principle as an important contribution to chemicals safety. Professor Dr. Ursula Gundert-Remy commented, "However, in important areas we urgently need improvements in order to guarantee a sufficient level of consumer health protection".
The REACH System aims to markedly improve knowledge about the use and potential risks of chemicals within a period of twelve years. Amended authorisation and test conditions are to ensure greater consumer protection. One of the new features is public access to information on chemicals which, at present, is currently only available in some cases to manufacturers. For consumers the benefits will be greater knowledge and transparency about use. The use of chemicals in products is also covered by the REACH System. In the same way as manufacturers, the intermediates industry must also comply with its information obligation and prove that no products are placed on the market which may be unsafe for the environment and health. Furthermore, the system also applies to the importers of chemical substances and products.
In concrete terms, the concept envisages the collection of data on toxicological and ecotoxicological properties and on the intended use of just under one third of the 100,000 chemicals on the market. The requirements concerning the scale of information are tiered in line with production volumes. More than 60,000 substances are unaffected by the provisions because of their low production volume (cf. bgvv Press Release 10/2001 of 2 March 2001).
For substances with a carcinogenic, mutagenic or reprotoxic effect, the REACH System prescribes an authorisation procedure in which the intended uses are restricted and specified. Information and existing data on substances with production volumes of more than one tonne must be submitted to a central European agency within certain deadlines.
In principle, BfR welcomes the draft decision and the REACH System on which it is based. The proposed measures promise major improvements for environmental protection. However, in order to sufficiently guarantee consumer protection as well, major improvements are necessary in the opinion of BfR. This applies in particular to the authorisation of chemicals. According to the draft decision only those chemical substances need to be authorized for which a risk from carcinogenic, mutagenic or reprotoxic effects has been proven. According to the Federal Institute for Risk Assessment, the authorisation must definitely be extended to encompass chemical substances for which up to now only indications of such effects are available. For reasons of precautionary consumer protection, they should be subjected to an intensive risk-benefit assessment.
The deadlines laid down in the draft decision reveal an ambitious time schedule. Manufacturers, users, importers and public authorities, too, will all be required to do their bit. At present, the draft decision still does not contain any mention of sanctions in order to guarantee that this time schedule is also complied with. According to the Federal Institute for Risk Assessment, the consumer is entitled to know which substances surround him and are contained in the products he uses every day. "This right", commend Ursula Gundert-Remy, "must be enforced today and not reserved for future generations."