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BgVV calls for improvements to future EU chemicals policy

10/2001, 02.03.2001

The white paper brings improvements for environmental protection but weakens the position of the consumer

In the middle of February the European Commission submitted a white paper on European chemicals policy. The elements outlined therein will be reflected in future European legislation. The central point is the introduction of an authorisation obligation for so-called "existing substances" which is dependent on a high production volume. Whereas the measures for environmental protection proposed in the white paper bring with them major improvements, they constitute a clear step back for consumer health protection. Substances with carcinogenic or reproduction-toxic properties, which are rightly banned today in consumer products, could in future be kept off the market only after lengthy negotiations about the refusal of marketing authorization. Control of new chemicals coming onto the market has more or less been abandoned. BgVV believes that improvements to the Commission proposals are essential in order to maintain the current level of consumer protection.

The proposals on chemicals policy contained in the white paper endeavour to reflect two orientations: protection of health and the environment on the one hand and the maintenance and strengthening of competition of the global leading European chemical industry on the other. The concept envisages recording data within the next 12 years about the toxicological properties of just under one-third of the 100,000 existing chemicals which came on to the European market without being tested prior to the entry into force of the Chemicals Act in 1981. The requirements concerning the scale of information are graduated depending on production volume. In practice, this means that for around 30,000 chemicals basic data for the assessment of acute and chronic toxicity must be submitted within the next 12 years. Only for a maximum 5,500 existing chemicals must data on possible reproduction-toxic and carcinogenic potential (for around 2,500 of 5,500 substances) be submitted within the next 10 to 12 years. More than 60,000 existing substances will not be affected by these provisions because of their low production volume.

Bearing in mind that one single study on carcinogenicity takes two to five years, the goal of assessing 5,500 substances in the course of 12 years seems to be more than ambitious. By way of comparison: the most extensive toxicological test programme in the world, the National Toxicology Programme of the United States took 20 years to test the carcinogenic effect of only 500 chemicals. In the opinion of BgVV any failure by industry to submit the data by the stipulated deadline should have clear consequences. This is the only way of ensuring that manufacturers will do everything they can to comply with the deadline.

Despite the above conceptual weaknesses, BgVV welcomes the planned accelerated assessment of existing chemicals. The Institute however repeats its demand that it should be made transparent to the general public as of now

• for which chemicals tests have already been conducted,
• for which chemicals an assessment and, where appropriate, classification could be undertaken
• for which chemicals an assessment and classification was not possible so far because no toxicological data were submitted by the manufacturers. Since this also means that indications of possible risks are missing, these chemicals could be erroneously classified as safe.

Like the European Commission in its white paper, BgVV explicitly calls on the manufacturers to use alternatives to animal experiments wherever possible for the necessary toxicological tests. Through the Centre for Documentation and Evaluation of Alternatives to Animal Experiments (ZEBET), BgVV supports the development of alternatives to animal experiments and also develops its own methods.

For the health assessment of new chemical substances, the recommendations in the white paper constitute considerable reductions in the previous safety standard for the consumer. At present, the Chemicals Act stipulates that so-called "basic data" must be submitted for each new authorisation. Based on these data around 70% of the new substances would not be accepted for processing in consumer products at all or only with constraints because of their toxicity, mutagenic, contact allergen or skin irritating effects. In future, these data must only be submitted for substances with a production volume of over 10 tonnes per year (just 10% of new chemicals). For 90% of new substances no toxicological data would have to be submitted any more. This would mean that no information would be available on the harmful properties of the 200 chemicals which force their way on to the market every year. Within a short space of time there would be a new "homespun" existing substance problem in the EU.

The argument that the previous safety standards for consumers would inhibit the innovation potential of the chemical industry is not accepted by BgVV given the operating results of the German chemical industry. According to the legal situation today marketing can be undertaken when the competent authority has not raised an objection on the grounds of health concerns within 60 days.

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