REACH: An opportunity for more consumer protection
On 1 June 2007 new chemicals legislation comes into force in Europe. The draft regulation of the European Commission - known to the public at large as "REACH"- was confirmed today by the European Council of Ministers. The chemical industry, the new European Chemicals Agency in Helsinki and the national authorities have 11 years from June to register approximately 30,000 chemicals, to assess the related risks, to facilitate their safe handling and to submit particularly dangerous substances to an approval process. They will all have to make major efforts if they are to meet the ambitious deadline. BfR has been heavily involved in the shaping of REACH over the last few years. "Many of our proposals have been taken over into the Regulation", was one comment by BfR President, Professor Dr. Dr. Andreas Hensel on the new legislation. "They will help to strengthen consumer and animal protection". Other demands were not taken into account at all or only to a limited degree. They included the protection of consumers from substances with a relatively small annual production volume as well as contact with one and the same chemical through various application areas and different exposure paths. BfR welcomes the obligation to replace highly dangerous substances with less dangerous ones but views the scale of the exemptions, however, critically.
The new European chemicals legislation adds important new elements to the existing provisions on consumer health protection during the production, transport and use of chemicals. For instance, the right of consumers to information about the harmfulness of substances and products has been considerably extended. Practical implementation will show whether this really succeeds.
For the first time REACH reverses the burden of proof: whereas up to now it was mainly the public authorities that had to prove the safety of chemicals, manufacturers and importers must now identify the dangers from their substances, assess potential risks and stipulate measures to rule out any damage to health and the environment.
Graduated according to the annual volume of the chemical placed on the market in Europe, the manufacturers must now for the first time - pursuant to the new chemicals legislation - submit data on the substance or carry out safety trials. What previously had applied to “new” substances only, now also applies to the large number of existing substances, some of which have been used for years. Chemicals placed on the market with volumes below 10 tonnes are exempt from this regulation - in the opinion of BfR this constitutes a deficit in the risk assessment of consumer substances. Furthermore, the Institute believes that the future labelling of consumer chemicals is inadequate because the consumer cannot determine whether and, if so, which dangerous properties a substance was tested for. Labelling is only envisaged if a hazard potential has in fact been identified in safety trials.
By contrast, the approval procedure constitutes a major improvement to consumer protection. Particularly dangerous substances that can cause cancer, modify the genotype, impair fertility or harm the unborn child in the womb must now go through this procedure. The number of such substances is estimated to be around 2,500.
Another important aspect in the legislative procedure was the expected increase in the number of animal experiments in conjunction with additional safety trials. BfR pointed out this critical development early on in a scientific study and proposed improvements to the legal text which permit a reduction in the numbers of animals as long as this does not impair health protection. BfR believes that it is a success of its work that in future scientifically accepted, alternative test methods can and should be used instead of animal experiments. The legislation explicitly obliges the Commission to examine developments in this area and to elaborate further alternative test methods to animal experiments. There are none available for instance for the testing of chemicals which may affect the hormone system and have not been effectively regulated up to now or for the testing of chemicals for possible impairments of fertility and pregnancy.