SUMMARY
The Proposals for new EU chemicals legislation published by the European Commission on 29 October 2003 attempt to bring tens of thousands of chemicals manufactured in or imported into the EU under a single regulatory regime. The process of Registration, Evaluation and Authorisation of Chemicals (REACH) aims to shift the burden of proof of the safety of chemicals on to manufacturers and make it easier to remove highly toxic chemicals from the market. It has proved controversial, largely because of fears that it could result in a disproportionate burden being placed on industry and an increase in the number of vertebrate animal experiments required by the Proposals.
A key issue has been the prioritisation of chemicals for Registration. Under the Proposals, Registration will take place in three stages over 11 years, with the highest production volumes taken first along with identified CMRs (carcinogens, mutagens and reprotoxins). We argue that in an ideal world the system would identify the chemicals that present the highest risk to humans and the environment and deal with those first. We consider this to be impractical and conclude that volume should form the basis for prioritisation. A single pre-Registration phase should be introduced and mass screening techniques used to identify high and low priority chemicals.
It is envisaged that Evaluation of the Registration dossiers will be conducted by Member States. While it is sensible to make use of their expertise and avoid a large new European structure, we believe that the proposed European Chemicals Agency should play a more dynamic role in ensuring that there is consistency across the enlarged EU and that Evaluations address the chemicals of highest concern in a timely fashion.
Environmental NGOs have expressed concern that the Authorisation process proposed does not have enough emphasis on requiring the substitution of chemicals of concern. We agree that there is little value in the legislation if it fails to limit the availability of toxic chemicals but consider the current wording to be sufficient. The subsequent interpretation of the text is of greater concern and we contend that substitution should be the norm but not the rule where there is a suitable alternative. Of equal concern to us is that useful chemicals with no apparent toxicity will be lost to the market because of the costs of testing.
It has been estimated that the Proposals will require the testing of 30,000 chemicals. While some test data may already exist and most chemicals will require little vertebrate animal testing, there are concerns that a substantial number of animal tests will be needed to comply with the legislation. We are concerned that the scale of animal testing has not been properly communicated and justified, in terms of human health and the environment, by either the European Commission or the UK Government. We are also concerned by the speed with which alternative, non-animal tests are being developed and validated.
The UK Government is advocating "one substance-one Registration" as a means of minimising animal testing and reducing costs and bureaucracy. We consider that the Commission's Proposals contain sufficient provision to avoid duplicate animal testing, provided that a single pre-Registration phase that requires the declaration of animal test data is introduced. The Government's proposal requires the formation of compulsory consortia to provide a basis for data-sharing. We consider this to be problematic and believe that companies should be able to make the commercial decision of whether to incur extra costs to ensure confidentiality.
There has been dispute about the impacts on industry and the health and environmental benefits of the Proposals. Particular concerns relate to the indirect costs of the legislation. We consider it important that the legislation has the confidence of all parties to deliver its aims with the lowest possible impact on European industrial competitiveness. The legislation is unlikely to be agreed much before the end of 2005. There is sufficient time to conduct a further impact assessment, with methodology agreed by all stakeholders.
The Government has played an important part in the development of the legislation. We conclude that its stance is, for the most part, sensible and that it has made a welcome attempt to make the debate in the UK an inclusive and constructive one.
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