EU legislation

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Ten years of REACH — An animal protection perspective

Katy Taylor

It has now been 11 years since the EU’s new chemicals legislation (Regulation No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals [REACH]) came into force. Two important statements in the REACH Regulation in relation to animal testing and alternatives are: Article 1(1), which states that one of its purposes is to promote alternative methods; and Article 25(1), which states that animal testing should be used as a last resort. This review looks at the mechanisms that were put in place within REACH to achieve these aims and asks, not only if they are being implemented properly, but also if they have been sufficient. Whilst the chemical industry has heavily used data-sharing and read-across, this review concludes that nevertheless over 2.2 million animals have already been used in new tests for REACH registrations. This equates to an annual average of 275,000 animals; 58,000 more per year than the best-case estimate made by the European Commission in 2004. The use of in vitro and (Q)SAR approaches as standalone replacements for animal tests has been relatively low. The levels of funding for research into alternative methods remain low, and there are concerns over the speed of formal adoption of those that have been validated. In addition, there have been issues with the recognition that testing as a last resort and the promotion of alternative methods applies to all parties, including the Commission, Member States and the agency responsible, the European Chemicals Agency. This review provides ten recommendations for better implementation of these two key aspirations, as well as lessons to be learned for future similar legislation.

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Introduction to the EU REACH Legislation

Christina Grindon and Robert Combes

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.
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Introduction to the EU REACH Legislation

Christina Grindon and Robert Combes

FRAME initiatives on the European Union REACH (Registration, Evaluation and Authorisation of Chemicals) system for the safety testing and risk assessment of chemicals, first proposed as a White Paper in 2001, are summarised. These initiatives considered the scientific and animal welfare issues raised by the REACH proposals, and resulted in a number of suggestions for improvement, many of which seem to have been adopted during the current progress of the legislation through the European Council and European Parliament.
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The New EU REACH Regulation Has Finally Been Adopted: Is This the End of the Campaign Trail… or Just the Beginning?

Christina Grindon

The final EU REACH legislation has recently been adopted. This article considers the progress that has been made toward reducing the numbers of animals likely to be required to fulfil the testing requirements, and also considers the benefits to animal welfare and science that have arisen since the original REACH system proposals were published in 2003. Several positive changes have been made, including: the use of exposure-based testing; the requirement for scientific justification of any proposed animal testing; mandatory data sharing; and the fact that the EU is to take responsibility for the development and validation of alternative methods. While these changes are to be commended, there is still much room for improvement, particularly with respect to the adoption of integrated testing strategies that make maximum use of non-animal approaches to expedite the risk assessment process of existing chemicals, with the use of refined and updated animal tests only as a last resort.
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