title: A survey of stakeholder organisations on the proposed new European chemicals policy.
abstract: In February 2001, the European Commission published a White Paper proposing that a single new system of chemical regulation should be applied throughout the Member States of the European Union. The proposed Registration, Evaluation and Authorisation of Chemicals (REACH) system was to include both new and existing chemicals, with the aim of ensuring that sufficient pertinent data were made available to enable human health and the environment to be protected. The policy was founded on the principle of sustainable industrial development, and ambitiously attempted to incorporate the needs and views of key stakeholder organisations, such as industry, trade associations, consumer groups, environmentalists, animal welfarists and Member State governments. During the period between the publication of the White Paper and the on-line publication of consultation documents, as part of a public consultation exercise, in May 2003, many of these key stakeholder organisations produced material in support of or critical of the White Paper, either in part or as a whole. In this paper, we have attempted to review this extensive material and to present it in the context of the current chemical regulatory system that the REACH system will replace. Emphasis is placed on the impact of the new policy on the number of animals used in the testing regimes within the REACH system and the inclusion of alternative methods into the legislation. Although supportive of the overriding aims of the new policy, FRAME believes that the fundamental concept of a risk-free environment is flawed, and that the new REACH system will involve the unjustifiable use of millions of laboratory animals. The new policy does include alternative methods, particularly for base-set substances. Nevertheless, alternative testing methods that are already available have been excluded and replaced with outdated in vivo versions. There is also insufficient detail with regard to the further development and validation of alternative methods, particularly for substances of high concern, such as endocrine disrupters or reproductive toxins, for which no alternative testing methods currently exist.
authors.affiliation: FRAME, Russell & Burch House, 96-98 North Sherwood Street, Nottingham NG1 4EE, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Dandrea
authors.forename: Robert D
authors.initials: RD
authors.lastname: Combes
mesh_terms: D032761:Animal Experimentation / Q000331:legislation & jurisprudence; D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence; D000827:Animal Welfare; D000818:Animals; D004345:Drug Industry; D005060:Europe; D005062:European Union; D006076:Government; D006801:Humans; D007880:Legislation, Drug; D011640:Public Policy; D012106:Research; D018675:Toxicity Tests; D014116:Toxicology; D006113:United Kingdom