Select Committee on Science and Technology Sixth Report


55. The Proposals outline two types of Evaluation, to be carried out by the competent authority in the Member State of production:

    a)  Dossier Evaluation (where the principal aim of preventing unnecessary animal testing would be achieved by Proposals being examined in advance) and

    b)  Substance Evaluation (which would enable an authority to require more information from industry).

56. Dossier Evaluation has two stages: a mandatory review of testing proposals and a voluntary compliance check of registrations. The Proposals suggest that the review of testing proposals will be carried out by Member States in order to assess whether the test proposed is necessary and, if so, whether the proposed test conditions are appropriate.[70] This is intended to avoid unnecessary animal testing. In addition, the Member State Competent Authority may check that any Registration complies with the registration requirements. The location of the registering company dictates which Member State will conduct the Dossier Evaluation.

57. For substance evaluation, the ECA would be required to develop guidance on the prioritisation of substances, in order to promote a consistent approach. Member States would then prepare rolling plans of the substances which they wished to evaluate. As with Registration, the new arrangements would be phased in, with testing for substances above 1,000 tonnes having to be completed within five years of the Regulation entering into force, and testing for those above 100 tonnes within seven years.

58. While the CBI welcomes the distinction between dossier and substance Evaluations, it regards the Evaluation system as "unnecessarily complex and burdensome". Particular concerns are the freedom of Member States to undertake Evaluation over and above criteria set by the ECA and the need to harmonise the approach across the EU. The CBI is also concerned that the Evaluation process has no clear end point.[71]

59. A driving principle for the Commission has been the abolition of the distinction between "old" and "new" chemicals. The Scientific Alliance argues that the distinction could still have some value in the Evaluation process: "the Evaluation process for pre-1981 chemicals should be more reactive than proactive. A full Evaluation process should only be enacted to investigate the chemicals where evidence exists that they cause harm".[72] Greenpeace rejects this position: Mark Strutt told us that "history has shown us that chemicals that will be perceived to be safe at one point have subsequently proved to be risky; that exposure has taken place when it was denied that it would take place, and that exposure has had health or environmental impact".[73] We agree. Treating old and new chemicals the same is one of the strengths of the REACH Proposals.

60. Despite Dr Delbeke's insistence that the Evaluation process was risk-based, the Government describes concern that "the European Commission's proposal may not in practice result in all evaluations which are needed being carried out".[74] As drafted, the Proposals indicate that Member States are responsible for drawing up a rolling programme of Evaluation, although the ECA will develop criteria and propose priorities for Evaluation.[75] The UK Environment Agency argues that it will "be crucial to develop a system of prioritisation which will enable a quick screen of the information supplied at Registration to identify chemicals which may be of concern and for which Evaluation should be prioritised".[76] The WWF is concerned that the Proposals would allow some Members States to carry out no Evaluations at all and argues that each country should have to undertake a minimum number of Evaluations.[77]

61. While there are merits in leaving the Evaluation process with the competent authorities in Member States, it is naïve to think that this will result in the rapid identification of substances of concern unless the rolling programmes are subject to ratification by the Commission of the ECA. It is unclear what incentive there is for Member States to either develop or implement their rolling programmes. Member States, protective of their chemical industries, could easily be tempted to move at a pedestrian pace when more energetic progress is required. The Government says it is "considering whether the obligation to conduct substance evaluations should be moved from the Member States' Competent Authorities to the European Chemicals Agency".[78] While this has its attractions, we feel that expertise in Member States' Competent Authorities should be utilised. What is missing from the Proposals, we believe, is strong oversight by the ECA to ensure that a speedy and risk-based approach to Evaluation is employed by all Member States. We recommend that Substance Evaluation remain the responsibility of Member States but their rolling programmes be subject to oversight by the European Chemicals Agency to ensure that Evaluations of chemicals are prioritised according to risk and rapidly undertaken.

70   Article 43. This only applies to Annexes VII and VIII. Back

71   Ev 96 Back

72   Ev 102 Back

73   Q 14 Back

74   DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 94, Q 136 Back

75   Article 38 Back

76   Ev 62 Back

77   Ev 76-77 Back

78   DEFRA, UK Consultation paper on the New EU Chemicals Strategy - REACH, March 2004, para 95 Back

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