1.

Refrains from opposing the adoption of the draft Commission Regulation in the light of the formal commitment received from the Commission in its letter of 5 May 2008 to make the following arrangements to streamline and speed up the Commission's internal procedures for the validation and regulatory acceptance of new alternative test methods: — the Commission will introduce a ‘preliminary analysis of regulatory relevance’ in all cases to ensure that subsequent scientific validation focuses on test methods that have the best potential to be considered suitable for clearly identified regulatory purposes; — the Commission will reduce the number of steps and establish new and clear deadlines to streamline and accelerate the current process, insofar as the role of advisory committees and consultation with Member States is concerned; — all important procedural decisions to be taken by the Commission will be taken at Director-General level; — the current reorganisation of the JRC Institute for Health and Consumer Protection (IHCP) will make an important contribution to accelerating the on-going efforts to advance alternative methods, including their validation, via ECVAM. This will involve reinforcement of ECVAM's work through support by other IHCP teams. The IHCP is also developing an integrated testing strategy which will leverage the synergies of many complementary activities within the IHCP and allow a more holistic and effective approach to the question of risk assessment, which is central to the regulatory process, thus avoiding unnecessary internal transmission delays. The integrated testing team will, in 2009, consist of about 85 staff members (including the present 62 ECVAM staff members). As part of its contribution to streamlining the process from scientific validation to regulatory acceptance, IHCP will ensure close and consistent follow-up of the regulatory acceptance process both within the Commission and at the level of the OECD; — the revised process will be more transparent. The procedures for regulatory acceptance of new test methods will be published on the Commission's website once the current review is formalised. The current status of proposed alternative methods will be posted on a specific website to be set up by the JRC allowing interested parties to track progress; the information will be regularly updated. This will happen from the moment any proposed new alternative method undergoes a preliminary regulatory analysis. The website will also include an indication of decisions not to proceed with a particular test method and the reasons why such decisions are taken; — the Commission will ensure that stakeholders have the opportunity to intervene, as observers, in Competent Authorities' meetings and in Committees of the European Chemicals Agency (for industrial chemicals) when matters relating to validation of non-animal tests are concerned; — in line with Article 13(2) of the REACH Regulation, the Commission will provide for a more transparent process involving consultation of stakeholders in the run-up to any proposal for an Adaptation to Technical Progress of the Test Methods Regulation; — the Commission will make the necessary resources available to ensure that real improvements are achieved, in particular by inviting applications from qualified staff with the relevant expertise to be seconded to the OECD Test Guidelines Programme (TGP) in the near future. It will look into possibilities of providing financial support to the OECD TGP Secretariat, concentrating specifically on regulatory acceptance of alternative test methods; — the Commission will monitor the OECD process closely in each individual case to make sure that following this route does not entail undue delays. This will include systematic stocktaking of the progress of each alternative method at regular intervals. Any unreasonable delays in relation to a particular method will result in the Commission launching the EU process for regulatory approval for the method in question;