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| TSAR : Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals |
| Regulatory Approval |
| Stage 4: Final Proposal and adoption |
Preparation and discussion by the Commission of a formal legislative proposal to the Member States that include the method in the regulation. Subsequent vote by the Member States and other comitology procedures, including scrutiny by the European Parliament.
DG ENV includes the draft test method guideline (as provided by the EU Coordinator) in a proposed adaptation to technical progress of the Test Methods Regulation. The proposed measure goes through Inter Service consultation and is translated in all required languages. This part of the process should take a minimum of six weeks. The proposed measure then goes through the regulatory procedure with scrutiny. |
Complete Summarised Scheme
Explanatory note to the revised procedure: The streamlined procedure deals with regulatory acceptance of an alternative test method at EU level. It is important to underline that this does not represent a new procedure; it simply clarifies and streamlines the steps that must be followed if the Commission decides to pursue regulatory acceptance at EU level. It is very clear, particularly following discussions with both the Competent Authorities and the European Parliament, that a new scientifically validated alternative test method will, in the first instance, be submitted to the OECD regulatory acceptance process. It is only in exceptional cases, if there is "undue delay" in the OECD process, that the Commission would then take a decision to "switch" to the EU process. |
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