| European CommissionJRCIHCPTSAR |
| Regulatory Approval |
| Stage 2: Technical conclusion and proposal agreement |
| The Commission, based on the advise received during stage 1 concludes on the appropriate way to incorporate (or not) the method in the regulatory context and preparesa draft proposal. The EU Coordinator (1) compiles and summarises all the comments (2) makes the necessary changes to the draft test method guideline; and (3) prepares a recommendation on whether to move forward with the test method guideline. This step should be completed within three weeks. In cases where further information is required, a further deadline shall be set on an adhoc basis, depending on the complexity of the issues. If necessary, in appropriate cases, a meeting of the National Coordinators may be arranged to discuss difficult issues. All difficult issues will be resolved at this stage of the procedure. |
| 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. |