TSAR : Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals

Regulatory Approval
Stage 3: Draft Proposal consultation
The Commission consults the draft proposal with Regulatory Competent Authorities and Stakeholders.

As soon as the consultation with the National Coordinators is completed, the EU Coordinator forwards the recommendation to DG ENV.
DG ENV seeks the advice of the Member States' Competent Authorities by means of a "silent consent" written procedure, with a deadline of three weeks.
It also ensures that stakeholders are consulted.
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.