Examination of testing proposals
Testing on vertebrate animals is the last resort for obtaining missing information on a substance and to be able to meet the information requirements of REACH. ECHA studies all the proposals to check that reliable and adequate data will be produced and to prevent unnecessary animal testing.
ECHA publishes every testing proposal that involves vertebrate animals and invites third parties to submit scientifically valid information or studies addressing the substance and hazard endpoints in question that could be taken into account by ECHA in preparing its decision on the testing proposal. The information has to be submitted within 45 days.
The options for the draft decision area:
- Acceptance of the testing proposal
- Acceptance of the testing proposal with modifications of the testing conditions
- Acceptance or rejection of the testing proposal but requiring one or more additional tests
- Rejection of the testing proposal
ECHA adopts the decision based on the proposal and the information submitted by third parties.
When the decision covers any of the first three options and several test proposals have been submitted for the same substance, registrants have to agree on who carries out the test.
Inadmissible testing proposals
There are several reasons for closing a testing proposal examination before referral to the Member State competent authorities. These include the cessation of manufacture or import by the registrant, withdrawal of the testing proposals, and inadmissibility.
Inadmissible testing proposals are those where REACH does not foresee a testing proposal examination. These cases are where:
- the proposal is addressing Annex VII and VIII endpoints;
- testing is already ongoing or completed;
- a testing proposal instead of testing results was submitted to address a previous decision of a Member State competent authority according to Article 16(1) or (2) of the directive for classification, packaging and labelling of dangerous substances (see also Article 135 of REACH).