REACH Metals Gateway

Testing Proposal Evaluation

Where information requirements addressing a number of intrinsic properties of a substance (as specified by the REACH Annexes) cannot be fulfilled, registrants are responsible for generating this data and providing it in their registration dossier. In some cases the filling of data gaps means that new animal testing will be necessary. REACH however obliges registrants to limit new studies and to conduct animal studies only as a last resort. Registrants must first collect and assess all existing data, precisely identify data gaps and consider whether these can be filled by using either in vitro/ex vivo studies or other alternative approaches, including prediction, methods before any new animal tests are conducted. A testing proposal should be submitted to ECHA and receive their prior approval before testing can start.  ECHA’s role in evaluating testing proposals is to ensure that reliable and adequate data will be produced and to prevent unnecessary animal testing.

ECHA will publish every testing proposal that involves vertebrate animals and invite 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.

Consultations on testing proposals can be found here :

ECHA will consider any scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal when preparing its decision. ECHA publishes non-confidential versions of its dossier evaluation decisions after they have been sent to the registrants.

The options for the draft decision are:

  • 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.

More information can be found here :

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).

Last page update: 1 October 2018