If your registration is for a substance manufactured or imported in quantities of 100 tonnes or more (REACH Annex IX), or respectively of 1 000 tonnes or more (Annex X), you need to submit a testing proposal for studies on vertebrate animals if a valid test result is not available.

As a registrant, you have to make an effort to consider the potential availability of non-animal testing methods before proposing testing on vertebrate animals. As part of the technical completeness check, ECHA verifies that your registration includes considerations for alternative methods for each proposed vertebrate study included in the endpoint study records.