Want to search for the relevant question and answer in your own language? Change the language in the dropdown menu above.



Follow up to dossier evaluation decisions

Is it possible to adapt the standard information requirements requested in a decision by using read-across, weight-of-evidence or alternative tests instead of the study requested?

Yes. If you believe that you have scientific grounds to fulfil the requested information by adapting the requests in the decision, you may do so on your own responsibility.

Any adaptation must fulfil the specific rules outlined in Annexes VII to X or the general rules of adaptations specified in Annex XI to the REACH Regulation.

See also ECHA’s Recommendations to registrants.

Categories Display