ECHA follows up on registrants' obligations to consider alternative tests

ECHA/NI/15/26

ECHA has analysed why registrants submitted 295 new higher tier studies on vertebrate animals without first seeking the Agency's decision to permit such tests.

In general, registrants were able to clarify why the new studies were conducted and submitted for registration purposes. However, in a number of cases further investigation may be needed and ECHA does not exclude the possibility that there may be potential non-compliance with the registrants' obligations to submit a proposal for testing.

As a follow-up to the 2014 report on the Use of Alternatives to Testing in Animals, ECHA screened registrations submitted for the 2013 registration deadline and contacted a number of registrants. The aim was to understand why they had provided information on animal studies in their registrations and had not submitted a prior testing proposal. There may be reasons which are not apparent from the registration dossier why the tests are available; for example, they had been conducted to meet other regulations. Hence there may be valid reasons why obligations under REACH for registrants to submit a testing proposal and await ECHA's decision, had not been followed in these cases.

The outcome of ECHA's analysis showed that some registrants provided complex or unclear responses, others did not provide any reasons for submitting the tests, while others had only generic reasons.

ECHA has informed the Member States on the findings, as it is under the national enforcement authorities' responsibility to decide on potential follow-up measures.