ECHA asks registrants to show how they considered alternative methods before consulting on testing proposals
To further ensure that testing on animals is only done as a last resort, ECHA has started requesting additional information from registrants who submit new testing proposals for vertebrate animal tests. This follows the European Ombudsman's recent decision about ECHA's role in evaluating testing proposals.
Helsinki, 2 November 2015 - ECHA has sent the first requests to registrants asking them to inform ECHA of their considerations of alternative methods to support their testing proposals involving vertebrate animals. This affects testing proposals made since 11 September 2015.
The information received will be published together with the testing proposals on ECHA's testing proposals consultation web page. Third parties can take this into account when deciding whether to submit relevant information about the substance from alternative methods that may avoid the test. Registrants could consider this information instead of testing on vertebrate animals to fulfil the REACH information requirements. In such cases, the registrant must show that the main objectives of the REACH Regulation, to ensure a high level of protection of human health and environment, can be achieved without the performance of a vertebrate test.
ECHA's Executive Director Geert Dancet says: "ECHA is committed to avoiding any unnecessary testing on animals while ensuring the safe use of chemicals. This new information request to registrants proposing a vertebrate animal test is one of the steps ECHA promised to take in response to the Ombudsman's proposed solution. Human health, safe environment and innovation are the main goals of the REACH Regulation but in ECHA's view, any unnecessary testing on vertebrate animals needs to be avoided whenever it is scientifically justified."
ECHA has started a consultation with the Member States and stakeholders on the further practical steps to implement the Ombudsman's conclusions. The aim is for companies to be able to show their considerations in registration dossiers following the next update of the IUCLID tool in 2016. In the meantime, registrants will be contacted through REACH-IT.
In closing its enquiry into a complaint, the European Ombudsman suggested that ECHA can require registrants that submit testing proposals on vertebrate animals to show that they have considered alternatives to animal testing. ECHA was also requested to share any relevant information concerning alternative testing methods for the registered substance with the registrant. As further measures may be necessary, the Ombudsman will review progress after six months.
- Ombudsman's decision (case 1606/2013/AN)
- Animal testing web page
- Practical guide 10 – how to avoid unnecessary testing on animals [PDF]