Considerations for alternative methods need to be included in your testing proposal
Are you proposing to test on vertebrate animals to fulfil an information requirement for your REACH registration? If so, you need to show that you have considered alternative methods first. With the launch of the new version of REACH-IT on 21 June, these considerations need to be documented in your registration dossier and will be subject to completeness check.
Helsinki, 15 June 2016 – Following a decision of the EU Ombudsman of 11 September 2015 (1606/2013/AN), ECHA has been separately requesting companies who propose tests involving vertebrate animals to show that they have fully considered alternative methods before concluding that a new animal test is necessary. Considerations submitted are published on the testing proposal consultations web page.
With the launch of the new version of REACH-IT, these considerations need to be documented in the registration dossier created with IUCLID 6 and will be subject to the completeness check that ECHA runs on each dossier it receives. This means that after 21 June, a dossier with a proposal to test on vertebrate animals needs to have documented considerations of alternatives for each proposed vertebrate study to pass the completeness check.
IUCLID 6 contains a specific form to assist you in documenting your considerations. Keep in mind that the details you provide have to be meaningful and comprehensive.
All considerations for alternatives submitted in the registration dossier will be published under the Information on Chemicals section of ECHA's website, and therefore you should not include any condifidential information in the form. The information is linked to the third party consultation so that third parties can then take it into account when submitting scientifically valid information or studies that address the substance and the endpoint subject to the testing proposal.
Your considerations and the third party information will be taken into account in ECHA's evaluation of whether the vertebrate animal testing is necessary.
- ECHA asks registrants to show how they considered alternative methods before consulting on testing proposals, Press release 15 November 2015
- Ombudsman's decision (case 1606/2013/AN)
- (consult manual How to prepare registration and PPORD dossiers, page 73 and Table 12)