Propuestas de ensayo
Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires that information on toxic effects of substances is obtained by manufacturers and importers of substances. They can then assess the hazards of those substances and ensure that the risks are documented and controlled during their manufacture, use and disposal. However, REACH also requires that new testing of a substance involving vertebrate animals is only carried out as a last resort.
To ensure that the best use has been made of existing information, particularly information on existing vertebrate tests, the European Chemicals Agency's (ECHA) publishes all test proposals involving vertebrate animals, for endpoints specified in Annexes IX and X under REACH, on this webpage before the testing is carried out. After a testing proposal has been published, third parties have 45 days to submit "scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal" (REACH, Article 40 (2)).
Tables for current and previous consultations, which are linked on this page, present the substances, hazard endpoints, deadlines for submitting information and links to the submission format for which ECHA is currently requesting "scientifically valid information" from third parties. If you want to submit such information, please use the links to the submission format given in Current Consultations table and submit your information by the deadline indicated. It would be helpful if you could send your information in English. Please note that the substance name presented in the first column may not, in some cases, provide sufficient description of the substance identity. Manufacturers and importers can in specific cases request that the substance name, including the IUPAC name, is kept confidential. In those cases ECHA cannot disclose the detailed substance name.
You are requested to provide a non-confidential version of the information, which ECHA may make available to the public. There is an opportunity to submit confidential details to support the non-confidential information (see detailed instructions in the submission format), but you must give a justification to explain why the information is confidential.
Any scientifically valid information and studies that address the relevant substance and hazard endpoint, relating to the testing proposal, will be taken into account by ECHA in preparing its decision. ECHA publishes non-confidential versions of its dossier evaluation decisions after they have been sent to the registrants. These decisions will also address ECHA's conclusions drawn from the information provided by third parties. In this way, ECHA wishes to increase the transparency of the dossier evaluation outcomes and encourage submission of relevant information.
This consultation is not for the registrant but it is reserved exclusively to third parties; this covers anybody not directly and individually concerned by the dossier. Specific procedures are available for registrants to provide additional information or modify a testing proposal. Any comments provided by registrants during this consultation will, therefore, not be considered at this stage in the procedure. Once a draft decision has been issued, registrants will have 30 days to submit their comments.