Current Testing Proposals
Current Testing Proposals
Here you can find the substances and hazard endpoints for which ECHA is currently inviting third parties to submit scientifically valid information and studies.
Please also note the following:
The link under 'View dossier' to the registered substances website allows easy access to the aggregated dossiers containing further details of the testing proposed including the test method (e.g. if a modified test method for a repeated dose toxicity study has been proposed). Related information on the substance subject to the testing proposal can also be seen through this link to the aggregated data per joint registration for a substance, which has been obtained from all registration dossiers that are part of that joint registration. If the related dossier has not yet been disseminated or the substance identity is confidential, such a link cannot be given.
The Total Tonnage Band published does not necessarily reflect the registered tonnage band(s) and associated information requirement obligations. For the 'Total Tonnage Band' of the disseminated dossier, compiled data is calculated from the non-confidential quantities of a substance manufactured and/or imported by all registrants, excluding any quantity directly used as an intermediate to produce a different chemical.
In some cases, the registrant may propose testing under Annex IX and X of the REACH Regulation even if the registration tonnage band is lower than the tonnage band of the REACH Annex for which the test is proposed. Such specific testing proposals may be triggered by a concern identified from previous study results and their assessment in the chemical safety report (e.g. based on Annex I.0.5 or the second column of Annex VIII section 8.7.1). This is indicated with a note after each relevant endpoint showing that the testing proposal is based on a concern identified by the registrant.
For testing proposals on extended one-generation reproductive toxicity study (EOGRTS) third parties are invited to submit scientifically valid information and studies especially on reproductive toxicity, (developmental) immunotoxicity, (developmental) neurotoxicity and endocrine disruption (evidence on hormonal changes). Further details of the study design proposed by the registrant for EOGRTS are available in the disseminated dossier if they are public. With the launch of the new IUCLID 6 in 2016 more structured information will be provided on the EOGRTS study design in the disseminated dossiers.
The registrant may have proposed to apply a read-across/category approach for one or more of the testing proposals based on adaptation according to Annex XI.1.5 of the REACH Regulation. This is indicated for the relevant testing proposal endpoint(s) with a note that testing is proposed for another substance than the registered substance, giving the proposed test substance name and, where available, the EC or CAS number.
As of 11 September 2015 ECHA requires registrants that make testing proposals involving vertebrate animals for details on how they have considered alternative methods to address the missing information. This is a follow-up action of the European Ombudsman's conclusion in case 1606/2013. The registrant's considerations on alternatives to testing can be found under each vertebrate testing proposal in the disseminated dossier accessible via the link under 'View dossier'. These considerations will be taken into account in ECHA’s evaluation of whether the vertebrate animal testing is necessary.
To see if testing proposals submitted by registrants, and for which ECHA has held a third-party consultation, were subsequently withdrawn, please consult the table below or the Previous Testing Proposals table. First, follow the link to the related aggregated registration dossier (if it is already published). There you can review the details of the testing proposed and other information on the substance that is subject to the testing proposal. The admissibility of any testing proposal will be concluded only after the third party consultation. Later during the testing proposal examination process, you may check the same section in the disseminated dossier to see if a testing proposal previously present has been withdrawn. The reasons for withdrawal may be that the registrant has reviewed their assessment or has taken into account the third-party comments provided to ECHA and communicated to them.