Current Testing Proposals
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.
Following a decision of the EU Ombudsman of 11 September 2015 (1606/2013/AN), companies who propose tests involving vertebrate animals have to show that they have fully considered alternative methods before concluding that a new animal test is necessary.
For testing proposals for vertebrate animal tests under REACH Annexes IX and X submitted from that date, ECHA has contacted registrants to complete a form with their considerations of alternative methods until an IT solution could be implemented. The completed forms are published on the ECHA testing proposal consultations web page.
With the launch of the new version of REACH-IT in June 2016, registrants need to include the considerations for alternatives for vertebrate animal testing proposals in the registration dossier created with IUCLID 6. The information must be provided in the field Justification for type of information of each vertebrate testing proposal record. The field contains a template that registrants are advised to follow to ensure that they address all the relevant points.
The considerations for alternatives are subject to the completeness check that ECHA performs on each dossier it receives. If the expected elements of the considerations have not been addressed, the whole dossier will fail the completeness check. Only dossiers that are considered complete can be taken into account by any other decision making process in ECHA or, for example, grant the right to an increase of the tonnage band of the registration. It is therefore advisable to ensure that the alternative considerations have been transparently documented in the dossier to avoid delays in responding to regulatory requests or other situations which require a timely update of the dossier.
For testing proposals submitted after 21 June 2016, the registrant's considerations on alternatives to testing can be found in the disseminated dossier accessible via the link under 'View dossier' and hence, a separate document is not published in the testing proposal consultation table.
To view the registrant’s considerations in the dossier, it is important to choose the correct endpoint (for which the vertebrate test is proposed) and, in particular, the correct drop-down menu under the “Currently viewing” options. Please select 002|No specified study adequacy|Planned experimental (testing proposal). The considerations for alternatives are provided in the field Justification for type of information of the testing proposal endpoint study record.
ECHA notes some that some registrations containing such testing proposals have not yet been prepared using IUCLID 6 and hence ECHA still continues requesting companies to send these considerations separately and publishes the completed forms on the Testing Proposal public consultation table.
The considerations and the third party information will be taken into account in ECHA's evaluation of whether the proposed 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.
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