Changes in ECHA's decisions for in vitro and in vivo requests to investigate chromosomal aberrations
At its June meeting, our Member State Committee (MSC) agreed:
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to remove the choice between the in vitro chromosomal aberration (CA) test and the in vitro micronucleus (MN) test for REACH Annex VIII data requirement, and request solely the in vitro MN test;
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to request the combined in vivo comet assay and MN test for substances with a chromosomal aberration concern identified in vitro, except for substances showing only aneugenic effects, for which an in vivo MN test must be requested. The MSC considered that substance-specific reasons could justify deviating from this generic principle;
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that centromere staining must be performed when the number of micronuclei is increased in the MN test, to investigate the mode of action (clastogenic and/or aneugenic) of the substance; and
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that ECHA will require the appropriate investigation of target tissue exposure when requesting an in vivo MN assay, alone or combined with a comet assay.
From September 2022, all new dossier evaluation draft decisions texts will follow the agreed approaches for in vitro and in vivo testing.
MSC meeting minutes
Consultation on SEAC's draft opinion on proposed restriction of lead in outdoor shooting and fishing
We are looking for comments on the draft opinion of the Committee for Socio-Economic Analysis (SEAC) concerning the proposed restriction on placing on the market and use of lead in ammunition (for firearms and airguns) for outdoor shooting and in fishing sinkers and lures.
Outdoor shooting includes hunting and sports shooting. Military uses of ammunition as well as uses by police and border authorities are outside the scope of the proposal.
This consultation is open until 29 August 2022.
Submitted restrictions under consideration
New intention to identify a substance of very high concern
An intention has been received for melamine (EC 203-615-4, CAS 108-78-1).
Registry of SVHC intentions until outcome
Assessments of substance groups published
Assessment of regulatory needs reports are now available for:
To get a full list of the substances covered in the group, you can filter the list on our website by group name. Similarly, you can search there if your substances are covered in any assessment of regulatory needs.
Assessment of regulatory needs
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