Substances of Very High Concern: Annex XV reports to be commented by Interested Parties
In the framework of the authorisation process, Member States Competent Authorities or the European Chemicals Agency (ECHA), on a request by the Commission, may prepare Annex XV dossiers for the identification of substances of very high concern (SVHC).
Substances of very high concern are defined in Article 57 of Regulation (EC) No 1907/2006 (“the REACH Regulation”) and include substances which are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC,
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
- Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to human health or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters)
The Annex XV report prepared by a Member State or the Agency is available in the table below in order to inform interested parties. The interested parties have 45 days from this publication to give scientific comments on the identification of the substance as SVHC as well as further information related to exposures, alternatives substances and risks and send their comments to the Agency. It would facilitate the evaluation process of comments to receive them in English.
The interested party is 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 below). A justification must be given by the submitting party to explain why the information is confidential. Such confidential information will only be used by ECHA, including its Committees.
In case you want to submit comments, please use the link to the submission form given in the table before the indicated deadline.