To make comments, the form provided for each substance must be used. Click on "Details" for the substance of interest in the general substance table, and then, at the bottom of the new page, click on the "link to form for consultation on ECHA's draft recommendation".
ECHA will publish the comments received at the end of the consultation. Responses to the comments are provided with the final recommendation.
ECHA takes the comments received into account when updating the draft recommendation. Comments are also consider by the Member State Committee when drafting its opinion.
Taking the MSC opinion into account, ECHA will finalise its recommendation. This is then submitted to the European Commission for the final decision on which substances to include in the Authorisation List.
Documents relevant for the consultation
For each substance included in the draft recommendation, there is a draft background document which contains justification for recommending the substance and for its draft Authorisation List entry.
The draft recommendation itself - which includes the draft entries to be inserted in the Authorisation List (Annex XIV of REACH) - as well as key documents supporting the draft recommendation (e.g. the general approaches used to develop the recommendation and the results of the comparison among Candidate List substances with regard to their priority for inclusion in the Authorisation List) are listed under ‘Related documents’.
The ‘Related documents’ section also contains ECHA's general responses on issues commonly raised in consultations on draft recommendations.
Making comments
When preparing comments, comment submitters are advised to take the descriptions of ECHA's general approaches into account. These approaches reflect how ECHA prioritises substances and how the draft Authorisation List entries are defined.
Comment submitters are also advised to refer to ECHA's general responses on issues commonly raised in consultations on draft recommendations. The document describes which information is relevant to this step of the authorisation process and also clarifies what type of information cannot be considered by ECHA at this step of the authorisation process including the reasoning. The document has been developed by compiling the responses provided in a consolidated form to address individual comments submitted in past consultations.
The following types of comments are relevant for the consultation. ECHA would be grateful if interested parties could submit their comments in English. Comments received after the deadline will not be taken into account.
- Comments on Authorisation List entries
The main focus of the consultation is on the draft Authorisation List entries for the substances prioritised by ECHA. In this context, comments on the complexity of the supply chain are particularly welcome.
Such information is used to support a comparative assessment among substances included in the draft recommendation on the time potentially needed for preparing authorisation applications. This will be taken into account when deciding on the latest application date slot (typically 18, 21 or 24 months after the inclusion of the substance in the Authorisation List) for the substance.
Relevant information includes in particular details of the sectors relying on the substance, as well as the type of products and articles in which the substance ends up. For each sector/application, further information on the number of successive actors in the supply chain (e.g. formulators, industrial, professional or consumers users, users of articles) is considered as well as the number of industrial sites where the substance is used.
- Comments on those uses that comment submitters believe should be exempted from the authorisation requirement are also welcome.
When proposing such exemptions, the conditions of specific EU (not only national) legislation ensuring that the risk resulting from the specific use of the substance for human health or the environment is properly controlled and imposes minimum requirements relating to the protection of human health or the environment for the use of the substance should be taken into account (Article 58(2) of REACH). For further information, see the approach for preparation of draft Annex XIV entries – Section 5 "Uses or categories of uses exempted from the authorisation requirement".
It should also be noted that if a use falls under the generic exemptions from authorisation, there is no need to propose an additional specific exemption.
- Comments on background information on volumes and uses
Comments can also be given on the information reported in the background documents for the prioritised substances. This includes information on volumes, types of uses, and (to the extent such considerations were used by ECHA for prioritising the specific substance) on the potential for substances to be "grouped" with high priority ones or with substances already included/previously recommended for inclusion in the Authorisation List.
REACH registrations are the main source of information for ECHA's assessment. Registrants are therefore advised to update their registration dossiers with any new relevant information. Registration updates as of the last day of the consultation will be taken into account (always in accordance with the prioritisation approach) by the MSC when preparing its opinion on the draft recommendation and by ECHA when finalising its recommendation.
Relevant information on volumes and uses submitted in the webform during the consultation will also be taken into account according to its reliability and representativeness.
Confidentiality
Comments are normally considered non-confidential and ECHA will make them available to the public on its website. However, there is an opportunity to attach confidential details.
In this case, a justification must be given by the comment submitter explaining why the information is considered confidential. Such confidential information will only be used by ECHA, including its committees, and the European Commission.
It is the comment submitters’ responsibility to make sure that no confidential information is included in the public version of the comments.
