Helsinki, 14. 1. 2009 - ECHA launched today a public consultation on the first draft recommendation of substances to be included in the list of substances subject to authorisation (Annex XIV or Authorisation List). Interested parties can submit comments by using the relevant web forms on the ECHA website until 14 April 2009.
The public consultation on the draft recommendation is part of the process to include substances in Annex XIV of REACH (Authorisation List).
Interested parties can comment both on:
• ECHA’s draft recommendation on seven substances (see below) and its reasoning behind their inclusion in Annex XIV and
• ECHA’s justification for prioritising these substances.
Interested parties are invited to comment in particular on uses which should be exempted from the authorisation requirements. The web forms on the ECHA website must be used for commenting. The closing date for comments is 14 April 2009.
ECHA’S DRAFT RECOMMENDATION
Based on an assessment of the available information, ECHA recommends prioritising seven substances out of the 15 substances that are on the Candidate List (published 28 October 2008). The prioritised substances are:
• 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
• Alkanes,C10-13,chloro (short chain chlorinated paraffins; SCCPs)
• Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified
• 4,4’-Diamino diphenyl methane (MDA)
• Bis (2-ethylhexyl) phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)
In the first draft recommendation ECHA furthermore proposes that:
• applications for authorisations should be submitted between 24 and 30 months after the above substances have been included in Annex XIV of REACH,
• these substances could not be used after 42 to 48 months after the inclusion date. ECHA proposes to include exemptions for uses of the prioritised substances that are permitted under specific conditions set out in the current legislation on Restrictions onMarketing and Use Directive (76/769/EEC) as explained in the consultation documents.
ECHA has assessed the available information on the substances included on the Candidate List against the three prioritisation criteria listed in the REACH Regulation, related to 1) the intrinsic properties of a substance, 2) the nature of its uses and 3) the volume supplied to uses subject to authorisation. A weight of evidence approach was used to come to an overall conclusion on the priority of a substance. For some substances the regulatory effectiveness of putting the substance under the authorisation regime was also taken into account. The methodology is explained in the consultation documents.
On the basis of the comments received during this consultation, ECHA may modify the draft recommendation. In this process, it will take into account the opinion of the Member State Committee. After this, the ECHA recommendation is submitted to the European Commission for final decision (see attachment to this press release).
The eight substances that have not been prioritised now may be reconsidered by ECHA for prioritisation at a later stage. Any substance on the Candidate List which is not yet included in Annex XIV can be part of a future priority setting.
Public consultation for draft recommendations for priority substances for the inclusion in Annex XIV (authorisation list):
Candidate List published on 28 October 2008:
An overview of the authorisation process under REACH:
Restrictions on Marketing and Use Directive (76/769/EEC):