PUBLIC CONSULTATION ON INCLUSION OF SUBSTANCES IN THE AUTHORISATION LIST

https://www.chemnet.com   Nov 14,2008

The public consultation on the draft recommendation is part of the process to include
substances in Annex XIV of REACH (Authorisation List). For an overview of the process.

PUBLIC CONSULTATION

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) and
• 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, and
• 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 on
Marketing 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.

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