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ECHA’s 12th recommendation for including substances in Annex XIV could be delayed

Earlier this year, the European Chemicals Agency (ECHA) published its 12th draft recommendation for substances to be included in Annex XIV (the Authorisation List) under the REACH Regulation. As per REACH guidelines, ECHA is required to recommend substances for inclusion every two years. The 11th recommendation was issued in April 2023, with the final 12th recommendation initially expected by April 2025.

However, discussions during the 87th Member State Committee meeting, held from October 8 to 10, 2024, suggest that a revision of the prioritisation process may be in the works. This potential change could delay ECHA’s final recommendation, pushing it to late 2025.

The ECHA Secretariat flagged a significant issue with the current process: when substances with a wide range of uses by many different industries are added to Annex XIV, the agency struggles to manage the large number of subsequent applications for authorisation. They also highlighted the need for a clear regulatory strategy that accounts for ongoing actions in other areas.

The current scoring system, which prioritises substances based on criteria outlined in Article 58(3) of REACH (such as wide dispersive use, high volumes, and PBT/vPvB properties), will likely remain. However, new considerations may be introduced, including:

  1. The risk of an overwhelming number of applications for suthorisation (AfAs); and
  2. The existence of other regulatory initiatives that could address the risks, making authorisation unnecessary.

Concerns were raised about the impact of delaying the 12th draft recommendation, including procedural, legal, and administrative complications. Some members questioned whether it would be appropriate to introduce new principles into a recommendation for which public feedback has already been submitted.

The substances included in the 12th draft recommendation are:

  1. Melamine (CAS 108-78-1, EC 203-615-4); 
  2. S-(tricyclo[5.2.1.02,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2- ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (CAS 255881-94-8, EC 401-850-9); 
  3. Diphenyl (2,4,6-trimethylbenzoyl) phosphine oxide (CAS 75980-60-8, EC 278-355-8); 
  4. Barium diboron tetraoxide (CAS 13701-59-2, EC 237-222-4) ; and 
  5. Bis (2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof. 

The ECHA Secretariat is expected to present a proposal for these changes at the next Member State Committee plenary meeting in December. For those concerned about how this potential delay might affect them, RPA is available to provide guidance and support.

For more information, please contact our Chemicals team at chemicals@rpaltd.co.uk, or take a look at the services on our website.