ECHA Recommends Addition of 7 New Substances to REACH Authorization List
In April 2021, the European Chemicals Agency (ECHA) issued a recommendation for the addition of seven new substances to Annex XIV to REACH (REACH Authorization List). Here we review the list and authorization process, and we consider the chemicals recommended for inclusion.
Authorization List and Process
The REACH Authorization List (REACH Annex XIV) includes chemicals that are subject to authorization under the REACH regulation. Authorization is intended to help control risks of high concern substances during their lifecycle.
The authorization process for chemicals, as noted by the ECHA, includes three key phases:
- Phase 1: Substances of Very High Concern (SVHCs)
- Phase 2: Recommendation for Authorization List Inclusion
- Phase 3: Authorization Application
- Phase 1 – General Steps
- Member States indicate their intention to classify a substance as an SVHC.
- Corresponding SVHC dossier is prepared.
- Relevant interested parties may provide additional information and comments on the proposal.
- Provided no comments debate its suitability for identification as an SVHC, the chemical substance is added to the REACH Candidate List.
- Phase 2 – General Steps
- Candidate List substances are reviewed to determine prioritized potential inclusion in the Authorization List.
- Substances are proposed for inclusion via draft recommendation.
- Draft recommendation is submitted for consultation and comments.
- Corresponding opinion on the recommendation is issued by the Member State Committee.
- ECHA sends recommendation to the European Commission.
- Phase 3 – General Steps
- Application for authorization is prepared and submitted to the ECHA.
- Consultation is initiated on possible alternative substances, and parties may provide additional information and comments.
- Committee for Risk Assessment (RAC) and Committee for Socio-economic Assessment (SEAC) issue opinion(s).
- If authorization is issued, the authorization holders must adhere to decision requirements. Authorization may be subject to further review.
- If use of the chemical substance is deemed necessary following the period of review, review report is submitted by the authorization holder.
There were several reasons for recommended inclusion of the new chemicals on the Authorization List:
- Octamethylcyclotetrasiloxane, Decamethylcyclopentasiloxane, and Dodecamethylcyclohexasiloxane – Regarded as persistent, bioaccumulative, and toxic (PBT) and/or very persistent and very bioaccumulative (vPvB), they are considered harmful to human health and the environment.
- Terphenyl, hydrogenated – Regarded as very persistent and very bioaccumulative, it is considered harmful to the environment.
- Dicyclohexyl phthalate – Considered to be reprotoxic and endocrine disrupting.
- Disodium octaborate – Considered to be reprotoxic.
- Benzene-1,2,4-tricarboxylic acid 1,2-anhydride – Considered to be respiratory sensitizing.
|#||Substance Name||EC Number||CAS Number|
|5||Dicyclohexyl phthalate (DCHP)||201-545-9||84-61-7|
|7||Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (TMA)||209-008-0||552-30-7|
Source: European Chemicals Agency
A complete list of all chemicals on the REACH Authorization List can be found on the European Chemicals Agency website.