Consultation on the 12th draft recommendation for the REACH authorization list
Topic: REACH Authorization List - Consultation on the 12th Draft Recommendation

Date of publication: 07/02/2024

On February 7, 2024, the European Chemicals Agency (ECHA) and the European Commission (EC) initiated a simultaneous three-month consultation regarding ECHA's 12th draft recommendation for the REACH Authorization List (Annex XIV), which recommends the inclusion of 5 substances to the list.

BACKGROUND

The European Chemicals Agency (ECHA) regularly proposes substances from the Candidate List to be added to the Authorization List by the European Commission.

On February 7, 2024, ECHA and the European Commission (EC) initiated simultaneous three-month consultations regarding ECHA’s 12th draft recommendation for the REACH Authorization List (Annex XIV).

In this scope, 5 substances have been prioritized based on agreed criteria within EU Member States. The draft recommendation is informed by an assessment of registration data and other available information, as well as initial discussions with the Member States’ Committee.

Once a substance is listed on the Authorization List, it cannot be marketed or used beyond a certain date unless specific authorization is granted for particular uses. Companies involved in the use, manufacture, or importation of these substances must seek authorization for their activities.

WHAT’S NEW?

This draft recommendation lists the following substances:

  • Melamine (CAS No: 108-78-1; EC No: 203-615-4)
  • Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH) (CAS No: 26040-51-7, EC No: 247-426-5
  • S-(tricyclo[5.2.1.0 2,6]deca-3-en-8(or 9)-yl) O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate (CAS No: 255881-94-8, EC No:401-850-9)
  • Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (CAS No: 75980-60-8, EC No: 278-355-8)
  • Barium diboron tetraoxide (CAS No:13701-59-2, EC No:237-222-4).

The classification of Melamine as a substance of very high concern (SVHC) is currently under dispute before the General Court of Justice. However, ongoing legal proceedings do not serve as valid reasons for postponing or delaying ECHA’s recommendation. The outcome of these cases will be evaluated once finalized.

ECHA is seeking additional details regarding the use of these substances within the scope of authorization, potential exemptions from the authorization mandate, and insights into the structure and intricacies of the supply chains. REACH registrants are urged to revise their usage data while providing feedback.

WHAT NOW?

The EU Member State’s Committee will formulate an opinion on ECHA’s draft recommendation, taking into account feedback from the consultation. Following this, ECHA will submit its final recommendation to the European Commission in spring 2025. The Commission will then determine which substances to include in the Authorization List and establish specific conditions for each.

References:

European Chemicals Agency (ECHA) – Consultation on recommending five substances for REACH authorisation list (ECHA/NR/24/04)

other REGULATORY UPDATES

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

Ingredients: BENZOPHENONE, TEOPHYLLINE, MELAMINE, AZADIRACHTA EXTRACTS, TRIMETHYLOLPROPANE TRIACRYLATE, PENTETIC ACID, PENTASODIUM PENTETATE

Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

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Any REGULATORY QUESTION?

French Anti-Waste Law – Impact in Cosmetics Packaging and Labelling

PACKAGING WASTE MANAGEMENT

Date of application: 01/01/2023, with a transition period until 09/03/2023 for packaging produced or imported before 09/09/2022.

The Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France in 2020. From January 2023 the requirements of the law became mandatory, including specific symbols on the packaging or labelling of cosmetic products.

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