Brief

"On 07/02/2024, the European Chemicals Agency (ECHA) issued an update regarding ECHA consults on recommending five substances for REACH authorisation. The Agency is considering recommending five substances, including Melamine and Bis(2-ethylhexyl) tetrabromophthalate, to be included in the REACH Authorisation List due to their potential harm to human health or the environment."

ECHA consults on recommending five substances for REACH authorisation
ECHA/NR/24/04
The Agency is also inviting comments regarding the implications of adding a new hazard to dibutyl phthalate (DBP) which is already on the Authorisation List. The consultations are open until 7 May 2024.
Helsinki, 7 February 2024 – The European Chemicals Agency (ECHA) is considering recommending the following substances for the REACH Authorisation List:

Melamine;
Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereof (TBPH);
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;
Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide; and
Barium diboron tetraoxide.

ECHA is looking for further information on the uses of these substances in scope of authorisation, their possible exemptions from the authorisation requirement and on the structure and complexity of the supply chains. REACH registrants are, therefore, encouraged to update their use information alongside sending their comments.
The European Commission is calling for information separately on the possible socio-economic impacts of adding these substances to the Authorisation List. The information will be passed on directly to the Commission and will not be considered by ECHA.
Melamine
The identification of melamine as a substance of very high concern is currently being challenged before the General Court of Justice. Ongoing actions before the Court are, however, not considered legitimate grounds for postponing or delaying ECHA’s recommendation. The conclusion of the cases will be assessed when available.
Bis(2-ethylhexyl) tetrabromophthalate (TBPH)
The Commission has also requested ECHA to carry out an investigation on flame retardants, which will cover Bis(2-ethylhexyl) tetrabromophthalate (TBPH), among other substances. This report will support the Commission to decide whether to request ECHA to prepare a restriction dossier. A call for evidence for this investigation is open until 5 April, and ECHA invites interested parties to provide information on TBPH via this call for evidence as well.
Considering that there is currently no decision yet on whether a REACH restriction process will be initiated on TBPH nor what could be the potential uses in scope of such a restriction, TBPH will remain for the moment in the draft recommendation for potential inclusion to REACH Authorisation List. A decision if it is included in the final recommendation will be taken later.
More information about the uses and reasons for including these substances in the draft recommendation for authorisation is in the annex.
Background
ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List by the Commission. It has prioritised these five substances from the Candidate List of substances of very high concern following the approach agreed with Member States. The draft recommendation is based on an assessment of the registration data and other available information, and an initial discussion with the Member State Committee.
The Member State Committee will prepare an opinion on ECHA’s draft recommendation considering the feedback gathered in this consultation. Following the Committee’s opinion and the information received during the consultation, ECHA will send its final recommendation to the European Commission in spring 2025. This will be ECHA’s twelfth recommendation. The Commission will decide which substances to include in the Authorisation List and on the specific conditions for each substance.
If a substance is included in the Authorisation List, it cannot be placed on the market or used after a given date unless an authorisation is granted for a specific use. Companies that are using, manufacturing or importing these substances can apply for authorisation.

Further information

Annex: Draft twelfth recommendation with examples of uses of the substances in the scope of authorisation [PDF][EN]
Consultation on draft recommendation for inclusion in the Authorisation List
Consultation on a draft recommendation for amendment of Authorisation List entries
Candidate List of substances of very high concern for Authorisation
Authorisation List
Overview of the authorisation process under REACH
General approach for prioritisation of SVHCs for Inclusion in the list of substances subject to Authorisation used in Recommendations [PDF][EN]
Uses generically exempted from the authorisation requirement [PDF][EN]
Call for evidence: on Brominated flame retardants including TBPH
Commission Request to prepare an investigation report on flame retardants [PDF][EN]

Press contact: Mikko Väänänen, press@echa.europa.eu, +358 40 520 3513

Highlights content goes here...

Purpose

The European Chemicals Agency (ECHA) is consulting on recommending five substances for inclusion in the REACH Authorisation List. The draft recommendation is based on an assessment of registration data and other available information, as well as an initial discussion with the Member State Committee. ECHA is seeking further information on the uses of these substances, possible exemptions from authorisation requirements, and the structure and complexity of their supply chains.

The five substances under consideration are melamine, Bis(2-ethylhexyl) tetrabromophthalate (TBPH), 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, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, and barium diboron tetraoxide. ECHA is also considering the implications of adding a new hazard to dibutyl phthalate (DBP), which is already on the Authorisation List.

The consultation process aims to gather information from REACH registrants, stakeholders, and interested parties on the potential inclusion of these substances in the Authorisation List. The European Commission will consider this feedback when making decisions on the specific conditions for each substance.

Effects on Industry

The potential inclusion of these five substances in the REACH Authorisation List could have significant effects on industries that use or manufacture them. Companies that are currently using, manufacturing, or importing these substances may need to apply for authorisation for a specific use after a given date. This could result in additional costs and administrative burdens for businesses.

The consultation process also aims to gather information on the possible socio-economic impacts of adding these substances to the Authorisation List. This will help inform decisions made by the European Commission, which will be passed on directly to the Commission without being considered by ECHA.

Relevant Stakeholders

This consultation affects various stakeholders, including:

  • Companies that use or manufacture melamine, TBPH, 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, diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, and barium diboron tetraoxide.
  • REACH registrants who are required to update their use information alongside sending comments on the draft recommendation.
  • Interested parties that may be affected by the potential inclusion of these substances in the Authorisation List.

Next Steps

The consultation process is open until 7 May 2024, and ECHA invites stakeholders to provide feedback on the draft recommendation. REACH registrants are encouraged to update their use information alongside sending comments.

After receiving feedback from this consultation, ECHA will prepare an opinion for the Member State Committee. The Committee will then consider this opinion when preparing its final recommendation to be sent to the European Commission in spring 2025.

Any Other Relevant Information

The draft recommendation is based on an assessment of registration data and other available information, as well as an initial discussion with the Member State Committee. This marks ECHA’s twelfth recommendation for inclusion in the Authorisation List.

ECHA regularly recommends substances from the Candidate List to be included in the Authorisation List following the approach agreed with Member States. The prioritization of these five substances was based on their identification as substances of very high concern and their potential use in various industrial applications.

European Chemicals Agency (ECHA)

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