ECHA Seeks Public Input on Potential Addition of Five Substances to the Authorisation List

On 7 February 2024, the European Chemicals Agency (ECHA) launched a consultation on the potential recommendation of five substances for inclusion in the Authorisation List (Annex XIV of REACH). ECHA is also seeking comments on the potential implications of adding a new hazard to dibutyl phthalate (DBP), an existing substance on the Authorisation List.

ECHA is particularly interested in gathering information on the uses of the five substances within the scope of authorisation, potential exemptions from the authorisation requirement, and the structure and complexity of the supply chains.

In addition, the European Commission is seeking information on the possible socio-economic impact of adding these substances to the Authorisation List. It is important to note that this information will be sent directly to the European Commission and will not be considered by ECHA.

The consultations is open until 7 May 2024.

The five proposed substances

The five substances under consideration are:

The identification of melamine as a substance of very high concern, is currently the subject of legal challenges before the General Court of Justice. Despite the ongoing legal actions, ECHA is proceeding with its recommendation and the outcome of the cases will be assessed after their conclusion.

Bis(2-ethylhexyl) tetrabromophthalate (TBPH) is part of an investigation on flame retardants requested by the European Commission. A call for evidence on this issue is open until 5 April. Given the uncertainty regarding the initiation of a REACH restriction process for TBPH and its potential uses, it remains in the draft recommendation for potential inclusion in the REACH Authorisation List. A final decision will be taken at a later stage.

More information on the substances in the consultation can be found here.

Key facts about dibutyl phthalate

Dibutyl phthalate (DBP) is used as a plasticiser in resins and polymers such as polyvinyl chloride (PVC). DBP was added to the Authorisation List in February 20211. The history of DBP as a substance of very high concern (SVHC) is as follows:

• 2008: DBP was identified as an SVHC for its reproduce toxicity properties and included in the Candidate List of SVHCs.

• 2011: DBP was added to Annex XIV of REACH (the Authorisation List), making it subject to authorisation.

• 2017: DBP was additionally identified as an SVHC due to its endocrine disrupting properties for human health.

• 202: The endocrine disrupting properties were added to Annex XIV.

• 2023: In December, DBP was again identified as an SVHC, this time for its endocrine disrupting properties to the environment.

Due to the recent identification of DBP as endocrine disrupting for the environment, ECHA has prepared a draft recommendation to amend the Annex XIV entry for DBP. The consultation on this draft aims to gather relevant information, in particular from stakeholders affected by the change in authorisation requirements due to the inclusion of the additional intrinsic property of DBP, which is already prioritised and included in the Authorisation List.

Background information

ECHA regularly recommends substances from the Candidate List for inclusion in the Authorisation List by the Commission. This time it has prioritised five substances from the Candidate List of substances of very high concern following the approach agreed with the Member States.

ECHA's draft recommendation is based on an assessment of registration data, available information, and initial discussions with the Member State Committee. The Member State Committee will formulate an opinion based on the feedback received during the consultation and ECHA will submit its final recommendation to the European Commission in spring 2025. The Commission will ultimately decide which substances will be included in the Authorization List and set the conditions for each substance. If a substance is included, it cannot be placed on the market or used after a certain date without a specific authorisation. Companies involved in the use, manufacture, or import of these substances can apply for authorisation.