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On 18 November 2025, the European Chemicals Agency (ECHA) made its 12th recommendation to the European Commission, that four additional substances be added to the Authorisation List (Annex XIV of the REACH Regulation (EC No 1907/2006)). If the Commission proceeds with this recommendation, manufacturers, importers and downstream users of these substances will need to apply for authorisation if they wish to continue using them beyond the set transition deadlines.

The authorisation process is intended to manage chemicals that have already been identified as Substances of Very High Concern (SVHCs), by imposing strict requirements on their use and promoting the use of safer alternatives. The four substances targeted in this recommendation are already listed on the Candidate List of SVHCs and their proposed inclusion in Annex XIV signals heightened regulatory scrutiny.

Substances Proposed for Authorisation

Below is a summary of the proposed entries and key use/volume data.

ECHA notes that the volumes and uses of barium diboron tetraoxide within the scope of authorisation are limited. Nevertheless, the substance is recommended based on grouping considerations, as it could otherwise be used to replace other boron compounds that are already recommended, which would risk regrettable substitution.

The document also notes that the draft entry for bis(2-ethylhexyl) tetrabromophthalate, covering all isomers and combinations, was not included in the final recommendation. This substance is being addressed in a parallel restriction initiative under the Restrictions Roadmap.

Implications and next steps

The recommendation will now be considered by the European Commission and EU Member States. If the substances are added to Annex XIV, the latest application dates and sunset dates will be set out in the authorisation list.

Companies that manufacture, import or use these substances in the European Economic Area will need to check whether their uses fall within the scope of the entries. Where relevant, they will also need to prepare for authorisation applications or consider alternatives in view of the future sunset dates.

On 6 November 2025, the European Commissioner for the Environment, Water Resilience and Forestry, Jessika Roswall, presented an update on the European Commission’s chemicals policy agenda. She confirmed that the long-awaited revision of the REACH Regulation is still in preparation. The Commissioner outlined the ongoing efforts to reinforce EU chemicals legislation and encourage the development of safer and more sustainable materials.

REACH Revision Still Under Preparation

Roswall acknowledged that the REACH revision process is taking longer than initially planned, noting that the Commission is still updating its supporting analysis and impact assessments. She confirmed that no proposal date could yet be given, indicating that the draft would only be published once the analytical work was complete.
This effectively confirms that the REACH revision will not be presented in 2025, in line with previous indications of delay.

New Databases to Support One Substance, One Assessment

The Commissioner also outlined the upcoming measures under the ‘One Substance, One Assessment’ Regulation, including the establishment of two new EU databases. One database will collect environmental sustainability data to support lifecycle-based assessments of chemicals. The second database will compile information on alternatives to substances of concern, with the aim of facilitating substitution and reducing regulatory duplication.

These databases are intended to increase transparency, improve coordination across EU agencies, and promote the development of safer substances.

Revised Safe and Sustainable by Design Framework

Roswall announced that the Commission will soon adopt an updated Safe and Sustainable by Design (SSbD) Framework to guide research and innovation funding towards safer and more sustainable chemical and material solutions. The revised framework will also help companies to integrate sustainability criteria at an early stage in the development of products.

EU Innovation and Substitution Hubs to Address PFAS and Promote Safer Alternatives

To complement these efforts, the Commission is establishing EU Innovation and Substitution Hubs under the EU Chemicals Industry Action Plan. These hubs are designed to accelerate the development of safer and more sustainable alternatives as well as addressing key challenges such as the substitution of PFAS and other substances of concern.

Roswall noted that the design phase is already underway and invited stakeholders to provide input on how the hubs can best support industry and research collaboration.

Upcoming Bioeconomy Strategy and Circular Economy Act

The Commissioner also confirmed that the new EU Bioeconomy Strategy will be adopted on 25 November 2025. The strategy aims to scale up the production of bio-based materials, strengthen biotechnology research, and extend sustainable value chains across industrial sectors.

A Circular Economy Act, expected in 2026, will follow as part of the Commission’s broader environmental policy package. This act will focus on creating a single market for secondary raw materials and fostering circular solutions throughout EU supply chains.

Collaboration and Outlook

Roswall emphasised that the success of these initiatives will depend on cooperation between Member States, industry, and research partners. She emphasised that the Commission’s long-term goal is to maintain high health and environmental protection standards while strengthening the competitiveness and resilience of the EU chemicals sector.