Much-anticipated publication of the REACH revision is now on hold

The delay was announced by the European Commission’s Executive Vice President Šefčovič in presenting the 2024 Commission Work Programme to the European Parliament.  

The REACH revision is still expected to address a wide range of topics such as the review of information requirements, including for endocrine disrupters, a polymer notification / registration scheme, mixture assessment factors, improved use and exposure information, essential use and extension of the generic risk assessment in the context of restrictions.  

Regarding the review of the information requirements, earlier this year the Commission set up a CARACAL sub-group to provide advice on how to amend the REACH Annexes (VI – XI). The Commission intends to request more information on low tonnage substances and to update information requirements to require New Approach Methodology (NAM)-based information derived from appropriate methods either as additional information or, where validated NAMs are available, instead of animal tests where possible. The Commission is also considering removing some existing information requirements for which the information can be derived through other means than testing in animals. In addition, the intention is to amend Annex XI to increase possibilities for the use of NAMs in adaptations (source: CARACAL CASG –IR mandate).   

On polymers, whilst the details of a future registration scheme still need to be agreed and fully worked out, it is our understanding that the process being considered may require a notification for all polymers, followed by a stepwise registration phase for specific polymers requiring registration, preferably in groups. Cefic is continuing to lead on the revision on behalf of the European chemical industry and providing input to the discussions with the Commission and competent authorities. 

In parallel, other initiatives are planned by the Commission such as an ECHA Founding Regulation to make the Agency’s financing more sustainable as well as a “one substance, one assessment” approach to address inconsistencies across EU chemical regulation and the work of different EU Agencies.  

 On 7 December, the Commission published legislative proposals with respect to the one substance, one assessment. More specifically, the package sets: (i) provisions to consolidate data on chemicals in a central IT infrastructure and to ensure that that information is secure, of high quality, findable, accessible, interoperable and re-usable to the extent possible. Data considered publicly available under related EU laws and contained in the infrastructure will be accessible by the public.

Member State competent authorities, EU agencies and the European Commission will have access to all data contained in the infrastructure. This availability of data will ensure the detection of early warning signals on emerging chemical risks and facilitate the generation of further scientific chemicals data when necessary. (ii) proposals regarding the re-attribution of scientific and technical tasks and improving cooperation among EU Agencies. The legal text will be tabled for negotiations by the Council and the European Parliament following the ordinary legislative procedure.