Regulatory Developments

European Union Opens Consultation on Changes to EU REACH

February 2, 2022

On January 20, 2022, the European Commission (EC) launched a public consultation seeking comment on a proposed revision of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (No. 1907/2006). The consultation is the most extensive to date; it covers many elements of the legislation and, once changes are implemented, will have a significant impact on industry for the future.

The consultation topics include:

  • Revision of the registration requirements, including increased information requirements and establishing the obligation to register certain polymers;
     
  • Introduction of mixture assessment factors (MAF);
     
  • Simplification of communication in the supply chain;
     
  • Revision of the provisions for dossier and substance evaluation;
     
  • Reform of the authorisation and restriction processes, including the extension of generic approaches to risk management and the introduction of the essential use concept; and
     
  • Revision of the provisions for control and enforcement.
     

The consultation is a product of the EC’s ambitious Chemicals Strategy for Sustainability (CSS), which was published on October 14, 2020. The strategy represents a key commitment to the European Green Deal and aims to better protect people and the environment from hazardous substances as well as boost innovation for safe and sustainable chemicals.

The consultation will run until April 15, 2022. A link to the consultation survey is available here.

Commentary

The CSS requires changes to the REACH regulation. This will likely mean an increase in regulatory obligations for importers, manufacturers, and users of substances, mixtures, and articles in the European Economic Area (EEA).

The following consultation topics are of key concern to industry:

  • Polymers – Though polymers are currently exempt, the EC proposes to extend the duty of registration to certain polymers of concern. A study carried out in 2020 suggested that up to 30,000 polymers may require registration at an estimated cost of approximately €2.5 billion.
     
  • MAFs – Various studies have shown that “unintentional” co-exposure to substances may lead to adverse effects on people and the environment. REACH registrants may be required to take into account the possibility of co-exposure to other substances.
     
  • Authorisation and restriction – Substances of Very High Concern (SVHC) may be added to the authorisation list and/or restriction list to help reduce their impact on human health and the environment. Some stakeholders view the current process as inefficient due to ambiguity in the legislation. The consultation aims to explore the meaning of “essential use of a chemical substance” so that the inclusion of SVHCs on these lists can be more effective, more predictable, and quicker.
     
  • Generic risk management – The current approach prohibits carcinogenic, mutagenic, and reprotoxic (CMR) substances based on their hazard and on generic exposure concerns. The consultation suggests applying the generic risk management approach to other hazard classes and extending to professional users the level of protection currently granted to consumers.
     

Stakeholders may wish to respond to the consultation to ensure that their interests are represented. The Acta Group (Acta®) can help your company to understand the proposed changes and their potential impacts on your business.

For further assistance, please e-mail or call Steven P. Brennan, Ph.D. at sbrennan@actagroup.com or +44 (0) 161 240 3842.


 
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