Regulatory Affairs overview: August 2024

Dive into our team's expertise in this Linkedin newsletter on the Biocides and REACH markets.

We're delighted to welcome you to the new issue of our newsletter, a little briefer this month, but we'll be back with all the latest news in September.

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REACH

1. Update of the REACH Restriction Roadmap

On the 25th of April 2022, the European Commission published a Restrictions Roadmap, outlining current progress and future plans for restrictions under REACH. The roadmap prioritises group restrictions for the most harmful substances to human health and the environment, and was published as part of a key deliverable of the EU’s Chemicals Strategy for Sustainability under the European Green Deal. The document was updated for the first time on the 1 st of July 2024 and categorises substances/restrictions under the following headings:

• Pool 0: substances already on the Registry of Intention (RoI), and where the Commission has requested ECHA to prepare a restriction dossier (e.g. CMRs in childcare articles),
• Pool 1: planned restrictions which are not yet on the RoI (e.g. flame retardants),
• Appendix 1: restriction cases under opinion making, decision making or recently decided (e.g. PFAS)
• Annex II – Groups of substances under assessment with a restriction as a potential regulatory management option (e.g. Formaldehyde),
• Annex III - Overview of REACH Article 69(2) assessments.

The full document can be accessed on the Commission's website.

2. Updates to administrative charges

Based on Fee Regulation (EC) No 340/2008, when a natural or legal person has claimed to be entitled to a fee reduction but cannot demonstrate that it is entitled to such a reduction, ECHA levies the balance of the fee applicable to the correct company size category as well as an administrative charge. The charges are levied based on the decisions of ECHA’s Management Board, which are then confirmed by the European Commission. The latest decision of ECHA’s Management Board, applicable from the 22nd of July 2024, will see the issuing of only one administrative charge to a joint authorisation application that includes applicants with wrongly declared company sizes e.g. incorrectly declaring as an SME. The amount of the administrative charge will be determined by the size of the largest applicant within the joint application for authorisation group. The invoice will be sent to the lead applicant. If all applicants have declared their company sizes correctly, no administrative charge will be issued.

Biocides

1. Ethanol

ECHA published the updated work programme for active substance approvals. The Biocidal Products Committee (BPC) of Ethanol (CAS 64-17-5), used in PT1, 2 and 4, is scheduled for the session of 25-29 November 2024.

Following the timelines for the opinion-forming of active substance applications, the final opinion is expected to be delivered at the end of December 2024. Depending on the outcome?of the European decision, companies interested in supporting products containing ethanol as active substance for PT1, 2 and 4?uses, should start planning their?submission strategy.?Anticipate the approval of ethanol by contacting our team of regulatory experts.

In need for personalized regulatory advice to meet your specific needs? Whether you need assistance about compliance, product registration or any other regulatory issue, our experts are here to provide support. Contact us or visit our website for more information:

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