Biocides Regulatory Insights June 2024

Dear reader,

We are very proud to issue the new edition of our biocides newsletter, the sixth of 2024, and we are humbled by your increasing interest.?

I this issue, particular attention was devoted to the competent authority meeting’s documents.

If you missed our previous issues, no worries! You can catch up on all the insightful content by clicking?here.

Best regards,

The knoell Team?

Europe

Biocides Europe: Key Regulatory Updates and Industry Insights

The biocides industry in Europe is undergoing significant changes with new regulatory updates and essential industry discussions. Here are some of the highlights:

European Commission Highlights:

1. New Consolidated Text for Regulation (EU) No 528/2012: Update on Annex I: As of May 26th, 2024, Annex I now includes Nitrogen generated from ambient air as a Category 2 substance.

2. Expiry Date Postponement: Benzalkonium Chloride PT8: Due to Italy's comprehensive evaluation requirement, the expiry date for alkyl (C12-16) dimethylbenzyl ammonium chloride's approval in biocidal products has been extended to July 31, 2027.

Competent Authority (CA) Meeting Highlights:

1. Renewal of Biocidal Product Authorisation: Discussion Points: Separating renewal applications from change applications to avoid confusion.
2. Progress on Renewals of Active Substances: Overview: Detailed progress and deadlines from 2017 to 2027 available in the linked document. Click here!
3. Aligned with ECHA's bee risk assessment guidance, applicable from August 28, 2025.
4. The current REACH restriction proposal exempts active substances used in biocidal products, however, co-formulants in biocidal products, regulated under REACH, would be subject to the restriction proposal. In any case 11 biocide active substances are identified as PFASs and will be addressed.?
5. ?PFASs in Biocidal Products: Regulation: Current exemptions under REACH, but co-formulants in biocidal products are subject to restrictions.
6. Guiding Criteria for Essential Uses: Criteria: The use of harmful chemicals will be authorised only if necessary for health, safety, or critical societal functions, and there are no acceptable alternatives.
7. Antifouling PT21 Substances: Discussions: Exclusion of marinas from technosphere assessments, promoting less harmful alternatives, and refining risk assessments.
8. Disinfection By-products (DBP): Assessment: Emphasized need for comprehensive DBP assessment with the info available now also in the absence of the new guidance expected in two years.

Stay informed and connected with the latest regulatory updates and industry insights.

Read more here: Biocides Europe

ASIA

South Korea

New dossier template for biocidal product submissions

The National Institute of Chemical Safety (NICS), Korea's biocide authority, now mandates biocidal product approval applicants to submit a standalone assessment report starting June 10th. The report, available via the CHEMP (https://chemp.me.go.kr/)?portal, exceeds 100 pages and must be in Korean. This adds significantly to the workload, although active substance approvals currently do not require this report.

For a comprehensive overview of the latest news, click here.

USA

EPA Halts Acceptance of Data for Pesticide / Biocide Registration from a Non-Compliant Laboratory?

On May 24th, 2024, the EPA announced it will no longer accept studies from a non-compliant laboratory due to data integrity concerns raised by an inspection from the Indian NGCMA. This highlights the importance of adhering to Good Laboratory Practice (GLP) standards for pesticide/biocides registrants. Following a July 2023 inspection revealing falsified data in multiple studies, EPA has suspended acceptance of data from this lab. Registrants using affected data are urged to replace it promptly, and EPA is notifying impacted parties and discussing actions for existing registrations.?

Read more here.

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