On June 5, 2024, the Biocidal Products Committee (BPC) of the European Chemicals Agency (ECHA) adopted four opinions on active substances and seven on Union authorisations during its May meeting, noting a rise in opinions not supporting approvals due to insufficient data.

It should be noted that Joost van Galen, the BPC Chair, expressed increasing concern over incomplete data in applications for active substances and Union authorisations.

In response to the regulatory updates and the increasingly stringent application process, REACH24H offers this article to provide key takeaways and practical strategies for your compliance.

Click on our website to get more info about EU BPR.

Active Substances

The BPC issued the following opinions:

• Supported:

1. Renewal of dinotefuran for product-type 18 (insecticides, acaricides, and products to control other arthropods).

Dinotefuran is a neonicotinoid insecticide used to control various pests by targeting their nervous systems. It is effective and poses low toxicity to non-target organisms when used properly.

2. Approval of polymeric betaine for product-type 8 (wood preservatives).

Polymeric betaine is a wood preservative known for its efficacy in protecting wood against decay and pests. It is valued for its environmentally friendly profile and low toxicity to non-target organisms.

• Not Supported:

1. Renewal of medetomidine for product-type 21 (antifouling products).

Medetomidine is an antifouling agent used to prevent biofouling on submerged surfaces, such as ship hulls. It works by deterring the settlement and growth of marine organisms. However, its renewal for certain product types has faced regulatory challenges.

2. Approval of 5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) for product-type 6 (preservatives for products during storage).

5-Chloro-2-methyl-2H-isothiazol-3-one (CIT) is a preservative used to protect products during storage. It is effective against a broad spectrum of microorganisms but has faced regulatory scrutiny due to concerns over its safety and environmental impact.

Union Authorisations

The committee supported authorisations for:

• biocidal product containing propan-2-ol for product-type 2 (disinfectants and algaecides not intended for direct application to humans or animals);
• biocidal product family containing propan-1-ol and propan-2-ol for product-type 1 (disinfectants for human hygiene);
• biocidal product family containing Margosa extract from cold-pressed oil of the kernels of Azadirachta Indica extracted with super-critical carbon dioxide for product-type 19 (repellents and attractants for pest control);
• biocidal product containing Glutaral (Glutaraldehyde); Reaction mass of 5-chloro-2-methyl-2h-isothiazol-3-one and 2-methyl-2h-isothiazol-3-one (3:1) for product-type 6, 11 (preservatives for liquid-cooling and processing systems) and 12 (slimicides);
• biocidal product family containing Reaction mass of 5-chloro-2-methyl-2h-isothiazol 3-one and 2-methyl-2h-is thiazol-3-one (3:1) for product-type 4 (disinfectants for food and feed area), 11 and 12; and
• biocidal product family containing peracetic acid for product-type 2, 3 (disinfectants for veterinary hygiene) and 4.

Please note that the BPC did not support authorisation for a product family containing hydrogen peroxide for product-type 4.

How to Comply?

1. Providing Complete Data

REACH24H: Ensure your dossier is complete before submission to avoid non-approval. The responsibility lies with the applicant. Use available guidelines and consider early discussions with authorities.

REACH24H, with our experienced expert team and rich practical experience, can provide you with all-around compliance services including data preparations.

Evaluating Member States recommend non-approvals and non-authorisations if companies fail to provide the required data, such as information on efficacy or endocrine disruption, within the process deadlines. Consequently, the opinion of the Biocidal Products Committee will not be favorable.

BPC Chair Joost van Galen emphasized in the Safer Chemicals podcast that the responsibility for providing a complete dataset lies with the applicant, not the evaluating competent authority:

“It is not the responsibility of the evaluating competent authority to ensure that the dossier is complete, but the responsibility of the applicant. So, make sure your dossier is complete before you submit it.”

He also reminded applicants of the available resources:

“The data requirements are in the regulation, and there are guidance documents on the procedure and on data. Additionally, there’s the possibility for the evaluating competent authority to have early BPC working group discussions to exchange thoughts with other Member States.”

2. Paying Continuous Attention

REACH24H: For a more comprehensive understanding of the orientation of the regulation and the final decision, click the following links to learn more about and stay focused on ECHA’s incoming updates.

Click here to see the annex to news; Click here to visit ECHA’s website for final decisions; Click here to listen to the committee Chair Joost van Galen’s highlights on the topic. You can also see the “Reference Links” to get further information.

You can also constantly follow REACH24H to get first-hand industry news in a more convenient way. We are committed to delivering timely and insightful updates on the latest industry advancements.

The committee’s opinions are detailed in the annex, and the final decisions of the European Commission together with the EU Member States based on BPC’s opinions will be available on ECHA’s website shortly.

The European Commission, together with EU Member States, will make the final decisions based on the BPC’s opinions. The committee met from 27 to 31 May 2024, and the next meeting is scheduled for 17 and 18 September 2024.

3. Adhering to Compliance Requirements of EU BPR

REACH24H: Although the EU BPR is constantly updated, companies still need to pay attention to the basic requirements in the regulation to facilitate compliance. REACH24H can provide you with professional compliance consulting services.

The compliance level of EU BPR is divided into three major parts: biocidal active substances, biocidal products, and treated articles. You can visit our website for a detailed introduction to EU BPR compliance.

Based on the requirements and flexibility of EU BPR, different enterprises need to choose the most suitable compliance strategy according to their actual situations and requirements.

(Source: ECHA)

Reference Links

• Annex to news[PDF][EN]
• Agenda of the meeting[PDF][EN]
• Product-types
• Approval of active substances 
• Union authorisation
• Biocidal Products Committee (BPC) web pages

Contact Us

As for EU BPR compliance, our services encompass a broad spectrum of domains and reach.

• EU BPR Compliance
• Pesticide Risk Assessment
• QSAR Report
• GLP Study Monitoring
• Agrochemical Market Research & Regulation Compliance Report
• Active Substance Article 95 Listing
• Active Substance Approval/Renewal Application
• Product Authorisation Application
• National Registration/ Notification subject to National Laws
• …

Please contact us for more assistance. Apart from EU compliance, we can assist you with BPR services of other countries and regions, including China, US, Korea, etc.

Email: customer@reach24h.com | Tel: +86-400-809-5809