European Union Biocidal Services

Which services do we offer:

  • Biocides scoping assessments

  • EU representative appointment

  • Article 89 Transition period requirements

  • Active substance approval preparation and submission

  • Product authorisation preparation and submission

  • Article 95 submissions

  • Claim Substantiation

  • Efficacy & Endpoint testing

  • Product portfolio audits

  • Stakeholder communication, BPR consultancy and regulatory monitoring

New EU biocidal active substance approval decisions published

Recently, the European Chemicals Agency (ECHA) published several active substance approval regulations. These regulations detail the approval dates and legal entry into force of the approval under EU BPR of:

  • Didecyldimethylammonium chloride (DDAC) for Product Types 1 (Human hygiene) and 2 (Disinfectants and algaecides not intended for direct application to humans or animals)- Approval date 1st February 2024

  • Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide for Product Type 19 (Repellents and attractants) - Approval date 1st February 2024

  • Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents for Product Type 19 (Repellents and attractants) - Approval date 1st February 2024

  • Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with hydrocarbon solvents, PT 18 -Approval date - Approval date 1st February 2025

  • Chrysanthemum cinerariaefolium extract from open and mature flowers of Tanacetum cinerariifolium obtained with supercritical carbon dioxide for Product Type 18 (Repellents and attractants) - Approval date 1st February 2025

  • As of March 2023, commission regulation approving ADBAC/BKC for product-type 1 - Approval date 1st July 2024

  • Ozone generated from oxygen PT2,4,5 and 11- Approval date 1st July 2024

  • Sulfur dioxide generated from sulfur by combustion PT4 - Approval start date 1st October 2024

  • Formic Acid PT2,3,4 and 5 - Approval start date 1st November 2024

  • Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)) - Approval start date 1st July 2025

Following the active substance approval for a product-type, biocidal product authorisations must be submitted no later than the Approval (Start) Date of the active substance to ensure continuity on the EU market. The approval regulations also contain any substance-specific information which needs to be considered during the preparation of a BPR product authorisation application dossier. 

Do you require help developing a suitable authorisation strategy or with the preparation and submission of your authorisation? Get in touch with us today.

Biocidal Product Committee (BPC) updates to highlight

During the last BPC meeting, there were several BPC opinions adopted including two active substance applications approved and mentioned above , Formic acid and Sulfur dioxide generated from sulfur by combustion. In addition to approving BPC opinions on three Union authorisations for biocidal products containing propan-1-ol and Propan-2-ol for PT1, Propan-2-ol for PT2 and active chlorine released from calcium hypochlorite for PT2.

The BPC opinion approving Active substance bronopol application for 2, 11(preservatives for liquid-cooling and processing systems) and 12 (slimicides) is still under review and to be finalised in an additional meeting in December 2023 due to data gaps.

Other points included in the November 2023 BPC meeting discussion were:

  • Increased data gaps in active substance and Biocidal products application dossiers that are directly impacting the evaluation process and opinion forming of the BPC.

  • The update of procedures for managing new information on biocidal active substances.

  • Updated guidance has been published relating to shelf life and post-authorisation conditions for product authorisation and now applies to ongoing applications.

Yordas is here to help guide you through the BPR application processes step by step. If you require assistance with BPR submissions, testing strategies, commissioning of testing and more get in touch. Our Biocides team offers a full portfolio of services and will help manage your project from conception to completion ensuring your compliance. We can also assist with ad hoc services.

Pyrithione Zinc interest withdrawn

Companies supporting Pyrithione Zinc through active substance approval  have withdrawn their interest for the following uses:

  • disinfectants and algaecides not intended for direct application to humans or animals (product-type 2); and

  • construction material preservatives (product-type 10).

If any companies would like to keep this substance in the Review Programme and would like to support Pyrithione Zinc through the Active substance approval process, they must notify Echa by the 21st December 2024.

Reach out to our team so we can help support you with your notification submission.