ADBAC/BKC (C12-16) extension approved for PT2 by the EU – Are you ready for BPR approval?
The European Commission's recent approval of Alkyl (C12-16) Dimethylbenzyl Ammonium Chloride (ADBAC/BKC) as an active substance for use in biocidal products of product type (PT) 2 marks a significant milestone in the regulatory landscape. As the final disinfectant product type receives approval, it prompts stakeholders to prepare for the subsequent steps, particularly regarding Biocidal Product Regulation (BPR) approval.
Understanding the Approval:
ADBAC/BKC, with its Chemical Abstracts Service (CAS) number 68424-85-1, is a well-known cationic surfactant-type active substance utilized primarily as a cleaning or antimicrobial agent. Its inclusion in PT2 biocidal products underscores its efficacy and safety profile for general disinfection purposes. The European Commission's endorsement paves the way for its formal addition to the Union List of Approved Active Substances, scheduled to commence on July 1st, 2025.
Implications for BPR Approval:
The approval of ADBAC/BKC for PT2 triggers a series of preparatory measures for stakeholders aiming for BPR product authorization. This entails the meticulous compilation of a submission dossier, meticulously outlining the efficacy, safety, and environmental impact of biocidal products containing ADBAC/BKC. Such a dossier serves as a comprehensive document substantiating the product's compliance with BPR requirements, ensuring its marketability within the European Union.
Key Considerations for Stakeholders:
Stakeholders, including manufacturers, importers, and distributors of biocidal products containing ADBAC/BKC, must navigate several crucial considerations in anticipation of BPR approval:
Efficacy Assessment: Demonstrating the effectiveness of ADBAC/BKC-containing products against target microorganisms through robust testing protocols is paramount. This includes efficacy data generated under relevant conditions to validate the product's disinfectant properties.
Safety Evaluation: Assessing the safety profile of ADBAC/BKC is imperative to ensure consumer and environmental protection. This encompasses toxicological studies, exposure assessments, and risk mitigation strategies to address potential hazards associated with product usage.
Environmental Impact Analysis: Evaluating the environmental fate and ecotoxicological effects of ADBAC/BKC aids in understanding its potential ecological footprint. Comprehensive data on degradation, persistence, and toxicity facilitate informed decision-making concerning environmental risk management.
Compliance with Regulatory Standards: Adhering to BPR's stringent regulatory standards necessitates meticulous attention to detail throughout the product development and authorization process. Compliance with labelling requirements use instructions, and reporting obligations is essential to ensure legal conformity and market access.
What’s next?
The European Commission's approval of ADBAC/BKC for PT2 biocidal products signifies a pivotal development in the regulatory framework governing disinfectant substances. However, it also heralds the commencement of a thorough BPR approval process, demanding rigorous documentation and assessment to secure market authorization. As stakeholders gear up to navigate these regulatory requirements, adherence to efficacy, safety, and environmental standards remains paramount to foster consumer confidence and ensure sustainable product stewardship within the European Union's biocidal market.
For those companies marketing biocidal products containing ADBAC/BKC, they must prepare their submission dossiers to support BPR product authorisation and submit by July 1st, 2025 for continuity on the market. It's also worth noting that those companies who wish to market their products containing ADBAC/BKC for PT2 use under transitional requirements of Article 89 must comply with national requirements and the time to be able to submit such approvals varies across the EU once an approval date has been set. Otherwise companies will have to wait until BPR product authorisations are approved to market.
How can Yordas help?
Rosalinda Gioia, Principal Science (UK) said: “We have supported clients with Product Authorisation applications under EU BPR for the last 10 years. Throughout our work, we have forged excellent working relationships with several EU Member States Competent Authorities, and have developed a network of service providers such as test laboratories and legal advisers to contribute at all stages of the application process.”
At Yordas, our team can help you comply with regulatory updates by providing you with insight, strategic advice, preparation of the required dossier, submission, and liaising with the authorities. Get in touch today by sending us a message today. To learn more about our ADBAC-related services, visit our website. You can also stay up-to-date about upcoming regulatory changes by signing up for our monthly newsletter.
About our experts
Dr Rosalinda Gioia, Principal: Science
Rosalinda is an internationally recognised expert on ecotoxicology and is highly experienced in understanding chemical regulations. She has provided expert scientific advice and policy support to government regulators on chemical risk assessments relating to the oil & gas industry, for which she has authored technical bulletins and papers to the annual meeting of OSPAR’s Offshore Industry Committee (OIC). Rosalinda project manages REACH Lead Registrations and Biocides active substance approval and product authorisation dossiers. She also provides technical leadership and advice relating to the environmental fate of chemicals, persistence, bioaccumulation and toxicity (PBT) and risk assessments in the aquatic environments.
Dr Hayley Lewis, Senior Regulatory Consultant
Hayley is a Senior Consultant with more than 9 years of experience as a development chemist and quality manager within the fine and speciality chemical sectors. She has extensive technical experience with pesticide chemistry, hazard evaluation, classification and management systems such as ISO 9001 quality systems. Hayley holds a PhD in Molecular and Cellular Physiology from Liverpool University. Here at Yordas, she is Biocide Services lead dealing with the project management and delivery of Biocidal product regulatory services. She supports several UK and EU BPR projects.