Biocides

Biocidal Products Regulation (BPR) in the EU

The EU’s legislation for biocidal products is constantly changing and developing. Even since BPR became mandatory in September 2013, the different implementations and delegations make achieving approval challenging.

That’s where LKC helps. We specialise in supporting clients to reach active substance approval and biocidal product authorisation. Our proven track record shows how we have helped active substance and product manufacturers to successfully market the tools for professional pest control within the EU, Switzerland and the UK.

Our team of regulatory and technical specialists have valuable and essential knowledge gained during the evolution of biocides legislation from its infancy prior to Directive 98/8/EC to the current day. Through this expertise, our regulatory project managers are skilled in understanding your needs, delivering outcomes on time and within budget, helping you to achieve the ever-changing Regulation (EU) No. 528/2012.

LKC’s range of comprehensive specialist services include:

• Strategy and planning development for active substance approval and product authorisation
• Preparation, support and attendance at pre-submission meetings
• Article 95 inclusion, Transitional Authorisations and Technical Equivalence
• Data gap analyses and evaluation, including Product Type risk assessments and data waiving, providing expert statements
• Mutual Recognition and Same Biocidal Product authorisations
• Preparing dossiers and summaries in IUCLID on your behalf, and for draft Renewal Assessment Reports
• Classification and labelling of substances/products according to the CLP Regulation
• Exposure and risk assessments for human health and the environment (e.g. EUSES, SimpleTreat)
• Testing strategies, study contracting and monitoring for chemistry, toxicology, ecotoxicology, environmental fate and efficacy
• Scientific and regulatory advice during evaluation, preparing responses to regulators, management of projects via R4BP 3 and representation at Working Group meetings

Needed for the protection of human health and the environment, biocidal products are used in disinfectants, preservatives and pest control against harmful organisms through the biocidal action of the active substances.

Working alongside you, LKC’s committed team provide you with reliable, continuous and high-quality support as we work through the authorisation, approvals and renewals process. We get to know your product specifications and the way you work for your products to achieve entry into the EU in the most cost-effective manner.

Talk to one of the team today to discuss how LKC can help your transition into Europe. Contact us by emailing LKC@lkc-ltd.com or by phoning +41 (0) 61 906 8500.