Biocides in Europe

How do Ģ��tv's multidisciplinary teams provide effective strategy for biocides for all aspects of your active substance and product's lifecycle?

Ģ��tv's multidisciplinary teams brings decades of regulatory experience and expertise — from working in government, industry, contract research organizations, and as independent regulatory consultants — to your most formidable biocide challenges.

We have assisted clients in achieving active substance approvals and product authorizations under the EU Biocidal Products Regulation (BPR) and Biocidal Products Directive (BPD). We also evaluate and construct Biocidal Product Family dossiers under the BPR (EU and GB) and have experience analyzing global biocide regulatory systems as well as consulting on regulatory strategy, biocide efficacy and toxicity, product stewardship, portfolio management, task force and consortia management, data generation and evaluation, literature reviews and dossiers, representation as a registered agent, training, and sustainability analysis.

Capabilities and Services

Bringing biocide products to market in the EU comes with stringent registration and compliance standards not easily met without comprehensive, independent, third-party support. From human health and environmental risk assessments, data gap analysis, biocide efficacy advice to strategic regulatory consulting and regulatory submissions, Ģ��tv offers a full suite of services for understanding and meeting biocide compliance.

Drawing on methodology that nutritionists, dieticians, toxicologists, epidemiologists, and biochemists have used for more than 60 years, dietary exposure assessments and dietary risk assessments are designed to evaluate human exposure to chemical, microbiological, or physical agents present in foods and to identify foods associated with an acute outbreak. Ģ��tv has acquired and processed data from several national and international food consumption surveys and integrated them into models that can be used to efficiently estimate intake of foods, nutrients, and food additives (plus enzymes and flavorings), as well as dietary exposure to contaminants.
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Human health risk assessments use modeling and data to predict the exposure of operators, workers, residents, and bystanders to chemicals in products. Ģ��tv has extensive experience using the regulatory models required for risk assessment for plant protection products, biocides, and chemicals subject to Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation in the EU and the U.K.
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Regulatory authorities across the globe require that efficacy claims for biocidal products be substantiated with suitable data and demonstrate a level of performance that adequately supports the desired claims. Ģ��tv's experts are adept at identifying the efficacy data requirements for different biocidal products according to different regulations, and designing, reviewing, monitoring, and evaluating studies to meet them.
For 50+ years, we've thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
- Regulatory strategy — We offer regulatory advice on the EU Biocidal Products Regulation (BPR), including legislation, transitional arrangements, requirements for products and biocidal product families, and technical equivalence. Our product stewardship services help you promote best practice through responsible manufacturing, communication about product use, and portfolio management and can be tailored to your company's needs — from support for national registrations to developing and managing strategies for compounds in various stages of their regulatory lifecycle.
- Active substance and product dossiers — Our multidisciplinary teams assist with active substance and complete biocidal product dossier preparation and submission under the EU and GB BPR, including interpretation, study, and dossier summaries, guidance on interpretation of EU and national data requirements, proposals for classification and labelling of substances, human health and environmental risk assessments, and regulatory submissions.
- Biocidal Product Family assessment — A Biocidal Product Family (BPF) is a group of biocidal products used for similar purposes and containing the same active substances with similar composition within specified variations. Ģ��tv has extensive experience preparing biocidal product family dossiers for evaluation in the EU and GB. Ģ��tv can provide technical and regulatory expertise to assist with the grouping of products that may fall within a family by examining the composition, classification, exposure and risk assessments, and efficacy.
- The Same Biocidal Products (SBP) Regulation in the EU introduces the possibility to go from wider to narrower authorizations or markets, and to apply for authorization for a single product that is identical to another authorized biocidal product. Ģ��tv can assist with preparation and submission of Same Biocidal Products Regulation preparation and document submission required for approval.
- Data gap analysis, waiving strategy, and bridging arguments — Designed to maximize the benefit of existing data requirements by filling data gaps, preparing data waivers, and bridging arguments, this service reduces testing costs.
- Study placement and monitoring — We offer study design, protocol and report reviews, and troubleshooting assistance.
- Efficacy — We leverage our extensive expertise, particularly in insecticides, repellents, antifouling paints, rodenticides, and disinfectants, to offer efficacy test program design, product labeling, comparative assessment of new regulatory requirements, and training on all aspects of biocide efficacy.
- Exposure modeling and risk assessments — Ģ��tv has a vast amount of experience in tiered and refined human health and environmental risk assessments to support active substance and product authorizations. Our expertise enables us to ascertain when exposure scenarios may be unsuitable for a particular application and to present alternatives to regulators with confidence.
- In situ generated biocides — Ģ��tv has been at the forefront of discussions with the European Chemicals Agency (ECHA), the EU Commission, and member states regarding the methodology and interpretation of the regulations regarding in situ biocides.
- Technical Equivalence assessment (TE) — Preparation of Tier I and Tier II applications when there has been a change in manufacturing process or new source of the active substance.
- Post-submission support — We address Competent Authority (CA) queries and attend ECHA Working Group, Biocidal Products Committee, Coordination Group, and CA meetings with or on behalf of our clients.
- Global national registration — Ģ��tv has experience with biocide regulatory systems on a global scale. We can assist with obtaining information about national and international product notification, registration requirements, and regulatory submissions.
- Task force and consortia management — Ģ��tv has many years of experience in managing task forces and consortia for biocides and can construct dossiers using data from different task force members while maintaining data confidentiality.
- Ģ��tv also offers services that complement or augment your in-house expertise, including peer reviewing documents, acting as a sounding board on potential courses of action and strategies, and providing a "neutral viewpoint" to obtain views on issues from EU regulatory authorities.