Ä¢¹½tv

Capabilities and Services

• In Silico Toxicity Assessments - (Q)SAR

  Ä¢¹½tv has expertise in a variety of methods for in silico toxicity evaluations as well as toxicologists who can evaluate the implications of (Q)SAR outcomes.

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• Dietary Exposure & Human Health Risk Assessments

  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. Ä¢¹½tv 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 for Plant Protection Products, Biocides & Chemicals Under REACH Regulations

  Human health risk assessments use modeling and data to predict the exposure of operators, workers, residents, and bystanders to chemicals in products. Ä¢¹½tv 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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• Biocides Efficacy

  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. Ä¢¹½tv'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.

• Summary of Services

  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. Ä¢¹½tv has extensive experience preparing biocidal product family dossiers for evaluation in the EU and GB. Ä¢¹½tv 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. Ä¢¹½tv 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 —  Ä¢¹½tv 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 —  Ä¢¹½tv 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 —  Ä¢¹½tv 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 —  Ä¢¹½tv 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.
  • Ä¢¹½tv 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.