Biocides Efficacy

Regulatory authorities throughout the globe require that efficacy claims for biocidal products be substantiated with suitable data. To obtain regulatory approvals, such efficacy data must be generated using methodologies acceptable to the applicable competent authorities and demonstrate a level of performance that adequately supports the desired claims. In many cases, specific regulatory and scientific expertise is crucial to identifying the relevant efficacy data requirements and navigating those requirements and their associated complexities in an effective and efficient manner.

Exponent has experts adept at identifying the efficacy data requirements for different biocidal products, according to different regulations, and designing, reviewing, monitoring, and evaluating studies that meet those requirements. We routinely engage with competent authorities to develop new testing methodologies or adapt existing ones to suit novel products and technologies. Exponent’s experts are proficient with a wide variety of different biocidal product types including antimicrobial pesticides, conventional agricultural pesticides, biopesticides, insecticides and acaricides, rodenticides, repellents and attractants, molluscicides, preservatives, antifouling products, treated articles, etc. We can work in a tailored manner, seamlessly as part of your team, providing specific high-quality expertise not available in-house, or provide additional resources at times of work overload.

Exponent’s regulatory and scientific experts can provide strategic efficacy testing advice and help evaluate product portfolios and intended claims to streamline testing and increase speed to market. These experts have extensive experience helping our clients meet the applicable regulatory requirements in multiple geographies including the US, EU, UK, and Asia. Exponent’s staff include individuals with prior experience in industry, government, and academia, and this diversity of experience allows Exponent to approach regulatory matters from different points of view and go one step further in identifying solutions and paths forward.

EU/EEA/CH and UK

  • Experienced in writing EU regulatory dossiers (including IUCLID summaries), working in EU expert groups (e.g., ECHA, EPPO), harmonising efficacy data requirements and assisting in shaping and developing efficacy guidance documents, including efficacy of disinfectants and the new efficacy guidance concerning repellents and attractants.
  • Assist in designing efficacy testing programmes including test protocols, using relevant guidance/methodologies (i.e., ECHA, EN, ASTM, OPPTS, FAO, WHO, and OECD) to fulfil data requirements.
  • Manage efficacy-testing programmes (including advising on study placement, study monitoring, reviewing reports, and assessing and collating data).
  • Help represent your needs in meetings with regulatory competent authorities.
  • Assist in drafting product labels.
  • The EU/UK Exponent efficacy team has successfully delivered several efficacy-training workshops at the EU level, taking an in-depth look at claim substantiation for biocidal products in disinfection and pest control.
  • Our efficacy team has successfully supported several disinfectant Biocidal Product Families with hundreds of efficacy reports acquiring significant experience.

USA and Canada

  • Identification of efficacy requirements for different product types and claims.
  • Proactive protocol review and study monitoring to ensure data suitability.
  • Strategic guidance on how to streamline efficacy testing programs and design studies to limit regulatory risk.
  • Engaging regulatory authorities to develop new efficacy studies for novel products and technologies that will meet regulator expectations.
  • Active and inert ingredients: registrations, amendments, and management.
  • Advertising and claims reviews: on-line, in-market, websites, and storyboards.
  • Bio-chemical, bio-stimulants, and antimicrobial pesticide classifications and registrations.
  • Registration strategy.
  • Innovative products and claims development.
  • Labelling: compliance, development, and reviews.
  • Minimum Risk Pesticides (25b).
  • Pesticide product testing placement and study management with Good Laboratory Practices (GLPs).
  • Regulatory and registration requirements.

Asia

  • Familiar with biocide laws and efficacy requirements in Asian countries including China, South Korea, India, Australia, and New Zealand.
  • Able to provide disinfectant and pesticide registration services in the above-mentioned Asian countries and customize product registration strategy for customers.
  • Exponent routinely works with local laboratories to obtain test reports quickly to save valuable time to market.
  • Active ingredient and inert ingredient review and registrations.
  • Label claim review.
  • Advertising and claim reviews: on-line, in-market, websites, and storyboards.
  • Other regulatory and registration requirements.

Exponent can provide biocides efficacy support in other regions as well with our colleagues and network of associates around the world, and our staff regularly attend expert meetings and workshops, keeping up to date with the latest issues to maintain current scientific and regulatory knowledge. We can provide strategic regulatory advice to help you navigate regulatory hurdles now and in the future.

Professionals