Human Health Risk Assessments for Plant Protection Products, Biocides & Chemical Under REACH Regulations

Thought leadership

Considerations for the Successful Submission of Biocidal Product Dossiers in the EU

How can you assess the human health exposure of your products to support regulatory compliance?

We support clients in the chemicals industry throughout the regulatory process from preliminary risk assessment and data generation to submission and post-submission support. Our exposure specialists work closely with our toxicologists to perform thorough human health risk assessments and help you make the best use of your data. We keep up with the constantly changing regulations, study guidelines, and data requirements to overcome future challenges that may impact your products.

Plant protection products

Exponent consultants have helped develop operator (non-dietary) exposure assessment models used by regulatory authorities and continue to advise in the development of new models. We have extensive experience with the current European Food Safety Authority online model as well as national models used by individual Member States. Our expertise includes monitoring higher-tier exposure and toxicology studies, which may be required for more complex product assessments.

Biocides

Leveraging extensive experience in tiered and refined human health risk assessments, we support active substance and product authorizations for all biocidal product types. We have in-depth knowledge of risk assessment scenarios, exposure modeling tools (e.g., ConsExpo), and product-type specific guidance documents by the Human Exposure Expert Group and the Health Exposure Ad-hoc Working Group. In addition, our consultants assist in the construction of biocidal product families (considering similarity of risk); identify and evaluate substances of concern; and perform livestock, companion animal, and consumer dietary risk assessments where necessary.

SERVICES

For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

• Human health risk assessments in compliance with EU and U.K. plant protection product, biocides, and REACH legislation

• Data gap analysis and preliminary risk assessment

• Development of strategies to address specific regulatory concerns using expert justification, alternative exposure models, and higher-tier studies

• Set up and study monitoring of higher-tier studies, including in vitro dermal absorption studies, and operator and worker exposure studies, such as dislodgeable foliar residue (DFR) studies and studies to address bystander and resident exposure

5 Steps to Support Evolving REACH Regulations

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Our Capabilities Are Unparalleled

With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.

Experts

Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.