Human Health Risk Assessment

Human health risk assessment in biocidal products

BPR product types cover an immense range of diverse biocidal products. While plant protection product risk assessments are prescriptive and well established, the BPR has greater variability in approach to ensure all exposure scenarios are considered. Generally, the requirements will vary on a case-by-case basis and are heavily dependent on the use scenario. Consequently, identifying the correct approach to cover the worst-case scenario (the most biocide exposure in this case) is important from the start of the human health risk assessment process.

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The main questions to identify approach

  • What is the active substance?
  • Are there co-formulants to consider?
  • What is the product type, including format and purpose?
  • How much product is used?
  • When is the product used?
  • How frequently is the product used?
  • How is the product applied?
  • Who will use the product?
  • Where is the product used?

Each active substance and substance of concern present in the formulation must be assessed for any potential direct and indirect exposure. Assuming that an appropriate letter of access is available, the active substance competent authority report (CAR, the active substance approval document) can provide all required active substance properties and any EU-agreed acceptable exposure limits (AEL). The CAR is also useful to indicate relevant use scenarios and indicates previously approved approaches to risk assessments for the chosen product type. It is, however, important to note that the data requirements and approach will vary depending upon the product type and specific use patterns required. A ‘risk envelope’ approach can be taken if planned appropriately, encompassing all possible uses and composition variance within the biocidal product family under one assessment.

Once the use patterns are established, the primary exposure scenarios covering mixing, application, post-application activities and disposal can be identified along with any potential secondary exposure scenarios (who else, other than the main user, may be exposed). Risk assessments can be carried out using modelling software such as ConsExpo as well as returning to first principles and using the calculations taken directly from guidance. Both acute (short term) and chronic (long term) exposure must be considered, as well as exposure via dermal (skin) absorption, inhalation and ingestion. As with environmental risk assessments, there are refinements that can be carried out and risk mitigation measures suggested to reduce exposure, such as personal protective equipment (PPE) for professional users.

Human health (non-dietary exposure) risk assessment of plant protection products

Across the EU and UK, plant protection products (PPP) are governed by Regulation (EC) No 1107/2009 with the primary goal of safeguarding human health, animal health and the environment. Before placing a product on the market, companies need to demonstrate safe use of a PPP is expected when the product is used as intended and described on the label. Human health exposure for the product needs to be presented in the Mammalian Toxicology section of a PPP dossier, Part B Section 6, for evaluation by competent authorities. This also includes performing a non-dietary exposure risk assessment. The latest guidance for assessing human health exposure is provided by the European Food Safety Authority (EFSA), EFSA Journal 2022;20(1):7032, which includes an accompanying exposure model through an online application to be used for assessments, the ‘EFSA calculator’. The calculator presents outputs concerning the predicted acceptable levels of PPP active substance exposure towards:

  • operators (applicators of the product)
  • workers (persons performing post-application tasks, e.g., harvesting)
  • residents (people living in the surrounding area who are exposed over a long period)
  • bystanders (passers-by who are exposed over a short period).

Our services

Enviresearch has more than 10 years of experience in conducting human health exposure risk assessments for biocides and PPPs and presenting them to competent authorities for evaluation according to the latest guidance. Our services cover all aspects of an exposure assessment, from a preliminary assessment to aid clients in refining their uses and application rates to full assessments, including refinements and higher-tier approaches as well as authoring of relevant dossier sections.

Other expertise

Regulatory Affairs
Endocrine Disruption
Effects Modelling
Ecotoxicology
Environmental Fate
Aged Sorption
Efficacy
Analytical Chemistry
Residues Chemistry
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