Question to the Department for Environment, Food and Rural Affairs:

To ask His Majesty's Government whether a user-risk assessment has been completed concerning the chronic human exposure to fipronil and its metabolites, especially in households where pets are treated with spot-on pet medicines containing those agents.

User risk assessments (URAs) are a core element of the authorisation process for veterinary medicinal products, and they include consideration of chronic human exposure in households where pets receive spot‑on treatments. The Veterinary Medicines Directorate conducts URAs in line with established international guidance, including the Committee for Veterinary Medicinal Products (CVMP) Guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03‑Rev.1) and the CVMP Guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/721059/2014).

These assessments follow a stepwise approach: hazard identification (drawing on extensive pharmacological and toxicological datasets, including for vulnerable sub‑populations), exposure assessment (covering short‑term direct and longer‑term indirect exposures), and risk characterisation using appropriate safety thresholds and conservative assumptions. For fipronil, the assessment considers relevant metabolites. Where indicated, risk mitigation measures are applied, such as user safety warnings, child‑resistant closures, and advice to minimise contact with the application site, reflected in the Summary of Product Characteristics and product literature (package leaflet).