Asked by: Lord Teverson (Liberal Democrat - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what plans, if any, they have to change the classification of spot-on pet treatments containing fipronil and imidacloprid from the current general sales (AVM-GS) to the prescription only (POM-V) classification.
Answered by Baroness Hayman of Ullock - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
Spot‑on flea and tick treatments containing fipronil and imidacloprid remain important for protecting animal and human health. Many of these products are currently classified as AVM‑GSL, meaning they may be supplied without professional advice. The Veterinary Medicines Directorate (VMD) recognises increasing concerns about the environmental presence of these substances, which have been detected in some UK watercourses at levels above toxicity thresholds for aquatic invertebrates.
The VMD is carrying out a regulatory review of the AVM‑GSL status of products containing fipronil and imidacloprid. Further details on this review will be made available early this year. The review will assess whether requiring professional advice at the point of sale, such as through a minimum NFA‑VPS classification, could support more responsible use and disposal.
The regulatory review will consider all legal distribution channels with any future decisions being transparent, evidence‑based and to maintain animal welfare and access to treatment.
Asked by: Lord Teverson (Liberal Democrat - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government what assessment they have made of the adequacy of safety advice provided to users of the spot-on pet treatments containing fipronil.
Answered by Baroness Hayman of Ullock - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
The adequacy of safety advice provided to users of spot‑on veterinary medicines is assessed as part of the statutory authorisation process for veterinary medicinal products. The Veterinary Medicines Directorate (VMD) conducts a comprehensive user‑risk assessment in accordance with established international guidance, including the Committee for Veterinary Medicinal Products (CVMP) guideline on user safety for veterinary medicinal products (EMA/CVMP/543/03‑Rev.1) and the CVMP guideline specifically addressing topically administered products (EMA/CVMP/SWP/721059/2014).
These assessments consider both direct and indirect routes of exposure, including contact with treated animals. Where the assessment identifies potential risks, appropriate risk‑mitigation measures are implemented. These are reflected in the product information, including the Summary of Product Characteristics and the package leaflet, and typically comprise clear instructions on correct application, advice to minimise human contact with the application site, and warnings intended to protect vulnerable household members, including children.
The adequacy of this safety advice is kept under continual review through the VMD’s pharmacovigilance system, which monitors reports relating to user safety and allows updates to product information where required. Publicly available assessment reports and product literature can be accessed via the Product Information Database on GOV.UK.
Asked by: Lord Teverson (Liberal Democrat - Life peer)
Question to the Department for Environment, Food and Rural Affairs:
To ask His Majesty's Government whether the steps being taken to reduce the current levels of fipronil and imidacloprid in rivers will result in meeting their mandated obligation to achieve the Water Frameworks Directive’s requirement for good ecological and chemical status by 2027.
Answered by Baroness Hayman of Ullock - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
The Pharmaceuticals in the Environment group, supported by the Veterinary Medicines Directorate, has put in place a roadmap for reducing exposure of these substances to water courses, with workstreams looking at several complementary activities. These include educating vets and the pet-owning public, investing in research to plug scientific evidence gaps, including routes to the environment and pet owner behavioural change, and reviewing the guidance for environmental risk assessments, which will all contribute to the desired aim.
Asked by: Lord Teverson (Liberal Democrat - Life peer)
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.
Answered by Baroness Hayman of Ullock - Parliamentary Under-Secretary (Department for Environment, Food and Rural Affairs)
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).