FOI release

EIR2025/00352 - Sales Data for Fluralaner and Isoxazolines

Published 19 March 2026

Your request

Based on the data submitted to the VMD by Marketing Authorisation Holders (MAHs) as part of their Periodic Safety Update Reports (PSURs) and Pharmacovigilance Sales Submissions (PSS).

Total Sales Volume for Fluralaner (Primary Request):

The total mass of the active substance Fluralaner (CAS Number: 864731-61-3) sold in the United Kingdom in kilograms (kg) for the most recently completed calendar year (ideally 2024).

Please provide the figure broken down by animal species where available (e.g., companion animal vs. food-producing animal uses).

Aggregate Sales Volume for Isoxazolines (Fallback Request):

If the disclosure of the Fluralaner figure is considered commercially sensitive, please provide the aggregated total mass in kilograms (kg) for the entire isoxazoline class of active substances sold in the United Kingdom for the same period (2024).

This aggregate figure should include, but not be limited to, Fluralaner, Afoxolaner, Sarolaner, and Lotilaner.

Public Interest Statement (EIR Justification)

I acknowledge that the VMD may consider this information commercially sensitive under Regulation 12(5)(e). However, I assert that the public interest in disclosure is overwhelming in this instance, and should outweigh any commercial prejudice.
Environmental Information: This request falls under the EIR because the sales volume directly dictates the quantity of a persistent and biologically active chemical substance (Fluralaner) being introduced into the UK environment via pet faeces and disposal.

Presumption in Favour of Disclosure: The EIR requires a presumption in favour of disclosure and mandates that the exception relating to commercial interests be narrowly interpreted.

Emissions and Accountability: Regulation 12(9) states that information on emissions shall not be withheld. Given that pet waste is a primary route of environmental entry for these substances, the total volume sold is foundational to understanding the scale of this emission and the efficacy of environmental risk assessments.

Academic and Public Health: My research contributes directly to public understanding and scientific debate concerning the potential long-term harm these highly potent compounds pose to non-target invertebrates (e.g., dung beetles and aquatic organisms). Disclosure is necessary to hold manufacturers and regulators accountable for the environmental fate of approved medicines.
 If any information is withheld, please state clearly which exemption/exception is being applied, and provide a full explanation of the public interest test that was carried out.
 I require this information for my academic research project. Please provide the data in an easily reusable electronic format, such as a spreadsheet (.xlsx) or text file.

Our reply

Fluralaner is contained within only 3 product ranges all held by the same Marketing Authorisation Holder group. It is the VMD’s established approach not to disclose sales data for active substances where the market is so narrow that aggregation does not meaningfully protect commercial confidentiality. Therefore, we are refusing this part of your request under Regulation 12(5)(e) of the Environmental Information Regulations 2004.

We have considered whether sales data constitutes information on emissions for the purposes of Regulation 12(9). While we acknowledge that veterinary medicinal products may ultimately enter the environment, sales volumes alone do not represent emissions data. They reflect commercial transactions rather than the quantity, timing, pathway, or extent of any actual release into the environment. Sales data cannot reliably be equated with use, excretion, or environmental exposure and therefore does not constitute direct emissions information. As such, the absolute prohibition on withholding emissions information does not apply in this case.

Public Interest Test

We recognise the public interest in transparency and in understanding the potential environmental impacts of veterinary medicinal products. There is a legitimate public interest in supporting environmental research and public debate regarding the environmental fate of active substances.

However, this must be balanced against the strong public interest in protecting commercially sensitive information supplied to the regulator in confidence. Disclosure of substance‑specific sales volumes would be likely to undermine commercial confidence, discourage full and frank regulatory reporting, and prejudice the legitimate economic interests of companies operating lawfully within a regulated market.

On balance, we consider that the public interest in maintaining the exception outweighs the public interest in disclosure of the specific sales volume of Fluralaner.

While we acknowledge the environmental relevance of veterinary medicines, sales data alone does not constitute emissions information under EIR and we have not been presented with evidence to suggest that this information has a direct link to emissions.   Therefore, as it reflects commercial transactions rather than actual release into the environment, the presumption in favour of disclosure for emissions does not automatically apply to these data.

Aggregate Sales Volume for Isoxazolines

However, we can provide the aggregated total mass in kilograms (kg) for the isoxazoline class of active substances (Afoxolaner, Esafoxolaner, Fluralaner, Lotilaner, Sarolaner, Tigolaner).

The full data set for 2024 is not yet available but for 2023, a total of 4,361.2 kg of active substances belonging to the isoxazoline class were sold in the United Kingdom, largely for companion animals.

We are refusing to provide this information by species under Regulation 12(5)(e) because of the commercial sensitivities described above. This is because only 1 product in this group is authorised for use in food-producing species (chickens) and disclosure of such a breakdown would likely undermine commercial confidence.

Data published by the VMD are not subject to independent verification and the VMD does not guarantee their accuracy. VMD databases change over time as new and follow-up information is constantly being received and reviewed.