FOI release

EIR - Information in regards to Section 40 of the Natural Environment and Rural Communities Act 2006

Published 30 October 2025

ATI1087 Request

To provide the following information:

1. in relation to VMD functions exercised in England, any consideration as has been given by VMD to actions to further the general biodiversity objective, as per section 40(1); and

2. assuming that such consideration has been given, any “policies and specific objectives” that have been applied by VMD to further the general biodiversity objective (as per section 40(1A)(a)); and

3. assuming that consideration has been given, and policies and objectives applied, any actions that have been taken by VMD to further that objective (per section 40(1A)(b)).

Our reply

The VMD has long integrated protecting the environment and biodiversity in its policy and regulatory decision making. Assessment processes for veterinary medicine approvals have required environmental impact assessments since the early 2000s in line with international standards.

In May 2024, we amended the Veterinary Medicines Regulations (VMR) 2013, which was the culmination of many years of preparation and policy development. The review of the VMR started in 2014, alongside the EU’s proposal to update the EU legislation on veterinary medicines. The UK had significant input in the discussions prior to us leaving the EU.

As part of this work the VMD had already determined there were several policy objectives where we could seek to protect and promote biodiversity in the environment both domestically and as part of the EU review.

Although the Duty under the Environment Act 2021, did not come into effect until January 2023, these existing policy development processes complimented the duty under Section 40.

As part of the review specific changes that seek to protect and promote diversity were made to the VMR, these include:

• A new requirement for the reporting of adverse environmental events where a non-target organism, population or ecosystem is adversely affected as a result of exposure to a veterinary medicine, its active substances or its metabolites present in soil, water or animal remains.

• Future-proofing the summary of product characteristics for Marketing Authorisations (MAs) to include take-back schemes for veterinary medicines for the disposal of unused veterinary medicines or waste materials derived from the use of such products and, if appropriate, additional precautions regarding hazardous waste disposal of unused veterinary medicines or waste materials derived from the use of such products.

• Explicitly including reasons for refusing an MA where risks to the environment are not sufficiently addressed; if the active substance within the veterinary medicine meets the criteria for being considered persistent, bio-accumulative and toxic and the veterinary medicine is intended to be used in food-producing animals (except where it is demonstrated that the active substance is essential to prevent or control a serious risk to animal health).
• The continued requirement for applicants to provide various assessments to determine the benefit-risk balance of a medicine in line with international standards and guidelines.

These amendments will help to protect and improve biodiversity by ensuring that risks have been properly considered when assessing applications for MAs and ensure that risks continue to be monitored through adverse event reporting, allowing the VMD to take action where necessary.

Following the Duty coming to effect, In November 2023 we carried out a formal assessment of the environmental impacts of the proposed changes to the VMR, giving due regard to the Environmental Principles as set out in as set out in section 17(5) of the Environment Act.

Further to these legislative changes, the VMD has been instrumental in establishing a cross-government Pharmaceuticals in the Environment (PiE) Group, which has recently published a roadmap, available online, to address levels of fipronil and imidacloprid detected in UK surface waters.

Key actions have been identified, including:

• Communication and Education (Short Term):
  The VMD will collaborate with veterinary professionals and industry stakeholders to improve pet owner awareness about the appropriate use and disposal of flea and tick treatments.
• Evidence Gathering (Medium Term):
  The PiE Group will build a comprehensive understanding of the environmental impacts of these chemicals, alongside evaluating potential consequences of changing use patterns on animal and human health. The VMD has commissioned scientific research investigating how these substances enter rivers and streams and is working closely with the Environment Agency to assess the environmental risks they pose.
• Regulatory Actions (Long Term):
  Based on the evidence collected, the PiE Group will support a review of international environmental risk assessment guidelines and consider future regulatory approaches to mitigate environmental risks.

The VMD has funded research, carried out by the University of Sussex, to investigate how flea and tick treatments might be entering the environment. The studies, published in 2024 and 2025, found that some spot-on treatments containing imidacloprid and fipronil can contribute to environmental contamination—primarily through household wastewater and when treated dogs swim in natural water bodies.

The VMD welcomes these findings as part of its broader efforts to understand and manage the environmental impact of veterinary medicines. This research adds to a growing body of evidence that will help shape future regulatory decisions.

I hope the above sets out how the VMD meets its obligations and aims to protecting animal health, public health and the environment, whilst ensuring our decisions are robust and evidence based.