The European Medicines Agency (EMA) has published a new concept paper outlining plans to assess the risks of humans developing antimicrobial resistance (AMR) from veterinary medicinal products (VMPs) via the environment.
AMR occurs when harmful bacteria or viruses develop a resistance to antimicrobials (antibiotics) that could previously be used for treatment. This poses several challenges, including reduced treatment options, lengthened illnesses and worsening symptoms. For these reasons, the EMA describes AMR as a ‘global public health threat’ and is keen to encourage the safe and careful use of antimicrobials in animals so that the impact on human health is reduced.
The concept paper explains a risk assessment that will involve hazard identification, release, exposure and consequence assessment, as well as the risk estimation to humans via the environment. Specifically, this will focus on indirect exposure that can occur through consuming agricultural products and accessing water supplies. If a high risk for humans is identified, risk mitigation measures will be proposed.
The concept paper provides details for an upcoming reflection paper and, in preparation for this, legislation such as Regulation (EU) 2019/6 - Article 8(2)(a) will help to guide the assessment process. The One Health approach, which recognises that ‘the health of people is closely connected to the health of animals and our shared environment,’ will also be taken into consideration.
The Environmental Risk Assessment Working Party (ERAWP) and the Antimicrobials Working Party (AWP) will jointly develop the reflection paper. The draft reflection paper is due to be published in February 2027.
The EMA welcomes public comments for the concept paper with a deadline of October 2025.
