European Legislation
European Legislation
European legislation requires that all veterinary medicines undergo an environmental risk assessment (ERA) based on their expected use. The ERA is an evaluation of the possible hazards to the environment posed by a veterinary medicine.
The purpose of the ERA is to:
- identify potential environmental hazards and risks
- identify the need for specific risk-minimisation measures, where appropriate
- ensure appropriate labelling is in place for users and healthcare professionals
There are two phases to the ERA. Phase 1 is an environmental impact assessment which considers the medicine’s active substance and excipients, its method of administration, target species and proposed pattern of use.
Phase 2 is an ecotoxicological assessment, which is tier-based and structured around the risk quotient (RQ) which provides an indication of the likelihood of adverse effects on the environment. Medicines whose phase 1 assessment concludes that their environmental exposure is not negligible (e.g. PECsoil value higher than 100 µg/kg) have to undergo the phase 2 ecotoxicological assessment. This generally applies to veterinary medicines used for aquaculture, intensively reared terrestrial animals, or pasture animals.
Currently the assessment for veterinary products used in companion animals is limited to phase 1, as exposure from veterinary medicinal products used in companion animals has been considered negligible in the scope of the current environmental risk assessment framework.
However, a recent concept paper, published by the European Medicines Agency (EMA) challenges the conclusion that environmental risk associated with these products is always negligible, and calls for a review of the current blanket exclusion of a higher-tier risk assessment for all these products. The concept paper recommends the development of a more detailed reflection paper, on whether the current approach for the environmental risk assessment of Veterinary Medicinal Products containing parasiticides, that are used in companion animals, remains scientifically justified and the need and feasibility of mitigation measures for such products.
- Veterinary Regulatory: Environmental risk assessment of veterinary medicines [European Medicines Agency] [online] Available from: https://www.ema.europa.eu/en/veterinary-regulatory/marketing-authorisation/environmental-risk-assessment-veterinary-medicines#phase-i:-environmental-impact-assessment-section [accessed 29/1/2021]
- Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals [European Medicines Agency] [online] Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-environmental-risk-assessment-parasiticide-veterinary_en.pdf [accessed 29/1/2021]
Other publications from the EMA indicate that the effect of veterinary medicines on the broader environment is a subject of interest.
- Antimicrobial resistance in the environment: considerations for current and future risk assessment of veterinary medicinal products [European Medicines Agency] [online] Available from: https://www.ema.europa.eu/en/antimicrobial-resistance-environment-considerations-current-future-risk-assessment-veterinary [accessed 29/1/2021]
- Assessing the toxicological risk to human health and groundwater communities from veterinary pharmaceuticals in groundwater
[European Medicines Agency] [online] Available from: https://www.ema.europa.eu/en/assessing-toxicological-risk-human-health-groundwater-communities-veterinary-pharmaceuticals [accessed 29/1/2021]
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