Environmental Assessment of Veterinary Medicinal Products in Denmark
7. Recommendations
On the basis of the overall conclusions drawn above and the identification of gabs in our knowledge on consumption, release, fate and effects of veterinary medicinal products a number of recommendation is made. The recommendations do not represent the opinion of the individual academia or regulatory authority organisations represented in the advisory group but reflects the opinion of the experts of the group.
The aim of the recommendations is to stimulate regulatory, academia and industry efforts to improve the current understanding and assessment of environmental risks associated with the use of veterinary medicinal products. It is by no means the aim of the recommendations to preclude the use of veterinary medicines in animal health treatment or to hinder a rational medicinal management of livestock in Denmark.
The report identifies a considerable lack of basic knowledge on the environmental release, fate and effects of veterinary medicinal products. Therefore, it is recommended that research in environmental fate and ecotoxicological effects of veterinary medicinal products is stimulated.
The report has furthermore identified certain limitations regarding the assessment of environmental exposure and effects of veterinary medicinal products. In order to improve such assessments, the following recommendations should be considered:
 | It should be considered to register the use of both prescription and non-prescription veterinary medicinal products. This would provide an overview of all veterinary medicinal products used in Denmark. At present prescription veterinary medicinal products (A- and B-labelled products) are registered, but non-prescription veterinary medicinal products (H- and V-labelled products) are not. |
Antimicrobial active substances and antiparasitic substances constitute the greater part of veterinary medicines used in Denmark. Harmful effects on non-target fauna, flora and microbial organisms have been reported for these types of veterinary medicines. Furthermore, the environmental release of these substances and/or their metabolites may be of significance. Nevertheless, the actual impact on the environment of these products is not known. Therefore, it is recommended to consider an evaluation of individual existing high-use substances from these product classes. Such an evaluation could include present concepts and principles in environmental risk assessment procedures for veterinary medicine, and where relevant those employed for other use categories of substances.
Other therapeutic products used in lower quantities (e.g. hormones), which may be suspected of having potential environmental impact may also be considered for further evaluation.
Actions according to the recommendations given above should be considered being made known to other regulatory and scientific bodies in the EU member states for stimulating further improvement of the current EU methodology for environmental risk assessment of veterinary medicinal products.
The advisory group has discussed the current methodologies of environmental risk assessment of veterinary medicinal products in the European Union. In lieu of the recommended use of arbitrary exposure related cut-of-values in the evaluation of veterinary substances, in addition, it may be considered to substitute the use arbitrary cut-of-values in soil and manure with triggers based on biological effects with relevant test organisms. Another alternative is to conduct an actual risk assessment of VMPs, i.e. a comparison of exposure and effects for target environments/environments following the same principles as these for new and existing chemicals.
Furthermore, it may be useful to include new endpoints for the evaluation of some veterinary medicines. Compared to industrial chemicals which often have a general narcotic mode of action, veterinary medicines generally have a specific mode of action. In the light of the current doubt about the existing standardised test battery being sufficient to evaluate e.g. the risk of endocrine disrupters, new and more appropriate test methods for evaluating the risk of certain veterinary medicines could be considered. Prior to the implementation of such new tests, they need, however, to be developed, validated and standardised.