title: Legal constraints in EU product labelling to mitigate the environmental risk of veterinary medicines at use.
abstract: This paper summarises what possibilities and obligations are created by the EU Directive 2001/82/EC on the registration of veterinary medicines to mitigate the environmental impact of the use of a veterinary medicinal product. More specifically, an identified environmental risk may be mitigated to an acceptable level by special precautions in the information that accompanies the product in labelling and packaging. These precautions can address the fate of contaminated slurry and treated animals, but are only acceptable under the EU Directive if their effect can be demonstrated using the risk assessment methodology. Next, all possible keepers of the animals or the manure, including third parties, should be addressed, either in the precaution, or in the national regulation that should enforce the precautions. A number of examples illustrate that some precautions used are not quantifiable in the risk methodology, and that others are legally inadequate. To render risk mitigation measures effective, hence suitable for labelling and packaging, it is imperative that the risk assessment methodology is further developed and applied adequately, and that the legality of precautions is established in national regulation, harmonised between Member States.
authors.affiliation: National Institute for Public Health and the Environment, Bilthoven, The Netherlands. mark.montforts@rivm.nl
authors.forename: M H M M
authors.initials: MH
authors.lastname: Montforts
authors.forename: H F M W
authors.initials: HF
authors.lastname: van Rijswick
authors.forename: H A Udo
authors.initials: HA
authors.lastname: de Haes
mesh_terms: D000465:Algorithms; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D004349:Drug Packaging; D004784:Environmental Monitoring; D004787:Environmental Pollution / Q000331:legislation & jurisprudence* / Q000517:prevention & control*; D005062:European Union; D007880:Legislation, Drug; D018570:Risk Assessment; D019155:Veterinary Drugs / Q000592:standards*
chemical_list: D019155:Veterinary Drugs