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Comparing user risk assessment - veterinary medical products versus biocides

Comparing User Risk Assessment – Veterinary Medicinal Products versus Biocides Introduction User safety is a critical aspect in the marketing authorization process for a diversity of products, including veterinary medicinal products (VMPs) and Biocides. Along with the application a user risk assessment needs to be submitted in order to evaluate potential risks resulting from the use of the product. Not only the active substance itself, but also metabolites thereof and as well other product ingredient(s) might be of concern and need to be considered in the exposure and risk assessment. Materials and Methods For this overview on user risk assessment the requirements for both product types as laid down in Directive 2001/82/EC (VMPs) and Regulation (EC) No 1451/2007 (biocides) as well as relevant guidance documents were reviewed and a comparison was made between the product classes regarding general aspects, prerequisites and dossier requirements. Differences and similarities in user risk assessment will also be illustrated by practical example. Results For both product classes, general considerations on product properties and exposure scenarios form the basis of the user risk assessment. The data that serve as reference point for the risk assessment, i.e. the toxicity studies investigating the effects resulting from acute and repeated exposure towards the active ingredients, are the same for biocides and VMPs, whereby for the latter in addition to trials in laboratory animals, investigations on target animal safety are required. Based on these studies, suitable reference values need to be established and the exposure, resulting from the use of the product, is then compared to it. The scenarios leading to exposure and the user groups, however, differ between VMPs and biocides: For example, in case of biocidal products, exposure in industrial settings might need to be covered by the risk assessment. In contrast, the use of VMPs is usually related to a veterinarian, farmer or the animal owner. Another difference concerns the so-called secondary exposure. This term describes the exposure of adults and children that occurs after a product has been applied (e.g. via contact with a disinfected surface or by petting a treated animal). Due to the diversity of biocidal products and the resulting wide distribution into different areas of life, the secondary exposure is more widespread compared to VMPs. Conclusion Despite the distinct legal basis and considerable differences of biocides and VMPs, the exposure routes of a user are the same and therefore the basic considerations that need to be made with regard to performing a human risk and exposure assessment are similar.

DATE » 19.07.2015

AUTHORS » D. Pfeifer, K. Hellmann, B. Lohr

PUBLISHED » Journal of Veterinary Pharmacology and Therapeutics, Volume 38 supplement, p. 152; July 2015; Special issue: Abstracts of the 13th International Congress of the European Association for Veterinary Pharmacology and Toxicology (EAVPT 2015), 19-22 Juli, Nantes, France.