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What makes a chemical substance a 'natural substance'? A case study in the context of the EU veterinary medicines marketing authorisation procedure

: Hahn, Torsten; Floeter, Carolin; Schwonbeck, Susanne; Könnecker, Gustav

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Society for Environmental Toxicology and Chemistry -SETAC-:
SETAC Europe 28th Annual Meeting 2018. Abstract Book : Responsible and Innovative Research for Environmental Quality, 13 - 17 May 2018, Rome, Italy
Brussels: SETAC Europe, 2018
pp.335, Abstract WE026
Society for Environmental Toxicology and Chemistry (SETAC Annual Meeting) <28, 2018, Rome>
Abstract, Electronic Publication
Fraunhofer ITEM ()

The marketing authorisation process for veterinary pharmaceuticals in the EU and other countries requires an environmental impact assessment (EIA) for each veterinary medicinal product (VMP). This EIA follows a phased approach with conservative estimates of environmental exposure in phase I, which may later require refinement by experimental data in phase II. Core of the phase I assessment is a catalogue of 19 questions on use and characteristics of the VMP under consultation. These questions aim at establishing an initial predicted environmental concentration, which, together with information on therapeutic use and targeted animal species, may trigger the necessity to perform an in-depth phase II assessment. According to question 2 in the phase I assessment a substance is exempted from further investigation when there is scientific proof that it is a natural substance “the use of which will not alter the concentration or distribution in the environment”. At first sight this definition appears unambiguous. Nevertheless may it be a hurdle for applicants because no further guidance is given which criteria apply for acceptance or rejection of a given concentration as ‘natural’. Here, we present a case study comprising two substances in order to highlight possible uncertainties for applicant companies, as well as for competent authorities.