Background Veterinary medicinal products (VMPs) administered to livestock might affect the environment. Therefore, an environmental risk assessment (ERA) is conducted during the approval process of VMPs. In the European Union (EU), the ERA, which was established approximately 10 years ago, consists of two phases. In the present review, we examined the first phase. In this phase, VMPs are subjected to a decision-making process comprising 19 questions and several tables with default values published in the “Guideline on environmental impact assessment for veterinary medicinal products in support of the VICH guidelines GL6 and GL38 (European Medicines Agency 2016).” Since a proportion of livestock husbandry systems is currently shifting toward ecological husbandry and free-range production systems, there is a lower risk of VMP consumption in general, but livestock excretions possibly containing VMPs might be directly released into the environment instead of being stored and applied as manure. In the present study, the first phase of the current ERA of VMPs in the EU was critically discussed with respect to the changes in animal husbandry. The large number of default values used in the ERA were checked for topicality. In a three-step approach, firstly trends and changes in animal husbandry in Europe that might be relevant for the ERA were collected, secondly, the interactions between Phase I and animal husbandry were evaluated and thirdly, the default values used in Phase I were verified in order to identify research gaps. Results Several default values used in the current ERA were identified as outdated. Together with the lack of valid data (e.g., on animal husbandry systems or VMP treatments), this may have an impact on the predicted environmental concentration (PEC) as the central decision threshold of the ERA. Conclusions The results of the present study indicate that an update of the ERA of VMPs in the EU is required to consider the changes in animal husbandry. Several aspects related to this issue are critically discussed.

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Background The default values in the models used for environmental risk assessment are mostly more than a decade old. Market developments, structural and legal changes lead to adaptions of animal husbandry and manure management during this time. The scope of this research project was the critical review with regard to the topicality and plausibility of the default values for the assessment of insecticides/larvicides and disinfectants in stables, which are mentioned in the relevant emission scenario documents (Joint Research Centre, Institute for Health and Consumer Protection, Raffael B, Van de Plassche E (2012) Emission scenario document for product type 3: veterinary hygiene biocidal products. Publications Office. 10.2788/29747; OECD (2006) Emission Scenario Document for Product Type 18 No.14 Emission Scenario Document for Insecticides for Stables and Manure Storage Systems”, ENV/JM/MONO(2006)4), supplemented by the draft of Addendum 1 (European Chemicals Acd 1999 agency (ECHA) (draft recommendation of 2021). Addendum to OECD SERIES ON EMISSION SCENARIO DOCUMENTS, Number 14: Emission Scenario Document for Insecticides for Stables and Manure Storage Systems, ENV/JM/MONO(2006)4 Version 1.2). Results Several default values used in the current emission scenario documents (ESDs) were identified as outdated such as the housing scenarios for laying hens. It should be evaluated if outside climate housing was already covered by the existing scenarios or requires the addition of a new one. Additionally, the lack of valid data regarding for instance biocide application and biodegradation data, may also have an impact on the predicted environmental concentration (PEC). Conclusions Based on the results of the present study an update of the ESDs is suggested.