Environmental risk assessment of veterinary medicinal products: A Feasibility Study for an Active Substance-Based System in the EU

Project Background

Residues of veterinary medicines often enter the environment without filtering in agriculture and private animal husbandry. Contaminated water and soil can harm humans, animals and plants. However, the current environmental risk assessment for marketing authorization of veterinary medicinal products is product-based, which is associated with data gaps on environmental safety and disadvantages, e.g. multiple assessment of the same active ingredient.

Project Description

In the project, the feasibility study required by the European Union (EU) Regulation 2019/6 will be carried out for the European Commission. The organizational, legal and financial aspects of an active substance-based system will be analyzed in comparison to the product-based system. The aim is to develop a proposal for an active substance-based system.


Literature-guided analysis of the legal, organizational, and financial aspects of different audit systems is conducted. Exploratory interviews are used to gather the perspectives of different stakeholders within the EU. Data gaps identified from the literature are filled through a quantitative survey. The information collected will then be synthesized and processed and submitted to the European Commission.

Project Tasks

The health economics team of the Fraunhofer IMW is responsible for the analysis of  the financial aspects within this project. Costs and benefits for various stakeholders are examined in comparison to the existing system. Information is generated by the Fraunhofer IMW using a systematic literature research, an online questionnaire and interviews, these are then analyzed and processed. With the results of this analysis, the Fraunhofer IMW contributes to political decision support on a European level.


European Commission 
Directorate General Health and Food Safety (SANTE)

Duration of Project



Project partners

Fraunhofer ITEM (Head of Project)

Hochschule für Angewandte Wissenschaften Hamburg

Ecologic Institut gemeinnützige GmbH

Teppe Rechtsanwälte

Project Sheet Mono4ERA