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Department Pesticides Safety

The remit of the department comprises the health risk assessment of plant protection products and biocides as outlined in Directive (EC) No. 2009/128/EC for establishing a framework for Community action to achieve the sustainable use of pesticides.

The department’s mandate is the protection of humans, pets and livestock from potential harm from pesticides. Central tasks hence comprise the toxicity assessment of active substances and product formulations, the establishment of dose-effect relationships, the classification and labelling of active substances as well as the derivation of toxicological limit values. In addition the department also is responsible for the assessment and proposal of risk mitigation measures and maximum residue concentrations. The department also reviews analytical monitoring methods and works on the development and improvement of regulatory testing and assessment strategies and technical guidelines.

Assessments are communicated by means of scientific opinions, commentaries or assessment reports. The department’s risk assessments are the basis for subsequent, regulatory approval, risk management and national, European and worldwide regulations in line with the following laws on pesticides and chemicals.

• Regulation (EC) No. 1107/2009 concerning the placing of plant protection products on the market,
• Regulation (EC) No. 528/2012 concerning the making available on the market and use of biocidal products,
• Regulation (EC) 396/2005 on maximum residue levels of pesticides,
• Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures and
• the Infection Protection Act (IfSG), §18.

Research

The department conducts extensive research in support of its regulatory remit. Projects predominantly focus on methodological and conceptual issues as well as molecular toxicology and exposure assessment. One focus is on so-called "New Approach Methodologies" (NAMs) for improved and less animal-intensive risk assessment (Next-Generation-Risk-Assessment). In addition potentially new risks are also analysed and addressed.

Key projects currently address the following issues:

• cumulative toxicity of mixtures,
• residues and multiple residues of plant protection products and biocidal products including their degradation products,
• relevant mechanisms of molecular toxicity,
• endocrine disruptors,
• possible substance toxification by the human microbiome and
• in silico toxicology as well as data formats and AI-based data evaluation.

Finally, the department provides specialist advice to the German government on issues relating to national and European legislation on active substances in pesticides as well as on pesticide and biocide applications.

The Department comprises the following six units and two junior research groups:

• Junior Research Group Skin Microbiome
• Junior Research Group Mixture Toxicity
• Unit Steering and Overall Assessment - Plant Protection
• Unit Steering and Overall Assessment - Biocides
• Unit Toxicology of Active Substances and their Metabolites
• Unit Toxicology of Products and their Safe Use
• Unit Residues and Analytical Methods
• Unit Testing and Assessment Strategies Pesticides

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