Assessment and authorization of plant protection products

Regulatory research beyond standard toxicology

Risk assessment of plant-protecting active substances and plant protection products

Plant protection products: assessment and authorization
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Plant protection products enable control of undesirable plant growth and destruction of unwanted plants or parts of plants, thereby contributing to improved agricultural production.

Plant protection products are widely used to protect plants and plant products from harmful organisms. According to the Plant Pro­tection Products Regulation (EC) No. 1107/2009, a complex assessment involv­ing comprehensive data is required for the authori­za­tion of active substances and plant protection products. In a two-stage process, active substances are first thoroughly evaluated and assessed by the European Commission (EFSA). In a second step, the active substance-containing products are examined and evaluated by the national authorities of the EU to ensure sufficient effectiveness on the one hand and protection of human and animal health and the environment on the other hand.

Based on our cross-disciplinary, in-depth expertise and many years of experience, we support you in all scientific and regulatory issues. In addition to analyzing data gaps and evaluating all data, we assess potential substances of concern, residues and metab­olites, prepare dossiers including risk assessments and expert statements, and submit and defend dossiers. Our aim is to identify risks to health and the environment and to reduce these, while not losing sight of the desired efficacy.

Our services

Scientific and regulatory support

  • Development of an authorization strategy
  • Support with the implementation of regulatory requirements
  • Communicating with competent authorities
  • Support with letter of access (LoA) negotiations
  • Submission of MRL (maximum residue levels) applications
  • Support with the new application rules, e.g. with regard to biodiversity

Data collection and study monitoring

  • Identification of data gaps
  • Commissioning and monitoring of required experimental studies in the fields of specification, analytics, physicochemical properties, efficacy (in compliance with the EPPO guidelines), toxicology and ecotoxicology (in vitro, in vivo) etc.
  • Development of testing strategies and use of (Q)SAR models

Risk assessment of plant protection products

  • Assessment of the potential hazard including classification and labeling
  • Assessment of the regulatory need (e.g. adaptation of studies, study evaluation/interpretation and justifications for study waiver) resulting from reformulation to avoid “unacceptable co-formulants” according to Article 27 of the Regulation (EC) No. 1107/2009
  • Identification and assessment of endocrine-disrupting properties (ED assessment)
  • Identification and assessment of residues and metabolites (MRL procedure according to (EC) No. 396/2005)
  • Exposure assessment and risk assessment for humans and the environment
  • In-house exposure measurements and analytics

Dossier preparation and submission

  • Dossier preparation (submission report) for: “EU PPP Basic substance application”, “EU PPP Active substance application (represen­tative product)”, “EU PPP Micro-organisms application (representative product)”, and “EU PPP MRL application” aimed at obtaining authorization of active sub­stances and products, including IUCLID, draft Registration Report (dRR) including GAP table, draft assessment reports (DAR) and renewal assessment reports (RAR)
  • Support with simplified authorization procedures for adjuvants, plant strengtheners, and basic substances
  • Dossier submission, e.g. via the BVL portal or the EFSA IUCLID cloud portal
  • Support with the MRL procedure
  • Response to additional data requests by the authorities

Our expertise

  • Long-term experience in regulatory research and practice (dossier preparation, communication with authorities, dossier defense)
  • Exposure and emission evaluation and risk assessment
  • Consulting in related regulatory areas including biocidesREACHveterinary medicinal productsfoodsmedical devices, and cosmetics
  • Development and evaluation of concepts and methods for chemical risk assessment including development of quantitative structure-activity relationships ((Q)SAR, read-across and bridging principles, and integrated testing strategies or exposure models
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Fraunhofer ITEM provides tailored support in the assessment and authorization of plant protection products and corresponding communication with the authorities.
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Regulatory support and risk assessment of plant protection products

Your contact for the assessment and authorization of plant protection products

Franziska Breuer

Contact Press / Media

Dr. Franziska Breuer


Phone +49 511 5350-360