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.

Based on our cross-disciplinary, in-depth expertise and many years of experience, we support our clients 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.

For questions beyond standard toxicology, we create tailor-made solutions for our clients by applying read-across and bridging principles or by developing integrated testing strategies including in-vitro methods.

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 and support in the implementation of regulatory requirements
  • Communicating with competent authorities
  • 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 experimental studies required according to the regulations (EC) No. 1107/2009, (EC) No. 283/2013 and 284/2013  in the fields of specification, analytics, physico-chemical properties, efficacy (in compliance with the EPPO guidelines), toxicology and ecotoxicology (in vitro, in vivo)
  • Development of testing strategies and use of (Q)SAR

Risk assessment of active substances and plant protection products

  • Assessment of the potential hazard including classification and labeling
  • Identification and assessment of potential substances of concern
  • 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 for the authorization of active substances and plant protection products, including CADDY, GHSTS, draft Registration Report (dRR) incl. GAP table, draft assessment reports (DAR) or renewal assessment reports
  • Support in simplified authorization procedures for adjuvants, plant strengtheners, and basic substances
  • Dossier submission, e.g. via the BVL portal (BVL = German Federal Office of Consumer Protection and Food Safety) or the Plant Protection Products Application Management System (PPPAMS)
  • Support in the MRL procedure
  • Response to additional data requests by the authorities

Our expertise

Our team of experienced human and environmental toxicologists offers:

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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