Chemistry Services for Plant Protection Products, Biocides and Chemicals in the EU

The Exponent Chemical Regulation and Food Safety chemistry team has significant expertise in testing, evaluating, and supporting registrations of active substances and formulated products in the EU, for Plant Protection Products (Regulation 1107/2009), Biocidal Products (Regulation 528/2012) and Industrial Chemicals (REACH Regulation 1907/2006) . Our team is also experienced in the compilation of the relevant sections of EU regulatory dossiers, including OECD, dRR, AIR and IUCLID formats, and in the design and monitoring of all relevant studies.

Our Services Include:

Identity

  • Study design/monitoring of 5-batch analysis for technical grade active substance
  • Setting of technical specification for active substance
  • Use of manufacturing QC data to support proposed technical specification
  • Preparation and submission of technical equivalence dossiers to support existing or alternative sources of active substance
  • Preparation of confidential sections of EU regulatory dossiers
  • Submission of FAO/WHO specifications to the Joint Meeting on Pesticide Specifications (JMPS)

Physical and Chemical Properties

  • Data gap analysis on existing physical and chemical properties data set(s) for active substance and formulated product
  • Preparation of data waivers and bridging (read-across) arguments
  • Advice on appropriate testing methods (e.g. EC, OECD, CIPAC)
  • Stability testing requirements (accelerated and long term) for formulated products (e.g. SC, WP, WG, SL, LN, aerosols, vaporising mats)
  • Study design/monitoring of all physical and chemical properties studies
  • Preparation of physical and chemical properties sections of EU regulatory dossiers
  • Advice on classification implications (CLP Regulation (EC) 1272/2008 ) of physical and chemical properties studies
  • Preparation of the physical hazards section of EU biocide dossiers (CLP)

Analytical Methods

  • Data gap analysis on existing analytical method validation data set(s)
  • Production of data waivers
  • Pre-registration method validation requirements in accordance with EU guidance documents SANCO/3029/99 and SANCO/3030/99
  • Post-registration ‘monitoring’ method validation requirements in accordance with EU guidance document SANCO/825/00 (e.g. relevant matrices, ILV)
  • Advice on appropriate limit of quantification (LOQ) for individual matrices, in accordance with MRL’s and other guidance
  • Assessment of extraction efficiency data for monitoring methods
  • Study design/monitoring of all analytical method validation studies
  • Preparation of pre-registration and post-registration monitoring analytical method sections of EU regulatory dossiers 

Professionals