The need for reliable information on the physical and chemical (phys-chem) properties of chemical substances and mixtures is widely applicable across a variety of chemical legislation. Whether compliance is being sought under REACH, Plant Protection Product, or Biocidal Products regulations, having a robust package of information on the phys-chem properties of the substance or product under consideration is essential in establishing appropriate CLP hazard classifications and informing risk assessments relied upon to ensure human health and the environment are appropriately protected.

Our regulatory affairs team consists of consultants from academic, industry and regulatory backgrounds who are strongly embedded within the field of chemistry. Our consultants have many years of experience in working with phys-chem data packages and analytical method validation for the purpose of supporting regulatory registrations in the EU and UK.

Our services

Data gap analysis

  • Review substance (REACH), active substance (PPP, BPR) and product (PPP, BPR) phys-chem data packages against regulatory data requirements
  • Advice on strategies for filling identified data gaps

Study commissioning

  • Design and commission GLP study testing for generating phys-chem data packages (REACH, PPP, BPR)
  • Design and commission GLP five-batch analysis studies of active substance technical materials for setting technical specifications (PPP, BPR)

Formulation comparisons

  • Assess chemical composition of similar formulations for comparability (PPP, BPR)
  • Assess significant/non-significant formulation changes (PPP, BPR)

Analytical method validation

  • Assess method validation data following SANCO/3030/99 for analysis of technical active substances and formulations (PPP, BPR)
  • Assess method validation data following SANTE/2020/12830 for analysis residues in crop and environmental matrices (PPP, BPR)

CLP hazard classification and labelling requirements

  • Analyse and interpret phys-chem data to establish CLP physical and human health hazard classifications for substances and mixtures
  • Advise on implications of phys-chem properties and CLP hazard classification on labelling requirements for substances and mixtures

Dossier authoring

  • Prepare identity (Part B1), phys-chem (Part B2) and analytical methods (Part B.5) sections of draft registration reports to support PPP authorisations in the UK and EU
  • Prepare phys-chem sections of IUCLID dossiers and product assessment reports (PAR) to support biocidal product authorisations in the UK and EU
  • Identity phys-chem sections of IUCLID registration dossiers to support substance registrations under EU and UK REACH

Other expertise

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Enviresearch is part of the RSK group of companies

The RSK group is a leading integrated environmental, engineering and technical services business offering bespoke end-to-end solutions to a variety of sectors. Headquartered in the UK but with an established presence throughout Europe, Africa, the Middle East, Asia and Australia, RSK helps organisations around the world achieve their business aspirations in a sustainable and efficient manner.