Industrial Chemicals – REACH | Services

Data-gap analysis, closing of data-gaps and study monitoring

  • The basis for any data-gap analysis are the specific dossier requirements, which depend on the tonnage band of the substance and it’s possible status as an intermediate. Based on the formal requirements and the available data, the so-called data-gap analysis is conducted by assessing whether sufficient data are available for a complete dossier, or whether data-gaps exist which need to be closed.
  • EBRC provides a comprehensive service to address data gaps under REACH, as follows:
    • Initiation and supervision of experimental studies:
      • Obtaining quotations from reliable contract research organisations
      • Cost comparisons
      • Generation and maintenance of testing programme schedules
      • Project co-ordination, study monitoring and report auditing
    • In cases where the conduct of studies may be avoided based on scientific or technical reasons, EBRC provides:
      • Development of read-across concepts
      • Generation of expert statements and waivers / derogation statements
      • Supportive QSAR model calculations