In product dossiers, read across to the exposure and risk assessment of the respective active substance dossier(s) may be sufficient if the following conditions apply:

  • The use pattern of the product is fully covered by the exposure and risk assessment in the active substance dossier(s).
  • The product does not contain any substances of concern requiring additional exposure and risk assessments.
  • The product does not contain any components which may influence the toxicological, environmental fate and eco-toxicological properties of the active substance(s).
  • The exposure scenarios and models used in the active substance dossier(s) for the performance of exposure and risk assessments are still valid.

In all other cases, the applicant is likely required to submit adapted, refined or extended exposure and risk assessments.

Environmental exposure and risk assessments
Human health exposure and risk assessments