Equivalence assessment of active substances

Active substances used in plant protection products are approved within the EU. One member state prepares a draft assessment report and proposes the approval or non-approval of the active substance. Other member states can comment the draft assessment report. Equivalency for an active substance can be applied if the active substance in question already has an approval.

Equivalency assessment is a quicker and lighter procedure than a full risk assessment and approval process. Equivalency application must be prepared if one of the following differs from the original approval:

  • manufacturer of the active substance
  • volume of production (from a pilot scale to an industrial scale)
  • production process or production method
  • production site.

Finnish Safety and Chemicals Agency (Tukes) performs equivalency assessment for the following active substances for which Finland is the Rapporteur Member State:

  • aminopyralid AIR V
  • amidosulfuron AIR III
  • phenmedipham AIR III
  • flonicamid AIR IV
  • hexythiazox AIR IV
  • clopyralid AIR III
  • quizalofop-P-ethyl AIR IV
  • mepiquat chloride AIR IV.

More information on equivalency assessment and the preparation of equivalency application is provided in EU Guidance Documents.

When you initiate a process for the equivalency assessment of an active substance, please contact Tukes ppp.activesubstance (at) tukes.fi. Tukes provides advice related to submitting the application. 

Application form for equivalence assessment of active substance