Approval - New Active Substances

All active substances (active ingredient in a plant protection product) must be approved at EU level under Regulation (EC) 1107/2009/EC.

An applicant wishing to seek approval for a new active substance must submit a detailed dossier to a Member State who agrees to act as the Rapporteur Member State (RMS).  The dossier contains a comprehensive data set, arranged under the following main headings:

  1. Identity
  2. Physical and chemical properties
  3. Data on application, efficacy and further information
  4. Classification, Labelling and Packaging
  5. Analytical methods
  6. Toxicological and metabolism studies on the active substance
  7. Residues in or on treated products, food and feed and plant metabolism
  8. Fate and behaviour in the environment
  9. Ecotoxicological studies on the active substance
  10. Literature data

The RMS evaluates and appraises the dossier and then prepares a draft assessment report (DAR).  The DAR includes a recommendation for approval or non-approval of the active substance.    

Once completed, the DAR is subjected to detailed peer review by experts from all Member States, a process which is managed by the European Food Safety Authority (EFSA).  Based on the outcome of the expert peer review, the EFSA sends its conclusions to the Commission, who then propose a decision on approval or non-approval.

Commission proposals regarding approval or non-approval are voted on at the European Commission’s Standing Committee on plants, animals, food and feed (SCoPAFF).  The SCoPAFF is a Committee consisting of representatives of all Member States and the main function of this committee is to proffer an opinion on Commission proposals.  The SCoPAFF may vote on full or conditional approval of the active substance or it may vote against its approval. The voting process results in an opinion being expressed by the SCoPAFF, the Commission may then adopt, or not, their proposal.  First approval lasts for a maximum of 10 years, but substances may be reviewed at any time in light of new information.

Further details of the active substance approval process are available on the European Commission website.