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Approval of active substances

A plant protection product usually contains more than one component. The active component against pests/plant diseases is called “active substance”. The Commission evaluates every active substance for safety before it reaches the market in a product. Substances must be proven safe for people's health, including their residues in food and effects on animal health and the environment.

Procedure

  1. Application to an EU country called Rapporteur Member State (RMS);
  2. RMS verifies if the application is admissible;
  3. RMS prepares a draft assessment report;
  4. EFSA issues its conclusions;
  5. Standing Committee for Food Chain and Animal Health votes on approval or non-approval;
  6. Adoption by the Commission;
  7. Publication of a Regulation in the EU Official Journal.

Under the new EU rules, it takes 2.5 to 3.5 years from the date of admissibility of the application to the publication of a Regulation approving a new active substance.

This time varies greatly depending on how complex and complete the dossier is.

Dossiers considered complete before 14 June 2011 follow a slightly different procedure
(Regulation 188/2011).

 

List of Candidates for Substitution

“The European Commission is required by Regulation (EC) No 1107/2009 to establish a list of substances identified as “candidates for substitution”. The list identifies active substances with certain properties.

For plant protection products (PPPs) containing these active substances, Member States will be required to evaluate if they can be replaced (substituted) by other adequate solutions (chemical and non-chemical). To prepare such a list, the Commission requested a consultant to prepare a report on the implementation of the criteria set by the Regulation. The report does not contain any official listing, but presents different options drawn from possible interpretations of the criteria.

Member States and stakeholders were consulted on the approach taken and on the input values taken to determine if an active substance qualifies to be a candidates for substitution. The analysis has been conducted by comparing the agreed and peer reviewed endpoints, against the relevant seven conditions specified in Annex II, point 4 of the Regulation. The information is grouped in a comprehensive database that will be updated on a regular basis. The current draft list contains 77 candidates for substitution. More information can be found in the Q&A document below.