The evaluation, marketing and use of pesticides (herbicides, insecticides, fungicides etc.) in plant protection in the Community are regulated under Council Directive 91/414/EEC. This Directive lays out a comprehensive risk assessment and authorisation procedure for active substances and products containing these substances. Each active substance has to be proven safe in terms of human health, including residues in the food chain, animal health and the environment, in order to be allowed to be marketed. It is the responsibility of industry to provide the data showing that a substance can be used safely with respect to human health and the environment.
The first step of the evaluation process involves a Rapporteur Member State, which transmits its preliminary conclusions on the substance to the European Food Safety Authority. A scientific risk assessment involving the European Food Safety Authority is then carried out, followed by risk management steps carried out by the Commission with the assistance of the Member States within the Standing Committee on the Food Chain and Animal Health.
If the evaluation shows that the substance has no harmful effect on human or animal health and that it has no unacceptable influence on the environment, the substance can be approved.
An EU list of approved active substances (Annex I to Directive 91/414/EEC) is established, and Member States may authorise only plant protection products containing active substances included in this list.
- Directive 91/414/EEC
- New active substances placed on the market after 1993
- Existing active substances placed on the market before 1993
- Regulation (EC) No 1095/2007
- Regulation (EC) No 33/2008
- State of the works (SANCO/629/00 rev. 88), 19 January 2007
- Contact Points Revision 106 - updated on 13/07/2012
- Renewal Commission Regulation (EU) No 1141/2010
- Renewal Guidance on implementation of Regulation (EU) No 1141/2010
- Renewal Competent Authorithies in Member States
- List of admissible applications under Regulation 1141/2010
- Commenting on draft assessment report for new active substances under the scope of Regulation (EU) No 188/2011 Updated on 18-07-2012