EFSA completes 2nd stage of EU-wide pesticides peer review process
EFSA has completed its work on the 2nd stage of the EU-wide peer review of active substances used in plant protection products (commonly referred to as pesticides) , and issued conclusions on 50 substances that have been peer reviewed for safety by experts from the EU Member States and EFSA. The conclusions are published on the EFSA website along with a comprehensive set of documentation. The Commission and the Member States should now be able to finalise decision-making on these substances in the next six months, which will determine whether these substances can continue to be used in the EU. Meanwhile, EFSA has already begun work on the 137 substances covered by the 3rd stage of the review which is to be completed by 2008.
“EFSA is at the centre of a truly European process involving experts from all the EU Member States, pooling their knowledge to improve the quality of risk assessment in the interests of consumers and operators”, said EFSA Director of Science, Dr. Herman Koëter.
The peer review of active substances is a major undertaking that began in 1993 involving the risk assessment of several hundred chemicals used as plant protection products. Because of the scale of the task, it has been divided into four stages. The 1st stage of the peer review programme was carried out by the European Commission and covered 90 substances, the last decisions on which should be taken by the end of this year. EFSA has now issued conclusions on the 50 substances included in the 2nd stage of the peer review process, which was launched in 20033 .
Based on these conclusions, which were arrived at through the input of experts from EU Member States, in the coming six months the Commission and Member States now need to decide whether to include these substance in the ‘positive list’ of active substances authorised for use in plant protection products. Once an active substance has been peer reviewed, Member States may authorise its use only if it has been included in the positive list.
EFSA’s Pesticide Risk Assessment Peer Review Unit (PRAPeR) organised a thorough scientific peer review of the Draft Assessment Reports (DARs) initially prepared by rapporteur Member States, and has now provided the results in a comprehensive set of documentation made publicly available on the EFSA website. The peer review is based on scientific assessments: the applicant has to prove that a substance can be used safely as regards human health, the environment and residues in the food chain.
EFSA has already begun work on the 3rd stage of the peer review, which is due to cover 137 substances and needs to be completed by 2008. Expert meetings are being held since September 2006 with the first conclusions expected by the end of the year. For the 3rd stage there will be a 40-day public commenting period on each DAR.
- Further information on the regulatory framework for plant protection products in the EU: European Commission’s DG Health and Consumer Protection and “Questions and answers on plant protection products”
Context: The European Directive on the placing of plant protection products on the market is the legal framework for the market authorisation of plant protection products in Europe. Under this legislation, active substances cannot continue to be used in plant protection products in the EU unless they are included in a Community ‘positive list’. A programme of evaluation to create this list was launched in 1993, when the European Commission started a review process for all active substances used in plant protection products in the EU, to be completed by 2008 and covering several hundred substances. Because of the scale of the task, the review process has been divided into four stages. With the establishment of EFSA, risk assessment was separated from risk management. In mid 2003, EFSA launched the peer review process of the assessments made by Member States, which is managed by EFSA’s Pesticide Risk Assessment Peer Review Unit (PRAPeR). Market authorisation of active substances used in plant protection products is the responsibility of the European Commission and Member States who make risk management decisions taking into account EFSA’s conclusions of the risk assessments.
The peer review process: The PRAPeR unit is responsible for the peer review of initial assessments, called Draft Assessment Reports (DAR), carried out by rapporteur Member States on new and existing active substances used in plant protection products. ‘New’ and ‘existing’ refers to whether a substance was on the EU market in July 1993 when Directive 91/414/EEC entered into force: substances notified after its entry into force are considered ‘new’. New substances are not included in the four stages of the peer review process, but they are peer reviewed following the same methodology as existing substances. The DAR is peer reviewed by experts from EFSA and all 25 Member States. Regulation (EC) No. 451/2000 listed 52 substances of the 2nd stage . During the peer review, 2 substances were withdrawn by the respective applicants from the EU re-evaluation. PRAPeR was not involved in the 1st stage of the peer review programme, which covered 90 substances in total and was carried out by the European Commission. The last decisions regarding the inclusion of 1st stage substances in the positive list should be taken by the end of this year.
Organisation of EFSA’s work on plant protection products: Two scientific teams are dealing with the scientific risk assessment of plant protection products: the EFSA pesticide risk assessment peer review unit (PRAPeR) and the Scientific Panel on Plant Protection Products and their Residues (PPR). The PPR Panel gives scientific advice on request if there are any issues that cannot be resolved within the PRAPeR peer review assessment procedure or when further scientific guidance is needed. It also answers specific scientific questions related to plant protection product risk assessment, including matters of residues, submitted by the European Commission, the European Parliament and Member States.
New proposal for a Regulation concerning the placing of plant protection products on the market: The proposal issued by the European Commission on 12 July 2006 aims to streamline and simplify the authorisation procedures for plant protection products including a considerable time limitation for the peer review to 3 months (compared to 10 months in the current review programme). If adopted, this would replace Directive 91/414/EEC. It is expected that EFSA’s scientific work on the ongoing four stages of the peer review process will continue as foreseen and will not be directly affected by the adoption of the new Regulation.