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Pesticide risk assessment peer review (PRAPeR)
Last updated: 18 July 2006    
Publication Date: 31 March 2005    

The Pesticide Risk Assessment Peer Review Unit (PRAPeR) is responsible for the peer review of initial assessments carried out by rapporteur Member States on new or existing active substances used in plant protection products. PRAPeR also holds the responsibility for providing reports on the evaluation of these pesticides to the European Commission.

Pesticide Risk Assessment Peer Review [PRAPeR]

Around 850 active substances used in plant protection products were on the EU market in 1993. In order to comply with Council Directive 91/414/EEC concerning the placing on the market of plant protection products, risk assessments for these substances should be completed by 2008.

As risk manager, the European Commission is responsible for carrying out a work programme leading to the establishment of a positive list of active substances (Annex 1of the Directive) following their assessment according to safety criteria laid down in this legislation. In order to organise and structure the workload over time, the programme is broken down into four stages, thereby separating the total number of substances into manageable groups.

With the establishment of the European Food Safety Authority (EFSA), risk assessment was separated from risk management. In compliance with this requirement, EFSA is responsible for the risk assessment of active substances contained in plant protection products which includes existing active substances already on the market in July 1993 as well as new active substances submitted by applicants.

For the risk assessment of existing pesticides and following notification procedures to establish those substances with sufficient support for continued use, Commission Regulations (EC) No 451/2000, No 1490/2002 and No 2229/2004 assign to EFSA the task of conducting risk assessments for the remaining substances of stages 2 (52 substances), 3 (144 substances) and 4 (249 substances) of the review programme. These concern those substances for which the submission of a complete dossier could be expected. Included in stage 1 are those substances for which risk assessments were initiated prior to the establishment of EFSA and which are being finalised by the European Commission.

With regard to new active substances, EFSA will conduct the risk assessments for those substances for which dossiers were considered complete after June 2002, i.e. satisfying the data requirements of Directive 91/414/EEC, thereby pursuing the work initiated in this area prior to the establishment of EFSA. .

For both existing and new active substances, EFSA’s pesticide risk assessment peer review unit (PRAPeR) will follow the same approach. The Unit will undertake in cooperation with the Member States a peer review of the initial assessment provided by a rapporteur Member State leading to the provision of a conclusion to the European Commission within 12 months. These conclusions are also made publicly available through publication on the EFSA website.

The evaluation of new and existing active substances used in plant protection products begins with an evaluation of a substance by a rapporteur Member State. The draft assessment report (DAR) on this initial assessment provided by the Member State is then submitted to a peer review by EFSA scientists and experts from Member States. This process is summarised in a guidance document which can be found in the left menu of this page. The PRAPeR Unit is currently preparing an updated version, taking into account procedural developments, which will be made available shortly.

The DARs provided to the PRAPeR Unit concern new and existing substances included in the second, third and fourth stages of the review programme. Documents related to these preliminary assessments will be made available shortly through publication on the EFSA website taking into account EU legislation regarding public access to documents.

Committed to openness and transparency, EFSA will seek to increase the involvement of stakeholders in the review process. EFSA therefore intends in the future to submit the initial assessment of active substances, included in the DARs, for public consultation. Open consultation will be launched by EFSA for those substances included in the third and fourth stages of the review programme and future new active substances. Due to the legislative timetable for submission of the conclusions of the peer review, it is not possible to follow at this stage a similar process for substances included in stage 2.

Documents made available for public consultation will in future be accessed through a left menu item entitled “Public Consultation.”

The final EFSA conclusions on the peer review of the risk assessments provided to the European Commission can be found by clicking in the left menu under “Conclusions” along with relevant background documents.

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