EFSA’s work on active substances used in pesticides

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In 2008, EFSA has completed an important milestone in its work on the safety review of existing active substances used in pesticides, as foreseen in the context of Council Directive 91/414/EEC. EFSA’s work has enabled the Commission to conclude the review process on all substances which were on the market before 1993 and to decide on a list of active substances that may be included in plant protection products throughout the European Union[1].

In 1993 the European Commission began a review programme for all active substances used in plant protection products in the EU. Since its establishment, EFSA has played a major role in the process and has assessed, since 2003, the safety of over 120 active substances. As foreseen in the context of Council Directive 91/414/EEC, EFSA’s role in co-ordinating the peer review of risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation. of active substances used in pesticides will now continue. This work is conducted in close collaboration with scientific experts from the Member States and with the aim of protecting human health and the environment in Europe[2].

EFSA’s Pesticide Risk Assessment Peer Review Unit (PRAPeR) and the Member States together made significant efforts to meet the challenging deadlines of the review programme, resulting in a threefold increase in the number of conclusions on active substances delivered in 2008 in comparison to the previous year.

EFSA is also the independent risk assessment body responsible within the EU for assessing Maximum Residue Levels (MRLs) of pesticides, which are the upper legal levels of residues in or on food or feed. In the period 2006-2008, the PRAPeR Unit has already carried out the review of 280 active substances to assist the Commission in setting some 74,000 MRLs, and the finalisation of the review programme now triggers a full review programme on MRLs established at EU level for 350 active substances in the next couple of years.

In September 2008, EFSA set up a new Pesticide Steering Committee, which is made up of representatives from EFSA, the European Commission and Member States. It was established with a specific responsibility to manage and plan the overall pesticide risk assessment and MRL programmes, and in particular to consider ways to further streamline the process in the face of an ever-growing workload and evolving regulatory environment.

[1] In the European Union system, the placing on the market and use of plant protection products is regulated under Council Directive 91/414/EC, which sets out the rules that must be followed by Member States in relation to plant protection products. These cannot be placed on the market or used without prior authorisation and Member States can only authorise those products containing active substances, which have been approved at EU level. This Directive is to be superseded by a new set of regulations which are expected to come into force in 2010.
[2] Since the establishment of EFSA, risk assessment has been separated from risk management The management of risks which have been identified by risk assessment. It includes the planning, implementation and evaluation of any resulting actions taken to protect consumers, animals and the environment.. The evaluation of pesticides is carried out in two phases. An “active substance” is first evaluated by a designated rapporteur Member State and the risk assessment is then peer-reviewed by EFSA’s Pesticide Risk Assessment and Peer Review Unit (PRAPeR) in close co-operation with scientists in the EU Member States.

Pesticides