EFSA Press Statement, 22 April 2005

PESTICIDES - EFSA presents new work and explains its role in the evaluation of pesticides

The EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit co-ordinates the peer review of active substances used in plant protection products in collaboration with Member States. In a new section of its website, EFSA presents today the work of PRAPeR including an overview of its programme, the legal background for its work and the conclusions on the risk assessments carried out to date for six active substances.

In the European Union (EU), the placing on the market and use of plant protection products are regulated under Council Directive 91/414/EC. This Directive contains rules to be applied in a uniform way by the Member States on the conditions and procedures for the authorisation of plant protection products. Plant protection products cannot be placed on the market or used without prior authorisation and Member States can only authorise those products which contain active substances approved at Community level. Hence, the Directive sets out a dual system where the Community evaluates active substances and Member States evaluate and authorise, at national level, products containing these substances.

With the establishment of the European Food Safety Authority and the separation of risk assessment from risk management, the evaluation of pesticides is carried out in two phases. An “active substance” is first evaluated by a designated Member State . This initial evaluation is subsequently peer reviewed by a team of EFSA scientists working in close co-operation with experts in EU Member States. Legislation allows EFSA one year to finalise the evaluation and to come to a conclusion which is formally reported to the European Commission and made publicly available.

The presentation of the work of the PRAPeR Unit on the EFSA website includes the conclusions of the first six pesticide risk assessments carried out to date along with accompanying documents such as the initial risk assessment of the designated Member State and the documentation of the peer review. One of the reports concerns the evaluation of the active substance glufosinate; the conclusions of Member States' experts revealed evidence of risk with respect to the possible effects of this substance on human or animal health and the environment. Among the uses considered for this active substance is that relating to transgenic maize. It should be noted, however, that the evaluation of the active substance and its degradation products carried out through the peer review process relates to their use as pesticides. In parallel the EFSA Panel on Genetically Modified Organisms (GMO Panel) has conducted a risk assessment and recently published an opinion on 1507 maize, a type of maize which has been genetically modified for protection against such lepidopteran pests as the corn borer. It also contains a gene providing tolerance to the herbicide glufosinate.

The following additional notes are provided:

• Around 850 active substances used in plant protection products were on the market of at least one of the EU Member States in 1993. In order to comply with Community rules, risk assessments for these substances should be completed by 2008.
• The European Commission established a work programme including a notification procedure whereby industry was requested to provide further support for the continued use of these substances. As a result of notifications received EFSA was then assigned the task of evaluating over 400 substances. EFSA has also been charged with the evaluation of new active substances.