Brussels, 27 July 2001
Commission proposes a revised approach towards the evaluation of pesticides safety
The European Commission has identified in a new report the need for a fresh approach towards the evaluation of the safety of active substances in plant protection products. This is called for in the light of the experience and progress over the past ten years in the evaluation of existing substances authorised for use by the Member States. The existing mechanisms and lack of resources in both the Member States and the Commission have slowed progress. The Commission is of the view that improved procedures and increased resources are necessary if the goal of evaluation at the Community level of existing and new active substances is to be achieved within a reasonable time period. This is in turn necessary to provide improved safeguards that plant protection products, including pesticides, can be used in a manner which is safe for the environment and human health.
"This report gives a complete overview of the hugely ambitious exercise of pesticides evaluation that was started in 1991, and its results so far", Health and Consumer Protection Commissioner David Byrne said. "All this work is intended to make sure that the active substances used in pesticides do not present a risk or harm to health and the environment. It is therefore of the utmost importance that it is done thoroughly, even if that means it takes more time than originally envisaged. The reality is that the resources necessary to carry out this exercise were not fully appreciated when the key legislation was adopted in 1991. I am keen to have the views of the European Parliament and the Council on this report before proposing further decisions, because we need to carefully weigh the potential impacts of extending, or not, the original deadline of 2003 for the completion of the evaluation process. I also feel there are definite improvements to be made in the way this work is done, and have high expectations for the role of the future European Food Authority in this respect."
Directive 91/414 on the authorisation, use and control of plant protection products - insecticides, fungicides, herbicides etc. - was adopted in 1991. It sets up a harmonised authorisation system for the active substances used in plant protection products at EU level. Member States may then approve products containing such EU agreed substances for use on their territory. The 1991 rules make EU authorisations of active substances subject to a positive outcome of safety evaluations, for which producers must present data. The target set for completing these evaluations is July 2003, with an interim progress report in July 2001. An option to extend the July 2003 deadline for certain substances is also foreseen. The 1991 Directive also stipulates that plant protection products authorised nationally can remain in use only until July 2003, or until a decision to authorise or ban them is reached at EU level. This would imply that plant protection products containing active substances that have not been fully evaluated and approved cannot be used anymore as of that date.
At the time of adoption of Council Directive 414/91 in 1991, there were over 800 such substances authorised for use in the Member States. The goal was to have these evaluated at the Community level within a 12 year time frame. The report highlights that progress made in such safety evaluations has been much slower than originally assumed. Of the more than 800 active substances to be evaluated by 2003 as foreseen by the legislation, almost half remain to be evaluated at the Community level. However, the substances already evaluated include the most important and sensitive products, in terms of market share and potential safety risk. The report points to the need to extend the 12-year evaluation programme for remaining substances if their continued use is to be allowed. It also identifies strategies to speed up the evaluation process.
These new strategies include changes in the procedures for examining and evaluating data presented by producers, tighter timelines, better use of information technologies and an increase in resources in the Commission and the future European Food Authority. The Authority will take over the role of scientific peer review from the current Scientific Committee on Plants. A significant increase in the personnel dealing with the assessment of active substances is also foreseen in the EFA proposals, expected to be adopted by Council and European Parliament before the end of the year. In the light of these developments, the report estimates that the evaluation programme could be completed by 2008.
The report will now be submitted to the European Parliament and the Council of Ministers. Once they will have taken a position, the Commission will consider bringing forward proposals to amend Directive 91/414 in 2002. Further details on the state of play of the evaluation programme, including details of the active substances, their current status and authorisations in the Member States are available at http://ec.europa.eu/food/fs/ph_ps/pro/index_en.htm , where the full report will also be published shortly.
Finally, the Commission highlights that there are measures already in place to ensure that the active substances currently in use are monitored with a view to identifying levels in excess of the maximum residue limits (MRLs). This allows Member States to take the necessary corrective action to ensure the safe use of the plant protection products implicated and thus to ensure that there is no risk to health. Details of the most recent monitoring programme are included in a report also just published by the Commission (see IP/01/1133).