EU regulation
Safeguarding humans and the environment
The pesticide industry is continually developing new, innovative products and technologies that deliver a wide range of benefits in direct response to public demand. The official approval process for pesticides (also known as crop protection products) in the EU is one of the most stringent in the world and is primarily designed to safeguard human health and the environment.
A fundamental principle lies behind the European legislation governing these products: it is more important to protect human health, wildlife and the environment than to improve agricultural productivity. Today, before product approval is granted, more than 100 specific tests must be completed. Researching, developing and bringing to market a new substance can take up to nine years and typically costs about € 200 million. Pesticides are more thoroughly tested for all impacts than any other products - including human medicines.
EU and national approval
The main legal instrument that currently governs agrochemicals in Europe is Directive 91/414/EEC. The Directive regulates the placing of crop protection products on the market and harmonises national product approval requirements throughout Europe. The approval process consists of two main stages: in the first, the active substance in the pesticide must be approved at the EU level, and in the second, formulations (products) containing these approved substances must be registered by the member states.
The active substance of a pesticide is the ingredient that controls the pests, weeds and fungal diseases. Formulated products - the form in which farmers and other users apply the product - contain this active substance along with other materials to optimise the performance of the product when it is applied to crops. Before being placed on the market, all active substances are evaluated by experts in one of the EU's national regulatory authorities, and are peer reviewed by the European Food Safety Authority (EFSA) before being approved by the European Commission's Standing Committee on the Food Chain and Animal Health (SCFCAH). The key criterion to decide whether the active substance shall be authorised or not, is a thorough scientific assessment of any possible risks that the active substance may pose. When, and if, an active substance has been approved at the EU level, the formulated product containing the approved active substance must be registered in each individual member state. This takes into account specific local variations in climate, cropping and diet. Under EU regulations, the members of the national regulatory authorities who decide on products authorisations are highly qualified and independent scientists.
The revision of Directive 91/414/EEC
The process to replace Directive 91/414/EEC. It has entered its final stages and the new regulation is expected to be adopted mid 2009, and to apply from 2011 onwards.
While ECPA believes the revision has the potential to introduce a better coordinated system in the EU, it has concerns regarding several provisions of the proposed new regulation. The main issues for the crop protection industry is the introduction of criteria for immediate ban of active substances (‘cut-off criteria’).
ECPA and its members will continue to work with the Commission, national regulators and key stakeholders to ensure that the legislation put forward is workable and sustainable.
For more information:
ECPA statement: Alleged impact of new pesticide legislation, 13 February 2009
Fact sheet - future of European Agriculture
Please contact Euros Jones or Aurélie Dhaussy at ECPA for any questions about the approval process or the revision of Directive 91/414/EEC
