Frequently Asked Questions - Product approval
The Council of EU Ministers has adopted Regulation 1107/2009, replacing Directive 91/414 governing the placement of pesticides on the market.
The directive regulates the placing of crop protection products on the market and harmonises national product approval requirements throughout Europe. Before being placed on the market, all active substances are evaluated at EU level, and the products containing the approved active substances are evaluated at national level, by taking into account specific local variations in climate, cropping and diet.
Both EU and national evaluations are performed by highly qualified and independent scientists. The key criterion to decide whether the pesticide shall be authorised or not, is a thorough scientific assessment of any possible risks to health and environment.
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC came into force on the 14th of June 2011.
For a detailed overview of the European situation, read our publication 'Registering plant protection products (pesticides) in the European Union' at http://www.ecpa.eu/information-page/regulatory-affairs/publications-regulatory-affairs
The approval of plant protection products is strictly regulated by EU rules which are the most stringent ones, together with the regulation of medicines. Pesticides also follow stringent quality checks in the factory, at every stage of the process until the end product is ready for transport. Factories need the necessary ISO standards (eg. 9001). The packaging shall also comply with strict EU rules, and is carefully checked to ensure the integrity of the product.
To meet international regulatory requirements, and before they can be sold, pesticides must undergo extensive testing. This involves between 250 and 300 individual studies which take many years to complete.
The first step in the evaluation of a substance is to understand its intrinsic properties ‐ the hazard. This includes conducting studies to identify any endocrine disruption potential, and to determine any adverse effects which may occur as a result.
The second step is to evaluate the levels to which people or animals are exposed, and to conduct a risk assessment. Clearly, when there is no exposure there can be no risk, regardless of the properties (hazard) of the substance concerned.
Currently there is no internationally agreed, scientific definition for endocrine disrupters (ED), nor clarity on the many proposed tests that may be used. Therefore it is important to realize that ED is a mechanism not an endpoint, and that chemicals demonstrating any ED potential should not be banned without risk assessment, to avoid regulatory decisions that are scientifically unsound and unworkable in practice. It is important that regulatory decisions to approve or to restrict the use of a chemical are made on the basis of sound science and not on subjectivity or political agendas.
It is essential to make the difference between endocrine disrupters and endocrine active substances.
Decisions must be based on the principles of risk assessment, considering both hazard and exposure.
