Pesticide European registration requirements

Until 1991, manufacturers seeking authorizations for pesticides had to fulfil country-specific requirements of validation of enforcement methods. The term enforcement method means analytical methods which are developed for post-registration control and monitoring purposes. The harmonization of these requirements was initiated with the European Economic Community (EEC) Council Directive 91/414/EEC and temporarily finalized with the Guidance Document on Residue Analytical Methods SANCO/825/00 rev. 6, dated 20 June 2000 [Santd et Protection des Consommateurs (SANCO)]. The evaluation of validation studies by the competent authority is conducted by comparison of these European Union (EU) requirements with the study results and most often without any practical experience of the method. Some details of this evaluation are discussed below. 

Field residue data, which are generated to meet requirements in the pesticide registration process, are used to regulate the use of agriculture products within the European Union (EU). This article examines the best practices to conduct crop field trials and to generate crop residue samples in Europe in order to provide part of the data that the agrochemical producers of the active ingredients must provide to the EU Commission. 

Integrating the data requirements in European countries, which concentrate alternatively on different registration aspects, reflecting the influence and interest of individual officials, I am not in a position to say that they are less exhaustive than in the USA, as Hahn ( ) did when he reviewed pesticide regulation in Europe in 1972. However, I feel that certainly the political and legal possibilities and perhaps the status of the authorities to apply the flexibility of the regulations in individual cases are still more favorable in Europe than e.g. presently in the U.S. 

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