European Union pesticide registration

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. 

Economic incentives have not been used much in chemical safety (OECD 2009e). At the national level some countries use fees, and there are a few examples of taxes. The fees for registration of pesticides have worked as deterrents to the marketing of many pesticides. It remains to be seen whether the REACH registration in the European Union will have a similar effect for low production volume substances. 

In 1996 and 1997 the International Conference on Harmonization (ICH) published guidelines for analytical method validation [18]. These documents present a discussion of the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the European Union, Japan, and the United States. Regulatory agencies have emitted documents, largely inspired by ICH documents. It is the case of the FDA [19, 20], the European Medicines Agency (EMA) [21,24], and the Australian Pesticides and Veterinary Medicines Authority [25], to name just a few. 

EU the European Union of 28 countries (2013) with 20 official languages, formerly known as the European Community (EC) and originally the European Economic Community. The Biocidal Products Directive and Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) determine pesticide regulatory status throughout the EU (http //europa.eu.int/). 

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