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Data requirements

In Directive 91/414 Annex II (human health) and Annex III (environment) contain data requirements. Data requirements are data an applicant needs to deliver if it likes to place a pesticide on the market as well as the tests to be performed to generate these data.  EU and others try to harmonise tests in OECD. But because this is a very time-consuming procedure, EU-tests and sometimes EPPO-tests (an intergovernmental organisation for Europe and West-Asia) are used.

Standard tests make it easy for regulators to evaluate the outcome but given their lengthy development, they are ‘blind’ for new insights and for new science and they are generally running miles behind scientific knowledge. This is why EU Parliament and Council decided in the new Regulation 1107/2009, scientific peer-reviewed open literature should also be taken into account.

Because of a few large cases of fraud in the past with industry testing, testing now needs to be done according to GLP, Good Laboratory Practice.  Through GLP tests deliver a lot of details, but reliability and quality is still not guaranteed. These points still need to be addressed.

DG SANCO is working on a revision of the first data requirements since 2002 in close cooperation with Member States and industry (see fi. ppt M.Clook). Other duties of regulators often delayed the revision. Now new Regulation 1107/2009 enters in force soon, also the new provisions of this Regulation need to be included. It is not sure of DG SANCO will make the deadline of June 14, 2011 and include completely new and up-to-date data requirements.

Draft versions were presented and discussed in a September 2010 stakeholder meeting. EFSA also submitted several opinions on data requirements. Next step is a discussion with Member States and ‘scrutiny’ in EU Parliament.

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