# Commission Regulation (EU) No 284/2013 of 1 March 2013 setting out the data requirements for plant protection products, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance), Division 3.4: By way of derogation from point 3.1:

Extent: E+W+S+N.I.

3.4.1.For active substances consisting of micro-organisms or viruses, tests and analyses performed to obtain data on their properties and safety with respect to other aspects than human health, may be conducted by official or officially recognised testing facilities or organisations which satisfy at least the requirements specified at points 3.2 and 3.3.
3.4.2.Studies conducted before the application of this Regulation, although not fully compliant with GLP requirements or with current test methods, may be integrated into the assessment, when accepted by the competent authorities as scientifically valid, thereby removing the need for repeating animal tests, especially for carcinogenicity and reprotoxicity studies. This derogation applies to studies on all vertebrate species.

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Source: https://www.legislation.gov.uk/eur/2013/284/annex/division/INTRODUCTION/division/3/division/3.4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-284/annex/division-INTRODUCTION/division-3/division-3.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.