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Commission Regulation (EU) No 284/2013Show full title
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)
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- Revised 17/09/20150.68 MB
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INTRODUCTION
(i)This Part provides data requirements for the authorisation of a plant protection product based on preparations of micro-organisms including viruses.
The term ‘micro-organism’ as defined in the introduction of part B of the Annex to Regulation (EU) No 283/2013, also applies to the Part B of this Annex.
(ii)Where relevant, data shall be analysed using appropriate statistical methods. Full details of the statistical analysis shall be reported (e.g. all point estimates shall be given with confidence intervals, exact p-values should be given rather than stating significant/non significant).
(iii)Pending the acceptance of specific guidelines at international level, the information required shall be generated using test guidelines accepted by the competent authority (e.g. USEPA guideline(1)); where appropriate test guidelines as described in Part A of the Annex to Regulation (EU) No 283/2013, shall be adapted in such a way that they are appropriate for micro-organisms. Testing shall include viable and, if appropriate, non-viable micro-organisms, and a blank control.
(iv)Whenever a study implies the use of different doses, the relationship between dose and adverse effect must be reported.
(v)Where testing is done, a detailed description (specification) of the material used and its impurities, in accordance with the provisions of point 1.4, must be provided.
(vi)In cases where a new preparation is to be dealt with, extrapolation from Part B of the Annex to Regulation (EU) No 283/2013, could be acceptable, provided that all the possible effects of the co-formulants and other components, especially on pathogenicity and infectiveness, are also evaluated.
(1)
USEPA Microbial Pesticide Test Guidelines, OPPTS Series 885, February 1996(http://www.epa.gov/oppbppd1/biopesticides/guidelines/series885.htm).
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