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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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A trial shall, where possible, consist of the following three components: test product, reference product and untreated control.
The performance of the plant protection product shall be investigated in relation to suitable reference products, where they exist. A plant protection product shall be considered a suitable reference product if it fulfils the following requirements: it is authorised and has proved a sufficient performance in practice under the conditions of the area of intended use (plant health, agricultural, horticultural, forestry, climatic, environmental, as appropriate). The working spectrum, time and method of application, mode of action shall be close to those of the tested plant protection product. If this is not possible, reference product and test product shall be applied according to their specified use.
Plant protection products shall be tested in circumstances where the target harmful organism has been shown to have been present at a level causing or known to cause adverse effects (yield, quality, operational benefit) on an unprotected crop or area or on plants or plant products which have not been treated or where the harmful organism is present at such a level that an evaluation of the plant protection product can be made.
On plant protection products for control of harmful organisms trials shall be performed which show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made. Trials shall include the different stages of growth of life cycle of the harmful species, where this is relevant and the different strains or races, where these are likely to show different degrees of susceptibility. Where relevant, these considerations may be addressed in laboratory studies.
Trials to provide data on plant protection products which are plant growth regulators, shall show the level of effects on the species to be treated, and include investigation of differences in the response of a representative sample of the range of cultivars on which its use is proposed.
In order to clarify the dose response, dose rates lower than the recommended one shall be included in some trials in order to enable assessment of whether the recommended rate is the minimum necessary to achieve the desired effect.
The duration of the effects of treatment shall be investigated in relation to the control of the target organism or effect on the treated plants or plant products, as appropriate. When more than one application is recommended for the proposed use pattern of the product, trials shall be reported, which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.
Evidence shall be submitted to show that the dose, timing and method of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.
If there is clear evidence that the performance of the plant protection product is likely to be affected by environmental factors, such as temperature or rain, an investigation of the effects of such factors on performance shall be carried out and reported, particularly where it is known that the performance of chemically related products is so affected.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection products or adjuvants information on the performance of the mixture shall be provided.
Trials shall be designed to investigate specified issues, to minimise the effects of random variation between different parts of each site and to enable statistical analysis to be applied to results amenable to such analysis. The design, analysis, conduct and reporting of trials shall be in accordance with the specific standards of the European and Mediterranean Plant Protection Organisation (EPPO), where available. Deviations from available EPPO guidelines, may be acceptable provided the trials design meets the minimum requirements of the relevant EPPO standard, and is fully described and justified. The report shall include a detailed and critical assessment of the data.
A statistical analysis of results amenable to such analysis shall be carried out; where necessary the test guideline used shall be adapted to enable such analysis.
Where relevant, evidence of yield and quality may be required as a demonstration of effectiveness.
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