The data supplied must be sufficient to permit an evaluation of the plant protection product to be made. In particular it must be possible to evaluate the nature and extent of benefits that accrue following use of the preparation, where they exist in comparison to suitable reference products and damage thresholds, and to define its conditions of use.
The number of trials to be conducted and reported depends mainly on factors such as the extent to which the properties of the actieve substance(s) it contains are known and on the range of conditions that arise, including variability in plant health conditions, climatic differences, the range of agriculral practices, the uniformity of the crops, the mode of application the type of harmful organism and the type of plant protection product.
Sufficient data must be generated and submitted to confirm that patterns determined hold for the regions and the range of conditions, likely to be encountered in the regions concerned, for which its use is to be recommended. Where an applicant claims that tests in one or more of the proposed regions of use are unnecessary because conditions are comparable with those in other regions where tests have been carried out, the applicant must substantiate the claim for comparability with documentary evidence.
In order to assess seasonal differences, if any, sufficient data must be generated and submitted to confirm the performance of the plant protection product in each agronomically and climatically different region for each particular crop (or commodity)/harmful organism combination. Normally trials on effectiveness or phytotoxicity, where relevant, in at least two growing seasons must be reported.
If to the opinion of the applicant the trials from the first season adequately confirm the validity of claims made on the basis of extrapolation of results from other crops, commodities or situations or from tests with closely similar preparations, a justification, which is acceptable to the competent authority for not carrying out a second seaons's work must be provided. Conversely, where, because of climatic or plant health conditions or other reasons the data obtained in any particular season are of limited value for the assessment of performance, trials in one or more further seasons must be conducted and reported.
Reports in summary form of preliminary tests, including glasshouse and field studies, used to assess the biological activity and dose range finding of the plant protection product and of the active substance(s) it contains, must be submitted when requested by the competent authority. These reports will provide additional information for the competent authority when it evaluates the plant production product. Where this information is not submitted a justification which is acceptable to the competent authority must be provided.
The tests shall provide sufficient data to permit an evaluation of the level, duration and consistency of control or protection or other intended effects of the plant protection product in comparison to suitable reference products, where they exist.
Normally a trial consists of three components: test product, reference product and untreated control.
The performance of the plant protection product must be investigated in relation to suitable reference products, where they exist. A suitable reference product is defined as an authorized plant protection product which has proved a sufficient performance in practice under the agricultural, plant health and environmental (including climatic) conditions in the area of proposed use. In general, formulation type, effects on the harmful organisms, working spectrum and method of application should be close to those of the tested plant protection product.
Plant protection products must 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.
Trials to provide data on plant protection products for control of harmful organisms must show the level of control of the species of harmful organisms concerned or of species representative of groups for which claims are made. Trials must 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.
Similarly, trials to provide data on plant protection products which are plant growth regulators, must how 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 must be included in some trials in order to enable to assess whether the recommended rate is the minimum necessary to achieve the desired effect.
The duration of the effects of treatment must 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, trials must be reported which establish the duration of the effects of an application, the number of applications necessary and the desired intervals between them.
Evidence must be submitted to show that the dose, timing and medthod of application recommended give adequate control, protection or have the intended effect in the range of circumstances likely to be encountered in practical use.
Unless there are clear indications that the performance of the plant protection production is unlikely to be affected to a significant degree by environemental factors, such as temperature or rain, an investigation of the effects of such factors on performace must be carried out and reported, particularly where it is known that the performance of chemically related products os so affected.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s) or adjuvant(s) information on the performance of the mixture must be provided.
Trials must be designed to investigate specified issues, to minimize 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 and reporting of trials must be in accordance with European and Mediterranean Plant Protection Organization (EPPO) guidelines 152 and 181. The report shall include a detailed and critical assessment of the data.
The trials must be carried out in accordance to specific EPPO guidelines, where available, or when a requires so and when the test is carried out on the territory of this, with guidelines satisfying at least the requirements of the corresponding EPPO guideline.
A statistical analysis of results amenable to such analysis must be carried out; where necessary the test guideline used must be adapted to enable such analysis.
Laboratory data and where it exists, field information relating to the occurrence and development of resistance or cross-resistance in populations of harmful organisms to the active substance(s), or to related actived substances, must be provided. Where such information is not directly relevant to the uses for which authorization is ought or to be renewed (different species of harmful organism or different crops), it must, if available, nevertheless be provided, as it may provide and indication of the likelihood of resistance developing in the target population.
Where there is evidence or information to suggest that, in commercial use, the development of resistance is likely, evidence must be generated and submitted as to the sensitivity of the population of the harmful organism concerned to the plant protection product. In such cases a management strategy designed to minimize the likelihood of resistance or cross-resistance developing in target species must be provided.
The tests shall provide sufficient data to permit an evaluation of the possible occurrence of taint or odour or other quality aspects of plants or plant products after treatment with the plant protection product.
The possibility of the occurrence of taint or odour in food crops must be investigated and be reported where:
the nature of the products or its use is such that a risk of occurrence of taint or odour might be expected,
or
other products based on the same or a closely similar active ingredient have been shown to present a risk of occurrence of taint or odour.
The effects of plant protection products on other quality aspects of treated plants or plant products must be investigated and reported where:
the nature of the plant protection product or it use could have an adverse influence on other quality aspects (for example in the case of use of plant growth regulators close or harvest), or
other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on the quality.
Testing should be conducted initially on the main crops on which the plant protection product is to be used, at twice the normal rates of application and using, where relevant, the main methods of processing. Where effects are observed it is necessary to perform testing at the normal rate of application.
The extent of investigation necessary on other crops will depend on their degree of similarity of the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product and methods of processing the crops, are similar. It is generally sufficient to perform the test with the main formulation type to be authorized.
The tests shall provide sufficient data to permit an evaluation of the possible occurrence of adverse effects after treatment with the plant protection product on transformation processes or on the quality of their products.
When the treated plants or plant products are normally intended for use in transformation process such as wine making, brewing or bread making and when at harvest significant residues are present, the possibility of the occurrence of adverse effects must be investigated and reported where:
there are indications that the use of the plant protection product could have an influence on the processes involved (for example in the case of use of plant growth regulators or fungicides close to harvest),
or
other products based on the same or a closely similar active ingredient have been shown to have an adverse influence on these processes or its products.
It is generally sufficient to perform the test with the main formulation type to be authorized.
The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of possible occurrence of yield reduction or loss in storage of treated plants or plant products.
The effects of plant protection products on the yield or yield components of treated plant products must be determined where relevant. When treated plants or plant products are likely to be stored the effect on the yield after storage, including data on starage life must be determined where relevant.
This information will normally be available from the tests required under the provisions of point 6.2.
The test shall provide sufficient data to permit an evaluation of the performance of the plant protection product and of the possible occurrence of phytotoxicity after treatment with the plant protection product.
For herbicides and for other plant protection products for which adverse effects, however transitory, are seen during the trials, performed in accordance to point 6.2, the margins of selectivity on target crops must be established, using twice the recommended rate of application. Where serious phytotoxic effects are seen, an intermediate application rate must also be investigated.
Where adverse effects occur, but are claimed to be unimportant in comparison with the benefits of use or transient, evidence to support this claim is required. If necessary yield measurement must be submitted.
The safety of a plant protection product to the main cultivars of the main crops for which it is recommended must be demonstrated, including effects of crop growh stage, vigour, and other factors which may influence suspectibility to damage or injury.
The extent of investigation necessary on other crops will depend on their degree of similarity to the main crops already tested, the quantity and quality of data available on those main crops and how far the manner of use of the plant protection product, if relevant, is similar. It is generally sufficient to perform the test with the main formulation type to be authorized.
Where proposed label claims include recommendations for the use of the plant protection product with other plant protection product(s), the provisions of the previous paragraphs apply for the mixture.
Observations concerning phytotoxicity must be performed in the tests provided for under point 6.2.
Where phytotoxic effects are seen, they must be accurately assessed and recorded in accordance with EPPO guideline 135 or when a Member State requires so and when the test is carried out on the territory of this Member State, with guidelines satisfying at least the requirements of this EPPO guideline.
A statistical analysis of results amenable to such analysis must be carried out, where necessary the test guideline used must be adapted to enable such analysis.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on succeeding crops.
Where data, generated in accordance with Section 9, point 9.1, shows that signification residues of the active substance, its metabolites or degradation products, which have or may have biological activity on succeeding crops, remain in soil or in plant materials, such as straw or organic material up to sowing or planting time of possible succeeding crops, observations must be submitted on effects on the normal range of succeedings crops.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on other plants, including adjacent crops.
Observations must be submitted on adverse effects on other plants, including the normal range of adjacent crops, when there are indications that the plant protection product could affect these plants via vapour drift.
Sufficient data must be reported to permit an evaluation of possible adverse effects of a treatment with the plant protection product on plants or plant products ot be used for propagation.
Observations must be submitted on the impact of plant protection products on plant parts used for propagation except where the proposed uses preclude use on crops intended for production of seeds, cuttings, runners or tubers for planting, as appropriate.
for seeds — viability, germination and vigour;
cuttings — rooting and growth rates;
runners — establishment and growth rates;
tubers — sprouting and normal growth.
Seeds testing shall be done according to ISTA Methods (1) .
Any effects, positive or negative, on the incidence of other harmful organisms, observed in the tests performed in accordance with the requirements of this section, shall be reported. Any observed environmental effects must also be reported, especially effects on wildlife and/or beneficial organisms.
A summary of all data and informations provided under points 6.1 to 6.6 must be provided, together with a detailed and a critical assessment of the data, with particular reference to the benefits that the plant protection product offers, adverse effects that do or may arise and measures necessary to avoid or minimize adverse effects.]
Textual Amendments
[F1International rules for seed testing, 1985. Proceedings of the International Seed Testing Association, Seed Science and Technology , Volume 13, No 2, 1985.]