AGROCHEMICALS design, statistical considerations and reporting formats, as well as detailed crop / pest specific trial protocols.
In practice, it is EPPO guidance that effectively provides the detailed data requirements that fulfil those broad strokes requirements outlined in Regulation 284 / 2013. Compliance with these standards is expected and any deviation, for example in terms of trial design or quantity, must be supported by clear scientific justification.
Under EPPO guidance, all trials must be run to Good Experimental Practice( GEP) standards. This means trials must be planned with robust design, and include appropriate untreated controls and reference treatments, with sufficient pest pressure.
Regulators also require that trials should be carried out only by officially recognised( OR) efficacy testing organisations, with various such schemes operating across
EU member states. This ensures that data supporting label claims come from competent, audited field trial organisations working to consistent standards.
Another important EPPO provision is the division of Europe into four climatic zones( Northern, Maritime, Mediterranean and Southeast, Figure 1), which take into consideration the differing conditions across the continent. These overlay the three regulatory registration zones( Northern, Central and Southern) and impact decisions on location and quantity of trials, with a requirement to show product efficacy across the full range of climatic conditions in the target EU markets where registrations are sought.
Efficacy trial programme design
Efficacy programme planning and design begins long before the commencement of registration field trials. Early-stage preliminary testing is vital for understanding how a plant protection product behaves under controlled or small-scale conditions.
These early studies identify which pests or diseases the product can control, the dose range and application timing required for adequate control, as well as any potential crop safety concerns. These preliminary data are not always submitted as part of a registration dossier, but they are essential for shaping the draft Good Agricultural Practice( GAP) table.
The GAP table defines the patterns of use of the plant protection product, listing the target pests and crops, application rates and timings that will ultimately form the basis of the product label. The draft GAP then is the key document in determining the structure and scope of an efficient efficacy field trial programme.
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