Guidance document Efficacy
A more harmonised dRR will lead to more clarity, simplify the assessment and consequently reduce the turnaround time. For efficacy, a comprehensive, guidance document is available for preparing DRR Part 7 Core.
Plant protection: efficacy on apples can be extrapolated to pears
Subject to certain conditions, plant protection products can be authorised more broadly than for only the specific crop on which they have been tested. According to a guideline of the European and Mediterranean Plant Protection Organization (EPPO), it is possible to extrapolate data about the efficacy of products. This means that a product can be authorised for use on a different crop. The EPPO guideline and tables are based largely on data from professional use in the Netherlands and the UK.
The idea behind the guideline is that if a product is effective against mildew on apples, it is plausible that it will also be effective against mildew on pears. You are therefore allowed to extrapolate the efficacy on apples to pears (in the Netherlands, apples and pears are both major crops). However, you must still test whether the product is harmful to the crop itself.
In the Netherlands, you can even extrapolate efficacy data about a minor crop – a crop that is grown only on a small area – to a major crop. At the European level, it is it is usually possible to extrapolate only from a major crop to a minor crop, while in the Netherlands the production area of a crop does not matter. The efficacy for many minor crops is supported with credible data.
In addition, experience – expert judgement – is also taken into account. The experience that has been acquired with one crop can be used to make decisions about using a particular product on a different crop. These are extrapolations that are not included in tables, but are indeed well supported. Consequently, the Netherlands must be able to make it clear to other Member States why the efficacy of a product on one crop is being extrapolated to another crop. Manufacturers who request authorisation for a product should therefore supply this type of information.
Before product is authorised for the first time in the Netherlands, a manufacturer is required to support the claims of efficacy on one or more crops; from there the efficacy can be extrapolated to other crops. Moreover, the lack of damage to the crop must sometimes be supported with tests. This does not apply to all crops, but to exclude possible damage to pears from an apple mildewcide, for example, tests are still required.
- For an example of extrapolations from ornamental crops in the European contex
- Netherlands extrapolation list (see evaluation manual)
- EPPO extrapolation tables
Guidance document Efficacy
For efficacy, a comprehensive, guidance document is available for preparing DRR Part 7 Core. This guidance document is derived from the guidance document for DRR Part B7, which is currently being completed at the European level and harmonised with the Member States. A more harmonised DRR will lead to more clarity, simplify the assessment and consequently reduce the turnaround time.
For preparing the national addendum for efficacy, a guidance document (SANCO 10055/2013) is available which describes what must be reported in the CORE dossier and what must be reported in the national addendum. To provide more clarity about exactly what is expected from applicants in the national addendum regarding efficacy, the Ctgb has additional guidance available. For applications submitted after 3 April 2015, the national addendum is mandatory.
The relationship between the various documents that must be submitted for efficacy is explained in the document Trial report BAD and dRR part b7 Efficacy.
For microbiological products, a DRR template for efficacy is available. The chapter structure differs on a number of points.