Minor use or not ?
In the European Regulation 1107/2009 for placing plant protection products on the market, Article 51 concerns extensions of authorisations with minor uses. Art. 51, clause 2 stipulates that the intended use is minor in nature. The definition of a minor use is included in the PPPR 1107/2009:
“Use of a plant protection product in a particular Member State on plants or plant products which are:
a) not widely grown in that Member State, or
b) widely grown to meet an exceptional plant protection need;”
Also refer to article 2.2 of the RGB: “Artikel 2.2 Regeling gewasbeschermingsmiddelen en biociden”
Ctgb follows a standard procedure to ascertain a minor use, described below and visualised in a decision tree.
Step 1: Crop area limit
Based on crop area data (source: Statistics Netherlands – CBS), the area for a proposed use is determined. Not all crops or crop groups, as defined in the DTG list, are registered by CBS. In these cases, other sources can be used.
- If the crop area is smaller than the area limit, then the use is defined as minor (in accordance with the definition).
- If the crop area is larger than the area limit, go to step 2.
Step 2: Crop group area
Determine the percentage of the specific crop area relative to the parent crop group (see classification in DTG list).
- If this percentage is lower than 5%, then the crop is defined as minor; consequently this is a minor use.
- If this percentage is higher than 5%, go to step 3.
Regarding the term “not widely grown”, a distinction is made between unprotected and protected cultivation. For unprotect cultivation, a maximum area limit of 5000 ha is used, and for protected cultivation the maximum is 1000 ha. All crops covering an area smaller than these limits will be considered to be minor.
Step 3: Evaluating the criterion “exceptional plant protection need”.
Besides the widely occurring pests and diseases that are controlled with a standard use, some pests and diseases occur only under exceptional circumstances. These can be pests and diseases that occur only regionally, only in certain types of soil, at specific locations, are rare, etc. Uses to control these pests and diseases are considered to be minor because an exceptional plant protection need is involved. The applicant must submit verifiable information on the nature and magnitude of the use. The assessment of the exceptional circumstances is based on expert judgement.
Step 4: Conclusion
If a use does not comply with any of the above-mentioned criteria, then it is defined as a standard use.
Substantiate that the requested use is minor
The starting point is to determine the area that will potentially be treated. The area is compared to a threshold value (area limit) or related to the overall production area of the main group or subgroup to which the crop belongs. The applicant must submit verifiable information on the nature and magnitude of the use. The following sources may be relevant:
- The Netherlands keep up a list of minor uses. This list is based on a survey of current production area of the crop in relation to defined acreage limits.
Till november 1, 2019, version 2.1 of the List of Minor Uses had to be used; from 1 november 2019 the List of Minor Uses version 3.0 must be used.
The basic principle for a minor use application is that the applicant refers to crop or cultivar groups as high as possible in the hierarchy of the DTG if a disease or pest occurs widely in this group. This prevents many minor crops from a single crop or cultivar group from being listed separately on the Legal Conditions for Use (WG). Applying for minor use authorisations for individual crops is possible only if the pest or disease occurs in just these crops and not in the entire crop group.
- In case of a minor use in a major crop (exceptional plant protection need, e.g. due to the type of soil or unusual pest or disease) the argumentation is based on expert judgement. Substantiation of statements is required from the Minor Uses Desk of the NVWA (Netherlands Food and Consumer Product Safety Authority).
For a summary of minor uses in other MSs, you may consult the European minor use database EUMUDA.
Need for residue studies
Data on residue behaviour in/on minor crops may not always be available. When for minor uses insufficient residue studies are available, it may be possible to obtain the required data by extrapolation from residue data on currently authorized uses (SANCO 7525/VI/95) …….
If a plant protection need, pest or disease occurs widely in cultivar group, as a basic principle the minor use application should refer to crop or cultivar groups as high as possible in the DTG. Thus, if the parent crop group must be claimed as part of an application for a minor use (because the pest or disease occurs widely in this group), residue data for all crops within this crop group must be available or must be extrapolated from other crops. If this is not the case, then the parent group does not have to be claimed, and the crop specified in the application can be listed as a minor use on the WG (legal instructions for use).
However, if the residue data can be supplied from other crops at a later time, and the entire group can be claimed, then it must be determined whether the minor use complies with the criterion of crop area limits. If the parent crop group is large, then efficacy data must be submitted.
The interpretation of the decision tree method prescribed here, where the parent crop group does not always have to be claimed, applies only to crops and products for which residue data are required.
For all other situations, the current method continues to apply.
For a number of crops for which residue data is required, it has become apparent that one of the basic principles – which requires the application to be submitted as high as possible in the crop hierarchy – can hamper the approval of minor uses. For minor crops, residue studies are not always available nor is it always possible to extrapolate residue data from another crop to a specific minor crop; as a result, the “parent” crop group cannot be claimed. To prevent these crops from being excluded from minor use criteria, the basic principle is now as follows:
for minor crops for which residue data is lacking or insufficient or for which the residue data cannot be extrapolated, the parent crop group does not have to be claimed. In this case, the application for the minor crop can be considered to be a minor use. However, if the residue data can be supplied from other crops at a later time, and the entire group can be claimed, then it must be determined whether the minor use complies with the criterion of crop area limits. If the parent crop group is large, then efficacy data must be submitted. The method described above applies only to crops for which residue data are required. For all other situations, the current method continues to apply.
Survey on relevant guidance
The right hand column provides a search engine that allows you to generate an overview of relevant documentation. For a survey on ‘minor uses’, the filter ‘minor uses’ should be chosen under the heading ‘aanvraagtypen’.