Article 51 – minor uses

Date: 8 May 2020

Article 51 REGULATION (EC) No 1107/2009 sets out the conditions under which extensions of authorizations for minor uses can be applied for. Besides other issues to be considered, authorizations can be extended for minor uses if e.g. the extension is in the public interest and the intended use is minor in nature, taking into account that these individual requirements are set nationally by the single member states. Accordingly, the criteria and guidelines for determining what constitutes a minor use vary amongst member states, keeping also in mind that all aspects related to the authorizations of minor uses are product issues and not those relevant for active substances.

In order to address the complex minor use facts in a more coherent way the European Commission (EC) has established the EU Minor Uses Coordination Facility (MUCF) which shall support farmers in the EU to produce high quality crops by filling minor uses gaps through efficient collaboration to improve availability of chemical and non-chemical tools. Accordingly, the term ‘minor use’ describes situations where the need for, and the use of, a plant protection product is relatively small. Typically these situations encompass crops grown on a small scale, high value or speciality crops e.g. most vegetables, fruits and ornamentals (also classified as ‘minor crops’), but can also involve the need for plant protection products on infrequent pests and diseases in major crops. Minor (or speciality crops) have a high economic value for producers, but are usually of low economic interest for the plant protection industry, considering the costs for development and authorization and keeping in mind the low acreage of minor crops which results in an insufficient return on investment of the expenditures that are required to attain regulatory approval. This situation leads to a lack of authorized products on the market to be used on minor crops which in turn can lead to illegal uses or to loss of crop production.

The requirement to generate a considerable amount of data would make the authorization process quite expensive for minor uses. In order to still have a sufficient number of crop protection products available, it is therefore possible e.g. to rely on fate or ecotoxicity data provided for major uses or to submit just a reduced amount of efficacy data. This includes also the option to explore other possibilities for determining the efficacy and crop safety of a plant protection product, e.g. by case-by-case extrapolation of authorizations given to major crops to minor crops in order to simplify the registration process.

Additionally, the "minor use" aspect can also have a considerable influence on important regulatory issues such as Comparative Assessment or the classification of an active substance as Candidate for Substitution.

Joachim Kranz