Minor use authorisations (formerly off-label)

An authorisation of a plant protection product for minor use allows the already authorised plant protection product to be applied in uses that are minor in nature. These were previously called 'off-label' authorisations.

Mutual recognition of minor use authorisations from another Member State within the North zone may also be sought if the use is also for a minor crop or another use that is minor in nature in Denmark. Read more about the rules for mutual recognition.

Who can apply
The authorisation holder, official or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users may apply for a minor use authorisation.

Circumstances under which minor use authorisations are granted
The use for which a minor use authorisation is being sought must either be for a minor crop or a minor use in a more widely grown crop (e.g., a rare pest found only in limited areas).

Authorisation for minor use may only be granted if all the usual conditions relating to health and environmental safety are satisfied and the use is in the public interest.

In general, the Environmental Protection Agency does not grant minor use authorisations where authorised plant protection products for the purpose in question already exist.

Application requirements
There is no application form. The application should be accompanied by a proposal for instructions for use and documentation for the residual content of active substances in the crop if the product is intended for use on an edible crop.

The application may be sent by e-mail to if no documentation accompanies the application. Write: 'Application for minor use authorisation of (product name)' in the subject field.
If the application contains documentation, it should be sent on a CD-ROM to:

The Environmental Protection Agency, Pesticides and Gene Technology
Strandgade 29
DK-1401 COPENHAGEN K

The cost of applying
Application for a minor use authorisation is free of charge.

After authorisation
The Environmental Protection Agency grants a minor use authorisation on the condition that the use is is under the liability of the person using the plant protection product.

If the authorisation is granted to persons other than the authorisation holder, the Environmental Protection Agency will request of the authorisation holder to include the use on the label of the plant protection product. If this is not accomodated, the authorisation and the use instructions will be published on the Environmental Protection Agency's website.

Administratively, authorisations for minor use follow ordinary authorisations in that they expire at the same time and must be renewed at the same time if continued minor use authorisation is desired.

The holder of the minor use authorisation does not pay an annual fee, as the authorisation holder of the plant protection product itself pays DKK 500 per annum, together with the relevant duties due to the Danish Tax and Customs Administration.

Regulations
The regulations for minor use are described in detail in Article 51 of Regulation No 1107/2009.