Authorisation of plant protection products for minor use is an authorisation of an already authorised product in a minor crop, or a pest which is not widespread, that is not already covered by the authorisation of the product. Minor uses were previously called ‘off-label’.
Who can apply
The authorisation holder of the plant protection product, official or scientific organisations, professional agricultural organisations or professional users may apply.
What can you apply for
The use applied for must be in a minor crop or for a minor pest in a larger crop (e.g. a rare pest which can only be found in restricted local areas).
In one application you can apply for crops in one of the following groups:
- Crops for seed production
- Ornamentals in green houses and in the field
- Fruits and berries, including strawberries
- Vegetables
- Christmas trees, decorative greenery, forest use, hedgerows between fields, as well as crops for energy production
- Golf courses, lawn areas
For fruits and berries, including strawberries, and vegetables, use in green houses and in the field cannot be applied for in the same application. This is because for uses in green house and uses in field, different assessments of risk to human health, the environment and residues are required.
Cost of applying
In order to process your application you will be charged a fee. Click on Fees to read more about the fees.
How to apply
In order to apply you must fill out the application form below, as well as instructions for minor use (in Danish), for which a template is also provided below.
Instructions for minor use (in Danish)
If you are applying for a use in edible crops, you must also provide residue data, or a justification for why residue data can be extrapolated from the crops covered by the authorisation of the product.
The filled out application form and the filled out instructions for minor use, as well as any residue data, can be sent to our email address (pesticider@mst.dk). Please write 'Application for minor use authorisation of (product name)' in the subject field.
You may also send your application by postal services to:
The Environmental Protection Agency, Pesticides
Tolderlundsvej 5
DK-5000 Odense C
Assessment of minor use
A minor use can only be authorised if the use meets all the same requirements to toxicology, fate and behaviour, and ecotoxicology as well as any residues concentrations (for edible crops) that applies to the authorisation of the plant protection product.
Furthermore, authorisation of a minor use is normally not granted, if products for the use in question are already authorised. There may, however, be reasons as to why an authorisation of a minor can be granted anyway, e.g. prevention of resistance.
After the authorisation
The Environmental Protection Agency grants an authorisation of a minor use on the condition that the use 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 product. Furthermore, the use will be published on the Environmental Protection Agency’s database, Bekæmpelsesmiddeldatabasen.
Administratively, authorisations for minor use follow authorisations of the product in that they expire at the same time and must be renewed at the same time if continued authorisation of the minor use is desired.
Annual fee: The holder of the minor use authorisation does not pay an annual fee, as the authorisation holder of the product pays DKK 500 per annum, together with the relevant duties due to the Danish Tax and Customs Administration.
Regulations
The regulations for authorisation of minor use are described in Article 51 of Regulation No 1107/2009.