If a product has been authorised in the Netherlands and an extension with minor uses is requested for product application solely in the Netherlands, this request can be assessed in a non-zonal national procedure, based on regulation 1107/2009, article 51 with an application for extension of national authorization with minor uses (NLKUG).
The legal basis
The definition of ‘minor’ can be different in the EU-memberstates. For more details information see general information on minor uses. The application for extension of national authorization with minor uses (NLKUG) finds its legal basis in article 51 of the regulation 1107/2009 and 'Regeling gewasbeschermingsmiddelen en biociden' (Rgb), article 2.2
Application type criteria
What are the conditions for a national application for an extended authorisation with minor uses?
- The plant protection product for which extended authorisation is requested has already been authorised in the Netherlands.
- The use concerns a minor crop or a minor use in a major crop, such as cultivation on an unusual type of soil or an unusual pest or disease.
- The application concerns professional use only.
The national extension with minor uses (NLKUG) cannot be used for seed treatment. For this purpose, an interzonal application is required.
For a national authorisation with minor uses, it is not mandatory to prove efficacy for the minor use applied for and also phytotoxicity is exempted from evaluation.
Duration Period Product Authorisation
The extension with minor uses is fully linked to product authorisation. A product authorisation is granted for a period not exceeding 1 year after the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product (reuglation1107/2009, art.32).
Developments in legislative framework and processes for authorisation of minor uses are addressed in the Coördination Facility ‘Minor Uses’ established by the European Commission.