Extension of use and extension of product authorisation for minor use

Extension of use

The authorisation holder may ask for the uses of an authorised plant protection product to be extended, provided that the requirements set for approval are still met. For example, the preparation Källi has been approved for weed control for beetroot and the applicant wants to extend the authorisation to weed control use for fodder beet, carrot, caraway and turnip rape. This is a case of extension of use to multiple intended uses.

The applicant should submit applications to all Member States within the zone or interzone where they wish to gain a label extension. The application must be submitted in accordance with the current Northern Zone guidance document (section 6.3 Submission of label extension).

Link to the Northern Zone guidance can be found on the zonal authorization pages.
 

Applying for an authorisation for extension of use

  • Fill in the application form
  • Include in the application:
    • Instructions for use- table
    • research material on biological efficiency and usability
    • research material on residues
    • if necessary, research material on health and environmental effects
    • a draft registration report (dRR)

Submit the application to Tukes at the address ppp (at) tukes.fi.

Processing time: 1 year 

Extension of product authorisation for minor use

The authorisation holder, official or scientific bodies involved in agricultural activities, or professional agricultural organisations may ask for the authorisation of a plant protection product already authorised to be extended to minor uses not yet covered by that authorisation.

Tukes may extend the authorisation provided that

  • the cultivated area of ​​the crop is no more than 8,000 ha or the pest itself (target) meets the same minor use definition and

  • the general conditions for approval are satisfied and
  • the extension is in the public interest.

In deviation from ordinary authorisation, Tukes may extend the authorisation without extensive testing to measure biological efficiency and usability. In practice, authorisations of plant protection products for minor use concern crops that are farmed on small land areas (maximum 8000 ha) but are nevertheless of high significance and economic value. 
With caraway (Carum carvi), the definition of a minor use authorisation in terms of cultivated area is only met if the use of the product is applied for only on the year of establishment.


Applying for extension of product authorisation for minor use

  • Fill in the application form
  • Include in the application:
    • Instructions for use- table
    • all data available on residue studies and maximum residue levels (MRL) in particular
    • all documentation available on assessment of risks caused to users, employees and third parties
    • before submitting the application, contact the authorisation holder of the product or his or her representative to obtain any documentation to support the application. Deliver a letter of consent from the authorisation holder with the application.

Submit the application to Tukes at the address ppp (at) tukes.fi.

Application Processing:

In connection with a minor use application, Tukes reviews or models the necessary parts of the risk assessment to ensure that the extension to minor uses can be proved safe. The parts to be reviewed depend on the product and its intended use, and may relate to environmental risks, residues and consumer safety, as well as modeling of worker exposure. Tukes performs the necessary modeling itself, unless the modeling is included in the main authorization’s risk assessment or in the minor use application documentation.

A basic fee is charged for a minor use authorization. If the processing of the application requires additional work, it will be invoiced according to the hourly rate. Link to Tukes’ fee regulation.

Processing time: 1 year

Combining Separate Minor Use Authorizations:

If there are multiple minor use authorizations for the same product, the applicants may combine them into a single minor use authorization. In such cases, the applicant(s) must submit to Tukes a draft of the use instruction table and a draft of the minor use instructions.

Reapplication for a minor use authorisation:

When the main authorisation of the product is renewed, the extension for minor use must be reapplied for. The minor use authorisation holder must contact the main authorisation holder to stay informed about the status of the main authorisation. Submit the application and documents for the minor use extension to Tukes no later than three months after the renewal of the main authorisation.