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.

Applying for an authorisation for extension of use

  • Fill in the application form
  • Include in the application:
    • draft label text in Finnish and Swedish
    • the GAP table concerning the use and application doses (GAP (Good Agricultural Practices) table on the uses for which the authorisation is asked for in DOC format)
    • research material on biological efficiency and usability
    • research material on residues
    • if necessary, research material on health and environmental effects

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

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 intended use of the product is minor in nature 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 but are nevertheless of high significance and economic value.


Applying for extension of product authorisation for minor use

  • Fill in the application form
  • Include in the application:
    • draft instructions for use in Finnish and Swedish in Word format
    • GAP Table (GAP (Good Agricultural Practices) table on the uses for which the extension is asked for in DOC format)
    • 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.

Processing time: Extension of use and extension of product authorisation for minor use 1 year

Fees

Extension of use      
Multiple uses, Art. 33 basic fee 3,000 euros additional evaluation 95 euros/h maximum fee 40,000 euros
Single use, Art. 33 basic fee 1,100 euros additional evaluation 95 euros/h maximum fee 20,000 euros
Minor use, Art. 51 1,100 euros - -