Derogations and trials

Derogations (120 days) in emergency situations in plant protection

If no product has been authorised for averting the pest in any of the Member States or it cannot be contained by other reasonable means, a Member State may grant an authorisation by derogation for the placing on the market and use of a plant protection product for a maximum of 120 days. The use of the product must be limited and controlled.

Applying for an authorisation by derogation

  • Fill in the application form
  • Include in the application:
    • Justifications why the use of the product is necessary
    • Draft label text with instructions for use
    • The residue studies or residue data available on the product
  • Email the application to the address ppp (at) tukes.fi.

You can also submit the application to the EU's PPPAMS database. For further information on application procedures submit your questions to Tukes’ Plant Protection Products Unit, ppp (at) tukes.fi.

Tukes enters the data on all authorisations granted by derogation with their justifications in the EU Commission’s information system. The Commission Standing Committee will review the authorisations granted by derogation.

On the Derogations page you will find information on derogations granted by Tukes.

Processing time: 60 days
Fees

Emergency situations in plant protection (120 days), Art. 53 1,100 euros

Trial and research activity permits and notifications

It is possible to acquire a trial permit for a product that has not yet been approved as a plant protection product by Tukes. A permit is also needed when a trial is conducted on an authorised product but for a new intended use.

If you want to conduct small-scale testing on the biological efficacy and usability of plant protection products or field testing of such products in Finnish conditions, you must apply for a trial permit.

The application for a trial permit can be submitted by a facility or organisation that has access to appropriate testing facilities and equipment to carry out such testing. The Ministry of Agriculture and Forestry Decree 9/2012 provides further instructions on the trial permit and the reporting of testing activities.

Applying for a trial permit:

  • Fill in the application form (link Application form).
  • Email the application to the address ppp (at) tukes.fi and write in the subject field: Application for a trial permit at least two months before initiating the planned trial.

The application must contain the following information:

  • the name and contact information of the applicant and the person responsible for the trial
  • objective of the trial
  • testing site: locality, code of agricultural holding or, in lack of one, the parcel number, area size of the testing site,
  • holder of the testing site
  • time of testing
  • product being tested: name, composition, application dose, application method, label text if the product is in use within the European Union
  • residue data, if available, in crops used both as food and as feed
  • for plants, proposal on the use of the crops
  • data on toxicity and other health effects of the product, if available
  • information on the environmental behaviour and effects of the product, if available
  • occupational health and safety: specified instructions concerning personal protective equipment, safety data sheet.

Requirements for granting a trial permit:

  • the trial is not expected to be likely to have harmful effects on human or animal health or the environment
  • the applicant has access to appropriate testing facilities for the trial, and
  • the trial will take place under controlled conditions using a restricted amount of products in a restricted area
  • the applicant must name a person responsible for the trial
  • pursuant to the Plant Protection Products Act the size of the restricted area for which a trial permit can be granted is interpreted to be less than 100 ha
  • in deviation from this, a trial permit for activities supporting integrated pest management (IPM) can be granted for an area larger than 100 ha
  • the products used in testing under a trial permit are required to meet the same restrictions on use for the protection of health, consumers and the environment as other products containing similar active substances. If the applicant has not proposed any restrictions and Tukes lacks information on the product’s
  • health and environmental risks, the product is required to meet the generally applicable restrictions, such as the buffer zones for plant protection products, prohibition of use in groundwater areas and restrictions related to protection of bees
  • Tukes does not grant several repeated trial permits for the same product or the same intended use.

The trial must be interrupted if it turns out during testing that the product has such significant adverse effects on human or animal health or the environment that could not be anticipated when the permit was granted. If any such effects occur, immediately inform Tukes about this at ppp (at) tukes.fi.

Permit holders must provide Tukes with a report on the trial conducted no later than within three months of the date of the permit's expiry.

Remember to include the following information in the report:

  • permit holder and the person responsible for the trial: name and contact information
  • objective of the trial
  • testing site: locality, code of agricultural holding or, in lack of one, the parcel number, area size of the testing site,
  • holder of the testing site
  • time of testing: when was the plant protection product used and total duration of the experiment
  • product being tested: name, composition, application dose, application method, label text if the product is in use within the European Union
  • weather information concerning the experiment: air temperature, wind velocity and cloudiness at the time of application
  • results of the trial, their analysis and conclusions.

When just a notification of testing is enough?

A permit is not needed if the facility conducting the testing is an officially recognised facility testing the biological efficacy and usability of plant protection products. Such testing facilities only need to submit a free-from notification to Tukes at ppp (at) tukes.fi of upcoming trials one week before their commencement.

Processing time: 60 days

Fees

Permit for trials conducted for the purpose of research and development, Art. 54
cultivation trial 700 euros/product
plot trial or less than 1-hectare cultivation trial 300 euros/product

Official recognition of facilities testing the biological efficacy and usability of plant protection products (GEP)

A facility can be officially recognised as a facility testing the biological efficacy and usability of plant protection products if its testing operations meet the requirements set for Good Experimental Practice, GEP (Ministry of Agriculture and Forestry Decree 9/2012, Annex 1).

To seek for recognition send an application form to Tukes. Tukes examines whether the applicants meet the requirements set for recognition by examining the application documents and conducting on-site inspections at the facility.

The requirements concern the following matters:

  • staff
  • buildings and storage facilities
  • machinery and equipment used for testing
  • materials used in testing
  • research environment
  • products being tested and control products
  • performance of trials
  • reporting of results and
  • archiving.

All the aspects listed above must meet the requirements set for Good Experimental Practice.

Processing time: 420 days

Fees

Facility testing the biological efficacy and usability of plant protection products
(Plant Protection Products Act 1563/2011, section 18)

recognition 3,500 euros
reapproval 1,300 euros
inspection fee/visit 600 euros