Change of the authorization process for plant protection products

Starting from May 1, 2025, the decisions for authorization plant protection products will be changed to table-form usage instructions instead of verbal instructions. Tukes will no longer attach verbal usage instructions to authorizations; instead, the official instructions will be provided in the "Usage and Restrictions" annex containing the instructions for use -table. The aim of this reform is to streamline the authorization process and improve the clarity of the instructions.

The new procedure applies to all applications and decisions made on or after May 1, 2025. Previously approved label texts will remain unchanged in KemiDigi, but the new procedure will be applied to new and updated authorizations. It is the responsibility of the authorization holder to ensure that the package label corresponds to the approved instructions for use -table and Tukes has authorized any changes to it.

How should the applicant proceed in the future?

The applicant's task is to prepare the instructions for use -table in both Finnish and Swedish. It is important to carefully fill out the table, as it forms the basis for the official usage instructions for the product. The approved instructions for use -table is attached to the application and will be an appendix of the decision. The table will be the official usage instructions for the product.

The instructions for use -table can be downloaded from Tukes' website

Additionally, the applicant must prepare the label text based on the approved usage instruction table. The information presented on the label must be consistent with the table, and the text must meet the requirements set by the EU regulation on the labeling of plant protection products (EU regulation on labeling requirements for plant protection products No. 547/2011). The authorization holder publishes the final label text, for example, on their own website and ensures its up-to-date status. The authorization holder is responsible for ensuring that the label text provided to users is always up-to-date and corresponds to the approved usage instruction table.

If changes to the label are desired later, a new application must be submitted to Tukes if the content of the usage instructions or restrictions is changed. The authorization holder can independently make changes related to wording or appearance.

Changes in the KemiDigi register and effects on users

Tukes will no longer publish complete label texts in KemiDigi. In the register will only be published the "Usage and Restrictions" annex, where the usage instructions for the product are presented in table form.

This means that the complete label text of the product will no longer be visible in the official register. If the complete label is not found, for example, on the authorization holder's website, users must request it directly from the authorization holder or the product representative if necessary.

During the transition period, KemiDigi will contain both old-style verbal usage instructions and new table-based appendices.

Tukes' role in the authorization process

Tukes processes applications, utilizes the instructions for use -table provided by the applicant in the processing, and makes the final decision. The approved instructions for use -table is published as part of the "Usage and Restrictions" annex in the KemiDigi plant protection product register.

Tukes ensures that the label texts on the market correspond to the approved information, comply with the EU labeling regulation, and are consistent with the instructions of use -table.

For more information:
Applying for approval for a new product | Finnish Safety and Chemicals Agency (Tukes)
Plant protection products register - KemiDigi
E-mail: [email protected]

New authorization process for plant protection products (pdf)