There is a significant modification to Finland’s plant protection product authorisation process. The Finnish Safety and Chemicals Agency, Tukes, has instituted a new system that will replace the current verbal descriptions in permit decisions with tabular instructions for usage as of May 1, 2025. The purpose of this reform is to improve the clarity of the usage requirements for these items and expedite the permit processing flow.

Tukes will no longer provide distinct spoken instructions for usage in conjunction with permission determinations going ahead. Rather, a specific “Use and restrictions” appendix will include the official instructions in a clear and simple tabular style.

A new method will be used for all new and updated preparation texts, however previously authorised sales package texts will still be available in the KemiDigi registry. Authorisation holders must make sure that any changes are authorised by Tukes and that the labelling on their product package appropriately reflects the authorised table of instructions for use.

Permit Applicants Must Do:

In accordance with the new rules, it is the permit applicant’s responsibility to draft an extensive table of instructions that may be used in both Swedish and Finnish. Since this table will serve as the foundation for the product’s official usage recommendations, accuracy is crucial. The application for the permission must include this table. Once approved by Tukes, it will be included as an appendix to the permit decision and will serve as the definitive instructions for product use.

Additionally, candidates must now create a sales label that exactly matches the authorised table of instructions. In accordance with the EU Plant Protection Products Labelling Regulation, the information on the package must match the contents of the table. An authorisation holder is responsible for publishing and maintaining the final sales label text on their website. Licensors are ultimately responsible for updating sales labels to reflect authorised usage instructions.

Any subsequent changes to the packaging that involve modifications to the content or restrictions of the instructions for use will necessitate a new application to Tukes. However, permit holders can independently make alterations to other aspects of the wording or the visual appearance of the packaging.

Changes in KemiDigi and Implications for Users:

Tukes will no longer publish complete sales label texts in the register. Instead, only the “Use and restrictions” appendix, containing the table of instructions for use, will be available.

This means that the full label text of a product will no longer be directly visible in the official register. If users require the complete label information, they will need to consult the authorization holder’s website or, if necessary, request it directly from the authorization holder or their representative.

During a transitional period, KemiDigi may contain a mix of older verbal user instructions and the new table-based attachments.

This move to tabular instructions is a big step towards making Finland’s plant protection product authorisation procedure more transparent and effective.

Reference: KemiDigi gathers chemical information into a single service – KemiDigi