KemiDigi has brought changes to chemical notifications and quantitative information reporting for plant protection products

Operators placing on the market or distributing plant protection products are required to submit a chemical notification to the KemiDigi system maintained by Tukes for those products for which a chemical notification is required, as specified below. In addition, for plant protection products for which a chemical notification has been submitted, the notifier must report quantitative information through the KemiDigi system by the end of February each year. Currently, holders of plant protection product authorisations report their associated sales volumes using the online form on the Tukes website, but in future, this information will be reported via KemiDigi. Authorisation holders will be informed of the transition at a later date.

Operators placing on the market or distributing plant protection products

Who must submit a chemical notification and where?

The first company with a Finnish business ID in the product supply chain is obliged to submit a chemical notification about the product it has placed on the Finnish market. The chemical notification can only be submitted by a logged-in user of the KemiDigi system. The notification must be made by a Finnish manufacturer or importer with a Finnish business ID. If there is more than one company importing the same product into Finland, each company is responsible for its own part for the import of the product concerned, and each of them must submit the notification. Companies without a Finnish business ID cannot submit a chemical notification to the register.

Which products require notification and when?

A chemical notification must be submitted if the product is classified under the CLP Regulation, and also if an unclassified product contains hazardous substances or contains a substance with an occupational exposure limit value set by EU legislation (in accordance with Article 31 of the REACH Regulation). In practice, a chemical notification must be submitted whenever a safety data sheet is required to be provided on a mandatory basis or upon request in accordance with Article 31 of the REACH Regulation. A chemical notification must also be submitted for plant protection products if the above criteria are met.

The operator must submit its chemical notification to KemiDigi at the latest when the product is placed on the market.

For what products, how and when must quantitative information associated with chemical notifications be reported?

Quantitative information must be reported to KemiDigi for chemicals for which a chemical notification has been submitted. Companies that have submitted chemical notifications to KemiDigi (i.e. manufacturers and importers with a Finnish business ID) are also responsible for reporting the associated quantitative information. The quantitative data must be reported by the end of February each year for the previous year and expressed in tonnes with the precision required in the relevant decree (the reporting precision depends on the quantity).

Legal basis for the chemical notification and for reporting associated quantitative information:

• Provisions on the chemical products register are laid down in sections 17 and 22 of the Chemicals Act.

• Further provisions on submitting information referred to in section 22, subsections 1 and 2 of the Chemicals Act will be given by a decree of the Ministry of Social Affairs and Health.

• On the obligation to prepare a chemical notification, see Decree 553/2008 of the Ministry of Social Affairs and Health

• On submission of quantity information, see Decree 1155/2011 of the Ministry of Social Affairs and Health

• REACH Regulation (EC) No 1907/2006, Article 31 and Appendix II

• CLP Regulation (EC) No 1272/2008

Holders of plant protection product authorisations

Who must report the sales volumes associated with the authorisation and how?

All holders of plant protection product authorisations (it is not relevant whether or not the authorisation holder has a Finnish business ID) must report the sales volumes of plant protection products they have placed on the market in Finland using the online form available on the Tukes website at https://tukes.fi/en/online-services/forms/plant-protection-products (i.e. NOT via KemiDigi).

For which products must sales volumes associated with authorisations be reported and when?

Authorisation holders were required to report by 30 April 2020 the 2019 sales volumes for all plant protection products that were included in the plant protection product register that year. The report should also have indicated if the product has not been sold at all. Information on how and when the sales volumes for 2020 must be reported via KemiDigi will be communicated to the authorisation holders at the end of this year, or at the latest at the beginning of 2021.

Legal basis for the reporting of quantitative information associated with authorisations:

• Plant Protection Products Regulation (EC) No 1107/2009, Article 67

• Regulation (EC) No 1185/2009 concerning statistics on pesticides

Reporting of quantitative information concerning plant protection products in the future

In the future, all notifications relating to plant protection products, including quantitative information associated with chemical declarations and authorisations, will be reported via the KemiDigi system. More information is coming later.

Further information:                [email protected]

[email protected]

Chemical notifications and associated quantitative information: Senior Officer Anu Matilainen, tel. +358 (0)29 5052 706

Quantitative information related to permits: Senior Specialist Eija-Leena Hynninen, tel. +358 (0)29 5052 049

E-mail format: [email protected]