Applying authorisation of national transitional period for biocidal products and test notification
- Permit or other obligation
- Public service
Biocidal products are subject to the EU Biocidal Products Regulation. The active substances used in biocidal products must be included in the EU's review programme for biocidal substances in that product-type and the products containing biocidal active substances must be authorised before making them available on the market. However, not all the requirements of the Regulation come into force immediately, but in many cases only after the transitional periods. Biocidal products containing new active substances must already be approved in advance in accordance with the Biocidal Products Regulation, products containing old active substances will be subject to prior authorisation once the review of the active substance in accordance with the Biocidal Products Regulation has been completed.
During the transitional period of the Biocidal Products Regulation, Finland also has a national prior authorisation procedure in accordance with the Chemicals Act (599/2013) for biocidal products belonging to certain product-types. These include wood preservatives, slimicides used in the pulp and paper industries, antifouling products, rodenticides, insecticides and acaricides, and repellents for pest control. Disinfecting biocides, for example, do not yet require prior authorisation before entering the market in Finland, and they must only be granted an authorisation after a few years in accordance with the Biocidal Products Regulation.
Applications for prior authorisation are submitted directly to the national authority, in Finland to Tukes. The authorisation may be applied for by a company or its representative with a permanent office in the European Union, Norway or Switzerland.
Production tests carried out with biocides, which may cause emissions into the environment, require that a notification be submitted to Tukes.
Do the following
The application for approval shall be accompanied by information on the product and the active substances contained therein. Provisions on information requirements are laid down in Ministry of the Environment Decree 419/2014.
The application material may be in Finnish, Swedish or English. The completed application form and its appendices will be submitted to Tukes. The instructions for use and other labels and the safety data sheet must be in Finnish and Swedish. Re-authorisation must be applied for one year before the expiry of the valid authorisation. If information is missing from the application, the applicant shall provide a timetable for its submission. If the information is not provided for scientific or technical reasons, the application must be accompanied by a written justification.
Production tests carried out with biocides, which may cause emissions into the environment, require that a notification be submitted to Tukes. Scientific tests require records of the tests and the substances or products used in it. During the transitional period of the BPR, a test report shall be submitted for products of product-types 8, 11, 12, 18, 19 and 21 in accordance with national regulations.
To whom and on what terms
In addition to the actual application, the application material must include research data on the product and its active substances and other substances. Instead of conducting their own tests, the applicant may provide written permission from another operator to use the information and studies in their application. Based on the material, Tukes assesses the health and environmental hazards of the product and decides whether the product can be made available on the market in Finland.
The Chemicals Act imposes general obligations on operators concerning all hazardous chemicals. They must be complied with in addition to the obligations laid down in the biocidal legislation (e.g. the national obligation to notify chemicals, REACH and CLP regulations).
All changes to the product must be notified to Tukes in advance before the changes take effect. Tukes collects annual data on the import, manufacture and use volumes of products.
A fee is charged for the service.
Before making the product available on the market.
Depends on the authorisation procedure.
Period of validity
Authorisation shall be valid for a determined period of time.