Antifouling products are biocidal products used on surfaces including boats and other vessels as well as underwater structures that contain chemical active substances and prevent the attachment of fouling organisms on vessels and structures.
Manufacturers and importers of antifouling products must obtain Tukes's authorisation before they can begin the manufacturing, import or placing on the market of such products. The authorisation applies to all chemicals used for the above-mentioned purposes, regardless of how hazardous they may or may not be.
The authorisation procedure only applies to antifouling products that function by chemical or biological (i.e. biocidal) means used to control the attachment of organisms (algae, barnacles, etc.) on vessels, aquaculture equipment or other structures used in water. Products based on physical impact are not covered by the authorisation obligation. Examples of such products include those used because they create a very smooth surface that reduces the attachment of biofoulers.
The advertising of antifouling products is subject to special regulations concerning biocidal products.
Authorisation procedure for antifouling products
Authorisation can only be requested for products with an active substance that has been notified for evaluation in the review programme of biocidal active substances and that is not found in the Commission's list of active substances on which a non-inclusion decision has been taken. After the transitional period the authorisation of antifouling products will in all respects take place under the Community authorisation procedure. The transitional period is due to extend until 31 December 2024 but it may also be shorter, ending once a decision concerning the authorisation of the active substance the antifouling product contains has been made in accordance with the Biocidal Products Directive or Regulation.
To learn more about the authorisation procedure and the research requirements see the Application Guide.
Those planning to use antifouling products for process-oriented research and development must submit an application for an experimental permit to Tukes. Use in scientific research and development calls for written records about the experiments and the substances or products used in them.
Each application for the authorisation of an antifouling product must be accompanied by a dossier of information regarding the product and its active substances. Provisions regarding the information required are laid down in a Ministry of the Environment Decree on applications and notifications regarding biocidal products and their active substances 419/2014. During the transitional period the data requirements in the national procedure applied in Finland are less extensive.
Application documentation can be in Finnish, Swedish or English. The completed application form and appendices must be submitted to Tukes. The product's safety data sheet, instructions for use and other package labelling must be provided in Finnish and Swedish. The applicant must provide a schedule for the submission of any required information not included in an application. Written justification for the non-submission of information for scientific or technical reasons must be provided with the application. Applications for renewal must be made one year prior to the expiry date of the valid authorisation.
Tukes will charge a fee to cover the processing of each application.
Details of authorised antifouling products are filed in a list.
Questionnaire on quantities sold
Manufacturers or importers of antifouling products must, on request, provide Tukes with annual information about the amounts of chemicals manufactured and imported by them (Chemicals Act 599/2014, 22 §). The questionnaire should be filled in annually by March 31.