National procedures during the transitional period

Following biocidal products may during the transitional period not be manufactured, imported, placed for sale or used without an authorisation decision made by a competent authority:

 

  • wood preservatives and slimicides; product type 8, part of product types 11 and 12;
  • antifouling products; product type 21;
  • biocidal pesticides: insecticides, acaricides and products to control other arthropods, and repellents; product types 18 and 19

 

The Biocidal Products Directive was to be implemented by 13 May 2000. With the Biocidal Products Directive the transitional period was extended until 31 December 2024. During this transitional period, risk assessments are prepared under a review programme on biocidal active substances that were already on the European market before 14 May 2000 and decisions are made regarding their inclusion in the list of permitted active substances. A list of existing active substances to be evaluated under the review programme (notified active substances) can be found in Annex II to the Commission Regulation (EU) Nr 1062/2014. Products containing active substances included in the above-mentioned list in the product type concerned are transferred to the product authorisation procedure with the introduction of Community authorisation. In other words, the authorisation of products begins once their active substances have been included in the list of authorised active substances under the product type in question. Before authorisation in accordance with the Biocidal Products Regulation, Member States can during the transitional period comply with their national legislation regarding such products. If an active substance is prohibited at Community level under a decision of non-inclusion, biocidal products containing the substance cannot, however, be authorised nationally either. 

Products containing new active substances

If a product contains a new active substance that was not on the market in the EU before 14 May 2000, it must be authorised directly under the EU procedure for biocidal products (not under national procedures) before it can be placed on the market. This means a decision at the EU level will first be taken on the authorisation of a new active substance, after which Tukes will make a decision on its placing on the Finnish market. Tukes may, however, issue a temporary authorisation of a biocidal product containing a new active substance before this if it considers that the product meets the criteria set for authorisation.

 

Those planning to use biocidal 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. During the transitional period set by the Biocidal Products Regulation, applications for experimental permits regarding products falling in product types 8, 11, 12, 18, 19 and 21 must take place in accordance with national regulations.

 

Details of nationally authorised biocidal products can be found in the list of authorised wood preservatives and slimicides (in Finnish), the list of authorised antifouling products or the register of authorised biocidal pesticides (in Finnish).

 

Tukes will charge a fee to cover the processing of each application. 

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