The Finnish Environment Institute (SYKE) and The National Product Control Agency for Welfare and Health (STTV) are the Finnish competent authorities for the Biocidal Products Directive (BPD). They are responsible for the authorization of biocidal products in Finland as well as assessments of active substances. Information on the procedures related to the BPD is available at our internet-pages in Finnish, Swedish and English.

• Annex I: Identified active substances
• Annex II: Active substances to be examined under the review programme
• Annex III: Requirements for the complete dossier and the summary dossier

Annex II lists notified active substances and their product types that are included in the review programme. Active substances that have been withdrawn or for which no dossier has been submitted after the previous amendments of the Review Regulations have not been deleted from Annex II. Such substances are excluded from the review programme by separate non-inclusion Decisions of the Commission. A consolidated list of these substances has been published by the Commission. This list indicates also the dates when biocidal products containing these active substances shall be removed from the market. These Decisions are directly applicable to the member states and companies. Member state authorities will cancel authorizations of the relevant products.

The list of non-inclusion decisions

The new Regulation excludes food and feed from the scope of the review programme. It is also stipulated that the participant for a notified active substance may only be changed once. This is to avoid the possibility of repeatedly delay the submission of the dossier in the review programme.

Consolidated Regulation has been published in the Official Journal (11 December 2007, number L325).

Notices on substances withdrawn from the review programme or for which no dossier has been submitted are published by the Commission. Within three months of this notice producers, formulators, associations or other persons may take over the role of participants for the active substance / product type combination concerned. Unless no new participant appears, the Commission shall make a non-inclusion Decision on the active substance / product type combination and products shall be removed from the market within a given time period.

Notices on substances withdrawn from the review program

• Date of inclusion to Annex I or IA 
• Expiry date of inclusion 
• Deadline for member states to make decisions on applications for approval of products containing the active substance 
• Specific provisions for placing on the market and use of the active substance.

In Finland the inclusion directives will be adopted by a Ministry of the Environment Decree (20/2008). Deadlines for submission of applications for product authorization will also be imposed in the Decree. The Decree will come into force 1 February 2008 and it will be amended later when more inclusion directives become available. The Consolidated Decree will be available in Finnish and Swedish in Finlex.

Guidance to companies marketing biocides 

• After inclusion of the active substance in Annex I or IA of the BPD, approval for products containing it must be applied for in all the member states where products are to be placed on the market. 
• Application may concern either approval or mutual recognition of approval. For products already on the market the deadline for submission of both applications is the same. Application for mutual recognition shall be completed after the first approval has been granted. For products that are new on the Finnish market mutual recognition may be applied at any time after the first approval. In the case where the same product is marketed by several companies, the application shall be made by the company that is responsible for the first placing on the market in Finland. 
• For products containing more than one active substance, applications for approval shall be made after all the relevant active substances have been included in the Annexes for the product type in question. 
• Those products, for which an application for either authorization or mutual recognition has been made in due date, can then remain on the market in Finland until decision on application has been made. All products, for which no application has been submitted or the application has been rejected, shall be removed from the market within 6 months. 
• For products already authorized by SYKE, STTV or The Pesticides Board according to the older national legislation, approval shall be applied for in the same way than to the other products already on the market. Placing on the market is allowed until the decision as a biocidal product has been made. However, in case the national approval expires before the application deadline stipulated in the Ministry of the Environment Decree, reauthorization shall be applied for. All products that have not been on the Finnish market before the active substance is included in Annex I or IA shall be authorized before placing on the market.

Application forms and guidance will become available at internet-pages of SYKE and STTV.

In addition some active substances has been handled and approved in the Standing Committee on Biocidal Products, but the inclusion directives have not been published yet.

(Read more).

• Biocidal active substances are regarded as registered within REACH. Thus, they do not require separate pre-registration or registration. 
• All the other components in the biocidal products shall be pre-registered between 1 June 2008 and 1 December 2008 to European Chemicals Agency (ECHA). Registration of these substances shall be made in three phases during 11 years' period. Notification of the hazard classification is also being applied to these substances. ECHA will provide software tools for these procedures. 
• Safety Data Sheets shall be made according to REACH.

If you produce or formulate biocidal products, make sure that your suppliers have included the use of their chemicals in biocidal products in their registration. Without registration the use of the substances is not allowed unless producer/importer self makes a chemical safety report (CSR) and informs ECHA about it.

REACH Help Desk will provide further guidance.