Biosidit

Biocides

Implementation of Biocides Directive

The European biocides legislation came into force in Finland in May 2000. Placing on the market of biocidal products is regulated by the Finnish Chemicals Act and related decrees, which are in accordance with the European Parliament and Council Directive 98/8/EC concerning the placing of biocidal products on the market (BPD).

Placing on the market covers any supply and subsequent storage of biocidal products. The only exception is storage prior to export out of the customs territory or disposal. Placing on the market covers also the use phase of a biocidal product.

Biocides legislation applies immediately to those substances which were not on the market on 13 May 2000 as biocides. If a biocidal product contains at least one active substance new to the EU market, authorisation has to be applied before import, marketing and use in Finland.

The substances which were on the market on 14May 2000 are evaluated in the Biocides Review Programme during a ten-year transitional period.

The provisions on advertising of biocides have been applied to all products from January 2001.

Competent Authorities

The competent authorities for biocides are the National Product Control Agency for Welfare and Health (STTV) and the Finnish Environment Institute (SYKE). The competent authority appointed for a certain product type shall make decisions concerning authorisation or registration of biocidal products within that product type. The competent authority is also responsible for other procedures relating to biocidal products and active substances that belong to the product type in question.

The product types appointed to STTV:

disinfectants, in-can, film, material or metalworking-fluid preservatives, insecticides and repellents, preservatives for food or feedstocks, and embalming and taxidermist fluids.

The product types appointed to SYKE:

wood or masonry preservatives, process or cooling water preservatives, slimicides, and rodenticides, avicides, molluscicides, piscicides and vertebrate control products (according to the new EU system), and antifouling products.

Questions on general issues should be addressed to the appointed competent authority. Specific human health issues belong to the competence of STTV and environmental issues to SYKE.

How to Apply for an Annex I Inclusion and Product Authorisation

Applications shall be submitted to the appointed competent authority. Application forms can be downloaded here.

The data requirements for biocides are listed in Annexes II-IV of the BPD. A detailed guidance on data requirements and other issues related to the approval system of biocides are available at the ECB website on biocides in Technical Guidance Documents.

Guidance on other administrative procedures can be found in the Directive.

National Fees for Biocides

All member states charge for applications under BPD. The fees shall correspond to the costs of work for authorities as far as possible. In Finland, the amount charged from the applicant is divided between STTV and SYKE as defined in the decrees mentioned below.

Fees for biocides

Application for inclusion of an active substance in Annexes I, IA or IB
- completeness check of the dossier	19 800 €
- evaluation of the first product type	217 500 €
- evaluation of the second and subsequent product types	108 750 €
Application for authorization of a biocidal product for the first time in the EU
- completeness check of the dossier	9 900 €
- evaluation of the dossier	39 600 €
- additional fee per active substance for the second and subsequent a.s.	9 900 €
Application for provisional authorization
- completeness check of the dossier	9 900 €
- evaluation of the dossier	39 600 €
- additional fee per active substance for the second and subsequent a.s.	9 900 €
Application for mutual recognition of a biocidal product	7 900 €
Application for registration of a low risk biocidal product for the first time in the EU	9 900 €
Application for mutual registration of a low risk biocidal product	2 500 €
Application (made by applicant) for establishment of a frame formulation	2 500 €
Application for authorisation of a (established) frame formulation product	2 500 €
Application for temporal use of a biocidal product (120 d permit)	2 500 €
Notification on process-oriented R & D	500 €
Application for authorisation of an experiment (art. 17(2))	1 500 €

General criteria:

· The fee for completeness check is charged with the submission of the application and the fee for evaluation is to be paid when the CA’s decision is given

· Applications for reauthorisation or re-registration cost 50% of the original fee

· 65 €/ working hour is charged for the performed work if the application is withdrawn

· The fee is the same for negative and positive decisions

· The charges are fixed. In individual cases charges may be 25 or 50% higher or lower, should the application require a substantially higher/lower amount of work than an average application

The statutory basis for the fees related to procedures under BPD consists of the Ministry of Social Affairs and Health Decree (1395/2006, amendment 827/2007) and the Ministry of the Environment Decree (1207/2006).

Under the Chemicals Act the collection of the charge may be waived if the charge would be otherwise unreasonable.

National Authorisations during Transitional Period

Transitional period started from the coming into force of the biocides legislation and it ends once an active substance is accepted to the annexes of BPD in defined product types. During the transitional period the Finnish national legislation applies.

Wood preservatives (product type 8) and slimicides used in cooling water treatment or in paper mills (part of product type 11 and part of 12) must be authorised by the Finnish Environment Institute (SYKE) before their import, marketing and use in Finland.

Rodenticides, insecticides, acaricides and insect repellents (product types 14, 18 and 19) must also be registered as biocidal pesticides before import, marketing and use. The registration of rodenticides shall be submitted to SYKE and for insecticides, acaricides and insect repellents to STTV.

Antifouling products (product type 21) previously on the market had to be authorised by SYKE by the end of 2001, and thereafter all new antifouling products entering the Finnish market.

Review of Existing Active Substances under BPD

Biocidal active substances placed on the market before 14 May 2000 are evaluated in a review programme during the transitional period. After evaluation, accepted active substances will be included in the annexes of BPD.

The first review regulation (1896/2000) sets out rules for identification and notification of active substances. Notified substances will be evaluated in four phases of the review programme.

Deadline for the submission of dossiers for the second phase (product types 16, 18, 19 and 21) was 30 April 2006. Updated information on the review process (timetables, withdrawn applications, public versions of the draft evaluation reports etc.) can be followed at the Commission DG ENV website on chemicals.

After annex I(A) inclusion, product containing the active substance have to be accepted nationally in each Member State where they are placed on the market. It is suggested that applications for product authorisation shall be submitted within two years after annex I inclusion. Product authorisations shall be granted within one and a half years thereafter.

Phase out of Biocides

The third review regulation (1048/2005) defines a date of phase out for some of the existing biocidal active substances and related products.

· By the 1^st of September 2006, identified substances (annex III of 2032/2003), unidentified existing active substances (annex VII of 1048/2005), active substances of rodenticides and wood preservatives which are not supported for review by any applicant and active substances in such product types for which there is no notification.

· By the 31^st of December 2007, substances in product types 16, 18, 19 and 21 which are not supported for review by any applicant.

A consolidated version of the second and third review regulation with annexes is available at the Commission DG ENV website on chemicals.

The second review regulation will be updated and amended with a fourth review regulation which will be laid down during the autumn 2006.

Scope of BPD

The scope of BPD is defined in the Directive. The Directive lists a number of other directives that apply to products which are thereby excluded from BPD.

Borderline between e.g. a medicine/medical device, plant protection product or cosmetics and a biocide is not always clear. The European Commission has produced separate documents and a Manual of Decisions (MOD) to clarify unclear cases. The borderline papers include general principles with examples. MOD is an update summary of individual interpretations concerning the scope of BPD. The documents are available at the Commission DG ENV website on chemicals.

Regulation on Detergents in relation to Biocides

An EU regulation on detergents (648/2004) came into force on 8 October 2005. It lays down requirements on labelling of consumer products and biodegradability of surfactants etc. Besides BPD, the regulation on detergents applies to disinfecting cleaning agents.

Restrictions on certain Dangerous Chemicals

EU-wide restrictions on the marketing and use of certain dangerous substances and preparations imposed by Council Directive 76/769/EEC (the so-called Limitations Directive) are implemented by Council of State Decrees.

Currently the following biocidal active substances are subject to restrictions under this Directive: arsenic, creosote, organic tin compounds, mercury and pentachlorophenols. The corresponding directives are available at the Commission DG ENV website on chemicals.

There are restrictions also in the use of nonylphenols and nonylphenol ethoxylates in cleaning, textile and leather processing, metal working and personal care products at 0.1% concentration by weight or more. Use in domestic cleaning, as emulsifiers in agricultural teat dips, in pulp and paper manufacture, in cosmetic products and as co-formulants in biocides is totally prohibited. (2003/53/EC)

Biocidal products classified as toxic, very toxic or as category 1 or 2 carcinogens, mutagens or toxic to reproduction are not allowed for consumer use. (98/8/EC)

Duties of the Finnish Manufacturer or Importer

The Finnish chemical legislation sets some general provisions that apply also to biocides. The Finnish company that is the first to place a chemical on the market in Finland is obliged to provide information on the chemical to the Product Register Unit of STTV.

Information is submitted on chemicals that are classified as dangerous to health or the environment or as causing fire and explosion hazards. Information is also submitted on chemicals that are not classified but contain one or more substances that are dangerous to health or the environment or a substance for which there is an occupational exposure limit, if the concentration of such a substance exceeds 1 % by weight.

Registration forms and further guidance

Material Safety Data Sheets (MSDS) of dangerous chemicals have to be provided to the work places.

Biocidal active substances are considered as registered substances under the new European chemicals legislation (REACH). For other substances in biocidal products the requirements of REACH apply.

Useful Links:

Biosinfo – biocide news from SYKE and STTV

Finnish Environment Institute (SYKE) (>Finnish Environment Institute>Expert services>Chemicals>Chemicals requiring authorisation)

· Information on approval of biocides

European Chemicals Bureau (ECB)

· Legislation, Technical guidance Documents

European Commission

· Borderline and guidance documents, Biocidal product types, Review programme, Competent authorities in the Member States, Related legislation

EURLEX

· European Union law

National Agency for Medicines

· Medicines and medicinal devices