The Biocidal Products Directive is implemented in Norwegian law through the Norwegian Biocides Regulation.

Contents:

• The Biocidal Products Directive covers 23 product types divided into four main groups
• The review programme
• Registration of biocidal products in Norway
  - After decision on Annex I/IA inclusion of active substance
  - Prior to decision on Annex I/IA inclusion of active substance
• Special national regulations
• Registration fees

The BPD covers 23 product types divided into four main groups

• disinfectants and general biocidal products
• preservatives
• pest control products
• other biocidal products

For a list and description of all the product types, see Annex V of the BPD.

The review programme

Existing active substances are those substances which were present in biocidal products on the EU/EEA market prior to 14 May 2000. By 31 January 2003, the biocide industries had to notify the EU Commission as to which of these substances they were interested in continuing to use in biocidal products.

These notified substances are currently being reviewed for biocidal use at EU/EEA level. The evaluation of each substance is based on information (provided by the industry) on the characteristics of the substance and risks to human health and the environment resulting from the foreseen use.

The country performing the evaluation, i.e. the rapporteur, carefully considers this information and prepares a risk assessment report which is submitted to the Commission. The result is either that the substance is approved or not approved for the biocidal use outlined in the application.

Before the final decision is taken, the reports are published on the Commission’s web pages for a three-month public consultation.

The notified substances and the use areas (biocidal product types) they are being reviewed for, can be found in Annex II of Commission Regulation EC 1451/2007

Registration of biocidal products in Norway

All the conditions for registration of biocidal products laid down in EU law apply in Norway. More specifically, the current regulation of a biocidal product depends on the status of the active substance in the review programme.

After decision on Annex I/IA inclusion of active substance

For products containing active substances for which the risk assessment is finalised, the following requirements given in the BPD apply fully:

• The product’s active substance(s) must be included in Annex I/IA to the BPD, i.e. authorised on EU level, and the inclusion must cover the use area in question.
• An authorisation must be applied for in the country where the product is sought to be marketed. A biocidal product which is already authorised in one EEA country, can be authorised in another EEA country through mutual recognition. This is a simplified authorisation procedure. 
• The inclusion directive for each active substance contains a date for the formal inclusion into Annex I/IA. An authorisation or mutual recognition must be applied for by this date.

Prior to decision on Annex I/IA inclusion of active substance

For products whose active substances are not yet fully evaluated, the following requirements apply:

• The active substance must be notified in the review programme (Annex II to EC 1451/2007), and the notification must cover the use area in question.
• The notification must not have been withdrawn or changed in such a way that the use area in question is not longer covered by the notification. This consolidated list shows notified substances for which there has been made a decision of non-inclusion into Annex I/IA, as well as deadlines for phasing out the products containing these active substances.
• The product must be registered in the Norwegian Product Register. In addition, all hazardous chemicals (chemical preparations requiring a hazard label according to classification and labelling legislation) must be fully declared in the Product Register.

Special national regulations

Some national regulations have to be followed in the interim period prior to Annex I/IA inclusion of the active substances in question. This concerns certain use areas within PTs 2, 3 and 4: technical use of chemical disinfectants in public health areas, cleaning and disinfection of equipment in aquaculture and disinfection of equipment in fish processing industry.

Registration fees

The fees for registration of products whose active substances are included in Annex I/IA of the BPD can be found in Annex 4 to the Norwegian Biocides Regulation. An invoice will be sent upon receipt of the application. The standard annual fee is NOK 1 400,- per biocidal product. The additional differentiated fee is based on amount of product as well as classification and labelling.

Regarding products whose active substances are notified, but not yet included in Annex I/IA, no fees will be charged for registration in the Norwegian Product Register. (Note that for the special national regulations for PTs 2, 3 and 4, fees may apply.)

However, all hazardous chemicals, i.e. chemical preparations requiring a hazard label according to the classification and labelling legislation, have to be fully declared in the Product Register. A yearly control fee will be charged for this declaration.

For further information on the regulation and marketing of biocides in Norway, please contact us at biocides@klif.no.