National transitional requirements

The requirements for placing a biocidal product on the market in the transitional phase, i.e. prior to approval of the active substance for use in the relevant product type, are as follows:

  • The active substance must be notified in the review programme (EU 1062/2014), and the notification must cover the product type in question. The notification must not have been withdrawn or changed in such a way that the product type in question is no longer covered by the notification. To find the status of a substance / product type combination, please see ECHA’s list of biocidal active substances.
  • The product must be registered in the Norwegian Product Register, using the form “Biocide Notification Form”. This registration is free of charge.
  • If the biocidal product requires a hazard label according to classification and labelling legislation and is manufactured and/or placed on the market in Norway in quantities of 100 kg or more per year, it must be fully declared in the Product Register, using the form “Declaration form”. This is a general requirement for all hazardous chemicals. A yearly control fee of 820 NOK is presently charged for such products. 

Please note that all suppliers of active substances and biocidal products in the EU/EEA must either have submitted an active substance dossier or a letter of access to such a dossier, by 1 September 2015 (read more about this on ECHA's web page).  A self declaration form for companies making biocidal products available on the market and a letter of confirmation of supply to be used by product/substances suppliers included in the Article 95 list have been developed by the Commission. These templates can be used to document that the requirement is fulfilled (shall not be submitted to the Norwegian Environment Agency unless specifically requested by us). The templates are annexed to the Commission document CA-May 15-Doc.4.13-Annex-Final.

Furthermore, general chemical legislation, e.g. REACH, CLP and the Norwegian Product Regulations, also apply to biocides.

For certain use areas within product types 2, 3, 4 and 5, there are specific national regulations that have to be followed during the transitional phase, in addition to the requirements given above. Please see Specific national regulations.

Upon decision of approval of an active substance in a certain product type, a Commission Decision is adopted, where a date for formal approval of the substance is given. This date is the deadline for the application of authorisation of the affected biocidal products.