Transitional requirements

Biocidal products can be made available on the Norwegian market without an authorisation from the Norwegian Environment Agency, if they comply with the transitional measures given in Article 89 of the BPR and additional national requirements.

In order to find out whether a certain biocidal product is subject to the transitional measures or not, you need to know which product-type your biocidal product belongs to, which active substance(s) it contains, and the status of the active substance(s) in the BPR review programme.

The ECHA website contains a searchable list of biocidal active substances. If an active substance is included on this list, you can check its status – whether it is under review, approved or not approved for use in the relevant product-type. In the search criteria, you can distinguish between active substances in the review programme, new active substances and Annex I active substances.

The transitional measures can apply to biocidal products whose active substances are under review, and in some cases to biocidal products with only approved active substances. Some biocidal products are not allowed on the market under the transitional measures. Details on all these cases can be found below.

This concerns both biocidal products where all active substances are under review in the review programme, and biocidal products with a combination of approved active substances and active substances which are under review. The review or approval of all active substances must cover the relevant product-type.

These products are allowed on the Norwegian market in accordance with the transitional measures, provided that the following national transitional requirements are met:

  • The label must comply with the requirements given in the Norwegian Biocide Regulation § 2-1: The label, including the use area and use description, must be in Norwegian. Biocidal products shall be packaged and labelled in a way that avoids mistaking them for food or feed. Labels must not be misleading and cannot mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, or any similar indications. Where relevant, the label must also meet CLP requirements.
  • The biocidal product must be declared to the Norwegian Product Register. If the biocidal product requires a hazard label according to CLP and is manufactured and/or placed on the market in Norway in quantities of 100 kg or more per year, this information must also be declared to the Product Register.
  • The suppliers of the active substance(s) must be on ECHA's Article 95 list, and the listing must cover the relevant product-type.
  • The biocidal product must comply with other relevant chemical legislation, e.g. Reach, CLP and the Product Control Act. This includes a responsibility for ensuring safe and effective products.
  • For certain use areas within product-types 2, 3, 4 and 5, there are specific national regulations that must be followed during the transitional phase, in addition to the requirements given above. Read more about these specific regulations below.

This concerns biocidal products where all active substances have been reviewed in the review programme and are approved for use in the relevant product-type, but where a BPR product authorisation has not been granted yet.

Such biocidal products can be allowed on the Norwegian market in accordance with the transitional measures only if both of the following two conditions are met:

  • An application for a BPR product authorisation must have been submitted to the Norwegian Environment Agency within the deadline. The deadline for such an application is identical to the approval start date of the last approved active substance. To find the approval start date of a substance / product-type combination, please see Echas’s list of biocidal active substances.
  • The biocidal product must have been on the Norwegian market by the deadline given in the previous bullet point.

The national transitional requirements for such biocidal products are identical to those listed above, for biocidal products whose active substances are under review.

These biocidal products can stay on the Norwegian market while the Norwegian Environment Agency evaluates the application for a BPR authorisation. When we reach a decision on the authorisation or non-authorisation of a biocidal product, existing versions of the biocidal product can be made available for up to 180 days after the decision. The use of the product may continue for up to 365 days after the decision.

The following biocidal products are not allowed on the Norwegian market, or have limited possibilities, according to the transitional measures:

  • Biocidal products where one or more active substances is neither under review nor approved in the relevant product-type. Such biocidal products can only be allowed after all active substances have been applied for and approved on EU level, and a subsequent product authorisation for the Norwegian market has been granted.
  • Biocidal products for which an application for BPR product authorisation in Norway was submitted by the deadline, but which were not on the Norwegian market within this deadline. Such biocidal products cannot be made available on the Norwegian market before a BPR product authorisation has been granted.
  • Biocidal products for which an application for BPR product authorisation in Norway was not submitted by the deadline (the approval start date of the last approved active substance). The making available on the market and the use must be phased out within 180 and 365 days after the application deadline, respectively.
  • Biocidal products with new active substances and biocidal products eligible for the simplified procedure according to BPR Article 25. These products can only be made available on the Norwegian market after a BPR product authorisation has been granted.

Specific national regulations

Some national regulations and authorisation schemes must be followed during the transitional period for a biocidal product. This concerns the following use areas within product-types (PTs) 2, 3 and 5: 

  • PT 2: technical use of chemical disinfectants in public health areas
  • PT 3: disinfection in aquaculture
  • PT 5: chemical disinfectants used for drinking water and associated equipment used in public water supplies

Please contact the Norwegian Medicines Agency for information on the regulations for the mentioned use areas within PTs 2 and 3, and the Norwegian Food Safety Authority for information on disinfection related to public water supplies (PT 5).