Frequently asked questions

  1. How do I determine if my product is a biocide?

  2. Is the Biocidal Products Regulation (BPR – EU 528/2012) implemented in Norway?

  3. How do I know if my biocidal product is allowed on the Norwegian market?

  4. How do I find out whether or not an active substance is notified in the biocidal review programme?

  5. How do I find out whether or not an active substance is approved for use in a certain product type?

  6. What are the requirements for placing on the market biocidal product in Norway whose active substances are not yet approved?

  7. What are the requirements for bringing new products on the market if the active substances are already approved for the relevant use area?

  8. How do I apply for authorisation of a biocidal product in Norway whose active substance is evaluated and accepted for use in the relevant product type?

  9. What is a biocidal product family?

  10. How can I bring biocidal products with new active substances (i.e. not covered by the review programme) on the Norwegian market?

  11. What is R4BP?

  12. What are the national fees concerning biocidal products?

  13. What is the phase-out period for biocidal products for which no product application according to BPR will be submitted?

  14. When is the correct time to apply for product authorisation for products containing more than one active substance and/or products belonging to more than one product type?

  15. What are treated articles and which requirements apply? 

 

1. How do I determine if my product is a biocide?

According to the definition (Article 3) in the Biocidal Products Regulation (BPR – EU 528/2012), biocidal products have the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action. The BPR also applies to substances generated where they are used, in situ generated substances.

The scope of the BPR is very wide, covering 22 product types. All product types are listed in Annex V of the BPR.

The BPR does, in general, not cover products that are regulated by other EU legislation, e.g. agricultural pesticides, cosmetics, medicinal products, medical devices and food additives.

The European Commission has published more detailed guidance on the borderline between the BPD/BPR and other specific legislation through the database CIRCABC

2. Is the Biocidal Products Regulation (BPR – EU 528/2012) implemented in Norway?

Yes, the BPR is implemented in Norwegian law through the Norwegian Biocides Regulation (only available in Norwegian).

3. How do I know if my biocidal product is allowed on the Norwegian market?

The requirements for registration/authorisation of a biocidal product depend on whether the active substance is under evaluation or is approved. Prior to approval of the active substance for use in the relevant product type, national transitional measures apply. Please see National transitional requirements. If the active substance is approved for use in the relevant product type, an application for authorisation of the biocidal product must be submitted. If the product is on the Norwegian market, i.e. registered in the Norwegian product register, and the application is submitted within the deadline (date of formal approval of the active substance), the product can stay on the market during the evaluation of the application. A product authorisation application can also be submitted after the deadline, but then the product cannot be on the market until after the authorisation has been granted.

4. How do I find out whether or not an active substance is notified in the biocidal review programme?

You can ask the manufacturer of the substance in question to provide the current status of the substance, i.e. whether it is notified, and if so, which product types the notification of the substance covers.

You can search for the substance in ECHA’s list of biocidal active substances.

Alternatively, you can look up the substance in Commission Delegated Regulation (EU) 1062/2014. You will however need to ensure that the notification covers the product type in question and that the notification has not been withdrawn. We recommend using ECHA’s list of biocidal active substances (link given above) instead, as this is regularly updated.

5. How do I find out whether or not an active substance is approved for use in a certain product type?

The active substances that have been fully evaluated and approved for further use in a certain product type according to the criteria in the BPR, can be found on ECHA's web site. The legislative act (approval decision document) for each active substance is also available here.

The deadline for applying for product authorisations for biocidal products containing a specific active substance is identical to the date of approval, which is provided in the decision document.

6. What are the requirements for placing on the market biocidal product in Norway whose active substances are not yet approved?

For biocidal products whose active substances are notified in the biocidal review programme, but not yet approved, please see the information given under National transitional requirements.

For biocidal products whose active substances are not notified in the biocidal review programme, please see Q&A no. 10 below.

7. What are the requirements for bringing new products on the market if the active substances are already approved for the relevant use area?

New products, not on the market (i.e. registered in the Norwegian product register) by the date of the formal approval of the active substance, must be applied for and receive a product authorisation before being brought on the market.

For further information regarding the product application requirements, please refer to Q&A no. 9 below.

8. How do I apply for authorisation of a biocidal product in Norway whose active substance is evaluated and accepted for use in the relevant product type?

There are several types of product authorisation, please see ECHA's web pages for more information. The most common way of applying for product authorisation in Norway is through the Mutual Recognition process, with Norway as a Concerned Member State (CMS).

All applications for product authorisation must be submitted via R4BP 3 (see Q&A 11). The product data set/dossier should be included in an IUCLID 5 dossier.

The following documentation must be submitted to the Norwegian Environment Agency:

  • Data or letter of access to data for the biocidal product, according to Annex III of the BPR
  • Data or letter of access to data for each active substance in the product, according to Annex II of the BPR
  • Summary of Product Characteristics (SPC) in English in XML format (has to be translated into Norwegian at a later stage)
  • Safety Data Sheet in Norwegian (for products supplied to professionals)
  • Draft Label (in Norwegian or English), if available 

9. What is a biocidal product family?

A biocidal product family is a group of biocidal products that are used for similar purposes and contain active substances with same specifications. All products within a biocidal product family are covered by one authorisation. Please see ECHA's information on product families for further details.

10. How can I bring biocidal products with new active substances (i.e. not covered by the review programme) on the Norwegian market?

Such products cannot be placed on the market until the active substances have been evaluated and approved, and the products have subsequently received an authorisation. Information on the application for approval of active substances can be found on ECHA's web pages.

11. What is R4BP?

R4BP is an abbreviation for “Register for Biocidal Products”. This is a common EU/EEA data base for biocidal products administered by ECHA. All applications for biocidal products in accordance with the BPR must be submitted through R4BP 3. For further information about R4BP 3, including user manuals, please see ECHA's R4BP 3 information.

12. What are the national fees concerning biocidal products?

Please see Fees.

13. What is the phase-out period for biocidal products for which no product application according to BPR will be submitted?

If no product application is submitted by the deadline specified in the relevant active substance approval decision (i.e. the formal approval date), the biocidal product shall no longer be made available on the market with effect from 180 days after the deadline. All disposal and use of existing stocks has to stop within one year after the deadline. This is in accordance with Article 89 of the BPR.

14. When is the correct time to apply for product authorisation for products containing more than one active substance and/or products belonging to more than one product type?

For existing products within one product type with several active substances, the deadline for applying for authorisation will expire when the last of the active substances is approved.

For cases where the existing biocidal product itself belongs to more than one product type, the deadline for applying for authorisation will expire when the last active substance / product type combination is approved.

15. What are treated articles and which requirements apply?

Treated articles are products treated with or intentionally incorporating biocidal products. The BPR gives requirements to the content of biocidal active substances in treated articles, as well as labelling of treated articles in certain circumstances. Please see ECHA's information on treated articles.

More information on biocidal products can be found on ECHA's web site.

If you still cannot find the answer to your question, please contact us at biocides@miljodir.no.

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