Biocides

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.

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

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

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

The requirements for registration/authorisation of a biocidal product depends on whether the active substance is approved or is still under risk assessment.

Prior to approval of the active substance for use in the relevant product type, national transitional measures apply. Please see National transitional requirements. While one of the active substances is still under evaluation the biocidal product can be made available on the market. If the product is classified as hazardous, the Poison Centre (Eitrunarmiðstöð – Landspítali) needs to be informed of the chemical composition and toxicity of the product (eitur@landspitali.is). 

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 Icelandic market 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 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.

5. How do I find out whether 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 there.

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. Can I continue to make a biocidal product available on the market whose active substances have been evaluated with a non-approval decision?

For biocidal products, whose active substances have been evaluated with a non-approval decision, transitional measures apply.

The biocidal product shall no longer be made available on the market 180 days after the date of the non-approval decision. Disposal and use of existing stocks may continue until 365 days after the date of the non-approval decision.

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 in Iceland by the date of the formal approval of the active substance, must be applied for and receive a product authorisation before being placed on the market.

For further information regarding the product application requirements, please see, How do I apply for authorisation of a biocidal product in Iceland whose active substance is evaluated and accepted for use in the relevant product type?

8. How do I apply for authorisation of a biocidal product in Iceland 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 Iceland is through the Mutual Recognition process, with Iceland as a Concerned Member State (CMS).

All applications for product authorisation must be submitted via R4BP 3 (see What is R4BP?) The product data set/dossier should be included as an IUCLID dossier.

The following documentation must be submitted to the Environmental Agency of Iceland:

• 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 XML format in Icelandic, English or a Nordic language other than Finnish.
• Safety Data Sheet in Icelandic, for products supplied to professionals, if available.
• Draft Label (in Icelandic or English), if available. Please note that if a biocidal product placed on the market is classified according to regulation no. 415/2014 (CLP) the labelling elements required by that regulation have to be in Icelandic.

9. What is a Union authorisation?

Union authorisation allows companies to place their biocidal products on the market throughout the entire Union and EFTA states, without the need to obtain a specific national authorisation. Union authorisation can be granted to both individual biocidal products and biocidal product families.

Please see ECHA‘s information on Union authorisation for further details.

10. What is a biocidal product family?

A biocidal products family is a group of biocidal products that have:

• similar uses;
• the same active substances;
• similar composition with specified variations; and
• similar levels of risk and efficacy.

Under the Biocides Regulation all products within the biocidal product family are covered by one authorisation for the family as a whole, rather than each individual product requiring authorisation. Each product within the biocidal product family will have a suffix to the authorisation number (Article 17 (6)).

New products can be added to the family if they fall within the existing ranges of the biocidal product family authorisation. Article 17(6) of the Biocides Regulation states that a company must notify the relevant Competent Authority 30 days before first placing the new product on to the market. Variations in dyes, perfumes or pigments within existing ranges already established in the family authorisation do not need to be notified.

Please see ECHA's information on product families for further details.

11. How can I place biocidal products with new active substances (i.e. not covered by the review programme) on the Icelandic 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.

12. What is R4BP?

R4BP is an abbreviation for “Register for Biocidal Products”. This is a joint EU/EEA database 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.

13. What are the national fees concerning biocidal products?

Please see Fees.

14. 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 must stop within 365 days after the deadline. This is in accordance with Article 89 of the BPR.

15. 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.

16. What about biocidal products that are imported from countries outside the EEA, do they need authorisation?

Biocidal products that are imported from countries outside of EEA need to have an authorisation in the same way as biocidal products that originate from Europe.

17. What are treated articles and which requirements apply?

Article 3 of regulation (EU) No 528/2012 defines a treated article as “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”.

Some articles that contain biocides will be considered biocidal products and will therefore need to be authorised under the regulation. Others, whilst not being biocidal products themselves, will be subject to restrictions on what can be placed on the market and may need to be labelled in accordance with Article 58 of the biocides regulation. The labelling requirements came into force from 1 September 2013, so any articles entering the supply chain since then should meet those requirements as appropriate. There is also a requirement to provide information to consumers, on request, within 45 days which is also in force since 1 September 2013.

It is not always clear whether a product is concidered a biocidal product or a treated article. If the biocidal product, that the product is treated with, is used to achieve a certain function that is the main purpose of the product, then the product is considered a biocidal product. On the other hand, if the biocidal product, that the product is treated with, is used to achieve a certain function that is not the main purpose of the product, then the product is concidered a treated article, i.e. anti-bacterial socks.

Please see ECHA's information on treated articles.

18. When will the active substance review programme be completed?

The European Commission has published Regulation (EU) No 736/2013, which extends the deadline for completion of the biocide active substance review programme to the end of 2024.

To ensure that the biocides active substance review programme is complete by the end 2024, Annex III of the Review Regulation (Regulation (EU) No. 1062/2014) of the EU Biocides Regulation establishes legally binding deadlines for competent authorities to submit their assessment reports to the European Chemicals Agency (ECHA) and deadlines for ECHA to submit their approval/non-approval opinions to the EU Commission.

19. What is the Article 95 Active Substance Suppliers list?

ECHA is responsible for publishing the so-called Article 95 list of persons having submitted a dossier or a letter of access.

A biocidal product cannot be made available on the market unless either the active substance supplier or the biocidal product supplier is included in the Article 95 list for the product-type to which the product belongs.

The list is available on ECHA’s website.

20. My active substance supplier isn't on the Article 95 list of active substance suppliers, should I be concerned about this?

In accordance with Article 95 of the EU Biocides Regulation it is a requirement that either the active substance supplier, or if necessary the biocidal product supplier, appear on the Article 95 list. They gain entry to the list by submitting to ECHA either an active substance dossier or a letter of access to such a dossier. Those organisations that have already complied with this requirement appear in ECHA's list of active substance suppliers. If your supplier is not on the list, we suggest that you contact him and enquire about his intentions with regard to Article 95. If your active substance supplier does not intend to comply with Article 95 then you may have to consider switching to an alternative source that is included on the Article 95 list or applying for entry to the list yourself as a product supplier. Biocidal products containing active substances from suppliers that fail to be included on the Article 95 list cannot be made available on the EU market as of September 1st 2015.

21. How can I find out if a product is already approved/authorised?

Each biocidal product approved/authorised via the Environmental Agency of Iceland is given a unique reference, which must appear on the product label, e.g. IS-xxxxxxxx-yyyy or USTxxxx-yyy. Biocidal products that have been authorised through Union authorisation will have a reference starting with EU instead of IS or UST. All products that are authorised in Iceland should have a reference starting with IS, UST or EU on the label.

There is a list of products that have been authorised in Iceland under EU BPR that includes details such as product name, product type, active ingredient and authorisation holder/marketing company.

22. I am concerned that a biocidal product is being misused and as a result may be causing harm to either humans, animals or the environment. Who should I contact?

The Environmental Agency of Iceland, local authorities and several other bodies have roles in investigating incidents and carrying out enforcement for the Biocidal Products Regulations (BPR). Depending on where the product has been used, the use of biocidal products is usually enforced by either the Environmental Agency of Iceland or Public Health Authorities.

23. Are biocidal products safe?

Biocides are subject to a risk assessment to decide if they can be used without any undue risk to people, animals or the environment.

The label on an approved/authorised product contains health and safety advice associated with the product. If the advice given on the product label is followed, we would not expect any adverse effects to be experienced following the use of an approved/authorised product.

However, if somebody (human or animal) does become ill or is adversely affected after a biocide has been used the Poison Information Centre should be contacted.

Eitrunarmiðstöð

Landspítali

101 Reykjavík

Iceland

eitur@landspitali.is

Phone number: +354 543 2222

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

If you still cannot find the answer to your question, please contact us at ust@ust.is.