Active substances in biocidal products
Active substances used in biocidal products must be approved within the EU before they can be put on the market. If you want to market an active substance which has not already been approved or is under review, you must submit an application for approval to the European Chemicals Agency (ECHA).
Active substances must be approved
Active substances used in biocidal products must be approved within the EU before they can be put on the market. Before an active substance can be approved, it must be evaluated with respect to effectiveness and impact on human health and the environment. Then, after active substances have been approved, biocidal products containing the substances must also be authorised.
If your company wants to market an active substance which has not already been approved or is under review, you must submit an application for approval to the European Chemicals Agency (ECHA). You should be aware that applying for approval of an active substance at EU level is a long and costly process that requires extensive documentation.
Which substances can be used in biocidal products before they are approved?
Active substances in biocidal products are divided into two categories; new substances and existing substances. Existing active substances are those that were already on the market on 14 May 2000 while new active substances are those introduced after that date.
Existing active substances
Active substances that are classified as existing active substances are evaluated through a special EU Review Programme. They may be used in biocidal products of a specified product type, in accordance with current national rules and practice, for as long as the evaluation is in progress. Current practice in Sweden means that some products need to be authorised in order to be sold and used while others do not.
New active substances
New active substances may only be made available on the EU market before the substance has been approved if the biocidal product has been granted temporary national authorisation in accordance with Article 55 (2) of the EU Biocidal Regulation.
Status of active substances
On the ECHA website for biocides, there is a database of active biocidal substances. In the database, you can see the status of each substance in combination with product type. This means that you can see whether the active substance is approved or is still undergoing evaluation for a certain product type. The database also shows decisions taken for substances which have been denied approval.
Please note that the ECHA database does not state whether a substance is classified as an existing active substance which is undergoing the EU Review Programme or whether it is being evaluated as a new active substance. If you need to know for sure that the substance is classified as an existing substance and that it is undergoing the EU Review Programme, you will also need to search in the following regulation:
Commission Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products (last consolidated 9 May 2017). External link.
Another way to find out the status of an active substance is to look in the Article 95 list. You can find the Article 95 list on the ECHA website External link..
Active substances listed in Annex I of the EU Biocidal Products Regulation are considered as approved. Read more about active substances in Annex I and the possibility of applying for product authorisation according to a simplified procedure.
The process for approval of active substances
Before an active substance can be approved, it must be evaluated with respect to effectiveness and impact on human health and the environment. The evaluating authority writes a report and makes a proposal either to authorise or not to authorise the substance for use in a specific product type. Then the Biocidal Product Committee (BCP) External link. will provide an opinion about whether or not the active substance can be authorised. If the substance is to be authorised, the Commission will adopt an implementation regulation which specifies the date of authorisation, when the authorisation will expire, and specific conditions for the biocidal products or treated articles containing the active substance.
Swedish evaluation of an active substance
A company that is planning to submit an application to ECHA for the approval of an active substance must state which EU member state it would prefer to do the evaluation. If a company is considering choosing Sweden as the evaluating member state, the company must contact the Swedish Chemicals Agency without delay in order to facilitate the planning of resources. When an agreement on the evaluation has been reached with the Swedish Chemicals Agency, an application must be submitted to ECHA, together with a confirmation from the Swedish Chemicals Agency that we are going to conduct the evaluation.
Phasing-out periods for biocidal products
Phasing-out after substance authorisation has been denied
If an active substance has not been approved after evaluation, a biocidal product containing the substance can continue to be made available, under national rules, for maximum twelve months after the date of the decision.
Phasing-out if no application for product authorisation is submitted
If an active substance is approved after substance evaluation, an application for product authorisation must be submitted latest the same day that the active substance in the product is authorised. If an application has not been submitted, the product may only be marketed and sold for 180 days after the date the substance was approved. In that case, the use of existing stocks may continue for 365 days after the date the substance was approved.
Applications for product authorisation are submitted via the ECHA database R4BP External link..
Article 95 list of suppliers of biocidal active substances
Companies supplying substances or products which consist of, contain or generate biocidal active substances must be included in the Article 95 list. This has applied to the EU market as of 1 September 2015.