Active substances used in biocidal products must be authorised within the EU before they can be put on the market. If you want to market an active substance which has not already been authorised or is under review, you must submit an application for authorisation to the European Chemicals Agency (ECHA).
Active substances used in biocidal products must be authorised within the EU before they can be put on the market. Before an active substance can be authorised, it must be evaluated with respect to effectiveness and impact on human health and the environment. Then, after active substances have been authorised, biocidal products containing the substances must also be authorised.
If you want to market an active substance which has not already been authorised or is under review, you must submit an application for authorisation to the European Chemicals Agency (ECHA).
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 authorised if the biocidal product has been granted temporary national authorisation in accordance with Article 55 (2) of the EU Biocidal Regulation.
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 authorised or is still undergoing evaluation for a certain product type. The database also shows decisions taken for substances which have been denied authorisation.
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:
Before an active substance can be authorised, 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) 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.
A company that is planning to submit an application to ECHA for the authorisation 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 after substance authorisation has been denied
If an active substance has not been authorised 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 authorised 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 authorised. In that case, the use of existing stocks may continue for 365 days after the date the substance was authorised.
Applications for product authorisation are submitted via the ECHA database R4BP.
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.