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Evaluation of active substances in biocidal products

Active substances used in biocidal products must be approved before they can be released on the market. If you are going to manufacture or market an active substance, you must submit an application for approval to the European Chemicals Agency (ECHA).

New or existing active substances

Active substances in biocidal products are divided into the categories new substances or existing active substances. Existing active substances are those that were already on the market on 14 May 2000 and new substances are those which have appeared since then.

The EU Review Programme on biocides

Active substances in biocidal products are evaluated under an EU Review Programme in cases where one or more interested parties support the evaluation by financing it. The substances covered by the Review Programme can be found in Annex II to the Regulation (EU) No 1062/2014 concerning the Review Programme. According to current practice and national rules, these substances may continue to be released on the market for the duration of the evaluation.

Find out more about why biocidal products must have authorisation.

Article 95 listed companies as the suppliers of biocidal active substances

As of 1 September 2015, only those biocidal products which consist of, contain or generate active substances and come from suppliers included in the so-called Article 95 List may be made available on the EU market. The supplier can be either a substance supplier or a product supplier.

See the list of suppliers approved by ECHA.

The Article 95 List on the ECHA website - List of active substances and suppliers.

Find out more about the need for sellers of biocidal products to have access to facts on active substances (in Swedish).

Active substances which are not part of the Review Programme

Active substances which are still not included in the EU Review Programme may in certain cases continue to be made available on the EU market. This is only possible if the following conditions are met:

  • That these are active substances included in a treated article that has been imported into the EU. In this case an application for approval of the active substance(s) for the relevant product types must be submitted to ECHA no later than 1 September 2016. Otherwise the articles treated with these substances may not be released on the EU market after 1 March 2017.
  • That these are active substances included in biocidal products that are covered by the Biocidal Products Regulation but not by the Biocidal Products Directive (Directive 98/8/EU), such as certain active substances created in situ. Biocidal products containing such active substances may be placed on the market in accordance with current practice in the member states. In this case too, an application must be submitted to ECHA no later than 1 September 2016. Otherwise those biocidal products containing such substances may not be released on the EU market after 1 September 2017.
  • Active substances that are not existing active substances and that are being evaluated for possible approval - so-called new active substances - may be used in biocidal products before they are approved, but only if the biocidal product has been granted temporary national authorisation in accordance with Article 55(2) of the Biocidal Products Regulation.

Approval and non-approval of active substances

If an active substance is to be approved, it must have been evaluated with regard to its effectiveness and impact on health and the environment. The evaluating authority writes a report and proposes a decision to approve or not approve the substance for use in a particular product type. If the substance is to be approved, the Commission adopts an Implementing Regulation stating the date of approval and expiry date of approval, and also the conditions specific to biocidal products or treated articles containing the active substance.

The ECHA website on biocides provides a database of all active substances.
Go to the database of active substances.

The ECHA website provides further information on the approval process for substances.

Swedish evaluation of an active substance

A company that plans to submit an application to ECHA for approval of an active substance must suggest the EU member country in which it would like the evaluation to take place. If the company decides to choose Sweden as the evaluating country, it must contact the Swedish Chemicals Agency as soon as possible to facilitate the planning of resources. Once agreement has been reached with the Swedish Chemicals Agency on the evaluation, an application must be submitted to ECHA, together with confirmation from us that the Swedish Chemicals Agency will carry out the evaluation.

See the fee overview for a Swedish evaluation of an active substance.