In order that active substances may be used as or for biocidal products, they have to be "approved" or at least be notified for approval.
Approval of an active substance
In most cases the approval of the active substances is based on an assessment by the EU authorities.
Switzerland adopts the assessment procedures for biocidal active substances from the EU. However, Switzerland is actively integrated into the assessment process. Consequently, it is possible for Swiss applicants and European applicants to have a substance assessed by the Swiss authorities or by an authority in the EU with a view to inclusion in Annex 1 or 2 of the Ordinance on Biocidal Products (OBP; SR 813.12).
The procedure for assessing dossiers on existing biocidal active substances is regulated by the Delegated Regulation (EU) no 1062/2014 (see list of links). The data requirements for an application for approval of an active substance are described in Article 6 of Regulation (EU) no 528/2012 (BPR). Applications for existing and new biocidal active substances shall be submitted through the European Register for Biocidal Products R4BP. The European Chemical Agency ECHA provides guidelines for the submission of these types of dossier (see list of links).
Biocidal active substances are defined as substances and microorganisms including viruses with an intended effect for use as a biocidal product.
Active substance use
Active substances may be placed on the market, if:
- they are placed on the market exclusively for use in or as a biocidal product. In other words: they are mixed into a formulation in order that the resulting product becomes a biocidal product, or the active substance is itself a biocidal product (e.g. a gas); and
- the active substances are either notified (see below) or included in the lists in Annex 1 (XLS, 133 kB, 07.10.2021) or Annex 2 (XLSX, 152 kB, 01.10.2023) of the OBP (Lists of active substances for the simplified procedure and Union lists of authorised active substances).
The list of notified active substances was established within the framework of an EU-Review Programme for biocidal active substances. The active substance list was originally part of Annex II of Regulation (EC) no 1451/2007. At the end of October 2014 it was replaced by Regulation (EU) no 1062/2014. In Annex II part 1 of the new Regulation active substances are listed that are still under examination in the scope of the programme (under certain conditions, with an appropriate declaration, an interest for notification and therefore for later approval can be indicated[1] for unlisted active substances). The approval or non-approval of all active substances is expected by 2024. Each active substance will be scientifically assessed for the product categories in which it was notified in regard to its risk for human health and the environment and its efficacy. After the assessment a decision is taken on whether the active substance is approved for a product-type or not. In the latter case the active substance for the product-type will be struck off the list of notified active substances. If the inclusion of the active substance is published in the list of Annex 1 or 2 OBP (List of active substances for the simplified authorisation procedure and Union List of approved active substances), the Notification Authority communicates this to the owner of an AN or AC authorisation of a biocidal product with this active substance.
The following consequences arise:
- In order to use an approved active substance as or in a biocidal product, an application must be submitted for an AL authorisation or for a simplified authorisation. In addition, an application can also be submitted for acceptance of a product authorised in the EU/EFTA or a Union authorisation.
- For active substances which have been struck off the list of notified active substances for the product-type in question, then the existing transitional authorisation AN or AC with this active substance will be revoked by the Notification Authority.
- An application AN can be submitted for notified active substances, whose authorisation has not yet been decided. This type of authorisation is not a subject of the MRA and represents a purely Swiss provision for the transitional period.
N.B. The list of notified active substances is published in the European Review Regulation no 1062/2014. Both the list of the notified active substances as well as the deleted and included or authorised active substances need to be examined. The Notification Authority has published an unofficial, consolidated list to facilitate this (green: included in the lists in Annex 1 or 2 OBP; red: no longer notified).
Remark
The processes and procedures for the authorisation of biocidal products can be modified at short notice as a result of technical and administrative guidelines of the EU Commission and/or the ECHA. Consequently, we advise interested parties to regularly consult the website of the Notification Authority Chemicals and to subscribe to the Consumer Protection newsletter from the FOPH.
[1] New active substances; see OBP Art. 2 para. 2 letter g
Last modification 27.04.2021
