Biocides

In the Regulation on the review programme (EU) No. 1062/2014, the term "existing active substances" describes those active substances that were already used as active substances in biocidal products and marketed for commercial purposes on 14 May 2000. If a corresponding notification and an active substance dossier have been submitted for these substances, the existing active substance is then evaluated by the member states and the ECHA and, ideally, approved. Theoretically, all existing active substances should be finally evaluated by 2024, although it is already becoming apparent that this deadline will be extended.

Existing active substances in the review programme can benefit from the transitional measures described in Article 89 of the BPR. This means that biocidal products with at least one existing active substance that is still under review can be placed on the market without a biocidal product authorisation under the BPR. However, the national regulations and, where applicable, notification requirements of the respective member state must be complied with.

If all existing active substances in a product are approved or if this product contains approved new active substances, an authorisation procedure specified in the Biocidal Products Ordinance must be followed. For this purpose, a complete product dossier must be submitted that fulfils the data requirements of the BPR. Depending on the product and the planned marketing, different types of authorization can be applied for. For active substances listed in Annex I of the BPR, a simplified authorisation procedure can also be used.

Instead of individual biocidal products, biocidal product families can also be authorized. These consist of a grouping of products that are all used for the same purpose and contain the same active substances. The composition of non-active substances can vary slightly between the different members of the family. For example, antimicrobial paints can be assessed as a biocidal product family if they differ only in their colour shades and therefore have a slightly varying composition due to different colourants.

Authorised suppliers of active substances are included in the list in accordance with Article 95 of the Biocidal Products Regulation. Since 1 September 2015, biocidal products have only been permitted on the EU market under the Biocidal Products Regulation if the respective product or active substance supplier, manufacturer or distributor is included on the list in accordance with Article 95. In order to be included on the list as a legal entity, a letter of access to the respective active substance dossier must generally be submitted. As a result of Brexit and the introduction of the UK BPR, a separate UK Article 95 list now exists for the UK market.

The Biocidal Products Ordinance also regulates the provision and use of goods that have been treated with biocidal products or contain them, for example in the form of preservatives. Special provisions apply to the labelling of treated goods in accordance with Article 58 of the Biocidal Products Regulation.