Biocidal product family
An authorisation as a biocidal product family allows several products to be placed on the market through a single authorisation.
A biocidal product family is a group of biocidal products that have the following common characteristics:
- similar uses,
- same active substances,
- similar composition with specified deviations,
- similar risk potential,
- similar efficacy.
The risk assessment for humans, animals and the environment as well as the efficacy, depending on the type of authorisation, is based on the same requirements as for a single biocidal product. For more detailed information of the corresponding type of authorisation, please consult the internet page of the Notification Authority for Chemicals Union authorisation, Simplified authorisation, Authorization AL, Mutual recognition.
The concept of the biocidal product family represents a further development of the concept of frame formulations.
Prerequisites / Basics
A biocidal product family contains defined concentration ranges of the specified ingredients. These concentration ranges, with the exception of the concentration range for the active substance, can also be defined by the concentration range zero.
Biocidal product families can also consist of a plurality of sub-families. In this case the concentration ranges of the variable ingredients have also to be defined for the sub-families. All biocidal products of a sub-family have to have the same classification and labelling, but they can differ in the type of product, use, methods of use, use categories, preparation and/or packaging.
Procedure
- Applications for authorisation AL or for recognition as biocidal product families are to be submitted exclusively through the register for biocidal products R4BP 3 at the Notification Authority for Chemicals.
- If you intend to submit an application for an authorisation of a biocidal product family with sub-families, it is recommended to consult the guidance document of the European competent authorities (CA meeting) for the union authorisation, the authorisation (AL) and recognition.
- New members (in connection with union authorization, AL or recognition), whose composition lies within the defined deviations of an already authorised biocidal product family, can be notified to the Notification Authority for Chemicals via the European chemical register R4BP at a later date and brought to the market 30 days after the notification (Art. 13d para. 1 OBP).
Application
The application modalities depend on the type of authorisation. Further information on applications for the various types of authorisation can be found on the corresponding internet pages of the Notification Authority for Chemicals. Unionszulassung, vereinfachte Zulassung, Zulassung ZL, Ankerkennung
ECHA provides manuals and guidance documents on R4BP and the biocidal product family on their website.
The following additional documents must be submitted for an application for a biocidal product family together with the other documents specific to the respective authorisation type:
Processing time
The time for processing the application depends on the type of authorisation of the biocidal product family (Art. 19 para. 1 Ordinance on Biocidal Products OBP).
Fees
The fee for biocidal product families is made up of the basic fee for the relevant authorisation (e.g. Authorisation AN, CHF 1000). In the case of biocidal product families with one sub-family, the basic fee is increased by 50%. An increase of a further 25% is made for each additional sub-family. 10 biocidal products may be included in each sub-family. For each additional biocidal product in a sub-family, the fee increases by one per cent. No additional charge is made for biocidal products in a biocidal product family or sub-family that do not differ (i.e. whether in their use, method of use etc.) other than by their concentration of pigments, colorants or fragrances.