The concept of the biocidal product family represents a further development of the concept of frame formulations. Under certain conditions, an authorisation as a biocidal product family is more flexible and enables a plurality of products to be brought to the market by means of 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 authorization AL, recognition).
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.
Important: 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 (PDF, 187 kB, 19.10.2016) document of the European competent authorities (CA meeting) for the union authorisation, the authorisation (AL) and recognition and to contact the Notification Authority for Chemicals beforehand.
Additional members of a biocidal product family can be notified to the Notification Authority for Chemicals at a later date (see below "Notification of biocidal products that are brought to the market at a later date").
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. Further information on applications for the various types of authorisation can be found on the corresponding internet pages of the Notification Authority for Chemicals. Applications for union authorisation are to be submitted exclusively through the register for biocidal products (R4BP) at the European Chemical Agency (ECHA). ECHA provides manuals and guidance documents on R4BP and the biocidal product family on their website.
If the application is intended to be submitted for parallel or sequential recognition of a biocidal product family in Switzerland by another person (for example by the owner of the previous Swiss transitional authorisation) as the request for first authorisation in the EU, then the Swiss applicant should initially clarify all legal, technical and IT requirements with the applicant in the EU.
If the applicant for the recognition of a biocidal product family is not the same as the applicant for the first authorisation, then the former must additionally submit a letter of access for the biocidal product and for each biocidal active substance contained in the product.
The SPC-Editor of ECHA should be used to compile the SPC .
Under certain circumstances, which are regulated in Article 12 para. 2 OBP, the recognition of an authorisation in regard to the conditions or requirements laid down can differ from the EU-authorisation.
Notification of biocidal products brought to the market at a later date
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).
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). For example, this is 30 + 360 days (validation and evaluation, without recognition in parallel) for an application for an authorisation AL as a biocidal product family.
On 1.03.2018, when the revised Biocidal Products Ordinance came into force, a new system came into operation in which fees for biocidal product families are charged according to the actual cost.
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.
The processes and procedures for the authorisation of biocidal products can be modified at short notice. 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.
Last modification 24.04.2018