Biocidal product family
Content:
Under certain conditions, you can apply for authorisation of a so-called biocidal product family under the EU Biocidal Products Regulation. A biocidal product family consists of several similar products which, among other things, have the same active substances and similar uses. A family authorisation applies to all the products in the family and makes it possible to offer several similar products on the market in an easier and cheaper way.
Family authorisation can be a good option if you have several similar biocidal products with only slight variations in content and usage. Products within a biocidal product family must have the same active substances and a similar use and composition. Variations in composition must not affect the level of risk or effectiveness of the products.
Application for authorisation of a biocidal product family
The application may be submitted in accordance with the EU Biocidal Products Regulation for a national authorisation, union authorisation or in accordance with a simplified procedure for authorisation.
You can also include a product in another company's authorisation of a biocidal product family, provided that you contact the other company and conclude an agreement. In such cases, the product included will have the same authorisation period as the family.
The fee for applying for authorisation of a biocidal product family is lower per product than if you apply for an individual product authorisation for each of the products in the family.
Read more about application fees.
Adding a product to a family
If you want to add a product to a family, a notification must be submitted 30 days before the new product is made available on the market. However, no notification is necessary if the variation in composition applies only to pigments, perfumes and dyes within permitted variations.
Guidance on how biocidal product families are evaluated
In order to ensure that applications for authorisations of biocidal product families are processed in a uniform way across the EU, a guidance document that describes the process in more detail is available. The document deals, among other things, with how the similarity within the family is evaluated and how a so-called pre-submission meeting is conducted. A pre-submission meeting is a meeting between the applying company and the evaluating authority prior to an application of authorisation. The guidance may be relevant for those wishing to apply for authorisation of a biocidal product family.
Read the guidance document here
External link.
Biocidal product families are divided into three levels
In order to administer the authorisation of a biocidal product family, it has been decided at EU level to include three levels of information in the product summary, also known as SPC, Summary of Product Characteristics, which is a conditional annex to a decision on authorisation of a biocidal product family.
- Level 1 describes the composition and permitted variations within the biocidal product family. It also includes administrative information, such as the authorisation holder.
- Level 2 (also called meta-SPC) describes the composition and permitted variations within subgroups of the biocidal product family. At this level, there are also conditions for use and instructions for use for the products included in the subgroup.
- Level 3 describes the composition of individual biocidal products within the family. These products are referred to as family members.