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What is a biocidal product family?
A biocidal product family is a group of biocidal products with similar product characteristics. It comprises three levels: the overarching family (Level 1) consisting of one or more meta Summaries of Product Characteristics (meta-SPCs) (Level 2), which in turn consist of one or more products (Level 3).
Within one meta-SPC, the products must have the same classification and labelling. They may differ slightly in respect of the product type, intended use, method of use, use categories, composition and/or packaging, provided that they meet the equivalence criteria.
All products within a biocidal product family must meet the following equivalence criteria:
- A similar composition (with specific variations). A biocidal product family consists of one or more active substances that share the same characteristics. A common basic structure must be defined for all the products within the family, which at least comprises the active substance(s). If the use of the product justifies this, formulants may also be added to the basic structure.
At Levels 1 and 2, all the constituents of the family may be defined as concentration ranges. At Level 1, these ranges can be defined by a zero limit (except for the active substance). To avoid a zero value at Level 2 for certain formulants, groups of constituents with the same function may be created. However, precise compositions are required at Level 3. - Similar uses. Only biocidal products with similar uses may belong to the same biocidal product family. To evaluate comparability, several criteria have been developed and combined within a decision tree. Specifically, these criteria relate to the main group to which the biocidal products belong, the product type within the same group, the article type to be treated and the method of use.
- A similar level of efficacy and risk. For the evaluation of the risk posed to humans, animals and the environment, as well as the evaluation of efficacy, a ‘worst-case’ composition is usually assumed: the core assessment. The ‘worst-case’ composition may be different for each domain (efficacy, human or animal health, environment) and is defined within a particular concentration range that covers a significant part of the biocidal product family.
Authorisation procedure
A European authorisation for a biocidal product family applies to all the biocidal products in that family. The possible authorisation procedures are identical to the procedures for a single biocidal product. The processing times are also identical.
Adding products
Once a biocidal product family has been authorised, the authorisation holder may add new products to the family via a simple notification. The notification must be made at least 30 days before the product is made available on the market and must be sent via the European Biocidal Products Register (R4BP) to the competent authority that has granted the authorisation for the biocidal product family. In case of a national authorisation, this is the evaluating Member State and, in the case of a Union authorisation, this is the European Chemicals Agency (ECHA) and the European Commission.
If a variation is limited to a change in the product colours, fragrances or pigments, and if the variation remains within the authorised concentration ranges, a product within a particular biocidal product family may be made available on the market without notification.
Fee
The table of fees lists the required fees for each type of authorisation application. It should be noted that, in addition to the application fee for the product family, you must also pay an additional fee for each product in the biocidal product family. These costs may vary depending on the procedure followed. You are also required to pay an annual contribution for each product in a biocidal product family.