An authorisation may be granted for a biocidal product family
A company can make a new biocidal product available on the market more easily if it fits into an already authorised biocidal product family. A biocidal products family is a group of biocidal products that are used for similar purposes and contain active substances with same specifications.
A biocidal product family is defined as "a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products."
A biocidal product family is based on the concept of frame-formulations which was introduced under the Biocidal Products Directive. This may allow for:
• Reduction in the percentage of one or more active substances.
• Variation in percentage of one or more non-active substances.
• Replacement of one or more non-active substances by other specified substances presenting the same or lower risk.
The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same.
Under the BPR, all products within the biocidal product family are covered by one authorisation as a whole. Therefore, authorisation for each individual product is not necessary. A suffix to the authorisation number of the biocidal product family will be applied to each product within the family.
New products meeting the given criteria for members of an authorised biocidal product family may be made available on the market in the Member State that authorised the family. However, the competent authority (e.g. the Danish EPA in Denmark) must be notified at least 30 days in advance.
Prior notification is not required if the products only differ from the other products in the family in terms of pigments, perfumes and dyes within the permitted variations for that family.
Biocidal product families may be authorised by national authorisation, authorisation through mutual recognition, authorisation under the simplified procedure or EU authorisation, exactly as for single biocidal products.
If the biocidal product family has been authorised for the entire EU, ECHA must be notified when new products within the family are made available on the market.
A fee will be charged by the Member States processing national applications, decisions pursuant to the simplified procedure and mutual recognitions of biocidal product families. ECHA will also charge a fee from companies applying for EU authorisation of a biocidal product family.
Read more about the danish fees here.
and in Article 80 of the BPR
Click here to see the ECHA fees