Product family
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 also has specified variations in the composition of the products to ensure that the level of risk is not increased or the efficacy of the product is not reduced. This concept is a development from the concept of frame formulations under the Biocidal Products Directive 98/8/EC.
All products within a biocidal product family are covered by one authorisation under the Biocidal Products Regulation.
In other words, several biocidal products can be grouped under a single authorisation, provided that the difference in the composition among the "members" of the family remains within a specified range. The composition can be either a reduction in the active substance concentration or a variation of the concentration of non-active substances.
The replacement of non-active substances in products which are members of a product family, with other non-active substances presenting the same or lower risk, is also permitted.
However, classification, hazard and precautionary statements for all products within the biocidal product family have to be the same or less "severe" than in the product first authorised.
Notification
The composition of products belonging to an authorised product family can differ within the range defined during the assessment. The assessment and evaluation of representative members of the family establish the ranges of acceptability of a biocidal product family authorisation.
If the composition of a new product falls within these established ranges an authorisation holder only needs to notify the product to the authorities 30 days before placing the new product on the market. Notifications for placing the product on a national market must be sent to the relevant competent authority who has granted a national authorisation for a biocidal product family. In the case of a Union authorisation the notification must be sent to ECHA and the Commission. All notifications must be sent through R4BP 3.
However, products can be placed on the market without notification if the variations concern only dyes, perfumes or pigments and are within existing permitted ranges.