Scope Biocidal Products Regulation

Assessment framework Biocides | 29-08-2019

The Biocidal Products Regulation (EU) 528/2012 (BPR) art.3 defines a ‘biocidal product’as being:

1. “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”
2. “any substance or mixture, generated from substances or mixtures which do not themselves fall under the first indent, to be used with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action”

Despite this definition, in practice it is not always instantly clear if a product falls within the scope of the BPR.

Traditionally borderline cases arise on the interface with plant protection products, medicines, cleaning agents,  food additives. Medicines, medical devices, cosmetics and plant protection products are covered by alternative, specific directives and regulations. Since these products are regulated by other EU legislation, these product categories are excluded from the BPR. On the interfaces between e.g. the Commodities Act, the Medicines Act, the Medical Devices Act, and the Biocidal Products Regulation, there are products that cannot be easily assigned to one specific group.

Please note the regulation shall not apply to food or feed used as repellents or attractants. A note for guidance has been written for explanation about the provisions of Article 2(5)(a).

For products that contain pheromones or attractants (non feed/food): Ctgb has clarified when an authorisation is required for such products. This policy is compatible with the European guidances and other European agreements on these products. More information about this can be found here.

Scope documentation

CG-45 e-c In situ - washing machines FINAL

The Coordination group has agreed on an approach to classify mixtures in products (case type 1) for the in situ generation of active substances.

Assessment framework Biocides; 08-05-2019.

Ctgb policy for products containing pheromones and attractants

The Ctgb has enacted a policy for biocidal products and plant protection products that contain pheromones or attractants, and has ...

Assessment framework Biocides; 08-05-2019

Producten op de grensvlakken Warenwet – Wet op de medische hulpmiddelen – Biocidenverordening

Producten op de grensvlakken Warenwet – Wet op de medische hulpmiddelen – Biocidenverordening. M. Woutersen et al, RIVM Rapport ...

Assessment framework Biocides; 21-09-2017

Disinfection of greenhouses and releated (in Dutch)

From June 2016 on, the Board is on the position that disinfection products used in empty greenhouses or related areas are ...

Assessment framework Biocides; 21-09-2017