Are products for human hygiene biocidal products, medical devices, pharmaceuticals or cosmetics?
In July 2009, the Netherlands Food and Consumer Product Safety Authority (NVWA) published a manual (in Dutch) for the classification of products for human hygiene which specifies the distinction between biocidal products, cosmetics, medical devices and medicinal products.
Furthermore, a joint memorandum of the CBG and Ctgb was published in May 2013 on disinfectant products which explains the distinction between biocidal products and veterinary pharmaceuticals/medicinal products. This memorandum is summarised below:
Use on inert surfaces
Disinfectant products for use on inert surfaces fall within the scope of biocidal product legislation .
Use on the skin of humans or animals
Various situations can exist which are explained below.
Disinfectant use on skin which is intact and will remain intact
This concerns skin disinfection in a general sense, including ‘hygienic hand disinfection’. The skin is intact and remains intact. The claim concerns disinfection only. No claim is made with respect to curing or preventing disease or treating a wound. These products fall under biocidal product legislation.
Disinfectant use on skin that is intact and will remain intact for surgeons and surgical staff, preceding a medical intervention (on a patient)
These products actually fall under the scope of the above-mentioned category ‘Disinfectant use on skin that is intact and will remain intact’. This is because it does not concern skin that will be opened during a medical intervention, but the skin (hands and forearms) of the surgeon/surgical personnel. The claim concerns disinfection only. No claim is made with respect to curing or preventing disease or treating a wound. These products therefore fall under biocidal products legislation.
Use on non-intact skin (a wound)
Given the definition of a medicinal product, products that are used on a wound (i.e. non-intact skin) fall under the scope of the Dutch Medicines Act.
Application to skin which is intact, but which will subsequently be opened (thus creating a wound)
Because it is likely that the product will come into contact with a wound after the skin is opened, products for disinfecting the skin with the intention of opening the skin immediately afterwards are subject to the Medicines Act. It is irrelevant whether the skin is opened for a medical purpose, such as surgery or injection, or for another purpose such as tattooing, piercing or applying permanent makeup.