Regulatory Classification of Hand Cleansers and Hand Disinfectants in the EU
In the EU market, hand cleansers and hand disinfectants are regulated either under the EU Cosmetics Regulation or the EU Biocidal Products Regulation (BPR), depending on the product’s claims, ingredients, and intended use.
In principle, one product is subject to only one regulatory framework and is not required to comply with both regulations simultaneously.
The applicable regulation can be determined by first assessing the active substances contained in the product and its primary purpose.
Products whose main or sole function is to cleanse the skin—including waterless hand cleansing for cosmetic purposes—are regulated under the EU Cosmetics Regulation.
By contrast, products whose primary purpose is biocidal activity, such as controlling or eliminating harmful microorganisms, and which contain active substances, fall under the scope of the Biocidal Products Regulation.
If a product contains active substances and makes claims such as “disinfecting,” “antiviral,” or “antibacterial,” it goes beyond the scope of personal hygiene and is no longer considered a cosmetic product. Instead, it is classified as a biocidal product, with antibacterial gels being a typical example.
Claims Applicable to Hand Cleansing Products Regulated as Cosmetics
Claims such as “physically clean,” “visually clean,” and “hand cleaner” are typically considered compliant with the definition of a cosmetic product, as they indicate functions related to cleansing and improving the appearance of the hands or body.
By contrast, claims such as “hygienically clean” or similar wording may result in the product being classified as a biocidal product, as the term “hygiene” is broad and can convey different meanings depending on the context of use.
In a cosmetic context, “hygiene” generally refers to personal hygiene, meaning products intended to cleanse the skin and help maintain it in good condition.
However, in the context of biocidal products, “hygiene” is often associated with disinfection or microbial control, which may bring the product within the scope of the EU Biocidal Products Regulation.
“Antibacterial”
“Unique antibacterial formulation.”
“Kills bacteria”
“Kill bacteria/a wide range of germs”
“Antiviral”
“Kills viruses, Virokill”
“Effective against flu virus H1N1”
“Effective against coronavirus”
Important Notice
Claims alone are not the sole criterion for determining whether a product is regulated as a cosmetic or as a biocidal product.
Before the applicable regulatory framework is finally determined, a case-by-case assessment must be carried out, taking into account all characteristics of the product, including its ingredients, intended use, and mode of action against harmful microorganisms.
from SGS China
