Recently, the use of hand-cleaning preparations and various disinfectants in the form of alcoholic solutions, gels, wipes, and sprays has increased significantly.
These products may be subject to Regulation (EC) No 1223/2009 on cosmetic products OR Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products (hereinafter referred to as the BPR Regulation).
In other words, you have to choose one or the other legislation that applies to your products. Now let's look at both options.
When is a product cosmetic?
Products supplied solely for cosmetic purposes are cosmetic products and are governed by the Regulation on cosmetic products.
‘Cosmetic product’ means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with teeth and mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors;
Therefore, if the label indicates that the product is intended for cleaning hands, it falls within the scope of cosmetic legislation.
However, if the product is accompanied by the statement "hygienic cleaning" or similar text (e.g. sanitizing ...), the word "hygienic" in this context indicates the biocidal meaning of cleaning.
The term "hygiene" has a wide range of meanings, ranging from simple cleanliness to disinfection, depending on the context in which it is used. In the sense of biocidal products, the term "hygiene" is associated with "disinfection".
If it is clear that the product is mainly intended to protect public health through biocidal action (e.g. disinfection) that goes beyond the general perception of personal hygiene, the product is considered a biocidal product.
Let's take a closer look...
When is a product biocidal?
Products containing an active substance and having a biocidal purpose (management of harmful organisms) fall within the scope of biocidal products and are governed by the BPR Regulation.
‘Biocidal product’ means 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.
The following statements indicate that it is a biocidal product:
- Antibacterial effect
- It kills bacteria
- Antiviral effect
- Effective against coronavirus
In these cases, the biocidal purpose is considered to be the main function and the product is a biocidal product.
So now you know when a product is cosmetic and when biocidal. However, if you are still in doubt, feel free to contact me.