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Placing a product on the European market primarily depends on its legal classification. This classification directly determines the regulatory framework that applies to it and carries significant implications, particularly regarding consumer safety.
In cosmetics, this step can prove challenging when certain products fall at the boundary with other categories, such as medicinal products, biocides, medical devices, or even toys.
Regulation (EC) No. 1223/2009 defines a cosmetic product as:
“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 the teeth and the 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 odours.”
Therefore, the product’s presentation, function, area of application, and claims may lead to a change in its regulatory status.
Examples of “borderline” products:
- Skin patches
- Children’s party make-up
- Breath-freshening sprays or chewing gums
- “Bumps and bruises” balms
- Anti-lice shampoos
How can you ensure compliance with cosmetic status?
The definition of a cosmetic product highlights three cumulative criteria used to verify its regulatory status:
- Product type: substance or mixture
- Area of application
- Function
To support manufacturers, the European Commission relies in particular on the “Manual of the Working Group on Cosmetic Products (Sub-Group on Borderline Products) on the Scope of Application of the Cosmetic Regulation (EC) No. 1223/2009.”
Updated in June 2025, this manual reiterates these three qualification criteria and provides numerous examples in a Q&A format.
1. Product type: substance or mixture
Dental floss is an interesting example: it meets the criteria for area of application (teeth and oral mucosa) and function (cleaning/protecting/maintaining in good condition). However, it is not presented as a substance or mixture and therefore does not meet the definition of a cosmetic product.
Similarly, skin patches are not considered cosmetic products as such due to their form. However, they generally contain a substance that may meet the “product type” criterion for cosmetics, provided the function is not physiological.
2. Area of application: external parts of the human body
A product claiming a cosmetic function, such as a breath-freshening spray or chewing gum, is not considered a cosmetic because the released substance is intended to be ingested (oral route). It is not predominantly spat out like toothpaste, where ingestion is accidental. These products are generally considered foodstuffs under Regulation (EC) No. 178/2002.
Likewise, a product intended for cleansing the vagina does not meet the definition of a cosmetic product, as the site of application does not correspond to the external genital organs.
3. Intended function
Children’s party make-up, due to its presentation, may fall within the scope of Directive 2009/48/EC on toy safety. Its function of applying make-up to the skin also brings it under cosmetic regulations, regardless of the user’s age. The same applies to fun bath products intended for children, such as bath bombs.
A product intended for application to the skin in cases of minor “bumps and bruises” will not be considered a cosmetic if it is intended to reduce bruising and swelling and is likely to exert a physiological effect. It may fall at the boundary with medicinal products or medical devices.
Anti-lice shampoos are not cosmetic products because their exclusive or primary function is not to clean, unlike conventional shampoos.
Depending on their composition, mode of action, and claims, these products may fall under medicinal products, medical devices (with a physical mode of action), or biocides (repellent/insecticidal).
Be careful with claims
The claims attributed to your product may also change its status. Reference should be made to Regulation (EU) No. 655/2013—establishing common criteria—as well as the ARPP recommendation on cosmetic products. Particular care should be taken not to assign therapeutic claims, implying action beyond the superficial layers of the human body, or claims that could create confusion with food products.
What about international status ?
In Europe, the classification of borderline products relies on a detailed, case-by-case analysis ensuring a high level of regulatory standards.
Internationally, approaches differ, with categories such as OTC (Over-The-Counter drugs) in the United States (notably for sunscreens), Natural Health Products (NHP) in Canada, or special cosmetics in China. In this context, the same product may fall under different regulatory frameworks depending on the market, making classification a key strategic issue for global commercialization.
CLEAR can support you in securing the classification of your cosmetic products in Europe and internationally, feel free to contact us!
Sources :
Borderline products – Internal Market, Industry, Entrepreneurship and SMEs
MANUAL ON THE SCOPE OF APPLICATION OF THE COSMETICS DIRECTIVE 76/768/EEC (ART
