Borderline products

1.  Is a hand sanitizer a cosmetic product or a biocidal product?

2.  How to distinguish a cosmetic product for hand hygiene from a medicinal product?

3.  How to identify a cosmetic product for hand hygiene?

4.  How to identify a biocidal product for hand disinfection?

Answers:

1.    Is a hand sanitizer a cosmetic product or a biocidal product?

Answer: Based on the 2020 March 30 European Commission's guidelines on the legislation applicable to non-washable hand cleaners and hand disinfectants (gels, liquids, etc.), these products can be classified as cosmetic products or biocidal products. This depends on whether the active substance is present and what the main purpose of the product is. According to the 2020 September Manual of the working group on cosmetic products (subgroup on borderline products) on the scope of application of the cosmetic products Regulation (EC) No 1223/2009, products with antiseptic or antibacterial effects can be considered as cosmetic products, biocidal products, medicinal products or medical devices. It is therefore necessary to apply consumer product safety legislation in order to ensure that products are used for their intended purpose.

Taking into account the borderline cosmetic products and biocidal products, they should be assessed for the applicability of the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products3 (hereinafter – Regulation (EC) 1223/2009) and Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products4 (hereinafter – Regulation (EC) 528/2012).

2.    How to distinguish a cosmetic product for hand hygiene from a medicinal product?

Answer: With regard to the “borderline” between cosmetic products and medicinal products “by virtue of presentation”, the decision whether the product is presented as treating or preventing diseases is to be taken on a case-by-case basis. A product which presents itself as antiseptic and antibacterial products for the treatment or prevention of infection and lesions of the skin is likely to be considered as medicinal product by virtue of presentation.

3.    How to identify a cosmetic product for hand hygiene?

Answer: Regulation (EC) 1223/2009 applies to products whose main or exclusive purpose is cosmetics (i.e. skin cleansers that are not washable with water).

Although product claims are not the main reason for classifying a product as a cosmetic product or a biocidal product, they are important in assessing the intended use of the product. The wording “Physically clean / visually clean” and “Hand cleaner” on the product are typical claims where the function of the product meets the definition of a cosmetic product - cleansing, smelling, changing appearance, protecting to maintain good condition or eliminating body odors.

However, if the product is presented with a claim stating “Hygienically clean” (or similar wording), the function “hygiene” might indicate in this context that it could be considered as biocidal. The term hygiene has a broad spectrum of meaning which range from simple cleanliness to disinfection, depending on the context in which it is used. While in the context of cosmetics, the term normally refers to “personal hygiene”, i.e. products for cleaning and keeping in good condition the skin, in a context of biocidal products, the term “hygiene” is associated with “disinfection”.

In order to distinguish such products, it is important to take into account all the characteristics of the product, in particular its composition, purpose and function, in order to meet the objective criteria for such a product to be considered a biocidal product or a cosmetic product.

4.    How to identify a biocidal product for hand disinfection?

Answer: Products containing an active substance and supplied with a primary biocidal purpose (i.e. intended to control harmful organisms) are not covered by the cosmetics legislation and therefore fall within the scope of the Regulation (EC) 528/2012. Examples include products containing an active substance and making a claim to improve public health through the control of infectious organisms, such as “disinfecting”, “kill viruses”, “kill bacteria”, which would go beyond the general perception of personal hygiene and can include antibacterial hand gels. These are biocidal products with claims on the packaging that suggests the product is guaranteed to improve public health by controlling infectious micro-organisms, such as:

  • “Antibacterial”;
  • “Unique antibacterial formulation.”;
  • “Kills bacteria”;
  • “Kill bacteria/a wide range of germs and words having the same meaning”;
  • “Antiviral” and words having the same meaning;
  • “Kills viruses, Virokill” and words having the same meaning;
  • “Effective against flu virus H1N1”;
  • “Effective against coronavirus”.

In these examples, the product clearly makes a claim of general human hygiene through skin disinfection, and hence a claim to protect public health through biocidal action. In this case, the biocidal function is likely to be considered as the main function to which the cosmetic function has become secondary. In consequence, if the product contains an active substance and has the required function, the product would be excluded from the scope of the Cosmetics Products Regulation, and would need to comply with the Regulation (EC) 528/2012.

It is therefore important to take into account all the characteristics of the product, in particular its composition, intended use and function. If it is clear that the product is mainly intended to protect public health through biocidal action (e.g. disinfecting, antimicrobial/virus function), which would go beyond the general perception of personal hygiene, and the objective criteria for considering such a product as “biocidal product” are fulfilled, the product cannot be considered as a cosmetic product and will have to comply with the Regulation (EC) 528/2012.

Atnaujinimo data: 2023-11-20