Borderline products

Cosmetics

1. How to demarcate cosmetic produt from biocidal product?
2. What biocidal functions are considered inherent to the cosmetic function?
3. When biocidal function is considered to be a primary (not a secondary claim of a cosmetic product)?
4. May cosmetic products legislation and biocidal products legislation be applied to the same product?

5. Which biocidal product types can be misleading supported as a cosmetic product?
6. What claims/declarations indicate that this is biocidal product and not a cosmetic product?

Medicines 

7. How should skin antiseptics be legalized?


Medical devices

8. Is it allowed to use the same disinfectant for disinfection of medical devices and other objects in personal healthcare institutions?



Treated articles

1. How to demarcate cosmetic produt from biocidal product?

A. Where a product has a biocidal function that is inherent to its cosmetic function, or where that biocidal function is considered to be a secondary claim of a cosmetic product, product is regulated by cosmetics legislation only.
The assessment of whether a product is a cosmetic or biocidal product has to be made on the basis of a case-by-case assessment, taking in to account all the characteristics of the product (e.g. overall presentation, composition, claims). The delimitation between cosmetic and biocidal products legislation follows in particular from the detailed definition of cosmetic biocidal products, wich refers both to their areas of application and to the purposes of their use.

The purpose of the cosmetic product must be exclusively or mainly to clean, perfume, change the appearance, protect, keep in good condition or correct body odours. The fact that a cosmetic product may have a main cosmetic funktion allows for secondary functions, wich may not be cosmetic. As a result, a product can be covered by the cosmetics legislation even if secondary, non-cosmetic claims (e.g. antibacterial) are made, provided that it is clear, from the presentation of the product, that such claims are secondary and the main function is cosmetic (e.g. to parfume, keep in god condition or correct body odour).
If it is reasonable expectations of the average consumer that the product is mainly intended to protect public health through biocidal action, the product should be considered as a biocidal product and will have to comply exclusively with the biocidal product legislation.

2. What biocidal functions are considered inherent to the cosmetic function?

A. Decisions are made using principles in the examples below:
- Deodorants - the presence of a biocide might foster the targeted end result: the cosmetic function is one of controlling body odours caused by bacterial growth and the bacterial breakdown of perspiration. This is commonly achieved through a combination of several mechanisms; including antibacterial activity.

- Anti-dandruff shampoos - dandruff is commonly caused by a combination of several causes, including metabolic by-products of skin micro-organisms. These ingredients often also have a mild antimicrobial, antifungal effect helping to control the activity of the skin organisms that contribute to dandruff formation.

- Toothpastes and mouthwashes. The control the oral microflora is inherent to the cosmetic function of oral care products, and is achieved not only by removing bacteria, but also through the antibacterial properties of surfactants, flavour ingredients (e.g. menthol) or preservatives.

3. When biocidal function is considered to be a primary (not a secondary claim of a cosmetic product)?

A. Where a product is supplied with a claim to protect public health through a control of infectious organisms, which would go beyond the personal hygiene as a contribution to public health, considering the reasonable expectations of the average consumer, that function is of primary importance.

4. May cosmetic products legislation and biocidal products legislation be applied to the same product?

A. No, with the exceptions in very few cases. An example of dual regulation is a sun block with insect repellent (both cosmetic and biocidal funtions are primary). Such a cases should be avoided, especially bearing in mind Judgment of the Court of 21 March 1991 in Case C-60/89, ECR 1991, Page I 01547 (where the Court clarified that where a given product is supplied with the intention of providing certain health benefits, and falls within the definition of two product categories (in that case cosmetics and medicinal products) of which one is subject to more rigorous rules because of its implications for public health (in that case the medicinal products legislation), the product in question may have to be made subject to the rules of the latter category).

5. Which biocidal product types can be misleading supported as a cosmetic product?

Because of the contact whit human skin misleading supported as a cosmetic product can be biocidal product type 1 (human hygiene). Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp. Also misleading supported as a cosmetic product can be biocidal product type 19 (repelents), which are used to control harmful organisms invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.

6. What claims/declarations indicate that this is biocidal product and not a cosmetic product?

A. As already mentioned in answer 2, there is a claim to protect public health through a control of infectious organisms, which would go beyond the personal hygiene as a contribution to public health. No matter where claim/declaration of th intended use or purpose of product is made – on the label, in advertising material or product information, following wordings indicate that product is biocidal:
- Kills up to 99.9% of bacteria
- Unique antibacterial formulation
- Antiviral (and words having the same meaning)
- Antifungal (and words having the same meaning)
- Kills a wide range of germs
- Disinfection of hands (other body parts)


7. How should skin antiseptics be legalized?

Skin antiseptics only for intact skin before medical interventions (for example skin preparation before surgery, punctures, injections, blood sampling for diagnostic purposes) and/or hand antispetic (hygienic and surgical) are attributed to biocidal products (product-type 1) and should be authorised as biocidal products in Lithuania. In case skin antiseptics are intended for medical treatment (for example for treatment of burns, wounds, skin diseases) and infection prevention (for example antiseptics for intact skin) they are attributed to medicines and should be registered as medicines.


8. Is it allowed to use the same disinfectant for disinfection of medical devices and other objects in personal healthcare institutions?

There is no ban to use the same disinfectant for disinfection of medical devices and other objects in personal healthcare institutions. Personal healthcare institutions willing to use the same disinfectant for medical devices and other objects must be sure that this disinfectant is legalized according to legal acts on medical devices and biocidal products; to disinfect medical devices only according to usage requirements for this particular purpose and to disinfect other objects (that are not medical devices) only according to requirements established in biocidal product authorization certificate.