Cosmetics borderlines update 

By Irene Zaldívar Notario
Strategy & Business Development Manager
Zurko Research SL 

When we are referring to borderline products, we must remember the definition of the cosmetic products according to the current regulation (article 2 of Regulation 1223/2009). Cosmetics are 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 clean, perfume, change the appearance, correct body odors, protect or keep in good condition. With regard to this latter purpose of the cosmetic, it should be noted that it does not cover the prevention or treatment of diseases.

In this way, the cosmetic definition includes the three fundamental criteria which must be considered when we are working with borderline products, that are:

1.- Physical/chemical form. Cosmetics must be substances or mixtures. In this way, articles are not cosmetic products, even if they are applied to the skin and fulfill a cosmetic function. However, substances or preparations intentionally released from an article can be considered cosmetic products (cosmetic wipes..)

2.- Application site. It is the external parts of the human body. In this way, products intended to be placed in contact with nasal or vaginal mucous membranes, even joints, cannot be considered cosmetics.

3.- Primary function. The main function must be a cosmetic function. Additionally, cosmetic products can have certain secondary non-cosmetic functions.

How can we determine the main function?  We should consider some important aspects:

– The manufacturer intention;

– The presentation, labelling, advertising and claims;

– The mode of action and the composition;

– Consumer perception

On the other hand, sometimes the line that separates cosmetics from other close regulations (biocides, medical devices, medicinal products) is very narrow. Then, we can find products that can meet at the same time in more than one regulation. In these cases, a question arises: To what normative frame is the borderline product belongs? Because a cosmetic is not regulated equal that a medical product.

 This issue is addressed by the principle of non-cumulation, which excludes the possibility that both regulatory regimes can be cumulatively applied to the same product. In this way, if a product falls within the definition of medicinal product and cosmetic product, the principle of non-cumulation establishes that the pharmaceutical product directive is the applicable one, since it is the most restrictive.

In any case, the final decision relating to the qualification of the product has to be made by the national competent authorities, on a case-by-case basis, considering all the relevant characteristics of the product (presentation, composition, absorption, concentration, frequency of application and degree of penetration).