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The Regulation of Hydroalcoholic Products for Skin Use By The Scientis Institute

The Regulation of Hydroalcoholic Products for Skin Use By The Scientis Institute

Whether in the metro, in hospitals, in nurseries and other communities, for professional or strictly personal use, Hydro-alcoholic products endure in the market.
For skin use, however, these are not cosmetic products under EC Regulation 1223/2009.

Clarifications by Corinne Benoliel , from the INSTITUT SCIENTIS.

Hydro-alcoholic products (lotions, gels commonly called GHA), washing gels with antimicrobial activity … all are intended to be applied to the skin, more or less frequently. Skin destination… so cosmetic products? … This is the first logical reflex. But who ignores the existence of EU Regulation 528/2012 concerning the making available on the market and the use of biocidal products. Indeed, among the different products concerned by this text, the type of products 1 designates “biocidal products used for human hygiene with the main aim of disinfecting the skin or scalp”.

THE ACTORS OF THE DEBATE

Microorganisms

Infinitely small and ubiquitous, they accompany us throughout our life…
Both protective and / or pathogenic, sometimes opportunistic of a defective immune system, they breathe, multiply very quickly and invade any type of inert or living support. Naturally present in our environment, they can therefore generate, depending on the case and the context, various infections and diseases.
The control of these invaders with which we coexist is notably linked to basic hygiene measures and the use of effective biocidal products.

Biocides

To fight against undesirable microorganisms, chemical agents with antimicrobial activity cross their membranes, disturb their metabolism and can thus inhibit or destroy them . For disinfectants we then speak of bactericidal, fungicidal, yeasticidal and / or virucidal power relating to their spectrum of activity.
But it is necessary to ensure that these products combine safety and efficacy. They are thus often used in synergy to increase antimicrobial power at doses compatible with their use.

Skin hygiene products

We distinguish:

  • Simple cleaning products (Lotions, non-antimicrobial washing gels): these products are cosmetics and are not affected by the issue of this article.
  • Products with antimicrobial activity (Lotions, gels for hygienic treatment of hands, but also Hydro-alcoholic gels for treatment by friction of hands): these products have the double objective of respecting the skin hydrolipidic film and preventing infections (elimination of transient flora, reduction of resident flora). And they are what interest us today.

THE REGULATORY FRAMEWORK

Cosmetic products which are no longer exclusively linked to aesthetics…
Medicines which are no longer only to be recognized as being health products… The products intended to be applied to the skin in order to disinfect it are therefore biocidal products for skin use.

Even if their composition, their mode of use can be confusing, they should not be called “border” products from a regulatory point of view. Hydro-alcoholic products for skin use are biocidal products and not cosmetic products.
Regardless of knowledge in chemistry, biology, microbiology, galenics, toxicology, skin physiology, etc., placing a cosmetic product or a biocidal product on the market requires that the corresponding regulations be properly mastered.
Even if these products fall under the regulation of biocidal products, it is also essential to take into account the regulation of cosmetic products.

The EC Cosmetic Regulation 1223/2009

In article 2, this Regulation lays down the definition of a cosmetic product: “any substance or mixture intended to be put in contact with the superficial parts of the human body (epidermis, hair and capillary systems, nails, lips and external genital organs) or with teeth and oral mucous membranes with a view, exclusively or mainly, to cleaning, perfuming, ” modify their appearance, protect them, keep them in good condition or correct body odors.

This definition specifies the place of application, namely a superficial part of the human body, as well as the aim pursued which will constitute a cosmetic claim.

No systemic effect of the cosmetic product should result from its application so that it remains very distinct from the drug.

In the case of products intended for human hygiene, the problem is not the cosmetic / drug border, but the cosmetic / biocidal link, the difference of which is fully linked to the importance of the activity antimicrobial.
The products in question are not antiseptic drugs since they do not act on damaged skin. They are intended to prevent infections without having any therapeutic claim.
Why aren’t they cosmetics?

The Cosmetic Regulations state:

  • that it only covers cosmetic products and not drugs, medical devices or biocidal products,
  • that “agents preservatives “are antimicrobial substances which are exclusively or mainly intended to prevent the development of microorganisms in the cosmetic product (a list of the preservatives admitted in cosmetic products appears in Appendix V),

[19459005 ] The EU Biocidal Regulation 528/2012

The regulation of biocidal products was created to meet a main objective, that of increasing the protection of health and the environment by gradual elimination of the substances and products deemed to be the most dangerous.
In its article 2, the Regulation currently in force stipulates: “Biocidal products are understood to mean active substances and preparations containing one or more active substances which are presented in the form in which they are delivered to the user, which are intended to destroy, repel or make harmless harmful organisms, to prevent their action or to combat them in any other way, by chemical or biological action.

An exhaustive list of the twenty-two types of products, including an indicative series of descriptions for each type, is given in Annex V “. The 22 “TPs” are divided into 4 large families, including the “TP1s” which are therefore defined as “disinfectants for human hygiene”.

BIOCIDE REGULATIONS, INSTRUCTIONS FOR USE

Biocidal products are subject to an evaluation relating to their dangerousness vis-à-vis humans, animals and environment for obtaining a marketing authorization (MA).
Particular attention is also paid to the claimed biocidal efficacy (just like the claims of cosmetic products!).

The principles of the Biocides Regulations

  • All the active biocidal substances have been studied or are still under examination. Some have been disapproved and can no longer be incorporated into biocidal product formulas, others have been approved for one or more types of products.
    Thus the ethanol of a hydroalcoholic product is an active substance still under examination. As for isopropanol, it has already been approved for TP1: it can therefore be used as an active substance in hydro-alcoholic gels.
  • Upon approval of the biocidal active substance or substances of a product, the latter must be the subject of a marketing authorization application file, filed with the competent authorities: the National Health Security Agency Food, Environment and Work (ANSES) is the competent authority for the issuance of marketing authorizations in France.
  • during the examination of the active substances, the products containing them are in “transitional period”.
    The evaluation program for active biocidal substances is substantial. Constantly pushed back, the deadline is today fixed at December 31, 2024.
    During this period, the products can therefore be marketed without Marketing Authorization, but respecting national relative requirements: labeling…

[ 19459005] The obligations of the marketer of biocidal products in France

The person responsible for placing a biocidal product on the market must ensure that they comply with the following requirements:

  • the active biocidal substances used must be approved or be part of the examination program as presented in the EU Delegated Regulation 2017/698,
  • the suppliers of the active substances must be entered on the list of article 95 of EU Regulation 528/2012
  • the labeling of the product must comply with article 10 of the decree of May 19, 2004,
  • on product must be declared to the National Research and Safety Institute (INRS) for toxicovigilance purposes (Synapse declaration), the product must also be declared on Simmbad to facilitate the inventory of biocidal products on the French market.

And of course, one should not neglect parallel regulations such as REACH and CLP which add regulatory constraints to the products concerned.
The effectiveness of biocidal products ECHA has published a guide to determine the effectiveness of biocidal products. It defines in particular for TP1 products the tests to be carried out and the associated experimental conditions (target microorganisms; field, site and mode of application) to support the antimicrobial claims of biocidal products.

Requirements according to the Cosmetic Regulations?

Biocidal products for skin use are also affected by certain requirements of the Cosmetic Regulations:

    • biocidal products must not contain substances prohibited in cosmetic products,

[ 19459013] they must also take into account the existing restrictions for certain substances, for example the maximum concentrations of preservatives.

These products, hybrids between regulatory biocide and cosmetic skin use, must combine safety and biocidal efficacy, the main objective having to be the protection of public health. Thus, carrying out a safety assessment such as that to be carried out in the context of cosmetic products remains entirely relevant.

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