It can be tricky to categorize a product: is it a cosmetic, a drug, a food, medical devices, etc.? EcoMundo provides some guidance to explain the main differences so you can better assess the regulatory status of a given borderline product.

Produits cosmétiques frontières : comment les classifier ?

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Cosmetic product: the EU definition

A cosmetic product in Europe is regulated by the European regulation 1223/2009. The regulation 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 odors”.

According to the definition, if you have any doubt about the nature of your product you have to remember that your product must:

  • be a substance or mixture: therefore artificial nails or false eyelashes are not considered as cosmetics.
  • be in contact with certain defined parts of the human body (see the definition above): As article 2.2 (1223/2009) specifies “ a substance or mixture intended to be ingested, inhaled, injected or implanted into human body shall not be considered to be a cosmetic product”
  • have “certain defined exclusive or main functions”: Cleaning, perfuming, changing the appearance, protecting or correcting odors. To determine the primary function, one shall consider the following parameters:
    • Manufacturer intention
    • Presentation, Labeling, Advertising, Claims
    • Mode of action, Composition
    • Consumer perception

Note: You have to be careful when you are making claims; as a claim can directly affect the main function of your product and therefore define the category of the product: cosmetic, drug, biocide, etc.

E.g.: A mouthwash can be a cosmetic or a drug, depending on its main function based on the associated claims.

Take a look at our last article on how to make cosmetic claims in Europe

What other regulations gravitate around the cosmetics regulation?

The cosmetics regulation 1223/2009 is obviously key to cosmetic compliance, however you must also consider other regulatory frameworks that may apply.. Here’s a non-exhaustive list of related regulatory frameworks:

What is a borderline product?

Products can sometimes evolve between two or more regulatory definitions; the European commission defines these products as ‘borderline’. The scope of borderline products is wide and the European commission has published a guideline that helps define the category of the product.

In this guideline that you can access here, you will find 3 categories:

1- Type of product: Substance or Mixture

Wigs and tooth floss: are neither substances nor mixtures even if they are usually considered as cosmetics in the common sense. In light of the regulations, they would be considered as ‘articles’ under the REACH regulation Please check our REACH page to understand the regulatory obligations associated to articles or contact us directly for more information.

Wipes or clothes releasing cosmetic substances: If textile such as clothes or wipes are not cosmetics on their own, they become cosmetics when impregnated by a substance or mixture. They are considered as the “vehicle” to deliver the substance or the mixture. If they meet the criteria for a cosmetic function (cleaning, perfuming, changing the appearance, protecting, correcting body odors), such products must comply with the cosmetics regulation, but also with the directives that may also apply e.g. 2008/121/EC on textiles names.

Tongue brushes releasing a mixture: by their nature, tongue brushes are not cosmetic products. If the product released is a substance or mixture and is intended to be placed in contact 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 and/or correcting body odors and/or protecting them or keeping them in good condition, the product will fall under the Cosmetics Regulation.

2- The application site

Article 2 of Regulation 1223/2009 established the scope of application site: “cosmetic product means 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 (…)”

Ingestion (tablets or chewing gum): The food and safety regulation includes chewing-gum as a food according to article 2 of the Food Regulation 178/02. Also, the guidance specifies: “a product which is intended to be ingested or which contains substances intended to be ingested is under no circumstances a cosmetic product.”

Nasals sprays: No, “nasals sprays are not cosmetic products due to their place of application”

Vagina: A cosmetic should be used on the external parts of the human body including the external genital organs. The definition of a vagina doesn’t meet the criteria thus a cosmetic product could not be used for the vagina.

3- The intended cosmetic purpose

Borderline with toys

Products, which according to their presentations, are destined to be used as make-up on dolls: are not considered as cosmetics but have to be compliant with directive 2009/48 EC; “Toys, including the chemicals they contain, shall not jeopardize the safety or health of users or third parties when they are used as intended or in a foreseeable way, bearing in mind the behavior of children”.

Products, which according to their presentations, are destined to be used as make-up on children: If the intended purpose is to be a cosmetic, the cosmetics regulation will apply regardless of the consumer’s age.

Bath products for children with a Play Value: they can be cosmetic depending on the intended purpose. If the main purpose is to play, the toys directive must apply, conversely if the intended purpose is to be placed in contact with external parts of the human body or with a function of cleaning, perfuming, changing the appearance, protecting, correcting odors; then the cosmetics regulation will be the one to follow.

Borderline with Biocides

The Biocides regulation and cosmetics regulation are noncumulative. The distinction between a cosmetic and a biocide product will be set by the primary function of the product which is determined by the claims.

E.g. a sunscreen that has a repulsive action will be considered as biocidal product.

"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 and is therefore regulated under [the CPR], that function and the product should remain outside the scope of this [BPR] Regulation."

Borderline with Pharmaceutical Products

According to the guidance: “A product expressly indicated or recommended as having therapeutic or prophylactic properties has to be regarded as a medicinal product ‘by virtue of its presentation even if it has no known therapeutic effect”, and that the averagely well-informed consumer is to be considered as the addressee of the presentation”.

Borderline with medical devices

An intimate lubricant is a medical device as the application zone is internal. You always have to remember the definition of a cosmetic to assess the category of the product: “Intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) etc.” with the function of cleaning, perfuming, changing the appearance, protecting, and correcting body odors." Medical devices are considered to be intended for medical purpose, the claim that you’ll use will help to define the category of your product.

NB: In any case, a decision on the qualification of the products has to be made by the national competent authorities, on a case-by-case basis, and taking into account all the relevant elements, such as the presentation of the products, the ingredients, the mode of action and the claims.

Discover our European Cosmetics Regulation services

Please do not hesitate to contact us: [email protected], if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:

Contact us via phone: for North America please use + 1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54

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Comments

  • Alix Perrier

    Hi Yolanda,

    Thanks for your post. We will contact you via email.
    Have a great day!
    Alix

    Mon 02/10/2017 - 16:36
  • YOLANDA PELAEZ .

    Please,
    We, GRIFOLL PRINT PROMOTIONS, are a printing industry in Europe (Spain). We produce promotional items which are considered as cosmetic products as well as toys products (ie. temporary tattoo, water removable face-paint card).
    We are looking for a partner/collaborator to help us to know what requirements/regulations are needed to export these two products aroung the world (outside Europe), for example, Japan or Mexico.
    Please, could you advise if you can provide this consultor service?
    Many thanks in advance.

    Fri 22/09/2017 - 14:55

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