European Regulation nº 1223/2009: when to apply?

Understanding Regulation 1223/2009 and knowing if we are applying it correctly can be a daily challenge. Sometimes, it is easy to fall into a “grey zone” of cosmetics products, the “borderline product”, and difficult to decide whether to follow the cosmetic legislation or other legislation. There are several boundaries between cosmetic products and other health products, such as medical devices or biocides, however, there is no law with specific rules, only a guiding manual on which the safety assessor and authority can support themselves to make a correct product classification. Then why is it so important to define the product? The deal is that depending on the product classification there are different requirements: the assessment of risk, the registration or even the labelling compliance.

So, where to start? First of all, we need to understand the definition of a cosmetic product: “… 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 odours.” So, do we have a substance or a mix of substances? Where is the application? What’s the function of the product? While a common hand cream is easy to understand if it is a cosmetic product, a cream for acne or cellulite can be more difficult to classify!

In order to comply with the appropriate regulation for your product and understand whether it can actually be a cosmetic, it is necessary to ask yourself:

- what is the main function of the product?

- where’s the application of the product?

- what are the product claims?

- what is the consumer's perception?

Considering the definition of a cosmetic product, it is easy to understand now that a cosmetic product can’t prevent infections or be an antiseptic nor can’t have a therapeutic action, such as pharmacological, immunological, or metabolic action. Let’s show some examples!

 1.     The Borderline Cosmetic – Biocide

According to the European Regulation (EU) No 528/2012, a biocidal product is “any substance or mixture, in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action.” Summing up, a biocidal product can be a hygienic healthy product. For example, a cleaning solution or a hydro-alcoholic gel can be a biocidal product.

So how can we distinguish it? If the main purpose of a skin cleaning product is an antimicrobial or antiseptic properties, it is likely to expect to classify it has a biocidal product. However, if the antimicrobial effect is a secondary effect of the product it may be classified as a cosmetic product.

2.     The Borderline Cosmetic - Medical Device

According to the European Regulation (EU) No 2017/745, a medical device is considered a “instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

— investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state,

— providing information by means of in vitro examination of specimens derived from the human body, including organ, bloo,d and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological, or metabolic means, in or on the human body, but which may be assisted in its function by such means.”

In simple words, a medical device is a health product with medicinal intentions, without a metabolic, pharmacological, or immunologic action, otherwise, it would make it a drug. Let’s see some examples!

- A product to be applied to the female genital organs a cosmetic product or a medical device? We need to analyse it a case-by case: if it only hydrates the skin, it may be a cosmetic product, however, if it is intended to lubricate the vagina, it may be a medical device.

- Is a skin-peeling product a cosmetic product? According to the manual of borderlines, “They may fulfill a cosmetic function (e. g. cleansing the skin, changing its appearance and keeping it in good condition), but may also be used in some circumstances to restore, correct or modify physiological functions of the skin (e.g. removal of scar tissue).” In this particular case, the authorities will have to evaluate the characteristics of the product, its claims, and the depth of peeling per application as well as the frequency of application, and choose whether it is a cosmetic or a medical device.

3.     The Borderline Cosmetic – Drug

Finally, according to the European Directive 2001/83/EC, a medicinal product is “Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

When classifying a cosmetic product, the ingredients can also help in these decisions: if the ingredient is an active substance in a medicinal product it is not decisive but it can be an indicator of a pharmacological, metabolic, or immunological effect. Let’s see some examples!

- Is a product that stimulates hair growth or reducing hair loss a cosmetic product? This kind of claim, whether a product can restore or modify physiological functions needs to be studied in a case-by-case. Besides its active substances, it is necessary to consider the absorption of the product, its concentration, the frequency of usage, and, of course, its claims. “Promoting hair growth” may indicate the product is a pharmaceutical product however “preventing hair fall” may be a cosmetic product. The presence of specific substances, such as minoxidil may also help classify the product as a drug since this ingredient is not allowed in the cosmetic industry.

- Can a product that reduces cellulite in the skin be a cosmetic product? According to the manual of borderlines, this kind of product is classified as a medicinal product because of its function as it modifies physiological functions “… by exerting a pharmacological, immunological or metabolic action. However, not any minor modification of physiological function suffices to render a product a medicinal product by virtue of function”.

- Are products to reduce dark circles under the eyes, bruises, or blue spots cosmetic products? Reducing the dark circle under the eyes can be done by covering it with makeup or acting on its causes. According to the manual of borderlines, concealers or foundations only cover or mask this kind of discolorations, so they can be considered cosmetics. However, when a product applied in this kind of discoloration will restore, correct, or modify physiological functions will not be considered a cosmetic as it will have a pharmacological, immunological,l or metabolic action.

To sum up, although the borderlines manual helps decodified some products and when to follow the Regulation (EC) No 1223/2009 or not, it is just a guide, and knowing your product is essential for a correct classification. This manual is not a law and each competent authority will have to analyse case-by-case and decide when to classify as a cosmetic product, according to the product characteristics and the available information. It is easy to attribute different functions and characteristics to a product and fall into borderline products, however starting by classifying your product, knowing where to be applied, and its function, and working on the labelling claims is important to define your product and be in the right side of the law. Finally, one thing is clear: a borderline status or an intermediate classification does not exist and the consumer should understand clearly the product.