The first step to register a cosmetic product in the market is to ensure that it is considered a cosmetic product in Europe and UK. To do this, it is necessary to know the definition of a cosmetic product. According to European Regulation 1223/2009, the official definition of cosmetic product is “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 mucous membranes of the oral cavity for the exclusive or main purpose of cleaning, perfuming, modifying their appearance, protecting them, keeping them in good condition or correcting body odors”.
When defining a cosmetic product, there are 4 aspects to consider:
substances listed in Annex II of prohibited substances must not be present. If substances listed in Annex III of restricted substances are present in the formula, they must comply with the restrictions established. The colorants, preservatives and sunscreens allowed in cosmetics are listed in Annexes IV, V and VI
Area of application:
As the definition itself indicates, a cosmetic must be applied to the external parts of the body or to the teeth and mucous membranes of the oral cavity and external genital organs. Therefore, all products that are ingested, inhaled, injected or implanted in the body are not considered cosmetics and will be regulated by other legislation depending on the type of product (medicine, medical devices, etc.).
The exclusive or main function of a cosmetic product is to cleanse, perfume, modify body appearance, protect, maintain in good condition or correct body odors. It is possible that some products may be considered borderline with drugs, medical devices, biocides, toys, etc. In these cases, the product should have as its primary or exclusive function one of those described in the definition of cosmetic (cleaning, perfuming, modifying body appearance, protecting, maintaining in good condition, correcting body odors).
As stated in the previous points, it is logical that also the labels have to reflect this definition. For this reason, claims are regulated. We cannot claim that our product cures or treats any disease, as this is typical for drugs and/or medical devices. Likewise, claims such as “bactericidal, sanitizing, virucidal” will not be allowed as the product will fall under the Biocide Regulation. We will discuss this aspect further in the section dedicated to how to create the labeling of a cosmetic product. Likewise, it is not allowed to mention or visually present any disease or medical condition in the labeling of a cosmetic product.
Below is a list of products that can be defined as cosmetics:
- Creams, emulsions, lotions, gels, oils for the skin
- Face masks
- Tinted based
- Make-up powders
- Toilet soaps
- Deodorant soaps
- Perfumes, eau de toilette, eau de parfum
- Bath and shower products (gels, oils, foams, salts)
- Deodorants and antiperspirants
- Hair colorants
- Products for waving, straightening and fixing hair
- Hair conditioners (creams, oils, lotions)
- Hairdressing products
- Shaving products (creams, lotions, foams)
- Make-up and make-up removal products
- Products intended for application to the lips
- Products for care of the teeth and the mouth (toothpaste, mouthwashes)
- Nail care products
- Products for external intimate hygiene
- Sunscreen products
- Products for tanning without sun
- Skin-whitening products
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