The regulatory definition of a Cosmetic Product is set out in EU Regulation (EC) No1223/2009 and is the foundational element that determines compliance requirements. This definition relies strictly on two factors: where the product is applied and its exclusive or main function.
The Core Definition
A Cosmetic Product is defined as any substance or mixture intended to be placed in contact with:
- External Parts of the Human Body: Epidermis, hair system, nails, lips, and external genital organs.
- Oral Cavity: The teeth and the mucous membranes of the oral cavity.
The product must be applied to these areas with a view exclusively or mainly to: cleaning, perfuming, changing their appearance, protecting, keeping them in good condition, or correcting body odours.
Categories of Cosmetic Product
Many common items naturally fit this definition:
- Skincare: Moisturizers, toners, and facial oils are cosmetic products because their main function is to keep the skin in good condition and protect it.
- Makeup: Products like foundation, mascara, and lipstick are cosmetic products as their main function is to change appearance.
The Challenge of Borderline Products
Borderline products are items that do not clearly fit the Cosmetic Product definition and may be classified under other regulations (such as Medicines or Medical Devices). Determining the correct classification depends on a case-by-case assessment of the following:
- Intended Use and Claims: If a product claims to treat or prevent a disease (e.g., a specific pharmacological action), it falls under the definition of a medicine. For instance, a basic moisturizing cream is a cosmetic, but a specialized anti-itch cream making therapeutic claims may be a medicine.
- Mode of Action: Cosmetics act superficially; they do not restore, correct, or modify physiological functions through systemic action.
Crucial Note: If a product meets the definitions of both a cosmetic and a medicine, it is always classified as a medicine in the EU. This strict rule prevents companies from avoiding the rigorous testing and authorization required for medicines.
