EU Regulation (EC) No 1223/2009 establishes the legal definition of a cosmetic product and forms the basis for all cosmetic compliance requirements within the European Union. This definition plays a critical role in determining whether a product falls under cosmetic legislation or is subject to alternative regulatory frameworks.
The classification relies strictly on two criteria: the area of application and the product’s exclusive or primary function.
Legal Criteria Used to Define a Cosmetic Product in the EU
EU law relies on two decisive factors to classify a product as a cosmetic: the area of application and the product’s exclusive or primary function.
A cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body, including the epidermis, hair system, nails, lips, and external genital organs. The definition also includes products applied to the teeth and the mucous membranes of the oral cavity.
The intended purpose must be exclusively or mainly cosmetic, such as cleaning, perfuming, changing appearance, protecting, keeping the body in good condition, or correcting body odours.
Examples of Products That Qualify as Cosmetic Products Under EU Law
Many everyday consumer items clearly meet the EU cosmetic product definition.
Skincare products, including moisturizers, toners, and facial oils, qualify as cosmetic products because their primary function is to protect the skin and maintain its condition.
Makeup products such as foundation, mascara, and lipstick also fall under EU cosmetic regulation, as their main purpose is to change or enhance appearance.
Borderline Products Under EU Cosmetic Regulation
Some products do not clearly qualify as cosmetic products under EU law and may fall under medicinal product or medical device legislation. These borderline products require a detailed, case-by-case regulatory assessment.
Authorities evaluate intended use and product claims closely. Products that claim to treat or prevent disease, or that suggest pharmacological action, fall outside the cosmetic product definition. For example, a basic moisturizing cream is a cosmetic, while a product making therapeutic anti-itch claims may be classified as a medicine.
Regulators also assess the mode of action. Cosmetic products act superficially and do not modify physiological functions through systemic mechanisms.
Cosmetic Product vs Medicinal Product Classification in the EU
EU legislation applies a strict rule when a product appears to meet both the cosmetic and medicinal definitions. In such cases, authorities always classify the product as a medicinal product.
This principle prevents companies from avoiding the extensive testing and authorization requirements applicable to medicines. Correct classification therefore represents a critical compliance step when placing products on the EU market.
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