Understanding a product’s classification for regulatory compliance
The distinction between product classes can be unclear and/or ambiguous, sometimes requiring interpretation and input from competent authorities. A product can have similar characteristics with other products but may be governed by different regulatory frameworks. When products straddle between two or more regulatory definitions, the European Commission (EC) defines these products as “borderline.” Understanding a product category is essential in assessing the regulatory requirements for a particular market.
Product evaluation and classification difficulties can arise even within the same legal framework. For example, under the EU Cosmetics Regulation 1223/2009, a mouthwash with “antibacterial” or “antiseptic” claims can be categorised as a cosmetics product, a biocidal product, or as a medicinal product. When a device, such as implants is involved, the product can be categorised as a medical device. In the case of these “borderline products,” the decision on a product’s classification is decided on a case-by-case basis by the EC.
What is a cosmetic product?
A cosmetic product, as defined by the EU Cosmetic Regulation, shall mean any substance or mixture intended to be placed in contact with the various external parts of the human body or with the teeth and mucous membranes of the oral cavity for the purposes of cleaning them, perfuming them, changing their appearance, correcting body odours, and/or protecting them or keeping them in good condition. To classify a cosmetic product under the EU Cosmetic Regulation, thepurpose/function, formulation, and site of application must be clearly defined.
Primary functions include altering of appearance (makeup), cleaning, beautifying, perfuming, protecting or correcting odours. A cosmetic product can also have a secondary function (e.g., biocidal/antimicrobial claims in oral hygiene products or deodorants where the primary purpose is of a cosmetic nature). In the evaluation of a cosmetic product function, the following considerations are important, these include, the manufacturer’s intention, presentation, labeling, advertising, claims, mode of action, composition, and consumer perception. The indications for not allocating a clearly defined primary or main function to a cosmetic product, it stands the risk of being defined into a different product category.
There is a strong association between the composition of a cosmetic product and its function. Claims are made on the strength of specific ingredients used in the formulation of a cosmetic product (i.e., ingredients associated with a therapeutic use like fluoride in toothpaste). A cosmetic product formulation should not contain prohibited ingredients listed in Annex II of the EU Cosmetics Regulation; must comply with the guidelines on restricted substances in Annex III; and need to conform to the requirements relating to colorants (Annex IV), preservatives (Annex V), and ultraviolet (UV) filters (Annex VI).