Borderline Cosmetics in the EU
Understanding a product's classification for regulatory compliance
15 November 2022
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).
Site of Application:
Cosmetic products are intended for application on external parts of the human body such as the epidermis, hair system, nails, lips and external genital organs, or the teeth and mucous organs of the oral cavity.
What is a biocidal product?
A biocidal product is a product with an active substance that is intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on harmful or undesired organisms. A product's primary function, as determined by claims, is a major determinant in making a distinction between a cosmetic and a biocidal product. For example, bath soaps with antibacterial or antiseptic properties are classified as biocidal products, and sunscreens, with their UV repelling properties, are also considered biocidal products.
What is a medicinal product?
According to the Medicines and Healthcare products Regulatory Agency (MHRA), a medicinal product is any substance or mixture that has therapeutic or prophylactic properties in human beings. This includes substances administered with the aim of restoring, correcting, or modifying a physiological function by exerting a pharmacological, immunological, or metabolic action, or making a medical diagnosis. For example, shampoo is considered a cosmetic product since its intended use is to cleanse the hair; however, an anti-dandruff treatment is categorised as a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug.
What is a medical device?
According to EU Directive 93/42/EEC, a medical device refers to any instrument, apparatus, appliance, material, or other article, whether used alone or in combination, including the software necessary for its proper application to be used for human beings for the purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease, investigation, replacement or modification of the anatomy or of a physiological process, and/or control of conception. The major differentiator between a cosmetics product and a medical device includes the site of application, the intended use of product, and the use of a device or device accessory which is intended to administer a medicinal product.
Site of Application:
Medical devices are intended for application on internal and external parts of the human body.
Medical devices are intended for medical purposes only (i.e., a patch intended for the slow release of pharmaco-active substances is considered an article and is therefore not a cosmetic product as it is not a substance or mixture. Equally, this substance may be categorised as a medicinal product "by presentation" or "by function").
Wrong product classification can negatively impact a business and can have serious safety ramifications for the end user if the intended product use or function is confused or misunderstood. Other direct consequences can include potential product recalls, redesign of product labels, re-application or re‑notification to the appropriate competent authorities, reformulation of the product, and/or application for variation in some product class within the same regulatory framework. There is also the burden of associated costs, loss of brand reputation, loss of time, etc.
It is imperative that manufacturers, suppliers, and distributors correctly classify their products from the onset; this will subject the product to the appropriate regulatory framework and meet relevant compliance requirements. In the case of uncertainty, the competent national authorities in the EU and UK Member States will decide on a case-by-case basis. Do you have questions about this topic, your obligations under the relevant regulatory framework, or a related topic? Contact our experts at Intertek Assuris—we're here to help!
For more information about our service offerings for the consumer healthcare, cosmetics, and toiletries industries, visit: https://www.intertek.com/assuris/cosmetics/.
Reference Manual Of The Working Group On Cosmetic Products (Sub-Group On Borderline Products) On The Scope Of Application Of The Cosmetics Regulation (Ec) No 1223/2009 (Art. 2(1)(A)) Version 5.2 (September 2020).