Borderline Products in the EU: Cosmetic Products or Not?

Properly classifying a product is crucial in determining its pre- and post-market compliance requirements in the EU. Therefore, when developing cosmetic products, it is essential to possess a comprehensive understanding about whether the products being developed fall under the scope of Regulation (EC) No 1223/2009 on Cosmetic Products (Cosmetics Regulation).

The Cosmetics Regulation specifies the criteria of being classified as a cosmetic product, along with the essential compliance requirements for cosmetic product's entry into the EU market. Despite the provided definition, there are cases where uncertainty arises regarding the classification of certain products as cosmetics, or other types of products as per other sectorial legislation. These products are termed as "borderline products" in the EU. To provide guidance on determining whether a borderline product falls within the scope of the Cosmetics Regulation, the European Commission has published the 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)) (Borderline Manual). In this article, ChemLinked explores the key points of the Borderline Manual, and its latest updates.

Classification Criteria and Principle

As per the Cosmetics Regulation, cosmetic product refers to 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 the mucous membranes of the oral cavity, with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors. Based on this definition, three criteria determine whether a product qualifies as a cosmetic product, including the product nature, the application site, and the intended purpose.

1. Product nature

The product should be either a substance or a mixture. Articles, such as wigs, are not classified as cosmetic products. In the case of a wipe that releases a substance or a mixture, the wipe itself can be regarded as the "vehicle" for delivering a substance or mixture to the human skin. In this case, if the substance or mixture to be delivered meets the definition of a cosmetic product, it falls within the scope of the Cosmetics Regulation.

2. Application site

The product should be intended for contact with the various external parts of the human body, or with teeth and the mucous membranes of the oral cavity. In light of this description, nasal sprays, products used for vagina cleaning, and orally ingested tablets are not classified as cosmetics.

3. Intended purpose

The product should exclusively or mainly serve a cosmetic purpose. Even if the product has a non-cosmetic function, it can still be categorized as a cosmetic product as long as this function remains secondary to its main cosmetic purpose. When determining the product's primary function, careful consideration should be given to factors such as the manufacturer's intention, the product's presentation, labelling and claims, as well as how it is perceived by consumers. Consequently, products that are presented as having properties for treating diseases, or have strong claims regarding their biocidal function, are not considered as cosmetic products.

According to the Borderline Manual, the classification of an individual product should be conducted on a case-by-case basis. In situations where there is uncertainty regarding the product's qualification as a cosmetic, national competent authorities are responsible for identifying the applicable regulatory framework, taking into account all characteristics of the product.

Borderline Products in Relation to Cosmetics

In some cases, a cosmetic product may share blurred borderline with biocides, medicinal products, medical devices, and toys. Key points that aid in understanding the boundaries between cosmetics and these categories are presented in the table below.

Product Type	Definition	Key Points
Biocides	Products that contain one or several active substances designed to control viruses, fungi, and/or other microbes before they cause harm, and in some cases, to repel or attract organisms such as insects.	i. To distinguish a cosmetic product from a biocide, it is essential to assess the applicability of Regulation (EU) No 528/2012 *(Biocidal Products Regulation), and the primary function of the product. ii. A specific product cannot be subject to both the Cosmetics Regulation* and the Biocidal Products Regulation simultaneously. iii. A cosmetic product can possess a secondary biocidal function, but remains regulated solely under the Cosmetics Regulation.
Medicinal products	Products presented as treating or preventing diseases, and/or used with the intention of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.	i. To differentiate between a cosmetic product and a medicinal product, it is necessary to evaluate whether the product can be classified as a medicinal product based on its presentation or function. ii. A specific product cannot be subject to both the Cosmetics Regulation and the Directive 2001/83/EC (Medicinal Products Directive) simultaneously. iii. A cosmetic product can have a secondary health benefit, but remains regulated solely under the Cosmetics Regulation.
Medical devices	Products or equipment intended to be used for human beings for one or more medical purposes.	i. To distinguish between a cosmetic product and a medical device, it is crucial to assess the primary function of the product. ii. A specific product cannot be subject to both the Cosmetics Regulation and the Regulation (EU) 2017/745 (Medical Devices Regulation) simultaneously. iii. A cosmetic product can have a secondary medical device function, but remains regulated solely under the Cosmetics Regulation.
Toys	Products designed or intended, whether exclusively or not, for use in play by children under 14 years of age.	i. A product can be a cosmetic and a toy (e.g., a cosmetic product with a play value). ii. A specific product can be subject to both the Cosmetics Regulation and the Directive 2009/48/EC (Toy Safety Directive) simultaneously (e.g., a cosmetic product with a secondary function as a toy).

Latest Updates

On February 20, 2024, the Commission released the updated Borderline Manual, introducing two new entries: (1) magnetic eyelines, and (2) glues or adhesives intended to fix articles, like fake nails, false eyelashes, jewelry on teeth, etc.¹

Magnetic eyelines: Magnetic eyeliner aligns with the definition of a cosmetic product in terms of its nature, application site, and intended purpose. Therefore, it can be classified as a cosmetic product similar to a regular eyeliner. In addition to its primary function of changing the appearance of the applied skin area, it enables the attachment of magnetic false lashes to the eyelid. This purpose can be considered as a secondary purpose to the main cosmetic purpose.

Glues or adhesives intended to fix articles: The glue or adhesive in question fulfils two criteria of the cosmetic product's definition, the product nature and the application site. Therefore, the determination of its exclusive or main purpose should be assessed on a case-by-case basis. If its main function is to change the appearance by itself, it is likely to be considered as a cosmetic product. However, if its exclusive purpose is to attach an article to an external body part, it cannot be considered as a cosmetic product.