New section in the Cosmetics Borderline Manual: products in vials or ampoules

On 24 January 2025, the European Commission published an updated version of the Borderline Manual on Cosmetic Products.

The Borderline Manual is a non-legally binding document prepared by the Sub-Group on Borderline Products and approved by the Working Group on Cosmetic Products. It serves as a reference tool for manufacturers and national authorities, compiling practical guidance for the case-by-case application of EU legislation and helps define the scope of the EU Cosmetics Regulation.

The latest version introduces a new section on products in vials or ampoules.

Borderline between cosmetics and pharmaceutical/medicinal products

The new section on products presented in vials or ampoules has been added to the chapter addressing products considered borderline with pharmaceutical products.

According to the EU Cosmetics Regulation, a cosmetic product’s primary function is defined as one or more of the following: cleaning, perfuming, changing appearance, correcting body odours, protecting, or keeping in good condition. These functions apply specifically to external body parts, the oral mucous membrane, or teeth.

In contrast, medicinal products are defined as:

1. Any substance or combination of substances presented as having properties for treating or preventing disease in human beings or
2. Any substance or combination of substances that may be used in or administered to human beings to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action or for making a medical diagnosis.

According to the Borderline Manual, a product may be classified as a medicinal product by virtue of its presentation. As a result, products contained in vials or ampoules may be considered borderline cases.

Borderline manual new entry: key considerations for classification

If a product in a vial or ampoule is designed for injection, it cannot be classified as a cosmetic under Article 2(2) of the EU Cosmetics Regulation, which states:

“A substance or a mixture intended to be (…) injected or implanted into the human body shall not be considered a cosmetic product.”

However, if the product is intended for external application and serves cosmetic functions such as skin cleansing, moisturizing, or enhancing appearance, it may be classified as a cosmetic, provided that:

• • Its instructions and labelling clearly indicate external use only.

• • The overall presentation does not create confusion regarding its classification.

• • It is not marketed with a device that enables injection or delivery below the skin.

Additionally, the manual highlights that case law has established that products exerting significant pharmacological, immunological, or metabolic action are not considered cosmetics.

A case-by-case assessment

Competent authorities can, on a case-by-case basis, decide on the classification of a product. Among others, they would assess:

• The product’s presentation and whether its instructions clearly indicate external use.
• Its intended function.
• The ingredients used.
• Its mode of action.
• How it is advertised and promoted across various channels.

Do you have any questions on compliance of cosmetics in the EU, UK, or US? Contact us here and write an email to COSlaw@obelis.net.

References

European Commission. (2024). 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)). Retrieved on 3 February 2025.

EUR.lex (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council on Cosmetic Products. Retrieved on 3 February 2025.

EUR.lex (2001). Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Retrieved on 3 February 2025.