On 24 January 2025, the European Commission published a key update to the Cosmetics Borderline Products Manual. This document, prepared by the Subgroup on Borderline Products and approved by the Cosmetics Working Group, serves as an essential reference for manufacturers and national authorities, offering detailed guidance on the application of EU legislation in the cosmetics sector. One of the most relevant novelties of this version is the inclusion of a specific section on products in vials or ampoules.
Table of contents
What is the Cosmetics Borderline Products Manual?
This manual is a fundamental tool for the interpretation and application of the EU Cosmetics Regulation . It aims to help industry players correctly classify their products and avoid confusion with other categories, such as medicines or medical devices.
Classification of Products in Vials or Ampoules
The update introduces a detailed analysis of how cosmetic products presented in vials or ampoules should be classified, which represents a category of products on the border between cosmetics and medicine.
According to European regulations, a cosmetic product must fulfil at least one of the following functions:
Cleaning
Perfume
Change the appearance
Correcting body odor
Protect the skin
Keeping external parts of the body in good condition
In contrast, medicinal products are intended to treat, prevent diseases or modify physiological functions of the body.
Difference between Cosmetics and Medicines in Vials or Ampoules
The classification of a product may be influenced by its mode of application and presentation. According to Article 2(2) of the EU Cosmetics Regulation, any substance intended to be injected or implanted into the human body is not considered a cosmetic product.
Therefore:
If a product in vial or ampoule is designed for injection, it cannot be classified as a cosmetic.
If its use is exclusively external and meets the established cosmetic criteria, it can be considered a cosmetic.
In addition, labelling, instructions for use and the way it is marketed are key factors in determining its classification.
Recommendations for Manufacturers and Professionals
We stress the importance of companies and professionals in the cosmetics sector closely following these regulatory updates. To avoid confusion and possible sanctions, we recommend:
Check the application mode of the products : Avoid any presentation that could lead to misclassification.
Ensure clear and accurate labelling : Explicitly indicate the external use of the product.
Consult with cosmetic regulatory experts : Ensure regulatory compliance before launching a product on the market.
Monitoring the evolution of legislation : Stay up to date with changes in European regulations.
Conclusion
The update of the Cosmetics Borderline Products Manual reflects the need to precisely define which products belong to the cosmetics category and which should be considered medicines or medical devices.
At Belab Services , we are committed to providing up-to-date information and advice to enable the cosmetics industry to adapt to these changes and ensure regulatory compliance.
If you want to know more about this update and its impact on the sector, we invite you to follow our blog and consult with our experts in cosmetic regulation.
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