The European Commission has just made available the new version (5.4) of the “Borderline” Manual, the guidelines drawn up by the sub-working group dedicated to determining the classification of a “borderline” product. A new section has been added dealing with products presented in vials or ampoules.
This new version of the Borderline Manual was adopted on 22 November 2024, and made available by the Commission on 24 January 2025.
To the question: “Are products presented in a vial or ampoule, not specifically presented for injection, cosmetics?”, the Manual gives the following answer.
• If a substance or mixture presented in a vial or ampoule is for use by injection, then the product cannot be considered to meet the definition of a cosmetic product.
• However, if a product presented in vials or ampoules has a cosmetic function,is not intended to be injected, and the instructions for use and its overall presentation clearly inform that the product is for external use only, then such a product could be considered as a cosmetic.
• The presentation of the product should not cause any confusion regarding whether it is for external or internal use or whether it is a medicinal product, medical device or a cosmetic product. Its overall presentation including a label or use instructions should clearly inform the consumer that the product is to be applied externally to the skin and it is not to be injected.
• Furthermore, the product should not be marketed with a …
