The Working Group on Cosmetic Products (sub-group on borderline products) has released an update to the Borderline Manual on Cosmetic Products which was endorsed 22 November 2024. The revision adds new section 3.3.34 for the inclusion of ‘Products in a vial or ampoule’. It makes clear that a substance or mixture presented in a vial or ampoule is for use by injection then it is a medicinal product. However, if a product presented in vials or ampoules has a cosmetic function (cleaning, perfuming, changing the appearance, protecting, keeping in good condition or correcting body odours of the external parts of the human body or the teeth and the mucous membranes of the oral cavity), it 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. A decision on the qualification of the product has to be made by the national competent authorities, on a case-by-case basis, taking into account all the characteristics of the product.