Properly classifying a product is crucial in determining its pre- and post-market compliance requirements in the EU. To provide guidance on determining whether a borderline product falls under the scope of the Regulation (EC) No 1223/2009 on Cosmetic Products (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). The current consolidated Borderline Manual was released on January 24, 2025. Compared with the previous version, the new section "3.3.34 Products in a Vial or Ampoule" is added, which offers specific guidance on determining whether these products meet the criteria for classification as cosmetics under the Cosmetics Regulation.