News

12.02.2025 - Cosmetics

NewBorderlineHandbook-BorderlineAssessment

Products that are classified as borderline products are those which, due to their intended use, may fall under more than one legal jurisdiction. To provide guidance on classification issues, the Working Group on Cosmetic Products under the chairmanship of the European Commission published a new version of the Borderline Manual in November 2024.

In addition to the existing classification categories, a new category has been added, namely products delivered in ampoules or vials. Depending on the recommended use, these can be classified as cosmetic products (then regulated under Regulation (EC) No. 1223/2009) or pharmaceutical/medical products (Medicinal Products Act).

Our Regulatory Team is happy to review your cosmetic products for correct usage recommendations to avoid unintended classification as a medical device.

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