On January 24, 2025, the European Commission (EU) updated the classification guidance manual for cosmetic products (borderline products) within the scope of the Cosmetics Regulation (EC) 1223/2009 (Art.2(1)(A)).
The update to the manual includes the addition of a section on vial and ampoule products, providing specific guidance on the criteria for classifying these products as cosmetics.
The detailed content of the newly added Section 3.3.34 is as follows:
Mixtures in the form of injectable vials or ampoules intended for injection or implantation do not qualify as cosmetics.
For products provided in vial or ampoule form that are not intended for injection, the criteria for classification as cosmetics are as follows:
- They must have a cosmetic function (such as cleansing, perfuming, or improving body odor on the external parts of the human body, teeth, or oral mucosa.)
- They must not be intended for injection, and their Instruction for Use (IFU) and labeling must clearly indicate that they are for external use.
- Their labeling must not cause confusion with medicinal products or medical devices.
- They must not be sold together with a device capable of injecting or delivering the product beneath the epidermis.
Please refer to this information for your work regarding CPNP registration of cosmetic products in vial and ampoule form.
Please refer to the attached document below.
If you have any quesitons about cosmetics,
please contact us with the below.
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