Borderline Regulierung

3.3.11. Products delivered through invasive techniques, such as needle roller

  1. Question: Can products intended to be used with needle rollers or similar mechanisms be cosmetic products?
  1. Answer: Needle-rollers are not cosmetic products; they are articles used to enhance the absorption rate of cosmetic ingredients by the skin. The needle rollers should only be used with products intended for such devices, otherwise, it could be considered as a misuse of the cosmetic products.
  1. The needles can have different lengths and reach different layers of the skin. If the use of the roller only enables the application of the product in the epidermis, then the product is a cosmetic and its safety should be assessed taking into account the composition and the mode of delivery. On the other hand, if the needles reach the dermis, the use of the roller induces a deeper application of the product, and therefore this product cannot be qualified as a cosmetic.
  1. A case-by-case evaluation of all characteristics of the product, including, concentration, route of administration, frequency of application, sequence of application56, application site, and the degree of penetration, in light of the specific mode of delivery, should be carried out by the national competent authority, in order to decide on the classification of the product. The recommendation to use the roller after applying an anaesthetic cream to the area to be treated may be an indication that the depth of application intended by the device is greater than what is usually expected for a cosmetic product.