Borderline-Manual 3-0 November 2017
- Question: Are products that influence the growth of eyelashes cosmetic products?
- Answer: The question of whether such products significantly restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action has to be assessed on a case-by-case basis.
- In assessing the proper classification of these eyelash products, one has to consider all characteristics of the product, including, for example, the presentation of the product, any promotional literature, the composition, the product’s specific pharmacological, immunological or metabolic properties, the mode of application under normal and reasonably foreseeable conditions of use, the frequency of application, the application site, the degree of penetration, and the risk which its use may entail.
- The fact that a substance is used in medicinal products as an active ingredient is not decisive. However, this may be an indicator for a pharmacological, immunological or metabolic action of the product.
- On the other hand, other substances with an influence on eyelash growth may exist (or be designed), which are not used as active drug ingredients, but the product containing them could still restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action (e.g. some specially designed peptides).
- The presentation of the product may give useful indications to the competent authorities, without, however, replacing a careful assessment of the mode of action and all the elements indicated above. For example, the claim to the effect of „eyelash growth“ would indicate an intention to modify a physiological function. The absence of such claims, however, does not necessarily mean that the product does not influence eyelash growth.
 „It follows that products containing a substance which has a physiological effect cannot automatically be classified as medicinal products by function unless the competent administration has made an assessment, with due diligence, of each product individually, taking account, in particular, of that product’s specific pharmacological, immunological or metabolic properties, to the extent to which they can be established in the present state of scientific knowledge“ (Case C‑140/07 Hecht‑Pharma  ECR I‑0000, paragraph 40).
 „In its case-law prior to the amendment of Directive 2001/83 by Directive 2004/27, the Court indicated that, for the purpose of determining whether a product falls within the definition of a medicinal product by function, the national authorities, acting under the supervision of the courts, must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail“ (Case Hect-Pharma, paragraph 32).
 e.g. prostaglandines and their analogues.