Chemische Fabrik Kreussler & Co. GmbH v Sunstar Deutschland GmbH, formerly John O. Butler GmbH.
Date: 2012-09-06
23. In that regard, it must be stated that, in itself, that guidance document drawn up by the Commission’s services, which is not one of the legal acts of the European Union referred to in Article 288 TFEU, cannot be of a legally binding nature or enforceable against individuals.
30. By contrast, it is apparent from Article 1(2)(b) of Directive 2001/83 that the substance in question must be capable of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action and that capability must have been scientifically established (see, to that effect, Case C - 140/07 Hecht-Pharma  [2009] ECR I - 41, paragraph 26).
33. Moreover, it must be pointed out that products containing a substance which has a physiological effect cannot automatically be classified as medicinal products ‘by function’, for the purposes of Article 1(2)(b) of Directive 2001/83, 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 ( Hecht-Pharma , paragraph 40, and Case C - 27/08 BIOS Naturprodukte  [2009] ECR I - 3785, paragraph 19).
34. It is also important to bear in mind that, as well as the pharmacological, immunological or metabolic properties of the product in question, which constitute the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of Article 1(2)(b) of Directive 2001/83, be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions, account must be taken, in determining whether a product falls within the definition of a medicinal product ‘by function’ for the purposes of that provision, of all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (see BIOS Naturprodukte , paragraphs 18 and 20).
35. Lastly, it must be added that, to be capable of being regarded as being a medicinal product by function, the product in question must, having regard to its composition – including its content in active substances – and if used as intended, be capable of appreciably restoring, correcting or modifying physiological functions in human beings (see Hecht-Pharma , paragraph 42, and BIOS Naturprodukte , paragraph 23), which it is for the national court to ascertain.
36. Having regard to all the foregoing considerations, the answer to the second question is that Article 1(2)(b) of Directive 2001/83 must be interpreted as meaning that, for a substance to be regarded as exerting a ‘pharmacological action’ within the meaning of that provision, it is not necessary for there to be an interaction between the molecules of which it consists and a cellular constituent of the user’s body, as an interaction between that substance and any cellular constituent present within the user’s body may be sufficient.
The third question