Sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation.
In the case of these 'borderline products', the decision on a product’s classification must be taken on a case-by-case basis.
The European Commission has published guidance documents to facilitate the application of EU legislation in these cases.
GUIDANCE DOCUMENT ON THE DEMARCATION BETWEEN THE COSMETIC PRODUCTS DIRECTIVE 76/768 AND THE MEDICINAL PRODUCTS DIRECTIVE 2001/83 AS AGREED BETWEEN THE COMMISSION SERVICES AND THE COMPETENT AUTHORITIES OF MEMBER STATES
INTRODUCTION
The clear determination of the demarcation between the scope of application of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (“Cosmetics Directive”) and Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (“Medicinal products Directive”) is crucial for the proper implementation of the two Directives and the correct interpretation and enforcement of transposing national laws.
This document attempts to provide such guidance on the demarcation between the two Directives.
The Cosmetics Directive
Art. 1(1) of the Cosmetic Directive defines cosmetic product as
“any substance or preparation intended to be placed in contact with the various external parts of the human body branes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.”
The Cosmetics Directive “is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease.
The Medicinal Products Directive
Art. 1(2) of the Medicinal Products Directive defines “medicinal product” as follows:
“(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings;
(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
‼️In cases of doubt, where a product may fall within the definition of a ‘medicinal product’ and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply.‼️
Art. 2 (2) intends to reflect the “principle of non-cumulation” as established by the Court in the Upjohn-ruling.
Read also: European Drug Master File
Resource Person: BARBARA PIROLA
