VERSION 5.2 (SEPTEMBER 2020)
The clear determination of the scope of application of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (“Cosmetics Regulation”) is crucial for the proper implementation of the Cosmetics Regulation and its correct interpretation and enforcement by national competent authorities of the Member States.
With regard to 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”), the Commission has published a “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” “Cosmetics/medicinal products guidance document”) setting out the legal rules for the demarcation between the Cosmetics Directive (now replaced by the Cosmetics Regulation) and the Medicinal products Directive.
In the course of the discussion with Member States the Commission concluded that guidance is needed which goes beyond abstract rules and addresses their actual application. To this end, a “Borderline Sub-Group”, comprised of experts from within the “Working Group on Cosmetic Products” and from other Commission Services concerned, meets on a regular basis to discuss the application of Article 2(1)(a) of the Cosmetics Regulation in order to ensure a uniform approach.
This manual represents the views agreed in this group on products, or categories of products, which have raised doubts in the past.
However, please note that the views expressed in this manual are not legally binding, since only the Court of Justice (“Court”, “ECJ”) can give an authoritative interpretation of Union law.
This manual does not relieve national competent authorities from their obligation to determine for any individual product, on a case-by-case basis, whether it falls within the scope of application of the Cosmetics Regulation or within the scope of
application of other sectorial legislation. The Court has repeatedly held that the national authorities, acting under the supervision of the courts, must proceed on a case-by-case basis, taking account of all the characteristics of a product.
Therefore, this manual shall not “prescribe” what regulatory framework applies. Rather, it shall serve as one out of many elements supporting the national competent authorities in their case-by-case decision on individual products.