INTRODUCTION
1. 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”)2 (“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.
2. 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 use3 (“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”)4 setting out the legal rules for the demarcation between the Cosmetics Directive (now replaced by the Cosmetics Regulation) and the Medicinal products Directive.
3. Also, with regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market5 (“Biocidal products Directive”), the Commission has published such a guidance document (hereinafter the “Cosmetics/biocidal products guidance document”).6
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