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. They include a manual on the scope of application of the Cosmetics Regulation and the various guidelines on the borderline between cosmetics legislation and other sectorial legislation.
- Borderline products manual on the scope of application of the Cosmetics Regulation (EC) No 1223/2009 (Art. 2(1)(a)) (September 2020, version 5.2) (1 MB)
- Guidance document on the demarcation between the Cosmetic Products Directive 76/768 and the Medicinal Products Directive 2001/83 (66 kB)
Coronavirus response in relation to the production capacity of hand cleaners and hand disinfectants
Enhanced personal hygiene is one of the main ways to prevent the spread of the Coronavirus: the WHO recommends washing your hands with soap and water for at least 20 seconds or cleaning hands with alcohol-based solutions, gel being one of the main types.
Because of this, the use of hand cleaners and hand disinfectants (i.e. gels, hand wipes or other leave-on products) has increased dramatically in the EU. As a result, most EU countries experienced a general shortage of those products.
Economic operators of the cosmetic and of other sectors are increasing or converting their production capacity to address this shortage on the EU market.
The Coronavirus crisis guidance informs economic operators, including small and medium-sized enterprises, on the applicable legal framework of those products (i.e. the Cosmetic Products Regulation or the Biocidal Products Regulation) on the EU market and the claims which can be made to the user.