The NEW European Cosmetic Products Regulation -- MEDICA - World Forum for Medicine


Obelis O.E.A.R.C.

The NEW European Cosmetic Products Regulation

On the 30 November 2009, the European Parliament adopted the new Cosmetic Products Regulation, EU Regulation 1223/2009, aimed to replace the European Cosmetics Directive 76/768/EEC.

Most of the provisions of this new regulation are expected to be applicable as of July 11th, 2013. The new regulation is also implementing European Notifications as of July 11th, 2012. The regulation reinforced the ban of animal testing.

By grouping the existing 55 European directives into a single European regulation, the new regulation simplifies the rules and procedures relating to cosmetic products marketed in the EU. As the regulation is directly applicable to the 27 Member-states, there will be no room for interpretation and different implementation rules as imposed on the current Directive by the member states authorities.

The new regulation will employ the uniform application of rules, the enhanced coordination of market surveillance activities and the reinforcement of responsibilities of economic operators, “Responsible Person” (Authorized Representative) in terms of registration, maintenance of product technical files, safety assessments, packaging and labeling requirements etc. The intention is to ensure a higher level of consumer protection. This also introduced the specific product information file requirements.

Furthermore, the New Regulation sets out a new set of safety requirements related to theuse of nanomaterials as well as the conditions in which Carcinogenic, Mutagenic or Reprotoxic Substances may be used in cosmetic products.