Cosmetic Regulation EC 1223/2009
On the 30th of November 2009, the European Cosmetics Regulation, EC 1223/2009, was published in the official journal of the European Commission, The Regulation came into full force on July 11th, 2013, completely replacing the previous law the Cosmetics Directive 76/768/EEC.
The general objectives of this Regulation are to cover the ubiquitous gaps from the previous Directive, which lead to the several amendments in the past, and to harmonize the European Market.
A regulation, by definition, does not allow transposition into national legislations. As a consequence, a regulation has the power of superseding all national laws, preventing Member States from adjusting or adapting regulations for their own purposes. Hence, the main achievement coming with the Cosmetics Regulation 1223/2009/EC is bringing the EU cosmetics market to even greater uniformity.
The Cosmetics Regulation 1223/2009/EC aims, same as the Cosmetics Directive 76/768/EEC did, at the free movement of cosmetic products within the EEA market but also and as important at ensuring the safety of the users of cosmetic products in Europe. Cosmetics free to circulate within the market must acquire evidence to their conformity with the stipulated requirements in their respective Product Information File.
The novelty comes from assigning a greater responsibility to the EU Responsible Person (RP) by clearly indicating that cosmetic products may be placed on the EU market only if an EU Responsible Person (RP) has been designated towards them;
“Only cosmetic products for which a legal or natural person is designated within the community as ‘responsible person’ shall be placed on the market” (Art.4, p.1).
Furthermore, the regulation brings a new centralized pre-market notification system. This implies that national notifications will not be completed anymore but instead the notification will be electronical towards the European Commission Cosmetic Products Notifications Portal (CPNP). Once a product will be notified by the RP to the CPNP, the product may circulate in all EU Member States.
The Responsible Person is to ensure compliance with the relevant obligations set out in the Regulation: Safety, Good Manufacturing Practices (GMP), Product Information File (PIF), Composition-Restricted Substances, Nano-Materials, Labelling, Claims, Serious Undesirable Effects (SUE), Animal Testing and EU Pre-Market Notifications of Cosmetic Products.
“Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2)and (5), as well as Articles 20, 21, 23 and 24” (Art.5, p.1).
- Scope & Classification
- EU Responsible Person
- Product Information File
- Good Manufacturing Practices
- Cosmetic Product Safety Report (CPSR) - Part A & B
- Mandatory Safety Testing
- EU Labeling
- Pre-Market Notification: Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance
- Risks of Non-Compliance
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