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The Role of a Responsible Person



According to European law, each cosmetic product placed on the European market requires the designation of a Responsible Person (“RP”) to ensure compliance with the relevant obligations (EC 1223/2009 Article 4.1). This compliance includes, but is not limited to, safety, Good Manufacturing Practice, a Product Information File, sampling and analysis, composition, notification, restricted substances, nano-materials, animal testing, labeling, claims and communication of serious undesirable effects.

The role of Responsible Person is essential for bringing cosmetic products to the European market for several main reasons. The RP will provide solutions or services such as: a contact address in the EU, compile and update the PIF, complete the European notification in the Cosmetic Product Notification Portal (CPNP) which will be dispatched to the national Competent Authorities and the Anti-toxic Centers, keeping the PIF readily accessible to the authorities for 10 years at the address indicated on the label, reporting on serious undesirable effects, handling any cosmeto-vigilance issues, representing the client towards the Competent Authorities, anti-toxic Centers, end users and health professionals,  and constantly updating and consulting the manufacturer on EU Regulation. Overall, the Responsible Person ensures compliance and safety at all times while serving as the main contact point within the European Community.

Obelis operates as one of the largest regulatory centers in Europe today, providing “EU Responsible Person” (RP) and Cosmetic Notification services in Europe.

Last updated Mar 12, 2012

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