Cosmetic 76/768/EEC Services

Obelis European Authorized Representative Center

Obelis European Responsible Person Center (O.E.R.P.C.) acts as the European Responsible Person providing notification and regulatory services for the successful introduction of your cosmetic products within the European territory. Our services are backed by 20 years of experience in regulatory affairs services, CE marking consulting, and European Authorized Representative services. We are located within a walking distance from the European Commission, maintaining close relations with the EU Administration.

European Responsible Person Services

European Responsible Person: A European appointed registered place of business within the European Economic Area acting as the legal identity of a non-EU manufacturer towards the European Member State Competent Authorities as a central EEA vigilance and contact point in the Community
Product classification
Product Information File (PIF) preparation to be submitted to the EU Authorities per EU Member State
Organize a Safety Assessment of the cosmetic finished product by an external Safety Assessor
Pre- Market Notification of cosmetic products per EU Member State
Notification to Anti-Toxic Centers per EU member state
Cosmeto-vigilance reporting and complaint handling coordination (Cosmetics Cosmetic Directive 76/768/EEC & Cosmetic Regulation 1223/2009/EC)
Product labeling compliance: European Responsible Person address on the product related printing materials (i.e., catalogs, instruction sheets, packaging, manuals) and verification of labeling compliance with the Cosmetics Directive 76/768/EEC & New Regulation 1223/2009/EC
Observance of the compliance of the non-EU manufacturer at all times, once the product is properly put on the European market

Advisory services

Ongoing language maintenance and glossary development (for over 40 different languages)
Cosmetic products listing and notification according to European Member State national requirements
Product Information File (PIF) documentation review
Guidance on QMS implementation
Guidance on product testing and certification services
Guidance on Nano-materials Notification & Animal Testing
Support on GMP (EN ISO 22716) compliance

For additional information or to receive an offer, please visit our Fast Lane for E.A.R. services.