Obelis European Responsible Person Center (O.E.R.P.C.) established since 1988 and ISO 9001:2008 certified, acts as a "responsible person" covering the whole EU, all in accordance with the Cosmetic Directive 76/768/EEC & the new Regulation EC 1223/2009. The "Responsible Person" must ensure compliance with European requirements. As such, we collect and verify all the technical documentations required for the compilation of the Product Information File (PIF) and we complete the mandatory Pre-Market notification of the Cosmetic products.
"Responsible Person" - Professional Services :
"Responsible Person" covering 31 EEA countries
Classification & Identification of Proper Regulation.
Product Information File (PIF) Compiling, Keeping and Updating (including Safety Assessment).
Keeping the PIF readily accessible to the Competent Authorities for the duration required.
Cosmeto-vigilance Contact Point and communication of Serious Undesirable Effects (SUE).
Labeling and Language Requirements covering 31 EEA countries.
Pre-market notification to the EU Competent Authorities and Toxic Centers.
Additional Consultancy : GMP good manufacturing practices, GLP good laboratory practices,
Safety Assessment, notification of nanomaterials, animal testing.
