With its team specialised in Regulatory Affairs, COSMETIC OFFICE offers you a wide variety of regulatory services in 5 different areas of expertise

PRODUCT INFORMATION FILE (PIF)

  • Elaboration of the Product Information File, in accordance with the requirements of European Regulation No. 1223/2009

– Completion of the inventory and the analysis of the data concerning the cosmetic product security (part A of the PIF), working closely with the manufacturers and subcontractors.

– Storage of all information via our R&D software

– Implementation of the conformity and security tests if necessary (challenge test, cutaneous tolerance, use test…)

– Coordination of the assessment of the safety of your products for human health (part B of the PIF), by compiling and verifying the data necessary for drawing up the safety report (toxicology data, challenge test, cutaneous tolerance, SDS etc.).

– Creation of the digital PIF and storage on a secure platform.

– Availability of the PIF in French and/or in English

 

  • Updating of the PIFs as the product evolves (name change, change in subcontractor etc.).

 

  • Pre-validation of the compliance and safety of the formulae, depending on the desired marketing areas.

Regarding regulatory support for borderline products (home fragrance products, biocidal products), contact us.

NOTIFICATION ON THE EUROPEAN CPNP

  • Creation of the obligatory electronic notification for the cosmetic products on the European CPNP (Cosmetic Products Notification Portal).

REGULATORY SURVEILLANCE

  • Implementation of a regulatory surveillance in order to create a warning system for changes that will have an impact on the compliance of the products.
  • Alert message in case of modification of the status of the substances.

LABELLING

  • Verification and validation of the regulatory compliance of the labels (allegations, compositions, obligatory mentions etc.) with the requirements of European regulation No. 1223/2009 or with foreign regulations.

PREPARATION OF EXPORT REGISTRATION FILES

  • Preparation of the elements necessary for drawing up the Export Registration Files (registration forms, specification documents, MSDS etc.) in accordance with the regulations of each of the countries concerned.

Our range of services is intended for all companies marketing cosmetic products or perfumes in Europe. It is therefore designed for people in charge of inventory, manufacturers, subcontractors and distributors concerned by the application of the European Cosmetics Regulation.

Iso 9001