Sinerga checks the conformity to the laws in force the cosmetics manufacturing


Sinerga provides a constant support to its customers in terms of Regulatory Affairs, concerning Cosmetics, Medical Device and Raw materials.

Our Regulatory Dept. provide a broad range of services:



  • Verification of formulation compliance with the requirements of CEE regulation n. 1223/2009.
  • Constant monitor on the legislative adjournments in order to inform the client accordingly.
  • Support in the selection of safety and efficacy tests to carry out the product’s launch.
  • Evaluation of the correct wording, claims and icons to be printed on labels and packaging.
  • Drafting of P.I.F. (Product Information File) and related safety assessments.
  • Support and notification at the European portal CPNP (Cosmetic Products Notification Portal).
  • Support in the creation of documents useful to export in non-EU countries.



  • Verification of formulation compliance with the requirements of the Directive 93/42/CEE; legislative decree February, 24th 1997, n. 46.
  • Support in the choice and implementation of biocompatibility tests in collaboration with the most qualified testing laboratories.
  • Support in the choice of a protocol for clinical investigations and the subsequent implementation.
  • Support in the preparation of the technical dossier.
  • CE Marking.



  • Safety Data Sheets in accordance with the 1907/2006 Regulation (EC) and subsequent amendments.
  • Drafting of technical datasheets.
  • Creation of Technical Dossiers.
  • Verification of compliance with major international inventories (IECIC, DSL / NDSL AICS ICL etc.).
  • Compilation of COSMOS, ECOCERT, NATRUE questionnaires.
  • Additional documentation available (questionnaires, additional efficacy tests...) to fulfill the customer’s requirements.