CEPRA for Chemicals

Cosmetovigilance

CEPRA offers a consultancy service for the management of surveillance of cosmetic products already placed on the market (COSMETOVIGILANCE).
Regulation 1223/2009 requires the Responsible Person to promptly notify the competent authorities of any case of serious undesirable effect (SUE) resulting from the use of a cosmetic product.

CEPRA provides companies with full assistance in the management of cosmetovigilance by providing the following services:

  • Establishment and management of a post-marketing surveillance system: We support companies in establishing and maintaining an internal continuous monitoring system for the detection and management of undesirable effects.
  • Collection, evaluation and monitoring of adverse effect reports: We manage the collection of reports of undesirable effects observed during or after product use, providing all the information needed to open a file and launch a thorough investigation.
  • Causality assessment: We analyse the possible correlation between the reported effects and the use of the suspected cosmetic product.
  • Notification to competent authorities: In case of an SUE, we take care of the official notification to the competent authorities, filling out the appropriate forms and ensuring that all information is complete and timely.
  • Updating the Cosmetic Product Safety Report (CPSR): We support the continuous updating of the CPSR, taking into account data on serious undesirable effects and cosmetic product safety.
  • Archiving and organisation of documentation: We take care of the systematic archiving and management of all documentation relating to undesirable effects (UE).

Latest News

Switzerland, FDHA: More targeted control of furocoumarins in cosmetics
Switzerland, FDHA: More targeted control of furocoumarins in cosmetics

On 9 December 2025, the Swiss Federal Department of Home Affairs (FDHA) updated the Cosmetics Ordinance, introducing more targeted control of furocoumarins in leave-on cosmetic products with...

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France: ban on PFAS in cosmetics from 1 January 2026 On 28
France: ban on PFAS in cosmetics from 1 January 2026 On 28

On 28 December 2025, France published Decree No. 2025-1376, aimed at preventing the risks arising from exposure to perfluoroalkyl and polyfluoroalkyl substances (PFAS). The measure introduces a ban...

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Consultation on harmonised waste-sorting labels in EU

Currently, the EU has no harmonised labelling requirements for waste recycling. This leads to the need to differentiate labelling according to different national requirements. In view of the new...

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