Essential Requirements

Safety Assessment

  • The safety assessment is the written evaluation on the safety of the cosmetic product
  • The safety assessment is required by Article 10 of the European Regulation (EC) No. 1223/2009 for every cosmetic product on the European market and must in place in place prior to notification via CPNP.
  • The safety assessment is the core element of the Product Information File (PIF) and shall certify the safety of the cosmetic product for human health.
  • The safety assessment shall be conducted only by a qualified person holding a degree in chemistry, toxicology or a related discipline which is recognized within the European Union.
  • The safety assessment of your cosmetic product will be prepared on your behalf by an external expert on the basis of provided documentation and established literature, considering raw materials, packaging information as well as toxicological, dermatological and microbiological aspects.
  • If any additional testing of your cosmetic products may be required for the safety assessment, MDSS’ partner companies and laboratories will be glad to help you further.
  • The provided documents together with the safety assessment results in the Cosmetic Product Safety Report (CPSR).

Notification via Cosmetic Product Notification Portal (CPNP)

  • MDSS will immediately notify your cosmetic product via Cosmetic Product Notification Portal (CPNP) as soon as the Product Information File is completed (including safety assessment).
  • The notification via CPNP can be usually conducted within one or two working days.
  • Your product will be then ready to be placed on the European market.
  • No further approval or notification on European level will be additionally necessary.
  • Full access to the CPNP information is only granted for the competent authorities of the European Union Member States and the European poison centers. Responsible Persons have only access to their own entries and product information.
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