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Compilation of safety assessment of cosmetic products


Services related to the authorization of cosmetic products

 

In order to demonstrate that a cosmetic product complies with law, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up. 

 

The information needed for compiling the safety assessment:

  • Data and contact of the manufacturer and the distributor company.
  • Product formulation.
  • The safety data sheet of the components conforming to the REGULATION No EU 453/2010, the specification of the components, the components’ certificate of analysis, ensuring that they meet the requirements on cosmetic products. (It shall be marked in the specification and certificates that the cosmetic product has been produced (also) for application as basic substance.). LOAEL or NOAEL values relevant to the components shall be attached to the components (these can be given by the supplier of the raw materials).
  • List of Allergen fragrances
  • Data relevant to the finished product, specification (physical, chemical parameters, microbiological cleanness, etc.). Microbiological cleanness shall be justified by laboratory testing
  • Specification of pack sizes, packing, packaging material, certificate that they meet the requirements relevant to cosmetic product packaging.
  • Stability tests
  • Description of manufacturing method, manufacturing site certificates (about GMP compliance)
  • User manual
  • The original product’s label in the language of the country where the product was first placed on the market
  • Statement on whether animal testing was used

 

The list is for information only. Besides the information above, more data may be used depending on the product’s type/nature.

Please note that the collection of the data above may take a long time, so it is worth to begin collecting the documents/data at the initial steps in case of notifying a new product.

 

Legal background:

We compile the safety assessment relevant to the new regulation on cosmetic products!

REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

 

 

Tags:  1223/2009/ECcosmeticssafety assessment


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