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The EU Cosmetic Products Regulation (Regulation (EC) No 1223/2009) will fully replace the Cosmetic Directive in July, 2013. The new regulation requires the Cosmetic Product Safety Report which will replace the Toxicological Risk Assessment which is formerly required.


Toxicological Risk Assessment (TRA) is a safety evaluation of cosmetic product based on its ingredients before the product is put on the market. It is legally required according to the EU Cosmetic Directive (76/768/EEC) as a measure to ensure a cosmetic will not cause damage to human health under normal or reasonably foreseeable conditions of use. Manufacturer/supplier has to provide the following information to perform the TRA:

  • Product identity
  • Full formulation of all ingredients with respective chemical names and CAS No., added up to 100%
  • Percentage active of ingredients (normally applicable for surfactants)
  • Material Safety Data Sheet (MSDS)
  • Allergen declaration, IFRA certificate and MSDS of parfum/ fragrance if used


The EU Cosmetic Products Regulation (Regulation (EC) No 1223/2009) will fully replace the Cosmetic Directive in July, 2013. The new Regulation has as its main objectives to guarantee a high level of consumer protection while ensures the good functioning of the internal market. To continuously fulfill the safety requirement, TRA will be replaced by the Cosmetic Product Safety Report. Annex I of the Cosmetic Regulation has provided a framework on particulars that has to be included in the report.
In comparison with those required by TRA, additional information has to be submitted and included in the Cosmetic Product Safety Report to ensure a more holistic assessment of the product. Below as a few examples:

  • Intended function of ingredients
  • Physical/ chemical characteristics e.g. pH value
  • Stability of cosmetic product
  • Microbiological specifications, preservation challenge test
  • Surveillance complaint and undesirable effects received
  • Usage and dosage for novel cosmetic product

If you would like to know more about the details of the cosmetic safety report, SGS can help to provide you an answer. Contact us now!

Download information on the (EU Cosmetic Product Safety Report)

Ms. Harrient HO (Healthcare & Cosmetics)
t: +852 2609 9611 (ext 3356)
f: +852 2603 7577

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 75,000 employees, SGS operates a network of over 1,500 offices and laboratories around the world.