Safety assessment

Cosmetics Regulation 1223/2009 aims to ensure the safety of cosmetic product consumers. This means that each cosmetic product has to be the subject of a safety assessment performed by a qualified person before the product can be placed on the EU market.

Safety assessment is part B of the cosmetic product safety report (CPSR), and therefore the vital part of the Product Information File. It is conducted based on the part A of the CPSR, which is cosmetic product safety information.

In order to demonstrate that a cosmetic product complies with Article 3, 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 in accordance with Annex I. (EU Regulation 1223/2009, Article 10.1)

Safety assessment:

  • Concludes whether the product is safe and in conformity with the regulation or not
  • Provides reasoning that led to such conclusion
  • Lists any precautions for use that have to appear on the label
  • Includes assessor’s credential and their approval

The EU Cosmetics Regulation also lists requirements for the safety assessors. That person should of course be knowledgeable about the EU cosmetics regulation, but the regulation also poses some additional requirements. It says that the safety assessment has to be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, from the EU, or a course recognized as equivalent in the EU.

CE.way’s safety assessors are highly skilled and have years of experience in conducting safety assessments for cosmetic products.