Cosmetics safety assessment

Before being introduced to the European Union market, each cosmetic product must be tested and assessed in terms of its safety of use by consumers.

The safety assessment is carried out by a qualified Safety Assessor and ends with the issuance of a Cosmetic Product Safety Report (CPSR). It includes, among others, an assessment of the conducted research and a risk analysis, supported by a toxicological analysis of the ingredients and the calculation of exposure factors.

Cosmetic safety assessment consists of several stages:

  • Assessment of compliance of the product composition with legal regulations,
  • Toxicological assessment of cosmetic ingredients,
  • Exposure assessment or exposure assessment,
  • Risk assessment for cosmetic ingredients,
  • Assessment of the results of laboratory and dermatological tests of the finished cosmetic,
  • Assessment of cases of adverse reactions,
  • Preparation of a cosmetic safety assessment report by the Safety Assessor

The Product Safety Assessment Report is the basis for registering the product in the Cosmetic Products Notification Portal (CPNP) database.

In order to prepare a complete product dossier, the following documents must be submitted:

  • Cosmetic product recipe (qualitative and quantitative composition),
  • Information on product specifications (application, operation, method of use, name, target group, e.g. product for children)
  • Raw material documentation – safety data sheets (SDS), certificates of analysis
  • A declaration by the manufacturer of the fragrance composition that it complies with IFRA recommendations, including a list of allergens
  • In the case of dyes – certificate that the dye meets the purity criteria in accordance with Commission Regulation 95/45/EC of 26 July 1995
  • Declaration of absence of CMR substances categories 1A and 1B and category 2 within the meaning of Part 3 of Annex VI to Regulation (EC) 1272/2008
  • GMP compliant production method statement
  • Label design
  • Declaration that the finished cosmetic and raw materials used in production are not tested on animals
  • Statement of no reports of adverse effects (for products already on the market)
  • Information about the material from which the packaging is made – preferred quality certificate
  • All laboratory test results

Ekolabos Laboratory provides full range of cosmetics registration/safety assessment services. Regarding the offer, please contact the Customer Service Office by phone: 22 378 30 34 or cosmetics@ekolabos.pl