Before being placed on the European Union market, each cosmetic product should be tested and assessed in terms of its safety by consumers. These requirements have been imposed on Producers and Distributors by the provisions of national and European law:

Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 relating to cosmetic products

The Cosmetics Act of March 30, 2001 (Journal of Laws No. 42, item 473)

Act on general product safety of December 12, 2003 (Journal of Laws No. 229, item 2275)

Cosmetics safety assessment consists of several steps:

  • Assessment of the compliance of the product composition with the law,
  • Toxicological assessment of cosmetic ingredients,
  • Exposure assessment or otherwise exposure assessment,
  • Risk assessment for cosmetic ingredients,
  • Evaluation of the results of laboratory and dermatological tests of the finished cosmetic,
  • Assessment of undesirable effects,
  • Preparation of a cosmetic safety assessment report by the Safety Assessor

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

Number of samples necessary for testing:

  • epidermal dermatological examination: at least 2 packages of 50g
  • Laboratory tests: 10-15 samples in target packages
  • application dermatological testing of 25 samples in target packaging

To prepare a complete product dossier, the following documents must be submitted:

  • Recipe of a cosmetic product (qualitative and quantitative composition), individual raw materials signed according to INCI nomenclature, dye numbers according to Color Index (CI No.), CAS No., percentage
  • Material Safety Data Sheets (MSDS) for all raw materials
  • Statement by the fragrance manufacturer that it complies with IFRA recommendations, along with a list of allergens
  • In the case of dyes – a certificate that the dye meets the purity criteria in accordance with Commission Regulation 95/45 / EC of July 26, 1995.
  • Statement on the 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
  • Statement on the GMP-compliant production method
  • Label design or information on product specification (application, action, method of use, name, target group e.g. product for children)
  • A declaration that the finished cosmetic and raw materials used for production are not tested on animals
  • Statement of no reported adverse effects (for products already on the market)
  • Information on the packaging material – the preferred certificate of quality.
  • All the results of laboratory and dermatological tests

The Ekolabos Laboratory provides a full range of cosmetics registration / cosmetic product safety assessment services. For the offer, please contact the Customer Service Office at the number: +48 22 378 30 34 or cosmetics@ekolabos.com