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 national and European law:
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products < / span>
Cosmetics Act of March 30, 2001 (Journal of Laws No. 42, item 473)
General Product Safety Act of December 12, 2003 (Journal of Laws No. 229, item 2275)
Cosmetics safety assessment consists of several steps:
- Assessment of product composition compliance with legal regulations,
- 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 the cosmetic safety assessment report by the Safety Assessor
The Product Safety Assessment Report is the basis for product registration in Cosmetic Products Notification Portal (CPNP)
Number of samples needed for testing:
- epidermal dermatological examination: at least 2 packages of 50g
- laboratory tests: 10-15 samples in target packaging
- application dermatological examination 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
- For all MSDS raw materials
- Statement by the fragrance manufacturer that it complies with IFRA recommendations, including an allergen list
- In the case of dyes – a certificate that the dye meets the purity criteria in accordance with Commission Regulation 95/45 / EC of 26 July 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 the Regulation (EC) 1272/2008
- GMP Compliant Manufacturing Method Statement
- Label design or product specification information (application, action, usage, name, target group e.g. product for children)
- Statement on the non-testing of the finished cosmetic and raw materials used in production on animals
- Statement of no reported adverse effects (for products already on the market)
- Information about packaging material – preferred certificate of quality.
- All lab and dermatological test results
Ekolabos Laboratory provides services of Cosmetics Registration / Cosmetic Product Safety Assessment in full. For the offer, please contact the Customer Service Office at the number: 71 738 20 25 or biuro@ekolabos.pl