Cosmetic raw materials
The animal testing ban – which applies not only for cosmetic products, but also for ingredients – makes it sometimes challenging to the compile toxicological profiles for cosmetic raw materials. Based to our extensive experience in the toxicological evaluation of substances and alternative methods (read-across, in silico methods) we can provide advice for the compilation of toxicological profiles of your ingredients.
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Cosmetic products
Cosmetic products are applied directly to the human body. This requires a detailed legal regulation and control for the protection of the consumer. Therefore, there are high demands on the safety assessment, the preparation and the notification for manufacturers and importers of cosmetic products.
The Cosmetic Regulation (EC) No. 1223/2009 establishes the obligations of manufacturers, importers and distributors.
In a nutshell: Prior to the release of a cosmetic product, a detailed and comprehensive safety assessment is required. The safety of the cosmetic product must be demonstrated by a toxicological assessment of all ingredients taking into account the exposure for intended and reasonably foreseeable use.
Due to our longstanding experience in the toxicological evaluation of substances and products, we are your partner for the implementation of the EU Cosmetics Regulation (EC) No. 1223/2009 and Swiss regulation of the DFA on cosmetic products (Vkos). We assist you from your idea to market launch and also advise you on matters relating to the implementation of Good Manufacturing Practice (GMP for cosmetics).
Our services at a glance:
- Compilation of toxicological profiled for ingredients (e.g. to set maximum use concentrations in different product types)
- literature research
- read-across from analogous substances
- in silico methods (quantitative structure activity relationships (QSAR) etc.)
- Competent and comprehensive strategy consulting, from idea to market
- Evaluation of marketability (demarcation from drugs, medical devices, biocidal products; evaluation of conformity with respect to prohibited/ restricted ingredients; evaluation of conformity with existing natural cosmetics criteria)
- Guidance on required laboratory tests (e.g. microbiological tests)
- Preparation of safety assessments in accordance with Art. 10 of the EC Regulation 1223/2009
- Preparation of the product information file according to Art. 11 of the EC Regulation 1223/2009
- Notification according to Art. 13 of the EC Regulation 1223/2009
- Evaluation/review of existing safety assessments and product information files
- Review of labelling according to Art. 19 of the EC Regulation 1223/2009
- Consultancy and auditing of compliance with Good Manufacturing Practice (GMP) DIN EN ISO 22716
- Training in topics related to the Cosmetics regulation/ cosmetic GMP
Dr. Jutta Fuhlrott