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 requirements for manufacturers and importers of cosmetic products.
Since 11 July 2013 the new Cosmetic Regulation (EC) No. 1223/2009 applies. Therein the obligations of manufacturers, importers and distributors were revised.
Prior to the release of a cosmetic product, a detailed and comprehensive safety assessment is required. Here, the sanitary harmlessness of the product must be assigned by a toxicological assessment of all ingredients by taking the exposure for intended and reasonably foreseeable use into account.
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. We accompany you till your market launch and also advise you on matters relating to the implementation of Good Manufacturing Practice (GMP for cosmetics).
Our services at a glance:
- 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 guidelines)
- 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
- Preparation of material on (serious) undesirable effects
- Services for communication with authorities
- Preparation of ingredient profiles (e.g. to determine maximum use concentration)
- Evaluation of requirements and application for EU Ecolabel for rinse-off cosmetic products
- Training in topics related to the Cosmetics regulation/ cosmetic GMP
We will be happy to make you an individual offer. Therefore we need the number and the composition of the products which have to be evaluated.
For further questions about the implementation of the EU Cosmetics Regulation, please contact our specialist:
Dr. Jutta Fuhlrott
Phone: +49 201 798 70 – 192
Fax: +49 201 798 70 – 386