The EU Regulation (EC) no. 1223/2009 regulates the essential requirements and obligations for cosmetic products at European level to ensure consumer safety and to secure an international market for cosmetics. It is complemented by Regulation (EU) no. 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products.
In addition, cosmetics are subjected to national regulations. In Germany this includes notification of cosmetic companies, the use of the German language and the labeling of non-prepacked cosmetic products.
For cosmetic products a central notification using the cosmetic product notification portal is required. By this notification national reporting requirements do no longer exist. The obligation for notification of the location of manufacturing facility in Germany (acc. to § 5d of German cosmetic regulation) remains.
The notification of a cosmetic product involves comprehensive documentation requirements of the product properties.
We support you in fulfilling the legal compliance to ensure a fast marketability for your efficient and safe cosmetic products.
- Regulatory advice for the marketability of cosmetic products
- Borderline assessments
- CPNP notification of cosmetic products
- Preparation of safety assessment and the product information file
- Toxicological assessment of raw materials
- In vitro safety testing (development of testing programs and study monitoring)
- Local tolerance studies
- Evaluation of systemic availability and safety
- Proof of efficacy in clinical studies
- Clinical studies for claim substantiation