The EU Regulation (EC) No. 1223/2009 defines and regulates the various requirements and obligations for cosmetic products. It is supplemented by Regulation (EU) No. 655/2013 laying down common criteria for the justification of claims related to cosmetic products.
A cosmetic product does not have to be authorized per se, but responsible persons – manufacturers, importers or distributors – have to consider a large number of rules in order to be able to demonstrate the safety of their cosmetic products. A product information file (PID) that contains a safety assessment for your cosmetic product has to be set up. In addition, cosmetic products must be registered in the Cosmetic Product Notification Portal (CPNP) so that in an event of any adverse health effects caused by a cosmetic product the necessary information is available to the relevant authorities for a rapid and effective medical treatment. Also the labelling of a cosmetic product must follow legal requirements.
We will be happy to assist you in this complex area:
- Preparation of the product information file (PID)
- Preparation of the safety assessment report
- Notification of cosmetic products in the European online portal “CPNP” (Cosmetic Products Notification Portal)
- Labelling: preparation of a draft for a label or verification of your labels, preparation of the list of ingredients (INCI)
- Efficacy statements/advertising: research of available scientific studies and advice on advertising possibilities
- In-house training on cosmetics law, individually designed to your products, your advertising material and your web presentation
The EU rules and regulations call for medical devices to be labeled with a CE label in order to be marketed in Europe and they must comply with the requirements of the medical device law with regard to safety, performance and lack of adverse health effects. This must be documented in writing as part of the conformity assessment.