Your Consultant for Cosmetics
As your RP, Obelis will:
Once products have been registered (notified), the EU Responsible Person should also provide:
- Ongoing Regulatory updates & EU Market Consultancy
- Post-Marketing Surveillance: reporting of Serious Undesirable Effects (SUE), support regarding any EU Competent Authority requests, corrective measures,
- Immediate corrective measures, withdrawal/recall if appropriate in case of non-compliance.
- Immediate information to competent authorities (CA) and other economic operators in case of risk to the protection of human health.
- Provide information and documentation to demonstrate conformity as per requests by national authorities. Keep the PIF readily accessible to the Competent Authorities for a period of 10 years after the last batch was placed on the market.
We register your Cosmetic Products in Europe in 8 working days!
Supporting tools
- Labelling Guidance
This tool provides you with useful guidance on the labelling requirements set out by Cosmetic Regulation 1223/2009. You will get an overview of the elements you will need to display on your label to comply with European legislation.
- How to compile your PIF
Compiling a Product Information File (PIF) is one of the key steps you need to comply with when it comes down to putting your cosmetic products on the European market. This tool provides you with the guidelines you will need to follow.
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
About us
