Cosmetic Formulation Review

One key component of your Product Information File (PIF) – the mandatory documentation for manufacturers – is the formula. The formula you are selling in a non-EU country might not be allowed in the European Union. Indeed, the EU has very strict rules on banned and restricted ingredients.

As your Responsible Person (RP), Obelis checks your ingredient one by one, making sure they are meet the regulatory requirements on restrictions and bans.

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                                       Cosmetic Product Composition

As your RP, Obelis will help you prepare the formula overview to send for the Safety Assessment Report (SAR). Each formulation must show the INCI name, CAS number, concentration, and function of each ingredient.

Obelis provides you with all necessary documents and guidance to help you compile the formula template. If any information is missing, we provide you with the tools to retrieve the information or proactively contact the producers. Our goal is to ensure that your formula will be promptly accepted by the Safety Assessor.

If your producer does not want to disclose any formulation details, we guarantee confidentiality by signing a Non-Disclosure Agreement (NDA) between the parties.

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Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.