EU Regulations and Compliance of Cosmetic Products
In order to ensure the protection of human health as well as the functioning of the European market, the European Commission established, in 2009, Regulation EC No 1223/2009 pertaining to the cosmetics industry.
This regulation has five objectives:
- To protect the consumer against unsafe products
- To protect the consumer against unfair commercial practices
- To provide the consumer with meaningful information in order to facilitate reasonable purchase decisions
- To implement specific values important to European citizens (e.g., animal testing, precautionary principles, etc.)
- To enable the effective functioning of the EU market (one regulation for all EU Member States)
This Regulation imposes various requirements which all cosmetic products in the EU market must meet.
For more than 12 years, BIORIUS has been an expert in European Cosmetics legislation (among other legal frameworks). We are proud to guide cosmetic brands, from start to finish, through the various steps of the regulatory process and to help cosmetics brands succeed in Europe.
EU Compliance Services:
Cosmetics Product Registration
The registration process consists of four requirements that a product must meet in order to be marketed within the European Union: a Product Information File (including a Cosmetic Product Safety Report), a compliant label, a CPNP number and a Responsible Person.
BIORIUS can manage the European registration process for your cosmetics brand, from start (collecting the data from your manufacturer) to finish (ongoing monitoring of your product to help consumers experiencing undesirable effects).
A cosmetics brand located outside the EU needs a Responsible Person (Article 4 and 5 of the European Cosmetics Regulation). By default, this Responsible Person is its importer. The problem with this is most importers refuse to serve in this role because it comes with complex obligations and significant risks. Therefore, no appointed Responsible Person for a non-EU cosmetics brand generally means no importer, and no importer generally means no access to the market.
Being a Responsible Person involves specific obligations and regulatory activities that require a high level of expertise. BIORIUS provides this service at a level not found elsewhere in the market and is fully equipped to fulfill this role.
And now that the UK has decided to leave the EU, you will also need a Responsible Person in the UK if you sell your cosmetic products there. Fortunately, BIORIUS has offices both in the UK and in the EU, and is happy to offer a true European response to this political dilemma.
Audit & Due Diligence
Life can be complicated, and there are many reasons that might push a cosmetics brand to change their Responsible Person. Before your new Responsible Person agrees to represent your products, her or she will need to understand the risk profile of your brand by checking the quality of your dossiers.
If you’ve chosen BIORIUS, thank you very much for your trust. We guarantee that our audit strategy will be adapted to ensure that it’s as rapid and cost-effective as possible for you.
To acquire (and sell) cosmetic brands is an exciting moment for a company, but is this exciting new line of products really safe and compliant? No one wants to buy blind and, in turn, be overwhelmed by legal issues that may end up being costly and damaging your reputation.
BIORIUS offers a top-notch due diligence service performed by our most senior experts to shed light on a company’s regulatory situation. With a high level of reactivity and an impressive drive for perfection, reports highlighting compliance issues are delivered in easy-to-understand language, intended to evaluate risks and expected costs.
Chemical substances contained in cosmetic products are required to comply with the European REACH Regulation (CE 1907/2006). BIORIUS can help your cosmetics brand by ensuring the compliance of the ingredients used in your cosmetic formulations.
A Responsible Person manages most of the regulatory issues and, in doing so, helps importers and distributors focus on their true talents: advertising and selling cosmetic products. However, importers and distributors are not exempt from all regulatory requirements and may still get into trouble as a result of the legislation. Because BIORIUS seeks to prevent these troubles from occurring, we’ve developed a consistent and effective program that’s 100% dedicated to the protection and the support of importers and distributors.