EU/UK 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, the Regulation EC No 1223/2009 pertaining to the cosmetics industry. This regulation has mainly 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, etc.)
To enable the effective functioning of the EU market (one regulation for all EU Member States)
This Regulation enforced various requirements that all cosmetic products in the EU market must meet.
The four main ones can be summarized as follows. If one of these obligations is not fulfilled, the placing on the market is not allowed. A fifth obligation, almost trivial and embedded in the four others, is to ensure that cosmetic products do not contain prohibited ingredients, ingredients above their maximum use levels, and ingredients containing prohibited impurities.
Product Information File (PIF)
Responsible Person (RP)
Compliant Product Label
Brexit and Legislation
Following the Brexit, the UK enforced its own cosmetics legislation, known as The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, Schedule 34 », generally abbreviated as the « UK Cosmetics Regulation ». We do not know how this piece of legislation will evolve over time but right now, the main legal requirements remain the same as in the EU, apart from the notification, which must be notified on SCPN (UK portal) and the Responsible Person, which must be based in the UK. For more detail, please, check this page.
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:
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.
Cosmetic Product Registration (CPSR, PIF, CPNP,..)
As outlined above, the registration process in the EU (and the UK) consists of four requirements that a product must meet in order to be marketed: 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 (marketing brief review, data collection from your manufacturer) to finish (management of questions and inspections from the national competent Authorities, cosmetovigilance follow-up to help consumers experiencing undesirable effects).
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, it 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 (EC No 1907/2006). BIORIUS can help cosmetic brands to take care of their Downstream User’s obligations and, by doing that, reassure EU importers and distributors (normally responsible for this verification).
If needed, BIORIUS can even proceed to REACH registration of substances used or imported to the EU beyond 1 ton/year.
Similarly to the role of Responsible Person, BIORIUS can play the role of Only Representative in the EU and the UK.
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 also have to comply with the European Cosmetics Regulation (and related legal texts) and may get in trouble if they underestimate their obligations. As a response, BIORIUS developed a consistent and effective program entirely focused on the protection of importers and distributors: the best regulatory service possible to support the growth of a solid distributor network.