EU Cosmetic Regulation
How to start selling cosmetics in Europe?
The sale of cosmetic products on the European market requires prior care to ensure full compliance with the obligations established in Regulation (EC) No. 1223/2009.
With more than 500 million consumers and high purchasing power, the EU market is, without a doubt, one of the most attractive for cosmetics brands, but it is also one of the most demanding. Pharmilab, with more than a decade of experience helping customers from different countries enter the market, will guide you through all the necessary steps to be able to sell your cosmetic product on the European market.
Step 1
Formulation review
This is the first step in the entire process, and an essential moment where the Regulatory and safety compliance of the ingredients is assessed (some ingredients are restricted/banned), the list of ingredients is established and the mandatory laboratory tests are carried out.
This step is a prerequisite for preparing the CPSR (Cosmetic Product Safety Report) and checking the product label.
Formula review is a meticulous review of your cosmetics formula to ensure that all ingredients are safe for the intended use and comply with European cosmetics regulations.
Thus, the composition is entirely reconstructed from its raw materials. Raw material documentation is reviewed to verify regulatory compliance and the impurity profile is assessed.
Preliminary calculations and investigations are carried out to ensure that each ingredient and impurity is safe, taking into account the cosmetic product, its intended use and the target population.
Step 2
Security Assessment Report (CPSR)
The CPSR (Cosmetic Product Safety Report) is a long and complex dossier in accordance with the EU cosmetics regulation.
The CPSR is an exhaustive document prepared by a qualified toxicologist (in accordance with number 2 of article 10 of regulation 1223/2009). This safety report aims to support and confirm the safe use of the cosmetic product, taking into account all available information, such as toxicological profiles of each ingredient and impurity, test results, certificates, declarations, raw material documentation, etc. . The introduction of a cosmetic product onto the EU market without a high-quality RPCS is a serious infringement leading to market withdrawal, significant financial sanctions and serious damage to the cosmetic brand's reputation.
The CPSR is made up of two distinct sections, Part A and Part B.
Part A: Information on the Safety of Cosmetic Products. This part of the report contains all the data necessary to evaluate the cosmetic product.
Part B: Cosmetic Product Safety Assessment. This part of the report includes an assessment of the cosmetic product's safety and conclusions. Part B is essential as it certifies the efficacy and safety of a product before it is placed on the EU market.
Step 3
Review of Labels and Claims
EU rules on cosmetics labeling can seem very confusing, and although they are the responsibility of distributors (according to Article 6 of the EU Cosmetics Regulation), developing and publishing labels and packaging is continue to be a costly task for cosmetics brand owners.
Some elements will, in fact, have to be translated into all official languages of the countries where the products are sold, and distributors must ensure that this information is properly translated. In fact, labels in English alone are not always sufficient. Labels (or certain parts of labels) must be translated into the country's language, but this largely depends on each EU country, which considering its 27 countries, with their 24 different languages, may not be an easy task.
Distributors naturally have every right to refuse products that do not meet these requirements.
A clear label is important to help consumers with their purchases and to protect their health. All important information must always be easily accessible, legible and understandable to the consumer at the time of purchase. The rule is quite simple: the end consumer must understand exactly what they are buying when they check the product.
A Label Review is a complete compliance of packaging and labels, which checks claims, PAO (Period After Opening), INCI list, etc.
Therefore, a review of labels and support on specific claims or topics that the brand wants to promote as marketing text (by a specialized team like Pharmilab) is essential.
Step 4
Product Information File (PIF) and CPNP notification
A PIF (Product Information File) is a cosmetic regulatory dossier that contains:
Qualitative and quantitative product formula
Microbiological and physicochemical specifications
Packaging information
Label
CPSR
Manufacturing method
Declaration of GMP and non-testing on animals
Proof of claimed effects
A Product Information File is a large, highly structured dossier that contains all information related to a particular cosmetic product. Some of the data comes from product manufacturers, some data comes from independent laboratories, and some data comes from a suitably qualified safety assessor.
Once the preparation of the PIF has been completed, the cosmetic product can be notified electronically to the European Commission through the CPNP (Cosmetic Product Notification Portal) and is assigned a unique CPNP number. This number can be requested from the importer and the Responsible Person at any time, particularly by customs officials.
In other words, a notification consists of announcing to Europe that a product is going to be sold in Europe.
Technically, cosmetic products are not registered in the EU; are notified. Unlike other countries and regions that require pre-approval of products by competent authorities, the EU requires notification before the product can be launched on its market. This means that verification by competent authorities is carried out after the product has been launched on the EU market. For this reason, the selection of a qualified and competent Responsible Person is especially important.
Etapa 5
Responsible Person in the EU
The Legal Representation for cosmetics in Europe is called the Responsible Person. The Responsible Person has many responsibilities and will be held responsible in the event of a non-compliance issue.
A simple and easy way to explain the Responsible Person is:
Who do European countries have to contact if they want to control their cosmetic product?
Who should a consumer contact if they have an unusual reaction to their cosmetic product?
In the CPNP, a Responsible Person is designated for each notified product. Among other important functions, this Responsible Person will ensure compliance of cosmetic products on an ongoing basis and update the PIF when necessary.
In short, choosing the Responsible Person is extremely important, as it involves many responsibilities. Working with an experienced company like Pharmilab is the best choice for the success of the cosmetic brand in the European market.
FAQ
What is a PIF (Product Information File)?
Every product placed on EU and UK markets must have a product information file (PIF) compiled. The PIF is a set of various documents and tests related to the finished product, raw materials, packaging specifications, manufacturing process, etc. The content of the PIF is described in Article 11 of the EU Cosmetic Products Regulation, where it is written that the PIF must contain the following information and data:
A description of the cosmetic product that allows the product information file to be clearly attributed to the cosmetic product
The cosmetic product safety report referred to in paragraph 1 of article 10.
A description of the manufacturing method and a declaration of compliance with good manufacturing practice referred to in Article 8.
Where the nature or effect of the cosmetic product justifies it, proof of the effect claimed for the cosmetic product
Data on animal testing carried out by the manufacturer, its agents or its suppliers in connection with the development or safety assessment of cosmetic products or their ingredients, including any animal testing carried out to comply with country legislative or regulatory requirements the 3rd.
The product information file must be maintained by the responsible person, at a single address in the EU (which must be specified on the label), readily accessible to the competent authority of the Member State where the responsible person maintains the PIF, even for 10 years after the last batch of the product was placed on the market.
The documents contained in the BIP must be written in a language that is easily understandable by the competent authority of the Member State where the BIP is stored.
What is GMP (Good Manufacturing Practice)?
To ensure the safety of cosmetic products placed on EU and UK markets, cosmetic products must be produced in accordance with good manufacturing practice (GMP).
There are several GMP standards, but the applicable standard in the EU is ISO 22716. This standard provides guidance for the production, control, storage and dispatch of cosmetic products and affects manufacturers, as well as suppliers, retailers, brand holders and cosmetic product retailers.
What is the CPNP?
CPNP is the acronym for Cosmetic Products Notification Portal. This is an EU online notification system where responsible persons submit certain information about the cosmetic products they place or make available on the EU market. This information is then made available to competent authorities and poison centers in EU Member States.
What is SCPN?
SCPN stands for Submit Cosmetic Product Notifications. This is a Great Britain (GB) online notification system in which responsible persons submit certain information about the cosmetic products they place or make available on the GB market. This portal is managed by the Office for Product Safety and Standards (OPSS).
