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Regulamento cosmético na União Europeia


EU Cosmetic

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.


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.

Formulation review

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.

Security Assessment Report (CPSR)

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.

Product Information File (PIF) and CPNP notification

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.

Review of Labels and Claims

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.

Responsible Person in the EU
FAQ regulametos cosmético na União Europeia e Estados Unidos

Clarify your doubts about European Union and United Kingdom Cosmetic Regulations with our FAQ.

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