EU cosmetics regulation

Are you planning to sell your cosmetics in Europe ?

Europe is a lucrative market of nearly 500 million consumers. Europe is, along-side the USA, the largest market of cosmetic products in the world (valued at €80 billion at retail sales price in 2021). However ensuring that a cosmetic product complies with the EU cosmetics regulation and a number of other European or national regulatory frameworks before launching into the market can be a long and bumpy road for cosmetic brands. As nicely worded by a piece of European legislation: “No data, no market”.

Europe is one of the most complicated cosmetic regulation in the world

EU cosmetics regulation: much legislation has been enacted over years to better protect consumers, animals and the environment, to better inform end users and to better harmonize national laws. As such, every cosmetic product available in the European market, whether for payment or free of charge, needs to comply with a long list of legal requirements.

 

Biorius, Specialist in EU cosmetic safety assessments

As specialists in EU cosmetic safety assessments and EU cosmetics regulation for more than 15 years, Biorius offers a reliable turnkey solution for verifying and registering cosmetic products in an effective way. This solution, based on in-depth knowledge of the legislation, consists of a team of more than 50 scientific consultants offering a wide range of expertise and sophisticated IT tools and is the fastest and most reliable way to access the European market.

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How does Biorius assist you?

Our European registration process requires 5 IMPORTANT STEPS for cosmetic products:

Step 1: Formula Review

The first step is a Formula Review:

  • Regulatory and Safety Compliance of the Ingredients (because some ingredients are restricted/prohibited)
  • Establishment of the INCI List
  • Confirmation of the mandatory lab tests

This step is a prerequisite for the preparation of the CPSR (Cosmetic Product Safety Report) and the verification of the product label.

The formula review is a meticulous review of your cosmetics formula to ensure that all ingredients are safe for their intended use and comply with the European cosmetics regulation:

  • The composition is entirely rebuilt from its raw materials and the formula is expressed in trade names. The raw materials documentation is reviewed to verify its regulatory compliance, and the impurities profile is highlighted.
  • Preliminary calculations and investigations are conducted to ensure that each ingredient and impurity is safe, given the cosmetic product, its intended use and the targeted population.

Step 2: Cosmetic Product Safety Report (CPSR)

The CPSR (Cosmetic Product Safety Report) A&B (signed by a Toxicologist) is a long and complex file of the EU cosmetic regulation.

The CPSR is a comprehensive document produced by a qualified toxicologist. This safety report intends to support and confirm the safe use of the cosmetic product, taking into consideration all pieces of information available, such as toxicological profiles of each ingredient and impurity, test results, certificates, declarations, raw materials documentation, etc. Introducing a cosmetic product to the EU market without a high-quality CPSR is a serious offensive that typically leads to withdrawal from the market, significant financial penalties and serious damage to the cosmetic brand’s reputation.

The CPSR takes the form of two distinct sections, Part A and Part B.

Part A: Cosmetic Product Safety Information

This part of the report contains all data needed for the evaluation of the cosmetic product.

Part B: Cosmetic Product Safety Assessment

This part of the report includes an evaluation of the cosmetic product’s safety and conclusions. The Part B is essential, as it certifies the effectiveness and safety of a product before being placed on the EU market.

Step 3: Product Information File (PIF) and CPNP Notification

A PIF (Product Information File) is a complete cosmetic regulatory file that contains:

  • Formula
  • CPSR A&B
  • Labels

A Product Information File is a large and highly-structured dossier containing every piece of information related to a given cosmetic product. Some of the data come from product manufacturers, other data from independent laboratories, and yet other data comes from a duly-qualified safety assessor. Learn more about the Product Information File (PIF)

Once the PIF has been completed, the cosmetic product can be notified electronically in the European Commission via the CPNP (Cosmetic Product Notification Portal) and a unique CPNP number is delivered. This number can be requested from the importer and the Responsible Person at any time, notably by customs officers.

In other words, a notification is to announce to Europe that you will sell a product in Europe.

Technically, cosmetic products are not registered in the EU; they are notified. Unlike other countries and regions that require pre-approval of the products by the competent authorities, the EU requires notification before the product can be launched in its market. This means that verification by the competent authorities is performed after the product is launched in the EU market. For this reason, selecting a qualified and competent Responsible Person is especially important.

Step 4: Labels and Claims Review

The EU cosmetic labelling rules may seem very confusing and although it falls under the responsibility of the distributors (according to Article 6 of the EU cosmetics regulation), the design and edition of labels and packaging are and remain a costly exercise for cosmetic brand owners.

Some elements will indeed have to be translated into all the official languages of the countries where the products are sold, and Distributors have to ensure this info is properly translated. Labels only in English are indeed not always sufficient. The labels (or certain parts of the labels) indeed must be translated in the country’s language, but it really depends on each EU country. Welcome to EU, one of the largest market for cosmetic products in the world… and their 27 countries with their 24 different languages!

The distributors are of course fully entitled to refuse products that would not comply with these requirements.

A clear label is important to help consumers for their purchases and to protect their health, all important information always has to be easily accessible, readable and understandable by the consumer at the time of purchase. The rule is actually quite simple: the end-consumer has to understand precisely what he is buying when he is checking the product.

A Label Review is a complete compliance of packaging and labels and the experts will check everything on the packaging and labels: claims, PAO (Period After Opening), warnings, INCI list, … .

In summary, making a Label Review in Europe (complete review and revision of labels and claims that take into account all European regulations) and a consultancy on specific claims or topics that the brand wants to promote as marketing text (by a recognized and renown company like Biorius) is the best idea for your business.

Step 5: Legal Representation

The Legal Representation for cosmetics in Europe is called the Responsible Person. The Responsible Person comes with many responsibilities and the Responsible Person will be held responsible in the event of a non-compliance problem.

A simple and easy way to explain the Responsible Person is:

  • Who do European countries have to call if they want to control your cosmetic product?
  • Who should a consumer call if they have an unusual reaction to your cosmetic product?

Responsible Person is designated in CPNP for each notified product. Among other important functions, this Responsible Person will ensure the compliance of the cosmetic products on an ongoing basis and will update the PIF when necessary.

In short, being a Responsible Person implies many responsibilities and is an important and delicate matter that should not be taken lightly. Cosmetic brands should really invest time in this crucial step. Check out the best way to choose your Responsible Person

Learn more about Responsible Persons and their obligations

EU cosmetics regulation

When it comes to cosmetics, the key legal requirements to comply with are contained in the European Cosmetics Regulation (EC n°1223/2009) and related pieces of legislation. To summarize this legal framework, five main requirements must be fulfilled before making a a product available in the European market:

A compliance check of the cosmetic formula (cosmetic formulation or cosmetic check ingredients)

according to Articles 14 (prohibited and restricted cosmetic ingredients), 15 (CMR ingredients), 16 (nanomaterials), 17 (unavoidable traces of prohibited substances) and 18 (no animal testing). Beyond this compliance check, it is up to the toxicologist in charge to determine that each legally-used ingredient is safe at the used concentration. Finally, the bans and restrictions of transversal legal acts (e.g., REACH Regulation EC No 1907/2006, ‘Fluorinated Greenhouse Gases’ Regulation EU No 517/2014, ‘Ozone Layer’ Regulation EC No 1005/2009) also need to be taken into consideration.

A redaction of a Product Information File (PIF) and a Cosmetic Product Safety Report (CPSR)

 According to Article 3, Article 10, Article 11, Annex I and related legal texts (e.g., Commission Implementing Decision EU No 2013/674), European guidelines (e.g., SCCS Notes of Guidance SCCS/1602/18) and international norms (ex. IFRA Standards), compliant cosmetic labels conforming to Article 19, Article 20 and related pieces of legislation (e.g., ‘Common Criteria’ Regulation EU No 655/2013) and guidelines (e.g., very specific rules have to be followed and the devil is in the details). In addition to these European requirements, a number of national provisions may also apply depending on the EU country where the product is sold.

A CPNP number (Cosmetic Product Notification Portal)

Obtained according to Article 13 and the CPNP Usage Guide. The notification of cosmetic products can be done in exact concentrations, in concentration ranges or in frame formulations according to the preferences of the cosmetic brands. Each notification method comes with its own rules, benefits and obligations. Furthermore, cosmetic products containing nanomaterials not reported in the annexes of the European cosmetics regulation (regulated under Article 14) must be notified in the CPNP (according to Article 16) six months prior to the product being introduced to the market.

A Responsible Person based in the European Union territory

Must be appointed according to Article 4 and Article 5. For an imported cosmetic product, each importer shall be the Responsible Person for the specific cosmetic product he or she introduces to the market. However, the importer may, by written mandate, designate a person established within the European Union as the Responsible Person, who shall accept this role in writing. Many importers are very reluctant to take on the role of Responsible Person. It is difficult, requires numerous qualifications, and comes with important legal responsibilities. Therefore, it is recommended that non-European cosmetic brands appoint a Responsible Person before contacting potential importers.

If you wish to check our other services or to develop the sales of your cosmetic products in other countries, check the link below:

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As specialists in cosmetic Regulations for more than 15 years, Biorius offers a reliable turnkey solution for placing cosmetic products in various markets:

  • First Class specialists in cosmetic regulations in Europe, the United Kingdom, the United States, and in more than 60 countries
  • 50 regulatory experts, toxicologists, pharmacists, and chemists to serve you.
  • A unique model that guarantees you both the fastest turnaround possible and high-quality services. Curious? Ask us to know more!
  • No hidden costs: Biorius does not charge you for any question, call, or meeting.
  • A best-in-class IT tool, free of charge, and saving a lot of your time.
  • More than 1,500 international clients have already chosen Biorius!
  • We evaluated more than 100,000 products and never had any compliance issues (fines, withdrawals from the market, etc.) in 15 years of existence.