Comprehensive Guide to EU Cosmetics Regulation (EC 1223/2009)

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EU Cosmetics Regulation

Biorius: Experts in EU Cosmetics Regulation and Safety Assessment.

At Biorius, we transform the complexity of EU cosmetic compliance into a clear and efficient process. Our team guides you through every step, from formula review and cosmetic safety assessment to label validation and CPNP notification, ensuring that each product fully meets EU regulatory requirements.

With more than 15 years of experience in EU cosmetic safety assessments and the EU Cosmetics Regulation, Biorius provides a reliable turnkey solution for the verification and registration of cosmetic products. Our expertise is backed by a team of over 50 scientific consultants and advanced IT tools, making our approach the fastest and most dependable way for brands to access and grow within the European market.

Understanding EU Cosmetics Regulation Compliance

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.

The EU Cosmetics Regulation (EC) No 1223/2009 is the cornerstone of cosmetic product safety in the European Union. It applies to all cosmetic products made available on the EU market, whether manufactured within the EU or imported. Its main objective is to ensure a high level of protection for human health, while also supporting innovation and the free movement of cosmetic products within the EU.

To achieve compliance, cosmetic brands must address several essential requirements:

Every cosmetic product must be safe for human health when used under normal or reasonably foreseeable conditions. This safety must be demonstrated through a Cosmetic Product Safety Report (CPSR), which forms part of the Product Information File (PIF). The CPSR is prepared by a qualified safety assessor based on toxicological profiles, ingredient concentrations, exposure scenarios, and the intended use of the product.

In addition, all ingredients must comply with the restrictions outlined in the Regulation’s annexes, including:

• Annex II: Prohibited substances

• Annex III: Restricted substances (e.g. with maximum concentrations, warnings, or specific conditions of use)

• Annexes IV to VI: Lists of allowed colorants, preservatives, and UV filters

Ensuring ingredient compliance is a critical step in the safety assessment and overall product compliance.

Each product must have a Responsible Person established within the EU. This entity (or individual) is legally responsible for product compliance, ensuring safety, proper labelling, claims substantiation, and communication with competent authorities.

Before being placed on the market, each product must be notified through the Cosmetic Products Notification Portal (CPNP). This centralized EU system allows authorities to monitor products and respond quickly in case of a health concern.

Labels must include mandatory information such as the name and address of the Responsible Person, country of origin (for imports), weight/volume, expiry or PAO, batch number, function, precautions for use, and a full list of ingredients (INCI).
Marketing claims must be truthful, substantiated, and comply with the principles set out in Regulation (EU) No 655/2013, including criteria such as honesty, fairness, and informed decision-making for the consumer.

Cosmetic products must be manufactured according to GMP, as defined by ISO 22716. This ensures product quality and consistency through proper hygiene, process control, documentation, and personnel training.

Once on the market, cosmetic products remain under the surveillance of national authorities. The Responsible Person must report serious undesirable effects (SUEs) and cooperate fully in case of inspections or investigations.

How to Launch Your Cosmetics in the EU Market?

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 ± €90 billion at retail sales price). 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”.

5 Steps to Achieve EU Cosmetics Compliance with Biorius

Formula Review

Cosmetic Product Safety Report (CPSR)

CPNP Notification & Product Information File (PIF)

Labels & Claims Review

Legal Representation

Step 1: Thorough Formula Review

This first step includes the:

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 EU Cosmetic Regulations:

The review is based on the composition expressed in the raw materials trade names. The documentation of each raw material 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 type, its intended use and the targeted population.

A Formula Review can also be performed on its own, outside of our EU registration. Discover our Cosmetic Formula review service.

Step 2: Creating a Cosmetic Product Safety Report (CPSR)

The CPSR (Cosmetic Product Safety Report) is a comprehensive document produced by a qualified toxicologist. It 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.

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 the 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.

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.

Our services specialize in guiding you through this process. We’ll help you assess your product’s ingredients, formulation, and intended use to ensure compliance with EU regulations. With our expertise, you can confidently bring your cosmetics to market while meeting all necessary safety requirements.

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

A Product Information File (PIF) is an extensive and meticulously structured dossier containing all relevant information pertaining to a specific cosmetic product. This data encompasses various sources: some provided by product manufacturers, others by independent laboratories, and yet more by duly-qualified safety assessors. Read more about the Product Information File (PIF).

Upon the completion of the PIF, the cosmetic product becomes eligible for electronic notification to the European Commission through the Cosmetic Product Notification Portal (CPNP). Subsequently, a unique CPNP number is issued. This identifier can be requested from both the importer and the Responsible Person at any given time, notably by customs officers.

With our expertise, we’ll guide you through the process of reaching CPNP notification. Our role as a Responsible Person entails collecting the Product Information File (PIF) and ensuring its availability to authorities as required.

Step 4: Ensuring Accurate Labels & Claims

The EU cosmetic labelling rules can appear perplexing at first glance. While distributors bear the responsibility, as outlined in Article 6 of the EU cosmetics regulation, for label compliance, the creation and refinement of labels and packaging pose significant expenses for cosmetic brand owners. Certain elements must be translated into the official languages of the countries where products are sold, a task that distributors must oversee diligently. Merely English labels may not suffice, as translation requirements vary across EU countries with their diverse linguistic landscapes.

Moreover, all marketing claims must align with the definition of a cosmetic product and must be truthful, substantiated, and verifiable. Several guidelines provide general principles to ensure claims remain compliant.

A legible label is crucial for aiding consumers in their purchasing decisions and safeguarding their health. All pertinent information must be readily accessible, legible, and comprehensible at the point of purchase. The principle is straightforward: the end-consumer should have a clear understanding of the product they are purchasing upon inspection.

A Label Review is a complete compliance verification. Our experts meticulously examine your labels, ensuring compliance with relevant legislation and the inclusion of all mandatory elements (INCI List, PAO, eventual warnings, etc.). Additionally, we verify marketing claims and other communications to ensure they adhere to authorized guidelines.

Step 5: Legal Representation in the EU

The Legal Representation for cosmetics in Europe is designated as the Responsible Person. A Responsible Person is designated on the CPNP for each notified product.

This role carries numerous responsibilities, and the Responsible Person assumes accountability in cases of non-compliance.

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. Read more about the EU Responsible Person.

As the Responsible Person, we ensure your cosmetics comply with EU Regulation EC No 1223/2009. We represent and defend your brand to authorities, handle legal queries, manage customer complaints, and monitor regulations to maintain ongoing compliance.

We address any adverse effects and keep your Product Information File updated. Additionally, your brand must utilize our name and address on labels if we are the product’s Responsible Person, allowing us to handle regulatory matters and consumer complaints on your behalf.

Additional Resources on 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, four main requirements must be fulfilled before making a product available in the European market.

Compliance check of the cosmetic formula

Our services ensure that your products comply with key regulatory articles, including:

• Article 14: Prohibited and restricted cosmetic ingredients

• Article 15: CMR (Carcinogenic, Mutagenic, or Reprotoxic) ingredients

• Article 16: Nanomaterials

• Article 17: Unavoidable traces of prohibited substances

• Article 18: No animal testing

Our experienced toxicologists go beyond basic compliance checks. They meticulously evaluate each legally-permissible ingredient to ensure safety at the concentrations used in your formulations.

Additionally, we help you navigate the broader regulatory landscape, ensuring your products meet the requirements of transversal legal acts such as:

• REACH Regulation (EC No 1907/2006)

• Fluorinated Greenhouse Gases Regulation (EU No 517/2014)

• Ozone Layer Regulation (EC No 1005/2009)

Responsible Person based in the European Union territory

According to Articles 4 and 5 of the EU Cosmetic Regulation, every imported cosmetic product must have a designated Responsible Person within the EU. Each importer automatically assumes this role for the products they bring into the market. However, importers can transfer this responsibility by formally appointing a designated Responsible Person established in the EU.

Many importers are hesitant to take on the role of Responsible Person due to its stringent requirements and significant legal responsibilities. This role demands extensive qualifications and a thorough understanding of EU regulations.

To streamline the process and ensure compliance, we recommend that non-European cosmetic brands appoint a Responsible Person before engaging with potential importers. This proactive step not only simplifies market entry but also provides peace of mind, knowing that your products meet all regulatory standards.

CPNP (Cosmetic Product Notification Portal) number

The CPNP registration is a requirement under Article 13 of the European cosmetics regulation.

Cosmetic products must be notified via the CPNP prior to being placed on the EU market. This ensures that all relevant information is available to the competent authorities before the product is available to consumers.

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. In simpler terms, notification serves as an announcement to Europe of your intent to sell a product within its borders.

The following information must be provided during the notification process:

• Product Category and Name: Details about the product type and specific name.

• Responsible Person’s Contact Details: Including their address and contact information.

• Member State of Market Placement: Indicating where the product will be first marketed within the EU.

• Frame Formula or Quantitative Formula: Depending on the notification method chosen (exact concentrations, concentration ranges, or frame formulations).

• Nanomaterials Information: If applicable, details about any nanomaterials used, their identification, and safety data.

• Label Information: A digital copy of the product’s label and packaging.

• Notification of Serious Undesirable Effects (SUE): Information about any serious undesirable effects reported from the use of the product.

Nanomaterials Notification:

For products containing nanomaterials not listed in the annexes of the regulation, a specific notification is required under Article 16. This must be done at least six months before the product is introduced to the market, including detailed safety assessments and data about the nanomaterials.

Any changes to the product’s formulation, labeling, or market information must be updated in the CPNP to ensure that the data remains accurate and current.

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

In order to sell cosmetics products within the European Union, adherence to stringent regulatory standards is imperative. This includes the meticulous preparation of a Product Information File (PIF) and a Cosmetic Product Safety Report (CPSR) in accordance with Article 3, Article 10, Article 11, Annex I, and other pertinent legal frameworks such as Commission Implementing Decision EU No 2013/674, European guidelines like SCCS Notes of Guidance SCCS/1602/18, and international norms such as IFRA Standards.

Ensuring compliance extends to crafting compliant cosmetic labels that meet the requirements outlined in Article 19, Article 20, and related legislation such as the ‘Common Criteria’ Regulation EU No 655/2013, along with adherence to specific guidelines where the intricacies matter significantly.

Furthermore, beyond these European standards, it’s essential to consider the diverse array of national provisions that may apply depending on the specific EU country where the product is intended to be sold. Our consulting services specialize in navigating this complex regulatory landscape, providing tailored guidance to ensure your cosmetics business meets all necessary requirements for successful market entry and continued compliance.