Cosmetics Regulatory Registration Process
Ensuring that a cosmetic product complies with the European 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 a cosmetics brand. Europe is a lucrative market of nearly 500 million consumers. However, as nicely worded by a piece of European legislation, “No data, no market”.
The European Union is one of the most regulated regions in the world, and cosmetics products fall under strict regulations. 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.
As specialists in the regulatory evaluation and safety assessment of cosmetic products for more than 10 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 40 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.
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 according to Articles 14 (prohibited and restricted 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), a compliant product label 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.
Our European registration process requires five important steps for cosmetic products.
1. Formula Review
This step is a prerequisite for the preparation of the 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 and other pieces of legislation:
- 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.
- An exhaustive regulatory investigation is performed to ensure that each ingredient can be used with respect to numerous legal constraints, including but not limited to the European Cosmetics Regulation (REACH Regulation EC No 1907/2006), substances that deplete the ozone layer (Regulation EC No 1005/2009), fluorinated greenhouse gases (Regulation EU No 517/2014) etc.
- The list of ingredients to be labeled is prepared according to Article 19, Article 33 and related pieces of legislation.
2. Cosmetic Product Safety Report (CPSR)
The CPSR is a comprehensive document produced by a qualified toxicologist (according to Article 10 §2 and related provisions implemented by each member state). 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, as specified by Annex I of the European Cosmetics Regulation and the Commission Implementing Decision, EU No 2013/674:
Part A: Cosmetic Product Safety Information
All required information in the safety assessment is included in this section and is structured as follows:
- Quantitative and qualitative formula of the cosmetic product
- Physicochemical characteristics and stability of the cosmetic product
- Microbiological quality
- Impurities, traces, information regarding the packaging material
- Normal and reasonably foreseeable use
- Exposure to the substances
- Toxicological profile of the substances
- Undesirable effects and serious undesirable effects
- Information regarding the cosmetic product
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. It includes four sections:
- Conclusion of the safety assessment
- Warnings and instructions for use on the label
- Assessor credentials and approval of Part B
Part B is essential, as it certifies the effectiveness and safety of a product before being placed on the EU market.
3. Labels and Claims Review
According to Article 19, consumer information should be labeled on the container and/or the packaging to allow a well-informed purchase decision. Many requirements need to be taken into consideration, and it can be a challenge for a cosmetics brand to understand how to comply with the legislation. This is particularly difficult since the labeling requirements go beyond the mere application of the European Cosmetics Regulation: Council Directive 76/211/EEC, Council Directive EEC No 75/324, Regulation EU No 517/2014, Commission Recommendation EC No 2006/647, etc. Many pieces of legislation may affect the compliance of a product label and, above and beyond EU law, national provisions cannot be ignored. The intent of the label review is to ensure that the artwork designed by a cosmetics brand for its product complies with all applicable rules. So, yes, the label review ensures that the legal elements are properly reported in Article 19, such as:
- Responsible Person contact details
- List of ingredients
- Nominal net content
- Precautions for use
- Expiration date
- ID batch number
- Country of origin
- Name and address of the manufacturer/distributor (not required but recommended)
Furthermore, many languages are spoken within the European Union, and this linguistic complexity should not be ignored. Knowing what to translate and how is another area of expertise for BIORIUS.
The claims review is another verification performed by BIORIUS on the product artwork. While the label review is a technical verification mainly requiring the careful application of strict and precise legal requirements, the claims review is almost an art. Beyond the in-depth understanding of the legislation, the review of marketing communications requires creativity, significant experience and a solution-oriented mindset.
In the EU, claims are not regulated by a simple list of allowed versus prohibited words as it exists in other regions of the world. Instead, guiding principles called ‘Common Criteria’ are spelled out in Regulation EU No 655/2013 and provide direction on what is acceptable and what is not. Are the marketing communications honest? Fair? Truthful? Objective? Does it denigrate competitors or legally-used ingredients? The ‘Common Criteria’ regulation is not the only thing to consider. The definition of a ‘cosmetic product’, such as what’s specified in Article 2, must be considered with due care. ONe incorrect claim or one wrong word, and a cosmetic product can become a drug, a biocide, a detergent, a toy, etc., and this automatically comes with a need to fulfill the legal obligations of those legal frameworks. Finally, specific legal instruments such as the ‘Unfair Business-to-Consumer Commercial Practices’ Directive (EC No 29/2005) and the commission’s recommendations on sun care products (EC No 2006/647) come with additional requirements and limitations that need to be applied carefully.
BIORIUS delivers smart labels and claims reviews in a client-oriented fashion. Safe wording is proposed for replacing risky marketing communications. Legislation is explained in layperson’s terms and flawless technical support (e.g., which test to conduct to substantiate a claim) is provided.
4. Product Information File (PIF) and CPNP Notification
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 comes from product manufacturers, other data from independent laboratories, and yet other data comes from a duly-qualified safety assessor with degrees recognized by Article §2.
Typically, a Product Information File includes the following elements:
- Administrative information regarding the cosmetic product
- Certificates & declarations (e.g., manufacturing methods, a GMP compliance statement, a “No Animal Testing” declaration)
- Toxicological information on every ingredient and impurity
- Cosmetic Product Safety Report (CPSR)
- Raw materials documentation (e.g., material safety data sheets, technical data sheets, certificates of analysis, IFRA certificates, fragrance allergen reports, purity statements, non-animal testing statements)
- Test results (e.g., stability test, preservative efficacy test, efficacy tests such as SPF tests, tolerance studies, use tests)
- Artwork for the cosmetic product (container and packaging)
- 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 Cosmetic Product Notification Portal (CPNP) 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.
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 a 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.
5. Legal Representation
A 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.