How to get access to EU and 447+ million people?
Regulation EC No. 1223 is the one challenge you have to complete to perfection to enter all 27 the EU markets
The European Union might be the most regulated region in the world, and also cosmetics products fall under strict regulations.
Over the years much legislation has been enacted to
- protect consumers, animals and the environment
- inform end-users better
- harmonize national laws
Every cosmetic product available in the European market, whether for payment or free of charge, needs to comply with the long list of legal requirements.
Get an impression of the document yourself: REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products
Since our start in 2003 we have been specialists in the regulatory evaluation and safety assessment of cosmetic products and today offers a reliable turnkey solution for verifying and registering cosmetic products in an effective way.
Our team deliver a fast and reliable way to access the EU market. The regulatory team has an in-depth knowledge of the legislation along with a wide range of hands-on experience and market knowledge. It is headed by a former member of the French Cosmetic commission at the French health and medicine agency (appointed by law in 2000).
Having the label and content right is just the beginning. If it was simple you wouldn’t need us. Knowing the regulations as we do it is no longer complicated, it is just complex. That makes the difference.
Do you want the fast track to instant overview and a turnkey solution to get your products EU ready fast? Request a compliance review of your product line.
We are proud to do compliance for
EU Compliance is a core business area for us
EU compliance has always been an important business field for QSC, as important as distribution. Many partnerships with foreign brands start with making it possible to sell in the EU.
EC No. 1223, better known as the regulations on beauty products, is 10 chapters, 40 articles and 10 annexes. It requires brands and economic operators in the industry to follow legal constraints covering all 27 countries and enabling the open market and free movement of goods. The regulation has four main objectives:
- protect the consumer against unsafe products and unfair commercial practices
- provide the consumer with meaningful information in order to facilitate the right purchase decisions
- implement specific values important to European citizens, ie. animal testing.
EC No. 1223 enforces numerous requirements that all cosmetic products in the EU market must meet. The four main requirements are:
- PIF (Product information file)
- CPNP Notification
- Compliant product packaging
- RP (Responsible Person)
If one of these obligations is not fulfilled, you are preventer from selling your products on any EU market. When you are in full compliance you have access to all.
The key compliance requirements
The Product Information File is a structured dossier for every product in your range.
The PIF dossier contains every piece of information related to the given cosmetic product. Data is provided by you as well as independent laboratories and duly-qualified safety assessors.
The standard Product Information File includes the following:
- 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 datasheets, 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)
When 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 Responsible Person at any time, notably by customs officers.
Technically, cosmetic products are not registered in the EU; they are notified through the Cosmetic Product Notification Portal (CPNP).
Unlike other regions and countries 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 important.
The cosmetic products notification portal (CPNP) is free of charge online notification system created for the implementation of Regulation EC No 1223/2009 on cosmetic products. When a product has been notified in the CPNP, there is no need for any further notification at national level within the EU.
The notification of cosmetic products can be done in exact concentrations, in concentration ranges or in frame formulations according to your preferences. Each notification method comes with its own rules, benefits and obligations.
Cosmetic products containing nanomaterials not reported in the annexes of the European Cosmetics Regulation must be notified in the CPNP six months prior to the product being introduced to the market.
Since July 11, 2013, Regulation EC No 1223/2009 requires that a Responsible Person (RP) established within EU be designated for each cosmetic product marketed within the EU territory.
The role of the Responsible Person is to ensure continued product compliance with cosmetics regulations and safety regarding human health.
As defined in Article 4 of Regulation EC No 1223/2009, a Responsible Person is a legal or natural person who ensures the compliance of each cosmetic product in the EU market with relevant obligations as set forth in this Regulation. It can be the manufacturer (if based in the EU), the importer, the distributor or a third party located in the EU who has been designated by a written mandate.
The Responsible Person is in charge of ensuring that cosmetic products marketed in the European Union comply with Regulation EC No 1223/2009.
Among the numerous obligations, the Responsible Person for a cosmetic product must ensure:
- Safety with respect to human health and the production of a Cosmetic Product Safety Report (CPSR)
- Compliance of labelling, including the substantiation of a claim
- Compliance with good manufacturing practices (GMP)
- Proper maintenance of the Product Information File (PIF)
- Notification in the Cosmetic Product Notification Portal (CPNP)
- Compliance related to nanomaterials
- Ongoing monitoring of the product, including the reporting of any undesirable or serious side effects to the relevant authorities.
In addition to ensuring compliance with the requirements, the Responsible Person, in some EU member states, must demonstrate that it has the expertise and the financial resources to carry out its duties.
Our service offer
We have the expertise and resources to effectively fulfil this role for your company. When appointing us as the Responsible Person within EU for your products, it is our role to:
- Ensure that your Product Information File is up to date
- Perform regulatory monitoring and guarantee the ongoing compliance of your cosmetic products by taking into consideration any regulatory changes
- Represent and defend your cosmetic brand to the authorities
- Assist your cosmetic brand with any legal questions related to the EU Cosmetics Regulation
- Manage customer complaints if and when they arise along with any undesirable effects from your cosmetic products
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 labelled is prepared according to Article 19, Article 33 and related pieces of legislation.
Consumer information should be labelled on the container and/or the packaging to allow a well-informed purchase decision. Multiple requirements need to be taken into consideration, and it can be a challenge to understand how to comply with the legislation.
It is particularly difficult as 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.
Several parts of the EU legislation may affect the compliance of a product label and, above and beyond EU law, national provisions cannot be ignored.
The label review must ensure that the artwork designed by a you complies with all applicable rules. Our label review ensures that all the legal elements are properly reported:
- 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)
27 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 our expertise.
The claims review is another verification we perform on the product artwork. While the label review is a technical verification mainly requiring application of precise legal requirements, the claims review is a balancing act.
Beyond the in-depth understanding of the legislation, the review of marketing communications requires creativity, 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. Common Criteria, the guiding principles, are defined in EU Regulations and provide direction on what is acceptable and what is not.
The marketing communications must be honest, fair, truthful and objective. The Common Criteria regulation is not the only thing to consider. The definition of a cosmetic product 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 fulfil the legal obligations of those frameworks.
Finally, specific legal instruments such as the ‘Unfair Business-to-Consumer Commercial Practices’ Directive and the commission’s recommendations on sun care products come with additional requirements and limitations that need to be applied.
We deliver solution-oriented smart labels and claims reviews. Safe wording is proposed for replacing risky marketing communications. Legislation is explained in layperson’s terms and flawless technical support is provided, ie. which test can substantiate a claim.
The CPSR is a comprehensive document produced by a qualified toxicologist (according to Article 10 §2 and related provisions implemented by each member state).
The safety report supports and confirms 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 quality CPSR is an offence that leads to withdrawal from the market, financial penalties and 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:
A: Cosmetic Product Safety Information
All required information in the safety assessment is included in this section:
- The 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.
B: Cosmetic Product Safety Assessment
This part of the report is 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.