Abstract
The registration of cosmetic products in the European market is regulated by Regulation (EC) 1223/2009. This regulatory framework requires a comprehensive compliance process that includes supplier selection, safety testing, and labeling. This article reviews the fundamental steps for successful registration in Europe, focusing on how proper supplier management, document preparation, safety testing, and labeling compliance can save companies significant time and costs.
Introduction
The European Union Regulation (EC) 1223/2009 establishes strict standards for the manufacturing and commercialization of cosmetic products. The regulation pursues two main objectives: harmonizing registration procedures across member countries and ensuring consumer safety. Since its implementation, the standards have required advanced technical qualifications in development, testing, and documentation processes.
For cosmetic manufacturers, the registration process in Europe can seem complex due to strict regulations and the extensive documentation required. However, with a detailed understanding and proper planning, the process can become more manageable, reducing risks and accelerating market entry. This article outlines the crucial steps that cosmetic companies must follow to comply with regulations and market their products safely and legally in Europe.
- Classification of Cosmetic Products
Before starting the registration process, it is essential to confirm that the product in question qualifies as a “cosmetic” according to the regulation. A cosmetic product is defined as any substance or mixture designed to be applied to external parts of the body (such as skin, hair, nails, and lips) or the oral cavity with the purposes of cleansing, perfuming, protecting, maintaining in good condition, or correcting body odors. The following key aspects must be considered:
- Ingredients: The formula should not contain prohibited substances or, if applicable, must comply with restrictions set for specific allowed ingredients.
- Application Area: Cosmetic products must be applied to external surfaces of the body or in the oral cavity.
- Function: The main purpose must be cosmetic; healing or treatment properties are exclusive to pharmaceutical products.
- Advertising Claims: Products cannot claim medicinal or disinfecting properties, as this would disqualify them as cosmetics and place them under other regulatory categories.
- Selecting the Supplier
The supplier plays a critical role in the registration process of a cosmetic product. Choosing reliable suppliers for ingredients, packaging, and finished products ensures the availability of necessary documentation for safety evaluation. Suppliers must adhere to Good Manufacturing Practices (GMP) as per ISO 22716:2007 standards and be prepared to provide documents such as Safety Data Sheets and Certificates of Analysis.
Additionally, suppliers must deliver all documentation promptly, as delays in obtaining necessary documents can postpone the product’s registration. If a supplier is unable or unwilling to provide the required documentation, it may be necessary to find a replacement.
- Documentation: Product Information File (PIF)
Gathering appropriate documentation is essential and is organized into the Product Information File (PIF), which is required before the product can be marketed in Europe. This file contains the technical details of the product and is indispensable for safety evaluation. It must be retained for at least ten years and be available at all times for competent authorities. The PIF components are:
- Product Description: Includes the commercial name, batch number, function, manufacturer, and responsible person within the EU.
- Cosmetic Product Safety Report (CPSR): Includes a detailed assessment of each substance in the formula, covering toxicological profile, product stability, manufacturing methods, and safety evaluation by an authorized safety assessor.
- Manufacturing Method and GMP Compliance: The manufacturing process must adhere to ISO 22716:2007 quality standards.
- Tests and Efficacy Results: Test data that validate the efficacy of ingredients and the finished product must be presented.
- Animal Testing Data: If tests were conducted outside the EU, these must be included in the PIF, though animal testing for cosmetics is prohibited in Europe.
- Notification on the CPNP Portal
Notification of the product on the Cosmetic Products Notification Portal (CPNP) is a critical and mandatory step. Before launching the product on the market, the responsible person must notify it in the CPNP, an electronic platform accessible to both competent authorities and the responsible person. The notification process assigns a reference number to the product, which should only be registered once the PIF is complete and approved.
Mandatory Testing
The regulation requires several tests to ensure the product’s safety throughout its lifespan. These include:
- Stability Testing: Stability tests determine product durability under accelerated storage conditions to ensure it maintains its physical, chemical, and microbiological properties throughout its shelf life.
- Packaging Compatibility: The product must be compatible with its packaging to avoid alterations in the formula.
- Microbiological Testing: Ensures the product does not become contaminated during storage and use. Products with low microbiological risk, such as those with high alcohol percentages or low water activity, may be exempt.
- Challenge Test: Verifies the efficacy of the preservative system in the formula to prevent contamination.
Labeling
Labeling of cosmetic products is a fundamental aspect and must comply with European standards, which include:
- Name and Address of the Responsible Person: This information must appear on both primary and secondary packaging.
- Country of Origin: If the product is imported from outside the EU, the country of origin must be specified with the phrase “Made in + Country.”
- Nominal Content: Expressed in weight or volume; it is not mandatory for products under 5 ml or for free samples.
- Expiration Date or Period After Opening (PAO): Depending on the product’s shelf life, the expiration date or PAO must be indicated.
- Precautions and Warnings: Certain products require specific warnings about their use.
- Batch Number: To identify each production batch.
- Product Function: Should be specified unless obvious from the presentation.
- List of Ingredients: Preceded by the word “INGREDIENTS,” ingredients must be listed in descending order of concentration, followed by colorants according to their Colour Index (CI).
Marketing Claims
Claims about the benefits of a cosmetic product, such as “moisturizing” or “paraben-free,” are regulated and must be objective and verifiable. Additionally, it is important to avoid claims that disparage other products or ingredients. Each claim must be supported by scientific evidence, such as in vitro tests, consumer perception studies, or specific properties of the ingredients. Regulations require that claims be clear to consumers and allow them to make informed decisions about the product.
Conclusion
The registration process for a cosmetic product in the European market may seem complex due to the extensive documentation, testing, and regulatory requirements. However, by following a structured process and establishing effective collaboration with suppliers, testing laboratories, and registration consultants, companies can ensure the legal compliance of their products. This approach not only ensures compliance with European regulations but also protects consumer safety and enhances brand trust.
Careful planning in supplier selection, PIF management, and adherence to mandatory testing and labeling requirements can streamline the registration process, making it faster and more economical. In this way, companies will be better prepared to leverage the world’s largest cosmetics market, meeting the European consumer’s expectations for safety and quality.
Why Choose SHAPYPRO
SHAPYPRO understands the complexity of regulatory changes in cosmetics post-Brexit and is ready to assist your company in meeting requirements in both the European Union and the United Kingdom. Our team offers product compliance advisory services, registration in notification platforms, and labeling management to avoid setbacks in your international operations. Trust us to navigate both markets successfully! Contact us for more information about our services.