+86 571 8659 2517
+86 180 5841 8258
info@zmuni.com
导航菜单
Entering the EU cosmetics market requires more than a CPNP notification.
The EU Cosmetics Regulation (EC) No. 1223/2009 establishes comprehensive requirements for cosmetic products placed on the European market, covering product safety, ingredients, labelling, documentation and notification. Companies must ensure that their products meet these requirements before placing them on the EU market.
ZMUni helps cosmetic brands navigate EU regulatory requirements and prepare their products for market entry — from formula review and safety assessment to PIF preparation, labelling review, CPNP notification and ongoing compliance support
To place a cosmetic product on the EU market, companies need to address several regulatory requirements throughout the product lifecycle.
Before reviewing the formulation against EU cosmetic ingredient requirements, it is important to determine whether the product falls within the scope of the EU Cosmetics Regulation.
Under Article 2 of Regulation (EC) No. 1223/2009, product classification depends on factors such as intended use, area of application, and product function. Products with borderline characteristics may require further assessment under other relevant EU regulatory frameworks.
How ZMUni Can Help
We assess product classification based on intended use, composition, presentation, and claims, helping identify borderline products and potential regulatory classification issues before market entry.
Once a product is classified as a cosmetic, its formulation must comply with EU ingredient requirements, including restrictions on certain substances, permitted uses and concentration limits.
Particular attention may be required for preservatives, UV filters, colorants, CMR substances and nanomaterials. A formulation accepted in another market may not necessarily comply with EU requirements.
How ZMUni Can Help
We review cosmetic formulations against applicable EU ingredient requirements, including:
Prohibited and restricted ingredients
Preservatives, UV filters and colorants
CMR substances and nanomaterials
Concentration limits and conditions of use
INCI nomenclature and ingredient information
Cosmetic products marketed in the EU must meet specific labelling requirements under Regulation (EC) No. 1223/2009. These include mandatory information such as the Responsible Person's name and address, ingredient lists, product durability, precautions for use, and other relevant details.
Labelling requirements may vary across EU Member States, and additional language requirements may also apply. Brands entering the EU market may therefore need to adapt their existing packaging to meet the specific requirements of each target market.
Cosmetic claims, whether on packaging or in marketing materials, must also comply with EU regulations and be supported by appropriate evidence.
How ZMUni Can Help
We review packaging artwork, mandatory labelling information, product names and claims against applicable EU requirements. We identify potential compliance issues and recommend necessary adjustments to help ensure that product labelling meets the applicable regulatory requirements in target EU markets.
A Product Information File(PIF) must be maintained for each cosmetic product placed on the EU market. It contains essential technical and regulatory documentation, including:
Product description
Cosmetic Product Safety Report (CPSR)
Manufacturing method GMP compliance information
Evidence supporting claimed effects
Information relating to animal testing
The CPSR is a key component of the PIF and must be prepared by a suitably qualified safety assessor. It evaluates product safety based on factors such as formulation, intended use, exposure and available toxicological data.
Depending on the product and available evidence, additional testing or documentation, such as stability, microbiological quality and preservative efficacy data, may be necessary to support the safety assessment.
How ZMUni Can Help
We support CPSR and PIF preparation by reviewing technical documentation, identifying missing information and testing needs, and coordinating safety assessments conducted by qualified safety assessors. For existing products, we also review and update PIF documentation to address missing, outdated, or inconsistent information.
Every cosmetic product placed on the EU market must have a Responsible Person (RP), who must be a natural or legal person established within the EU. The RP is responsible for ensuring compliance with applicable requirements, including product safety, documentation, labelling and CPNP notification.
Depending on the circumstances, the RP may be the manufacturer, importer, distributor or a designated third party. Where applicable, the designation must be made through a written mandate accepted by the designated person.
How ZMUni Can Help
We provide EU Responsible Person services and support related regulatory obligations, including documentation management and communication with competent authorities within the agreed service scope.
Before a cosmetic product is placed on the EU market, the required product information must be submitted through the Cosmetic Products Notification Portal (CPNP).
CPNP is an EU notification system rather than a product approval or certification process. Completing the notification does not replace the obligation to comply with applicable EU cosmetic regulatory requirements.
How ZMUni Can Help
We prepare and submit the required product information through CPNP in coordination with the designated EU Responsible Person.
EU cosmetic compliance does not end at market entry. Changes to formulations, ingredients, packaging, claims, or regulatory requirements may require further assessment and updates to existing documentation.
How ZMUni Can Help
We provide ongoing regulatory support to help brands manage product changes, update compliance documentation, and respond to evolving EU requirements throughout the product lifecycle.
ZMUni provides cosmetic regulatory support across the EU, US, UK, China, ASEAN, Taiwan China and Canada. Our team of 20+ specialists brings an average of over five years of cosmetics industry experience, supporting coordinated regulatory assessments across multiple markets to reduce duplicated work and improve efficiency.
Rather than reviewing compliance documents in isolation, we assess product classification, formulations, safety documentation, packaging, and claims together to identify potential compliance gaps and provide practical regulatory guidance.
From early-stage regulatory assessments for new products to compliance gap analysis for existing products and post-market updates, our services are tailored to different product stages and business needs.
Whether you are launching a new cosmetic product in the EU, reviewing an existing product portfolio or seeking support with specific compliance requirements, ZMUni can help you assess your regulatory needs and determine the next steps.
Contact our regulatory team to discuss your project or request a quotation.
+86 571 8659 2517
+86 180 5841 8258
info@zmuni.com