Introduction
Expanding into the European Union (EU) cosmetic market presents vast opportunities, but it also comes with a rigorous compliance framework. Governed by Regulation (EC) No 1223/2009, the EU enforces one of the most comprehensive cosmetic regulations in the world. This regulation aims to ensure product safety and market transparency across the entire European Economic Area (EEA), including the 27 EU member states, Norway, Iceland, and Liechtenstein.
If you’re planning to export cosmetic products to the EU, it’s critical to understand the regulatory definition of cosmetics, the role of the Responsible Person, and the key steps in the compliance process—from formula and label review, preparation of PIF, to CPNP notification.
What Is Recognized as a Cosmetic in the EU?
According to Regulation (EC) No 1223/2009, a “cosmetic product” is any substance or mixture intended to be applied to the external parts of the human body (e.g., skin, hair, nails, lips, and external genital organs) or to the teeth and the mucous membranes of the oral cavity. The purpose must be to clean, perfume, change appearance, protect, maintain in good condition, or correct body odor.
This definition explicitly excludes products administered via ingestion, inhalation, injection, or implantation, and distinguishes cosmetics from pharmaceuticals, biocides, or medical devices. Companies must carefully assess whether a product meets the EU cosmetic definition and comply with the applicable regulations based on the classification.
To support proper classification, the European Commission provides guidance documents that help differentiate cosmetics from borderline products like pharmaceutical/medicinal products or medical devices.
Appointing a Responsible Person (RP)
Every cosmetic product sold in the EU must have a designated Responsible Person (RP) established within the EU. The RP can be the manufacturer, importer, distributor, or a third party mandated in writing. Their name and address must be clearly labeled on the product packaging.
The RP bears full legal responsibility for product compliance and safety. Their obligations include:
Compiling and maintaining the Product Information File (PIF)
Submitting the product notification via the CPNP system
Conducting post-market surveillance and reporting serious undesirable effects
Providing documentation to regulatory authorities upon request
EU Cosmetic Compliance Process: Step-by-Step
Ingredient Compliance and Formula Review
Unlike China’s approach to classifying ingredients as “existing” or “new,” the EU uses a positive and negative list system. Formulators must ensure:
Prohibited substances(Annex II) and CMR substances under Regulation (EC) No 1272/2008 are strictly avoided.
Restricted substances, colorants, preservatives, and UV filters must comply with the conditions specified in Annexes III–VI, including product type and body parts, concentration limits, and warning labels.
Labelling Requirements
EU cosmetic labels must display the following information:
Name and address of the RP
Net content
Expiry date (or Period After Opening symbol)
Precautions and warnings
Batch number or product reference
Ingredient list (INCI format)
Product function (unless obvious)
In addition, any claims made on the label or in marketing materials must meet six legal criteria under Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making.
Preparing the Product Information File (PIF)
Before placing a product on the market, the RP must compile a Product Information File, to be stored for 10 years after the last batch is placed on the market. The PIF must include:
A detailed product description
Cosmetic Product Safety Report (Part A: safety information; Part B: safety assessment)
Description of the manufacturing process and GMP compliance statement
Proof supporting any product claims
Data on any animal testing conducted by manufacturers or suppliers, especially if done to meet non-EU regulatory requirements
CPNP Notification
The Cosmetic Products Notification Portal (CPNP) is the EU’s official online platform for cosmetic product notifications. Before submission, companies must register for an EU Login and obtain SAAS access.
Required CPNP information includes:
Product category and name
RP’s name and address where the PIF is stored
Country of origin (for imports)
First EU country of market launch
Contact details for rapid communication
Identification and exposure details for nanomaterials, if applicable
CMR substance identification (category 1A or 1B, if present)
Label artwork and product photos
Frame formulation for efficient emergency response
For products containing nanomaterials, an additional notification must be submitted at least six months before the product is marketed. This report should include:
Nanomaterial specifications (particle size, physical and chemical properties)
Annual volume of use
Toxicological profile and safety data
Reasonably foreseeable exposure scenarios
Final Thoughts: Stay Ahead of Compliance and Market Expectations
Navigating EU cosmetic compliance involves far more than ticking regulatory boxes. As a manufacturer or brand owner, staying informed on regulatory updates, engaging with industry bodies, and building a compliance strategy aligned with the EU’s standards will position your products for long-term success in a competitive market.
For companies seeking expert guidance on regulatory affairs, ingredient safety, and dossier preparation, partnering with REACH24H can help streamline the compliance journey and protect your brand’s reputation.
Our Services
• EU RP service as a third party (located in Dublin)
• Cosmetic Products Notification Portal (CPNP) Notification
• Cosmetic Product Safety Report (CPSR)
• Product Information File (PIF)
• Consulting Service
• Customized Training
For more information or service inquiries, please feel free to contact us at customer@reach24h.com.
FAQ
Q1: In small packaging, such as ampoules or vials of 5 mL or less, must the adverse event contact information be included on the label?
A: Yes. According to EU Regulation 2023/988, there is no specific exemption for small packaging. If space on the primary packaging is limited, the adverse event contact information can be provided on an accompanying leaflet.
Q2: Can clinical reports from a Chinese lab (GLP, English version) be used for UK/EU cosmetic notification?
A: If these clinical reports pertain to human safety testing, in addition to confirming they are from a GCP-certified lab and are in English, it is crucial to further verify that the report content and testing procedures fully comply with the relevant ethical requirements of the EU/UK. This compliance is key to their acceptance.
Q3: How are nanomaterials identified according to EU cosmetics regulations?
A: The EU Cosmetics Regulation defines 'nanomaterial' as: ‘nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm. It is primarily judged based on factors such as solubility, biopersistence, natural/synthetic origin, and particle size.
