EU Cosmetics Regulation (EC 1223/2009): Everything Brands Need to Know
Complete guide to the EU Cosmetics Regulation — CPNP notifications, Product Information Files, safety assessments, ingredient restrictions, responsible person requirements, and labeling compliance.
The EU Cosmetics Regulation (EC) No 1223/2009 is the world's most comprehensive framework for cosmetic product safety. It governs every cosmetic product placed on the market in the 27 EU member states plus the EEA, setting requirements for safety assessment, ingredient restrictions, labeling, notifications, and post-market surveillance.
This guide covers the key requirements and how to comply efficiently.
What Does the Regulation Cover?
A "cosmetic product" under EU law is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair, nails, lips, external genital organs) or with the teeth and mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition, or correcting body odours.
This covers everything from moisturizers and shampoos to makeup, fragrances, toothpaste, and deodorants.
CPNP Notification
Before placing any cosmetic product on the EU market, the responsible person must submit a notification to the Cosmetic Products Notification Portal (CPNP). The notification includes:
- Product category and name
- Name and address of the responsible person
- Country of origin
- Member state where the product will first be placed on the market
- Contact details for rapid notification in case of problems
- Presence of nanomaterials (with specific identification)
- Presence of substances classified as CMR (carcinogenic, mutagenic, or toxic to reproduction)
- Frame formulation (general ingredient composition by category)
Notification is free through the CPNP portal.
Responsible Person
Article 4 of the regulation requires that every cosmetic product placed on the EU market has a designated Responsible Person who must be established within the EU. The RP is responsible for:
- Ensuring compliance with the regulation
- Maintaining the Product Information File (PIF)
- Submitting CPNP notifications
- Cooperating with competent authorities
- Reporting serious undesirable effects
For EU-manufactured products, the RP is typically the manufacturer. For imported products, the RP is the importer. Brands can also designate a third-party Responsible Person by written mandate.
Product Information File (PIF)
The Responsible Person must maintain a Product Information File for each product. The PIF must contain:
- Product description — allowing clear identification of the product
- Cosmetic Product Safety Report (CPSR) — Parts A and B
- Manufacturing method and GMP compliance — statement of conformity with ISO 22716
- Proof of claimed effects — evidence supporting any claims made
- Animal testing data — data on any animal testing by the manufacturer or suppliers
The PIF must be kept for 10 years after the last batch is placed on the market, and must be readily accessible to competent authorities at the address indicated on the label.
Cosmetic Product Safety Report (CPSR)
The CPSR is the cornerstone of EU cosmetics compliance. It consists of two parts:
Part A — Cosmetic Product Safety Information
- Quantitative and qualitative composition
- Physical/chemical characteristics
- Microbiological quality
- Impurities and traces
- Normal and reasonably foreseeable use
- Exposure to the product
- Exposure to substances in the formulation
- Toxicological profile of each substance
- Undesirable effects and serious undesirable effects
- Product information
Part B — Cosmetic Product Safety Assessment
Must be carried out by a qualified safety assessor (university degree in pharmacy, toxicology, medicine, or equivalent). The assessment must conclude whether the product is safe under normal and reasonably foreseeable conditions of use.
Typical costs: €300–900 per product depending on complexity.
Ingredient Restrictions
The EU maintains the world's most extensive ingredient restriction system across six annexes:
| Annex | Content | Count |
|---|---|---|
| Annex II | Prohibited substances | 1,657+ |
| Annex III | Restricted substances (conditions apply) | 300+ |
| Annex IV | Permitted colorants | 150+ |
| Annex V | Permitted preservatives | 57 |
| Annex VI | Permitted UV filters | 28 |
Key examples of restricted ingredients:
- Retinol: Max 0.3% in body lotion, 0.05% in hand cream (SCCS/1576/16)
- Salicylic acid: Max 2% rinse-off, 0.5% leave-on, not for children under 3 (SCCS/1601/18)
- Titanium dioxide: Banned in spray products due to inhalation risk (SCCS/1617/20)
- Parabens: Methylparaben max 0.4%, propylparaben max 0.14%, not in nappy area for children under 3
Cosmetica cross-references your formulation against all six annexes instantly and links each finding to the specific SCCS opinion or annex entry.
Labeling Requirements
EU cosmetic labels must include:
- Name and address of the responsible person
- Nominal content (weight or volume)
- Date of minimum durability (or PAO symbol for products lasting >30 months)
- Particular precautions for use
- Batch number
- Product function (unless obvious from presentation)
- INCI ingredient list in descending order of concentration
- Country of origin for imported products
Language requirements vary by member state. Ingredients must always be listed using INCI nomenclature.
How Cosmetica Streamlines EU Compliance
- AI Ingredient Checker: Cross-reference formulations against EU Annexes II-VI with verified citations
- PIF Builder: Structured PIF generation with all required documentation sections
- CPNP-Ready Data: Format product data for CPNP notification
- SCCS Opinion Links: Every restriction finding links directly to the official SCCS scientific opinion
- Multi-Market: Check EU compliance alongside US, UK, Canada, and 11 more markets simultaneously
Ready to automate your compliance?
See how Cosmetica replaces manual regulatory work with AI-powered automation.