EU Cosmetic Regulation (EC) No 1223/2009 is the primary legislation governing cosmetic products in the European Union, ensuring product safety, compliance, traceability, and quality. Effective from 11 July 2013, it requires all cosmetic products to undergo a safety assessment documented in the Cosmetic Product Safety Report (CPSR) before market launch. Although "cosmeceuticals" are widely marketed, they are subject to the same regulatory requirements as cosmetics, including products with skin lightening, moisturising, and anti-aging claims. Therefore, regulatory planning is critical for cosmeceutical product development, particularly for formulations containing peptides, botanical extracts, and other bioactive ingredients, to ensure safety, support claims, follow good manufacturing practices, and maintain compliance throughout the product lifecycle.[1]
Understanding EU Cosmetic Regulation (EC 1223/2009) for Safe Cosmeceutical Product Development
EU Cosmetic Regulation (EC) No 1223/2009 is the primary legislation governing cosmetic products in the European Union, ensuring product safety, compliance, traceability, and quality. Effective from 11 July 2013, it requires all cosmetic products to undergo a safety assessment documented in the Cosmetic Product Safety Report (CPSR) before market launch. Although “cosmeceuticals” are widely marketed, they are subject to the same regulatory requirements as cosmetics, including products with skin lightening, moisturising, and anti-aging claims. Therefore, regulatory planning is critical for cosmeceutical product development, particularly for formulations containing peptides, botanical extracts, and other bioactive ingredients, to ensure safety, support claims, follow good manufacturing practices, and maintain compliance throughout the product lifecycle.[1]
Core Requirements of EU Cosmetic Regulation (EC) 1223/2009
Regulatory Framework and Key Compliance Requirements
EU cosmetic Regulation (EC) 1223/2009 sets the common rules for safety of cosmetics in all 27 member states of the European Union. The regulation requires manufacturers, importers and EU/EEA established Responsible Persons (RP) to bear the legal responsibilities of ensuring that cosmetics are safe before they reach the market.
Article 3: Safety Requirement (Mandatory)
Article 3 states that a cosmetic product must be safe for human health when used under normal or reasonably foreseeable conditions. This requirement forms the foundation of Cosmetic safety regulations Europe and supports both Safe skincare product development and Safe cosmeceutical product development through scientifically supported safety evaluations.
Article 4: Responsible Person (Legal Liability)
The Responsible Person is held legally liable for product safety and must:
- Complete the Cosmetic Product Safety Report (CPSR)
- Keep the Product Information File (PIF)
- Register the cosmetic product notification to the CPNP (Cosmetic Products Notification Portal)
- Ensure compliance of ISO 22716 cosmetics GMP
- Oversee the monitoring of cosmetic products and report adverse events
Article 8: Good Manufacturing Practice
ISO 22716 cosmetics GMP compliance is mandatory, so that products are manufactured according to quality requirements, and to ensure products consistency over time. The application of a cosmetic quality management system based on ISO 22716 is the symbol of respect toward the cosmetic manufacturing standards and regulatory compliance. [2]
Safety Assessment Requirements for Cosmeceutical Products
The safety assessment of cosmeceutical product development is the key factor for ensuring a safe product. According to EU legislation, every cosmeceutical product before its distribution in the EU market should be thoroughly evaluated in a report, Cosmetic Product Safety Report (CPSR), written by the cosmetic safety assessor (a pharmacist, toxicologist or doctor).
CPSR Structure:
Part A: Cosmetic Safety Information includes:
It presents all data and characteristics of the cosmetic product:
- Composition of cosmetic product (qualitative and quantitative)
- Physicochemical and microbiological characteristics of cosmetic product and stability of the product
- Cosmetic product safety characteristics such as impurities, traces, packaging materials
- Cosmetic product normal/foreseeable condition of use and exposure to the cosmetic product
- Cosmetic toxicological assessmentof all ingredients
- Existing safety data and undesirable effect reports
Part B: Cosmetic Safety Assessment
Part B contains the final safety conclusion, conditions of use, warnings, and scientific justification supporting product safety. The report evaluates the combined impact of all ingredients and forms a critical component of the Product Information File (PIF). Under EU cosmetic compliance requirements, the PIF must be retained for ten years after the last batch is placed on the market. [3]
Ingredient Compliance and Regulatory Restrictions
The selection of ingredients is an important process in the safe cosmeceutical product development. In the European union, the safety of ingredients is regulated under the EU Cosmetic Regulation (EC) 1223/2009 by means of annexes covering which materials are banned, restricted and permitted substances.
Key Annexes:
H3 Annex II (Prohibited Substances)
Annex II report over 1,400 banned substances. Commission Regulation (EU) 2024/996 (23 April 2024) added several CMR (Carcinogenic, Mutagenic, Toxic for Reproduction) and endocrine disrupting substances.
Annex III (Restricted Substances)
Annex III contains 260+ substances with concentration limits. The 2024 regulation introduced critical restrictions:
Ingredient | Maximum Concentration | Compliance Date |
Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) | 0.3% leave on face, 1.0% rinse off, 0.05% lip products | 1 November 2025 |
Alpha-Arbutin/Arbutin | 2.0% face;10% body | 1 February 2025 |
Mandatory Vitamin A labeling: “Contains Vitamin A. Consider your daily intake before use”
Annexes IV-VI
These cover approved colorants, preservatives, and UV filters with specific concentration limits.
- Annex IV: colorants
- Annex V: preservatives
- Annex VI: UV filters [4]
Nanomaterials Requirements (Article 16)
For all products containing nanomaterials, a further notification is necessary in addition to the general Article 13 CPNP notification, which is to be made under Article 16(3) at least 6 months prior to placing on the market and must contain information on material identification and safety considerations. [2]
Cosmetic Products Notification Portal (CPNP) Requirements
The Cosmetic Products Notification Portal (CPNP) is mandatory before any cosmetic product can be launched on the EU market. Completion of the Cosmetic Products Notification Portal (CPNP) process is a mandatory requirement for obtaining EU cosmetic market authorization and legally placing cosmetic products on the European market. The system is centralized and provided for free to authorities’ access to:
- Product category and name
- Responsible person details
- Origin of product
- Member states where it will be sold
- Presence of nanomaterials (yes/no and specification if yes)
- Formulation qualitative and quantitative
Notification on CPNP can also be accessed to by the competent authorities, poison centers and member states to facilitate emergency response and market surveillance. Companies implementing the Cosmeceutical regulations Europe need a thorough ingredient review process to check if the formulation conforms before its development to avoid extensive reformulation and late launch into the market. [5]
Scientific Evidence, Claims, and Labeling Compliance Under EU Cosmetic Regulation
Product Claims Requirements
Under Regulation (EU) No 655/2013, cosmetic claims must be truthful, supported by evidence, and not mislead consumers. Compliance with the cosmetic products claim regulation requires claims to be legally compliant, accurate, fair, and scientifically substantiated.
For Safe cosmeceutical product development, Cosmetic claims substantiation plays a critical role. Claims related to hydration, anti-aging, skin brightening, barrier repair, and soothing effects must be supported by appropriate scientific evidence.
Permitted cosmetic claims may include moisturizing, anti-wrinkle, brightening, and skin-conditioning benefits when adequately substantiated. However, claims suggesting disease prevention, treatment, or cure may result in the product being classified as a medicinal product rather than a cosmetic.
Cosmetic Labeling Compliance Under Article 19
Accurate and transparent labeling is required by EU cosmetic labeling and is the most frequently inspected area for compliance.
Mandatory Label Elements
Under Cosmetic labelling requirements EU, labels must include:
- Name and address of the Responsible Person
- Country of origin for imported products
- Nominal product quantity
- Durability information or PAO symbol
- Safety warnings and precautions
- Batch number
- Product function
- Full ingredient list using INCI nomenclature
Ingredient Listing Standards
Ingredients above 1% must be listed in descending order by weight, while ingredients below 1% may appear in any order. Products containing nanomaterials must include the term “(nano)” following the ingredient name. Compliance with EU cosmetic labeling requirements improves product transparency, traceability, and consumer confidence. [6]
Latest Regulatory Updates and Emerging Trends (2024–2026)
Recent changes continue to enhance Cosmeceutical regulations Europe and EU cosmetic compliance overall.
Regulation (EU) 2024/996 set new concentration limits for derivatives of Vitamin A and Alpha-Arbutin, while adding to already-imposed limits for certain carcinogenic, mutagenic, reproductive toxic, and endocrine-disrupting compounds.
Regulation (EU) 2026/78 restricted the use of CMRs and added transitional time for existing products to the regulatory timeline. Innovative new cosmetic, skincare, and beauty product manufacturers will have to remain actively involved and keep pace with current Regulatory trends to ensure ongoing Cosmetic regulatory compliance, including alignment with current SCCS guidelines.
Post-Market Obligations and Market Surveillance
Post-market activities are critical to ongoing product approval. According to new EU cosmetic market surveillance directives, product manufacturers and the Responsible Person are required to oversee each of their products’ effectiveness on the market and maintain records of any severe undesired effects from the consumer.
Where safety or toxicity is a concern, the product must be withdrawn, recalled, or reformatted, and the relevant regulatory authorities must be informed. Post-market surveillance ensures that manufacturers’ product approval activities are perpetually viable and consumers are assured safe and EU cosmetic compliance, Skincare, and Beauty items remain accessible. [7]
Conclusion
The EU Cosmetic Regulation (EC) 1223/2009 sets strict guidelines on product safety evaluation, labeling and claims to allow cosmetic products on the European market. With crucial bans of Vitamin, A and Alpha-Arbutin coming into effect in 2025-2026, professional regulatory consulting is critical to avoid time-consuming errors.
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References
- Morel, S., Mura, G., Gallarate, M., & Sapino, S. (2024). Cosmetic packaging: European regulatory aspects and sustainability. Cosmetics, 11(4), 110. https://doi.org/10.3390/cosmetics11040110
- European Parliament, & Council of the European Union. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Official Journal of the European Union. https://eur-lex.europa.eu/eli/reg/2009/1223/oj/eng
- Gautam, P., Ghanghas, D., Mittal, P., Gupta, V., & Dhiman, K. (2022). Regulatory framework of cosmetic in the European Union. https://doi.org/10.53388/20220202013
- European Parliament, & Council of the European Union. (2024). Commission Regulation (EU) 2024/996 amending Regulation (EC) No 1223/2009 on cosmetic products. Official Journal of the European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400996
- Stojiljković, D., Jocić, D., & Vojvodić, S. (2026). Safety of cosmetic products: Regulatory foundations and practical challenges. https://doi.org/10.51738/kpolisa.2026.1r.dsdjsv
- European Parliament, & Council of the European Union. (2025). Consolidated version of Regulation (EC) No 1223/2009 on cosmetic products. EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02009R1223-20250901
- European Commission. (2026). Commission Regulation (EU) 2026/78 amending Regulation (EC) No 1223/2009 on cosmetic products. Official Journal of the European Union. https://eur-lex.europa.eu/eli/reg/2026/78/oj/eng
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