General

How should you label cosmetic products for the EU market (Responsible Person indication requirements)?

I need to update my cosmetic product labeling for the EU market. What are the specific requirements for indicating the Responsible Person on labels and packaging under EU Cosmetics Regulation?
💬 1 answers 👁️ 3 views 👍 0
Asked by Lo H. Khamis

Answers

✓ Accepted Answer
👍 0
## How Should You Label Cosmetic Products for the EU Market? Regulation (EC) No 1223/2009 provides clear rules for Responsible Person indication on product labels and packaging. Understanding these requirements is critical to avoid compliance issues and market access delays. ### Responsible Person Indication Requirements Under Regulation 1223/2009, cosmetic products must clearly indicate the Responsible Person on: - **Primary packaging** - The immediate container of the product - **Secondary packaging** - Outer packaging (if applicable) - **Accompanying documents** - Any documentation that accompanies the product ### Required Information The labeling must include: 1. **RP Name and Address** - The complete name and address of the Responsible Person 2. **Clear Identification** - The RP must be clearly identified 3. **Contact Information** - The RP's address must allow direct contact ### Labeling Format The regulations allow flexibility in how the RP is indicated: - You can use text such as "Responsible Person" or "RP" - The RP information must be clearly distinguishable from manufacturer information - The information must be in a language easily understood by end users (typically the language of the member state where the product is sold) ### Manufacturer Indication **Important**: The manufacturer must also be indicated on the label. The RP indication is in addition to (not instead of) the manufacturer information. **Label Hierarchy:** 1. Manufacturer name and address (required) 2. RP name and address (required for non-EU manufacturers) 3. Other required information (ingredients, warnings, etc.) ### Other Required Labeling Elements In addition to RP information, cosmetic product labels must include: - **Product name** - Clear identification of the product - **Ingredient list** - All ingredients in INCI nomenclature - **Net content** - Weight or volume - **Best before date** - If applicable - **Batch number** - For traceability - **Warnings and precautions** - If applicable - **Function of the product** - If not obvious from presentation ### Practical Best Practice To reduce regulatory risk and ensure compliance: **Put RP details on:** 1. **Primary packaging** - At minimum, include on the immediate container 2. **Secondary packaging** - Include on outer packaging if space permits 3. **Accompanying documents** - Include in any documentation that accompanies the product **Why this approach?** - Ensures information is always accessible - Meets Regulation 1223/2009 requirements regardless of which packaging is reviewed - Provides redundancy in case one label is missing - Aligns with best practices for international regulatory compliance ### Labeling Checklist Before printing labels for the EU market, verify: - ✅ Manufacturer name and address is present - ✅ RP name and address is present - ✅ RP address is a complete address (not just PO box) - ✅ Information appears on primary packaging - ✅ Text is legible and in appropriate language(s) - ✅ All other required labeling elements are present - ✅ Labeling complies with other Regulation 1223/2009 requirements ### Common Mistakes to Avoid - ❌ Using only a PO box for RP address - ❌ Omitting manufacturer information - ❌ Placing RP info only on secondary packaging (may be removed) - ❌ Using incomplete or incorrect RP address - ❌ Forgetting to update labeling when switching RPs - ❌ Missing required labeling elements (ingredients, warnings, etc.) ### Coordination with RP Before finalizing your labeling: 1. **Confirm RP details** - Get the exact name and complete address from your RP 2. **Review with RP** - Some RPs have specific preferences for how their information is displayed 3. **Plan for updates** - If you switch RPs, you'll need to update all labeling—plan your label print runs accordingly ### Next Steps 1. Coordinate labeling requirements with your RP provider 2. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers that offer labeling support and guidance --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Regulation (EC) No 1223/2009 - Article 19](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)