What exactly must be on the cosmetic label for the EU market?

## What Exactly Must Be on the Cosmetic Label for the EU Market? EU cosmetics labeling requirements are comprehensive and specific. Understanding all mandatory elements helps ensure compliance and avoid market access delays. ### Mandatory Labeling Elements According to Article 19 of Regulation (EC) No 1223/2009, cosmetic product labels must include specific information^{<a href="#cite-11">[1]</a>}. ### EU Cosmetics Labeling Checklist #### 1. Responsible Person Information - [ ] RP name - [ ] RP complete address (must be accessible, not just PO box) - [ ] RP information clearly identified #### 2. Product Identification - [ ] Product name - [ ] Product function (unless obvious from presentation) #### 3. Content Information - [ ] Nominal content (weight or volume) - [ ] Content must be in metric units #### 4. Durability Information - [ ] Best before date (if product has durability < 30 months) - [ ] Period After Opening (PAO) symbol and period (if applicable) - [ ] Durability information format must comply with requirements #### 5. Precautions and Warnings - [ ] All required warnings and precautions - [ ] Specific warnings for certain ingredients or uses - [ ] Instructions for use (if necessary for safe use) #### 6. Batch/Reference Information - [ ] Batch number or reference for traceability - [ ] Must allow identification of manufacturing batch #### 7. Ingredients List - [ ] Complete list of all ingredients - [ ] Ingredients in INCI nomenclature - [ ] Ingredients listed in descending order of weight - [ ] Ingredients list format must comply with requirements - [ ] Colorants must be listed at end (if applicable) - [ ] Fragrance allergens must be listed (if applicable) ### Detailed Labeling Requirements **Responsible Person Address:** - Must be complete address (not just PO box) - Must be accessible to authorities - Must match address where PIF is accessible **Ingredients List:** - Must use INCI (International Nomenclature of Cosmetic Ingredients) names - Must list in descending order of weight at time of manufacture - Colorants listed at end with "CI" numbers - Fragrance allergens must be listed if present above threshold **Durability Information:** - Products with durability < 30 months: "Best before end" date - Products with durability ≥ 30 months: Period After Opening (PAO) symbol - Format must be specific (e.g., "12M" for 12 months) **Language Requirements:** - Information must be in language(s) easily understood by end users - Typically means language of member state where product is sold - Some countries require local language for all information ### Labeling Placement Requirements Information must appear on: - [ ] Primary packaging (immediate container) - [ ] Secondary packaging (outer packaging, if applicable) - [ ] Accompanying documents (if space is limited) **Minimum Requirements:** - RP information must be on primary packaging - Ingredients list must be on primary packaging - Other information can be on secondary packaging if space is limited ### Common Labeling Mistakes to Avoid - ❌ Missing RP address or incomplete address - ❌ Using PO box only for RP address - ❌ Incorrect INCI nomenclature for ingredients - ❌ Missing or incorrect durability information - ❌ Missing required warnings - ❌ Incorrect content information - ❌ Missing batch number - ❌ Information not in required language(s) ### Labeling Compliance Checklist Before printing labels: - [ ] RP name and complete address are present - [ ] Product name and function are clear - [ ] Nominal content is accurate and in metric units - [ ] Durability information is correct and properly formatted - [ ] All required warnings and precautions are present - [ ] Batch number or reference is included - [ ] Complete ingredients list in INCI nomenclature - [ ] Ingredients are in descending order of weight - [ ] Colorants and fragrance allergens are properly listed - [ ] Information is in appropriate language(s) - [ ] Labeling meets placement requirements ### Labeling Update Requirements Labels must be updated when: - RP information changes (e.g., switching RPs) - Product formulation changes - New warnings are required - Other required information changes ### Practical Tips 1. **Review with RP** - Have your RP review labels before printing 2. **Verify INCI Names** - Double-check all INCI nomenclature 3. **Check Language Requirements** - Verify language requirements for target markets 4. **Plan for Updates** - Consider label update needs when changing RPs or products 5. **Maintain Consistency** - Ensure labeling is consistent across product variants ### Next Steps 1. Review labeling requirements for your products 2. Prepare compliant labels 3. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers that offer labeling review services --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: <a id="cite-11"></a>[1] [Regulation (EC) No 1223/2009 - Article 19](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)