If I private-label cosmetics, do I become the Responsible Person?

## If I Private-Label Cosmetics, Do I Become the Responsible Person? **Potentially, yes—if you place the product on the market under your name or trademark, you may become the Responsible Person** and inherit the compliance responsibilities that come with that role. ### When Private Labeling Makes You the RP According to Article 4 of Regulation (EC) No 1223/2009, a distributor becomes the RP if they sell products under their own name or trademark^{<a href="#cite-14">[1]</a>}. **You become the RP if:** - ✅ You sell products under your own brand name - ✅ You place products on the market under your trademark - ✅ You rebrand products with your name - ✅ You modify products in ways that affect compliance ### Private Label Scenarios #### Scenario 1: Full Private Label - Manufacturer produces products - You sell under your brand name - **You become the RP** (unless you appoint another EU/EEA entity) #### Scenario 2: Co-Branding - Manufacturer's brand and your brand both appear - Depends on who is "placing on market" - May need to clarify RP designation #### Scenario 3: White Label with Modifications - Manufacturer produces base product - You modify or rebrand - **You likely become the RP** ### RP Responsibilities for Private Labelers If you become the RP, you're responsible for: - [ ] Ensuring product safety before market placement - [ ] Maintaining Product Information File (PIF) - [ ] Submitting CPNP notifications - [ ] Ensuring proper labeling compliance - [ ] Serving as contact point for authorities - [ ] Reporting serious undesirable effects (SUEs) - [ ] Responding to authority inquiries ### Private Label RP Checklist Before private labeling: - [ ] Understand you may become the RP - [ ] Verify you can fulfill RP obligations - [ ] Ensure you have access to product information - [ ] Confirm PIF can be maintained or accessed - [ ] Verify CPNP notification can be submitted - [ ] Understand SUE reporting requirements - [ ] Consider appointing an EU RP provider if needed ### Can You Appoint Another RP? **Yes—even if you're placing products on the market, you can appoint another EU/EEA entity as RP** by written mandate^{<a href="#cite-14">[1]</a>}. **Consider appointing an RP provider if:** - You don't have EU establishment - You lack regulatory expertise - You want to reduce operational burden - You need professional RP services ### Private Label Considerations **Advantages of Being RP:** - Direct control over compliance - No need to coordinate with separate RP - May be more cost-effective for large operations **Advantages of Appointing RP Provider:** - Professional regulatory expertise - Reduced operational burden - Access to established systems - Faster market access ### Common Private Label Mistakes - ❌ Not realizing you become the RP - ❌ Not understanding RP obligations - ❌ Not having EU establishment (if required) - ❌ Not maintaining PIFs properly - ❌ Not submitting CPNP notifications - ❌ Not handling SUE reporting ### Questions to Ask Yourself 1. **"Am I placing products on the market under my brand?"** - If yes, you likely become the RP 2. **"Can I fulfill RP obligations?"** - Do you have EU establishment? - Do you have regulatory expertise? - Can you maintain PIFs? 3. **"Should I appoint an RP provider?"** - Consider your capabilities and resources - Evaluate cost vs. operational burden ### Next Steps 1. Determine if private labeling makes you the RP 2. Assess your ability to fulfill RP obligations 3. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers if you need to appoint an RP --- *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-14"></a>[1] [Regulation (EC) No 1223/2009 - Article 4](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)