What must be in the written mandate (agreement) with the EU Cosmetics Responsible Person?

## What Must Be in the Written Mandate with the EU Cosmetics Responsible Person? Regulation (EC) No 1223/2009 requires a **written mandate** between the manufacturer and the Responsible Person. This isn't optional—it's a regulatory requirement. To make your mandate "operational" and avoid delays, include these essential elements: ### 1. **Scope Definition** Clearly define which products, brands, and product categories are covered. Avoid vague "all products" wording unless it's truly accurate. **Include:** - Specific product names or product families - Product categories (makeup, skincare, haircare, etc.) - Brand names if applicable - Any exclusions or limitations ### 2. **Regulatory Handoffs** Define the operational workflow for regulatory activities: - **Who prepares** CPNP notifications? - **Who reviews** and submits CPNP notifications? - **Who maintains** the Product Information File (PIF)? - **Who handles** SUE reporting and authority inquiries? - **Response timelines** - How fast must you respond to authority requests? - **Escalation procedures** - What happens if there are disagreements or urgent issues? ### 3. **PIF Management** Specify how the Product Information File will be handled: - **Option A**: RP maintains the complete PIF - Where is it stored? - How is it kept up to date? - What format is required? - **Option B**: Manufacturer commits to provide PIF directly to authorities upon request - What triggers the request? - What format must the PIF be in? - What happens if you can't meet the deadline? - What evidence does the RP need to be confident you can meet this requirement? This clause is a **major differentiator** between RP providers—some run full PIF management workflows, while others operate on contractual access and escalation. ### 4. **CPNP Notification Procedures** Establish how CPNP notifications will be handled: - **Who prepares** CPNP notification data? - **Who submits** CPNP notifications? - **Who updates** CPNP when products change? - **Timeline expectations** - How quickly are notifications submitted? - **Change notification** - How are product changes communicated? ### 5. **Change Control Procedures** Establish how you'll handle changes: - **Product formulation changes** - How are ingredient changes reported? - **Labeling changes** - How are label updates communicated? - **Product discontinuation** - How are discontinued products handled? - **Regulatory changes** - How are updates to EU Cosmetics Regulation handled? ### 6. **Termination and Transition** Define what happens if you switch RPs: - **Market presence** - Can products remain on the market during transition? - **Records retention** - Who holds historical PIFs and for how long? - **CPNP transfer** - How are CPNP notifications transferred? - **Open SUE cases** - How are ongoing investigations transferred? - **Notification requirements** - Who notifies authorities of the change? - **Transition timeline** - How long does the handover take? ### 7. **Financial and Liability Terms** While not directly regulatory, include: - Fee structure and payment terms - Liability allocation for regulatory non-compliance - Insurance requirements - Dispute resolution procedures ### Best Practices 1. **Be Specific** - Vague mandates lead to operational confusion and regulatory risk 2. **Define Timelines** - Set clear expectations for response times and deliverables 3. **Document Workflows** - Create process maps for key activities (CPNP, PIF requests, SUE reporting) 4. **Regular Review** - Update the mandate as your product portfolio or operations change 5. **Legal Review** - Have your legal team review the mandate before signing ### Red Flags to Avoid - ❌ Mandates that say "all products" without defining what that means - ❌ Missing PIF management procedures - ❌ Unclear CPNP notification responsibilities - ❌ No termination or transition procedures - ❌ Vague response time commitments ### Next Steps 1. Prepare your mandate requirements checklist 2. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers that offer comprehensive mandate support --- *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 4](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)