How long must the PIF be kept, and where must it be stored?

## How Long Must the PIF Be Kept, and Where Must It Be Stored? The Product Information File (PIF) has specific retention and storage requirements under EU Cosmetics Regulation. Understanding these requirements is essential for compliance. ### PIF Retention Period According to Article 11 of Regulation (EC) No 1223/2009, **the RP must keep the PIF for 10 years after the last batch is placed on the market**^{<a href="#cite-6">[1]</a>}. **Key points:** - The 10-year period starts from when the **last batch** is placed on the market - This applies even if you discontinue the product - The retention period is mandatory, not optional ### Where Must the PIF Be Stored? The PIF must be **readily accessible** to competent authorities at the RP's address indicated on the label^{<a href="#cite-6">[1]</a>}. **Practical requirements:** - The PIF must be accessible at the RP's address shown on product labels - The RP must be able to provide the PIF to authorities within a reasonable time (typically 3-7 days) - The address must be a real, accessible location (not just a PO box) - Authorities can request the PIF at any time during the retention period ### PIF Storage Checklist Ensure your PIF storage meets these requirements: - [ ] PIF is stored at RP's address indicated on labels - [ ] PIF is accessible within required timeframe (3-7 days) - [ ] Storage location is a real, accessible address - [ ] PIF is maintained for 10 years after last batch placement - [ ] PIF is kept current and updated when products change - [ ] RP can provide PIF to authorities upon request - [ ] Storage system allows for quick retrieval ### Practical Storage Considerations **Physical Storage:** - PIFs can be stored physically at RP's address - Must be organized and easily retrievable - Must be protected from damage or loss **Digital Storage:** - PIFs can be stored digitally - Must be accessible from RP's address - Must be in a format authorities can access - Must have backup and security measures **Hybrid Approach:** - Many RPs use a combination of physical and digital storage - Digital storage for efficiency, physical backup for security - Must ensure both are accessible from RP's address ### What Happens If PIF Is Not Accessible? If the PIF is not accessible when authorities request it: - ❌ Non-compliance with Regulation 1223/2009 - ❌ Potential regulatory action - ❌ Possible product withdrawal from market - ❌ Fines or penalties - ❌ Damage to business reputation ### PIF Retention Best Practices 1. **Maintain Complete Records** - Keep all PIF components for the full 10-year period 2. **Update Regularly** - Keep PIF current when products change 3. **Organize Systematically** - Use clear organization for quick retrieval 4. **Backup Securely** - Maintain backups to prevent loss 5. **Document Access** - Keep records of when PIFs are accessed or provided 6. **Plan for Discontinuation** - Have a plan for PIF retention when discontinuing products ### Transition Considerations If you change RPs: - Previous RP may need to retain PIFs for products they were responsible for - New RP must have access to PIFs for products they take over - Ensure continuity of PIF accessibility - Update labels with new RP address ### Next Steps 1. Verify your PIF storage meets accessibility requirements 2. Ensure retention period compliance (10 years) 3. **[Compare EU Cosmetics Responsible Person providers & request quotes](https://cruxi.ai/regulatory-directories/cosmetics_rp)** - Find providers with robust PIF management systems --- *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-6"></a>[1] [Regulation (EC) No 1223/2009 - Article 11](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009R1223)