1. What is a Cosmetic Product Information File (PIF)?
A Cosmetic Product Information File (PIF) is a comprehensive dossier required by cosmetic regulations, which must be established for each cosmetic product before it is marketed. The file should include details such as the product's formula, manufacturing process, safety assessment report, labeling information, and more, with the goal of ensuring the product's safety and compliance.
2. Which Products Require a PIF?
- Special Cosmetics: Must complete registration and establish the PIF by July 1, 2024.
- Baby Products, Lip Products, Eye Products, Non-Medicated Toothpaste, and Mouthwash: Must complete by July 1, 2025.
- General Cosmetics: Must complete by July 1, 2026.
3. What Does the PIF Include?
- Product Formula: Names, percentages, and functions of the ingredients.
- Safety Assessment: Toxicological data analysis and safety report conducted by professional safety assessors (SA).
- Manufacturing Process: Detailed description of the manufacturing process, including critical control points.
- Label Information: All information on the product's label and packaging, including usage, directions, and warnings.
- Product Testing Reports: If applicable, reports such as microbiological testing and stability testing.
4. Who is Responsible for Preparing and Maintaining the PIF?
- Domestic Cosmetic Manufacturers: Responsible for establishing the PIF for products produced domestically.
- Commissioned Manufacturers (Brand Owners): The brand company that commissions a domestic factory to produce cosmetics is responsible for the PIF.
- Importers: Responsible for establishing the PIF for imported cosmetics in the importing country.
5. Key Considerations for the PIF
- Accuracy and Completeness: All data must be accurate and complete to be readily available for inspection by regulatory authorities.
- File Storage: The PIF can be stored in either paper or electronic form. It does not need to be registered online but must be properly maintained within the company.
- Updates and Maintenance: The PIF must be updated promptly whenever there are changes to the product formula or labeling information.
6. Services Provided by Sin Yi Cosmetic International
Our professional team can assist you with:
- Quick and Accurate PIF Creation: Ensuring compliance with regulations.
- Transparent and Reasonable Pricing: Offering the best value for our services.
- Fast Processing of Urgent Cases: Handling urgent needs efficiently.
This guide presents the key points of PIF creation in a simple and understandable way, helping clients quickly grasp the process. If you need further information or have other requests, please feel free to contact us.
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