Bilgiye hızlı erişim:
For manufacturers, importers, and distributors operating in the cosmetics industry, the responsibilities defined under the Cosmetic Products Regulation are of great importance in ensuring both product safety and legal compliance. One of the most fundamental requirements is the obligation to prepare and maintain a Product Information File (PIF).
This article provides up-to-date information regarding the legal provisions and penalties associated with the PIF.
What is a Product Information File (PIF)?
The Product Information File (PIF) is a comprehensive set of technical and administrative documents that must be prepared for each cosmetic product placed on the market and kept up to date for as long as the product remains available. Required under the Turkish Cosmetic Products Regulation, the PIF is also in alignment with European Union legislation (EC No 1223/2009).
The main purposes of the PIF are to:
Document the product’s safety for human health
Demonstrate regulatory compliance during inspections
Confirm that the responsible person has fulfilled their legal obligations prior to placing the product on the market
What Should the PIF Contain?
The PIF is detailed and must be prepared separately for each product. Key information that must be included:
Product Description: Trade name, intended use, product type (e.g., emulsion, solution, cream)
Formulation Components: INCI names of raw materials, their concentrations, and functions
CPSR – Cosmetic Product Safety Report: Toxicological analysis, exposure calculations, and safety assessment
Description of the Manufacturing Process: Production stages and declaration of compliance with Good Manufacturing Practices (GMP)
Label and Packaging Information: Product label samples, usage instructions, warnings, PAO (Period After Opening)
Physicochemical, Microbiological, and Stability Tests
Evidence Supporting Claims: Test results supporting claims such as “moisturizes” or “suitable for sensitive skin”
Animal Testing Statements (if the product is cruelty-free)
Product Release Date and Batch Records
The PIF must be readily available for submission to the competent authority during market inspections. It also fulfills the manufacturer’s/importer’s obligation of transparency regarding product safety.
By compiling all scientific and technical aspects of a product, the PIF plays a vital role in both consumer protection and smooth regulatory audits.
The PIF must be completed before the product is placed on the market. Article 14 of the Cosmetic Products Regulation requires the responsible person to retain the PIF for at least 10 years after the last batch of the product has been marketed. During inspections, no grace period is granted to prepare the file. Therefore, the PIF must be complete and accessible before the product launch. Otherwise, the product may face both monetary penalties and withdrawal from the market.
If deficiencies are found in the PIF or if the file is entirely missing, Article 20, Paragraph 1(c) of Law No. 7223 stipulates the following penalties:
If the PIF is Incomplete:
An administrative fine of 96,226 TRY is imposed.
Product recall from the market is mandatory.
If the PIF is Completely Absent:
An administrative fine of 120,282 TRY is imposed.
A mandatory product recall is also enforced.
These penalties are not only financial burdens but also have a direct impact on the market reputation and brand value of the products.
At COSMİNG Laboratory, we offer technical support for the preparation, updating, and regulatory compliance of the Product Information File for your cosmetic products.
We manage the structuring of the file contents according to current legislation, integration of analytical reports, and preparation of the Cosmetic Product Safety Report (CPSR) on your behalf.
For detailed information or to request our services, please feel free to contact us.
Stay informed about the latest developments in the industry and our company by subscribing to our e-newsletters.
Cosming Laboratuvar Bilgi Yönetim Eğitim Danışmanlık San. Ve Tic. Ltd Şti.
Get a Quote Register