Product Information File and Product Safety Assessment Service

Product Information File (PIF) and Product Safety Assessment Report

What is a Product Information File?

The product information file is a document containing all relevant technical documents that companies need to prepare for the cosmetic product they want to market.

According to the Turkish Medicines and Medical Devices Agency, the provisions regarding the product information file (PIF) are included in Article 14 of the Cosmetic Products Regulation. The person responsible for preparing the product information file shall have it ready in electronic or another format at the address specified on the label for submission to the Agency upon request. The file is prepared in Turkish or English.

What Should Be Included in the Product Information File?

The product information file, which is mandatory for each cosmetic product, contains all technical information about the product. While not limited to the following, the most important information is as follows:

1. Product name, code name, if any, local name in use, qualitative and quantitative structure of the product; in the case of perfume and perfume composition, the composition code and supplier identity must be included. The requested information should contain the following elements:
• Reference number of the cosmetic product, its commercial brand, national code, and what it represents should be clear.
• Quantitative and qualitative information about the composition of the cosmetic product should be included, and the product components should be indicated with their INCI names and intended uses in these documents.
• If a product component used as a mixture is included among the cosmetic product components, the amounts of the components forming the mixture should be specified in percentages, arranged from least to most, in terms of quantity.
2. Physical-chemical (including color, odor, temperature, density, viscosity, pH, etc.) and microbiological specifications of raw materials and finished products, and control criteria related to the compliance of the cosmetic product with physical-chemical and microbiological specifications,
3. Explanation of the manufacturing method compliant with good manufacturing practices; declaration of compliance with good manufacturing practices, evidence determining that the manufacturer has an appropriate level of professional competence or necessary experience, and training and work documents,
4. A Cosmetic Product Safety Assessment Report (ÜGDR / Safety Assessment Report (SAR)) made to demonstrate that a cosmetic product is safe,
5. Available data on potential adverse effects on human health resulting from the use of cosmetic products,
6. When required by the nature, structure, or effect of the cosmetic product, evidential information and documents concerning the claimed effect of the cosmetic product.

What is a Product Safety Assessment Report-ÜGDR?

The "Product Safety Assessment Report" or "Cosmetic Safety Assessment Report" (Cosmetic Product Safety Assessment Report - CPSR) is the most important part of the product information file (PIF) and is mandatory for each cosmetic product. The product safety assessment report consists of two parts and must include at least the following elements.

PART A - Cosmetic Product Safety Information

1. The formulation of the product should be given with INCI names, CAS and EINECS numbers, raw material functions, and concentrations.
2. Physical and Chemical Properties and Stability of the Cosmetic Product:
   This is the area where the physical and chemical properties of both the ingredients and/or mixtures in the formulation and the final product are evaluated. The stability of the product is examined over the shelf life under reasonable and foreseeable storage conditions.
3. Microbiological Quality:
   The microbiological specifications of both the ingredients and/or mixtures in the formulation and the final product are examined. Two separate categories have been defined.
   
   Category 1: Cosmetics used on or near the eyes, generally on mucous membranes, on damaged skin, on children under 3 years of age, on the elderly, and on individuals with compromised immune responses.
   Category 2: Other products
   
   Quantitative/numeric limits:
   Category 1: The total viable aerobic mesophilic microorganism count (bacteria, yeast, and mold) should not exceed 102 cfu/g or 102 cfu/ml.
   Category 2: The total viable aerobic mesophilic microorganism count should not exceed 103 cfu/g or 103 cfu/ml.
   
   The results of preservative efficacy testing (Screening-Challenge) are also examined in this area. This test, also known as the Challenge Test, is a test that examines whether the product is protected by the preservative(s) added to the formulation against the risk of contamination from the production of the product until it is consumed under normal storage and use conditions for 28 days.
4. Information about impurities, residues, packaging materials:
   Evidence that substances are technically unavoidable in trace amounts of banned substances in the composition of the substance and/or mixture, especially purity and stability, is examined under this heading. Reference is made specifically to the relevant properties of the packaging material, including purity and stability.
5. Normal and Reasonably Foreseeable Use:
   The normal and reasonably foreseeable use of the product should be justified, taking into account the usage instructions and warnings on the label.
6. Exposure to the Cosmetic Product:
   Exposure information for the cosmetic product should be calculated and generated based on Part A (5). 
   • Application location(s)
   • Application surface area(s)
   • Amount of product applied
   • Duration and frequency of use
   • Normal and reasonably foreseeable exposure route(s)
   • Target populations
7. Exposure to Substances in the Formulation:
   Results of exposure to substances in the cosmetic product are calculated based on the information in Part A (6). As a result of the calculation, judgment is made as to whether the substance in the cosmetic product is safe in that product when exposed to the declared concentration and use.
8. Toxicological Profile of Substances in the Formulation:
   The toxicological profile of the substance present in the cosmetic product for all relevant toxicological limits is examined by clearly defining the source of the information.
9. Adverse Effects and Serious Adverse Effects:
   All data (including statistical data) on adverse effects and serious adverse effects related to the cosmetic product are included in this section.
10. Information about the Cosmetic Product:
    Other data, such as confirmed and verified findings obtained from studies conducted on volunteer humans or risk assessments in other relevant areas, are added to this field.

PART B - Cosmetic Product Safety Assessment

1. Evaluation Result:
   The evaluation of each piece of information, document, and report given in Part (A) should be made in this section. It includes the conclusion.
2. Warnings and Usage Instructions on the Label:
   According to Article 22 of the Cosmetic Regulation, specific warnings and usage instructions must be stated on the label.
3. Justification:
   The explanation of the scientific justification forming the basis of the evaluation result in Part (B-1) and the statements in Part (B-2) is discussed. This explanation is based on the explanatory information in Part (A).
4. Information about the Safety Assessment Officer and Approval of Part B:
   The name, address, diploma, qualification certificates, signature, and date of the evaluator.

Companies are obliged to prepare the Cosmetic Product Information File to comply with the Cosmetic Products Regulation. By benefiting from our Product Information File Preparation service within our Cosmetic Product Consultancy service, you can easily ensure legal compliance.

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