A Cosmetic Product Information File (PIF) is a mandatory dossier that must be prepared before a cosmetic product can be placed on the market. According to the Turkish and European Cosmetic Products Regulations, every cosmetic product made available on the market must have its own Product Information File. This file must be complete and readily available for inspection by the competent authorities.
The Cosmetic Product Information File serves as a key regulatory document containing all necessary information to ensure the product’s safety, efficacy, and compliance with applicable legislation.
Chemleg is ready to support you in the preparation of these essential regulatory documents.
What Should a Cosmetic Product Information File Contain?
A complete Product Information File must include the following main sections:
- General information such as product name, formulation, intended use, and instructions for use.
- Name, address, and contact details of the manufacturer, producer, importer, or distributor, as well as the Responsible Person.
- All components contained in the product and their respective concentrations.
- Documentation and calculations evaluating the product’s effects on human health and identifying potential risks.
- Details about materials in contact with the product and the labelling used at the time of market placement.
- Confirmation that the product has not been tested on animals.
- Relevant notification details under the applicable regulation.
Key Points to Consider in Cosmetic Product Information File
Article 14 of the Turkish Cosmetic Products Regulation defines the following requirements for the Product Information File:
“ (1) The Responsible Person must keep the PIF for ten years following the date when the last batch of the product is placed on the market.
The PIF must include and be updated with the following information and data: a) Description of the cosmetic product clearly identifying it. b) Cosmetic Product Safety Report as referred to in Article 13(1). c) A description of the manufacturing method and a declaration of compliance with Good Manufacturing Practices (GMP) as specified in Article 11. ç) Proof of the claimed effects of the cosmetic product, where justified by its nature or function. d) Data on all types of animal tests conducted by the manufacturer, its representatives or suppliers in relation to the development or safety assessment of cosmetic products or ingredients, including those conducted to meet the legal or regulatory requirements of countries other than Türkiye and EU member states.
The responsible person must keep the product information file ready to be submitted to the Agency upon request, in electronic or other format, at the address specified on the label.
The PIF must be prepared in Turkish or English.”
Chemleg Makes Your Cosmetics Market-Ready in Türkiye
Chemleg offers a comprehensive PIF preparation service to assist cosmetic companies in compiling and maintaining a fully compliant Product Information File, ensuring smooth and compliant market access in Türkiye and the EU.
Our Scope of Service Includes:
- Compilation of All Required PIF Documents: Gathering and organizing all documents in line with legal requirements.
- Safety Assessment & Toxicological Profile: Preparation of the Cosmetic Product Safety Report (CPSR) to ensure all ingredients are safe for human use.
- Formula & Ingredient Compliance Check: Verification of INCI lists and compliance with restricted or prohibited substance lists under Turkish and EU law.
- Microbiological & Stability Testing Support: Coordination of accredited laboratory tests to ensure product safety and stability.
- Claims & Labelling Compliance Review: Review of product labels and marketing claims to ensure compliance with the Turkish Medicines and Medical Devices Agency guidelines.
- Good Manufacturing Practice (GMP) Support: Guidance to ensure compliance with ISO 22716 standards for cosmetic production.
- Regulatory Submission Support: Assistance with registration and notification procedures in the ÜTS – Product Tracking System.
Why Choose Chemleg?
- Expertise in Turkish & EU Cosmetic Regulations
- Comprehensive Documentation & Compliance Assurance
- Faster Market Access with Regulatory Support
With our PIF preparation service, you can ensure full legal compliance and seamless entry into the Turkish cosmetics market.
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Frequently Asked Questions
What is the difference between a Cosmetic Product Information File and a Product Information Form?
The Product Information File (PIF) is a detailed and comprehensive dossier prepared for regulatory authorities such as TİTCK (Turkish Medicines and Medical Devices Agency), whereas the Product Information Form is a simplified document intended for consumers. Their purposes differ — the PIF demonstrates regulatory compliance and is subject to inspection by authorities, while the Product Information Form aims to inform and protect consumers.
Do I need to prepare a separate Cosmetic Product Information File for each cosmetic product I sell?
Yes. Each product placed on the market — including variants with different formulas, names, or packaging — must have its own complete PIF. For example, if a shampoo comes in three different scents, a separate file must be prepared for each version.
Who is responsible for preparing the PIF?
The responsibility lies with the Responsible Person as defined in the regulation. Chemleg can act as your Responsible Person and support you throughout the process.
I produce natural soaps or creams at home and sell them. Do I still need a PIF?
Yes. Regardless of production scale (home, workshop, or factory), every cosmetic product sold commercially must have a PIF, and all requirements of the Cosmetic Products Regulation must be fulfilled.
Do I need to submit my PIF to TİTCK for approval?
No. The Product Information File is not submitted or approved by TİTCK prior to market placement. It must, however, be kept available at the Responsible Person’s address indicated on the label, ready for inspection. It must be presented to TİTCK upon request.
