Product Information File (ÜBD/PIF) is a mandatory file for cosmetic products, documenting the safety and compatibility of the product.
File; It includes product description, Cosmetic Product Safety Report (CPSR), production method and Good Manufacturing Practices statement, evidence of claims and animal testing data where necessary. It must be available upon request of the competent authority.
ONAY Mühendislik provides UBD preparation and safety assessment service.
What is a Product Information File
ÜBD (PIF) is the file prepared before the cosmetic product is placed on the market and is the first file requested in the inspection. Includes product description, full formulation, manufacturing method, good manufacturing practice statement, evidence of efficacy claims, and safety report.
The most frequently missing items in the file
Evidence of effectiveness claims and packaging compatibility data are the two most frequently overlooked topics. If a statement such as “dermatologically tested” is used, the test itself should be included in the file.
Storage period
The file is kept available for ten years after the last batch of the product was placed on the market. Even if the responsible person changes during this period, the file must be transferred.
Relationship to notification
ÜBD and notification are separate but based on the same data. When the formulation in the notification contradicts the formulation in the file, non-compliance occurs in the audit; It is safest to update both at the same time.
Mandatory Sections in ÜBD Content
The product information file must be completed before the cosmetic product is placed on the market and must include the product's qualitative-quantitative composition, physical-chemical and microbiological properties, production method, declaration of conformity with good manufacturing practices, product safety assessment and undesirable effect data. Missing any of these sections may result in the entire file being deemed invalid during the audit.
Role of the Safety Assessor
A product safety assessment may only be signed by an evaluator qualified in the field of pharmacy, medicine, chemistry, biology or toxicology, who has qualifications defined by the legislation. The evaluator calculates the exposure for each component and establishes the margin of safety. Gathering the component list and placing it in the template is not a substitute for evaluation; An unsigned or unjustified report does not protect the file.
File Storage and Accessibility
The file is kept for ten years from the last batch the product was placed on the market and must be accessible upon request by the competent authority. The file must be available in electronic or printed form at the address of the responsible person specified on the packaging. In cases where subcontracted production is made, it should be clearly stated in the contract which side the file will be kept, otherwise the responsibility remains with the supplier to the market.
Situations Requiring Updates
Every change in the formulation, switching to a new raw material supplier, change of packaging material or restriction of one of the components in the legislation requires updating the file. Reports of undesirable effects should also be recorded in the file and evaluated separately whether they change the outcome of the safety assessment.
Related pages
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Official full text of the regulation: KKDIK Regulation - Official Gazette.