The Product Information File (PIF) is a collection of technical documentation for each cosmetic product to be introduced to the market.
According to EU Cosmetics Regulation 1223/2009/EC, the product information file should contain at least the followings:
• Product description and categories
• Safety assessment report
Part A – Safety Information
Part B – Safety Assessment
• Manufacturing method
• Declaration on compatibility with Good Manufacturing Practices (GMP)
• Proof of claims
• Data of tests conducted on animals
• Labelling (containers and packaging into consideration)
• Data on serious undesirable effects
Product Information File is stored at the address written on the label for a period of 10 years following the last batch of products being made avaliable on the market by the Responsible Person. The Responsible Person should ensure that the language of the PIF is easily understandable by the competent authorities and should update the document when necessary. PIF should be stored in a safe area. It should be accessible in electronic or in another format.
According to Article 12 of the Turkish Cosmetics Regulation, the product information file is required to be made available at the indicate address for market surveillance within three working days upon request of the Ministry.
The product information file should contain followings:
– Qualitative and quantitative structure of the product; in case it is perfume and perfume composition, the code of the composition and the identity of the supplier,
– The physical-chemical and microbiological specification of the raw material and finished product and the control criteria for the compatibility of the cosmetic product with the physical-chemical and microbiological specification,
– The manufacturing method in compliance with the provisions of the Good Manufacturing Practices Guide; education and working documents determining that the manufacturer has a professional competence or required experience at the appropriate level,
– Safety assessment for human health in the finished product
– The name and address of the authorized or responsible person to conduct the assessment included in the paragraph (d); this person is required to have a diploma in the fields of pharmacy, veterinary medicine, biology, chemistry, biochemistry, toxicology, microbiology, dermatology, medicine or equivalent sciences as well as sufficient experience.
– Current data on UNDESIRABLEe effects on human health as a result of the use of cosmetic products,
– Documents relating to the scientific studies which prove the claimed effects of the cosmetic product or the substance,
– Data of tests conducted on animals due to the requirements of the legislation or other regulations of countries outside the European Union, data of tests conducted on animals for the development of the product or for the safety assessment of the product.
The preparation or control of your Product Information Files for Turkey or Europe is among the services of our company. As Pim Group, we provide all of the services listed above through a single channel.