Product information file and safety report for Turkey is essential technical data to complete thre registration to the system and maintain your business in Turkey.
The Product Information File (PIF) is a collection of technical data and paperwork that are required for any cosmetic product to be released to the market.
The manufacturer shall have the product information, including the information stipulated in the Regulation, ready within three working days at the address indicated in the label, according to the second paragraph of Article 10 of the Cosmetics Regulation.
The cosmetic PIF must be kept for ten years from the date the final batch of the relevant cosmetic product was placed on the market, and it must be updated as needed.
Product Information File and Safety Report for Turkey must include the following items:
- In the case of a perfume and perfume composition, the product name, code name, name in local use if available, qualitative and quantitative nature of the product, the code of the composition, and the identity of the provider. The following elements must be included in the information asked above;
- The cosmetic product’s reference number, trademark, and other information should be clearly mentioned.
- In the specified documents, quantitative and qualitative information on the cosmetic product composition should be provided, as well as product components, INCI names, and intended use.
- If a product component is used in a mixture with other cosmetic product components, the usage rates of the components that make up the mixture should be mentioned in order from least to most, with percentage quantities specified.
2. The raw material and final product’s physicochemical and microbiological specifications, as well as the control criteria for the cosmetic product’s adherence to the physicochemical and microbiological specifications (including color, odor, temperature, density, viscosity, pH, and so on).
3. A description of the manufacturing method in accordance with the Good Manufacturing Practices Guide, a statement of conformity to good manufacturing practices, training, and working documents demonstrating that the manufacturer has the appropriate level of professional competence or required experience should be included.
4. Before a cosmetic product is placed on the market, a person with the qualities described in the Cosmetic Regulation prepares a Cosmetic Product Safety Report comprising the information contained in Annex I / B, Part A and B of the Cosmetic Regulation.
5. Existing evidence on unfavorable/serious side effects that may arise as a result of using cosmetic items.
6. When a cosmetic product’s feature, structure, or effect calls for proof, the cosmetic product’s claimed effect must be supported by information and documents.
7. Information on animal experiments conducted by the manufacturer for the development of the product or the safety evaluation of the product or its components, including animal tests required by legislation or other regulations in countries outside the European Union.
8. Information and documents pertaining to the presence of nanomaterials in cosmetic goods shall be included within the scope of Annex VIII of the Cosmetic Regulation.