Regulation (EC) No 1223/2009 requires a Product Information File (PIF) should ready for all Cosmetics intended for marketing within the EU.
CPSR
Cosmetic Product Safety Report
A PIF, or Product Information File, in cosmetics, is a comprehensive document that contains detailed information about a cosmetic product. It is a mandatory requirement for the marketing of cosmetic products in many regions, including the European Union. The PIF includes information such as the product's description, manufacturing process, safety assessment, and proof of the claimed benefits. This file serves as a key element in ensuring product safety and regulatory compliance, as it provides authorities with essential information for evaluation and market surveillance purposes.
The PIF is a package containing all information on authorisations for the sale of cosmetic products in Europe, including the Safety Report/CPSR.Each cosmetic product must have its own product information file containing precise information about the product. The PiF should include a product description, a report on the safety of cosmetic products, information on production methods in accordance with good manufacturing practices and confirmation of the claimed effect. Official requirements for a PiF dossier The competent authority must have free access to the PiF file at the address indicated on the product label. It should be possible to submit the PIF dossier to any supervisory body of the European Union within 72 hours. The PiF file for each cosmetic product must be kept for ten years from the date on which the last batch of a given cosmetic product was placed on the EU or UK market.
1
Description of the cosmetic product
A description that clearly links the PIF to its cosmetic product.
2
Cosmetics Product Safety Report ( CPSR)
A detailed account of the safety of the cosmetic product completed in line with EU Annex1 Regulation.
3
Method of Manufacture
A description of how the product is made and a statement of the compliance with good manufacturing practices
( GMP)
4
Proof of the effect Claimed
Substantiation for all claims made on the cosmetic product and ant promotional material.
5
Data animal testing
Animal testing conducted by the manufacturer , raw material supplier or RP to meet the requirements of other regulatory if applicable.
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