Product Information File (PIF)
A mandatory dossier required under EC 1223/2009 (Article 11) that the Responsible Person must maintain for each cosmetic product on the EU market. It contains the CPSR, product description, manufacturing method, GMP evidence, and claims substantiation.
The Product Information File (PIF) is a comprehensive dossier required by Article 11 of the EU Cosmetics Regulation (EC 1223/2009). The Responsible Person must maintain a PIF for each cosmetic product and make it readily accessible to competent authorities at the address indicated on the product label.
The PIF must contain: a product description sufficient to clearly relate the PIF to the product; the Cosmetic Product Safety Report (CPSR) containing both Part A (safety information) and Part B (safety assessment); a description of the manufacturing method and a statement of conformity with Good Manufacturing Practices (ISO 22716); evidence of claimed effects (where justified by the nature of the product or claim); and data on any animal testing performed by the manufacturer, agents, or suppliers relating to the development or safety evaluation of the product or its ingredients.
The PIF must be maintained for 10 years after the date on which the last batch of the cosmetic product was placed on the market. It must be available in the language easily understood by the competent authority of the member state where it is kept.
While the UK has its own version of the PIF requirement under its domestic regulations, the content requirements are substantially the same. Non-EU brands entering the European market typically work with their EU Responsible Person to compile and maintain the PIF.
Related Terms
Cosmetic Product Safety Report (CPSR)
A two-part safety assessment document required within the PIF under EC 1223/2009 (Annex I). Part A compiles safety data for each ingredient; Part B is a qualified safety assessor's conclusion on whether the product is safe for human health.
ProcessResponsible Person
An entity established within the EU (or UK for the GB market) who is legally responsible for ensuring a cosmetic product complies with the Cosmetics Regulation. The Responsible Person maintains the PIF, submits CPNP/SCPN notifications, and reports serious undesirable effects.
RegulationEU Cosmetics Regulation (EC 1223/2009)
The primary European Union law governing cosmetic products, establishing requirements for safety assessment, CPNP notification, responsible person designation, ingredient restrictions (Annexes II-VI), labeling, and post-market surveillance across all EU/EEA member states.
StandardISO 22716
The international standard for cosmetics Good Manufacturing Practices (GMP), providing guidelines for the production, control, storage, and shipment of cosmetic products. Compliance with ISO 22716 creates a presumption of GMP conformity under the EU Cosmetics Regulation.
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