What is a PIF in the UK?
A Product Information File (PIF) is a document containing all the information relating to a cosmetic product and which must be available before the product is marketed in the UK. This file ensures transparency and product safety for consumers and regulatory authorities.
The PIF must be drawn up and maintained by the person responsible for placing the product on the market (often the manufacturer or importer) and must be accessible to national authorities for 10 years after the last production of the batch.
The Product Information File (PIF) for cosmetic products in the UK follows similar principles to those in the European Union, as the regulations are based on the EU Cosmetics Regulation (Regulation (EC) No 1223/2009), although some adaptations have been made since Brexit.
Key features of the UK PIF
Exhaustiveness
Contains all relevant information on the safety, efficacy and manufacturing of the product.
Accessibility
It must be available to national authorities for a period of 10 years.
Continuous update
The PIF must be updated if there are changes to the product or regulations.
Regulatory compliance
Ensures that the product complies with Good Manufacturing Practices and other UK regulations.
Main characteristics of a PIF
Person Responsible for PIF in the United Kingdom
As in the EU, there must be a Responsible Person (RP) in the UK, who can be the manufacturer, importer or an authorised representative. This person is responsible for the regulatory compliance of the cosmetic product in the UK market.
The responsible person must be established in the United Kingdom (England, Scotland, Wales or Northern Ireland).
The content of the UK PIF is very similar to that of the EU, with the following essential elements:
Availability
The PIF must be available in physical or electronic format and must be accessible to UK regulatory authorities, such as the Medicines and Healthcare products Regulatory Agency (MHRA) or Trading Standards, for 10 years after the last batch of the product is placed on the market.
The document must be in English .
PIF Contents
Product Description
CPSR Cosmetic Product Safety Report
Description of the manufacturing method and compliance with Good Manufacturing Practices (GMP)
Tests and studies on the effects attributed to the product
Stability testing
Microbiological tests
Data on animal testing (if applicable)
Marketing date
The PIF must include information about the date on which the product is placed on the market in the UK.
Continuous review
The PIF is not a static document and must be continually reviewed and updated if there are changes in the product formulation, the manufacturing process or if there are new applicable regulations.
Any changes to product safety or new testing must be reflected in the PIF.
Confidentiality
The PIF contains confidential information, such as product formulations. Only UK regulatory authorities have access to this information in the event of an inspection or security check, thus ensuring confidentiality.
Registration on the UK Submit Cosmetic Product Notification (SCPN) Portal
Following Brexit, the UK implemented its own Submit Cosmetic Product Notification (SCPN) portal.
All cosmetic products placed on the market in the UK must be notified on this portal before they are placed on the market. This notification process is separate from the EU CPNP portal.
The information contained in the PIF must match that reported in the SCPN.
UK Regulatory Compliance
Although the UK PIF follows the structure of the EU Cosmetics Regulation, it must specifically comply with the laws and regulations of the Cosmetic Regulations 2013 (UK) and post-Brexit updates.
UK PIF is expected to comply with Good Manufacturing Practices (GMP) and labelling and safety regulations specific to the UK market.
Storage period
The PIF must be kept for a minimum of 10 years after the last batch of the product has been placed on the market.
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