Cosmetics PIF: safety assessment and retention
As Responsible Person, maintain an English Product Information File, commission a qualified assessor before sale and retain the file for ten years after the last batch was placed on the GB market. Keep evidence of that date and update the safety report as new information emerges. Cambridge China Bridge can help gather factory documents.
Turn the existing checklist into a working file
Our beauty and personal care sourcing guide covers the core file contents, labelling and notification. Here, focus on assembling evidence you can retrieve: create a product index linking the description, safety report, manufacturing method and good manufacturing practice statement, claims evidence and relevant animal-testing data.
The file must be maintained in English and made accessible to the authorities at the notified address. Keep a controlled English copy with a named document owner. Ask someone other than the compiler to retrieve the complete file, including attachments, to expose missing documents or access problems.
Agree the information handover with the factory
The safety report separates product safety information, supplied by the Responsible Person, from the assessment supplied by the assessor. Ask the assessor for a document request list before commissioning tests. Use it to gather the full formula, ingredient specifications, stability and microbiological evidence, packaging details and intended use.
Agree how the factory will disclose confidential formulation details directly to the assessor; our guide to protecting your IP helps frame that discussion. Match each document to the actual formula and pack being ordered. Ask the assessor to identify gaps and explain which tests or further information would resolve them.
Check the assessor and the completed report
OPSS identifies university study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by the Secretary of State, as the qualification route. Request the assessor’s qualification evidence before appointment and ask about experience with your product type. A laboratory quotation alone does not identify who will make the safety assessment.
The assessment should contain the assessor’s name, address and proof of qualifications, and be signed and dated. Check the safety conclusion, reasoning and warnings against the product and artwork you intend to supply. Use our test report verification guide when checking supporting laboratory evidence.
Keep the file current when the product changes
OPSS says the safety assessment should be reviewed and revised regularly, particularly when new data might alter its safety conclusion. The file should also be updated as necessary. A significantly different product sold under the same name may need a new file rather than an update.
Set a change-notification arrangement with the factory for formula, ingredient supplier, manufacturing process and packaging changes. Send proposed changes and new safety information to the assessor for review. Archive previous versions and record which formula, pack and batches each report covers.
Record the retention trigger and protect access
Keep the file for ten years after the date the last batch was placed on the GB market. OPSS defines placing on the market as the first making available of a product on that market. Do not calculate the deadline simply from the assessment date or the factory’s production date.
Maintain a batch ledger with evidence of first GB supply and identify the final batch when the product is discontinued. Record the retention deadline alongside the file. Keep backups under your control and plan access if a supplier, assessor or storage provider stops trading. Cambridge China Bridge’s staff in China can help chase factory records; you retain responsibility for the file.
Frequently asked questions
Does my cosmetics PIF have to be in English?
Yes. Maintain the file in English and make it accessible to the authorities at the notified address. Keep English versions of the documents needed to support the assessment.
Who can assess cosmetic product safety?
A suitably qualified assessor. OPSS identifies university study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by the Secretary of State. Check qualification evidence.
How long must I keep a cosmetics PIF?
Ten years after the date the last batch was placed on the GB market. Record evidence of that event and calculate the retention deadline from it.
Can I reuse the file after changing the formula?
Refer the change to your assessor and update the safety report and file as necessary. OPSS says a significantly different product under the same name may need a new file.