Cosmetics guide · Sources checked October 2026
Cosmetic PIF retention period and how to update a PIF
The cosmetic PIF retention period is ten years following the date on which the last batch of the product was placed on the market, under Article 11(1) of Regulation (EC) No 1223/2009, in both Great Britain and the EU. While the product is on sale, the file must be “updated as necessary”, and the safety report inside it must be kept up to date as new relevant information appears.
Last updated .
How long to keep a cosmetic PIF
Retention and update duties in the regulation
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| Duty | What the regulation says | Source |
|---|---|---|
| Retention period | Ten years following the date on which the last batch of the cosmetic product was placed on the market. The same wording appears in the GB and EU texts | Article 11(1), GB text; EU text, checked October 2026 |
| Updating the PIF | The file’s contents “shall be updated as necessary”. The regulation does not set a review frequency or list the events that require an update | Article 11(2), GB text; EU text, checked October 2026 |
| Updating the safety report | The Responsible Person must ensure the safety report is kept up to date in view of additional relevant information generated after the product is placed on the market | Article 10(1)(c), GB text; EU text, checked October 2026 |
| Serious undesirable effects | The Responsible Person and distributors must notify serious undesirable effects without delay: in GB to the Secretary of State (GOV.UK says report to OPSS); in the EU to the competent authority of the Member State where the effect occurred | Article 23, GB text; EU text; GOV.UK guidance, checked October 2026 |
Sources checked October 2026. Legislation and guidance change: open the linked source before relying on any row. This page is general information, not legal or regulatory advice; take advice from a qualified safety assessor or regulatory adviser for your products.
How to update a cosmetic PIF
PIF update requirements: events that touch the file
Because the regulation says “as necessary” rather than listing triggers, a practical approach is to update the file whenever something changes in a part the regulation names. These are the common ones.
Whether a given change needs a new safety assessment, or makes it a new product that needs a new notification, depends on the change: ask your safety assessor. Sources checked October 2026. For the full list of contents, see the cosmetic PIF requirements checklist.
- Formulation change: the composition in Part A of the safety report no longer matches the product, so the safety information and assessment need to be looked at again (Annex I, Part A section 1).
- New safety data: new information about an ingredient or the product after launch, which Article 10(1)(c) says the safety report must take into account (Article 10).
- Undesirable effects and serious undesirable effects: Part A section 9 holds all available data on them, and serious ones must also be reported (Article 23).
- New claims: a new claimed effect may need its own proof in the file (Article 11(2)(d)).
- Changes to manufacturing, the manufacturer or the GMP statement, and new animal testing data from suppliers: both are items the file must contain.
Worked example (fictional)
One product’s PIF from launch to the end of retention
A fictional product, dates and events, for illustration only. It is not advice on what your product needs.
1
Launch, March 2027
Example Skin Co, a fictional GB Responsible Person, launches “Sample Night Serum”. The PIF holds the product description, a signed safety report, the manufacturer’s GMP statement and method, claim evidence and animal testing data.
2
Preservative change, November 2027
A supplier discontinues the preservative. The new formula is recorded in Part A, and the safety assessor reviews and re-signs Part B before the new batches are sold. The file keeps a dated record of which formula applied when.
3
New claim, February 2028
Marketing wants to say “hydrates for 24 hours”. The company adds the test report that supports the claim to the file before the new label is used.
4
Customer reaction, June 2028
A customer reports a mild rash. It is recorded with the undesirable effects data in Part A, section 9, and the assessor checks whether the assessment still holds. It was not a serious undesirable effect, so no report to OPSS was required; a serious one would have to be reported without delay.
5
Last batch, 14 March 2030
The serum is discontinued. Its last batch is placed on the market on 14 March 2030, so Example Skin Co keeps the PIF until at least 14 March 2040.
PIF retention period cosmetics: practical points
Keeping old versions
The ten years run from the last batch, not from launch, so a long-running product’s file can be kept for many years.
The regulation does not say how earlier versions must be stored; keeping them dated is a practical choice, not a legal requirement. For how the safety report and the PIF relate, read CPSR vs PIF: what’s the difference?
- Record the date the last batch of each product was placed on the market; the retention period runs from that date.
- Keep superseded safety reports and formulas with their dates, so you can show what applied to each batch.
- Keep the file readily accessible to a competent authority for the whole period, not only while the product is on sale.
PIF tracking is not available yet
Soteriaa is building PIF tracking; join the waitlist. It is not available yet, and it will not prepare or sign a safety report. Join the cosmetics PIF waitlist to hear when it opens.
FAQ
Common questions
How long do you keep a cosmetic PIF?
For ten years following the date on which the last batch of the product was placed on the market (Article 11(1)). The GB and EU texts use the same wording.
How often must a PIF be reviewed?
The regulation sets no fixed review frequency. It says the file must be updated as necessary and that the safety report must be kept up to date in view of new relevant information.
Does a formulation change mean a new PIF?
The regulation does not answer that directly. A changed formula changes Part A of the safety report, so at least that part must be reviewed. Ask your safety assessor whether the change makes it a new product.
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