Cosmetic Product Information File Example: A Page by Page Walkthrough

Makers searching for a PIF example or a PIF PDF usually want to know one thing: what does a finished, compliant Product Information File actually look like? The regulation lists the contents, in Article 11 of Regulation (EC) No 1223/2009 and the Cosmetic Products Enforcement Regulations 2013 in Great Britain, but it does not show you a file, and no one publishes their real one because it contains confidential formulas. So we have built a fictional but realistic example, a whipped shea body butter from an imaginary small brand, and walk through it page by page below. It is the file an inspector from the Office for Product Safety and Standards would expect to be able to open at the Responsible Person's address.

Read this alongside our free PIF template and checklist, which gives the structure this example follows.

The example product

Meadow Skin Co. is a fictional UK maker selling a whipped shea body butter in two scents, lavender and unscented, in 100 gram and 200 gram jars, online and at markets. Both scents were assessed together in a multiple variant CPSR, so they share one PIF. The file is kept electronically, with a printed copy, at the Responsible Person's address, which is the owner's registered business address shown on the label.

Page 1: cover and control sheet

The first page identifies the file and its owner. It shows the product name, Meadow Whipped Body Butter, the two variants, the Responsible Person's name and full address, the file reference, the version number, the date the file was created and the date of the last update. Beneath that is a change log table with four columns: date, what changed, why, and which sections were updated. The example log has three entries: file created at launch; lavender fragrance supplier changed with CPSR addendum and allergen relabel; label artwork updated to add a claim, with new claims evidence added. This page is the first thing an inspector reads, because it tells them whether the file has been maintained.

Pages 2 to 4: product description

Section one links the file to the physical product beyond doubt. Page two gives the product name, function (a leave on body moisturiser), the two variants and how they differ (fragrance only), the pack sizes and jar type, and the SCPN notification reference and date. Page three carries colour photographs of both variants in both sizes, front and back. Page four holds the final label artwork for each of the four packs, each dated, showing the INCI list, allergen declarations for the lavender variant, the Responsible Person's name and address, the nominal weight, the batch code position, the period after opening symbol and the warnings the assessor required. If the artwork on the shelf does not match page four, the file is out of date.

Pages 5 to 6: the CPSR and its supporting documents

Section two opens with the signed multiple variant CPSR itself, the document at the heart of the product's safety assessment. Part A runs through the eleven information headings for the body butter: the quantitative formula with each shea, cocoa, oil and fragrance ingredient and its percentage; the physical characteristics and the note that it is anhydrous; microbiological quality reasoning for a water free product; impurities and packaging; normal and foreseeable use as a body moisturiser applied daily; exposure calculations; the toxicological profile of each ingredient including the fragrance constituents; and undesirable effects data. Part B gives the assessor's reasoning, the margins of safety, the allergen declaration for the lavender variant, the required label warnings, and the assessor's name, qualifications, address and signature.

Behind the CPSR, still in section two, sit the documents it relies on: a Safety Data Sheet, specification and certificate of analysis for each raw material; the IFRA certificate and allergen statement for the lavender fragrance; the packaging specification for the jars; and a short stability observation record showing the butter's appearance, odour and texture at intervals over the claimed shelf life. A cover sheet lists every supporting document with its date so nothing is missing.

Pages 7 to 10: manufacturing and GMP

Section three shows how the product is made and that it is made hygienically. Page seven is the manufacturing method: melt the butters and oils, cool, add fragrance and antioxidant, whip, fill, cap, label. Page eight is the GMP statement, a signed declaration that manufacture follows the principles of the harmonised standard for cosmetic good manufacturing practice, ISO 22716, with a short summary of the hygiene, cleaning, storage and record keeping procedures that support it. Page nine is the blank batch record template. Page ten is a completed batch record for a real batch: date, batch code, quantities of each raw material with their supplier lot numbers, the operator's initials at each step, the release checks of appearance and odour, the number of units filled, and the sign off. Completed records for every batch sold are filed behind it. This section is what makes a recall possible: from a jar's batch code, the maker can trace every ingredient lot.

Page 11: the claims table

Section four is a single page that many makers find the most useful in the whole file. It is a table of every claim made about the product, wherever it appears, with the evidence for each. The example lists: deeply moisturising, supported by supplier substantiation for shea butter and by the product's high butter content; softens dry skin, supported the same way; whipped and light, a descriptive claim needing no proof; scented with lavender, descriptive; vegan and cruelty free, supported by supplier statements and the section five declaration; and handmade in small batches, descriptive. A final row confirms that no medicinal claims are made on the label, website or social media. When a new claim is added to the packaging, a new row is added here and the change log on page one is updated.

Page 12: animal testing statement

Section five is short but mandatory. The example holds a signed statement from the maker that no animal testing was carried out by the company or on its behalf on the finished product or its ingredients for the purposes of the Cosmetics Regulation, together with the supplier statements on ingredient testing gathered during formulation. Where a supplier could not provide a statement, the file records that the request was made and the answer received. Leaving this section out because the answer is none is one of the most common gaps inspectors find.

How the file and the label talk to each other

The most instructive thing about the Meadow example is how often the label appears in it. The artwork is filed in section one; the ingredient list on that artwork must match the formula in the CPSR in section two, in the correct descending order, with the allergen names the assessor identified; the warnings on the artwork must be the ones Part B required; the claims on the artwork must all appear in the section four table with evidence; the batch code position on the artwork must correspond to the coding scheme in section three; and the Responsible Person address on the artwork must be the address where the file is kept. Every one of those links is something an inspector can check in seconds by holding the jar next to the file. A single edit to the label that is not carried through the file breaks several of them at once, which is why the change log exists.

What an inspector reads first

An officer opening the Meadow file would start with page one, because the change log tells them immediately whether the file is alive. They would then hold a jar next to page four to check that the label artwork in the file is the label on the product, including the batch code position and the allergen list. Next comes the CPSR signature page: is the assessor qualified, is the report dated, does it cover the lavender variant as well as the unscented one, and does the required warning wording appear on the artwork? Then the claims table against the label and a quick look at the website. Finally, a batch record for the batch in their hand. Five checks, perhaps twenty minutes, and a file that passes them rarely faces further questions.

Gaps we see most often in real files

• No change log. Updates were made but the history cannot be shown, so the file looks unmaintained even when it is not.
• Artwork mismatch. The label was tweaked after the file was built and the file still shows the old version.
• CPSR covers fewer variants than are sold. A new scent was added to the range without an addendum.
• Claims on the website not in the table. The label is clean but the product page says calming or healing.
• Batch records not filed. A template exists; completed records do not.
• Supplier documents expired. An IFRA certificate against an old amendment, or an SDS several revisions out of date.
• Animal testing section empty. Assumed unnecessary because no testing was done.

Scaling the example to a range

Meadow Skin Co. later adds a body oil and a lip balm. Each is a different formula, so each gets its own Product Information File (PIF) with its own CPSR. The brand level documents, the GMP statement, hygiene procedures, supplier statements on animal testing and the batch record template, are written once and copied into each file, with each file recording which version it holds. Shared raw materials mean shared supplier documents, which are filed in each product's section two or held in a controlled shared library that each file references by document number and date. The change log in each file remains product specific. Done this way, a range of ten products has ten lean files and one well maintained library behind them, rather than ten copies of everything drifting out of step.

Version control without special software

You do not need a compliance platform to keep a PIF under control. A consistent file naming convention with the document type, product, version and date; a single cover sheet per file that lists every document and its current version; an archive folder for superseded versions; and the discipline of logging every change at the moment it is made will keep a small brand's files inspection ready. Platforms help once a range grows or several people are editing, but the habits matter more than the tool, and the Meadow example would pass an inspection from a well kept folder.

What is not in the file, and why

The example deliberately contains no marketing plans, sales figures or customer data, because the PIF is a compliance file and an inspector should be able to read it without wading through unrelated material. It also contains no documents the maker cannot stand behind: no unsigned assessments, no undated artwork, no supplier certificates the maker has not actually received. A lean, complete, dated file is far more persuasive than a thick one padded with irrelevance.

How the file changes over time

Twelve months after launch, Meadow Skin Co. changes fragrance supplier. The new lavender oil has a different allergen profile, so the assessor issues a CPSR addendum reflecting the updated safety assessment, the label is revised to declare the new allergens, and the file is updated: new IFRA certificate and allergen statement in section two, new label artwork in section one, a new row in the claims table if anything changed, and an entry in the change log. The old documents are retained, marked superseded, because the file must account for every batch sold, including those made with the old oil. This is what keeping the file updated means in practice.

Makers who would rather have the whole file assembled and maintained can use our Product Information File service, and those selling in the UK and EU can have the Responsible Person service hold it in each market.

Related reading on the Phoenix blog

• TRA vs CPSR: which safety assessment does your product need?
• CPSR for body mist
• CPSR for whipped soap
• All regulatory compliance articles

Phoenix services mentioned in this article

• Product Information File, single product
• Cosmetic Product Safety Report, single variant
• Cosmetic Product Safety Report, multiple variants
• All in one compliance pack: CPSR, PIF, SDS, SCPN
• UK and EU Responsible Person services
• Label and packaging review
• Expert regulatory consultation
• Contact Phoenix

Official sources and legislation

• Regulation (EC) No 1223/2009 on cosmetic products, Article 11 and Annex I
• Cosmetic Products Enforcement Regulations 2013
• Office for Product Safety and Standards
• Submit cosmetic product notifications (SCPN)
• European Commission cosmetics pages

About the author

Disclaimer: This article is general information, not legal advice. Regulations change and product decisions depend on your exact formulation, claims and market. Have your product assessed by a qualified professional before sale.