Cosmetic Product Information File (PIF)

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated November 2025 • EU Cosmetics Regulation 1223/2009, UK Cosmetics Regulation, ISO 22716, MoCRA • Regulatory, Quality, R&D, Manufacturing, Compliance

The Cosmetic Product Information File (PIF) is the legally required technical file that sits behind every cosmetic product placed on the EU/UK market. It is the single place where you prove that the product is safe, manufactured under cosmetics GMP, correctly labelled, supported by evidence for its claims and monitored after launch. Authorities do not want marketing slides; they want a structured, defensible dossier. If the product is on the shelf, the PIF must exist, be complete, and be accessible at the address of the Responsible Person for at least ten years after the last batch hits the market. Treat it as a regulatory artefact and you will constantly be chasing paperwork. Treat it as a controlled, digital asset integrated into your quality system and you can scale without losing control.

“No PIF, no defence. If you can’t show the file, regulators assume you don’t control the product.”

1) Definition & Regulatory Intent

The PIF is the structured collection of documents and data that proves a cosmetic product complies with applicable cosmetics law. It covers what the product is, what it contains, who it is for, how it is made, how safety has been assessed, how long it remains safe, how it is labelled and how you monitor it after launch. Regulators use the file to test one simple proposition: has the Responsible Person taken reasonable, documented steps to ensure that consumers are not exposed to unacceptable risk? If the answer is “no”, you are in trouble, regardless of how smooth your marketing story sounds.

The intent is preventative, not decorative. Authorities expect you to make technical and risk decisions on the basis of information that lives inside the PIF. When new science emerges, raw materials change, or signals appear from the market, those insights must be assessed and, where relevant, reflected in an updated file. A PIF compiled once at launch and then forgotten does not meet the spirit—or increasingly the letter—of regulatory expectations.

2) Legal Basis, Scope & Retention

Under EU Cosmetics Regulation 1223/2009 and its UK counterpart, every cosmetic product placed on the market must have a PIF held by a designated Responsible Person. The file must be kept at the address on the label or otherwise easily accessible to competent authorities. It must be available without delay on request and retained for at least 10 years after the last batch of the product is placed on the market. That retention clock does not start at launch; it starts when you stop selling. If you run seasonal products, limited editions or private‑label lines, you are signing up to maintain PIFs long after marketing has moved on.

In practice, this means your archival, backup and migration strategies must be able to survive organisational changes, system replacements and acquisitions. A PIF stored only on a local laptop or an obsolete shared drive is a time bomb. Align PIF retention with your broader record-retention & archival rules, but do not under‑cut the 10‑year minimum. If you cannot retrieve the correct file in front of an inspector, you effectively have no file.

3) Core Components of a PIF

While formats vary, regulators expect a consistent set of content. A robust PIF normally includes:

• Product description – trade name, internal codes, forms, colours, pack sizes, intended use and target population.
• Qualitative & quantitative formula – full list of ingredients with INCI names, concentrations and roles, tied to your BOM.
• Cosmetic Product Safety Report (CPSR) – Part A (data) and Part B (assessment and conclusion), signed by a suitably qualified safety assessor.
• Manufacturing method & GMP – process description, key controls and statement of compliance with ISO 22716 cosmetics GMP.
• Stability & compatibility – evidence supporting shelf life, storage conditions and packaging suitability.
• Microbiology & preservation – routine microbiology and challenge tests where appropriate.
• Labelling & claims – artwork masters, ingredient lists, mandatory statements, and proof for any performance or marketing claims.
• Animal‑testing information – product and ingredient testing history in relation to legal bans.
• Post‑market data – serious undesirable effects and trend information, linked to investigations and actions.

Weak PIFs cut corners on these sections, particularly stability, impurities, claims substantiation and post‑market surveillance. That is exactly where inspectors dig hardest.

4) Responsible Person & Cross‑Functional Ownership

The label names a single Responsible Person, but the PIF is the product of many teams. R&D and formulation own the technical design and version history. Safety assessors sign and update the CPSR. Quality manages GMP, deviations, CAPAs and recall readiness. Regulatory Affairs handles notifications, ingredient restrictions and labelling rules. Supply chain owns supplier data and CoAs. Marketing generates claims that must be backed by evidence. If any of these players operate off‑system or outside change control, your PIF integrity is at risk.

Mature organisations assign clear roles: who creates, who reviews, who approves, who owns ongoing maintenance. They treat the PIF like any other controlled record in the QMS, with formal responsibility, KPIs and periodic review. Immature organisations leave it to “Regulatory” to somehow assemble a complete dossier from scattered files whenever an inspection looms. Guess which model survives surprise inspections with less pain.

5) CPSR, GMP & Process Control

The Cosmetic Product Safety Report is the scientific core of the PIF. It pulls together ingredient toxicity, exposure estimates, impurities, vulnerable populations and margin‑of‑safety justifications. But the CPSR is only as strong as the manufacturing system that implements it. If your process does not follow cosmetics GMP, your elegant calculations mean little. That is why the PIF must include a description of the manufacturing method, critical steps, in‑process controls and finished product tests that keep the process inside the assumptions of the safety assessment.

In practice this means linking the PIF to controlled recipes, master manufacturing records (MMR), MES workflows and eBR. If the CPSR assumes certain process temperatures, mixing times or preservative levels, your execution systems must enforce those ranges and your batch records must show adherence. Otherwise, regulators will argue—rightly—that the PIF describes a theoretical product that is not the one actually sold.

6) Raw Materials, INCI, Suppliers & BOMs

Most PIF headaches start with raw materials. Each ingredient needs correct INCI naming, specifications, impurity limits, allergen data and regulatory status across markets. Supplier switches, site transfers, changes in purity or solvent systems all matter from a safety and labelling standpoint. If this information sits in emails or spreadsheets rather than controlled systems, your PIF will drift out of date fast.

Link PIF content to structured master data: raw material masters, INCI libraries, BOMs, supplier records and supplier quality management. Changes in suppliers or specs should trigger formal change control, safety review and, where relevant, PIF updates. If you let procurement swap suppliers without that loop, you are effectively running uncontrolled experiments on customers while your PIF insists nothing has changed.

7) Digital PIFs, QMS, DMS & LIMS Integration

A ring‑binder PIF might work for a single local product line. It does not work for a multi‑brand, multi‑market portfolio with constant reformulations. The only sustainable answer is a digital, structured PIF built on top of a controlled Document Management System (DMS), integrated with QMS, LIMS, MES, ERP and complaint systems. Instead of a monolithic Word file, think of a PIF as a view across controlled objects: specs, reports, studies, artwork, notifications and batch records.

Digitisation is not about scanning everything into a single PDF. It is about traceability, version control and the ability to regenerate an up‑to‑date dossier on demand. When systems are joined up, changes in formula, specs or labelling automatically flag PIF impact. When they are not, teams end up copying and pasting fragments into static documents, with inevitable version mismatches and missing attachments discovered at the worst possible time—during inspection or crisis.

8) Change Control, Reformulation & Versioning

Cosmetic products are rarely static. Fragrances change, colour ranges expand, preservatives are replaced, packaging evolves and regulations tighten. Every meaningful change must be assessed for its impact on safety, labelling and claims, and the PIF must be updated accordingly. That requires robust change control and effective versioning of formulas, CPSRs, artwork and supporting data.

A basic rule: there should be a clear, queryable link between the version of formula and label on the market at any given time and the PIF version in force. If you cannot answer “which PIF did we rely on for product X sold in country Y in 2022?”, you have a gap. Use structured recipe/version management, similar to recipe versioning in manufacturing, to manage PIF‑relevant changes. Anything else will collapse as your portfolio grows.

9) Claims, Labelling & Artwork Control

Authorities increasingly target misleading or unsubstantiated cosmetic claims. Every claim on pack or in advertising—SPF values, “24‑hour wear”, “dermatologically tested”, “hypoallergenic”, “clean”, “vegan”—needs support. That support lives in, or is referenced by, the PIF: clinical or consumer studies, instrumental measurements, literature reviews, benchmarking and reasoning for any extrapolation. If Marketing wants the claim, Regulatory must confirm the evidence exists and is properly stored.

Artwork and labelling are where technical realities meet consumers. The PIF must align with your artwork control process, typically managed via document control and labelling control. Changes in INCI lists, warning statements, language translations or claims should trigger PIF review. If your artwork tools and PIF system are disconnected, claims will drift away from their technical foundation and you will eventually be called out for it.

10) Post‑Market Surveillance, Complaints & SUEs

The PIF is not just a pre‑market file; it also captures post‑market reality. Complaints, adverse reactions and serious undesirable effects (SUEs) all feed into ongoing safety evaluation. Each significant signal should be logged, investigated, risk‑assessed and, where appropriate, trigger updates to the CPSR, instructions for use, warnings or even formula changes.

From a systems perspective, PIFs must be connected to complaint handling, cosmetovigilance and risk management. Regulators expect a clear line from “we saw this issue in the field” to “here is what we changed in the product, label or PIF as a result”. If complaints are handled in isolation and never feed back into the technical file, you are not operating a real safety system—you are simply firefighting and hoping no one notices the pattern.

11) Multi‑Market Portfolios & MoCRA Alignment

Many brands run global formulas with regional tweaks for local regulations, cost or marketing preferences. That creates a tangle of variants, SKUs and labels. Trying to maintain independent PIFs for each country with manual processes is a guarantee of inconsistency. A better pattern is to define a global technical file backbone and then configure regional overlays for restricted ingredients, banned claims or specific notification requirements.

In the US, the Modernization of Cosmetics Regulation Act (MoCRA) pushes in the same direction as 1223/2009: stronger safety substantiation, facility registration, product listing and adverse event reporting. Rather than building a separate “MoCRA file”, use your PIF architecture as the basis; map which data points serve both regimes and which are region‑specific. That way, one change in formula or safety assessment can propagate consistently instead of spawning multiple uncoordinated updates.

12) Outsourcing, CMOs & Vendor Governance

Most cosmetic brands outsource at least part of their value chain: manufacturing, filling, testing, safety assessment, packaging development. Outsourcing does not outsource liability. The Responsible Person still owns the PIF and must be able to produce it on demand. That means your contracts and systems with CMOs, fillers and labs must guarantee timely delivery of PIF‑relevant data in controlled formats.

Integrate PIF expectations into quality agreements, supplier quality management and audit programmes. Define exactly which party owns which documents (CoAs, microbiology results, stability, challenge tests, cleaning validation, batch records) and how they get into your systems. If your PIF depends on individuals chasing documents every time an authority calls, the model is fragile. Build the data flows once and enforce them relentlessly.

13) Data Integrity, Inspections & Typical Findings

Inspectors use PIFs as a quick diagnostic of your overall control. Chaos in the file often signals chaos in the factory. Typical findings include: safety reports that do not match current formula versions; missing or weak stability and microbiology data; poor traceability of raw material changes; claims not backed by evidence; inconsistent labels between countries; and no clear link between complaints and PIF updates. All of these are preventable if you treat the PIF as part of your data‑integrity and QMS architecture rather than an afterthought.

Apply data integrity principles (ALCOA+) to the PIF: attributable authorship and signatures, legible and complete documents, contemporaneous updates, original or true copies of reports, accurate and reconciled data from source systems. Run internal audits focusing specifically on PIFs: pick products at random and verify that the file matches reality on the market. If you find gaps, assume regulators will too—and fix them before they come knocking.

14) Implementation Roadmap & KPIs

Most companies are somewhere on the journey from paper PIFs to digital, integrated dossiers. A pragmatic roadmap looks like this: inventory all products on the market and those still within the 10‑year retention window; risk‑rank them (volume, population exposed, complexity, claims, incident history); define a standard PIF template and metadata model; migrate high‑risk products first into a controlled DMS/QMS spine; close gaps under formal deviation and CAPA; then embed PIF checkpoints into new product introduction (NPI), reformulation and change control so the problem does not regenerate.

Track KPIs that actually matter: percentage of marketed products with fully approved, current PIFs; time from significant change to PIF update; number and severity of inspection findings tied to documentation; and number of incidents where you could not produce the requested file within regulatory timelines. If you cannot measure PIF health, you do not control it—no matter how tidy the occasional PDF looks.

15) FAQ

Q1. Is a PIF mandatory for every cosmetic product?
Yes. Under EU and UK cosmetics law, every cosmetic product placed on the market must have a PIF held by the Responsible Person. Small brands, private‑label lines and online‑only products are not exempt. If it’s on the market, a PIF is required.

Q2. How long must we retain the PIF?
You must keep the PIF for at least 10 years after the date the last batch of the product was placed on the market. In practice, many companies align this with broader record‑retention policies and keep core safety and formulation records even longer, especially for high‑volume or high‑profile products.

Q3. Can the PIF be fully electronic?
Yes—and for any substantial portfolio it should be. Regulators accept electronic PIFs provided they are complete, readily accessible, secure and compliant with data‑integrity expectations. A validated DMS and integrated QMS usually provide a stronger control environment than paper or ad‑hoc shared drives.

Q4. Who is legally responsible for the PIF?
The Responsible Person named on the product label is legally accountable for holding and providing the PIF to authorities. Operationally, multiple functions contribute content—R&D, Safety, Quality, Regulatory, Supply Chain, Marketing—but none of that dilutes the Responsible Person’s obligation to ensure the file is complete and up to date.

Q5. What is the fastest way to improve weak or legacy PIFs?
Start with visibility. List all products in scope, confirm who is Responsible Person for each, and verify whether a complete, current PIF exists. Risk‑rank and focus on high‑impact products first. Migrate their PIFs into a controlled digital environment, close obvious gaps (CPSR alignment, stability data, claims substantiation, supplier documents), and hard‑wire PIF maintenance into NPI and change‑control workflows so you do not slip back into the old pattern.

Related Reading
• Cosmetics & Regulations: ISO 22716 (Cosmetics GMP) | MoCRA | Labelling & Claims Control
• Quality & Systems: QMS | DMS | Data Integrity | Record Retention & Archival
• Execution & Traceability: MES | eBR | WMS | Recall Readiness | Supplier Quality Management