Product Information File (PIF): What Goes In and How to Create It Correctly

The Product Information File (PIF) is the central compliance document for every cosmetic product in the EU. No product may be placed on the market without a complete PIF — Art. 11 of the EU Cosmetics Regulation (EC) No 1223/2009 sets this out unambiguously. Yet in practice the PIF is one of the most common weak points during market surveillance inspections.

The reasons are almost always the same: incomplete safety assessments, outdated formulation data, missing GMP evidence or a structure that cannot be found when it matters. Especially for small and contract manufacturers in the DACH region working with limited regulatory-affairs resources, maintaining the PIF quickly becomes a burden.

This guide explains, step by step, how to create a PIF correctly: which components are mandatory, what the safety assessment (CPSR) must contain, what a practical PIF structure looks like and which mistakes you should avoid. With concrete examples from cosmetics manufacturing.

What is a Product Information File — and why is it mandatory?

The Product Information File (PIF) — often simply called the product dossier — is the complete documentation of a cosmetic product. It contains all the information that proves a product is safe, correctly labelled and manufactured under GMP conditions.

The legal basis is Art. 11 of the EU Cosmetics Regulation (EC) No 1223/2009. In essence it states: from the moment a product is placed on the market, the Responsible Person must keep a product information file for the cosmetic product. The PIF must be “readily accessible” to the competent authorities at the address indicated on the label.

The PIF is not a static document. It must be updated whenever the formulation, the manufacturing method or the safety assessment changes — and that throughout the entire life cycle of the product. In practice this means: as long as a product is being manufactured, the PIF lives on too.

PIF components under the EU Cosmetics Regulation 1223/2009

Art. 11(2) of the EU Cosmetics Regulation defines five mandatory components that every PIF must contain. These requirements are non-negotiable — a PIF missing any one of these components is incomplete and therefore a compliance risk.

1. Product description and formulation

The PIF must contain a clear description of the product: name, category, intended use and the complete qualitative and quantitative composition. The formulation must list all ingredients with their INCI names and percentage shares.

• Product name and, where applicable, article number
• Product category (leave-on, rinse-off, etc.)
• Intended target group and area of application
• Complete formulation with INCI names and concentrations (%)
• Function of each ingredient (emulsifier, preservative, fragrance, etc.)

2. Safety report (CPSR / safety assessment)

The Cosmetic Product Safety Report (CPSR) is the heart of the PIF. It consists of two parts:

• Part A — safety information: Quantitative and qualitative composition, physico-chemical properties, stability data, microbiological quality, impurities, packaging data, exposure estimation and toxicological profiles of the ingredients.
• Part B — safety assessment: Conclusion of a qualified safety assessor (toxicologist, pharmacist or similar) as to whether the product is safe under intended and reasonably foreseeable use.

Part A in particular is the most demanding step for manufacturers: all formulation data, raw material specifications and exposure data must be prepared in a structured way before the external assessor can begin Part B. Tools such as the CPSR assistant in INCIkit support this preparatory work by compiling the data directly from formulation management — including MoS pre-calculation and exposure data.

3. Evidence of GMP compliance

The PIF must demonstrate that manufacturing meets the requirements of good manufacturing practice (GMP). In practice this means: a reference to ISO 22716 and the corresponding documentation (batch records, quality control reports, SOPs).

4. Proof of efficacy

If claims are made on the product or in advertising (e.g. “moisturising”, “anti-ageing”, “mattifying”), these must be substantiated by suitable evidence. This can take the form of clinical studies, in-vitro tests, consumer studies or literature references.

Without an advertised efficacy claim, this component does not apply — the PIF then only needs to document that no claims are made.

5. Animal testing data

If animal testing was carried out in connection with the development of the product (including tests performed to satisfy the legislation of third countries), it must be documented. Since 2013, animal testing for cosmetic products and their ingredients has been completely banned in the EU.

CPSR cosmetic safety assessment: the heart of the PIF

The CPSR is the most demanding and most expensive part of the PIF — and at the same time the most important. No product may be placed on the market without a valid safety assessment. The requirements are set out in detail in Annex I of the EU Cosmetics Regulation.

The safety assessor needs a range of information from the manufacturer in order to carry out the assessment:

• Complete quantitative formulation with INCI names
• Specification data sheets for all raw materials (TDS/SDS/CoA)
• Stability data (accelerated and long-term stability)
• Microbiological test results (challenge test / PET)
• Packaging specification including migration data
• Product category, target group and intended area of application

Practical example: PIF for a moisturising face cream

A natural cosmetics manufacturer in southern Germany is launching a new face cream. The PIF comprises:

In total, the manufacturer needed 8 weeks to create the PIF — of which 4 weeks were spent waiting for the external safety assessment. In practice, the lead time for the CPSR is the time-critical path.

Product Information File template: how to structure a PIF correctly

The EU Cosmetics Regulation does not prescribe any particular format for the PIF. In practice, however, a folder structure that clearly reflects the five mandatory components and is quick to navigate during audits has proven effective.

You will find a printable version of this structure in our free PIF template area.

Practical example: PIF responsibility in contract manufacturing

A start-up cosmetics brand from Vienna has its products manufactured by a contract manufacturer in Germany. The question: who creates and maintains the PIF?

The critical point: in contract manufacturing, the documents have to be brought together from different sources. If the contract manufacturer changes the formulation and the brand owner does not update the safety assessment, a gap arises — one that is immediately apparent during an audit.

Common mistakes when creating a PIF — and how to avoid them

Market surveillance authorities and auditors encounter the following mistakes regularly:

Checklist: creating a PIF for cosmetic products

Use this checklist as a quick reference before you finalise a PIF or hand it over to market surveillance:

Conclusion: the PIF is not a one-off document

The Product Information File is more than a mandatory filing — it is the living compliance document of your product. Every formulation change, every new batch, every new claim creates a need for updates. Anyone who sets this up in a structured way from the outset saves weeks of audit preparation when it matters.

The most important takeaways:

• Every cosmetic product in the EU needs a complete PIF with 5 mandatory components
• The CPSR (safety assessment) is the most demanding part — allow 4–8 weeks of lead time
• When the formulation changes, the entire PIF (including the CPSR) must be updated
• Structured folders with clear numbering make the PIF audit-ready
• In contract manufacturing, responsibilities for each PIF component must be clearly defined
• Digital management is not mandatory, but in practice strongly recommended

FAQ: Frequently asked questions about the PIF

Further resources