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How to Prepare a PIF (Product Information File) for Cosmetics

A Product Information File (PIF) is the mandatory technical dossier every cosmetic brand must maintain before placing a product on the market. Learn exactly what goes inside one and how to build yours step by step.

Esans.com.tr Academy ·✍️ Esans Academy Technical Team ·~7 min read·Updated: 21.10.2026
01

What Is a PIF, and Why Does It Exist?

Before a fragrance ever reaches a consumer's hands, an invisible ledger is kept on its behalf. That ledger is called the PIF (Product Information File). It is the technical record that explains who the product is, what it is made of, and why it is safe.

A PIF is a mandatory dossier that must be maintained for every cosmetic product placed on the market. Under Turkish and EU legislation, responsibility lies with the Responsible Person — the brand, importer, or manufacturer that places the product on the market. The file must be retained for the entire period the product is on the market and for at least 10 years after the last batch has been supplied.

When an inspection occurs, simply saying "my product is safe" is not enough. You will be required to demonstrate this with documentation. That is precisely what a PIF does: it converts a claim into evidence.

A PIF is not a marketing brochure. It is a current, complete technical archive that a competent authority can access within a reasonable timeframe. An incomplete file can result in the temporary withdrawal of a product from the market.
02

What Must the File Contain?

A PIF is not a disorganised pile of papers; it is a structured document with defined sections. The following sections form its backbone.

SectionContentSource
Product descriptionProduct name, category, intended useManufacturer / brand
CPSR (Cosmetic Product Safety Report)Safety information + expert assessment (Parts A and B)Qualified safety assessor
Manufacturing methodProduction workflow and Good Manufacturing Practice (GMP) declarationManufacturing facility
Substantiation of claimsEvidence supporting claims such as "lasts 24 hours"Test data / supporting evidence
Stability & microbiologyStability data, challenge test, preservative efficacyLaboratory
Raw material breakdownFull formula, INCI names, percentages, safety data sheetsSupplier (including fragrance oil)

In perfumery, the most critical item is the documentation for the fragrance oil. For every raw material sourced from us, the IFRA compliance certificate, allergen declaration, and safety data sheet (SDS) are the heart of your file. Without these, a CPSR cannot be written.

Tip: When sourcing a fragrance oil from a supplier, request the IFRA certificate and the allergen list at the same time. Chasing them down afterwards is far more time-consuming than the production itself.
03

IFRA Limits: A Common Mistake

Many new producers assume: "If I use the fragrance oil at 20%, it will be safe." This is incorrect. The limit does not operate on the basis of the total fragrance oil percentage.

IFRA limits are set according to the individual substances and allergens within the fragrance oil, as well as the product category. The key distinction here is between leave-on and rinse-off categories. A fragrance is leave-on — it remains on the skin — which means certain substances have lower permitted limits.

This means the same fragrance oil may be used freely in a room scent but be restricted in a leave-on skin product. There is no rule that states "all fragrance oils are safe up to 20%."

The correct approach: read the IFRA compliance certificate for your fragrance oil. The certificate specifies the maximum usage level for that fragrance oil in each product category. Include this document in your PIF and build your formula accordingly.

The natural vs. synthetic question is also resolved here: safety depends not on the "natural" or "synthetic" label, but on the usage level. A natural essential oil can also contain high levels of allergens.

04

Step-by-Step PIF Preparation

Once you put the process in order, the file that once seemed daunting becomes a concrete, manageable task. Here is the practical workflow.

  1. Freeze the formula

    Finalise the formula to 100% certainty. Record the source, percentage, and INCI name of every raw material. Lock in the fragrance oil percentage at this stage.

  2. Collect supplier documents

    For the fragrance oil: IFRA certificate + allergen list + SDS. For all other raw materials: safety data sheets. A missing document will block every subsequent step.

  3. Conduct stability and microbiology testing

    Stability testing demonstrates that the product does not deteriorate over time; the challenge test demonstrates that the preservative system suppresses microbial load. For alcohol-based fragrances, alcohol plays a preservative role, though assessment is still required based on the product category.

  4. Commission the CPSR

    A qualified safety assessor reviews the data you have gathered and signs the report. This is the most critical and externally sourced component of the entire file.

  5. Substantiate claims

    If the label states "long-lasting," the evidence must be in the file. One pitfall to note: longevity is not determined by fragrance oil concentration alone.

  6. Compile and store the file

    Bring all sections together in a single accessible archive. If you modify the formula, update the PIF accordingly — and retain the previous version as well.

FIGURE 01Process Strip — Step by Step
🔹1. Freeze theformula Finalise…🔹2. Collectsupplier…✅3. Conductstability and…🔹4. Commission theCPSR A qualified…🔹5. Substantiateclaims If the…🔹6. Compile andstore the file…
Note on longevity: The primary factor determining how long a formula lasts on skin is the volatility of its ingredients, not the concentration. A citrus-heavy 25% extrait can fade quickly, while a 10% product built around amber, oud, and musk can linger on skin for hours. Claiming "this concentration lasts X hours" is misleading — measure the longevity of your own formula, then make the claim.
05

Inspections, Maceration, and Frequently Asked Questions

When an inspector comes knocking, the file must be at hand. But a great fragrance is built not only on paperwork — production discipline matters just as much.

Just as the top notes fade and the heart takes over the stage, once a product leaves the warehouse, it is the PIF that represents it. In production, maceration should not be overlooked either: alcohol and fragrance oil don't merely settle through waiting — they undergo esterification (molecules slowly forming new bonds). Maceration at room temperature (~15–20°C), protection from light, and cold filtration (removing waxy particles) all help soften the harsh opening known as "alcohol blast." These process notes are also recorded in the production section of the PIF.

A note on solubility: adding more water than necessary to high-grade ethanol will cause the fragrance oil to cloud and the mixture to separate into phases. Keep the water content low, start with a small amount, and test for clarity. Where needed, use an appropriate perfumer's alcohol or solvent. The rest is your signature.

I'm a small brand — do I still need to maintain a PIF?
Yes. Anyone who places a product on the market is the Responsible Person and is legally obliged to maintain a PIF, regardless of company size. Scale may differ; the obligation does not.
Can I write the CPSR myself?
No. The safety assessment in Part B of the CPSR must be carried out and signed by a safety assessor with the required qualifications. Your role is to compile the data (formula, test results, IFRA certificates) completely and present it to the assessor.
If I increase the fragrance oil percentage, won't I exceed IFRA limits?
There is no automatic answer. The limit depends not on the total percentage but on the individual substances within the fragrance oil and the product category. The IFRA compliance certificate for the fragrance oil states the maximum usage level for that specific oil in each category. Always build your formula against that certificate.

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