What is a Product Information File for cosmetics?

A Product Information File (PIF) is a mandatory document required under EU Regulation 1223/2009 Article 11. It must contain: product description, Cosmetic Product Safety Report (CPSR), manufacturing method description, proof of claimed effects, and animal testing data. The PIF must be maintained by the Responsible Person and available to authorities for 10 years after the last batch is placed on the market.

What is a CPSR in cosmetics?

A CPSR (Cosmetic Product Safety Report) is the safety assessment required under EU regulation. It has two parts: Part A contains safety information (toxicological profiles, MoS calculations, microbiological quality, impurities) compiled by anyone. Part B contains the safety assessment conclusion, which must be performed by a qualified Safety Assessor with a university degree in pharmacy, toxicology, medicine, or equivalent.

How do I create a PIF for EU cosmetics?

Our PIF Audit tool guides you through every required section of the Product Information File. Check off completed sections, identify gaps, and get specific guidance on what each section requires. The tool covers product description, CPSR Part A and B, manufacturing method, proof of effects, and animal testing documentation. It flags missing elements that could trigger enforcement during authority inspections.

EU Regulation 1223/2009 Article 11

PIF Completeness Audit

Check your Product Information File (PIF) and CPSR against EU requirements. Identify gaps before submission.

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A CPSR Part A - Safety Information

1 Quantitative and Qualitative Composition

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Full INCI ingredient list with CAS/EINECS numbers

Complete list by INCI name. Include CAS numbers, EINECS/ELINCS numbers, function of each ingredient. For fragrances: IFRA 51st Amendment certificates + allergen disclosure for all 82 EU allergens (EU 2023/1545). Natural complex substances require composition breakdown identifying individual allergens.

Critical

Exact concentrations for all ingredients

Exact percentage (not ranges) for each ingredient. Common deficiency: vague descriptions or missing exact %

Critical

CAS numbers for raw materials

Chemical Abstract Service numbers where available

Function of each ingredient

Purpose/role in the formulation

Supplier specifications

Technical data sheets from suppliers

Nanomaterial identification

If applicable, identification of nano ingredients

Fragrance allergen disclosure (82 allergens)

EU 2023/1545: All 82 fragrance allergens (26 original + 56 new) with concentrations in finished product. Supplier IEDs (Information Exchange Documents) covering all 80+ substances. IFRA 51st Amendment certificates for each fragrance compound. Grouped allergen sums calculated where applicable. Deadline: July 31, 2026 (new products) / July 31, 2028 (all products). IMPORTANT: QR codes/digital labels CANNOT substitute for physical allergen declaration (Article 19(1)(g)). For space-constrained products: peel-back labels (€0.03-€0.15/unit), shrink sleeves, or attached tags per Article 19(2).

Critical

2 Physical/Chemical Characteristics & Stability

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Stability study data

Real-time and/or accelerated stability data

Critical

pH value

pH of the finished product

Viscosity (where relevant)

For semi-solid and liquid products

Physical appearance description

Color, odor, texture specifications

Packaging compatibility

Evidence of product-container compatibility

3 Microbiological Quality

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Preservative Challenge Test (ISO 11930)

PET/Challenge test per ISO 11930. Category 1 limits for infant products (<3 years): TAMC ≤100 CFU/g

Critical

TAMC/TYMC results

Total aerobic microbial count & yeast/mold count

Critical

Absence of specified pathogens

P. aeruginosa, S. aureus, C. albicans testing

Water activity (Aw) if applicable

For products where microbial growth risk varies

4 Impurities, Traces, Packaging Information

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Heavy metals analysis

Lead, arsenic, mercury, cadmium testing

Critical

1,4-Dioxane testing (if ethoxylated ingredients)

Required if product contains PEG or -eth ingredients

Nitrosamine testing (if applicable)

For products with amine-containing ingredients

Packaging material specifications

Container material type and grade

Migration testing (if relevant)

For products in contact with specific materials

5 Normal and Reasonably Foreseeable Use

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Intended use description

Clear description of product purpose and application

Critical

Application method

How the product is applied (spray, rub, etc.)

Body site application

Face, body, hands, hair, etc.

Target population

Adults, children, specific demographics

6 Exposure to the Cosmetic Product

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Application frequency

Times per day/week of expected use

Critical

Amount applied per use

Grams or milliliters per application

Surface area of application

cm² of skin exposed

Duration of exposure

Leave-on time or rinse-off duration

7 Exposure to Substances

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SED calculations for restricted substances

SED = (Conc. x Daily Amount x Dermal Absorption) / Body Weight. MoS = NOAEL/SED, must be ≥100

Critical

Dermal absorption data

Absorption % for key ingredients

Aggregate exposure consideration

Multiple product use scenarios

8 Toxicological Profile of Substances

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NOAEL values for restricted substances

No Observed Adverse Effect Level from literature

Critical

Sensitization data

Allergenicity information for key ingredients

Irritation potential

Skin/eye irritation data

Phototoxicity assessment

For UV-active ingredients

CMR substance check

Carcinogenic, mutagenic, reprotoxic screening

9 Undesirable Effects and Serious Undesirable Effects

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Known undesirable effects

Literature review of ingredient-related effects

Post-market surveillance plan

System for collecting adverse event reports

SUE reporting procedure

Serious Undesirable Effect notification process

10 Information on the Cosmetic Product

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GMP certificate (ISO 22716)

Manufacturing facility GMP compliance

Manufacturing process description

Overview of production process

Batch records reference

System for batch traceability

Existing data on formulation

Any prior testing on same/similar formulas

P PIF Components (Article 11)

P PIF Documentation Requirements

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Product description and identification

Product name, brand, category, function, target consumer, application site, physical form, container type

Critical

CPSR (complete Part A + Part B)

Signed by qualified safety assessor. Must be updated when formula, use, or regulations change

Critical

Manufacturing method description

Step-by-step process, flow diagram, critical parameters (temp, time, speed), in-process controls

Critical

GMP certificate or statement (ISO 22716)

Current certificate from accredited body, or signed statement of compliance

Critical

Proof of effect / claims substantiation

Test reports, clinical studies, statistical analysis for all efficacy claims made

Animal testing declaration

Signed declaration on finished product and ingredient testing. Third-country exceptions explained

Product labelling and artwork

All label versions, all languages, INCI list, PAO symbol, warnings, claims, contact info

B CPSR Part B - Safety Assessment

B1 Assessment Conclusion

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Specific safety conclusion (NOT generic)

Must be product-specific, reference actual use conditions, address target population. #1 deficiency: generic "product is safe" without context

Critical

Population considerations

Safety for specific populations (children, pregnant, etc.)

Any conditional statements

Limitations or conditions of safe use

B2 Labelled Warnings & Usage Instructions

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Required warnings (Annex III)

Mandatory warnings for restricted substances

Usage instructions

Clear directions for safe use

Special precautions

Professional use only, avoid eyes, etc.

B3 Reasoning

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MoS calculations (≥100)

Margin of Safety for restricted ingredients

Critical

Scientific reasoning

Explanation of safety conclusion basis

References to scientific literature

Citations supporting safety assessment

B4 Assessor Credentials

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Assessor qualifications (EU-recognized)

Degree in pharmacy, toxicology, medicine, chemistry, or biology with toxicology from EU-recognized institution. UK no longer auto-recognizes EU qualifications

Critical

Assessor name and contact

Full name and contact information

Date and signature

Signed and dated assessment

PIF Completeness Audit

A CPSR Part A - Safety Information

P PIF Components (Article 11)

B CPSR Part B - Safety Assessment

⚠️ Common CPSR Deficiencies (Market Surveillance Findings)

PIF Retention Requirements