Understanding Cosmetic PIF Documentation: A Guide for Beauty Brands

For prestige beauty brands, where formulation excellence and brand identity go hand in hand, a well-constructed PIF is more than a legal obligation—it is an opportunity to demonstrate rigor, transparency, and unwavering commitment to quality. Whether you are launching a minimalist serum or a complex multi-phase treatment, understanding what your PIF must contain is essential for confidently entering the EU market.

This guide walks you step-by-step through the documentation required for a complete Safety Assessment and explains why each component matters. Our goal is to make the PIF feel logical, approachable, and—dare we say—empowering.

At Taobé Consulting, we specialise in guiding high-end beauty brands through the regulatory intricacies that shape global compliance. In partnership with Coptis, this article aims to guide you step-by-step through the documentation required for a complete Safety Assessment.

Under EU Cosmetics Regulation (EC) No. 1223/2009, every cosmetic product placed on the market must be supported by a Product Information File, kept readily accessible for authorities by the Responsible Person. Think of the PIF as a structured dossier that brings together:

• Safety information
• Manufacturing and quality documentation
• Product composition and testing data
• Evidence supporting the product’s claims
• Information ensuring consumer protection

But the PIF is not merely a checklist—it is a narrative of the product’s life: where it comes from, how it is made, how it performs, and whether it can be used safely.

For luxury cosmetic brands, a robust PIF not only unlocks compliance—it enhances traceability, strengthens safety claims, and builds credibility in a regulatory environment where transparency is paramount.

At the centre of the PIF is the Cosmetic Product Safety Report (CPSR), prepared by an independent, qualified Safety Assessor. Their work cannot begin until they receive complete, coherent, and scientifically relevant documentation.

One crucial fact that brands sometimes overlook: every Safety Assessment is product-specific.

Even products in the same category—two mascaras, two moisturizers—may require different document sets depending on formulas, raw materials, packaging, and claims. This is why thorough and well-organised documentation is essential.

A Safety Assessment is only as strong as the documentation that supports it. Below is an overview of the core documents your Safety Assessor will require to build a scientifically sound, regulation-compliant Cosmetic Product Safety Report (CPSR).

To assess safety, the assessor must know:

• The product’s function (e.g., cleanser, eye cream, leave-on mask)
• Intended user group (e.g., adults, children, professionals)
• Use frequency and application method

This information allows precise exposure calculations—crucial for evaluating ingredient safety margins. A product used daily near the eyes requires a different risk assessment than a rinse-off shampoo or a once-a-week mask.

This is the backbone of the Safety Assessment.

You must provide:

• Trade names of all raw materials
• Names of their manufacturers
• Full INCI composition of each material
• Exact percentages of each ingredient
• The concentration of every raw material in the final formula

Complete transparency ensures assessors can evaluate potential allergens, impurities, traces, toxicological profiles, and interactions within the formula.

Every raw material requires:

• Material Safety Data Sheet (MSDS)
• Certificate of Analysis (COA)
• Non-Animal Testing (NAT) statement

And the finished product requires the same.

If composition details are unclear, the Safety Assessor will request a 100% ingredient breakdown, with exact INCI names summing to 100%.

These documents give insight into:

• Material purity
• Contaminant risks
• Hazard classifications
• Manufacturing consistency

For beauty brands using complex natural extracts or biotechnological ingredients, this level of transparency is especially important.

You must provide a GMP certificate or equivalent documentation demonstrating that the product has been manufactured following ISO 22716 guidelines.

This assures regulators that:

• Manufacturing conditions are controlled
• Production steps are traceable
• Quality management systems are in place

It is a cornerstone of cosmetic safety.

This internal document outlines:

• The production process
• Quality checkpoints
• Corrective actions when deviations occur

For the Safety Assessor, this is vital to evaluating consistency and identifying potential risks during production.

Brands must provide:

• Any reported undesirable effects
• Assessment of their potential causes
• Statistical information
• Number of units sold
• Or a justified statement confirming no occurrences

This documentation helps monitor post-market safety and demonstrates responsible oversight.

Packaging is not neutral—it can affect the product’s safety and stability.

Documentation should include:

• Composition of all packaging components
• Origin and certifications
• Technical drawings
• Any functional barriers

Packaging safety testing

A cosmetic product must remain safe, stable, and aesthetically consistent throughout its shelf life.

Two main options exist:

Accelerated Stability Test

• Typically 3 months
• Exposes product to high temperatures (40–45°C)
• Predicts long-term behaviour

Real-Time Stability Test

• Conducted for the full claimed shelf life
• Reflects real storage conditions

Both must assess compatibility with the final packaging and, ideally, an inert reference packaging. When multiple packaging formats are used, each must be tested.

This test determines whether the preservative system protects the product throughout its lifespan.
However, it is not required for every product.

The Safety Assessor will decide based on:

• Product type
• Water activity
• Packaging format
• Formulation characteristics

For example, a water-free balm may not require a Challenge Test, while a cream in a jar almost certainly will.

Depending on the formula, raw materials, and claims, additional documentation may be required:

• Allergen Report (EU 2023/1545)

Mandatory for fragrances, essential oils, or natural extracts, listing allergens and their exact concentrations.

• IFRA Certificate (51st Amendment)

Required for fragranced products to ensure compliance with current global fragrance safety standards.

• Purity Statement

Important for colourants, pigments, and minerals where impurities must be clearly declared.

• Origin Statement / Certification

Needed when the brand claims “Natural,” “Vegan,” “Organic,” or similar.

• Microplastic-Free Statement

Relevant when ingredients may fall under the scope of Regulation 2023/2055 on microplastics.

• Heavy Metals Test

Required for materials or finished products where heavy metal contamination may be a concern—especially colour cosmetics.

• Sunscreen Testing

For SPF products:

• UVA Test ISO 24443:2012
• UVB Test ISO 24444:2019

• Claim Support Documentation

Including:

• Instrumental efficacy tests
• Consumer perception tests
• In vitro studies
• Bibliographic evidence

Every claim must be truthful, substantiated, and not misleading. Depending on the characteristics of the claims, different documentation will be required to support them by your Safety Assessor.

A significant portion of the assessor’s time goes into verifying that the documentation is consistent across all sources. They ensure that:

• Raw materials have matching names across all documents
• Manufacturers are consistent
• Certificates are up to date and signed
• Formula data matches stability, microbiology, and packaging tests
• Claims align with evidence

Well-organised documentation shortens assessment timelines and reduces the need for clarifications.

The PIF is not designed to create barriers—it exists to protect consumers and support brand accountability. For beauty brands, mastering the PIF process is an opportunity to elevate quality, reinforce transparency, and demonstrate the scientific integrity behind each product.

At Taobé Consulting, we believe education is the foundation of compliance. The more your team understands the purpose and logic behind the PIF, the easier it becomes to integrate regulatory excellence into your product development process.

If assembling or reviewing your Cosmetic PIF feels overwhelming, you’re not alone. At Taobé Consulting, we help prestige beauty brands navigate regulatory requirements with clarity, precision, and a human-centred approach.

Contact Taobé Consulting for tailored support with your cosmetic regulatory and compliance needs: https://taobe.consulting