It is one of the most important documents in cosmetic regulatory compliance, as it collects the information needed to demonstrate the safety, conformity and proper market placement of a cosmetic product.

Each cosmetic product placed on the EU market must be supported by a complete, updated and coherent PIF, aligned with the formulation, labelling, safety assessment, CPNP notification and available technical documentation.

The PIF is therefore not just a collection of documents. It represents the core of the regulatory compliance of a cosmetic product.

What Is the Purpose of the PIF?

The Product Information File is intended to demonstrate that the cosmetic product has been properly assessed and can be considered safe under normal or reasonably foreseeable conditions of use.

Through the PIF, it is possible to show that:

• the product has undergone a safety assessment;
• the formulation complies with applicable cosmetic legislation;
• the ingredients have been evaluated from a toxicological point of view;
• the product is manufactured in accordance with Good Manufacturing Practices;
• the label is consistent with the technical documentation;
• the claims are supported by adequate evidence;
• the CPNP notification is aligned with the product information;
• the Responsible Person has the necessary documentation available in case of inspection by the competent authorities.

A well-structured PIF helps prevent regulatory issues, incomplete documentation requests, objections from authorities or problems during product marketing.

When Must the PIF Be Prepared?

The PIF must be prepared before the cosmetic product is placed on the market.

The Responsible Person must keep it available to the competent authorities at the address indicated on the product label.

The file must also be kept for a period of ten years from the date on which the last batch of the cosmetic product was placed on the market.

This means that the PIF must be available not only at the time of product launch, but throughout the commercial life of the product and for the period required by the regulation afterwards.

What Information Does the PIF Contain?

The Product Information File contains information and data that must be updated where necessary.

In particular, the PIF includes:

• a description of the cosmetic product;
• the Cosmetic Product Safety Report;
• the manufacturing method;
• a statement of compliance with Good Manufacturing Practices;
• proof of the effects claimed for the cosmetic product;
• data relating to animal testing, where applicable.

These elements must be consistent with each other and with all product-related information, including formulation, label, claims, laboratory tests and CPNP notification.

Description of the Cosmetic Product

The PIF must include a description of the cosmetic product that clearly links the file to the product concerned.

This section may include, for example:

• product name;
• cosmetic category;
• product function;
• cosmetic form;
• area of application;
• directions for use;
• target consumers;
• variants, references or shades;
• any information useful to clearly identify the product.

The description must be sufficiently clear to avoid ambiguity, especially in the case of cosmetic lines composed of several similar products or variants of the same product.

Cosmetic Product Safety Report

The Cosmetic Product Safety Report, often referred to as CPSR, is one of the most important sections of the PIF.

The CPSR is the safety report of the cosmetic product and is prepared on the basis of the available information on the formulation, ingredients, exposure, intended use and product characteristics.

The safety assessment must be carried out before the product is placed on the market and must be signed by a qualified safety assessor.

The CPSR is divided into two parts:

• Part A – Cosmetic Product Safety Information;
• Part B – Cosmetic Product Safety Assessment.

Part A – Cosmetic Product Safety Information

Part A collects the technical information required to assess the safety of the cosmetic product.

It includes, among other elements:

• qualitative and quantitative composition of the product;
• physical and chemical characteristics;
• stability of the cosmetic product;
• microbiological quality;
• impurities, traces and information on packaging materials;
• normal and reasonably foreseeable use;
• exposure to the cosmetic product;
• exposure to the individual substances;
• toxicological profile of the ingredients;
• undesirable effects and serious undesirable effects;
• other relevant information on the product.

This part represents the technical and scientific basis on which the safety assessment is built.

Part B – Cosmetic Product Safety Assessment

Part B contains the actual safety assessment of the cosmetic product.

In this section, the safety assessor provides their conclusions on the safety of the product, taking into account the information included in Part A.

Part B includes:

• conclusions of the safety assessment;
• warnings and instructions for use to be included on the label, where necessary;
• scientific reasoning supporting the assessment;
• credentials of the safety assessor;
• approval and signature of the safety assessor.

This section is particularly important because it formalises the professional judgement of the safety assessor on the safety of the cosmetic product.

The Role of the Safety Assessor

The safety assessor is the professional responsible for carrying out the safety assessment of the cosmetic product and signing Part B of the Cosmetic Product Safety Report.

The safety assessor must have appropriate qualifications in pharmacy, toxicology, medicine or similar disciplines, as required by Regulation (EC) No 1223/2009.

Their role is not limited to a formal review of the formulation. It involves a comprehensive assessment of the product, the ingredients, exposure, conditions of use and available technical documentation.

A proper safety assessment requires toxicological, regulatory and formulation expertise.

Manufacturing Method and GMP

The PIF must contain a description of the manufacturing method of the cosmetic product and a statement of compliance with GMP, meaning Good Manufacturing Practices.

Cosmetic GMP are the Good Manufacturing Practices applicable to the production of cosmetic products and are intended to ensure that the product is manufactured, controlled, stored and shipped according to appropriate procedures.

The main technical reference for cosmetic GMP is UNI EN ISO 22716.

Manufacturing documentation must be consistent with the finished product and with the production process actually used.

Proof of the Effects Claimed for the Product

Where justified by the nature of the product or the effects claimed, the PIF must contain evidence supporting the cosmetic claims.

Claims may concern, for example:

• moisturising effect;
• soothing effect;
• anti-ageing effect;
• barrier effect;
• brightening effect;
• depigmenting effect;
• wrinkle reduction;
• firming effect;
• antioxidant activity;
• sun protection;
• purifying action;
• improvement in the appearance of skin or hair.

Evidence may include instrumental tests, clinical tests, in vitro studies, bibliographic data, information on ingredients or other appropriate technical documentation.

It is essential that claims are consistent with the formulation, the available tests and the overall presentation of the product.

Data Relating to Animal Testing

The PIF must include, where applicable, data relating to any animal testing carried out by the manufacturer, their agents or suppliers in relation to the development or safety assessment of the cosmetic product or its ingredients.

This aspect must be managed with particular care, considering the prohibitions and restrictions laid down by European cosmetic legislation on animal testing.

PIF, Formula, Label and CPNP: Connected Documents

The PIF must not be considered as an isolated document.

Cosmetic product compliance depends on the consistency between several elements:

• qualitative and quantitative formulation;
• raw material documentation;
• safety assessment;
• label;
• claims;
• laboratory tests;
• manufacturing method;
• CPNP notification;
• Responsible Person data.

A change to the formulation, label, packaging, manufacturer, warnings or claims may require an update of the PIF or a reassessment of certain sections of the file.

For this reason, the PIF must be kept up to date over time.

Common Errors in PIF Management

In practice, many regulatory issues arise from incomplete or poorly coordinated documentation.

Common errors include:

• PIF not available before placing the product on the market;
• formulation not consistent with the label;
• CPNP notification not aligned with the actual product;
• missing or incomplete CPSR;
• outdated raw material documentation;
• claims not supported by adequate evidence;
• missing GMP statement;
• safety assessment not updated after formulation changes;
• insufficient data on impurities, traces or allergens;
• label not consistent with the safety assessor’s conclusions.

Accurate PIF management helps reduce these risks and allows the company to respond more effectively to any inspection or request from competent authorities.

Updating the PIF

The PIF must be updated whenever relevant changes occur to the product or its documentation.

An update may be necessary, for example, in case of:

• formulation change;
• replacement of a raw material;
• change of supplier;
• update of technical documentation;
• new toxicological data becoming available;
• packaging change;
• label modification;
• introduction of new claims;
• change in the manufacturing method;
• regulatory updates affecting ingredients or conditions of use;
• new tests or new evidence on the product.

Keeping the PIF updated is essential to ensure product compliance throughout its entire life cycle on the market.

Support in Preparing the PIF

Preparing a Product Information File requires regulatory, toxicological and documentary expertise.

Support may include:

• preliminary formula review;
• verification of prohibited or restricted ingredients;
• collection and review of raw material technical documentation;
• preparation of the Product Information File;
• preparation of the Cosmetic Product Safety Report;
• toxicological assessment of ingredients;
• review of allergens, impurities and traces;
• verification of GMP documentation;
• label review;
• claims assessment;
• alignment between PIF and CPNP notification;
• update of existing PIFs.

The objective is to prepare complete, coherent and usable documentation in case of inspection by the competent authorities.

A Complete Technical File for a Compliant Cosmetic Product

The PIF is one of the most important tools to demonstrate the compliance of a cosmetic product with European legislation.

A well-prepared file does not simply collect documents. It connects formulation, safety, manufacturing, labelling, claims and notification in a coherent way.

For this reason, PIF preparation must be approached with method, technical accuracy and continuous updating.

A complete and coherent Product Information File allows the Responsible Person and the company to place the product on the market with greater confidence, reducing the risk of non-compliance and improving the regulatory management of the cosmetic product over time.