Cosmetic product information file PIF EU guide

A cosmetic product information file PIF EU must be held in the European Union by the responsible person before a cosmetic product is placed on the market. It brings together the safety evidence, including the Cosmetic Product Safety Report (CPSR), plus manufacturing, claims and labelling information needed to answer a request from a competent authority.

Key takeaways

A cosmetic PIF is required for every cosmetic product placed on the EU market.

The responsible person must retain the product information file for ten years after the last batch of the product was placed on the market.

The Cosmetic Product Safety Report is part of the PIF and must be prepared by a person with the required qualifications.

CPNP notification does not replace the PIF, a safety assessment or compliant labelling.

An importer placing a non-EU manufacturer’s cosmetic product on the EU market may become the responsible person unless another EU-established entity has been designated in writing.

What is a cosmetic product information file PIF EU?

A PIF is the regulatory file demonstrating that a cosmetic product can be made available on the EU market under the applicable conditions. It must be available at the address shown on the label and accessible to authorities in a language they can understand.

The main legal framework is Regulation (EC) No 1223/2009 on cosmetic products. It defines a cosmetic product as a substance or mixture intended to be placed in contact with the external parts of the human body, teeth or oral mucous membranes, mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours.

Shampoo, facial serum, lipstick, deodorant and sunscreen can therefore fall within this regime. A product presented as preventing or treating disease may fall outside the cosmetic definition and under different rules. Classification depends on the composition, presentation and claims, so check it before printing packaging or publishing a marketplace listing.

The PIF is not a document you automatically submit to the European Commission. It is a file you retain and must be able to produce promptly if a market-surveillance authority requests it. If it is missing, you may face a withdrawal request, suspension of sales or a blocked listing where a platform asks for your compliance documents.

To map the obligations that may apply alongside cosmetics rules according to your products, storage countries and sales channels, use the EU Market Entry Compliance Assessment. It helps identify points to check, but does not replace a cosmetic safety assessment.

Who must keep the product information file available?

The cosmetic responsible person must keep the PIF available for authorities at the address shown on the label. That person must be established in the European Union and carries the regulatory responsibility for the product placed on the market.

Under Regulation (EC) No 1223/2009, an EU-established manufacturer is normally the responsible person. For an imported product, the importer normally becomes the responsible person. However, the importer may designate, by written mandate, an EU-established person that accepts the role. If you market a white-label formula under your own name or trade mark, your involvement can also make you responsible for that role.

Do not confuse a non-EU manufacturer with the importer

Imagine a US manufacturer selling a face cream to a French company that imports pallets into a warehouse in Germany. Unless another EU-based responsible person has been validly designated, the importer is the regulatory contact point. It must therefore be able to access the complete PIF, check that CPNP notification has been completed and ensure the label carries the required information.

A distributor that does not alter the product may not be the responsible person. It must still act with due care: retain traceability, check the information it makes available and cooperate with authorities. Repacking, mistranslating, changing the label or selling the product under your own brand can change your position and responsibilities.

The cosmetics responsible person must not be confused with a GPSR responsible person. Regulation (EU) 2023/988 on general product safety applies on a complementary basis where its provisions are not covered by harmonised sector-specific legislation. For cosmetics, Regulation (EC) No 1223/2009 remains the sector-specific reference for safety, the PIF, labelling and the responsible person.

EU Seller Kit — If you sell several product categories or ship from outside the EU, the EU Market Entry Compliance Assessment helps you structure product, customs and VAT checks before your first shipment.

What must a cosmetic product information file PIF EU contain?

The PIF must contain the elements required by the Cosmetics Regulation, adapted to the product concerned. A commercial product sheet, ingredient list and generic supplier certificate are not enough.

Regulation (EC) No 1223/2009 requires the product information file to include, among other things:

a description of the cosmetic product that clearly links the file to the product;
the Cosmetic Product Safety Report;
a description of the manufacturing method and a statement of compliance with good manufacturing practice;
proof of the effect claimed, where justified by the nature or effect of the product;
data on animal testing, where relevant.

Identify the product and its variants precisely

Your file must make it possible to link the formula, trade name, references, pack sizes and variants without ambiguity. One range may need several files, or clearly separated sections, where the formula, fragrance, concentration or intended use changes.

Example: a 50 ml moisturiser and its 15 ml travel size may share the same formula. A “sensitive skin” version containing a different fragrance should not be assumed to be covered without confirmation from the safety assessor. Claims such as “hydrates for 24 hours”, “dermatologically tested” or “suitable for sensitive skin” need supporting evidence when used.

Document manufacturing and good practice

The responsible person must be able to explain how the product is made and why it considers good manufacturing practice to be followed. In practice, request information from the manufacturer on the production site, batch controls, deviation management, raw-material traceability and packaging operations.

A common mistake is accepting a PIF written for an earlier formula after the supplier has changed a preservative, fragrance or subcontractor. Any change capable of affecting safety, quality, claims or labelling should trigger a review of the file before the amended batch is marketed.

How is the Cosmetic Product Safety Report structured?

The Cosmetic Product Safety Report, usually called the CPSR, is the central part of the PIF. It assesses product safety for human health under normal or reasonably foreseeable conditions of use.

The report has two parts: Part A contains cosmetic product safety information, while Part B contains the safety assessment and the assessor’s conclusion. Regulation (EC) No 1223/2009 sets its content and requires the assessment to be carried out by a person holding a recognised diploma or other formal qualification in a relevant discipline, such as pharmacy, toxicology, medicine or a similar discipline.

Part A: information reviewed by the assessor

Part A brings together the information needed for the assessment: qualitative and quantitative composition, physico-chemical characteristics, stability, microbiological quality, impurities, traces and information about packaging material. It also covers normal and reasonably foreseeable use, exposure to the product, exposure to substances, toxicological profiles and known undesirable effects.

Exposure for a rinse-off shower gel is not the same as for lipstick, which may be ingested in small amounts, or a leave-on lotion applied daily. An assessor cannot simply transfer a report from one product to another. The formula, target users, application area and instructions for use all matter.

Part B: the safety conclusion

Part B gives the safety conclusion, specifies warnings and instructions for use that must appear on the label, explains the reasoning and bears the assessor’s signature. It must match the formula actually manufactured and the commercial claims being made.

A cosmetic CPSR is not a simple certificate of compliance. It does not replace raw-material data, specifications, necessary testing or a consistency check of the label. If your supplier refuses to provide the material needed for the responsible person to maintain a complete PIF, treat that as an operational risk before ordering.

To organise identity, payment and delivery checks before placing an order, Supplier Check centralises the information and highlights inconsistencies for review. It does not validate a CPSR or replace a qualified safety assessor.

How do PIF, CPNP notification and labelling work together?

The PIF, CPNP notification and labelling are connected but separate requirements. The PIF documents compliance; notification informs authorities; the label informs the user and supports traceability.

Before placing a product on the market, the responsible person must notify it electronically through the Cosmetic Products Notification Portal (CPNP), in accordance with Regulation (EC) No 1223/2009. The notification includes, among other information, the product category, its name, the responsible person’s contact details, the country of origin for imports, the Member State of first placing on the market and certain composition information.

CPNP notification is not prior approval. It does not mean an authority has approved the product, its PIF or its claims. You should therefore finalise the safety assessment, labelling and file data before notification and sale.

What information must appear on cosmetic packaging?

A cosmetic label must include, among other information, the name or business name and address of the responsible person, nominal content, the date of minimum durability or period after opening as applicable, particular precautions for use, the batch number or a reference allowing identification, the product function where it is not obvious, and the ingredients list using INCI names.

Consumer-facing information must be available in the language or languages required by the Member State where the product is sold. Language requirements and certain practical details therefore vary by destination country. Before launching in France, Germany and Spain, check each country through Country Compliance, then ask the competent authorities or a qualified adviser to confirm the applicable requirements where your case is complex.

For distance sales, your product page should also present information consistent with the packaging. An incomplete or contradictory listing can be suspended by a marketplace. The Marketplace Product Compliance Scanner helps identify traceability and compliance information to check before publication.

What documents should you request from a non-EU cosmetic manufacturer or supplier?

Request documents before final payment and before mass production. You need usable material to build, check or maintain the PIF, not only marketing certificates.

Minimum document pack to request

the exact qualitative and quantitative formula, including INCI names, concentrations and version references;
technical data sheets, specifications and relevant safety data sheets for raw materials;
stability, packaging-compatibility and microbiological-quality data appropriate to the product;
information on impurities, traces and packaging materials;
the manufacturing-process description, quality controls and evidence concerning good manufacturing practice;
the complete CPSR, or the data needed to prepare and update it;
evidence supporting the intended claims;
label artwork, INCI list and instructions for use;
information needed for CPNP notification and batch traceability.

The method for checking a supplier before importing helps structure this collection. It is particularly useful if you buy from a factory in Shenzhen, a trading company or a laboratory offering white-label products.

Check consistency instead of collecting PDFs

Compare the formula name on the CPSR, the INCI list, specifications and label. Check that the responsible person’s details identify the entity that genuinely holds the PIF. Also make sure that claims on an Amazon or Shopify listing match the evidence available.

Example: if packaging says “fragrance-free” but the INCI list contains fragrance components, do not publish the listing as it stands. It may be a translation error, a changed formula or a questionable marketing classification. Ask the manufacturer and safety assessor to clarify the point.

How do you import cosmetic stock into the EU without separating customs from compliance?

Cosmetics compliance does not replace import formalities. If you ship pallets from Shenzhen to an Amazon FBA warehouse in Germany, you need to prepare the PIF, responsible person, CPNP notification, labelling, customs declaration and VAT treatment together.

An operator completing customs formalities in the EU will generally need an EORI number. The European Commission explains the function of this number in customs operations on its Economic Operators Registration and Identification (EORI) page, within the framework of Regulation (EU) No 952/2013 establishing the Union Customs Code.

Import VAT and VAT on later sales depend, among other things, on the import country, storage location, customer and sales model. Council Directive 2006/112/EC on the common system of VAT provides the EU framework, but filing arrangements must be considered in the relevant country. The EU VAT calculator compares common domestic, intra-EU and import VAT scenarios, but does not by itself determine your registration or filing obligations.

Practical sequence before shipment

Confirm that the product is a cosmetic and appoint an EU-established responsible person.
Build or verify the PIF and CPSR for the formula and variants actually being produced.
Approve the label, languages, claims and CPNP notification data.
Identify the appropriate tariff code; the HS classification assistant generates candidate subheadings to confirm in the Combined Nomenclature or TARIC.
Prepare the commercial invoice, packing list and customs-clearance documents. Review the EU import customs documents checklist to avoid common omissions.
Where needed, prepare your EORI application file; this service prepares the file, while the number itself is issued by the competent customs authority.

Do not assume that a DDP Incoterm resolves your obligations. It may allocate delivery responsibilities and certain costs contractually, but it does not automatically transfer cosmetics responsibility, the quality of the PIF or your tax obligations.

What checklist should you complete before placing a cosmetic product on the market?

Use this checklist immediately before the first sale, shipment to a warehouse or activation of a product listing. It does not replace review of the file by the responsible person and safety assessor.

A common error is working through this list after stock has arrived at the warehouse. At that point, correcting a label, reworking a CPSR or amending a notification can hold goods and delay sales. Plan these checks before final production, particularly for a first import or a white-label formula.

Tools and services to take action

EU Market Entry Compliance Assessment — use it before your first launch to organise checks for products, imports, VAT and sales countries.
Supplier Check — centralise a manufacturer’s or trader’s identity, payment and delivery information before ordering.
EU VAT calculator — compare import, storage and sales VAT scenarios in the EU before choosing your trade flow.
EORI file preparation — use this service if you need to prepare an EORI application; the customs authority issues the number.

Frequently asked questions

Does a cosmetic PIF need to be sent to an authority before sale?

No. The product information file is not automatically submitted as part of an approval application. The responsible person must retain it and make it available to competent authorities at the address shown on the label. The product must, however, be notified in CPNP before it is placed on the market.

How long must a cosmetic product information file be retained?

The responsible person must retain the PIF for ten years from the date on which the last batch of the cosmetic product was placed on the market. This requires organised archiving of formula versions, safety assessments, claims evidence and traceability records.

Is a GMP certificate enough to sell a cosmetic product in the EU?

No. A document concerning good manufacturing practice can support the manufacturing-method evidence, but it does not replace the PIF, CPSR, CPNP notification or compliant labelling. Check that each document covers the actual product and formula being marketed.

Can a distributor use the manufacturer’s PIF?

Yes, a PIF may be prepared using the manufacturer’s data, but the responsible person must be able to make it available and ensure it remains consistent. If you are the importer or sell under your own brand, secure contractual access to the complete file and to formula updates.

Does CPNP notification prove that a product has been approved?

No. CPNP notification is an information formality for authorities and relevant poison centres. It is not validation of the safety report, claims, labelling or the product’s overall compliance.

Do cosmetics need CE marking?

As a general rule, cosmetics do not fall under a CE-marking regime merely because they are cosmetics. A product combining functions, such as an electrical device supplied with a cosmetic preparation, may be subject to other rules for the device. Assess each component and its intended use separately.

Official sources

Regulation (EC) No 1223/2009 on cosmetic products — rules on the responsible person, PIF, safety report, CPNP notification and labelling.
Regulation (EU) 2023/988 on general product safety — the general product-safety framework and its relationship with sector-specific rules.
Regulation (EU) No 952/2013 establishing the Union Customs Code — framework for customs formalities applicable to EU imports.
European Commission — Economic Operators Registration and Identification (EORI) — the role of an EORI number in customs operations.
Council Directive 2006/112/EC on the common system of value added tax — the EU VAT framework relevant to imports and sales.

This content provides general information and does not constitute legal advice.