European cosmetic regulation

The legal framework

Selling a cosmetic in Europe is regulated

In Europe, every cosmetic product placed on the market must comply with Regulation CE 1223/2009Regulation (CE) No 1223/2009 is the reference text governing the manufacture, import and sale of cosmetic products in the European Union.. This regulation applies directly in all EU Member States, without the need for national transposition.

In practice, this means that before selling your cream, serum, soap or make-up, you must demonstrate that your product is safe for the consumer and that your documentation is complete.

Applies to any cosmetic product sold or distributed in the EU
Mandatory whether you are a manufacturer, importer or brand
Penalties for non-compliance: market withdrawal, fines, RAPEX notification

Obligation No.1

The Responsible PersonA legal entity established in the EU that assumes legal responsibility for placing a cosmetic product on the market. It guarantees the compliance of each product.

Every cosmetic product marketed in Europe must have a Responsible Person (RP) established in the European Union. This entity is legally accountable for the product's compliance to the authorities.

If your company is based outside the EU, or if you prefer to delegate this responsibility, you can designate a third party as Responsible Person by written mandate.

Guarantees that the product complies with Regulation CE 1223/2009
Keeps the PIF (Product Information File) available to authorities for 10 years
Their name and address must appear on the label

Our services in detail

Every step of your compliance, explained

Here is the detail of what we do for you, and why it is indispensable.

Regulatory study of your formula

Before any safety evaluation, we scrutinise every ingredient in your formula. The objective: to verify that your composition complies with the Regulation's annexesRegulation CE 1223/2009 includes annexes listing prohibited substances (Annex II), restricted substances (Annex III), and authorised colorants, preservatives and UV filters (Annexes IV, V, VI)..

We verify the maximum authorised concentrations, usage restrictions (application area, mandatory rinsing, etc.) and any recent regulatory alerts on certain ingredients.

Analysis of each ingredient vs. Annexes II to VI
Verification of concentrations and restrictions
Adjustment recommendations where necessary

Cosmetic Product Safety Report (CPSR)

The safety reportMandatory document prepared by a qualified toxicologist. It assesses the risks to human health under normal conditions of use of the product. is the cornerstone of your file. It is written by a qualified toxicologist and consists of two parts:

Part A — Technical data: quantitative composition, stability, microbiological quality, impurities, toxicological profile of each ingredient, safety margin calculations.

Part B — Assessor's conclusions: final opinion on product safety, necessary warnings, scientific reasoning.

Prepared by a qualified toxicologist
Compliant with Article 10 of CE 1223/2009
Indispensable for compiling the PIF

Product Information File (PIF)

The PIFThe PIF (Product Information File) brings together all the regulatory documentation for a cosmetic product. It must be kept up to date and accessible to the authorities. is your product's complete file. It brings together all the supporting documents for its compliance and must be kept for 10 years after the last batch is placed on the market.

The absence of a single element of the PIF constitutes non-compliance and may result in your product being withdrawn from the market.

Product description and qualitative/quantitative formula
Safety report (CPSR)
Description of the manufacturing method and GMP (Good Manufacturing Practices) compliance
Claims evidence (tests, studies)
Data on animal testing

Label & claims review

Your cosmetic product's label is the first thing authorities check. It must contain precise mandatory particularsName and address of the Responsible Person, nominal content, minimum durability date or PAO, precautions for use, batch number, product function, INCI list., and your claims must comply with the common criteria defined by Regulation CE 655/2013.

We verify every element of your label and validate that your claims are legal, truthful and substantiated.

All mandatory particulars present
INCI list compliant with international nomenclature
Claims compliant with CE 655/2013

Notification on the CPNP portal

Before marketing a cosmetic product in the EU, it must be declared on the CPNP portalThe CPNP (Cosmetic Products Notification Portal) is the European Commission's electronic platform where each cosmetic product must be notified before being placed on the market.. This notification allows market surveillance authorities and poison centres to quickly access information about your product.

We manage the complete notification: entry of product data, frame formula, label upload and final validation.

Complete entry on the European portal
Frame formula for poison centres
To be completed before any product launch

Frequently asked questions

Understanding mandatory compliance

Answers to the questions every brand asks before launching their product.

Market surveillance authorities can order the immediate withdrawal of your product. In the event of a risk to health, a RAPEX notification is issued to all Member States. Fines and criminal prosecution may apply under the national legislation of the country concerned.

Yes. Regulation CE 1223/2009 requires a separate Product Information File (PIF) for each cosmetic product placed on the market. If you have 10 references, you will need 10 PIFs. Each PIF must be kept up to date and retained for 10 years after the last batch is placed on the market.

Absolutely. You simply need to designate a Responsible Person established in the European Union. This entity assumes legal responsibility for your products on the European market. It can be your importer or a specialist service provider.

It depends on the complexity of your formula and the quality of the data you provide. Contact us to discuss your project — we will give you a realistic timeline tailored to your situation.

The Regulation defines a cosmetic product as any substance or mixture intended to be placed in contact with the external parts of the human body (skin, hair, nails, lips, external genital organs) or with the teeth and oral mucous membranes, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.

The typical journey

From formula to market launch

The key steps to making your cosmetic product compliant with COSCOMPLY.

1. Initial discussion

You describe your project, your products and your target markets. We assess your needs and propose tailored support.

2. Formula study

Regulatory analysis of each ingredient. Compliance verification against the annexes of Regulation CE 1223/2009.

3. Safety report

Complete toxicological assessment by a qualified expert. Drafting of Parts A and B of the report.

4. Compiling the PIF

Assembly of the complete Product Information File (PIF) with all required regulatory documents.

5. Label review

Verification of your labels, mandatory particulars, INCI list and cosmetic claims.

6. CPNP notification & launch

Notification of your product on the European portal. Your product is ready to be marketed in full compliance.