Cosmetics Regulation
If you’re a brand owner, manufacturer, distributor, or importer, understanding how cosmetics are regulated in the EU is essential. Whether you’re launching a new skincare line or importing makeup from outside Europe, you must comply with strict legal requirements before your product can be sold.
This beginner-friendly guide explains the basics of EU cosmetics regulation, including key responsibilities, product safety requirements, labelling, and registration. If you’re new to the process, this article will help you navigate compliance step by step.
What Is a Cosmetic Product?
Under EU law, a cosmetic product is defined as:
“Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs), or with the teeth and the mucous membranes of the oral cavity, 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.”
This includes:
Skincare creams and lotions
Makeup (lipstick, foundation, mascara)
Hair care (shampoo, conditioner, dye)
Perfumes and deodorants
Oral care products like toothpaste
The Main Law: Regulation (EC) No 1223/2009
The primary law for cosmetics in the EU is Regulation (EC) No 1223/2009 on cosmetic products. It has been in force since July 2013 and applies across all EU Member States.
This regulation sets high standards to ensure that only safe and properly labelled cosmetics are placed on the EU market. It covers:
Product safety and ingredients
Good manufacturing practices (GMP)
Labelling and claims
Responsible person designation
Cosmetic Product Notification Portal (CPNP) registration
Post-market surveillance
Who Is Responsible for Compliance?
One of the most important parts of EU cosmetics regulation is the appointment of a Responsible Person (RP).
The Responsible Person is legally responsible for ensuring the product meets all regulatory requirements. There must be one Responsible Person for each cosmetic product on the EU market.
The Responsible Person can be:
The EU-based manufacturer
The EU-based importer
A third-party regulatory service provider (like Patient Guard) acting under written agreement
For companies based outside the EU, it is mandatory to appoint an EU Responsible Person before placing any cosmetic product on the EU market.
Key Compliance Requirements for EU Cosmetics
Let’s look at the main compliance steps every cosmetic brand or importer must follow.
1. Product Safety Report (CPSR)
Before a cosmetic product can be sold in the EU, a Cosmetic Product Safety Report (CPSR) must be completed. This report assesses the safety of the product and its ingredients.
The CPSR is divided into two parts:
Part A – Safety Information (includes composition, toxicological profile, microbiology, exposure levels)
Part B – Safety Assessment (performed by a qualified safety assessor)
The safety assessment must be conducted by someone with a degree in pharmacy, toxicology, or a related field.
2. Product Information File (PIF)
Each cosmetic product must have a Product Information File (PIF). This is a detailed document containing all the information about the product and must be available to EU authorities upon request.
The PIF must include:
Cosmetic Product Safety Report (CPSR)
Description of the product
Manufacturing method (to show GMP compliance)
Proof of effect (if claims are made)
Animal testing statements
Label artwork and packaging
Certificate of analysis (if applicable)
The PIF must be stored for 10 years after the last batch is placed on the market.
3. Notification via the CPNP
Before placing the product on the EU market, the Responsible Person must notify it through the Cosmetic Product Notification Portal (CPNP).
The CPNP is a central EU database used by authorities and poison centres. It contains key product information, such as:
Product name and category
Responsible Person’s details
Country of manufacture
Ingredients (with CAS and INCI names)
Product packaging images and labels
This step must be completed before the product becomes available for sale.
4. Label Requirements
Labels must comply with Article 19 of the Cosmetic Regulation. Labels must be clear, permanent, and easy to read, and must include:
Product function (if not obvious)
Nominal content (e.g., 50 ml)
Date of minimum durability or PAO (Period After Opening) symbol
Batch number
Precautions or warnings
Name and address of the Responsible Person
Country of origin (if manufactured outside the EU)
Ingredient list in INCI format (descending order of weight)
All information must be provided in the official language of the country where the product is sold.
5. Claims and Advertising
All product claims (e.g., “anti-ageing”, “moisturising”, “natural”) must be:
Truthful and supported by evidence
Not misleading to consumers
In line with EU guidelines on cosmetic claims
Misleading advertising can lead to enforcement action or product withdrawal.
6. Good Manufacturing Practices (GMP)
Cosmetic products must be manufactured in line with Good Manufacturing Practice (GMP). The EU accepts ISO 22716 as the harmonised standard for cosmetic GMP.
Documentation and traceability of ingredients, equipment, processes, and batches are crucial under GMP.
Importing Cosmetics into the EU
If you’re importing cosmetics from outside the EU (e.g. the USA, China, or the UK), you must:
Appoint an EU-based Responsible Person
Ensure the product meets all safety, labeling, and PIF requirements
Notify the product via CPNP
Make sure animal testing bans are respected
Non-EU companies cannot act as their own Responsible Person. They must work with a third-party regulatory expert based in the EU.
Enforcement and Market Surveillance
Each EU country has its own competent authority (e.g., health or consumer safety agency) that enforces cosmetics regulation.
Authorities can:
Request access to the PIF
Test products for banned ingredients
Check label accuracy and claims
Investigate complaints or adverse events
Failure to comply can lead to:
Product recalls
Market bans
Fines or legal penalties
How Patient Guard Can Help
At Patient Guard, we offer full-service support for cosmetics companies seeking EU compliance. Whether you’re a start-up or an international brand, we can help you:
Appoint an EU Responsible Person
Prepare CPSRs and PIFs
Ensure GMP and ISO 22716 documentation
Submit your products via the CPNP
Review labelling, claims, and packaging
Our experienced consultants make sure your cosmetics are legally ready for the EU market.
Frequently Asked Questions (FAQs)
Yes. Every cosmetic product must have a designated Responsible Person based in the EU. This individual or organisation is legally responsible for ensuring the product complies with Regulation (EC) 1223/2009.
Yes, but only if you appoint an EU-based Responsible Person. This person will handle regulatory compliance, documentation, and product notifications on your behalf. from a Notified Body is also required.
No. The EU bans animal testing for cosmetics and cosmetic ingredients. Products tested on animals cannot be sold in the EU market.
You must keep the PIF available for 10 years after the last batch of the product is placed on the EU market. It must be accessible to regulatory authorities at any time.
Summary
Navigating the world of the EU cosmetics regulations may seem overwhelming at first. But once you understand the basics—product safety, documentation, labeling, and Responsible Person requirements—compliance becomes manageable.
Taking the right steps early on will protect your business, your customers, and your brand reputation.
If you need expert help with your cosmetic product compliance, Patient Guard is here to support you every step of the way.
