How To Sell Cosmetics In The European Union [5 Step Guide]
Are you ready to sell your cosmetics in the European Union (EU)?
Whether you are selling in-store or shipping to the EU online, there are strict legal requirements for any skincare, makeup, or other cosmetic sold on the EU market.
Looking for guidance on how to comply with these cosmetic rules?
Our in-depth guide below breaks down the 5 key steps for EU-compliant cosmetics. Plus, we provide tips on selecting manufacturers that can (re)formulate your products and test them to meet EU standards.
Finding A Manufacturer For The EU Market
To sell your products on the EU market, you must follow the EU’s Regulation (EC) No 1223/2009 on cosmetic products, which is available to read in full on the EU’s official website here.
Ideally, choose a manufacturer that can formulate and test to EU standards from day one. Otherwise, you may need to reformulate your finished products to comply with the EU’s strict ingredient restrictions, manufacturing practices, documentation requirements, and testing standards.
During the manufacturer selection process, ask each potential supplier about their ability to meet EU standards and any prior experience working with businesses who sell in the EU:
Do they follow the ISO good manufacturing practices (GMPs) outlined in ISO:22716 which are required for all cosmetics on the EU market?
Can they provide all of the material documents and test results necessary for the product information file (PIF)?
At Genie Supply, we can formulate clean skincare and cosmetics from scratch (or reformulate your existing products) to meet EU standards. Learn more about our formulating services here.
Although cosmetic regulations are stricter in the EU, the new MoCRA legislation brings the requirements for the US market closer to the EU. Learn more about MoCRA and how your business can comply with the new US rules here.
5 Essential Steps To Sell Your Cosmetic Product In The EU
Once you select a manufacturer, there are 5 key steps to place your cosmetic product on the EU market.
We cover the most important elements of each step in this brief blog post. For further information, we highly recommend reading Regulation {EC) No. 1223/2009 carefully and reviewing CEWAY’s full YouTube series on this EU regulation.
1. Classify Your Product And Ensure All Ingredients Are Permitted
Is The Product A Cosmetic?
The first step is to confirm that your product meets the EU’s definition of a ‘cosmetic’.
Under Regulation (EC) No 1223/2009, a cosmetic 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.”
Based on this definition, products like false eyelashes are not considered cosmetics. As noted by Ithos Global, anti-acne products are considered medical products in the EU and also do not fall under the definition of a ‘cosmetic’.
If you find it difficult to classify your product, it may be a ‘borderline product’ and assessed on a case-by-case basis. Learn more about borderline products on the EU’s website here.
Are Any Of The Ingredients Banned Or Restricted In The EU?
The next step is to confirm that all of the ingredients in your product are permitted for cosmetics in the EU. The list of over 1,000 prohibited ingredients is available in Annex 2 of the Cosmetics Regulation 1223/2009 here.
As outlined by EcoMundo for Covalo, you must also cross reference your ingredients against the following lists:
‘Restricted’ ingredients (Annex III of Regulation 1223/2009)
‘Authorized’ ingredients (colorants in Annex IV, preservatives in Annex V, and UV filters in Annex VI of Regulation 1223/2009)
CMR substances [Carcinogenic, Mutagen, Reprotoxic] (Annex VI of the CLP Regulation (EC No 1272/2008). These are prohibited if they are of categories 1A, 1B, or 2, however, as explained by COSLAW, there are exceptions to this rule)
How To Make Your Cosmetic EU Compliant
What if one or more of your ingredients is on the prohibited list, or the percentage used falls into the restricted category? In this case, you must change the formula before placing the product on the EU market.
At Genie Supply, we can help make your cosmetics compliant with EU law. We specialize in formulating clean, vegan, and cruelty-free skincare and color cosmetics, including turning “dirty” cosmetics clean. Learn more about our custom formulating process here.
2. Compile The Product Information File
Every cosmetic product must have a product information file (PIF) under EU law. The PIF is the responsibility of the ‘responsible person’ (RP) (see step 3 below), and it must be readily accessible at the address on the cosmetics label and retained for 10 years after the last batch is placed on the market.
As outlined by HPRA, the PIF must contain:
A description of the cosmetic product
Physico‐chemical & microbiological specifications of raw materials and the finished product
Method of manufacture (outlining how the cosmetics comply with GMP under ISO:22716)
Proof of any effects (support for any claims made on the product labels, packaging, and promotional material)
Data on animal testing by the manufacturer, agents, or suppliers
The Cosmetic Product Safety Report (in accordance with Annex 1 of the Cosmetics Regulation (EC) No. 1223/2009)
The Cosmetic Product Safety Report
The Cosmetic Safety Report is split into two parts:
A: Cosmetic Product Safety Information:
This includes data about the product's composition, the results of mandatory stability and compatibility tests, and (if applicable) PET testing.
B: Cosmetic Product Safety Assessment:
Based on the information gathered in A, a theoretical risk assessment is performed by a professional safety assessor who must decide (and justify) if the product is safe and compliant with the regulation or not.
Testing Required For The Product Information File
To complete the PIF, test results are required to prove:
The microbiological specifications of your cosmetic product
The stability of your product
The compatibility of your product with its packaging
The effectiveness of your preservatives (if required)
EU Compliant Product Formulating And Testing At Genie Supply
To sell cosmetics in the EU, you must manufacture your products according to the international good manufacturing practices (GMP) outlined by the International Organization for Standardization in ISO:22716. Proof of compliance with these GMPs must be included in the PIF.
At Genie Supply, we can formulate products to the ISO:22716 standards and we also offer the following tests for full EU compliance:
Microbiology Testing (For Microbiological Specifications)
Microbial (USP 61): $25 per ingredient
Tests for the presence of contamination or a high level of bacteria, yeast, mold, or fungi
Candida Albicans: $35 per ingredient
Yeast test based on ISO 18416:2015
Heavy Metal Testing For Products With Pigments: $300 per pigment
Tests for the presence of substances like lead, mercury, or cadmium
Products With Phenoxyethanol: $750 for 1,4 dioxane and ethylene oxide tests combined
Phenoxyethanol is partially made from the reaction of a suspected carcinogen ‘ethylene oxide’ and can unintentionally create the suspected carcinogen ‘1,4-dioxane’ as a byproduct.
As noted in a 2016 EU report, phenoxyethanol is only allowed up to a 1% concentration in cosmetics in the EU.
Learn more about phenoxyethanol in our full guide to the ingredient here.
Stability And Compatibility Testing
Cost For Both Tests Combined: $2,000
Stability and compatibility testing are used to determine the shelf life and the stability of the product over time.
Compatibility testing includes testing the compatibility of the product with its packaging.
Preservative Efficacy Testing (PET)/Challenge Testing
Cost for PET (ISO 19930:2019): $750 (500g)
This test checks the effectiveness of preservatives in the product and how well it can withstand contamination.
As outlined in ISO 29621:2019, not all products legally require PET. Exemptions include products that:
Don’t contain water
Have a PH below 3 or above 10
Contains more than 20% alcohol
Are filled in containers at more than 65 degrees Celsius
Are packaged in pressurized containers, pump dispensers, or single-dose units
Learn more about our testing capabilities at Genie Supply here.
3. Appoint A Responsible Person
Each cosmetics product placed on the EU market must have an assigned ‘responsible person’ (RP) who ensures the product is safe and compliant with the relevant obligations set out under Regulation No. 1223/2009.
These responsibilities include:
Ensuring the product is manufactured according to good manufacturing practices (GMPs)
To review, retain, and update (as needed) the product information file (PIF)
Overseeing the safety assessment and CPNP notification (see step 5)
Ensuring the product label is compliant
Ensuring product claims are substantiated
Informing the authorities of any noncompliance with the law or any potential risk to human health
Informing the relevant authorities about any reported serious undesirable effect
The responsible person must be based in the EU and can either be a person or a company:
The manufacturer
The importer or distributor
A third-party designated person/company who accepts this role in writing
4. Comply With Labeling Requirements
Under Regulation No. 1223/2009, cosmetic labels must be provided in the appropriate language(s) in the country of sale and must include:
Product function
A list of ingredients, including the INCI denomination. Ingredients with 1% concentration or more must be written in the correct order
Precautions for use
Expiry date
Nominal quantity (in weight or by volume)
Batch number
The responsible person’s name and address
Product country of origin
Any claims on the labels must be proven. See Regulation 655/2013 for more information regarding the justification of cosmetic product claims.
5. Complete The Cosmetic Product Notification Process
The EU requires a record of every cosmetic product on the market. The responsible person must create a profile on the cosmetic product notification portal (CPNP) and upload specific information (largely based on the product information file) about your cosmetic product.
Once the product notification is complete, you will receive a CPNP notification number as proof that the product has been notified.
Most products can be placed on the EU market immediately after completing the profile on the CPNP website. However, if your product contains nanomaterials, you must notify the CPNP six months before the product is placed on the market.
Learn more about the product notification process on the EU’s website here.
In sum, there are 5 essential steps for EU-compliant cosmetics:
Classify your product and ensure the ingredients are permitted for cosmetics in the EU
Compile the product information file (PIF), including proof of GMP compliance and testing
Appoint the responsible person (RP)
Comply with labeling requirements
Complete the cosmetic product notification process (CPNP) online
Are you ready to formulate or reformulate your cosmetics for the EU market? Genie Supply would love to work with your cosmetics business! To learn more, get in touch through email: customerservice@geniesupply.com or call: (812) 329-1105.
