Planning to import cosmetic products to the European Union? In this guide, we explain what importers and exporters must know about the Regulation (EC) No. 1223/2009, REACH, cosmetics labeling, national cosmetics regulations, lab testing, and much more.
Mentioned Products
- Makeup products
- Haircare products
- Skincare products
- Facial masks
- Body moisturizer
- Deodorants
- Perfumes
Content Overview
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Regulation (EC) No. 1223/2009 on Cosmetics Products
Regulation (EC) No. 1223/2009 establishes requirements for cosmetics products that are placed within the European Union market. This includes cosmetics both manufactured in the EU and imported from overseas.
This regulation requires that manufacturers or importers of certain kinds of cosmetic products abide by the required manufacturing practice, content requirement, and the labeling requirements, and ensure the safety and quality of the cosmetic products, which should not pose harm to human health. Ultimately, the aim of the regulation is to ensure that cosmetics containing certain substances cannot be legally sold in the EU.
In the event of non-compliance, when the cosmetic products are tested or proven to present serious harm to humans, the risk is that the product might be denied entry to the EU, or that that is subjected to a forced recall from the market – or heavy fines.
Product Scope
According to the definition of the European Union Regulation, cosmetics are products or substances that are intended to be applied to the external parts of the human body, including skin, hair, nails, lips, or teeth and oral cavity, for the purpose of cleansing or changing the form or appearance in order to beautify or maintain the good condition of these parts.
The EU classified a broad-range variety of products as cosmetic products, including:
- Body creams or lotions
- Facial masks
- Haircare products
- Deodorants
- Perfumes
- Suncare products
- Shaving products
- Makeup products
Responsible Person
The Regulation also established the accountability system for the cosmetics placed in the EU market and requires such products to have a responsible person to contact, usually either a manufacturer or importer.
A responsible person should take up the duty of performing the product safety assessment, preparing product information files (PIF), submitting product notifications, and reporting serious undesirable effects.
Note that if you or your company are not based in the EU, then you shall appoint an EU based entity or individual as the responsible person.
Cosmetic Product Safety Report – Information & Assessment
Importers and manufacturers should prepare a report that contains information about the cosmetic product. The report is divided into two parts – A and B.
Part A: Cosmetic Product Safety Information
Part A of the Cosmetic Product Safety Report shall include:
- Composition of the cosmetic product
- Physical and chemical characteristics of the product
- Usage instructions
- Packaging material information
- Side effects
Importers should also include information concerning the microbiological quality, chemical identity of the substances, and other technical information regarding the product materials and packaging materials.
For more detailed information, please refer to Annex I, Part A of Regulation (EC) No. 1223/2009.
Part B: Cosmetic Product Safety Assessment
Part B of the Cosmetic Product Safety Report shall include:
- Assessment conclusion
- Labeled warnings and information on how to use the product
- Explanation on how the conclusion was reached (based on Part A)
- Assessor’s credentials and approval
For more detailed information, please refer to Annex I, Part B of Regulation (EC) No. 1223/2009.
Product Information File
The responsible person should retain a copy of the product information file, which should be in the form of electronic or other accessible formats when launching the product to the market, and should include the following information (and may require a regular update) :
- The cosmetic product description
- The Cosmetic Product Safety Report
- A statement of compliance with the Good Manufacturing Practice
- When necessary, proof of the effect claimed for the cosmetic product
- Data on any performed animal testing
Notification via the EU Cosmetic Products Notification Portal
The regulation requires that the responsible person of the cosmetic products submits relevant product information through the online system Cosmetic Products Notification Portal (CPNP).
The submitted information will be available to authorities, poison centers, distributors, and other relevant organizations.
Harmonized Standards
Cosmetic manufacturers and importers should abide by relevant harmonized standards to produce, test, and distribute cosmetic products. A list of harmonized standards can be found in the Directive 98/34/EC.
Requirements on Ingredients
Regulation (EC) No. 1223/2009 sets aside several sections specifically explaining the permissible and banned substances that could be used in cosmetic products. Users can refer to Annex II, and Annex III for the lists of banned and restricted substances; to Annex IV, Annex V, and Annex VI for allowed substances and preservatives.
For example, epinephrine, estrogens, and oleandrin are on the prohibition list.
Importers and manufacturers can see the complete lists via Cosmetic Ingredient Database (EU CosIng).
Nano Materials
The regulation also requires the responsible person to notify the European Commission if the cosmetic products contain nanomaterials, six months prior to being placed on the market.
The responsible person should prepare the following information to submit to the Commission:
- Identification and specification of the nanomaterials
- Toxicological profiles
- Exposure conditions of the materials
Moreover, cosmetics containing nanomaterials should be distinctively indicated in the product label packaging.
Labeling
The regulation established labeling requirements for cosmetic products.
The label shall include basic information of the supplier and the product; such information shall not be misleading and shall not exaggerate the efficacy and function of the products. The following information is required to be displayed in the product label:
- Name and registered address of the responsible person
- Product content and a list of ingredients
- Product functionality
- Expire date
- Directions for use
- Batch number of manufacture
The language of the labeling and packaging shall be determined by the laws in the member state where you intend to market and sell the product.
You can learn more about cosmetics products labeling in Article 19 of the regulation.
Good Manufacturing Practices (GMP)
Article 8 of the regulation specifies that cosmetic manufacturers should observe good manufacturing practice (GMP) during the production process and ensure that the products do not pose harm to human health.
The GMP will be considered compliant if it is executed according to the relevant harmonized standards such as CEN ISO 22716: Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices.
Lab Testing
As previously mentioned, non-compliant products sold in the EU market might be subject to forced recall or withdrawal. To verify the compliance of the products, importers should contact a third party lab testing company, such as SGS, QIMA, and TUV, to conduct a battery of product lab tests.
Ban on animal testing
The regulation bans using animals to test finished cosmetics products and prohibits the marketing of finished cosmetic products that were tested on animals.
Animal testing on single ingredients might also be banned. You can find out the details in the regulation.
National Cosmetics Regulations
United Kingdom: Cosmetic Products Enforcement Regulations
The Cosmetic Products Enforcement Regulations were drafted based on the Regulation (EC) No. EC 1223/2009, and applies to all cosmetic products made available on the UK market.
These two regulations are similar in the content and subjects, as the Cosmetic Products Enforcement Regulations concerns the safety of cosmetic products, the responsibility of manufacturers and distributors, documentation and notification procedures, restricted and allowed substances, animal testing, labeling requirements.
German Cosmetics Directive
Germany also has a national cosmetics regulation, the Kosmetikverordnung (KVO), that outlines requirements similar to the one outlined in the Regulation (EC) No. EC 1223/2009.
REACH
REACH regulates the maximum amount of toxic substances contained in consumer products placed in the EU market, including cosmetics. Toxic substances that are commonly found in cosmetic products include inorganic heavy metals, organic solvents, stabilizers, antibiotics, and hormones.
Cosmetics that contain these substances can cause irritation, allergy, and infections to the human body. The following are examples of restricted substances by REACH on cosmetic products:
- Lead
- Cadmium
- Mercury
- Arsenic
Substances of Very High Concern (SVHC)
The European Union proposed a list of Substances of Very High Concern (SVHC) in order to inform the public, manufacturers, and importers about the dangerous chemical substances that might be contained in consumer products.
The list is updated on a regular basis in order to encompass as many toxic chemical substances to humans as possible in consumer products.
Lab testing
In order to ensure that their product complies with REACH, importers need to conduct lab testing on their products. Companies offering REACH testing services include SGS, QIMA, and TUV.
You can find more companies in this guide.
Costs
The basic cost to complete a REACH test is around $200. The price can vary depends on the individual lab and product characteristics.
Learn more
You can learn more about REACH testing in this guide.
Directive 94/62/EC: Packaging Regulations
The following is a brief description of packaging materials regulations for goods placed in the European Union must meet.
Heavy Metals Restrictions
Importers are responsible for keeping the level of lead, mercury, cadmium, or other regulated substances within the limit set by Directive 94/62/EC in product packaging and arranging for compliance testing of the packaging of all products they plan to sell.
Labs that offer packaging material testing services include Intertek, SGS, TUV, QIMA
Additional Packaging Information
1. Materials and structure of the packaging should be easy to recollect, reuse, and recycle.
2. Required labels such as compliance marks should be printed directly on the package surface.
Compliance Risks
Makeup and other cosmetic products manufactured outside the European Union may contain banned chemicals and other substances. Importers should not assume that cosmetics manufacturers outside the EU have the capability or expertise necessary to ensure compliance with Regulation (EC) No. 1223/2009.
Further, it’s ultimately up to the importer to arrange lab testing, registration, and create label files.
Hi,
Thank you for all beneficial information.
Are homemade soaps considered cosmetics?
Kind regards.
Can a US company open an office in the EU and act as their own RP and perform the notifications?
For EU compliance, cosmetics products like shampoo, conditioner which parameters needs to tested? any specific standard to be followed for testing?
Yes, I am quite sure that testing is mandatory. The specific parameters should be determined by a qualified lab, which likely depends on the ingredients and usage.
Hi Fredrik,
Does German Cosmetics Directive is till in force and do you know where I can find a ENG text of Directive ? Thanks!
Hi i does europe have fda approval for face and body serums? Need answer please, since i bought serums from Serbia and Customs here in Philippines is asking for FDA and the company says that they cannot provide fda?
FDA is in the United Statese
Hello,
This page was really helpful.
Would you have a list of all the European Union toxicologists who are accredited to write Cosmetic Product Safety Report as well as Information & Assessment of product reports?
Looking forward to hearing from you.
Kind regards.
Naks