This article is intended as a practical guide for sellers to address common product safety questions. Sellers are ultimately responsible for the safety and compliance of their products.
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Is my product considered a cosmetic in the EU?
EU law defines cosmetics 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 odors” (Article 2(1)(a) of Regulation (EC) 1223/2009). In other words, it means that a cosmetic product must:
- Be a chemical solution, not an object (e.g., tooth floss and laser device are not cosmetic products);
- Be applied on the skin, hair, nails, lips, external genital organs, teeth, or oral mucosa (e.g., nasal spray and product for cleaning the vagina are not cosmetic products);
- Have one of the following functions: cleaning, perfuming, changing look, protecting, or masking body odors.
Hence, to classify a product as a cosmetic, you have to consider its composition, function, and site of application. Your product will not be considered a cosmetic if you claim that it has properties beyond the above definition (e.g., claims that the product treats acne, is antibacterial, or can kill or repel head lice). In such a case, your product will be classified under a different regulatory framework (e.g., medicinal products, biocides, medical devices, etc.), and it will need to follow different compliance processes.
In the EU, cosmetics are regulated by the EU Cosmetics Regulation, and some of the main regulatory requirements are discussed below.
Which steps do I have to follow to ensure my cosmetics can be lawfully placed on the EU market?
Before placing a cosmetic product in the EU, you must:
- Appoint by written mandate an EU-based Responsible Person (RP), that will ensure your product is compliant with applicable EU law. Please, be aware that by law your importer automatically becomes the RP for your cosmetic products, unless you have an RP mandate in place. The RP mandate is the legal agreement under which your designated RP becomes effectively responsible for the products listed there. Alternatively, EU-based manufacturers can be their own RPs. However, it is strongly recommended to appoint a professional RP (i.e., someone who provides RP services as their core business).
- Verify whether your product is considered a cosmetic in the EU, using the standards outlined above.
- Obtain the product’s Safety Assessment Report (SAR) by a qualified Safety Assessor. The SAR is the toxicological evaluation of the safety of a single cosmetic product, and its content is described in Annex I to the EU Cosmetics Regulation.
- Build the cosmetic’s Product Information File (PIF). The PIF is the technical file of each cosmetic, and it must include the documents listed in Article 11 of the EU Cosmetics Regulation. These documents include the product description, safety information (including tests results), method of manufacture, and the Safety Assessment Report
- Notify the cosmetic to the Cosmetic Products Notification Portal (CPNP)
Only products that have completed the above compliance process can be lawfully placed on the EU market. In the EU, Authorities do not approve cosmetics prior to their commercialization, but they do monitor the market. In case of non-conformities, Competent Authorities (CA) could fine you and/or require you to withdraw your cosmetics. Member States CA may also add the information about non-compliant products to Safety Gate, the EU rapid alert system for dangerous non-food items, accessible to everyone on the web.
What labeling information do I need to have on the cosmetic products I sell?
The labeling requirements for cosmetics can be found in Article 19 of the EU Cosmetics Regulation. The information that must appear on the inner and outer packaging is:
- Product function
- Responsible Person name and address
- Ingredients list: Include ingredients in descending order of weight and by International Nomenclature Cosmetic Ingredient (INCI) nomenclature. May be placed only on the outer packaging when the container is too small
- Nominal content in gr or ml: Exempted if the product is less than 5 gr or ml
- Expiration date and/or product after opening (PAO)
- Country of origin: Where the cosmetic was last made
- Precautions for use: May be included in a separate leaflet provided that the symbol ‘refer to insert’ (open book symbol) is affixed to the product
- Batch number
You have to translate the product function and any precautions for use into the national languages of the EU Member States where you will sell your cosmetics. For this purpose, you might use a concertina/fold-out label.
In the EU and UK, cosmetic products do not bear the CE and UKCA marks. Thus, it is prohibited to add CE and UKCA marks on cosmetic products.
Do I need to include warnings on the labels?
Yes. Your label should include any precautions to be observed when using the product. The law requires some warnings explicitly, and you can find these requirements in Annexes III to VI to the EU Cosmetics Regulation. For example, cosmetics with Salicylic acid must bear the warning ‘not to be used for children under 3 years of age’. It is the responsibility of the Safety Assessor (SA) to determine the safe use of a cosmetic product and if needed any accompanying information for the customer. A qualified Safety Assessor is a person with a degree in pharmacy, medicine, toxicology, or a related discipline obtained in the EU or recognized by an EU Member State. The main role of the SA is to issue the Safety Assessment Report for each cosmetic product. For more information on the Safety Assessment Report, see the question ‘Which steps do I have to follow to ensure my cosmetics can be lawfully placed on the EU market?’ below.
Lastly, when a product is meant to be used by professionals only, this must be clearly stated on the label.
Are there any rules for claims in the EU?
Yes. In the EU, cosmetics claims are regulated by Commission Regulation (EU) 655/2013, laying down common criteria that cosmetics must comply with, and by the technical document on cosmetic claims. The regulations relate to truthfulness, evidential support, honesty, fairness, and informed decision-making. Specifically, all claims must be supported by adequate and verifiable evidence, and they cannot be misleading.
It is important to note that in the EU, the claim “not tested on animals” is not allowed because cosmetic products cannot bear claims that are legal requirements. The EU has banned animal testing on finished cosmetic products and raw ingredients intended to be used exclusively in cosmetics. For the same reason, the variations of this claim, such as “cruelty-free” and “animal friendly,” are not allowed as well.
If you make claims that go beyond the scope of the EU Cosmetics Regulation, your product may no longer be considered a cosmetic. Please see the question ‘Is my product considered a cosmetic?’.
Are there any products or ingredients that I may not use in my cosmetics?
You must ensure that your cosmetics only contain allowed ingredients within limits set in EU law.
Annex II to the EU Cosmetics Regulation lists all the substances prohibited for use in cosmetics. There are more than 1600 banned ingredients, and the list is constantly being updated! For instance, 23 cosmetic ingredients were added to Annex II through the Commission Regulation (EU) 2021/1902, and, as of March 1, 2022, they cannot be used anymore. Among them, there is Lilial (Butylphenyl methylpropional), a very common fragrance ingredient.
Annex III to the EU Cosmetics Regulation lists additional restrictions for ingredients that may be used in cosmetics. The exclusive list of colorants, preservatives, and UV filters that are allowed in cosmetics are listed respectively in Annexes IV, V, and VI. Items not listed in these annexes may not be used in the formulation of cosmetics.
Annexes to the EU Cosmetics Regulation are updated several times per year. Your Responsible Person (RP) has an obligation to inform you about all the news.
Are there any categories of chemicals banned in the EU?
Yes. According to Article 15 of the EU Cosmetics Regulation, substances which are carcinogenic, mutagenic, or toxic for reproduction (CMR) are generally prohibited. They can only be used if they meet certain requirements—the most important is that they have been assessed by the Scientific Committee on Consumer Safety (SCCS) and found safe for use in cosmetics. Thus, CMR substances can be either banned or restricted in cosmetics.
The list of CMR substances (Part 3 of Annex VI to CLP Regulation) is regularly updated.
The EU Cosmetics Regulation is undergoing revision, and is expected to be updated in 2023-2024.
Do I need to perform any tests on my cosmetics?
Yes. Before being placed on the EU market, cosmetics must undergo at least stability, compatibility, and challenge tests.
The stability test aims at verifying if the cosmetic keeps its physiochemical properties and functionality when stored appropriately, as well as determining the cosmetic expiration date and/or period after opening.
The compatibility test is performed to ensure that the possible migration of chemicals from the packaging does not affect the cosmetic product safety and quality.
Lastly, the challenge test verifies the efficacy of the preservative system and provides information for the assessment of microbiological safety of the product. This should be performed in line with one of well-recognized standards, such as ISO Standard 11930:2019, Ph. Eur.7, or USP 35.
Are there any additional requirements for essential oils?
Essential oils are considered cosmetic products when they fall within the definition for cosmetics, provided that they are not medicinal products (see the question ‘Is my product considered a cosmetic in the EU?’). For example, essential oils intended to be inhaled or ingested, or used exclusively in aromatherapy are not cosmetics.
Essential oils, even when used as cosmetic ingredients, must meet the requirements for allergens and be accompanied by a relevant IFRA Certificate. The IFRA Standards are a globally accepted and recognized set of rules for the safe use of fragrances. Therefore, all fragrances must comply with the latest amendment to the IFRA Standards.
Are there other tips for making sure the cosmetics I sell are safe?
It is your responsibility to make sure that your cosmetics are safe and compliant with the EU Cosmetics Regulation. This means, among others, avoiding banned ingredients, using restricted substances within limits, and providing all required labels and warnings. It also means applying Good Manufacturing Practices (a mandatory requirement in the EU) and following the compliance process (see the question ‘Which steps do I have to follow to ensure my cosmetics can be lawfully placed on the EU market?’).
If you become aware of potential safety or compliance issues relating to your cosmetics, you must immediately notify your RP and the Competent Authority of the EU Countries in which the products are sold and take the appropriate corrective measures, potentially including the recall of the cosmetics.
How are cosmetic products regulated in the UK?
As of January 1, 2021, the United Kingdom (UK) is no longer an EU member state. Thus, cosmetic products in the UK are regulated by Regulation (EC) No 1223/2009 on Cosmetic Products, as amended by the Product Safety and Metrology etc. Schedule 34 (Amendment etc.)(EU Exit) Regulations 2019. To place cosmetic products in Great Britain (England, Wales, and Scotland), beauty brands must follow the UK Cosmetics Regulation and appoint a UK-based RP that takes care of the regulatory compliance. Moreover, the RP must notify the cosmetic products on the SCPN web portal.
Although the ground rules are the same (cosmetic product definition, PIF and labels requirements, step to compliance, etc.), the UK and EU Cosmetics Regulations differ, mainly regarding banned and restricted ingredients, and allowed claims. For example, in the UK, the claim “not tested on animals” is permitted. It is expected that differences will widen in the future.
On the other hand, according to the EU-UK Withdrawal Agreement, in Northern Ireland, the EU Cosmetics Regulation fully applies. Hence, to sell cosmetic products in Northern Ireland, brands must comply with all the EU requirements, including the appointment of an EU-based RP and notification to the Cosmetic Products Notification Portal.
Words by Etsy Staff
