In this fact sheet you can read about the requirements for labelling cosmetics, following the EU Cosmetic Regulation (no 1223/2009).
What do the rules say?
Article 20 of the Cosmetics Regulation (No. 1223/2009) states that cosmetic products must not be marketed with statements attributing properties or functions to the products that they do not have.
To this end, a list of common criteria for claims that can be used for cosmetic products has been adopted in the Claims Regulation of 11 July 2013 (No. 655/2013).
As guidance to the Claims Regulation, the Commission's Guidance on Common Criteria from July 2017 (the technical document) can be used as a starting point, which sets out some clarifications and examples of how to assess the common criteria.
The guide is only available in an English version.
What is the purpose of the rules?
The rules aim at ensuring that consumers obtain important information about cosmetics. This may e.g. be what the cosmetics are used for, what they contain, and the date of durability (sell-by date). Information about any safety instructions and enterprise name and address must also be provided.
Interpretation of various claims in relation to the misleading marketing regulations
Labels, sales packaging and advertising for cosmetic products must not have texts, designations, brands, images or other figures and symbols that attribute properties to the products that they cannot actually be documented to have. Marketing must be understood broadly and also includes product names, packaging and advertising material.
There can be no fixed rules for when marketing is misleading. It always depends on a concrete and overall assessment of the individual product and the marketing of it.
When the Danish Environmental Protection Agency assesses whether there is misleading marketing, the starting point is the current legislation and the above-mentioned guidance to it, as well as the perception and expectations consumers of the product have of the product as a result of the claim. However, it always depends on a concrete assessment of the individual product.
Below are listed a number of examples of specific claims where, as a retailer of a cosmetic product, you need to be extra attentive to whether you are complying with the legislation. The Commission's Guidance on Common Criteria, July 2017, describes, among other things, claims about "free from" and "hypoallergenic", and the new elements therein apply from 1 July 2019.
"Free from" claims
The following text is an excerpt from the EU Guidance. If you wish to market a cosmetic product with a "free from" claim, you can read more in the guidance, which also provides specific examples of misleading "free from" claims.
- It is considered misleading to use "free from" claims if the ingredient is already not legal to use in cosmetics. (statutory requirements)
- It is considered misleading to use "free from" claims if the cosmetic product nevertheless contains or releases the chemical substance referred to in the claim. (accuracy)
- It is considered misleading to use "free from" claims about ingredients that typically are not found in the type of cosmetic products the claim refers to. (honesty)
- It is considered misleading to use "free from" claims for a given functional group (e.g., preservatives) if the cosmetic product contains an ingredient with a similar property, regardless of whether this ingredient is added for a different purpose. (honesty)
- Claims that degrade an ingredient or a group of ingredients that are assessed to be safe to use in the specific situation should not be used, even though the group of ingredients/ingredient is generally perceived negatively in the population (e.g., parabens). (fairness)
- "Free from" claims can, however, be used when it is assessed that the claim contributes to giving the consumer an informed choice - if the claim otherwise complies with the other common criteria in the field. Examples can be: "free from" alcohol or "free from" ingredients derived from animals. (decision on a well-informed basis)
Does not contain endocrine disruptors
Since it cannot be guaranteed that all endocrine disruptors are known, it cannot be guaranteed that a cosmetic product is free of substances with endocrine disrupting potential. Therefore, the claim is misleading.
Claims about the absence of carcinogenic, mutagenic or reprotoxic substances (CMR substances)
Just like for allergenic and endocrine disrupting substances, it cannot be guaranteed that all carcinogenic, mutagenic or reprotoxic substances are known. Chemical substances classified as CMR are not allowed in cosmetic products as a starting point. There are some exceptions – read more here.
Claim about the absence of chemicals/chemistry
All cosmetic products are composed of chemical substances, and it is therefore incorrect to claim a product as being "without chemicals".
“Perfume-free”, “unscented”, “no perfume added” claims
The statements "fragrance-free" and "unscented" indicate that the product does not contain fragrance, even if it may be added for a different purpose, whereas "no added fragrance" indicates that no fragrance has been actively added. However, consumers are unlikely to distinguish between the different expressions. They will probably all be perceived as indicating that the product does not contain fragrance.
If a cosmetic product contains one of the compulsory declarable fragrance substances, the above-mentioned claims will always be considered misleading.
"Hypoallergenic"
In Annex IV of the EU guidance, there is a focus on "hypoallergenic" claims. The claim "hypoallergenic" must not give the impression that it guarantees that the product completely eliminates the risk of an allergic reaction, as no products can guarantee this. It varies how individuals react to different substances.
"Hypoallergenic" should only be used in cases where a cosmetic product is developed with special consideration to minimize its allergenic potential. At the same time, the responsible person must have documentation that supports the claim in the form of reliable scientific data. If one wants to use the claim, the product must not contain known allergenic substances, including the 26 mandatory declarable perfume substances or other allergens identified by the EU's Scientific Committee for Consumer Safety (SCCS).
"Safe" or "not harmful to health"
Practically, no chemical substances or products are absolutely harmless. Statements like "safe" or "not harmful to health" will therefore be misleading as a starting point.
"Not tested on animals"
The common criterion for compliance with statutory requirements does not allow claims that solely prescribe compliance with the law. According to the cosmetics regulation, it is not legal to test cosmetic products or ingredients for cosmetic products on animals. Therefore, the claim "Not tested on animals" is considered to be misleading, as all products must comply with the law. This applies to both the use of text, logos, images, and illustrations.
"Mild", "gentle", "sensitive", "sensitive skin", etc.
For claims such as "mild", "gentle" and "sensitive", a specific assessment of the individual product must be made to assess whether the claims can be misleading.
The Danish Environmental Agency assumes that in concrete examples it will not always be misleading for an average consumer (who is reasonably informed, attentive and well informed, cf. the Claims Regulation's Annex I, Criterion 1, No. 2) when cosmetic products are labeled with claims such as "mild", "gentle", "sensitive".
However, it should be noted that:
- expressions such as "mild", "gentle", "sensitive", "sensitive skin", etc. can create an expectation in the consumer that the product poses a lesser risk than other products
- if e.g. "sensitive", "sensitive skin" claims are used on perfume-containing cosmetic products, where the perfume is assessed to be allergenic by the EU's Scientific Committee for Consumer Safety (SCCS), there is a risk that certain consumers may be misled about the content of the products if these claims are wanted to be used on perfume-containing cosmetic products
- it should therefore be described on the cosmetic product, what the claim such as "sensitive", "sensitive skin" specifically relates to, and how such a claim should be understood in more detail
- The Danish Environmental Agency must point out that the responsible person for the product must always be able to support the claim used on the cosmetic product with relevant documentation thereof.
"Organic"
Organic cosmetic products, like all cosmetic products, must comply with the Cosmetics Regulation. If a product is advertised as being organic or having a content of organic ingredients, this must be documented.
The Danish Consumer Ombudsman has issued Guidance on the use of environmental and ethical claims etc. in marketing updated 1 July 2017. It is stated in this guidance that a cosmetic product can be referred to as organic if at least 95% of all raw materials/ingredients (i.e., excluding added water) come from certified vegetable and/or animal organic production (e.g., ingredients of agricultural origin) covered by Regulation (EC) No 834/2007 on organic production and labelling of organic products, etc.
f the product cannot immediately meet the stated criteria, it must be assessed specifically whether the product can generally be marketed as organic. In such an assessment, it could be significant if the product is certified under a private scheme recognized in Europe or meets the requirements of such a scheme.
If the product as a whole cannot be described as organic, instead the content of certified organic substances can be indicated in percentages.
A cosmetic product that is organic or has a content of organic ingredients cannot immediately pose a lesser risk to health, for example in relation to allergies. Claims suggesting that organic products are, for example, less allergenic or in other ways pose a lesser health risk than other comparable products will therefore initially be considered misleading.
"Natural", "naturally occurring", "natural origin", etc.
As a starting point, an average consumer will expect a product with the above claim to pose a lesser risk to health and/or the environment than similar products.
The same considerations apply here as with the use of the claims "mild" and "gentle"; the product should not contain substances with significant allergenic potential, and the pH should not be strongly acidic or basic. At the same time, it should be clear what the claim refers to. Since substances of natural origin can be harmful to health, for example by being allergenic, statements about a product's content of natural ingredients can in themselves be difficult for the average consumer to understand.
Specifically about sunscreens
The Commission has in 2006 issued a recommendation on sunscreens - the Commission's recommendation on the effectiveness of sunscreens and indications in connection therewith. This is still applicable. The recommendation covers, among other things:
- claims that should not be used on sunscreens
- indication of precautions and instructions for use
- minimum effectiveness of sunscreens to ensure a high level of protection against UVB and UVA radiation
- simple and understandable labeling to help consumers choose the right product
Read the Commission's recommendation
Proof of effect
Article 11 of the Cosmetics Regulation lists a number of information about the specific cosmetic product, which the responsible person must have, and which the authorities must have easy access to. Among other things, it applies that for products where the nature or effect of the product justifies it, there must be evidence of the claimed effect.
For example, as a responsible person, you should be able to document that a sunscreen has the stated protection factor.
General statements concerning effects that occur with normal use of certain product groups and which can reasonably be expected do not need to be documented. For example, that a shampoo washes the hair clean, or if it is a clear exaggeration, e.g., it will not be taken literally that a "perfume gives you wings".
Who is responsible?
It is the company that is the responsible person who is responsible for compliance with the rules. If a distributor changes the claims, this company becomes the responsible person, as in this respect it is a new product.
Control
The Danish Environmental Protection Agency's chemical inspectors monitor compliance with the rules, and ensure that illegal situations are brought into compliance. This may involve withdrawing the product from the Danish market, or making the product legal in some other way. Anyone who breaches the rules may additionally be subject to a fine or a prison sentence of up to two years.
More information
Cosmetic Regulation (EC) No. 1223/2009 (the original legal act): The Cosmetic Regulation contains all relevant rules for cosmetic products.
Correction to Article 13, paragraph 3: The translation of Article 13, paragraph 3 in the Danish version of the Cosmetic Regulation was corrected in 2014 (Correction, OJ L 318 of 5.11.2014, p. 34 (1223/2009).
Cosmetic Regulation (EC) No. 1223/2009 (the consolidated version of 31 July 2022)
Executive Order No. 803 of 21 June 2013 on cosmetic products (the Cosmetic Products Executive Order): The Danish Cosmetic Products Executive Order contains administrative rules on supervision and punishment and stipulates that the required labelling on cosmetic products must be in Danish.
Executive Order No. 655 of 19 May 2020 on prohibition of import and sale of rinse-off cosmetic products containing microplastics (the Microplastics Executive Order): This Executive Order contains a national ban on the import and sale of rinse-off cosmetic products containing microplastics. It came into force on 1 July 2020.
Executive Order No. 1217 of 11 October 2013 on prohibition of import, sale and use of certain parabens in cosmetic products for children under 3 years: This Executive Order contains special Danish rules for certain parabens in cosmetic products aimed at children under 3 years.
REACH rules and cosmetics
The ingredients in cosmetics are considered to be chemical substances, and these are initially covered by the REACH legislation.
Interpretation and guidance to legislation
Nail products - which legislation?
There are many variants of products to be applied on and around nails as well as products to make artificial nails. Some of these products can be difficult to define in terms of which legislation they are regulated under. Therefore, the Environmental Protection Agency has made this guiding note.
Download the document. (revised 7.12.20). In danish
Interpretation of the terms "rinse off" and "leave on"
The Danish Environmental Protection Agency has prepared a note that illuminates the distinction between cosmetic products that are rinsed off and cosmetic products that are not rinsed off.
Download the note, (revised 7.12.20).In danish