Effects claimed for cosmetic products must be proved

This article has been translated from Finnish to English by Semantix. You can find the original article at the web adress://www.kosmetiikka-allergia.fi/tietoa-kosmetiikasta/kokosmetiikan-vaitetyt-vaikutukset-pitaa-pystya-todentamaan

Active advertising is typical for cosmetic products. Advertising of cosmetic products is subject to the same legislation and guidelines as other consumer goods. The main idea is that advertising must not be misleading. Advertising of cosmetic products is particularly linked to the function, composition and effects claimed for the products. In addition to general regulations, these claims have a separate sector-specific legislation. Thus, advertising of cosmetic products is not a jungle without rules. 

The definition of cosmetic product forms the basis for the claims

In order to understand the regulation on cosmetic product claims, we must first understand what cosmetic products are. According to the EU Regulation (EC) No 1223/2009 on Cosmetic Products, ‘cosmetic product’ means 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. In practice, cosmetic products include perfumes, make-up, skin and hair care products, as well as personal hygiene products. 

The Commission Regulation (EU) No 655/2013 on claims used in relation to cosmetic products must be followed in the claims and advertising of all products that fall under the definition of a cosmetic product, irrespective of the medium, type of marketing tool used or target audience. In other words, it does not matter whether the product is advertised on TV or whether claims are made on the packaging or social media, the claims must comply with the legislation. When making product claims, it is particularly important to keep in mind the definition of cosmetic product, as the claims can contribute to the product’s classification and could define it as other than a cosmetic product. For example, if a product is claimed to have medical properties, it could be classified as a medicine. 

Summary of the Regulation on cosmetic product claims

The Regulation on cosmetic product claims is based on six common criteria: legal compliance, truthfulness, honesty, fairness, informed decision-making and evidential support. Each cosmetic product claim must be viewed in the light of these criteria because it is a EU level Regulation. In other words, these criteria are legally binding. 

However, the Regulation does not list accepted or prohibited claims but sets the framework for the types of claims that can be made in relation to cosmetic products. The linguistic and cultural factors of the target audience must also be taken into account, and therefore the acceptability of the claims may vary from country to country. Room has been left for innovation: the aim is to enable versatile claims that give truthful information about cosmetic products and allow the consumer to compare different products and make informed choices.

To help the interpretation of the Regulation on cosmetic product claims, the European Commission has published a technical document with some examples of what kind of claims should be avoided to ensure their compliance with the six criteria. The document also takes a stand on the much discussed ‘does not contain’ claims. A rule of thumb is that ‘does not contain’ claims should not be used for individual ingredients, as it does not matter whether the ingredient is allowed or not in cosmetic products. A few practical examples of unacceptable claims are ‘does not contain parabens’ and ‘does not contain sodium dodecyl sulphate’. 

However, there are some ‘free from’ claims that are allowed to use. A good example is 'free from animal-derived ingredients', which, of course, can be expressed with the word ‘vegan’. 

Evidence must substantiate the claims

There must be scientific research and evidence to support the claims for cosmetic products. Each enterprise responsible for the product is also responsible for the claims they make and they must be supported by adequate evidence. For example, if evidence for a claim regarding the sun protection factor of a product is inadequate, it could cause a health hazard. The enterprise responsible must document all the test results underlying the claims in the product information file (PIF), which, in the same way as the safety assessment information, must be made readily available to the national authorities that monitor cosmetic products. In Finland, the Finnish Safety and Chemicals Agency (Tukes) supervise the cosmetic products.

The Regulation does not determine what kind of tests should be done to substantiate the claims. Instead, each enterprise chooses their test methods according to the claims they make and follow the good scientific practice. A claim can also be made on the basis of the results of various tests. The used test types include, for example, in vivo (testing of finished cosmetic product on human skin), ex vivo (e.g. hair used for testing), in vitro (test conducted ‘in a test tube’ with cultured cells) and consumer research. 

Discussion about the claims

Although there are no lists of allowed and prohibited claims, there are still some claims that should not be used unless they can be supported by scientific evidence and the needs of the target audience. Some types of claims are regularly under discussion: for example, can a product be claimed to be free from allergenic substances? And what does natural cosmetics mean?

As stated earlier, cosmetic products should not include ‘does not contain’ claims for individual ingredients allowed or prohibited in cosmetic products. Prohibited ingredients should not be underlined, as they are not allowed in any cosmetic product. A claim that a product does not contain, for example, hydroquinone, which is a prohibited substance, could imply that other cosmetic products may contain it, when in fact the substance is not allowed in any cosmetic product. This is a typical example of misleading advertising.

‘Does not contain’ claims should neither be used for substances that are allowed in cosmetics. Firstly, it is not relevant to mention ingredients that the product does not contain, and secondly, such claims give a negative impression of substances that are safe to use in cosmetics. ‘Contains’ claims are more relevant to consumers than ‘does not contain’ claims as they give more information about the product and may help consumers decide which product to purchase. Of course, ‘contains’ claim must also be relevant to the product.

Free from allergenic substances or similar claims should not be used in cosmetics. This is based on the fact that any substance can cause hypersensitivity (allergies are individual), and the possibility of an allergic reaction cannot be completely ruled out with any cosmetic product. Cosmetic products must include lists of ingredients so that consumers can check whether product contain substances that cause allergy to them. 

On the other hand, the product can contain the claim fragrance-free if it does not contain any fragrances. The claim can be used because it can be relevant for a specific target audience. Of course, you have to keep in mind that fragrance-free does not necessarily mean unscented as the ingredients may have their own distinctive odour. The claim hypoallergenic is permitted under strict conditions: roughly speaking, a hypoallergic product must not contain any substance that is known to cause hypersensitivity. The guidelines for using the hypoallergic claim are included in the Commission’s technical document on cosmetic products.

How about natural cosmetics and its claims? The EU Regulation on Cosmetic Products does not have a separate definition for natural cosmetics. In general, natural cosmetics mean cosmetic products which have been manufactured with paying special attention to the natural origin of the ingredients and considering how to products’ life cycle affects the human and the environment. Natural cosmetics can be identified, for example, by certificates or claims. 

The claims of natural cosmetics are subject to the same legislation as other cosmetic product claims. In the advertising of any cosmetic product, it is not allowed to give a misleading impression of the safety of the products to human health: all cosmetic products, including natural cosmetics and so-called regular cosmetics, must comply with the strict safety requirements. From an allergy perspective, it is important to notice that the ingredients of cosmetic products may cause allergic reactions regardless of whether they are of synthetic or natural origin. Being allergic to or become sensitized to ingredients in cosmetics is as unique as having food allergies. However, the majority of consumers can use both natural and regular cosmetics safely.

In the discussions on natural cosmetics, it should be considered that organic and natural cosmetics are different things. The word ‘organic’ refers to the raw materials which have been produced according to the organic farming methods. Vegan cosmetics are an emerging trend. It is not the same as natural cosmetics but it is cosmetics that have been produced without animal-derived ingredients. The ingredients may be both synthetic and natural. 

It is good to be aware that CE-marked products are not covered by the legislation on cosmetic products. ‘Cosmetic products’ with CE marking include, for example, sunscreens and toothpastes. The claims used in relation to CE-marked products are allowed to be more comprehensive: for example, a sunscreen product with a CE marking can include the claim ‘prevents skin cancer’ since the CE-marked products fall under the regulations on healthcare devices and equipment. A sunscreen that is considered a cosmetic product cannot include such a claim.

Claims help make purchase decisions

Cosmetic products marketed in the EU must comply with the requirements of both the EU Regulation on Cosmetic Products and the Regulation on cosmetic product claims. The purpose of the Regulation on cosmetic product claims is to provide a framework for the claims, so that consumers can better compare the products and decide which products to buy. 

For example, the claim ‘contains moisturizing aloe vera’ indicates that the product contains that substance. If the substance is suitable for the consumer but they are allergic to some other ingredient used in cosmetic products, they should not make a purchase decision on the basis of that claim. In addition to claims, it is recommended to check the ingredient list of the product and make sure that it does not contain any other unsuitable ingredients.

You should be careful when shopping, especially in online stores outside the EU. The regulations on cosmetic products and their claims in other countries may differ from those of the EU. For example, if a product is claimed to cure an unhealthy skin, you should be critical of the claim, as cosmetic products are not allowed to cure diseases. The product may even contain substances that are prohibited in the cosmetics in the EU.

There is a huge selection of cosmetic products available, and everyone will certainly find the suitable products for them. When shopping the products, consumers should also ask help from the professionals, who can help them make decisions and find out whether a product is suitable for them. Also, the Cosmetics Allergy Portal serves consumers in Finland who have allergies. In the Portal, consumers can make a list of the cosmetic products that are suitable for them. 


Eeva-Mari Karine
Expert (legislation on cosmetics)
Finnish Cosmetic and Hygiene Industry Association
Twitter: @Eeppok