The legislative requirement for cosmetic claims in the EU is set out in Commission Regulation (EU) 655/2013, with the aim of ensuring that claims shall not imply cosmetic products have characteristics or functions which they do not have, and for not misleading the consumer.
In this article we explain the legal requirements for making product claims on cosmetics in the European Union.
Commission Regulation 655/2013 is based on Article 20 of the European Cosmetic Regulation (EC) 1223/2009, (ECR), which established EU harmonized common criteria in order to assess whether or not a claim is justified. Article 20 of the ECR applies to all products which fall under the definition of a cosmetic, therefore 655/2013 is not applicable to non-cosmetic products, such as pharmaceuticals and biocidal products.
The Responsible Person, as defined in Article 5 of the ECR, must ensure compliance with the requirements of 655/2013.
The philosophy of Regulation 655/2013 is based on adherence to the following six common criteria:
- Legal compliance
- Evidential support
- Informed decision making
These criteria are aimed at not misleading the consumer, they are all of equal importance. Examples of the application of these criteria are discussed below.
Application Of The Criteria: Dos and Don’ts
Claims that indicate that a product has been authorized or approved by a competent authority in the EU are not allowed since a cosmetic product is allowed in the EU without any governmental approval. Consequently the following claims, as examples, are not allowed:
- “This product complies with EU legislation”, as all cosmetic products placed on the EU market must comply
- “Approved by UK Trading Standards”, as Trading Standards cannot approve products, only ensure their legal compliance
- “This product does not contain Hydroquinone”, as Hydroquinone is banned for use in cosmetics
The general presentation of a cosmetic or individual claims for a product must not be based on false, irrelevant or misleading information. Consequently, the following examples are not allowed:
- “Silicone Free”, if the product contains silicone or a silicone derivative
- “48 Hour Hydration” if the supporting evidence is based on less than 48 hours
- “Contains Honey” if the product only has a honey flavor
Claims for a consumer product, whether explicit or implied, must be supported by evidence for their substantiation. This information should be retained in the Product Information File for the product.
Statements of clear exaggeration, which are not to be taken literally, do not need such substantiation. For example:
- “This perfume gives you wings” is hyperbolic as no one would expect to be able to grow wings through the use of the product
Presentations of a product’s performance shall not go beyond supporting evidence. For example:
- “The best antiperspirant in the world” is unlikely to be capable of being substantiated
Claims about improved properties of a new formulation should reflect the actual improvement and not be overstated. For example:
- “New formula – Improved cleaning” needs substantiation
Claims for cosmetic products shall be objective and not denigrate the competition or any other ingredients legally used. For example:
- “Contains no parabens which can cause breast cancer” is not allowed since it denigrates parabens, many of which can be legally used
- “Well tolerated as it does not contain Mineral Oil” is an unfair statement towards other products which contain mineral oil and which are equally well tolerated
- “Low in allergens because this product is without preservatives” is not allowed as it assumes all preservatives are allergenic
Informed decision making
All claims shall be clear and understandable to the average end user. Consumers should not be misled by confusing or unclear claims.
The Advertising Standards Authority (ASA) is the United Kingdom’s independent regulator of advertising across all media. They proactively check the media and act on complaints regarding misleading, harmful or offensive advertisements. In 2016, advertisements from several companies working in the cosmetics sector have been ruled upon by the ASA.
In one case, a television advertisement for a shower gel that featured a voice over stating: “This is dry skin. It's a common problem. Introducing our clinically proven way to hydrate it. A shower gel. New xxxxx Advanced Hydrate 24 hours, proven to moisturise your skin for 24 hours. Recommended by 97% of women who tried it. xxxxx. Keeps skin healthy. Onscreen text at the bottom of the screen stated “Results shown after one week of use. 97% of 32 daily body lotion users”.
Complaints were raised about the claims in this message in so far as:
- At best the product provided the same level of moisturization as other shower gels on the market
- The moisturization and hydration effect lasted for 24 hours could be misleading and may not be substantiated
- The advert implied that the product provided 24 hours of moisturization from the first use, and the qualification "Results shown after one week of use" contradicted that impression and the ad was therefore misleading
The Responsible Person did have some data based on clinical, user and instrumental trials which they claimed supported the statements used in the advertisement. However, the ASA considered the data to be insufficient and as such concluded that the claims made were misleading, exaggerated and could not be substantiated. The advertisement had to be withdrawn.
A second company advertising an eye cream showed a ‘before and after shot’ of a consumer and claimed that the wrinkles and puffiness under her eyes had decreased after using the cream. A voice over stated: “We're so confident in the performance of 'xxxxxx', we had it examined by UK dermatherapist Dr xxxx xxxxxx, using a VISIA scanner and here's what he found." Dr xxxxx said "As you can see from the screen where we've measured her wrinkle scores on VISIA, to be honest, they've virtually disappeared and the computer does give us the score of 27 before and 10 afterwards. I really am very impressed by the effectiveness."
A member of the public challenged whether the claims made by the dermatherapist about the temporary reduction in wrinkles, as demonstrated by the 'before and after photos' taken by the VISIA scanner, were misleading and could be substantiated. Again, the Responsible Person submitted their statement and supporting data to the ASA. In this case the ASA ruled that the claims made in the advertisement were acceptable as the claims related to a temporary change in appearance and the fact that the product had been assessed in three different ways: dermatologically examining fine lines and wrinkles around the eyes and eye puffiness; digital photographs by a blinded independent assessor; and, self-assessment by the subject. In this case the advertisement was allowed to continue to be shown in its existing form.
More details on these rulings can be found at:
About SGS Cosmetics Safety Services
It is crucial for all cosmetic and personal care products to be safe, effective and stable. SGS provides testing, inspection, auditing and consulting services to manufacturers, distributors and importers to ensure a high level of product quality in every area. The company also has extensive capabilities in performance testing, claim support studies and consumer panels. All testing is conducted according to customer specific or recognized standard methods, some of which were developed by SGS. The company’s cosmetic safety assessors and other technical experts can support customers by making sure new products comply with regulatory requirements.
For information and advice on the cosmetic regulation please contact a local SGS representative or the global team.
Janine Bottomley and Roger Pengilly
SGS United Kingdom Limited
Cosmetic Safety Assessors
Units 41 & 43,
The Listerhills Park of Science and Commerce,
t: +44 (0)1274 303 080