EU 655/2013: How to avoid issues with claims about cosmetics

European Union (EU) regulation 655/2013 sets out the legislative requirements for claims made about cosmetics. The aim is to help manufacturers make accurate statements and not imply any false characteristics or functions relating to their products. This protects consumers from being misled or otherwise harmed, and reduces the risk for the producers of legal challenges.

Commission Regulation 655/2013 is based on Article 20 of the European Cosmetic Regulation (ECR) 1223/2009, which applies to all products falling under its definition of a cosmetic. Article 5 of that ECR defines “The Responsible Person” whose task is to ensure compliance with the requirements of 655/2013.

The ECR harmonized the criteria across the EU for assessing whether or not a claim is justified. The six common criteria, which are equally important, are:

1. Legal compliance
2. Truthfulness
3. Evidential support
4. Honesty
5. Fairness
6. Informed decision-making

Legal compliance
Claims indicating that a product has been authorized or approved by a competent EU authority aren’t acceptable, since cosmetic products are allowed into the EU without any governmental approval. For example, the following claims would not be 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

Truthfulness
The general presentation of a cosmetic, or individual claims for a product, must not be based upon false, irrelevant or misleading information. Here are some examples that aren’t 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

Evidential support
Explicit or implied claims for a consumer product must be supported and substantiated by relevant evidence, and the information retained in the Product Information File.

Statements of clear exaggeration are not to be taken literally and therefore don’t need such substantiation. For example:

• “This perfume gives you wings” is hyperbolic - nobody would expect to be able to grow wings through use of the product

Honesty
Claims about a product’s performance shouldn’t exceed supporting evidence. For example:

• “The best antiperspirant in the world” is unlikely to be capable of being substantiated

Statements about the improved properties of a new formulation should reflect the actual improvement and not be overstated. For example:

• “New formula – Improved cleaning” would need substantiation

Fairness
Claims for cosmetic products shall be objective and not denigrate competitor products or their ingredients that are being used legally. 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 that 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 users, to ensure that consumers aren’t mislead. Here are two 2016 examples from the United Kingdom (UK), as assessed by the Advertising Standards Authority (ASA) - the UK’s independent regulator for all media advertising.

1) A television advertisement for a shower gel 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.”

The on-screen text stated “Results shown after one week of use. 97% of 32 daily body lotion users”.

The following complaints were raised about the claims:

1. At best, the product provided the same level of moisturization as other shower gels on the market
2. The claim that the moisturization and hydration effect lasted for 24 hours could be misleading and may not be substantiated
3. 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 concluded that the claims made were misleading, exaggerated and could not be substantiated. The advertisement had to be withdrawn.

For more details on this ruling, see: ASA Ruling on Colgate-Palmolive (UK) Ltd

2) A 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 'My Perfect Eyes', 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.

The Responsible Person submitted their statement and supporting data to the ASA, which ruled that the claims made in the advertisement were acceptable. This was because the claims related to a temporary change in appearance, and 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.

For more details on this ruling, see: ASA Ruling on The Perfect Cosmetics Company Ltd

About SGS Cosmetics Safety Services
All cosmetic and personal care products have 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 help to ensure new products comply with regulatory requirements.

For information and advice on cosmetic regulations, please contact your local SGS representative or the global team.

Janine Bottomley and Roger Pengilly
Cosmetic Safety Assessors
SGS United Kingdom Limited
Email: cts.media@sgs.com
Website: www.sgs.com/cpch

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

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This release was published on openPR.