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How to Make Cosmetic Claims in Europe  4/12/2016

Cosmetic claims are the best tools for marketing and communication purposes but they are also highly regulated in Europe so as to avoid any misleading advertising, when it comes to placing your cosmetic products on the European market, make sure your claims are compliant. EcoMundo gives you a few tips and tricks!

What is a claim?
Cosmetic claims are usually used to market the final product. Claims will appear on the label but also on ads, magazines, etc. They:
  • Describe the effects of a product
  • Help consumers/users choose a product
  • Make the product seem more appealing than the competition
E.G.: “MOISTURIZER”, “REDUCES THE APPEARANCE OF WRINKLES”, ETC.

Cosmetic product claims are mentioned in article 20 of Regulation 1223/2009: “In the labeling, making available on the market and advertising of cosmetic products, text, names, trademarks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.”

Moreover, the European commission has published a regulation specific to cosmetic claims (EC: 655/2013) as well as guidelines to improve the understanding of these rules by the Industry. The European regulation 655/2013 aims to ensure that the information conveyed to the end users through claims is useful, understandable and reliable. It must enable them to make informed decisions and to choose the product that best suits their needs and expectations.


Claims: what are the rules?

First, your product must be a cosmetic.
According to the EU cosmetic regulation, a cosmetic product is: “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 cleaning them, perfuming them changing their appearance, protecting them, keeping them in good condition or correcting body odors”.

Quiz: Is it a cosmetic or not?  Click here to take our special quiz to check your knowledge and understanding of the cosmetic product definition!

In other words, a cosmetic is considered as such if it meets the following criteria:
  • Must be used on external parts of the human body including teeth & oral cavity
  • Has one of these functions: cleaning, perfuming, protecting, changing, keeping or correcting.


You must comply with the six common criteria
The EU commission has set 6 common criteria covered by the 655/2013 regulation. You’ll find the official text here for your information. These criteria are cumulative and you must ensure compliance with each of them.

1.  Legal compliance
  • It’s prohibited to claim “that a product has been approved or authorized by a competent authority”.  E.G.: “OUR PRODUCT COMPLIES WITH THE EU REGULATION” WHEN ALL PRODUCTS MUST COMPLY WITH THE REGULATION.
  • It’s prohibited to claim the “specific benefit of a product when this benefit is mere compliance with minimum legal requirements”.  E.G.: “THIS PRODUCT DOES NOT CONTAIN BENZENE” WHEN BENZENE IS A PROHIBITED INGREDIENT.  E.G.: “NOT TESTED ON ANIMALS” WHEN ANIMAL TESTING IS ALREADY PROHIBITED
  • The claim should “be based on the perception of the average end user of a cosmetic product”.

2.  Truthfulness
  • If you claim that your product “contains a specific ingredient, the ingredient must be deliberately present”.  E.G.: “THIS PRODUCT CONTAINS HONEY ”, THEN HONEY MUST BE PART OF THE INGREDIENT LISTING.
  • “Ingredient claim referring to properties of a specific ingredient must not imply that the finished product has the same properties when it does not”.
  • If you use opinion for marketing purposes, it must be truthful i.e., you should not say that “opinions are verified claims unless the opinion reflects verifiable evidence”.  E.G.: “OFFERS A 48-HOUR HYDRATION” SHOULD BE SUBSTANTIATED WITH ADEQUATE EVIDENCE.

3. Evidential support
  • Cosmetic product claims must be supported by adequate and verifiable evidence. Claim substantiation comes in various forms:
  • Experimental tests: in vitro or in silico or clinical
  • Consumer perception tests: the test sample must be representative of the target population.  E.G.: “79 OUT OF 100 WOMEN AGED BETWEEN 35 AND 50 FIND THAT “XXX” MAKES THE WRINKLES LESS NOTICEABLE » FOR AN ANTI-AGING CREAM
  • The use of published scientific data and market data is accepted to support stronger evidence mentioned above.  E.G.: COLLAGEN STUDY RESEARCH

4. Honesty
  • Claims must not go beyond the actual performance of the product. E.G.: “500 CONSUMERS PREFER THIS PRODUCT” SHOULD BE SUBSTANTIATED WITH ADEQUATE SURVEY.
  • You cannot market your product as “unique” if similar products have the same specificities. 
  • If your product requires specific conditions of use or if it has to be used in association with other products, it must appear clearly.

5. Fairness
  • Cosmetic products claims must “be objective and must not denigrate the competitors, or ingredients that are legally used”.  E.G.: “OUR PRODUCTS ARE SAFE BECAUSE THEY DO NOT CONTAIN PARABENS”
  • Claims for cosmetic products must “not create confusion with the product of a competitor”.  E.G.: “OUR PRODUCT IS BETTER THAN “XXX”

6. Informed decision-making
  • Claims must be “clear and understandable” to the average consumer.  E.G.: “THIS CREAM INHIBITS THE CYCLOOXYGENASE PATHWAY” WILL NOT BE EASILY UNDERSTOOD BY THE AVERAGE CONSUMER.
  • “Marketing communication must take into account the capacity of the target audience to comprehend” and must be “clear, precise, relevant and understandable by the target audience”.
  • NB: Claim substantiation is the process of proving and documenting that the claims you plan to make are true. The Responsible Person will ensure the compliance of your claims with Annex II of the guidelines to commission Regulation 655/2013.


Specific claims

“Free from” claims
The European commission is trying to better define and regulate the use of the “free from” claims. In 2016, a new guideline should be published for each of the six common criteria.
  • The ingredient targeted by the claim must not be a legally prohibited substance (i.e.: Criterion 1 - Legal compliance) or usually not used in this type of product.
  • The claim must be true and based on verifiable data according to the claim substantiation process (i.e.: Criteria 2 and 3 -truthfulness and evidence).
  • It is prohibited to denigrate an ingredient legally accepted by using the mention “free from” (i.e.: Criterion 5).
  • Claims must be useful to the consumer for informed decision making (i.e.: Criteria 4 and 6.)

EXAMPLE OF ACCEPTED “FREE FROM” CLAIMS: “ALCOHOL-FREE” OR “FRAGRANCE-FREE”.

EXAMPLE OF PROHIBITED “FREE FROM” CLAIMS: “PARABEN-FREE”; THIS CLAIM DENIGRATES THE ENTIRE FAMILY OF PARABENS WHEN THE VAST MAJORITY IS SAFE FOR USE IN COSMETICS.

Borderline products
According to the European commission, “Sometimes it may be unclear whether a particular product is a cosmetic product under cosmetics legislation or whether it falls under other sectorial legislation. In the case of these “borderline products”, the decision on a product’s classification must be taken on a case-by -case basis”.  Example of borderline products:
  • Products that are destined to be used as make-up on dolls or children
  • Soap that contains a biocide
  • Mouthwash
The European commission has published a guide with the most common cases. These guidelines give an orientation but they do not have any legal force. You have to keep in mind that borderline products must be classified on a case-by-case basis.


Sunscreen products
In Europe sunscreen is considered as a cosmetic product and not as a drug.  The efficacy of a sunscreen protection is a major public health challenge. The European commission has also published guidelines for sunscreen products.  The main rules are:

EcoMundo's services
Please do not hesitate to contact us: contact@ecomundo.eu, if you have any questions about cosmetic compliance or if you’re looking for specific services. EcoMundo acts as Responsible Person for Europe and can provide the following services:
  • Formula review
  • Artwork & claim review
  • PIF creation & Safety Assessment
  • CPNP notification
Contact us via phone: for North America please use + 1 (778) 231-1607 or for Europe +33 (0)1 83 64 20 54

Interested in Learning More?  

Join us for the upcoming International Health & Beauty Care Efficient Program Planning Session (EPPS) on June 12th from 5:40-6:20pm to hear Marie Roussel of EcoMundo speak about practical details you should know if you intend to do business with Europe. She’ll also explain how the EU Regulatory framework is impacting other international markets such as Middle East, Brazil or Australia. View more presentation details here!

Upcoming Efficient Program Planning Sessions (EPPS):
Meet with a global audience during the upcoming ECRM EPPS events:
For more information about international EPPS events, please contact Liz Lantz at 440.248.3051 or llantz@ECRM.MarketGate.com.
For more information about domestic EPPS events, please contact Lisa Carrillo at 440-528-0427 or lisac@ECRM.MarketGate.com.

Marie Roussel

EcoMundo
Email Me
Phone: (440) 498 - 0500

After having obtained a Master’s degree in International Studies from Adelaide University (Australia) and a Master in Business from Paris University (France), Marie joined EcoMundo in 2009 and developed a strong expertise in EU Regulatory management, including the REACH Regulation for chemicals. In 2012, Marie launched EcoMundo’s North American branch, from Vancouver, Canada. Today, she mainly assists US, Canadian but also Australian companies in complying with EU Regulations and ensuring sec

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