Claims in cosmetic products

23/3/2016

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�.

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.

WHAT SHOULD I CHECK FOR EACH CRITERION?

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.
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. �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.)

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.

Recommandation

Sunscreen products

In Europe sunscreen is considered as a cosmetic product and not 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:

  • It is prohibited to claim a 100% protection against UV filters.
    E.G.: �SUNBLOCKER� �ALL UV FILTER�
  • It is prohibited to say or imply that it is not necessary to renew the application during the day.
    E.G.: � ALL DAY PREVENTION�
  • "Claims indicating the efficacy of sunscreen products should be simple, unambiguous and meaningful and based on standardized, reproducible criteria�

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�.

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.

WHAT SHOULD I CHECK FOR EACH CRITERION?

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.
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. �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.)

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.

Recommandation

Sunscreen products

In Europe sunscreen is considered as a cosmetic product and not 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:

  • It is prohibited to claim a 100% protection against UV filters.
    E.G.: �SUNBLOCKER� �ALL UV FILTER�
  • It is prohibited to say or imply that it is not necessary to renew the application during the day.
    E.G.: � ALL DAY PREVENTION�
  • "Claims indicating the efficacy of sunscreen products should be simple, unambiguous and meaningful and based on standardized, reproducible criteria�