What is a claim?
Cosmetic claims are usually used to market the final product. Claims will appear on the label but also in ads, magazines, website, 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 criteria 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.
Why do I need to substantiate claims?
The third common criteria ‘Evidential support’ of the European Regulation 655/2013 states that "claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments. Evidence for claim substantiation shall take into account state of the art practices."
Claim substantiation helps authorities to protect consumers from scams or unsafe products for health. Also, it allows brands to prove the effects of their products and ensure efficient marketing.
How do I substantiate claims?
To comply with the regulation, there are three main methods to substantiate your claims.
- The first one is to collect evidence to back up your claim through the use of consumer perception tests, based on parameters that consumers can observe or feel. The sample of volunteers should be statistically representative of the target population. And most importantly, the questionnaire used to gather impressions should be neutral to be valid, meaning the way that questions are being asked should not influence answers for example.
- The second way is the use of experimental studies, from in silico (meaning performed on computer), in vitro (meaning performed with cells or molecules outside their biological context), etc. You can perform different types of experiments from studies conducted on volunteers to investigator evaluation, as long as methods are reliable and reproducible.
- Finally the use of published information such as scientific publications or market data is a good addition to the first two methods but is insufficient by itself.
These procedures are described in the COLIPA Guideline.
Evaluation on human volunteers
Sensorial tests
Based on human volunteers, these tests can be carried out on different sensorial approach (vision, olfaction, somatic sensation). To perform these tests, you can either do blind use tests or concept use tests.
Blind use tests: " Without providing any information such as brand decor, communication which could influence the consumers' judgment and alter their perception of the effect of the product alone”.
Concept use tests: "Product tests combined with elements of communication that help to check whether the concept, the communication and the effect of the product as perceived by the consumers match up; information from concept use tests are used to complement what is in the product efficacy dossier."
Sensorial tests must be supervised by qualified experts and a strict protocol must be set up with the observed criteria. These parameters must be fixed before the tests are carried out.
You can also perform sensorial tests on volunteers under medical supervision. These tests are supervised by a physician who evaluates all clinical parameters allowing him to draw conclusions on product’s effects. A placebo can be provided to a group of volunteers to assess the real effectiveness of a product.
You can also conduct tests on a panel of professionals from the sector (hairdressers, aestheticians, for example), to evaluate the performance of a product.
2- Instrumental tests
These tests are conducted by machines that can precisely measure predefined parameters by simulating an application on human subjects.
Two types of tests are allowed:
- Laboratory tests: they are carried out under professional control and can accurately measure degrees of hydration, sun protection, UVA/UVB filters, elasticity, etc.
- Laboratory tests in combination with an assessment of industry experts.
Ex Vivo / In Vitro tests
1- Definition
Ex Vivo is a Latin term meaning “off living”. An Ex-Vivo test is an instrumental test performed by a laboratory for example on human hair (which has been cut).
In Vitro is a Latin term meaning “in glass”. An In-Vivo test is observed by a laboratory technician in artificial media (e.g. test tubes). It allows to measure the performance of ingredients or finished products.
2- Tests
The Annex of Regulation 655/2013 describes the “best practice for claim substantiation evidence”.
The guideline states “Ex-Vivo /In-vitro test must be conducted under standardized conditions and their protocols must refer to published and/or ‘in house’ validated methods. Clear descriptions of the methodology will be documented, as well as the statistical analysis of the data. These tests shall be conducted in a controlled environment. To be used as evidence, such tests shall be predictive of an action or representative of an in-vivo effect, but studies on humans must validate these predictive effects”.
The report defines four commonly used claims when these tests are performed, namely: “tolerance tested”, “tested under medical supervision”, “dermatologically tested”, and “clinically tested” See below for more information.
Information which should appear on the test report
General information
Whatever the way you choose to substantiate your claim, the final report must contain:
- Type of product
- Quantity of product applied (if applicable)
- Product to be tested and reference product(s) (if applicable)
- Protocol of the test
- Identification of the sponsor
- Name and qualification of the technician
- Timetable including starting and finishing date
- Date and location
- Equipment/means
- Sample identification or batch number
- Results and discussion
- Conclusion of the tests
- Issuance date of report
- Signatures of all experts involved in the tests
- Summary of the report
NB: This is a non-exhaustive list; to comply with the regulation, please check the complete guidance.
Specific information
When the evaluation is conducted on human volunteers, you must provide additional information such as:
- Number of volunteers and justification of the number (statistical expertise)
- Demographic information: age, gender, type of skin, etc.
- Schedule, training, etc.
- Any interruption of the test
- Size of sample analyzed
- Wording of questions if applicable
- Assessment method
- Chosen/assessed criteria
When the evaluation is conducted Ex-Vivo / in vitro, you must provide:
- Result recording
- Interpretation of results
NB: This is a non-exhaustive list; to comply with the regulation, please check the complete guidance.
What is a claim?
Cosmetic claims are usually used to market the final product. Claims will appear on the label but also in ads, magazines, website, 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 criteria 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.
Why do I need to substantiate claims?
The third common criteria ‘Evidential support’ of the European Regulation 655/2013 states that "claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments. Evidence for claim substantiation shall take into account state of the art practices."
Claim substantiation helps authorities to protect consumers from scams or unsafe products for health. Also, it allows brands to prove the effects of their products and ensure efficient marketing.
How do I substantiate claims?
To comply with the regulation, there are three main methods to substantiate your claims.
- The first one is to collect evidence to back up your claim through the use of consumer perception tests, based on parameters that consumers can observe or feel. The sample of volunteers should be statistically representative of the target population. And most importantly, the questionnaire used to gather impressions should be neutral to be valid, meaning the way that questions are being asked should not influence answers for example.
- The second way is the use of experimental studies, from in silico (meaning performed on computer), in vitro (meaning performed with cells or molecules outside their biological context), etc. You can perform different types of experiments from studies conducted on volunteers to investigator evaluation, as long as methods are reliable and reproducible.
- Finally the use of published information such as scientific publications or market data is a good addition to the first two methods but is insufficient by itself.
These procedures are described in the COLIPA Guideline.
Evaluation on human volunteers
Sensorial tests
Based on human volunteers, these tests can be carried out on different sensorial approach (vision, olfaction, somatic sensation). To perform these tests, you can either do blind use tests or concept use tests.
Blind use tests: " Without providing any information such as brand decor, communication which could influence the consumers' judgment and alter their perception of the effect of the product alone”.
Concept use tests: "Product tests combined with elements of communication that help to check whether the concept, the communication and the effect of the product as perceived by the consumers match up; information from concept use tests are used to complement what is in the product efficacy dossier."
Sensorial tests must be supervised by qualified experts and a strict protocol must be set up with the observed criteria. These parameters must be fixed before the tests are carried out.
You can also perform sensorial tests on volunteers under medical supervision. These tests are supervised by a physician who evaluates all clinical parameters allowing him to draw conclusions on product’s effects. A placebo can be provided to a group of volunteers to assess the real effectiveness of a product.
You can also conduct tests on a panel of professionals from the sector (hairdressers, aestheticians, for example), to evaluate the performance of a product.
2- Instrumental tests
These tests are conducted by machines that can precisely measure predefined parameters by simulating an application on human subjects.
Two types of tests are allowed:
- Laboratory tests: they are carried out under professional control and can accurately measure degrees of hydration, sun protection, UVA/UVB filters, elasticity, etc.
- Laboratory tests in combination with an assessment of industry experts.
Ex Vivo / In Vitro tests
1- Definition
Ex Vivo is a Latin term meaning “off living”. An Ex-Vivo test is an instrumental test performed by a laboratory for example on human hair (which has been cut).
In Vitro is a Latin term meaning “in glass”. An In-Vivo test is observed by a laboratory technician in artificial media (e.g. test tubes). It allows to measure the performance of ingredients or finished products.
2- Tests
The Annex of Regulation 655/2013 describes the “best practice for claim substantiation evidence”.
The guideline states “Ex-Vivo /In-vitro test must be conducted under standardized conditions and their protocols must refer to published and/or ‘in house’ validated methods. Clear descriptions of the methodology will be documented, as well as the statistical analysis of the data. These tests shall be conducted in a controlled environment. To be used as evidence, such tests shall be predictive of an action or representative of an in-vivo effect, but studies on humans must validate these predictive effects”.
The report defines four commonly used claims when these tests are performed, namely: “tolerance tested”, “tested under medical supervision”, “dermatologically tested”, and “clinically tested” See below for more information.
Information which should appear on the test report
General information
Whatever the way you choose to substantiate your claim, the final report must contain:
- Type of product
- Quantity of product applied (if applicable)
- Product to be tested and reference product(s) (if applicable)
- Protocol of the test
- Identification of the sponsor
- Name and qualification of the technician
- Timetable including starting and finishing date
- Date and location
- Equipment/means
- Sample identification or batch number
- Results and discussion
- Conclusion of the tests
- Issuance date of report
- Signatures of all experts involved in the tests
- Summary of the report
NB: This is a non-exhaustive list; to comply with the regulation, please check the complete guidance.
Specific information
When the evaluation is conducted on human volunteers, you must provide additional information such as:
- Number of volunteers and justification of the number (statistical expertise)
- Demographic information: age, gender, type of skin, etc.
- Schedule, training, etc.
- Any interruption of the test
- Size of sample analyzed
- Wording of questions if applicable
- Assessment method
- Chosen/assessed criteria
When the evaluation is conducted Ex-Vivo / in vitro, you must provide:
- Result recording
- Interpretation of results
NB: This is a non-exhaustive list; to comply with the regulation, please check the complete guidance.
