Product Claims Common Criteria Irina T ă nase Toxicologist - National Institute of Public Health, Romania TAIEX Workshop on the Introduction of EU Legislation on Cosmetic Products February, 22-23, 2016

Agenda Definitions Legal basis Actors & their obligations Common criteria – Examples Best practice for claim substantiation evidence – Examples Claims = Safety What’s next…

Definition Claim - to assert something or to state something as true fact Claims for cosmetic products - statements made, usually in advertising, with regard to a product’s functions (R. Schueller and P. Romanowski, C&T, January 1998) Claims are text, names, trade marks, pictures and figurative or other signs that convey explicitly or implicitly product characteristics or functions in the labelling, making available on the market and advertising of cosmetic products (Art. 20(1) of CPR)

Legislation

Guidelines and Recommendations

Claims Importance of claims inform end users about the characteristics and qualities of the products. Contribute to stimulating innovation and fostering competition. Protect consumer (against misleading practices); Ensure fair competition Rules applicable to claims : Have to be in line of the definition of a cosmetic  are essential ways of differentiating between products - borderline products Is to be assessed on the basis of the expectations of the “average consumer” i.e. a consumer “who is reasonably well informed and reasonably observant and circumspect”

Claims differentiating between products category “Cleansing”=cosmetic“Kills germs”=biocide“Treats”=pharmaceutical

Actors & their obligations RESPONSIBLE PERSON Art. 20 of the CPR Ensure that the wording of the claim is in compliance with the common criteria Ensure the consistency with the documentation proving the effect claimed DISTRIBUTORS Art. 6 of the CPR Translate any claim provided by the RP Keep the essence of the claim (otherwise they become the RP under Article 4(6) of the CPR). COMPETENT AUTHORITIES Art. 22 of the CPR Monitor compliance with Claim Regulation via in-market controls

Introducing Common criteria Claims are governed by defined principles (‘common criteria’), not by regulating specific wording Protecting end-users, in particular from misleading claims ensuring better convergence of actions and a common approach of MS Prevent distortions in the internal market Mandatory & legally binding EU text

The Six Common Criteria 1. Legal compliance 2. Truthfulness 3. Evidential support 4. Honesty 5. Fairness 6. Informed decision-making ***Criteria are applicable for each claim used for each product marketed in EU

1. Legal compliance NOT ALLOWED CLAIMS: indicating that the product has been authorized or approved by a competent authority within the EU conveying the idea of a specific benefit when this benefit is mere compliance with minimum legal requirements

Non-compliance Hydroquinone in not allowed to be used in such type of product “Notified to the Ministry of Health”

2. Truthfulness General presentation of the cosmetic and individual claims shall be based on true and relevant information A claimed specific ingredient shall be deliberately present in the cosmetic product A claimed property of a specific ingredient shall imply that the finished product has the same property. Opinions are not verified claims unless the opinion reflects verified evidence

Non-compliance The ingredients claimed in the name of product (i.e. Bergamot & Acacia Mel) are not listed INCI list

Non-compliances “silicone-free” (if the product contains silicone) “48-hour hydration” (if the set of evidence only supports a shorter period of hydration) “contains honey” (if product only contains no honey, but honey flavour) “contains moisturising aloe vera” (if the product itself has no moisturising effect)

3. Evidential Support All RPs should provide proof of effect claimed for their products, taking into account the state of the art at the moment when the product is marketed. Product claims must be supported by adequate and appropriate evidence, regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments

Example : The presentation of results from in vitro or in silico studies should not suggest a result in vivo.

Exceptions: Obvious exaggerations (e.g. ‘makes you fly’) Self-evident properties (e.g. cleansing claim for a soap product)

3. Evidential Support The level of evidence or substantiation shall be consistent with the type of claim being made, in particular for claims where lack of efficacy may cause a safety problem; the studies used must be relevant to the product and the benefit claimed; Experimental studies and consumer perception tests must be conducted in accordance with best practices;

Best practice for claim substantiation evidence Studies used as evidence must be: Relevant to the product Relevant to the benefit claimed Follow well-designed, well-conducted methodologies Respect ethical considerations

Claims = Safety Sun protection claims Products for sensitive skin Products for babies

Claims related to the nature of experimental studies Tolerance tested - supervision of a scientifically qualified professional Tested under medical supervision - supervision of a medically qualified professional, (eg medical doctor or a dentist). Dermatologically tested - supervision of a dermatologist. Clinically tested - supervision of a medically qualified professional according to a clinical protocol or in a clinical setting.

Substantiating claims Literature review Using independently peer-reviewed supporting data. Data should ensure that – the ingredient is effective at the concentration present in the product – its activity is maintained in the product Sensorial approach perception of product efficacy based on factors the volunteers can observe or feel. (Ex. ‘8 out of 10 women appreciated as ease of spreading, cooling effect, absorbency, thickness, rich feel and wetness.’ Instrumental approach Instrumental measurements according to a defined protocol on human subjects (ex. colorimetric tests for the measurement of colour) should adhere to ethical guidelines

4. Honesty (1) Presentations of a product’s performance shall not go beyond the available supporting evidence. Claims about efficacy shall not be based on electronically manipulated ‘before’/ ‘after’ The claim ‘one million consumers prefer this product’ shall not be allowed if based only on the sale figure of one million units.

4. Honesty (2) Not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics. improved properties of a new formulation shall reflect the actual improvement and shall not be overstated fragrances containing high amount of alcohol – not allowed to claim “no preservatives”.

4. Honesty (3) If the action of a product is linked to specific conditions, such as use in association with other products, this shall be clearly stated shampoo with a hair conditioner

5. Fairness (1) Comparative claims must be objective and must not denigrate the competition NOT ALLOWED: ‘contrary to product X, this product does not contain ingredient Y which is known to be irritating’. ‘Well tolerated as it does not contain mineral oils’ ‘Low in allergens because without preservatives’

5. Fairness (2) Neither shall they denigrate ingredients legally and safely used in cosmetics Claims must not create confusion with the product of a competitor Comparing the effectiveness against wetness of an antiperspirant with a deodorant: there are two are different products with different functions

6. Informed decision-making Claims - shall be clear and understandable to the average end user. -are an integral part of products -shall contain information allowing the average end user to make an informed choice.

In the future… Claim for discussion: – « Free of… » – « hypoallergenic » – « Natural / organic » Need to develop guidance on how to apply the common criteria to these specific claims

Exceptions for “free of…” claims Certain claims should be allowed for an informed choice of consumers who want to avoid certain ingredients based on lifestyle or religious reasons alcohol-free no animal derived fragrance free

Common mistakes 1. Read-across* using logical connections :  - Study shows that the product has the efficacy A  - known that efficacy A is associated with efficacy B  - not alowed to claim that the product has the efficacy B Example: the study shows that the oral care product raises the orally pH; known that the acidic pH causes the development of dental plaque; Not alowed to claim that the product remove the dental plaque; Read-across entails the use of relevant information from analogous substances (the ‘source’ information) to predict properties for the ‘target’ substance(s) under consideration (ECHA definition)

Common mistakes 2. Read-across using different dose, route of administration, usage, matrix, etc: Example: The study proves the efficacy of the ingredient A in mouthwash Not alowed to claim the efficacy of the ingredient A in toothpaste; 3. Read-across using the data statistically significant but no clinical significant

Common mistakes Claims made on the basis of a study testing a single ingredient must not related to the overall formula. product may help to maintain healthy gums – not alowed It should provide as follows: ingredient A may help to maintain healthy gums Must demonstrate that the presence of additional ingredients does not change the effectiveness of the formula