Cosmetic product claims

COSMETIC CLAIMS

EU REGULATION 1223/2009

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LEGISLATION

• EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC)

• EU cosmetic regulation 655/2013






COSMETIC PRODUCT CLAIMS

• Claims have to be in line with the definition of a cosmetic product in the EU

• This definition does not encompass products presented as having properties for treating or preventing disease in human beings While not intending to be exhaustive, the following list contains

examples of such words or phrases which present a medicinal intent: cures; heals; treats; restores; prevents; clears; protects against disease; helps control the symptoms of; traditionally used for treatment of; strengthens the immune system

• The product should also not claim that it kills germs and microbes, as it would fall under the biocide regulation

• Etc.






CLAIMS IN REGULATION 1223/2009

• “In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.”

• The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products







• Regulation that is laying down common criteria for the justification of claims used in relation to cosmetic products

• The common criteria only come into play when it has been assessed that the product in question is indeed a cosmetic product

• The common criteria are not aimed at defining and specifying the wording that can be used for cosmetic product claims







Common criteria established by the Regulation 655/2013:• Legal compliance• Truthfulness• Evidential support• Honesty• Fairness• Informed decision-making






LEGAL COMPLIANCE

• Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed since a cosmetic product is allowed on the Union market without any governmental approval

• Equally, a CE-mark shall not be applied on cosmetic products

• The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product

• Claims that convey an idea that a product has specific benefit, when this benefit is mere compliance with minimum legal requirements shall not be allowed






TRUTHFULNESS

• Neither the general presentation of the cosmetic product nor individual claims made for the product shall be based on false or irrelevant information

• If a product claims that it contains a specific ingredient, the ingredient shall be deliberately present

• Ingredient claims referring to the properties of a specific ingredient shall not imply that the finished product has the same properties when it does not

• Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion reflects verifiable evidence






EVIDENTIAL SUPPORT

• 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

• Any evidential support needs to be kept in the PIF• Where studies are being used as evidence, they shall be relevant to the product

and to the benefit claimed, shall follow well-designed, well conducted methodologies and shall respect ethical considerations

• 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

• Statements of clear exaggeration which are not to be taken literally by the average end user (hyperbole) or statements of an abstract nature shall not require substantiation

• A claim extrapolating (explicitly or implicitly) ingredient properties to the finished product shall be supported by adequate and verifiable evidence, such as by demonstrating the presence of the ingredient at an effective concentration






HONESTY

• Presentations of a product’s performance shall not go beyond the available supporting evidence

• Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics

• If the action of a product is linked to specific conditions such as use in association with other products, this shall be clearly stated






FAIRNESS

• Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used

• Claims for cosmetic products shall not create confusion with the product of a competitor






INFORMED DECISION-MAKING

• Claims shall be clear and understandable to the average end user

• Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice

• Marketing communications shall take into account the capacity of the target audience to comprehend the communication. Marketing communications shall be clear, precise, relevant and understandable by the target audience







Best practices for claim substantiation evidence:• Experimental studies• Consumer perception tests• Published information (scientific publications)






OTHER RECOMMENDATIONS

• Where additional recommendations from the European Commission are available, they should also be taken into consideration

• For example, the European Commission recommendation “on the efficacy of sunscreen products and the claims made relating thereto” (2006/647/EC) giving recommendations on labelling and claims that can be made for sunscreen products, and how they should be substantiated






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