Reg. Affairs Manager
Marie Magnan is regulatory affairs manager at COSMED and specialised in cosmetic regulations in the EU and Asia-Oceania. COSMED, the French Professional Association for SMEs in the cosmetic field, counts more than 920 members. Cosmed Regulatory Monitoring is a tool that helps companies to be informed of cosmetic regulation in Europe and abroad, thanks to an extensive database on 120 countries, real-time alerts and assistance.
With claims, putting the cosmetic in the spotlight
The cosmetic field is an industrial sector that is constantly evolving and where competition is fierce. Products mainly use claims to distinguish themselves.
Facing pandemic-induced transformations, changes in regulations and in consumer perception, companies are increasingly creative, developing new claims.
If we look back at the end of 2020 and the beginning of 2021, claims are mainly focused on environmental protection, natural cosmetics, sustainability and ethical issues, on the origin of the product (“made in”), and wellness particularly in skin care.
Nevertheless, cosmetic claims are strictly regulated in Europe, and a great part is let to the interpretation and control of the responsible person. Therefore, the latter must understand the requirements set by the regulations to apply them correctly.
Entered into force on 11 July 2013, Regulation (EC) 1223/2009 on cosmetic products only defines claims and relies on another regulation, (EU) 655/2013, to set up common criteria justifying the use of claims. It has been then completed by Technical Document on Cosmetic Claims, recommendations written by the Cosmetics working group of the European Commission.
Responsibilities and definitions of claims
The definition of a claim is given by both the European regulation on cosmetics and the regulation on common criteria. These two texts define claims as text, names, trademarks, pictures and figurative or other signs […] irrespective of the medium or type of marketing tool used, the product functions claimed, and the target audience.
This definition is often highlighted by the authorities during their controls: when you are considering claims, the full characteristics of the product, namely packaging, text, colors, and figurative elements must be examined.
The perception of the normally informed consumer must also be considered: claims should be well understood and must not be ambiguous, considering social, cultural, and linguistic factors of the targeted population. Advertising leaflets and TV spots are also considered as claims and must conform to the regulation.
The regulations do not provide a list of tests to perform according to a claim. But, the level of proof or justification should match the type of claim, particularly if the product, ineffective, constitutes a health risk to consumers.
The Product Information File must contain the justifications and evidence. It is also important to build a reasoning: the reason of the claim, the presumed perception of the average end user, the data acquired, the quality of the data, evaluation and conclusion.
Common criteria on cosmetic claims
Regulation 655/2013 lays down the six common criteria for the justification of claims used in relation to cosmetic products.
Legal Compliance: claims indicating that the product is compliant to European regulation or has been approved by a competent authority are not allowed. Indeed, every product on the European Market must conform to the Regulation.
For example, claiming that the cosmetic does not contain any prohibited substances is not allowed, as well as printing any logo of authorities.
Truthfulness: product presentation, or claims shall not be based on false or non-relevant information.
For example, a product cannot be named Aloe Vera cream if it does not contain any aloe vera. Also, there should be no ambiguities in the presentation; it is questionable to have a huge picture of aloe vera on the packaging if there is none in the formula.
Evidential Support: this criterion sets requirements for proofs and evidence.
The evidence must be adequate and verifiable and take into account the current practices. Studies shall follow well-designed, well-conducted methodologies and respect ethical considerations.
Honesty: claims must not exaggerate the product performance and must not attribute specific characteristics to the product concerned if similar products possess the same characteristics.
For example, claims on efficacy shall not be based on before/after pictures that have been retouched on computer.
Fairness: a claim shall be objective and shall not create confusion. It must not denigrate the competitors, or ingredients legally used.
Informed decision-making: claims shall be clear and understandable by the average end user and by the target audience.
Technical document on cosmetic claims
The technical document on cosmetic claims was published in addition to Regulation 655/2013 and is regularly updated. Regarding its legal scope, Cosmed, acting as cosmetic professional association, had a legal analysis carried out with the following conclusion: contrary to a regulation or a directive, a technical document constitutes a non-binding invitation for the Member States to enforce the recommendations. However, this document will serve as an interpretative tool for national authorities if they were to take a position on claims.
It contains 4 annexes: Annex I provides a detailed description of the common criteria, with examples and Annex II provides best practices for evidential support.
Annex III picks up again the common criteria and explains what is allowed or not regarding the ‘free from’ claim.
The most important clarification relates to the absence of unpopular substances (free from parabens, triclosan, allergens…). Yet, some of these substances are safe when used in accordance with Regulation 1223/2009. Since all cosmetic products must be safe, the claim 'free from these substances' is not accepted, because it is denigrating authorized ingredients.
Some of "free from" claims are still permitted if they do not constitute the main argument of the communication, and if they comply with the common criteria. For example, “alcohol-free" for a mouthwash used for the whole family, "no animal ingredients" for products intended for vegans, "silicone-free" in hair products because this substance can make the hair heavier…
Annex IV regulates more strictly the “hypoallergenic” claim. The ingredients contained must not be generally recognized, identified, or classified as sensitizers. Besides the product should not give the impression that it guarantees a complete absence of risk of allergic reactions.
Differentiating oneself while respecting regulations and meeting consumer expectations in terms of safety and respect for the environment is a real challenge. But whatever the claim imagined for the product, the responsible person must pay attention to the wording and reminds that the claim should be evaluated in relation to the six common criteria.