Editor’s note: This article is the twelfth in a series covering the EU requirements for cosmetic products; see the previous: Part I (European Regulations), Part II (Responsible Person), Part III (PIF compliance), Part IV (Cosmetic Product Safety Report), Part V (data mandate), Part VI (risk assessment), Part VII (sensitization test), Part VIII (preservatives), Part IX (stability), Part X (toxicity) and Part XI (labeling).
European Commission (EC) Cosmetics Regulation No. 1223/2009 is the main regulatory framework for finished products placed on the EU market.1 Within Chapter VI, consumer information and communication is a key objective: two major Articles outline the criteria for labeling (Article 19) and product claims (Article 20). Regarding product claims, these serve mainly to inform end users about the characteristics and qualities of the products. Rules for these claims are outlined herein.
What Are Claims?
Claims are text, names, trademarks, pictures and figurative or other signs that explicitly or implicitly convey product characteristics or functions in the labeling, which are made available on the market and in the advertising of cosmetic products (Article 20.1). They do not include the information mandated for product labeling, as outlined by Article 19 (see part 11 on labeling). Claims should not be used to imply that cosmetic products have characteristics and functions they do not have (Article 20.1).
Claims are governed by defined principles or “common criteria”; they are not held to specific wording. The governing criteria to justify claims have been laid down by EU authorities,2 which:
- Aim principally to protect end users, i.e., consumers and professionals, of cosmetic products from misleading claims; and
- Apply to any claim within the scope of EC Cosmetics Regulation No. 1223/2009, irrespective of the medium or type of marketing tool used, the product functions claimed and the target audience.
The criteria are a mandatory and legally binding EU text. The common criteria only apply once it has been determined that the product in question is, indeed, a cosmetic product.
6 Criteria for Claims
The following six criteria, as outlined in the Annex2 of EU Regulation No. 655/2013, are legally binding—and guidance has been provided for their application:3
1. Legal compliance. A claim must comply with all legal requirements.
2. Truthfulness. Neither the general presentation of the product nor individual claims made for the product shall be based on false or irrelevant information.
3. Evidential support. Claims, whether explicit or implicit, must be supported by adequate and verifiable evidence, regardless of the type of evidential support used to substantiate them, including appropriate expert assessments. Evidence for claim substantiation shall take state-of-the-art practices into account.
4. Honesty. Claims must not be misleading. Presentations of a product’s performance shall not go beyond available supporting evidence.
5. Fairness. Claims must be objective and not denigrate competitors. They also shall not denigrate ingredients that are used legally.
6. Informed decision-making. Claims shall be clear and understandable to the average end user. Claims are an integral part of products and must contain information allowing the average end user to make an informed choice.
The Responsible Person is responsible for ensuring compliance with these criteria. Furthermore, the Product Information File (see PIF compliance) must include, “where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product.”
Best Practices to Substantiate Evidence
Different types of evidential support can be used to substantiate claims: experimental studies, consumer perception, published information, etc.; guidelines on best practices have been provided.3
Experimental studies: These include in silico, in vitro, ex vivo, instrumental or biochemical methods; studies conducted on volunteers; investigator and sensory evaluations, etc. The studies must:
- Comprise methods that are reliable and reproducible;
- Follow a well-designed and scientifically valid methodology according to best practices. The criteria used to evaluate product performance must be defined with accuracy.
- Rely on knowledge and awareness of statistical principles in the design and analysis of the study, i.e., number of subjects, samples, etc., to achieve valid conclusions;
- Include a validated protocol to conduct and monitor the study appropriately; and
- Follow ethical principles. When tests are conducted on volunteers, products must have previously been deemed safe. Studies shall be conducted on the target population where necessary, and be defined by strict inclusion/exclusion criteria.
In addition, the technician conducting the study must have the appropriate qualifications, training and experience in the field of the study, highly ethical quality standards and professional integrity. The study facility must maintain a quality assurance system, including standard operating procedures. Upon completion, a report from the study shall be prepared, including a clear identification of the product, the study’s objective, the test schedule and test protocol, the presentation of the results and their interpretation, statistics and finally, the signature of the individual in charge of the study.
Consumer perception tests: These tests evaluate consumers’ perceptions of product efficacy and cosmetic properties based on parameters the panelists can observe or feel. The elements described previously for experimental tests also apply. A critical point here is the wording of the questionnaire. The questions and proposed answers shall be clear enough to be unequivocally understood by participants. The answer scale shall be well-balanced and incapable of influencing the answer.
Published information: Finally, as noted, evidential support for claims may also include scientific publications, state-of-the-art science and market data.