Claim Substantiation is a fundamental requirement, especially in areas directly affecting consumer health and choice, such as cosmetic products, to ensure the reliability and veracity of product claims. In the European Union (EU), Cosmetic Claims and their basis are governed by detailed regulations.
The Foundational Framework for Cosmetic Claims in the EU
EU legislation aims to ensure that claims made about cosmetic products are not misleading to consumers and are based on accurate information.
1. Legal Basis
The core provisions concerning Cosmetic Claims are set out in Article 20 of the Cosmetic Products Regulation (EC) No 1223/2009. This article stipulates that, in the labelling, making available on the market, and advertising of cosmetic products, no text, names, trademarks, pictures, or other signs shall be used to imply that the products possess characteristics or functions that they do not have.
2. The Common Criteria: Regulation (EU) No 655/2013
To implement this basic provision and ensure consistent application across the EU, Commission Regulation (EU) No 655/2013 established six common criteria for the justification of claims used in relation to cosmetic products. Compliance with all six criteria is mandatory for a cosmetic claim to be legally made:
- Legal Compliance: Claims that suggest approval by a competent authority or convey a specific benefit that is merely compliance with minimum legal requirements are not allowed.
- Truthfulness: Claims must be true and not misleading. If an ingredient is claimed to be present, it must be deliberately included in the product. Ingredient claims should not imply the finished product has the same properties unless supported by evidence.
- Evidential Support: All claims, whether explicit or implicit, shall be supported by adequate and verifiable evidence. This criterion is the core of Claim Substantiation.
- Honesty: The presentation of a product’s performance should not go beyond the available supporting evidence.
- Fairness: Claims should be objective and not unfairly criticise competitors’ products.
- Informed Decision-Making: Claims should be clear and understandable for the average end-user, who is reasonably well-informed and reasonably observant, allowing for an informed choice.
The Technical Document on Cosmetic Claims
The European Commission published a Technical Document on Cosmetic Claims to aid in the application of Regulation (EU) No 655/2013 and provide non-binding guidance on how the Common Criteria should be interpreted on a case-by-case basis.
This technical document offers detailed information, particularly on how to meet the Evidential Support criterion:
- Nature of Evidence: The evidence must be scientifically sound, relevant, reliable, and robust. Types of evidence can include experimental studies (in vivo, in vitro, ex vivo), consumer perception tests, and scientific literature.
- The Responsible Person: The Responsible Person placing the product on the EU market is accountable for the claims made and must ensure that the necessary evidence is held and referenced in the Product Information File (PIF).
- Quality of Evidence: The evidence must be consistent with the nature and scope of the effect claimed. Where ingredient properties are extrapolated to the finished product, adequate and verifiable evidence—such as demonstrating the presence of the ingredient at an effective concentration—is required.
Conclusion: Why Claim Substantiation Matters
Claim Substantiation is not only a legal requirement but also an ethical obligation. The EU legislation, particularly the guidance provided in the Technical Document on Cosmetic Claims, ensures that cosmetic claims are grounded in scientific facts and that transparent, honest, and reliable information is provided to consumers, thereby protecting them. It mandates high standards in marketing communication while preserving the innovative spirit of the industry.
