Cosmetic claims are a key element of the cosmetics industry. Every brand wants to make their product claims as noticeable and appealing to consumers as possible – it is the industry’s job to ensure cosmetic claims are fair, honest and legally compliant through compliance to relevant regulations.
What are claims?
In the domain of cosmetic product regulation, a “claim” encompasses any assertion regarding a product’s attributes, efficacy, or intended effects. Under Article 20 of the European Union (EU) Cosmetics Regulation, such claims are rigorously monitored to prevent misleading representations, ensuring that product labeling, marketing, and advertising do not suggest properties or functionalities that the product does not demonstrably possess.
Cosmetic Claims in the European Union
Cosmetic claims in the EU are subject to EU Regulation 1223/2009, which delineates overarching principles for permissible statements regarding cosmetic products. Unlike some regulatory bodies, the EU does not maintain an exhaustive positive list of acceptable claims. This is a deliberate approach, recognizing the dynamic nature of scientific discovery and technological advancements in the cosmetic industry.
Instead, the EU mandates adherence to Common Criteria for Cosmetic Claims, effective since July 2013, which emphasize:
- Legal Compliance
- Truthfulness
- Evidential Support
- Honesty
- Fairness
- Informed decision-making
A 2016 compliance review demonstrated a 90% adherence rate to these criteria. Notably, regulatory scrutiny identified significant concerns regarding “free-from” claims and the evidentiary threshold for “hypoallergenic” claims. Consequently, the EU promulgated supplementary guidance, particularly addressing misleading “free-from” assertions (e.g., “paraben-free”), which may imply unjustified safety concerns about legally sanctioned ingredients.
The Product Information File (PIF) must comprehensively document scientific substantiation for any claim. Commission Regulation (EU) No. 655/2013 provides additional clarity, particularly regarding ambiguous claims such as “free-from” and “hypoallergenic.”
Legal compliance
- (1) Claims that indicate that the product has been authorised or approved by a competent authority within the Union shall not be allowed.
- (2) The acceptability of a claim shall be based on the perception of the average end user of a cosmetic product, who is reasonably well-informed and reasonably observant and circumspect, taking into account social, cultural and linguistic factors in the market in question.
- (3) Claims which convey the idea that a product has a specific benefit when this benefit is mere compliance with minimum legal requirements shall not be allowed.
Truthfulness
- (1) If it is claimed on the product that it contains a specific ingredient, the ingredient shall be deliberately present.
- (2) 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.
- (3) Marketing communications shall not imply that expressions of opinions are verified claims unless the opinion reflects verifiable evidence.
Evidential Support
- (1) 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.
- (2) Evidence for claim substantiation shall take into account state of the art practices.
- (3) 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 (valid, reliable and reproducible) and shall respect ethical considerations.
- (4) 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.
- (5) 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.
- (6) 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.
- (7) Assessment of the acceptability of a claim shall be based on the weight of evidence of all studies, data and information available depending on the nature of the claim and the prevailing general knowledge to the end users.
Honesty
- (1) Presentations of a product’s performance shall not go beyond the available supporting evidence.
- (2) Claims shall not attribute to the product concerned specific (i.e. unique) characteristics if similar products possess the same characteristics.
- (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.
Fairness
- (1) Claims for cosmetic products shall be objective and shall not denigrate the competitors, nor shall they denigrate ingredients legally used.
- (2) Claims for cosmetic products shall not create confusion with the product of a competitor.
Informed decision-making
- (1) Claims shall be clear and understandable to the average end user.
- (2) Claims are an integral part of products and shall contain information allowing the average end user to make an informed choice.
- (3) Marketing communications shall take into account the capacity of the target audience (population of relevant Member States or segments of the population, e.g. end users of different age and gender) to comprehend the communication. Marketing communications shall be clear, precise, relevant and understandable by the target audience.
Cosmetic Claims Across the Globe
United States of America (USA)
The US regulatory framework for cosmetic claims is codified in Title 21, Chapter 9, Subchapter VI of the United States Code. This legislation mandates that:
- Product labeling must not be false or misleading (Section 5a).
- Advertising claims must be verifiable, truthful, and non-deceptive (enforced by the National Advertising Division (NAD)).
A primary distinction between US and EU regulation concerns medicinal implications in cosmetic claims. Statements implying structural or physiological modifications—such as “stimulating collagen production”—may reclassify a product as a drug, thereby subjecting it to more stringent FDA oversight.
ASEAN Region
ASEAN regulatory frameworks largely mirror the EU model. However, localized adaptations exist, such as Indonesia’s mandatory Halal certification initiative, projected for full implementation between 2019 and 2024. Compliance with such region-specific mandates is critical for market entry.
Japan
Japan bifurcates cosmetic products into Cosmetics and Quasi-drugs, permitting only 56 pre-approved claims. While rewording claims is allowed, their substantive meaning must remain within the established cosmetic definitions.
- Cosmetic Claims: Skin cleansing, UV protection, and hydration
- Quasi-drug Claims: Acne prevention, melanin suppression, and skin irritation mitigation
South Korea
South Korean regulations classify products into Cosmetics, Functional Cosmetics, and Quasi-drugs. Functional cosmetics encompass products such as skin whiteners, sunscreens, and anti-aging formulations. Additionally, several product categories—including acne washes and hair-loss prevention treatments—have been reclassified from Quasi-drugs to Functional Cosmetics.
China
China’s regulatory structure categorizes specific claims (e.g., whitening, slimming, hair regrowth) as “Special Cosmetics,” necessitating rigorous validation and potential re-evaluation by regulatory authorities. Ongoing regulatory reforms aim to implement a risk-based classification system, reducing the number of products classified as Special Cosmetics while reclassifying oral care products as General Cosmetics.
Canada
Cosmetic claims in Canada are governed by the Consumer Packaging and Labelling Act and the Competition Act, under the oversight of the Competition Bureau. These regulations ensure that advertising claims are transparent, verifiable, and compliant with fair trade principles.
Australia
Australia regulates cosmetic claims through the Therapeutic Goods Administration (TGA) and the Australian Competition and Consumer Commission (ACCC), focusing on ensuring that marketing claims are neither misleading nor deceptive under consumer protection statutes.
Cosmetic Claim Enforcement
The advertising of cosmetic products is subject to stringent regulatory scrutiny. In the UK, for example, the Advertising Standards Authority (ASA) monitors compliance across broadcast and non-broadcast platforms:
- Broadcast Advertising: Encompasses television, radio, and cinema advertisements, necessitating pre-clearance from regulatory entities such as Clearcast (for television) and the Radio Advertising Clearance Centre (RACC) (for radio). The Broadcast Codes of Advertising Practice (BCAP codes) dictate the regulatory framework for such media.
- Non-Broadcast Advertising: Covers digital platforms, print media, and websites. While pre-clearance is not obligatory, adherence to the CAP Code (regulated by the Committee of Advertising Practice (CAP)) is required to ensure that claims are substantiated, clear, and non-misleading.
The UK’s telecommunications and broadcasting regulator, OFCOM, delegates pre-clearance authority for television advertisements to Clearcast, while radio advertisements undergo evaluation by the RACC. Additionally, Pay-TV networks such as QVC operate within proprietary regulatory frameworks aligned with BCAP codes.
The advertising industry also facilitates preemptive regulatory consultation, offering advertisers the opportunity to seek advisory opinions on prospective campaigns, thereby mitigating non-compliance risks prior to dissemination.
