Cosmetic claims are statements, messages or indications used to describe the characteristics, functions, benefits or performance of a cosmetic product.

They may appear on labels, packaging, websites, e-commerce pages, catalogues, product sheets, advertising materials, social media and commercial communications.

In the cosmetic sector, claims play an essential role because they help consumers understand the function of the product and make informed purchasing decisions. However, they must be accurate, truthful, documented and compliant with the applicable regulatory framework.

The main reference is Regulation (EU) No 655/2013, which establishes common criteria for the justification of claims used in relation to cosmetic products. This regulation applies in connection with Regulation (EC) No 1223/2009 on cosmetic products.

Why Cosmetic Claims Are Important

A claim is not just a marketing statement.

Every claim attributed to a cosmetic product must be consistent with:

• the formulation;
• the cosmetic function of the product;
• the ingredients used;
• the concentration of active ingredients;
• the available tests;
• the technical documentation;
• the Product Information File;
• the labelling;
• the way the product is communicated to consumers.

A claim that is not properly supported may be considered misleading, especially if it attributes unproven effects, irrelevant properties or benefits that the product cannot actually provide.

For this reason, claims should be assessed before the label, website content or promotional material is published.

The Regulatory Framework for Cosmetic Claims

Regulation (EC) No 1223/2009 provides that, in labelling, making available on the market and advertising of cosmetic products, texts, names, trademarks, pictures or other signs must not be used to imply that products have characteristics or functions which they do not have.

Regulation (EU) No 655/2013 introduced common European criteria to assess whether a cosmetic claim is justified.

The European Commission has also published technical guidance to support the application of these criteria, including specific indications for claims such as “free from” and “hypoallergenic”.

The Six Common Criteria for Cosmetic Claims

According to Regulation (EU) No 655/2013, cosmetic claims must comply with six common criteria:

• legal compliance;
• truthfulness;
• evidential support;
• honesty;
• fairness;
• informed decision-making.

These criteria aim to ensure that claims are useful, understandable, reliable and not misleading for the final consumer.

Legal Compliance

A cosmetic claim must not suggest that the product has a specific benefit when that benefit is simply the result of compliance with legal requirements.

For example, it is not appropriate to present the absence of an ingredient already prohibited by cosmetic legislation as a distinctive product benefit.

Similarly, a product should not be promoted as “compliant with the law” as if this were a special advantage over other products, since legal compliance is a mandatory requirement for all cosmetic products placed on the market.

Truthfulness

Claims must be truthful and consistent with the actual composition and function of the product.

If a cosmetic product is claimed to contain a specific ingredient, that ingredient must actually be present in the formulation.

Furthermore, the properties of a single ingredient cannot automatically be attributed to the finished product unless there is adequate evidence showing that the finished formulation actually provides the claimed benefit.

For example, the presence of an active ingredient known for a specific function is not sufficient on its own to justify a claim if the concentration, bioavailability or overall formulation does not support the declared effect.

Evidential Support

Every claim, whether explicit or implicit, must be supported by adequate and verifiable evidence.

Evidential support may come from different sources, including:

• tests on the finished product;
• instrumental studies;
• clinical studies;
• in vitro tests;
• bibliographic data;
• ingredient documentation;
• experimental data;
• technical and scientific assessments;
• information included in the Product Information File.

Where studies are used as evidence, they should be relevant to the product and to the claimed benefit, and should be based on valid, reliable and reproducible methodologies.

The type of evidence required depends on the claim used. A general claim may require a different level of support compared with a very specific, quantitative or performance-related claim.

Honesty

The presentation of the product’s performance must not go beyond the available supporting evidence.

A claim must describe the benefit in a way that is proportionate to the data available. If a test demonstrates a specific result under defined conditions, the communication should not improperly extend that result to conditions, subjects or benefits that were not assessed.

For example, data obtained on a limited number of subjects, using a specific methodology or measuring a specific parameter, should be communicated in a way that reflects the actual meaning of the study.

Fairness

Claims must be objective and must not denigrate competing products or legally used ingredients.

This criterion is particularly relevant for statements such as “free from”, “without” or similar claims.

A claim should not lead consumers to believe that a legally permitted ingredient is dangerous or should be avoided when it is used in compliance with applicable legislation.

Therefore, claims based on the absence of a substance should also be carefully assessed to ensure that they are useful, accurate and not denigrating.

Informed Decision-Making

Claims must be clear, understandable and useful for the average final user.

Consumers must be able to correctly understand the meaning of the statement, without being misled by ambiguous, overly technical, exaggerated or disproportionate wording.

The context in which the claim is used must also be considered. The same wording may have a different impact depending on whether it appears on a label, in an advertisement, on a website or in a social media campaign.

Explicit and Implicit Claims

Claim assessment does not concern only clearly written statements.

Images, symbols, graphics, product names, product descriptions, communication tone and visual associations may also constitute implicit claims.

For example, claims may also be conveyed through:

• images suggesting a specific effect;
• product names evoking a benefit;
• commercial descriptions on e-commerce pages;
• icons or pictograms;
• comparisons with other products;
• references to functional ingredients;
• social media content;
• advertising slogans.

For this reason, claims assessment should cover the entire product communication, not only the label.

“Free From” and “Without” Claims

Claims such as “free from”, “without” or similar statements must be managed with particular care.

In general, a “free from” claim must be truthful, useful for the consumer and must not denigrate ingredients that are legally allowed under cosmetic legislation.

Examples of claims requiring particular attention include:

• “paraben-free”;
• “silicone-free”;
• “preservative-free”;
• “allergen-free”;
• “fragrance-free”;
• “chemical-free”;
• “free from harmful ingredients”.

Some of these statements may be problematic if they suggest that legally authorised ingredients are dangerous, or if they are not technically correct in relation to the composition of the product.

“Hypoallergenic” Claim

The “hypoallergenic” claim also requires specific assessment.

This type of claim should only be used when the product has been designed to minimise its allergenic potential and when adequate evidence is available to support the statement.

The term “hypoallergenic” cannot be understood as an absolute guarantee that no allergic reaction will occur. It must be assessed in relation to the formulation, ingredients, product profile and available documentation.

Borderline Claims

Some claims may bring a cosmetic product close to other regulatory categories, such as medicinal products, medical devices or biocides.

Particularly sensitive claims include references to:

• cure or treatment of diseases;
• therapeutic action;
• pharmacological effect;
• healing;
• inflammation;
• infections;
• dermatitis;
• acne as a pathological condition;
• antibacterial or antimicrobial action;
• tissue regeneration;
• treatment of pathological skin conditions.

These statements must be assessed carefully, as they may affect product classification and make cosmetic legislation no longer applicable.

Evidence Supporting Claims

The choice of supporting evidence depends on the type of claim and the level of substantiation required.

Depending on the product and the statement, the following may be necessary:

• efficacy tests;
• clinical studies;
• instrumental tests;
• self-assessment studies;
• in vitro tests;
• bibliographic data;
• ingredient documentation;
• comparative assessments;
• scientific literature data;
• technical formulation rationale.

A quantitative claim, such as “reduces wrinkles by 20%”, requires a different level of support compared with a more general claim such as “helps keep the skin moisturised”.

The evidence must be proportionate, relevant and consistent with the message communicated.

Claims and the Product Information File

Proof of the effects claimed for the cosmetic product must be included or made available in the PIF – Product Information File, where justified by the nature of the product or the claim.

This means that claim substantiation must be consistent with:

• formulation;
• tests;
• labelling;
• promotional material;
• website;
• product sheets;
• commercial communication;
• safety assessment;
• CPNP notification, where relevant.

A claim appearing online but not supported in the PIF may still represent a regulatory issue, even if it is not included directly on the product label.

Common Errors in Claim Management

The most common errors include:

• claims that are too strong compared with the available evidence;
• using the properties of an ingredient as if they automatically applied to the finished product;
• “free from” claims that have not been properly assessed;
• claims that denigrate legally permitted ingredients;
• claims with a medical or therapeutic meaning;
• lack of tests or documentation to support the claim;
• improper use of percentages and numerical results;
• inconsistent communication between label, website and social media;
• claims not updated after formulation changes;
• incorrect translations for foreign markets.

A preventive review helps avoid objections and supports clearer, more transparent and compliant communication.

Support in Cosmetic Claim Assessment

Cosmetic claim assessment requires a technical, regulatory and communication-based approach.

Support may include:

• review of claims used on labels;
• review of website, e-commerce and promotional texts;
• assessment of consistency between claims and formulation;
• verification of available evidence;
• evaluation of supporting tests;
• review of “free from” claims;
• assessment of “hypoallergenic” claims;
• analysis of borderline claims;
• support in choosing the most appropriate tests;
• alignment between claims, PIF, labelling and commercial communication;
• review of translations and adaptations for foreign markets.

The objective is to ensure that every claim is correct, sustainable and consistent with the technical documentation of the product.

Clear, Accurate and Documented Claims

Effective communication does not need to be excessive.

A well-formulated claim should highlight the value of the product while respecting the limits set by the regulation and by the available documentation.

Proper claim management allows cosmetic benefits to be communicated transparently, reducing the risk of objections and strengthening the credibility of the product on the market.

For this reason, claim assessment should be integrated from the earliest stages of product development, together with formulation, testing, labelling and the Product Information File.