The Compliance Boundaries of "Gentle Makeup Removal" Claims: A Comparison of Efficacy Substantiation Requirements in China, the EU, and the US

I. "Gentle Makeup Removal" is the Most Popular Claim, but Also the Most Prone to Compliance Pitfalls

On makeup remover product pages, claims such as "gentle and non-irritating," "zero-irritation gentle formula," and "suitable for sensitive skin" are among the most frequently used. However, as regulatory scrutiny tightens in major global cosmetic markets, this phrase has evolved from a mere marketing rhetoric into a legal commitment that requires scientific substantiation.

The cost of getting it wrong is rising. The EU's Green Claims Directive is expected to be fully enforced in 2026; the US MoCRA has statutoryized safety and efficacy substantiation since 2023; and China has fully implemented the Specification for Cosmetics Claim Substantiation since 2022. Although the regulatory logic across the three major markets differs, the direction is consistent: "gentle" can no longer be just the formulator's subjective judgment; it must be backed by data.

This article will deconstruct the compliance boundaries and verification pathways for "gentle makeup removal" claims in practical operations based on the regulatory frameworks of the three markets, helping brand owners and OEM/ODM factories establish clear compliance awareness in international business.

II. The Chinese Market: Efficacy Claim Evaluation Has Entered the Mandatory Era

Regulatory Framework

On April 9, 2021, the National Medical Products Administration (NMPA) issued two core documents: the Classification Rules and Catalog for Cosmetics and the Specification for Cosmetics Claim Substantiation, which officially came into effect on May 1, 2021, marking the formal entry of the Chinese cosmetics industry into the era of efficacy evaluation.

Since January 1, 2022, cosmetic registrants and filers applying for special cosmetic registration or filing general cosmetics must evaluate product efficacy claims in accordance with the Specification and upload a summary of the basis for the efficacy claims to a dedicated website designated by the NMPA, subject to public supervision.

Specific Requirements for "Gentle" Claims

The regulatory granularity for "gentle" claims in China is continuously being refined. The Beijing Cosmetics Advertising Publication Guidelines, issued by the Beijing Medical Products Administration in June 2025, explicitly stipulates:

• For cosmetics advertising claiming "mild and non-irritating," there must be efficacy claim evaluation test proof, conducting efficacy evaluation through human efficacy evaluation tests, consumer use tests, or laboratory tests.

• For cosmetics advertising claiming suitability for sensitive skin or tear-free formulas, efficacy evaluation must be conducted through human efficacy evaluation tests or consumer use tests—the standard is higher, and purely laboratory tests are not accepted as the sole basis.

Analysis of Three Verification Methods

According to the Specification for Cosmetics Claim Substantiation, efficacy evaluation can be conducted through the following methods, with different claims corresponding to different minimum requirements:

1. Literature Support: Supporting the "gentleness" at the raw material level by citing published scientific research data. Suitable for conservative claim descriptions that can be directly matched with raw material safety data (e.g., "Amino acid formula, mild and non-irritating").

2. Laboratory Testing: Includes in vitro eye irritation alternative tests (such as the HET-CAM method) and skin irritation tests. Can serve as effective support for "gentle" claims, but for higher-level safety statements like "suitable for sensitive skin" or "tear-free formula," laboratory tests cannot be the sole basis for substantiation.

3. Human Efficacy Evaluation / Consumer Use Tests: For sensitive skin suitability claims, human-level evaluation data must be provided, typically requiring no less than 30 (some institutions require 50) subjects to participate, and an evaluation report stamped by a qualified institution must be issued.

Notably, in November 2025, the NMPA issued the Opinions on Deepening Cosmetic Regulatory Reform to Promote High-Quality Industry Development, explicitly stating that, except for spot-removing/whitening, sunscreen, and anti-hair-loss efficacy, cosmetic registrants/filers are allowed to independently choose efficacy claim evaluation test methods and allowed to share efficacy claim evaluation test data for products of the same brand with similar formulation systems. This reduces compliance costs to a certain extent, but the substantiation requirements for "gentle/sensitive skin" claims remain uncompromised.

III. The EU Market: Six Common Criteria Build the Claim Baseline, with Flexible but Strict Substantiation

Regulatory Framework

The core regulations for EU cosmetic claims are Regulation (EU) No 655/2013 (Common Criteria for Cosmetic Claims), which, combined with Article 20 of Regulation (EC) No 1223/2009 (Cosmetics Regulation, CPR), constitutes the claim compliance system.

According to the Common Criteria, all cosmetic claims—whether explicit or implicit—must be supported by adequate and verifiable evidence, regardless of the type of evidence used. If studies are used as evidence, they must be relevant to the product and the claimed efficacy, follow well-designed, methodologically sound testing protocols (valid, reliable, and reproducible), and comply with ethical considerations.

The Six Common Criteria are: Legal Compliance, Truthfulness, Evidential Support, Honesty, Fairness, and Informed Decision-Making.

Verification Pathways for "Gentle" Claims

In the EU, "Mild/Gentle," "For Sensitive Skin," and "Hypoallergenic" are all efficacy claims requiring substantiation.

Taking the "Hypoallergenic" claim as an example, according to EU technical document guidelines, the product should not contain any allergens, and there must be sufficient, statistically reliable data proving the product has an extremely low sensitization potential. Notably, this claim faces additional regulatory restrictions in some member states (such as Germany).

Under the EU regulatory framework, claims need to be substantiated through one of the following methods: rigorously designed efficacy tests, consumer use studies, or a combination of both.

The characteristic of the EU system is that the substantiation methods are relatively flexible (no mandatory designated methods), but each claim must establish a clear evidence chain and be filed in the Product Information File (PIF) for regulatory authorities to review at any time.

Key 2026 Compliance Milestone

EU Regulation 2023/1545 has expanded the list of fragrance allergens requiring mandatory labeling to approximately 82. When allergens exceed a concentration of 0.001% in leave-on products or 0.01% in rinse-off products, they must be individually labeled. The compliance deadline for newly launched products is July 31, 2026, and for existing products on the market, it is July 31, 2028. For all gentle makeup removers labeled "hypoallergenic" or "allergen-free," this means the fragrance formulation must be comprehensively reviewed this year.

IV. The US Market: MoCRA Builds the Statutory Safety Substantiation Framework, FTC Regulates Claim Expression

MoCRA: Safety Substantiation Enters the Statutory Track for the First Time

According to the Modernization of Cosmetics Regulation Act (MoCRA) passed in the US in 2022, manufacturers must maintain records of safety substantiation based on toxicological data, safety testing, or written assessments by qualified experts, which must be readily available for FDA inspection.

The safety substantiation requirements officially took effect on December 29, 2023. This marks the first time in US cosmetic regulatory history that manufacturers are required at the federal level to maintain written records of product safety substantiation, signaling a historic shift from "passive regulation" (post-incident accountability) to "active substantiation" (pre-market filing).

FTC: Claims Must Have "Competent and Reliable Scientific Evidence"

At the claim expression level, the US Federal Trade Commission (FTC) is the primary regulator for claims such as "gentle," "non-irritating," and "non-sensitizing."

The FTC reviews claims like "Hypoallergenic," "Natural," and "Dermatologist Recommended," especially when such claims are used to imply that a product is safer or more effective than others. Without adequate substantiation, such claims may trigger FTC enforcement actions.

The FTC defines "Competent and Reliable Scientific Evidence" as: tests, analyses, research, or studies conducted and evaluated by experts in the relevant field in an objective manner, where the methods are generally accepted by peers to produce accurate and reliable results. The research must be sufficient in both quality and quantity and meet the standards generally accepted in the relevant scientific field.

This means that for health-related statements like "gentle and non-irritating," the actual substantiation standard in the US market is: randomized controlled human clinical trials, rather than simple consumer perception surveys or raw material safety data citations.

Are you looking for a reliable Skincare factory?

Are you seeking a trusted partner to launch or scale your skin care line? At Deva Skincare,we specialize in developing safe formulations that combine barrier science with clean, compliant manufacturing.

Our R&D team and certified production facilities deliver turnkey OEM/ODM solutions tailored to your target market’s regulatory and consumer expectations.

By collaborating with Deva Skincare, you gain access to industry-leading expertise and innovative formulations that set your brand apart in the competitive global market. Contact us today to discover how we can help you succeed.