Label Warnings for "Eye-Area Safe" Makeup Removers: Which Ingredients Require "Avoid Contact with Eyes" Labeling?

I. "Eye-Area Safe" is One of the Most Easily Misunderstood Claims

On makeup remover packaging, claims such as "Suitable for Eye Area," "Gentle enough for eyes," and "Ophthalmologist-Tested" are becoming increasingly common. However, behind these claims lies a compliance question that brand owners rarely proactively ask: Does the formula contain ingredients that EU regulations explicitly require to be labeled with "Avoid contact with eyes"? If so, can the product still claim "Suitable for Eye Area"?

The answer directly impacts product launch, label design, and brand claim strategies. It is also a core compliance boundary that OEM/ODM factories must clarify with brand owners right at the formulation stage.

II. The Regulatory Source of the "Avoid Contact with Eyes" Label: The Mandatory Labeling Mechanism of EU Annex III

In the EU, the use of the "Avoid contact with eyes" warning on cosmetic labels is not merely a conservative voluntary measure by the brand—it is the result of a regulatory mandate.

EU Cosmetics Regulation (EC) No 1223/2009 Annex III lists restricted ingredients and their corresponding conditions of use, which include mandatory warnings to be printed on the product label. "Avoid contact with eyes" is one of the most common regulatory mandatory warnings. The Annex requires that if a product contains specific restricted ingredients listed in Annex III, the corresponding warnings or conditions of use must be indicated on the label.

The EU Cosmetics Regulation defines warnings as statements alerting consumers to potential risks, hazards, or specific safety precautions. The "Avoid contact with eyes" warning applies to scenarios where specific ingredients pose an eye contact risk, and it is listed alongside other core mandatory EU cosmetic label warnings such as "Patch test before use" or "Not suitable for children under three years of age."

This means: if a product formula contains specific restricted ingredients listed in Annex III, the brand must print the corresponding warning on the label, and this requirement is completely independent of whether the brand subjectively wants to claim "Suitable for Eye Area."

III. 2026 Latest Developments: New "Avoid Contact with Eyes" Requirements in the EU Omnibus Act VIII

2026 is a critical node for EU cosmetic label compliance—the formal implementation of Omnibus Act VIII introduces new ingredient restrictions and labeling requirements.

EU Regulation (EU) 2026/78 (Omnibus Act VIII) was officially published on January 13, 2026, and takes effect on May 1, 2026. It makes no distinction between newly launched products and existing products—from this date, all non-compliant products must be withdrawn from the EU market, with no inventory transition period.

Omnibus Act VIII Updates to Annex V (List of Allowed Preservatives): The use of o-Phenylphenol and its sodium salt as antimicrobial preservatives is restricted to a maximum of 0.2% for rinse-off products and 0.15% for leave-on products, and it must be mandatorily labeled with "Avoid contact with eyes"; it is also banned in oral products and products that may cause consumers pulmonary inhalation exposure.

EU Omnibus Act VIII was officially notified to the World Trade Organization on May 21, 2025, and takes effect on May 1, 2026. All non-compliant products must be withdrawn from the EU market before this date.

Direct Implication for Brand Owners: New formulas developed entering 2026 must re-evaluate their preservative systems for Annex V compliance, ensuring that formulas using o-Phenylphenol have updated labels and have evaluated their compatibility with "eye-area safe" claims.

IV. Which Ingredients Require "Avoid Contact with Eyes" Labeling? A Systematic Categorical Analysis

Below are the most common categories of ingredients in makeup remover formulas that trigger the mandatory "Avoid contact with eyes" warning label under the EU cosmetics regulatory framework:

Category 1: Active Acid Ingredients — Salicylic Acid, AHAs

Salicylic Acid Salicylic acid is a common efficacy ingredient in oil-control makeup removers. Under EU regulations, it is an Annex III restricted ingredient, with a maximum allowed concentration of 2% in facial makeup removers (rinse-off). The eye irritation mechanism of salicylic acid comes from two levels: first, the lipophilicity of BHA (beta-hydroxy acid) allows it to penetrate the lipid barrier and contact the conjunctival lipid layer; second, the formulation pH ≤4.5 has a significant gap with tear pH 7.4, causing burning and stinging upon contact with the eye mucosa. EU Regulatory Requirement: Rinse-off products containing salicylic acid must state "Not to be used for children under three years old" on the label; in practice, makeup removers containing salicylic acid at higher concentrations (>0.5%) usually must bear the "Avoid contact with eyes" warning, and claiming "Suitable for Eye Area" is not recommended. Brand Impact: There is a fundamental tension between the product demands of "salicylic acid oil-control makeup remover" and "eye-area safe"—brand owners must make a clear choice between the two rather than claiming both simultaneously.

Category 2: Peroxides/Oxidizing Agents — Hydrogen Peroxide

Hydrogen Peroxide Some makeup removal products with whitening or antibacterial efficacy have introduced hydrogen peroxide, but this ingredient has explicit labeling requirements in EU Annex III. EU Cosmetics Regulation Annex III explicitly stipulates that cosmetics containing hydrogen peroxide must be labeled with "Contains hydrogen peroxide" and must include the warning "Avoid contact with eyes." Hydrogen peroxide has oxidative damaging effects on corneal epithelial cells; even low-concentration contact can cause corneal irritation and temporary blurred vision. In the category of makeup removers, which carry a risk of eye-area contact, its use should be particularly cautious, and any content must bear the complete warning.

Category 3: Preservative Ingredients — Specific Preservatives Trigger Eye-Area Warnings

o-Phenylphenol / Sodium o-Phenylphenate As mentioned earlier, these preservatives were updated in Omnibus Act VIII (effective May 1, 2026) to require mandatory labeling of "Avoid contact with eyes" on product labels, with maximum usage of 0.2% for rinse-off and 0.15% for leave-on products. Benzalkonium Chloride (BAK) Although BAK is allowed as a preservative in rinse-off products under EU regulations, its toxicity to corneal epithelial cells has been confirmed in extensive ophthalmological literature. It usually requires explicit eye-area usage warnings on the label, and it is recommended to replace it with a safer preservation system in eye-area products.

Category 4: Zinc Salt Ingredients — Zinc 4-hydroxybenzene sulphonate

EU Cosmetics Regulation Annex III explicitly stipulates the conditions of use for Zinc 4-hydroxybenzene sulphonate: the product label must state "Avoid contact with eyes." This ingredient is not uncommon in oil-control makeup removers; its astringent and oil-control efficacy makes brand owners inclined to include it in oil-control/refreshing makeup remover formulas—but once used, the eye-area warning must be labeled, which directly conflicts with the product positioning of "eye-area makeup removal."

Category 5: High-Concentration Active Ingredients — Retinol, Niacinamide

These two ingredients themselves are not listed in EU regulations as requiring mandatory "Avoid contact with eyes" labeling, but there are the following points to note in actual product label design:

Retinol: The irritation of retinol comes from its acceleration of cell turnover; using retinol in products that contact the eye area like makeup removers, even at low concentrations (0.01%–0.3%), requires the brand to fully evaluate the eye contact scenario in the safety assessment (CPSR) and note corresponding usage instructions on the label. Many retinol-containing products proactively label "Avoid contact with eyes" as a safety margin.

Niacinamide: At the usual usage concentration of 2%–5%, niacinamide has low irritation to the eye mucosa and generally does not trigger the mandatory "Avoid contact with eyes" labeling requirement. However, makeup removers with high concentrations (>5%) of niacinamide are recommended to undergo specific eye irritation assessments before confirming the label copy.

V. Compliance Pathways to Achieve the "Eye-Area Safe" Claim

For brand owners, the compliance pathway to achieve the "eye-area safe" claim requires systematic planning starting from the formulation design stage:

Pathway 1: Completely Exclude "Triggering Ingredients" at the Formulation Level

The most fundamental solution is: during the formulation design stage, proactively exclude all ingredients in Annex III/V that trigger the mandatory "Avoid contact with eyes" labeling. Specific Strategies:

• Use Poloxamer 184 as the core cleansing ingredient to replace the oil-control mechanism of active acids (salicylic acid).

• Replace o-Phenylphenol and Benzalkonium Chloride preservation systems with Pentylene Glycol + Phenoxyethanol (≤0.5%).

• Use Niacinamide (≤3%) + Zinc PCA to achieve oil-control efficacy, replacing Zinc 4-hydroxybenzene sulphonate.

• Control Menthol usage at ≤0.1% (if used), or replace it with Menthyl Lactate (≤0.2%).

After excluding the above triggering ingredients, there are no ingredients in the formula that legally mandate "Avoid contact with eyes," laying the formulation foundation for the "eye-area safe" claim.

Pathway 2: Conduct Specific Eye Irritation Testing

Even if triggering ingredients have been excluded at the formulation level, the "eye-area safe" claim still requires scientific data support. The following tests are recommended:

• In Vitro Eye Irritation Alternative Tests: Such as the EpiOcular™ eye irritation model (in vitro test based on reconstructed human corneal epithelium) or the HET-CAM (Hen's Egg Test-Chorioallantoic Membrane) test, replacing animal eye irritation tests (Draize Eye Test), aligning with the EU direction of animal testing alternatives.

• Human Tolerance Assessment (Human Patch Test / In-Use Study): Recruit volunteers with sensitive periorbital skin to conduct a 28-day repeat-use evaluation under the supervision of an ophthalmologist, recording the incidence of eye irritation reactions.

• pH Verification: Confirm the product pH is within the 6.5–7.2 range, close to tear pH (7.42 ± 0.1), to reduce the risk of pH irritation upon contact with the eye mucosa.

Pathway 3: Precise Label Wording

Even if both the formulation and test data support eye-area use, the wording on the label must still be cautious:

Claim Method	Compliance Assessment
"Ophthalmologist-Tested"	✅ Compliant, but specific testing methods and results must be provided.
"Suitable for use around eyes"	✅ Compliant, must be supported by test data.
"Gentle enough for contact with skin around eyes"	✅ Compliant, more conservative wording.
"Specifically for eyes and lips, can directly contact eyes"	⚠️ High-risk wording, requires extremely strong data support.
"No need to avoid contact with eyes"	❌ High risk unless there is sufficient clinical evidence.

VI. Comparison of "Eye-Area Warning" Compliance Requirements Across Different Markets

Market	Regulatory Basis	"Avoid Contact with Eyes" Trigger Mechanism	Special Requirements
European Union (EU)	EC 1223/2009 Annex III/V; EU 2026/78 Omnibus Act VIII	Mandatory labeling for ingredients listed in regulations	New ingredients must comply from May 1, 2026.
United Kingdom (UK)	Post-Brexit independent execution; UK version basically parallel to EU system	Refer to EU Annex III/V	Must separately confirm the latest status of UK regulatory authorities.
United States (MoCRA)	FDA cosmetic labeling 21 CFR 701	No similar mandatory ingredient trigger mechanism as the EU	Claims determine regulatory category; efficacy claims must avoid crossing into drug claims.
China (NMPA)	Cosmetics Labeling Management Measures (2021)	Labeling content must be determined based on product safety assessment	Eye cosmetics must undergo eye irritation testing.
ASEAN	ACD (ASEAN Cosmetics Directive)	Refer to international standards; enforcement intensity varies by member state	Must check the local refined requirements of the target sales countries.

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Makeup Remover Conclusion: Every Warning on the Label is a Mirror of Formulation Decisions

The four words "Avoid contact with eyes" printed on the label may seem like just a line of small text, but it is the endpoint manifestation of the entire formulation decision chain—it tells consumers the usage boundaries of the product, and it tells regulatory agencies the brand owner's level of awareness regarding formulation risks.

In a market environment where more and more brands are competing to claim "eye-area safe," the formulations that truly realize this claim—completely excluding all EU mandatory warning triggering ingredients, completing scientific validation of eye irritation, and having label copy professionally reviewed by regulatory experts—are the products that possess a true competitive moat.

If you are planning eye-specific makeup removers, full-face usable makeup removal liquids, or eye-area safe cleansing series, please feel free to connect deeply with our formulation and compliance teams.