EU Claims Rules for Eye Care: How to Make “Anti-Wrinkle / Brightening” Claims Without Regulatory Risk

Eye care formulations promise noticeable improvements—but within the EU, “anti-wrinkle” and “brightening” claims are heavily scrutinized. Brand owners must align scientific evidence, product classification, and labeling wording before any marketing rollout. This guide helps sourcing managers and brand teams design compliant claims from the start, reducing rework and launch delays.

1. Understanding What Triggers EU Claims Scrutiny

Under Regulation (EC) No. 1223/2009 and the Commission’s “Common Criteria for Claims,” every statement on-pack, online, or in ads must be truthful, supported, and not mislead the consumer. The EU differentiates between:

• Cosmetic claims – concerns about beautifying, cleansing, or maintaining skin condition.
• Medical or therapeutic claims – targeting skin structure or physiological function, which may trigger medicinal classification.
• Borderline cases – “anti-wrinkle,” “lifting,” or “regenerating” are acceptable only when effects are surface-level and reversible.

2. Key Decision Points Before You Order Samples

• ✔️ Define if your “anti-wrinkle” narrative is appearance-based (safe) or functional skin modification (risk).
• ✔️ Lock the reference actives early (peptides, niacinamide, plant extracts) and secure technical data sheets.
• ✔️ Request your manufacturer’s claim substantiation dossier, not just marketing slides.
• ✔️ Check that all substantiation studies are conducted on similar formulations, concentrations, and finished products.
• ✔️ Align the wording: “reduces the appearance of fine lines” passes review; “stimulates collagen synthesis” requires caution.

3. What Evidence You Must Request from Your Manufacturer

4. Words to Use (and Words to Avoid)

In EU audit practice, small wording differences determine compliance status:

• Safe: “Helps reduce the appearance of dark circles” / “Visibly improves radiance.”
• Borderline: “Stimulates microcirculation” / “Boosts cell repair.”
• Unsafe (medical): “Heals wrinkles” / “Restores collagen structure.”

Best Practice Wording Tips

• Focus on appearance improvement, not physiological modification.
• Avoid verbs like “repair”, “regenerate”, “heal”.
• Prefer measurable qualifiers: “after 4 weeks”, “clinically tested to improve brightness by 12%.”
• Keep consistency between digital claims and on-pack text.

5. Process Controls During Product Development

1. Pre-formulation: Confirm that the functional ingredients have cosmetic-grade documentation (e.g. IFRA compliance, toxicology data).
2. Testing phase: Commission instrument tests—such as profilometry for wrinkles, chromametry for brightness.
3. Registration: File with CPNP portal before launch; attach responsible person’s details.
4. Marketing approval: Review each claim’s evidence against EU’s six criteria (Legal compliance, Truthfulness, Evidential support, Honesty, Fairness, Informed choice).

6. Practical Actions for Sourcing Managers

• Include “claim substantiation folder” in your RFQ bill of documents.
• Lock test plan before pilot run; otherwise, data won’t be valid for that lot.
• Ask for stability test results (≥3 months at 40 °C) before approving pack materials.
• Validate outer-pack artwork via your Responsible Person or notified consultant.
• Cross-check INCI listings against CosIng database.

7. FAQ: EU Eye Care Claims

1. Can I claim “anti-wrinkle” if I have only consumer feedback tests?

Consumer self-assessment may support a secondary claim (“users noticed fewer wrinkles”), but it cannot stand alone. EU regulators expect instrumental or clinical assessment for performance claims.

2. Is “brightening” accepted under cosmetic scope?

Yes, if it relates to skin radiance or reduction in appearance of dullness. Avoid wording implying physiological bleaching or melanin inhibition without clinical evidence.

3. What studies count as valid proof?

Either published peer-reviewed data on the same concentration or third-party instrumental testing (profilometry, colorimetry). Always link to your exact formulation batch.

4. Can I reuse raw-material supplier data?

Only when conditions match your finished product’s use level and formulation matrix. Otherwise, perform a bridging summary validated by a safety assessor.

5. What happens if a claim is non-compliant?

Authorities may request withdrawal or impose penalties. Additionally, distributors must remove stock from shelves until claims are corrected.

Final Advice

EU regulators focus less on creativity and more on substantiation traceability. For eye care lines positioned as “anti-wrinkle” or “brightening,” source manufacturing partners that proactively supply PIFs and clear claims evidence. Align your compliance review before peak marketing cycles to avoid costly reformulations.

Request a Quote to start your EU-compliant eye care development with claim substantiation support today.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.