EU Claims Rules for Skincare: Evidence Standards Under Regulation (EU) 655/2013 (Practical Guide)

Any skincare product placed on the EU market must comply with Regulation (EU) No 655/2013, which sets out common criteria for cosmetic claims. For sourcing managers and brand owners, this isn’t just about marketing wording—it determines what tests, documents, and proof you’ll need before launch. This guide walks you through procurement-ready steps to ensure your product’s claims can stand up to regulatory review without costly relabeling or recalls.

Understanding Regulation (EU) 655/2013 Criteria

The regulation defines six common criteria that all cosmetic claims must meet: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Each has procurement implications:

• Legal compliance: Claims must align with product classification and ingredient restrictions.
• Truthfulness: Marketing text must accurately reflect formulation and proven performance.
• Evidential support: Claims must be substantiated by adequate, verified evidence.
• Honesty: Avoid exaggeration and omit misleading comparisons.
• Fairness: Claims should not denigrate competitors improperly.
• Informed decision-making: Claims must help consumers make informed choices, not cause misunderstanding.

Procurement Actions for Claim Compliance

1. Lock Core Claims Early

• Define up to 3 core claims you plan to feature on packaging and marketing.
• Ensure they match your formulation and intended market positioning.

2. Align Testing with Claims

• For performance claims (e.g., “reduces wrinkles”), request relevant bench, in-vivo, or consumer perception studies.
• Document test protocols and results; these form part of the Product Information File (PIF).

3. Evidence Pack to Request from Manufacturer

4. Label Review and Guardrails

• Ensure INCI list accuracy and match tests to claimed effects.
• Remove any unsubstantiated superlatives (“miracle”, “instant cure”).

Best Practices for Evidence Standards

• Independent verification: Prefer third-party lab reports over internal-only data.
• Representative sampling: Test finished product batches, not only raw ingredients.
• Traceability: Link each claim to specific batch numbers and formulas.

FAQ

Q1: Can I use supplier ingredient studies to support my product’s claims?
Yes, if the ingredient concentration in your formula matches or exceeds the tested level, and the study is relevant to finished product use.

Q2: Do I need consumer perception tests for all claims?
Not always. For sensory claims (e.g., “absorbs quickly”), consumer panels add value; performance claims require technical/clinical data.

Q3: What happens if a claim is found non-compliant?
You may need to withdraw or relabel product, potentially facing fines and reputational damage.

Q4: Is the PIF mandatory for export outside the EU?
The PIF is mandatory for EU sales; other jurisdictions may have similar requirements under different names.

Next Steps

Before locking your product launch timeline, confirm that your manufacturer can supply all claim substantiation documents aligned with Regulation (EU) 655/2013. This will safeguard compliance and market readiness.

Request a Quote now with your product specs, target market, and intended claims to receive a compliance-focused sourcing plan.

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.