Which claims are considered "high-risk" and need stronger evidence?

Efficacy claims (e.g., "reduces wrinkles by X%"), comparative claims (e.g., "better than Brand Y"), and clinically proven claims carry the highest substantiation burden and typically require consumer studies or clinical trials.

Is a claims review the same as a CPSR?

No. A CPSR (Cosmetic Product Safety Report) is a broader safety assessment. Claims substantiation specifically assesses whether your marketing claims are adequately supported by evidence. Both are required but are separate documents.

Book a Cosmetic Claims Substantiation Review Online

Book a cosmetic claims substantiation review online. Compare vetted EU Cosmetics Regulation Article 12 specialists for product claims evidence review. Instant pricing.

✓ 3 active providers available right now · EUR 253 – 313

Why this page is different

Instant pricing: See a price estimate immediately (no back-and-forth RFQ needed for these services).
Compare before booking: Review inclusions, exclusions, turnaround, and communication channels.
Charged only when accepted: You are charged only after a provider accepts your order and scope.
Live availability: 3 active providers available right now for this service.

What you can compare here

Total price: See live price ranges and instant pricing rules where available.
Coverage & scope: Markets served, what is included, and what is explicitly excluded.
SLA & responsiveness: Acceptance SLAs and typical turnaround windows.
Add-ons: Optional extras you can book next (shown as add-on chips).
Onboarding time: How quickly providers can start and what you need to supply.

Compare providers (instant pricing + book)

Provider	Estimated base price	Accept SLA	Turnaround	Start
Alpha Regulatory Partners	USD 275	24h	3–7 days	Within 2 business days
Beta Compliance Group	USD 313	24h	3–7 days	Within 2 business days
Gamma RegTech Solutions	USD 253	24h	3–7 days	Within 2 business days

Estimates are derived from each provider’s published pricing rules (and may vary by your inputs).

What affects pricing

These are the inputs providers use to price your order. Enter them once, then compare providers and book instantly.

claimsCount (Required)
min 1
markets (Required)
min 1
productType (Required)
general|baby|eye_area|aerosol|hair_dye|oral_care|sunscreen_otc
claimsRisk (Required)
low|medium|high
turnaround (Required)
standard|rush
desiredOutputs (Required)
min 1
uploads (Optional)
optional supporting materials
buyerNotes (Optional)

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Standard

EU Reg. 655/2013

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Output

Claims gap report

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Turnaround

2–7 business days

💰

Pricing

Per product / claim set

How it works

1

Submit your product claims and evidence

Share the marketing or on-pack claims you wish to make, along with any supporting test data or studies.
2

Compare claims review specialists

View fees and turnaround from cosmetic regulatory experts familiar with Reg. 655/2013 common criteria.
3

Receive your claims gap report

Your reviewer assesses which claims are substantiated, which need additional evidence, and which should be amended.

What is cosmetic claims substantiation under EU law?

Under EU Cosmetics Regulation 1223/2009 and implementing Regulation 655/2013, all marketing claims for cosmetic products sold in the EU must comply with six common criteria: (1) legal compliance — the claim must not violate applicable law; (2) truthfulness — the claim must not attribute characteristics or functions that the product does not possess; (3) evidential support — the claim must be supported by adequate and verifiable evidence; (4) honesty — the claim must not mislead by implication or omission; (5) fairness — comparative claims must be fair and not denigrate competitors; and (6) informed decision-making — claims must not mislead consumers about the overall benefit. Substantiation files must be kept in the Product Information File (PIF) and available to competent authorities on request.

What types of evidence can substantiate a cosmetic claim?

Acceptable forms of evidence include: laboratory test results (e.g., in-vitro studies of active ingredient performance); clinical studies (consumer use studies, expert panel assessments, dermatological studies); instrumental measurement studies (e.g., corneometry, tewametry, chromametry); literature reviews of published scientific data; ingredient supplier data sheets; and consumer perception studies (for subjective claims like "feels softer"). Higher-impact claims require higher-quality evidence — a clinical trial or peer-reviewed study is expected for claims like "clinically proven to reduce wrinkles by X%" whereas a single consumer perception study may support a claim like "skin feels more hydrated."

High-risk claims: what needs strong substantiation

The following claim categories carry the highest regulatory scrutiny in EU markets: comparative claims ("better than Brand X"), quantified efficacy claims ("reduces wrinkles by 40%"), clinical or dermatological endorsement claims ("clinically tested," "dermatologist approved"), before/after imagery, anti-ageing claims with specific biological mechanism references, and SPF claims. For each of these, your substantiation dossier must include methodology-specific evidence, adequate sample sizes in studies, and clearly defined endpoints. Claims that imply a medicinal effect (e.g., "heals skin," "cures eczema") are not permitted for cosmetics and would reclassify the product as a medicine.

UK claims substantiation after Brexit

The UK follows the retained EU Cosmetics Regulation for claims substantiation, including the six common criteria framework from Regulation 655/2013 which was incorporated into UK law. In practice, a substantiation dossier prepared for the EU market is generally also acceptable for the UK market, as the requirements are nearly identical. The OPSS (Office for Product Safety and Standards) enforces UK claims rules and has been active in issuing guidance and enforcement actions for misleading cosmetic claims, particularly in digital marketing and social media channels. Always ensure your claims substantiation covers both the on-pack claims and any digital marketing content.

Frequently asked questions

What is cosmetic claims substantiation?: Under EU Cosmetics Regulation Reg. 655/2013, all cosmetic product claims must comply with six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. Substantiation is the documented evidence that supports each claim.
Which claims are considered "high-risk" and need stronger evidence?: Efficacy claims (e.g., "reduces wrinkles by X%"), comparative claims (e.g., "better than Brand Y"), and clinically proven claims carry the highest substantiation burden and typically require consumer studies or clinical trials.
Is a claims review the same as a CPSR?: No. A CPSR (Cosmetic Product Safety Report) is a broader safety assessment. Claims substantiation specifically assesses whether your marketing claims are adequately supported by evidence. Both are required but are separate documents.

How Cruxi Bridge vets providers

✓ Every provider submits regulatory expertise evidence and jurisdictional coverage claims
✓ Providers that go live agree to the Cruxi Bridge Provider Terms including service delivery and accuracy obligations
✓ Payment is held by Cruxi and only released to the provider after service delivery milestones
✓ Buyers can raise a dispute within 30 days — Cruxi reviews and mediates per the platform terms

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