From one claim to a substantiation decision

Step 1 · The catalogue record

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Step 2 · The evidence target

Target evidence level

Not assessed

Method profile

Not assessed

Scientific confidence

Not assessed

The target level sets the ceiling a dossier can reach: a dossier declared at E5 is capped at 89/100 whatever its component scores.

Step 3 · Market screening

Screening risk flags where wording and procedure need attention first. It is never an authorisation.

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Step 4 · Complete product dossier assessment

Worked example. The dossier is scored for one product and one exact wording; it never changes the catalogue score.

Product and batch

Demo moisturising cream — batch D-2419

Country

France (EU)

Reviewer

Evidence review, internal panel

Achieved evidence level

E5 (cap 89)

Exact wording assessed · Increases skin hydration by 38% after 4 weeks of twice-daily use

Evidence held · Randomised, vehicle-controlled clinical study, 62 subjects, 28 days, corneometry at D0/D14/D28, controlled room (21 °C, 45% RH), acclimatisation 30 min, per-protocol and ITT analyses, external CRO report ref. CRO-2245.

• Design /25 — 21
  Randomised, vehicle-controlled, adequate sample size
• Endpoint /20 — 18
  Corneometry is the accepted direct endpoint for hydration
• Effect /20 — 15
  +38% versus baseline, +21% versus vehicle
• Statistics /15 — 12
  p<0.001, effect size and CI reported, ITT plus per protocol
• Relevance /10 — 7
  Population matches target consumers, single ethnicity group
• Transparency /10 — 8
  Full CRO report, raw data available, protocol pre-registered internally

• ✓ Local regulatory procedure verified (EU Reg. 655/2013 common criteria)
• ✓ Safety assessment confirmed for the finished product
• ✗ Final wording signed off by regulatory and marketing

Dossier score: 81/100

One mandatory check is still open (final wording sign-off), so the claim cannot be considered substantiated for launch, whatever the score.