A robust substantiation plan starts before testing. First define the precise meaning of the claim, then choose the method, population, comparator and endpoint capable of demonstrating it.
Turn the marketing idea into a measurable claim
Statements such as moisturises, smooths, reduces the appearance of wrinkles or works for 24 hours have different evidential needs. Define the effect, magnitude, duration, use conditions and target population.
A vague concept can lead to a study that produces interesting data but does not support the wording marketing wants to publish. Regulatory and marketing teams should agree the wording before commissioning work.
Select the type of evidence
Instrumental measurements quantify physical properties, clinical assessment involves expert observation and consumer studies record subjective experience. Literature and ingredient data may provide supporting evidence.
Ingredient evidence cannot automatically be transferred to the finished product. Concentration, vehicle, use and interactions determine whether an extrapolation is justified.
Practical checkpoint
Every conclusion should be linked to the exact formula, document and market-material version. This makes it possible to demonstrate which evidence supported the regulatory decision.
Study design and bias control
The plan defines inclusion criteria, sample size, duration, instructions, comparator or baseline, statistical approach and handling of deviations. Design should follow the claim, not the other way round.
Blinding, randomisation and standardised conditions can reduce bias where applicable. All predefined outcomes should be reported, including those that are not statistically significant.
Interpret results and word the claim
Statistical significance is not the same as a practically meaningful effect. Wording should reflect the magnitude, consistency and limitations of the evidence without exaggeration.
A percentage of participants, average change and maximum individual result are not interchangeable. A footnote can explain the method but cannot repair a misleading headline.
Retain evidence and control communication
The protocol, report, tested-product identity, statistics and approved wording are retained as evidence of effect. It must be clear that the tested formula is the marketed formula or a justifiably comparable version.
Websites, packaging, advertising and influencers should use approved wording. New variations are reviewed so that results are not extended beyond what the study demonstrates.
Frequently asked questions
Does every claim require a clinical study?
No. The type of evidence depends on claim meaning; a clinical study is not the only possible form of support.
Can an active-ingredient study be used?
It may contribute, but applicability to the concentration and finished formula must be justified.
Can the wording be changed after the study?
Only within the boundaries genuinely supported by the design and results.
Official sources and further reading
- Commission Regulation (EU) No 655/2013 on common criteria for claims
- Regulation (EC) No 1223/2009 on cosmetic products
This article is for general information and does not replace an assessment of the specific product, formula and supply chain. Legislation and guidance may change after publication.