Dermatologically-Tested
clinical verification of skin compatibility and tolerability, via controlled occlusive patch testing under dermatological supervision.
Clinical dermatology & allergy testing
Prove your product is safe on skin — and built not to sensitise.
Independent, clinically-tested seals from KIND TO BIOME, run under dermatology and allergy specialist oversight. We verify skin compatibility and, uniquely, answer both halves of the allergy question, is the product designed not to sensitise, and does it not sensitise on real skin. For any product with direct, prolonged skin contact.
Two clinically-tested seals
Allergy-Tested
verification of low sensitisation potential, built on two complementary studies rather than one, so it protects both the first-time user and the already-sensitised consumer.
Dermatologically-Tested Seal
Independent clinical verification of skin compatibility
For products with direct, prolonged skin contact — based on controlled occlusive patch testing on human volunteers, under dermatological supervision.
Method
- 1Standardised occlusive patch application
- 2Defined exposure under controlled clinical conditions
- 3Dermatological scoring of the skin response (e.g. erythema, irritation)
- 4Full documentation and an expert dermatological report
Gold
Sensitive skin20 + 10
normal + sensitive skin volunteers
Adds a sensitive-skin cohort for higher clinical relevance — the evidence behind a “tested on sensitive skin” positioning.
Silver
20
volunteers (normal skin)
Confirms good skin tolerability.
Allergy-Tested Seal
Independent clinical verification of low sensitisation potential
Most allergy testing answers only half the question — and sells it as the whole. Sensitisation risk actually breaks into two distinct questions, and each needs a different study:
Is the product built not to sensitise?
Our formula-based Sensitising Potential Study reasons at the ingredient level, screening the composition against known and suspected skin sensitisers. This is hazard-based evidence, and it’s the only way to protect the person who is already sensitised, who can react to trace amounts far below anything a human panel would ever flag.
Does the product actually not sensitise on real skin?
Our in-vivo HRIPT (Human Repeated Insult Patch Test, 50 volunteers) tests the finished product on live human skin under repeated, exaggerated exposure, capturing formulation effects, penetration and interactions that no paper review can see. This is response-based evidence, at the level of the real product.
Complementary coverage across both axes
Why one method alone is only half an answer
HRIPT alone.
A product can pass on a generally-naive panel while still containing a recognised sensitiser. HRIPT is weighted toward induction in naive volunteers, so it’s structurally weak at protecting the already-sensitised consumer, exactly the person an allergy claim most needs to protect.
Formula study alone.
A composition can be clean on paper, but paper cannot observe the finished product on skin. You get a defensible hazard verdict with no empirical confirmation.
Both together.
The formula study protects the sensitised and catches known-hazard risk the panel misses; the HRIPT confirms the real product and catches formulation surprises the paper misses. Each closes the other’s blind spot.
The bottom lineoffering both is the only configuration that substantiates the full allergy claim set and protects both the first-time and the already-allergic consumer. Anyone offering one is selling a partial answer as a whole one.
HRIPT study conditions
50 healthy adult volunteers, controlled clinical environment, dermatology & allergy specialist oversight.
HRIPT method
An induction phase of repeated occlusive applications over roughly three weeks, a rest period, then a challenge application.
Formula-based Sensitising Potential Study
Screens the full composition at ingredient level against recognised skin-sensitiser references:
- substances carrying a harmonised CLP (1272/2008/EC) classification as skin sensitiser (H317, Category 1/1A/1B);
- the fragrance allergens subject to individual labelling under Annex III of the EU Cosmetics Regulation (1223/2009/EC);
- ingredients identified as sensitisers by the SCCS or other official risk-assessment bodies;
- substances flagged as sensitising in the ECHA C&L inventory or peer-reviewed literature;
- and, on a precautionary basis, ingredients for which relevant sensitisation data are missing.
From sample to seal
- 1
Scope.
We agree the right study set for your product and target claims — dermatological compatibility (Silver/Gold), the formula-based Sensitising Potential Study, the HRIPT, or the full combination.
- 2
Design & recruit.
We recruit the appropriate panel under dermatology and allergy specialist oversight.
- 3
Study phase.
Controlled, occlusive, standardised application and expert assessment; for HRIPT, the full induction → rest → challenge sequence.
- 4
Report & seal.
A full documented expert report and, on a pass, the clinically-tested seal(s) to display.
Turnaround: HRIPT runs several weeks by design because of the induction + rest + challenge phases; the formula study is faster. (Exact turnaround to be confirmed.)
What these studies let you say — a discussion
These studies substantiate skin-safety and tolerability claims that sit on the cosmetic side of the line. Wording still matters and should be signed off by a regulatory adviser per market. Guidance, not legal advice.
Two ground rules
- “Tested” means tested, to a proper standard — not “approved” or “risk-free.” Every claim must be truthful, honest, fair and backed by adequate, verifiable evidence on your product.[1]
- There is a hard ceiling. No method, alone or combined, supports “free from allergens” or any guarantee of zero reaction; that claim is disallowed. The honest, defensible register is “minimises,” “reduces the risk of,” “designed to.”[2]
Where the evidence is strong
- “Dermatologically tested” / tolerance claims require testing on humans — our patch testing (and the HRIPT) unlock that language; a paper study alone cannot.[1]
- “Allergy tested” is supported by the HRIPT — framed as tested for low sensitisation potential, never as a promise no one will react.
- “Hypoallergenic” is the demanding one, and it’s where offering both studies pays off. The claim requires two things: that the product was designed to minimise allergenic potential, and that its very low allergenic potential is confirmed through scientifically robust, statistically reliable data, kept current.[2] Our formula-based study is the design-out evidence; our HRIPT is the robust in-vivo confirmation. Together they map onto both halves of the requirement in a way a single method does not — which is precisely why we recommend both for any brand that wants to reach for this claim.
The takeawaya formula study proves the product was built not to sensitise; an HRIPT proves it doesn’t on real skin. One earns the design-out logic behind “hypoallergenic” and protects the already-allergic; the other earns “dermatologically tested” and confirms the finished product empirically. We help your regulatory lead land the strongest wording the evidence can defend — and stay the right side of the ceiling.
Built for products that live on the skin
At a glance
Use it when:
your product has direct, prolonged skin contact — leave-on skincare, deodorants, intimate and baby care, body care, makeup — and you want independent proof of tolerability and low sensitisation potential for retailer listings, marketing and dossier support.
Reach for both allergy studies when:
you intend to make a “hypoallergenic” or strong low-allergy claim, or your audience includes sensitive and allergy-prone consumers.
Who it's for:
brand, R&D and regulatory leads preparing a launch or a retailer submission.
Selected clients
Trusted across skincare, personal care and wellness
FAQs
What's the difference between the two seals?
The Dermatologically-Tested Seal verifies overall skin compatibility/tolerability and lack of irritation via controlled patch testing. The Allergy-Tested Seal verifies low sensitisation potential — and we assess it with two complementary studies (a formula-based Sensitising Potential Study and an in-vivo HRIPT).
Why do you offer two allergy studies instead of just HRIPT?
Because sensitisation is two questions. A formula study asks whether the product is built not to sensitise (protecting the already-sensitised, who react to trace amounts a panel won't flag); the HRIPT asks whether it actually doesn't sensitise on real skin (catching formulation effects paper can't see). Either alone leaves a blind spot; together they're complete.
What's the difference between Silver and Gold (dermatologically tested)?
Silver uses 20 normal-skin volunteers to confirm good tolerability. Gold adds 10 sensitive-skin volunteers (20 + 10) for higher clinical relevance and a “tested on sensitive skin” positioning.
Can we claim “hypoallergenic”?
It's the most demanding claim, and it needs both design-out evidence and robust confirmatory data — which is exactly why we pair the formula study with the HRIPT. Even then, “free from allergens” or any zero-reaction guarantee is not permitted; defensible wording is “minimises / reduces the risk of / designed to.” We'll advise per market. (See the claims discussion.)
Is this independent?
Yes — independent, third-party clinical testing under dermatology and allergy specialist oversight.
References
- Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products. Official Journal of the European Union, 2013. (Claims must be evidence-based; “dermatologically tested”/tolerance claims require testing on humans.)
- European Commission, Technical Document on Cosmetic Claims (Annex III to the guidelines for Regulation (EU) No 655/2013) — criteria for “hypoallergenic” (design to minimise allergenic potential + robust confirmatory data; must not imply zero risk) and the prohibition of “free from allergens.”