Testing Glossary
A reference guide to the testing methodologies, regulatory standards and measurement tools referenced across Ambernay product documentation and Clinical Notes.
A
Active ingredient
An ingredient included in a formula because it has a defined, evidence-supported function relevant to the product's cosmetic objective. Distinguished from functional ingredients (emulsifiers, preservatives, pH adjusters) that serve a technical formula role without a primary cosmetic effect claim.
B
Broad-spectrum protection
UV protection covering both UVA and UVB wavelengths. In EU regulation, a product claiming broad-spectrum protection must achieve a UVA-PF of at least one-third of its SPF value (Critical Wavelength ≥ 370 nm).
Corneometry
Instrumental measurement of stratum corneum hydration using a capacitance-based probe. Values are expressed in arbitrary units (a.u.); higher values indicate greater hydration. Standard tool in moisturiser efficacy studies.
Cosmetic claim substantiation
The body of evidence required to support a specific claim made about a cosmetic product. Under EU Cosmetics Regulation (EC 1223/2009) Article 20 and the Common Criteria (EU 655/2013), claims must be truthful, substantiated, honest, fair and non-deceptive.
Critical Wavelength (CW)
A measure of the breadth of UV protection across the spectrum. A CW of 370 nm or above is required for broad-spectrum labelling under EU guidelines.
D
Dermatologist-tested
A claim indicating the product was tested under dermatological supervision. The claim communicates the presence of oversight — not the nature, outcome or standard of the test. See: What dermatologically tested should mean.
Double-blind study
A study design in which neither the participant nor the researcher knows which treatment is being administered. Reduces both subject and assessor bias.
H
HRIPT (Human Repeat Insult Patch Test)
A standardised patch test protocol conducted on human volunteers to assess sensitisation potential of a cosmetic formula. Forms the basis of most dermatologically tested claims.
Hypoallergenic
A cosmetic claim indicating a lower risk of allergic reaction. Not a regulated term in most markets; typically substantiated by HRIPT or by exclusion of known common allergens. Not equivalent to allergy-free.
I
INCI (International Nomenclature of Cosmetic Ingredients)
The standardised Latin/English naming system for cosmetic ingredients. INCI lists ingredients in descending order of concentration (above 1%); ingredients below 1% may be listed in any order.
In vitro
Testing conducted in a controlled laboratory environment rather than on human subjects. In vitro data can support mechanism-of-action claims but requires additional validation before extrapolation to human outcomes.
In vivo
Testing conducted on living subjects — typically human volunteers. In vivo data is generally more directly applicable to cosmetic claim substantiation.
ISO 24444
The international standard for in vivo SPF testing. Defines the methodology for measuring UVB protection factor, including application weight (2 mg/cm2), solar simulator specifications and subject criteria.
ISO 24443
The international standard for in vitro UVA protection testing. Used to determine UVA-PF and Critical Wavelength.
M
Microbiological challenge testing
A standardised test (ISO 11930) confirming that a cosmetic product's preservation system is effective against specified challenge organisms (bacteria, yeast, mould). Required for product safety assessment under EU Cosmetics Regulation.
P
PA (Protection Grade of UVA)
A Japanese UVA grading system based on PPD methodology. Grades range from PA+ to PA++++. PA++++ indicates a UVA-PF of 16 or above.
Persistent Pigment Darkening (PPD)
An in vivo method for measuring UVA protection factor. The ratio of UVA dose required to produce darkening with vs. without product defines the UVA-PF.
Product Information File (PIF)
The mandatory documentation file required under EU Cosmetics Regulation for every cosmetic product placed on the EU market. Contains: safety assessment, product description, method of manufacture, proof of claimed effects, stability data and microbiological data.
R
Responsible Person (RP)
Under EU Cosmetics Regulation (EC 1223/2009), the legal entity — established in the EU — responsible for ensuring a cosmetic product complies with regulation before market entry. See: Responsible Person / Compliance.
S
Safety Assessment
A mandatory evaluation under Article 10 of EU Cosmetics Regulation, conducted by a qualified cosmetic safety assessor. Covers ingredient toxicology, formula stability, microbiological quality and packaging compatibility. Not an efficacy assessment.
SPF (Sun Protection Factor)
A measure of UVB protection. Calculated as the ratio of the minimum erythema dose on protected skin to that on unprotected skin. Tested at 2 mg/cm2 application weight under ISO 24444.
Stratum corneum
The outermost layer of the epidermis — approximately 10 to 20 cell layers of corneocytes embedded in a lipid matrix. The primary site of interaction for most leave-on cosmetic products.
T
TEWL (Transepidermal Water Loss)
The rate of water vapour passing through the skin to the external environment. Measured with a tewameter. Elevated TEWL indicates compromised barrier function. Reduction in TEWL is a key outcome measure in barrier-support and moisturiser efficacy studies.
U
UVA-PF (UVA Protection Factor)
The measured protection factor against UVA radiation. In EU regulation, the minimum UVA-PF must be at least one-third of the labelled SPF value for a broad-spectrum claim.
This glossary is provided for educational reference. Terminology and standards may vary by jurisdiction. For regulatory decisions, consult a qualified regulatory affairs professional.
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