Dermatological Testing — Volunteer Studies / 1223/2009

What Is Dermatological Testing?

Dermatological testing applies the product to volunteers under dermatologist supervision and assesses skin reactions. Closed patch testing, open application testing and in-use studies are the main methods. Because cosmetics legislation bans animal testing, irritation potential is additionally assessed with in vitro methods (reconstructed human epidermis models).

Purpose of Dermatological Testing

The purpose is to show the product does not cause skin irritation or sensitisation in normal use, and to provide the basis for claims such as "dermatologically tested".

Which Products Is Dermatological Testing Applied To?

All skin-contact cosmetic products
Facial and body care products
Baby care products
Deodorant and shaving products
Sensitive-skin products

In Which Sectors Is Dermatological Testing Used?

CosmeticsChemistryRetail

Standards Related to Dermatological Testing

TS EN ISO 10993-10 (irritation and skin sensitisation — reference approach)
OECD TG 439 (in vitro skin irritation — reconstructed human epidermis)
OECD TG 431 (in vitro skin corrosion)
OECD TG 442C/D/E (in chemico and in vitro skin sensitisation)
SCCS Notes of Guidance (safety assessment guidance)

Dermatological Testing Conditions

Animal testing: Banned for cosmetic products and ingredients under (EC) 1223/2009
Volunteer study: Informed consent, ethical review and dermatologist supervision are mandatory
Application: Under closed patch, open application or normal-use conditions
Assessment: Erythema, oedema and other skin reactions on a defined scale

Equipment for Dermatological Testing

Patch test plasters and application materials
Skin assessment instruments (corneometer, TEWL meter, chromameter)
In vitro skin model laboratory facilities
Imaging systems

Sample Requirements for Dermatological Testing

Market formulation
Sufficient specimen quantity for the number of volunteers
Formulation and INCI list must be provided
The intended manner and frequency of use must be provided

Duration of Dermatological Testing

Closed patch studies run to a schedule covering application and reading days. In-use studies run for the product's normal period of use and take weeks. The ethical approval process is also part of the timeline.

Dermatological Testing Procedure

1The study protocol is prepared and undergoes ethical review.
2Volunteers are selected per the inclusion criteria and informed consent is obtained.
3The product is applied to the defined site at the defined amount.
4Dermatologist assessment is performed at the defined time points.
5Erythema, oedema and other reactions are recorded on a scale.
6Results are assessed statistically.

Dermatological Testing Acceptance Criteria

The acceptance criterion is no unexpected or unacceptable skin reaction observed during the study. If a claim is to be used, it must be evidence-based and must not mislead the consumer, per the common criteria of (EU) 655/2013.

Evaluation of Results

The result is specific to the formulation tested, the application site and the volunteer group. Claims such as "hypoallergenic" are not automatically earned by these studies; the level of evidence for the claim is separately assessed under (EU) 655/2013. The test result alone does not establish compliance: (EC) 1223/2009 also requires appointing a responsible person, maintaining a Product Information File, having a qualified person carry out the safety assessment, and notifying the product to the CPNP. Laboratory data feeds into this file.

Dermatological Testing Report

Product identification and INCI list
Study protocol and ethical approval information
Number of volunteers, selection criteria and skin types
Application site, amount and frequency
Time-point assessments and scale results
Dermatologist's final assessment

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

(EC) 1223/2009 Cosmetic Products Regulation (including the animal testing ban)
(EU) 655/2013 Common Criteria for Cosmetic Claims

Kozmetik Testleri — What Does This Testing Field Cover?

The section below describes the field that the Dermatological Testing test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Cosmetics testing shows that a product stays microbiologically safe throughout its use, delivers the performance it claims and contains no restricted substances. There is NO PRODUCT APPROVAL in this family: no authority approves a cosmetic product; responsibility rests entirely with the manufacturer and with the responsible person established in the EU.

This responsibility model shapes how the field works. Before the product is placed on the market a product information file (PIF) is prepared, a safety assessment (CPSR) is carried out and notification is completed. Inspection comes afterwards and asks for the file; if the file is incomplete the product is withdrawn from the market. Test reports form the evidence base of that file.

On the microbiological side there are two different questions and each is answered by a separate test. The CURRENT microbiological quality of the product is measured by enumeration and testing for specified microorganisms. The EFFECTIVENESS of the preservative system is examined by deliberately inoculating the product with microorganisms (challenge test): can the product resist repeated contamination throughout its use? A jar of cream is touched by a finger at every use; the preservative system must cope with that.

On the performance side, claim substantiation studies are carried out. For sunscreens, determination of SPF and UVA protection and measurement of water resistance are mandatory and are the basis of the value declared on the label. Evidence is also produced by in vivo or in vitro methods for claims such as moisturisation, appearance of wrinkles, hair care and colour retention.

On the chemical side, banned and restricted substances are screened: heavy metals, prohibited colorants, preservative concentrations, UV filter levels and contaminants such as nitrosamines. Products containing nanomaterials carry a separate notification obligation.

The BAN ON ANIMAL TESTING is the most defining constraint of the field. Animal testing cannot be carried out on finished products or ingredients, and a product tested on animals cannot be placed on the market. Alternative in vitro methods (reconstructed human skin models, cell culture based tests) are therefore at the centre of the field, and toxicological assessment rests largely on existing data, read-across approaches and in vitro results.

Stability and packaging compatibility studies determine shelf life and the period after opening (PAO). The interaction of the product with its packaging is also assessed: an active substance may migrate into the packaging, and substances that should not be present may pass from the packaging into the product.

On the process side, good manufacturing practice is demonstrated through ISO 22716; this is separate from product testing but a mandatory part of the file.

Method groups in this field

Microbiological quality
Enumeration of aerobic mesophilic bacteria, yeasts and moulds; testing for Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans and E. coli.
Preservative efficacy
Resistance of the preservative system to repeated contamination by challenge test (ISO 11930).
Sun protection
In vivo SPF determination, in vitro UVA protection determination, water resistance and critical wavelength measurements.
Chemical analysis
Heavy metals, banned and restricted substances, quantification of preservatives and UV filters, contaminant screening.
Safety assessment
In vitro irritation and sensitisation methods, toxicological risk assessment, exposure calculations.
Stability and compatibility
Real-time and accelerated stability, packaging compatibility, PAO determination, sensory and physicochemical monitoring.

Commonly confused in this field

There is NO CE marking on cosmetics; conformity is demonstrated through the PIF, the safety assessment and notification.
The responsible person must be established in the EU; unless the exporter arranges this, the product cannot be placed on the market.
Microbiological quality and preservative efficacy are different tests; a product that comes out clean may still have a weak preservative system.
The animal testing ban covers ingredients too; animal test data generated for another market creates a problem of use.
An SPF claim must be supported by measurement; a formulation change requires a new measurement.
A change of packaging may require the stability and compatibility studies to be repeated.

Which decisions these results support

The product information file and the safety assessment
Verification of the preservative system design
Substantiation of SPF and efficacy claims
Determining shelf life and the period after opening
Compliance with destination market restrictions for export

Related Tests

Frequently Asked Questions About Dermatological Testing

Can animal testing be carried out?

No, not for cosmetic products or ingredients. (EC) 1223/2009 bans both the testing itself and placing on the market products tested on animals. Safety assessment is carried out using in vitro methods, existing data and volunteer studies.

Can I state "dermatologically tested"?

The claim must be based on an actual study and must not mislead the consumer. (EU) 655/2013 requires claims to be evidence-based; the scope of the study performed must match the scope of the claim.