Accredited patch test

In October, 2017, Dermatest® GmbH became the first company in the world to operate a accredited test procedure for assessing the tolerability of substances applied directly to people’s skin. Based on our many years of experience and our high quality standards, this new test method was developed and established, and accredited by the German Accreditation Service (DAkkS) to DIN EN ISO/IEC 17025 as the first test procedure of its kind. This accredited method is based on the guidelines from the German Dermatological Society (DDG) and the German Society for Allergology and Clinical Immunology (DGAKI) for “performing the patch test with contact allergens” (AWMF guidelines register). Beyond the already demanding requirements of our standard patch tests, a positive and a negative control check are incorporated, in order to guarantee the highest level of confidence in the study results. All substances are applied over 24 hours under closed (occlusive) conditions in order to test the tolerability of the products under extreme conditions. The irritation/sensitivity threshold must be exceeded in order for a positive reaction to be provoked. A positive reaction to a correctly applied patch test is considered evidence of primary irritation from the test substance, but not necessarily evidence of sensitisation. Before each test, the test substances are inspected and approved by a safety assessor. Approval is also sought from an ethics committee. Products investigated using the accredited patch test method therefore demonstrate the highest quality and safety standards which can be met with a patch test.

Benefits of the seal of approval

The Original Dermatest® seal of approval is evidence of consumer safety for your customers and consumers of cosmetics and consumer goods.

Recognition of the Original Dermatest® seal has risen sharply in recent years. Consumers are coming across the Original Dermatest® seal more and more, not only in product advertising in print and online media, but also particularly on product packaging in the retail sector.

Consumers are coming across the Original Dermatest® seal of approval as evidence of consumer safety in more and more ways. And as a guarantee for the traceability of the test methods, the Original Dermatest® seal of approval is a clear mark of quality for your products.

Products which have earned this seal are keeping the promise of tested and verified quality. Guaranteed.

Your route to the seal of approval in 4 steps

You send us your enquiry.We would be delighted to tell you all about our four categories for the seal of approval, and plan the required testing together as well as define the study criteria. We work out the most suitable study design for your product in-house, based around your preferences and ideas and our requirements.

You decide on one of the available studies and send the requisite sample quantities and information to go with it. We can then start immediately with the internal risk analysis, specific preparations for the study, and recruiting the test subjects!

We carry out the jointly agreed study - perhaps a patch test for our Original Dermatest® seal or application test for using the Dermatest® 5-star seal - at one of our test sites. As always, our primary focus remains checking skin tolerability.

Provided your product passes our review stage successfully once the study is complete, we then send you the study report and authorisation to use the appropriate Dermatest® seal. Besides the German version, we would be delighted to provide you with the Dermatest® seal to support sales in the national language of your sales markets as appropriate.

Companies who trust our seal

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The Original Dermatest® seals represent traceability of test methods as well as for consumer safety and manufacturer endorsement. Depending on the test design and type of study, the seals have four different categories signifying their importance.

The Dermatest® guarantee seal requires a patch test (brief and localised contact with human skin) on at least 30 test subjects, with no adverse reactions.

The seals come free of charge provided your product has successfully passed the relevant testing.

There is no time limit set for using the seal. However, if anything changes in the composition or formulation of the products, a new test must be arranged. Under EU legislation, the date the testing was carried out must appear on the product packaging, which is why the month and year of testing are included as part of the seal.

This is possible subject to strict limits. Our design manual gives you further information about how our Dermatest seals may be used. Please get in touch.

Our team is at your disposal

Dr. Katja Adames

Study Director, Quality Management

Magdalena Wojtaszczyk

Teamassistenz Epikutantestungen

Diana Thrun

Study Coordinator Patch Testing

Dr. Sarah Risse

Study Director, Quality management

Sandra Klokkers

Teamassistenz Epikutantestungen

Dorothee Arenskötter

Teamassistenz Epikutantestungen
Dr. Imke Göllner

Dr. Imke Göllner

Study Director
Liane Bolke

Dr. Liane Bolke

Head of study management


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