Certification and Registration
Dermatest ®
Category:
Dermatest
Dermatest ®
Dermatest® is an independent scientific research institute founded in 1978 by a German dermatologist. Its mission is to evaluate the efficacy and safety of all products that come into contact with the skin. The rigorous scientific, dermatological, and biological methods employed in its comprehensive clinical studies enable the institute to accurately assess product efficacy and safety. Its dermatologists and allergists are renowned for their international expertise and conduct these tests with complete impartiality.
Dermatest® Certified Product Scope
Dermatest ® seals are particularly suitable for cosmetics, cosmetic-related products (such as pressed powders and powder puffs), body washes, shampoos, soaps, facial creams, lotions, detergents, and wet wipes, Diapers , sanitary napkins, hygiene products, and other related industries.
What can a Dermatest ® seal prove?
To obtain a Dermatest® seal, products must undergo a series of tests. When you see a Dermatest® seal on a product, you can rest assured that it has undergone the highest standards of safety and efficacy testing. The Dermatest® certification seal is a clear indication of product quality. Dermatest®-certified products ensure maximum efficacy and excellent skin tolerance, guaranteeing user safety.
What is patch test?
The patch test was developed in the 19th century to identify causes of allergic contact dermatitis. Today, it is a well-established procedure governed by internationally defined rules and guidelines that are continually reviewed and updated. In the cosmetics industry, the patch test can assess the potential irritancy of products. Regular patch testing evaluates the irritant and allergenic potential of topical formulations, thereby supporting the safety profiles of cosmetics and everyday consumer goods.
In 2016, Dermatest® developed an accredited patch test to ensure the highest standards and maximum safety in patch‑test results. This certified testing method was designed based on years of experience and stringent quality criteria, becoming the first of its kind to be accredited by the Deutsche Akkreditierungsstelle (DAkkS, the German national accreditation body) under DIN EN ISO/IEC 17025.
Dermatest ® Seals
The Dermatest® seal signifies traceability of the testing method, as well as consumer safety and manufacturer accreditation. Depending on test design and study type, the seal falls into four categories.
DERMATEST ® ACCREDITED PATCH TEST
The substances used in patch testing are applied under occlusive conditions for 24 hours to assess product tolerance under extreme conditions. In addition to the stringent requirements of the standard patch test, positive and negative controls are included to ensure maximum result reliability. The irritant/sensitizing threshold must be exceeded to elicit a positive reaction. A positive response in a properly conducted patch test is considered evidence of primary irritation caused by the test substance, but does not necessarily indicate an allergic reaction. Prior to each test, the test substance is reviewed and approved by a safety assessor, and ethics committee approval is also obtained. Consequently, products evaluated using validated patch‑test methods demonstrate the highest standards of quality and safety achievable through this approach.
DERMATEST ® GUARANTEE SEAL OF APPROVAL
Obtaining the DERMATEST ® GUARANTEE SEAL OF APPROVAL requires passing a patch test, which provides information on the product's potential to cause primary skin irritation and/or exacerbate existing sensitivities.
The test substance is applied to the skin at an appropriate concentration and examined at 24, 48, and 72 hours. If the product passes this patch test, in addition to the evaluation report and certificate, it will also receive the "Dermatest Guarantee" approval seal.
DERMATEST ® 3-STAR SEAL
DERMATEST ® 3-STAR SEAL requires either a short-term patch test at the intended site of application, or a long-term assessment of skin condition or function on an area other than the intended site—for example, evaluating the cream’s effect on skin hydration via a forearm patch test.
DERMATEST ® 3-STAR SEAL denotes a significantly more complex study design, carrying greater weight than a simple patch test. Tests eligible for this designation may include measurements of cutaneous physiological parameters, such as assessments of skin roughness or elasticity. Three-star‑rated tests may also encompass investigations into the potential for sensitization—intended for repeat patch testing with a duration exceeding 4–6 weeks—and must involve at least 20 participants.
DERMATEST ® 5-STAR SEAL
DERMATEST ® 5-STAR SEAL are suitable for long-term application testing, providing the highest level of protection to minimize the risk of subsequent skin reactions in the target population; products tested in this manner may be described as “clinically tested.”
DERMATEST ® 5-STAR SEALaims to thoroughly assess a product’s tolerability and, where appropriate, its efficacy according to clinical dermatological standards. As a general rule, at least 20 participants use the product for a minimum of four weeks, following the manufacturer’s instructions. If the product is applied to the intended skin area—such as an eye cream around the eyes—and the study is successfully completed, it receives the 5-STAR SEAL.
Dermatest ®Procedure
1.Upon customer request for Dermatest certification, a suitable study design will be developed according to customer specifications.
2. Check the product's ingredient information to ensure it can be safely tested.
3. Conduct testing according to the established plan's objectives.
4. After the product passes review, a research report is issued and authorization to use the Dermatest® seal is granted.
Dermatest Frequently Asked Questions (FAQ)
1. What is Dermatest for skincare products?
2. How can skincare products achieve Dermatest’s Excellent rating?
3. What are the testing methods used for Dermatest of skincare products?
Dermatest ® Microbiome-friendly Seal
SATISFY offer a one-stop German Dermatest certification service, including risk analysis, safety assessments, certification study protocols, and guidelines for the use of certification seals. For more details, please contact SATISFY customer service.
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