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Cosmetics testing
Patch test.
The Cosmetic Patch Test is a dermatological study used to evaluate the skin compatibility and irritation potential of cosmetic products when applied under controlled conditions to healthy human volunteers. It helps determine whether a product is well tolerated by the skin and provides valuable evidence supporting product safety before market launch.
When performed under dermatological supervision, the results may also support claims such as "dermatologically tested", subject to the study design and outcome.
Why it matters
Proving your products are safe for the skin.
Both natural and synthetic ingredients alike can cause negative reactions on people's skin and those are not only limited to people that have a very sensitive skin, which is why it is recommended that producers of cosmetic products perform a patch test before they place their products on the market. Patch test is therefore a test that helps determine whether the use of a cosmetic product would cause irritation on people's skin.
Patch test is not a mandatory test according to the EU Regulation 1223/2009 or UK Schedule 34 to the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, but since the primary focus of these cosmetics regulations is product safety, it is recommended that a patch test is performed as this would give a further proof that your products are safe for use.
The method
How is a patch test performed?
The method
How is a patch test performed?
Patch test is performed by applying approximately 0.2g or 0.2ml of the cosmetic product on the intact skin on the arm or on the back of adult subjects. The area where the product has been applied is then covered with an occlusive or semi-occlusive patch for 48 hours. Observations of the effects caused by the application of the product on the skin are performed 1 hour and 24 hours after the patch is removed. These observations are done under the supervision of a dermatologist, which then also enables the companies to claim that their products have been dermatologically tested.
Products are applied to the skin either in a pure state or diluted, depending on the type of product and on the intended use. Leave-on products are applied undiluted, while rinse-off products are diluted either in demineralized water or in mineral oil. Test products that contain high levels of, or ingredients that require dilution in, volatile solvents that are to be applied using occlusive patches may need to be left to evaporate for a couple of minutes before application to the skin.
Recommendations
When is a Patch Test recommended?
Recommendations
When is a Patch Test recommended?
- New leave-on cosmetic products
- Products intended for sensitive skin
- Products containing active ingredients
- Reformulated products
- Products intended to support dermatological claim
Deliverables
What will you receive?
After completion of the study, you receive:
- Dermatological evaluation report
- Study protocol
- Summary of observations
- Final conclusion
- Documentation supporting the evaluated claim(s)
A successful Patch Test demonstrates that:
- the product shows good skin compatibility under the test conditions;
- no clinically significant irritation was observed in the study population;
- the product has been evaluated under dermatological supervision;
- the results may support appropriate skin compatibility claims.
Cosmetics patch test
FAQ
A cosmetics patch test is a dermatological test used to evaluate whether a cosmetic product may cause skin irritation when applied to human skin. It is performed on healthy adult volunteers under controlled conditions and helps determine the product's skin compatibility and overall irritation potential.
A patch test is not mandatory under EU Cosmetics Regulation 1223/2009 or UK regulations, but it is highly recommended. Since the main goal of these regulations is consumer safety, performing a cosmetics patch test provides additional proof that the product is non irritating.
A patch test is important because both natural and synthetic ingredients can cause skin reactions, even in individuals without sensitive skin. This test helps identify potential irritation risks before the product reaches the market, reducing the likelihood of consumer complaints and enhancing product credibility.
A cosmetics patch test involves applying a small amount of the product (typically 0.2 g or 0.2 ml) to the skin of the arm or back. The area is then covered with an occlusive or semi-occlusive patch for 48 hours. After removal, the skin is evaluated at specific intervals (usually after 1 hour and 24 hours) for any signs of irritation.
The results of a cosmetics patch test are assessed under the supervision of a qualified dermatologist. This ensures that any skin reactions are properly evaluated and documented, allowing companies to support claims such as "dermatologically tested".
A patch test is recommended for all types of cosmetic products, especially those intended for leave-on use, such as creams, serums, and lotions. It is particularly important for products with active ingredients, fragrances, or formulations that may increase the risk of skin irritation.
During a cosmetics patch test, products are applied either in their pure form or diluted, depending on their intended use. Leave-on products are typically tested undiluted, while rinse-off products are diluted in demineralized water or mineral oil to reflect real-life usage conditions.
A product passes the patch test if there are no significant signs of irritation, such as redness, swelling, or discomfort, during the observation period. Minimal or no reaction confirms good skin compatibility and supports the product's acute irritation profile.
While a cosmetics patch test significantly reduces the risk of adverse skin reactions, it cannot guarantee that no individual will ever experience irritation. Human skin varies, and rare reactions may still occur. However, the test provides strong evidence of general product irritation potential.
A patch test strengthens both regulatory documentation and marketing claims. It supports statements such as "dermatologically tested", increases consumer trust, and complements other safety assessments like CPSR and microbiological testing, contributing to a well-documented and compliant product launch.
Related services
Related services
CE.way can offer various services related to cosmetics patch testing. We can offer:
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