Patch test for cosmetic products: is it required?

While cosmetic products bring added value into our daily lives, sometimes an unexpected skin reaction can happen even with safe products. From one person to another, the skin sensitivity and response vary, and in some cases, irritation can occur.

To test the irritation potential, manufacturers of cosmetic products can perform patch test on their product, which is especially important where intended use includes vulnerable groups or body parts, such as children, sensitive skin or intimate areas. In some cases, patch test may be even required as additional supportive evidence of safety.

How does a patch test work?

A patch test is a procedure conducted under the supervision of qualified dermatologist to observe skin reaction to substances. It is an in-vivo test conducted on a group of volunteers which may include people with normal or self-declared sensitive skin. It aims at discovering a delayed hypersensitive reaction by applying small amounts of the suspected allergens to the skin for a pre-determined period of time. It consists of:

1. Application of the substance on intact skin under an occlusive patch, typically on upper back.
2. Leaving it occluded for specified time, normally 48h.
3. Evaluating the skin appearance after occlusion’s removal at different periods of time.

What is the added value?

A patch test may serve as evidence for many claims relevant for the consumers, such as:

• “suitable for sensitive skin”,
• “for all skin types”,
• “dermatologically tested”.

Moreover, products intended for babies or for use in intimate areas are strongly recommended to be patch-tested as further evidence of their safety. In such case, the path test is recommended to be performed on individuals with sensitive skin.

In the EU, UK and Switzerland where Cosmetic Product Safety Report (CPSR) is required, the safety assessor may request a patch test to be conducted where found relevant for the safety.

Do you have questions on compliance of cosmetics and market access? Contact us here or at coslaw@obelis.net!

References

CTPA. (2024). Patch Testing Guidelines: CTPA Guidelines for the Supply of Patch Test Materials for Diagnostic Patch Testing. Retrieved on 27/07/2026.

Johansen, J.D., Aalto-Korte, K., Agner, T., Andersen, K.E., Bircher, A., Bruze, M., Cannavó, A., Giménez-Arnau, A., Gonçalo, M., Goossens, A., John, S.M., Lidén, C., Lindberg, M., Mahler, V., Matura, M., Rustemeyer, T., Serup, J., Spiewak, R., Thyssen, J.P., Vigan, M. & Wilkinson, M. (2015). European Society of Contact Dermatitis Guideline for Diagnostic Patch Testing – Recommendations on Best Practice. Contact Dermatitis, 73(4), 195–221. Retrieved on 27/07/2026.