Which Products are Exempt from the Challenge Test?

Challenge test (Preservative Efficacy Test) is a procedure used to assess the effectiveness of preservatives in cosmetic and personal care products. The primary purpose of this test is to evaluate the ability of preservatives to prevent microbial contamination and growth in the product over time. Microbial contamination can lead to product spoilage, reduced shelf life, and potential health risks for consumers.

Regulatory framework require preservative efficacy testing to all cosmetic products unless they meet the exemption criteria to ensure that they comply with established safety and quality standards.

According to the ISO 29621:2017 Cosmetics — Microbiology — Guidelines for the risk assessment and identification of microbiologically low-risk products standard, Challenge Test is not required for products with low-risk product groups.

 

 

 

Exemption Criteria & Examples

Physic -Chemical Factor and Limit Cosmetic Product Examples
pH ≤3.0 Chemical Exfoliating products (skin peels with AHA)
pH≥10.0 Bar soap, permanent hair styling products
Water Activity ≤0.75 Body oils, Lip balm, lipsticks , cream blushes
Ethanol / Other Alcohols ≥ 20% Hair sprays, perfumes
Filling temperature ≥65.0°C Lip balm, lipsticks, cream blushes
Organic solvent Content (Ethyl acetate, Butyl acetate) > 10% Nail polishes, nail polish removers
Alkaline Content (
Ammonia ≥ 0.5%Monoethanolamine  ≥1%
Permanent Oxidative Hair dyes,  permanent hair styling products
Aluminum chlorohydrate/ salt related substances ≥ 25% Antiperspirant products
Hydrogen peroxide ≥ 3% Permanent Hair dyes, Hair lighteners, bleaches

 

Does your product meet these criteria and does not require a challenge test? Please note that you still need to have your product tested for stability and compatibility. Please check our shop page for Accelerated Stability and Compatibility Test.

Accelerated Stability and Compatibility Test