Challenge test – Preservative Efficacy Test
The challenge test for a cosmetic product is performed to determine the shelf life after opening a product. The responsible person hereby substantiates that the product does not present a risk of microbiological contamination. This substantiation is an obligation from the Cosmetic Regulation, EC 1223/2009. This makes the challenge test an obligation in the safety assessment (CPSR) and the Product Information File (PIF).
SkinConsult is happy to help you prepare the safety assessment (CPSR) and Product Information File (PIF), including laboratory tests.
How is a challenge test performed?
In the challenge test, your product is exposed to various germs. The product is registered to the following species: Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans, Aspergilus niger. Next, it is measured how many of these germs survive. With a well-preserved product, there will be very few.
Your product is tested according to the European Phamacopoeia 5.1.3. This protocol is used extensively within Europe and is a high quality standard.
To be able to carry out the challenge test, 100 ml or gram of your product is required. This may be spread over several packages, since this test is not carried out in the package.
The challenge test lasts a month.