Challenge Testing for Cosmetics – Premarket Testing

The FDA regulates cosmetics in the United States. The FDA requires cosmetics to be safe when the consumer uses them according to the directions on the product label. The FDA does not have guidelines for pre-market testing for safe cosmetics.

The text below has been copied directly from the FDA website

“FDA does not have a list of tests required for any particular cosmetic product or ingredient, but you are responsible for ensuring that your product is safe when it is used according to labeled directions, or in the way it is customarily used.”

“Newcomers to cosmetic manufacture sometimes think that because they have used a product themselves with no apparent problems, or because the ingredients are “natural,” “organic,” or “botanical,” the product must be safe. This assumption is not correct.”

“FDA does not have the legal authority to approve cosmetic products and ingredients (other than color additives) before they go on the market. We also do not have a list of tests required for any particular cosmetic product or ingredient. However, a manufacturer or distributor of a cosmetic is legally responsible for ensuring that a marketed product is safe when consumers use it according to the directions in the labeling or in the customary or expected way. FDA can take action against the manufacturer of a cosmetic on the market if we have reliable information to show that a cosmetic does not meet the legal requirement for safety.”

“Cosmetics do not have to be sterile, but they must not contain any harmful microorganisms, and the number of aerobic microorganisms per gram must be low.”

“Many factors can affect how a product may become contaminated, including use by consumers, such as dipping one’s fingers into a jar. If a manufacturer does not have the technical expertise to determine the best way to ensure that a product is protected from contamination, the company may want to work with a consultant.”

Pre-Market Testing
Once a cosmetic formulation is developed it needs to go through microbial efficacy testing. It must pass challenge testing. Challenge testing is performed in a scientific lab.

Challenge Testing
Challenge testing is performed as a one-month challenge test or two-month challenge test. Millions of household forms of bacteria, yeast and mold are introduced into the formulation. The test determines if the preservative system is effective. Cost: $500-$2,000 depending on the lab.

Challenge Testing Method 1 month
The one-month challenge test is now considered standard in the cosmetic industry.
Cost: $500-$900.

CTFA Challenge Testing Method 2 month – Double Challenge Test
This is an extensive and effective test. This test has been around for over 50+ years and is the standard test and used by large cosmetic houses. The cost is $600-$2,500 depending on the formulation. If the formulation contains active ingredients the cost is higher.

The first inoculation introduces over 10 million bacteria, yeast and mold into the formulation sample. If the formulation’s preservative system is effective and it passes, the sample is inoculated again at the beginning of the second month with over 10 million bacteria, yeast and mold and tested again at the end of two months. If the formulation sample passes, generally, the formulation will have a 2-3 year shelf life of effective preservation (it must also pass stability testing).

Batch Testing
Routine testing must be performed on every batch of product made for market, testing for bacteria, yeast and mold by sending it to a lab for plate counts.

Aerobic plate count (APC) Fungal/yeast count (F/YC) aka Plate Counts
This test is performed in a scientific lab on a sample of the formulation. It tests for bacteria, yeast and mold and the test will tell you the counts of the bacteria, yeast and mold. It shows if GMP (Good Manufacturing Practices) was used and if the sample is free of pathogens at that point in time.

It does not tell you how long the formulation’s preservation system will be effective.
Cost: $30-$50

Do-It-Yourself Test Kits
This kit allows you to perform your own testing for bacteria, yeast and mold, similar to the plate counts test listed above except that it does not give the plate counts. It will show if bacteria, yeast or mold are present in the formulation. It shouldn’t be relied on as the only testing.

The kit is simple to use. Apply the formulation such as lotion or cream to each slide with a sterilized swab and read the slide in 24-48 hours. For a water solution, dip the slide into the solution. Clear directions come with the kit. An incubator will speed up the results. The temperature should be around 80°F and the results appear on the slide in 24-48 hours. Without an incubator, it will take about one week. Cost: $5

This information can be overwhelming at first but once you develop a foundation for your business using GMP it will become a part of business. Safe cosmetics, GMP and templates for SOP’s is an in-depth topic we cover in the Professional Skin Care Course and Professional Hair Care Course.

In the next post I will talk about stability testing and how you can perform stability testing. Read about cosmetic stability testing here.

 Joan Morais is a natural cosmetic formulator, instructor, author and the owner of Joan Morais Naturals. Joan assists product makers on how to make high quality, stable and effective natural body, hair and skin care products for personal use and a product making business.