Cosmetic Microbial Test Kits & FDA Regulations

We can’t see microbes, and they’re literally everywhere. They’re the sneakiest little sneaky-sneaks you’ve ever seen. Or, not seen. So unless you’re manufacturing cosmetics in a completely sterile environment, your product is going to get some contaminants. It’s just a fact of life, and once again, Lotioncrafter LLC is going to help us out.

They have SO much knowledge in the industry, we had to break it up into three posts, so this week, we’re discussing how to use their microbial test kit, as well as FDA regulations you should be aware of.

Contaminants in cosmetics are okay to a certain extent, but there are two things you need to check:

  1. Are any of the contaminants harmful pathogenic microorganisms?
  2. What is the density of contaminants in your product?

Let’s take a look…

Testing Cosmetics for Sneaky-Sneaks

cosmetic microbial test kits, dipslides, testing cosmetics for contaminants

Lotioncrafter sells a DIY microbial test kit with 10 dipslides and 20 sterile swabs or a smaller kit with 4 dipslides and 8 sterile swabs. The best way to test your product is by using the following method:

  1. Carefully remove a dipslide from the container without touching the agar surfaces. Remember, your hands are covered in bacteria, so if you accidentally touch the agar, you’ve contaminated it before even testing your product.

Liquids

  1. If your product is very liquid, you can pour some of it into the sterile dipslide tube.
  2. Dip the paddle into the tube.
  3. Keep contact with the sample for 5-10 seconds so both sides of the paddle are completely wetted.
  4. Pour out the sample, and replace the paddle in the tube.

Creams / Lotions

  1. If you’re testing a thicker substance, such as cream or lotion, use a sterile swab.
  2. Dip the swab into your sample and streak the surface of both sides of the paddle.  You don’t have to streak a large, thick amount onto the paddle (1mL is all you need).
  3. Place the paddle back in the tube.

Incubation

  1. If dipslides are incubated, growth should be visible within 24-48 hours for bacteria and 72 hours for fungi.
  2. If you don’t use an incubator, leave the dipslides out at room temperature, or find a warm place out of direct sunlight, such as the top of a refrigerator. Without an incubator, growth should be visible within 2-4 days for bacteria (check again after 2 days for slow-growing bacteria) and 4-7 days for fungi.

Easy-peasy, right?! If you still need more instruction, check out this Youtube video on how to use Microslides.

FDA Regulations

cosmetic microbial test kits, dipslides, testing cosmetics for contaminants

Once you’ve tested your product for contaminants, it’s important to know standard regulations. Yeah, yeah, we know, regulations are boring. Don’t worry, we’ll keep this short and sweet.

According to the FDA, cosmetics do not need to be sterile, but they should not be contaminated with any pathogenic microorganisms, and the number of aerobic microorganisms per gram should be low.

Pathogens or opportunistic pathogens of particular concern include:

  • Staphylococcus aureus
  • Streptococcus spp.
  • Pseudomonas aeruginosa
  • Klebsiella spp.
  • Candida albicans

These potential pathogens must not be detectable in 0.1g or 0.1ml of a cosmetic product.

According to the Personal Care Products Council (Formerly the Cosmetic, Toiletry and Fragrance Association), the suggested criteria for maximum microbial content are as follows:

  • Baby products – no more than 10² CFU / gram or ml
  • Eye area products – no more than 10² CFU / gram or ml
  • All other products – no more than 10³ CFU / gram or ml

It’s important to remember that these are recommended criteria only. The FDA leaves it to the cosmetic manufacturers to determine the appropriate safety level for their specific products. Many cosmetic and personal care product manufacturers choose to set higher standards for their products requiring <10 CFU / g or ml in their products to be accepted.

Next week, to round out our Tech Talk with Lotioncrafter, we’re giving you a free tool to help with identification of pathogenic microorganisms on the Microbial Test Kit dipslides, as well as identification of other microorganisms you might expect to find when testing cosmetics.

Keep an eye out for our Facebook giveaway of a Lotioncrafter Microbial Test Kit! The giveaway will be announced on April 20th, and a winner will be selected on April 30th.