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Natural Cosmetics
 New Cosmetic or Personal Care Product Formulation? 

These are the steps manufacturers should take to get their products to market and ensure their products are safe for consumer use as required by the FDA. 

Natural Cosmetics

The 3 Steps To Get Your Product To Market

Cosmetic Products
Cosmetic Products

Step 1:

Screening for baseline levels of microbes (bacteria, yeast, and mold), and presence or absence of skin associated pathogens like Staphylococcus aureus. 

We follow the internationally recognized methodology (USP 61 and 62), with a typical turnaround time of 1-3 weeks to receive your report. 

We require a sample volume of at least: 40 grams or mL to run all microbial analysis in this method. 

  • We highly recommend sending in a second retainer sample in case any retests need to be done.

  • If the microbial baseline is above the recommended FDA limits or any pathogens are present, the manufacturer will need to run an internal audit to determine the source of contamination and may require a new formulation or sourcing raw materials from a different manufacturer. In these cases, the new formulation should be re-tested once produced. 

  • If the product passes USP 61 and 62 it’s time to move on to the next step 

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Step 2:

Preservative efficacy test (PET), is used to determine how efficient your formulations preservative system is at preventing microbial growth and its stability over 28 days. This length is the standard, however, additional time points can be requested. 

We follow the internationally recognized methodology (ISO 19930 or equivalent USP 51), with a typical  turnaround time of 5-6 weeks to receive your report. 

  • We offer a basic report, stating whether your product passed and which criteria (A or B), with A being more stringent. 

  • If a more detailed report is needed, please request detailed report through our online sample submission portal for an additional fee

  • Click here to see an example of our detailed report  

We require a sample volume of at least: 120 grams or mL to run both a standard neutralization validation (included in the price) and the actual test. 

  • If the neutralization validation fails, we must re-run it using a different approach for an additional fee. 

  • The neutralization validation is necessary to ensure we get accurate cell recovery counts to determine preservative efficacy by calculating the % reduction (cell die off) at test points: 7, 14, 28 days in comparison to day 0. 

If the product passes either criteria A or B it’s time to move on to the next step, if it does not pass your product will need to be re-formulated to have a more robust preservation system and re-tested. 

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Step 3:

Determination of estimated shelf life by conducting a stability study, either accelerated or real-time. We highly recommend running the accelerated and real time concurrently. 

  • Typical accelerated studies run for 3-6 months, and real time studies run for 1-3 years. 

  • However, it is up to the manufacturer to decide on the length of the study. 

Our basic package includes: 

  • Physical appearance, odor, pH, water activity, package compatibility, and general microbial (bacteria, yeast, and mold counts). 

  • To determine package compatibility, it is recommended to send 1 product in a clear glass container to be compared to at the end of the study. 

  • Additional tests can be requested for each pull date, such as active ingredient verification, freeze thaw cycles, viscosity, specific microbial contaminates (Ex: E. coli). 

Accelerated study: 

​At the end of the accelerated study, we will evaluate all the data and either provide approval or rejection of the product, and if applicable, estimation of the recommended shelf life. 

  • For the accelerated stability study, we place your product in an accelerated stability chamber at an increased temperature of 40C (we can run the study at other requested temperatures). 

    • ​If there are any formulation issues, under these conditions any deterioration will occur much more rapidly. So, you will know more quickly if your formulation has an issue using accelerated study. 

    • It is most likely your product will not encounter these conditions during its actual shelf-life, so if it passes in these conditions then your product is deemed stable for our estimated shelf-life. 

    • However, we highly recommend running a real time stability study concurrently in the actual storage conditions it will experience during its shelf-life to validate the accelerated data. Many distributors will require that a real time study be done to carry a specific product. 

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