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How Does Preservative Efficacy Testing Work for Aqueous Health and Beauty Products?

Every cosmetic or personal care product you produce carries your reputation. Preservatives play a critical role in safeguarding aqueous product quality, reducing the risk of harmful microbial contamination, and helping support your product’s safety throughout its shelf life. Preservative efficacy testing helps ensure your product’s safety and provides scientific and regulatory evidence to support your shelf life claims. 

Preservative Efficacy Testing for Over-the-Counter (OTC) Health and Beauty Products

At Perritt Laboratories, we offer preservative efficacy testing that includes deliberately inoculating product samples with specific types of mold, bacteria, and yeast. The microorganisms depend on the regulatory requirements required for your market and product. 

When you contact us, we assess your formulation and usage, then suggest a suitable testing protocol. Once we receive your samples, we expose them to specified microbes, incubate them, and monitor microbial levels at set intervals.

Once testing is complete, we provide the documentation you need to substantiate safety and satisfy regulatory bodies such as the U.S. Food and Drug Administration (FDA). Our clear report outlines your compliance status and next steps. We’re happy to review results and answer any questions, regardless of your technical background.

We test cosmetics and personal care products to meet the following standards:

  • The Japanese Pharmacopoeia (JP) 19
  • The United States Pharmacopoeia (USP) <51>, for U.S. market compliance with aqueous-based cosmetics and some healthcare products
  • The European Pharmacopoeia (Ph. Eur. or EP), specifically Ph. Eur. 5.1.3, which determines whether preservatives inhibit microbial proliferation over 28 days
  • AOAC International standards 
  • Association for the Advancement of Medical Instrumentation (AAMI)
  • ASTM International (ASTM) standards
  • International Organization for Standardization (ISO) 11930, for microbiological evaluation of cosmetic product preservatives (for EU and international markets)
  • PCPC (formerly CTFA) M-3 through M-6 PET Microbiology Guidelines

What Is PET Testing in Cosmetics?

Preservative Efficacy Testing (PET), also called Antimicrobial Effectiveness Testing (AET) or USP <51> testing, evaluates a product’s ability to prevent microbial growth over time with intended use. PET is the more common term in cosmetics, while AET is more typically used for non-sterile pharmaceuticals.

While many industries require preservative efficacy testing, we have processes specifically designed for the health and beauty sector. We understand the unique contamination risks, regulatory standards, and consumer expectations for this industry.

What Is the Cosmetic Preservative Challenge Test?

This test, similar to PET and AET, is also known as cosmetic challenge testing and applies specifically to cosmetics. In this simulation test, a sample of the finished product is intentionally contaminated with specific types of mold and bacteria to determine whether the product’s preservatives suppress or kill the microbes. 

Do I Need Preservative Efficacy Testing for My OTC Health or Beauty Product?

Personal care and beauty products pose unique risks. When users open a product, they may dip their fingers into the formula, introducing mold, skin oils, bacteria, and other contaminants from the skin. Opening the product can also introduce moisture and contaminants from air exposure. Preservatives can reduce these risks, but testing is the only way to evaluate your formulation of preservatives and the product’s ability to protect customers.

Products with a water phase are especially vulnerable to bacterial and mold growth, and nearly always require preservative efficacy testing to ensure safety. 

All manufacturers or distributors of cosmetic products and many OTC health products are responsible for product safety. Under regulations such as the Federal Food, Drug and Cosmetic Act (FD&C Act), you must prove that your product is safe and not adulterated.

The FDA monitors product safety and can take enforcement action against unsafe items. As of July 1, 2024, the Modernization of Cosmetics Regulation Act (MoCRA) requires facility registration and product listing for cosmetic manufacturers and processors in the U.S. While the FDA and MoCRA do not require PET or microbial testing by name, documentation from preservative efficacy testing shows you have taken steps to make your products safe. 

It’s about more than just compliance. Preservative failures cause product recalls and major financial losses in the cosmetic industry. Routine efficacy testing helps you identify weaknesses before products reach consumers, protecting your brand’s reputation and bottom line while keeping your customers safer. When you’re launching a new product or changing a formulation, testing shows you care about product quality.

Why Work With Perritt Laboratories?

Our experts design custom solutions to support innovation. Custom testing methods can be especially helpful in addressing innovative packaging, new ingredients, and sensitive formulations. Our custom solutions can also help you test multiple products in development to choose the optimal one. 

We also help you address some of your largest concerns:

  • Regulatory requirements: Our full-service, cGMP- and ISO 17025:2017-accredited microbiological laboratory has extensive experience in the health and beauty industry. If you’re unsure about FDA, EU, or international safety requirements for your specific formula, we’ll guide you in selecting the right testing standards. Our regulatory specialists work directly with you so your product meets all necessary cosmetic safety guidelines for your target markets.
  • Consumer safety: As an FDA-registered facility, our award-winning, state-of-the-art facilities and experienced team follow best practices to deliver defensible results that demonstrate whether your product is safe from microbial contamination.
  • Complex challenges: Although testing can be complex, we make the process straightforward. Even if you don’t have an in-house lab or quality control team, we can help with all your compliance needs. You’ll have direct access to our scientists, and no previous microbiological expertise will be necessary.

Whether you need to validate the shelf life of a new formulation, test different preservative combinations to find the right one, or reformulate an existing product, our testing services help you evaluate the efficacy of preservative systems. We support a smooth launch by reducing your risk of costly recalls caused by microbial contamination. 

Beyond preservative efficacy testing, we offer validation, routine, and qualification testing for facilities, as well as R&D method development.

Contact Us for Preservative Efficacy Testing

Ready to ensure customers can use your cosmetic or OTC health product with minimal risk of microbes? With experience spanning more than 50 years, Perritt Laboratories is equipped to handle a wide variety of regulatory standards. Contact us to speak with an experienced member of our team.

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