Enzyme Quality Questions

As manufacturers explore the possibilities available for adding enzymes for nutrient absorption and health benefits, suppliers caution to keep an eye on safety. The Enzyme Technical Association (EnzymeTechnicalAssoc.org) offers brochures about safely working with enzymes and other industry concerns. Also, manufacturers that are new to the enzyme field could benefit from working with an experienced contract packer that can assist with production. Many suppliers offer contract-packing services and are familiar with the safety and processing aspects inherent to functional food and dietary supplement production.

“One of the best ways to tell if an enzyme product is of good quality is to know the manufacturer and only select manufacturers that adhere to strict GMP [good manufacturing practice] standards for quality,” suggested Nena Dockery, technical resources manager, National Enzyme Co. “Ideally, a manufacturer could be pre-qualified by having random products tested for the stated activity by a third-party lab. This isn’t always feasible, however. The newly enacted GMPs would ideally guarantee that a product met certain specifications for ingredient content and activity. However, that probably will not be the case, so it is up to the distributor to do their homework.”

Mike Smith, sales and marketing manager, Specialty Enzymes & Biochemicals, said buyers may wish to work with an actual manufacturer of enzymes versus buying through a distributor. “The technical abilities will nearly always be superior with the manufacturer,” he said. “And consistency and reliability that comes with quality in-house testing is essential since enzymes lose potency over a period of time and/or with improper handling. Also, most quality companies have a technical person who can provide information about products and quality.”

For manufacturers purchasing enzymes for use in nutraceutical and/or functional food and beverage products, suppliers suggest taking several steps to ensure the enzymes meet quality requirements. The Committee on Food Chemicals Codex (FCC) publishes a reference manual including monographs and testing methods for enzymes; the U.S. Pharmacopeia (USP) also publishes standard assays directed more toward pharmaceutical use and animal-derived enzymes. Rather than purchasing by weight, enzymes are sold on the basis of potency. Assays evaluate the quantity of hydrolysis that occurs under specific conditions, and the assays are specific to the type of enzyme and the source. This includes a range of concentrations, quantities, pH’s, temperatures and substrates. Just because a buyer receives 50 mg of papain, he cannot know whether the activity is 1 FCC unit/mg or 50,000 FCC unit/mg.

“When it comes to enzymes, weight measurements are useless and can be misleading, as there is no direct relationship between weight and units of activity,” said Troy Aupperle, Enzymology Research Center Inc. “In other words, enzymes can still have a weight and contain zero activity. When comparing enzymes, look for the internationally recognized standard for measurement. FCC is expressed in units like HUT for protease, LIP for lipase and SKB for amylase. This way, you know you are comparing apples to apples.”

With attention to detail in sourcing and formulation, marketers can ensure consumers have the ability to harness the power of these workhorses in an efficacious manner.

To learn more about enzymes and formulation considerations, click here.