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Determining the safety of microbial cultures for consumption by humans and animals


Published in Regulatory Toxicology and Pharmacology

In July 2015, the journal Regulatory Toxicology and Pharmacology published “Determining the safety of microbial cultures for consumption by humans and animals.” This paper, which was recently made open source, serves as a valuable asset to ingredient manufacturers operating within the microbial cultures space. In providing a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications, this resource serves as a decision tree for the safety assessment of microbial strains to be used in food applications. Access and download the full paper below.

Abstract

Fermented foods and feeds have been consumed for millennia, and microorganisms isolated from traditional fermentations have been used as probiotics. There is interest in developing new microbial cultures for these uses, but to date safety evaluation procedures have only been discussed in general terms. We propose a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications. Three scenarios are considered: (1) substantially increased exposure to a culture that has an established record of safety in a more limited application; (2) a new strain without a history of safe use that was isolated from a food or feed that has a history of safe use; and (3) a new strain isolated from a non-food or non-feed source. Our safety evaluation process is based on scientific procedures and is in the form of a decision tree composed of 13 questions. Our decision tree for determining the safety of microbial cultures for consumption by humans or animals is modeled on previous decision trees that are used worldwide to evaluate the safety of microbial enzymes for use in human food or animal feed.

Determining the safety of microbial cultures for consumption by humans and animals


Published in Regulatory Toxicology and Pharmacology

In July 2015, the journal Regulatory Toxicology and Pharmacology published “Determining the safety of microbial cultures for consumption by humans and animals.” This paper, which was recently made open source, serves as a valuable asset to ingredient manufacturers operating within the microbial cultures space. In providing a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications, this resource serves as a decision tree for the safety assessment of microbial strains to be used in food applications. Access and download the full paper below.

Abstract

Fermented foods and feeds have been consumed for millennia, and microorganisms isolated from traditional fermentations have been used as probiotics. There is interest in developing new microbial cultures for these uses, but to date safety evaluation procedures have only been discussed in general terms. We propose a comprehensive approach for determining the safety of microbial cultures that lack an established history of safe use for their intended new applications. Three scenarios are considered: (1) substantially increased exposure to a culture that has an established record of safety in a more limited application; (2) a new strain without a history of safe use that was isolated from a food or feed that has a history of safe use; and (3) a new strain isolated from a non-food or non-feed source. Our safety evaluation process is based on scientific procedures and is in the form of a decision tree composed of 13 questions. Our decision tree for determining the safety of microbial cultures for consumption by humans or animals is modeled on previous decision trees that are used worldwide to evaluate the safety of microbial enzymes for use in human food or animal feed.

Changes Headed to a Food Label Near You

In the spring of 2016, the U.S. Food and Drug Administration (FDA) announced new changes to the Nutrition Facts Label for packaged foods. The changes were made to allow consumers to make more informed and healthful decisions in their diets.  While you may have already seen this new format on food products, the FDA has extended the compliance deadline to 2020, although manufacturers with less than $10 million in annual food sales have until Jan. 1, 2021 to comply.

So, what’s different?

  1. New Look, Bigger Font
    The type size for the total calories, serving size and number of servings has been increased and bolded. Along with making the serving size more visible, the actual size of each serving has been updated to reflect a typical serving size. However, the serving sizes listed on food products are not recommendations from the FDA but rather a measurement which is intended to reflect realistic intake. For example, the serving size for ice cream was previously 1/2 cup, and is now 2/3 cup.
  2.  “Added Sugars” make it to the label
    A line for “Added Sugars” has been added to the label beneath the listing for “Total Sugars” to help consumers understand the amount of sugar that is being added to a product. This means that the number does not include the naturally-occurring sugar found in fruits and vegetables. Naturally-occurring sugars are accounted for in “Total Sugars” on the label. These new designations are meant to help consumer understand the source of sugar.
  3. “Total Fat” to replace “Calories from Total Fat”
    Research has shown the type of fat (e.g., polyunsaturated fat) is more important to consider than the total calories from fat alone. Therefore, FDA has chosen to remove calories from total fat, but will continue to require listing of “Total Fat,” “Saturated Fat” and “Trans Fat.”
  4. The amount of vitamin D and potassium required to be listed
    This change is based on research from the Institute of Medicine (IOM) which shows that Americans do not always get the recommended amounts of vitamin D and potassium. These vitamins will be required to be listed in order to increase visibility of their requirements. Similar information for vitamins A and C may still be included, but their inclusion is now voluntary as deficiencies of these vitamins are rare today.
  5. New footnote on “Percent Daily Value” (% DV)
    The footnote at the bottom of the label has been updated to read as: “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.” This change has been made to better explain what daily value means.

Facts Up Front

While the above changes will be required and regulated by the FDA, manufacturers can opt to include an additional ‘Facts Up Front’ label on the front of packaging. Introduced by First Lady Michelle Obama in 2010, this nutrition labeling system places the amount of calories, saturated fat, sodium and sugars per serving side by side in a simple format on the front display area of a food product. Small packages that cannot fit all four nutrients may display only one icon, for example, calories per serving. If the package size permits, manufactures may also include up to two “nutrients to encourage” if the product has more than 10 percent of the daily value per serving of potassium, fiber, protein, vitamin A, vitamin C, vitamin D, calcium or iron. This optional label is designed to act as a convenient tool to help consumers understand the nutrient quality of foods at first-glance.