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September 2017 - Volume 17, Number 9


This month we go back to school on understanding the many nuances surrounding compliant ingredient statements with a focus on "and/or" labeling. Read on to learn for which classes of ingredients FDA allows this flexibility. In separate news, because gluten-free products continue to gain in popularity, we reprise a reader favorite about the final rule for gluten-free. You can also learn about how to handle a Prop 65 list ingredient that one reader has used in a formula for years.

In this issue:

Wishing you all the best,  

Karen C. Duester, President, Food Consulting Company

Karen C. Duester, President, Food Consulting Company

And/or Labeling in the Ingredient Statement

Understanding the many nuances surrounding compliant ingredient statements continues to drive food labelers for clarification. In recent months, Food Label News has focused on various ingredient labeling rules. This month the focus is on when FDA provides leeway in developing ingredient statements for manufacturing flexibility. That is, for manufacturers who are unable to maintain a constant usage pattern of certain ingredients and may sometimes use one or more of these ingredients in a product, FDA does not require listing them in descending order of predominance following the collective name and permits labeling with "and/or."

Use of and/or labeling applies only to the following class of ingredients: fats and oils provided they are not the primary ingredient, leavening agents, yeast nutrients, dough conditioners, firming agents, wax/resin and fish protein ingredients. And/or labeling can be expressed in one of three ways: 1) "contains one or more of the following:"; 2) "and/or"; 3) "or."

Specific statements and rules apply to each class of ingredients. See examples below.

  • Fats and oils that are not the primary ingredient – Vegetable oil shortening (cottonseed oil, palm oil, or soybean oil).
  • Leavening agents – Leavening agents (baking soda, monocalcium phosphate, or calcium carbonate).
  • Yeast nutrients – Yeast nutrients (calcium sulfate or ammonium phosphate).
  • Dough conditioners – Dough conditioners (L-cysteine and/or ammonium sulfate).
  • Firming agents – Firming agents (calcium carbonate and/or calcium sulfate).
  • Fish protein ingredients – When a manufacturer of processed seafood products is unable to adhere to a constant pattern of fish species because of seasonal or other limitations of availability, the following is used: fish proteins (contains one or more of the following: pollock, cod, pacific whiting).
  • Wax and resin on fresh produce – When a coating is used on fresh produce to maintain freshness, it must be declared by the phrase "coated with [specific name] wax" where food labelers can use and/or labeling for the following: food-grade animal-based wax, food-grade vegetable-, petroleum-, beeswax-, and/or shellac-based wax or resin.

Bullseye: It's worth noting that an ingredient can be both in the ingredient list in order of predominance and included in an and/or statement for the same product. For example, if canola oil is added to a cracker formula in addition to vegetable shortening that may contain canola oil, then canola oil would appear twice in the ingredient statement: the first time as a consistent ingredient of the formula and then as part of the and/or declaration for vegetable oil shortening (canola oil, modified palm oil, and/or soybean oil).

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Answers to Your Important Questions

Q. We use a caramel color in our cookies that contains furfuryl alcohol. I understand that it was put on the Prop 65 list and has no "safe harbor," even though we have always used it. How do we handle this?
— R.Y., Manufacturer, Ohio

A.  As of September 2016, the California Office of Environmental Health Hazard Assessment (OEHHA) included furfuryl alcohol on California’s Proposition 65 list because of cancer risk and as of now, has not published a "safe harbor" limit or indicated a "no significant risk level." MORE

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In Case You Missed It...

Finally, a Final Rule for Gluten-free

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