August 2017 - Volume 17, Number 8
In between your summer reading and vacation, take a look at how to handle labeling for ingredients that are at small or insignificant levels in your formula. Ingredients at 2% or less and incidental additives are treated differently according to FDA regulations. In this issue, you’ll also learn what to do when color is also an allergen in our Reader Q&A. Lastly, read up on all the new regulations from 2016 to ensure your nutrition labeling plan is on track.
In this issue:
Karen C. Duester, President, Food Consulting Company
Ingredients at 2% or Less and Incidental Additives
Food labelers are aware that FDA regulations require that every ingredient be listed by common name in order of predominance in the final product. There are, however, circumstances that allow flexibility in this general requirement. The scenarios we have covered in recent months include use of: 1) collective names, and 2) composite ingredient lists. Two additional scenarios for ingredient lists are: 1) small amounts of ingredients, and 2) incidental additives at insignificant levels.
Small amounts – The first scenario that allows flexibility in creating the ingredient list is when there are small amounts of ingredients in the final formulation. There is a choice to either: 1) list in order of predominance like any other ingredient, or 2) at the end of the ingredient statement with a clause such as "2% or less of the following" and then list the minor ingredients in any order. Note: if the minor ingredients are even less than 2%, it is acceptable to use 1.5%, 1% or 0.5% in the clause.
There are several reasons why it could be advantageous to us the "2% or less" clause.
Incidental additives – The second scenario that allows flexibility in creating the ingredient list is when there are trace amounts of ingredients in the final formulation. According to 21 CFR 101.100, if ingredients are present in a food at insignificant levels and provide no technical or functional effect, these ingredients do not have to be listed in the ingredient statement. FDA defines incidental additives as:
Note incidental additives should always be listed in the ingredient statement when they are:
Answers to Your Important Questions
product uses carmine color that is derived from a cod fish protein. How do I
declare this on the ingredient statement since fish protein is an allergen?
— N.S., Manufacturer, Thailand
A. Carmine is one of the color additives that must always be listed by common or usual name within the ingredient statement. The fact that your carmine is derived from fish, one of the big 8 allergens, also requires that you alert consumers about a potential allergic reaction by specifying the exact species of fish. MORE
In Case You Missed It...
What Matters Most in Food Labeling
Food Label News, now in its 17th year, is a monthly e-newsletter reaching over 10,000 subscribers around the world. We welcome your colleagues to subscribe for news and insights about food labels.
Your Virtual Food Label Partner
Food Consulting Company, founded in 1993, provides nutrition analysis, food labeling and regulatory support for more than 1,500 clients worldwide. Our guarantee: 100% regulatory compliance. Contact us for the help you need now.
You may reprint all or part of this newsletter provided you attribute it to Food Label News and include a link to www.foodlabels.com.
Copyright © 1997-2017. Food Consulting Company, Del Mar, CA. All rights reserved. | CONFIDENTIALITY + PRIVACY