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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations
making a nutrient content claim. This is not what we had intended under the regulatory framework of 130.10 after NLEA was enacted.
We have decided that nonnutritive sweeteners should only be permitted when making a nutrient content claim and therefore when the product is subject to the general definition and standard in 130.10. As such, products containing nonnutritive sweeteners, but that otherwise comply with the requirements in 131.200, are not the standardized food yogurt and are different standardized foods e.g., reduced calorie yogurt under 130.10. The name of each of these foods must be prominently displayed in the statement of identity on the product label in accordance with 101.3. We note that this approach is consistent with the approach under our current regulations as 130.10 permits deviations to 131.200, 131.203, and 131.206 in order to comply with a nutrient content claim defined by regulation e.g., reduced calorie.
We further note that, under this approach, products deviating from 131.200 due to the use of nonnutritive sweeteners are not required to declare the presence of the nonnutritive sweeteners in the name or statement of identity of the food. Instead, 130.10
requires them to bear the nutrient content claim achieved by use of nonnutritive sweeteners in the name or statement of identity. We believe this approach will address comments concerning the presence and disclosure of artificial sweeteners while also providing manufacturers flexibility to make modified yogurt products with nonnutritive sweeteners. Unlike the proposed rule, the final rule does not permit the use of nonnutritive sweeteners in yogurt under 131.200d2. However, under 130.10, products marketed with a nutrient content claim in the name of the food e.g., reduced calorie yogurt will signal to consumers that the food differs from yogurt, lowfat yogurt, and nonfat yogurt and contains nonnutritive sweeteners. Consumers will continue to be informed about the presence of specific nonnutritive sweeteners by their declaration under their common or usual names in the ingredient statement on the label, as required by 101.4a.
We have also considered comments concerning safety. We consider the safety of nonnutritive sweeteners as part of the food additive review process or GRAS notification process. There is no evidence to indicate that nonnutritive sweeteners, either as approved food additives or as GRAS substances in
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yogurt, are unsafe when used in modified yogurt products. We understand that some consumers may have sensitivities to artificial sweeteners. As explained above, the name or statement of identity of the product will put consumers on notice about the presence of artificial sweeteners and the particular sweetener can be confirmed by referencing the ingredient statement.
Comment 19 Some comments asked us to require prominent declaration or display e.g., in large type on the principal display panel of nonnutritive sweeteners on yogurt containers in addition to listing the nonnutritive sweeteners in the ingredient statements.
Response 19 We do not agree that the name of the nonnutritive sweetener should be prominently displayed on the yogurt containers because, under 130.10, a yogurt product with nonnutritive sweeteners will bear a nutrient content claim, such as reduced calorie, in its statement of identity. Section 101.3d requires that the statement of identity be presented in bold type on the principal display panel, in a size reasonably related to the most prominent printed matter on such panel, and in lines generally parallel to the base on which the package rests as it is designed to be displayed. The nutrient content claim will signal to consumers the presence of nonnutritive sweeteners and prompt consumers to check the ingredient statements for the types of nonnutritive sweeteners used.
Disclosure of nonnutritive sweeteners in the ingredient statement, rather than the name or statement of identity, is consistent with the labeling of other foods made with nonnutritive sweeteners. Nonnutritive sweeteners are declared by their common or usual names in the ingredient statement on the food labels in accordance with 101.4a.
In some instances, specific requirements are necessary for the safe use of a nonnutritive sweetener. The conditions for including this information on the label and how and where this information is to be presented on the label are established in the relevant food additive regulations.
For example, labels of food that contain aspartame must bear the statement PHENYLKETONURICS: CONTAINS
PHENYLALANINE, either on the principal display panel or on the information panel, in accordance with 172.804 21 CFR 172.804.
Other than what is provided in these regulations, we do not see a basis to require disclosure of nonnutritive sweeteners other than in the ingredient statement. Therefore, we decline to
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require the name of the nonnutritive sweetener be prominently displayed on the yogurt container. However, manufacturers may declare, voluntarily, on the principal display panel that the product is artificially sweetened or is made with nonnutritive sweeteners as long as the declaration is truthful and not misleading.
Comment 20 One comment opposed the use of high fructose corn syrup HFCS in yogurt.
Response 20 HFCS is a nutritive carbohydrate. HFCS is affirmed as GRAS and can be used in food with no limitation other than current good manufacturing practice 184.1866 21
CFR 184.1866. The comment did not provide any data or other information to support prohibiting the use of HFCS in yogurt, so we decline to revise the rule to exclude HFCS as a sweetener.
Comment 21 The proposed rule would revise 131.200d5 to permit the use of safe and suitable emulsifiers in addition to stabilizers as optional ingredients in the manufacture of yogurts.
A few comments opposed the use of emulsifiers and questioned the need for these ingredients in yogurt. Other comments supported the use of emulsifiers in yogurt, indicating that this would allow industry more flexibility in formulating products.
Response 21 There are no data suggesting that emulsifiers pose any safety or characteristic concerns in yogurt, provided they are used within good manufacturing practice as described in 21 CFR 172.5a and within limitations specified by our relevant food additive regulations or are GRAS.
Therefore, we decline to remove emulsifiers as an optional ingredient in yogurt. However, to clarify that stabilizers and emulsifiers are two different functional classes, we have, on our own initiative, decided to list stabilizers and emulsifiers separately as 131.200d5 and 6, respectively. We also have renumbered 131.200d6 as 131.200d7.
Comment 22 The proposed rule, at 131.200d6, would permit preservatives as an optional ingredient in yogurt. Some comments supported permitting the use of safe and suitable preservatives as optional ingredients in the manufacture of yogurt and stated that the use of preservatives should not be limited only to heat-treated yogurt.
Other comments opposed the use of any preservatives.
Response 22 The proposed rule would not limit the use of preservatives to heat-treated yogurt and would, instead, allow the use of preservatives for all types of yogurt. The comments
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