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Federal Register / Vol. 86, No. 111 / Friday, June 11, 2021 / Rules and Regulations comment stated that over 80 percent of the yogurt products sold in the United States in the time around 2009 declared the presence of live and active cultures either on the labels or on company websites. Another comment provided consumer survey results to contend that consumers expect yogurt products to contain live and active cultures. Other comments indicated that the requirement of live and active cultures is consistent with the Codex standard.
Other comments disagreed whether yogurt can be heat-treated after culturing. Some comments strongly opposed heat treatment after culturing and indicated that labeling the resultant product as yogurt is misleading and deceptive because consumers expect yogurt to contain live and active cultures. Other comments did not object to heat treatment after culturing if the package states that the product does not contain live and active cultures.
Some comments opposed any changes to the heat treatment provisions in the existing yogurt standard. The comments argued that, with extended shelf life, heat-treated yogurt gives consumers an additional option for a healthy dairy product. The comments also claimed that neither the presence nor the number of living bacteria in yogurt has any demonstrated health benefit. Some comments also suggested that some yogurt manufacturers may want to market their yogurt products with the claim contains live and active cultures. Many comments expressed interest in knowing whether a yogurt product contains live and active cultures.
Response 7 We analyzed survey data submitted by the NYA and found that, while a majority of respondents expected to find live and active cultures as an ingredient in yogurt, the absence of a discussion in the survey on the response rates raises questions regarding potential bias in the results Ref. 6.
Consequently, we are unable to conclude, based on this survey, that yogurt should necessarily contain live and active cultures or that heat treatment after culturing should be prohibited.
Based on the comments discussing live and active cultures, we believe that many consumers are interested in knowing whether the yogurt products they purchase contains live and active cultures and that this information may impact their purchasing decisions. We therefore conclude that the labeling of yogurt should disclose the absence of live and active cultures rather than the use of heat treatment after culturing.
The disclosure statement in 131.200f1ii has been changed in
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the final rule to require an accompanying statement of does not contain live and active cultures on the product label. Thus, the rule permits the treatment of yogurt after culturing to inactivate viable microorganisms and extend shelf life of the product, provided that the label bears this accompanying statement. We discuss the labeling requirements for such treated yogurt in more detail in responses 27, 28, and 29.
We note that, in the future, new technologies other than heat treatment e.g., high pressure processing may be used to inactivate viable microorganisms in yogurt and extend yogurt shelf life. Therefore, the final rule, at 131.200a, states that, to extend the shelf life of the food, yogurt may be treated after culturing to inactivate viable microorganisms rather than limiting yogurt specifically to heat treatment after culturing to extend the shelf life of the food. Such treated foods require an accompanying statement of does not contain live and active cultures on the product label.
In a summary and analysis of the consumer survey results submitted by one comment, we did not find that the consumer research results provided evidence that consumers expect all yogurt products to contain live and active cultures Ref. 6.
Given consumer interest in knowing the presence of live and active cultures in yogurt, manufacturers may wish to affirmatively convey to consumers that live and active cultures are present.
Therefore, the final rule, at 131.200f2, permits the optional labeling statement contains live and active cultures or another appropriate descriptor if the yogurt product contains a minimum level of live and active cultures as explained further in response 8.
As for the comments regarding the Codex standard, the final rule is consistent with the Codex standard, which also does not require live and active cultures in heat treated yogurt.
For yogurt that is not heat treated, the requirement to permit the optional labeling statement contains live and active cultures is consistent with the Codex standard.
Comment 8 Many comments supported setting a minimum level of live and active cultures. Some comments provided general support without mentioning any specific levels of live and active cultures. Other comments addressed the issue of what level of live and active cultures must be present when the label bears a statement to this effect. Among these comments, some agreed with our proposed levels of
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live and active cultures. Some supported the minimum level of 107
CFU/g of live and active cultures at the time of manufacture but did not support the inclusion of reasonable expectation of 106 CFU/g throughout the manufacturers assigned shelf life of the product. One comment stated that manufacturers do not always have control over the storage conditions at retail levels. One comment requested that we not set a minimum level of live and active cultures in the final rule because, for yogurt that is not heattreated, the provisions on fermentation, minimum titratable acidity, and maximum pH already ensure that the bacterial culture is above 107 CFU/g after culturing.
Response 8 The proposed rule specified a minimum level of live and active cultures of 107 CFU/g at the time of manufacture with a reasonable expectation of 106 CFU/g through the manufacturers assigned shelf life of the product. We have included these minimum levels in the final rule under 131.200f2 for the optional labeling statement contains live and active cultures. We decline to revise the rule to specify the minimum level of live and active cultures only at the time of manufacture. The time of manufacture is not the point when consumers purchase or consume their yogurt products. Even though manufacturers do not always have full control over the storage conditions at retail level, yogurt products should be properly refrigerated throughout the distribution channel.
Studies generally indicate that the characterizing yogurt cultures survive well during cold storage and at lowered pH levels Refs.7 through 9. One study shows that, when commercial yogurt products were stored at 4 C, levels of characterizing yogurt cultures remained relatively stable over the study period of 4 weeks, with 1.0 or less log reduction Ref. 8. Studies also show that, in nonheated yogurt, the mixture of S.
thermophilus and L. bulgaricus is typically well above the minimum 106
CFU/g at the end of refrigerated storage, even though some reduction occurred during storage depending on the specific culture used, the storage temperature, and other factors Refs. 7
through 9. Given these data indicating the minimum of 106 CFU/g of live and active cultures will likely exist throughout the shelf life of the food, and to promote honesty and fair dealing in the interest of consumers, the final rule permits the optional labeling statement contains live and active cultures or another appropriate descriptor if the yogurt product contains a minimum of
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