Document ID: FDA-2013-N-0888-0002
Agency: fda
Document Type: Rule
Title: Food Additives Permitted for Direct Addition to Food for Human Consumption: Vitamin D2 and Vitamin D3
Posted Date: 2016-07-18T04:00Z

[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Rules and Regulations]
[Pages 46578-46582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16738]

[[Page 46578]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2013-N-0888]

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Vitamin D2 and Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulations to expand the safe uses of vitamin 
D2 as a nutrient supplement in edible plant-based beverages 
intended for use as milk alternatives and in edible plant-based yogurt 
alternatives and vitamin D3 as a nutrient supplement in milk 
at levels higher than those currently permitted. We are taking this 
action in response to a food additive petition filed by Dean Foods 
Company and WhiteWave Foods Company.

DATES: This rule is effective July 18, 2016. See section VIII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing by August 
17, 2016. The Director of the Federal Register approves the 
incorporation by reference of certain publications listed in the rule 
as of July 18, 2016.

ADDRESSES: You may submit objections and requests for a hearing as 
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of 
Dockets Management, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0888 for ``Food Additives Permitted for Direct Addition to 
Food for Human Consumption; Vitamin D2 and Vitamin 
D3 Final Rule.'' Received objections will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The 
Agency will review this copy, including the claimed confidential 
information, in its consideration of comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition (CFSAN) (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1071.

SUPPLEMENTARY INFORMATION: 

I. Background

    In a document published in the Federal Register of August 16, 2013 
(78 FR 49990), FDA announced that Dean Foods Company (Dean Foods) and 
WhiteWave Foods Company (WhiteWave), c/o Hogan Lovells US LLP, Columbia 
Square, 555 13th Street NW., Washington, DC 20004, had jointly filed a 
food additive petition (FAP 3A4801). The petition proposed to amend 21 
CFR 172.379 to provide for the safe use of vitamin D2 as a 
nutrient supplement in edible plant-based food products intended for 
use as alternatives to milk and milk products and to amend 21 CFR 
172.380 to provide for the safe use of vitamin D3 as a 
nutrient supplement in milk at levels higher than those currently 
permitted. After the notice of filing published, the petitioners 
amended the petition to limit the proposed use of vitamin D2 
to only edible plant-based beverages intended as alternatives to milk 
(e.g., soy-, rice-, almond-, coconut-based beverages) and edible plant-
based yogurt alternatives. This final rule is a complete response to 
the petition.
    Dean Foods/WhiteWave have requested that we amend Sec.  172.379 to 
authorize the use of vitamin D2 as a nutrient supplement at 
levels not to exceed 84 International Units (IU) per 100 grams (g) in 
edible plant-based beverages intended for use as milk alternatives and 
not to exceed 89 IU per 100 g in edible plant-based yogurt 
alternatives. Dean Foods/WhiteWave requested that the proposed use of 
84 IU vitamin D2 per 100 g in edible plant-based beverages 
replace the current allowable maximum use of 50 IU per 100 g in soy 
beverages authorized under

[[Page 46579]]

Sec.  172.379(c). Specifically, Dean Foods/WhiteWave requested that we 
amend Sec.  172.379(c) to eliminate the ``soy beverages'' category, and 
instead create a new category of food that may be supplemented with 
vitamin D2. This category, ``edible plant-based beverages 
intended for use as milk alternatives'', would include soy beverages 
intended as milk alternatives, and would have a maximum allowable use 
of 84 IU vitamin D2 per 100 g. This category would also 
include other edible plant-based beverages made from rice, almond, and 
coconut, among other foods, that are intended as milk alternatives. 
Dean Foods/WhiteWave also requested that we amend Sec.  172.380 to 
allow for the addition of vitamin D3 as a nutrient 
supplement in milk at levels not to exceed 84 IU per 100 g milk. For 
milk with more than the amount of vitamin D provided for in the milk 
standard of identity in 21 CFR 131.110(b)(2), the milk would be 
required to be named by use of a nutrient content claim and a 
standardized term in accordance with 21 CFR 130.10.
    Vitamin D comprises a group of fat-soluble seco-sterols and comes 
in many forms. The two major physiologically relevant forms are vitamin 
D2 and vitamin D3. Vitamin D without a subscript 
represents either vitamin D2 or vitamin D3 or 
both. Vitamin D is affirmed as generally recognized as safe (GRAS) for 
use in food as a nutrient supplement in accordance with 21 CFR 
184.1950(c)(1) and 21 CFR 184.1(b)(2), with the following specific 
limitations:

------------------------------------------------------------------------
                                            Maximum  levels in food  (as
             Category of food                          served)
------------------------------------------------------------------------
Breakfast cereals.........................  350 IU/100 grams (g).
Grain products and pasta..................  90 IU/100 g.
Milk......................................  42 IU/100 g.
Milk products.............................  89 IU/100 g.
------------------------------------------------------------------------

    Additionally, under Sec.  184.1950(c)(2) and (3), vitamin D is 
affirmed as GRAS for use in infant formulas and margarine, 
respectively. Under Sec.  172.380, vitamin D3 is approved 
for use as a food additive as a nutrient supplement in calcium-
fortified fruit juices and fruit juice drinks, meal replacement and 
other type bars, soy protein-based meal replacement beverages 
represented for special dietary use in reducing or maintaining body 
weight, certain cheese and cheese products, meal replacement beverages 
that are not intended for special dietary use in reducing or 
maintaining body weight, and foods represented for use as a sole source 
of nutrition for enteral feeding.
    Under Sec.  172.379, vitamin D2 is approved for use as a 
food additive as a nutrient supplement in soy beverages, soy beverage 
products, soy-based butter substitute spreads, and soy-based cheese 
substitutes, and soy-based cheese substitute products.
    Under Sec.  172.381, vitamin D2 bakers yeast is approved 
for use as a food additive as a source of vitamin D2 and as 
a leavening agent in yeast-leavened baked goods and baking mixes and 
yeast-leavened baked snack foods.
    Vitamin D is essential for human health. The major function of 
vitamin D is the maintenance of blood serum concentrations of calcium 
and phosphorus by enhancing the absorption of these minerals in the 
small intestine. Vitamin D deficiency can lead to abnormalities in 
calcium and bone metabolism, such as rickets in children or 
osteomalacia in adults. Excessive intake of vitamin D elevates blood 
plasma calcium levels (hypercalcemia) by increased intestinal 
absorption and/or mobilization from the bone.
    To ensure that vitamin D is not added to the U.S. food supply at 
levels that could raise safety concerns, FDA affirmed vitamin D as GRAS 
with specific limitations as listed in Sec.  184.1950. Under Sec.  
184.1(b)(2), an ingredient affirmed as GRAS with specific limitations 
may be used in food only within such limitations, including the 
category of food, functional use of the ingredient, and level of use. 
Any addition of vitamin D to food beyond those limitations set out in 
Sec.  184.1950 requires either a food additive regulation or an 
amendment of Sec.  184.1950.
    To support their petition, Dean Foods/WhiteWave submitted dietary 
exposure estimates of vitamin D from the proposed uses of vitamin 
D2 and vitamin D3, as well as all dietary sources 
from naturally occurring sources of vitamin D and uses in accordance 
with our approved food additive regulations (Sec. Sec.  172.379, 
172.380, and 172.381) and our GRAS affirmation regulation (Sec.  
184.1950). They also included dietary supplements in their estimates 
and compared these intake estimates to the Tolerable Upper Intake Level 
(UL) for vitamin D established by the Institute of Medicine (IOM) of 
the National Academies. Dean Foods/WhiteWave also submitted a number of 
publications pertaining to human clinical studies on vitamin D. Based 
on this information, Dean Foods/WhiteWave concluded that the proposed 
uses of vitamin D2 in edible plant-based beverages intended 
as alternatives to milk, edible plant-based yogurt alternatives, and 
vitamin D3 in milk are safe.

II. Evaluation of Safety

    To establish with reasonable certainty that a food additive is not 
harmful under its intended conditions of use, we consider the projected 
human dietary exposure to the additive, the additive's toxicological 
data, and other relevant information (such as published literature) 
available to us. We compare the estimated daily intake (EDI) of the 
additive from all food sources to an acceptable daily intake level 
established by toxicological data. The EDI is determined by projections 
based on the amount of the additive proposed for use in particular 
foods and on data regarding the amount consumed from all food sources 
of the additive. We commonly use the EDI for the 90th percentile 
consumer of a food additive as a measure of high chronic dietary 
intake.

A. Acceptable Daily Intake Level for Vitamin D

    In 2011, the Standing Committee on the Scientific Evaluation of 
Dietary Reference Intakes of the Food and Nutrition Board at the IOM 
conducted an extensive review of relevant published scientific 
literature on vitamin D to update current dietary reference intakes and 
ULs for vitamin D. Based on this information, the IOM revised the ULs 
for vitamin D and developed a report on their findings (Ref. 1). In 
their 2011 assessment of vitamin D, the IOM established a UL of 1,000 
IU per day (IU/p/d) for infants 0 months to 6 months of age and a UL of 
1,500 IU/p/d for infants 6 months to 12 months of age. For children 1 
year to 3 years of age, the IOM established a UL of 2,500 IU/p/d; for 
children 4 years to 8 years of age, the IOM established a UL of 3,000 
IU/p/d. For children 9 years to 18 years of age and adults, the IOM 
established a UL of 4,000 IU/p/d.
    The IOM considers the UL as the highest average daily intake level 
of a nutrient that poses no risk of adverse effects when the nutrient 
is consumed over long periods of time. The UL is determined using a 
risk assessment model developed specifically for nutrients. The dose-
response assessment, which concludes with an estimate of the UL, is 
built upon three toxicological concepts commonly used in assessing the 
risk of exposures to chemical substances: No-observed-adverse-effect 
level, lowest-observed-effect level, and application of an uncertainty 
factor. We considered the ULs established by the IOM relative to

[[Page 46580]]

the intake estimates as the primary basis for assessing the safety of 
the petitioned uses of vitamin D2 and vitamin D3. 
We also reviewed scientific articles on the safety of vitamin D 
submitted in the petition, as well as other relevant published studies 
available to FDA.

B. Estimated Daily Intake for Vitamin D

    For the proposed uses of vitamin D2 and vitamin 
D3, Dean Foods/WhiteWave provided dietary intake estimates 
of vitamin D for 11 population groups, assuming maximum levels of 
vitamin D in all foods that could be fortified (except for one scenario 
where typical fortification levels in infant formula were used), as 
well as in the petitioned foods. They also included exposure from 
dietary supplements as reported in the 2003-2008 National Health and 
Nutrition Survey (NHANES) 30-day dietary supplement use data (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) and 
from naturally occurring food sources.
    The exposure estimates performed by Dean Foods/WhiteWave are 
appropriate. However, there are some exposure parameters that have 
changed since the estimates were completed in 2013. In particular, Dean 
Foods/WhiteWave provided estimates that included vitamin D exposure 
from fortification of edible plant-based dairy analogs other than 
edible plant-based yogurt alternatives, which they are no longer 
seeking to fortify. Dean Food/WhiteWave also included fortification of 
meal replacement bars at a level of 500 IU/40 g in anticipation of the 
approval of FAP 2A4788 (Abbott Laboratories); however, this use was 
subsequently withdrawn from the petition before the final rule issued 
(see 79 FR 46993, August 12, 2014). In addition, more recent 24-hour 
recall dietary supplement data from the 2009-2012 NHANES (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) have 
become available that may better represent current vitamin D exposure 
from dietary supplements than the 30-day dietary supplement use data 
from the 2003-2008 NHANES used by Dean Foods/WhiteWave. Moreover, a 
recent published study suggests that it may be appropriate to include 
dietary sources of the vitamin D metabolite, 25-hydroxyvitamin D 
(25(OH)D), in vitamin D exposure estimates to take into account 
discrepancies seen between dietary intake and blood serum levels of 
vitamin D (Ref. 2). The foods that were identified in the study as 
sources of 25(OH)D were beef, pork, chicken, turkey, and eggs. The 
study also indicated that 25(OH)D may have a potency five times that of 
vitamin D. For these reasons, we have used the 2009-2012 NHANES data to 
estimate dietary exposure to vitamin D from: (1) The petitioned uses in 
milk, edible plant-based beverages intended as milk alternatives, and 
edible plant-based yogurt alternatives; and (2) cumulative exposure 
from all current sources of vitamin D (i.e., naturally occurring 
sources, approved fortified sources, and dietary supplements), the 
petitioned uses of vitamin D in milk, edible plant-based beverages 
intended as milk alternatives, and edible plant-based yogurt, and 
exposure from sources of 25(OH)D, which have been adjusted to account 
for the difference in potency between 25(OH)D and vitamin D.
    For the overall U.S. population 1 year of age and older, the 
cumulative exposure at the 90th percentile from all food sources of 
vitamin D, including the proposed uses, dietary supplements, and 
25(OH)D, was estimated to be 2,000 IU/p/d. The cumulative exposure for 
infants 0 to 6 months of age and infants 6 to 12 months of age from all 
food sources of vitamin D, including the proposed uses, dietary 
supplements, and 25(OH)D, was estimated to be 948 IU/p/d and 988 IU/p/
d, respectively, for the 90th percentile consumer (Ref. 3).

C. Safety of the Petitioned Uses of Vitamin D2

    We reviewed and evaluated the information submitted by Dean Foods/
WhiteWave regarding the safety of the dietary intake of vitamin D from 
the proposed uses in milk, edible plant-based beverages intended as 
milk alternatives, and edible plant-based yogurt alternatives. Dean 
Food/WhiteWave submitted reports of scientific studies published 
subsequent to the 1997 IOM report and issuance of the final rule (79 FR 
46993) authorizing the use of vitamin D3 in meal replacement 
beverages that are not intended for special dietary use in reducing or 
maintaining body weight and in foods represented for use as a sole 
source of nutrition for enteral feeding. Dean Food/WhiteWave concluded 
that these publications support a conclusion that the proposed use of 
vitamin D is safe.
    We reviewed the published reports of scientific studies on vitamin 
D submitted by Dean Food/WhiteWave, as well as other relevant published 
studies available to us since our previous evaluations of six food 
additive petitions for fortifying a variety of foods with vitamin D (77 
FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 FR 69435, 
November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June 22, 
2005; 68 FR 9000, February 27, 2003). These studies did not raise any 
new safety concerns regarding the current or proposed uses of vitamin 
D. The most recent food additive petition resulted in our amendment of 
the food additive regulations in Sec.  172.380 to allow for the safe 
use of vitamin D3 in meal replacement beverages that are not 
intended for special dietary use in reducing or maintaining body weight 
and in foods represented for use as a sole source of nutrition for 
enteral feeding (79 FR 46993). The six earlier food additive petitions 
also resulted in amendments of the food additive regulations to allow 
for the safe use of vitamin D as a nutrient supplement in certain 
foods.
    We considered the ULs established by the IOM relative to the intake 
estimates as the primary basis for assessing the safety of the 
petitioned uses of vitamin D. Depending on the age group, the IOM UL 
for vitamin D for the U.S. population 1 year of age and older ranges 
from 2,500 IU/p/d to 4,000 IU/p/d. The estimated dietary exposure to 
vitamin D from all food sources, including the proposed uses, at the 
90th percentile for the U.S. population (1 years of age and older) is 
estimated to be 2,000 IU/p/d, which is below the lowest IOM UL of 2,500 
IU/p/d in the range of ULs for the overall U.S. population (1 year of 
age and older). Estimated exposure to vitamin D from all food sources, 
including the proposed uses, for infants 0 months to 6 months of age at 
the 90th percentile is 948 IU/p/d; for infants 6 months to 12 months of 
age, estimated exposure to vitamin D is 988 IU/p/d. Both of these 
estimates are below the IOM UL of 1,000 IU/p/d for infants 0 months to 
6 months of age and 1,500 IU/p/d for infants 6 months to 12 months of 
age. Because the 90th percentile EDI of vitamin D from all current and 
proposed food sources for each population group is less than the 
corresponding IOM UL for that population group, we conclude that 
dietary intake of vitamin D2 from the proposed use as a 
nutrient supplement in edible plant-based beverages intended as milk 
alternatives and edible plant-based yogurt alternatives and the 
proposed increased maximum permitted level of vitamin D3 in 
milk are safe (Ref. 4).

III. Incorporation by Reference

    FDA is incorporating by reference two monographs from the Food 
Chemicals Codex 9th Edition (FCC 9), which was approved by the Office 
of the Federal Register. You may purchase a copy of the material from 
the United States Pharmacopeial Convention, 12601

[[Page 46581]]

Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/.
    The current regulation for the use of vitamin D3 in food 
(Sec.  172.380) indicates that the additive must meet the 
specifications in the FCC 8. The more current FCC is the 9th Edition. 
The current regulation for vitamin D2 (Sec.  172.379) 
indicates the additive must meet the specifications in the 7th edition 
of the FCC (FCC 7). Because the specifications for vitamin 
D2 and vitamin D3 in FCC 9 are identical to those 
in FCC 7 and FCC 8, respectively, Dean Foods/WhiteWave requested that 
the respective regulations be updated to reference the specifications 
in FCC 9. Therefore, we are amending Sec. Sec.  172.379 and 172.380 by 
adopting the specifications for vitamin D2 and vitamin 
D3 in FCC 9 in place of FCC 7 and FCC 8, respectively.

IV. Conclusion

    Based on all data relevant to vitamin D that we reviewed, we 
conclude that the petitioned uses of vitamin D in milk and edible 
plant-based beverages intended as milk alternatives and edible plant-
based yogurt alternatives within the limits proposed by Dean Food/
WhiteWave are safe. Consequently, we are amending the food additive 
regulations as set forth in this document.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that we considered and relied upon in reaching our 
decision to approve the petition will be made available for public 
disclosure (see FOR FURTHER INFORMATION CONTACT). As provided in Sec.  
171.1(h), we will delete from the documents any materials that are not 
available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as 
stated in the August 16, 2013, Federal Register document of petition 
for FAP 3A4801. We stated that we had determined, under 21 CFR 
25.32(k), that this action ``is of a type that does not individually or 
cumulatively have a significant effect on the human environment'' such 
that neither an environmental assessment nor an environmental impact 
statement is required. We have not received any new information or 
comments that would affect our previous determination.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VIII. Objections

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Division of Dockets Management (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at http://www.regulations.gov.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    Our review of this petition was limited to section 409 of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348). 
This final rule is not a statement regarding compliance with other 
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act 
(21 U.S.C. 331(ll)) prohibits the introduction or delivery for 
introduction into interstate commerce of any food that contains a drug 
approved under section 505 of the FD&C Act (21 U.S.C. 355), a 
biological product licensed under section 351 of the Public Health 
Service Act (42 U.S.C. 262), or a drug or biological product for which 
substantial clinical investigations have been instituted and their 
existence has been made public, unless one of the exemptions in section 
301(ll)(1) to (4) of the FD&C Act applies. In our review of this 
petition, FDA did not consider whether section 301(ll) of the FD&C Act 
or any of its exemptions apply to food containing this additive. 
Accordingly, this final rule should not be construed to be a statement 
that a food containing this additive, if introduced or delivered for 
introduction into interstate commerce, would not violate section 
301(ll) of the FD&C Act. Furthermore, this language is included in all 
food additive final rules and therefore should not be construed to be a 
statement of the likelihood that section 301(ll) of the FD&C Act 
applies.

X. References

    References marked with an asterisk (*) are on display at the 
Division of Dockets Management (see ADDRESSES), under Docket No. FDA-
2013-N-0888, and are available for viewing by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. References 
without asterisks are not on display; they are available as published 
articles and books.

1. Committee to Review Dietary Reference Intakes for Vitamin D and 
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary 
Reference Intakes for Calcium and Vitamin D,'' National Academies 
Press, Washington, DC, 2011.
2. Taylor, C., K. Patterson, J. Roseland, et al., ``Including Food 
25-Hydroxyvitamin D in Intake Estimates May Reduce the Discrepancy 
Between Dietary and Serum Measures of Vitamin D Status,'' Journal of 
Nutrition, 144:654-659, 2014.
*3. FDA Memorandum from D. Folmer, CFSAN Chemistry Review Group, 
Division of Petition Review, to J. Kidwell, Regulatory Group I, 
Division of Petition Review, January 27, 2016.
*4. FDA Memorandum from T. Tyler, CFSAN Toxicology Team, Division of 
Petition Review, to J. Kidwell, Division of Petition Review, 
February 10, 2016.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for part 172 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Amend Sec.  172.379 by revising the first sentence in paragraph (b) 
and revising the table in paragraph (c) by removing the entry for ``Soy 
beverages'' and adding entries for ``Edible plant-

[[Page 46582]]

based beverages intended as milk alternatives'' and ``Edible plant-
based yogurt alternatives'' in alphabetical order to read as follows:

Sec.  172.379  Vitamin D2.

* * * * *
    (b) Vitamin D2 meets the specifications of the 2015 Food 
Chemical Codex, 9th edition (through Third Supplement), effective 
December 1, 2015, pp. 1260-1261, which is incorporated by reference. * 
* *
    (c) * * *

------------------------------------------------------------------------
                                            Maximum  levels in food  (as
             Category of food                          served)
------------------------------------------------------------------------
Edible plant-based beverages intended as    84 IU/100 g.
 milk alternatives.
Edible plant-based yogurt alternatives....  89 IU/100 g.
 
                                * * * * *
------------------------------------------------------------------------

0
3. Amend Sec.  172.380 by revising the first sentence in paragraph (b) 
and by adding paragraph (c)(8) to read as follows:

Sec.  172.380  Vitamin D3.

* * * * *
    (b) Vitamin D3 meets the specifications of the 2015 Food 
Chemical Codex, 9th edition (through Third Supplement), effective 
December 1, 2015, pp. 1261-1262, which is incorporated by reference. * 
* *
    (c) * * *
    (8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk 
that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and 
that meets the requirements for foods named by use of a nutrient 
content claim and a standardized term in accordance with Sec.  130.10 
of this chapter.

    Dated: July 11, 2016.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for 
Food Safety and Applied Nutrition.
[FR Doc. 2016-16738 Filed 7-15-16; 8:45 am]
 BILLING CODE 4164-01-P