[Federal Register Volume 59, Number 237 (Monday, December 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-30496]


[[Page Unknown]]

[Federal Register: December 12, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Parts 182 and 184

[Docket No. 80N-0218]

 

Citric Acid and Certain Citrate Derivatives; Affirmation of GRAS 
Status as Direct Human Food Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is affirming citric 
acid, dibasic ammonium citrate, calcium citrate, potassium citrate, 
sodium citrate, isopropyl citrate, stearyl citrate, and triethyl 
citrate as generally recognized as safe (GRAS) for use as direct human 
food ingredients. The safety of these ingredients has been evaluated 
under the comprehensive safety review conducted by the agency.

DATES: Effective December 12, 1994. The Director of the Office of the 
Federal Register approves the incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in new 
Secs. 184.1033(b), 184.1195(b), 184.1625(b), 184.1751(b), and 
184.1911(b), effective December 12, 1994.

FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3098.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of January 7, 1983 (48 FR 834), FDA 
published a proposal to affirm that citric acid, dibasic ammonium 
citrate, calcium citrate, potassium citrate, sodium citrate, isopropyl 
citrate, stearyl citrate, and triethyl citrate are GRAS for use as 
direct human food ingredients. The proposal was published in accordance 
with the announced FDA review of the safety of GRAS and prior-
sanctioned food ingredients.
    In accordance with Sec. 170.35 (21 CFR 170.35), copies of the 
scientific literature review and the report of the Select Committee on 
GRAS Substances (the Select Committee) on citric acid and these citrate 
derivatives have been made available for public review in the Dockets 
Management Branch (address above). Copies of these documents are also 
available for purchase from the National Technical Information Service, 
U.S. Department of Commerce, 5285 Port Royal Rd., Springfield, VA 
22161.
    The proposal gave interested parties an opportunity to submit 
comments. Several letters, each containing one or more comments, were 
received in response to the proposal. The substantive comments received 
addressed several points, among which were additional uses for certain 
citrates, changes in the description of the manufacturing methods for 
other specific citrates, and other technical corrections to the 
regulations proposed for other specific citrates.
    In the Federal Register of August 20, 1992 (57 FR 37738), FDA 
published a tentative final rule announcing that it was tentatively 
affirming the GRAS status of citric acid and the citrate derivatives 
named above. In the tentative final rule, the agency responded to the 
comments that had been received in response to the proposal. The agency 
published a tentative final rule before proceeding to final action 
because a significant period of time had elapsed since publication of 
the proposal. In addition, the agency wished to allow for comment on 
two provisions in the tentative final rule that were not part of the 
original proposal: (1) The inclusion of the changes published in the 
third supplement to the Food Chemicals Codex, 3d ed., in the 
specifications for citric acid in new Sec. 184.1033(b); and (2) the 
revised description of isopropyl citrate in new Sec. 184.1386(a) and of 
stearyl citrate in new Sec. 184.1851(a).

II. Response to Comments

    Three comments were received in response to the agency's tentative 
final rule on citric acid and the citrates named above. None of the 
comments addressed the provisions in the tentative final rule on which 
the agency had requested comments. Two of the comments merely expressed 
general support for the agency's tentative affirmation of the GRAS 
status of citric acid and the above named citrates. One comment 
reported additional direct food uses for calcium citrate and requested 
inclusion of these uses in the final rule. The additional uses, for 
which the comment provided information on dietary exposure, were in 
home-prepared jams and jellies, and in beverages and beverage bases; 
the technical effects specified were as an anti-caking and free-flow 
agent, or as a processing aid. The comment also indicated that calcium 
citrate is used as a pH control agent.
    In its safety review, the Select Committee had concluded that no 
evidence in the available information on calcium citrate demonstrates, 
or suggests reasonable grounds to suspect, a hazard to the public at 
levels that are now current or might reasonably be expected in the 
future. In the proposal, the agency stated that it had undertaken its 
own review of the available information on calcium citrate and 
concurred in the conclusion of the Select Committee (48 FR 834 at 836). 
The agency has considered the requested additional uses of this 
ingredient and finds that the additional amounts consumed would not be 
large enough to change that conclusion and that sufficient safety data 
exist to affirm the uses as GRAS when the ingredient is used in 
accordance with current good manufacturing practice. The agency also 
concludes that the ingredient will perform the technical effects 
specified.
    The agency concludes that a large margin of safety exists for 
current and reasonably expected future uses of calcium citrate in food. 
In light of this large margin of safety, the agency finds that 
inclusion of all of the food categories and technical effects in which 
calcium citrate is used, or in which its use was requested, would 
result in a regulation for calcium citrate that would be unnecessarily 
long. Therefore, the agency is no longer including a list of technical 
effects nor a list of food categories in new Sec. 184.1195(c).

III. Scope of the Rule

    FDA is amending the current regulations by removing 21 CFR 
182.1033, 182.1195, 182.1625, 182.1751, 182.1911, 182.6033, 182.6195, 
182.6386, 182.6511, 182.6625, 182.6751, 182.6851, and 182.8195. The 
agency is adding new 21 CFR 184.1033, 184.1140, 184.1195, 184.1386, 
184.1625, 184.1751, 184.1851, and 184.1911.

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule that published in the 
Federal Register of January 7, 1983 (48 FR 834). No new information or 
comments have been received that would affect the agency's previous 
determination that there is no significant impact on the human 
environment and that an environmental impact statement is not required.

V. Economic Impact

    FDA has examined the economic implications of this rule, which 
affirms that citric acid, dibasic ammonium citrate, calcium citrate, 
potassium citrate, sodium citrate, isopropyl citrate, stearyl citrate, 
and triethyl citrate are GRAS for use as direct human food ingredients, 
under Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 
96-354). Executive Order 12866 directs Federal agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic and environmental benefits, 
public health and safety effects, distributive impacts and equity). The 
Regulatory Flexibility Act requires analyzing options for regulatory 
relief for small businesses.
    The agency finds that this rule is not a significant regulatory 
action as defined by Executive Order 12866. Because no current activity 
is prohibited by this rule, the compliance cost to firms is zero. 
Because no increase in the health risks faced by consumers will result 
from this final rule, total costs are also zero. Potential benefits 
include the possible wider use of these substances to achieve intended 
technical effects and any resources saved by reducing the need to 
prepare further petitions to affirm the GRAS status of certain of these 
substances. In accordance with the Regulatory Flexibility Act, FDA has 
also determined that this rule will not have a significant impact on a 
substantial number of small businesses.

List of Subjects

21 CFR Part 182

    Food ingredients, Food packaging, Spices and flavorings.

21 CFR Part 184

    Food ingredients, Incorporation by reference.

    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 parts 182 and 184 are amended as follows:

PART 182--SUBSTANCES GENERALLY RECOGNIZED AS SAFE

    1. The authority citation for 21 CFR part 182 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).


Sec. 182.1033  [Removed]

    2. Section 182.1033 Citric acid is removed from subpart B.


Sec. 182.1195  [Removed]

    3. Section 182.1195 Calcium citrate is removed from subpart B.


Sec. 182.1625  [Removed]

    4. Section 182.1625 Potassium citrate is removed from subpart B.


Sec. 182.1751  [Removed]

    5. Section 182.1751 Sodium citrate is removed from subpart B.


Sec. 182.1911  [Removed]

    6. Section 182.1911 Triethyl citrate is removed from subpart B.


Sec. 182.6033  [Removed]

    7. Section 182.6033 Citric acid is removed from subpart G.


Sec. 182.6195  [Removed]

    8. Section 182.6195 Calcium citrate is removed from subpart G.


Sec. 182.6386  [Removed]

    9. Section 182.6386 Isopropyl citrate is removed from subpart G.


Sec. 182.6511  [Removed]

    10. Section 182.6511 Monoisopropyl citrate is removed from subpart 
G.


Sec. 182.6625   [Removed]

    11. Section 182.6625 Potassium citrate is removed from subpart G.


Sec. 182.6751   [Removed]

    12. Section 182.6751 Sodium citrate is removed from subpart G.


Sec. 182.6851   [Removed]

    13. Section 182.6851 Stearyl citrate is removed from subpart G.


Sec. 182.8195   [Removed]

    14. Section 182.8195 Calcium citrate is removed from subpart I.

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    15. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    16. New Sec. 184.1033 is added to subpart B to read as follows:


Sec. 184.1033  Citric acid.

    (a) Citric acid (C6H8O7, CAS Reg. No. 77-92-9) is 
the compound 2-hydroxy-1,2,3-propanetricarboxylic acid. It is a 
naturally occurring constituent of plant and animal tissues. It occurs 
as colorless crystals or a white powder and may be anhydrous or contain 
one mole of water per mole of citric acid. Citric acid may be produced 
by recovery from sources such as lemon or pineapple juice; by 
mycological fermentation using Candida spp., described in Secs. 173.160 
and 173.165 of this chapter; and by the solvent extraction process 
described in Sec. 173.280 of this chapter for the recovery of citric 
acid from Aspergillus niger fermentation liquor.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 86-87, and its third supplement (March 1992), 
pp. 107-108, which are incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National 
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, and 
the Center for Food Safety and Applied Nutrition (HFS-200), 200 C St. 
SW., Washington, DC 20204, or may be examined at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitations other than current good manufacturing 
practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

    17. New Sec. 184.1140 is added to subpart B to read as follows:


Sec. 184.1140  Ammonium citrate, dibasic.

    (a) Ammonium citrate, dibasic ((NH4)2HC6H 
5O7, CAS Reg. No. 3012-65-5) is the diammonium salt of citric 
acid. It is prepared by partially neutralizing citric acid with 
ammonia.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for ammonium citrate, dibasic. In the interim, this ingredient must be 
of a purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavor enhancer as defined in 
Sec. 170.3(o)(11) of this chapter and as a pH control agent as defined 
in Sec. 170.3(o)(23) of this chapter.
    (2) The ingredient is used in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter and in cheeses as defined in 
Sec. 170.3(n)(5) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    18. New Sec. 184.1195 is added to subpart B to read as follows:


Sec. 184.1195  Calcium citrate.

    (a) Calcium citrate (Ca3(C6H5O7) 
2.4H2O, CAS Reg. No. 813-94-5) is the calcium salt of 
citric acid. It is prepared by neutralizing citric acid with calcium 
hydroxide or calcium carbonate. It occurs as a fine white, odorless 
powder and usually contains four moles of water per mole of calcium 
citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 49 and 50, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or may be 
examined at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
Calcium citrate may also be used in infant formula in accordance with 
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or 
with regulations promulgated under section 412(a)(2) of the act.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section do not exist or have been waived.

    19. New Sec. 184.1386 is added to subpart B to read as follows:


Sec. 184.1386  Isopropyl citrate.

    (a) Isopropyl citrate is a mixture of the mono-, di-, and 
triisopropyl esters of citric acid. It is prepared by esterifying 
citric acid with isopropanol.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for isopropyl citrate. In the interim, this ingredient must be of a 
purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; a sequestrant as defined in 
Sec. 170.3(o)(26) of this chapter; and a solvent and vehicle as defined 
in Sec. 170.3(o)(27) of this chapter.
    (2) The ingredient is used in margarine in accordance with 
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    20. New Sec. 184.1625 is added to subpart B to read as follows:


Sec. 184.1625  Potassium citrate.

    (a) Potassium citrate (C6H5K3O7 .H2O, 
CAS Reg. No. 006100-05-6) is the potassium salt of citric acid. It is 
prepared by neutralizing citric acid with potassium hydroxide or 
potassium carbonate. It occurs as transparent crystals or a white 
granular powder, is odorless and deliquescent, and contains one mole of 
water per mole of potassium citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), p. 242, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or may be 
examined at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    21. New Sec. 184.1751 is added to subpart B to read as follows:


Sec. 184.1751  Sodium citrate.

    (a) Sodium citrate (C6H5Na3O7 .2H2O, 
CAS Reg. No. 68-04-2) is the sodium salt of citric acid. It is prepared 
by neutralizing citric acid with sodium hydroxide or sodium carbonate. 
The product occurs as colorless crystals or a white crystalline powder. 
It may be prepared in an anhydrous state or may contain two moles of 
water per mole of sodium citrate.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), pp. 283-284, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are 
available from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or may be 
examined at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    22. New Sec. 184.1851 is added to subpart B to read as follows:


Sec. 184.1851  Stearyl citrate.

    (a) Stearyl citrate is a mixture of the mono-, di-, and tristearyl 
esters of citric acid. It is prepared by esterifying citric acid with 
stearyl alcohol.
    (b) The Food and Drug Administration, in cooperation with the 
National Academy of Sciences, is developing food-grade specifications 
for stearyl citrate. In the interim, this ingredient must be of a 
purity suitable for its intended use.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as an antioxidant as defined in 
Sec. 170.3(o)(3) of this chapter; an emulsifier and emulsifier salt as 
defined in Sec. 170.3(o)(8) of this chapter; a sequestrant as defined 
in Sec. 170.3(o)(26) of this chapter; and a surface-active agent as 
defined in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in margarine in accordance with 
Sec. 166.110 of this chapter; in nonalcoholic beverages as defined in 
Sec. 170.3(n)(3) of this chapter; and in fats and oils as defined in 
Sec. 170.3(n)(12) of this chapter at levels not to exceed current good 
manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    23. New Sec. 184.1911 is added to subpart B to read as follows:


Sec. 184.1911  Triethyl citrate.

    (a) Triethyl citrate (C12H20O7, CAS Reg. No. 77-93-
0) is the triethyl ester of citric acid. It is prepared by esterifying 
citric acid with ethyl alcohol and occurs as an odorless, practically 
colorless, oily liquid.
    (b) The ingredient meets the specifications of the Food Chemicals 
Codex, 3d ed. (1981), p. 339, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available 
from the National Academy Press, 2101 Constitution Ave. NW., 
Washington, DC 20418, and the Center for Food Safety and Applied 
Nutrition (HFS-200), 200 C St. SW., Washington, DC 20204, or may be 
examined at the Office of the Federal Register, 800 North Capitol St. 
NW., suite 700, Washington, DC.
    (c) In accordance with Sec. 184.1(b)(1), the ingredient is used in 
food with no limitation other than current good manufacturing practice. 
The affirmation of this ingredient as generally recognized as safe 
(GRAS) as a direct human food ingredient is based upon the following 
current good manufacturing practice conditions of use:
    (1) The ingredient is used as a flavoring agent as defined in 
Sec. 170.3(o)(12) of this chapter; a solvent and vehicle as defined in 
Sec. 170.3(o)(27) of this chapter; and a surface-active agent as 
defined in Sec. 170.3(o)(29) of this chapter.
    (2) The ingredient is used in foods at levels not to exceed current 
good manufacturing practice.
    (d) Prior sanctions for this ingredient different from the uses 
established in this section, or different from those set forth in part 
181 of this chapter, do not exist or have been waived.

    Dated: November 29, 1994.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 94-30496 Filed 12-9-94; 8:45 am]
BILLING CODE 4160-01-F