[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
