[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR172.135]
[Page 35-36]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 172_FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN
Subpart B_Food Preservatives
Sec. 172.135 Disodium EDTA.
The food additive disodium EDTA (disodium ethylenediaminetetraace
tate) may be safely used in designated foods for the purposes and in
accordance with the following prescribed conditions:
(a) The additive contains a minimum of 99 percent disodium
ethylenedia-minetetraacetate dihydrate
(C10H14O8N2Na2[mid
dot]2H2O).
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as anhydrous calcium disodium EDTA:
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Aqueous multivitamin preparations... 150 With iron salts as a
stabilizer for
vitamin B \12\ in
liquid multivitamin
preparations.
Canned black-eyed peas.............. 145 Promote color
retention.
Canned kidney beans................. 165 Preservative.
Canned strawberry pie filling....... 500 Promote color
retention.
Cooked sausage...................... 36 As a cure accelerator
with sodium ascorbate
or ascorbic acid.
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Frozen white potatoes including cut 100 Promote color
potatoes. retention.
Gefilte fish balls or patties in \1\ 50 Inhibit discoloration.
packing medium.
Legumes (all cooked canned, other 165 Promote color
than black-eyed peas). retention.
Mayonnaise.......................... 75 Preservative.
Ready-to-eat cereal products \2\ 315 Promote color
containing dried bananas. retention.
Salad dressing...................... 75 Preservative.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
\1\ Based on total weight of finished product including packing medium.
\2\ In dried banana component of cereal product.
(2) With calcium disodium EDTA (calcium disodium ethylenediamine
tetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the
following foods at not to exceed, in combination, the levels prescribed,
calculated as anhydrous
C10H12O8N2CaNa2:
[[Page 36]]
------------------------------------------------------------------------
Limitation
Food (parts per Use
million)
------------------------------------------------------------------------
Dressings, nonstandardized.......... 75 Preservative.
French dressing..................... 75 Do.
Mayonnaise.......................... 75 Do.
Salad dressing...................... 75 Do.
Sandwich spread..................... 100 Do.
Sauces.............................. 75 Do.
------------------------------------------------------------------------
(3) Alone, as a sequestrant in the nonnutritive sweeteners that are
listed in Sec. 180.37 of this chapter and that, in addition, are
designed for aqueous solution: Provided, That the amount of the
additive, calculated as anhydrous calcium disodium EDTA, does not exceed
0.1 percent by weight of the dry nonnutritive sweetener.
(c) To assure the safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraphs (b) (1) and (2)
of this section the additives are used only in compliance with the
applicable standards of identity for such foods.
[42 FR 14491, Mar. 15, 1977, as amended at 65 FR 48379, Aug. 8, 2000]