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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21
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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 3]
[CITE: 21CFR172.135]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B - FOOD FOR HUMAN CONSUMPTION (CONTINUED)

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

Subpart B - Food Preservatives

Sec. 172.135 Disodium EDTA.

The food additive disodium EDTA (disodium ethylenediaminetetraacetate) 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 (C10H14O8N2Na2-2H2O).

(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:

Food Limitation (parts per million) Use
Aqueous multivitamin preparations150With iron salts as a stabilizer for vitamin B 12 in liquid multivitamin preparations.
Canned black-eyed peas145Promote color retention.
Canned kidney beans165Preservative.
Canned strawberry pie filling500Promote color retention.
Cooked sausage36As a cure accelerator with sodium ascorbate or ascorbic acid.
Dressings, nonstandardized75Preservative.
French dressing75 Do.
Frozen white potatoes including cut potatoes100Promote color retention.
Gefilte fish balls or patties in packing medium 1 50Inhibit discoloration.
Legumes (all cooked canned, other than black-eyed peas)165Promote color retention.
Mayonnaise75Preservative.
Ready-to-eat cereal products containing dried bananas 2 315Promote color retention.
Salad dressing75Preservative.
Sandwich spread100 Do.
Sauces75 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 ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo) tetraacetate), in the following foods at not to exceed, in combination, the levels prescribed, calculated as anhydrous C10H12O8N2CaNa2:

Food Limitation (parts per million) Use
Dressings, nonstandardized75Preservative.
French dressing75 Do.
Mayonnaise75 Do.
Salad dressing75 Do.
Sandwich spread100 Do.
Sauces75 Do.

(3) Alone, as a sequestrant in the nonnutritive sweeteners that are listed in § 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]

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