---
kind: "section"
citation: "21 C.F.R. § 184.1063"
title: "21"
number: "184.1063"
heading: "Enzyme-modified lecithin."
url: "https://uscodex.org/cfr/21/184.1063"
---

# §184.1063. Enzyme-modified lecithin.

- (a) Enzyme-modified lecithin is prepared by treating lecithin with either phospholipase A2 (EC 3.1.1.4) or pancreatin.
- (b) **The ingredient meets the specifications in paragraphs (b)(1) through (b)(8) of this section.** Unless otherwise noted, compliance with the specifications listed below is determined according to the methods set forth for lecithin in the Food Chemicals Codex, 4th ed. (1996), pp. 220-221, which are incorporated by reference in accordance with 5 U.S.C. [552(a)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington DC 20418, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
  - (1) Acetone-insoluble matter (phosphatides), not less than 50.0 percent.
  - (2) **Acid value, not more than 40.**
  - (3) Lead, not more than 1.0 part per million, as determined by atomic absorption spectroscopy.
  - (4) **Heavy metals (as Pb), not more than 20 parts per million.**
  - (5) Hexane-insoluble matter, not more than 0.3 percent.
  - (6) **Peroxide value, not more than 20.**
  - (7) Water, not more than 4.0 percent.
  - (8) Lysolecithin, 50 to 80 mole percent of total phosphatides as determined by “Determination of Lysolecithin Content of Enzyme-Modified Lecithin: Method I,” dated 1985, which is incorporated by reference in accordance with 5 U.S.C. [552(a)](/usc/5/552.md?p=a) and [1](/usc/5/1.md) CFR [part 51](/cfr/21/part51.md). Copies are available from the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200, or may be examined at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
- (c) In accordance with [§ 184.1(b)(1)](/cfr/21/184.1.md?p=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 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 emulsifier as defined in [§ 170.3(o)(8)](/cfr/21/170.3.md?p=o-8) of this chapter.
  - (2) **The ingredient is used at levels not to exceed current good manufacturing practice.**

## Notes

### Amendments

[61 FR 45889, Aug. 30, 1996, as amended at 78 FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023]

### Authority

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

### Source

Source: 42 FR 14653, Mar 15, 1977, unless otherwise noted.

### Amendments

[61 FR 45889, Aug. 30, 1996, as amended at 78 FR 14666, Mar. 7, 2013; 81 FR 5595, Feb. 3, 2016; 88 FR 17724, Mar. 24, 2023]