(a) Peptones are a variable mixture of polypeptides, oligopeptides, and amino acids that are produced by partial hydrolysis of casein, animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg albumin, or lactalbumin (whey protein). Peptones are produced from these proteins using proteolytic enzymes that either are considered to be generally recognized as safe (GRAS) or are regulated as food additives. Peptones are also produced by denaturing any of the proteins listed in this paragraph with safe and suitable acids or heat.

(b) The ingredients must be of a purity suitable for their intended use.

(c) In accordance with §184.1(b)(1), these ingredients are used in food with no limitation other than current good manufacturing practice. The affirmation of these ingredients as GRAS as direct human food ingredients is based upon the following current good manufacturing practice conditions of use:

(1) These ingredients are used as nutrient supplements as defined in §170.3(o)(20) of this chapter; as processing aids as defined in §170.3(o)(24) of this chapter; and as surface-active agents as defined in §170.3(o)(29) of this chapter.

(2) These ingredients are used in food at levels not to exceed current good manufacturing practice.

(d) Prior sanctions for these ingredients different from the uses established in this section do not exist or have been waived.

[49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985; 73 FR 8607, Feb. 14, 2008]