Food and Drug Administration, HHS § 172.410 North Frederick Ave., suite 500, Gai- (f) To assure safe use of the additive, thersburg, MD 20877, or may be exam- in addition to the other information re- ined at the National Archives and quired by the Act: Records Administration (NARA). For (1) The label of consumer-sized or information on the availability of this bulk containers of the additive shall material at NARA, call 202–741–6030, or bear the name ‘‘whole fish protein con- go to: http://www.archives.gov/ centrate’’. federallregister/ (2) The label or labeling of containers codeloflfederallregulations/ of the additive shall bear adequate di- ibrllocations.html. rections for use to comply with the (2) Moisture content shall not exceed limitations prescribed by paragraphs 10 percent by weight of the final prod- (d) and (e) of this section. uct, as determined by the method de- (3) Labels of manufactured foods con- scribed in section 24.003 of the AOAC. taining the additive shall bear, in the See paragraph (c)(1) of this section for ingredient statement, the name of the availability of the material incor- additive, ‘‘whole fish protein con- porated by reference. centrate’’ in the proper order of de- (3) Fat content shall not exceed 0.5 creasing predominance in the finished percent by weight of the final product, food. as determined by the method described [42 FR 14491, Mar. 15, 1977, as amended at 49 in section 24.005 of the AOAC. See para- FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, graph (c)(1) of the this section for 1989] availability of the material incor- porated by reference. § 172.395 Xylitol. (4) The additive may contain residues Xylitol may be safely used in foods of isopropyl alcohol and ethylene di- for special dietary uses, provided the chloride not in excess of 250 parts per amount used is not greater than that million and 5 parts per million, respec- required to produce its intended effect. tively, when used as solvents in the ex- traction process. § 172.399 Zinc methionine sulfate. (5) Microwave radiation meeting the Zinc methionine sulfate, CAS Reg. requirements of § 179.30 of this chapter No. 56329–42–1, may be safely used in may be used to reduce residues of the accordance with the following pre- solvents used in the extraction process. scribed conditions: (6) The additive shall contain not in (a) The additive is the product of the excess of 100 parts per million fluorides reaction between equimolar amounts of (expressed as F). zinc sulfate and DL-methionine in puri- (7) The additive shall be free of Esch- fied water. erichia coli and pathogenic organisms, (b) The additive meets the following including Salmonella, and shall have a specifications: total bacterial plate count of not more Zinc content—19 to 22 percent. than 10,000 per gram. C5H11NO2S ‘‘DL-methionine’’—46 to 50 per- (8) The additive shall have no more cent. than a faint characteristic fish odor Cadmium—not more than 0.05 part per mil- and taste. lion. (d) When the additive is used or in- (c) The additive is used in tablet form tended for use in the household as a as a source of dietary zinc. protein supplement in food for regular consumption by children up to 8 years [46 FR 58297, Dec. 1, 1981] of age, the amount of the additive from this source shall not exceed 20 grams Subpart E—Anticaking Agents per day (about one heaping table- spoon). § 172.410 Calcium silicate. (e) When the additive is used as a Calcium silicate, including synthetic protein supplement in manufactured calcium silicate, may be safely used in food, the total fluoride content (ex- food in accordance with the following pressed as F) of the finished food shall prescribed conditions: not exceed 8 ppm based on the dry (a) It is used as an anticaking agent weight of the food product. in food in an amount not in excess of 55 VerDate Mar<15>2010 13:59 Jul 24, 2014 Jkt 232072 PO 00000 Frm 00065 Fmt 8010 Sfmt 8010 Y:\SGML\232072.XXX 232072 pmangrum on DSK3VPTVN1PROD with CFR.