§184.1535 食品添加剂烟酰胺(Niacinamide)

    更多关于已证实属于一般公认为安全（GRAS）的可直接加入食品中的物质种类，请点击美国FDA 21 CFR 第184部分已证实属于一般公认为安全（GRAS）的可直接加入食品中的物质种类汇总

　　§ 184.1535   Niacinamide.

　　（a） Niacinamide （C6H6N2O, CAS Reg. No. 98–92–0） is the chemical 3-pyridinecarboxylic acid amide （nicotinamide）. It is a white crystalline powder that is soluble in water, alcohol, ether, and glycerol. It melts between 128° and 131 °C.

　　（b） The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. （1981）, p. 205, which is incorporated by reference. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or available for inspection 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）, 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 （GRAS） as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

　　（1） The ingredient is used as a nutrient supplement as defined in §170.3（o）（20） of this chapter.

　　（2） The ingredient is used in foods at levels not to exceed current good manufacturing practice. The ingredient may also be used in infant formula in accordance with section 412（g） of the Federal Food, Drug, and Cosmetic Act （the act） or with regulations promulgated under section 412（a）（2） of the Act.

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

　　[48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983]