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§172.345 食品添加剂叶酸(Folic acid (olacin))

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放大字体  缩小字体 2011-04-25 01:31:24  来源:GPO  浏览次数:4554
核心提示:规定了叶酸安全用于食品中需符合的条件。叶酸的加入量对170.3中所指的早餐谷物,每份不得超过400μg,在粗玉米粉中的加入量,应使每454g中叶酸的含量不超过1.0mg。叶酸在婴儿配方食品中的加入量应符合法规412中规定。叶酸可加入特殊膳食用食品中,其量不得超过配方食品特殊膳食的需要量。叶酸可加入到膳食补充制品类食品中,每天食用一次者,每份不得超过400μg,每天食用超过一次者,每份不得超过200μg.
发布单位
FDA
FDA
发布文号 61 FR 8807
发布日期 1996-03-05 生效日期 暂无
有效性状态 废止日期 暂无
备注 规定了叶酸安全用于食品中需符合的条件。叶酸的加入量对170.3中所指的早餐谷物,每份不得超过400μg,在粗玉米粉中的加入量,应使每454g中叶酸的含量不超过1.0mg。叶酸在婴儿配方食品中的加入量应符合法规412中规定。叶酸可加入特殊膳食用食品中,其量不得超过配方食品特殊膳食的需要量。叶酸可加入到膳食补充制品类食品中,每天食用一次者,每份不得超过400μg,每天食用超过一次者,每份不得超过200μg.

  § 172.345   Folic acid (folacin).

  Folic acid (CAS Reg. No. 59–30–3), also known as folacin or folate, may be safely used in food as a nutrient in accordance with the following prescribed conditions:

  (a) Folic acid is the chemical N -[4-[[(2-amino-1,4-dihydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]- L -glutamic acid.

  (b) Folic acid meets the specifications of the “Food Chemicals Codex,” 4th ed. (1996), pp. 157–158, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address http://www.nap.edu ), or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 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) Folic acid may be added to foods subject to a standard of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act (the act) when the standard of identity specifically provides for the addition of folic acid.

  (d) Folic acid may be added, at levels not to exceed 400 micrograms (μg) per serving, to breakfast cereals, as defined under §170.3(n)(4) of this chapter, and to corn grits at a level such that each pound of corn grits contains not more than 1.0 milligram of folic acid.

  (e) Folic acid may be added to infant formula in accordance with section 412(i)(1) of the act or with regulations issued under section 412(i)(2) of the act which are codified in §107.100 of this chapter.

  (f) Folic acid may be added to a medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), at levels not to exceed the amount necessary to meet the distinctive nutritional requirements of the disease or condition for which the food is formulated.

  (g) Folic acid may be added to food for special dietary use at levels not to exceed the amount necessary to meet the special dietary needs for which the food is formulated.

  (h) Folic acid may be added to foods represented as meal-replacement products, in amounts not to exceed:

  (1) Four hundred μg per serving if the food is a meal-replacement that is represented for use once per day; or

  (2) Two hundred μg per serving if the food is a meal-replacement that is represented for use more than once per day.

  [61 FR 8807, Mar. 5, 1996, as amended at 61 FR 27779, June 3, 1996; 64 FR 1758, Jan. 12, 1999]

  更多关于美国 FDA 已批准的直接用于人类食品的添加剂种类法规,请点击美国FDA 21 CFR 第172部分已批准的直接用于人类食品的添加剂种类汇总

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