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§170.50 供人类消费食品中的甘氨酸(氨基乙酸)(Glycine (aminoacetic acid) in food for human consumption)
2011-09-26 09:42  点击:3378
发布单位:FDA
发布文号:暂无
发布日期:暂无
生效日期:暂无
有效性状态:
废止日期:暂无
备注:在GMP条件下,在人食用的食品中使用甘氨酸,从某些影响的角度来看,在一般情况下被认为是安全的;然而:在试验动物的饲料中加入高剂量的甘氨酸时,表现出有害影响,人类从饮食中所摄取的甘氨酸的量,可能会由于其在食品工艺中的使用形式的改变而增加。应当重新制定人食用的食品的配方,以消除掉其中的甘氨酸及其盐类成分,或必须使这类制品符合食品添加剂法规的规定。甘氨酸在动物饲料中的使用,仍然列为GRAS。

  §170.50 Glycine (aminoacetic acid) in food for human consumption.

       (a) Heretofore, the Food and Drug Administration has expressed the opinion in trade correspondence that glycine is generally recognized as safe for certain technical effects in human food when used in accordance with good manufacturing practice; however:

  (1) Reports in scientific literature indicate that adverse effects were found in cases where high levels of glycine were administered in diets of experimental animals.

  (2) Current usage information indicates that the daily dietary intake of glycine by humans may be substantially increasing due to changing use patterns in food technology.

  Therefore, the Food and Drug Administration no longer regards glycine and its salts as generally recognized as safe for use in human food and all outstanding letters expressing sanction for such use are rescinded.

  (b) The Commissioner of Food and Drugs concludes that by May 8, 1971, manufacturers:

  (1) Shall reformulate food products for human use to eliminate added glycine and its salts; or

  (2) Shall bring such products into compliance with an authorizing food additive regulation. A food additive petition supported by toxicity data is required to show that any proposed level of glycine or its salts added to foods for human consumption will be safe.

  (c) The status of glycine as generally recognized as safe for use in animal feed, as prescribed in § 582.5049 of this chapter, remains unchanged because the additive is considered an essential nutrient in certain animal feeds and is safe for such use under conditions of good feeding practice.

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