170.50 Glycine (aminoacetic acid) in food for human consumption.
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[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
PART 170_FOOD ADDITIVES--Table of Contents
Subpart C_Specific Administrative Rulings and Decisions
Sec. 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all outstanding letters expressing sanction for such use are rescinded.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,
(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 Sec. 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
Additives that reference this regulation:
Source: U.S. Code of Federal Regulations - CFR Title 21, Part 170, Section 50
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