FDA食品添加劑使用衛(wèi)生標(biāo)準(zhǔn).rar

FDA食品添加劑使用衛(wèi)生標(biāo)準(zhǔn).rar,FDA,食品添加劑,使用,衛(wèi)生標(biāo)準(zhǔn) [Code of Federal Regulations] [Title 21, Volume 3] [Revised as of April 1, 2006] [CITE: 21CFR172] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED) PART 172 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION Subpart A--General Provisions Sec. 172.5 General provisions for direct food additives. (a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purposes of this part, good manufacturing practice shall be defined to include the following restrictions. (1) The quantity of the substance added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritive, or other technical effect in food. (2) Any substance intended for use in or on food is of appropriate food grade and is prepared and handled as a food ingredient. (b) The existence of a regulation prescribing safe conditions of use for a food additive shall not be construed to relieve the use of the substance from compliance with any other provision of the Act. (c) The existence of any regulation prescribing safe conditions of use for a nutrient substance does not constitute a finding that the substance is useful or required as a supplement to the diet of humans. Subpart B--Food Preservatives Sec. 172.105 Anoxomer. Anoxomer as identified in this section may be safely used in accordance with the following conditions: (a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol, 4,4'-(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No. 60837-57-2) prepared by condensation polymerization of divinylbenzene (m- and p-) with tert-butylhydroquinone, tert-butylphenol, hydroxyanisole, p-cresol and 4,4'-isopropylidenediphenol. (b) The polymeric antioxidant meets the following specifications: (1) Polymer, not less than 98.0 percent as determined by an ultraviolet method entitled "Ultraviolet Assay, "1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 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. (2) Molecular weight: Total monomers, dimers and trimers below 500 not more than 1 percent as determined by a method entitled "Low Molecular Weight Anoxomer Analysis," 1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 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. (3) Phenol content: Not less than 3.2 milliequivalent/gram and not more than 3.8 milliequivalent/gram as determined by a method entitled "Total Phenols," 1982, which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), 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. (4) Heavy metals as lead (as Pb), not more than 10 parts per million. Arsenic (as As), not more than 3 parts per million. Mercury (as Hg), not more than 1 part per million. (c) Anoxomer may be safely used as an antioxidant in food at a level of not more than 5,000 parts per million based on fat and oil content of the food. [48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12, 1989] Sec. 172.110 BHA. ------------------------------------------------------------------------ Limitations (total BHA Food and BHT) parts per million ------------------------------------------------------------------------ Dehydrated potato shreds................................... 50 Active dry yeast........................................... \1\ 1,000 Beverages and desserts prepared from dry mixes............. \1\ 2 Dry breakfast cereals...................................... 50 Dry diced glazed fruit..................................... \1\ 32 Dry mixes for beverages and desserts....................... \1\ 90 Emulsion stabilizers for shortenings....................... 200 Potato flakes.............................................. 50 Potato granules............................................ 10 Sweet potato flakes........................................ 50 ------------------------------------------------------------------------ \1\ BHA only. ------------------------------------------------------------------------ Limitations (total BHA Food and BHT) parts per million ------------------------------------------------------------------------ Dehydrated potato shreds................................... 50 Active dry yeast........................................... \1\ 1,000 Beverages and desserts prepared from dry mixes............. \1\ 2 Dry breakfast cereals...................................... 50 Dry diced glazed fruit..................................... \1\ 32 Dry mixes for beverages and desserts....................... \1\ 90 Emulsion stabilizers for shortenings....................... 200 Potato flakes.............................................. 50 Potato granules............................................ 10 Sweet potato flakes........................................ 50 ------------------------------------------------------------------------ \1\ BHA only. The food additive BHA (butylated hydroxyanisole) alone or in combination with other antioxidants permitted in food for human consumption in this subpart B may be safely used in or on specified foods, as follows: (a) The BHA meets the following specification: Assay (total BHA), 98.5 percent minimum. Melting point 48 deg. C minimum. (b) The BHA is used alone or in combination with BHT, as an antioxidant in foods, as follows: (c) To assure safe use of the additive: (1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive. (2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture. (3) The label or labeling of dry mixes for beverages and desserts shall bear adequate directions for use to provide that beverages and desserts prepared from the dry mixes contain no more than 2 parts per million BHA. Sec. 172.115 BHT. ------------------------------------------------------------------------ Limitations (total BHA Food and BHT) parts per million ------------------------------------------------------------------------ Dehydrated potato shreds................................... 50 Dry breakfast cereals...................................... 50 Emulsion stabilizers for shortenings....................... 200 Potato flakes.............................................. 50 Potato granules............................................ 10 Sweetpotato flakes......................................... 50 ------------------------------------------------------------------------ ------------------------------------------------------------------------ Limitations (total BHA Food and BHT) parts per million ------------------------------------------------------------------------ Dehydrated potato shreds................................... 50 Dry breakfast cereals...................................... 50 Emulsion stabilizers for shortenings....................... 200 Potato flakes.............................................. 50 Potato granules............................................ 10 Sweetpotato flakes......................................... 50 ------------------------------------------------------------------------ The food additive BHT (butylated hydroxytoluene), alone or in combination with other antioxidants permitted in this subpart B may be safely used in or on specified foods, as follows: (a) The BHT meets the following specification: Assay (total BHT) 99 percent minimum. (b) The BHT is used alone or in combination with BHA, as an antioxidant in foods, as follows: (c) To assure safe use of the additive: (1) The label of any market package of the additive shall bear, in addition to the other information required by the Act, the name of the additive. (2) When the additive is marketed in a suitable carrier, in addition to meeting the requirement of paragraph (c)(1) of this section, the label shall declare the percentage of the additive in the mixture. Sec. 172.120 Calcium disodium EDTA. ------------------------------------------------------------------------ Limitation Food (parts per Use million) ------------------------------------------------------------------------ Cabbage, pickled.................... 220 Promote color, flavor, and texture retention. Canned carbonated soft drinks....... 33 Promote flavor retention. Canned white potatoes............... 110 Promote color retention. Clams (cooked canned)............... 340 Promote color retention. Crabmeat (cooked canned)............ 275 Retard struvite formation; promote color retention. Cucumbers pickled................... 220 Promote color, flavor, and texture retention. Distilled alcoholic beverages....... 25 Promote stability of color, flavor, and/or product clarity. Dressings, nonstandardized.......... 75 Preservative. Dried lima beans (cooked canned).... 310 Promote color retention. Egg product that is hard-cooked and \1\ 200 Preservative. consists, in a cylindrical shape, of egg white with an inner core of egg yolk. Fermented malt beverages............ 25 Antigushing agent. French dressing..................... 75 Preservative. Legumes (all cooked canned, other 365 Promote color than dried lima beans, pink beans, retention. and red beans). Mayonnaise.......................... 75 Do. Mushrooms (cooked canned)........... 200 Promote color retention. Oleomargarine....................... 75 Preservative. Pecan pie filling................... 100 Promote color retention. Pink beans (cooked canned).......... 165 Promote color retention. Potato salad........................ 100 Preservative. Processed dry pinto beans........... 800 Promote color retention. Red beans (cooked canned)........... 165 Promote color retention. Salad dressing...................... 75 Preservative. Sandwich spread..................... 100 Do. Sauces.............................. 75 Do. Shrimp (cooked canned).............. 250 Retard struvite formation; promote color retention. Spice extractives in soluble 60 Promote color and carriers. flavor retention. Spreads, artificially colored and 100 Promote color lemon-flavored or orange-flavored. retention. ------------------------------------------------------------------------ \1\ By weight of egg yolk portion. ------------------------------------------------------------------------ Limitation Food (parts per Use million) ------------------------------------------------------------------------ Dressings, nonstandardized.......... 75 Preservative. French dressing..................... 75 Do. Mayonnaise.......................... 75 Do. Salad dressing...................... 75 Do. Sandwich spread..................... 100 Do. Sauces.............................. 75 Do. ------------------------------------------------------------------------ ------------------------------------------------------------------------ Limitation Food (parts per Use million) ------------------------------------------------------------------------ Cabbage, pickled.................... 220 Promote color, flavor, and texture retention. Canned carbonated soft drinks....... 33 Promote flavor retention. Canned white potatoes............... 110 Promote color retention. Clams (cooked canned)............... 340 Promote color retention. Crabmeat (cooked canned)............ 275 Retard struvite formation; promote color retention. Cucumbers pickled................... 220 Promote color, flavor, and texture retention. Distilled alcoholic beverages....... 25 Promote stability of color, flavor, and/or product clarity. Dressings, nonstandardized.......... 75 Preservative. Dried lima beans (cooked canned).... 310 Promote color retention. Egg product that is hard-cooked and \1\ 200 Preservative. consists, in a cylindrical shape, of egg white with an inner core of egg yolk. Fermented malt beverages............ 25 Antigushing agent. French dressing..................... 75 Preservative. Legumes (all cooked canned, other 365 Promote color than dried lima beans, pink beans, retention. and red beans). Mayonnaise.......................... 75 Do. Mushrooms (cooked canned)........... 200 Promote color retention. Oleomargarine....................... 75 Preservative. Pecan pie filling................... 100 Promote color retention. Pink beans (cooked canned).......... 165 Promote color retention. Potato salad........................ 100 Preservative. Processed dry pinto beans........... 800 Promote color retention. Red beans (cooked canned)........... 165 Promote color retention. Salad dressing...................... 75 Preservative. Sandwich spread..................... 100 Do. Sauces.............................. 75 Do. Shrimp (cooked canned).............. 250 Retard struvite formation; promote color retention. Spice extractives in soluble 60 Promote color and carriers. flavor retention. Spreads, artificially colored and 100 Promote color lemon-flavored or orange-flavored. retention. ------------------------------------------------------------------------ \1\ By weight of egg yolk portion. ------------------------------------------------------------------------ Limitation Food (parts per Use million) ------------------------------------------------------------------------ Dressings, nonstandardized.......... 75 Preservative. French dressing..................... 75 Do. Mayonnaise.......................... 75 Do. Salad dressing...................... 75 Do. Sandwich spread..................... 100 Do. Sauces.............................. 75 Do. ------------------------------------------------------------------------ The food additive calcium di