Eggs and Egg Products (21 CFR 160.100-160.190)

642 21 CFR Ch. I (4–1–16 Edition) Pt. 160 (b) A mixture of 95 parts of formula 3A denatured alcohol and five parts of isopropanol v/v. (ii) Eighty percent alcohol (8 liters of extracting solutions, specified in para graph (b)(3)(i) (a) or (b) of this section, diluted to 9.5 liters with water). (iii) Drying dish—a flat-bottom dish with a tight fitting cover. (iv) Drying oven—a properly venti lated oven thermostatically controlled at 100±2 °C. (v) Procedure—Transfer frozen con tents of package to plastic bag; tie bag securely and immerse in water bath with continuous flow at room tempera ture. Avoid agitation of bag during thawing by using clamps or weights. When sample completely thaws, re move bag, blot off adhering water, and transfer peas to U.S. No. 8 sieve, using (20 cm.) size for container of less than 3 lb. net weight and (30.5 cm.) for larger quantities. Without shifting peas, in cline sieve to aid drainage, drain 2 min utes. With cloth wipe surplus water from lower screen surface. Weigh 250 g. of peas into high-speed blender, add 250 g. of water and blend to smooth paste. For less than 250 g. sample, use entire sample with equal weight of water. Weight 20 g.±10 mg. of the paste into 250 ml. distillation flask, add 120 ml. of extracting solutions specified in para graph (b)(3)(i) (a) or (b) of this section, and reflux 30 minutes on steam or water bath or hotplate. Fit into a buchner funnel a filter paper of appro priate size (previously prepared by dry ing in flatbottom dish for 2 hours in drying oven, covering, cooling in desic cator, and weighing). Apply vacuum to buchner funnel and transfer contents of beaker so as to avoid running over edge of paper. Aspirate to dryness and wash material on filter with 80 percent alco hol until washings are clear and color less. Transfer paper and alcohol-insol uble solids to drying dish used to pre pare paper, dry uncovered for 2 hours in drying oven, cover, cool in desic cator, and weigh at once. From this weight deduct weight of dish, cover, and paper. Calculate percent by weight of alcohol-insoluble solids. (4) Brine flotation test. (i) Expla nation—The brine flotation test uti lizes salt solutions of various specific gravities to separate the peas accord ing to maturity. The brine solutions are based on the percentage by weight of pure salt (NaCl) in solution at 20 °C. In making the test the brine solutions are standardized to the proper specific gravity equivalent to the specified ‘‘percent of salt solutions at 20 °C’’ by using a salometer spindle accurately calibrated at 20 °C. A 250 ml glass beak er or similar receptacle is filled with the brine solution to a depth of ap proximately 50 mm. The brine solution and sample (100 peas per container) must be at the same temperature and should closely approximate 20 °C. (ii) Procedure—After carefully re moving the skins from the peas, place the peas into the solution. Pieces of peas and loose skins should not be used in making the brine flotation test. If cotyledons divide, use both cotyledons in the test and consider the two sepa rated cotyledons as 1 pea; and, if an odd cotyledon sinks, consider it as one pea. Only peas that sink to the bottom of the receptacle within 10 seconds after immersion are counted as ‘‘peas that sink’’. (5) If the quality of the frozen peas falls below the standard prescribed in paragraph (b)(1) of this section, the label shall bear the general statement of substandard quality specified in the Code of Federal Regulations but in lieu of the words prescribed in the second line of the rectangle the following words may be used where the frozen peas fall below the standard in only one respect: ‘‘Below standard in qual ity lll’’, the blank to be filled in with the specific reason for sub standard quality as listed in the stand ard. [42 FR 14461, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 58 FR 2883, Jan. 6, 1993] PART 160—EGGS AND EGG PRODUCTS Subpart A [Reserved] Subpart B—Requirements for Specific Standardized Eggs and Egg Products Sec. 160.100 Eggs. 160.105 Dried eggs. 160.110 Frozen eggs. 160.115 Liquid eggs. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00652 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 643 Food and Drug Administration, HHS § 160.110 160.140 Egg whites. 160.145 Dried egg whites. 160.150 Frozen egg whites. 160.180 Egg yolks. 160.185 Dried egg yolks. 160.190 Frozen egg yolks. AUTHORITY: 21 U.S.C. 321, 341, 343, 348, 371, 379e. SOURCE: 42 FR 14462, Mar. 15, 1977, unless otherwise noted. Subpart A [Reserved] Subpart B—Requirements for Spe cific Standardized Eggs and Egg Products § 160.100 Eggs. No regulation shall be promulgated fixing and establishing a reasonable definition and standard of identity for the food commonly known as eggs. § 160.105 Dried eggs. (a) Dried eggs, dried whole eggs are prepared by drying liquid eggs that conform to § 160.115, with such pre cautions that the finished food is free of viable Salmonella microorganisms. They may be powdered. Before drying, the glucose content of the liquid eggs may be reduced by one of the optional procedures set forth in paragraph (b) of this section. Either silicon dioxide complying with the provisions of § 172.480 of this chapter or sodium silicoaluminate may be added as an op tional anticaking ingredient, but the amount of silicon dioxide used is not more than 1 percent and the amount of sodium silicoaluminate used is less than 2 percent by weight of the fin ished food. The finished food shall con tain not less than 95 percent by weight total egg solids. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxi dase-catalase preparation and hydro gen peroxide solution are added to the liquid eggs. The quantity used and the time of reaction are sufficient to sub stantially reduce the glucose content of the liquid eggs. The glucose-oxidase catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hy drogen peroxide solution used shall comply with the specifications of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not con tain a preservative. (2) Yeast procedure. The pH of the liq uid eggs is adjusted to the range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically pure hydrochloric acid, and controlled fermentation is maintained by adding food-grade baker’s yeast (Saccharomyces cerevisiae). The quantity of yeast used and the time of reaction are sufficient to sub stantially reduce the glucose content of the liquid eggs. (c) The name of the food for which a definition and standard of identity is prescribed by this section is ‘‘Dried eggs’’ or ‘‘Dried whole eggs’’ and if the glucose content was reduced, as pro vided in paragraph (b) of this section, the name shall be followed imme diately by the statement ‘‘Glucose re moved for stability’’ or ‘‘Stabilized, glucose removed’’. (d)(1) When either of the optional anticaking ingredients specified in paragraph (a) of this section is used, the label shall bear the statement ‘‘Not more than 1 percent silicon dioxide added as an anticaking agent’’ or ‘‘Less than 2 percent sodium silicoaluminate added as an anticaking agent’’, which ever is applicable. (2) The name of any optional ingre dient used, as provided in paragraph (d)(1) of this section, shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such statement likely to be read and under stood by the ordinary individual under customary conditions of purchase. (e) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.110 Frozen eggs. (a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food prepared by freezing liquid eggs that conform to § 160.115, with such precautions that the finished food is free of viable Salmonella microorganisms. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00653 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 644 21 CFR Ch. I (4–1–16 Edition) § 160.115 (b) Monosodium phosphate or monopotassium phosphate may be added either directly or in a water car rier, but the amount added does not ex ceed 0.5 percent of the weight of the frozen eggs. If a water carrier is used, it shall contain not less than 50 percent by weight of such monosodium phos phate or monopotassium phosphate. (c) When one of the optional ingredi ents specified in paragraph (b) of this section is used, the label shall bear the statement ‘‘Monosodium phosphate (or monopotassium phosphate) added to preserve color’’, or, in case the optional ingredient used is added in a water car rier, the statement shall be ‘‘Mono sodium phosphate (or monopotassium phosphate), with l percent water as a carrier, added to preserve color’’, the blank being filled in to show the per cent by weight of water used in propor tion to the weight of the finished food. The statement declaring the optional ingredient used shall appear on the principal display panel or panels with such prominence and conspicuousness as to render it likely to be read and un derstood under customary conditions of purchase. (d) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.115 Liquid eggs. (a) Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are eggs of the domestic hen broken from the shells and with yolks and whites in their natural proportion as so broken. They may be mixed, or mixed and strained, and they are pasteurized or otherwise treated to destroy all viable Salmonella microorganisms. Pasteuriza tion or such other treatment is deemed to permit the adding of safe and suit able substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable sub stances are those that perform a useful function in the pasteurization or other treatment to render the liquid eggs free of viable Salmonella microorga nisms, and that are not food additives as defined in section 201(s) of the Fed eral Food, Drug, and Cosmetic Act; or, if they are food additives, they are used in conformity with regulations estab lished pursuant to section 409 of the act. (b) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.140 Egg whites. (a) Egg whites, liquid egg whites, liq uid egg albumen is the food obtained from eggs of the domestic hen, broken from the shells and separated from yolks. The food may be mixed, or mixed and strained, and is pasteurized or otherwise treated to destroy all via ble Salmonella microorganisms. Pas teurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essen tial to the method of pasteurization or other treatment used. Safe and suit able substances that aid in protecting or restoring the whipping properties of liquid egg whites may be added. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function as whipping aids or in the pasteurization or other treatment to render liquid egg whites free of viable Salmonella microorga nisms and that are not food additives as defined in section 201(s) of the Fed eral Food, Drug, and Cosmetic Act; or, if they are food additives, they are used in conformity with regulations estab lished pursuant to section 409 of the act. (b) Any optional ingredients used as whipping aids, as provided for in para graph (a) of this section, shall be named on the principal display panel or panels of labels with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under cus tomary conditions of purchase. (c) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00654 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 645 Food and Drug Administration, HHS § 160.145 applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.145 Dried egg whites. (a) The food dried egg whites, egg white solids, dried egg albumen, egg al bumen solids is prepared by drying liq uid egg whites conforming to the re quirements of § 160.140 (or deviating from that section only by not being Salmonella free). As a preliminary step to drying, the lysozyme and avidin con tents may be reduced. If lysozyme and avidin levels are reduced, cation ex change resins regulated for use under § 173.25 of this chapter shall be used. As a further preliminary step to drying, the glucose content of the liquid egg whites is reduced by adjusting the pH, where necessary, with food-grade acid and by following one of the optional procedures set forth in paragraph (b) of this section. If the food is prepared from liquid egg whites conforming in all respects to the requirements of § 160.140, drying shall be done with such precautions that the finished food is free of viable Salmonella microorga nisms. If the food is prepared from liq uid egg whites that are not Salmonella free, the dried product shall be so treated by heat or otherwise as to render the finished food free of viable Salmonella microorganisms. Dried egg whites may be powdered. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxi dase-catalase preparation and hydro gen peroxide solution are added to liq uid egg whites. The quantity used and the time of reaction are sufficient to substantially reduce the glucose con tent. The glucose-oxidase-catalase preparation used is one that is gen erally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hy drogen peroxide solution used shall comply with the specifications of the United States Pharmacopeia, except that it may exceed the concentration specified therein and it does not con tain a preservative. (2) Controlled fermentation proce dures—(i) Yeast procedure. Food-grade baker’s yeast (Saccharomyces cerevisiae) is added to the liquid egg whites and controlled fermentation is maintained. The quantity of yeast used and the time of reaction are sufficient to sub stantially reduce the glucose content. (ii) Bacterial procedure. The liquid egg whites are subjected to the action of a culture of glucose-fermenting bacteria either generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act or the subject of a regulation es tablished pursuant to section 409 of the act, and the culture is used in con formity with such regulation. The quantity of the culture used is suffi cient to predominate in the fermenta tion and the time and temperature of reaction are sufficient to substantially reduce the glucose content. (c)(1) Dried egg whites in which the lysozyme and avidin have been reduced shall not be nutritionally inferior, as defined in § 101.3(e)(4)(i) of this chapter, and shall be considered nutritionally equivalent to untreated egg whites if they meet the conditions that the bio logical quality of the protein contained is equal to or greater than that of un treated egg white from the same batch of liquid egg white. (2) Compliance with the biological quality of protein requirement of para graph (c)(1) of this section shall be de termined by the analytical method pre scribed in ‘‘Official Methods of Anal ysis of the Association of Official Ana lytical Chemists,’’ 14th Ed. (1984), sec tion 43.253–43.257, ‘‘Protein Efficiency Ratio, Rat Bioassay, Final Action,’’ which is incorporated by reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the avail ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (d) When the dried egg whites are prepared from liquid egg whites con taining any optional ingredients added as whipping aids, as provided for in § 160.140(a), the common names of such optional ingredients shall be listed on the principal display panel or panels of VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00655 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 646 21 CFR Ch. I (4–1–16 Edition) § 160.150 the label with such prominence and conspicuousness as to render the names likely to be read and understood by or dinary individuals under customary conditions of purchase. (e) The name of the food for which a definition and standard of identity is prescribed in this section is alter natively ‘‘Dried egg whites’’, Egg white solids’’, ‘‘Dried egg albumen’’, or ‘‘Egg albumen solids’’. If the lysozyme and avidin content is reduced as provided in paragraph (a) of this section, the name shall be immediately preceded or followed by the statement ‘‘lysozyme and avidin reduced’’ when the dried egg whites are sold as such. When the dried egg whites are used in a fabricated food, the statement ‘‘lysozyme and avi din reduced’’ may be omitted from any declaration of ingredients required under § 101.4 of this chapter. (f) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 51 FR 11435, Apr. 3, 1986; 51 FR 25362, July 14, 1986; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 160.150 Frozen egg whites. (a) Frozen egg whites, frozen egg al bumen is the food prepared by freezing liquid egg whites that conform to § 160.140, with such precautions that the finished food is free of viable Salmonella microorganisms. (b) When frozen egg whites are pre pared from liquid egg whites con taining any optional ingredients added as whipping aids, as provided for in § 160.140(a), the common names of such optional ingredients shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such names likely to be read and understood by ordinary individuals under cus tomary conditions of purchase. (c) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.180 Egg yolks. (a) Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of eggs of the do mestic hen so separated from the whites thereof as to contain not less than 43 percent total egg solids, as de termined by the method prescribed in ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), sections 17.006 and 17.007 under ‘‘Total Solids, Vacuum Method (3)—Official Final Ac tion,’’ which is incorporated by ref erence. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. They may be mixed, or mixed and strained, and they are pasteurized or otherwise treated to de stroy all viable Salmonella microorga nisms. Pasteurization or such other treatment is deemed to permit the add ing of safe and suitable substances (other than chemical preservatives) that are essential to the method of pas teurization or other treatment used. For the purposes of this paragraph, safe and suitable substances are those that perform a useful function in the pasteurization or other treatment to render the egg yolks free of viable Sal monella microorganisms, and that are not food additives as defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or, if they are food addi tives, they are used in conformity with regulations established pursuant to section 409 of the act. (b) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19, 1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989; 58 FR 2883, Jan. 6, 1993; 63 FR 14035, Mar. 24, 1998] § 160.185 Dried egg yolks. (a) Dried egg yolks, dried yolks is the food prepared by drying egg yolks that VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00656 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B 647 Food and Drug Administration, HHS Pt. 161 conform to § 160.180, with such pre cautions that the finished food is free of viable Salmonella microorganisms. Before drying, the glucose content of the liquid egg yolks may be reduced by one of the optional procedures set forth in paragraph (b) of this section. Either silicon dioxide complying with the pro visions of § 172.480 of this chapter or so dium silicoaluminate may be added as an optional anticaking ingredient, but the amount of silicon dioxide used is not more than 1 percent and the amount of sodium silicoaluminate used is less than 2 percent by weight of the finished food. The finished food shall contain not less than 95 percent by weight total egg solids. (b) The optional glucose-removing procedures are: (1) Enzyme procedure. A glucose-oxi dase-catalase preparation and hydro gen peroxide solution are added to the liquid egg yolks. The quantity used and the time of reaction are sufficient to substantially reduce the glucose con tent of the liquid egg yolks. The glu cose-oxidase-catalase preparation used is one that is generally recognized as safe within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall comply with the specification of the United States Pharmacopeia, except that it may ex ceed the concentration specified there in and it does not contain a preserva tive. (2) Yeast procedure. The pH of the liq uid egg yolks is adjusted to the range of 6.0 to 7.0, if necessary, by the addi tion of dilute, chemically pure hydro chloric acid, and controlled fermenta tion is maintained by adding food grade baker’s yeast (Saccharomyces cerevisiae). The quantity of yeast used and the time of reaction are sufficient to substantially reduce the glucose content of the liquid egg yolks. (c) The name of the food for which a definition and standard of identity is prescribed by this section is ‘‘Dried egg yolks’’, or ‘‘Dried yolks’’, and if the glucose content was reduced, as pro vided in paragraph (b) of this section, the name shall be followed imme diately by the statement ‘‘Glucose re moved for stability’’ or ‘‘Stabilized, glucose removed’’. (d)(1) When either of the optional anticaking ingredients specified in paragraph (a) of this section is used, the label shall bear the statement ‘‘Not more than 1 percent silicon dioxide added as an anticaking agent’’ or ‘‘Less than 2 percent sodium silicoaluminate added as an anticaking agent’’, which ever is applicable. (2) The name of any optional ingre dient used, as provided in paragraph (d)(1) of this section, shall be listed on the principal display panel or panels of the label with such prominence and conspicuousness as to render such statement likely to be read and under stood by the ordinary individual under customary conditions of purchase. (e) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2883, Jan. 6, 1993] § 160.190 Frozen egg yolks. (a) Frozen egg yolks, frozen yolks is the food prepared by freezing egg yolks that conform to § 160.180, with such pre cautions that the finished food is free of viable Salmonella microorganisms. (b) Label declaration. Each of the in gredients used in the food shall be de clared on the label as required by the applicable sections of parts 101 and 130 of this chapter. [42 FR 14462, Mar. 15, 1977, as amended at 58 FR 2884, Jan. 6, 1993] PART 161—FISH AND SHELLFISH Subpart A—General Provisions Sec. 161.30 Declaration of quantity of contents on labels for canned oysters. Subpart B—Requirements for Specific Standardized Fish and Shellfish 161.130 Oysters. 161.136 Olympia oysters. 161.145 Canned oysters. 161.170 Canned Pacific salmon. 161.173 Canned wet pack shrimp in trans parent or nontransparent containers. 161.175 Frozen raw breaded shrimp. 161.176 Frozen raw lightly breaded shrimp. 161.190 Canned tuna. VerDate Sep<11>2014 17:31 May 24, 2016 Jkt 238071 PO 00000 Frm 00657 Fmt 8010 Sfmt 8010 Q:\21\21V2.TXT 31lp o w e ll o n D S K 5 4 D X V N 1 O F R w ith $ $ JO B