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Home , Magnesium carbonate

Food and Drug Administration, HHS § 184.1425

following current good manufacturing chapter for the interesterification of practice conditions of use: fats and oils. (1) The ingredient is used as an en- (2) The ingredient is used in food at zyme as defined in § 170.3(o)(9) of this levels not to exceed current good man- chapter to hydrolyze fatty ufacturing practice. glycerides. [63 FR 24419, May 4, 1998] (2) The ingredient is used in food at levels not to exceed current good man- § 184.1425 . ufacturing practice. (a) Magnesium carbonate (molecular [60 FR 32911, June 26, 1995] formula approximately (MgCO3)4·Mg(OH)2·5H2O, CAS Reg. No. § 184.1420 Lipase enzyme preparation 39409–82–0) is also known as magnesium derived from Rhizopus niveus. carbonate hydroxide. It is a white pow- (a) Lipase enzyme preparation con- der formed either by adding an alkaline tains lipase enzyme (CAS Reg. No. carbonate (such as carbonate) 9001–62–1), which is obtained from the to a solution of or culture filtrate resulting from a pure by carbonation of a slurry of magne- culture fermentation of a nonpatho- sium hydroxide followed by boiling of genic and nontoxigenic strain of the resulting magnesium carbonate. Rhizopus niveus. The enzyme prepara- (b) The ingredient meets the speci- tion also contains diatomaceous earth fications of the Food Chemicals Codex, as a carrier. The characterizing activ- 3d Ed. (1981), p. 177, which is incor- ity of the enzyme, which catalyzes the porated by reference. Copies are avail- interesterification of fats and oils at able from the National Academy Press, the 1- and 3-positions of triglycerides, 2101 Constitution Ave. NW., Wash- is triacylglycerol lipase (EC 3.1.1.3). ington, DC 20418, or available for in- (b) The ingredient meets the general spection at the National Archives and requirements and additional require- Records Administration (NARA). For ments for enzyme preparations in the information on the availability of this monograph on Enzyme Preparations in material at NARA, call 202–741–6030, or the ‘‘Food Chemicals Codex,’’ 4th ed. go to: http://www.archives.gov/ (1996), pp. 133 and 134, which is incor- federallregister/ porated by reference in accordance codeloflfederallregulations/ with 5 U.S.C. 552(a) and 1 CFR part 51. ibrllocations.html. Copies are available from the National (c) In accordance with § 184.1(b)(1), Academy Press, 2101 Constitution Ave. the ingredient is used in food with no NW., Washington, DC 20418, or may be limitation other than current good examined at the Center for Food Safety manufacturing practice. The affirma- and Applied Nutrition’s Library, 5100 tion of this ingredient as generally rec- Paint Branch Pkwy., College Park, MD ognized as safe (GRAS) as a direct 20740, or at the National Archives and human food ingredient is based upon Records Administration (NARA). For the following current good manufac- information on the availability of this turing practice conditions of use: material at NARA, call 202–741–6030, or (1) The ingredient is used as an go to: http://www.archives.gov/ anticaking and free-flow agent as de- federallregister/ fined in § 170.3(o)(1) of this chapter; a codeloflfederallregulations/ flour treating agent as defined in ibrllocations.html. § 170.3(o)(13) of this chapter; a lubricant (c) In accordance with § 184.1(b)(1), and release agent as defined in the ingredient is used in food with no § 170.3(o)(18) of this chapter; a nutrient limitation other than current good supplement as defined in § 170.3(o)(20) of manufacturing practice. The affirma- this chapter; a pH control agent as de- tion of this ingredient as generally rec- fined in § 170.3(o)(23) of this chapter; a ognized as safe as a direct human food processing aid as defined in § 170.3(o)(24) ingredient is based upon the following of this chapter; and a synergist as de- current good manufacturing practice fined in § 170.3(o)(31) of this chapter. conditions of use: (2) The ingredient is used in foods at (1) The ingredient is used as an en- levels not to exceed current good man- zyme as defined in § 170.3(o)(9) of this ufacturing practice.

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(d) Prior sanctions for this ingredient this section do not exist or have been different from the uses established in waived. this section do not exist or have been [50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, waived. 1985] [50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, § 184.1428 . 1985] (a) Magnesium hydroxide (Mg(OH)2, § 184.1426 . CAS Reg. No. 1309–42–8) occurs natu- (a) Magnesium chloride (MgC1 ·6H O, rally as the colorless, crystalline min- 2 2 eral brucite. It is prepared as a white CAS Reg. No. 7786–30–3) is a colorless, precipitate by the addition of sodium deliquescent, crystalline material that hydroxide to a soluble magne- occurs naturally as the sium or by hydration of reactive bischofite. It is prepared by dissolving grades of . magnesium oxide, hydroxide, or car- (b) The ingredient meets the speci- bonate in aqueous hydrochloric acid so- fications of the Food Chemicals Codex, lution and crystallizing out magnesium 3d Ed. (1981), p. 178, which is incor- chloride hexahydrate. porated by reference. Copies are avail- (b) The ingredient meets the speci- able from the National Academy Press, fications of the Food Chemicals Codex, 2101 Constitution Ave. NW., Wash- 3d Ed. (1981), p. 177, which is incor- ington, DC 20418, or available for in- porated by reference. Copies are avail- spection at the National Archives and able from the National Academy Press, Records Administration (NARA). For 2101 Constitution Ave. NW., Wash- information on the availability of this ington, DC 20418, or available for in- material at NARA, call 202–741–6030, or spection at the National Archives and go to: http://www.archives.gov/ Records Administration (NARA). For federallregister/ information on the availability of this codeloflfederallregulations/ material at NARA, call 202–741–6030, or ibrllocations.html. go to: http://www.archives.gov/ (c) In accordance with § 184.1(b)(1), federallregister/ the ingredient is used in food with no codeloflfederallregulations/ limitation other than current good manufacturing practice. The affirma- ibrllocations.html. tion of this ingredient as generally rec- (c) In accordance with § 184.1(b)(1), ognized as safe (GRAS) as a direct the ingredient is used in food with no human food ingredient is based upon limitation other than current good the following current good manufac- manufacturing practice. The affirma- turing practice conditions of use: tion of this ingredient as generally rec- (1) The ingredient is used as a nutri- ognized as safe (GRAS) as a direct ent supplement as defined in human food ingredient is based upon § 170.3(o)(20) of this chapter; a pH con- the following current good manufac- trol agent as defined in § 170.3(o)(23) of turing practice conditions of use: this chapter; and a processing aid as (1) The ingredient is used as a fla- defined in § 170.3(o)(24) of this chapter. voring agent and adjuvant as defined in (2) The ingredient is used in foods at § 170.3(o)(12) of this chapter and a nutri- levels not to exceed current good man- ent supplement as defined in ufacturing practice. § 170.3(o)(20) of this chapter. (d) Prior sanctions for this ingredient (2) The ingredient is used in foods at different from the uses established in levels not to exceed current good man- this section do not exist or have been ufacturing practice. The ingredient waived. also may be used in infant formula in [50 FR 13559, Apr. 5, 1985, as amended at 64 accordance with section 412(g) of the FR 405, Jan. 5, 1999] Federal Food, Drug, and Cosmetic Act (the act) or with regulations promul- § 184.1431 Magnesium oxide. gated under section 412(a)(2) of the act. (a) Magnesium oxide (MgO, CAS Reg. (d) Prior sanctions for this ingredient No. 1309–48–4) occurs naturally as the different from the uses established in colorless, crystalline mineral .

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