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Magnesium Chloride
Handling/Processing
November 30, 2016 Technical Evaluation Report Page 1 of 12 Compiled by OMRI for the USDA National Organic Program_
2 Identification of Petitioned Substance
3 There are two forms of magnesium chloride: 4 5 Chemical Names: MgCl 2 · 6H 2 O 6 Magnesium chloride hexahydrate 7 Magnesium chloride 8 Magnesium dichloride 9 Magnesium chloride 6H 2 O 10 Magnesium chloride, 6-hydrate
11 Magnesium chloride hydrate 12 Magnesium chloride, hydrous
13 14 CAS Number : 7791-18-
18 Chemical Names: MgCl (^2) 19 Magnesium chloride anhydrous 20 Magnesium chloride 21 Magnesium dichloride
CAS Number: 7786-30-
Other Codes: E511, INS511 (both forms)
23 Summary of Petitioned Use
24 25 Magnesium chloride is currently allowed under the National Organic Program regulations at 7 CFR
26 205.605(b) as a nonagricultural synthetic substance for use as an ingredient in or on processed products 27 labeled “organic” or “made with organic (specified ingredients or food group(s)).” The current annotation 28 reads, “derived from sea water.” The primary uses of magnesium chloride in organic food processing are as
29 a firming agent in tofu processing and as a source of the essential mineral magnesium in organic infant 30 formula. It is also allowed by the FDA as a flavoring agent, adjuvant, and as a nutrient supplement.
31 32
33 Characterization of Petitioned Substance
34 35 Composition of the Substance:
36 Magnesium chloride is the simple salt of the halogen chlorine and the alkaline earth metal magnesium. As 37 noted in the Identification section above, two forms of magnesium chloride (hexahydrate or anhydrous) are
38 analytically defined and commercially available. 39 40 Magnesium chloride hexahydrate is the form of magnesium chloride that is authorized by the FDA for use
41 as a direct food substance (21 CFR 184.1426). It is described in the Merck Index and occurs as colorless, 42 odorless flakes, crystals, granules or lumps (Budavari 1996). The Joint FAO/WHO Expert Committee on
43 Food Additives (JECFA) and the Food Chemicals Codex (FCC) require that the material assays at 99% to 44 105% MgCl 2 ·6H 2 O (JECFA 1980; U. S. Pharmacopeia 2010). The hexahydrate form is far more available and
45 far less expensive than the anhydrous form. 46 47 Anhydrous magnesium chloride as described in the Merck Index is prepared from magnesium ammonium
48 chloride hexahydrate in the presence of hydrochloric acid (Budavari 1996). It occurs as soft leaflets and is 49 used as a chemical reagent.
50 51 Both forms of magnesium chloride are hygroscopic (absorb water) and deliquescent (absorb enough water
52 to form a solution), so containers of this GRAS ingredient must be closed tightly to avoid moisture pick-up. 53 54 The remainder of this report will focus on the hexahydrate form of magnesium chloride used as a food
55 additive. 56
58 Source or Origin of the Substance: 59 The most common sources of magnesium chloride hexahydrate are “derived from sea water” in the very 60 broadest sense. Mineral deposits of magnesium chloride were created thousands to millions of years ago 61 when isolated sea water bodies dried up and their mineral constituents crystallized out (Butts 2004). These 62 mineral deposits are tapped by solution mining, which involves pumping water thousands of feet below 63 the earth’s surface to dissolve the minerals and form brines. The brines are pumped to the surface and 64 separated into the component mineral salts. Other important brine sources are active terminal lakes, such 65 as the Great Salt Lake in North America and the Dead Sea in Israel and Jordan (Butts 2004). Underground 66 brine can be found in the remains of ancient terminal lakes that have dried up, such as under Midland, 67 Michigan (Chemical Heritage Foundation 2015). The production of sea salt by solarization has been an 68 important human activity for the last three millennia. Sodium chloride-depleted solar brine is a good 69 source of magnesium chloride, since magnesium chloride makes up 17% of sea water solids (Aikawa 70 1991 ). Evaluation Question 1 provides a full description of these natural sources and how the extraction 71 and isolation of magnesium chloride is accomplished. 72 73 Magnesium chloride can also be produced by chemical synthesis, which is also described in Evaluation 74 Question 1. 75 76 77 Properties of the Substance 78 Physical and chemical properties of the substance are summarized in Table 1. 79 80 Table 1: Physical and Chemical Properties of Magnesium Chloride Hexahydrate (Budavari 1996; U. S. 81 Pharmacopeia 2010; JECFA 1980) Property Value CAS Reg. Number 7791 - 18 - 6 Chemical formula MgCl 2 · 6 H 2 O Molar mass 203. Appearance Deliquescent crystals Solubility, cold water 1 g in 0.6 mL (~ 166 g/100mL) Solubility, 100°C water 1 g in 0.3 mL (~ 333 g/100mL) Solubility, alcohol 1 g in 2 mL ethanol (~50 g/100mL) 82 83 The two significant characteristics of magnesium chloride hexahydrate that enable its isolation and 84 purification from natural sources are its high water solubility (Lewis 1997b) and its high alcohol solubility. 85 86 87 Specific Uses of the Substance: 88 The primary use of magnesium chloride hexahydrate in organic food processing is as a firming agent for 89 tofu. Magnesium chloride hexahydrate is also used as a source of the essential mineral magnesium in 90 infant formula (21 CFR 184.1426(c)(2)). 91 92 93 Approved Legal Uses of the Substance: 94 Magnesium chloride hexahydrate is affirmed by the FDA as Generally Recognized As Safe (GRAS) as a 95 food ingredient (21 CFR 184.1426). It is allowed by the FDA as a flavoring agent, adjuvant, nutrient 96 supplement, and may be used in infant formula. 97 98 The EPA regulates magnesium chloride as a pesticide on List D, pesticides of less concern (EPA 1998). 99 Magnesium chloride has also been used to treat bovine hypomagnesemia (low blood magnesium levels) 100 (Budavari 1996). 101 102 103 Action of the Substance:
158 The Codex organic guidelines permit the use of magnesium chloride (INS 511) in food category 06.8, 159 soybean products (excluding soybean products of food category 12.9 and fermented soybean products of
160 food category 12.10); food category 12.9.1, soybean protein products; and food category 12.10, fermented 161 soybean products.
162 163 European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/ 164 The European Community regulation permits the use of the magnesium chloride (or “nigari”) in
165 processing organic foods of plant origin as a coagulation agent (EC No. 889/2008 Annex VIII, Section B – 166 Processing Aids).
167 168 Japan Agricultural Standard (JAS) for Organic Production 169 Article 4, Table 1, Food Additives permits the use of food additive INS 511, magnesium chloride, and also 170 “crude seawater magnesium chloride,” for processed foods of plant origin as a coagulating agent or for
171 processed bean products. 172 173 IFOAM – Organics International
174 The IFOAM Norms, Appendix 4, Table 1, permit the use of magnesium chloride (INS 511) as an additive 175 and also as a processing and post-harvest handling aid for soybean products only.
176 177
178 Evaluation Questions for Substances to be used in Organic Handling
179 180 Evaluation Question #1: Describe the most prevalent processes used to manufacture or formulate the 181 petitioned substance. Further, describe any chemical change that may occur during manufacture or 182 formulation of the petitioned substance when this substance is extracted from naturally occurring plant, 183 animal, or mineral sources (7 U.S.C. § 6502 (21)). 184 185 Magnesium chloride from natural sources
186 Natural commercial sources of magnesium chloride can be classified as (a) sea water; (b) terminal lake 187 brines; (c) subsurface brine deposits; and (d) mineral ore deposits (Butts 2004). Magnesium chloride
188 produced from each of these natural sources is the product of a brine comprising soluble ions of various 189 mineral elements, primarily sodium, potassium, magnesium, calcium, chloride and sulfate. 190 191 Sea Water
192 Sea water is processed in solar ponds to produce concentrated brines from which specific minerals 193 crystallize and are recovered. These specific minerals, called “evaporites,” crystallize in a sequence based
194 on the concentrations of anions and cations in the brine and their innate solubility in water (Butts 2004). 195
196 Table 2. Important evaporites formed during sea water solarization in their order of formation (Butts 2004) Mineral name CAS Registry No. Other names Chemical formula Halite 14762 - 51 - 7 salt, sodium chloride NaCl Epsomite 14457 - 55 - 7 Epsom salts, magnesium sulfate MgSO 4 · 7H 2 O Schoenite 15491 - 86 - 8 picromerite K 2 SO 4 · MgSO 4 · 6H 2 O Kainite 1318 - 72 - 5 4KCl· 4MgSO 4 · 11H 2 O Carnallite 1318 - 27 - 0 crackel salt MgCl 2 · KCl · 6H 2 O Bischofite 13778 - 96 - 6 magnesium chloride MgCl 2 · 6H 2 O
197 198 Table 3. Mineral composition of typical sea water and its calculated disposition as evaporites (Lenntech 199 2005 ).
Ionic species Typical sea water, per liter
sediment halite epsomite carnallite bischofite
Anions mg %,w/w mEq mEq mEq mEq mEq mEq Chloride (Cl-^ ) 18,980 55.0% 535 -459 -30 - Sulfate (SO 4 2-^ ) 2,649 7.7% 55 -18 -
Bicarbonate (HCO 3 -^ ) 140 0.4% 2 - Bromide (Br-) 65 0.2% 1 Borate (BO 3 3-^ ) 26 0.1% 1 Fluoride (F -^ ) 1 0.0% 0 Silicate (SiO 3 2-^ ) 1 0.0% 0 Iodide (I-^ ) < 1 0.0% 0 Total anions 595 Cations Sodium (Na +) 10,556 30.6% 459 - Magnesium (Mg 2+) 1,262 3.7% 104 -37 -20 - Calcium (Ca 2+) 400 1.2% 20 - Potassium (K+) 380 1.1% 10 - Strontium (Sr2+) 13 0.0% 0 Total cations 593 Total solids 34,483 (100%)
200
201 Solar evaporation of over 90+% of the water in sea water creates a saturated solution of sodium chloride. 202 During this phase of solarization, calcium carbonate and calcium sulfate crystallize and become sediment
203 in the initial solar pond. Further evaporation of water leads to crystallization of relatively pure sodium 204 chloride as the mineral “halite.” Sodium chloride represents 76.5% of the mass of typical sea water
205 minerals. “Sea salt,” the commercial product produced by solar evaporation of the sea water, contains as 206 much sodium chloride (> 98.5%) as mined “salt” does. Salt production from solar ponds represents 14% of 207 the total salt produced in the United States (Butts 2004).
208 209 Crystallization of sodium chloride from sea water creates magnesium-rich solar brine. As more water is
210 evaporated from solar brine, magnesium combines with any remaining sulfate to form epsomite 211 (crystalline magnesium sulfate), or with potassium to form a double sulfate evaporite called schoenite.
212 213 The final evaporites formed depend on the ionic composition of the brine. Potassium and magnesium form 214 a double chloride salt, called carnallite. If the formation of carnallite removes all the potassium from the
215 solar brine, and magnesium is the only remaining cation, magnesium chloride in the form of the mineral 216 bischofite is the last mineral to crystallize since it is the most water-soluble evaporite. Bischofite is the
217 natural mineral form of magnesium chloride hexahydrate. 218
219 220 Terminal lake brines 221 A terminal lake is a lake where water is flowing in but no water flows out, so that the dissolved salts 222 concentrate and form brine as the water evaporates. The Great Salt Lake in Utah is a familiar example.
223 Great Salt Lake brine is the primary source of magnesium chloride in North America. The Great Salt Lake 224 contains sodium-magnesium-chloride-sulfate brine with low alkalinity (Domagalski, Orem, and Eugester
225 1989 ). Like solarization of seawater, the first evaporite of Great Salt Lake brine to form is halite (sodium 226 chloride), followed by schoenite (magnesium-potassium sulfate), kainite (potassium chloride-magnesium
227 sulfate double salt), and carnallite (potassium-magnesium chloride), resulting in a magnesium chloride 228 brine (Neitzel 1971 ). Evaporating the water in this magnesium chloride brine creates crude solid 229 magnesium chloride.
230 231 The Dead Sea is also a terminal lake. Magnesium chloride is produced in Israel and Jordan from Dead Sea
232 brine. Magnesium chloride accounts for about half of Dead Sea solids. The major minerals in Dead Sea 233 brine are magnesium chloride and potassium chloride, which crystallize as the double salt carnallite (Sadan
234 1979 ). Carnallite is then treated with water to isolate the magnesium chloride, taking advantage of the fact 235 that magnesium chloride is over three times more soluble in water than is potassium chloride. 236
237 The sequence of crystallization of the dissolved salts in natural brines during isothermal (solar) 238 evaporation produces the same minerals found in mineral deposits in prehistoric sea beds (Fezei, Hammi,
239 and M'nif 2012). Successive evaporation sequences lead to precipitation of sodium chloride (halite) and
295 Groenhof 1982; Nylander 1972 ). However, because magnesium chloride is soluble in alcohol while 296 potassium chloride is not, several patented processes for separating pure magnesium chloride from
297 carnallite employ a low molecular weight alcohol, such as methanol, to recover pure magnesium chloride 298 (Chassagne 1974; Lambly, Leibson, and Chassagne 1976; Fox, Degen, and Leibson 1977). At the end of the
299 extraction process, the magnesium chloride has not been changed into a different substance, and any 300 alcohol used as an extraction aid has been removed from the final substance.
301 302 303 Magnesium chloride formed by chemical synthesis 304 Several synthetic processes that create magnesium chloride use hydrochloric acid. Three are described by
305 the FDA at 21 CFR 184.1426:
306 • reaction of magnesium oxide with hydrochloric acid,
307 • treatment of magnesium ammonium chloride hexahydrate with hydrochloric acid, and 308 • dissolution of magnesium oxide, hydroxide, or carbonate in aqueous hydrochloric acid.
309 310 Other synthetic pathways include:
311 • action of hydrochloric acid on magnesium oxide or hydroxide, especially the hydroxide, when
312 precipitated from seawater or Great Salt Lake brine by addition of calcium (Lewis 1997a), and
313 • as a by-product in the manufacture of titanium (Jackson et al. 2000). 314 315 316 Evaluation Question #2: Discuss whether the petitioned substance is formulated or manufactured by a 317 chemical process, or created by naturally occurring biological processes (7 U.S.C. § 6502 (21)). Discuss 318 whether the petitioned substance is derived from an agricultural source.
319 320 Two magnesium chloride-containing evaporites, carnallite and bischofite, are created by the solarization of 321 sea water or natural brines, which is a naturally occurring process. Carnallite and bischofite also occur as
322 mineral deposits that formed naturally over millions of years in salt lakes. Solar evaporation and 323 crystallization are considered physical (not chemical) processes.
324 325 The process by Fezei et al. that removes sulfate from terminal lake brines by adding calcium chloride to
326 precipitate calcium sulfate is a chemical process that produces additional magnesium chloride. 327 328 The two-step process of extracting magnesium chloride from terminal lake brines involves adding lime
329 (calcium hydroxide) to precipitate magnesium hydroxide, and then mixing the solid magnesium hydroxide 330 with the brine and carbon dioxide to generate pure magnesium chloride liquor. This process is similar to
331 how citric acid produced by microbial fermentation is isolated. Calcium hydroxide is added to the citric 332 acid-containing culture to precipitate citric acid as calcium citrate. Citric acid is recovered by reacting
333 calcium citrate with sulfuric acid. Calcium precipitates as calcium sulfate and citrate is converted to citric 334 acid. Citric acid produced in this manner is classified as a nonsynthetic substance at §205.605(a).
335 336 Several patented processes for purifying magnesium chloride sourced from solution mining rely on 337 synthetic alcohols, such as methanol, to take advantage of the high alcohol solubility of magnesium
338 chloride (Chassagne 1974; Lambly, Leibson, and Chassagne 1976; Fox, Degen, and Leibson 1977). 339
340 Synthesis of magnesium chloride by the reaction of a magnesium compound such as the oxide, hydroxide, 341 or carbonate with hydrochloric acid is a chemical process, which involves chemical reaction of an acid and
342 an alkali to form a salt. 343 344 Agricultural vs. Nonagricultural sources 345 Magnesium chloride made directly or indirectly from sea water, brine, or mineral ore is considered to be
346 derived from nonagricultural sources. 347
348
349 Evaluation Question #3: If the substance is a synthetic substance, provide a list of nonsynthetic or 350 natural source(s) of the petitioned substance (7 CFR § 205.600 (b) (1)). 351
352 Magnesium chloride produced by reacting a magnesium compound or mineral with hydrochloric acid is 353 considered synthetic. This is because the substance undergoes a chemical change so that it is chemically or 354 structurally different from how it naturally occurs in the source material.
355 356 Natural sources of magnesium chloride are described in Evaluation Question 1, and the substance can be
357 extracted by various means which may affect the classification of the final substance as synthetic or 358 nonsynthetic. Evaporation and crystallization are physical processes which do not result in chemical
359 change. Magnesium chloride extracted from brine by the two-step process involving calcium hydroxide 360 and carbon dioxide is not chemically or structurally different from how it naturally occurs in the source 361 material.
362 363 364 Evaluation Question #4: Specify whether the petitioned substance is categorized as generally 365 recognized as safe (GRAS) when used according to FDA’s good manufacturing practices (7 CFR §
366 205.600 (b)(5)). If not categorized as GRAS, describe the regulatory status. 367 368 Magnesium chloride hexahydrate is affirmed as GRAS at 21 CFR 184.1426, and is allowed by the FDA as a 369 flavoring agent and adjuvant and as a nutrient supplement.
370 371 372 Evaluation Question #5: Describe whether the primary technical function or purpose of the petitioned 373 substance is a preservative. If so, provide a detailed description of its mechanism as a preservative ( 374 CFR § 205.600 (b)(4)). 375
376 Magnesium chloride does not function as a preservative. 377
378 379 Evaluation Question #6: Describe whether the petitioned substance will be used primarily to recreate 380 or improve flavors, colors, textures, or nutritive values lost in processing (except when required by law) 381 and how the substance recreates or improves any of these food/feed characteristics (7 CFR § 205. 382 (b)(4)). 383 384 Magnesium chloride is not used to recreate or improve characteristics lost in processing. Magnesium
385 chloride is used to create and modify the texture of the soy bean curd product, tofu. Magnesium chloride is 386 a salt of the essential nutrient magnesium, and is specifically permitted as a nutrient supplement at 21 CFR
387 184.1426. Nutritionally complete products intended as the sole item in the diet of human infants frequently 388 contain magnesium chloride as a source of both magnesium and chloride as required at 21 CFR 107.100.
389 390 391 Evaluation Question #7 : Describe any effect or potential effect on the nutritional quality of the food or 392 feed when the petitioned substance is used (7 CFR § 205.600 (b)(3)). 393
394 Adding magnesium chloride to any food or feed will increase the amounts of the essential mineral 395 nutrients magnesium and chloride. Severe magnesium deficiency is rare in the United States, but
396 habitually low intakes are commonplace. Magnesium depletion has cardiovascular effects, including 397 increased blood pressure, atrial fibrillation, ventricular tachycardia and fibrillation, and increased risk of 398 cardiac ischemia.
399 400 401 Evaluation Question #8: List any reported residues of heavy metals or other contaminants in excess of 402 FDA tolerances that are present or have been reported in the petitioned substance (7 CFR § 205.
403 (b)(5)). 404
459 Evaluation Question #12: Describe all natural (non-synthetic) substances or products which may be 460 used in place of a petitioned substance (7 U.S.C. § 6517 (c) (1) (A) (ii)). Provide a list of allowed 461 substances that may be used in place of the petitioned substance (7 U.S.C. § 6518 (m) (6)). 462 463 Magnesium chloride is a prime candidate mineral salt for supplementing a human food with soluble
464 magnesium. Few food grade magnesium salts possess good solubility and acceptable taste profiles and are 465 included on the National List. A human requirement for preformed sulfate has not been established,
466 whereas chloride is known to be an essential nutrient (Institute of Medicine 2005), so magnesium chloride 467 is a more acceptable source of this nutrient for formulated products than is magnesium sulfate. 468
469 A natural mineral that provides nutritionally available magnesium is dolomite, a calcium carbonate- 470 magnesium carbonate. Dolomite is insoluble in water so it is unsuitable for nutritional fortification of
471 liquid products and for making tofu, but it can be useful in some solid and dry food products. 472
473 For tofu processing, four basic types of coagulants are used: chloride types (such as magnesium chloride 474 and calcium chloride), sulfate types (such as calcium sulfate and magnesium sulfate), glucono delta- 475 lactone, and acidic agents (such a citrus juices, vinegar, or lactic acid sources) (Shurtleff and Aoyagi 2000).
476 Each of these has unique effects on the texture of tofu (deMan, deMan, and Gupta 1986). Calcium chloride, 477 calcium sulfate, glucono delta-lactone, and lactic acid and citric acid are all classified as nonsynthetic on
478 §205.605(a). 479
480 Calcium sulfate, calcium chloride, magnesium chloride, and glucono-delta-lactone are the most frequently 481 used coagulants for precipitating soy protein curd to make tofu (Arii and Takenaka 2013; Shurtleff and 482 Aoyagi 1975). Glucono delta-lactone is an effective coagulant used to make tofu, especially “silken” tofu.
483 The Japanese typically use “nigari,” the solids remaining in salt water after sea salt and magnesium sulfate 484 crystallize, which contains as much as 90% magnesium chloride, as one component of the coagulants. They
485 then use calcium chloride or calcium sulfate as a second component, since too much calcium and too much 486 magnesium each can adversely impact tofu texture (Arii and Takenaka 2013). Magnesium sulfate has a
487 bitter, saline taste that limits its use as a total replacement for magnesium chloride. 488 489 Various acidic substances can curdle soy protein. Jeong et al. (Jeong et al. 2004) developed a method for
490 preparing bean curd containing lactic acid for the Korean market by preparing bean soup using soybeans, 491 cooling the bean soup, and adding a lactic acid-containing bacterial culture to the bean soup to curdle the
492 bean protein, thus forming bean curd. Citrus juices, particularly lemon juice, are effective coagulants. Tofu 493 made with lemon juice may be too tart for some tastes (Chang 2006), but it is great tasting for others
494 (Obatolu 2008). 495 496
497 Evaluation Information #13: Provide a list of organic agricultural products that could be alternatives for 498 the petitioned substance (7 CFR § 205.600 (b) (1)). 499 500 Juice from organic lemons can be used as a coagulant for tofu (Sanjay et al. 2008). However, each coagulant 501 has unique effects on tofu taste and texture. Tofu made with lemon juice may be too tart for some tastes
502 (Chang 2006), but it is great tasting for others (Obatolu 2008). 503
504
505 References
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