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The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives MOHW Food No.1091301559, 11 August, 2020 Appendix 1: 07

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The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives MOHW Food No.1091301559, 11 August, 2020 Appendix 1: 07 The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives MOHW Food No.1091301559, 11 August, 2020 Appendix 1: 07. Food quality improvement, fermentation and food processing agents Code Food Additive Items Scope and Application Standards Limitations For manufacturing All foods: not more than 3 g/kg calculated as 07029 Sodium Dihydrogen Phosphate or processing phosphate. purpose. For manufacturing Sodium Phosphate, Monobasic All foods: not more than 3 g/kg calculated as 07030 or processing (Anhydrous) phosphate. purpose. For manufacturing All foods: not more than 10 g/kg calculated as 07075 Calcium Chloride, Anhydrous or processing Ca. purpose. 08. Nutritional additives Code Food Additive Items Scope and Application Standards Limitations 08194 Calcium Chloride Dehydrate Foods in capsule or tablet form and labeled For supplementing with daily dosage: not more than 1800 mg of purpose. total calcium in daily intake. 08195 Calcium Chloride Hexahydrate Foods in capsule or tablet form and labeled For supplementing with daily dosage: not more than 1800 mg of purpose. total calcium in daily intake. 08286 Sodium Dihydrogen Phosphate Foods in capsule or tablet form and labeled For supplementing with daily dosage: not more than 1200 mg of purpose. total phosphorus in daily intake. 09. Colors Code Food Additive Items Scope and Application Standards Limitations 09001 Ponceau 4R All foods: as practically needed. Not allowed in fresh raw meat, fish, shellfish, beans, vegetables, fruits, miso, soy 1 sauces, seaweeds, and tea. 11. Seasoning Agents Code Food Additive Items Scope and Application Standards Limitations 11005 Sodium Fumarate All foods: as practically needed. For manufacturing or processing purpose. 11018 Sodium Lactate (solution) All foods: as practically needed. For manufacturing or processing purpose. 11019 Sodium Lactate Solution All foods: as practically needed. For manufacturing or processing purpose. 13. Coagulating Agents Code Food Additive Items Scope and Application Standards Limitations For manufacturing Meat products, minced fish surimi products: 13009 Sodium Dihydrogen Phosphate or processing not more than 3 g/kg calculated as phosphate. purpose. For manufacturing Sodium Phosphate, Monobasic Meat products, minced fish surimi products: 13010 or processing (Anhydrous) not more than 3 g/kg calculated as phosphate. purpose. 2 The Amendment of Standards for Specification, Scope, Application and Limitation of Food Additives MOHW Food No.1091301559, 11 August, 2020 Appendix 2: Standards for Specification of Food Additives 07. Food quality improvement, fermentation and food processing agents 08. Nutritional additives 13. Coagulating Agents § 07029 § 08286 § 13009 Sodium Dihydrogen Phosphate Synonyms Monobasic sodium phosphate, monosodium monophosphate sodium acid phosphate, sodium biphosphate; INS No. 339(i) Definition Chemical names Sodium dihydrogenphosphate, monosodium dihydrogenortho- phosphate, monosodium dihydrogen monophosphate C.A.S. number 7558-80-7 Chemical formula Anhydrous: NaH2PO4 Monohydrate: NaH2PO4 · H2O Dihydrate: NaH2PO4 · 2H2O Formula weight Anhydrous: 119.98 Monohydrate: 138.00 Dihydrate: 156.01 Assay Not less than 97% after drying Description White odourless, slightly deliquescent powder, crystals, or granules Characteristics 3 Identification Solubility Freely soluble in water; insoluble in ethanol, ether or chloroform pH 4.2 - 4.6 (1 in 100 soln) Test for sodium Passes test Test for phosphate Passes test Test for To a 1% solution of the sample add silver nitrate TS; the orthophosphate yellow precipitate formed is soluble in dilute nitric acid TS. Purity Loss on drying Anhydrous: Not more than 2% (60o , 1 h, then 105o , 4 h) Monohydrate: Not more than 15% (60o , 1 h, then 105o , 4 h) Dihydrate: Not more than 25% (60o , 1 h, then 105o , 4 h) Free acid and 2.00 g of the sample dissolved in 40 ml of water require for disodium neutralization not more than 0.3 ml of either N sodium phosphate hydroxide or N sulfuric acid, using methyl orange TS as indicator. Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 4 mg/kg Category Food additives category (07) (08) (13) Functional uses Food quality improvement, fermentation and food processing agents; Nutritional additives; Coagulating Agents. 4 09. Colors § 09001 Ponceau 4R Synonyms CI Food Red 7; Cochineal Red A; New Coccine; Brilliant Scarlet; CI (1975) No. 16255; INS No. 124 Definition Ponceau 4R consists essentially of trisodium 2-hydroxy-1- (4-sulfonato-1- naphthylazo)-6,8-naphthalenedisulfonate, and subsidiary colouring matters together with sodium chloride and/or sodium sulfate as the principal uncoloured components. May be converted to the corresponding aluminium lake. Chemical names Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo)-6,8- naphthalenedisulfonate C.A.S. number 2611-82-7 Chemical formula C20H11N2Na3O10S3 Structural formula Formula weight 604.48 Assay Not less than 80% total colouring matters Description Reddish powder or granules Characteristics Identification Solubility Soluble in water; sparingly soluble in ethanol Spectrophotometry Maximum wave length: Between 505 and 510 nm Purity Loss on drying Not more than 20% at 135° together with chloride and sulfate calculated as sodium salts Water-insoluble Not more than 0.2% 5 matter Subsidiary Not more than 1% colouring matters Organic 4-amino-1-naphthalenesulfonic acid、7-hydroxy-1,3- compounds other naphthalenedisulfonic acid、3-hydroxy-2,7- than colouring naphthalenedisulfonic acid、6-hydroxy-2- matters naphthalenesulfonic acid、7-hydroxy-1,3,6- naphthalenetrisulfonic acid: Not more than 0.5% Unsulfonated Not more than 0.01% calculated as aniline primary aromatic amines Ether-extractable Not more than 0.2% matter Lead Not more than 2 mg/kg Category Food additives category (09) Functional uses Colors 6 11. Seasoning Agents § 11005 Sodium Fumarate Synonyms Monosodium fumarate; INS No. 365 Definition Chemical names Monosodium fumarate, monosodium trans-butenedioic acid, monosodium trans-1,2-ethylenedicarboxylate; monosodium trans-1,2-ethylenedicarboxylic acid C.A.S. number 7704-73-6 Chemical formula C4H3NaO4 Structural formula Formula weight 138.06 Assay Not less than 98.0% and not more than 102.0% on the dried basis Description Odourless, white crystalline powder Characteristics Identification Solubility Soluble in water pH 3 - 4 (1 in 30 solution) 1,2-Dicarboxylic Place 50 mg of the sample in a test tube, add 2 to 3 mg of acid resorcinol and 1 ml of sulfuric acid, shake, heat at 130o for 5 min. and cool. Dilute with water to 5 ml and add sodium hydroxide solution (2 in 5) dropwise to render the solution alkaline, cool and dilute with water to 10 ml. A greenish blue fluorescence is observed under an ultraviolet lamp. 7 Test for double Add 10 ml of water to 0.5 g of the sample and dissolve by bond boiling. Add 2 or 3 drops of bromine TS to the hot solution. The colour of bromine TS disappears. Test for sodium Passes test Purity Loss on drying Not more than 0.5% (120o , 4 h) Sulfates Not more than 0.01% Maleic acid Not more than 0.05% Lead Not more than 2 mg/kg Category Food additives category (11) Functional uses Seasoning Agents 8 11. Seasoning Agents § 11018 Sodium Lactate (solution) Synonyms INS No. 325 Definition Chemical names Sodium lactate, sodium 2-hydroxypropanoate C.A.S. number 72-17-3 Chemical formula C3H5NaO3 Structural formula Formula weight 112.06 (anhydrous) Assay Not less than 95% and not more than 110% of the labelled amount. This specification is based on a 60% w/w solution of C3H5NaO3 in water. Description Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour Characteristics Identification Ignition Ignite to an ash. The ash is alkaline, and an effervescence occurs when acid is added Colour reaction Overlay 2 ml of the sample on 5 ml of a 1 in 100 solution of catechol in sulfuric acid. A deep red colour is produced at the zone of contact Test for lactate Passes test Test for sodium Passes test 9 Purity Acidity Neutralization of 1 g of sample shall require not more than 0.5 ml of 0.1 N sodium hydroxide solution, using phenolphthalein TS pH 6.5 - 7.5 (1 in 5 soln) Lead Not more than 2 mg/kg Category Food additives category (11) Functional uses Seasoning Agents 10 12. Pasting Agent § 12001 Sodium Alginate Synonyms INS No. 401 Definition Sodium salt of alginic acid C.A.S. number 9005-38-3 Chemical formula (C6H7NaO6)n Structural formula The number and sequence of the Mannuronate and Glucuronate residues shown above vary in the naturally occurring alginate. The water molecules associated with the alginate molecule are not shown in the above structural formula. Formula weight Structural unit : 198.11 (theoretical), 222 (actual average) Macromolecule : 10,000 - 600,000 (typical average) Assay Yields, on the dried basis, not less than 18.0% and not more than 21.0% of carbon dioxide (CO2), equivalent to not less than 90.8% and not more than 106.0% of sodium alginate (C6H7 NaO6)n. Description White to yellowish brown filamentous, grainy, granular or powdered forms Characteristics Identification Solubility Dissolves slowly in water, forming a viscous solution; 11 insoluble in ethanol and ether Precipitate To a 0.5% solution of the sample in sodium hydroxide TS formation with add one-fifth of its volume of a 2.5% solution of calcium calcium chloride chloride. A voluminous, gelatinous precipitate is formed. Precipitate To a 0.5% solution of the sample in sodium hydroxide TS formation with add one-half of its volume of a saturated solution of ammonium ammonium sulfate. No precipitate is formed. sulphate Test for alginate Passes test Test for sodium Passes test Purity Loss on drying Not more than 15% (105o , 4 h) Water-insoluble Not more than 2% on the dried basis matter Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Microbiological Total plate count: Not more than 5,000 colonies per gram.
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