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. 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. criteria Yeasts and moulds: Not more than 500 colonies per gram Coliforms: Negative by test Salmonella: Negative by test Category Food additives category (12) Functional uses Pasting Agent

12 16. Emulsifiers § 16001 Glycerin Fatty Acid Ester Synonyms Mono- And Diglycerides: Glyceryl monostearate, glyceryl monopalmitate, glyceryl monooleate, etc; monostearin, monopalmitin, monoolein, etc.; GMS (for glyceryl monostearate); INS No. 471 Acetic and Fatty Acid Esters of Glycerol: Acetic acid esters of mono- and diglycerides, acetoglycerides, acetylated mono- and diglycerides, INS No.472a Definition Mono- And Diglycerides: A mixture of mono- and diglyceryl esters of long chain, saturated and unsaturated fatty acids that occur in food fats; contain not less than 30% of alpha-monoglycerides and may also contain other isomeric monoglycerides, as well as di- and triglycerides, free glycerol, free fatty acids, soap and moisture; usually manufactured by the glycerolysis of edible fats and oils, but may also be prepared by esterification of fatty acids with glycerol, with or without molecular distillation of the product. Acetic and Fatty Acid Esters of Glycerol: Mixed glycerol esters of acetic acid and fatty acids of food fats. Contains mono- and diesters of fatty acids with glycerol which is itself partially acetylated; may also contain free glycerol and free fatty acids. Structural formula Mono- And Diglycerides:

where -OCR represents the fatty acid moiety Acetic and Fatty Acid Esters of Glycerol:

where R1, R2 and R3 each may be a fatty acid moiety, -

COCH3 or H Formula weight Mono- And Diglycerides: Glyceryl monostearate: 358.6 Glyceryl distearate: 625.0 These are two major components of commercial products Acetic and Fatty Acid Esters of Glycerol: - Description Mono- And Diglycerides: White or cream coloured hard fats of waxy appearance, plastic products or viscous liquids. Acetic and Fatty Acid Esters of Glycerol: From liquid to solid in consistency; white to pale yellow, may have the odour of acetic acid The article of commerce may be further specified as the saponification value, acid value, free fatty acid content, solidification point of the free fatty acids, Reichert-Meissl value, iodine value and free glycerol content. Characteristics

14 Identification Solubility Mono- And Diglycerides: Insoluble in water; soluble in ethanol, chloroform and benzene Acetic and Fatty Acid Esters of Glycerol: Insoluble in water; soluble in ethanol Infrared absorption Mono- And Diglycerides: The infrared spectrum of the sample is characteristic of a partial fatty acid ester of a polyol Acetic and Fatty Acid Esters of Glycerol: - Tests for fatty acids Passes tests Test for glycerol Passes tests Purity Water Mono- And Diglycerides: Not more than 2.0% (Karl Fischer Method) Acetic and Fatty Acid Esters of Glycerol: - Acid value Mono- And Diglycerides: Not more than 6 Acetic and Fatty Acid Esters of Glycerol: - Free glycerol Mono- And Diglycerides: Not more than 7% Acetic and Fatty Acid Esters of Glycerol: - Soap Mono- And Diglycerides: Not more than 6%, calculated as a sodium oleate Add 10.00 g of the sample to a mixture of 60 ml of acetone and 0.15 ml of bromophenol blue solution (0.5%), previously neutralized with 0.1 N hydrochloric acid or 0.1 N sodium hydroxide. Warm gently on a water bath until solution is complete, and titrate with 0.1 N hydrochloric acid until the blue colour is discharged. Allow to stand for 20 min, warm until any solidified matter has re-dissolved and, if the blue colour reappears, continue the titration. Each ml of 0.1 N hydrochloric acid is equivalent to 0.0304

15 g of C18H33O2Na. Acetic and Fatty Acid Esters of Glycerol: - Lead Not more than 2 mg/kg Category Food additives category (16) Functional uses Emulsifiers