Regulation of Minister of Health of the R.I. No. 033 Year 2012 on Food Additives

REGULATION OF MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA NO. 033 YEAR 2012 ON FOOD ADDITIVES WITH THE GRACE OF THE ALMIGHTY GOD MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA, Considering: a. that, society should be protected from use of food additives that do not meet health requirements; b. that, regulation concerning food additives in Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives as already amended by Regulation of Minister of Health No. 1168/Menkes/Per/X/1999 is no longer suitable to the development of science and technology in food sector; c. that, based on the considerations as meant in letters a and b, it is necessary to stipulate Regulation of Minister of Health on Food Additives; In view of: 1. Law No. 7/1996 on Food (Statute Book of 1996 No. 99, Supplement No. 3656); 2 2. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement No. 3821); 3. Law No. 36/2009 on Health (Statute Book of 2009 No. 144, Supplement No. 5063); 4. Government Regulation No. 69/1999 on Food Label and Advertisement (Statute Book of 1999 No. 131, Supplement No. 3867); 5. Government Regulation No. 28/2004 on Food Safety, Quality and Nutrition (Statute Book of 2004 No. 107, Supplement No. 4424); 6. Presidential Decree No. 103/2001 on Position, Task, Function, Authority and Organization Structure of Non-Departmental Government Institution as already amended several times and lastly by Presidential Regulation No. 64/2005; 7. Presidential Regulation No. 24/2010 on Position, Task and Function of State Ministry and Organization Structure, Task and Function of Echelon I of State Ministry; 8. Regulation of Minister of Health No. 1144/Menkes/Per/VIII/2010 on Organization and Work Procedure of the Ministry of Health (State Gazette of the Republic of Indonesia of 2010 No. 585); 3 DECIDED: To stipulate: REGULATION OF MINISTER OF HEALTH ON FOOD ADDITIVES. CHAPTER I GENERAL PROVISIONS Article 1 The terms in this Regulation shall have the following meanings: 1. Food Additive, hereinafter referred to as BTP, is an ingredient added into food to affect characteristic or form of food. 2. Acceptable Daily Intake, hereinafter referred to as ADI, is maximum amount of food additive in milligram per kilogram of body weight that can be consumed daily without creating a negative effect on health. 3. Maximum Tolerable Daily Intake, hereinafter referred to as MTDI, is maximum amount of a substance in milligram per kilogram of body weight that can be consumed daily without creating a negative effect on health. 4. Provisional Tolerable Weekly Intake, hereinafter referred to as PTWI, is a provisional maximum amount of a substance in 4 milligram per kilogram of body weight that can be consumed weekly without creating a negative effect on health. 5. Minister is the minister who handles administrative affairs in the field of health. 6. Head of Drug and Food Control Agency, hereinafter referred to as Agency Head, is Head of Agency whose task and responsibility is in the field of drug and food control. 7. Director General is the Director General at the Ministry of Health whose task and responsibility is in the field of pharmaceutical and health equipment industry development. Article 2 BTP used in food must meet the following requirements: a. BTP is not intended for direct consumption and/or not being treated as food raw material. b. BTP could have or not have nutritional value, which is intentionally added to food for technological purposes in food making, processing, packing, packaging, storage and/or transportation to produce or expected to produce a component or to affect characteristic of the food, directly or indirectly. 5 c. BTP is not classified as contaminant or ingredient added to food to maintain or increase nutritional value. CHAPTER II BTP CLASSIFICATION Article 3 (1)BPT used in food consists of several categories as follows: 1. antifoaming agent; 2. anticaking agent; 3. antioxidant; 4. carbonating agent; 5. emulsifying salt; 6. packaging gas; 7. humectants; 8. glazing agent; 9. sweetener; 10.carrier; 6 11.gelling agent; 12.foaming agent; 13.acidity regulator; 14.preservative; 15.raising agent; 16.emulsifier; 17.thickener; 18.firming agent; 19.flavor enhancer; 20.bulking agent; 21.stabilizer; 22.color retention agent; 23.flavoring; 24.flour treatment agent; 25.color; 26.propellant; and 7 27.sequestrant. (2)BPT categories, as referred to in paragraph (1), consist of several types of BTP. (3)In addition to the BTP categories, as referred to in paragraph (1), the Minister may stipulate other BTP categories. CHAPTER III TYPE AND PERMITTED MAXIMUM LIMIT OF BTP Article 4 (1)BTP types permitted in the categories, as referred to in Article 3 paragraph (1), are specified in Attachment I which is an inseparable part of this Regulation. (2)Addition and reduction of BTP types, as referred to in paragraph (1), shall be stipulated by the Agency Head. Article 5 (1)BTP may only be used not exceeding the maximum limit for use in food category. (2)The maximum limit for use in food category, as referred to in paragraph (1), shall be stipulated by the Agency Head. 8 Article 6 Stipulation of addition and reduction of BTP types, as referred to in Article 4 paragraph (2), and stipulation of maximum limit for use in food category, as referred to in Article 5 paragraph (2), shall consider: a. health requirement based on a valid scientific proof; b. ADI/MTDI/PTWI; and c. exposure assessment on food product consumption. Article 7 Every addition and reduction of BTP types, as referred to in Article 4 paragraph (2), and stipulation of maximum limit for use in food category, as referred to in Article 5 paragraph (2), shall be reported periodically to the Minister through the Director General once in every six (6) months. CHAPTER IV INGREDIENTS PROHIBITED FOR USE AS BTP Article 8 (1)Ingredients prohibited for use as BTP are specified in Attachment II which is an inseparable part of this Regulation. 9 (2)Agency Head may stipulate other ingredients prohibited for use as BTP after obtaining Minister’s approval. CHAPTER V BTP PRODUCTION, IMPORT, AND DISTRIBUTION Article 9 (1)BTP which is produced, imported to Indonesian territory, and distributed shall meet standards and requirements in the Indonesian Food Codex as stipulated by the Minister. (2)In case that BTP standards and requirements are not specified in the Indonesian Food Codec, as referred to in paragraph (1), other standards and requirements may be used. (3)BTP may only be produced by industry having an industry license in accordance with the provisions of the legislation. (4)The industry, as referred to in paragraph (3), shall be registered at an Agency whose task and responsibility is in the field of drug and food control. (5)Further provisions concerning BTP production, import, and distribution shall be stipulated by Regulation of Agency Head. 10 Article 10 (1)BTP may only be imported to Indonesian territory by importer after obtaining approval from the Agency Head. (2)Further provisions concerning procedure of BTP import shall be stipulated by Regulation of the Agency Head. Article 11 BTP which is to be produced, imported to Indonesian territory, and distributed shall have a distribution license from the Agency Head which is implemented in accordance with the provisions of the legislation. CHAPTER VI LABEL Article 12 Food containing BTP or BTP preparations shall meet food labeling requirement in accordance with the provisions of the legislation. Article 13 (1)For food containing BTP, the label shall specify BTP category. 11 (2)Label of food containing BTP categories antioxidant, artificial sweetener, preservative, color and flavor enhancer, shall also specify type name of BTP and index number of color. (3)Label of food containing artificial sweetener shall contain the words “containing artificial sweetener, not recommended for consumption by children under 5 years old, pregnant and breastfeeding mothers”. (4)Label of food for diabetes sufferers and/or low-calorie food using artificial sweetener shall contain the words “for diabetes sufferers and/or people who need low-calorie diet”. (5)Label of processed food containing artificial sweetener aspartame, shall contain a warning “containing phenylalanine, unsuitable for phenylketonuria sufferers”. (6)Label of processed food containing polyol sweetener, shall contain a warning “excessive consumption may have a laxative effect”. (7)Label of processed food containing sugar and artificial sweetener shall contain the words “containing sugar and artificial sweetener”. (8)Label of processed food containing flavoring, shall specify name of flavoring group on list of ingredients or ingredients. 12 (9)Label of processed food containing carryover BTP, “carryover BTP” shall be mentioned after the ingredients containing the carryover BTP. Article 14 (1)Label of BTP preparations shall contain: a. the words “Food Additive”; b. category name of BTP; c. type name of BTP; and d. registration number of BTP producer, except for table-top sweetener preparations. (2)Label of artificial sweetener preparations shall contain: a. comparison to sugar sweetness; b. the words “for diabetes sufferers and/or people who need low-calorie diet”; c. the words “containing artificial sweetener, not recommended for consumption by children under 5 years old, pregnant and breastfeeding mothers” 13 d. mg amount of artificial sweetener permitted for daily use per kg of body weight (Acceptable Daily Intake/ADI). (3)Label of polyol sweetener preparation shall contain a warning “excessive consumption may have a laxative effect”. (4)Label of aspartame artificial sweetener preparation shall contain: a. a warning “containing phenylalanine, unsuitable for phenylketonuria sufferers” b. the words “unsuitable for use in material which is to be heated”. (5)Label of color preparation shall contain: a. index number (Color Index, Cl); b. the words “food color” written in green capital letters in a green rectangular box; and c. M letter logo in a black circle. 14 CHAPTER VII DEVELOPMENT AND CONTROL Article 15 (1)Development of industry and BTP use shall be conducted by the Director General. (2)Guidelines on development, as referred to in paragraph (1), shall be stipulated by the Director General. Article 16 (1)Control over industry and BTP use shall be conducted by the Agency Head. (2)The Agency Head shall submit report on implementation of control, as referred to in paragraph (1), to the Minister through the Director General periodically once in every six (6) months. (3)The provisions of paragraphs (1) and (2) shall be implemented based on the guidelines stipulated by the Agency Head. 15 Article 17 (1)In the framework of control, the Agency Head may impose administrative sanctions for violations of this Regulation in the form of: a. written reminder; b. temporary prohibition on circulation and/or instruction for withdrawal from circulation; c. instruction for destruction if it is proven not meeting safety or quality requirement; and/or d. revocation of distribution license. (2)The administrative sanctions, as referred to in paragraph (1), shall be imposed by the Agency Head with or without proposal from Head of Provincial Health Agency, Head of Regental/City Health Agency. CHAPTER VIII TRANSITIONAL PROVISIONS Article 18 (1)All applications for license on use of BTP submitted before the effective date of this Regulation shall be processed based 16 on the provisions of Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on BTP as already amended by Regulation of Minister of Health No. 1168/Menkes/Per/X/1999. (2)Food that already obtained distribution license shall be adjusted to the provisions of this Regulation within not later than one (1) year since date of enactment of this Regulation. (3)Food whose application for extension of distribution license is in process, will still be processed in accordance with Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives as already amended by Regulation of Minister of Health No. 1168/Menkes/Per/X/1999 with the condition that the validity period of distribution license is one (1) year since date of enactment of this Regulation. CHAPTER IX CLOSING PROVISIONS Article 19 All implementing regulations of Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives as already amended by Regulation of Minister of Health No. 1168/Menkes/Per/X/1999 shall remain applicable as long as they are not in contradictory to and have not been amended in this Regulation. 17 Article 20 On the date this Regulation comes into force: a. Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives; b. Regulation of Minister of Health No. 1168/Menkes/Per/X/1999 on Amendment to Regulation of Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives; and c. Regulation of Minister of Health No. 208/Menkes/Per/IV/1985 on Artificial Sweetener; shall be revoked and declared inapplicable. Article 21 This Regulation comes into force on the date of enactment. In order that everyone shall take cognizance, this Regulation shall be enacted by placing it in the State Gazette of the Republic of Indonesia. 18 Stipulated in Jakarta July 12, 2012 MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA signed and sealed NAFSIAH MBOI Enacted in Jakarta July 27, 2012 MINISTER OF JUSTICE AND HUMAN RIGHTS OF THE REPUBLIC OF INDONESIA signed AMIR SYAMSUDIN STATE GAZETTE OF THE REPUBLIC OF INDONESIA OF 2012 NO. 757 19 ATTACHMENT I OF REGULATION OF MINISTER OF HEALTH NO. 033 YEAR 2012 ON FOOD ADDITIVES TYPES OF BTP PERMITTED IN CLASSIFICATION 1. Antifoaming agent Antifoaming agent is a food additive to prevent or reduce foam formation. NO. NAME OF BTP Code 1. Calcium alginate 404 2. Mono-and diglycerides of fatty acids 471 2. Anticaking agent Anticaking agent is a food additive to prevent caking of food product. NO. NAME OF BTP Code 1. Calcium carbonate 170(ii) 2. Tricalcium orthophosphate 341(iii) 3. Microcrystalline cellulose 460(i) 20 4. Powdered cellulose 460(ii) 5. Myristic, palmitic & stearic acid and their salts Myristic, palmitic & stearic acids and their calcium, potassium and sodium (Ca, K, Na) salts 470(i) 6. Salts of oleic acid with calcium, potassium, and sodium (Ca, K, Na) 470(ii) 7. Sodium carbonate 500(i) 8. Magnesium carbonate 504(i) 9. Magnesium oxide 530 10. Sodium ferrocyanide 535 11. Potassium ferrocyanide 536 12. Calcium ferrocyanide 538 13. Silicon dioxide amorphous 551 14. Calcium silicate 552 15. Sodium aluminosilicate 554 16. Magnesium silicate 553(i) 3. Antioxidant Antioxidant is a food additive to prevent or inhibit food damage as a result of oxidation. 21 NO. NAME OF BTP Code 1. Ascorbic acid 300 2. Sodium ascorbate 301 3. Calcium ascorbate 302 4. Potassium ascorbate 303 5. Ascorbyl palmitate 304 6. Ascorbyl stearate 305 7. Tocopherol; d-alpha tocopherol 307a Mixed tocopherol concentrate 307b Gamma tocopherol 308 8. Propyl gallate 310 9. Erythorbic acid 315 10. Sodium erythorbate 316 11. Tertiary butylhydroquinone 319 12. Butylated hydroxyanisole 320 13. Butylated hydroxytoluene 321 4. Carbonating agent Carbonating agent is a food additive to provide carbonation in food. 22 NO. NAME OF BTP Code 1. Carbon dioxide 290 5. Emulsifying salt Emulsifying salt is a food additive to disperse protein in cheese in order to prevent fat separation. NO. NAME OF BTP Code 1. Sodium dihydrogen citrate 331(i) 2. Trisodium citrate 331(iii) 3. Potassium dihydrogen citrate 332(i) 4. Tripotassium citrate 332(ii) 5. Monosodium orthophosphate 339(i) 6. Disodium orthophosphate 339(ii) 7. Trisodium orthophosphate 339(iii) 8. Monopotassium orthophosphate 340(i) 9. Dipotassium orthophosphate 340(ii) 10. Tripotassium orthophosphate 340(iii) 11. Edible gelatin 428 12. Disodium diphosphate 450(i) 23 13. Tetrasodium diphosphate 450(iii) 14. Tetrapotassium diphosphate 450(v) 15. Dicalcium diphosphate 450(vi) 16. Sodium tripolyphosphate 451(i) 17. Potassium tripolyphosphate 451(ii) 18. Sodium polyphosphate 452(i) 19. Potassium polyphosphate 452(ii) 20. Calcium polyphosphate 452(iv) 21. Acetic and fatty acid esters of glycerol 472a 22. Lactic and fatty acid esters of glycerol 472b 23. Citric and fatty acid esters of glycerol 472c 24. Diacetyltartaric and fatty acid esters of glycerol 472e 25. Sodium gluconate 576 6. Packaging gas Packaging gas is a food additive in the form of gas, injected into food package before, during, or after package is filled with food to maintain food quality and to protect food from damage. 24 NO. NAME OF BTP Code 1. Carbon dioxide 290 2. Nitrogen 941 7. Humectant Humectant is a food additive to maintain humidity of food. NO. NAME OF BTP Code 1. Sodium lactate 325 2. Potassium lactate 326 3. Sodium hydrogen malate 350(i) 4. Sodium malate 350(ii) 5. Glycerol 422 6. Polydextroses 1200 7. Triacetin 1518 8. Glazing agent Glazing agent is a food additive to coat food surface in order to provide a protective effect and/or a shiny appearance. 25 NO. NAME OF BTP Code 1. Beeswax 901 2. Candelilla wax 902 3. Carnauba wax 903 4. Shellac 904 5. Microcystalline wax 905c(i) 9. Sweetener Sweetener is a food additive in the form of natural sweetener or artificial sweetener that gives a sweet flavor to food product. a. Natural sweetener Natural sweetener is a sweetener that can be found in natural ingredients although it is through a synthetic or fermentation process. NO. NAME OF BTP Code 1. Sorbitol 420(i) Sorbitol syrup 420(ii) 2. Mannitol 421 3. Isomalt/isomaltitol 953 4. Steviol glycosides 960 26 5. Maltitol 965(i) Maltitol syrup 965(ii) 6. Lactitol 966 7. Xylitol 967 8. Erythritol 968 b. Artificial sweetener Artificial sweetener is a sweetener which is chemically processed, and the compound does not exist in nature. NO. NAME OF BTP Code 1. Acesulfame potassium 950 2. Aspartame 951 3. Cyclamic acid 952(i) Calcium cyclamate 952(ii) Sodium cyclamate 952(iv) 4. Saccharin 954(i) Calcium saccharin 954(ii) Potassium saccharin 954(iii) 5. Sucralose/trichlorogalactosucrose 955 6. Neotame 961 27 9. Carrier Carrier is a food additive used to facilitate handling, application or use of other food additives or nutritional substances in food by dissolving, diluting, dispersing, or physically modifying other food additives or nutritional substances without altering its function and without having any technological effect on food. NO. NAME OF BTP Code 1. Sucrose acetate isobutyrate 444 2. Triethyl citrate 1505 3. Propylene glycol 1520 4. Polyethylene glycol 1521 10.Gelling agent Gelling agent is a food additive used to form gel. NO. NAME OF BTP Code 1. Alginic acid 400 2. Sodium alginate 401 3. Potassium alginate 402 4. Calcium alginate 404 28 5. Agar 406 6. Carrageenan 407 7. Processed euchema seaweed 407a 8. Gellan gum 418 9. Edible gelatin 428 10. Pectins 440 11. Foaming agent Foaming agent is a food additive to form or maintain homogeneity of dispersion of a gaseous phase in a liquid or solid food. NO. NAME OF BTP Code 1. Xanthan gum 415 2. Microcrystalline cellulose 460(i) 3. Methyl ethyl cellulose 465 12.Acidity regulator Acidity regulator is a food additive to acidify, neutralize and/or maintain acidity of food. 29 NO. NAME OF BTP Code 1. Calcium carbonate 170(i) 2. Acetic acid 260 3. Sodium acetate 262(i) 4. Calcium acetate 263 5. Lactic acid 270 6. Malic acid 296 7. Fumaric acid 297 8. Sodium lactate 325 9. Potassium lactate 326 10. Calcium lactate 327 11. L-ammonium lactate 328 12. Citric acid and its salts: Citric acid 330 Sodium dihydrogen citrate 331(i) Disodium monohydrogen citrate 331(ii) Trisodium citrate 331(iii) Potassium dihydrogen citrate 332(i) Tripotassium citrate 332(ii) Tricalcium citrate 333(iii) 13 Tartaric acid and potassium hydrogen tartrate Tartaric acid 334 Potassium hydrogen tartrate 336(i) 30 14. Orthophosphoric acid 338 15. Sodium hydrogen malate 350(i) 16. Sodium malate 350(ii) 17. Calcium DL-malate 352(ii) 18. Adipic acid and its salts: Adipic acid 355 Sodium adipate 356 Potassium adipate 357 19. Sodium carbonate 500(i) 20. Sodium hydrogen carbonate 500(ii) 21. Potassium carbonate 501(i) 22. Potassium hydrogen carbonate 501(ii) 23. Ammonium carbonate 503(i) 24. Ammonium hydrogen carbonate 503(ii) 25. Magnesium carbonate 504(i) 26. Hydrochloric acid 507 27. Sodium sulphate 514(i) 28. Potassium sulphate 515(i) 29. Calcium sulphate 516 30. Sodium hydroxide 524 31. Potassium hydroxide 525 32. Calcium hydroxide 526 33. Magnesium hydroxide 528 31 34. Calcium oxide 529 35. Glucono delta lactone 575 36. Calcium gluconate 578 13. Preservative Preservative is a food additive to prevent or inhibit fermentation, acidation, dispersal, and other deterioration of food caused by microorganisms. NO. NAME OF BTP Code 1. Sorbic acid and its salts: Sorbic acid 200 Sodium sorbate 201 Potassium sorbate 202 Calcium sorbate 203 2 Benzoic acid and its salts: Benzoic acid 210 Sodium benzoate 211 Potassium benzoate 212 Calcium benzoate 213 3. Ethyl para-hydroxybenzoate 214 4. Methyl para hydroxybenzoate 218 32 5. Sulphites: Sulphur dioxide 220 Sodium sulphite 221 Sodium bisulphite 222 Sodium metabisulphite 223 Potassium metalbisulphite 224 Potassium sulphite 225 Calcium bisulphate 227 Potassium bisulphate 228 6. Nisin 234 7. Nitrites: Potassium nitrite 249 Sodium nitrite 250 8. Nitrates: Sodium nitrate 251 Potassium nitrate 252 9. Propionic acid and its salts: Propionic acid 280 Sodium propionate 281 Calcium propionate 282 Potassium propionate 283 10. Lysozime hydrochloride 1105 33 14.Raising agent Raising agent is a food additive in the form of a single or mixed compound to release gas in order to increase volume of dough. NO. NAME OF BTP Code 1. Sodium carbonate 500(i) 2. Sodium hydrogen carbonate 500(ii) 3. Potassium hydrogen carbonate 501(ii) 4. Ammonium carbonate 503(i) 5. Ammonium hydrogen carbonate 503(ii) 6. Sodium aluminium phosphates 541(i) 7. Glucono delta lactone 575 8. Dextrins 1400 9. Starch acetate 1420 15.Emulsifier Emulsifier is a food additive to assist the formation of a homogenic emulsion of two or more unmixable phases such as oil and water. NO. NAME OF BTP Code 1. Calcium carbonate 170(i) 34 2. Lecithins 322(i) 3. Sodium lactate 325 4. Calcium lactate 327 5. Sodium dihydrogen citrate 331(i) 6. Disodium monohydrogen citrate 331(ii) 7. Trisodium citrate 331(iii) 8. Potassium dihydrogen citrate 332(i) 9. Tripotassium citrate 332(ii) 10. Monosodium orthophosphate 339(i) 11. Disodium orthophosphate 339(ii) 12. Trisodium orthophosphate 339(iii) 13. Monopotassium orthophosphate 340(i) 14. Dipotassium orthophosphate 340(ii) 15. Tripotassium orthophosphate 340(iii) 16. Alginic acid 400 17. Sodium alginate 401 18. Potassium alginate 402 19. Calcium alginate 404 20. Propylene glycol alginate 405 21. Agar 406 22. Carrageenan 407 23. Locust bean gum 410 24. Guar gum 412 35 25. Tragacanth gum 413 26. Arabic gum 414 27. Karaya gum 416 28. Glycerol 422 29. Edible gelatin 428 30. Polysorbates: Polyoxyethylene (20) sorbitan monolaurate 432 Polyoxyethylene (20) sorbitan monopalmitate 434 Polyoxyethylene (20) sorbitan monooleate 433 Polyoxyethylene (20) sorbitan monostearate 435 Polyoxyethylene (20) sorbitan tristearate 436 31. Pectins 440 32. Glycerol ester of wood rosin 445(iii) 33. Disodium diphosphate 450(i) 34. Trisodium diphosphate 450(ii) 35. Tetrasodium diphosphate 450(iii) 36. Tetrapotassium diphosphate 450(v) 37. Dicalcium diphosphate 450(vi) 38. Calcium dihydrogen diphosphate 450(vii) 39. Sodium polyphosphate 452(i) 40. Potassium polyphosphate 452(ii) 41. Sodium calcium polyphosphate 452(iii) 42. Calcium polyphosphate 452(iv) 36 43. Microcrystalline cellulose 460(i) 44. Powdered cellulose 460(ii) 45. Methyl cellulose 461 46. Hydroxypropyl cellulose 463 47. HYdroxypropyl methyl cellulose 464 48. Methyl ethyl cellulose 465 49. Sodium carboxymethyl cellulose 466 50. Myristic, palmitic & stearic acids and their calcium, potassium and sodium (Ca, K, Na) salts 470(i) 51. Salts of oleic acid with calcium, potassium and sodium (Ca, K, Na) 470(ii) 52. Mono- and di-glycerides of fatty acids 471 53. Acetic and fatty acid esters of glycerol 472a 54. Lactic and fatty acid esters of glycerol 472b 55. Citric and fatty acid esters of glycerol 472c 56. Diacetyltartaric and fatty acid esters of glycerol 472e 57. Sucrose esters of fatty acids 473 58. Polyglycerol esters of fatty acids 475 59. Polyglycerol esters of interesterified ricinoleic acid 476 60. Polyglycerol esters of fatty acids 477 61. Sodium stearoyl 2-lactylate 481(i) 37 62. Sorbitan esters of fatty acids: Sorbitan monostearate 491 Sorbitan tristearate 492 63. Beeswax 901 64. Candelilla wax 902 65. Polydextroses 1200 66. Acid treated starch 1401 67. Bleached starch 1403 68. Oxidized starch 1404 69. Enzymed treated starch 1405 70. Monostarch phosphate 1410 71. Distarch phosphate 1412 72. Phosphated distarch phosphates 1413 73. Acetylated distarch phosphate 1414 74. Starch acetate 1420 75. Acetylated distarch adipate 1422 76. HYdroxypropyl starch 1440 77. Hydroxypropyl distarch phosphate 1442 78. Starch sodium octenyl succinate 1450 79. Acetylated oxidized starch 1451 80. Sodium caseinate 38 16.Thickener Thickener is a food additive to increase viscosity of food. NO. NAME OF BTP Code 1. Calcium acetate 263 2. Sodium lactate 325 3. Calcium lactate 327 4. Alginic acid 400 5. Sodium alginate 401 6. Potassium alginate 402 7. Calcium alginate 404 8. Propylene glycol alginate 405 9. Agar 406 10. Carrageenan 407 11. Processed eucheuma seaweed 407a 12. Locust bean gum 410 13. Guar gum 412 14. Tragacanth gum 413 15. Arabic gum 414 16. Xanthan gum 415 17. Karaya gum 416 18. Tara gum 417 19. Gellan gum 418 39 20. Ghatti gum 419 21. Glycerol 422 22. Edible gelatin 428 23. Pectins 440 24. Glycerol ester of wood rosin 445(iii) 25. Alpha-cyclodextrin 457 26. Gamma-cyclodextrin 458 27. Mycrocrystalline cellulose 460(i) 28. Powdered cellulose 460(ii) 29. Methyl cellulose 461 30. Ethyl cellulose 462 31. Hydroxypropyl cellulose 463 32. Hydroxypropyl methyl cellulose 464 33. Methyl ethyl cellulose 465 34. Sodium carboxymethyl cellulose 466 35. Sodium carboxymethyl cellulose, enzymatically hydrolised 469 36. Mono- and di- glycerides of fatty acids 471 37. Potassium chloride 508 38. Calcium chloride 509 39. Calcium sulphate 516 40. Potassium hydroxide 525 41. Bromelain 1101(iii) 40 42. Polydextroses 1200 43. Dextrins 1400 44. Acid treated starch 1401 45. Alkaline treated starch 1402 46. Bleached starch 1403 47. Oxidized starch 1404 48. Enzymed treated starch 1405 49. Monostarch phosphate 1410 50. Distarch phosphate 1412 51. Phosphated distarch phosphate 1413 52. Acetylated distarch phosphate 1414 53. Starch acetate 1420 54. Acetylated distarch adipate 1422 55. Hydroxypropyl starch 1440 56. Hydroxypropyl distarch phosphate 1442 57. Starch sodium octenyl succinate 1450 58. Acetylated oxidized starch 1451 59. Sodium caseinate 17.Firming agent Firming agent is a food additive to firm or maintain tissues of fruits and vegetables, or to interact with gelling agent to strengthen gel. 41 NO. NAME OF BTP Code 1. Calcium lactate 327 2. Tricalcium citrate 333(iii) 3. Potassium chloride 508 4. Calcium chloride 509 5. Calcium sulphate 516 6. Calcium gluconate 578 18.Flavor enhancer Flavor enhancer is a food additive to enhance or modify the existing taste and/or aroma of food without adding a new taste and/or aroma. NO. NAME OF BTP Code 1. L-glutamic acid and its salts: L-glutamic acid 620 Monosodium L-glutamate 621 Monopotassium L-glutamate 622 Calcium di-L-glutamate 623 2. Guanylic acid and its salts: 5’-guanylic acid 626 Disodium 5”-guanylate 627 Dipotassium 5’-guanylate 628 42 Calcium 5’-guanylate 629 3. Inosinic acid and its salts: 5’-inosinic acid 630 Disodium 5’-inosinate 631 Dikalium 5’-inosinate 632 Calcium 5’-inosinate 633 4. Salts of 5’-ribonucleotides: 634 Calcium 5’-ribonucleotides 634 Disodium 5’-ribonucleotides 635 19.Bulking agent Bulking agent is a food additive to increase volume of food. NO. NAME OF BTP Code 1. Sodium lactate 325 2. Alginic acid 400 3. Sodium alginate 401 4. Propylene glycol alginate 405 5. Agar 406 6. Carrageenan 407 7. Guar gum 412 8. Tragacanth gum 413 9. Arabic gum 414 43 10. Karaya gum 416 11. Glycerol ester of wood rosin 445(iii) 12. Microcrystalline cellulose 460(i) 13. Powdered cellulose 460(ii) 14. Methyl cellulose 461 15. Ethyl cellulose 462 16. Hydroxypropyl methyl cellulose 464 17. Sodium carboxymethyl cellulose 466 18. Mono- and di-glycerides of fatty acids 471 19. Calcium sulphate 516 20. Polydextroses 1200 21. Acid treated starch 1401 22. Alkaline treated starch 1402 23. Bleached starch 1403 24. Oxidized starch 1404 25. Enzymed treated starch 1405 26. Monostarch phosphate 1410 27. Distarch phosphate 1412 28. Phosphated distarch phosphate 1413 29. Acetylated distarch phosphate 1414 30. Acetylated distarch adipate 1422 31. Hydroxypropyl starch 1440 32. Hydroxypropyl distarch phosphate 1442 44 20.Stabilizer Stabilizer is a food additive to stabilize homogenic dispersion system in food. NO. NAME OF BTP Code 1. Calcium carbonate 170(i) 2. Calcium acetate 263 3. Fumaric acid 297 4. Lecithins 322(i) 5. Sodium lactate 325 6. Calcium lactate 327 7. Sodium dihydrogen citrate 331(i) 8. Disodium monohydrogen citrate 331(ii) 9. Trisodium citrate 331(iii) 10. Potassium dihydrogen citrate 332(i) 11. Tripotassium citrate 332(ii) 12. Tricalcium citrate 333(iii) 13. Monosodium orthophosphate 339(i) 14. Disodium orthophosphate 339(ii) 15. Trisodium orthophosphate 339(iii) 16. Monopotassium orthophosphate 340(i) 17. Dipotassium orthophosphate 340(ii) 18. Tripotassium orthophosphate 340(iii) 45 19. Calcium phosphates: 341 Monocalcium orthophosphate 341(i) Dicalcium orthophosphate 341(ii) Tricalcium orthophosphate 341(iii) 20. Adipic acid 355 21. Alginic acid 400 22. Sodium alginate 401 23. Potassium alginate 402 24. Calcium alginate 404 25. Propylene glycol alginate 405 26. Agar 406 27. Carrageenan 407 28. Processed eucheuma seaweed 407a 29. Locust bean gum 410 30. Guar gum 412 31. Tragacanth gum 413 32. Arabic gum 414 33. Xanthan gum 415 34. Karaya gum 416 35. Tara gum 417 36. Gellan gum 418 37. Ghatti gum 419 38. Glycerol 422 46 39. Edible gelatin 428 40. Pectins 440 41. Glycerol ester of wood rosin 445(iii) 42. Disodium diphosphate 450(i) 43. Trisodium diphosphate 450(ii) 44. Tetrasodium diphosphate 450(iii) 45. Tetrapotassium diphosphate 450(v) 46. Dicalcium diphosphate 450(vi) 47. Sodium tripolyphosphate 451(i) 48. Potassium tripolyphosphate 451(ii) 49. Sodium polyphosphate 452(i) 50. Potassium popyphosphate 452(ii) 51. Sodium calcium popyphosphate 452(iii) 52. Calcium polyphosphate 452(iv) 53. Alpha-Cyclodextrin 457 54. Gamma-Clyclodextrin 458 55. Microcrystalline cellulose 460(i) 56. Powdered cellulose 460(ii) 57. Methyl cellulose 461 58. Hydroxypropyl cellulose 463 59. HYdroxypropyl methyl cellulose 464 60. Methyl ethyl cellulose 465 61. Sodium carboxymethyl cellulose 466 47 62. Crosscarmelose sodium 468 63. Sodium carboxymethyl cellulose, enzymatically hydrolised 469 64. Myristic, palmitic & stearic acids and their calcium, potassium and sodium (Ca, K, Na) salts 470(i) 65. Salts of oleic acid with calcium, potassium, and sodium (Ca, K, Na) 470(ii) 66. Mono- and di-glycerides of fatty acids 471 67. Acetic and fatty acid esters of glycerol 472a 68. Lactic and fatty acid esters of glycerol 472b 69. Citric and fatty acid esters of glycerol 472c 70. Diacetyltartaric and fatty acid esters of glycerol 472e 71. Polyglycerol esters of interesterified ricinoleic acid 476 72. Sodium carbonate 500(i) 73. Sodium hydrogen carbonate 500(ii) 74. Potassium carbonate 501(i) 75. Potassium hydrogen carbonate 501(ii) 76. Ammonium carbonate 503(i) 77. Ammonium hydrogen carbonate 503(ii) 78. Potassium chloride 508 48 79. Calcium chloride 509 80. Calcium sulphate 516 81. Potassium hydroxide 525 82. Calcium hydroxide 526 83. Magnesium hydroxide 528 84. Beeswax 901 85. Papain 1101(ii) 86. Bromelain 1101(iii) 87. Polydextroses 1200 88. Dextrins 1400 89. Acid treated starch 1401 90. Alkaline treated starch 1402 91. Bleached starch 1403 92. Oxidized starch 1404 93. Enzymed treated starch 1405 94. Monostarch phosphate 1410 95. Distarch phosphate 1412 96. Phosphate distarch phosphates 1413 97. Acetylated distarch phosphate 1414 98. Starch acetate 1420 99. Acetylated distarch adipate 1422 100 Hydroxypropyl starch 1440 101 Hydroxypropyl distarch phosphate 1442 49 102 Starch sodium octenyl succinate 1450 103 Acetylated oxidized starch 1451 104 Sodium caseinate 21.Color Retention Agent Color Retention Agent is a food additive that can maintain, stabilize, or strengthen intensity of food color without creating a new color. NO. NAME OF BTP Code 1. Magnesium carbonate 504(i) 2. Magnesium hydroxide 528 22.Flavoring Flavoring is a food additive in the form of concentrate preparation with or without flavoring adjunct used to give flavor with the exception of salty, sweet, and sour taste. Flavoring is grouped into: 1. natural flavoring; 2. natural identical flavoring; and 3. artificial flavoring. 50 The above groups consist of one more types specified in the table below: NO. BTP 1. Natural aromatic raw material is a food additive derived from plant or animal which is suitable for use in the preparation/making/processing of natural flavoring. The raw material includes foodstuff, spices, herbs and other plant sources which are correct for the application concerned, amongst others, onion powder, chili powder, sliced lime leaves, sliced bay leaves, sliced ginger. 2. Flavoring preparation is an ingredient prepared or processed to give flavor acquired through physical, microbiological or enzymatic process of plant or animal foodstuff directly acquired through processing process. The ingredient is suitable for human consumption at a certain use level, but is not intended for direct consumption, amongst others, orange oil, tea extract, paprika oleoresin, cheese powder, yeast extract. 3. Smoke flavoring is a flavoring preparation derived from, hard wood including sawdust, shell and woody plant which does not experience treatment and is not contaminated 51 through controlled burning process or dry distillation or treatment in very hot steam, and thereafter condensed and defractionated to obtain an expected flavor. 4. Process flavoring is a flavoring preparation from ingredient or a mix of ingredients permitted for use in food, or which naturally exists in food or permitted for use in the making of process flavoring at a condition equal to a temperature and time not exceeding 180°C and 15 minutes and with pH not exceeding 8.0, amongst others, flavoring produced from reducing sugar and amino acid. 23.Flour Treatment Agent Flour treatment agent is a food additive added to flour to improve color, dough or baking quality including leavening agent, flour bleaching and maturing agents. NO. NAME OF BTP Code 1. L-ammonium lactate 328 2. Sodium stearoyl-2-lactylate 481(i) 3. Ammonium chloride 510 4. Calcium sulphate 516 5. Calcium oxide 529 52 6. Alpha-amylase from bacillus licheniformis (carbohydrase) 1100 7. Alpha-amylase from aspergillus oryzae, var 1100 8. Alpha-amylase from bacillus stearothermophilus 1100 9. Alpha-amylase from bacillus stearothermophilus expressed in bacillus subtilis 1100 10. Alpha-amylase from bacillus subtilis 1100 11. Alpha-amylase from bacillus megaterium expressed in bacillus subtilis 1100 12. Protease from aspergillus oryzae, var 1101(i) 13. Papain 1101(ii) 14. Bromelain 1101(iii) 24.Color Color is a food additive in the form of natural color and synthetic color, when it is applied on food can add or restore color. a. Natural Color Natural color is a color produced through process of extraction, isolation, or derivation (partially synthetic) from plants, animals, minerals or other natural sources, including natural identical color. 53 NO. NAME OF BTP Code 1. Curcumin CI No. 75300 100(i) 2. Riboflavins: Riboflavin, synthetic 101(i) Riboflavin 5’-phosophate sodium 101(ii) Riboflavin (Bacilus subtilis) 101(iii) 3. Carmines and cochineal extract CI No. 75470: Carmines CI No. 75470 120 Cochineal extract CI No. 75470 120 4. Chlorophyll CI No. 75810 140 5. Chlorophylls and colorophyllins, copper complexes CI No. 75810 141 6. Caramel I-plain 150a 7. Caramel III-ammonia process 150c 8. Caramel IV-sulphite ammonia process 150d 9. Vegetable carbon CI No. 77266 153 10. Beta-carotenes, vegetables CI No. 75130 160a(ii) 11. Annatto extracts CI No. 75120, bixin based 160b(i) 12. Carotenoids: Beta-carotenes, synthetic CI No. 40800 160a(i) Beta-carotenes (Blakeslea trispora) 160a(iii) 54 Beta-Apo-8’-carotenal CI No. 40820 160e Beta-apo-8’-carotenic acid ethyl ester CI No. 40825 160f 13. Beet red 162 14. Anthocyanins 163 15. Titanium dioxide CI No. 77891 171 b. Synthetic Color Synthetic color is a color acquired by chemical synthetic process. NO. NAME OF BTP Code 1. Tartrazine CI No. 19140 102 2. Quinoline yellow CI No. 47005 104 3. Sunset yellow FCF CI No. 15985 110 4. Carmoisine CI No. 14720 122 5. Ponceau 4R CI No. 16255 124 6. Erythrosine CI No. 45430 127 7. Allura red CI No. 16035 129 8. Indigotine CI No. 73015 132 9. Brilliant blue FCF CI No. 42090 133 10. Fast green FCF CI No. 42053 143 11. Brown HT CI No. 20285 155 55 25. Propellant Propellant is a food additive in the form of gas to expel food from container. NO. NAME OF BTP Code 1. Nitrogen 941 2. Dinitrogen monoxide 942 3. Propane 944 26. Sequestrant Sequestrant is a food additive that can bind polyvalent metal ions to form complexes in order to improve stability and quality of food. NO. NAME OF BTP Code 1. Calcium disodium ethylene diamine tetra acetate 385 2. Isopropyl citrates 384 3. Sodium gluconate 576 4. Potassium gluconate 577 56 MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA signed and sealed NAFSIAH MBOI 57 ATTACHMENT II OF REGULATION OF MINISTER OF HEALTH NO. 033 YEAR 2012 ON FOOD ADDITIVES INGREDIENTS PROHIBITED FOR USE AS BTP NO. INGREDIENTS 1. Boric acid and its compounds 2. Salicylic acid and its salt 3. Diethyl pyrocarbonate, DEPC 4. Dulcin 5. Formaldehyde 6. Potassium bromated 7. Potassium chlorate 8. Chloramphenicol 9. Brominated vegetable oils 10. Nitrofurazone 11. Dulcamara 12. Cocaine 13. Nitrobenzene 14. Cinnamyl anthranilate 58 NO. INGREDIENTS 15. Dihydrosafrole 16. Tonka bean 17. Calamus oil 18. Tansy oil 19. Sasafras oil MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA signed and sealed NAFSIAH MBOI