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STATE NEWS
REPUBLIC OF INDONESIA
| No. 679, 2013 | THE SUPERVISORS OF THE DRUG AND FOOD. Food Supplement. Stabilised. Maximum Limit. |
REGULATION OF THE HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND FOOD SUPERVISORS
No. 24 YEAR 2013
ABOUT
THE MAXIMUM LIMIT OF THE USE OF STABLE FOOD ADDUSE MATERIALS
BY THE GRACE OF THE ALMIGHTY GOD
HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND MEDICINE SUPERVISORS,
Weighing: that to carry out the provisions of Article 4 of the paragraph (2) and Article 5 paragraph (2) of the Regulation of the Minister of Health Number 033 of 2012 on Food Additional Materials need to establish the Regulation of the Head of the Food and Drug Administration about the Maximum Limit of Stable Food Supplemental Materials;
Given: 1. Act Number 8 of 1999 on Consumer Protection (State Sheet of Indonesia Year 1999 Number 42, Additional Gazette Republic of Indonesia Number 3821);
2. Law No. 36 Year 2009 on Health (State Sheet of the Republic of Indonesia Year 2009 Number 144, Additional Sheet of State of Indonesia Republic No. 5063);
3. Act No. 18 Year 2012 on Food (Sheet State Republic Of Indonesia In 2012 Number 227, Additional Sheet Of State Republic Of Indonesia Number 5360);
4. Government Regulation No. 69 of 1999 on the Label and Food Advertising (State Sheet of the Republic of Indonesia Year 1999 Number 131, Additional Gazette Republic of Indonesia Number 3867);
5. Government Regulation No. 28 of 2004 on Security, Mutu and Food Nutrition (State Gazette 2004 No. 107, Additional Gazette Republic of Indonesia No. 4424);
6. Presidential Decree Number 103 of 2001 on the Position, Duties, Functions, Authority, Organizational Arrangements, and the Working Governance of the Non-Department Government as it has been several times amended with the Presidential Regulation Number 3 of 2013;
7. Presidential Decree Number 110 of 2001 on Unit of Organization and Duty of Eselon I Institute of Non-Department Government as it has been several times amended last with Presidential Regulation No. 4 of 2013;
8. Health Minister Regulation Number 033 Year 2012 on Food Additional Materials (State News of the Republic of Indonesia 2012 Number 757);
9. Decree of the Head of the Food and Drug Administration Number 02001 /SK/KBPOM 2001 on the Organization and the Working Board of the Food and Drug Administration as amended by the Decree of the Head of the Board of Trusts of Drug and Food Number HK. 00.05.21.4231 2004;
DECIDED:
establish: The rules of the head of the drug and food supervisors head about the maximum limit of the use of additional stable food ingredients.
BAB I
UMUM PROVISIONS
Article 1
In this Regulation referred to:
1. Food is everything that comes from the natural resources of agricultural products, plantations, forestry, fisheries, farms, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water, water and water, including food adders, food raw materials, and other materials used in the process of preparation, processing, and/or making food or beverages.
2. Food adders, further abbreviated as BTP, are ingredients that are added to the food to influence the nature or form of food.
3. BTP name or type of BTP, subsequently called BTP type, is the chemical/generic/umum/common name used for the identity of the additional ingredients of food, in Indonesian or in English.
4. Penstable (Stabilizer) is a food addreser to stabilize the homogeneous dispersion system on food.
5. BTP supplies are food adders packaged and labeled in a suitable size for consumers.
6. An acceptable daily intake or Acceptable Daily Intake, which is next abbreviated ADI, is the maximum amount of food addate in milligrams per kilogram of body weight that can be consumed every day during life without It causes adverse effects on health.
7. ADI not specified or ADI not specified/ADI not limited/ADI acceptable/no ADI Allocated/no ADI necessary is a term used for food additive materials that have very low toxicity, based on data (chemistry, biochemistry, or so as to be used for food). toxicology and other data), the amount of intake of such food additives if used in the exchange required to achieve desired effects as well as other considerations, according to the opinion Joint FAO/WHO Expert Committee on Food Additives (JECFA) does not pose a danger to health.
8. A tolerable maximum daily intake or Maximum Tolerable Daily Intake, which is next abbreviated MTDI, is the maximum amount of a substance in milligrams per kilogram of body weight that can be consumed in a day without incurable Adverse effects on health.
9. Maximum limit is the maximum number of BTP allowed to be present in food in the specified unit.
10. Maximum Boundary Way of Good Food Production or Good Manufacturing Practice, further called the CPPB Maximum Boundary, is the number of BTP allowed to be present in food in the amount of sufficient quantity required to produce the effect Wanted.
11. BTP Ikutan (Carry over) is a BTP that comes from all the raw materials that are mixed and packaged separately but are still a single product unit.
Food Category is a food grouping based on the type of food.
13. Head of the Agency is the Head of the Agency whose duties and responsibility in the area of the supervision of medicine and food.
BAB II
BTP SCOPE SPACE
Section 2
(1) BTP is not intended to be consumed directly and/or not treated as a food raw material.
(2) BTP may have or may not have a nutritional value, which is intentionally added to the food for technological purposes on the manufacture, processing, treatment, packaging, packaging, storage and/or transportation of the food for the purpose of the technology. producing or expected to produce a component or affect the nature of the food, either directly or indirectly.
(3) BTP does not include a spruce or ingredient added to the food to maintain or increase nutritional value.
BAB III
THE TYPE AND MAXIMUM BTP-STABLE LIMIT
Section 3
The type of Penstable BTP permitted use in food consists of:
1. Calcium carbonate (
Calcium carbonate);
2. Calcium acetate
(
Calcium acetate);
3. fumaric acid
(
Fumaric acid);
4. Lesitin
(
Lecithins);
5. Natrium lactate
(
Sodium lactate);
6. Kalsium lactate
(
Calcium lactate);
7. Natrium dihydrogen citrate (
Sodium dihydrogen citrate);
8. Dinatrium monohydrogen citrate
(
Disodium monohydrogen citrate);
9. Trinatrium citrate
(
Trisodium citrate);
10. Kalium dihydrogen citrate
(
Potassium dihydrogen citrate);
11. Tripotassium citrate
(
Tripotassium citrate);
12. Tricalcium citrate (
Tricalcium citrate);
13. Mononatrium phosphate (
Monosodium orthophosphate);
14. Dinatrium phosphate
(
Disodium orthophosphate);
15. Trinatrium phosphate
(
Trisodium orthophosphate);
16. Monokalium phosphate
(
Monopotassium orthophosphate);
17. Dikalium phosphate
(
Dipotassium orthophosphate);
18. Tripotassium phosphate
(
Tripotassium orthophosphate);
19. Calcium phosphate (
Calcium phosphates);
20. Acid adipat
(
Adipic acid);
21. Alginic acid
(
Alginic acid);
22. Natrium alginate
(Sodium alginate);
23. Kalium alginate
(
Potassium alginate);
24. Calcium alginate
(
Calcium alginate);
25. Propilen glycol alginate
(
Propylene glycol alginate);
26. So-so
(Agar);
27. Karagen
(
Carrageenan);
28. Sea rump
eucheuma processed
(
Processed eucheuma seaweed);
29. Gom bean locus
(
Locust bean gum);
30. Gom guar (
Guar gum);
31. Gom tragakan
(
Tragacanth gum);
32. Gom arab
(
Arabic gum);
33. Gom
xanthan (
Xanthan gum);
34. Gom karaya
(
Karaya gum);
35. Gom tara
(
Tara gum);
36. Gom gelan
(
Gellan gum);
37. Gom gatti
(
Gum ghatti);
38. Gliserol (
Glycerol);
39. Gelatin
(
Edible gelatin);
40. Pektin
(
Pectins);
41. Esther glycerol wood resin
(Glycerol ester of wood rosin);
42. Dinatrium diphosphate
(
Disodium diphosphate);
43. Trinatrium diphosphate
(
Trisodium diphosphate);
44. Tetrandium diphosphate
(
Tetrasodium diphosphate);
45. Tetrakalium diphosphate
(
Tetrapotassium diphosphate);
46. Dikalcium diphosphate
(Dicalcium diphosphate);
47. Natrium tripolyphosphate (
Sodium tripolyphosphate);
48. Kalium tripolyphosphate (
Potassium tripolyphosphate);
49. Natrium polyphosphate
(
Sodium polyphosphate);
50. Kalium polyphosphate (
Potassium polyphosphate);
51. Natrium calcium polyphosphate
(
Sodium calcium polyphosphate);
52. Calcium polyphosphate
(
Calcium polyphosphates);
53. Alfa-Siklodekstrin (a
lpha-Cyclodextrin);
54. Gama-Siklodekstrin (g
amma-Cyclodextrin);
55. Selulosa microcrystalline
(
Microcrystalline cellulose);
56. Selulosa powder
(
Powdered cellulose);
57. Metil cellulose
(
Methyl cellulose);
58. Hydroxypropill cellulose
(
Hydroxypropyl cellulose);
59. Hydroxypropill methyl cellulose
(
Hydroxypropyl methyl cellulose);
60. Etil methyl cellulose
(
Methyl ethyl cellulose);
61. Natrium carboxymethyl cellulose
(
Sodium carboxymethyl cellulose);
62. Natrium kroskarmelos (
Croscarmellose sodium);
63. Natrium carboxymethyl cellulose hydrolysa enzyme (Sodium carboxymethyl cellulose, enzyme matically hydrolysed);
64. Miristat acid, palmitate and stearate and its salts (calcium, potassium and sodium (Ca, K, Na)) (Myristic, palmitic & stearic acids and their calcium, potassium and sodium (Ca, K, Na) salts);
65. Garam-salt of oleic acid with calcium, potassium and sodium (Ca, K, Na) (Salts of oleic acid with calcium, potassium, and sodium (Ca, K, Na));
66. Mono and diglycerides fatty acids (Mono-and di-glycerides of fatty acids);
67. Esther fatty acids and acetates of glycerol (Acetic and fatty acid esters of glycerol);
68. Esther fatty acids and lactates of glycerol (Lactic and fatty acid esters of glycerol);
69. Esther fatty acids and citrates of glycerol (Citric and fatty acid esters of glycerol);
70. Esther fatty acids and diacetytartrates of glycerol (Diacetyltartaric and fatty acid esters of glycerol);
71. Esther polyglycerol of interesterified risinoleic acid (Polyglycerol esters of interesterified ricinoleic acid);
72.
Natrium carbonate (
Sodium carbonate);
73. Natrium hydrogen carbonate (
Sodium hydrogen carbonate);
74.
Kalium carbonate
(
Potassium carbonate);
75. Kalium hydrogen carbonate
(
Potassium hydrogen carbonate);
76.
Amonium carbonate
(
Ammonium carbonate);
77. Ammonium hydrogen carbonate
(
Ammonium hydrogen carbonate);
78.
Kalium chloride
(
Potassium chloride);
79. Calcium chloride
(
Calcium chloride);
80. Calcium sulfate
(
Calcium sulphate);
81. Kalium hydroxide
(
Potassium hydroxide);
82. Calcium hydroxide
(
Calcium hydroxide);
83. Magnesium hydroxide
(
Magnesium hydroxide);
84. Night
(
Beeswax);
85. Papain
(
Papain);
86. Bromelain (
Bromelain);
87. Polidekstrosa
(
Polydextroses);
88. Decstrin
(
Dextrins);
89. Pati modified acid
(
Acid treated starch);
90. The basic modification Pati (
Alkaline treated starch);
91. Pati pale
(
Bleached starch);
92. Pati oxidation
(
Oxidized starch);
93. Pati modified enzyme
(
Enzymed treated starch);
94. Monopathy phosphate
(
Mono starch phosphate);
95. Dipati phosphate (
Distarch phosphate);
96. Fosfat dipati phosphate
(
Phosphated distarch phosphate);
97. Dipati phosphate teracetylated
(
Acetylated distrarch phosphate);
98. Pati acetate
(
Starch acetate);
99. Dipati adipat teracetylated
(
Acetylated distarch adipate);
100. Hydroxypropyl starch
(
Hydroxypropyl starch);
101. Hydroxypropyl dipati phosphate
(
Hydroxypropyl distarch phosphate);
102. Starch sodium octenylsuccinate
(
Starch sodium octenyl succinate);
103. Asetil starch oxidation
(
Acetylated oxidized starch); and
104. Sodium kaseinate (
Sodium caseinate).
Section 4
Maximum limit use of BTP Penstable as referred to in Article 3 for each Food Category as set forth in Appendix I which is an inseparable part of this Regulation.
BAB IV
STABILISED BTP USE
Section 5
(1) The use of Penstable BTP is attested with a quantitative analysis certificate.
(2) Excluded from the provisions as referred to in paragraph (1), for the use of BTP in the Food Category with the Maximum Boundary of CPPB is evidenced by a qualitative analysis certificate.
(3) The type of Penstable BTP that cannot be analyzed, the Maximum Limit is calculated based on the addition of the Penstable BTP used in food.
Section 6
(1) The Penstable BTP can be used singly or mixed.
(2) In terms of BTP the Stable is used in a mixture as referred to in paragraph (1), the calculation of the results for each BTP with the Maximum Limit of its use if it is summed up should not be more than 1 (one).
(3) Example the calculation of the results for as referred to in paragraph (2) as set forth in Annex III which is an inseparable part of this Regulation.
(4) Excluded from the provisions as referred to in paragraph (2) for the use of BTP in the Food Category with CPPB Maximum Boundary.
Section 7
(1) The type and limit of the BTP Stabilised Stable (carry over) follows the terms of the type and the Maximum Limits of BTP as set forth in Annex I as referred to in Section 4.
(2) In terms of the BTP Stable Ikutan as referred to in paragraph (1) not listed in Annex I, then must first get the written consent of the Head of the Agency.
(3) To obtain the consent as referred to in paragraph (2), the applicant must submit a written request to the Head of the Board with the completeness of the data using the form as set forth in Annex II which It's an inseparable part of this rule.
(4) The decision of the consent/rejection of the Head of the Agency is given the longest 6 (six) months since the acceptance of the application is complete.
Section 8
(1) The type and use of Penstable BTP other than those listed in Annex I may only be used as BTP Penstable after it gets written approval from the Head of the Agency.
(2) To obtain the consent as referred to in paragraph (1), the applicant must submit a written request to the Head of the Board with the completeness of the data using the form as set forth in Annex II which It's an inseparable part of this rule.
(3) The decision of the consent/rejection of the Head of the Agency is given the longest 6 (six) months since the acceptance of the application is complete.
BAB V
The RUN
Section 9
Is prohibited from using the Penstable BTP as referred to in Appendix I for the purpose:
a. hide the use of materials that do not meet the requirements;
B. hiding the way of work that is contrary to the way food production is good for food; and/or
c. hide food damage.
BAB VI
THE SANCTION
Section 10
The violation of the provisions in this Regulation may be subject to administrative sanction:
a. warning in writing;
B. prohibition of circulate for a temporary time and/or order for the recall of the circulation;
c. extermination command, if proven not to meet security or quality requirements; and/or
D. revocation of edar clearance.
BAB VII
THE TRANSITION PROVISION
Section 11
(1) Stable BTP and Food Stability (BTP) contain Penstable BTP which has had the approval of the registration must conform to the provisions in this Regulation the longest of 1 (one) years since the promulgations of this Regulation.
(2) Penstable and Food BTP (BTP) Supplies contain Penstable BTP which are being submitted for extension of the registration agreement prior to the implementation of this Regulation, remaining processed under the Regulation of the Minister of Health Number 722 /Menkes/Per/IX/1988 on Food Additional Materials as amended by Health Minister Regulation Number 1168 /Menkes/Per/Per/X/1999 with the terms of the terms of the registration of the registration letter for the term 1 (one) year since This is the rule of the law.
BAB VIII
CLOSING PROVISIONS
Section 12
These rules begin to apply on the date of promulgations.
So that everyone is aware of ordering the invitational of this Regulation by placing it in the State News of the Republic of Indonesia.
Specified in Jakarta
on May 6, 2013
THE HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND FOOD SUPERVISORS,
LUCKY S. SLAMET
It is promulred in Jakarta
at the date of
MINISTER OF LAW AND HUMAN RIGHTS OF THE REPUBLIC OF INDONESIA,
AMIR SYAMSUDIN
Attachment:
bn679-2013
