Regulation of the Minister of Health No. 722/Menkes/Per/IX/1988 on Food Additives

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA REGULATION NO. 722/MENKES/PER/IX/88 ON FOOD ADDITIVES THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Attachment Attachment (Indonesian, pdf, I, V) Considering :  a. that food containing additive which is not in compliance with the regulation can affect the health of consumers;  b. that the consumers need to be protected from food containing additive which does not conform to the health standard;  c. that the Regulation of the Minister of Health No. 235/MenKes/Per/VI/79 on Food additives; the Regulation of the Minister of Health No. 237/MenKes/Per/VI/79 on Revision of Compulsory Food Registration and the Regulation of the Minister of Health No. 238/MenKes/SK/VI/79 on the Requirement for each imported food additive to be accompanied by Certificate of Analysis, have not been sufficient anymore to meet the needs arising from science and technology development, so that they need to be rearranged;  d. that based on the above considerations, the amendment of the Regulation of the Minister of Health of the Republic of Indonesia on Food Additives must be promulgated. In view of :  1. Law No. 9/1960 on Basic Health (State Gazette of the Republic of Indonesia No. 131, 1960, supplement to the State Gazette of the Republic of Indonesia No. 2068);  2. Law No. 10/1961 on Goods (State Gazette of the Republic of Indonesia No. 215, 1961, Supplement to the State Gazette of the Republic of Indonesia No. 2210); http://rulebook-jica.ekon.go.id/english/70.772-88.eng.qc.html#a http://rulebook-jica.ekon.go.id/pdfs/070 722 MENKES PER IX 1988 i Lamp1&5.pdf  3. Law No. 11/1962 on Hygiene for Public Enterprises (State Gazette of the Republic of Indonesia No. 48, 1962, Supplement to the State Gazette of the Republic of Indonesia No. 2475);  4. Law No. 8/1981 on Civil Law (State Gazette of the Republic of Indonesia No. 76, 1981, Supplement to the State Gazette of the Republic of Indonesia No. 3209);  5. Ordinance on Hazardous Substances (Stbl. 1949 No. 377);  6. The Regulation of the Minister of Health of the Republic of Indonesia No. 329/MenKes/Per/XII/76 on Food Production and Distribution;  7. The Regulation of the Minister of Health of the Republic of Indonesia No. 330/MenKes/Per/XII/76 on Compulsory Food Registration;  8. The Regulation of the Minister of Health of the Republic of Indonesia No. 79/Menkes/Per/III/78 on Food Labelling and Advertising;  9. The Regulation of the Minister of Health of the Republic of Indonesia No. 558/Menkes/SK/84 on The Organization Structure and The Work Procedures of the Ministry of Health;  10. The Regulation of the Minister of Health of the Republic of Indonesia No. 239/Menkes/Per/85 on Certain Colouring Agent Stated as a Hazardous Substance. DECIDES To Promulgate : THE REGULATION OF THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA ON FOOD ADDITIVES CHAPTER I GENERAL PROVISION Article 1 For the purpose of the Regulation :  1. Food Additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional additional of which to food for a technological (including organoleptic) purpose in the manufacture, processing, for the manufacturer or food industry;  4. Certificate of Analysis means a report as a result of an analytical test of a product which issued by an analytical laboratory recognized by the Ministry of Health or a producer of imported product;  5. Antioxidant means a food additive which can prevent or delay oxidation;  6. Anti-caking agent means a food additive which can prevent caking and/or to provide a free flowing product;  7. Acidity regulator means a food additive which can acuidify neutralize and maintain the acidity of food;  8. Artificial sweetener means a food additive which can impart sweet taste in food, that has or nearly has no nutritional value;  9. Flour bleaching and maturing agent (flour improver) means a food additive which can speed up the process of flour whitening and maturing so that it can improve the baking properties;  10. Emulsifier, stabilizer and thickener means a food additive which can assit in forming or stabilizing the homogenous dispersion system of food;  11. Preservative means a food additive which is capable of slowing or stopping the processes of fermentation, acidification or other deterioration of food by hindering the development of microorganism;  12. Firming agent means substance added to precipitate recidual pectin, thus strengthening the supporting tissue and preventing its collapse during processing;  13. Colour means a food additive which can improve or impart colour to the food;  14. Flavour and flavour enhancer means substances added to impart or help impart a taste or aroma in food;  15. Sequestrant means substances which combine with polyvalent metal ions to form a soluble metal complex, to improve the quality and stability of products. CHAPTER II PERMITTED FOOD ADDITIVES Article 2 1. Permitted food additive with its permitted maximum limit of usage in specified food is determined as stated in the Attachment I which is inseparated from this Regulation; 2. Food Additives other than specified in paragraph (1), can only be used as food additives after prior approval of the Director General of Drug and Food Control based on the evaluation specified in article 5. CHAPTER III PROHIBITED FOOD ADDITIVES Article 3 1. Additives which prohibited to be used as food additives have been laid down as stated in Attachment II which is inseparated from this Regulation; 2. In addition to additives specified in paragraph (1), colours prohibited to be used as food additives. Are laid down in the Regulation of the Minister of Health of the Republic of Indonesia on Certain Colouring Agent Stated as a Hazardous Substance. Article 4 1. Additive specified in article 3 paragraph (1) is stated as a hazardous substance when used in food; 2. Food containing the additives specified in article 3 is considered as a hazardous food. CHAPTER IV PRODUCTION, IMPORTATION AND DISTRIBUTION Article 5 Food Additives other than listed in the Attachment I when used as food additive, can only be produced, imported or distributed after having been evaluated by the Directorate General of Drug and Food Control. Article 6 Food Additives which are produced, imported or distributed shall conform to the requirements stated in the Indonesian Food Codex on Food Additives or other requirements which are determined by the Minister of Health. Article 7 Producers who produced food additives shall be registered with the Directorate General of Drug and Food Control. Article 8 Certain Food Additives which decided by the Director General of Drug and Food Control shall be registered with the Directorate General of Drug and Food Control. Article 9 Food Additives importer shall report in writing, as soon as possible to the Director General of Drug and Food Control regarding imported food additives after the arrival of the mentioned food additive at the harbour. Article 10 Imported Food Additives shall be accompanied by a certificate of analysis from the producer in the country of origin. Article 11 Imported Food Additives can only be distributed when the Certificate of Analysis specified in article 10 approved by the Director General of Drug and Food Control. Article 12 The Director General of Drug and Food Control will determine the evaluation procedure specified in article 5, the registration procedure specified in article 7 and 8, the reporting procedure specified in article 9, and provision regarding Certificate of Analysis specified in article 10. Article 13 (1) The package of food additive shall be labelled. (2) The label of food additive shall comply with the Regulation of the Minister of Health of the Republic of Indonesia on Food Labelling and Advertising. (3) In addition to the provision in paragraph (2) of this article, the label of food additives shall also contain the following :  a. Words : "Bahan Tambahan Makanan" or "Food Additive";  b. The name of food additive, and index number for colour;  c. The class title of the food additive;  d. Registration number of producer;  e. Registration number of the product, for food additive which shall be registered. (4) In addition to the provisions in paragraph (2) and (3) of this article, the label of the food additives in retail package shall also contain the instruction for use. Article 14 In addition to the provisions of article 13 the Director General of Drug and Food Control will decide that label of specified food additive, shall comply with particular provision. Article 15 (1) The label of food containing food additive, shall contain the class title of the food additive. (2) In addition to the provision in paragraph (1) of this article, the label of the food containing food additives, such as antioxidant, artificial sweetener, preservative, colour or flavour enhancer shall also contain the name of the food additive, and index number for colour. Article 16 In addition to the provision in article 15, the Director General of Drug and Food Control will decide that the label of food containing a certain food additive, shall comply with particular provision. CHAPTER V PROHIBITION Article 17 It is prohibited to use food additive specified in article 2 if :  a. it is used to camouflage poor quality or adulterated materials;  b. it is used to disguise the use of processing technique which are contrary to GMP (Good Manufacturing Practice);  c. it is used to camouflage deterioration of the food. Article 18 It is prohibited to produce, import or distribute food additive specified in article 2 paragraph (2) as food additive without prior approval of the Director General of Drug and Food Control. Article 19 It is prohibited to produce, import, distribute or use additive specified in article 3 as food additives. Article 20 It is prohibited to produce, import or distribute food specified in article 4 paragraph (2) and food additive which has not been evaluated by the Director General of Drug and Food Control specified in article 5. Article 21 It is prohibited to produce, import or distribute food additive which is not in comformity with the requirement specified in article 6. Article 22 It is prohibited to distribute food additive produced by producer who is not registered specified in article 7. Article 23 It is prohibited ro distribute certain food additive specified in article 8 which is not registered with the Directorate General of Drug and Food Control. Article 24 It is prohibited to distribute food additive specified in article 11 before its Certificate of Analysis approved by Director General of Drug and Food Control. Article 25 It is prohibited to distribute food and food additive which is not complying with the label provision. Article 26 It is prohibited to use additive in excess of the maximum limit of usage which has been permitted for each kind of food. CHAPTER VI AUTHORITY Article 27 The Director General of Drug and Food Control or the officer assigned by him has the authority to control the implementation of this Regulation. CHAPTER VII SANCTION Article 28 Notwithstanding stipulations of the Penal Code, any violation of article 19 and 20 shall be liable to sanction based on article 2 paragraph (1) of the Ordinance on Hazardous Substances. Article 29 Violation of other provisions in this Regulation shall be liable to administrative sanction and or other sanction based on the existing laws. CHAPTER VIII TRANSITIONAL PROVISION Article 30 (1) The company which has been produced or imported food additives or food containing food additive at the time of issuance of this Regulation, is given 6 months time to comply with this Regulation; (2) Food containing food additive which has been in distribution shall be allowed to be sold for a period of 1 (one) year after this Regulation comes into force. CHAPTER IX CLOSING PROVISION Article 31 As of this Regulation comes inti force, the following Regulations are hereby revoked :  1. The Regulation of the Minister of Health of the Republic of Indonesia No. 235/Menkes/Per/VI/79 on Food additives;  2. The Regulation of the Minister of Health of the Republic of Indonesia No. 237/Menkes/Per/VI/79 on the Amandement of the Compulsory Food Registration;  3. The Regulation of the Minister of Health of the Republic of Indonesia No. 238/Menkes/SK/VI/79 on the Requirement for each Imported Food Additives to be accompanied by the Certificate of Analysis. Article 32 Technical matters which are not sufficiently arranged in this Regulation, will be further regulated by the Director General of Drug and Food Control. Article 33 This Regulation shall come into force as from the date of its enactment. For public cognizance, this Regulation shall be published in the State Gazette of the Republic of Indonesia. Stipulated in Jakarta On September 20, 1988 THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA Sgn, DR. ADHYATMA, MPH Attachment I Food Additives Permitted for Use in Food (Regulation of the Minister of Health of Republic of Indonesia No. 722/Menkes/Per/IX/88 on Food Additives) 1. Functional classes of Food Additives permitted for use in food are as follows :  1. Antioxidant;  2. Anticaking Agent;  3. Acidity Regulator;  4. Artificial Sweetener;  5. Flour Treatment Agent;  6. Emulsifier, Stabilizer, Thickener;  7. Preservative;  8. Firming Agent;  9. Colour;  10. Flavour, Flavour Enhancer;  11. Sequestrant. 2. Where more than one antioxidant is added to afood, the sum of the fraction obtained by dividing the quantity of each antioxidant used bay maximum quantity of such antioxidant permitted to be present if used alone, shall not exceed unity. 3. Where more than one preservative is added to a food, the sum of the fraction obtained by dividing the quantity of such preservative permitted to be present if used alone, shall not exceed unity. 4. Good Manufacturing Practice means that :  a. the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical, nutritional or other technical effect in food  b. the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of afood and which is not intended to accomplish any physical, or other technological effect in the food itself, is reduced to the extent reasonably possible;  c. the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. 5. For preservative, maximum level of use of salt of benzoic acid shall be calculated as benzoic acid; salt of sorbic acid shall be calculated as sorbic acid and sulphites compounds shall be calculated as SO2.