Regulations Of The Food And Drug Supervisory Agency No. 14 Year 2013

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor 14 Tahun 2013

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Read the untranslated law here: http://peraturan.go.id/inc/view/11e44c50ad826ae0a181313233303132.html

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Back NEWS REPUBLIC of INDONESIA No. 553, 2013 FOOD and DRUG SUPERVISORY AGENCY. Addictives. The propellant. The Maximum Limit.
REGULATION of the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the REPUBLIC of INDONESIA number 14 YEAR 2013 ABOUT MAXIMUM LIMIT USE of ADDICTIVES PROPELLANT with the GRACE of GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: that in order to implement the provisions of article 4 paragraph (2) and article 5 paragraph (2) of the regulation of the Minister of health the number 033 in 2012 about Food Additives have to set rules of the head of the food and drug Watchdog Agency about the limits of maximum use of Addictives Propellant;
Remember: 1. Act No. 8 of 1999 on the protection of the consumer (State Gazette of the Republic of Indonesia Number 42 in 1999, an additional Sheet of the Republic of Indonesia Number 3821);
2. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia Number 144 in 2009, an additional Sheet of the Republic of Indonesia Number 5063);
3. Law number 18 in 2012 about Food (Gazette of the Republic of Indonesia Number 227 by 2012, an additional Sheet of the Republic of Indonesia Number 5360);
4. Government Regulation Number 69 in 1999 about labeling and advertising of food (Gazette of the Republic of Indonesia year 1999 Number 131, an additional Sheet of the Republic of Indonesia Number 3867);
5. Government Regulation Number 28 in 2004 about the safety, quality and nutrition of the food (the State Gazette of the Republic of Indonesia Number 107 in 2004, an additional Sheet of the Republic of Indonesia Number 4384);
6. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities, Organization, Arrangement and Layout of Non Government agencies Work Department as it has several times changed the last presidential Regulation No. 3 by 2013;
7. Presidential Decree Number 110 in 2001 about the Task and Organizational Unit Echelons of Non Government agencies I Department as it has several times changed the last presidential Regulation number 4 by 2013;
8. Regulation of the Minister of health the number 033 in 2012 about Food Additives (news of the Republic of Indonesia year 2012 Number 757);
9. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM 2001 about the Organization and the Work of drug and food Supervisory Agency as amended by decision of the head of the food and drug Watchdog Agency the number of HK. 00.05.21.4231 2004;
DECIDED: setting: RULE the HEAD of FOOD and DRUG WATCHDOG AGENCY ABOUT the LIMITS of MAXIMUM USE of ADDICTIVES PROPELLANT.
CHAPTER I GENERAL PROVISIONS article 1 In this regulation, the definition of: 1. the Food is everything derived from biological sources of agricultural products, forestry, forestry, fisheries, animal husbandry, aquatic, and water, whether processed or not processed are intended as food or drink for human consumption, including food additives, food, raw materials and other materials used in the Setup process , processing and/or manufacture of food or drink.
2. Food Additives, hereinafter abbreviated BTP, is added to food to affect the nature or form of the food.
3. The name or type of BTP BTP BTP type, hereafter, was the name of a chemical/generic/common/uncommon identities used for food additives in Indonesia or in the language of United Kingdom.
4. The propellant (the craft) is a form of food additives of the gas to push the food out of the packaging.
5. Material of BTP are addictives are packed and labelled in sizes appropriate for the consumer.
6. the acceptable daily intake or Acceptable Daily Intake, hereinafter abbreviated to ADI, is the maximum amount of food additives in milligrams per kilogram of body weight which can be consumed every day for life without causing adverse effects on health.
7. ADI is not stated or ADI not specified/ADI not limited/ADI acceptable/no ADI Allocated/no ADI necessary is the term used for food additives that have a very low toxicity, based on the data (chemistry, biochemistry, toxicology and other data), the amount of intake of these food additives if used in the measure necessary to achieve the desired effect as well as other considerations, according to the opinion of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) poses no danger on health.
8. Maximum limit is the maximum number of allowed BTP found on food in units specified.
9. Maximum limit How a good food production or Good Manufacturing Practice, hereinafter referred to as CPPB, maximum limit is the amount of allowed BTP found on the amounts of food to taste as needed to produce the desired effect.
10. BTP Followup (Carry over) is the BTP which comes from all raw materials either blended or packaged separately but still a single unit of the product.
11. Food food is a grouping of Categories based on the type of food.
12. The head of the Agency is the head of the Agency's tasks and their responsibilities in the field of supervision of food and drug.
CHAPTER II SCOPE article 2 BTP (1) BTP are not meant to be consumed directly and/or is not treated as food raw materials.
(2) the BTP can have or have no nutritional value, which are intentionally added to food for a technological purpose in the manufacture, processing, treatment, packing, packaging, storage and/or transporting food to produce or are expected to generate a component or affect the nature of the food, either directly or indirectly.
(3) the BTP did not include materials or impurities added to food to preserve or enhance nutritional value.
CHAPTER III the TYPES and MAXIMUM LIMIT BTP BTP Type article 3 PROPELLANT Propellant is allowed to use in food consists of: 1. Nitrogen (Nitrogen);

2. Dinitrogen monoxide (Dinitrogen monoxide); and 3. Propane (Propane).

Article 4 maximum limit use of BTP Propellant as referred to in article 3 for each Food Category as listed in Annex I which is part an integral part of this regulation.

CHAPTER IV USE of BTP PROPELLANT article 5 (1) the use of the BTP Propellant is evidenced by the certificate in quantitative analysis.
(2) are excluded from the provisions referred to in subsection (1), for the use of the BTP on Food Category with maximum limit CPPB evidenced by a certificate of analysis is qualitative.
(3) types of BTP Propellant that can not be analyzed, the maximum limit is calculated based on the addition of the BTP Propellant used in food.
Article 6 (1) of the BTP Propellant can be used singly or in mixtures.
(2) in case of BTP Propellant used in a mixture as referred to in paragraph (1), the calculation of the results for each of the BTP with maximum limit its use if aggregated should not be more than 1 (one).
(3) example calculation the quotient as referred to in paragraph (2) as listed in Annex III which is part an integral part of this regulation.
(4) excluded from the provisions referred to in subsection (2) for the use of the BTP on Food Category with maximum limit CPPB.
Article 7 (1) the type and Maximum Followup Propellant BTP (carry over) the following provisions of the type and maximum limit BTP as listed on Appendix I as referred to in article 4.
(2) in case of BTP Propellant Followup as referred to in paragraph (1) are not listed in Annex I, then it should first get written approval from the head of the Agency.
(3) for approval as referred to in paragraph (2), the applicant must apply in writing to the head of the Agency accompanied the completeness of data by using form as contained in annex II that is part an integral part of this regulation.
(4) the decision of the approval/rejection from the head of the Agency was given the longest 6 (six) months from the receipt of the complete application.
Article 8 (1) the type and use of the BTP Propellant in addition to those listed in Appendix I should only be used as BTP Propellant after obtaining written consent of the head of the Agency.
(2) for approval as referred to in paragraph (1), the applicant must apply in writing to the head of the Agency accompanied the completeness of data by using form as contained in annex II that is part an integral part of this regulation.
(3) the decision of the approval/rejection from the head of the Agency was given the longest 6 (six) months from the receipt of the complete application.
Chapter V RESTRICTIONS article 9 Prohibited use BTP Propellant as referred to in Annex I for the purpose of: a. hide the use of materials that do not meet the requirements;

b. hide the workings that are contrary to the way a good food production to food; and/or c. hide the damage the food.

CHAPTER VI SANCTIONS article 10 breach of the provisions of this Regulation may be subject to administrative sanction in the form of: a. a written warning;

b. Prohibition of passing for a time and/or the order to withdrawal from circulation;

c. orders the destruction, if proven to not meet the security requirements or quality; and/or d. revocation order.

CHAPTER VII TRANSITIONAL PROVISIONS article 11 (1) Preparations and food containing Propellant BTP BTP Propellant that has had the registration agreement should comply with the provisions of this rule of not longer than one (1) year of the promulgation of these regulations.

(2) Preparations and food containing Propellant BTP BTP Propellant that is being filed the petition for extension of approval of the registration prior to the enactment of these regulations, the processed remains based on the regulation of the Minister of health the number 717/Menkes/Per/IX/1988 on food additive as amended by regulation of the Minister of health Number 1168/Menkes/Per/X/1999 with the provisions of the registration agreement will be valid for a period of one (1) year of the promulgation of these regulations.
CHAPTER VIII PROVISIONS COVER article 12 this Regulation comes into force on the date of promulgation.

In order to make everyone aware of it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia.

Established in Jakarta on April 1, 2013, HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the REPUBLIC of INDONESIA, LUCKY s. SLAMET Enacted in Jakarta on April 5, 2013 the MINISTER of LAW and HUMAN RIGHTS REPUBLIC of INDONESIA, AMIR SYAMSUDDIN Attachment: bn553-2013lamp fnFooter ();