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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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STATE NEWS
REPUBLIC OF INDONESIA

No. 553, 2013 THE SUPERVISORS OF THE DRUG AND THE FOOD. Food Supplement. Slow down. Maximum Limit.

REGULATION OF THE HEAD OF THE REPUBLIC OF INDONESIA ' S MEDICINE AND FOOD SUPERVISORS
Number 14 YEAR 2013
ABOUT
MAXIMUM USE LIMIT
PROPELLANT FOOD ADDERS
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 Use of Propellant Food Enhancements;

Given: 1.   Law No. 8 Year 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 Decision of Head of the HK Drug and Drug Administration Board. 00.05.21.4231 Year 2004;

DECIDED:

specify: The REGULATION OF THE HEAD OF THE DRUG AND FOOD SUPERVISORS IS ABOUT THE MAXIMUM LIMIT OF THE USE OF ADDITIONAL INGREDIENTS OF FOOD PROPELLANT.

BAB I
UMUM CONDITIONS
Section 1
In this Regulation, which is referred to:
1. Food is everything that comes from the natural resources of agricultural products, plantations, forestry, fisheries, farms, water, water, and water, whether or not treated as food or drink for consumption. human, including food adders, food raw materials, and other materials used in the process of preparation, processing, and/or making food or drink.
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. Propellant (Propellant) is a food addlant for gas to drive food out of packaging.
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. Maximum limit is the maximum number of BTP allowed to be present in food in the specified unit.
9. Maximum Boundary Way of Good Food Production or Good Manufacturing Practice, further called 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.
Ten. BTP Ikutan (Carry over) is a BTP derived from all the raw materials that are mixed and packaged separately but are still a single product unit.
11. The Food category is a food grouping based on the type of food.
Twelve. The head of the Agency is the Head of the Agency whose duty and responsibility is in the area of supervision of medicine and food.

BAB II
BTP SCOPE ROOM
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 MAXIMUM TYPE AND LIMIT OF BTP PROPELLANT
Section 3
The type of BTP Propasting permitted use in food consists of:
1. Nitrogen (Nitrogen);
2. Dinitrogen monoxide (Dinitrogen monoxide); and
3. Propane (Propane).

Section 4
The maximum limit use of BTP Proslowing 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
USE OF BTP PROPELAN
Section 5
(1) The use of BTP Proslow is evidenced by 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) Non-analysed BTP types that cannot be analyzed, the Maximum Limit is calculated based on the addition of the Proslow BTP used in food.

Section 6
(1) BTP Proslowing can be used single or mixed.
(2) In terms of BTP ProSlow is used in a mixture as referred to in paragraph (1), the calculation of the results for each BTP with the Maximum Limits of its use if 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 BTP Proslow Ikutan (carry over) follow 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 regard to the BTP Proslowing 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 BTP Probations other than those listed in Annex I may only be used as BTP Proslow 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
Forbidden to use BTP Proslow as referred to in Appendix I for the purposes:
a. hide the use of materials that do not meet the requirements;
B. hide ways of working that are contrary to the way food production is good for food; and/or
c. hide food damage.

BAB VI
SANCTION
Section 10
A 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 the security or quality requirements; and/or
D. revocation of edar clearance.

BAB VII
TRANSITION PROVISIONS
Section 11
(1) The BTP Proslow and Foods Supplies contain BTP Proslowing 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) The BTP ProSlow and Food Supplies contain BTP ProSlow which is 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 go into effect on the date of the promulgations.

So that everyone knows it, ordering the invitational of this Regulation with its placement in the News of the Republic of Indonesia.

Specified in Jakarta
on April 1, 2013
THE HEAD OF THE DRUG AND FOOD SUPERVISORS
REPUBLIC OF INDONESIA,

LUCKY S. SLAMET

It is promulred in Jakarta
on 5 April 2013
MINISTER OF LAW AND HUMAN RIGHTS REPUBLIC OF INDONESIA,

AMIR SYAMSUDIN


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