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Regulations Of The Food And Drug Supervisory Agency No. 9 By 2013

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor 9 Tahun 2013

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(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 BTP Pengeras which cannot be analyzed, the Maximum Limit is calculated based on the addition of BTP Pengeras used in food.

Section 6
(1) BTP Pengeras can be used singly or mixed.
(2) In terms of BTP Pengeras 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 maximum extent of the BTP Service (carry over) follows the terms of the type and the Maximum Limits of the BTP as set forth in Appendix I as referred to in Section 4.
(2) In regard to the BTP Pengeras Ikutan as referred to in paragraph (1) is 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 Pengeras other than those listed in Annex I may only be used as BTP Pengeras after receiving 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
Prohibited using BTP Pengeras 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 of Eras And Foods contain BTP Pengeras which have had the registration consent must conform to the provisions in this Regulation the longest one of the year since the promulgations of this Regulation.
(2) The BTP of the Eras And Foods contain BTP Pengeras which are being submitted for extension of the registration agreement prior to the implementation of this Regulation, continue to be 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 the promulctest.

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 5, 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


Attachment:bn548-2013lamp 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
TYPE AND MAXIMUM BTP LOUDSPEAKER
Section 3
BTP types of speakers allowed in food consist of:
1. Calcium lactate (Calcium lactate);
2. Tricalcium citrate (Tricalcium citrate);
3. Kalium chloride (Potassium chloride);
4. Calcium chloride (Calcium chloride);
5. Calcium sulfate (Calcium sulphate); and
6. Calcium gluconate (Calcium gluconate)

Section 4
The maximum limit use of BTP Pengeras 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
BTP LOUDSPEAKER USAGE
Section 5
(1) The use of BTP Pengeras is attested with a quantitative analysis certificate.