REGULATION OF THE MINISTER OF HEALTH
No. 382/MENKES/PER/VI/1989

ON
THE REGISTRATION OF FOODS

MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA,

Considering :

In view of :

DECIDES :

To stipulate :

THE REGULATION OF THE MINISTER OF HEALTH ON THE REGISTRATION OF FOODS

CHAPTER I
GENERAL PROVISIONS

Article 1

Hereinafter referred to as :

CHAPTER II
REGISTRATION

Article 2

(1) Producers or importers shall be obligated to register the foods they produce or import.

(2) Producers or importers shall be obligated to guarantee the safety, quality and truth of labels of the foods they register.

Article 3

(1) The foods requiring registration shall be processed foods originating from domestic production as well as from imports which are distributed in retail and labelled packages.

(2) Processed foods originating from domestic production as meant in paragraph (1) shall be foods which are processed by companies.

(3) Processed foods originating from imports shall fulfil health requirements and other provisions in force.

Article 4

(1) Home industries which have followed extension programs shall register the foods they produce, covering:

(2) Home industries which have not yet followed extension programs shall register all the foods they produce.

(3) The extension programs for home industries of foods as meant in paragraphs (1) and (2) shall be realised according to the laws in force.

Article 5

(1) Foods exempted from the requirement for registration shall be :

(2) Processed foods which constitute a contribution as meant in paragraph (1) point c. shall bear clear signs on their containers or packages indicating that the said foods are meant as a contribution.

(3) Processed foods originating from imports in small quantities as meant In paragraph (1) point d. shall be only meant for :

Article 6

Companies intending to register processed foods shall possess the industrial licence or shall be already registered pursuant to the laws in force.

Article 7

Companies or home industries which register foods as meant in Article 3 and Article 4 shall be prepared to undergo inspection conducted by officers appointed by the Director General.

Article 8

(1) The registration of foods originating from domestic production as meant in Article 3 and Article 4 shall be done by the managers in charge.

(2) The registration of foods originating from imports as meant in Article 3 shall be done by the managers of importers, or representative offices of overseas factories appointed or authorised by the factories concerned.

Article 9

The personnel responsible for registration shall provide genuine information upon registering their foods.

Article 10

The registration of foods shall not be subject to fees in whatever forms.

Article 11

The procedure for registration shall be stipulated by the Director General.

CHAPTER III
APPROVAL OF REGISTRATION

Article 12

Approval of the registration of foods shall be granted by the Minister of Health in this case the Director General or authorised officials.

Article 13

(1) Based on the evaluation of the Director General or authorised officials, the following decision shall be determined:

(2) The decision on applications for registration as meant in paragraph (1) shall be issued not later than 3 (three) months starting from the receipt of such applications by the Director General by using the appropriate form according to Model M1, M2 or M3.

Article 14

The approval of registration as meant in Article 13 shall be valid for an indefinite period as long as the requirements imposed remain fulfilled.

Article 15

(1) The approval as meant in Article 14 shall stipulate the labels allowed to be used.

(2) The labels of registered foods in circulation shall be in line with and shall not deviate from the labels as meant in paragraph (1).

Article 16

(1) Foods which based on results of evaluation are given approval of registration shall be granted registration numbers.

(2) Registration numbers for domestic products shall bear the code MD and registration numbers for imports shall bear the code ML.

(j) Registration numbers shall be printed on labels of the foods concerned so as to be easily noticed.

Article 17

(1) Every 4 (four) years after obtaining registration numbers, applicants shall submit reports to the Director General or authorised officials by using the form according to model M4.

(2) Copies of the reports as meant in paragraph (1) shall be addressed to the Head of the Regional Office, Ministry of Health, and the Head of the Centre for Food and Drug Inspection concerned.

Article 18

(1) Registration number shall be revoked in the following cases :

(2) Registration numbers shall be cancelled in the following cases:

CHAPTER IV
RE-EVALUATION

Article 19

Foods which have obtained approval of registration can be subject to re-evaluation if based on developments of science and technology improper things are later found out.

CHAPTER V
SANCTIONS

Article 20

(1) Companies or importers violating Article 9 or Article 15 of this regulation, or producing or distributing foods which later turn out to endanger or adversely affect human health, shall withdraw the said foods from circulation and report its implementation to the Director General or authorised officials by using the form according to model M6.

(2) The sanction as meant in paragraph (1) shall be stipulated by the Director General by using the form ac cording to model M5.

(3) If within 2 (two) months producers or importers fail to carry out the sanctions as meant in Paragraph (1) they shall be subject to revocation of registration numbers of other punitive measures in line with the laws in force.

(4) The sanction as meant in paragraph (3) shall be stipulated by the Director General by using the form according to model M7.

(5) Decisions on the sanctions as referred to above shall be made public.

CHAPTER VI
TRANSACTIONAL PROVISIONS

Article 21

(1) Foods obtaining registration numbers before the enforcement of this regulation can still be distributed for 1 (one) year starting from the date of stipulation of this regulation.

(2) Producers or importers already possessing registration numbers shall make adjustments to this regulation within a maximum of 1 (one) year.

CHAPTER VII
CONCLUSION

Article 22

With the enforcement of this ministerial regulation, the Regulation of the Minister of Health No. 33/ Menkes/Per/XII/1976 on the obligation of food registration shall be declared null and void.

Article 23

Matters which are not yet stipulated in this regulation shall have further provisions laid down by the Director General.

Article 24

This regulation shall come into force as from the date of stipulation.

For public cognizance, this regulation shall be announced by publishing it in the State Gazette of the Republic of Indonesia.

Stipulated in Jakarta
On June 2, 1989

MINISTER OF HEALTH OF THE REPUBLIC INDONESIA
sgd.
Dr. ADHYATMA, MPH