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REGULATION OF THE HEAD OF DRUG AND FOOD SUPERVISORY AGENCY
No. HK.00.05.23.1455

CONCERNING
SUPERVISION ON THE ENTRY OF PROCESSED FOOD

BY THE GRACE OF ALMIGHTY GOD
HEAD OF DRUG AND FOOD SUPERVISORY AGENCY,

Considering:

that in the framework to implement the provisions in Article 40 of Government Regulation No. 28/2004 concerning Food Safety, Quality and Nutrition, it is necessary to stipulate Regulation of the Head of the Drug and Food Supervisory Agency concerning Supervision on the Entry of Processed Food;

In view of:

1. Government Regulation No. 28/2004 concerning Food Safety, Quality and Nutrition (Statute Book No. 107/2004, Supplement to Statute Book No. 4244);

2. Presidential Decree No. 103/2001 concerning Position, Duties, Authorities and Organizational Structure of Non Ministerial Government Agency, as amended several times, the latest by Presidential Regulation No. 64/2005;

3. Presidential Decree No. 110/2001 concerning Organization Unit and Task of Echelon I of Non Ministerial Government Agency, as amended several times, the latest by Presidential Decree No. 52/2005;

4. Regulation of the Minister of Health No. 329/Menkes/Per/XII/76 concerning Food Production and Distribution;

5. Regulation of the Minister of Health No. 826/Menkes/Per/XII/1987 concerning Irradiation Food;

6. Regulation of the Minister of Health No. 722/Menkes/Per/IX/88 concerning Food Additives Substances;

7. Decree of the Head of Drug and Food Supervisory Agency No. 02001/SK/KBPOM/2001 concerning the Organization and Work Flow of Drug and Food Supervisory Agency, as amended by Decree of the Head of Drug and Food Supervisory Agency No. HK.00.05.21.4231 of 2004;

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF DRUG AND FOOD SUPERVISORY AGENCY CONCERNING SUPERVISION ON THE ENTRY OF PROCESSED FOOD

CHAPTER I
GENERAL PROVISIONS

Article 1

In this regulation:

1. Food is anything that comes from biological sources and water, whether processed or unprocessed, which is applied as a food or beverage for human consumption, including food additives substances, food raw materials, and other substances used in the preparation, processing and or manufacture of food or beverage.

2. Processed food is food and or beverage result of processing by specified means or methods with or without additional substances.

3. Food Safety is the condition and the effort needed to prevent food from possible contamination of biological, chemical, and other objects that may interfere, harm, and dangerous for human health.

4. Letter of approval for registration is the letter of approval for registration of food that is issued by the Head of the Drug and Food and Supervisory Agency to be distributed in the territory of Indonesia.

5. Importation of food is the importation of food by land, sea, and air into the territory of Indonesia.

6. Each person is an individual or business entity, whether incorporated or not.

7. Head of Agency is the Head of Drug and Food Supervisory Agency of the Republic of Indonesia.

CHAPTER II
IMPORTATION OF PROCESSED FOOD

Article 2

Every person who imports the processed food into territory of Indonesia has responsible for the safety, quality, and nutrition of processed food.

Article 3

(1) Processed food that is imported into the territory of Indonesia must comply with legislation.

(2) In addition to meeting the provision as intended in paragraph (1) must obtain approval from the Head of Agency.

(3) The provision as intended in paragraph (1) and paragraph (2) shall also apply to the entry of raw materials, food additives substances, auxiliary materials, food ingredients, and other substances.

CHAPTER III
REQUIREMENTS

Article 4

Processed food that is imported into the territory of Indonesia must meet the following requirements:

Article 5

(1) In addition to the requirements as intended in Article 4, any processed food that is imported into the territory of Indonesia to be traded in retail packages are required to have registration approval letter from the Head of the Agency.

(2) Exempted from the provision as intended in paragraph (1) of processed food in retail packaging that:

Article 6

(1) The approval as intended in Article 3 paragraph (2), is given to applicants who import processed food into the territory of Indonesia.

(2) The application shall be submitted in writing to the Head of the Agency to pay the appropriate fee according to provisions.

(3) Each application is only valid for 1 (once) import (per shipment).

CHAPTER IV
SUPERVISION

Article 7

Supervision on the implementation of the provisions of this regulation is conducted by the Drug and Food Supervisory Agency.

CHAPTER V
SANCTIONS

Article 8

(1) Violation of the provisions in this regulation may be subject to administrative and or criminal sanctions in accordance with statutory regulations.

(2) The administrative sanctions as intended in paragraph (1) are:

CHAPTER VI
TRANSITIONAL PROVISION

Article 9

With the enforcement of this regulation, all provisions of legislation relating to the importing of processed food, raw materials, food additives substances, auxiliary materials, food ingredients, and other materials that have been there still remain valid as long as not contrary to and or have not been replaced based on this regulation.

CHAPTER VII
CLOSING PROVISION

Article 10

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

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

Stipulated in Jakarta
On March 24, 2008
HEAD OF DRUG AND FOOD SUPERVISORY AGENCY
signed,
Dr. HUSNIAH RUBIANA THAMRIN AKIB, MS, Mkes, SpFK