to Indonesian

REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLER AGENCY
NUMBER HK.03.1.23.03.12.1564 OF 2012

CONCERNING
CONTROL ON THE LABELING OF GENETICALLY ENGINEEREED PRODUCTS OF FOOD

BY THE GRACE OF ALMIGHTY GOD
THE HEAD OF DRUG AND FOOD CONTROLER AGENCY OF THE REPUBLIC OF INDONESIA,

Considering:

a. that the public needs to be protected from genetically engineered food products that do not meet the requirements, safety, quality and nutrition;

b. that the public needs to be informed and not misled on the Genetically Engineered Products of Food through the information contained in the label;

c. that based on the considerations as intended in paragraphs a and b it is necessary to stipulate the Regulation of Head of National Agency of Drug and Food Controller concerning Control on the Labeling of Genetically Engineered Products of Food;

In view of:

1. Law Number 7 of 1996 concerning Food (Statute Book of the Republic of Indonesia Number 99 of 1996, Supplement to Statute Book of the Republic of Indonesia Number 3656);

2. Law Number 8 of 1999 concerning Consumer Protection (Statute Book of the Republic of Indonesia Number 42 of 1999, Supplement to Statute Book of the Republic of Indonesia Number 3821);

3. Law Number 21 of 2004 concerning Ratification of the Cartagena Protocol on Bio-safety to the Convention on Biological Diversity (Statute Book of the Republic of Indonesia Number 88 of 2004, Supplement to Statute Book of the Republic of Indonesia Number 4414);

4. Law Number 36 of 2009 concerning Health (Statute Book of the Republic of Indonesia Number 144 of 2009, Supplement to the Republic of Indonesia Number 5063);

5. Government Regulation Number 69 of 1999 concerning Food Label and Advertisement (Statute Book of the Republic of Indonesia Number 131 of 1999, Supplement to Statute Book of the Republic of Indonesia Number 3867);

6. Government Regulation Number 28 of 2004 concerning Food Safety, Quality and Nutrition (Statute Book of the Republic of Indonesia Number 107 of 2004, Supplement to Statute Book of the Republic of Indonesia Number 4424);

7. Government Regulation Number 21 of 2005 concerning Bio-safety of Genetically Engineered Products (Statute Book of the Republic of Indonesia Number 44 of 2005, Supplement to Statute Book of the Republic of Indonesia Number 4498);

8. Presidential Decree Number 103 of 2001 concerning Position, Duties, Function, Authority, Organizational Structure and Work Flow of Non Ministry Government Agencies as amended several times, the latest by Presidential Regulation Number 64 of 2005;

9. Presidential Decree Number 110 of 2001 concerning the Organizational Unit and Duties of First Echelon of Non Ministry Agencies, as amended several times the latest by Presidential Decree Number 52 of 2005;

10. Presidential Decree Number 39 of 2010 concerning the Bio-safety of Genetically Engineered Products Commission;

11. Decree of the Head of Drug and Food Controller Agency Number 02001/SK/KBPOM/2001 concerning the Organization and Work Flow of Drug and Food Controller Agency, as amended by the Decree of the Head of the Drug and Food Controller Agency Number HK.00.05.21.4231 of 2004;

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLLER AGENCY CONCERNING CONTROL ON THE LABELING OF GENETICALLY ENGINEEREED PRODUCTS OF FOOD.

CHAPTER I
GENERAL PROVISIONS

Article 1

In this Regulation what is referred as:

1. Food is anything that comes from biological sources and water, whether treated or untreated, which are intended as food or drink for human consumption, including food additives, food raw materials and other materials used in the preparation, processing, and or production of food or drink.

2. Processed Food is a food or beverage or a process result by specific means or methods, with or without additives.

3. Genetically Engineered Products or modified organisms hereinafter abbreviated as PRG is a living organism, the parts and/or process products that have the new genetic structure of the results of the application of modern biotechnology.

4. PRG Food is a food produced by using raw materials, food additives, and/or other materials resulting from the genetically engineered process.

5. Food Label is any information on the food in the form of images, text, a combination of both, or other forms that is included on the food, put in, attached to, or part of food packaging.

6. Head of Agency is the Head of the Non Ministry Government Agency who has duties and responsibilities in the field of drug and food supervision.

CHAPTER II
SCOPE

Article 2

(1) This Regulation applies to the PRG Food that is produced domestically or imported into the territory of Indonesia.

(2) PRG Food as intended in paragraph (1) may be in the form of Processed Foods, raw materials and food additives.

Article 3

PRG food produced domestically or imported into territory of Indonesia for distribution must have a PRG Food distribution permit decree issued by the Head of the Agency.

Article 4

In addition to the PRG Food distribution permit decree as intended in Article 3, the PRG Food must have a registration approval certificate in accordance with regulation.

CHAPTER III
LABELING

Article 5

(1) RPG Food must include Label in accordance with provisions of regulation.

(2) In addition must include Food Label as intended in paragraph (1), PRG Food which has been declared safe based on PRG Food distribution permit decree as intended in Article 3 and circulated in a packaging, the label must be included statement in the form of "GENETICALLY ENGINEERED FOOD PRODUCT" text.

Article 6

(1) PRG Food traded in the form of bulk or unpacked should be given clear information that food is the PRG Food.

(2) The information as intended in paragraph (1) is placed in such a way that it is easily visible and should be in a place or near of the place where the PRG food is sold.

Article 7

(1) The text of "GENETICALLY ENGINEERED FOOD PRODUCT" as intended in Article 5 shall be listed if the food contains at least 5 (five) percent of PRG Food, based on the percentage content of Deoxyribonucleic Acid/DNA of PRG on the non PRG Deoxyribonucleic Acid content.

(2) In case of food containing more than 1 (one) PRG Foods, the percentage content is for each PRG Food.

Article 8

(1) Food that use 1 (one) PRG Food as a single material, the text as intended in Article 5 stated after writing the name of the types of food on the main part of label.

(2) In case of food using the Food PRG, the text as intended in Article 5, after writing the name of food ingredients at the list of ingredients used.

(3) Size of the font for the text as intended in paragraphs (1) and (2) must be equal to the size of the font of the type of food name or food ingredients names.

Article 9

Exempted from the provisions as intended in Article 5 to food that has pass a process of next purification that were not identified RPG protein including but not limited to oils, fats, sugars, and starches.

CHAPTER IV
ADMINISTRATIVE SANCTIONS

Article 10

Violation of the provisions of this Regulation may be subject to administrative sanctions such as:

CHAPTER V
CLOSING

Article 11

This Regulation shall come into force on the date of promulgation.

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 7, 2012
HEAD OF DRUG AND FOOD CONTROLLER AGENCY OF THE REPUBLIC OF INDONESIA,
signed,
LUCKY OEMAR SAID

Promulgated in Jakarta
on April 3, 2012
MINISTER OF LAW AND HUMAN RIGHTS OF REPUBLIC OF INDONESIA,
signed,
AMIR SYAMSUDIN

STATUTE BOOK OF THE REPUBLIC OF INDONESIA NUMBER 370 OF 2012