DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.23.0131

CONCERNING
THE MENTIONING OF ORIGIN OF CERTAIN MATERIALS, ALCOHOL CONTENT AND EXPIRY DATE ON THE MARKING/LABEL OF DRUGS, TRADITIONAL DRUGS, FOOD SUPPLEMENTS, AND FOODS

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,

Considering:

• a. that the community need to be given with objective, complete and clear and non misleading information on the marking/label of drugs, traditional drugs, food supplements, and foods in circulation;
• b. that the decision of the Head of National Agency of Drug and Food Control No. HK.00.05.23.02769 on The Mentioning of Origin of Certain Materials, Alcohol Content, and Expiry Date on the Marking/Label of Drugs, Traditional Drugs, Food Supplements and Foods need to be completed and rectified;
• c. in accordance with letter a and b above, it is necessary to stipulate a decision of the Head of National Agency of Drug and Food Control on The Mentioning of Origin of Certain Materials, Alcohol Content, and Expiry Date on the Marking/Label of Drugs, Traditional Drugs, Food Supplements and Foods.

In view of:

• 1. Law No. 23/1992 on Health (Statute Book of 1992 No. 100, Supplement to Statute Book No. 3495);
• 2. Law No. 7/1996 on Food (Statute Book of 1996 No. 99, Supplement to Statute Book No. 3656);
• 3. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
• 4. Government Regulation No. 72/1998 on Safeguarding of Pharmaceutical Product and Medical Devices (Statute Book of 1998 No. 138, Supplement to Statute Book No. 3781);
• 5. Government Regulation No. 69/1999 on Label and Advertisement of Food (Statute Book of 1999 No. 131, Supplement to Statute Book No. 3867);
• 6. Presidential Decree No. 103/2001 on Satatus, Duties, Functions, Authorities, Organizational Structure, and Work System of Non Departmental Government Institutions as amended by Presidential Decree No. 46/2002;
• 7. Presidential Decree No. 110/2001 on Organizational Unit and Duties of Echelon I Non Departmental Government Institutions as amended by Presidential Decree No. 5/2002;
• 8. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM dated February 26, 2001 on Organization and Work System of the National Agency of Drug and Food Control.

DECIDES:

To stipulate:

DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON THE MENTIONING OF ORIGIN OF CERTAIN MATERIALS, ALCOHOL CONTENT AND EXPIRY DATE ON THE MARKING/LABEL OF DRUGS, TRADITIONAL DRUGS, FOOD SUPPLEMENTS, AND FOODS

CHAPTER I
GENERAL PROVISION

Article 1

Meant in this decision as:

• 1. Certain Materials shall be materials that are sourced from, or containing, or originating from pork animal, either in sole form or in combination or any of its processed products or derivatives.
• 2. Alcohol is ethyl-alcohol (C2H5OH)
• 3. Expiry date is information in the form of date, month and year.
• 4. Marking/label is any information concerning product which is in the form of picture, writing, combination of both, or other forms that are included in the product, inserted in, attached to, or constituting a part of product package.

Article 2

(1) Drugs, traditional drugs, food supplements, and foods which contain certain materials or contain alcohol, in addition to being required to meet provision in the prevailing statutory regulations, must also mention all requirements as stipulated in this decision in their marking/label.

(2) Certain materials as contemplated in paragraph (1) can take the form of gelatine, enzyme, fat, collagen, colostrums, embryo extract, blood extract, hydrolyzed haemoglobin, keratin, hair extract, placenta, protein, thymus extract, thymus hydrolisate, stomach extract, compounding materials, oil, cerotic oil (shortening), thickening, emulsifier, stabilizer, 1-sistein, monoglyceride, diglyceride, and others.

CHAPTER II
MARKING/LABEL OF CERTAIN MATERIALS

Article 3

(1) Drugs, traditional drugs, food supplements, and foods that contain certain materials must mention the origin and information of such certain materials in the marking/label composition.

(2) For drugs, traditional drugs, and food supplements, in addition to mentioning information as contemplated in paragraph (1), must also include a writing Bersumber BabiE(Sourced of Pork) in a black box on the white base in the marking/label, as exemplified bellow:

(3) For drugs, traditional drugs, and food supplements as contemplated in paragraph (1) must also include a writing and picture “mengandung babi + picture of a pork” in a red box on white base in the marking/label, as exemplified bellow:

CHAPTER III
MARKING OF ALCOHOL

Article 4

(1) Drugs, traditional drugs, food supplements, and foods that contain alcohol must mention the alcohol concentration in the marking/label composition.

(2) Alcohol concentration as contemplated in paragraph (1) must be mentioned in percentage.

CHAPTER IV
EXPIRY DATE

Article 5

(1) Drugs, traditional drugs, food supplements, and foods must mention the expiry date in their marking/label.

(2) The expiry date as contemplated in paragraph (1) must be mentioned in a part that is easy to see and read.

(3) provision as contemplated in paragraph (1) excludes traditional drugs that are not obliged to register.

(4) Provision as contemplated in paragraph (1) excludes the following foods:

• a. Fresh vegetables and fruits,
• b. Alcoholic beverages of wine type,
• c. Beverages that contain alcohol more than 10%,
• d. Vinegars,
• e. Sugar (sucrose),
• f. Food additives with storage period of more than 18 months,
• g. Bread and cakes with storage period of less than or equal to 24 hours.

Article 6

(1) The writing of expiry date for drugs, traditional drugs, and food supplements, and foods shall be conducted by mentioning month or year, as long as not written in 4 digits number.

(2) The writing of expiry date for foods with storability of less than 3 (three) months must mention date, month and year.

CHAPTER V
SANCTIONS

Article 7

In addition to being subjected to criminal sanctions in accordance with the provisions in the prevailing statutory regulation, any violations of provisions in this decision shall be subjected to administrative sanctions in the form of:

• a. Written warning;
• b. Circulation permit freezing;
• c. Circulation permits revocation;
• d. Other administrative sanctions in accordance with the prevailing statutory regulations.

CHAPTER VI
TRANSITIONAL PROVISION

Article 8

(1) All provisions of statutory regulations concerning marking/label which have been in operation when this decision is stipulated shall remain be valid, as long as not contradictory to this decision.

(2) Drugs, traditional drugs, food supplements, and foods that have had circulation permit and have been produced before this decision, are obliged to conduct assessment on their marking/label in accordance with the provisions in this decision not later than 1 (one) year as of issuance of this Decision.

(3) Excluded from provision in Article 8 paragraph (2) is Article 3 because it is applicable since this decision is stipulated.

CHAPTER VII
CLOSING PROVISION

Article 9

(1) Upon enactment of this decision, the decision of the Head of National Agency of Drug and Food Control No. HK.00.05.23.02769 on the mentioning of origin of certain materials, alcohol content, and expiry date on the marking/label of drugs, traditional drugs, food supplements, and foods shall be declared as null and avoid.

(2) This decision shall come into force as of the stipulation date.

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

Stipulated in Jakarta
On January 13, 2003
THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL,
sgd
H.SAMPURNO