REGULATION OF THE HEAD OF DRUGS AND FOODS CONTROL AGENCY
NO. HK.00.05.1.23.3516

CONCERNING
DISTRIBUTION PERMIT OF MEDICINE, TRADITIONAL MEDICINE, COSMETICS, FOOD SUPPLEMENT AND FOOD PRODUCTS FROM, CONTAINING OR ORIGINATING FROM CERTAIN SUBSTANCES AND/OR CONTAINING ALCOHOL

BY GRACE OF THE ALMIGHTY GOD
THE HEAD OF DRUGS AND FOODS CONTROL AGENCY,

Considering:

• a. that the public is required to be protected from the use of medicine, traditional medicine, cosmetics, food supplement, and food products which scientifically do not meet requirements on safety, quality, and benefit.
• b. that there are medicine, traditional medicine, cosmetics, food supplement and food products from certain substances, containing or originating from certain substances which according to Islamic law (syariah) contain substances not allowed and not commonly used by the Indonesian community, where the majority are Muslims;
• c. that in order to exercise control on medicine and food, it is necessary to regulate the circulation permits of medicine, traditional medicine, cosmetics, food supplement and food products from certain substances, containing or originating from certain substances and/or containing alcohol;
• d. that Decree of the Head of Drug and Food Products Control Agency No. HK.00.05.23.0131 of 2003 concerning Inclusion of the Origin of Certain Substance, Alcohol Content, and Expiry Date on Labels of Medicine, Traditional medicine, Food supplement, and Food is no more suitable with the development of science and technology, therefore it is required to be perfected;
• e. that based on the considerations as intended in a. until d., it is necessary to stipulate a regulation of the Head of Drug and Food Products Control Agency concerning circulation permit of medicine, traditional medicine, cosmetics, food supplement, and food products containing or originating from certain substances and/or containing alcohol;

In view of:

• 1. Law No. 23/1992 concerning Health (Statute Book of the Republic of Indonesia of 1992 No. 100, Supplement to Statute Book No. 3495);
• 2. Law No. 7/1996 concerning Food (Statute Book of the Republic of Indonesia No. 99/1996, Supplement to Statute Book No. 3656);
• 3. Law No. 8/1999 concerning Consumers Protection (Statute Book of the Republic of Indonesia No. 42/1999, Supplement to Statute Book No. 3821 );
• 4. Government Regulation No. 72/1998 concerning Securing the Supply of Pharmacy and Health instruments (Statute Book No. 138/1998, Supplement to Statute Book No. 3781);
• 5. Government Regulation No. 69/1999 concerning Food Label and Advertisement (Statute Book No. 131/1999, Supplement to Statute Book No. 3867);
• 6. Government Regulation No. 28/2004 concerning Food Safety, Quality and Nutrient (Statute Book No. 107/2004, Supplement to Statute Book No. 4424);
• 7. Presidential Decree No. 103/2000 concerning Position, Mission, Functions, Authority, Organization Structure, and Work Mechanism of Non-Department Government Agencies having been amended several times, lastly by Presidential Regulation No. 64/2005;
• 8. Decree of the Minister of Health No. 82/MENKES/SK/I/1996 concerning Inclusion of the inscription "Halal" on Food Product Labels;

DECIDES:

To stipulate:

REGULATION OF THE HEAD OF DRUG AND FOOD CONTROL AGENCY OF THE REPUBLIC OF INDONESIA CONCERNING CIRCULATION PERMIT ON MEDICINE, TRADITIONAL MEDICINE, COSMETICS, FOOD SUPPLEMENT AND FOOD PRODUCTS FROM CERTAIN SUBSTANCES, CONTAINING CERTAIN SUBSTANCES AND/OR CONTAINING ALCOHOL

CHAPTER I
GENERAL PROVISIONS

Article 1

In this Regulation, definitions of terms used are:

• 1. Circulation permit is a form of registration approval for medicine, traditional medicine, cosmetics, food supplement, and food products issued by the Drug and Food Control Agency of the Republic of Indonesia so that the products can be legally circulated within the territory of Indonesia.
• 2. Medicine is finished medicine, including biological products, solely or mixture of active substances, including narcotics and psycho-tropics, additional substances, contraception and health instruments containing medicine.
• 3. Additional substance in medicine is medicine component used as substance for filler, solvent, coating, aid, propellant, and substances meant to enhance its benefit, stability, preservation or as colouring substance, and having no pharmacology effect.
• 4. Traditional medicine is substance or ingredients in the form of vegetation substance, animal substance, mineral substance, supply or mixture of those substances which traditionally are used for medical treatment based on experience.
• 5. Cosmetics is the substance or supply purported to be used on human outer parts (epidermis, hair, nails, lips, outer parts of genital organ) or teeth and mouth mucosa, particularly to clean, perfume, change the appearance, and/or improve body odour or protect or maintain the body to be in good condition.
• 6. Food supplement is concentrate products containing one or more vitamins and/or minerals, consumed in measured small amount, and not in the form of general food products, and marketed in the form of among others capsule, tablet, powder or liquid, purported to fulfil! intake of vitamin and/or mineral of normal diet.
• 7. Food products and/or drinks are processed food achieved from a process using certain methods with or without additional substances.
• 8. Certain substances are substances containing or originating from animals or other living beings solely by itself or a mixture or processed product or its derivative excluding bee honey, or in its process, got in contact with certain substances.
• 9. Alcohol is ethanol with chemical formula C2H5OH
• 10. Agency is the Drug and Food Control Agency of the Republic of Indonesia.
• 11. Head of the Agency is the Head of Drug and Food Products Control Agency of the Republic of Indonesia.

Article 2

Animals or other living beings as intended in Article 1 number 8 cover:

• a. pig, dog and offspring born from their inter-marriage;
• b. Corpse, including dead animals not due to being slaughtered in accordance with Islamic method, except fish and grasshoppers;
• c. Any animal deemed and felt as disgusting to be eaten in accordance with human nature such as worms, lice, leech, and the like;
• d. Any animal with tusk/fangs;
• e. Any animal with claws, and devouring its prey by pouncing or swooping and seizing;
• f. Animals prohibited by Islam to be killed, such as bees, Hud-hud bird, frogs, and ants;
• g. Meat cut from a permitted halal animal whereas the animal is still alive;
• h. Any poisonous animal and disadvantageous if eaten;
• i. Any animal living in two natures, such as turtle, crocodile, alligator, and the like; and
• j. Blood, urine, faeces, and placenta.

CHAPTER II
MEDICINE PRODUCTS

Article 3

(1) Medicine products originating from, containing or during its production process got in contact with certain substances may be provided with a circulation permit if it has an emergency nature.

(2) Circulation permit for the products as intended in paragraph (1) shall be given based on an evaluation on safety, benefit, quality, and recommendation from the Inter-Sector Team on Permissiveness and Emergency.

(3) Membership of the Inter-Sector Team as intended in paragraph (2) consist of:

• a. Health Department;
• b. Drug and Food Products Control Agency;
• c. Indonesia Muslim Leader Council;
• d. Group of related expert doctors.

(4) The Team as intended in paragraph (3) is stipulated by the Head of the Agency and has an ad hoc nature.

(5) The alcohol level of medicine products containing alcohol shall be stated on the composition label.

(6) The alcohol level as intended in paragraph (3) shall be stated in percentage.

(7) Information on medicine products and bio-products originating from pigs/porcine shall be stated in its box with the inscription "Originating from Pig" in red colour on a white colour base as shown in the sample.

(8) Information on medicine products and bio-products which in its production process got in contact with substances originating from pig/porcine shall be stated in its box in red colour on a white colour base as shown in the following sample:

CHAPTER III
TRADITIONAL MEDICINE, COSMETICS, AND FOOD SUPPLEMENT PRODUCTS

Article 4

(1) Traditional medicine, cosmetics, and food supplement products generally do not have an emergency nature.

(2) If the products as intended in paragraph (1) contain or originate from such substances, it shall not be given a circulation permit.

Article 5

(1) The alcohol level of traditional medicine, cosmetics and food supplement products containing alcohol not included in the provisions meant in Article 4 paragraph (2), must be stated in the composition on the label.

(2) The level of alcohol as intended in paragraph (1) shall be stated in percentage.

CHAPTER IV
FOOD PRODUCTS AND DRINK PRODUCTS

Article 6

(1) Food products and drink products from, containing or originating from certain substances shall not be given a circulation permit.

(2) Exempted from the provisions as intended in paragraph (1), food products and drink products from, containing, or originating from pig may be provided with a circulation permit on condition it must meet requirements on safety, quality, and nutrient, and labels of the food products are also required to include the inscription and picture "containing pig + picture of pig" in its box in red colour on a white colour base as shown in the sample:

(3) The inscription "CONTAINING PIG" as intended in paragraph (2) must meet the following provisions:

(4) Level of alcohol contained in food products and drink products containing alcohol must be stated in the composition on the label.

(5) The level of alcohol as intended in paragraph (3) shall be stated in percentage.

CHAPTER V
SANCTIONS

Article 7

(1) Any violation on provisions of this Regulation may be imposed to administrative sanctions in the form of:

• a. written warning for three (3) times;
• b. temporary cessation of production and distribution activities;
• c. freezing and/or cancellation of Approval Letter;
• d. Withdrawal of all products from circulation and destruction.

(2) Besides being imposed to the administrative sanction as intended in paragraph (1), criminal sanctions can also be imposed in accordance with provisions of prevailing legislations.

CHAPTER VI
TRANSITIONAL PROVISIONS

Article 7

(1) By the time this Regulation of the Agency Head commences to come to effect, decree of the Head of Drug and Food Control Agency No. HK.00.05.23.0131of 2003 is revoked and declared as no more in effect.

(2) Medicine, traditional medicine, cosmetics, food supplement and food products that had received a circulation permit and produced before the stipulation of this Regulation are obligated to be adjusted within one (1) year at the latest from the stipulation of this Regulation.

CHAPTER VII
CLOSING PROVISIONS

Article 8

This Regulation comes to effect from the dated of stipulation.

For public cognizance, this Regulation shall be announced in the State Gazette of the Republic of Indonesia.

Stipulated in Jakarta
on August 31, 2009
THE HEAD OF DRUG AND FOOD CONTROL AGENCY
signed,
Dr. Husniah Rubiana Thamrin Akib, MS.,Mkes, SpFK