DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
No. HK.00.05.5.1.4547

ON
REQUIREMENTS OF USE OF ARTIFICIAL SWEETENER FOOD ADDITIVES IN FOOD PRODUCT

THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA,

Attachment

Considering:

• a. that epidemiological transition and the change of life style has boosted the increase in production of food products by using artificial sweetener food additives;
• b. that the use of artificial sweetener in food products incorrectly and excessively may result in health hazard;
• c. that the existing regulations on artificial sweetener are inadequate anymore by the current advancement of food science and technology
• d. that in relation with letters a, b and c, it is necessary to stipulate a Decision of the Head of National Agency of Drug and Food Control on Basic Provisions of Food Supplement Control on Requirements of Use of Artificial Sweetener Food Additives In Food Products.

In view of:

• 1. Law No. 7/1996 on Food (Statute Book No. 99/1996, Supplement to Statute Book No. 3656);
• 2. Law No. 8/1999 on Consumer Protection (Statute Book of 1999 No. 42, Supplement to Statute Book No. 3821);
• 3. Government Regulation No. 28/2004 on Food Safety, Quality and Nutrition (Statute Book of the Republic of Indonesia year 2004 No. 107, Supplement to Statute Book of the Republic of Indonesia No. 4424);
• 4. Presidential Decree No. 103/2001 on Status, Duties, Functions, Authorities, Organizational Structure and Activity of Non Departmental Government Institution as amended by Presidential Decree No. 46/2002;
• 5. Presidential Decree No. 110/2001 on Organisation Unit and Duties of Echelon I in Non Departmental Government Institutions as amended by Presidential Decree No. 48/2002;

Bearing in mind:

Decision of the Head of National Agency for Standardization No. 12/Kep/BSN-SNI.03/05/2004 on Stipulation of 23 (Twenty Three) National Standards of Indonesia.

DECIDES:

To stipulate:

DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL ON REQUIREMENTS OF USE OF ARTIFICIAL SWEETENER FOOD ADDITIVES IN FOOD PRODUCTS

CHAPTER I
GENERAL PROVISIONS

Article 1

Meant in this decision by:

• 1. Food Additive is a substance that is added into food to affect characteristics or form of the food, either those which have nutrition value or not.
• 2. Artificial sweetener is a food additive that may cause sweet taste in food products that have no or little nutrition value or calorie, must only be added into food products in a certain amount.
• 3. Poliol is alcohol sugar that is safe in its use, which is naturally found in fruits, including aktitol, maltitol, manitol, silitol and sorbitol, whereas that are commercially obtained are through monosaccharide fermentation process by using kapang/khamir for foods such as Moniliella pollinis.
• 4. Flavour emphasiser is another functional terminology which can be used for artificial sweetener that is able to provide, add or emphasize sweet taste of sugar, fruit flavour or certain fragrances.
• 5. ADI (Acceptable Daily Intake) is maximum quantity of artificial sweetener in milligram per kilogram of body weight that can be consumed every day along life without resulting in harmful effects to the health.
• 6. Calorific Value is calorie or energy that is generated from sweetener and expressed as number of kilo calorie (kcal) per gram of artificial sweetener or can be expressed in Joule unit with equivalence 1 kcal = 4.18 kJ.
• 7. Maximum limit of use is number of milligrams per kilogram (mg/kg) of artificial sweetener that is permitted to be added to the food product or quantity of artificial sweetener that is sufficient to produce desirable sweet taste in accordance with CPPB.
• 8. CPPB (Proper Food Production Method) is a guideline that is applied to produce food that meets quality standards or requirements that are consistently applied.
• 9. Artificial sweetener preparation is artificial sweetener in tablet, granule, powder, crystal or liquid form that is packaged in the form of ready use and served like sugar.
• 10. GRAS (Generally Recognized As Safe) is statement of safe for food additive including artificial sweetener for adding in food products in quantity in accordance with CPPB.
• 11. Agency Head is the Head of National Agency of Drug and Food Control of the Republic of Indonesia.

CHAPTER II
THE USE OF ARTIFICIAL SWEETENER IN FOOD PRODUCTS

First Part
General Use of Artificial Sweetener In Food Products

Article 2

(1) Artificial sweeteners that are permitted to be added into food products in certain amount are 13 (thirteen) kinds in accordance with provisions as specified in Attachment 1 to this Decision.

(2) Artificial sweetener can be used either in sole form or in combination in low calorie food products and foods without sugar addition.

(3) Low calorie food as contemplated in paragraph (2) being synonym of Weight Reduction Foods, Reduce Calorie, Reduce Joule, or Low Joule is food product that at least contains less or equals to 40 calorie per serving.

(4) Foods without sugar addition as contemplated in paragraph (2) being a synonym of no added sugar foods, without added sugar, and no sugar added are food products processed without addition of sugar (saccharose / sucrose), including ingredients that contain sugar (syrup, fruit juice, Apple sauce, and others), or whose processing dos not increase sugar content significantly.

(5) Permitted artificial sweeteners can be consumed in general including by diabetes mellitus patients and diet performers with maximum limit of use as specified in Attachment 1 To this Decision.

(6) Determination of the maximum limit of artificial sweetener in food products also includes artificial sweeteners that originate from food product composition or as a result of its processing (inventive artificial sweetener) that are allowed to exist in food product composition.

Second Part
The Use of Artificial Sweetener of Poliol Group

Article 3

(1) Poliol group, addition to functioning as artificial sweetener, can also function as flavour enhancer, stuffs, stabilizer, thickener, antic coagulant, humectants, sekuestran and main materials.

(2) Functions of the poliol group in addition to as artificial sweetener as provided for in paragraph (1) above shall be regulated separately by the Agency Head.

(3) Poliol group which functions as main materials as contemplated in paragraph (1) is sorbitol, can be used in production of food products with the following requirements:

• a. Candies with maximum usage 99 percent,
• b. Bubble gums with maximum usage 75 percent,
• c. Jam and jelly with maximum usage 30 percent and
• d. Roasted food products with maximum usage 30 percent.

Third Part
Approval to Use Artificial Sweetener

Article 4

The use of artificial sweetener other than as referred to in Attachment 1 to this Decision must obtain approval of the Agency Head.

Fourth Part
Prohibition To Use Artificial Sweetener In Food Products

Article 5

Artificial sweetener is not allowed to be used in certain processed food products for consumption by certain groups including babies, children under five, pregnant women, breast feeding mothers in the effort of maintaining and improving their health quality.

CHAPTER III
LABEL PROVISIONS

Article 6

(1) Food products which use artificial sweetener must mention the kind and quantity of artificial sweetener in composition of ingredients or list of ingredients on the label.

(2) Artificial sweetener in the form of preparation, on its label must mention:

• a. Name of Artificial Sweetener;
• b. Quantity of artificial sweetener in the form of tablet expressed in milligram (mg) and in granule or powder form expressed in milligram (mg) in a disposable package;
• c. Acceptable Daily Intake unless for artificial sweetener that has no ADI;
• d. Warning: not for use in materials to be tanned or roasted.

(3) It is obliged to mention warning Fenilketonuria: mengandung phenylalanine (contains phenylalanine), that is typed and viewable clearly on the label if the foods or beverages or preparations use artificial sweetener aspartame.

(4) It is obliged to mention warning: Konsumsi berlebihan dapat mengakibatkan efek laksatif (Excessive consumption may result in lacsative effect, that is typed and viewable clearly on the label if the foods or beverages or preparations use artificial sweetener laktitol or manitol or sorbitol, which if believed as consumed more than 20 gram laktitol per day or 20 gram manitol per day or 50 gram sorbitol per day.

(5) Claims that are permitted and can be written on the label are:

• a. Not causing tooth cirrhosis;
• b. Low Calorie Food and Food Without Sugar Addition if the food product fulfils requirements as low calorie food products as contemplated in Article 2;
• c. Foods for diabetes patients or other statements as contemplated in Article 2 paragraph (5).

CHAPTER IV
SUPERVISION AND DEVELOPMENT

Article 7

Supervision and development to the use of artificial sweetener in food products is conducted fully by the Head of National Agency of Drug and Food Control.

CHAPTER V
SANCTIONS

Article 8

(1) Violation to any provisions in this decision shall be subjected to administrative sanctions in the form of:

• a. Written warning;
• b. Circulation license revocation, and
• c. Withdrawal and abolishment of food products that contain sweetener in circulation.

(2) In addition to administrative sanctions as contemplated in paragraph (1), violation to any provisions in this decision shall also be subjected to criminal sanction in accordance with the prevailing statutory regulations.

CHAPTER VI
TRANSITIONAL PROVISION

Article 9

Upon stipulation of this Decision, all food products that use artificial sweetener before stipulation of this Decision are obliged to adjust to the provisions in this Decision not later than 12 (twelve) months as of this Decision is issued.

CHAPTER VII
CLOSURE

Article 10

(1) Any technical matters that have not been regulated sufficiently in this decision will be regulated further by the Agency Head in charge of drug and food.

(2) This decision shall come to effect as of the stipulation date.

For public cognizance, this decision shall be placed in the State Gazette of the Republic of Indonesia.

Stipulated in: JAKARTA
On: October 21, 2004
The Head of National Agency of Drug and Food Control of the Republic of Indonesia
Sgd.
H. SAMPURNO

Attachment to DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.5.1.4547