DECISION OF THE DIRECTOR GENERAL OF DRUG AND FOOD CONTROL
No. 02592/B/SK/VIII/91

CONCERNING
THE USE OF FOOD ADDITIVES

DIRECTOR GENERAL OF DRUG AND FOOD CONTROL ,

Attachment

Considering:

• a. that the use of additives in food processing other than as permissible under Regulation of the Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives, are only allowed after passing the assessment process;
• b. that in relation to the foregoing, and as implementation of article 2 paragraph (2), article 12 and article 32 of the Regulation of the Minister of Health No. 722/Menkes/Per/IX/88 on Food Additives, it is necessary to stipulate a Decision of the Director General of Drug and Food Control on the Use of Food Additives.

In view of:

Regulation of the Minister of Health RI No. 722/Menkes/Per/IX/88 on Food Additives

To stipulate:

DECISION OF THE DIRECTOR GENERAL OF DRUG AND FOOD CONTROL ON THE USE OF FOOD ADDITIVES.

CHAPTER I
APPLICATION FOR APPROVAL

Article 1

(1) Types and functions/purposes of the use of food additives and types of foods that are allowed to contain the food additives with maximum usage limit as specified in Attachment I to the Regulation of the Minister of Health RI No.722/Menkes/Per/IX/88 on Food Additives.

(2) Using other additives or using for other purposes, other than as contemplated in paragraph (1) shall only be allowed after obtaining approval from Director General of Drug and Food Control.

Article 2

(1) In order to obtain approval as contemplated in article 1 paragraph (2), the applicant obliged to submit or deliver application to the Director General of Drug and Food Control;

(2) Annexes of the application as contemplated in paragraph (1) shall be delivered in triplicate, after completed completely and correctly.

Article 3

Application as contemplated in article 2 shall be furnished with:

• a. Form BTM 1 containing information on trade name, type name, packaging type and netto and business entity that will produce or import.
• b. Form BTM 2 containing information on food additives including chemical name, composition, specification or quality of materials, physical and chemical properties, chemical formula and geometrical formula of the additive.
• c. Form BTM 3 containing information on production method and analysis method for determination of grade and purity of the additives.
• d. Form BTM 4 containing information on function/purpose of usage, recommendation and direction of use, physical effects, techniques and method of using additive and types of food and maximum quantity of its use in food.
• e. Form BTM 5 containing information to verify the safety of use of additives and maximum limit of additive residues that may still exist in the food product.
• f. Form BTM 6 containing other information that are deemed necessary by the applicant to support evaluation of his application, such as photocopy of literatures explaining that the additive is safe for use food and regulation / reference that the use of such a material is permitted in other countries.

Article 4

Annexes of application for approval to use additives include:

• a. Forms BTM 1,2,3,4, 5 and 6;
• b. Sample of relevant additive;
• c. Example label.

Article 5

Annexes of application for approval on function/purpose of usage or type of foods that contain the additive, consist of Forms : BTM 4 and BTM 6.

Article 6

(1) Annexes of application as contemplated in articles 4 and 5 above are examined immediately after the application dossiers are received, and the applicant whose application dossiers are complete will be issued a letter of receipt of his application, by using example form BTM 7 and to those that are incomplete will be issued letter of application rejection by using example form BTM 8;

(2) Application dossier that is rejected can be retrieved not later than 3 months as of the notice date.

CHAPTER II
EVALUATION

Article 7

(1) Evaluation of application is conducted based on provisions and guidelines prescribed by the evaluation team who is appointed by the Director General;

(2) Based on the results of evaluation, The Head of Directorate of Beverage and Food Control make decision on behalf of the Director General.

Article 8

(1) Decision as contemplated in article 7 paragraph (2) can take the forms of approval, conditional approval or rejection;

(2) Application that obtains approval will be issued with letter of approval by using example form BTM 9;

(3) Application that obtains conditional approval will be notified in writing regarding with conditions (requirements) to be meet to obtain approval by using example form BTM 10;

(4) Application that doe not obtain approval will be issued with letter of rejection by using example form BTM 11.

Article 9

(1) Additives that has obtained approval can be used in food processing in accordance with requirements specified in the letter of approval and must comply with all provisions relating to food additives;

(2) Additives that has obtained approval, in addition to being used in food processing as contemplated in paragraph (1), can also be used in other foods to the extent not contradicts with the special conditions that are stipulated for such foods.

Article 10

(1) Food additives that are produced, imported or circulated, must comply with requirements as specified in the Indonesia Food Codex (Kodeks Makanan Indonesia) concerning Food Additives or other requirements outlined by the Minister of Health;

(2) For food additives that are not specified in the Indonesia Food Codex (Kodeks Makanan Indonesia) or whose requirements are not stipulated yet by the Minister, must comply with requirements on food additives that are recommended by FAO/WHO Codex Alimentarius Commission or requirements specified in the Food Chemicals Codex.

CHAPTER III
CLOSURE

Article 11

Other technical matters that are not already regulated in this Decision will be stipulated further by the Director General of Drug and Food Control.

Article 12

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

Stipulated in: JAKARTA
On: Augustus 14, 1991
DIRECTOR GENERAL OF DRUG AND FOOD CONTROL
DRS. SLAMET SOESILO
NIP 140051341

Attachment to DECISION OF THE DIRECTOR GENERAL OF DRUG AND FOOD CONTROL
No. 02592/B/SK/VIII/91