DECISION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL OF THE REPUBLIC OF INDONESIA
No. HK.00.05.23.3644

CONCERNING
BASIC PROVISIONS OF FOOD SUPPLEMENT CONTROL

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

Attachment

Considering:

• a. that the change of life style and consumption pattern of the community has resulted in the increase of circulation and use of food supplements;
• b. that the community must be protected from food supplements that are not in compliance with requirements of quality, safety and effectiveness as well as from the risk of unsafe, incorrect and irrational usage;
• c. that the existing regulations on food supplements are inadequate anymore by the advancement of science and technology in the field of food supplements;
• 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.

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 No. 99/1996, 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. 17/2001 on Non-Tax State’s Revenue Rate applicable in the National Agency of Drug and Food Control (Statute Book of 2001 No. 35, Supplement to Statute Book No. 4087);
• 5. 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;
• 6. 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;
• 7. Decision of the Head of National Agency of Drug and Food Control No. 02001/SK/KBPOM of 2001 on Organisation 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 BASIC PROVISIONS OF FOOD SUPPLEMENT CONTROL

CHAPTER I
GENERAL PROVISIONS

Article 1

Meant in this decision by:

• 1. Food supplement is a product that is aimed to complete the required food nutritious agents, containing one of more materials in the form of vitamin, mineral, amino acid or other materials (originating from plants or non-pants) which has nutrition value and or physiological effects in a concentrated amount.
• 2. Composition is qualitative and quantitative composition of main materials in food supplements.
• 3. Proper Production Methods is a guidance relating to all aspects in production and quality control, including all series of food supplement manufacturing that is aimed to assure that the product produced always meet the quality requirements that have been prescribed in accordance with its use purposes.
• 4. Container is a package that contacts directly with the content.
• 5. Wrapping is a package that does not contacts directly with the content.
• 6. Marking is complete information on benefits, safety and method of use and other information contained in the etiquettes and or brochures that are furnished with the food supplements.
• 7. Etiquette is information in the form of writing with or without pictures that are attached to, printed on, and mentioned at the container and or wrapping.
• 8. Brochure is a sheet made of paper or other materials that contain marking on food supplement that is attached at the wrapping or distributed separately.
• 9. Examiner is a personnel appointed by the Agency Head to conduct examination.
• 10. Agency Head is the Head of National Agency of Drug and Food Control.
• 11. Deputy is the Deputy of Supervision Section of Traditional Drug, Cosmetic and Complement Product of the National Agency of Drug and Food Control.

CHAPTER II
SCOPE OF FOOD SUPPLEMENT CONTROL

Article 2

(1) Food supplement control is conducted through the following activities:

• a. Stipulation of standards and requirements of benefits, safety, and quality of product as well as standards and requirements of production and distribution facility;
• b. Assessment of benefits, safety, quality, and marking as well as laboratory analysis;
• c. Granting of circulation license;
• d. Granting of production facility license and certification;
• e. Examination of production and distribution facility;
• f. Sampling and laboratory tests as well as monitoring of markings / labels;
• g. Withdrawal from circulation and abolishment;
• h. Assessment and monitoring of promotion including advertisement;
• i. Coaching in the filed of production and distribution;
• j. Surveillance and monitoring of side effect;
• k. Awarding of administrative sanction;
• l. Provision of information.

(2) Implementation of food supplement control as contemplated in paragraph (1) is conducted by a supervisor appointed by the Agency Head.

Article 3

(1) Food supplement produced and or circulated within Indonesia territory must have circulation license from the Agency Head.

(2) In order to obtain the circulation license as contemplated in paragraph (1), registration must be conducted.

(3) Procedures of registration as contemplated in paragraph (2) are stipulated separately by the Deputy.

CHAPTER III
CRITERIA

Article 4

Food supplement must have the following criteria:

• a. Using materials that meet quality standards and safety requirements as well as other prescribed standards and requirements;
• b. Benefits that are assessed from the composition and or supported by the evidential data;
• c. Produced by applying the Proper Production Methods;
• d. Marking that must mention complete, objective, correct and non misleading information;
• e. In the form of pill, tablet, capsule, powder, granule, semi-solid and liquid preparations that are purposed not for food.

CHAPTER IV
QUALITY STANDARDS AND REQUIREMENTS

First Part
Quality Standard

Article 5

Food supplement must be produced by using materials that meet the quality standards in accordance with Farmakope Indonesia, Materia Medika Indonesia or other recognized standards.

Article 6

(1) Food supplement is obliged to be produced by using the Proper Production Methods.

(2) Proper Production Methods as contemplated in paragraph (1) are:

• a. Proper Medicine Production Method (CPOB) for pharmaceutical industry;
• b. Proper Food Production Method (CPPB) for food industry;
• c. Proper Traditional Drug Production Method (CPOTB) for traditional drug industry.

(3) Proper Production Methods as contemplated in paragraph (1) are stipulated by the Agency Head.

Second Part
Requirements

Article 7

(1) Ingredients that take the form of vitamin, mineral, amino acid and other materials that are permitted for use in the food supplements with limitation in accordance with one that is stipulated as specified in Attachment 1.

(2) Additive in the form of artificial sweeteners that are permitted for use in food supplements as specified in Attachment 2.

(3) Other additives in the form of preservatives, colouring agents, flavour enhancers, fragrant and thickeners that are permitted for use in food supplements in accordance with the prevailing provisions in food sector.

Article 8

Materials that are prohibited for use in food supplements are as specified in Attachment 3.

Article 9

(1) Benefits of food supplement must comply with quantity and composition of materials it contains.

(2) Materials that are originating from plants / animals / non-pathogen micro organism that are used in combination with vitamin, mineral and amino acid must have benefit compliance that is supported by the evidential data.

CHAPTER V
PRODUCTION

Article 10

(1) Food supplement can only be produced by pharmaceutical industry or traditional drug industry or food industry that has fulfilled Proper Production Method requirements.

(2) Food industry as contemplated in paragraph (1) can only produce food supplements in the form of liquid preparation and or powdered preparation that is served in the form of liquid.

CHAPTER VI
CONTAINER AND MARKING

First Part
Container

Article 11

(1) Food supplements container must:

• a. Protect the content against external influences;
• b. Secure quality, integrity and originality of its content.

(2) Container as contemplated in paragraph (1) must be made by considering safety of its user and made from materials that will not emit or generate dangerous materials nor a substance that can disturb the health nor affects the quality.

(3) The container lid must comply with the requirements as contemplated in paragraphs (1) and (2).

Article 12

(1) In order to protect the container during in circulation, the container as contemplated in Article 11 can be furnished with wrapping.

(2) Wrapping as contemplated in paragraph (1) must be made of materials that are able to protect the container during in circulation.

Second Part
Marking

Article 13

Container and wrapping must be accompanied with marking that contains complete, objective and non misleading information.

Article 14

(1) Marking must contain information that conforms to the marking which has been approved in the registration.

(2) Marking other than as contemplated in paragraph (1) must obtain a prior approval of the Agency Head.

Article 15

Marking must mention at least:

• a. The writing "Suppmelen Makanan" or "Food Supplement";
• b. Product name, can be either generic name or trade name;
• c. Name and address of producer or importer;
• d. Size, content, net weight;
• e. Composition in qualitative and quantitative;
• f. Alcohol content, is any;
• g. Benefits, method of use and dosage of use;
• h. Contraindication, side effects and warnings, if any;
• i. Circulation license number;
• j. Batch Number/production code;
• k. Expiry date;
• l. Other information relating to safety or quality or origin of certain materials in accordance with the prevailing provisions.

CHAPTER VII
ADVERTISEMENT

Article 16

(1) Food supplement can only be advertised after obtaining circulation license.

(2) Materials of the advertisement as contemplated in paragraph (1) must be approved by the Agency Head.

Article 17

(1) Advertisement materials as contemplated in Article 16 paragraph (2) must contain:

• a. Complete, objective and non misleading information;
• b. Information in accordance with the claim which has been approved in the registration.

(2) Provisions of Advertisement Guidelines shall be regulated later by the Agency Head.

CHAPTER VIII
PROHIBITIONS

Article 18

(1) Food supplements are prohibited to contain any substances that are categorized as drug or narcotics or psychotropics in accordance with the prevailing provisions.

(2) Food supplements are prohibited to contain materials exceeding maximum limit as specified in Attachment 1 and or contain materials that are stipulated as specified in Attachment 3.

(3) Food supplement are prohibited to use plants and or animals that are protected in accordance with the prevailing provisions.

(4) Food supplement in the form of liquid per oral are prohibited to contain ethyl alcohol with concentration of more than 5 (five) %.

CHAPTER IX
COACHING

Article 19

(1) Coaching on implementation of activities of production, import, circulation and use of food supplements is conducted by the Agency Head.

(2) In coaching as contemplated in paragraph (1) the Agency Head may involve professional organizations and related associations.

Article 20

Coaching as contemplated in Article 19 is directed to:

• a. Assure the quality, safety and benefits of food supplements being circulated;
• b. Improve technical ability and application of the Proper Production Methods and to support business development in food supplement sector.

CHAPTER X
EXAMINATION

Article 21

(1) Examination is conducted by the Agency Head to the activities of production, import, circulation, use and promotion of food supplements.

(2) In implementing examination as contemplated in paragraph (1) the Agency Head appoints an examiner.

Article 22

Examiner as contemplated in Article 21 paragraph (2) has the following authorities:

• a. To enter into any site used or allegedly used in activities of production, import, distribution, storage, transportation and delivery of food supplements in order to examine, observe and take samples of anything used in the activities of production, import, distribution, storage, transportation, delivery and promotion of food supplements;
• b. To conduct examination to the documents or other records that contain or allegedly contain information on activities of production, import, distribution, storage, transportation, delivery and promotion of food supplements including reproducing or quoting such information;
• c. To order to show business license or any other documents;
• d. To conduct in-situ safeguarding of the food supplements not complying with the prevailing provisions.

Article 23

Anyone who is responsible for the site where the examination is to be conducted by the examiner shall have the right to refuse such an examination if the relevant examiner is not equipped with identity and examination instruction letter.

Article 24

If the results of examination by the examiner indicates any allegation or reasonably allegation of criminal act, an investigation shall be conducted immediately by the investigator of the National Agency of Drug and Food Control.

CHAPTER XI
SANCTIONS

Article 25

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

• a. Written warning;
• b. Advertisement withdrawal;
• c. Withdrawal of food supplements from circulation;
• d. Suspension of production, import and distribution activities;
• e. Circulation license revocation.

(2) In addition to administrative sanctions as contemplated in paragraph (1), criminal sanction shall be applied in accordance with the prevailing statutory regulations.

CHAPTER XII
TRANSITIONAL PROVISION

Article 26

(1) All of the prevailing statutory regulations on food supplement that are existent when this decision is stipulated shall still valid as long as not in contradictory to this decision.

(2) Food supplements which have possessed circulation license before stipulation of this decision and have not fulfilled provisions as specified in this decision are obliged to make adjustment and report to the Agency Head not later than 1 (one) years as of decision is stipulated.

CHAPTER XIII
CLOSING PROVISION

Article 27

(1) Any technical matters that have not been regulated sufficiently in this decision will be regulated further by the Deputy.

(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: 9 August 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.00.05.23.3644