REGULATION OF THE HEAD OF NATIONAL AGENCY OF DRUG AND FOOD CONTROL
No. HK.00.05.52.0685

ON
BASIC PROVISIONS ON FUNCTIONAL FOOD SUPERVISION

THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD,

Considering:

• a. that various kinds of food products claimed beneficial in caring and enhancing health, commonly called functional food grow rapidly;
• b. that the public must be protected from the distribution and use of functional food failing to meet the requirements for security, quality, nutrition as well as label and advertisement;
• c. that in relation to points a and b, it is necessary to stipulate a Decree the Head of Food and Drug Administration regarding Basic Provisions for Functional Food Surveillance.

In view of:

• 1. Law No. 7/1996 on food (Statute Book of 1996 No. 99, 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. 17/2001 on tariffs of non-tax state revenues effective within the Food and Drug Supervisory Board (Statute Book of 2001 No. 35, Supplement to Statute Book No. 4087);
• 4. Government Regulation No. 28/2004 on security, quality and nutrition of food (Statute Book of 2004 No. 107, Supplement to Statute Book No. 4424);
• 5. Presidential Decree No. 103/2001 on the status, tasks, functions, authority and organizational structures of non-ministerial government institutions, as already amended by Presidential Decree No. 46/2002;
• 6. Presidential Decree No. 110/2001 on first-echelon organizational units and tasks of non-ministerial government institutions, as already amended by Presidential Decree No. 48/2002;
• 7. Decision of the Head of the Food and Drug Supervisory Board No. 02001/SK/KBPOM dated February 26, 2001 on the organization and working arrangement of the Food and Drug Supervisory Board as already amended by Decision of the Head of the Food and Drug Supervisory Board No. 00.05.21.4231/2004;
• 8. Decision of the Head of the Food and Drug Supervisory Board No. HK. 00.05.1.2569 dated May 31, 2004 on criteria and procedures for evaluation of food products;

DECIDES:

To stipulate:

THE REGULATION OF THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD ON BASIC PROVISIONS ON FUNCTIONAL FOOD SUPERVISION

CHAPTER I
GENERAL PROVISION

Article 1

Referred to in this regulation as:

• 1. Food shall be everything coming from biological resources and water, whether processed or not, designated as food or drink for human consumption, including food supplement, food raw material and other materials used in the process of preparation, processing and/or production of food or beverage.
• 2. Processed food shall be food or beverage resulting from a process by certain means or method, with or without additive.
• 3. Functional food shall be proceeded-food containing one functional component or more, which based on scientific analysis has certain physiological functions, is proven not dangerous and beneficial to health.
• 4. Food label shall be every kind of information about food, in the form of picture, writing, combination of writing and picture, or other form attached to the food, inserted into, affixed at or being part of food package.
• 5. Food advertisement shall every kind of information or statement on food in the form of picture, writing or other form, realized in various methods to market and/ or trade food.
• 6. Everybody shall be individual or business entity in the form of statutory body or not.
• 7. Head of the Board shall be the Head of the Food and Drug Supervisory Board.
• 8. Deputy shall be the Deputy in charge of Supervision Over Food Security and Dangerous Materials.
• 9. Peer Reviewer Team shall be experts evaluating components of function foods stipulated by the Head of the Board.

CHAPTER II
SCOPE OF FUNCTIONAL FOOD SUPERVISION

Article 2

Functional Food Supervision shall be executed through the following activities:

• a. stipulation of standards and requirements for security, quality and nutrition;
• b. stipulation of standards and requirements for production and distribution;
• c. evaluation of security, quality and nutrition of products as well as label in the framework of the issuance of registration approval;
• d. inspection and certification of products;
• e. examination of production and distribution facilities;
• f. sampling and laboratory test as well as monitoring of product label;
• g. evaluation of substances of promotion, including advertisement, before the distribution and monitoring of the distribution;
• h. provision of counseling in the production and distribution fields;
• i. withdrawal from distribution and destruction;
• j. imposition of administrative sanction;
• k. provision of information.

Article 3

The functional food supervision as meant in Article 2 shall be executed by supervisors appointed by the Head of the Board.

CHAPTER III
CRITERIA FOR FUNCTIONAL FOOD

Article 4

(1) Functional food shall meet the criteria for food products in accordance with the provisions of decisions of the Head of the Board.

(2) Besides fulfilling the provisions as meant in paragraph (1), functional food shall:

• a. use materials fulfilling the quality standard and security requirement as well as other stipulated standards and requirements;
• b. have benefit to the health, evaluated from components of functional food on the basis of scientific analysis by the Peer Reviewer Team;
• c. be presented and consumed like food and beverage;
• d. have sensoric characteristics, such as appearance, color, texture or consistency and taste acceptable to consumers.

(3) The components of functional food shall not give unexpected interaction with other components.

CHAPTER IV
COMPONENTS OF FUNCTIONAL FOOD

Article 5

(1) The components of functional food shall be classified into the following groups:

• I. Vitamin
• II. Mineral
• III. Alcoholic Sugar
• IV. Unsaturated fatty acid
• V. Peptida and certain protein
• VI. Amino acid
• VII. Food fiber
• VIII. Prebiotic
• IX. Probiotic
• X. Kolene, lecithin and inositol
• XI. Karnitin and squalene
• XII. Isoflavon )soybean)
• XIII. Fitostero! and fitostanol
• XIV. Polyphenol (tea)
• XV. Other functional components to be stipulated later.

(2) The permitted claim related to every functional component shall be as contained in the attachment to this regulation.

(3) The other functional components as meant in paragraph (1) point XV can be considered as functional components by submitting scientific evidence and claim for evaluation by the Peer Reviewer Team.

(4) Based on the evaluation by the Peer Reviewer Team as meant in paragraph (2), the Head of the Board in this case the Deputy in Charge of Supervision Over Food Security and Dangerous Materials shall give approval as functional food and the claim permitted for the components.

CHAPTER V
PRODUCTION

Article 6

(1) Industries producing functional food of the certain processed food category shall meet the proper production method of food and system of Hazard Analysis and Critical Control Points (HACCP).

(2) The functional food as meant in paragraph (2) shall be stipulated by the Head of the Board.

CHAPTER VI
LABEL

Article 7

(1) Labels of functional food shall meet the provisions in Decision of the Board of the Food and Drug Supervisory Board No. HK.00.05.52.4321 on general guidelines on the labeling of food products.

(2) The labels of functional food shall mention warning and other information in accordance with recommendations of the Peer Reviewer Team.

(3) The labels of functional food shall mention claim about content of nutrition, function of nutrition and/or benefit to the health as contained in the attachment to this regulation.

(4) The functional food can mention claims other than those mentioned in paragraph (3) after securing approval from the Head of the Board on the basis of recommendations of the Peer Reviewer Team.

Article 8

(1) If functional food labels emphasize one functional component or more having nutrition sufficiency figure not yet stipulated or description of food certifies the advantage of the material, the percent of content (b/b) of the material shall be mentioned.

(2) If food labeling emphasizes on one material or more having low content, the percentage of content of the material shall be disclosed.

CHAPTER VII
ADVERTISING

Article 9

Functional food only can be advertised after securing approval of registration.

Article 10

(1) Substances of functional food advertisements shall secure approval from the Head of the Board, before the distribution.

(2) Procedures for securing the approval of functional food advertisement shall be regulated further in a special regulation.

CHAPTER VIII
SANCTION

Article 11

Any violation of the provisions in this regulation shall be liable to administrative sanction and criminal sanction in accordance with the provisions of the law in force.

CHAPTER IX
CONCLUSION

Article 12

The Head of the Board shall stipulate further matters not yet regulated sufficiently in this regulation.

Article 13

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

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

Stipulated in Jakarta
On January 27, 2005
THE HEAD OF THE FOOD AND DRUG SUPERVISORY BOARD
H. SAMPURNO