DECISION OF HEAD OF DRUG AND FOOD SUPERVISORY BOARD OF REPUBLIC OF INDONESIA
No. HK.00.05.1.2569

CONCERNING
CRITERIA AND PROCEDURES OF FOOD PRODUCTS ASSESSMENT

HEAD OF DRUG AND FOOD SUPERVISORY BOARD,

Attachment

Considering:

• a. whereas upon the fast growth in number and type of food products circulated in Indonesia, either domestic made or imported, then it is necessary to apply an effective supervision system before and after the products have been distributed;
• b. whereas to protect people from distribution of food products that do not meet the provision on standard and or requirements, safety, quality, and nutrition as well as food label, it is necessary to carry out assessment prior to distribution;
• c. with regard to point a and b above, it is necessary to stipulate Decision of Head of Drug and Food Supervisory Board on Criteria and Procedures of Food Products Assessment.

In view of:

• 1 Law of Republic of Indonesia No. 23/1992 on Health (Statutory Gazette of Republic of Indonesia Year 1992 No. 100, Supplementary Statutory Gazette of Republic of Indonesia No. 3495);
• 2. Law of Republic of Indonesia No. 7/1996 on Food (Statutory Gazette of Republic of Indonesia Year 1996 No. 99, Supplementary Statutory Gazette of Republic of Indonesia No. 3656);
• 3. Law of Republic of Indonesia No. 8/1999 on Consumer Protection (Statutory Gazette of Republic of Indonesia Year 1999 No. 42, Supplementary Statutory Gazette of Republic of Indonesia No. 3821);
• 4. Regulation of Government of Republic of Indonesia No. 69/1999 on Food Label and Advertisement (Statutory Gazette of Republic of Indonesia Year 1999 No. 131, Supplementary Statutory Gazette of Republic of Indonesia No. 3867);.
• 5. Regulation of Government of Republic of Indonesia No. 17/2001 on Rate of Non Tax State Revenue applicable to Drug and Food Supervisory Board (Statutory Gazette of Republic of Indonesia Year 2001 No. 35 Supplementary Statutory Gazette of Republic of Indonesia No. 4087);
• 6. Presidential Decree No. 103/2001 on Position, Duty, Authority and Structure of Organization of Government Agency Non Department, as has been amended with Presidential Decree No. 46/2002;
• 7. Presidential Decree No. 110/2001 on Unit of Organization and Duty of Echelon I of Government Agency Non Department, as has been amended with Presidential Decree No. 48/2002;
• 8. Decision of Head of Drug and Food Supervisory Board No. 02001/SK/KBPOM on Organization and Code of Conduct of Drug and Food Supervisory Board.

DECIDED:

To stipulate:

DECISION OF HEAD OF DRUG AND FOOD SUPERVISORY BOARD ON CRITERIA AND PROCEDURES OF FOOD PRODUCTS ASSESSMENT

CHAPTER I
GENERAL PROVISION

Article 1

In this decision meant by:

• 1. Assessment of food products shall be assessment process in the framework of supervision of food products before distributed covering safety, quality and nutrition and label of food products to secure Food registration number.
• 2. Food products shall be processed food either domestic product or imported distributed in retail package and labeled.
• 3. Supplements shall be substances originally not used as food and usually not typical ingredient of food, either containing nutrition value or not, purposely added into food for technology (including organoleptic) in the production, processing, preparation, treatment, packing, wrapping, storage or transportation of food to produce or to expect production of (direct or indirect) a component or to affect the typical nature of the food.
• 4. Processed food shall be food or beverage result of process in certain way or method with or without supplement.
• 5. Special Food shall be processed food among other things specifying claim, logo or special sign on the label, genetically engineered food product (PRG food), irradiation food, functional food and organic food.
• 6. Specific processed food shall be processed food for consumption of certain group, such as formula milk for baby, food for pregnant or suckling mother, Special Food for sufferer of certain disease, or other similar food having significant effects toward development of human health quality, including food for baby and children, food for those undergoing special diet, food for elder people.
• 7. Food label shall be any information concerning food in form of picture, writing, combination of both, or other forms accompanied the food, entered into, patched to, or being part of the food wrapping.
• 8. Applicant shall be producer, importer, and or distributor of food products who has secured business license pursuant to the provision of prevailing statutory regulation.
• 9. Producer shall be individual and or business entity manufacturing, processing, changing form, preserving, repackaging food products for distribution.
• 10. Assessor shall be Team appointed by Board Head to carry out assessment of safety, quality and nutrition and food label.
• 11. Food Products Registration Number shall be number provided for processed food in the framework of food distribution
• 12. Board Head shall be Head of Drug and Food Supervisory Board of Republic of Indonesia.
• 13. Deputy shall be Deputy of Supervisory of Safety Food and Dangerous Material Drug.

Article 2

(1) Food products distributed in the territory of Indonesia shall be obliged to meet requirements of safety, quality, and nutrition and food label.

(2) In order to meet requirements as intended in paragraph (1), food products shall be assessed by Board Head prior to distribution.

(3) Food products based on assessment declared to have satisfied the requirements as intended in paragraph (1) shall be provided with Food Products Registration Number.

Article 3

Exception from provision as intended in Article 2 paragraph (2) shall be given to:

• a. processed food produced by home industry that has attended workshop;
• b. processed food expired no more than 7 (seven) days in room temperature;
• c. processed food entered to Indonesian territory in small quantity for purpose of:
• 1. assessment of food products;
• 2. research;
• 3. own consumption.

CHAPTER II
CRITERIA OF FOOD PRODUCTS

Article 4

Food products eligible for securing Food Products Registration Number shall satisfy criteria concerning:

• a. safety covering maximum limit of microbe pollution, chemical pollution, physical pollution and pollution of other dangerous substances;
• b. quality assurance assessed from production process pursuant to Good Practice of Food Production.
• c. nutrition pursuant to stipulated requirements such as information on nutrition value and nutrition adequacy rate.
• d. information and or statement on the label must be true and not misleading, either concerning writing, picture or any other form pursuant to the prevailing provision and specify at least information concerning:
• 1. name of product;
• 2. net weight or net content; and
• 3. name and address of party producing or entering food to Indonesian territory.

CHAPTER III
PROCEDURES OF ASSESSMENT OF FOOD PRODUCTS

Article 5

(1) Applicant shall be obliged to complete Registration Form in order to apply for assessment of food products in writing.

(2) Applicant shall be responsible for:

• a. completeness of submitted documents;
• b. validity of information specified in Registration documents;
• c. validity and legality of documents attached for Registration;
• d. change of data and information of products that have secured Registration Approval Certificate.

(3) Any change as intended in paragraph (2) letter d shall obtain Board Heads approval.

Article 6

(1) Producer of domestic or imported food products of which the products are in assessment process shall be obliged to prepare for inspection.

(2) Inspection as intended in paragraph (1) shall be conducted against production structure and facilities including administration facilities pursuant to guidelines on Good Practice of Food Production.

(3) Importer and or distributor shall be obliged to be inspected concerning structure and facilities owned including administration facilities pursuant to guidelines on Good Practice of Food Distribution.

(4) Inspection as intended in paragraph (1), and (3) shall be conducted by officer appointed by Board Head.

Article 7

Producer, importer and or distributor shall be obliged to guarantee safety, quality, and nutrition and label of food distributed pursuant to information proposed in the framework of Registration approved by Board Head.

Article 8

(1) Registration of food products to Drug and Food Supervisory Board shall be conducted by producer, importer and or distributor.

(2) Registration of food products as intended in paragraph (1) may only be conducted by a competent person and secure power of attorney from producer, importer and or distributor.

Article 9

(1) Registration proposal shall be conducted by submitting Registration documents in 2 (two) copies to Drug and Food Supervisory Board for inspection of document supplies and stipulation of costs in accordance with type of food products.

(2) Document supplies as intended in paragraph (1) including:

• a. Registration Form filled in correctly and completely pursuant to guidelines;
• b. sample of food products concerned
• c. design of color label and brochures if any
• d. in addition to those listed in letter (a, b, and c), Applicant should enclose:
• 1. for domestic product food: copy of license or registration certificate from Industry and Trading Ministry, or license from Capital Investment Coordinating Board pursuant to prevailing provision.
• 2. for repackaged products: in addition to enclosures as intended in point 1 should also be accomplished with certification from original manufacturer.
• 3. for food produced under license and or the kind: in addition to enclosures as intended in point 1 should also be accomplished with license certificate and or the kind from original manufacturer.
• 4. for imported products: appointment letter from manufacturer abroad; health certificate or Free Sale and other certificates pursuant to prevailing provision.

(3) Based on the result of inspection as intended in paragraph (1) Applicant shall be provided with introduction letter of payment at appointed bank using P1 form.

(4) Payment Receipt shall be enclosed to Registration documents submitted to Drug and Food Supervisory Board for assessment.

Article 10

Registration of food products fee as intended in article 9 paragraph (1) shall be pursuant to provision of Regulation of Government No. 17/2001 on Tariff for Non Tax State Revenue (PNBP) applicable for Drug and Food Supervisory Board.

Article 11

(1) Registration documents as intended in Article 9 paragraph (1) shall consist of:

• a. form A containing general information concerning food, name or address of applicant, and factory or company;
• b. form B containing information concerning composition, quality of substance, container and cap; method of production, including method of cleaning the container and cap; quality control and final products test;
• c. form C containing information on Good Practice of Food Production.

(2) Form A, B and C as intended in paragraph (1) constitutes documents that must be supplied for Registration of food products pursuant to Appendix 1.

(3) In addition to Registration documents as intended in paragraph (1), it is necessary to supply supporting documents on technical data to assure safety, quality and nutrition, and claim label of food products.

Article 12

(1) Registration form and documents shall be in bahasa Indonesia or English.

(2) Registration Form shall be completed pursuant to Appendix 2.

CHAPTER IV
ASSESSMENT

Article 13

Registration of food products documents fulfilling provision of Article 9 shall be assessed for safety, quality and nutrition and label pursuant to the risk level.

Article 14

(1) Assessment of Registration documents shall be carried out by Assessor Team of food products of Drug and Food Supervisory Board.

(2) if necessary, a National Committee for Assessor of Food products may be established involving experts in safety, quality and nutrition and food label.

(3) Establishment of duty and function of Assessment Team and or National Committee of Assessor of Food products as intended in paragraph (1) and paragraph (2) shall be stipulated by Board Head.

CHAPTER V
DECISION MAKING

Article 15

(1) Based on recommendation of Assessor, Board Head shall make decision.

(2) Decision as intended in paragraph (1) shall be made at the latest 60 business days commencing receiving of complete and correct Registration documents.

Article 16

(1) Decision as intended in article 15 may be in term of approval, request for additional data or refusal.

(2) Food products securing Registration approval shall be provided with Food Products Registration Number using form P2 along with label designed approved.

(3) Domestic Food Products Registration Number shall be provided with label BPOM RI MD and Imported Food Products Registration Number shall be marked with BPOM RI ML.

(4) For food products requiring additional data, Applicant shall be notified in writing concerning requirements for additional data that must be satisfied using form P3.

(5) Requirements as intended in paragraph (4) may be in term of result of inspection or test by Head Office or Drug and Food Supervisory Board for validity of information provided by Applicant.

(6) Decision for Registration that still requires additional data shall be stipulated at the latest 6 months as of notification as intended in paragraph (4).

(7) Decision for refusal of Registration shall be notified in writing to Applicant along with reasons for the refusal using form P4.

Article 17

(1) Applicant wishing to make change of food products securing Food Products Registration Number shall be obliged to apply in writing to Board Head using form P5.

(2) Change of food products as intended in paragraph (1) may be made provided that not change Food registration number.

(3) Change of food products as intended in paragraph (1) may be made after 3 (three) months as of approval date.

CHAPTER VI
HEARING

Article 18

(1) In case there is objection against result of assessment on safety, quality, and nutrition and food products label by Assessor Team and or National Committee of Assessor of Food products as intended in Article 16, Applicant may propose hearing in writing to Board Head.

(2) Proposal as intended in paragraph (1) shall be submitted at the latest 15 days as of date of notification of result of assessment on safety, quality, and nutrition and food products label.

CHAPTER VII
REVIEW

Article 19

(1) In case there is objection against refused Registration as intended in Article 16 paragraph (7), Applicant may apply for review to Board Head in writing.

(2) Review as intended in paragraph (1) may be proposed at the latest 1 (one) month as of refusal and may only be proposed 1 (once).

(3) Review should be accomplished with new data and or old data with justification.

Article 20

In case Registration is refused due to safety, quality, and nutrition and food products label reasons, Re-registration may only be proposed after there has been newest scientific evidences at the shortest 3 (three) months after refusal date.

CHAPTER VIII
REGISTRATION APPROVAL CERTIFICATE PERIOD

Article 21

(1) Registration Approval Certificate shall be valid for 5 (five) years provided that it still satisfies the prevailing provision.

(2) expired Registration Approval Certificate, should be re-registered.

CHAPTER IX
IMPLEMENTATION OF REGISTRATION APPROVAL CERTIFICATE

Article 22

Supply of ready distribution label shall be carried out at the latest 3 months after approval of Registration.

CHAPTER X
REASSESSMENT

Article 23

(1) Food products that has secured Registration approval may be reassessed by Board Head if it is finds matters contradicting with development of science and technology.

(2) Reassessed Food products as intended in paragraph (1) shall be drawn from distribution by Applicant.

CHAPTER XI
REGISTRATION APPROVAL CERTIFICATE CANCELLATION

Article 24

(1) Board Head may cancel Registration Approval Certificate if one of the followings occurs:

• a. at the request of the producer, importer and or distributor applying for assessment on safety of food products,
• b. distributed food products are not in accordance with data approved during arrangement of Registration Approval Certificate,
• c. food products promoted deviate from prevailing provision,
• d. food products are no longer manufactured or imported,
• e. it is found matters contradicting with development of science and technology,.
• f. brand used has been duly registered by other party to the competent authority.
• g. based on survey and or monitoring after distribution, it appears not satisfying criteria as intended in Article 4,
• h. failure to perform obligation as intended in article 5, article 21 and article 22
• i. food industry license to produce, importer license, and or distributor license is revoked
• j. owner of Registration Approval Certificate commits infringement in production and or distribution of food products.

(2) Cancellation of Registration Approval Certificate for food products shall be carried out by Board Head using form P6.

CHAPTER XII
SANCTION

Article 25

(1) Those distributing food products not pursuant to provision herein may be imposed with administrative sanction in term of:

• a. written warning;
• b. temporary termination of activities;
• c. dissolution and/or cancellation of Registration Approval Certificate of Food products concerned;
• d. drawing of food products from market
• e. other administrative sanction pursuant to prevailing statutory regulation.

(2) Beside subjecting to administrative sanction as intended in paragraph (1) it may be imposed criminal sanction pursuant to provision of prevailing statutory regulation.

CHAPTER XIII
TRANSITIONAL PROVISION

Article 26

Any provision of statutory regulation on Criteria and Procedures of Food Products Assessment issued prior to stipulation hereof shall remains enforceable provided that it is not in contradiction or not yet superseded by provision hereof.

CHAPTER XIV
CLOSING PROVISION

Article 27

This Decision shall be effective as of stipulation date.

For public cognizance, this decree shall be published by placing it in the Statutory Gazette of Republic of Indonesia.

Stipulated in: JAKARTA
Dated: 31 May 2004
Head of DRUG AND FOOD SUPERVISORY BOARD,
H. SAMPURNO

Attachment to DECISION OF HEAD OF DRUG AND FOOD SUPERVISORY BOARD
No. HK.00.05.1.2569