to Indonesian
a. that the public needs should be protected from processed foods that do not meet security, quality, and nutrition requirements;
b. that the regulation on the requirements for supplement of nutrients and non nutrients in the Regulation of the Head of the Drug and Food Controller Agency No. HK.00.05.1.52.3572 of 2008 concerning Supplement of Nutrients and Non Nutrients in Food Products is not in accordance with the development of science and technology;
c. that based on the considerations as intended in paragraphs a and b, it is necessary to stipulate Regulation of the Head of Drug and Food Controller Agency concerning Requirements for Supplement of Nutrients and non nutrients In Processed Food;
1. Law No. 7/1996 concerning Food (Statute Book of the Republic of Indonesia No. 99/1996, Supplement to Statute Book of the Republic of Indonesia No. 3656);
2. Law No. 8/1999 concerning Consumer Protection (Statute Book of the Republic of Indonesia No. 42/1999, Supplement to Statute Book of the of the Republic of Indonesia No. 3821);
3. Law No. 36/2009 concerning Health (Statute Book of the Republic of Indonesia No. 144/2009, Supplement to Statute Book of the Republic of Indonesia No. 5063);
4. Government Regulation No. 69/1999 concerning Food Labeling and Advertising (Statute Book of the Republic of Indonesia No. 131/1999, Supplement to Statute Book of the of the Republic of Indonesia No. 3867);
5. Government Regulation No. 28/2004 concerning Food Safety, Quality and Nutrients (Statute Book of the Republic of Indonesia No. 107/2004, Supplement to Statute Book of the of the Republic of Indonesia No. 4424);
6. Presidential Decree No. 103/2001 concerning Position, Task, Function, Authority, Organizational Structure and Work Flow of Non Ministerial Government Agencies as amended several times, the latest by Presidential Decree No. 64/2005;
7. Presidential Decree No. 110/2001 concerning Organization Unit, and Tasks of Non Ministerial Government Agencies as amended several times, the latest by Presidential Decree No. 52/2005;
8. Decree of the Head of Drug and Food Controller Agency No. 02001/SK/KBPOM/2001 concerning Organization and Work Flow of Drug and Food Controller Agency, as amended by Decree of the Head of Drug and Food Controller Agency No. HK.00.05.21.4231 of 2004;
REGULATION OF THE HEAD OF DRUG AND FOOD CONTROLLER AGENCY CONCERNING REQUIREMENTS FOR SUPPELEMENT OF NUTRIENTS AND NON NUTRIENTS IN PROCESSED FOODS.
In this Regulation:
1. Processed foods are foods or beverages process results in a certain manner or method, with or without supplement substances.
2. Substances are basic materials used to produce food, either fresh food or intermediate processed food.
3. Nutrients are substance that provides energy needed for growth, development and/or maintenance of health, if the deficiency or excess can cause changes in biochemical and physiological characteristics of the body.
4. Non Nutrients are substances found in food that do not serve as nutrients but affect health.
5. Infant formula is a formula instead of breast milk (ASI) for infants up to age 6 (six) months that is specifically formulated to be the sole source of nutrition in the first months of life until the infants were introduced to foods as breast milk complementary (MP-ASI).
6. Advanced formula is a formula derived from cow's milk or other animal milk and/or substances derived from animal and/or derived from plants which all have been proven suitable for infants aged more than 6 (six) up to 12 (twelve) months and children aged 1 (one) to 3 (three) years.
7. Nutritional value information is a list of nutrient content of food on the food label in accordance with a standardized format.
8. Nutrition claims are statements, advice or anything related to the certain nutritional characteristics including but not limited to, the value of energy, protein, fat and carbohydrates contains, also vitamins and minerals contains.
9. Health claims are claims that the relationship of food or substances contained in food with health.
10. Food label is a description of each food in the form of images, text, a combination of both, or another form that is included in the food, put in, affixed to, or is part of food packaging.
11. Business Entity is any individual or business entity, whether legal or not a legal entity, established and domiciled or conducting activities within the jurisdiction of the Republic of Indonesia, either individually or jointly by agreement carry on business in various economic fields.
12. Head of Agency is the Head of the Drug and Food Controller Agency of the Republic of Indonesia.
Nutrients and Non Nutrients are governed in this Regulation consist of:
DHA and ARA substances are allowed to be used in Processed Food can be derived from:
1. oily fish, such as:
2. single cell oils, such as:
(1) DHA Oil preparations as intended in Article 3 paragraph 1 a must meet specifications as listed in Attachment I that is an integral part of this Regulation.
(2) DHA powder preparations as intended in Article 3 paragraph 1 b must meet specifications as listed in Attachment II that is an integral part of this Regulation.
(3) DHA Oil preparations as intended in Article 3 paragraph 2 a must meet specifications as listed in Attachment III which is an integral part of this Regulation.
(4) The preparation ARA oils as intended in Article 3 paragraph 2 b must meet specifications as listed in Attachment IV that is an integral part of this Regulation.
Compliance with the requirements of the specifications as intended in Article 4 must be proved by certificate of analysis issued by an accredited testing laboratory in accordance with rules.
Information about the content of DHA and ARA can only be included in the label on the Nutritional Value Information.
Business Entities are prohibited to:
(1) Violation of the provisions of this Regulation may be subject to administrative measures.
(2) The administrative measures as intended in paragraph (1), can be:
(3) The provision of administrative measures as intended in paragraph (2) carried by the official issuing of production licenses, business licenses, or registration approval in accordance with each duties and authority.
(4) Excluded from the provisions as intended in paragraph (3), an administrative measure in the form of revocation of production licenses or business licenses as intended in paragraph (2) e can only be done by the official issuing production licenses or business licenses.
Within a maximum period of 12 (twelve) months from this Regulation enacted, Processed Foods which has been circulating must follow to the requirements stipulated in this Regulation.
With the enacted of this Regulation, the Regulation of the Head of the Drug and Food Controller Agency No. HK.00.05.1.52.3572 of 2008 concerning Supplement of Nutrients and Non Nutrients in Food Products shall be revoked and declared null and void.
This Regulation shall come into force on the date of promulgation.
For public cognizance, this Regulation shall be promulgated by placing it in the State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on November 18, 2011
HEAD OF DRUG AND FOOD CONTROLLER AGENCY
signed.
KUSTANTINAH
STATE GAZETTE OF THE REPUBLIC OF INDONESIA No. 809/2011