Regulations Of The Food And Drug Supervisory Agency Number Hk. 03.1.23.11.11.09657 In 2011

Original Language Title: Peraturan Badan Pengawas Obat dan Makanan Nomor HK.03.1.23.11.11.09657 Tahun 2011

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Read the untranslated law here: http://peraturan.go.id/inc/view/11e44c50b6eadff0a4b2313233303237.html

Microsoft Word-bn809-2011 REPUBLIC of INDONESIA No. 809, 2011 DRUG SUPERVISORY and MAKANANAN. Nutrients and Non-nutrients. The addition of. Processed Food. REGULATION of the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the REPUBLIC of INDONESIA NUMBER HK. 03.1.23.11.11.09657 in 2011 ABOUT the REQUIREMENTS of the ADDITION of NUTRIENTS and SUBSTANCES NON PROCESSED FOOD with NUTRITION in the MERCY of GOD ALMIGHTY HEAD of FOOD and DRUG WATCHDOG AGENCY of the Republic of INDONESIA, Considering: a. that the public needs to be protected from the processed food that does not meet the requirements of security, quality, and nutrition; b. that the arrangements regarding the requirements for addition of nutrients and non-nutrients in the regulations the head of food and drug Watchdog Agency Number HK. 00.05.1.52.3572 in 2008 about the addition of Nutrients and Non-Nutrients In food products are not in accordance with the development of science and technology; b. that based on considerations as referred to in letter a and letter b need to set rules of the head of the food and drug Watchdog Agency about the requirements for addition of Nutrients and substances for Non Food Nutrition in Processed; www.djpp.kemenkumham.go.id 2011, no. 809 2 Remember: 1. Act No. 7 of 1996 on Food (Gazette of the Republic of Indonesia Number 99 in 1996, an additional Sheet of the Republic of Indonesia Number 3656); 2. Law number 8 of 1999 on the protection of the consumer (State Gazette of the Republic of Indonesia Number 42 in 1999, an additional Sheet of the Republic of Indonesia Number 3821); 3. Act No. 36 of 2009 about health (State Gazette of the Republic of Indonesia Number 144 in 2009, an additional Sheet of the Republic of Indonesia Number 5063); 4. Government Regulation Number 69 in 1999 about labeling and advertising of food (Gazette of the Republic of Indonesia year 1999 Number 131, an additional Sheet of the Republic of Indonesia Number 3867); 5. Government Regulation Number 28 in 2004 about the safety, quality and nutrition of the food (the State Gazette of the Republic of Indonesia Number 107 in 2004, an additional Sheet of the Republic of Indonesia Number 4384); 6. Presidential Decree Number 103 in 2001 about the position, duties, functions, authorities, Organization, Arrangement and Layout of Non Government agencies Work Department as it has several times changed the last presidential regulation Number 64 in 2005; 7. Presidential Decree Number 110 in 2001 about the Organizational Unit, and the task of the Non Government agencies I Echelon Department as it has several times changed the last presidential regulation Number 52 in 2005; 8. The decision of the head of the food and drug Supervisory Agency Number 02001/SK/KBPOM/2001 on the Organization of Work and the food and drug Supervisory Agency as amended by decision of the head of the food and drug Supervisory Agency Number HK. 00.05.21.4231 2004; DECIDED: Setting: RULE The HEAD Of FOOD And DRUG WATCHDOG AGENCY ABOUT The REQUIREMENTS For ADDITION Of NUTRIENTS And SUBSTANCES For NON FOOD NUTRITION In PROCESSED. www.djpp.kemenkumham.go.id 2011, no. 8093 CHAPTER I GENERAL PROVISIONS article 1 In this regulation, the definition of: 1. The processed Food is food or beverage process results in a manner or method, with or without additional material. 2. Raw materials are the basic materials used to produce food, either fresh or processed food food semi-finished. 3. Nutrients is the substance which gives the energy needed for growth, development and/or maintenance of health, that if a shortage or excess can cause biochemical and physiological characteristics changes of the body. 4. Substances of Non Nutrients is a substance found in food do not serve as nutrients but affect health. 5. Baby Formula is a formula as a substitute for breast milk (ASI) to infants until the age of 6 (six) months that are specifically formulated to be the sole source of nutrition in the first months of life until the baby was introduced with the food escort breast milk (MP-ASI). 6. Advanced Formula is the formula obtained from cow's milk or milk of another animal and/or material derived from animals and/or plants that come from all of which has been proven suitable for infants aged more than 6 (six) to 12 (twelve) months and children aged 1 (one) to 3 (three) years. 7. Nutritional value Information is a list of the contents of nutrients in food on the food label in accordance with a standardised format. 8. Nutrition Claims are statements, advice or something related to a particular nutritional properties including, but not limited to, energy value, protein, fat and carbohydrates, as well as the content of vitamins and minerals. 9. Health claims are claims that States the relationship of food or substances contained in the food with health. 10. Food Label is any description of the foodstuff in the form of pictures, writings, a combination of both, or other forms that are included in the food, put in, affixed to, or a part of the food packaging. 11. Trade is any individual person or business entity, either in the form of a legal entity or not legal entities www.djpp.kemenkumham.go.id 2011, no. 809 4 established and domiciled or conduct activities within the jurisdiction of the Republic of Indonesia, either alone or jointly through the agreement to convene the business activities in different areas of the economy. 12. The head of the Agency is the head of the food and drug Supervisory Agency of the Republic of Indonesia. CHAPTER II SCOPE article 2 Nutrients and substances of Non nutrients provided for in these regulations consist of: a. Dokosaheksaenoat Acid (Docosahexaenoic Acid/DHA); b. Arakidonat Acid (Acid/Arachidonic FIG); c. Lutein; d. Sphingomyelin; and e. Gangliosida. CHAPTER III the TERMS of the first part of the raw material requirements of the DHA and ARA article 3 of raw materials allowed DHA and ARA used in Processed Food can come from: 1. the fish oil, in the form of: a. the preparation of DHA Oils; and b. Preparation of powder DHA. 2. single cell oil, be either: a. DHA Oil Preparations; and b. the FIG Oil Preparations. Article 4 (1) Oil DHA Preparations referred to in article 3 1 a must meet the specifications as listed in Annex I which is part an integral part of this regulation. www.djpp.kemenkumham.go.id 2011, no. 28 (2) DHA Powder Preparations referred to in article 3 1 letter b must meet the specifications as listed in annex II which are part an integral part of this regulation. (3) Preparations of DHA Oils as referred to in article 2 letter a 3 digit must meet the specifications as listed in Annex III which is part an integral part of this regulation. (4) FIG Oil Preparations referred to in article 3 number 2 letter b must meet the specifications as listed in Annex IV that is part an integral part of this regulation. Article 5 Compliance against the requirements of the specifications referred to in article 4 must be evidenced by a certificate of analysis issued by an accredited testing laboratory in accordance with the legislation. The second part of the article 6 Information Label Requirements about the content of DHA and ARA can only be listed in the label information section on nutritional value. Part three article 7 ban on Trade is prohibited: a. adding Lutein, Sphingomyelin, and Gangliosida on infant Formula and Follow-up Formula; and/or b. lists and advertise nutrition claims and health claims about DHA and ARA in infant Formula and Follow-up Formula; CHAPTER IV article 8 ADMINISTRATIVE ACTIONS (1) violation of the provisions of this Regulation may be subject to administrative action. www.djpp.kemenkumham.go.id 2011, no. 809 6 (2) of administrative Action as referred to in paragraph (1), can be either: a. a written warning; b. the prohibition to circulate for a while; c. destruction of food if it proves injurious to health and the human soul; d. termination of production for a while; and/or e. revocation of production or business license. (3) the grant of administrative action as referred to in paragraph (2) was performed by the official of the issuer permits the production, business license, registration or approval of concerned in accordance with the duties and authority of each. (4) excluded from the provisions referred to in paragraph (3), an administrative action in the form of revocation of production or business license as referred to in paragraph (2) letter e can only be done by official publisher permission production or business license. Chapter V TRANSITIONAL PROVISION article 9 within 12 (twelve) months from this rule applies, the processed Food that has been in circulation must be adapted to the requirements stipulated in this regulation. CHAPTER VI CLOSING PROVISIONS article 10 with the introduction of these regulations, then the head of the Regulatory food and drug Watchdog Agency Number HK. 00.05.1.52.3572 in 2008 about the addition of Nutrients and Non-Nutrients In food products was revoked and declared inapplicable. Article 11 this Regulation comes into force from the date of promulgation. www.djpp.kemenkumham.go.id 2011, no. 8097 so that everyone knows it, ordered the enactment of this regulation with its placement in the news of the Republic of Indonesia. Established in Jakarta on November 18, 2011, at the HEAD of the FOOD and DRUG SUPERVISORY AGENCY of the Republic of INDONESIA, KUSTANTINAH Enacted in Jakarta on December 12, 2011 MINISTER of LAW and HUMAN RIGHTS Republic of INDONESIA, AMIR SYAMSUDDIN www.djpp.kemenkumham.go.id


2011, no. 809 of 8 ANNEX I RULE the HEAD of FOOD and DRUG WATCHDOG AGENCY of the REPUBLIC of INDONESIA NUMBER HK. 03.1.23.11.11.09657 in 2011 ABOUT the REQUIREMENTS of the ADDITION of NUTRIENTS and SUBSTANCES NON PROCESSED FOOD NUTRITION in the PREPARATION of SPECIFICATIONS of OIL DHA FISH OIL that COMES FROM the Requirements Specification Methods * common characteristics of colored light yellow Oil that has a distinctive aroma of fish oil ingredient in Visual: DHA (C22:6) (mg/g) min. 210 GC-FID DHA Ratio EPA: min. 4:1-total omega 3 fatty acids (mg/g) 265 Min. GC-FID total omega 6 fatty acids (mg/g) max. 100 GC-FID trans fatty acid (%) Max. 2 GC-FID Negative protein Residue Bicinconinic Acid moisture content (%) Max. Gravimetric 0.1 Askorbil palmitate (ppm) max. 5000 AOAC 2005 Ch 50 Tocopherol (ppm) max. 5000 AOAC 2005 Ch 50 Vitamin A (IU/ml) max. 100 HPLC Vitamin D (IU/ml) max. 50 HPLC Cholesterol (mg/g) max. 10 GC-MS/GC-FID chemical Characteristics: www.djpp.kemenkumham.go.id 2011, no. 8099 Specifications Requirements Method * number of iodium (g I2/100 g) min. 190 acid Number Titration (mg KOH/g) max. peroxide Number Titration 0.6 (meq O2/kg) max. 5 not Number Titration tersabunkan (%) Max. 2 Titration Numbers penyabunan (mg KOH/g) Min. 195 p-anisidine Titration Max. 15 AOCS Cd 18-90 (1997) totox Number max. 19-Impurities in metals: Arsenic (As) (ppm) max. GF-AAS 0.1 Cadmium (Cd) (ppm) max. 0.1 AAS of lead (Pb) (ppm) max. 0.1 AAS Mercury (Hg) (ppm) max. 0.1 AAS/MVU heavy metals (ppm) max. 10 Test the limits of heavy metal chemical Impurities: Dioxins and furans total (pg WHO-PCDD/F-TEQ/g fat) max. 2 GC-MS (IE) Dioxins, furans and dioxin-like PCBs total (pg WHO-PCDD/F-PCB TEQ/g fat) max. 10 GC-MS (IE) www.djpp.kemenkumham.go.id 2011, no. 809 10 Requirements Specification Methods * Benzo [a] piren (ppb) max. 2 HPLC the total Pesticide