THE REPUBLIC OF INDONESIA NEWS

No. 809, 2011 THE SUPERVISORS OF THE DRUG AND MACANANAN. Nutritionist and non-Gizi. The addition. Food

Olahan.

REGULATION OF THE DRUG AND FOOD SUPERVISORS HEAD

REPUBLIC OF INDONESIA

NUMBER HK.03.1.23.11.11.09657 IN 2011

ABOUT

REQUIREMENTS OF THE ADDITION OF NUTRITIONAL AND NON-NUTRITION SUBSTANCES

IN PROCESSED FOODS

WITH THE GRACE OF GOD ALMIGHTY

HEAD OF THE DRUG AND FOOD SUPERVISORS

REPUBLIC OF INDONESIA,

DRAWS: A. that the public needs to be protected from processed foods that do not meet the safety, quality, and nutrition requirements;

b. that arrangement concerning the requirements of the addition of malnutrition and non-nutrition in the Regulation of the Head of the Food and Drug Administration HK.00.05.1,52,3572 Year 2008 on Adding Nutritional And Non-Gizi substances in the Food Products is already not compatible with the development of science and technology;

b. that based on consideration as intended in the letter a and the letter b need to establish the Rule of the Head of the Drug and Drug Administration on the Nutritional Requirements and Nutrient Non-nutrition In processed foods;

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2011, No. 809 2

Given: 1. Law No. 7 of 1996 on Food (State Gazette of Indonesia in 1996 Number 99, Additional Gazette of the Republic of Indonesia Number 3656);

2. Law No. 8 of 1999 on Consumer Protection (State Sheet of Indonesia in 1999 No. 42, Additional Gazette of the Republic of Indonesia Number 3821);

3. Law Number 36 Year 2009 on Health (State Gazette of Indonesia Year 2009 Number 144, Additional Gazette Republic of Indonesia Number 5063);

4. Government Regulation No. 69 of 1999 on Label and Food Advertising (State Sheet of Indonesia Year 1999 Number 131, Additional Gazette Republic of Indonesia Number 3867);

5. Government Regulation No. 28 of 2004 on Security, Mutu and Food Nutrition (State Gazette 2004 No. 107, Additional Gazette of the Republic of Indonesia No. 4424);

6. President's decision number 103 of 2001 on the position, duties, functions, authority, organizational structure and work order of the non-department government agencies as amended last several times with the Presidential Regulation No. 64 of 2005;

7. The Presidential Decree No. 110 of 2001 on the Organization Unit, and the Eselon Task Force of the Non-Department Government, as amended last several times with Presidential Regulation No. 52 of 2005;

8. Decision of the Head of the Food and Drug Administration Number 02001 /SK/KBPOM/2001 on the Organization and the Working Services of the Food and Drug Administration as amended by Decision of Head of the Board of Drug and Drug Administration HK.00.05.21.4231 Year 2004;

DECIDED:

SET: THE REGULATION OF THE HEAD OF THE DRUG AND FOOD SUPERVISORS ON THE REQUIREMENTS OF THE ADDITION OF MALNUTRITION AND NON-NUTRITIOUS SUBSTANCES IN PROCESSED FOODS.

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2011, No. 8093

BAB I

provisions of UMUM

Article 1

In this Regulation, which is referred to:

1. Processed foods are food or beverage products processes in a particular way or method, with or without additional material.

2. Raw materials are the basic ingredients used to produce food, whether fresh food or processed foods are half so.

3. A nutritionist is a substance that gives energy, necessary for growth, development and/or health care, which if the deficiency or excess can lead to changes in the biochemical and physiological characteristics of the body.

4. The non-nutritious substance is the substance that is in food that does not serve as a nutritional substance but affects health.

5. Formula Baby is the formula as a substitute for breast milk for the baby until the age of 6 (six) months specifically formulated to be the only source of nutrition in the first months of her life until the baby is introduced with a Mother's milk bath food.

6. The Advanced formula is a formula obtained from cow ' s milk or other animal milk and/or materials derived from animals and/or those derived from plants that have all been proven appropriate for infants aged over 6 (six) to 12 (two) The month and child ages 1 (one) to 3 (three) years.

7. Nutritional value information is a list of the ingredients of food nutrition on food labels according to the standardized format.

8. Nutritional claims are statements, suggestions or something related to certain nutritional properties including, but not limited to, energy values, protein content, fats and carbohydrates, as well as vitamin and mineral content.

9. A Health claim is a claim that claims food or substance is contained in food with health.

10. A Food Label is any description of a food-shaped food, a writing, a combination of the two, or any other form that is included on food, put in, pasted on, or is a packaged section of food.

11. An Entity is a person or entity that is a legal entity or not a legal entity

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2011, No. 809 4

established and located or performing activities within the country's legal territory of the Republic of Indonesia, both alone and together through the agreement of organizing business activities in a variety of economic fields.

12. The head of the Agency is the head of the Indonesian Food and Drug Administration.

BAB II

SCOPE

Article 2

The Gizi Substance and the Non-Gizi Substance are set up in this Regulation are:

a. Dokosahexaenoic acid (Docosahexaenoic Acid/DHA);

b. Arakidonic Acid (Arachidonic Acid/ARA);

c. Lutein;

d. Sphingomyelin; and

e. Gangliocide.

BAB III

REQUIREMENTS

First Section

Default Materials Requirements DHA and ARA

Article 3

The raw materials DHA and ARA permitted use in the Food Olahan can be derived from:

1. Fish oil, which is:

a. DHA Oil Supplies; and

b. The DHA Powder.

2. Single-cell oil, which is:

a. DHA Oil Supplies; and

b. ARA Oil.

Section 4

(1) The provisions of DHA Oil as referred to in Article 3 of the letter 1 letter a must meet the specifications as set forth in Annex I which is an inseparable part of this Regulation.

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2011, No. 8095

(2) The supply of DHA Serbuk as referred to in Article 3 of the letter 1 letter b must meet the specifications as set forth in Annex II which is an inseparable part of this Regulation.

(3) Supplied The DHA oil as referred to in Article 3 of the 2-letter figure must meet the specifications as set forth in Annex III which is an inseparable part of this Regulation.

(4) ARA ' s Oil Supplies as referred to in Article 3 2 letter b 2 letters must meet the specifications as set forth in Annex IV to which is an integral part of this Regulation.

Section 5

The fulfilment of the specifications requirements as referred to in Section 4 must be proven by the certificate of analysis results published by the test laboratory Which is accredited by the terms of the laws.

Second Section

Label Requirements

Section 6

Information about the DHA and ARA content can only be included in the label on the Gizi Value Information section.

Third Section

Prohibition

Article 7

The offender was banned:

a. add Lutein, Sphingomyelin, and Gangliosida on Formula Baby and Advanced Formula One; dan/or

b. list and advertise nutritional claims and health claims about DHA and ARA in Formula Baby and Formula One.

BAB IV

ADMINISTRATIVE ACTIONS

Article 8

(1) The violation of the provisions in this Regulation can be subject to administrative actions.

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2011, No. 809 6

(2) The administrative actions as referred to in paragraph (1), may be:

a. warning in writing;

b. prohibition of circulate for a while;

c. the destruction of food if it proves to harm the health and soul of the human;

d. production outage for the time being; and/or

e. revocation of production or business permission.

(3) The granting of administrative actions as referred to in paragraph (2) is performed by a production license, business permit, or registration agreement in question according to the field. Tasks and authoring each.

(4) Excluded from the provisions as referred to in paragraph (3), an administrative action of the revocation of the production license or an attempt permit as referred to in paragraph (2) of the letter e may only be performed by a production permit issuer or effort.

BAB V

TRANSITIONAL provisions

Section 9

Within the longest 12 (twelve) months since this Regulation is applicable, the outstanding Food Olahan must be adjusted to the requirements as set in This rule.

BAB VI

provisions CLOSING

Article 10

With The Regulation of the Food and Drug Administration Number HK.00.05.1,52,3572 Year 2008 on Adding Nutritional And Non-Gizi substances in the Food Products is revoked and declared to be not applicable.

Article 11

Regulation It's been in effect from the date of the invitation.

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2011, No. 8097

For everyone to know, ordering the invitational of this Regulation with its placement in the News of the Republic of Indonesia.

Specified in Jakarta on November 18, 2011

THE HEAD OF THE BODY DRUG SUPERVISOR AND

FOOD REPUBLIC OF INDONESIA,

KUSTANTINAH

Diundâu in Jakarta On 12 December 2011

MINISTER OF LAW AND HUMAN RIGHTS

REPUBLIC OF INDONESIA,

AMIR SYAMSUDDIN

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2011, No. 809 8

ANNEX I REGULATIONS SUPERVISING BODY AND FOOD SUPERVISORS OF THE REPUBLIC OF INDONESIA NUMBER HK.03.1.23.11.11.09657 2011 ON THE REQUIREMENTS OF THE ADDITION OF NUTRITIONAL AND NON-NUTRITIOUS SUBSTANCES IN PROCESSED FOODS

SPECIFICATION

OIL SUPPLY

DERIVED FROM FISH OIL

SPECIFICATION OF METHOD REQUIREMENTS *

GENERAL CHARACTERISTICS OF COLOR OIL

bright yellow that

has a distinctive aroma

fish

Visual

The ingredients in oil:

DHA (C22: 6) (mg/g) Min. 210 GC-FID

Ratio DHA:EPA Min. 4: 1-

fatty acids omomega 3 total

(mg/g)

Min. 265

GC-FID

6 total omega fatty acids

(mg/g)

Maks. 100

GC-FID

trans fatty acids (%) Maks. 2 GC-FID

Residu Negative protein Bicinconinic Acid

Kadar water (%) Maks. 0.1 Gravimetry

Askorbil palmitat (ppm) Max. 5000 AOAC 2005 Ch 50

Tokoferol (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:

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2011, No. 8099

Method Requirements Specification *

iodine numbers (g I2/100g) Min. 190 Titration

Acid Numbers (mg KOH/g) Maks. 0.6 Titration

Numbers peroxide (meq

O2/kg)

Maks. 5

Titration

The numbers are not sputed

(%)

Maks. 2

Titration

The coding number (mg

KOH/g)

Min. 195 Titconstellations

Numbers p-anisidine Maks. 15 AOCS Cd 18-90

(1997)

Numbers totox Maks. 19-

Metal Cements:

Arsen (As) (ppm) Maks. 0.1 AAS-GF

Cadmium (Cd) (ppm) Maks. 0.1 AAS

Timbal (Pb) (ppm) Maks. 0.1 AAS

Merkuri (Hg) (ppm) (ppm) Maks. 0.1 AAS/MVU

Heavy metals (ppm) Maks. 10 Metal Limit Test

Weight

Chemical spurts:

Dioxins and furan total (pg

WHO-PCDD/F-TEQ/g fat)

Maks. 2 GC-MS (IE)

Dioxins, furan and dioxin-

like PCBs total (pg WHO-

PCDD/F-PCB TEQ/g fat)

Maks. 10 GC-MS (IE)

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2011, No. 809 10

Method Requirements Specification *

Benzo [a] piren (ppb) Maks. < 2 HPLC

Pesticide Total: GC-ECD, NPD/PFPD

a. Endosulfan (α, β-isomer) Maks. 0.1 ppm,

calculated as

endosulfateb. Endosulfan sulfate

c. Esfenvalerate

d. Chlordane Maks. 0.2 ppm,

calculated as

chlordanee. Oxychlordane

f. DDT

(dichlorodiphenyltrichloroetha

ne)

Maks. 0.05 ppm,

counts as DDT

g. DDD

(dichlorodiphenyldichloroetha

ne)

h. DDE

(dichlorodiphenyldichloroethyl

en)

i. Heptachlor (α, β-isomer) Maks. 0.2 ppm,

calculated as

heptachlorj. Heptachlor epoxide

k. Benzene hexachloride

* Can use other methods that are validated

HEAD OF THE DRUG AND FOOD SUPERVISORS

REPUBLIC OF INDONESIA,

KUSTANTINAH

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2011, No. 80911

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2011, No. 809 12

ANNEX II REGULATION OF THE HEAD AND FOOD SUPERVISORS OF THE REPUBLIC OF INDONESIA NUMBER HK.03.1.23.11.11.09657 IN 2011 ON THE TERMS OF THE ADDITION OF NUTRITIONAL AND NON-NUTRITIOUS SUBSTANCES IN PROCESSED FOODS

SPECIFICATION THE DHA POWDER

DERIVED FROM THE IKAN* OIL

SPECIFICATION OF THE METHOD REQUIREMENT * *

COMMON CHARACTERISTICS: WHITE MASHED

up to yelp,

with a distinctive aroma

fish

Visual

Material in powder:

Lemak (%) Min. 25 Gravimetry

DHA (C22: 6) (mg/g) Min. 50 GC-FID

Ratio of DHA:EPA Min. 4: 1-

Total omega fatty acid 3 total

(mg/g)

Min. 65

GC-FID

6 total omega fatty acids

(mg/g)

Maks. 50

GC-FID

trans fatty acids (%) Maks. 1 GC-FID

Residu protein (%) Negative Bicinconinic Acid

Susut drying (%) Maks. 3 Gravimetry

Ascorbil palmitat (ppm) Max. 5000 AOAC 2005 Ch 50

Tokoferol (ppm) Maks. 5000 AOAC 2005 Ch 50

Microbiology:

The total plate number of Maks. 1x104 coloni/g Quantitative Easing

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2011, No. 80913

Method Requirements Specification * *

Bacilus cereus Maks. 1x102 coloniation/g Quantitative

Enterobacteriace Negatif/5 g Qualitative

E. sakazakii Negatif/10 g Qualitative

Samonella Negatif/25 g Qualitative

Staphilococcus aureus

positive collament

Max. 1x101 colonials/Quantitative Easing

Metal Cements:

Arsen (As) (ppm) Maks. 0.1 AAS-GF

Cadmium (Cd) (ppm) Maks. 0.1 AAS

Timbal (Pb) (ppm) Maks. 0.1 AAS

Merkuri (Hg) (ppm) (ppm) Maks. 0.1 AAS/MVU

Heavy metals (ppm) Max. 10 Metal Boundary Test

Weight

Chemical Cemation:

Dioxins and furan total (pg

WHO-PCDD/F TEQ/g fat)

Maks. 2 GC-MS (IE)

Dioxins, furan and dioxin-like

PCBs total (pg WHO-PCDD/F-

PCB TEQ/g fat)

Maks. 10 GC-MS (IE)

Benzo [a] piren (ppb) Maks. < 2 HPLC

Pesticide Total: GC-

ECD, NPD/PFPD

a. Endosulfan (α, β-isomer) Maks. 0.1 ppm,

counts as b. Endosulfan sulfate

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2011, No. 809 14

Method Requirements Specification * *

c. Esfenvalerate endosulfate

d. Chlordane Maks. 0.2 ppm,

calculated as

chlordanee. Oxychlordane

f. DDT

(dichlorodiphenyltrichloroethane)

Maks. 0.05 ppm,

counts as DDT

g. DDD

(dichlorodiphenyldichloroethane)

h. DDE

(dichlorodiphenyldichloroethylen)

i. Heptachlor (α, β-isomer) Maks. 0.2 ppm,

calculated as

heptachlor

j. Heptachlor epoxide

k. Benzene hexachloride

* The fish oil used in the manufacture of DHA powder must

meet all requirements of the DHA Oil Supply Specification Requirements

From Fish Oil (Appendix I).

** Can use other methods of Validation

HEAD OF THE DRUG AND FOOD SUPERVISORS

REPUBLIC OF INDONESIA,

KUSTANTINAH

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2011, No. 80915

ANNEX III REGULATION OF THE HEAD AND FOOD SUPERVISORS OF THE REPUBLIC OF INDONESIA NUMBER HK.03.1.23.11.11.09657 2011 ON THE REQUIREMENTS OF THE ADDITION OF NUTRITIONAL AND NON-NUTRITIOUS SUBSTANCES IN PROCESSED FOODS

SPECIFICATION DHA ' S OIL

DERIVED FROM SINGLE CELL OIL

SPECIFICATION OF METHOD REQUIREMENTS *

COMMON CHARACTERISTICS: CLEAR-COLORED OIL

TO YELP,

HAS A DISTINCTIVE AROMA AND

NO TENGIC.

Visual

Materials in oil:

Askorbil palmitat (ppm) Maks. 5000 AOAC 2005 Ch 50

Tokoferol (ppm) Maks. 5000 AOAC 2005 Ch 50

Dokosahexadenoic acid

22: 6 n-3 (DHA) mg/g

Min. 210 GC-FID

trans fatty acids (% acid

total fat)

Maks. 2 GC-FID

Water Kadar (%) Max. 0.1 Gravimetry

chemical characteristic:

Numbers

sabunkan (%)

Maks 2

Titration

Numbers peroxide (meq

O2/kg)

Maks. 2

Titration

The coding number (mg

KOH/g)

Min. 170 Titration

Numbers iodine (g I2/100g) Min. 190 Titration

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2011, No. 809 16

Metal Cements:

Arsen (As) (ppm) (ppm) Maks. 0.1 AAS-GF

Cadmium (Cd) (ppm) Maks. 0.1 AAS

Timbal (Pb) (ppm) Maks. 0.1 AAS

Merkuri (Hg) (ppm) (ppm) Maks. 0.1 AAS/MVU

Heavy metals (ppm) Maks. 10 Metal Limit Test

Weight

Heksan (ppm) Max. 0.3 GC-FID

Hydrocarbon Solvent

aromatic (Aromatic

Hydrocarbon Solvent)-

as marker BTX

(Benzene, Toluene, Xylene)

Negative GC-FID

* Can use other methods that are Validate

BODY HEC DRUG AND FOOD SUPERVISOR

REPUBLIC OF INDONESIA,

KUSTANTINAH

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2011, No. 80917

ATTACHMENT IV REGULATIONS SUPERVISING BODY AND FOOD SUPERVISORS REPUBLIC OF INDONESIA NUMBER HK.03.1.23.11.11.09657 IN 2011 ON THE TERMS OF THE ADDITION OF NUTRITIONAL AND NON-NUTRITIOUS SUBSTANCES IN PROCESSED FOODS

SPECIFICATION FIG OIL

DERIVED FROM SINGLE CELL OIL

SPECIFICATION OF METHOD REQUIREMENTS *

COMMON CHARACTERISTICS: CLEAR-COLORED OIL

TO YELP,

HAS A DISTINCTIVE AROMA AND

NO TENGIC.

Visual

Materials in oil:

Askorbil palmitat (ppm) Maks. 1000 AOAC 2005 Ch 50

Tokoferol (ppm) Maks. 1500 AOAC 2005 Ch 50

Arakhidonic acid (ARA)

mg/g

Min. 350 GC-FID

Kadar water (%) Maks. 0.1 Karl Fischer

trans fatty acids (% acid

total fat)

Maks. 2

GC-FID

Chemical Characteristics:

Numbers

sabunkan (%)

Maks. 2

Titration

Numbers peroxide

(meq/kg)

Maks.2

Titration

The coding number (mg

KOH/g)

Min.170 Titration

The iodine number (g

I2/100g)

Min.155

Titration

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2011, No. 809 18

Metal Cements:

Arsen (As) (ppm) (ppm) Maks. 0.1 AAS-GF

Cadmium (Cd) (ppm) Maks. 0.1 AAS

Timbal (Pb) (ppm) Maks. 0.1 AAS

Merkuri (Hg) (ppm) (ppm) Maks. 0.1 AAS/MVU

Heavy metals (ppm) Maks. 10 Metal Limit Test

Weight

Heksan (ppm) Maks. 0.3 GC-FID

Butan (ppm) Max. 1 GC-FID

Hydrocarbon Solvent

aromatic (Aromatic

Hydrocarbon Solvent) ---

as marker BTX

(Benzene, Toluene, Xylene)

Negative GC-FID

* Can use other methods that validate

HEAD OF THE DRUG AND FOOD SUPERVISORS

REPUBLIC OF INDONESIA,

KUSTANTINAH

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