Ir. Gasilan. Head of Sub Directorate Standardization Food Additive and Raw Materials

Transcription

1 SAFETY RISK ASSESSMENT FOR FOOD ADDITIVES Ir. Gasilan Head of Sub Directorate Standardization Food Additive and Raw Materials Seminar on Uses and Safety of Sweeteners Jakarta, May

2 AGENDA 1. Introduction 2. Risk Assessment for Food Additive 3. Current Regulation for Food Additive Health Minister Regulation No. 033 Year 2012 on Food Additives 4. Sweeteners in Indonesia 2

3 1 Introduction 3

4 Food Shall mean: Anything originating from biological of agricultural products, farming, forestry, fisheries, livestock, and water sources either processed and unprocessed, designated as food or beverages as human consumption. Include: Food raw materials Food additives Other material used in the process of preparing, processing, and/or making food or beverages. (Law No.18, 2012 on Food)

5 Food science and technology, Change in life style, Food Innovation Growth of the food industry Type of food VARIES Food additives play an important and essensial role in the food production 5

6 Current Food Law and Regulations Law No. 18, 2012 on Food Government Regulation No. 69, 1999 on Food Labeling and Advertisement Government Regulation No. 28, 2004 on Food Safety, Quality, and Nutrition Government Regulation No. 21, 2005 on Biosafety of Genetically Modified Products Health Minister Regulation No. 033 Year 2012 on Food Additives 6

7 2 Risk Assessment for Food Additive 7

8 How Risk Assessment (RA) In Indonesia? as institutions which provide permit the use of food additive- RA is needed 8

9 Risk Analysis(Codex Alimentarius Commission) 1. Hazard identification 2. Hazard characterization 3. Exposure assessment 4. Risk characterization Science Based Policy Based Interactive Exchange of Information and Opinions

10 How Risk Assessment (RA) In Indonesia? JECFA Codex By experts from scientific institutions including universities Regulation from other countries Exposure assessment: Existing data (Directorate of Food Safety Assessment, Directorate of Food Inspection and Certification, NADFC) National Consumption Survey Controling capabilities---laboratorium Is it Comprehensive yet??? 10

11 Exposure Assessment to ADI/MTDI/PTWI Exposure perday(%) = The maximum level (mg/kg) x consumption (kg) X 100% ADI (mg/kg) x BW (kg) Acceptable daily intake (ADI) is the amount of a food additive expressed on a body weight basis that can be ingested daily over a lifetime without appreciable risk. (standard human = 60 kg). The ADI is listed in units of mg per kg of body weight. Maximum Tolerable Daily Intake (MTDI) is the amount of a substances expressed on body weight basis that can be ingested in a day without appreciable risk. Provisional Tolerable Weekly Intake (PTWI) is the amount temporary of a substances expressed on body weight basis that can be ingested in a week without appreciable risk.

12 Case study Maximum Level Sweetener X Indonesia Codex Other Countries Country 1 Country 2 Country 3 a b x y z Why Indonesia different??? Touching manager (risk manager) Justification: - Exposure - Different culture 12

13 Consideration to Established Functional Classes for Food Additives Codex Class Names and The International Numbering System for Food Additives CAC/GL Amandment 2011 regulated 27 functional classes Functional classess for food additives based on technological function in food. Food additives approved by CAC viewed from the safety aspect to human/consumer health.

14 3 Current Regulation for Food Additive 14

15 (Health Minister Regulation No. 722/Menkes/Per/IX/88 on Food Additives) Revision Health Minister Regulation No. 033 Year 2012 on Food Additives (Delegate NADFC to establish the technical regulation in food product) 15

16 Health Minister Regulation No. 033 Year 2012 on Food Additives Functional Classes of Food Additive Type of Food Additive Labelling Control and Supervision Transitional Provisions

17 Functional Classes and Type of Food Additive Health Minister Regulation No. 722/Menkes/Per/IX/88 (Old Regulation) 1. Antioxidant (12) 2. Anticacking agent (11) 3. Acidity regulator (53) 4. Sweetener (4 have not distinguished natural nor artificial) 5. Flour treatment agent (8) 6. Emulsifier, Thickener, stabilizer (85) 7. Preservatives (26) 8. Firming agent (11) 9. Natural colour (13) 10. Syntethic colour (12) 11. Flavouring (75) 12. Flavour enhancer (4) 13. Sequestrant (4) Health Minister Regulation No. 033 Year 2012 (The New Regulation) 1. Antioxidant (13) 2. Anticaking agent (16) 3. Acidity regulator (36) 4. Sweetener - Natural sweetener (8) - Artificial sweetener (6) 5. Flour treatment agent (14) 6. Emulsifier (80) 7. Thickener (59) 8. Stabilizer (104) 9. Preservative (10) 10. Firming agent (6) 11. Colour Natural colour (15) Synthethic colour (11) 12. Flavouring (Typ :5, Classess : 4 (In draft NADFC 1994 flavouring substances)) 13. Flavour enhancer (4) 14. Sequestrant (4) 15. Antifoaming agent (2) 16. Carbonating agent (1) 17. Emulsifying salt (25) 18. Packaging gas (2) 19. Humectant (7) 20. Glazing agent (5) 21. Carrier (4) 22. Gelling agent (10) 23. Foaming agent (3) 24. Raising agent (9) 25. Bulking agent (32) 26. Colour retention agent (2) 27. Propellant (3)

18 4 Sweeteners in Indonesia 18

19 Health Minister Regulation No. 722/Menkes/Per/IX/88 on Food Additives: 1.Aspartame (only in table top) 2.Saccharin (and sodium salts) 3.Cyclamate (and sodium and calcium salts) 4.Sorbitol Have Been approved by Director Jenderal POM based on assessment and evaluation: 1. Isomalt 2. Aceculfame potassium 3. Maltitol 4. Xylitol 5. Mannitol 6. Alitame 7. Sucralose 19

20 (Health Minister Regulation No. 722/Menkes/Per/IX/88 on Food Additives) Revision Decree of The Head of The National Agency for Drug and Food Control No. HK Year 2004 on The use of Food Additive Sweetener in Food: 1.Sorbitol 2.Mannitol 3.Isomalt 4.Maltitol 5.Lactytol 6.Xylitol 7.Aceculfame pottasium 8.Aspartame 9.Cyclamates 10.Saccharins 11.Sucralose 12.Neotame 13.Alitame Accommodate the previous regulation and follow regulatory development in other countries 20

21 Decree of the Head of the NationalAgency for Drug and Food Control No Decree of The Head of The National Agency for Drug and Food Control No. HK on The use of Food Additive Sweetener in Food No 1 Sorbitol 1 Sorbitol 2 Mannitol 2 Mannitol 3 Isomalt 3 Isomalt vs Health Minister Regulation Health Minister Regulation No. 033 Year 2012 Natural sweetener - 4 Steviol glycosides 4 Maltitol 5 Maltitol 5 Lactytol 6 Lactytol 6 Xylitol 7 Xylitol - 8 Erythritol 21

22 Decree of the Head of the NationalAgency for Drug and Food Control No Decree of The Head of The National Agency for Drug and Food Control No. HK on The use of Food Additive Sweetener in Food vs Health Minister Regulation No Health Minister Regulation No. 033 Year 2012 Artificial sweetener 7 Aceculfame pottasium 9 Aceculfame pottasium 8 Aspartame 10 Aspartame 9 Cyclamates 11 Cyclamates 10 Saccharins 12 Saccharins 11 Sucralose 13 Sucralose 12 Neotame 14 Neotame 13 Alitame - 22

23 Label Food product which contain: Artificial sweetener must include statement: contain artificial sweetener, not recommended to be consumed by children under 5 year, pregnant dan breastfeeding women contain fenilalanine, not suitable for fenilketonuric patient if contain artificial sweetener aspartame contain artificial sweetener and sugar if contain sugar and artificial sweetener for diabetic patient or people who need low calories food if it for diabetic patient purpose or food low calories which contain artificial sweetener Natural sweetener must include statement: exceed consumption have laxative effect if contain poliol

24 Label Tabel top artificial sweetener must include statement: equality sweetness compared with sugar for diabetic patient and or people who need low calories food contain artificial sweetener, not recommended to be consumed by children under 5 year, pregnant dan breastfeeding women Acceptable Daily Intake (ADI) for table top artificial sweetener aspartam: - contain fenilalanine, not suitable for fenilketonuric patient - not suitable for ingredient that are heated Tabel top natural sweetener must include statement: exceed consumption have laxative effect for table top poliol 24

25 Head of the National Agency for Drug and Food Control Regulation on Maximum Level The Use of Food Additive Sweetener (draft) Technical regulation from Health Minister Regulation No. 033 year 2012 Regulated Maximum level sweetener in each food category Sweetener other than permitted can only be used in food after approved by the Head of NADFC.

26 TERIMA KASIH Directorate of Food Product Standardization Tlp , Fax standarpangan@pom.go.id 26