Food Regulations & Safety Food Regulations & Safety of Food Ingredients of Food Ingredients

with special emphasis on sweetenerswith special emphasis on sweeteners

Prof. Jagadish S. PaiProf. Jagadish S. PaiExecutive DirectorExecutive DirectorProtein Foods & Nutrition Development Protein Foods & Nutrition Development Association of IndiaAssociation of IndiaPFNDAI

Safety of Food IngredientsSafety of Food Ingredients

Biological SafetyBiological Safety Chemical SafetyChemical Safety Physical SafetyPhysical Safety

Chemical Safety of SweetenersChemical Safety of Sweeteners

Toxicity Toxicity

LDLD5050 Aspartame 5g/kg in rat Aspartame 5g/kg in rat

NaCN (6.4mg), CaClNaCN (6.4mg), CaCl22 (1g), NaCl (1g), NaCl

(3g), (3g), Vit C (1.9g), Sugar (29.7g)Vit C (1.9g), Sugar (29.7g) Allergy Allergy Physiological Effect Physiological Effect

effect on blood sugareffect on blood sugar

Nutritive Sweeteners Nutritive Sweeteners SugarsSugars

sucrosesucrose

glucoseglucose

fructosefructose

HFCSHFCS Sugar Alcohols or PolyolsSugar Alcohols or Polyols

sorbitol, mannitol, xylitol, sorbitol, mannitol, xylitol,

maltitol, isomaltmaltitol, isomalt

High Intensity Low Calorie SweetenersHigh Intensity Low Calorie Sweeteners

SaccharinSaccharin CyclamateCyclamate AspartameAspartame Acesulfame KAcesulfame K Sucralose Sucralose Stevia Stevia

Safety of SugarsSafety of Sugars Sugars, including glucose, dextrose, fructose, sucrose, Sugars, including glucose, dextrose, fructose, sucrose,

high fructose corn syrup, lactose, and maltose, are high fructose corn syrup, lactose, and maltose, are “generally recognized as safe” (GRAS) as per US FDA “generally recognized as safe” (GRAS) as per US FDA

Inst of Medicine (2002) recommends calories from Inst of Medicine (2002) recommends calories from carbohydrates 45-65% of total. Very high intakes of carbohydrates 45-65% of total. Very high intakes of sugars associated with lower micronutrient intakes. Max. sugars associated with lower micronutrient intakes. Max. sugar intake recommended 25%sugar intake recommended 25%

WHO & FAO (2003) recommended free sugars not more WHO & FAO (2003) recommended free sugars not more than 10% of total calories stating epidemiologic, than 10% of total calories stating epidemiologic, economic, social impacts besides scientific reasonseconomic, social impacts besides scientific reasons

Anderson 1997: Except in dental caries, sugars are not Anderson 1997: Except in dental caries, sugars are not cause of chronic or acute diseases, confirmed by Mardis cause of chronic or acute diseases, confirmed by Mardis 20012001

Carbohydrate Technical Committee ILSI NA (2002) No Carbohydrate Technical Committee ILSI NA (2002) No health concerns with direct association with sugarhealth concerns with direct association with sugar

Am. Diet. Asso. 2004: All foods can fit into healthful Am. Diet. Asso. 2004: All foods can fit into healthful diets, even those high in added sugarsdiets, even those high in added sugars

Obesity & SugarsObesity & Sugars Increase in body weight & fat content due to excess of energy Increase in body weight & fat content due to excess of energy

intake over expenditure. Sugars are ingredients in favourite foods, intake over expenditure. Sugars are ingredients in favourite foods, may result overconsumptionmay result overconsumption

Studies show inverse relation of sugar intake & body weight & BMIStudies show inverse relation of sugar intake & body weight & BMI High sucrose diets not incompatible with weight lossHigh sucrose diets not incompatible with weight loss Sucrose contributes to satiety Sucrose contributes to satiety Hypothesis that low GI carbohydrates aid fat loss promoting Hypothesis that low GI carbohydrates aid fat loss promoting

satiety, higher metabolic rate & fat oxidationsatiety, higher metabolic rate & fat oxidation Overweight & obese children & adults have insulin resistance. Overweight & obese children & adults have insulin resistance.

Whether it causes obesity is inconclusiveWhether it causes obesity is inconclusive Calories in liquid different from calories in solid in satiety, Calories in liquid different from calories in solid in satiety,

proposing that increased intake of HFCS sweetened beverages proposing that increased intake of HFCS sweetened beverages responsible for obesity. Harvard School of Public Health responsible for obesity. Harvard School of Public Health researchers found positive association between sugar-sweetened researchers found positive association between sugar-sweetened beverages & obesity but acknowledged multifactorial nature of beverages & obesity but acknowledged multifactorial nature of obesity & results did not establish causalityobesity & results did not establish causality

National Health & Nutrition Examination survey found no statistical National Health & Nutrition Examination survey found no statistical association between consumption of sugar sweetened beverages association between consumption of sugar sweetened beverages and BMI.and BMI.

No difference in satiety found among sucrose, HFCS, No difference in satiety found among sucrose, HFCS, glucose/fructose 50/50 glucose/fructose 50/50

ObesityObesity

GI, GL & DiabetesGI, GL & Diabetes Slowly absorbed high-fibre foods may have metabolic benefits in Slowly absorbed high-fibre foods may have metabolic benefits in

diabetes & in preventing CVD riskdiabetes & in preventing CVD risk GI measures the rise in blood sugar upon consumption of GI measures the rise in blood sugar upon consumption of

carbohydratescarbohydrates GL indicates glucose response produced by total carbohydrate intake GL indicates glucose response produced by total carbohydrate intake

in a food considering quality (GI) as well as quantityin a food considering quality (GI) as well as quantity Studies produced inconsistent results hence more information Studies produced inconsistent results hence more information

needed to establish reliable GIneeded to establish reliable GI Study showed that hi GI/GL diets were not associated with probability Study showed that hi GI/GL diets were not associated with probability

of having insulin resistanceof having insulin resistance Am Diabetes Asso : not sufficient, consistent info to conclude that Am Diabetes Asso : not sufficient, consistent info to conclude that

low-GL diets reduce risk of diabetes although may have other low-GL diets reduce risk of diabetes although may have other benefitsbenefits

Am Diet Asso: present research does not support claim that lo GI diet Am Diet Asso: present research does not support claim that lo GI diet causes significant wt loss or help control appetitecauses significant wt loss or help control appetite

Studies have not established that total sugar intake is associated with Studies have not established that total sugar intake is associated with development of type II diabetes although possibility of hi GI/GL development of type II diabetes although possibility of hi GI/GL

DiabetesDiabetes

Sugar Alcohols or PolyolsSugar Alcohols or Polyols

  Calories per gram

Approximate Sweetness

(sucrose =100%)Typical Food Applications

Sorbitol  2.6 50 - 70% Sugar-free candies, chewing gums, frozen desserts and baked goods

Xylitol 2.4 100%

Chewing gum, gum drops and hard candy, pharmaceuticals and oral health products, such as throat lozenges, cough syrups, children’s chewable multivitamins, toothpastes and mouthwashes; used in foods for special dietary purposes

Maltitol 2.1 75% Hard candies, chewing gum, chocolates, baked goods and ice cream   

Isomalt 2.0 45 - 65% Candies, toffee, lollipops, fudge, wafers, cough drops, throat lozenges

Lactitol 2.0 30 - 40% Chocolate, some baked goods (cookies and cakes), hard and soft candy and frozen dairy desserts

Mannitol 1.6 50 - 70% Dusting powder for chewing gum, ingredient in chocolate-flavored coating agents for ice cream and confections

Erythritol 0 - 0.2* 60 - 80% Bulk sweetener in low calorie foodsBulk sweetener in low calorie foods

Hydrogenated Starch Hydrolysates (HSH) 3 25 - 50% Bulk sweetener in low calorie foods, provide sweetness, texture Bulk sweetener in low calorie foods, provide sweetness, texture

and bulk to a variety of sugarless productsand bulk to a variety of sugarless products

Sugar AlcoholsSugar Alcohols They are incompletely absorbed and metabolised in body so fewer caloriesThey are incompletely absorbed and metabolised in body so fewer calories Most polyols less sweet than sugar so require in bulk quantity for same Most polyols less sweet than sugar so require in bulk quantity for same

sweetnesssweetness Although they occur naturally in many fruits & vegetables, commercially Although they occur naturally in many fruits & vegetables, commercially

produced from sucrose, glucose & starch by hydrogenationproduced from sucrose, glucose & starch by hydrogenation They are partially absorbed and most are converted to energy using They are partially absorbed and most are converted to energy using

mechanism requiring little insulin & do not raise blood glucose muchmechanism requiring little insulin & do not raise blood glucose much Since incompletely absorbed they may cause laxative effect if consumed in Since incompletely absorbed they may cause laxative effect if consumed in

large quantities (ADA advises >50g sorbitol or >20g mannitol per day may large quantities (ADA advises >50g sorbitol or >20g mannitol per day may cause diarrhea)cause diarrhea)

Erythritol may be more completely absorbed and may be excreted as such Erythritol may be more completely absorbed and may be excreted as such through urine so v little calories and less laxative effectthrough urine so v little calories and less laxative effect

Bacteria in mouth cannot grow on polyols they do not cause tooth decayBacteria in mouth cannot grow on polyols they do not cause tooth decay Some polyols are GRAS in US but when used and claimed, have to be Some polyols are GRAS in US but when used and claimed, have to be

declared on nutrition information separately under carbohydratesdeclared on nutrition information separately under carbohydrates

Food RegulationsFood Regulations PFA Act & Rules since 1954PFA Act & Rules since 1954 FSSA 2006 is slowly taking over and FSSA 2006 is slowly taking over and

shortly will replace PFAshortly will replace PFA Food Authority has been appointed and Food Authority has been appointed and

various scientific committee & panels are various scientific committee & panels are also appointed recentlyalso appointed recently

Science based regulations using risk Science based regulations using risk analysis for allowing various ingredients analysis for allowing various ingredients and additivesand additives

PFA RulesPFA Rules Every package of food containing permitted artificial Every package of food containing permitted artificial

sweetener shall carry following sweetener shall carry following i. This ------ (name of food) contains ---------- (name i. This ------ (name of food) contains ---------- (name of artificial sweetener)of artificial sweetener)ii. Not recommended for childrenii. Not recommended for childreniii. iii. (a) Quantity of sugar added -------- gm/100gm(a) Quantity of sugar added -------- gm/100gm

(b) No sugar added in the product(b) No sugar added in the productiv. Not for phenylketoneurics (if Aspartame is added)iv. Not for phenylketoneurics (if Aspartame is added)

In addition to above declaration, following declaration In addition to above declaration, following declaration should also be written on packagesshould also be written on packages

CONTAINS ARTIFICIAL SWEETENER AND FOR CONTAINS ARTIFICIAL SWEETENER AND FOR CALORIE CONSCIOUSCALORIE CONSCIOUS

Table top SweetenerTable top Sweetener

Packages of artificial sweeteners Packages of artificial sweeteners marketed as table-top sweeteners must marketed as table-top sweeteners must carry following labelcarry following label

Contains ----------- (name of artificial Contains ----------- (name of artificial sweetener)sweetener)

Not recommended for childrenNot recommended for children

Permitted Levels of Artificial SweetenersPermitted Levels of Artificial Sweeteners Saccharin:Saccharin: carbonated water 100 ppm to carbonated water 100 ppm to

chocolates & Indian traditional sweets 500ppm to chocolates & Indian traditional sweets 500ppm to sugar based/sugar-free confectionery & chewing sugar based/sugar-free confectionery & chewing gum/bubble gum 3000ppm gum/bubble gum 3000ppm

Aspartame:Aspartame: carbonated water 700 ppm, biscuit, carbonated water 700 ppm, biscuit, bread, cakes 2000 ppm, Indian sweets 200 ppm, bread, cakes 2000 ppm, Indian sweets 200 ppm, jams jellies 1000 ppm, sugar based/free jams jellies 1000 ppm, sugar based/free confectionery 10000, ice cream 1000 ppm, confectionery 10000, ice cream 1000 ppm, flavoured milk 600 ppm, RTE cereal 1000 ppm, flavoured milk 600 ppm, RTE cereal 1000 ppm, still beverages 600 ppmstill beverages 600 ppm

Acesulfame K: Acesulfame K: carbonated water 300 ppm, carbonated water 300 ppm, biscuits, cakes etc. 1000 ppm, Indian sweets 500 biscuits, cakes etc. 1000 ppm, Indian sweets 500 ppm, sugar based/free confectionery 3500 ppm, ppm, sugar based/free confectionery 3500 ppm, still beverages 300 ppmstill beverages 300 ppm

Sucralose:Sucralose: carbonated water 300 ppm, biscuits, carbonated water 300 ppm, biscuits, cakes 750 ppm, Indian sweets 750 ppm, still cakes 750 ppm, Indian sweets 750 ppm, still beverages 300 ppm, jams jellies 450 ppm, ice beverages 300 ppm, jams jellies 450 ppm, ice lollies/candies 800 ppmlollies/candies 800 ppm

Neotame: carbonated water & soft drink conc. 33 Neotame: carbonated water & soft drink conc. 33 ppmppm

Mixture of Mixture of Aspartame & Acesulfame K Aspartame & Acesulfame K allowed allowed in carbonated water, soft drink conc., & synthetic in carbonated water, soft drink conc., & synthetic syrup for dispensersyrup for dispenser

Sugar Alcohols (Polyols)Sugar Alcohols (Polyols) Following polyols have been permittedFollowing polyols have been permitted

SorbitolSorbitolMannitolMannitolXylitolXylitolIsomaltIsomaltLactitolLactitolMaltitolMaltitol

Label declaration necessary: Label declaration necessary: Polyols may have laxative effectPolyols may have laxative effect

Polyols permitted in different foodsPolyols permitted in different foods

Sorbitol is permitted in jams, jellies, fruit cheese, fruit marmalades 3% maxSorbitol is permitted in jams, jellies, fruit cheese, fruit marmalades 3% max

New Regulation GSR 664New Regulation GSR 664The nutritional information or nutritional facts per 100 gm or 100ml or per serving of the product shall be given on the label containing the following:-

(A) energy value in kcal;

(B) the amounts of protein, carbohydrate (specify quantity of sugar) and fat

in gram (g);(C) the amount of any other nutrient for

which a nutrition or health claim is made:

Thank YouThank You