PROJECT NO: V5VA 1040 Steviol Glycosides Exposure Assessment Author: Phil Northing The Food and Environment Research Agency Sand Hutton York YO41 1LZ Sponsor: Coca-Cola Europe Start Date: June 2010 End Date: September 2010 Report Issue Date: September 2010 Pages in Report: 91 Final Report: 29th September 2010 Contents 1. Assessment Objectives ..................................................................................................................... 3 2. Model Specification ......................................................................................................................... 3 3. Food Baskets .................................................................................................................................... 3 4. Maximum Level data ....................................................................................................................... 5 5. Associations ..................................................................................................................................... 5 6. Modelling Approach ........................................................................................................................ 7 7. Exposure Results .............................................................................................................................. 8 8. Conclusions .................................................................................................................................... 12 9. References ...................................................................................................................................... 12 Appendix 1: Synopsis of the Methodology of the Exposure Assessment Model .............................. 13 Appendix 2: Food items ..................................................................................................................... 15 Final Report: 29th September 2010 2 Steviol Glycosides 1. Assessment Objectives This assessment aims to provide a dietary exposure assessment of Steviol Glycosides which are currently in the EU approval process. This assessment has the following objectives: 1. Use data provided by the customer on the maximum levels of Steviol Glycosides likely to be permissible in certain food categories. 2. Food groupings and association assumptions configured by customer experts. This addresses food items that contain, or may contain, Steviol Glycosides. 3. Generate exposure estimates based on UK National Diet and Nutrition Surveys1,2,3 (NDNS) for age groups Toddlers, Youth and Adults. The numbers of individuals and survey periods are shown in table 1. Full details on the exposure model may be found in Holmes et al (2005)4 and Northing et al (2009)5. Table 1: Surveys used within this exposure assessment. Name Country Year Age Duration Number UK Toddlers 1992/3 UK 1992/3 1.5 – 4.5 4 1675 UK Youth 1997 UK 1997 4-18 7 1701 UK Adults 2001 UK 2001 19 – 64 7 1724 2. Model Specification The following information shows the model specification established for the Steviol Glycosides Exposure model. This comprises of . Food baskets (Table 2) generated using the middle level of the hub codes (see Northing et al, 20095 for a full explanation of the Hub Codes) and then amended as appropriate in conjunction with the customer. (See Appendix 2 for items within each basket). Maximum level data from proposed levels provided by the customer (Table 3) . Association table (Table 4) shows the . Conversion factors - amending the exposure for certain food groups i. Liquid concentrates for dilution: dilution factors utilised from FSA survey6. Extrapolation factors – not utilised in this study . Market shares – estimates of the approximate split between items that could contain Steviol Glycosides and those that may not. i. Market share data are based on the following sources: Mintel food category reports, food sector association reports, verbal information from food sector associations, market research data or assumptions based on market insights. 3. Food Baskets The food groups (baskets) shown in Table 2 are based upon the middle level in the hub code hierarchy. Food items in each group are treated as equivalent in terms of the assumptions regarding maximum use level, conversion factors, extrapolation factors and market shares. Food groups that were deemed likely to not have Steviol Glycosides added to them were omitted in the association phase and therefore consumption of food items within these baskets do not contribute toward the exposure. Final Report: 29th September 2010 3 Table 2: Food group descriptors of contributory and non-contributory food groups. Contributing food groups (baskets) Minor or non-contributing food groups (baskets) Beers/lagers/ciders Brassicas/leafy/lettuce Biscuits Bread Breakfast cereals Bread substitutes eg crispbread Cakes Cereals grain Carbonated Beverages Cheese & cheese spreads Cereal snackbars Cream and cream based dishes/ toppings Chewing gum Deleted Items Chocolate spreads & sauces Dough Condiments, herbs, spices, ketchup, sauces, dips Dry other than formula or RTE (Infant food) Confectionary (chocolate and other fatty) Dry powdered formula (Infant food) Confectionary (sugar and other non-fatty) Dry -tea/coffee/chocolate/horlicks/bornvita etc Cooking sauces Eggs Crisps and crisp like Fish Fish & shellfish ready meals/pates etc inc. main meal Dietary supplements components Dressings Flour Egg dishes purchased Fresh fruit Hard Confectionery Legumes Ice cream / sorbets Liquid fats/oils Liquid concentrates for dilution Liquid formula RTF (Infant food) Liquid food supplements Meat & game inc. minced and sausages Liquid milk substitutes eg soymilk Milk & milk substitutes, dry, NOT infant formula Milk & milk based drinks wet Miscellaneous inc. pizza bottoms, dry deserts etc Milk based product inc desserts and powders to which milk is added Non Allocated Mustard Nut Spreads Nuts Offal Other Cereals (includes desserts) Pasta & noodles Other alcoholic drinks Pizza Pastries inc. fruit pies, tarts, pastries etc Potatoes/chips Processed fruit Poultry Ready meal and main meal component Pretzels Ready to drink juices drinks Rice Replacement drinks etc RTF foods (Infant food) Soups Salad vegetables/root vegetables (other than potatoes) Sugar & sugar substitutes (dry) Shellfish Sugar spreads (jams / honey) Solid fats/oils/spreads Spirits/liquors (full strength) Water Wet liquid tea/coffees Wines Final Report: 29th September 2010 4 4. Maximum Level data The maximum use level data (Table 3) were provided by the customer and are either based on the initial maximum permitted levels as per the EFSA opinion7 on the safety of Steviol Glycosides for the proposed uses as a food additive (2010) or based on suggested revised maximum permitted levels to address the concerns in respect to the ADI as per the EFSA evaluation. Table 3: maximum use level data for Steviol Glycosides in mg / kg (highlighted rows not utilised in the model). Name Data Beer/Cider/Alcopop 600 Breakfast cereals fibre>15%, bran>20% no added sugar 1000 Breath freshening micro-sweets, no added sugar 10000 Canned/Bottled Fruit 1000 Chewing Gum (No added sugar) 10000 Complete formulae & nutritional sup for medical supervision 1000 Complete formulae for weight control 800 Confectionery (Cocoa/dried fruit-based) 2000 Confectionery (Hard Candy) 1000 Confectionery (Soft Candy, Nougat, Marzipan) 1500 Confectionery (Starch-based) 2000 Delicatessen salads 350 Desserts 1000 Dilutable Non-Alcoholic - Water Based 300 Edible Ices 800 Essoblatten (wafer) 1000 Fine bakery products for special nutritional uses 1000 Food supplements/diet integrators based on vitamin/minerals, syrup-type or chewy 5500 Fruit/veg preparations (Energy reduced) 1000 Jam/Jelly/Marmalade (Energy reduced) 1000 Liquid food supplements/dietary integrators 600 Mustard 350 Non-Alcoholic - Milk/Fruit Based 600 Non-Alcoholic - Water Based 600 Sandwich Spreads 1000 Sauces 350 Snacks 500 Solid food supplements/dietary integrators 2000 Soups (energy reduced) 110 Soy based beverages 600 Spirits < 15% alcohol 600 Strongly flavoured freshening throat pastilles (no added sugar) 2000 Sweet/sour preserves fish etc 600 Sweet/sour veg/fruit preserves 600 Table Top Sweeteners 27800 5. Associations Table 4 illustrates the associations set up between the maximum level data and the food baskets. Food baskets are associated to maximum level data using conversion factors, extrapolation factors and market share of affected items. Market share data are based on the following sources: Mintel food category reports, food sector association reports, verbal information from food sector associations, market research data or assumptions based on market insights Final Report: 29th September 2010 5 Table 4: Association Table showing the conversion factors, extrapolation factors and market share (percentage assumed which may contain Steviol Glycosides). Conversion Extrapolation Market Share Baskets Maximum Level Data Factors Factors (%) Low Mid High Low Mid High Low Mid High Beers/lagers/ciders Beer/Cider/Alcopop 1 1 1 1 1 1 0.1 0.5 2 Biscuits Confectionery (Starch-based) 1 1 1 1 1 1 2 2.5 3.5 Breakfast cereals fibre>15%, bran>20% no added Breakfast cereals sugar 1 1 1 1 1 1 5 7 9 Cakes Jam/Jelly/Marmalade (energy reduced) 1 1 1 1 1 1 0.5 1 1.5 Carbonated Beverages Non-Alcoholic - Water Based 1 1 1 1 1 1 32 37 42 Cereal snackbars Confectionery (Starch-based) 1 1 1 1 1 1 0.5 1 1.5 Chewing gum Chewing Gum (No added sugar) 1 1 1 1 1 1 0.5 1 1.5 Chocolate spreads & sauces Sandwich Spreads 1