Your Stevia Launch Understanding the Regulatory Framework and matching a Stevia Portfolio to Solution. April 2016

Transcription

1 Your Stevia Launch Understanding the Regulatory Framework and matching a Stevia Portfolio to Solution April 2016

2 India Approval of Stevia

3 Agenda Natural Sweeteners & Stevia Safety & Regulatory Scope Stevia- the ingredient PureCircle Sweeteners PureCircle Flavors Opportunities to work together PureCircle Delivers- Matrix Solutions 3

4 Natural Sweeteners and Stevia 4

5 Sweeteners from Plant offer various solutions Natural Caloric Sweeteners Sugar Fructose Glucose High Fructose Syrup Glucose Syrup Natural Non-Caloric Sweetener Steviol Glycosides (Stevia) Mogrosides (Monk Fruit) Monatin (Sclerochiton) Thaumatin (Katemfe) Brazzein (Oubli) Caloric Sweeteners Sweetness Potency (Sucrose Equivalent) Sugar 1.0 Fructose 1.3 Glucose 0.6 HFCS 1.0 Non-Caloric Sweeteners Sweetness Potency (Sucrose Equivalent) Steviol Glycosides 250 Mogrosides 200 Monatin 1000 Thaumatin 14,000 5

6 Stevia is a Natural Sweetener with Flavoring Properties Sugar Natural origin Stevia Non- Caloric Artificial Sweetener Single Component Sweetness Multiple Components Sweetness & Flavor Modification Single Component Sweetness

7 Stevia is the first natural origin, calorie-free sweetening ingredient for mainstream use Naturally occurring plant native to Paraguay Widely grown for its sweet leaves Now grown in countries around the world Great Taste Adds no calories to foods and beverages Non-GMO Rebaudioside A, or Reb A, and Stevioside are the major molecules Economic Pricing Total Steviol Glycosides (TSG): The TSG represents the amount of glycosides as a % of the dry weight of the leaf Stevia is the only natural ingredient able to reduce calories while meeting mainstream F&B requirements. Sustainable & Scalable Supply

8 All of our stevia products and innovation originate from the leaf Steviol glycosides Sweetening Power Relative to Sucrose Relative Taste Quality Stevioside (G3) Rebaudioside A (G4) Rebaudioside B (G3) a 0 Rebaudioside C (G3R) Rebaudioside D (G5) Rebaudioside E (G4) Rebaudioside F (G3X) NA NA Rebaudioside M (G6) Rubusoside (G2) Steviolbioside (G2) Dulcoside A (G2R) G, R, and X represent, respectively, glucose, rhamnose, and xylose sugar moieties. G# means number of glucose units; NA = Not available. More than 40+ glycosides found in stevia leaf

9 Chemical Structures of Steviol Glycosides # Common Name Trivial Formula R 1 R 2 1) Steviol + Glucose (SvGn) Steviolmonoside Stevioside SvG1 SvG3 H Glcβ1- Glcβ1- Glcβ(1-2)Glcβ Other Steviol and Glucose (SvGn) Formulas 1.11 Rebaudioside A SvG4 Glcβ1- Glcβ(1-2)[Glcβ(1-3)]Glcβ Rebaudioside M SvG6 Glcβ(1-2)[Glcβ (1-3)]Glcβ1- Glcβ(1-2)[Glcβ(1-3)]Glcβ1-2) Steviol + Rhamnose + Glucose (SvR1Gn) Glc, glucose; Rha, rhamnose; Xyl, xylose DeoxyGlc, deoxyglucose Fru, fructose; 2.1 Dulcoside A SvR1G2 Glcβ1- Rhaα(1-2)Glcβ1- +6 Other Steviol Rebaudioside C SvR1G3 Glcβ1- Rhaα(1-2)[Glcβ(1-3)]Glcβ1- Rhamnose Rebaudioside O SvR1G6 Glucose (SvR1Gn) Glcβ(1-3)Rhaα(1-2)[Glcβ(1- Glcβ(1-2)[Glcβ(1-3)]Glcβ1- Formulas 3)]Glcβ1-3) Steviol + Xylose + Glucose (SvX1Gn) 3.1 Stevioside F SvX1G2 Glcβ1- Xylβ(1-2)Glcβ1- +2 Other Steviol Rebaudioside F SvX1G3 Glcβ1- Xylβ(1-2)[Glcβ(1-3)]Glcβ1- Xylose + Glucose (SvX1Gn) 4) Steviol + Fructose + Glucose (SvF1Gn) 4.1 Rebaudioside A3 SvF1G3 Glcβ1- Glcβ(1-2)[Fruβ(1-3)]Glcβ1-5) Steviol + deoxyglucose + Glucose (SvdG1Gn) 5.1 Stevioside D SvdG1G2 Glcβ1-6-deoxyGlcβ(1-2)Glcβ1- +1 Steviol Stevioside E SvdG1G3 Glcβ1-6-deoxyGlcβ(1-2)[Glcβ(1-3)]Glcβ1- deoxyglucose + Glucose (SvdG1Gn)

10 Safety & Regulatory 10

11 Authoritative Safety Opinions Steviol glycoside safety had been reviewed by: JECFA (51 st, 63 rd, 68 th, and 69 th meetings in 1998, 2004, 2007, and 2008) EFSA (1985, 1989, 1999, 2010, 2015) US FDA ( , issued >35 no objection to GRAS status) FSANZ (2008, 2015) Health Canada (2012, 2016) All established an acceptable daily intake (ADI) of 0 to 4 mg/kg body weight/day, as steviol equivalents Based on similar metabolic pathway of steviol glycosides No-observed-adverse-effect level (NOAEL) of 970 mg/kg body weight/day (383 mg steviol equivalents/kg body weight/day) from 2- year carcinogenicity study in rats (Toyoda et al., 1997) Safety factor of 100

12 Key Stevia Safety Studies and Findings Focus Area Intake assessment General safety Reproductive safety Blood pressure Glucose homeostasis Pharmacokinetics and Metabolism Study Description and Outcome Estimated intake of high purity stevia extract for average and high consumers using extensive international databases of actual high intensity sweetener intakes Evaluated safety of high purity stevia extract at very high doses No negative health effects associated with daily consumption equal to more than 2,000 8-ounce cans of soda sweetened with stevia extract for a 68 kg person Assessed reproductive and developmental impact of high purity stevia extract at very high doses No negative health effects in rats at doses equal to a 68 kg person consuming nearly 1, ounce cans of soda sweetened with stevia extract 4-week clinical study in people with normal to low-normal blood pressure Consumption of the equivalent of eight 8 ounce cans of soda sweetened with stevia extract had no significant blood pressure effects in healthy subjects (4 week study) 16-week clinical study in people with type 2 diabetes Consumption of 1,000 mg/day of stevia extract did not affect blood sugar control and was well-tolerated in people with type 2 diabetes (16 week study) In vitro and in vivo animal and human studies to show all steviol glycosides are metabolized same as stevioside and rebaudioside A Multiple studies showed that all steviol glycosides share the same metabolic fate independent of the number or type of sugar moieties attached to steviol backbone.

13 Metabolic Fate of Steviol Glycosides Steviol glycosides pass undigested through upper portion of the GI tract Enter colon intact and undergo microbial metabolism to steviol Steviol is absorbed into portal vein and conjugated with glucuronic acid in the liver and excreted in humans as steviol glucuronide, primarily in the urine R2 Glucuronic acid Steviol Microbial hydrolysis Steviol Absorption Conjugation Steviol Excretion via the urine R1 (R groups may be hydrogen or sugar moieties (one or more) such as glucose, rhamnose, xylose, fructose, and deoxyglucose) FCT 2008 RTP 2014 RTP 2015 RTP 2016

14 Americas Existing authorizations of Stevia as a food ingredient South & North Asia and APAC Europe Middle East Africa 1. United States of America 2. American Samoa 3. Antigua and Barbuda 4. Argentina 5. Bahamas 6. Barbados 7. Belize 8. Bolivia 9. Brazil 10. Canada 11. Cayman Islands 12. Chile 13. Colombia 14. Costa Rica 15. Dominica 16. Dominican Republic 17. Ecuador 18. El Salvador 19. Guatemala 20. Guyana 21. Haiti 22. Honduras 23. Jamaica 24. Mexico 25. Nicaragua 26. Panama 27. Paraguay 28. Peru 29. Trinidad Tobago 30. Uruguay 31. US Virgin Islands 32. Venezuela 1. Australia 2. Bangladesh 3. Brunei 4. China 5. Fiji 6. Guam 7. Hong Kong 8. India 9. Indonesia 10. Japan 11. Korean 12. Macao 13. Malaysia 14. Mongolia 15. Myanmar 16. New Zealand 17. Pakistan 18. Papua New Guinea 19. Philippines 20. Singapore 21. Sri Lanka 22. Taiwan 23. Thailand 24. Vietnam 1. Albania 2. Belarus 3. Bosnia 4. Kazakhstan 5. Russia 6. Switzerland 7. Turkey 8. Uzbekistan European Union 1. Austria 2. Belgium 3. Bulgaria 4. Croatia 5. Cyprus 6. Czech Republic 7. Denmark 8. Estonia 9. Finland 10. France 11. Germany 12. Greece 13. Hungary 14. Ireland 15. Italy 16. Latvia 17. Lithuania 18. Luxembourg 19. Malta 20. Netherlands 21. Poland 22. Portugal 23. Romania 24. Slovakia 25. Slovenia 26. Spain 27. Sweden 28. United Kingdom 1. Iran 2. Israel 3. Jordan 4. Lebanon GSO-GCC 1. Bahrain 2. Kuwait 3. Oman 4. Qatar 5. Saudi Arabia 6. UAE 7. Yemen (England, N. Ireland, Wales & Scotland) 1. Algeria 2. Angola 3. Botswana 4. Burkina Faso 5. Burundi 6. Cameroon 7. Cape Verde 8. Central African Republic 9. Chad 10. Comoros 11. Congo 12. Djibouti 13. Egypt 14. Equatorial Guinea 15. Eritrea 16. Ethiopia 17. Gambia 18. Ghana 19. Guinea 20. Guinea Bissau 21. Ivory Coast 22. Kenya 23. Lesotho 24. Liberia 25. Libya 26. Madagascar 27. Malawi 28. Mali 1. Mauritania 2. Mauritius 3. Morocco 4. Mozambique 5. Niger 6. Nigeria 7. Rwanda 8. Senegal 9. Sierra Leone 10. Somalia 11. South Africa 12. South Sudan 13. Sudan 14. Suriname 15. Swaziland 16. Togo 17. Tonga 18. Tunisia 19. Zambia 20. Zimbabwe

15 Regulatory Landscape for Flavored Beverage (water-based) JECFA Spec*: TSG>95% purity with Rebaudioside A, B, C, D, F, Stevioside, Dulcoside A, Rubusoside, Steviolbioside; Reb A & Stevioside primary components JECFA Spec/Codex (200 mg/kg) Africa Latin America, Canada** Australia & New Zealand India, Bangladesh, Pakistan Philippines, Vietnam, Myanmar Iran, Saudi Arabia & GCC JECFA Spec (use level in mg/kg of Steviol Equivalent)) EU (80)* Countries with EU specification (e.g. Israel,Morocco, Sri Lanka) Thailand (115) Indonesia (100) Singapore (160 ppm) JECFA SPEC+ (GMP) USA, Malaysia, Korea, Hong Kong Russian Federation Non-JECFA Spec (GMP) China Japan *New specification is being evaluated **Specification with larger number of Glycosides adopted

16 16 Approved Food Categories and Use Levels for India Market Serial Number Food Categories Description Dairy-based drinks, flavored and/or fermented (e.g. chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) Use level (ppm) Steviol equivalence Milk and cream powder analogues Dairy-based desserts (e.g. pudding, fruit or flavored yoghurt) Kulfi, Gulab Jamun, Lassi Edible ices, including sherbet and sorbet Jams, jellies, marmalades, fruit bar/toffee and fruit cheese Fruit preparations, including pulp, purees, fruit toppings and coconut milk Fermented fruit products Canned or bottled (pasteurized) or retort pouch vegetables Vegetable, seaweed, and nut and seed purees and spreads (e.g. peanut butter) Vegetable, seaweed, and nut and seed pulps and preparations (e.g. vegetable desserts and sauces, 165 candied vegetables) Almond Burfee Chewing gum Breakfast cereals, including rolled oats Cereal and starch based desserts (e.g. rice pudding, tapioca pudding) Soybean-based beverages Egg-based desserts (e.g. custard) Table-top sweeteners, including those containing high-intensity sweeteners 7 mg Fruit nectar Vegetable nectar Concentrates for fruit nectar Concentrates for vegetable nectar Water-based flavored drinks, including "sport," energy, or "electrolyte" drinks and 200 particulate drinks Includes all carbonated and non-carbonated varieties and concentrates. Includes products based on fruit and vegetable juices. 1 Also, includes coffee-, tea- and herbal-based drinks Carbonated water-based flavoured drinks Non-carbonated water-based flavoured drinks, including punches and ades Concentrates (liquid or solid) for water-based flavoured drinks Ready-to-eat savouries Snacks - potato, cereal, flour or starch based (from roots and tubers, pulses and legumes) 170

17 Stevia the ingredient: PureCircle Portfolio 17

18 PureCircle Innovations Originate from the Leaf More Than 40+ steviol glycosides in Stevia leaf According to regulations, only selected glycosides mixture need to make the >95% purity for the use as a sweetener Sweetness contribution is dependent on type & number of sugars in R1 & R2 Steviol is hydrophobic; R1 & R2 are hydrophilic. The combination provides the flavor modifying properties Numerous minor glycosides contribute significant flavor modification with very limited sweetness Overall Quality Sweet Onset Total Sweetness Bitterness Stevioside Steviolbioside Reb B Reb A Reb D Reb C Steviol

19 Innovation with Stevia derived Flavoring Stevia leaf extracts with selected major and minor glycosides provide excellent flavoring ingredients that contribute to modulation of sweetness profile, modifying flavor notes and masking of non-sweet taste notes. Sweet Modulation Onset sweetness Mouthfeel Long lasting Modifying flavor notes Citrus Brown Vanilla Creaminess Fruity Masking Bitterness Natural colors Vitamins Active Ingredients Modifying Non-Caloric Sweeteners profile Rounding sweetness making the flavor profile more sugar like 19

20 We have built a robust stevia portfolio High purity stevia sweeteners to naturally reduce calories Reb A Family SG95 Family Alpha Family Delta Family Zeta Family Flavor modifiers that offer synergies with stevia sweeteners NSF Family Category Solutions that maximize calorie reduction in specific applications Sigma Dairy Sigma Tea Custom Solutions

21 SG95 Family SG Acidified water solutions Sweetness Bitterness Sweet Aftertaste Bitter Aftertaste Composition Combination of nine steviol glycosides Sweetness Intensity 220 times sweeter than sugar Performance High potential in savory or more complex flavor system applications Key Application Complex flavor systems (Chocolate, coffee, etc.) Savory systems (Sauces, etc.) SE Ref Reb A97 Reb SG95-30 A85 SG 95

22 Reb A Family 6 Astringent Anise (Licorice) 0 Sweet 7 Salty Sour Reb-A Composition Single glycoside purified to high concentrations Sweetness Intensity 290 times sweeter than sugar 8.0 Fruity (Citrus) Fruity (Berry) Sweet Aftertaste Bitter Performance Delivers upfront sweetness Moderate to high sweetness replacement due to high sweetness maximum Intensity Key Application: CSDs Juices Flavored waters Alpha Time (min.sec) Reb-A

23 Anise (Licorice) Astringe nt Alpha Family Sweet Salty Sour Alpha Composition Proprietary combination of steviol glycosides Sweetness Intensity 260 times sweeter than sugar Intensity Fruity (Citrus) Fruity (Berry) Sweet Aftertaste Bitter Reduced linger Performance Cleanest taste profile with reduced linger/bitterness Key Application Delicate /lightly flavored systems (flavored waters, etc.) Time (min.sec) Alpha SG-95 Reb-A

24 PureCircle Flavors 24

25 PureCircle Flavors PureCircle Flavors (NSF) are derived from stevia leaf extract and contains mainly steviol glycosides. All NSF ingredients are FEMA GRAS PureCircle Flavors are developed to modify flavor or taste profile with no significant contribution of sweetness in food applications. The usage levels of each flavor in different food matrices are determined not to contribute significant sweet perception. 25

26 Contribution of NSF to Flavor Profile Orange CSD Unmodified Control Sweetened with Sugar Creamy, Mandarin, Fresh, Pithy, Oily NSF-01 Less creamy, higher jammy/marmalade, more bitter orange, more pithy NSF 05 Green, less ripe, woody note, more oily NSF-04 More Oily, peely, less fresh more cooked 26 NSF-03 Creamy, alcoholic/cocktail, note, spicy, woody

27 Contribution of NSF to Flavor Profile Lemon Lime CSD Control Sweetened with Sugar Fresh, zesty, higher lime, candy lemon, woody note NSF-01 Increased lemon, sherbet, lower lime more creamy. NSF 05 Cooked, lemon Curd, jammy, tonic/ quinine NSF 04 More limey, creamy lime, oily, body, pine 27 NSF-03 Green, piney, confectionery, medicinal lemon

28 Contribution of NSF to Flavor Profile Chocolate Milk Beverage NSF-04 Sweeter, more cream notes, less artificial, balanced cream/ cocoa flavor, rounded, more milk chocolate notes. NSF 05 Less bitter, malty, creamier, more milk chocolate flavor, supress dirty cocoa notes. NSF-04 More malty, more milk chocolate, high quality cocoa, more cocoa. 28

29 Contribution of NSF-01 & NSF-02 to Flavor Profile % Sugar Reduction Lemon Lime CSD 100% Sugar control 10% sugar reduced with 120 ppm NSF-02 10% sugar reduced with 30 ppm NSF01 Sweet Intensity Lemon Peely Flavor Lime Flavor Bitterness Bitter Aftertaste Sweet Aftertaste Overall Liking

30 Contribution of NSF-03 & NSF-04 to Flavor Profile B A 50% Sugar Reduced Cola B 200 ppm of SG-95 (Control) 100 A ppm of NSF-03 w/ SG B A 210 ppm SG ppm SG ppm NSF-04 * * A B a b * * a b A B * = 80% confidence level, lower case letter= 90% confidence level, upper case letter= 95% confidence Ievel

31 Capabilities and opportunities to work together 31

32 Current challenges facing calorie reduction projects Product changes upon reduction of sugar Taste Reduction of sweetness Increased acid perception Texture Loss in texture/bulk Functionality Reduction of functional benefits of sugar: Water binding Reducing sugar Texture and functionality addressed through bulking agents Taste challenges with sugar replacement ingredients in products Sweetness Perception Upfront Sweetness Sweetness Quality Time Linger Sucrose 32

33 We have extensive innovation programs focused on addressing stevia application challenges Innovation Programs Application and Technical Services Application development drives application specific advances Predictive Modeling/ Experimental Design Determine optimal glycoside combinations to optimize formulas Temporal Profiles Aftertaste Time Glycoside performance over time New stevia tools and analytic evaluation Expand stevia portfolio and evaluate new evaluation methods 33

34 PureCircle Delivers: Matrix Solutions 34

35 Taste the Next Generation of Stevia Introducing PureCircle Matrix Solutions Category-specific products that delivers speed to market alongside taste breakthroughs and deeper calorie reductions. The PureCircle Difference Powering Sigma breakthroughs are PureCircle s unique combination of: Great Taste + Speed to Market Superior Taste Profiles = Deep Stevia Expertise Extensive Portfolio Dairy Center of Excellence Proprietary Technology Sigma-D Range of Calorie Reductions High Success Rate Reduced Development Time Less resource intensive

36 Taste the Next Generation of Stevia Dairy Category Solution: Sigma-D What are the technical benefits of Sigma-D? Clean sweetness profile, with reduced sweetness linger and licorice aftertaste that performs well in most dairy systems Demonstrates parity to sugar and preference to Reb A on key attributes Great for mid calorie sugar reductions Shows excellent synergy with fructose, sugar and several polyols Stable through HTST and UHT processing Dairy Applications Chocolate Milk, 80% sugar reduced Sigma-D is parity to sugar on key attributes and outperforms Reb A Chocolate Milk: Full Sugar vs. 80% Reduced Sugar with Sigma-D A B B Sweet Intensity Bitterness Bitter Aftertaste *= 80% CI, lowercase= 90% CI, uppercase = 95% CI B A Full Sugar (Control- 8g) Reb A97 Sigma-D B C A B * * * Sweet Aftertaste A C B Overall Liking Dairy Applications Flavored Yogurt No Sugar Added Sigma-D is parity to sugar on key attributes and outperforms Reb A Flavored Yogurt: Full Sugar vs. No Sugar Added Reb A vs. No Sugar Added Sigma-D *= 80% CI, lowercase= 90% CI, uppercase = 95% CI Full Sugar (Control- 6.5g) Reb A97 Sigma-D

37 Taste the Next Generation of Stevia Tea Category Solution: Sigma-T What are the technical benefits of Sigma-T? Clean sweetness profile, with reduced astringency, bitterness and sweet aftertaste that complements herbal, earthy notes found in most tea systems Demonstrates parity to sugar and artificial blends in moderate to deep reductions Shows improvements to sugar and artificial blends for astringency, bitter and sweet aftertaste Shows excellent synergy with sugar and several polyols Stable through HTST and UHT processing Tea Applications 50% Sugar Reduced Sigma-T performs parity to sugar and improvement on astringency and bitter aftertaste Tea Applications 85% Sugar Reduced Sigma-T performs to artificial blend and improvement on bitter and sweet aftertaste Iced Lemon Black Tea 50% Sugar Reduced: Sugar vs. Sigma-T Iced Lemon Black Tea 85% Sugar Reduced: Sucrolose/AceK vs. Sigma-T A B 8 Full Sugar Control (7.5 Brix) 7 Sucralose/AceK 150 ppm Sigma T 185 ppm 6 Sigma T4 560 ppm B A a b 2 A 1 * B 0 * A B *= 80% CI, lowercase= 90% CI, uppercase = 95% CI

38 PureCircle Custom Solutions How can Stevia help optimize your formulations? A range of proprietary ingredients and customizable ingredient combinations to deliver the optimal taste and caloric reduction for your specific application Superior taste profile with more rounded sweetness Deeper calorie reductions through ingredient synergies Stevia solutions are application specific and dependent on: Formulation goal ph Flavor system Extent of calorie reduction

39 We combine our portfolio with industry-leading technical expertise and matrix- specific approach Our suite of technical services designed to reduce development time and improve in-market success Co-Development Stevia Expertise + Product Expertise Partner together to bring the maximum knowledge to the bench for quick results and strong success Sensory Research Extra Sensory Support Leverage our sensory capabilities to provide your teams with more guidance and development know-how Experimental Design Proprietary Research Platform Create a customized f solution based on your unique formulation requirements SRA Support A Changing Regulatory Landscape Consult with our regulatory experts on the latest stevia guidelines in your region