Food Additives Seminar Series Intense Sweeteners. Melanie Fisher General Manager Food Standards (Canberra)

Transcription

1 Food Additives Seminar Series Intense Sweeteners Towards a shared understanding of additives permitted for use in foods Melanie Fisher General Manager Food Standards (Canberra) Tuesday, 1 May 2007 Ann Naco Co-ordinator

2 Overview Opening remarks Melanie Fisher Introduction & permissions Dr Glenn Stanley Safety assessment of intense sweeteners Bronwyn Dixon Labelling requirements Lisa Katzer Intense sweetener survey - results & evaluation Christel Leemhuis P287 Review of cyclamate permissions Kirsti McVay Discussion & summing up Melanie Fisher

3 Introduction and Permissions Dr Glenn Stanley Senior Toxicologist/Risk Manager

4 Amending the Code Policy Guidance/Application/Other trigger Initial Assessment Report FSANZ Board Public consultation Draft Assessment Report FSANZ Board Public consultation Final Assessment Report FSANZ Board Gazettal Ministerial Council

5 Risk Analysis Framework Risk Assessment Science based Risk Management Policy based Risk Communication Interactive exchange of information and opinions concerning risks

6 Approval of sweeteners For food additives (sweeteners) to be approved, it must be established that: (1) it must not pose an unacceptable risk to health when used in amounts up to the approved limits even after a lifetime of consumption; (2) there is a technological need and it will provide a benefit to consumers; and (3) it will only be used up to a level commensurate with the function that the additive performs in food.

7 Intense sweeteners Definition = replace sweetness normally provided by sugars without contributing significantly to the available energy in foods Typically used in low-joule foods, artificially sweetened foods without added sugar and in specific foods where they are used in addition to sugar Common names - Splenda (sucralose), Nutrasweet (Aspartame), Equal (aspartame and Ace-K), Sugarless or Sugarine (saccharin)

8 Intense sweetener Cyclamate Aspartame Acesulphame-K Saccharin Aspartame-acesulphame salt Sucralose Alitame Thaumatin* Neotame Steviol glycosides* (pending) INS Number Approx. sweetness (relative to sucrose)

9 Foods with sweetening properties Polyols: isomalt, erythritol, mannitol, sorbitol, xylitol Polydextrose Trehalose (novel food) D-Tagatose (novel food) Isomaltulose (pending as a novel food)

10 Regulation of intense sweeteners Standard Food Additives Schedule 1 Restrictions on use due to technological need and risk assessment outcomes Specific maximum limits which restrict permissions in specific foods E.g. Confectionery (Neotame, 300 mg/kg; sucralose, 2500 mg/kg) Schedule 2 Permitted at Good Manufacturing Practice (GMP) levels in range of processed foods and beverages Need permissions in schedule 1

11 Questions?

12 Safety Assessment of Intense Sweeteners Bronwyn Dixon Risk Assessment Chemical Safety

13 Risk Assessment Pre-market assessment a requirement of Standard (Food Additives) Risk assessment (hazard identification and characterisation, exposure assessment and risk characterisation)

14 General requirements for risk assessment (1) Establishment of Acceptable Daily Intake (ADI) Dietary exposure assessment Comparison of estimated exposure with ADI

15 General requirements for risk assessment (2) In vitro studies Genotoxicity (e.g. Ames test) Animal studies Toxicokinetic studies Subchronic, chronic/carcinogenicity Reproductive, developmental studies Human studies Toleration studies

16 Intense sweetener Saccharin Cyclamate Aspartame Acesulphame-K Thaumatin Sucralose Alitame Neotame ADI (mg/kg body weight)* Not specified # Approx. sweetness (relative to sucrose) Note: *determined by the WHO/FAO Joint Expert Committee on Food Additives. # establishment of an ADI is not deemed necessary because of a good safety profile

17 Media highlights safety concerns Newspaper articles from

18 FSANZ Process New studies are assessed by FSANZ and other regulatory agencies around the world Is the study valid and does it outweigh all other studies indicating safety? Do permissions need to be reconsidered in light of study?

19

20 Conclusions Pre-market safety assessment conducted on each new sweetener Large body of safety data available for approved intense sweeteners New data assessed as it becomes available permissions can be revised if necessary

21 Questions?

22 Labelling Requirements of Intense Sweeteners Lisa Katzer Labelling and Information Standards

23 Identification of Intense Sweeteners Standard Labelling of Ingredients Sweeteners must be declared in the ingredient list Identification Class name (Example) INS code number 955; or Sweetener; and Specific name Sucralose

24 Sugar free confectionery

25 Pickled Gherkins

26 Flavoured Drinking Straw Labelling is non-compliant with the Code

27 General Labelling Requirements - continued Compound ingredient: an ingredient of a food which is itself made from two or more ingredients e.g. ingredient list for low joule, jam filled biscuit: Wheat flour, butter (milk, rennet, salt), strawberry jam (strawberries, sweetener (950), citric acid), milk solids. If 5 % in the food, must declare all ingredients, including intense sweeteners If < 5 %, must only declare the intense sweetener if it is still performing a technological function (sweetening) in the final food

28 Specific Information Requirements Standard Mandatory Warning and Advisory Statements and Declarations Label must include a mandatory advisory statement to the effect that the product contains phenylalanine, if the food contains: aspartame (951); or aspartame acesulphame salt (962) For unpackaged foods, this information should be provided to consumers upon request (either verbally or in writing)

29 Questions?

30 Intense Sweetener Survey Results and Evaluation Christel Leemhuis Food Composition, Evaluation and Modelling Section

31 Background FSANZ revised the food additive standard effective July 1999 Substantial changes to permissions for some intense sweeteners In , FSANZ surveyed intense sweeteners as part of its evaluation strategy to look at the effectiveness of key food regulatory measures Follow up to 1994 survey

32 Background cont. The survey aimed to collect data on the consumption of products containing intense sweeteners for the general population and people with diabetes in Australia and New Zealand We wanted to know if the changes to intense sweetener permissions in the new standard had significantly altered dietary exposure to intense sweeteners

33 The Survey The Survey had 4 parts 1. Product Review What products contain intense sweeteners Concentration of each intense sweetener in products by brand/flavour 2. Screener Survey Consumption of intense sweetened products by the general population Identification of high consumers of intense sweetened products

34 The Survey cont. 3. Main Diary Survey 7 day diary record of consumption of intense sweetened products and amounts consumed Dietary exposure to intense sweeteners for high consumers were estimated 4. Supplementary Survey dietary exposures for people with diabetes or glucose intolerance were estimated

35 How Do We Estimate Dietary Exposure? A dietary exposure estimate is where food consumption data and food chemical data are combined to estimate dietary exposure to food chemical(s) Dietary Exposure = Food consumption x Food chemical concentration Summed for all foods Can be adjusted for body weight Is compared to the Reference Health Standard (ADI)

36 Foods Looked at in the Survey carbonated soft drinks cordials fruit drinks tabletop sweeteners confectioneries flavoured yoghurts and mousses jellies and milk based puddings jams or conserves flavoured milks canned fruit toppings ice cream

37 Intense Sweeteners Included in the Survey Intense Sweetener Food Additive Number Aspartame 951 Acesulphame-K 950 Saccharin 954 Cyclamate 952 Sucralose 955 Alitame 956

38 Proportion of People Consuming Sugar and Intense Sweetened Products 51 Carbonated soft drinks 27 Total % Confectionaries Flavoured yougurts/mousses Table Top Sweeteners Cordials 8 28 Ice creams 7 48 Jams or conserves 5 46 Fruit drinks 3 23 Jellies/milk based puddings 3 9 Flavoured milks Canned Fruits Toppings 1 9

39 Proportion of People Consuming Products Total % Aus NZ Carbonated soft drinks Confectioneries Flavoured yoghurts/mousses Table top sweeteners Cordials Ice creams Jams or conserves Fruit drinks Jellies/milk based puddings Flavoured milks Canned fruits Toppings 1 1 1

40 Patterns of Consumption of Products Containing Intense Sweeteners Respondent Type Drinks Food Product Type Diabetics On a Weight control diet Females year olds Carbonated Soft Drinks v v v v Cordials v v v Fruit Drinks Flavoured Milks v v v Tabletop Sweeteners v v v v Confectioneries v v v v Flavoured Yoghurt & Mousses v v v Jellies & M ilk Baesd Puddings v v Jam or Conserve v v v Canned Fruit v v v Toppings Ice Cream v v v v 60+ year olds

41 Exposure to Intense Sweeteners - Past 7 Days Aus NZ Diabetic Aspartame Acesulphame-K Saccharin Cyclamate Sucralose Alitame % respondents

42 Mean Exposure as a Percentage of Acceptable Daily Intake (% ADI) Aus NZ Diabetic Aspartame Acesulphame-K 3 3 All respondents Consumers Saccharin Cyclamate Sucralose % of ADI

43 Cyclamate 95th Percentile Exposure Exceedance of the ADI Total Total Female - Aus Aus^ Aus NZ NZ (n=40) % of ADI

44 Major Food Contributors 100% 80% % 27 40% % 0% Aus NZ Diabetics sample^ Table top sweeteners Jellies/milk based puddings Cordial/ fruit drinks Other desserts Carbonated soft drinks

45 Key Survey Findings Across Australia and New Zealand, females, people with diabetes and those on weight control diets were more likely to use foods containing intense sweeteners Mean dietary exposure to all intense sweeteners was below the Reference Health Standard (ADI) High consumers of cyclamates exceeded the ADI Cordials, fruit drinks and carbonated soft drinks were the major contributors to cyclamate exposure People with diabetes and those with impaired glucose tolerance who consume foods containing intense sweeteners were not exposed to higher amounts of intense sweeteners than consumers who have neither of these medical conditions

46 Questions?

47 P287 - Review of Cyclamate Permissions in Food Kirsti McVay Product Safety Standards Section

48 Cyclamates Least sweet of intense sweeteners 30 x sucrose Heat stable during cooking and baking Water soluble Long shelf-life Pleasant taste when used in combination with other sweeteners Available at lower cost to other alternatives Readily available as it is a non-proprietary product

49 Australia/ New Zealand Permissions Standard Food Additives approved intense sweetener Schedule 1 permissions for a range of food types e.g. cordials, carbonated soft drinks, fruit drinks, jelly Not permitted in tabletop sweeteners Food Additive Number = 592

50 International Permissions Over 50 countries, including EU countries i.e. UK Codex Canada - tabletop sweeteners only USA - not permitted

51 Background to P287 Raised as a result of the 2003 Intense Sweeteners Survey Additional dietary modelling Australian children 2 11 yrs based on 1995 NNS food consumption data

52 Other considerations for P287 Former Application (A515) from Hermes Sweeteners (UK) Sought permission for cyclamate use in tabletop sweeteners: liquid & portion sized packages GMP levels sufficient levels to sweeten foods

53 Initial Assessment Report P287 Policy Guidance/Application/Other trigger Initial Assessment Report FSANZ Board Public consultation (Oct/Nov 04)* Draft Assessment Report FSANZ Board Public consultation Final Assessment Report FSANZ Board *13 submissions Ministerial Council Gazettal

54 Progress to Date Dietary exposure estimates refined and additional scenarios modelled Risk management strategy developed Discussion with industry Draft Assessment Report developed

55 Dietary Exposure Estimates Revised estimates using manufacturers current use levels of cyclamate and MPLs in Code (Scenario 1) Australian children aged 2-11 years exceed ADI for cyclamate at 95th percentile exposure Intensely sweetened soft drinks and cordials major contributors to cyclamate exposure

56 Additional Scenarios Modelled Extension of cyclamate use in tabletop sweeteners in addition to current permissions (Scenario 2) Reduced cyclamate permissions in waterbased flavoured drinks; no permission in tabletop sweeteners (Scenario 3) As above but with extension of use in tabletop sweeteners (Scenario 4)

57 95 th Percentile Dietary Exposures Aust/NZ Consumers Aged 12+ Years 12.0 Estimated dietary exposure to cyclamate (mg/kg bw/day) Scenario 1 Scenario years 12+ years 12+ years years years years years 60+ years Diab/IGT AUS NZ Australia and New Zealand Population group

58 95 th Percentile Dietary Exposures Australian Children Aged Years 18.0 Estimated dietary exposure to cyclamate (mg/kg bw/day) Scenario 1 Scenario 2 Scenario 3 Scenario years male 2-11 years female Population group

59 Draft Assessment Report P287 Policy Guidance/Application/Other trigger Initial Assessment Report FSANZ Board Public consultation (Oct/Nov 04) Draft Assessment Report FSANZ Board Final Assessment Report FSANZ Board Public consultation (May/Jun 07) Ministerial Council Gazettal

60 Key Issues Identified in DAR Can industry support reduced cyclamate levels in water-based flavoured drinks? What are the costs/benefits to stakeholders of reducing cyclamate levels? Can industry provide additional information to assist in refining dietary exposure estimates?

61 Questions?

62 Further information Please visit the FSANZ web site for information on: P287 Review of cyclamate permissions (public comment being sought in late May 07): Progress of all standards development work through the FSANZ work plan document: The full report of Consumption of intense sweeteners in Australia and New Zealand: /index.cfm Revised food additives booklet, Choosing the right stuff, (Murdoch Books) out in bookstores - 1 June 07 & retailing at AUD $14.95

63 Copyright Australia New Zealand Food Authority This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, noncommercial use or use within your organisation. Apart from any other use as permitted under the Copyright Act 1968, all other rights are reserved. Requests for further authorisation should be directed to