food additives seminar series intense sweeteners · intense sweetener survey ... (strawberries,...

Towards a shared understanding of additives permitted for use in foods

Melanie FisherMelanie FisherGeneral Manager General Manager

Food Standards (Canberra)Food Standards (Canberra)Tuesday, 1 May 2007

Ann Naco – Co-ordinator

Food Additives Seminar SeriesFood Additives Seminar SeriesIntense SweetenersIntense Sweeteners

OverviewOverviewOpening 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

Dr Glenn StanleyDr Glenn StanleySenior Toxicologist/Risk Senior Toxicologist/Risk

ManagerManager

Introduction and PermissionsIntroduction and Permissions

Gazettal

Public consultationFSANZ Board

Initial Assessment Report

Draft Assessment Report


Final Assessment Report

FSANZ Board

Ministerial Council

Policy Guidance/Application/Other trigger

Amending the Amending the CodeCode

Risk Assessment

Risk Management

Risk Communication

Science based Policy based

Interactive exchange of information and opinions concerning risks

Risk Analysis Risk Analysis FrameworkFramework

Approval of sweetenersApproval of sweetenersFor 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.

Intense sweetenersIntense sweetenersDefinition = 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)

300Steviol glycosides* (pending)

350-400962Aspartame-acesulphame salt

7000-13000961Neotame2000-3000957Thaumatin*2000956Alitame600955Sucralose

300954Saccharin200950Acesulphame-K180951Aspartame

30952Cyclamate

Approx. sweetness (relative to sucrose)

INS Number

Intense sweetener

Foods with sweetening propertiesFoods with sweetening properties

• Polyols: – isomalt, – erythritol, – mannitol, – sorbitol, – xylitol

• Polydextrose• Trehalose (novel food)• D-Tagatose (novel food)• Isomaltulose (pending as a novel food)

Regulation of intense sweetenersRegulation of intense sweetenersStandard 1.3.1 – Food AdditivesSchedule 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

Questions?Questions?

Bronwyn DixonBronwyn DixonRisk Assessment Chemical Risk Assessment Chemical

SafetySafety

Safety Assessment of Safety Assessment of Intense SweetenersIntense Sweeteners

Risk AssessmentRisk Assessment• Pre-market assessment a requirement of

Standard 1.3.1 (Food Additives)– Risk assessment (hazard identification and

characterisation, exposure assessment and risk characterisation)

General requirements for risk General requirements for risk assessment (1)assessment (1)

• Establishment of Acceptable Daily Intake (ADI)

• Dietary exposure assessment

• Comparison of estimated exposure with ADI

General requirements for risk General requirements for risk assessment (2)assessment (2)

• In vitro studies– Genotoxicity (e.g. Ames test)

• Animal studies– Toxicokinetic studies– Subchronic, chronic/carcinogenicity – Reproductive, developmental studies

• Human studies– Toleration studies

7000-130000-2Neotame20000-1Alitame6000-15Sucralose2000-3000Not specified #Thaumatin2000-15Acesulphame-K1800-14Aspartame300-11Cyclamate3000-5Saccharin

Approx. sweetness (relative to sucrose)

ADI (mg/kg body weight)*

Intense sweetener

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

Media highlightsMedia highlights safety concernssafety concerns

Newspaper articles from2005 - 2006

FSANZ ProcessFSANZ 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?

ConclusionsConclusions• 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

Lisa KatzerLisa KatzerLabelling and Information StandardsLabelling and Information Standards

LabellingLabelling Requirements of Requirements of Intense SweetenersIntense Sweeteners

Identification of Intense SweetenersIdentification of Intense Sweeteners

Standard 1.2.4 – Labelling of Ingredients• Sweeteners must be declared in the ingredient list

Identification (Example)

– Class name Sweetener; and

– INS code number 955; or

– Specific name Sucralose

‘‘Sugar freeSugar free’’confectioneryconfectionery

Pickled GherkinsPickled Gherkins

Labelling is non-compliant with the Code

FlavouredFlavoured Drinking StrawDrinking Straw

General Labelling Requirements General Labelling Requirements -- continuedcontinued

‘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 stillperforming a technological function (sweetening) in the final food

Specific Information RequirementsSpecific Information RequirementsStandard 1.2.3 – 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)

Intense Sweetener SurveyIntense Sweetener SurveyResults and EvaluationResults and Evaluation

Christel LeemhuisChristel LeemhuisFood Composition, Evaluation and Modelling Food Composition, Evaluation and Modelling

SectionSection

• FSANZ revised the food additive standard –effective July 1999

• Substantial changes to permissions for some intense sweeteners

• In 2001-2003, 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

BackgroundBackground

Background contBackground 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

The Survey had 4 parts1. Product Review

– What products contain intense sweeteners– Concentration of each intense sweetener in

products by brand/flavour2. Screener Survey

– Consumption of intense sweetened products by the general population

– Identification of high consumers of intense sweetened products

TheThe SurveySurvey

The Survey cont.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

How Do We Estimate Dietary Exposure?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)

DietaryExposure = ∑ Food

consumption x Food chemical concentration

Summed for all foodsCan be adjusted for body weightIs compared to the Reference Health Standard (ADI)

Foods Looked at in the SurveyFoods 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

Intense Sweeteners Included in Intense Sweeteners Included in the Surveythe Survey

Intense Sweetener Food Additive NumberAspartame 951Acesulphame-K 950Saccharin 954Cyclamate 952Sucralose 955Alitame 956

Proportion of People Consuming Sugar and Intense Proportion of People Consuming Sugar and Intense Sweetened ProductsSweetened Products

Total %

1

3

3

3

3

5

7

8

10

13

27

27

9

25

24

9

23

46

48

28

59

26

60

51

Toppings

Canned Fruits

Flavoured milks

Jellies/milk based puddings

Fruit drinks

Jams or conserves

Ice creams

Cordials

Table Top Sweeteners

Flavoured yougurts/mousses

Confectionaries

Carbonated soft drinks

Proportion of People Consuming ProductsProportion of People Consuming Products

27

27

13

10

8

7

5

3

3

3

3

1

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

Aus NZ

27 26

27 26

13 12

10 10

8 8

7 7

5 7

2 5

3 3

3 4

3 6

1 1

Total %

Patterns of Consumption of Products Patterns of Consumption of Products Containing Intense SweetenersContaining Intense Sweeteners

R espondent Type

Product Type D iabeticsO n a

W eightcontrol

diet

Females 12-17year olds

60+ yearolds

C arbonated Soft D rinks v v v vC ordials v v vFruit D rinks vD

rink

s

F lavoured M ilks v v vTabletop Sw eeteners v v v vC onfectioneries v v v vFlavoured Y oghurt & M ousses v v vJellies & M ilk B aesd Puddings v vJam or C onserve v v vC anned Fruit v v vToppings v

Food

Ice C ream v v

Exposure to Intense Sweeteners Exposure to Intense Sweeteners -- Past 7 DaysPast 7 Days

95

86

72

71

39

6

0 10 20 30 40 50 60 70 80 90 100

Aspartame

Acesulphame-K

Saccharin

Cyclamate

Sucralose

Alitame

% respondents

Aus NZ Diabetic

96 90 94

87 77 85

72 70 80

72 70 77

36 51 58

7 4 3

Mean Exposure as a Percentage of Acceptable Mean Exposure as a Percentage of Acceptable Daily Intake (% ADI)Daily Intake (% ADI)

6

3

7

19

1

6

3

9

27

3

0 5 10 15 20 25 30

Aspartame

Acesulphame-K

Saccharin

Cyclamate

Sucralose

% of ADI

All respondents

Consumers

Aus NZ Diabetic

6 4 67 4 6

3 2 34 3 4

7 4 910 6 11

20 14 2328 20 30

1 3 23 5 3

Cyclamate 95th Percentile Exposure Cyclamate 95th Percentile Exposure Exceedance of the ADIExceedance of the ADI

104

100

100

245

151

104

112

0 50 100 150 200 250 300

Total 25-39

Total 60+

Female - Aus

12-17 Aus^

25-39 Aus

25-39 NZ

60+ NZ (n=40)

% of ADI

Major Food ContributorsMajor Food Contributors

4

21

74

6

47

11

16

34

27

29

51

3445

0%

20%

40%

60%

80%

100%

Aus NZ Diabetics sample^

Table top sweeteners Other dessertsJellies/milk based puddings Carbonated soft drinksCordial/ fruit drinks

Key Survey FindingsKey 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

KirstiKirsti McVayMcVayProductProduct SafetySafety StandardsStandards SectionSection

P287 P287 -- Review of Review of Cyclamate Cyclamate

Permissions in FoodPermissions in Food

CyclamatesCyclamates• 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

Australia/ New Zealand PermissionsAustralia/ New Zealand Permissions

• Standard 1.3.1 – 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

International PermissionsInternational Permissions

• Over 50 countries, including EU countries i.e. UK

• Codex • Canada - tabletop sweeteners only • USA - not permitted

Background to P287Background 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

Other considerations for P287Other 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

Gazettal

Public consultation (Oct/Nov ’04)*FSANZ Board





FSANZ Board

Ministerial Council

Policy Guidance/Application/Other trigger

*13 submissions

Initial Assessment Initial Assessment Report Report –– P287P287

Progress to DateProgress to Date

• Dietary exposure estimates refined and additional scenarios modelled

• Risk management strategy developed

• Discussion with industry

• Draft Assessment Report developed

Dietary Exposure EstimatesDietary 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

Additional Scenarios ModelledAdditional Scenarios Modelled

• Extension of cyclamate use in tabletop sweeteners in addition to current permissions (Scenario 2)

• Reduced cyclamate permissions in water-based flavoured drinks; no permission in tabletop sweeteners (Scenario 3)

• As above but with extension of use in tabletop sweeteners (Scenario 4)

9595thth Percentile DietaryPercentile DietaryExposures Exposures –– Aust/NZ Aust/NZ Consumers Aged 12+ Consumers Aged 12+

YearsYears

0.0

2.0

4.0

6.0

8.0

10.0

12.0

12+years

12+years

12+years

12-17years

18-24years

25-39years

40-59years

60+years

Diab/IGT

AUS NZ Australia and New Zealand

Population group

Estim

ated

die

tary

exp

osur

e to

cyc

lam

ate

(mg/

kg b

w/d

ay)

Scenario 1

Scenario 2

9595thth Percentile DietaryPercentile Dietary Exposures Exposures –– Australian Australian Children Aged 2Children Aged 2--11 Years11 Years

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

18.0

2-11 years male 2-11 years female

Population group

Estim

ated

die

tary

exp

osur

e to

cyc

lam

ate

(mg/

kg b

w/d

ay)

Scenario 1

Scenario 2

Scenario 3

Scenario 4

Gazettal

Public consultation (Oct/Nov ’04)FSANZ Board



Public consultation (May/Jun ’07)FSANZ Board


FSANZ Board

Ministerial Council

Policy Guidance/Application/Other triggerDraft Assessment Report Draft Assessment Report –– P287P287

Key Issues Identified in DARKey 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?

Further informationFurther information• Please visit the FSANZ web site for information on:

– P287 Review of cyclamate permissions (public comment being sought in late May 07):http://www.foodstandards.gov.au/standardsdevelopment/documentsforpublicco868.cfm

– Progress of all standards development work through the FSANZ work plan document:http://www.foodstandards.gov.au/standardsdevelopment/standardsworkplan.cfm

– The full report of Consumption of intense sweeteners in Australia and New Zealand: http://www.foodstandards.gov.au/newsroom/publications/intensesweetenerssurveymarch2004/index.cfm

• Revised food additives booklet, Choosing the right stuff, (Murdoch Books) out in bookstores - 1 June 07 & retailing at AUD $14.95

© Australia New Zealand Food Authority 2007.

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