food additives seminar series intense sweeteners · intense sweetener survey ... (strawberries,...
Post on 03-Jul-2018
223 Views
Preview:
TRANSCRIPT
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
Public consultationFSANZ Board
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
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
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
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
Initial Assessment Report
Draft Assessment Report
Public consultationFSANZ Board
Final Assessment Report
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
Initial Assessment Report
Draft Assessment Report
Public consultation (May/Jun ’07)FSANZ Board
Final Assessment Report
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.
This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial 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 info@foodstandards.gov.au
Copyright
top related