Transcript Colours

National Institute of Public Health –
National Institite of Hygiene
„Exposure assesment of children
to Southampton colours”
Joanna Gajda-Wyrębek
16 April 2013
1
Exposure assesment of children
to Southampton colours
Presentation overview
• Introduction to exposure assessment
• Southampton study
• Implications of Southampton study findings
• Case study - intake of Southampton colours by children in Ireland
• Polish study on intake of Southampton colours
• Exposure of Polish children to Southampton colours – preliminary
results
2
Dietary exposure assessment
Occurence
of chemical in food
Food
consumption
EXPOSURE
3
Dietary exposure assessment
DIETARY EXPOSURE
CONCENTRATION x CONSUMPTION
•
•
Contribution from all food categories
Adjust to the body weight
∑ (chemical concentration x food consumption)
body weight
results in mg FA/kg bw/day
4
Risk characterisation
•
Aim:
to determine if population or fraction of the population would have
intakes >than the ADI
•
Possible conclusions
- the expected/present exposure is safe according to the established ADI
- reductions in exposure are needed to comply with the ADI (revise the use
levels).
5
Dietary exposure assessment
Data requirements
 Food consumption
•
•
EFSA Comprehensive European food consumption database
National food consumption data
 Occurence of chemical in food
•
•
MPL
Actual occurence of the chemical of interest
- Industry (use levels)
- Chemical analysis
- Food ingredient databases ( e.g. Ireland)
6
Dietary exposure assessment
Tiered approach
Commission report (EC,2001)
Theoretical food consumption
data x MPL
Tier 2
Tier 3
Crude
estimate
Tier 1
National food consumption
data x MPL
National food consumption
data x actual usage levels
Refined
estimate
7
Colours
„Food additives which add
and restore colour in
a food”
8
Southampton study
•
2007 - McCANN et al.
„Food Additves and hyperactive behaviour in 3-years-old
and 8/9-years-old children in the community: a
randomised, double-blinded, placebo-controlled trial”
The results of the study were published in the magazine
„The Lancet”
9
Southampton study
Colours used in the study:
• Tartrazine E102 - yellow
• Quinoline yellow E104 - yellow
• Sunset yellow E110 - orange
• Azorubine E122 - red
• Ponceau 4R E124 - red
• Allura Red E129 – dark red
10
Southampton study
297 Children took part in the study:
• 153 children 3-year old
- 79 boys
- 74 girls
• 144 children 8/9 year old
- 75 boys
- 69 girls
11
Southampton study
Study design:
6 week „additive free” diet with fortnightly challenges with
either an additive mix (juice with additive) or placebo juice
12
Southampton study
Children were given a juice cocktail containing:
Food additive
MIX A
MIX B
5 mg
7,5 mg
Azorubine E 122
2,5 mg
7,5 mg
Tartrazine E 102
7,5 mg
Sunset yellow E 110
Ponceau E 124
5 mg
Quinoline yellow E 104
7,5 mg
Allura Red E 129
7,5 mg
Sodium benzoate E 211
45 mg
45 mg
13
Southampton study
Results of study:
- 267 children completed the study
-
a mix of additives which was included in the juice drink increased the mean
level of hyperactivity in children (inattention, impulsivity, overactivity)
-
mix A had a significantly adverse effect compared with placebo for
3-year-old children but not mix B versus placebo
-
8/9 –year-old children showed a significantly adverse effect when given mix A
or mix B
14
Assessment of the Southampton study
results
Scientific Opinion of EFSA adopted on 7 March 2008
Conclusion:
There are a number of uncertainties that are apparent from Mc Cann et al.
research.
The study provides limited evidence that the two different mixtures of
synthetic colours and sodium benzoate tested had a small and statistically
significant effect on activity and attention in children, althougt the effects
were not statistically significant for the two mixtures in both age groups.
Since mixtures and not individual additives were tested in the study, it is not
possible to ascribe the obserevd effects to any of the individual compounds.
The clinical significance of the observed effects also remains unclear.
15
Risk management after Southampton
study
Regulation (EC) No 1333/2008
of the European Parliament and of the Council
of 16 December 2008
on food additives
(OJ L 354 31.12.2008)
16
New provision for labelling of foodstuffs
The labels of food containing one or more of the following colours:
Tartrazine E102
Quinoline yellow E104
Sunset yellow E110
Azorubine E122
Ponceau 4R E124
Allura Red E129
shall include the information:
„name or E number of the colour(s): may have an adverse effect on
activity and attention in children”
17
New provision for labelling of foodstuffs
Effect:
Many producers have replaced these colours by others colours
or plant extracts (colouring food).
18
Re-evaluation of food additives by
EFSA
Commission Regulation (EU) no 257/2010
of 25 March 2010
setting up a programme for the re-evaluation of approved food additives
in accordance with Regulation (EC) No 1333/2008 of the European
parliament and of the Council on food additives
(OJ L 80 26.03.2010)
19
Re-evaluation of Southampon colours
by EFSA
EFSA opinion of 23 September 2009
EFSA Journal 2009; 7(11)
Colours with new value of ADI
Name of colour
+ E number
Quinoline yellow E104
Sunset yellow E 110
Ponceau 4R E 124
Previous ADI
New ADI
[mg/kg body weight /day]
[mg/kg body weight /day]
10
2,5
4
0,5
1
0,7
The intake of these colours can be higher than the new ADI for children
and/or adults (refined exposure estimates)
20
Re-evaluation of Southampon colours
by EFSA
The intake of colours in relation to the new ADI (% ADI),
for „high consumers”
Name of colour
+ E number
Adults
Children
Quinoline yellow E 104
240
800
Sunset yellow E 110
90
580
Ponceau 4R E124
140
880
The intake of these colours can be higher than new ADI for children and/or
adults (refined exposure estimates)
21
Re-evaluation of Southampon colours
by EFSA
Colours for which there was no reason to revise ADI
[mg/kg body weight/day]
Tartrazine E 102 – 7,5
Azorubine E 122 – 4
Allura Red E 129 - 7
The intake of azorubine E 122 and Allura Red E 129 by children „high
consumers” can be higher than ADI.
22
Current authorization of Southampton colours
in some foodstuffs eaten by children
until the 1 st of June 2013
• Directive 94/36/EC of 30 June 1994 on colours for use in
foodstuffs
In Poland:
• Regulation of Ministry of Health of 22 November 2010 on authorized food
additives
23
Current authorization of Sounthampton colours
in some foodstuffs eaten by children
Colours: sunset yellow E110, azorubine E122, Ponceau 4R E124
•
•
•
•
•
non-alcoholic flavoured drinks,
ice-cream,
desserts,
fine bakery wares
confectionery
50 mg/kg or 50 mg/L
24
Current authorization of Sounthampton colours
in some foodstuffs eaten by children
Colours: Tartrazine E102, Quinoline yellow E104, Ponceau 4R E129
•
•
•
•
non-alcoholic flavoured drinks 100 mg/l
ice-cream, desserts including flavoured milk products 150 mg/kg
fine bakery wares 200 mg/kg
confectionery 300 mg/kg
25
Authorization of Southampton colours in some
foodstuffs eaten by children
since the 1 st of June 2013
Commission Regulation (UE) No 1129/2011
of 11 November 2011
amending Annex II to regulation (EC) No 1333/2008 of the European
Parliament and of the Council by establishing a Union list of food additives
26
Risk management after EFSA opinions
since the 1 st of June 2013
Commission Regulation (UE) No 232/2012
of 11 March 2012
amending Annex II to regulation (EC) No 1333/2008 of the European
Parliament and of the Council as regards the condition of use and the levels
for quinoline yellow E 104, sunset yellow E 110 and Ponceau 4R E 124
(OJ L 78, 17.03.2012)
27
Risk management after EFSA opinions
Quinoline yellow E 104, Sunset yellow E 110, Ponceau 4R E 124
It was necessary to amend the condition of use and use levels for these
colours to ensure that the new ADI are not exceeded.
• The maximum limits have been reduced by the same factor as the
reduction in daily intake which is aimed at.
Examples:
- confectionery – reduction from 300 mg/kg to 30 mg/kg
- decoration and coatings – reduction from 500 mg/kg do 50 mg/k
- non-alcoholic flavoured drinks
- reduction from 100 mg/l do 7 mg/l (E 140)
- reduction from 50 mg/l do 10 mg/l (E 110 i E 124)
28
Risk management after EFSA opinions
• Some provision have been deleted
Examples:
-
fine bakery wares
ice creams
flavoured processed cheese
jam, jellies, marmalades and sweetened chesnut puree
snacks
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Irish study on intake of Southampton
colours
A. Connoly, A. Hearty, A. Nugent, A.McKevitt, E. Boylan,
A. Flynn and M.J. Gibney
Pattern of intake of food additives associated with
hyperactivity in Irish children and teenagers
final version received 2 November 2009
Food Additives and Contaminants, 27 (4), pp. 447-456
30
Irish study on intake of Southampton
colours
Three scenarios were run to conduct the exposure analyses
Scenario 1: Using the Maximum Permitted Level (MPL) and assuming that if the
additive is legally permitted in a food group, it is present (tier I)
Scenario 2: Using the MPL and actual national food consumption data
(from INFID – National Food Ingredient Database) (tier 2)
Scenario 3: Using actual usage levels (from 4 sources) and
actual national food consumption data (from INFID) (tier 3)
-
Industry
Food Safety Authority of Ireland
United Kingdom Food Standards Agency
Food Standards Australia and New Zealand
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Irish study on intake of Southampton
colours
Exposure results: Irish children
•
The majority of additive-containing foods consumed by both the children or
teenagers contained one of the target additives
•
No food consumed by either the children or teenagers contained all seven of
the target food additives (6 colours and sodium benzoate)
•
For both groups, mean intakes of the food additives among consumers only
were far below the doses used in the Southampton study
•
Levels of exposure did not exceed ADI’s (the old ones)
•
This is true when applying 3 different scenarios’s – ranging from conservative to
more refined.
32
Exposure of Polish children to Southampton
colours
Project has been approved by National Science Centre and it is financed
by Polish Ministry of Science and Higher Education.
Time framework of the project: 2011-2013
Objective of the study:
Assessment of Southampton colour intake by children in Poland:
- 3-year old
- 8/9- year old
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Polish study on intake of Southampton
colours
Two scenarios have been planned to conduct the exposure analyses
Scenario 1: Using the MPL and actual food consumption data
Scenario 2: Using actual level in food and actual food consumption data
Limitations:
There is no national food consumption database in Poland.
34
Polish study on intake of Southampton
colours
Step I
•
Elaboration of a food frequency questionnaire for parents
the aim: to get information about the frequency and amount of food
containing Southampton colours and consumed by children
-
which products containing these colours are consumed by the child
(brand name and name of the producer)
how much
how often
which colours were present in the product (according to the label of product)
-
information about age and body weight of the child
•
•
7 succeeding days dietary survey
participation in the survey was voluntary and all data remained anonymous
35
Polish study on intake of Southampton
colours
Step I
7 days dietary survey
149 children took part in the survey:
- 83 children 3-year old
- 66 children 8/9 year old
They lived in:
- two districts of Warsaw: Praga Północ and Mokotów
- two suburban districts: Nieporęt and Wieliszew
Children were selected randomly.
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Polish study on intake of Southampton
colours
Step II
Scenario 1: Using the MPL and actual food consumption data
•
All products containing Sothampton colours and consumed by children have
been taken into consideration (the data from questionnaires)
- in 37 questionnaires (of all 149) food products containing one or more target
colours have been noted
- 49 food products contained Southampton colours: confectionary (candies,
lollypops), non-alcoholic beverages, desserts, snacks and food supplements
- all six target colours have been found in products mentioned in questionnaires
- no food contained all six of the target colours
37
Polish study on intake of Southampton
colours
Step II
Scenario 1: Using the MPL and actual food consumption data
Taking into account:
- maximum permitted usage level of colours in the product
- amount of product consumed by child
- body weight of child noted in questionnaire
the daily intake of each colour expressed on a bodyweight basis was computed
for consumers only.
The intake of colour has been compared to the ADI of this colour.
38
Intake of Southampton colours by children in
Poland
Step II
Scenario 1: Using the MPL and actual food consumption data
Colour
% ADI
Tartrazine E 102
0,2 – 30,8
Azorubine E 122
1,1 – 58,6
Allura Red E 129
2,6 – 44,6
Quinoline yellow E 104
17,6 – 441,2
Sunset yellow E 110
3,1 – 185,0
Ponceau 4R E 124
3,8 – 178,5
39
Polish study on intake of Southampton
colours
Step III (still being continued)
Scenario 2: Using actual level in food and actual food consumption data
•
Until now the level of target colours in 19 non alcoholic beverages have been
determined by HPLC method.
Taking into account:
- actual level of colour in product
- amount of product consumed by child
- average body weight of child
the daily intake of each colour expressed on a bodyweight basis was computed
for consumers only.
The intake of colour has been compared to the ADI of this colour.
40
Intake of Southampton colours by children in
Poland
Step III
Scenario 2: Using actual level in food and actual food consumption data
Colour
% ADI
Tartrazine E 102
1,2 – 13,5
Azorubine E 122
0,4 – 42,8
Allura Red E 129
11,0 – 36,4
Quinoline yellow E 104
34,0 - 36,0
Sunset yellow E 110
14,0 – 24,1
Ponceau 4R E 124
10,0 – 108,6
41
Intake of Southampton colours by
children in Poland
Exposure results: conclusion
•
The actual levels of target colours in the majority of non-alcoholic beverages
were far below the maximum permitted levels
•
No food contained all six of the target colours
•
Levels of exposure assessed in scenario 1 (using the MPL and actual food
consumption data) did not exceed ADI for colours with non-changed ADI
•
Levels of exposure assessed in scenario 1 exceeded ADI for all 3 colours with
reduced ADI
•
Levels of exposure assessed in scenario 2 (using actual level in beverages and
actual food consumption data) did not exceed ADI for all colours
42
Intake of Southampton colours
by children in Ireland
Exposure results: Irish children
•
Levels of exposure did not exceeded ADI’s (the old ones)
•
This is true when applying 3 different scenarios’s – ranging from conservative to
more refined.
43
Intake of Southampton colours
by children in Poland
Exposure results: conclusion
•
Running the two scenarios illustrates that application actual food consumption
data combined with the actual usage level of food additives is necessary to
provide realistic exposure analysis.
•
It is real need to create national food consumption database in Poland
in aim to monitor food additive consumption and to ensure that actual use food
additive does not exceed the acceptable daily intake (ADI).
•
According to the Regulation No 1333/2008 of European Parliament and of the
Council on food additives, Member States shall mantain system to monitor
the consumption and use of food additives and report their findings to the
Commission and EFSA.
44
Thank you for your attention.
45