National Institute of Public Health – National Institite of Hygiene 1 „ Exposure assesment of children to Southampton colours” Joanna Gajda-Wyrębek 16

National Institute of Public Health – National Institute of Public Health – National Institite of HygieneNational Institite of Hygiene

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„Exposure assesment of children

to Southampton colours”

Joanna Gajda-Wyrębek

16 April 2013

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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

Exposure assesment of children to Southampton colours

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Dietary exposure assessment

Occurence of chemical in food

Food consumption

EXPOSURE

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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

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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).

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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)

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Tiered approach Commission report (EC,2001)

Theoretical food consumptiondata x MPL

National food consumptiondata x MPL

National food consumptiondata x actual usage levels

Tier 1

Tier 2

Tier 3

Crude estimate

Refined estimate

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Colours Colours

„Food additives which add and restore colour in a food”

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• 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”

Southampton studySouthampton study

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• Tartrazine E102 - yellow

• Quinoline yellow E104 - yellow

• Sunset yellow E110 - orange

• Azorubine E122 - red

• Ponceau 4R E124 - red

• Allura Red E129 – dark red


Colours used in the study:

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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


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Study design:

6 week „additive free” diet with fortnightly challenges with either an additive mix (juice with additive) or placebo juice

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Children were given a juice cocktail containing:

Food additive MIX A MIX B

Sunset yellow E 1105 mg 7,5 mg

Azorubine E 122 2,5 mg 7,5 mg

Tartrazine E 102 7,5 mg

Ponceau E 1245 mg

Quinoline yellow E 104 7,5 mg

Allura Red E 129 7,5 mg

Sodium benzoate E 211 45 mg 45 mg

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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

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Assessment of the Southampton Assessment of the Southampton study resultsstudy 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.

Regulation (EC) No 1333/2008 of the European Parliament and of the Council

of 16 December 2008on food additives

(OJ L 354 31.12.2008)

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Risk management after Risk management after Southampton study Southampton study

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New provision for labelling of New provision for labelling of foodstuffsfoodstuffs

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”

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New provision for labelling of New provision for labelling of foodstuffsfoodstuffs

Effect: Many producers have replaced these colours by others colours or plant extracts (colouring food).

Commission Regulation (EU) no 257/2010

of 25 March 2010setting 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)

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Re-evaluation of food additives by Re-evaluation of food additives by EFSAEFSA

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Re-evaluation of Southampon Re-evaluation of Southampon colours colours

by EFSAby EFSA

Name of colour+ E number

Previous ADI[mg/kg body weight /day]

New ADI[mg/kg body weight /day]

Quinoline yellow E104 10 0,5

Sunset yellow E 110 2,5 1

Ponceau 4R E 124 4 0,7

EFSA opinion of 23 September 2009EFSA Journal 2009; 7(11)

Colours with new value of ADI

The intake of these colours can be higher than the new ADI for children and/or adults (refined exposure estimates)

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by EFSAby EFSA

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 colours in relation to the new ADI (% ADI), for „high consumers”

The intake of these colours can be higher than new ADI for children and/or adults (refined exposure estimates)

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by EFSAby 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.

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Current authorization of Southampton Current authorization of Southampton colours in some foodstuffs eaten by colours in some foodstuffs eaten by

childrenchildren

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

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Current authorization of Sounthampton Current authorization of Sounthampton colours in some foodstuffs eaten by colours in some foodstuffs eaten by

childrenchildren

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

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Current authorization of Sounthampton Current authorization of Sounthampton colours in some foodstuffs eaten by colours in some foodstuffs eaten by

childrenchildren

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

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Authorization of Southampton colours in Authorization of Southampton colours in some foodstuffs eaten by childrensome 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

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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)

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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)

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• 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

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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.

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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.

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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

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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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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

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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.

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Intake of Southampton colours by children in Poland


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

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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.

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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

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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

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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.

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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.

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Thank you for your attention.

Documents

National Institute of Public Health – National Institite of Hygiene 1 „ Exposure assesment of children to Southampton colours” Joanna Gajda-Wyrębek 16