1. National Institute of Public Health – National Institite of Hygiene 1 „ Exposure assesment of children to Southampton colours” Joanna Gajda-Wyrębek 16 April 2013

2. 2 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

3. 3 Dietary exposure assessment Occurence of chemical in food Food consumption EXPOSURE

4. 4 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

5. 5 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).

6. 6 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)

7. 7 Dietary exposure assessment Tiered approach Commission report (EC,2001) Theoretical food consumption data x MPL National food consumption data x MPL National food consumption data x actual usage levels Tier 1 Tier 2 Tier 3 Crude estimate Refined estimate

8. 8 Colours „Food additives which add and restore colour in a food”

9. 9 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 study Southampton study

10. 10 Tartrazine E102 - yellow Quinoline yellow E104 - yellow Sunset yellow E110 - orange Azorubine E122 - red Ponceau 4R E124 - red Allura Red E129 – dark red Southampton study Colours used in the study:

11. 11 297 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 Southampton study

12. 12 Southampton study Study design: 6 week „additive free” diet with fortnightly challenges with either an additive mix (juice with additive) or placebo juice

13. 13 Southampton study Children were given a juice cocktail containing: Food additiveMIX AMIX B Sunset yellow E 110 5 mg7,5 mg Azorubine E 122 2,5 mg7,5 mg Tartrazine E 102 7,5 mg 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

14. 14 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

15. 15 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.

16. 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 Risk management after Southampton study

17. 17 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”

18. 18 New provision for labelling of foodstuffs Effect: Many producers have replaced these colours by others colours or plant extracts (colouring food).

19. 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 food additives by EFSA

20. 20 Re-evaluation of Southampon colours by EFSA Name of colour + E number Previous ADI [mg/kg body weight /day] New ADI [mg/kg body weight /day] Quinoline yellow E104100,5 Sunset yellow E 1102,51 Ponceau 4R E 12440,7 EFSA opinion of 23 September 2009 EFSA 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)

21. 21 Re-evaluation of Southampon colours by EFSA Name of colour + E number AdultsChildren Quinoline yellow E 104240800 Sunset yellow E 11090580 Ponceau 4R E124140880 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)

22. 22 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.

23. 23 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

24. 24 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

25. 25 Current authorization of Sounthampton colours in some foodstuffs eaten by children Colours: T artrazine 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

26. 26 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

27. 27 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)

28. 28 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 )

29. 29 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

30. 30 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

31. 31 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

32. 32 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.

33. 33 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

34. 34 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.

35. 35 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

36. 36 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.

37. 37 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

38. 38 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.

39. 39 Intake of Southampton colours by children in Poland Step II Scenario 1: Using the MPL and actual food consumption data Colour% ADI Tartrazine E 1020,2 – 30,8 Azorubine E 1221,1 – 58,6 Allura Red E 1292,6 – 44,6 Quinoline yellow E 10417,6 – 441,2 Sunset yellow E 1103,1 – 185,0 Ponceau 4R E 1243,8 – 178,5

40. 40 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.

41. 41 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 1021,2 – 13,5 Azorubine E 1220,4 – 42,8 Allura Red E 12911,0 – 36,4 Quinoline yellow E 10434,0 - 36,0 Sunset yellow E 11014,0 – 24,1 Ponceau 4R E 12410,0 – 108,6

42. 42 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

43. 43 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.

44. 44 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.

45. 45 Thank you for your attention.