Refined exposure assessment for Quinoline Yellow (E 104)

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(3):4070 [33 pp.].
doi
10.2903/j.efsa.2015.4070
Acknowledgements

EFSA wishes to thank Polly Boon, Jean-Charles Leblanc and Oliver Lindtner, for the preparatory work on this scientific output and EFSA staff: Davide Arcella, Petra Gergelova, Alexandra Tard and Stavroula Tasiopoulou, for the support provided to this scientific output. EFSA acknowledges those European competent authorities, food industry and other stakeholders that provided occurrence data (usage and analytical data) on Quinoline Yellow (E 104) in food and beverages, and supported the data collection for the Comprehensive European Food Consumption Database.

Contact
Type
Statement of EFSA
On request from
European Commission
Question Number
EFSA-Q-2012-00888
Approved
23 March 2015
Published
25 March 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The European Food Safety Authority (EFSA) carried out an exposure assessment of Quinoline Yellow (E 104), taking into account additional information on its use in foods. In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Quinoline Yellow (E 104) and concluded that, at the maximum usage levels, refined intake estimates were generally well above the Acceptable Daily Intake (ADI) of 0.5 mg/kg body weight (bw)/day. Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission as regards the conditions of use such that Maximum Permitted Levels (MPLs), when not withdrawn (n = 14), were decreased by a factor of 1.1 to 50, depending on the food category, applicable from 1 June 2013 onwards. Following this, the European Commission requested EFSA to perform a refined exposure assessment for this food colour. Data on the presence of Quinoline Yellow (E 104) in foods were requested from relevant stakeholders through a call for usage and analytical data. Usage levels were provided to EFSA for 6 out of 28 food categories in which Quinoline Yellow (E 104) is authorised. In addition, 6 266 analytical results were reported. Following the amendment of Annex II to Regulation (EC) No 1333/2008, exposure estimates for Quinoline Yellow (E 104) presented in this statement were based on the currently authorised MPLs and analytical levels combined with food consumption data from the EFSA Comprehensive Food Consumption Database. Three scenarios were considered: (1) exposure estimates based on MPLs, (2) a refined brand-loyal exposure scenario and (3) a refined non-brand-loyal exposure scenario. Mean and high-level exposure estimates of Quinoline Yellow (E 104) were below the ADI for all population groups in all three scenarios.

Summary

Following an internal mandate proposed by the European Food Safety Authority (EFSA) to the Food Ingredients and Packaging (FIP) Unit for producing EFSA statements with refined exposure calculations for food colours with possible exceedance of the Acceptable Daily Intake (ADI), EFSA carried out a refined exposure assessment for Quinoline Yellow (E 104), taking into account additional information on its use in foods and beverages.

Quinoline Yellow (E 104) is a quinophthalone dye authorised as a food additive in the European Union (EU) for use in foods in accordance with Regulation (EC) No 1333/2008 of the European Parliament and of the Council on food additives, as amended. It was previously evaluated by the Joint Food and Agriculture Organization of the United Nations (FAO)/World Health Organization (WHO) Expert Committee on Food Additives (JECFA) in 1975, 1978 and 1984, and by the EU Scientific Committee for Food (SCF) in 1984. Both committees established an ADI of 0–10 mg/kg body weight (bw)/day.

In 2009, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive. The ANS Panel concluded that, at the maximum usage levels, refined intake estimates were generally well above the ADI of 0.5 mg/kg bw/day established by the Panel. Following conclusions of that opinion, Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission (EC) as regards the conditions of use (Commission Regulation (EU) No 232/2012) such that Maximum Permitted Levels (MPLs), when not withdrawn (n = 14), were decreased by a factor of 1.1 to 50, depending on the food category, applicable from 1 June 2013 onwards.

In 2011, JECFA established a new temporary ADI of 0–5 mg/kg bw/day and the previously established ADI of 0–10 mg/kg bw/day was withdrawn.

The present statement provides an exposure assessment of Quinoline Yellow (E 104) based on individual consumption data from the EFSA Comprehensive European Food Consumption Database, current MPLs and information on the reported analytical results of Quinoline Yellow (E 104) in foods, provided to EFSA Member States, following an EFSA call for data launched in March 2013. Three exposure scenarios were considered: (1) based on MPLs (regulatory maximum level exposure assessment—MPL scenario), (2) a brand-loyal exposure scenario assuming long-term exposure to Quinoline Yellow (E 104) at the maximum reported analytical level for one food category and mean analytical levels for other food categories and (3) a non-brand-loyal exposure scenario assuming a long-term exposure to Quinoline Yellow (E 104) at the mean reported analytical levels for all foods.

The regulatory maximum level exposure assessment scenario showed exposure estimates below the ADI of 0.5 mg/kg bw/day for all population groups, both at the mean and at the high level. The highest mean dietary exposure to Quinoline Yellow (E 104) was observed in toddlers (up to 0.23 mg/kg bw/day), and the highest 95th percentile exposure was in toddlers and children (up to 0.40 mg/kg bw/day).

The refined exposure scenarios also showed considerably low exposure for all population groups at both mean and high level with estimates below the ADI of 0.5 mg/kg bw/day. The highest mean dietary exposure to Quinoline Yellow (E 104) for the brand-loyal and non-brand-loyal scenarios was observed in toddlers with values of up to 0.15 mg/kg bw/day and up to 0.03 mg/kg bw/day, respectively, whereas the highest 95th percentile exposure was in children, with values of up to 0.29 mg/kg bw/day and up to 0.05 mg/kg bw/day, respectively.

For the MPL scenario, the mean and the 95th percentile exposure estimates of the current exposure assessment of Quinoline Yellow (E 104) are estimated to be much lower than in the evaluation carried out in 2009. In addition, for refined scenarios, the current exposure estimates of Quinoline Yellow (E 104) based on analytical levels are lower than those in the previous assessment for both the mean and the high exposure levels. These differences are the result of lower MPLs set out in 2012, different approaches used for refined scenarios, different data submitted, more food consumption data being available and a detailed nomenclature of foods categories, thus allowing a detailed selection of foods that can contain Quinoline Yellow (E 104).

In conclusion, considering the MPL and refined exposure scenarios, the mean and high-level exposure estimates of Quinoline Yellow (E 104) are below the ADI for all population groups.

Keywords
Quinoline Yellow, E 104, dietary exposure, EFSA Comprehensive European Food Consumption Database, food colours
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Number of Pages
33