Assessment for Ponceau 4R (E 124)

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 that may possibly exceed the Acceptable Daily Intake (ADI), EFSA carried out a refined exposure assessment for Ponceau 4R (E 124), taking into account additional information on its use in foods and beverages.

Ponceau 4R (E 124) is an azo dye authorised for use as a food additive in the European Union (EU). This food colour has been previously evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1983 and the Scientific Committee for Food (SCF) in 1984. Both committees established an ADI of 0-4 mg/kg body weight (bw) per day.

In 2009, the ANS Panel re-evaluated Ponceau 4R (E 124) as a food additive. The safety of using Ponceau 4R (E 124) was assessed on the basis of uses and use levels authorised in the legislation4 and of reported use levels, as provided by industry. The ANS Panel derived an ADI of 0.7 mg/kg bw per day, based on the lowest No Observed Adverse Effect Level (NOAEL) derived from a long-term mouse study.

The ANS Panel concluded that, at the maximum levels of use, intake estimates for adults at the high percentile (97.5th) and for 1- to 10-year old children at the mean and high percentiles (95th/97.5th) were generally above the ADI of 0.7 mg/kg bw per day even in the refined intake estimates. Following the conclusions of that opinion, Annex II to Regulation (EC) No 1333/2008 was amended by the European Commission (EC) regarding the conditions of use of Ponceau 4R (E 124) as a food additive applicable from 1 June 2013 onwards (Commission Regulation (EU) No 232/2012)5. Many Maximum Permitted Levels (MPLs) were withdrawn (n = 24), or were decreased by a factor 1.2 to 200 (n = 29), depending on the food category.

The present review provides a refined exposure assessment for Ponceau 4R (E 124) based on individual food consumption data from the EFSA Comprehensive European Food Consumption Database, current MPLs and newly submitted information on actual usage levels and analytical data of Ponceau 4R (E 124) in foods as consumed, provided to EFSA by the food industry and Member States respectively, following an EFSA call for data6 launched in March 2013. Three exposure scenarios were considered: (1) a scenario based on MPLs (regulatory maximum level exposure assessment — MPL scenario), (2) a ‘brand-loyal exposure’ scenario assuming long-term exposure to Ponceau 4R (E124) 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 Ponceau 4R (E 124) at the mean reported analytical levels for all foods. The last two scenarios are the so-called refined exposure assessment scenarios.

Usage levels of Ponceau 4R (E 124) reported by industry covered three out of the 31 authorised uses of Ponceau 4R (E 124) as a food additive, while analytical data from Member States covered 18 food categories.

The exposure estimates derived from the regulatory maximum level exposure assessment scenario were below the ADI of 0.7 mg/kg bw per day for all population groups, at both the mean and the high level (95th percentile). The highest mean dietary exposure to Ponceau 4R (E 124) was observed in toddlers (up to 0.23 mg/kg bw per day), and the highest 95th percentile exposures were observed in toddlers and children (up to 0.51 mg/kg bw per day).

In the refined exposure scenarios both mean and high level exposures to Ponceau R (E 124) were also below the ADI in all population groups. The highest mean dietary exposure to Ponceau 4R (E 124) for the brand-loyal and non-brand-loyal scenarios was observed in toddlers with values of up to 0.20 and 0.16 mg/kg bw/day, respectively; the highest 95th percentile exposure was also observed in toddlers for these scenarios, with values of up to 0.46 and 0.38 mg/kg bw/day, respectively.

For the regulatory maximum level exposure assessment scenario, the mean and the 95th percentile exposure estimates of the current exposure assessment of Ponceau 4R (E 124) were much lower than those reported in the evaluation of 2009. In addition, for the refined exposure scenarios, the current exposure estimates for Ponceau 4R (E 124) based on usage data and analytical levels were also lower than those reported in the previous assessment. These differences are the result of the lower MPLs from 2012 onwards, differences in approaches used to include use and analytical data in the exposure assessment, differences in concentration data submitted, availability of more food consumption data and a detailed nomenclature of foods categories, thus allowing a detailed selection of foods that could contain Ponceau 4R (E 124).

EFSA concluded that, considering the regulatory maximum level exposure assessment and the refined exposure scenarios, the mean and high-level exposure estimates of Ponceau 4R (E 124) were below the ADI for all population groups.