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EFSA: Allura Red safe at current levels

Following the adoption by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) in 2009 of a scientific opinion on the re-evaluation of Allura Red AC (E 129) used as a food additive, in which the Panel concluded that, at the high level, under both scenarios, that is using either the maximum […]

Following the adoption by the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) in 2009 of a scientific opinion on the re-evaluation of Allura Red AC (E 129) used as a food additive, in which the Panel concluded that, at the high level, under both scenarios, that is using either the maximum permitted levels (MPLs) or the reported use levels provided by industry, intake estimates for 1- to 10-year old children can be above the Acceptable Daily Intake (ADI) of 7 mg/kg body weight (bw) per day, EFSA carried out a refined exposure assessment for this colour, taking into account additional information on its use and usage levels in foods.

Allura Red AC (E 129) is an azo dye authorised 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 1980 and 1981 and the Scientific Committee for Food (SCF) in 1984 and 1989.

In 2009, the ANS Panel re-evaluated Allura Red AC (E 129) as a food additive. The safety in use of Allura Red AC (E 129) was assessed on the basis of uses and use levels authorised in the legislation and of reported use levels, as provided by industry. The ANS Panel concluded that there was no reason to revise the ADI of 7 mg/kg body weight (bw) per day.

The ANS Panel concluded that both at the maximum permitted levels (MPLs) and maximum reported levels of use of Allura Red AC (E 129), intake estimates for 1- to 10-year old children at the high percentile (95th or 97.5th) can be above the ADI of 7 mg/kg bw per day.

The present review provides a refined exposure assessment for Allura Red AC (E 129) based on individual food consumption data which became available within the EFSA Comprehensive European Food Consumption Database and newly submitted information on the actual usage levels and analytical data of Allura Red AC (E 129) in foods as consumed, provided to EFSA by the food industry and Member States, following an EFSA call for data launched in March 2013.

Usage levels of Allura Red AC (E 129) reported by industry covered six out of the 51 authorised uses of Allura Red AC as a food additive, while analytical data from Member States covered 35 food categories.

In comparison with the previous assessment, the current exposure estimates based on the MPLs scenario were in the same order of magnitude at the mean level for all populations, while high exposure levels (95th percentile) were lower for all populations except adults. Based on the refined scenarios, the current estimates were lower for all populations at both the mean and high exposure level.

EFSA concluded that, using MPLs (regulatory maximum level exposure assessment scenario), exposure estimates were lower than those from the previous opinion of the ANS Panel in 2009 and did not exceed the ADI of 7 mg/kg bw per day in any population. This was also true for the refined exposure scenarios based on usage/analytical levels at both the mean and high (95th percentile) level.