Re-evaluation of sucrose esters of fatty acids (E 473) and xanthan gum (E 415) as food additives in foods for infants below 16 weeks of age were published by the European Food Safety Authority (EFSA) on 21/04/2023 and 04/05/2023, respectively.
In 2017 (xanthan gum) and 2018 (sucrose esters of fatty acids) EFSA already published a re-evaluation for both food additives. Therein, however, EFSA pointed out, that the use for infants below the age of 16 weeks would require a specific risk assessment. This specific risk assessments were finalised now through the recently published re-evaluations.
E 473 - sucrose esters of fatty acids
Sucrose esters of fatty acids (E 473) are not used in food categories (FCs), including all types of food for infants below 16 weeks of age according to the available information to EFSA. As a consequence, an assessment of the safety for the uses of E 473 as food additive in these FCs and age group was not performed (infant formulae, dietary foods for infants for special medical purposes and special formulae for infant as well as dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC).
When the updated exposure estimates considering the provided use levels for some food categories are taken into account, the estimates of exposure to sucrose esters of fatty acids (E 473) exceed the group acceptable daily intake (ADI) of 40 mg/kg body weight (bw) per day for many population groups. The group ADI of sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) was established by EFSA already in 2004 (EFSA Journal 2023; 21(4):7961).
Furthermore, EFSA concludes in its assessment that the technical data provided support an amendment of the specifications for E 473.
On basis of this assessment by EFSA it is very likely that the EU Commission will further restrict the use of sucrose esters of fatty acids (E 473) as food additive as well as amend the specifications for E 473 laid down in Commission Regulation (EU) No 231/2012.
E 415 – xanthan gum
In the re-evaluation of xanthan gum (E 415) EFSA concluded, that due to the low validity of the available clinical studies in infants below the age of 6 months, a reference point could not be derived from them, but the results of the available studies on neonatal piglets could serve for this purpose. From the available piglet studies a NOAEL (No Observed Adverse Effect Level) of 750 mg/kg bw per day could be derived which could be used for calculation of a Margin of Exposure (MOE).
EFSA calculated the margin of exposure for infants below 16 weeks of age consuming food for special medical purposes (FC 13.1.5.1) for the highest xanthan gum exposure and concluded that there are no safety concerns for the use of xanthan gum (E 415) as a food additive in FC 13.1.5.1. (EFSA Journal 2023; 21(5):7951).
Furthermore, EFSA concludes in its assessment that the technical data provided support an amendment of the specifications for xanthan gum (E 415) laid down in Commission Regulation (EU) No 231/2012.
