News: Additives
This guidance document describing the food categories in Part E of Annex II to Regulation (EC) No 1333/2008 on Food Additives was elaborated by Commission services after consultation with the Member States' experts on food additives and the relevant stakeholders. In July 2024, the EU Commission published the 7th revised version of the guidance document on its website.
In its recent opinion concerning the re-evaluation of the additive guar gum (E 412) for infants below 16 weeks of age the European Food Safety Authority (EFSA) concluded that the submitted data are not sufficient to support the safe use of guar gum (E 412) in food for infants (below and above 16 weeks of age) and young children under the food categories (FC) 13.1.1, 13.1.5.1 and 13.1.5.2 according to Regulation 1333/2008 (EFSA Journal. 2024;22:e8748).
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.
On 09/02/2023 the European Food Safety Authority (EFSA) published the re-evaluation of the additive locust bean gum (E 410) for infants below 16 weeks of age (EFSA Journal 2023;21(2):7775).
Locust bean gum (E 410) was already re-evaluated as a food additive by EFSA in 2017. However, EFSA pointed out that a specific risk assessment was required for use of E 410 in foods for infants below 16 weeks of age (EFSA Journal 2017; 15(1):4646).
EFSA published the re-evaluation of mono- and digylcerides of fatty acids (E471) for infants under the age of 16 weeks on 08/11/21. According to EFSA, there are no safety concerns when using the food additive in infant formulae (food category (FC) 13.1.1) and in dietary food for infants for special medical purposes and special formulae for infants (FC 13.1.5.1). However, based on the risk assessment, EFSA considers it necessary to lower the maximum residue limits for lead, cadmium, mercury and arsenic and to establish limits for 3-MCPD, glycidyl esters and erucic acid in E471 (EFSA Journal 2021; 19(11):6885).
Following the begin of the application of Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain from 27 March 2021, the European Food Safety Authority (EFSA) updated several administrative and scientific guidance documents.
With regard to food improvement agents (food additives, food enzymes and flavourings), EFSA updated the following guidances:
- Administrative guidance for the preparation of applications on food improvement agents (food enzymes, food additives and food flavourings) (EFSA Supporting publication 2021:EN-6509)
- Guidance for submission for food additive evaluations (EFSA Journal 2012;10(7):2760)
- Guidance of the Scientific Panel of Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) on the Submission of a Dossier on Food Enzymes for Safety Evaluation by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids (The EFSA Journal (2009) 1305)
- Guidance on the data required for the risk assessment of flavourings to be used in or on foods (EFSA Journal 2010; 8(6):1623)
In 2015 EFSA published a scientific opinion in the re-evaluation of the food additive E 304(i). In this opinion EFSA concluded that there is no safety concern for the use of ascorbyl palmitate as food additive at the reported use and use level for the general population. However,
