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).
Thus, as a follow-up to that re-evaluation, EU Commission requested EFSA to assess the safety of E 410 for its uses as a food additive in foods for infants below 16 weeks of age. In addition, EFSA was requested to address the issues already identified in 2017 during the re-evaluation of the food additive when used in food for the general population, including the safety assessment for the food categories “dietary foods for infants for special medical purposes and special formulae for infants” (13.1.5.1) and “dietary foods for babies and young children for special medical purposes as defined in Directive 1999/21/EC” (13.1.5.2) as defined in Regulation 1333/2008.
As a basis for the risk assessment of locust bean gum (E 410) when used as a food additive in food categories 13.1.5.1 and 13.1.5.2, EFSA used data from a study on neonatal piglets regarding dose-dependent changes in blood zinc and glucose levels to derive a reference point applying the benchmark dose (BMD) approach. Based on this, EFSA identified a BMDL (Benchmark Dose Lower Confidence Limit) of 1,400 mg/kg body weight/day as reference point and concluded that a Margin of Exposure (MoE) above 1 to this BMDL would not raise a safety concern.
For some of the exposure levels for infants, EFSA identified a MoE above 1. For toddlers (who only consume food for special medical purposes), the MoE was above 1 for all exposure levels.
Furthermore, EFSA concluded in its assessment that the submitted technical data support an amendment of the specifications for locust bean gum (E 410) laid down in Commission Regulation (EU) No 231/2012, including a lowering of the limit values for heavy metals.
With the publication of the current EFSA assessment, the re-evaluation of E 410 is now completed.
