Re‐evaluation of lecithins (E 322) as a food additive

Abstract

The present opinion deals with the re-evaluation of lecithins (E 322) when used as a food additive. Lecithins (E 322) is an authorised food additive in the EU according to Annex II and Annex III to Regulation (EC) No 1333/2008 on food additives, and have been previously evaluated by JECFA in 1973 and by the SCF in 1982. Among lecithins, phosphatidylcholine is hydrolysed in choline in the cytidine-5-diphosphate-choline pathway in all cells of the body. Following the conceptual framework for the risk assessment of certain food additives re-evaluated under Commission Regulation (EU) No 257/ 2010, the Panel concluded that there was no need for a numerical ADI for lecithins (E 322) and that there was no safety concern for the general population from more than 1 year of age at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive. The Panel further concluded that there is no safety concern for the exposure to the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants (from 12 weeks up to 11 months of age), the Panel concluded that there was no safety concern at the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for the choline from lecithins (E 322) as a food additive at use and use levels reported by industry. For infants and young children consuming foods for special medical purposes, the Panel concluded that there was no safety concern with respect to the refined exposure assessment for the reported uses of lecithins (E 322) as a food additive and for exposure to choline resulting from these uses of lecithins (E 322).

Dietary Emulsifiers Alter Composition and Activity of the Human Gut Microbiota in vitro, Irrespective of Chemical or Natural Emulsifier Origin

“…For P80, only the polyethylene-sorbitan unit may reach the colon (Aguilar et al, 2015). Soy lecithin is mostly absorbed as lysolecithin and free fatty acids, but its detection in faces indicates that some fraction reaches the colon (Mortensen et al, 2017), where the choline and glycerol moieties are metabolized by the gut microbiota (Tang and Hazen, 2014). For both of these compounds, it will thus be necessary to verify if and to what extent the observed effects occur in vivo as well.…”

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2010‐85) for authorisation of food and feed containing, consisting of and produced from genetically modified soybean MON 87769 × MON 89788

“…The applicant was also asked to assess how the use of lecithin from soybean MON 87769 3 MON 89788 as food additive might impact the intake of SDA and GLA. Under the overly conservative assumption that all lecithin in the market is derived from soybean MON 87769 3 MON 89788, and considering 1) the lecithin consumption as estimated in the 2017 EFSA scientific opinion (EFSA ANS Panel et al, 2017), 2) the composition of soybean lecithin (Scholfield, 1981) and 3) the levels of SDA and GLA in lecithin (EFSA GMO Panel, 2014), maximum intakes (high consumers, 95th percentile) up to 0.73 g/day and 0.25 g/day for SDA and GLA, respectively, were estimated.…”

Opinion on the re‐evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow‐up of its re‐evaluation as food additive for uses in foods for all population groups

“…With regard to the dietary exposure to the food additive for infants below 16 weeks of age, the Panel considered the refined estimated exposure assessment scenario based on maximum use levels (95th percentile), at 260 mg/kg bw per day (see Table 8). For the general population, the exposure resulting from the refined brand-loyal scenario (95th percentile) was highest for children aged 3-9 years, at 187 mg/kg bw per day (see EFSA ANS Panel, 2017).…”