Safety of use of oat lecithin as a food additive

EFSA Panel on Food Additives and Flavourings (FAF); Maged Younes; Gabriele Aquilina; Laurence Castle; Karl-Heinz Engel; Paul Fowler; Maria Jose Frutos Fernandez; Peter Fürst; Rainer Gürtler; Ursula Gundert-Remy; Trine Husøy; Wim Mennes; Peter Moldeus; Agneta Oskarsson; Romina Shah; Ine Waalkens-Berendsen; Detlef Wölfle; Gisela Degen; Jean-Charles Leblanc; Alessandra Giarola; Ana Maria Rincon; Alexandra Tard

doi:10.2903/j.efsa.2020.5969

Safety of use of oat lecithin as a food additive

EFSA Panel on Food Additives and Flavourings (FAF), Maged Younes, Gabriele Aquilina, Laurence Castle, Karl-Heinz Engel, Paul Fowler, Maria Jose Frutos Fernandez, Peter Fürst, Rainer Gürtler, Ursula Gundert-Remy, Trine Husøy, Wim Mennes, Peter Moldeus, Agneta Oskarsson, Romina Shah, Ine Waalkens-Berendsen, Detlef Wölfle, Gisela Degen, Jean-Charles Leblanc, Alessandra GiarolaAna Maria Rincon, Alexandra Tard

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Abstract

The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of oat lecithin for use as a new food additive in the proposed food category (FC05.1) ?cocoa and chocolate products?. Oat lecithin is an oil, containing polar lipids (≥ 35% w/w) and non-polar lipids (55?65% w/w),obtained by ethanol extraction and subsequent fractionation (water/ethanol) from oat suitable for food consumption. This lecithin does not meet the specification parameter for the authorised food additive lecithins (E 322) of ?not less than 60% of substances insoluble in acetone? which represents the polar lipid content (phospholipids and glycolipids). Oat lecithin is expected to undergo hydrolysis in the gastrointestinal tract and this hydrolysis resembles that of other edible vegetable oils. Oat lecithin did not induce gene mutations or structural chromosomal aberrations in the absence or presence of metabolic activation. No treatment-related adverse effects were observed with oat lecithin in 28-day studies in rats and dogs at the highest dose tested. The toxicological database for oat lecithin was limited. Considering the composition of oat lecithin (similar components in different ratio) and the fact that it undergoes the same biotransformation, resulting in similar metabolites as those from lecithins (E 322) re-evaluated by the EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS) in 2017, the Panel considered the possibility to use the read-across approach from toxicological data on lecithins (E 322). Based on the toxicological data provided for oat lecithin along with read across from lecithins (E322) to oat lecithin no additional toxicological data were required. Therefore, the Panel considered that the previous conclusion for lecithins (E322) equally applies to oat lecithin to be used as food additive. Mean exposure ranged from

Original language	English
Number of pages	22
Volume	18
No.	1
Specialist publication	EFSA Journal
DOIs	https://doi.org/10.2903/j.efsa.2020.5969
Publication status	Published - 27 Jan 2020

Bibliographical note

Acknowledgements: The Panel wishes to thank all European competent institutions, Member State bodies and other organisations that provided data for this scientific output.

Keywords

oat lecithin
E 322
food additive

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10.2903/j.efsa.2020.5969Licence: CC BY-ND

Younes_et_al_EFSAJ_SafetyOfUseOfOat_VoR
© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. https://creativecommons.org/licenses/by-nd/4.0/
Final published version, 2.25 MBLicence: CC BY-ND

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EFSA Panel on Food Additives and Flavourings (FAF), Younes, M., Aquilina, G., Castle, L., Engel, K.-H., Fowler, P., Frutos Fernandez, M. J., Fürst, P., Gürtler, R., Gundert-Remy, U., Husøy, T., Mennes, W., Moldeus, P., Oskarsson, A., Shah, R., Waalkens-Berendsen, I., Wölfle, D., Degen, G., Leblanc, J.-C., ... Tard, A. (2020). Safety of use of oat lecithin as a food additive. EFSA Journal, 18(1). https://doi.org/10.2903/j.efsa.2020.5969

EFSA Panel on Food Additives and Flavourings (FAF), Younes, M, Aquilina, G, Castle, L, Engel, K-H, Fowler, P, Frutos Fernandez, MJ, Fürst, P, Gürtler, R, Gundert-Remy, U, Husøy, T, Mennes, W, Moldeus, P, Oskarsson, A, Shah, R, Waalkens-Berendsen, I, Wölfle, D, Degen, G, Leblanc, J-C, Giarola, A, Rincon, AM & Tard, A 2020, 'Safety of use of oat lecithin as a food additive' EFSA Journal, vol. 18, no. 1. https://doi.org/10.2903/j.efsa.2020.5969

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abstract = "The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of oat lecithin for use as a new food additive in the proposed food category (FC05.1) ?cocoa and chocolate products?. Oat lecithin is an oil, containing polar lipids (≥ 35% w/w) and non-polar lipids (55?65% w/w),obtained by ethanol extraction and subsequent fractionation (water/ethanol) from oat suitable for food consumption. This lecithin does not meet the specification parameter for the authorised food additive lecithins (E 322) of ?not less than 60% of substances insoluble in acetone? which represents the polar lipid content (phospholipids and glycolipids). Oat lecithin is expected to undergo hydrolysis in the gastrointestinal tract and this hydrolysis resembles that of other edible vegetable oils. Oat lecithin did not induce gene mutations or structural chromosomal aberrations in the absence or presence of metabolic activation. No treatment-related adverse effects were observed with oat lecithin in 28-day studies in rats and dogs at the highest dose tested. The toxicological database for oat lecithin was limited. Considering the composition of oat lecithin (similar components in different ratio) and the fact that it undergoes the same biotransformation, resulting in similar metabolites as those from lecithins (E 322) re-evaluated by the EFSA Panel on Food Additives and Nutrient Sources added to Food (EFSA ANS) in 2017, the Panel considered the possibility to use the read-across approach from toxicological data on lecithins (E 322). Based on the toxicological data provided for oat lecithin along with read across from lecithins (E322) to oat lecithin no additional toxicological data were required. Therefore, the Panel considered that the previous conclusion for lecithins (E322) equally applies to oat lecithin to be used as food additive. Mean exposure ranged from ",

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AU - Engel, Karl-Heinz

AU - Fowler, Paul

AU - Frutos Fernandez, Maria Jose

AU - Fürst, Peter

AU - Gürtler, Rainer

AU - Gundert-Remy, Ursula

AU - Husøy, Trine

AU - Mennes, Wim

AU - Moldeus, Peter

AU - Oskarsson, Agneta

AU - Shah, Romina

AU - Waalkens-Berendsen, Ine

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AU - Leblanc, Jean-Charles

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AU - Tard, Alexandra

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SN - 1831-4732

VL - 18

JO - EFSA Journal

JF - EFSA Journal

ER -

Safety of use of oat lecithin as a food additive

Abstract

Bibliographical note

Keywords

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