Scientific opinion on the tolerable upper intake level for manganese

D Turck; T Bohn; J Castenmiller; S de Henauw; K-I  Hirsch-Ernst; HK Knutsen; A Maciuk; I  Mangelsdorf; H McArdle; K. Pentieva; A Siani; F Thies; S Tsabouri |; M Vinceti; J Bornhorst; F Cubadda; A Dopter; R FitzGerald; A de Sesmaisons Lecarré |; P das Neves Ferreira; L Fabiani; Z Horvath; L Matijević; A Naska

doi:10.2903/j.efsa.2023.8413

Scientific opinion on the tolerable upper intake level for manganese

D Turck, T Bohn, J Castenmiller, S de Henauw, K-I Hirsch-Ernst, HK Knutsen, A Maciuk, I Mangelsdorf , H McArdle, K. Pentieva, A Siani, F Thies, S Tsabouri |, M Vinceti, J Bornhorst , F Cubadda, A Dopter, R FitzGerald, A de Sesmaisons Lecarré |, P das Neves FerreiraL Fabiani, Z Horvath, L Matijević , A Naska

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Abstract

Following a request from the European Commission (EC), the EFSA Panel on
Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific
opinion on the tolerable upper intake level (UL) for manganese. Systematic reviews
of the literature of human and animal data were conducted to assess evidence
regarding excess manganese intake (including authorised manganese salts) and
the priority adverse health effect, i.e. manganese-induced neurotoxicity. Available
human and animal studies support neurotoxicity as a critical effect, however, data
are not sufficient and suitable to characterise a dose–response relationship and
identify a reference point for manganese-induced neurotoxicity. In the absence
of adequate data to establish an UL, estimated background dietary intakes (i.e.
manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥18years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined.

Original language	English
Article number	e8413
Pages (from-to)	1-100
Number of pages	100
Journal	EFSA Journal
Volume	21
Issue number	12
Early online date	8 Dec 2023
DOIs	https://doi.org/10.2903/j.efsa.2023.8413
Publication status	Published (in print/issue) - 31 Dec 2023

Bibliographical note

Funding Information:
The Panel wishes to thank for their contribution to this output: the WG on Upper Levels: Peter Aggett, Brandy Beverly, Torsten Bohn, Julia Bornhorst, Marta Crous-Bou, Francesco Cubadda, Aymeric Dopter, Susan Fairweather-Tait, Rex FitzGerald, Susan Lanham New, Georg Lietz, Harry J McArdle, Anne Molloy, Giovanni Passeri, Kristina Pentieva, Marco Vinceti and Misha Vrolijk; hearing expert: Peter Willatts, individual scientific advisor (ISA) expert: Keyvin Darney and EFSA staff members: Constanza De Matteu Monteiro, Jean-Lou Dorne, Alessandra Giarola, Irene Muñoz Guajardo, Nena Karavasiloglou, Laura Ciccolallo, Roanne Marie Saad, Angeliki Sofroniou and Silvia Valtueña Martínez. The Panel also wishes to thank Carmen Peláez for her contribution as member of the NDA Panel until June 2023. The Panel acknowledges Thorhallur I Halldorsson, Bryndis Eva Birgisdottir, Anete Dudele, Jacob Juel Christensen and Birna Thorisdottir for the preparatory work as part of a procurement procedure. The Panel also wishes to acknowledge the contribution of all national institutions in European countries that provided consumption data for this scientific output.

Publisher Copyright:
© 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

Keywords

manganese
safe level of intake
tolerable upper intake level
UL

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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Cite this

Turck, D., Bohn, T., Castenmiller, J., de Henauw, S., Hirsch-Ernst, K.-I., Knutsen, HK., Maciuk, A., Mangelsdorf , I., McArdle, H., Pentieva, K., Siani, A., Thies, F., Tsabouri |, S., Vinceti, M., Bornhorst , J., Cubadda, F., Dopter, A., FitzGerald, R., de Sesmaisons Lecarré |, A., ... Naska, A. (2023). Scientific opinion on the tolerable upper intake level for manganese. EFSA Journal, 21(12), 1-100. Article e8413. https://doi.org/10.2903/j.efsa.2023.8413

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title = "Scientific opinion on the tolerable upper intake level for manganese",

abstract = "Following a request from the European Commission (EC), the EFSA Panel onNutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientificopinion on the tolerable upper intake level (UL) for manganese. Systematic reviewsof the literature of human and animal data were conducted to assess evidenceregarding excess manganese intake (including authorised manganese salts) andthe priority adverse health effect, i.e. manganese-induced neurotoxicity. Availablehuman and animal studies support neurotoxicity as a critical effect, however, dataare not sufficient and suitable to characterise a dose–response relationship andidentify a reference point for manganese-induced neurotoxicity. In the absenceof adequate data to establish an UL, estimated background dietary intakes (i.e.manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥18years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined.",

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author = "D Turck and T Bohn and J Castenmiller and {de Henauw}, S and K-I Hirsch-Ernst and HK Knutsen and A Maciuk and I Mangelsdorf and H McArdle and K. Pentieva and A Siani and F Thies and {Tsabouri |}, S and M Vinceti and J Bornhorst and F Cubadda and A Dopter and R FitzGerald and {de Sesmaisons Lecarr{\'e} |}, A and {das Neves Ferreira}, P and L Fabiani and Z Horvath and L Matijevi{\'c} and A Naska",

note = "Funding Information: The Panel wishes to thank for their contribution to this output: the WG on Upper Levels: Peter Aggett, Brandy Beverly, Torsten Bohn, Julia Bornhorst, Marta Crous-Bou, Francesco Cubadda, Aymeric Dopter, Susan Fairweather-Tait, Rex FitzGerald, Susan Lanham New, Georg Lietz, Harry J McArdle, Anne Molloy, Giovanni Passeri, Kristina Pentieva, Marco Vinceti and Misha Vrolijk; hearing expert: Peter Willatts, individual scientific advisor (ISA) expert: Keyvin Darney and EFSA staff members: Constanza De Matteu Monteiro, Jean-Lou Dorne, Alessandra Giarola, Irene Mu{\~n}oz Guajardo, Nena Karavasiloglou, Laura Ciccolallo, Roanne Marie Saad, Angeliki Sofroniou and Silvia Valtue{\~n}a Mart{\'i}nez. The Panel also wishes to thank Carmen Pel{\'a}ez for her contribution as member of the NDA Panel until June 2023. The Panel acknowledges Thorhallur I Halldorsson, Bryndis Eva Birgisdottir, Anete Dudele, Jacob Juel Christensen and Birna Thorisdottir for the preparatory work as part of a procurement procedure. The Panel also wishes to acknowledge the contribution of all national institutions in European countries that provided consumption data for this scientific output. Publisher Copyright: {\textcopyright} 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.",

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Turck, D, Bohn, T, Castenmiller, J, de Henauw, S, Hirsch-Ernst, K-I, Knutsen, HK, Maciuk, A, Mangelsdorf , I, McArdle, H, Pentieva, K, Siani, A, Thies, F, Tsabouri |, S, Vinceti, M, Bornhorst , J, Cubadda, F, Dopter, A, FitzGerald, R, de Sesmaisons Lecarré |, A, das Neves Ferreira, P, Fabiani, L, Horvath, Z, Matijević , L & Naska, A 2023, 'Scientific opinion on the tolerable upper intake level for manganese', EFSA Journal, vol. 21, no. 12, e8413, pp. 1-100. https://doi.org/10.2903/j.efsa.2023.8413

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AU - Turck, D

AU - Bohn, T

AU - Castenmiller, J

AU - de Henauw, S

AU - Hirsch-Ernst, K-I

AU - Knutsen, HK

AU - Maciuk, A

AU - Mangelsdorf , I

AU - McArdle, H

AU - Pentieva, K.

AU - Siani, A

AU - Thies, F

AU - Tsabouri |, S

AU - Vinceti, M

AU - Bornhorst , J

AU - Cubadda, F

AU - Dopter, A

AU - FitzGerald, R

AU - de Sesmaisons Lecarré |, A

AU - das Neves Ferreira, P

AU - Fabiani, L

AU - Horvath, Z

AU - Matijević , L

AU - Naska, A

N1 - Funding Information: The Panel wishes to thank for their contribution to this output: the WG on Upper Levels: Peter Aggett, Brandy Beverly, Torsten Bohn, Julia Bornhorst, Marta Crous-Bou, Francesco Cubadda, Aymeric Dopter, Susan Fairweather-Tait, Rex FitzGerald, Susan Lanham New, Georg Lietz, Harry J McArdle, Anne Molloy, Giovanni Passeri, Kristina Pentieva, Marco Vinceti and Misha Vrolijk; hearing expert: Peter Willatts, individual scientific advisor (ISA) expert: Keyvin Darney and EFSA staff members: Constanza De Matteu Monteiro, Jean-Lou Dorne, Alessandra Giarola, Irene Muñoz Guajardo, Nena Karavasiloglou, Laura Ciccolallo, Roanne Marie Saad, Angeliki Sofroniou and Silvia Valtueña Martínez. The Panel also wishes to thank Carmen Peláez for her contribution as member of the NDA Panel until June 2023. The Panel acknowledges Thorhallur I Halldorsson, Bryndis Eva Birgisdottir, Anete Dudele, Jacob Juel Christensen and Birna Thorisdottir for the preparatory work as part of a procurement procedure. The Panel also wishes to acknowledge the contribution of all national institutions in European countries that provided consumption data for this scientific output. Publisher Copyright: © 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH on behalf of European Food Safety Authority.

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Y1 - 2023/12/31

N2 - Following a request from the European Commission (EC), the EFSA Panel onNutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientificopinion on the tolerable upper intake level (UL) for manganese. Systematic reviewsof the literature of human and animal data were conducted to assess evidenceregarding excess manganese intake (including authorised manganese salts) andthe priority adverse health effect, i.e. manganese-induced neurotoxicity. Availablehuman and animal studies support neurotoxicity as a critical effect, however, dataare not sufficient and suitable to characterise a dose–response relationship andidentify a reference point for manganese-induced neurotoxicity. In the absenceof adequate data to establish an UL, estimated background dietary intakes (i.e.manganese intakes from natural dietary sources only) observed among high consumers (95th percentile) were used to provide an indication of the highest level of intake where there is reasonable confidence on the absence of adverse effects. A safe level of intake of 8 mg/day was established for adults ≥18years (including pregnant and lactating women) and ranged between 2 and 7 mg/day for other population groups. The application of the safe level of intake is more limited than an UL because the intake level at which the risk of adverse effects starts to increase is not defined.

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Scientific opinion on the tolerable upper intake level for manganese

Abstract

Bibliographical note

Keywords

UN SDGs

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