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Scientific opinion on the tolerable upper intake level for manganese - PubMed

  • ️Sun Jan 01 2023

Scientific opinion on the tolerable upper intake level for manganese

EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) et al. EFSA J. 2023.

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 ≥ 18 years (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.

Keywords: UL; manganese; safe level of intake; tolerable upper intake level.

© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.

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Conflict of interest statement

The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.

Figures

FIGURE 1
FIGURE 1

Distribution of manganese content in food supplements as displayed on labels in 24 EU Member States and Norway (mg/serving). Source: Mintel GNPD. Search for manganese‐containing supplements available in the EU market in the last 5 years (from November 2017 to November 2022). A total of 693 products available in 24 EU Member States and Norway were identified with complete data on mg/serving.

FIGURE 2
FIGURE 2

Mean, median, 5th and 95th percentiles of background manganese intakes in infants (≥ 4 to < 12 months), toddlers (≥ 1 year to < 3 years), young children (≥ 3 years to < 7 years), older children (≥ 7 years to < 10 years), intakes in young adolescents (≥ 10 to < 14 years) and older adolescents (≥ 14 to < 18 years), by sex and country.

AT

, Austria;

BE

, Belgium;

BG

, Bulgaria;

CY

, Cyprus;

CZ

, Czech Republic,

DE

, Germany;

DK

, Denmark;

EE

, Estonia;

EL

, Greece;

ES

, Spain;

FI

, Finland;

FR

, France;

HU

, Hungary;

IT

, Italy;

LV

, Latvia;

NL

, The Netherlands;

PT

, Portugal;

RO

, Romania;

SE

, Sweden;

SI

, Slovenia. Estimates for females are shown in orange and for males in blue. Squares correspond to medians and stars to means. Lines represent the range between the 5th and 95th percentiles. Estimated intakes from 5th and 95th percentiles are not presented when sample size is below 60 participants.

FIGURE 3
FIGURE 3

Mean, median, 5th and 95th percentiles of background manganese intakes in adults (≥ 18 years to < 65 years old) and older adults (≥ 65 years), by sex and country.

AT

, Austria;

BE

, Belgium;

CY

, Cyprus;

CZ

, Czech Republic;

DE

, Germany;

DK

, Denmark;

EE

, Estonia;

EL

, Greece;

ES

, Spain;

FI

, Finland;

FR

, France;

HR

, Croatia;

HU

, Hungary;

IE

, Ireland;

IT

, Italy;

LV

, Latvia;

NL

, The Netherlands;

PT

, Portugal;

RO

, Romania;

SE

, Sweden;

SI

, Slovenia. Estimates for females are shown in orange and for males in blue. Squares correspond to medians and stars to means. Lines represent the range between the 5th and 95th percentiles. Estimated intakes from 5th and 95th percentiles are not presented when sample size is below 60 participants.

FIGURE 4
FIGURE 4

Mean, median, 5th and 95th percentiles of manganese intakes in pregnant women and lactating women by country. AT, Austria; CY, Cyprus; EE, Estonia; EL, Greece; ES, Spain; LV, Latvia; PT, Portugal; RO, Romania. Squares correspond to medians and stars to means. Lines represent the range between the 5th and 95th percentiles. Estimated intakes from 5th and 95th percentiles are not presented when sample size is below 60 participants.

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