Scientific opinion on the safety and efficacy of manganese compounds (E5) as feed additives for all species: manganous oxide and manganous sulphate monohydrate, based on a dossier submitted by Eramet &amp; Comilog Chemicals S.A

Högstrand, Christer

doi:10.2903/j.efsa.2013.3435

Cited by 3 publications

(4 citation statements)

References 58 publications

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“…EFSA issued an opinion on the safety of the chelated forms of iron, copper, manganese and zinc with synthetic feed grade glycine (EFSA, 2005) and three opinions on a manganese chelate of hydroxy analogue of methionine (EFSA, 2008a(EFSA, , 2009a(EFSA, , 2010a. In the frame of re-evaluation EFSA has delivered three opinions on manganese-based additives: manganese chelate of amino acids, hydrate (EFSA FEEDAP Panel, 2013a), manganous oxide (EFSA FEEDAP Panel, 2013b, 2013c and manganous sulphate monohydrate (EFSA FEEDAP Panel, 2013c).…”

Section: Discussionmentioning

confidence: 99%

“…Tolerance studies are not required for compounds of trace elements already authorised (Regulation (EC) No 429/2008). The assessment of manganese safety for the target species is based on a previous opinion of the SCAN (EC, 2002) and on FEEDAP Panel opinions (EFSA, 2009a, 2010a, EFSA FEEDAP Panel 2013a, 2013b, 2013c.…”

Section: Safety For the Target Speciesmentioning

confidence: 99%

“…See previous FEEDAP Panel opinions on re-evaluation of manganese compounds as feed additives (EFSA FEEDAP Panel, 2013a, 2013b, 2013c.…”

Section: Assessment Of Consumer Safetymentioning

confidence: 99%

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Safety and efficacy of manganese compounds (E5) as feed additives for all animal species: manganous carbonate; manganous chloride, tetrahydrate; manganous oxide; manganous sulphate, monohydrate; manganese chelate of amino acids, hydrate; manganese chelate of glycine, hydrate, based on a dossier submitted by FEFANA asbl

2016

EFS2

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The safety assessment is based on the assumption that the current maximum total contents of manganese authorised in feed are respected. All manganese compounds under application are considered safe for all animal species/categories. The mean manganese intake of the European population includes already the manganese from animal products and does not pose a toxicological concern. The effect of dietary manganese fed to animals on tissue concentrations is limited. Supplementation of feed with the manganese compounds under assessment would consequently not affect consumer exposure and is of no concern for consumer safety. All manganese compounds are considered as eye irritants, the manganese chelate of glycine and the manganese chelate of amino acids as irritants to skin and the latter one as dermal sensitiser. However, the presence of nickel in all additives may induce contact dermatitis. Exposure to manganese in dust of all additives and to nickel (except manganous chloride and manganous oxide) poses a risk to users by inhalation. The use of the manganese compounds under assessment in animal nutrition for all animal species is not expected to pose a risk to the environment. The manganese compounds under assessment are recognised as efficacious sources of manganese in meeting animals' requirements.

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Section: Discussionmentioning

confidence: 99%

Section: Safety For the Target Speciesmentioning

confidence: 99%

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Safety and efficacy of manganese compounds (E5) as feed additives for all animal species: manganous carbonate; manganous chloride, tetrahydrate; manganous oxide; manganous sulphate, monohydrate; manganese chelate of amino acids, hydrate; manganese chelate of glycine, hydrate, based on a dossier submitted by FEFANA asbl

2016

EFS2

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“…EFSA's FEEDAP Panel assessed the safety of several manganese compounds used as additives in animal feed and considered them to be safe for the consumed products, provided that the total maximum authorised content of manganese in complete feed is respected (EFSA FEEDAP Panel, 2010, 2013a, 2013b, 2016a, 2016b.…”

Section: Context Of the Assessmentmentioning

confidence: 99%

Scientific opinion on the tolerable upper intake level for manganese

Turck,

Bohn,

Castenmiller

et al. 2023

EFS2

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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. K E Y W O R D Smanganese, safe level of intake, tolerable upper intake level, UL

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Safety and efficacy of manganese hydroxychloride as feed additive for all animal species

2016

EFS2

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The additive under assessment, manganese hydroxychloride, contains ≥ 45% manganese (Mn). Manganese hydroxychloride is a safe source of manganese for all target species when used up to the maximum level of total manganese in complete feed authorised in the EU (Fish 100 (total) and Other species 150 (total) mg Mn/kg feedingstuffs). Manganese hydroxychloride would substitute for other manganese sources in feed. It does not differently affect tissue deposition compared to manganese sulphate. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the use of manganese hydroxychloride in animal nutrition is safe for the consumers, provided the maximum authorised manganese content in complete feed is respected. In the absence of specific data, the FEEDAP Panel cannot conclude on the safety for the user when handling the additive. The use of manganese hydroxychloride in animal nutrition for all animal species is not expected to pose a risk to the environment. Manganese hydroxychloride is considered a source of bioavailable manganese as indicated by a dose-dependent increase of manganese deposition in bone and liver based on two studies on chickens for fattening. The FEEDAP Panel concludes that the additive is efficacious in meeting the manganese requirements for all animal species/categories.

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Scientific opinion on the safety and efficacy of manganese compounds (E5) as feed additives for all species: manganous oxide and manganous sulphate monohydrate, based on a dossier submitted by Eramet & Comilog Chemicals S.A

Cited by 3 publications

References 58 publications

Scientific opinion on the tolerable upper intake level for manganese

Safety and efficacy of manganese hydroxychloride as feed additive for all animal species

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