Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all species: Ferrous sulphate monohydrate based on a dossier submitted by Kronos International, Inc.

,

doi:10.2903/j.efsa.2014.3607

Cited by 7 publications

(2 citation statements)

References 32 publications

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“…8 Following the provisions of Article 10(1) of Regulation (EC) No 1831/2003 the compound was included in the EU Register of Feed Additives under the category "Nutritional additives" and the functional group "Compounds of trace elements". 9 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 has more recently delivered other opinions on reevaluation of the iron compounds: iron chelate of amino acids, hydrate (EFSA FEEDAP Panel, 2013), ferrous sulphate heptahydrate (EFSA FEEDAP Panel, 2014a) and ferrous sulphate monohydrate (EFSA FEEDAP Panel, 2014b).…”

Section: Discussionmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all animal species: ferrous carbonate based on a dossier submitted by Ankerpoort N.V.

2015

EFS2

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Iron from iron‐containing additives is safe in feed up to a maximum content of 250 mg/day for piglets up to one week before weaning, 450 mg/kg for bovines and poultry, 500 mg/kg for ovines, 600 mg/kg for pets and 750 mg/kg for other species/categories, except horses and fish. It was not possible to derive a maximum safe iron concentration in feed for horses or fish; as a provisional measure, the current value (750 mg/kg) could be maintained. Iron from ferrous carbonate is unlikely to modify iron concentration in edible tissues/products of animal origin; therefore, no concern for consumer safety was identified resulting from the use of ferrous carbonate in animal nutrition, provided the maximum iron content in complete feedingstuffs is respected. Owing to the presence of nickel, the additive should be regarded as a dermal and respiratory sensitiser. Ferrous carbonate should be considered as irritant to skin and eyes and to the respiratory tract. The handling of this additive is considered to be a risk by inhalation. Ferrous carbonate is generally less bioavailable than ferrous sulphate; whilst for adult animals ferrous carbonate might be efficacious, it would be insufficiently bioavailable for young animals–which require a highly efficacious iron source for a rapid response in haemoglobin synthesis. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) recommends that the currently authorised maximum iron content in feed be reduced for bovines and poultry from 750 to 450 mg Fe/kg, and for pets from 1250 to 600 mg Fe/kg. The Panel proposes the name of Iron(II) carbonate (siderite) to reflect the mineral nature and variability in composition and bioavailability of the ferrous carbonates from ores.

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Section: Discussionmentioning

confidence: 99%

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all animal species: ferrous carbonate based on a dossier submitted by Ankerpoort N.V.

2015

EFS2

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“…The safety of betaine and iron sulfate, when used as feed additives, has already been assessed and established by EFSA FEEDAP Panel ( 2012 , 2013 , 2014 , 2016 ).…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of iron(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

Bampidis,

Azimonti,

Bastos

et al. 2023

EFS2

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of iron(II)-betaine complex as a nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chickens the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of iron in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum iron levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the iron(II)-betaine complex in animal nutrition at the maximum iron levels authorised for the animal species poses no concern to the safety of consumers. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals, land-based and sea cages aquaculture is considered safe under the proposed conditions of use. Based on the deposition of iron in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the birds iron requirements. This conclusion can be extrapolated to all animal species and categories.

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Safety and efficacy of iron compounds (E1) as feed additives for all species: ferric oxide based on a dossier submitted by Poortershaven Industriële Mineralen B.V.

2016

EFS2

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The additive under assessment, ferric oxide, contains between 57% and 69% iron (Fe). The EFSA FEEDAP Panel could not conclude on the safety of ferric oxide for the target animals owing to that (i) the application of ferric oxide red is for all animal species, (ii) lifetime administration to animals is not excluded and (iii) a sufficient biological and toxicological database was not available. Regarding (i) the very low absorption of iron from the ferric oxide by target animals and (ii) the homoeostatic regulation of iron metabolism in animals, any influence of feeding the ferric oxide on the iron content of edible tissues and products is not expected. The use of ferric oxide in animal nutrition is unlikely to result in a direct exposure of the consumer to this oxide. Consequently, the supplementation of feed for food‐producing animals with ferric oxide would likely not constitute a risk to consumers. Ferric oxide is an irritant to skin and eyes by mechanical action. Owing to the nickel content in the additive, the ferric oxide should be regarded as dermal and respiratory sensitiser. Inhalation of ferric oxide, and the contained chromium and nickel, is a hazard; as exposure by inhalation is likely, handling ferric oxide would be a risk for the users. As there is concern about the possible genotoxicity of ferric oxide, any route of exposure should be considered as hazardous. Iron oxides are ubiquitous in the environment. Any additional input from the nutritional use of ferric oxide in food‐producing animals is considered negligible. It is unlikely that the use of the additive in animal nutrition would pose a risk to the environment. Ferric oxide should not be considered as iron source capable to meet iron requirements of animals.

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Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all species: Ferrous sulphate monohydrate based on a dossier submitted by Kronos International, Inc.

Cited by 7 publications

References 32 publications

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all animal species: ferrous carbonate based on a dossier submitted by Ankerpoort N.V.

Scientific Opinion on the safety and efficacy of iron compounds (E1) as feed additives for all animal species: ferrous carbonate based on a dossier submitted by Ankerpoort N.V.

Safety and efficacy of a feed additive consisting of iron(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

Safety and efficacy of iron compounds (E1) as feed additives for all species: ferric oxide based on a dossier submitted by Poortershaven Industriële Mineralen B.V.

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