Safety and efficacy of iron compounds (E1) as feed additives for all animal species: ferrous carbonate; ferric chloride, hexahydrate; ferrous fumarate; ferrous sulphate, heptahydrate; ferrous sulphate, monohydrate; ferrous chelate of amino acids, hydrate; ferrous chelate of glycine, hydrate, based on a dossier submitted by FEFANA asbl

,

doi:10.2903/j.efsa.2016.4396

Cited by 18 publications

(19 citation statements)

References 30 publications

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“…Previous assessments of the FEEDAP Panel on the safety for consumers of iron compounds stated that the evaluated compounds 29 would not change the iron concentration in edible tissues and products of animal origin and consequently not the consumer exposure (EFSA FEEDAP Panel 2013, EFSA FEEDAP Panel, 2014a,b, EFSA FEEDAP Panel 2015, 2016a; in contrast, iron dextran 10% would -at least transiently -increase the iron content of piglet body. However, the FEEDAP Panel is of the opinion that the use of the additive in suckling piglets would not result in a measurable increase in the iron intake of consumers since (i) any potential deposition in edible tissues and organs of suckling piglets would disappear within 30 days after administration, (ii) suckling piglets are a very minor food commodity in the EU and, most important, (iii) oral administration of iron dextran will not be used in addition but as a substitute to the current practice of iron injection.…”

Section: Consumer Safety Assessmentmentioning

confidence: 99%

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Safety and efficacy of iron dextran as a feed additive for piglets

Additives¹,

Rychen²,

Aquilina³

et al. 2017

EFS2

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The additive, 'Iron dextran 10%', is a liquid preparation containing iron dextran (25%, of which 10% is total iron), sodium chloride (1.5%), phenol (0.4%) and water (73.1%). Iron dextran 10% is considered safe for suckling piglets when given at an oral dose of 1 mL/kg body weight (bw) once in each of the first 2 weeks of life; this dose corresponds to 100 mg Fe/kg bw. The administration of iron dextran 10% to piglets deficient in vitamin E and/or selenium is considered a risk. The oral use of iron dextran 10% in suckling piglets does not pose any safety concerns to consumers, provided that the conditions identified as safe for the target animal are respected. Iron dextran 10% is considered a respiratory sensitiser and may be harmful if inhaled; however, exposure by inhalation is not expected; therefore, the risk is considered to be negligible. Iron dextran 10% is an irritant to skin and eyes; a risk by skin sensitisation cannot be excluded. The presence of phenol in the additive should be considered to pose a hazard for users. The use of the additive for suckling piglets at the proposed level does not pose a safety concern to the environment. The available studies with orally administered iron dextran indicate that the additive is a bioavailable source of iron for suckling piglets; however, the efficacy of the additive when given to newborn pigs as proposed via water for drinking (voluntary intake) has not been demonstrated. The Panel proposed some recommendations regarding the dextran used in the manufacture of the additive and the procedure for administering the additive to piglets.

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Section: Consumer Safety Assessmentmentioning

confidence: 99%

“…The safety for the environment of iron compounds used as feed additives has been previously assessed by the FEEDAP Panel concluding that the supplementation of feed with the evaluated compounds 29 was not expected to pose an environmental risk (EFSA FEEDAP Panel, 2013;EFSA FEEDAP Panel, 2014a,b;EFSA FEEDAP Panel, 2015, 2016a.…”

Section: Safety For the Environmentmentioning

confidence: 99%

Safety and efficacy of iron dextran as a feed additive for piglets

Additives¹,

Rychen²,

Aquilina³

et al. 2017

EFS2

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“…5 EFSA issued an opinion on the safety of the chelated forms of iron, copper, manganese and zinc with synthetic feed grade glycine (EFSA, 2005). In the frame of re-evaluation, EFSA has delivered five opinions on iron-based additives: iron chelate of amino acids, hydrate (EFSA FEEDAP Panel, 2013, 2016a In 2015, the EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS) adopted a scientific opinion on the re-evaluation of iron oxides and hydroxides (E 172) as food additives (EFSA ANS Panel, 2015). Following that, the FEEDAP Panel adopted a scientific opinion on the safety and efficacy of iron oxide black, red and yellow for all animal species as colourings in feed (EFSA FEEDAP Panel, 2016b).…”

Section: Additional Informationmentioning

confidence: 99%

“…The opinion is based on data provided by a company involved in the production/distribution of ferric oxide and publicly available literature. In particular, the Opinion on the re-evaluation of iron oxides and hydroxides (E 172) as food additives (EFSA ANS Panel, 2015) and the Opinions on ironbased feed additives (EFSA FEEDAP Panel, 2013, 2014a,b, 2015, 2016a) and on iron oxide black, red and yellow as colourings in feed (EFSA FEEDAP Panel, 2016b) were considered.…”

Section: Assessmentmentioning

confidence: 99%

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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“…The EFSA FEEDAP Panel (2016) published an in-depth consideration of the available literature on the maximum tolerated iron concentrations in feed. There were large differences between the animal species.…”

Section: Safety For the Target Speciesmentioning

confidence: 99%

Safety and efficacy of iron oxide black, red and yellow for all animal species

2016

EFS2

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Iron oxides black, red and yellow are intended to be used as colourings to add and restore colour to feedingstuffs at a recommended concentration between 500 and 1,200 mg/kg. No data on the tolerance of target animals were provided. The iron oxides black, red and yellow are excreted essentially unchanged in the faeces of the target animals. Iron absorption from these water insoluble iron oxides is low. However, no conclusion on the safety of the iron oxides under assessment for the target animals could be made as a sufficient biological and toxicological database, particularly genotoxicity data, was not available. The use of the iron oxides in animal nutrition is unlikely to result in a direct exposure of the consumer and would not influence the iron content of edible tissues and products from animals treated with iron oxides. Consequently, the supplementation of feed for food‐producing animals with the iron oxides under assessment would not provide a risk to consumers. Iron oxide black, red and yellow should be considered as irritant to skin and eyes. In the absence of any information, the Panel on Additives and Products or Substances used in Animal Feed FEEDAP cannot conclude on the potential of the additives to be a skin sensitiser. As the inhalation of iron oxides could cause unspecific lung inflammation, inhalation exposure of users should be considered to be a hazard. As there is concern about the possible genotoxicity of iron oxides, any route of exposure should be considered as hazardous. The use of iron oxide black, red and yellow in animal nutrition does not pose a risk to the environment. The iron oxides are effective in colouring feedingstuffs.

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Cited by 18 publications

References 30 publications

Safety and efficacy of iron dextran as a feed additive for piglets

Safety and efficacy of iron dextran as a feed additive for piglets

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.

Safety and efficacy of iron oxide black, red and yellow for all animal species

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