Scientific Opinion on Flavouring Group Evaluation 46, Revision 1 (FGE.46Rev1): Ammonia and three ammonium salts from chemical group 30

Flavourings,

doi:10.2903/j.efsa.2011.1925

Cited by 6 publications

(4 citation statements)

References 29 publications

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“…EFSA has issued two opinions on the safety and efficacy of this additive (EFSA FEEDAP Panel, 2012a, 2016. The safety of ammonium chloride used with foodstuffs has been assessed in two other opinions (EFSA, 2009;EFSA CEF Panel, 2011).…”

Section: Additional Informationmentioning

confidence: 99%

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for ruminants other than lambs for fattening, lambs for fattening, cats and dogs, consumers and the environment under the current authorised conditions of use. Inhalation exposure of the additive is considered very likely. Amoklor™ should be considered a potential respiratory sensitiser but not a skin sensitiser. The additive is not irritant to the skin, but the Panel could not conclude on its eye irritation potential. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the extension of use in sows, the FEEDAP Panel concludes that the additive is safe and efficacious for sows at the inclusion level of 5,000 mg/kg feedingstuffs from week 9th to 11th of gestation and from week 15th of gestation to 1st of lactation.

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Section: Additional Informationmentioning

confidence: 99%

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

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“…The safety of ammonium chloride used in food has been assessed in two other opinions (EFSA, 2009 ; EFSA CEF Panel, 2011 ).…”

Section: Introductionmentioning

confidence: 99%

Safety and efficacy of the feed additive consisting of ammonium chloride (Ammonium Chloride AF) for all ruminants, dogs and cats for the renewal of its authorisation (BASF SE)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

EFS2

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Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of the feed additive consisting of ammonium chloride (tradename: Ammonium chloride AF) as a zootechnical additive for ruminants, cats and dogs. In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive and subsequently the additive was authorised in the EU. The additive is authorised as ‘ammonium chloride with a content of ammonium chloride ≥ 99% and sodium chloride ≤ 0.5% in the active substance’ for ruminants, cats and dogs under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives’. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment. The FEEDAP Panel concludes that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but is not a dermal sensitiser. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive.

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“…In 2011, the EFSA CEF Panel reviewed ammonia, diammonium sulfide, ammonium chloride and ammonium hydrogen sulfide in the context of flavouring substances used in foodstuffs (EFSA CEF Panel, 2011).…”

Section: Previous Evaluationsmentioning

confidence: 99%

“…Carcinogenicity studies on other inorganic ammonium salts were evaluated previously by EFSA (EFSA CEF Panel, 2011;EFSA CONTAM Panel, 2012a,b). In 2012, the CONTAM Panel stated that 'ammonium can be considered of no carcinogenic concern ' (EFSA, 2012b).…”

mentioning

confidence: 99%

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

Knutsen¹,

Alexander²,

Barregård³

et al. 2017

EFS2

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Shipping of edible fats and oils into Europe is permitted in bulk tanks, provided that the previous cargo is included in a positive list. The European Commission requested EFSA to evaluate the acceptability as previous cargoes for fats and oils the substances calcium lignosulphonate, methyl acetate, ethyl tertbutyl ether (ETBE) and ammonium sulphate. The evaluation was based on the same criteria as those used for the evaluation of the substances currently on the list in the Annex to Commission Directive 96/ 3/EC as acceptable previous cargoes for edible fats and oils. Methyl acetate and ETBE meet the criteria for acceptability as previous cargoes. Due to uncertainties, mainly with regard to the composition and toxicity of the low molecular mass fraction, and the fact that the toxicological database is limited to the 40-65 grade and does not cover all grades of calcium lignosulphonate shipped as previous cargoes, the EFSA Panel on Contaminants in the Food Chain (CONTAM Panel) concluded that calcium lignosulphonate does not meet the criteria for acceptability as a previous cargo. Only food-grade ammonium sulphate meets the criteria for acceptability as a previous cargo due to uncertainties about impurities in other (non-food) grades.

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Scientific Opinion on Flavouring Group Evaluation 46, Revision 1 (FGE.46Rev1): Ammonia and three ammonium salts from chemical group 30

Cited by 6 publications

References 29 publications

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd)

Safety and efficacy of the feed additive consisting of ammonium chloride (Ammonium Chloride AF) for all ruminants, dogs and cats for the renewal of its authorisation (BASF SE)

Scientific opinion on the evaluation of substances as acceptable previous cargoes for edible fats and oils

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