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.

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) / V. Bampidis, G. Azimonti, M.D.L. Bastos, H. Christensen, B. Dusemund, M. Fašmon Durjava, M. Kouba, M. López-Alonso, S. López Puente, F. Marcon, B. Mayo, A. Pechová, M. Petkova, F. Ramos, Y. Sanz, R.E. Villa, R. Woutersen, N. Dierick, R. Brozzi, J. Galobart, L. Gregoretti, M.V. Vettori, M.L. Innocenti. - In: EFSA JOURNAL. - ISSN 1831-4732. - 20:4(2022 Apr), pp. e07255.1-e07255.9. [10.2903/j.efsa.2022.7255]

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)

R.E. Villa;
2022

Abstract

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.
Ammonium chloride AF; ammonium chloride; efficacy; other zootechnical additives; safety; zootechnical additives
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
apr-2022
Article (author)
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/962045
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