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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)

Authors :
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Fašmon Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Yolanda Sanz
Roberto Edoardo Villa
Ruud Woutersen
Noël Dierick
Montserrat Anguita
Rosella Brozzi
Jaume Galobart
Orsolya Holczknecht
Matteo Lorenzo Innocenti
Paola Manini
Alberto Navarro‐Villa
Fabiola Pizzo
Anita Radovnikovic
Barbara Rossi
Maria Vittoria Vettori
Angelica Amaduzzi
Source :
EFSA Journal, Vol 21, Iss 1, Pp n/a-n/a (2023)
Publication Year :
2023
Publisher :
Wiley, 2023.

Abstract

Abstract 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. The use of the additive in sows is regarded as safe for the consumers and the environment.

Details

Language :
English
ISSN :
18314732
Volume :
21
Issue :
1
Database :
Directory of Open Access Journals
Journal :
EFSA Journal
Publication Type :
Academic Journal
Accession number :
edsdoj.948d7dcf2cee41488acc81e620867713
Document Type :
article
Full Text :
https://doi.org/10.2903/j.efsa.2023.7696