Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.)

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 the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for part... Mehr ...

Verfasser: Vasileios Bampidis
Giovanna Azimonti
Maria de Lourdes Bastos
Henrik Christensen
Birgit Dusemund
Mojca Durjava
Maryline Kouba
Marta López‐Alonso
Secundino López Puente
Francesca Marcon
Baltasar Mayo
Alena Pechová
Mariana Petkova
Fernando Ramos
Roberto Edoardo Villa
Ruud Woutersen
Georges Bories
Jürgen Gropp
Jaume Galobart
Matteo Lorenzo Innocenti
Jordi Ortuño
Fabiola Pizzo
Barbara Rossi
Jordi Tarrés‐Call
Maria Vittoria Vettori
Anita Radovnikovic
Dokumenttyp: Artikel
Erscheinungsdatum: 2023
Reihe/Periodikum: EFSA Journal, Vol 21, Iss 10, Pp n/a-n/a (2023)
Verlag/Hrsg.: Wiley
Schlagwörter: safety / efficacy / copper / nutritional additives / trace elements / dicopper chloride trihydroxide and tribasic coper chloride / Nutrition. Foods and food supply / TX341-641 / Chemical technology / TP1-1185
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29116997
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://doi.org/10.2903/j.efsa.2023.8342

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 the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 μm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land‐based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.