Safety for the environment of Monimax® (monensin sodium and nicarbazin) for chickens for fattening, chickens reared for laying and for turkeys for fattening

coccidiostat, Monimax, monensin sodium, nicarbazin, safety, environment, chickens for fattening, turkeys for fattening
First published in the EFSA Journal
6. November 2019
Adopted
7. Oktober 2019
Type
Scientific Opinion

Abstract

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat Monimax® (monensin sodium and nicarbazin) when used in feed for turkeys or chickens for fattening. In previous assessments (2017, 2018), the FEEDAP Panel could not conclude on the safety of Monimax® for the environment due to concerns on monensin sodium and 4,4′‐dinitrocarbanilide (DNC, one of the moieties of nicarbazin). The applicant provided additional information that has been assessed. The use of monensin sodium from Monimax® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartment or for sediment. The bioaccumulation potential of monensin in the environment is low. No concerns would arise for the 4,6‐dimethylpyrimidin‐2‐ol (HDP) moiety of nicarbazin excreted from chickens for fattening, chickens reared for laying and turkeys fed Monimax®. The use of DNC moiety of nicarbazin from Monimax® in complete feed for chickens for fattening, chickens reared for laying and turkeys for fattening poses no risk for the aquatic compartment, the terrestrial compartments or for sediment. The bioaccumulation potential of DNC in the environment is low and the risk for secondary poisoning is not likely to occur

Substances
Nicarbazin
Cas: 330-95-0
Inchi: InChI=1S/C13H10N4O5.C6H8N2O/c18-13(14-9-1-5-11(6-2-9)16(19)20)15-10-3-7-12(8-4-10)17(21)22;1-4-3-5(2)8-6(9)7-4/h1-8H,(H2,14,15,18);3H,1-2H3,(H,7,8,9)
Iupac: 1,3-Bis(4-nitrophenyl)urea--4,6-dimethylpyrimidin-2-ol (1:1)
Monensin sodium
Cas: 22373-78-0
Inchi: InChI=1S/C36H62O11.Na/c1-10-34(31-20(3)16-26(43-31)28-19(2)15-21(4)36(41,18-37)46-28)12-11-27(44-34)33(8)13-14-35(47-33)17-25(38)22(5)30(45-35)23(6)29(42-9)24(7)32(39)40;/h19-31,37-38,41H,10-18H2,1-9H3,(H,39,40);/q;+1/p-1
Iupac: sodium 4-[2-[5-ethyl-5-[5-[6-hydroxy-6-(hydroxymethyl)-3, 5-dimethyloxan-2-yl]-3-methyloxolan-2-yl]oxolan-2-yl]-9-hydroxy-2, 8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl]-3-methoxy-2-methylpentanoate
Monensin sodium
Cas: 22373-78-0
Inchi: InChI=1S/C36H62O11.Na/c1-10-34(31-20(3)16-26(43-31)28-19(2)15-21(4)36(41,18-37)46-28)12-11-27(44-34)33(8)13-14-35(47-33)17-25(38)22(5)30(45-35)23(6)29(42-9)24(7)32(39)40;/h19-31,37-38,41H,10-18H2,1-9H3,(H,39,40);/q;+1/p-1
Iupac: sodium 4-[2-[5-ethyl-5-[5-[6-hydroxy-6-(hydroxymethyl)-3, 5-dimethyloxan-2-yl]-3-methyloxolan-2-yl]oxolan-2-yl]-9-hydroxy-2, 8-dimethyl-1,6-dioxaspiro[4.5]decan-7-yl]-3-methoxy-2-methylpentanoate
Nicarbazin
Cas: 330-95-0
Inchi: InChI=1S/C13H10N4O5.C6H8N2O/c18-13(14-9-1-5-11(6-2-9)16(19)20)15-10-3-7-12(8-4-10)17(21)22;1-4-3-5(2)8-6(9)7-4/h1-8H,(H2,14,15,18);3H,1-2H3,(H,7,8,9)
Iupac: 1,3-Bis(4-nitrophenyl)urea--4,6-dimethylpyrimidin-2-ol (1:1)

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5888
EFSA Journal 2019;17(11):5888
On request from
European Commission