PMID- 37089180
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231106
IS  - 1831-4732 (Electronic)
IS  - 1831-4732 (Linking)
VI  - 21
IP  - 4
DP  - 2023 Apr
TI  - Safety and efficacy of a feed additive consisting of halofuginone hydrobromide 
      (STENOROL(R)) for chickens for fattening and turkeys for fattening/reared for 
      breeding (Huvepharma N.V.).
PG  - e07978
LID - 10.2903/j.efsa.2023.7978 [doi]
LID - e07978
AB  - Following a request from the European Commission, EFSA was asked to deliver a new 
      scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL(R)) when 
      used as a feed additive for chickens for fattening and turkeys for 
      fattening/reared for breeding. The Panel on Additives and Products or Substances 
      used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening 
      established in its previous opinion can be extended to turkeys for breeding up to 
      12 weeks of age. Based on the new data provided on the safety for consumer, 
      environment and efficacy, the Panel updates its previous conclusions as follows: 
      halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 
      to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight 
      (bw) per day, an acceptable daily intake (ADI) of 0.3 mug halofuginone/kg bw is 
      established. The chronic exposure of consumers to residues of halofuginone would 
      amount to 6-19% of the ADI after 3 days of withdrawal. Therefore, the Panel 
      considers that the additive is safe for the consumer of tissues obtained from 
      chickens for fattening and turkeys for fattening fed the additive at a maximum 
      level of 3 mg/kg complete feed at a 3-day withdrawal time. For control purposes, 
      the Panel recommends the setting of the following maximum residue limits (MRLs): 
      liver, 50 mug/kg; kidney, 40 mug/kg; muscle, 3 mug/kg; skin/fat, 10 mug/kg wet 
      tissue. Based on an updated environmental risk assessment, no concern for 
      groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk 
      of secondary poisoning is not likely to occur. No safety concerns are expected 
      for terrestrial and aquatic environments. The additive has the potential to 
      control coccidiosis in chickens for fattening and turkeys for fattening/reared 
      for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.
CI  - (c) 2023 European Food Safety Authority. EFSA Journal published by Wiley-VCH GmbH 
      on behalf of European Food Safety Authority.
CN  - EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
FAU - Bampidis, Vasileios
AU  - Bampidis V
FAU - Azimonti, Giovanna
AU  - Azimonti G
FAU - Bastos, Maria de Lourdes
AU  - Bastos ML
FAU - Christensen, Henrik
AU  - Christensen H
FAU - Durjava, Mojca
AU  - Durjava M
FAU - Dusemund, Birgit
AU  - Dusemund B
FAU - Kouba, Maryline
AU  - Kouba M
FAU - Lopez-Alonso, Marta
AU  - Lopez-Alonso M
FAU - Lopez Puente, Secundino
AU  - Lopez Puente S
FAU - Marcon, Francesca
AU  - Marcon F
FAU - Mayo, Baltasar
AU  - Mayo B
FAU - Pechova, Alena
AU  - Pechova A
FAU - Petkova, Mariana
AU  - Petkova M
FAU - Ramos, Fernando
AU  - Ramos F
FAU - Sanz, Yolanda
AU  - Sanz Y
FAU - Villa, Roberto Edoardo
AU  - Villa RE
FAU - Woutersen, Ruud
AU  - Woutersen R
FAU - Gropp, Jurgen
AU  - Gropp J
FAU - Rychen, Guido
AU  - Rychen G
FAU - Finizio, Antonio
AU  - Finizio A
FAU - Poiger, Thomas
AU  - Poiger T
FAU - Teodorovic, Ivana
AU  - Teodorovic I
FAU - Aquilina, Gabriele
AU  - Aquilina G
FAU - Bories, Georges
AU  - Bories G
FAU - Brantom, Paul
AU  - Brantom P
FAU - Holczknecht, Orsolya
AU  - Holczknecht O
FAU - Navarro-Villa, Alberto
AU  - Navarro-Villa A
FAU - Rossi, Barbara
AU  - Rossi B
FAU - Vettori, Maria Vittoria
AU  - Vettori MV
LA  - eng
PT  - Journal Article
DEP - 20230420
PL  - United States
TA  - EFSA J
JT  - EFSA journal. European Food Safety Authority
JID - 101642076
PMC - PMC10116402
OTO - NOTNLM
OT  - chickens for fattening
OT  - coccidiostats
OT  - efficacy
OT  - halofuginone hydrobromide
OT  - safety
OT  - turkeys for fattening
OT  - turkeys reared for breeding
EDAT- 2023/04/24 06:41
MHDA- 2023/04/24 06:42
PMCR- 2023/04/20
CRDT- 2023/04/24 03:25
PHST- 2023/04/24 06:42 [medline]
PHST- 2023/04/24 06:41 [pubmed]
PHST- 2023/04/24 03:25 [entrez]
PHST- 2023/04/20 00:00 [pmc-release]
AID - EFS27978 [pii]
AID - 10.2903/j.efsa.2023.7978 [doi]
PST - epublish
SO  - EFSA J. 2023 Apr 20;21(4):e07978. doi: 10.2903/j.efsa.2023.7978. eCollection 2023 
      Apr.