Edición en línea: "Compendio de especificaciones para aditivos alimentarios"

      English     Français  

versión imprimible

Medicamento veterinario Ivermectina
La clase funcional Antiparasitic agent
Ultima evaluación 2013
Reunión de JECFA 78
IDA 0-1 µg/kg bw
Estatus de IDA Full
Monografías de residuos
Definición del residuo Ivermectin B1a 
Límites máximos para residuos (LMR) recomendados
Vacuno/Vaca Músculo 4 µg/kg F
Vacuno/Vaca Hígado 100 µg/kg F
Vacuno/Vaca Grasa 40 µg/kg F
Vacuno/Vaca Leche 10 µg/kg F
Oveja Hígado 15 µg/kg F
Oveja Grasa 20 µg/kg F
Cerdo Hígado 15 µg/kg F
Cerdo Grasa 20 µg/kg F
Otras observaciones  
El resumen de la evaluación The following points were considered by the Committee in recommending MRLs for ivermectin:
- The ADI for total residues is 0.0002 mg/kg body weight.
- The marker residue is H2B1a.
- H2B1a accounts for approximately 50% of total residues in liver, muscle and kidney in cattle and sheep, and about 40% of total residues in swine liver, muscle and kidney.
- As withdrawal times increase, the proportion of H2B1a in the total residues in fat decreases. At 28 days after ivermectin administration, H2B1a accounts for approximately 20% of total residues.
- The drug is widely used, with practical withdrawal times of at least 28 days.
- Liver and fat are the tissues of choice for determining compliance with safe residue limits.
- A suitable analytical method is available for measuring residues in liver and fat.
The recommended MRLs for liver and fat were set at levels high enough to ensure that, at 28 days withdrawal time, the 95% upper confidence limit for the 99th percentile of residue levels in cattle treated at 0.3 mg/ kg bw of ivermectin would be below the MRL. With these recommended MRLs, therefore, the intake of residues of ivermectin is well below the ADI.
The concentrations of ivermectin at the injection site were considered significant from the point of view of their magnitude; however, the human toxicological data indicate that consumption of an injection site, which is extremely rare, would not result in an adverse health effect. In addition, thetheoretical maximum daily intake of residues of ivermectin from muscle, liver, kidney, and fat is well below the ADI.