Food safety and quality: details

Medicamento veterinario

Neomycin

La clase funcional

Antimicrobial agent

Ultima evaluación

2003

Reunión de JECFA

IDA

0-60 µg/kg bw

Estatus de IDA

Full

Monografías de residuos

Definición del residuo

Parent drug

Límites máximos para residuos
(LMR) recomendados

Cattle	Fat	500 µg/kg	F
Cattle	Kidney	10000 µg/kg	F
Cattle	Liver	500 µg/kg	F
Cattle	Milk	1500 µg/kg	F
Cattle	Muscle	500 µg/kg	F
Chicken	Eggs	500 µg/kg	F
Chicken	Fat	500 µg/kg	F
Chicken	Kidney	10000 µg/kg	F
Chicken	Liver	500 µg/kg	F
Chicken	Muscle	500 µg/kg	F
Duck	Fat	500 µg/kg	F
Duck	Kidney	10000 µg/kg	F
Duck	Liver	500 µg/kg	F
Duck	Muscle	500 µg/kg	F
Goat	Fat	500 µg/kg	F
Goat	Kidney	10000 µg/kg	F
Goat	Liver	500 µg/kg	F
Goat	Muscle	500 µg/kg	F
Pig	Fat	500 µg/kg	F
Pig	Kidney	10000 µg/kg	F
Pig	Liver	500 µg/kg	F
Pig	Muscle	500 µg/kg	F
Sheep	Fat	500 µg/kg	F
Sheep	Kidney	10000 µg/kg	F
Sheep	Liver	500 µg/kg	F
Sheep	Muscle	500 µg/kg	F
Turkey	Fat	500 µg/kg	F
Turkey	Kidney	10000 µg/kg	F
Turkey	Liver	500 µg/kg	F
Turkey	Muscle	500 µg/kg	F

Otras observaciones

El resumen de la evaluación

Committee considered the following factors in recommending MRLs:
- An ADI of 0 - 60 mg/kg bodyweight based on a toxicological end-point, which results in a maximum daily intake of 3600 mg for a 60 kg person.
- Neomycin undergoes negligible metabolism following parenteral administration in animals and the parent drug represents the total of the residues present in the tissues.
- Neomycin is the marker residue for tissues, milk and eggs.
- A validated HPLC method with a LOQ of 0.1 mg/mL for neomycin in cow's milk is available and is suitable for routine use.
- Concentrations of neomycin up to 2 mg/l had no effect on bacterial starter cultures used in the production of fermented milk products.
- Data on residues in milk supported an MRL for cow's milk of 1500 mg/kg.
- Information on the registered use patterns for injectable formulations of neomycin in food-producing animals was requested from Governments and considered. The information indicated that use of parenteral formulations is not regarded as good practice in the use of veterinary drugs, and few such products were found to be approved.
- The MRLs for kidney of 20000 mg/kg and for liver of 15000 mg/kg recommended by the Committee at its 52nd Meeting to accommodate use of parenteral formulations are therefore unnecessary.
The Committee, having considered the data submitted since its 43rd meeting, decided to revert to the MRLs for cattle kidney and liver that it had recommended at its 47th meeting.
Based on the consumption of 300 g of muscle, 100 g of liver, 50 g of kidney, 50 g of fat, 1.5 kg of milk and 100 g of eggs, the theoretical maximum daily intake of neomycin residues is 3025 mg. This accounts for 84 % of the ADI of 3600 mg for a person of 60 kg bodyweight.
FNP 41/15

Edición en línea: "Residuos en drogas veterinarias"