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Veterinary medicinal products

 
Table 1. Substances categorized into 3 (1) of the guidance, “Substance for which an ADI is established by an international organization etc., and the estimated daily intake based on the current risk management does not exceed the said ADI.”
International
Nonproprietary
Name (INN)
Purpose of use
Reference risk assessment results by the international organisations or foreign governments etc.
The estimated daily intake based on the current risk management
Young children
(1 to 6 years old)
(mg/kg bw/d)
Risk
assessor
Year
ADI
(mg/kg bw/d)
Nitroxinil
 
Veterinary medicinal products
(parasite eliminator)
APVMA 1974 0.02 0.0034 *1
EMEA
1998 0.005
Isometamidium
Veterinary medicinal products
(parasite eliminator)
JECFA
1992 0.1 0.0021 *1
Oxyclozanide
 
Veterinary medicinal products
(parasite eliminator)
APVMA 1976 0.002 0.00023 *2
EMEA
1998 0.03
Isoeugenol
 
Veterinary medicinal products
(anesthetic, analgesics)
APVMA 1996 0.2 0.039 *1
EMA
2011 0.075
Trimethoprim
 
Veterinary medicinal products
(synthetic antibacterial product, parasite eliminator)
APVMA 2016 0.02 0.0015 *1
EMEA
1997 0.0042
Canthaxanthin
 
Feed additives
(colour additives)
JECFA 1990 0.03 0.017
EFSA
2010 0.03
FDA
1998 0.03
Maduramicin
 
Veterinary medicinal products
(antibacterial product, parasite eliminator)
APVMA 1986 0.001 0.00043 *1
EFSA
2011 0.001
FDA
1989 0.00204
Robenidine
 
Veterinary medicinal products
(synthetic antibacterial product, parasite eliminator)
APVMA 1997 0.005 0.00018 *1
EFSA
2019 0.055
Halofuginone
 
Veterinary medicinal products, Feed additives
(synthetic antibacterial product, antiprotozoal agent, parasite eliminator)
APVMA 2006 0.0003 0.00011 *1
EFSA
1998 0.0003
FDA 
1991 0.0007

Ampicillin

Veterinary medicinal products
(antibacterical product)

JECFA

2017

0.003

0.00071 *1

Bacitracin
 

Veterinary medicinal products, Feed additives(antibacterical product)

APVMA 1997 0.1 0.0029 *1
EMEA 2001 0.0039
FDA 2000 0.005

Phenoxymethylpenicillin

Veterinary medical products
(antibacterial product)

EMEA

2000

30 μg/person/d

(the maximum permitted daily intake)

1.3 μg/person/d *1

(for national average or pregnant women)

Coumaphos

Veterinary medical products

(Insecticide)

APVMA 1971 0.0005 *1
EMEA 1999 0.00025
EPA 1996 0.00025
*1: An estimation calculated by the Ministry of Health, Labour and Welfare (MHLW) using Theoretical Maximum Daily Intake (TMDI) based on the special calculation report on surveys of food intake and frequency (Fiscal year 2005-2007).

*2: An estimation calculated by MHLW using Estimated Daily Intake (EDI) based on the special calculation report on surveys of food intake and frequency (Fiscal year 2005-2007).

 

Table 2. Substances categorized into 3 (2) of the guidance, “Substance of which genotoxic carcinogenic potential cannot be denied.”  

International
Nonproprietary
Name (INN)
Purpose of use
Current risk management

Risk assessment result

Carbadox

Veterinary medical products

(synthetic antibacterial product)

The substance has been managed as a substance that should not be detected from foods.

The risk of the substance to human health through foods can be considered negligible.
Sodium niflustyrenate Veterinary medical products

(synthetic antibacterial product)

The substance has not been managed as a substance that should not be detected from foods.

The risk of the substance to human health through foods can not be considered negligible.
Roxarson Veterinary medical products

(synthetic antibacterial product)

The substance has not been managed as a substance that should not be detected from foods.

The risk of the substance to human health through foods can not be considered negligible.

 

Table 3. Substances categorized into 3 (3) i. of the guideline, “Substances with an enough margin between the NOAEL etc. confirmed from the documents and the estimated dairy intake specified on the basis of current risk management.” 

International
Nonproprietary
Name (INN)
Purpose of use
NOAEL etc.
The estimated daily intake based on the current risk management
Young children
(1 to 6 years old)
(mg/kg bw/d)
Studies
mg/kg bw/d
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