Veterinary medicinal products

The risk assessment results based on “Guidance on Risk Assessments of Veterinary Medicinal Products and Feed Additives for which the Provisional Standards are Established” are below.

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)
International Nonproprietary Name (INN)	Purpose of use	Risk assessor	Year	ADI (mg/kg bw/d)
Nitroxinil	Veterinary medicinal products (parasite eliminator)	APVMA	1974	0.02	0.0034 ^*1
Nitroxinil	Veterinary medicinal products (parasite eliminator)	EMEA	1998	0.005	0.0034 ^*1
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
Oxyclozanide	Veterinary medicinal products (parasite eliminator)	EMEA	1998	0.03	0.00023 ^*2
Isoeugenol	Veterinary medicinal products (anesthetic, analgesics)	APVMA	1996	0.2	0.039 ^*1
Isoeugenol	Veterinary medicinal products (anesthetic, analgesics)	EMA	2011	0.075	0.039 ^*1
Trimethoprim	Veterinary medicinal products (synthetic antibacterial product, parasite eliminator)	APVMA	2016	0.02	0.0015 ^*1
Trimethoprim		EMEA	1997	0.0042	0.0015 ^*1
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
Robenidine		EFSA	2019	0.055	0.00018 ^*1
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	0 ^*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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