Annexes

Annex 1. Summary of JECFA evaluations of veterinary drug residues from the 32nd meeting to the present
Annex 2. Recommendations on compounds on the agenda

Annex 1. Summary of JECFA evaluations of veterinary drug residues from the 32nd meeting to the present

This attached table summarizes the veterinary drug evaluations conducted by JECFA at the 32nd (1987), 34th (1989), 36th (1990), 38th (1991), 40th (1992), 42nd (1994), 43rd (1994), 45th (1995), 47th (1996) and 48th (1997) meetings. These meetings were devoted exclusively to the evaluation of veterinary drug residues in food. Please see reports of those meetings, published in WHO Technical Report Series (TRS).

Some notes regarding the Table:

· The "Status" column refers to the ADI and indicates if "No" ADI was established, if a full ADI was given, or if the ADI is Temporary (T).

· Where an MRL is temporary, it is so indicated by "T".

· Several compounds have been evaluated more than once. The data given is for the most recent evaluation.

Annex 2. Recommendations on compounds on the agenda

Anthelminthic agents

Moxidectin

Acceptable daily intake (ADI): 0-2 m g per kg of body weight (established at the forty-fifth meeting of the Committee (WHO TRS 864, 1996))

Residue definition: moxidectin (MRLs, except for sheep muscle, were recommended at the forty-fifth meeting of the Committee (WHO TRS 864, 1996); MRL for sheep muscle was recommended at the forty-seventh meeting (WHO TRS 876, 1998))

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	201	100	50	500
Sheep	50	100	50	500
Deer	20 T	100 T	50 T	500 T

¹ At the forty-fifth meeting the Committee noted the very high concentrations and great variation in the level of residues at the injection site in cattle over a 49-day period after dosing.

T = temporary pending re-evaluation in 1998.

Thiabendazole

Acceptable daily intake: 0-100 m g per kg of body weight

Residue definition: sum of thiabendazole and 5-hydroxythiabendazole (MRLs recommended at the fortieth meeting of the Committee (WHO TRS 832, 1993))

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	100	100	100	100		100
Pigs	100	100	100	100
Goats	100	100	100	100		100
Sheep	100	100	100	100

¹ These MRLs were established at the fortieth meeting of the Committee (WHO TRS 832, 1993), and were not reconsidered at the present meeting.

Antimicrobial agents

Ceftiofur

Acceptable daily intake: 0-50 m g per kg of body weight (established at the forty-fifth meeting of the Committee (WHO TRS 864, 1996))

Residue definition: desfuroylceftiofur

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	1000	2000	6000	2000		100
Pigs	1000	2000	6000	2000

Danofloxacin

Acceptable daily intake: 0-20 m g per kg of body weight
Residue definition: danofloxacin

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	200	400	400	100		100
Pigs	100	50	200	100
Chickens	200	400	400	1001

¹ Fat/skin in normal proportion.

Dihydrostreptomycin/streptomycin

Acceptable daily intake: 0-50 m g per kg of body weight (group ADI for the combined residues of dihydrostreptomycin and streptomycin)

Residue definition: sum of dihydrostreptomycin and streptomycin

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	500 T	500 T	1000 T	500 T		200 T
Pigs	500 T	500 T	1000 T	500 T
Sheep	500 T	500 T	1000 T	500 T
Chickens	500 T	500 T	1000 T	500 T

Temporary MRLs (T), established at the forty-third meeting (WHO TRS 855, 1995), were maintained. The following information is required for evaluation in 1999:

· validation of the HPLC assay to measure residues of streptomycin

· studies to determine whether the HPLC and bioassay methods give similar results for residues of both drugs using tissues with incurred residues

Enroflioxacin

Acceptable daily intake: 0-2 m g per kg of body weight

The evaluation of residues was postponed due to the late submission of data.

Flumequine

Acceptable daily intake: 0-30 m g per kg of body weight

Residue definition: flumequine

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	500	1000	3000	1000
Pigs	500 T	1000 T	3000 T	1000 T
Sheep	500 T	1000 T	3000 T	1000 T
Chickens	500 T	1000 T	3000 T	1000 T
Trout	500 T1

T= MRLs are temporary. The following information is required for review in 2000:

· studies with radiolabelled flumequine in pigs, sheep, chickens, and trout for estimating the ratio of the parent drug to total residues

¹ Muscle/skin in normal proportion

Gentamicin

The temporary acceptable daily intake established at the forty-third meeting of the Committee (WHO TRS 855, 199S) and temporary maximum residue limits recommended at that meeting were extended until 1998.

Spiramycin

Acceptable daily intake: 0-50 m g per kg of body weight (established at the forty-third meeting of the Committee (WHO TRS 855, 1995))

Residue definition: cattle and chickens-sum of spiramycin and neospiramycin pigs-spiramycin equivalents (antimicrobially active residues)

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	200	600	300	300		2001
Pigs	200	600	300	300
Chickens	200	600	800	300

¹ Recommended at the present meeting. All the other MRLs were established at the forty-seventh meeting of the Committee (WHO TRS 876, 1998).

Glucocorticosteroid

Dexamethasone

Acceptable daily intake: 0-0.015 m g per kg of body weight (established at the forty-second meeting of the Committee (WHO TRS 851, 1995))

Temporary maximum residue limits established at the forty-second and forty-third meetings of the Committee (WHO TRS 851, 1995 and TRS 855, 1995) were not extended due to non-availability of a method for regulatory monitoring requested by the forty-second meeting.

Insecticides

Cyfluthrin

Acceptable daily intake: 0-20 m g per kg of body weight

Residue definition: cyfluthrin

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	20	20	20	200		40

Fluazuron

Acceptable daily intake: 0-40 m g per kg of body weight

Residue definition: fluazuron

Recommended maximum residue limits (MRLs)

Species	Muscle	Liver	Kidney	Fat	Eggs	Milk
	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/kg)	(m g/l)
Cattle	200	500	500	7000