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CONSIDERATION OF PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS AT STEP 4 ARISING FROM THE 43RD AND 45TH JECFA AND THOSE RETAINED AT STEP 4 (Agenda Item 9)[10]

32. The Committee reaffirmed its previous decision that temporary MRLs should be retained at Step 4. The Committee also reiterated that if no method of analysis acceptable to the Committee was recommended to monitor an MRL, the MRL should not be advanced beyond Step 7.

Carazolol

33. The Committee was informed that the 43rd JECFA allocated a full ADI of 0-0.1 µg/kg body weight. The 43rd JECFA converted the MRL for pig muscle and fat/skin (5 µg/kg) to full status and lowered the MRL for pig liver and kidney to 25µg/kg (full status).

34. The MRL for pig liver and kidney were advanced to Step 5. The MRL for pig muscle and fat/skin were also advanced to Step 5, with the understanding that suitable methods of analysis would be identified prior to their final adoption at Step 8.

Spiramycin

35. The Committee noted that the 43rd JECFA allocated a full ADI of 0-50 µg/kg body weight.

36. The full MRLs for cattle muscle, liver, kidney, fat and milk; chicken muscle, liver, kidney and fat; and pig muscle were advanced to Step 5. The temporary MRLs for pig liver, kidney and fat were retained at Step 4.

37. Suitable methods of analysis were required prior to their final adoption at Step 8 for full MRLs for pig muscle and for cattle milk and temporary MRLs for pig liver, kidney and fat.

Febantel/Fenbendazole/Oxfendazole

38. The 45th JECFA lowered the temporary group ADI to 0-4 µg/kg body weight.

39. The temporary MRLs for febantel, fenbendazole and oxfendazole were all retained at Step 4. Suitable methods of analysis were required to support temporary MRLs for kidney and fat (cattle, pigs, sheep) and for milk (cattle).

Levamisole

40. The 42nd JECFA had withdrawn the temporary MRL for cattle milk and the Committee agreed to withdraw the milk MRL for levamisole.

Doramectin

41. The 45th JECFA allocated full MRLs for cattle muscle, liver kidney and fat. These were advanced to Step 5, with the understanding that suitable methods of analysis would be identified prior to their final adoption at Step 8.

Moxidectin

42. The 45th JECFA allocated full MRLs for muscle, liver, kidney and fat (cattle and sheep) and temporary MRLs for deer muscle, liver, kidney and fat. The Committee advanced all full MRLs to Step 5 and retained temporary MRLs for deer at Step 4. The Committee noted that suitable methods of analysis should be identified prior to their final adoption at Step 8.

43. The Delegation of Australia noted that residues in cattle fat could exceed the MRL due to uses involving multiple administration for tick control. It was agreed that the data would be provided to JECFA.

Ceftiofur sodium

44. The 45th JECFA allocated full MRLs for muscle, liver, kidney and fat (cattle and pigs) and cattle milk. The Committee advanced all these to Step 5 and noted that suitable methods of analysis were required for all MRLs prior to their final adoption at Step 8.

Azaperone/Chlortetracycline and tetracycline/Dexamethasone/Diclazuril/Dihydrostreptomycin and streptomycin/Gentamicin/Neomycin/Oxytetracycline/Spectinomycin

45. JECFA had set temporary MRLs for all these substances which the Committee agreed should be retained at Step 4. The Committee noted that there had been several Codex MRLs for certain animal products established for oxytetracycline and that the temporary MRL for oxytetracycline was for giant prawns.

46. Suitable analytical methods were required for MRLs for the following:

azaperone

fat (pigs);

chlortetracycline/tetracycline

liver (cattle, pigs, sheep, poultry) and eggs (poultry);

dexamethasone

all MRLs;

dihydrostreptomycin/streptomycin

all MRLs;

gentamicin

fat (cattle, pigs) and milk (cattle);

neomycin

muscle and fat (cattle, chickens, ducks, goats, pigs, sheep, turkeys); liver and kidney (chickens, ducks, goats, sheep, turkeys); eggs (chickens); and milk (cattle);

oxytetracycline

giant prawn; and

spectinomycin

muscle, liver, kidney and fat (cattle, chickens, pigs) and milk (cattle).


[10] ALINORM 95/31, Appendix V (MRLs retained at Step 4); CL 1995/1-RVDF (MRLs arising from 43rd JECFA); CL 1995/21-RVDF (MRLs arising from 45th JECFA); CX/RVDF 95/7 (comments from Canada, Czech Republic, France and Spain); and CRD 1 (comments from the EC). Also see Appendices IV and V of this report.

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