Veterinary drug residues in food: Maximum Residue Limits (MRLs) PNS/BAFS 48:2016 ICS 67.020 PHILIPPINE NATIONAL STANDARD BUREAU OF AGRICULTURE AND FISHERIES STANDARDS BPI Compound Visayas Avenue, Diliman, Quezon City 1101 Philippines Phone (632) 920-6131; (632) 455-2856; (632) 467-9039; Telefax (632) 455-2858 E-mail: [email protected]Website: www.bafps.da.gov.ph
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Veterinary drug residues in food: Maximum Residue Limits (MRLs)
PNS/BAFS 48:2016
ICS 67.020
PHILIPPINE NATIONAL
STANDARD
BUREAU OF AGRICULTURE AND FISHERIES STANDARDS BPI Compound Visayas Avenue, Diliman, Quezon City 1101 Philippines
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Foreword The revision of this Philippine National Standards (PNS) for Veterinary Drug Residues in Food: Maximum Residue Limits (MRLs) is an endorsement and identical adoption of the Codex Alimentarius Commission (CAC) MRL 2-2015, Maximum Residue Limits (MRLs) and Risk Management Recommendations (RMRs) for Residues of Veterinary Drugs in Food, as updated at the 38th Session of the Codex Alimentarius Commission (July 2015). This revision updates PNS/BAFPS 48:2015, Veterinary drug residues in food: Maximum residue limits (MRLs), reflecting the international developments that have occurred since. In the Philippines, the National Codex Organization (NCO) was formed to work in parallel with the Codex Committees. The NCO also serves as an advisory body to the government on issues arising from or related to the work of CAC (2010, MOP). The members of the Subcommittee of Veterinary Drug Residues in Food (SCRVDF) of the NCO, served as the Technical Working Group for this standard, in collaboration with the Bureau of Agriculture and Fisheries Standards (BAFS). The SCRVDF is composed of members coming from the academe, professional organizations, government agencies, and other consumer and producer groups, and led by the National Meat Inspection Service (NMIS). The SCRVDF agreed to the adoption of CAC|MRL 2-2015 as a Philippine National Standard (PNS) by virtue of the SCRVDF Resolution No. 03, series of 2015. This revision is necessary to ensure harmonization of the local setting with that of international level and serves to establish food safety standard on this concern.
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Pig Muscle 60 23rd
(1999)
Liver 100 Kidney 100 Fat 60
BENZYLPENICILLIN/PROCAINE BENZYLPENICILLIN
Cattle Muscle 50
23rd (1999)
Liver 50 Kidney 50 Milk (ug/l)
4
Chicken Muscle 50 Applies to procaine benzylpenicillin only. Liver 50 Applies to procaine benzylpenicillin only. Kidney 50 Applies to procaine benzylpenicillin only.
Pig Muscle 50 Liver 50 Kidney 50
CARAZOLOL
Pig
Muscle 5
26th (2013)
The concentration at the injection site two hours after treatment may result in an intake that exceeds the acute RfD and therefore, an appropriate withdrawal period should be applied.
Liver 25 Kidney 25 Fat/Skin 5 The concentration at the injection site
two hours after treatment may result in an intake that exceeds the acute RfD and therefore, an appropriate withdrawal period should be applied.
CEFTIOFUR
Cattle Muscle 1000
23rd (1999)
Liver 2000 Kidney 6000 Fat 2000 Milk (ug/l)
100
Pig Muscle 1000 Liver 2000 Kidney 6000 Fat 2000
CHLORTETRACYCLINE/OXYTETRACYCLINE/TETRACYCLINE
Cattle Muscle 200
26th (2003)
Liver 600 Kidney 1200 Milk (ug/l)
100
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Fish Muscle 200 Applies only to oxytetracycline Giant prawn (Paeneus monodon)
Due to the potential abuse of this drug, the MRLs are recommended only when associated with a national approved therapeutic use, such as tocolysis or as an adjunct therapy in respiratory diseases.
Liver 0.6 Kidney 0.6 Fat 0.2 Milk (ug/l)
0.05
Horse Muscle 0.2 Liver 0.6 Kidney 0.6 Fat 0.2
CLOSANTEL
Cattle Muscle 1000
20th (1993)
Liver 1000 Kidney 3000 Fat 3000
Sheep Muscle 1500 Liver 1500 Kidney 5000 Fat 2000
COLISTIN
Cattle Muscle 150
31st (2008)
Liver 150 Kidney 200 Fat 150 Milk 50
Sheep Muscle 150 Liver 150 Kidney 200
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Fat 150 Milk 50
Goat Muscle 150 Liver 150 Kidney 200 Fat 150
Pig Muscle 150 Liver 150 Kidney 200 Fat 150 The MRL includes skin + fat
Chicken Muscle 150 Liver 150 Kidney 200 Fat 150 The MRL includes skin + fat Eggs 300
Turkey Muscle 150 Liver 150 Kidney 200 Fat 150 The MRL includes skin + fat
Rabbit Muscle 150 Liver 150 Kidney 200 Fat 150
CYFLUTHRIN
Cattle Muscle 20
26th (2003)
Liver 20 Kidney 20 Fat 200 Milk (ug/l)
40
CYHALOTHRIN
Cattle Muscle 20
28th (2005)
Liver 20 Kidney 20 Fat 400 Milk 30
Pig Muscle 20 Liver 20 Kidney 20 Fat 400
Sheep Muscle 20 Liver 50 Kidney 20 Fat 400
CYPERMETHRIN AND ALPHA-CYPERMETHRIN
Cattle Muscle 50
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Liver 50 29th (2006)
Kidney 50 Fat 1000 Milk 100
Sheep Muscle 50 Liver 50 Kidney 50 Fat 1000
DANOFLOXACIN
Cattle Muscle 200
24th (2001)
Liver 400 Kidney 400 Fat 100
Chicken Muscle 200 Liver 400 Kidney 400 Fat 100 Fat/skin in normal proportion
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Liver 2.0 32nd (2009)
Kidney 1.0 Milk (ug/l)
0.3
Pig Muscle 1.0 Liver 2.0 Kidney 1.0
Horses Muscle 1.0 Liver 2.0 Kidney 1.0
DICLAZURIL
Poultry Muscle 500
23rd (1999)
Liver 3000 Kidney 2000 Fat/Skin 1000
Rabbit Muscle 500 Liver 3000 Kidney 2000 Fat 1000
Sheep Muscle 500 Liver 3000 Kidney 2000 Fat 1000
DICYCLANIL
Sheep Muscle 150 28th
(2005)
Liver 125 Kidney 125 Fat 200
DIHYDROSTREPTOMYCIN/STREPTOMYCIN
Cattle Muscle 600
24th (2001)
Liver 600 Kidney 1000 Fat 600 Milk 200
Chicken Muscle 600 Liver 600 Kidney 1000 Fat 600
Pig Muscle 600 Liver 600 Kidney 1000 Fat 600
Sheep Muscle 600 Liver 600 Kidney 1000
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Fat 600 Milk 200
DIMINAZENE
Cattle Muscle 500
22nd (1997)
Liver 12000 Kidney 6000 Milk (ug/l)
150 Limit of quantification of the analytical method
DORAMECTIN
Cattle Muscle 10
22nd
(1997)
High concentration of residues at the injection site over a 35 day period after subcutaneous or intramuscular administration of the drug at the recommended dose.
Liver 100 Kidney 30 Fat 150 High concentration of residues at the
injection site over a 35 day period after subcutaneous or intramuscular administration of the drug at the recommended dose.
Milk 15
29th (2006)
Depending on the route and/or time administration the use of doramectin in dairy cows may result in extended withdrawal periods in milk. This may be addressed in national/regional regulatory programs.
Pig Muscle 5 24th
(2001)
Liver 100 Kidney 30 Fat 150
EMAMECTIN BENZOATE
Salmon Muscle 100 38th
(2015)
Fillet 100 Muscle plus skin in natural proportion
Trout Muscle 100 Fillet 100 Muscle plus skin in natural proportion
EPRINOMECTIN Cattle Muscle 100
26th
(2003)
Liver 2000 Kidney 300 Fat 250 Milk (ug/l)
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ERYTHROMYCIN
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Chicken Muscle 100
31st (2008)
Liver 100 Kidney 100 Fat 100 The MRL includes skin + fat Eggs 50
Turkey Muscle 100 Liver 100 Kidney 100 Fat 100 The MRL includes skin + fat
ESTRADIOL - 17 BETA
Cattle Muscle Unnecessary
21ST (1995)
Residues resulting from the use of this substance as a growth promoter in accordance with good animal husbandry practice are unlikely to pose a hazard to human health.
Liver 1000 Kidney 400 Fat 100 Milk 100 JECFA evaluated the effect of pirlimycin
residues on starter cultures and for this reason recommended an MRL of 100 ug/kg of milk. Codex members may therefore adapt national/regional MRLs in order to address this technological aspect for trade of fresh liquid milk untended for processing using starter culture.
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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PORCINE SOMATOTROPIN
Pig Muscle Not specified
26th (2003)
Liver Not specified
Kidney Not specified
Fat Not specified
PROGESTERONE
Cattle Muscle Unnecessary
21st (2005)
Residues resulting from the use of this substance as a growth promoter in accordance with good animal husbandry practice are unlikely to pose a hazard to human health.
Liver Unnecessary
Kidney Unnecessary
Fat Unnecessary
RACTOPAMINE
Cattle Muscle 10
35th (2012)
Liver 40 Kidney 90 Fat 10
Pigs Muscle 10 Liver 40 Kidney 90 Fat 10 The MRL includes skin + fat
SARAFLOXACIN
Chicken Muscle 10
24th (2001)
Liver 80 Kidney 80 Fat 20
Turkey Muscle 10 Liver 80 Kidney 80 Fat 20
SPECTINOMYCIN
Cattle Muscle 500
23rd (1999)
Liver 2000 Kidney 5000 Fat 2000 Milk )ug/l)
200
Chicken Muscle 500
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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Liver 2000 Kidney 5000 Fat 2000 Eggs 2000
Pig Muscle 500 Liver 2000 Kidney 5000 Fat 2000
Sheep Muscle 500 Liver 2000 Kidney 5000 Fat 2000
SPIRAMYCIN
Cattle Muscle 200
22nd (1997)
Liver 600 Kidney 300 Fat 300 Milk (ug/l)
200
Chicken Muscle 200 Liver 600 Kidney 800 Fat 300
Pig Muscle 200 Liver 600 Kidney 300 Fat 300
SULFADIMIDINE
Cattle Milk (ug/l)
25
21st (1995)
Not specified
Muscle 100 Liver 100 Kidney 100 Fat 100
TESTOSTERONE
Cattle Muscle Unnecessary
21st (1995)
Residues resulting from the use of this substance as a growth promoter in accordance with good animal husbandry practice are unlikely to pose a hazard to human health.
Liver Unnecessary
Kidney Unnecessary
Fat Unnecessary
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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THIABENDAZOLE
Cattle Muscle 100
21st (1995)
The MRL also covers residues derived from feed containing the residues resulted from agricultural use.
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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TRICHLORFON (METRIFONATE)
Cattle Milk 50 29th (2006)
TRICLABENDAZOLE
Cattle Muscle 250
32nd (2009)
Liver 850 Kidney 400 Fat 100
Sheep Muscle 200 Liver 300 Kidney 200 Fat 100
TYLOSIN
Cattle Muscle 100
32nd (2009)
Liver 100 Kidney 100 Fat 100 Milk 100
Pig Muscle 100 Liver 100 Kidney 100 Fat 100
Chicken Muscle 100
Liver 100 Kidney 100 Fat/skin 100 Eggs 300
ZERANOL
Cattle Muscle 2 21st (1995)
Liver 10
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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RISK MANAGEMENT RECOMMENDATIONS (RMRs) FOR RESIDUES OF VETERINARY DRUGS CARBADOX (growth promoter and antimicrobial agent) JECFA evaluation: 36th (1990) and 60th (2003) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions on the available scientific information, there is no safe level of residues of carbadox or its metabolites in food that represents an acceptable risk to consumers. For this reason, competent authorities should prevent residues of carbadox in food. This can be accomplished by not using carbadox in food producing animals. CHLORAMPHENICOL (antimicrobial agent) JECFA evaluation: 12th (1968), 32nd (1987), 42nd (1994) and 62nd (2004) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions on the available scientific information, there is no safe level of residues of chloramphenicol or its metabolites in food that represents an acceptable risk to consumers. For this reason, competent authorities should prevent residues of chloramphenicol in food. This can be accomplished by not using chloramphenicol in food producing animals. CHLORPROMAZINE (tranquilliser agent) JECFA evaluation: 38th (1991) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of chlorpromazine or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of chlorpromazine in food. This can be accomplished by not using chlorpromazine in food producing animals. DIMETRIDAZOLE (antiprotozoal agent) JECFA evaluation: 34th (1989) JECFA CAC38 (2015) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of dimetridazole or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of dimetridazole in food. This can be accomplished by not using dimetridazole in food producing animals.
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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FURAZOLIDONE (antimicrobial agent) JECFA evaluation: 40th (1992) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions on the available scientific information, there is no safe level of residues of furazolidone or its metabolites in food that represents an acceptable risk to consumers. For this reason, competent authorities should prevent residues of furazolidone in food. This can be accomplished by not using furazolidone in food producing animals. IPRONIDAZOLE (antiprotozoal agent) JECFA evaluation: 34th (1989) JECFA CAC38 (2015) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of ipronidazole or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of ipronidazole in food. This can be accomplished by not using ipronidazole in food producing animals. MALACHITE GREEN (antifungal and antiprotozoal agent) JECFA evaluation: 70th (2008) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions on the available scientific information, there is no safe level of residues of malachite green or its metabolites in food that represents an acceptable risk to consumers. For this reason, competent authorities should prevent residues of malachite green in food. This can be accomplished by not using malachite green in food producing animals. METRONIDAZOLE (antiprotozoal agent) JECFA evaluation: 34th (1989) JECFA CAC38 (2015) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of metronidazole or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of metronidazole in food. This can be accomplished by not using metronidazole in food producing animals.
PHILIPPINE NATIONAL STANDARD PNS/BAFS 48: 2016 Veterinary drug residues in food: Maximum residue limits (MRLs)
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NITROFURAL (antimicrobial agent) JECFA evaluation: 40th (1992) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of nitrofural or its metabolites1 in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of nitrofural in food. This can be accomplished by not using nitrofural in food producing animals. 1 Semicarbazide is not a unique indicator of nitrofural use and low levels can be associated with other legitimate sources. OLAQUINDOX (antibacterial agent) JECFA evaluation: 36th (1990) and 42nd (1994) JECFA CAC37 (2014) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of olaquindox or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of olaquindox in food. This can be accomplished by not using olaquindox in food producing animals. RONIDAZOLE (antiprotozoal agent) JECFA evaluation: 34th (1989) JECFA and 42th (1994) JECFA CAC38 (2015) Recommended risk management measures: In view of the JECFA conclusions, although insufficient data were available or there was a lack of data to establish a safe level of residues of ronidazole or its metabolites in food representing an acceptable risk to consumers, significant health concerns were identified. For this reason, competent authorities should prevent residues of ronidazole in food. This can be accomplished by not using ronidazole in food producing animals. STILBENES (growth promoter) JECFA evaluation: 5th (1960) JECFA IARC evaluation: monograph 100A (2012) CAC37 (2014) Recommended risk management measures: In view of the available scientific information, there is no safe level of residues of stilbenes or their metabolites in food that represents an acceptable risk to consumers. For this reason, competent authorities should prevent residues of stilbenes in food. This can be accomplished by not using stilbenes in food producing animals.
BPI Compound Visayas Avenue, Diliman, Quezon City 1101 Philippines