LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 1
LE{ISLAZZJONI SUSSIDJARJA 231.34
REGOLAMENTI DWAR LIMITI MASSIMI TA’ 
FDALIJIET FI PRODOTTI MEDI¬INALI 
VETERINARJI
1 ta’ Ottubru, 1998
L-Avvi\ Legali 162 ta’ l-1998.
Titolu.
Limiti Massimi ta’ Fdalijiet fi Prodotti Medi`inali Veterinarji.
Tifsir.
ma te]tie[x xort’o]ra -
"Direttur" tfisser id-Direttur tas-Servizz Veterinarju;
"fdalijiet ta’ prodotti medi`inali veterinarji" tfisser is-sustanzi
kollha farmakolo[ikament attivi, sew prin`ipali attivi, prodotti
e``ipjenti jew ta’ degradazzjoni, u l-metaboliti tag]hom li jifdal
f’o[[etti ta’ l-ikel mag]mula minn annimali li lilhom ikun ing]ata
l-prodott medi`inali veterinarju involut;
"limitu ta’ fdal massimu" jew "MRL" tfisser l-kon`entrazzjoni
ta’ fdal massimu li tirri\ulta mill-u\u ta’ prodott medi`inali
veterinarju (espressa f’mg/Kg jew u/Kg fuq ba\i ta’ pi\ frisk) li
tista’ legalment ti[i permessa jew rikonoxxuta b]ala li tkun
a``ettabbli fl-ikel. Dan il-limitu jew ji[i ba\at fuq it-tip u l-ammont
ta’ fdal meqjus b]ala li mhux ta’ periklu tossolo[iku g]as-sa]]a
tal-bniedem kif espress bil-konsum ta’ kuljum a``ettabbli (ADI),
jew fuq il-ba\i ta’ ADI temporanja li tutilizza fattur ta’ sigurtà
g]all-bniedem addizzjonali. Sabiex ji[i kalkolat dan il-limitu
g]andhom jitqiesu wkoll riskji o]ra relevanti ta’ sa]]a pubblika kif
ukoll aspetti ta’ teknolo[ija ta’ l-ikel. Meta jkun qed ji[i stabbilit
limitu ta’ fdal massimu g]andhom jitqiesu wkoll fdalijiet li jinsabu
f’ikel li jori[ina mill-pjanti jew li jinkisbu mill-ambjent. Iktar minn
hekk, MRL jista’ jitnaqqas b’mod li jkun konsistenti ma’ kull
prattika tajba fl-u\u ta’ medi`inali veterinarji u sal-limitu ta’
disponibbiltà  ta’ metodi analiti`i pratti`i.
(2) Dawn ir-regolamenti m’g]andhomx japplikaw g]al
prin`ipali attivi ta’ ori[ini biolo[ika li jkunu ma]suba biex
jipprodu`u immunità  attiva jew passiva jew biex issir dijanjosi ta’
stat ta’ immunità  u\at fi prodotti medi`inali veterinarji immolo[i`i.
Sustanzi su[[etti 
g]al MRL.
3. Il-lista ta’ sustanzi farmakolo[ikament attivi u\ati fi
prodotti medi`inali veterinarji li dwarhom ikunu [ew stabbiliti
limiti ta’ fdalijiet massimi huma dawk li hemm fl-Ewwel Skeda.
 Sustanzi li mhux 
su[[etti g]al MRL.
4. Meta, wara li ssir evalwazzjoni ta’ xi sustanza
farmakolo[ikament attiva li tkun u\ata fi prodotti medi`inali
veterinarji, jkun jidher li din ma tkunx me]tie[a g]all-]arsien tas-
sa]]a pubblika sabiex ji[i stabbilit limitu ta’ fdal massimu, dik is-
sustanza g]andha ti[i inklu\a f’lista li hemm fit-Tieni Skeda.
 Sustanzi su[[etti 
g]al MRL 
provi\orju.
5. Il-lista ta’ sustanzi farmakolo[ikament attivi li jintu\aw fi
prodotti medi`inali veterinarji li dwarhom ikunu [ew stabbiliti l-
2 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
limiti ta’ fdal massimu provi\orji huma dawk li hemm fit-Tielet
Skeda.
Sustanzi fejn ma 
jistax ji[i stabbilit 
MRL.
6. (1) Meta jkun jidher li ma jistax ji[i stabbilit limitu ta’ fdal
massimu dwar xi sustanza farmakolo[ikament attiva li tintu\a fi
prodotti medi`inali veterinarji min]abba fil-fatt li l-fdalijiet tas-
sustanzi involuti, f’liema livell ikun, f’o[[etti ta’ l-ikel li jori[inaw
mill-annimali jkunu jikkostitwixxu periklu g]as-sa]]a tal-
konsumatur, dik is-sustanza g]andha tkun inklu\a f’lista li hemm
fir-Raba’ Skeda.
(2) G]andu jkun projbit l-g]oti tas-sustanzi fil-lista li hemm
fir-Raba’ Skeda lil annimali li jipprodu`u l-ikel.
Kif ji[i stabbilit 
MRL.
7. (1) Sabiex ji[u stabbiliti l-limiti ta’ fdal massimu ta’
prodotti medi`inali veterinarji u\ati f’o[[etti ta’ l-ikel ta’ ori[ini
mill-annimali ikun me]tie[ li ji[i spe`ifikat l-ispe`i ta’ l-annimal
fejn dawk il-fdalijiet jistg]u jkunu pre\enti, il-livelli li jistg]u
jkunu pre\enti f’kull wie]ed mit-tessuti tal-la]am relevanti
miksubin mill-annimal ikkurat (target tissue) u x-xorta tal-fdal li
jkun relevanti g]as-sorveljar ta’ fdalijiet (marker residue).
(2) Sabiex isir kontroll dwar il-fdalijiet, il-limiti ta’ fdal
massimu g]andhom ji[u stabbiliti g]at-target tissue tal-fwied jew
tal-kilwa; i\da, billi l-fwied u l-kilwa ta’ spiss jitne]]ew mill-
karkassi li jinbieg]u f’kummer` internazzjonali, il-limiti ta’ fdal
massimi g]andhom g]aldaqstant dejjem ji[u stabbiliti g]al tessuti
muskolari jew xa]min.
(3) Fil-ka\ ta’ prodotti medi`inali veterinarji ma]suba g]all-
u\u fuq tajr li jbid, annimali tal-]alib jew na]al tal-g]asel, il-limiti
ta’ fdal massimi g]andhom ukoll ji[u stabbiliti g]all-bajd, ]alib,
jew g]asel.
Tqeg]id ta’ 
prodotti fuq il-listi.
8. (1) Sustanza farmakolo[ikament attiva [dida, ma]suba
biex tintu\a fi prodotti medi`inali veterinarji li jing]ataw lil
annimali li jipprodu`u l-]alib, jistg]u biss ji[u inklu\i fl-Ewwel,
fit-Tieni u fit-Tielet Skedi jekk min ikun responsabbli g]at-tqeg]id
tag]hom fis-suq jag]mel applikazzjoni dwar dan lid-Direttur. Dik
l-applikazzjoni g]andu jkun fiha t-tag]rif u l-partikolaritajiet
imsemmija fil-}ames Skeda.
(2) Id-Direttur jista’, wara li jifli t-tag]rif [did jew wara li
jer[a’ jifli t-tag]rif li jkollu, jemenda kull disposizzjoni li hemm fl-
Ewwel, fit-Tieni, fit-Tielet u fir-Raba’ Skedi jekk dan ikun me]tie[
li jsir g]all-]arsien tas-sa]]a tal-bniedem jew ta’ l-annimali.
(3) Id-Direttur ma jistax jipprojbixxi jew i\omm il-kummer`
ta’ o[[etti ta’ l-ikel li jori[inaw mill-annimali u li jkunu [ejjin
minn pajji\i o]ra min]abba f’li jkun fihom fdalijiet ta’ prodotti
medi`inali veterinarji jekk il-kwantità  ta’ fdal ma tkunx te``edi l-
limitu ta’ fdal massimu li hemm fl-Ewwel Skeda jew fit-Tielet
Skeda, jew inkella jekk dik is-sustanza tkun qeg]da fil-lista li
hemm fit-Tieni Skeda.
Annimali li 
jipprodu`u l-ikel.
9. L-g]oti lil annimali li jipprodu`u l-ikel ta’ prodtti
medi`inali veterinarji li jkun fihom sustanzi attivi farmakolo[i`i li
ma jkunux imsemmija fl-Ewwel, fit-Tieni jew fit-Tielet Skedi
g]andhu jkun projbit, ]lief fil-ka\ ta’ provi klini`i li jkunu a``ettati
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 3
mill-awtoritajiet kompetenti u sakemm l-o[[etti ta’ l-ikel li
jinkisbu minn bhejjem li jintu\aw f’dawk il-provi ma jkunx fihom
fdalijiet li jkunu ta’ periklu g]as-sa]]a tal-bniedem.
Riserva.
L.S.231.32
10. Ebda ]a[a f’dawn ir-regolamenti m’g]andha tmur kontra
d-disposizzjonijiet tar-Regolamenti dwar Fdalijiet fil-La]am, li
jipprojbixxu l-u\u, fit-trobbija tal-bhejjem, ta’ `erti sustanzi li
g]andhom azzjoni ormonika.
4 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
L-EWWEL SKEDA
(Regolament 3)
Lista ta’ sustanzi farmakolo[ikament attivi li dwarhom ikunu [ew stabbilit limiti ta’ fdalijiet 
massimi
l. A[enti anti-infettivi
1.1. Kemoterapewti`i
1.1.1.  Sulfonamides
1.2. Antibiotics
1.2.1. Penicillins
1.2.2 Cephalosporins
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
Is-sustanzi kollha 
li jappartjenu 
g]as-sulfona-
mide group
Parent drug Kull spe`i li jip-
produ`i l-ikel
100 µ g/kg Muskolu, fwied, 
milsa, xa]am
Bovini, Ovini, 
Kaprini
100 µ g/kg }alib
Provdimenti o]ra: Il-fdalijiet totali kombinati ta’ kull sustanza fis-sulfonamide group 
m’g]andhomx je``edu 100 µ g/kg
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.1.1.
Benzylpenicillin
Benzylpenicillin Kull spe`i li jip-
produ`i l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa]am
4 µ g/kg }alib
1.2.1.2.
Ampicillin
Ampicillin Kull spe`i li jip-
produ`i l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa]am
4 µ g/kg }alib
1.2.1.3.
Amoxicillin
Amoxicillin Kull spe`i li jip-
produ`i l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa]am
4 µ g/kg }alib
1.2.1.4.
Oxacillin
Oxacillin Kull spe`i li jip-
produ`i l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa]am
30 µ g/kg }alib
1.2.1.5.
Cloxacillin
Cloxacillin Kull spe`i li jip-
produ`i l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa]am
30 µ g/kg }alib
1.2.1.6.
Dicloxacillin
Dicloxacillin Kull spe`i li jip-
produ`i l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa]am
30 µ g/kg }alib
1.2.1.7.
Penethamate
Benzylpenicillin Bovini 50 µ g/kg Muskolu, fwied, 
milsa, xa]am
4 µ g/kg }alib
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 5
1.2.3. Quinolones
1.2.4. Macrolides
1.2.5. Florfenicol u komposti relatati
1.2.6. Tetracyclines
1.2.2.1.
Cefquinome
Cefquinome Bovini 200 µ g/kg
100 µ g/kg
50 µ g/kg
50 µ g/kg
20 µ g/kg
Milsa,
Fwied,
Muskolu,
Xa]am
}alib
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.3.1.
Enrofloxacin
Total ta’ enro-
floxacin u cipro-
floxacin
Bovini, majjal, 
pullam
30 µ g/kg Muskolu, fwied, 
milsa
1.2.3.2.
Sarafloxacin
Sarafloxacin Flieles 100 µ g/kg
10 µ g/kg
Fwied
{ilda u xa]am
1.2.3.3.
Difloxacin
Difloxacin Flieles, dundjani 200 µ g/kg
150 µ g/kg
50 µ g/kg
200 µ g/kg
Fwied
Milsa
Muskolu
{ilda u xa]am
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.4.1.
Tilmicosin
Tilmicosin Bovini, ovini, 
majjal
1000 µ g/kg
50 µ g/kg
Fwied, milsa
Muskolu, xa]am
Ovini 50 µ g/kg }alib
1.2.4.2.
Spiramycin
Total ta’ 
spiramycin u 
neospiramycin
Bovini 300 µ g/kg
200 µ g/kg
200 µ g/kg
Fwied, milsa, 
xa]am
Muskolu
}alib
Flieles 400 µ g/kg
300 µ g/kg
200 µ g/kg
Fwied
{ilda u xa]am
Muskolu
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.5.1.
Florfenicol
Total ta’ Florfen-
icol u metabo-
lites relattivi 
mi\urati b]ala 
Florfenicolamine
Bovini 200 µ g/kg
300 µ g/kg
3000 µ g/kg
Muskolu
Milsa
Fwied
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
6 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
2. A[enti anti-parasiti`i
2.1. A[enti li ja[ixxu kontra endoparasiti
2.1.1. Avermectins
2.1.2. Salicylanilides
2.l.3. Tetra-hydro-imidazoles (imidazolthiazoles)
2.2. Agenti li ja[ixxu kontra ectoparasiti
1.2.6.1.
Tetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe`i li jip-
produ`i l-ikel
600 µ g/kg
300 µ g/kg
100 µ g/kg
100 µ g/kg
200 µ g/kg
Milsa
Fwied
Muskolu
}alib
Bajd
1.2.6.2.
Oxytetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe`i li jip-
produ`i l-ikel
600 µ g/kg
300 µ g/kg
100 µ g/kg
100 µ g/kg
200 µ g/kg
Milsa
Fwied
Muskolu
}alib
Bajd
1.2.6.3.
Chlortetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe`i li jip-
produ`i l-ikel
600 µ g/kg
300 µ g/kg
100 µ g/kg
100 µ g/kg
200 µ g/kg
Milsa
Fwied
Muskolu
}alib
Bajd
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.1.1.1.
Ivermectin
22,23-Dihydro-
avermectin B 1a
Bovini 100 µ g/kg
40 µ g/kg
Fwied
Xa]am
Majjal, ovini, 
equidae
15 µ g/kg
20 µ g/kg
Fwied
Xa]am
2.1.1.2.
Abamectin
Avermectin B 1a Bovini 20 µ g/kg
10 µ g/kg
Fwied
Xa]am
2.1.1.3.
Doramectin
Doramectin Bovini 15 µ g/kg
25 µ g/kg
Fwied
Xa]am
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.1.2.1.
Closantel
Closantel Bovini 1000 µ g/kg
3000 µ g/kg
Muskolu, fwied
Milsa, xa]am
Ovini 1500 µ g/kg
5000 µ g/kg
2000 µ g/kg
Muskolu, fwied
Milsa
Xa]am
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.1.3.1.
Levamisole
Levamisole Bovini, ovini, 
majjal, pullam
10 µ g/kg
100 µ g/kg
Muskolu, milsa, 
xa]am
Fwied
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 7
2.2.1. Organophosphates
2.2.2. Formamidines
3. A[enti li ja[ixxu fuq is-sistema nervu\
3.1. A[enti li ja[ixxu fuq is-sistema nervu\ awtomatiku
3.1.1. Anti-adrenergics
IT-TIENI SKEDA
(Regolament 4)
Lista ta’ sustanzi mhux su[[etti g]al-limiti ta’ fdalijiet massimi
1. Kimi`i inorgani`i
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.2.1.1.
Diazinon
Diazinon Bovini, ovini 700 µ g/kg
20 µ g/kg
Xa]am
Milsa, fwied
muskolu
Bovini, ovini, 
kaprini
20 µ g/kg }alib
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.2.2.1.
Amitraz
Total ta’ amitraz 
u metabolites 
kollha bi 2,4-
DMA moeity, 
espressa b]ala 
amitraz
Majjal 400 µ g/kg
200 µ g/kg
Xa]am u [ilda
Milsa, fwied
Sustanza/i farma-
kolo[ikament 
attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
3.1.1.1.
Carazolol
Carazolol Majjal 25 µ g/kg
5 µ g/kg
Fwied,milsa 
Muskolu, xa]am 
u [ilda
Sustanza/i farmakolo[ikament attivi Spe`i ta’ annimali
1.1. Hydrogen peroxide Kull spe`i li jipprodu`i l-ikel
1.2. Sulpur Bovini, majjal, ovini, kaprini, equidae
1.3. Iodine u iodine inorganic compounds 
inklu\i: Kull spe`i li jipprodu`i l-ikel
- Sodium u potassium-iodide
- Sodium u potassium-iodate
- Iodophors inklu\i Polyvinyl-pyrro-
lidone-iodine
1.4. Sodium chlorite Bovini (g]al u\u topikali biss)
1.5. Calcium acetate Kull spe`i li jipprodu`i l-ikel
Calcium benzoate
8 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
Calcium carbonate
Calcium chloride
Calcium gluconate
Calcium hydroxide
Calcium hypophosphite
Calcium malate
Calcium oxide
Calcium phosphate
Calcium polyphosphates
Calcium propionate
Calcium silicate
Calcium stearate
Calcium sulphate
1.6. Hydrochloric acid Kull spe`i li jipprodu`i l-ikel (g]al u\u 
b]ala e``ipjent)
1.7. Sodioum dichloroisocyanurate Bovini, ovini, kaprini (g]al u\u topikali 
biss)
1.8. Boric acid u borates Kull spe`i li jipprodu`i l-ikel
1.9. Magnesium Kull spe`i li jipprodu`i l-ikel
1.10. Magnesium sulphate Kull spe`i li jipprodu`i l-ikel
1.11. Magnesium hydroxide Kull spe`i li jipprodu`i l-ikel
1.12. Magnesium stearate Kull spe`i li jipprodu`i l-ikel
1.13. Magnesium glutamate Kull spe`i li jipprodu`i l-ikel
1.14. Magnesium orotate Kull spe`i li jipprodu`i l-ikel
1.15. Magnesium aluminium silicate Kull spe`i li jipprodu`i l-ikel
1.16. Magnesium oxide Kull spe`i li jipprodu`i l-ikel
1.17. Magnesium carbonate Kull spe`i li jipprodu`i l-ikel
1.18. Magnesium phosphate Kull spe`i li jipprodu`i l-ikel
1.19. Magnesium glycerophosphate
1.20. Magnesium aspartate
1.21. Magnesium citrate
1.22. Magnesium acetate
1.23. Magnesium trisilicate
2. Komposti Organi`i
Sustanza/i farmakolo[ikament attivi Spe`i ta’ annimali
2.1. Etiproston tromethamine Bovini, majjal
2.2. Ketanserin tartrate Equidae
2.3. Fertireline acetate Bovini
2.4. Human menopausal urinary gonado-
trophin Bovini
2.5. Lactic acid Kull spe`i li jipprodu`i l-ikel
2.6. Melatonin Ovini, kaprini
2.7. Iodine organic compounds Kull spe`i li jipprodu`i l-ikel
- Iodoform
2.8. Acetyl cysteine Kull spe`i li jipprodu`i l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 9
2.9. Gonadotrophin releasing hormone Kull spe`i li jipprodu`i l-ikel
2.10. Pregnant Mare Serum
Gonadotrophin Kull spe`i li jipprodu`i l-ikel
2.11. 17ß -Oestradiol Kull mammal li jipprodu`i l-ikel (g]al u\u 
terapewtiku u zootekniku biss)
2.12. Romifidine Equidae (g]al u\u terapewtiku biss)
2.13. Detomidine Bovini, Equidae (g]al u\u
terapewtiku biss)
2.14. Brotizolam Bovini, (g]al u\u terapewtiku biss)
2.1.5. Human chorion gonadotrophin (HCG) Kull spe`i li jipprodu`i l-ikel
2.16. Oxytocin Kull mammal li jipprodu`i l-ikel
 2.17. Lecirelin Bovini, equidae, fenek
2.18. Dinoprost tromethamine Kull spe`i mammarju
2.19. Malic acid Kull spe`i li jipprodu`i l-ikel (biex jintu\a 
b]ala e``ipjent)
2.20. L-tartaric acid u mono- u di-basic salt 
relattiv ta’ sodium potassium u calcium
Kull spe`i li jipprodu`i l-ikel (biex jintu\a 
b]ala e``ipjent)
2.21. Benzylalcohol Kull spe`i li jipprodu`i l-ikel (biex jintu\a 
b]ala e``ipjent)
2.22. Ethanol Kull spe`i li jipprodu`i l-ikel (biex jintu\a 
b]ala e``ipjent)
2.23. N-butanol Kull spe`i li jipprodu`i l-ikel (biex jintu\a 
b]ala e``ipjent)
2.24. Mineral hydrocarbons, b’viskosità  minn 
baxxa sa g]olja inklu\i micro cristalline 
waxes, approx. C10-C60; aliphatic, 
branched aliphatic u alicyclic com-
pounds
Kull spe`i li jipprodu`i l-ikel (esklu\i kom-
posti aromati`i u mhux saturati)
2.25. Buserelin Kull spe`i li jipprodu`i l-ikel
2.26. Ketoprofen Bovini, equidae
2.27. Caffeine Kull spe`i li jipprodu`i l-ikel
2.28. Theophylline Kull spe`i li jipprodu`i l-ikel
2.29. Theobromine Kull spe`i li jipprodu`i l-ikel
2.30. Ketoprofen Majjal
2.31. Propane Kull spe`i li jipprodu`i l-ikel
2.32. n-butane Kull spe`i li jipprodu`i l-ikel
2.33. Isobutane Kull spe`i li jipprodu`i l-ikel
2.34. Polysulphated
glycosaminoglycan Equidae
2.35. Rifaximin Bovini (g]al u\u intramammarju - ]lief 
jekk is-sider jista’ jintu\a b]ala ikel g]al 
konsum tal-bniedem - u u\u intrauterin 
biss)
2.36. Tau fluvalinate Na]al ta’ l-g]asel
2.37. Phenol Kull spe`i li jipprodu`i l-ikel
2.38. Papaverine Bovini (g]o[[iela tat-twelid biss)
2.39. Policresulene Kull spe`i li jipprodu`i l-ikel (g]al u\u 
topikali biss)
10 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
2.40. Papain Kull spe`i li jipprodu`i l-ikel
2.41. Dimethyl phtalate Kull spe`i li jipprodu`i l-ikel
2.42. Diethyl phatalate Kull spe`i li jipprodu`i l-ikel
2.43. Ethyl lactate Kull spe`i li jipprodu`i l-ikel
2.44. Heptaminol Kull spe`i li jipprodu`i l-ikel
2.45. Menthol Kull spe`i li jipprodu`i l-ikel
2.46. Phloroglucinol Kull spe`i li jipprodu`i l-ikel
2.47. Trimethylphloroglucinol Kull spe`i li jipprodu`i l-ikel
2.48. Peracetic acid Kull spe`i li jipprodu`i l-ikel
2.49. Carbetocin Kull spe`i mammarju li jipprodu`i l-ikel
2.50. Quillaia saponins Kull spe`i li jipprodu`i l-ikel
2.51. Butyl 4-hydroxybenzoate Kull spe`i li jipprodu`i l-ikel
2.52. Sodium butyl 4-hydroxybenzoate Kull spe`i li jipprodu`i l-ikel
2.53. Sodium benzyl 4-hydroxybenzoate Kull spe`i li jipprodu`i l-ikel
2.54. Cetrimide Kull spe`i li jipprodu`i l-ikel
2.55. Lobeline Kull spe`i li jipprodu`i l-ikel
2.56. Pancreatin Kull spe`i mammarju li jipprodu`i l-ikel 
(g]al u\u topikali biss)
2.57. Chlorocresol Kull spe`i li jipprodu`i l-ikel
2.58. Thymol Kull spe`i li jipprodu`i l-ikel
2.59. Dembrexine Equidae
2.60. Diclazuril Ovini (g]al u\u fil-]rief biss)
2.61. Etamiphylline camsylate Kull spe`i li jipprodu`i l-ikel
3. Sustanzi [eneralment mag]rufin b]ala siguri g]as-sa]]a
Sustanza/i farmakolo[ikament attivi Spe`i ta’ annimali
 3.1. Absinthium extract Kull spe`i li jipprodu`i l-ikel
3.2. Acetylmethionine Kull spe`i li jipprodu`i l-ikel
3.3. Aluminium hydroxide Kull spe`i li jipprodu`i l-ikel
3.4.  luminium monostearate Kull spe`i li jipprodu`i l-ikel
3.5. Ammonium sulfate Kull spe`i li jipprodu`i l-ikel
 3.6. Benzoyl benzoate Kull spe`i li jipprodu`i l-ikel
3.7. Benzyl p-hydroxybenzoate Kull spe`i li jipprodu`i l-ikel
3.8. Calcium borogluconate Kull spe`i li jipprodu`i l-ikel
3.9. Calcium citrate Kull spe`i li jipprodu`i l-ikel
3.10. Camphor Kull spe`i li jipprodu`i l-ikel (u\u estern 
biss)
 3.11. Cardamon extract Kull spe`i li jipprodu`i l-ikel
3.12. Diethyl sebacate Kull spe`i li jipprodu`i l-ikel
 3.13. Dimethicone Kull spe`i li jipprodu`i l-ikel
3.14. Dimethyl acetamide Kull spe`i li jipprodu`i l-ikel
3.15. Dimethyl sulphoxide Kull spe`i li jipprodu`i l-ikel
 3.16. Ethylenediaminetetraacetic acid and 
salts Kull spe`i li jipprodu`i l-ikel
 3.17. Eucalyptol Kull spe`i li jipprodu`i l-ikel
3.18. Epinephrine Kull spe`i li jipprodu`i l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 11
3.19. Ethyl oleate Kull spe`i li jipprodu`i l-ikel
3.20. Formaldehyde Kull spe`i li jipprodu`i l-ikel
3.21. Formic acid Kull spe`i li jipprodu`i l-ikel
 3.22. Follicle stimulating hormone (natural 
FS} from all species and their synthetic 
analogues) Kull spe`i li jipprodu`i l-ikel
3.23. Glutaraldehyde Kull spe`i li jipprodu`i l-ikel
3.24. Guaiacol Kull spe`i li jipprodu`i l-ikel
3.25. Heparin u l-imlu]a tieg]u Kull spe`i li jipprodu`i l-ikel
 3.26. Human chorionic gonadotropin (natural 
}CG and its synthetic analogues) Kull spe`i li jipprodu`i l-ikel
3.27. Iron ammonium citrate Kull spe`i li jipprodu`i l-ikel
 3.28. Iron dextran Kull spe`i li jipprodu`i l-ikel
3.29. Iron glucoheptonate Kull spe`i li jipprodu`i l-ikel
3.30. Isopropanol Kull spe`i li jipprodu`i l-ikel
3.31. Lanolin Kull spe`i li jipprodu`i l-ikel
 3.32. Luteinizing hormone (natural LH from 
all species and their synthetic ana-
logues) Kull spe`i li jipprodu`i l-ikel
3.33. Magnesium chloride Kull spe`i li jipprodu`i l-ikel
3.34. Magnesium gluconate Kull spe`i li jipprodu`i l-ikel
3.35. Magnesium hypophosphite Kull spe`i li jipprodu`i l-ikel
3.36. Mannitol Kull spe`i li jipprodu`i l-ikel
3.37. Montanide Kull spe`i li jipprodu`i l-ikel
3.38. Methylbenzonate Kull spe`i li jipprodu`i l-ikel
 3.39. Monothioglycerol Kull spe`i li jipprodu`i l-ikel
 3.40. Myglyol Kull spe`i li jipprodu`i l-ikel
3.41. Orgotein Kull spe`i li jipprodu`i l-ikel
3.42. Poloxalene Kull spe`i li jipprodu`i l-ikel
3.43. Poloxamer Kull spe`i li jipprodu`i l-ikel
3.44. Polyethylene glycol 200 Kull spe`i li jipprodu`i l-ikel
 3.45. Polyethylene glycol 400 Kull spe`i li jipprodu`i l-ikel
3.46. Polyethylene glycol 600 Kull spe`i li jipprodu`i l-ikel
3.47. Polyethylene glycol 3500 Kull spe`i li jipprodu`i l-ikel
3.48. Polysorbate 80 Kull spe`i li jipprodu`i l-ikel
3.49. Serotonin Kull spe`i li jipprodu`i l-ikel
 3.50. Sodium chloride Kull spe`i li jipprodu`i l-ikel
3.51. Sodium cromoglycate Kull spe`i li jipprodu`i l-ikel
3.52. Sodium dioctylsulphosuccinate Kull spe`i li jipprodu`i l-ikel
3.53. Sodium formaldehydesulphoxylate Kull spe`i li jipprodu`i l-ikel
3.54. Sodium lauryl sulphate Kull spe`i li jipprodu`i l-ikel
 3.55. Sodium pyrosulphite Kull spe`i li jipprodu`i l-ikel
3.56. Sodium stearate Kull spe`i li jipprodu`i l-ikel
3.57. Sodium thiosulphate Kull spe`i li jipprodu`i l-ikel
 3.58. Tragacanth Kull spe`i li jipprodu`i l-ikel
3.59. Urea Kull spe`i li jipprodu`i l-ikel
12 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
IT-TIELET SKEDA
(Regolament 5)
  Lista ta’ sustanzi farmakolo[ikament attivi u\ati fi prodotti medi`i veterinarji li dwarhom 
ikunu [ew stabbiliti l-limiti ta’ fdal massimu provi\orji
l.  A[enti anti-infettivi
1.1. Kemoterapewti`i
1.1.1. Diamino pyrimidine derivates
1.1.2. Benzenesulphonamides
3.60. Zine sulphate Kull spe`i li jipprodu`i l-ikel
3.61. Zinc oxide Kull spe`i li jipprodu`i l-ikel
3.62. Polyethylene glycols (pi\ molekolari 
bejn 200 u 10000) Kull spe`i li jipprodu`i l-ikel
4. Sustanzi u\ati fi prodotti medi`inali veterinarji ]omeopati`i
Sustanza/i farmakolo[ikament attivi Spe`i ta’ annimali
4.1. Kull sustanza li tintu\a fi prodotti 
medi`inali veterinarji homeopati`i 
sakemm il-kon`entrazzjoni tag]hom fil-
prodott ma tkunx te``edi parti wa]da 
g]al kull g]axart elef
Kull spe`i li jipprodu`i l-ikel
5. Sustanzi u\ati b]al addittivi ta’ l-ikel f o[[etti ta’ l-ikel g]all-konsum tal- bniedem
Sustanza/i farmakolo[ikament attivi  Spe`i ta’ annimali
5.l. Sustanzi b’E number Kull spe`i li jipprodu`i l-ikel (sustanzi biss 
li jkunu approvati b]ala addittivi f’o[[etti 
ta’ l-ikel g]all-konsum tal-bniedem).
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.1.1.1.
Trimethoprim
Trimethoprim Kull spe`i li jip-
produ`i l-ikel
50 µ g/kg Muskolu,fwied
Milsa, xa]am, 
]alib
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.1.2.1.
Clorsulon
Clorsulon Bovini 50 µ g/kg
150 µ g/kg
400 µ g/kg
Muskolu
Fwied
Milsa
1.1.2.2.
Baquiloprim
Baquiloprim Bovini 300 µ g/kg
150 µ g/kg
10 µ g/kg
30 µ g/kg
Fwied
Milsa
Xa]am
}alib
Majjal 50 µ g/kg
40 µ g/kg
Fwied, milsa
Xa]am u [ilda
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 13
1.2. Antibiotics
1.2.2. Macrolides
1.2.3. Thiamphenicol u komposti relatati
1.2.4. Cephalosporins
1.2.5. Aminoglycosides
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.2.1.
Spiramycin
Spiramycin Majjal 600 µ g/kg
300 µ g/kg
200 µ g/kg
Fwied
Milsa, muskolu
Xa]am
1.2.2.2.
Tylosin
Tylosin Bovini, majjal, 
pullam
100 µ g/kg Muskolu, fwied 
milsa
Bovini 50 µ g/kg }alib
1.2.2.3.
Erythromycin
Erythromycin Bovini, ovini, 
majjal, pullam
400 µ g/kg Fwied, milsa, 
muskolu, xa]am
Bovini, ovini 40 µ g/kg }alib
Pullam 200 µ g/kg Bajd
1.2.2.4.
Josamycin
Josamycin Flieles 400 µ g/kg
200 µ g/kg
200 µ g/kg
Milsa
Fwied, muskolu, 
xa]am
Bajd
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.3.1.
Thiamphenicol
Thiamphenicol Bovini, pullam 40 µ g/kg Muskolu, fwied, 
milsa, xa]am
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.4.1.
Ceftiofur
Total tal-fdali-
jiet kollha li 
g]andhom l-
istruttura ta’ 
betalactam 
espressa b]ala 
desfuroylceftio-
fur
Bovini 2000 µ g/kg
200 µ g/kg
600 µ g/kg
100 µ g/kg
Milsa, fwied
Muskolu
Xa]am
}alib
Majjal 4000 µ g/kg
3000 µ g/kg
500 µ g/kg
600 µ g/kg
Milsa
Fwied
Muskolu
Xa]am
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.5.1.
Spectinomycin
Spectinomycin Bovini, majjal, 
pullam
5000 µ g/kg
2000 µ g/kg
300 µ g/kg
500 µ g/kg
Milsa
Fwied
Muskolu
Xa]am
Bovini 200 µ g/kg }alib
14 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
1.2.6. Quinolones
1.2.7. Naphtalene-ringed ansamycin
1.2.5.2.
Streptomycin
Streptomycin Bovini, ovini, 
majjal
pullam
1000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xa]am
Bovini, ovini, 200 µ g/kg }alib
1.2.5.3.
Dihydrostnepto-
mycin
Dihydrostnepto-
mycin
Bovini, ovini, 
majjal
pullam
1000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xa]am
Bovini, ovini, 200 µ g/kg }alib
1.2.5.4.
Gentamicin
Gentamicin Bovini, majjal 1000 µ g/kg
200 µ g/kg
500 µ g/kg
Milsa
Fwied
Muskolu, xa]am
Bovini 100 µ g/kg }alib
1.2.5.5.
Neomycin
(inklu\i framyce-
tin)
Neomycin Bovini, ovini, 
kaprini, majjal, 
flieles, dundjani, 
papri
5000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xa]am
Bovini, ovini, 
kaprini
500 µ g/kg }alib
Flieles 500 µ g/kg Bajd
1.2.5.6.
Aminosidine
Aminosidine Bovini, majjal, 
fniek, flieles
1500 µ g/kg
500 µ g/kg
Fwied, milsa
Muskolu
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.6.1.
Danofloxacin
Danofloxacin Bovini 900 µ g/kg
500 µ g/kg
300 µ g/kg
200 µ g/kg
Fwied
Milsa
Muskolu
Xa]am
Flieles 1200 µ g/kg
600 µ g/kg
300 µ g/kg
Fwied, milsa
{ilda u xa]am
Muskolu
1.2.6.2.
Decoquinate
Decoquinate Bovini, ovini 500 µ g/kg Muskolu, fwied, 
milsa, xa]am
1.2.6.4.
Marbofloxacin
Marbofloxacin Bovini 150 µ g/kg
75 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
}alib
Xa]am
Majjal 150 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
Xa]am u [ilda
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.6.1.
Rifaximin
Rifaximin Bovini 600 µ g/kg }alib
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 15
1.2.8. Polymyxins
1.2.9. Penicillins
2. A[enti antiparasiti`i
2.1. A[enti li ja[ixxu kontra endo-parasiti
2.1.1. Benzimidazoles u pro-benzimidazoles
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.8.1.
Colistin
Colistin Bovini, ovini, 
majjal, flieles, 
fniek
200 µ g/kg
150 µ g/kg
Milsa
Fwied, muskolu, 
xa]am
Bovini, ovini 50 µ g/kg }alib
Flieles 300 µ g/kg Bajd
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
1.2.9.1.
Penethamate
Benzylpenicillin Ovini 50 µ g/kg
4 µ g/kg
Fwied, milsa, 
muskolu, xa]am
}alib
Majjal 50 µ g/kg Fwied, milsa, 
muskolu, xa]am
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.1.1.1.
Febantel
Total ta’ fdalijiet 
ta’ oxfendazole, 
oxfendazole 
sulfone u fenben-
dazole
Kull spe`i li jip-
produ`i l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa]am
}alib
Provdimenti o]ra: Kull MRL ikopri kull fdal ta’ febantel, fenbendazole u oxfendazole
2.1.1.2.
Febendazole
Total ta’ fdalijiet 
ta’ oxfendazole, 
oxfendazole 
sulfone u fenben-
dazole
Kull spe`i li jip-
produ`i l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa]am
}alib
Provdimenti o]ra: Kull MRL ikopri kull fdal ta’ febantel, fenbendazole u oxfendazole
2.1.1.3.
Oxfendazole
Total ta’ fdalijiet 
ta’ oxfendazole, 
oxfendazole 
sulfone u fenben-
dazole
Kull spe`i li jip-
produ`i l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa]am
}alib
Provdimenti o]ra: Kull MRL ikopri kull fdal ta’ febantel, fenbendazole u oxfendazole
2.1.1.4.
Albendazole
Total ta’ alben-
dazole u metabo-
lites li ji[u 
mi\urati b]ala 2-
amino-benzimi-
dazole sulphone
Bovini, Ovini 100 µ g/kg
500 µ g/kg
1000 µ g/kg
Muskolu, xa]am, 
]alib
Milsa
Fwied
16 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
2.2.  A[enti li ja[ixxu kontra ectoparasiti
2.2.l. Formamidines
2.2.2. Organophosphates
2.2.3. Iminophenyl thiazolidine derivative
2.1.1.5.
Thiabendazole
Total ta’ thiaben-
dazole u 5-
hydroxythiaben-
dazole sulfone u 
fenbendazole
Bovini, ovini, 
kaprini
100 µ g/kg Muskolu, fwied, 
milsa, xa]am, 
]alib
2.1.1.6.
Triclabendazole
Total ta’ fdalijiet 
estraibbli li 
jistg]u ji[u oxi-
dized g]al ket-
atriclabendazole
Bovini, ovini 150 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
2.1.1.7.
Flubendazole
Flubendazole Pullam, tajr li jit-
tiekel
500 µ g/kg
200 µ g/kg
400 µ g/kg
Fwied
Muskolu
Bajd
Majjal 10 µ g/kg Muskolu, fwied, 
milsa, xa]am
2.1.1.8.
Oxibendazole
Oxibendazole Bovini, Ovini, 
majjal, equidae
100 µ g/kg Muskolu, fwied, 
milsa, xa]am
Bovini, ovini 50 µ g/kg }alib
2.1.1.9.
Netobimin
Total ta’ neto-
bimin u albenda-
zole u 
metabolites ta’ 
albendazole 
mi\urati b]ala 2-
aminobenzimida-
zole sulphone
Bovini, ovini, 
kaprini
1000 µ g/kg
500 µ g/kg
100 µ g/kg
100 µ g/kg
Fwied
Milsa
Muskolu, xa]am
}alib
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.2.1.1.
Amitraz
Total ta’ amitraz 
u metabolites 
mi\urati b]ala 
2.4-dimethyl-
aniline
Bovini 200 µ g/kg
10 µ g/kg
Milsa, fwied, 
xa]am
}alib
Ovini 400 µ g/kg
200 µ g/kg
Xa]am
Milsa, fwied
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.2.2.1.
Azamethiphos
Azamethiphos Salmonidae 100 µ g/kg Muskolu u [ilda 
fi proprozjoni-
jiet naturali
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.2.3.1.
Cymiazole
Cymiazole Na]al 1000 µ g/kg G]asel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 17
2.3. A[enti li ja[ixxu kontra endo- u ectoparasiti
2.3.1. Avermectins
3. A[enti li ja[ixxu fuq is-sistema nervu\
3.1. A[enti li ja[ixxu fuq is-sistema nervu\ `entrali
3.1.1. Butyrophenone tranquillizers
3.2. A[enti li ja[ixxu fuq is-sistema nervu\ awtomatiku
3.2.1. ß 2 sympathomimetic agents
4. Corticoids
4.1. Glucocorticoids
5. A[enti anti-infjammatorji
5.1. A[enti anti-inflammatorji nonsteroidali
5.1.1. Arylpropionic acid derivative
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
2.3.1.1.
Moxidectin
Moxidectin Bovini, ovini 200 µ g/kg
20 µ g/kg
Xa]am
Milsa, fwied
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
3.1.1.1.
Azaperone
Azaperol  Kull spe`i li jip-
produ`i l-ikel
100 µ g/kg
50 µ g/kg
Milsa
Fwied, muskolu, 
xa]am
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
3.2.1.1.
Clenbuterol 
hydrochloride
Clenbuterol  Bovini
(Indikazzjoni: 
biss g]al tocoly-
sis f’baqar li 
jkunu se jwelldu)
0,5 µ g/kg
0,1 µ g/kg
0,05 µ g/kg
Fwied, milsa
Muskolu
}alib
Equidae
(lndikazzjoni-
jiet: Tocolysis u 
l-kura ta’ mardiet 
respiratorji)
0,5 µ g/kg
0,1 µ g/kg
Fwied, milsa
Muskolu
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
4.1.1.
Dexamethasone
Dexamethasone Bovini, majjal, 
equidae
2,5 µ g/kg
0,5 µ g/kg
Fwied
Muskolu, milsa
Bovini 0,3 µ g/kg }alib
Sustanza/i 
farma`ewtika-
ment attivi
Marker residue Spe`i ta’annimali MRLs Target tissues
5.1.1.1.
Vedaprofen
Vedaprofen Equidae 100 µ g/kg
1000 µ g/kg
50 µ g/kg
Fwied
Milsa
Muskolu
18 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
IR-RABA SKEDA
(Regolament 6)
Lista ta’ sustanzi farmakolo[ikament attivi li dwarhom ma jistg]ux ji[u stabbiliti 
livelli massimi
1. Nitrofurans minbarra furazolidone
2. Ronidazole
3. Dapsone
4. Chloramphenicol
5. Furazolidone
6. Dimetridazole
7. Colchicine
8. Avoparcin
IL-}AMES SKEDA
(Regolament 8)
Tag]rif u partikolaritajiet li g]andhom jidda]]lu f’applikazzjoni sabiex ji[i stabbilit 
x’ikun il-limitu ta’ fdal massimu g]al sustanza farmakolo[ikament attiva li ti[i u\ata 
fi prodotti medi`inali veterinarji
Partikolaritajiet amministrattivi
1) Isem jew isem tal-korp [uridiku u indirizz permanenti ta’ min japplika.
2) Isem tal-prodott medicinali veterinarju.
3) G]amla kwalitattiva u kwantitattiva skond il-prin`ipali attivi, b’tismija ta’ l-
isem internazzjonali mhux kummer`jali rakkomandat mill-G]aqda Dinija g]as-
Sa]]a (WHO), meta jkun hemm isem b]al dak.
4) Awtorizzazzjoni dwar il-manifattura, jekk ikun hemm.
5) Awtorizzazzjonijiet dwar il-kummer`jar, jekk ikun hemm.
6) Su``int tal-karatteristi`i ta’ prodott(i) medi`inali veterinarju/i.
A) Dokumentazzjoni dwar is-sigurtà  g]as-sa]]a tal-prodott
A.0 Rapport peritali
A.l) Identifikazzjoni pre`i\a tas-sustanza msemmija fl-applikazzjoni
5.1.1.2.
Carprofen
Carprofen Bovini 1000 µ g/kg
500 µ g/kg
Fwied, milsa
Muskolu, xa]am
Equidae 1000 µ g/kg
50 µ g/kg
100 µ g/kg
Fwied, milsa
Muskolu
Xa]am
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI [ L.S.231.34 19
1.1) Isem internazzjonali mhux kummer`jali.
1.2) Isem ta’ l-lnternational Union of Pure and Applied Chemistry
(IUPAG).
1.3) Isem tal-Chemical Abstract Service (CAS).
1.4) Klassifika:
- terapewtiku
- farmakolo[iku.
1.5) Sinonimi u abbrevjazzjonijiet.
1.6) Formola strutturali.
1.7) Formola molekulari.
1.8) Pi\ molekulari.
1.9) Grad ta’ impurità .
1.10) G]amla kwalitattiva u kwantitattiva ta’ impuritajiet.
1.11) Deskrizzjoni ta’ proprjetajiet fi\i`i:
- grad ta’ fu\joni
- temperatura meta jag]li
- pressjoni tal-fwar
- solubilità  fl-ilma u solventi organi`i espressi b]ala g/l,
b’indikazzjoni tat-temperatura
- densità
- indi`i refrattiv, rotazzjoni, e``.
A.2) Studji farmakolo[i`i relevanti
2.1) Farmakodinamika.
2.2) Farmakokinetika.
A.3) Studji tossolo[i`i
3.1) Tossi`ità  ta’ do\a wa]da.
3.2) Tossi`ità  ta’ do\i ripetuti.
3.3) Tolleranza fl-ispe`i ta’ annimal target.
3.4) Tossi`ità  riproduttiva, inklu\a terato[eni`ita.
3.4.1) Studji ta’ l-effetti fuq ir-riproduzzjoni.
3.4.2) Embrijotossi`ità /fetotossi`ità , inklu\a terato[eni`ità .
3.5) Muta[eni`ità .
3.6) Kar`ino[eni`ità .
A.4) Studji ta’ effetti o]ra
4.1) Immunotossi`ità .
4.2) Proprjetajiet ta’ fdalijiet mikrobijolo[i`i.
4.2.1) fuq il-flora ta’ l-imsaren tal-bniedem;
4.2.2) fuq l-organi\mi u l-mikro-organi\mi li jintu\aw g]all-
ippro`essar ta’ l-ikel industrijali.
4.3) Osservazzjonijiet fil-bniedem.
20 L.S.231.34 ]
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI¬INALI VETERINARJI
B) Dokumentazzjoni dwar fdalijiet
B.0) Rapport peritali
B.l) Identifikazzjoni pre`i\a tas-sustanza msemmija fl-applikazzjoni
Is-sustanza msemmija g]andha ti[i identifikata skond il-partita A.l.
Madankollu, meta l-applikazzjoni jkollha x’taqsam ma’ prodott medi`inali
veterinarju wie]ed jew aktar, il-prodott innifsu g]andu ji[i identifikat fid-dettal,
inklu\i:
- l-g]amla kwalitattiva u kwantitattiva;
- il-purità ;
- l-identifikazzjoni tal-lot tal-manifattura li jintu\a fl-istudji;
- affinità  mal-prodott finali;
- attività  spe`ifika u radio-purità  ta’ sustanzi tikkettjati;
- po\izzjoni ta’ atomi ittikkettjati fuq il-molekula.
B.2) Studji dwar fdalijiet
2.1) Farmakokinetika
(assorbiment, distribuzzjoni, biotrasformazzjoni, purgar).
2.2) Fasda ta’ fdalijiet.
2.3) Elaborazzjoni tal-limiti ta’ fdalijiet massimi.
B.3) Metodu analitiku ta’ rutina g]all-kxif ta’ fdalijiet
3.1) Deskrizzjoni tal-metodu.
3.2 Validement tal-metodu.
3.2.1) spe`ifi`ità ;
3.2.2) akkuratezza, inklu\a sensitività ;
3.2.3) pre`izjoni;
3.2.4) limiti ta’ tkixxif;
3.2.5) limitu ta’ kwaliflkazzjoni;
3.2.6) prattikabilità  u applikabilità  ta]t kondizzjonijiet tal-
laboratorju normali;
3.2.7) suxxettibiltà  g]al interferenza.
