LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 1
LE_GISLAZZJONI SUSSIDJARJA 231.34
REGOLAMENTI DWAR LIMITI MASSIMI TA’ 
FDALIJIET FI PRODOTTI MEDI_CINALI 
VETERINARJI
1 ta’ Ottubru, 1998
L-Avvi_z Legali 162 ta’ l-1998.
Titolu.
Limiti Massimi ta’ Fdalijiet fi Prodotti Medi_cinali Veterinarji.
Tifsir.
ma te_htie_gx xort’o_hra -
"Direttur" tfisser id-Direttur tas-Servizz Veterinarju;
"fdalijiet ta’ prodotti medi_cinali veterinarji" tfisser is-sustanzi
kollha farmakolo_gikament attivi, sew prin_cipali attivi, prodotti
e_c_cipjenti jew ta’ degradazzjoni, u l-metaboliti tag_hhom li jifdal
f’o_g_getti ta’ l-ikel mag_hmula minn annimali li lilhom ikun ing_hata
l-prodott medi_cinali veterinarju involut;
"limitu ta’ fdal massimu" jew "MRL" tfisser l-kon_centrazzjoni
ta’ fdal massimu li tirri_zulta mill-u_zu ta’ prodott medi_cinali
veterinarju (espressa f’mg/Kg jew u/Kg fuq ba_zi ta’ pi_z frisk) li
tista’ legalment ti_gi permessa jew rikonoxxuta b_hala li tkun
a_c_cettabbli fl-ikel. Dan il-limitu jew ji_gi ba_zat fuq it-tip u l-ammont
ta’ fdal meqjus b_hala li mhux ta’ periklu tossolo_giku g_has-sa_h_ha
tal-bniedem kif espress bil-konsum ta’ kuljum a_c_cettabbli (ADI),
jew fuq il-ba_zi ta’ ADI temporanja li tutilizza fattur ta’ sigurt_a
g_hall-bniedem addizzjonali. Sabiex ji_gi kalkolat dan il-limitu
g_handhom jitqiesu wkoll riskji o_hra relevanti ta’ sa_h_ha pubblika kif
ukoll aspetti ta’ teknolo_gija ta’ l-ikel. Meta jkun qed ji_gi stabbilit
limitu ta’ fdal massimu g_handhom jitqiesu wkoll fdalijiet li jinsabu
f’ikel li jori_gina mill-pjanti jew li jinkisbu mill-ambjent. Iktar minn
hekk, MRL jista’ jitnaqqas b’mod li jkun konsistenti ma’ kull
prattika tajba fl-u_zu ta’ medi_cinali veterinarji u sal-limitu ta’
disponibbilt_a  ta’ metodi analiti_ci pratti_ci.
(2) Dawn ir-regolamenti m’g_handhomx japplikaw g_hal
prin_cipali attivi ta’ ori_gini biolo_gika li jkunu ma_hsuba biex
jipprodu_cu immunit_a  attiva jew passiva jew biex issir dijanjosi ta’
stat ta’ immunit_a  u_zat fi prodotti medi_cinali veterinarji immolo_gi_ci.
Sustanzi su_g_getti 
g_hal MRL.
3. Il-lista ta’ sustanzi farmakolo_gikament attivi u_zati fi
prodotti medi_cinali veterinarji li dwarhom ikunu _gew stabbiliti
limiti ta’ fdalijiet massimi huma dawk li hemm fl-Ewwel Skeda.
 Sustanzi li mhux 
su_g_getti g_hal MRL.
4. Meta, wara li ssir evalwazzjoni ta’ xi sustanza
farmakolo_gikament attiva li tkun u_zata fi prodotti medi_cinali
veterinarji, jkun jidher li din ma tkunx me_htie_ga g_hall-_harsien tas-
sa_h_ha pubblika sabiex ji_gi stabbilit limitu ta’ fdal massimu, dik is-
sustanza g_handha ti_gi inklu_za f’lista li hemm fit-Tieni Skeda.
 Sustanzi su_g_getti 
g_hal MRL 
provi_zorju.
5. Il-lista ta’ sustanzi farmakolo_gikament attivi li jintu_zaw fi
prodotti medi_cinali veterinarji li dwarhom ikunu _gew stabbiliti l-
2 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
limiti ta’ fdal massimu provi_zorji huma dawk li hemm fit-Tielet
Skeda.
Sustanzi fejn ma 
jistax ji_gi stabbilit 
MRL.
6. (1) Meta jkun jidher li ma jistax ji_gi stabbilit limitu ta’ fdal
massimu dwar xi sustanza farmakolo_gikament attiva li tintu_za fi
prodotti medi_cinali veterinarji min_habba fil-fatt li l-fdalijiet tas-
sustanzi involuti, f’liema livell ikun, f’o_g_getti ta’ l-ikel li jori_ginaw
mill-annimali jkunu jikkostitwixxu periklu g_has-sa_h_ha tal-
konsumatur, dik is-sustanza g_handha tkun inklu_za f’lista li hemm
fir-Raba’ Skeda.
(2) G_handu jkun projbit l-g_hoti tas-sustanzi fil-lista li hemm
fir-Raba’ Skeda lil annimali li jipprodu_cu l-ikel.
Kif ji_gi stabbilit 
MRL.
7. (1) Sabiex ji_gu stabbiliti l-limiti ta’ fdal massimu ta’
prodotti medi_cinali veterinarji u_zati f’o_g_getti ta’ l-ikel ta’ ori_gini
mill-annimali ikun me_htie_g li ji_gi spe_cifikat l-ispe_ci ta’ l-annimal
fejn dawk il-fdalijiet jistg_hu jkunu pre_zenti, il-livelli li jistg_hu
jkunu pre_zenti f’kull wie_hed mit-tessuti tal-la_ham relevanti
miksubin mill-annimal ikkurat (target tissue) u x-xorta tal-fdal li
jkun relevanti g_has-sorveljar ta’ fdalijiet (marker residue).
(2) Sabiex isir kontroll dwar il-fdalijiet, il-limiti ta’ fdal
massimu g_handhom ji_gu stabbiliti g_hat-target tissue tal-fwied jew
tal-kilwa; i_zda, billi l-fwied u l-kilwa ta’ spiss jitne_h_hew mill-
karkassi li jinbieg_hu f’kummer_c internazzjonali, il-limiti ta’ fdal
massimi g_handhom g_haldaqstant dejjem ji_gu stabbiliti g_hal tessuti
muskolari jew xa_hmin.
(3) Fil-ka_z ta’ prodotti medi_cinali veterinarji ma_hsuba g_hall-
u_zu fuq tajr li jbid, annimali tal-_halib jew na_hal tal-g_hasel, il-limiti
ta’ fdal massimi g_handhom ukoll ji_gu stabbiliti g_hall-bajd, _halib,
jew g_hasel.
Tqeg_hid ta’ 
prodotti fuq il-listi.
8. (1) Sustanza farmakolo_gikament attiva _gdida, ma_hsuba
biex tintu_za fi prodotti medi_cinali veterinarji li jing_hataw lil
annimali li jipprodu_cu l-_halib, jistg_hu biss ji_gu inklu_zi fl-Ewwel,
fit-Tieni u fit-Tielet Skedi jekk min ikun responsabbli g_hat-tqeg_hid
tag_hhom fis-suq jag_hmel applikazzjoni dwar dan lid-Direttur. Dik
l-applikazzjoni g_handu jkun fiha t-tag_hrif u l-partikolaritajiet
imsemmija fil-_Hames Skeda.
(2) Id-Direttur jista’, wara li jifli t-tag_hrif _gdid jew wara li
jer_ga’ jifli t-tag_hrif li jkollu, jemenda kull disposizzjoni li hemm fl-
Ewwel, fit-Tieni, fit-Tielet u fir-Raba’ Skedi jekk dan ikun me_htie_g
li jsir g_hall-_harsien tas-sa_h_ha tal-bniedem jew ta’ l-annimali.
(3) Id-Direttur ma jistax jipprojbixxi jew i_zomm il-kummer_c
ta’ o_g_getti ta’ l-ikel li jori_ginaw mill-annimali u li jkunu _gejjin
minn pajji_zi o_hra min_habba f’li jkun fihom fdalijiet ta’ prodotti
medi_cinali veterinarji jekk il-kwantit_a  ta’ fdal ma tkunx te_c_cedi l-
limitu ta’ fdal massimu li hemm fl-Ewwel Skeda jew fit-Tielet
Skeda, jew inkella jekk dik is-sustanza tkun qeg_hda fil-lista li
hemm fit-Tieni Skeda.
Annimali li 
jipprodu_cu l-ikel.
9. L-g_hoti lil annimali li jipprodu_cu l-ikel ta’ prodtti
medi_cinali veterinarji li jkun fihom sustanzi attivi farmakolo_gi_ci li
ma jkunux imsemmija fl-Ewwel, fit-Tieni jew fit-Tielet Skedi
g_handhu jkun projbit, _hlief fil-ka_z ta’ provi klini_ci li jkunu a_c_cettati
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 3
mill-awtoritajiet kompetenti u sakemm l-o_g_getti ta’ l-ikel li
jinkisbu minn bhejjem li jintu_zaw f’dawk il-provi ma jkunx fihom
fdalijiet li jkunu ta’ periklu g_has-sa_h_ha tal-bniedem.
Riserva.
L.S.231.32
10. Ebda _ha_ga f’dawn ir-regolamenti m’g_handha tmur kontra
d-disposizzjonijiet tar-Regolamenti dwar Fdalijiet fil-La_ham, li
jipprojbixxu l-u_zu, fit-trobbija tal-bhejjem, ta’ _certi sustanzi li
g_handhom azzjoni ormonika.
4 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
L-EWWEL SKEDA
(Regolament 3)
Lista ta’ sustanzi farmakolo_gikament attivi li dwarhom ikunu _gew stabbilit limiti ta’ fdalijiet 
massimi
l. A_genti anti-infettivi
1.1. Kemoterapewti_ci
1.1.1.  Sulfonamides
1.2. Antibiotics
1.2.1. Penicillins
1.2.2 Cephalosporins
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
Is-sustanzi kollha 
li jappartjenu 
g_has-sulfona-
mide group
Parent drug Kull spe_ci li jip-
produ_ci l-ikel
100 µ g/kg Muskolu, fwied, 
milsa, xa_ham
Bovini, Ovini, 
Kaprini
100 µ g/kg _Halib
Provdimenti o_hra: Il-fdalijiet totali kombinati ta’ kull sustanza fis-sulfonamide group 
m’g_handhomx je_c_cedu 100 µ g/kg
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.1.1.
Benzylpenicillin
Benzylpenicillin Kull spe_ci li jip-
produ_ci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa_ham
4 µ g/kg _Halib
1.2.1.2.
Ampicillin
Ampicillin Kull spe_ci li jip-
produ_ci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa_ham
4 µ g/kg _Halib
1.2.1.3.
Amoxicillin
Amoxicillin Kull spe_ci li jip-
produ_ci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xa_ham
4 µ g/kg _Halib
1.2.1.4.
Oxacillin
Oxacillin Kull spe_ci li jip-
produ_ci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa_ham
30 µ g/kg _Halib
1.2.1.5.
Cloxacillin
Cloxacillin Kull spe_ci li jip-
produ_ci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa_ham
30 µ g/kg _Halib
1.2.1.6.
Dicloxacillin
Dicloxacillin Kull spe_ci li jip-
produ_ci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xa_ham
30 µ g/kg _Halib
1.2.1.7.
Penethamate
Benzylpenicillin Bovini 50 µ g/kg Muskolu, fwied, 
milsa, xa_ham
4 µ g/kg _Halib
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g 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_ham
_Halib
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci 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
_Gilda u xa_ham
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
_Gilda u xa_ham
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci 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_ham
Ovini 50 µ g/kg _Halib
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_ham
Muskolu
_Halib
Flieles 400 µ g/kg
300 µ g/kg
200 µ g/kg
Fwied
_Gilda u xa_ham
Muskolu
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.5.1.
Florfenicol
Total ta’ Florfen-
icol u metabo-
lites relattivi 
mi_zurati b_hala 
Florfenicolamine
Bovini 200 µ g/kg
300 µ g/kg
3000 µ g/kg
Muskolu
Milsa
Fwied
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
6 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
2. A_genti anti-parasiti_ci
2.1. A_genti li ja_gixxu kontra endoparasiti
2.1.1. Avermectins
2.1.2. Salicylanilides
2.l.3. Tetra-hydro-imidazoles (imidazolthiazoles)
2.2. Agenti li ja_gixxu kontra ectoparasiti
1.2.6.1.
Tetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe_ci li jip-
produ_ci 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
_Halib
Bajd
1.2.6.2.
Oxytetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe_ci li jip-
produ_ci 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
_Halib
Bajd
1.2.6.3.
Chlortetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull spe_ci li jip-
produ_ci 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
_Halib
Bajd
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci 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_ham
Majjal, ovini, 
equidae
15 µ g/kg
20 µ g/kg
Fwied
Xa_ham
2.1.1.2.
Abamectin
Avermectin B 1a Bovini 20 µ g/kg
10 µ g/kg
Fwied
Xa_ham
2.1.1.3.
Doramectin
Doramectin Bovini 15 µ g/kg
25 µ g/kg
Fwied
Xa_ham
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.1.2.1.
Closantel
Closantel Bovini 1000 µ g/kg
3000 µ g/kg
Muskolu, fwied
Milsa, xa_ham
Ovini 1500 µ g/kg
5000 µ g/kg
2000 µ g/kg
Muskolu, fwied
Milsa
Xa_ham
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci 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_ham
Fwied
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 7
2.2.1. Organophosphates
2.2.2. Formamidines
3. A_genti li ja_gixxu fuq is-sistema nervu_z
3.1. A_genti li ja_gixxu fuq is-sistema nervu_z awtomatiku
3.1.1. Anti-adrenergics
IT-TIENI SKEDA
(Regolament 4)
Lista ta’ sustanzi mhux su_g_getti g_hal-limiti ta’ fdalijiet massimi
1. Kimi_ci inorgani_ci
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.2.1.1.
Diazinon
Diazinon Bovini, ovini 700 µ g/kg
20 µ g/kg
Xa_ham
Milsa, fwied
muskolu
Bovini, ovini, 
kaprini
20 µ g/kg _Halib
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.2.2.1.
Amitraz
Total ta’ amitraz 
u metabolites 
kollha bi 2,4-
DMA moeity, 
espressa b_hala 
amitraz
Majjal 400 µ g/kg
200 µ g/kg
Xa_ham u _gilda
Milsa, fwied
Sustanza/i farma-
kolo_gikament 
attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
3.1.1.1.
Carazolol
Carazolol Majjal 25 µ g/kg
5 µ g/kg
Fwied,milsa 
Muskolu, xa_ham 
u _gilda
Sustanza/i farmakolo_gikament attivi Spe_ci ta’ annimali
1.1. Hydrogen peroxide Kull spe_ci li jipprodu_ci l-ikel
1.2. Sulpur Bovini, majjal, ovini, kaprini, equidae
1.3. Iodine u iodine inorganic compounds 
inklu_zi: Kull spe_ci li jipprodu_ci l-ikel
- Sodium u potassium-iodide
- Sodium u potassium-iodate
- Iodophors inklu_zi Polyvinyl-pyrro-
lidone-iodine
1.4. Sodium chlorite Bovini (g_hal u_zu topikali biss)
1.5. Calcium acetate Kull spe_ci li jipprodu_ci l-ikel
Calcium benzoate
8 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI 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_ci li jipprodu_ci l-ikel (g_hal u_zu 
b_hala e_c_cipjent)
1.7. Sodioum dichloroisocyanurate Bovini, ovini, kaprini (g_hal u_zu topikali 
biss)
1.8. Boric acid u borates Kull spe_ci li jipprodu_ci l-ikel
1.9. Magnesium Kull spe_ci li jipprodu_ci l-ikel
1.10. Magnesium sulphate Kull spe_ci li jipprodu_ci l-ikel
1.11. Magnesium hydroxide Kull spe_ci li jipprodu_ci l-ikel
1.12. Magnesium stearate Kull spe_ci li jipprodu_ci l-ikel
1.13. Magnesium glutamate Kull spe_ci li jipprodu_ci l-ikel
1.14. Magnesium orotate Kull spe_ci li jipprodu_ci l-ikel
1.15. Magnesium aluminium silicate Kull spe_ci li jipprodu_ci l-ikel
1.16. Magnesium oxide Kull spe_ci li jipprodu_ci l-ikel
1.17. Magnesium carbonate Kull spe_ci li jipprodu_ci l-ikel
1.18. Magnesium phosphate Kull spe_ci li jipprodu_ci 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_ci
Sustanza/i farmakolo_gikament attivi Spe_ci 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_ci li jipprodu_ci l-ikel
2.6. Melatonin Ovini, kaprini
2.7. Iodine organic compounds Kull spe_ci li jipprodu_ci l-ikel
- Iodoform
2.8. Acetyl cysteine Kull spe_ci li jipprodu_ci l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 9
2.9. Gonadotrophin releasing hormone Kull spe_ci li jipprodu_ci l-ikel
2.10. Pregnant Mare Serum
Gonadotrophin Kull spe_ci li jipprodu_ci l-ikel
2.11. 17ß -Oestradiol Kull mammal li jipprodu_ci l-ikel (g_hal u_zu 
terapewtiku u zootekniku biss)
2.12. Romifidine Equidae (g_hal u_zu terapewtiku biss)
2.13. Detomidine Bovini, Equidae (g_hal u_zu
terapewtiku biss)
2.14. Brotizolam Bovini, (g_hal u_zu terapewtiku biss)
2.1.5. Human chorion gonadotrophin (HCG) Kull spe_ci li jipprodu_ci l-ikel
2.16. Oxytocin Kull mammal li jipprodu_ci l-ikel
 2.17. Lecirelin Bovini, equidae, fenek
2.18. Dinoprost tromethamine Kull spe_ci mammarju
2.19. Malic acid Kull spe_ci li jipprodu_ci l-ikel (biex jintu_za 
b_hala e_c_cipjent)
2.20. L-tartaric acid u mono- u di-basic salt 
relattiv ta’ sodium potassium u calcium
Kull spe_ci li jipprodu_ci l-ikel (biex jintu_za 
b_hala e_c_cipjent)
2.21. Benzylalcohol Kull spe_ci li jipprodu_ci l-ikel (biex jintu_za 
b_hala e_c_cipjent)
2.22. Ethanol Kull spe_ci li jipprodu_ci l-ikel (biex jintu_za 
b_hala e_c_cipjent)
2.23. N-butanol Kull spe_ci li jipprodu_ci l-ikel (biex jintu_za 
b_hala e_c_cipjent)
2.24. Mineral hydrocarbons, b’viskosit_a  minn 
baxxa sa g_holja inklu_zi micro cristalline 
waxes, approx. C10-C60; aliphatic, 
branched aliphatic u alicyclic com-
pounds
Kull spe_ci li jipprodu_ci l-ikel (esklu_zi kom-
posti aromati_ci u mhux saturati)
2.25. Buserelin Kull spe_ci li jipprodu_ci l-ikel
2.26. Ketoprofen Bovini, equidae
2.27. Caffeine Kull spe_ci li jipprodu_ci l-ikel
2.28. Theophylline Kull spe_ci li jipprodu_ci l-ikel
2.29. Theobromine Kull spe_ci li jipprodu_ci l-ikel
2.30. Ketoprofen Majjal
2.31. Propane Kull spe_ci li jipprodu_ci l-ikel
2.32. n-butane Kull spe_ci li jipprodu_ci l-ikel
2.33. Isobutane Kull spe_ci li jipprodu_ci l-ikel
2.34. Polysulphated
glycosaminoglycan Equidae
2.35. Rifaximin Bovini (g_hal u_zu intramammarju - _hlief 
jekk is-sider jista’ jintu_za b_hala ikel g_hal 
konsum tal-bniedem - u u_zu intrauterin 
biss)
2.36. Tau fluvalinate Na_hal ta’ l-g_hasel
2.37. Phenol Kull spe_ci li jipprodu_ci l-ikel
2.38. Papaverine Bovini (g_ho_g_giela tat-twelid biss)
2.39. Policresulene Kull spe_ci li jipprodu_ci l-ikel (g_hal u_zu 
topikali biss)
10 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
2.40. Papain Kull spe_ci li jipprodu_ci l-ikel
2.41. Dimethyl phtalate Kull spe_ci li jipprodu_ci l-ikel
2.42. Diethyl phatalate Kull spe_ci li jipprodu_ci l-ikel
2.43. Ethyl lactate Kull spe_ci li jipprodu_ci l-ikel
2.44. Heptaminol Kull spe_ci li jipprodu_ci l-ikel
2.45. Menthol Kull spe_ci li jipprodu_ci l-ikel
2.46. Phloroglucinol Kull spe_ci li jipprodu_ci l-ikel
2.47. Trimethylphloroglucinol Kull spe_ci li jipprodu_ci l-ikel
2.48. Peracetic acid Kull spe_ci li jipprodu_ci l-ikel
2.49. Carbetocin Kull spe_ci mammarju li jipprodu_ci l-ikel
2.50. Quillaia saponins Kull spe_ci li jipprodu_ci l-ikel
2.51. Butyl 4-hydroxybenzoate Kull spe_ci li jipprodu_ci l-ikel
2.52. Sodium butyl 4-hydroxybenzoate Kull spe_ci li jipprodu_ci l-ikel
2.53. Sodium benzyl 4-hydroxybenzoate Kull spe_ci li jipprodu_ci l-ikel
2.54. Cetrimide Kull spe_ci li jipprodu_ci l-ikel
2.55. Lobeline Kull spe_ci li jipprodu_ci l-ikel
2.56. Pancreatin Kull spe_ci mammarju li jipprodu_ci l-ikel 
(g_hal u_zu topikali biss)
2.57. Chlorocresol Kull spe_ci li jipprodu_ci l-ikel
2.58. Thymol Kull spe_ci li jipprodu_ci l-ikel
2.59. Dembrexine Equidae
2.60. Diclazuril Ovini (g_hal u_zu fil-_hrief biss)
2.61. Etamiphylline camsylate Kull spe_ci li jipprodu_ci l-ikel
3. Sustanzi _generalment mag_hrufin b_hala siguri g_has-sa_h_ha
Sustanza/i farmakolo_gikament attivi Spe_ci ta’ annimali
 3.1. Absinthium extract Kull spe_ci li jipprodu_ci l-ikel
3.2. Acetylmethionine Kull spe_ci li jipprodu_ci l-ikel
3.3. Aluminium hydroxide Kull spe_ci li jipprodu_ci l-ikel
3.4.  luminium monostearate Kull spe_ci li jipprodu_ci l-ikel
3.5. Ammonium sulfate Kull spe_ci li jipprodu_ci l-ikel
 3.6. Benzoyl benzoate Kull spe_ci li jipprodu_ci l-ikel
3.7. Benzyl p-hydroxybenzoate Kull spe_ci li jipprodu_ci l-ikel
3.8. Calcium borogluconate Kull spe_ci li jipprodu_ci l-ikel
3.9. Calcium citrate Kull spe_ci li jipprodu_ci l-ikel
3.10. Camphor Kull spe_ci li jipprodu_ci l-ikel (u_zu estern 
biss)
 3.11. Cardamon extract Kull spe_ci li jipprodu_ci l-ikel
3.12. Diethyl sebacate Kull spe_ci li jipprodu_ci l-ikel
 3.13. Dimethicone Kull spe_ci li jipprodu_ci l-ikel
3.14. Dimethyl acetamide Kull spe_ci li jipprodu_ci l-ikel
3.15. Dimethyl sulphoxide Kull spe_ci li jipprodu_ci l-ikel
 3.16. Ethylenediaminetetraacetic acid and 
salts Kull spe_ci li jipprodu_ci l-ikel
 3.17. Eucalyptol Kull spe_ci li jipprodu_ci l-ikel
3.18. Epinephrine Kull spe_ci li jipprodu_ci l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 11
3.19. Ethyl oleate Kull spe_ci li jipprodu_ci l-ikel
3.20. Formaldehyde Kull spe_ci li jipprodu_ci l-ikel
3.21. Formic acid Kull spe_ci li jipprodu_ci l-ikel
 3.22. Follicle stimulating hormone (natural 
FS_H from all species and their synthetic 
analogues) Kull spe_ci li jipprodu_ci l-ikel
3.23. Glutaraldehyde Kull spe_ci li jipprodu_ci l-ikel
3.24. Guaiacol Kull spe_ci li jipprodu_ci l-ikel
3.25. Heparin u l-imlu_ha tieg_hu Kull spe_ci li jipprodu_ci l-ikel
 3.26. Human chorionic gonadotropin (natural 
_HCG and its synthetic analogues) Kull spe_ci li jipprodu_ci l-ikel
3.27. Iron ammonium citrate Kull spe_ci li jipprodu_ci l-ikel
 3.28. Iron dextran Kull spe_ci li jipprodu_ci l-ikel
3.29. Iron glucoheptonate Kull spe_ci li jipprodu_ci l-ikel
3.30. Isopropanol Kull spe_ci li jipprodu_ci l-ikel
3.31. Lanolin Kull spe_ci li jipprodu_ci l-ikel
 3.32. Luteinizing hormone (natural LH from 
all species and their synthetic ana-
logues) Kull spe_ci li jipprodu_ci l-ikel
3.33. Magnesium chloride Kull spe_ci li jipprodu_ci l-ikel
3.34. Magnesium gluconate Kull spe_ci li jipprodu_ci l-ikel
3.35. Magnesium hypophosphite Kull spe_ci li jipprodu_ci l-ikel
3.36. Mannitol Kull spe_ci li jipprodu_ci l-ikel
3.37. Montanide Kull spe_ci li jipprodu_ci l-ikel
3.38. Methylbenzonate Kull spe_ci li jipprodu_ci l-ikel
 3.39. Monothioglycerol Kull spe_ci li jipprodu_ci l-ikel
 3.40. Myglyol Kull spe_ci li jipprodu_ci l-ikel
3.41. Orgotein Kull spe_ci li jipprodu_ci l-ikel
3.42. Poloxalene Kull spe_ci li jipprodu_ci l-ikel
3.43. Poloxamer Kull spe_ci li jipprodu_ci l-ikel
3.44. Polyethylene glycol 200 Kull spe_ci li jipprodu_ci l-ikel
 3.45. Polyethylene glycol 400 Kull spe_ci li jipprodu_ci l-ikel
3.46. Polyethylene glycol 600 Kull spe_ci li jipprodu_ci l-ikel
3.47. Polyethylene glycol 3500 Kull spe_ci li jipprodu_ci l-ikel
3.48. Polysorbate 80 Kull spe_ci li jipprodu_ci l-ikel
3.49. Serotonin Kull spe_ci li jipprodu_ci l-ikel
 3.50. Sodium chloride Kull spe_ci li jipprodu_ci l-ikel
3.51. Sodium cromoglycate Kull spe_ci li jipprodu_ci l-ikel
3.52. Sodium dioctylsulphosuccinate Kull spe_ci li jipprodu_ci l-ikel
3.53. Sodium formaldehydesulphoxylate Kull spe_ci li jipprodu_ci l-ikel
3.54. Sodium lauryl sulphate Kull spe_ci li jipprodu_ci l-ikel
 3.55. Sodium pyrosulphite Kull spe_ci li jipprodu_ci l-ikel
3.56. Sodium stearate Kull spe_ci li jipprodu_ci l-ikel
3.57. Sodium thiosulphate Kull spe_ci li jipprodu_ci l-ikel
 3.58. Tragacanth Kull spe_ci li jipprodu_ci l-ikel
3.59. Urea Kull spe_ci li jipprodu_ci l-ikel
12 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
IT-TIELET SKEDA
(Regolament 5)
  Lista ta’ sustanzi farmakolo_gikament attivi u_zati fi prodotti medi_ci veterinarji li dwarhom 
ikunu _gew stabbiliti l-limiti ta’ fdal massimu provi_zorji
l.  A_genti anti-infettivi
1.1. Kemoterapewti_ci
1.1.1. Diamino pyrimidine derivates
1.1.2. Benzenesulphonamides
3.60. Zine sulphate Kull spe_ci li jipprodu_ci l-ikel
3.61. Zinc oxide Kull spe_ci li jipprodu_ci l-ikel
3.62. Polyethylene glycols (pi_z molekolari 
bejn 200 u 10000) Kull spe_ci li jipprodu_ci l-ikel
4. Sustanzi u_zati fi prodotti medi_cinali veterinarji _homeopati_ci
Sustanza/i farmakolo_gikament attivi Spe_ci ta’ annimali
4.1. Kull sustanza li tintu_za fi prodotti 
medi_cinali veterinarji homeopati_ci 
sakemm il-kon_centrazzjoni tag_hhom fil-
prodott ma tkunx te_c_cedi parti wa_hda 
g_hal kull g_haxart elef
Kull spe_ci li jipprodu_ci l-ikel
5. Sustanzi u_zati b_hal addittivi ta’ l-ikel f o_g_getti ta’ l-ikel g_hall-konsum tal- bniedem
Sustanza/i farmakolo_gikament attivi  Spe_ci ta’ annimali
5.l. Sustanzi b’E number Kull spe_ci li jipprodu_ci l-ikel (sustanzi biss 
li jkunu approvati b_hala addittivi f’o_g_getti 
ta’ l-ikel g_hall-konsum tal-bniedem).
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.1.1.1.
Trimethoprim
Trimethoprim Kull spe_ci li jip-
produ_ci l-ikel
50 µ g/kg Muskolu,fwied
Milsa, xa_ham, 
_halib
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci 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_ham
_Halib
Majjal 50 µ g/kg
40 µ g/kg
Fwied, milsa
Xa_ham u _gilda
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g 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_cewtika-
ment attivi
Marker residue Spe_ci 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_ham
1.2.2.2.
Tylosin
Tylosin Bovini, majjal, 
pullam
100 µ g/kg Muskolu, fwied 
milsa
Bovini 50 µ g/kg _Halib
1.2.2.3.
Erythromycin
Erythromycin Bovini, ovini, 
majjal, pullam
400 µ g/kg Fwied, milsa, 
muskolu, xa_ham
Bovini, ovini 40 µ g/kg _Halib
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_ham
Bajd
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.3.1.
Thiamphenicol
Thiamphenicol Bovini, pullam 40 µ g/kg Muskolu, fwied, 
milsa, xa_ham
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.4.1.
Ceftiofur
Total tal-fdali-
jiet kollha li 
g_handhom l-
istruttura ta’ 
betalactam 
espressa b_hala 
desfuroylceftio-
fur
Bovini 2000 µ g/kg
200 µ g/kg
600 µ g/kg
100 µ g/kg
Milsa, fwied
Muskolu
Xa_ham
_Halib
Majjal 4000 µ g/kg
3000 µ g/kg
500 µ g/kg
600 µ g/kg
Milsa
Fwied
Muskolu
Xa_ham
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci 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_ham
Bovini 200 µ g/kg _Halib
14 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI 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_ham
Bovini, ovini, 200 µ g/kg _Halib
1.2.5.3.
Dihydrostnepto-
mycin
Dihydrostnepto-
mycin
Bovini, ovini, 
majjal
pullam
1000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xa_ham
Bovini, ovini, 200 µ g/kg _Halib
1.2.5.4.
Gentamicin
Gentamicin Bovini, majjal 1000 µ g/kg
200 µ g/kg
500 µ g/kg
Milsa
Fwied
Muskolu, xa_ham
Bovini 100 µ g/kg _Halib
1.2.5.5.
Neomycin
(inklu_zi framyce-
tin)
Neomycin Bovini, ovini, 
kaprini, majjal, 
flieles, dundjani, 
papri
5000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xa_ham
Bovini, ovini, 
kaprini
500 µ g/kg _Halib
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_cewtika-
ment attivi
Marker residue Spe_ci 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_ham
Flieles 1200 µ g/kg
600 µ g/kg
300 µ g/kg
Fwied, milsa
_Gilda u xa_ham
Muskolu
1.2.6.2.
Decoquinate
Decoquinate Bovini, ovini 500 µ g/kg Muskolu, fwied, 
milsa, xa_ham
1.2.6.4.
Marbofloxacin
Marbofloxacin Bovini 150 µ g/kg
75 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
_Halib
Xa_ham
Majjal 150 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
Xa_ham u _gilda
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.6.1.
Rifaximin
Rifaximin Bovini 600 µ g/kg _Halib
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 15
1.2.8. Polymyxins
1.2.9. Penicillins
2. A_genti antiparasiti_ci
2.1. A_genti li ja_gixxu kontra endo-parasiti
2.1.1. Benzimidazoles u pro-benzimidazoles
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci 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_ham
Bovini, ovini 50 µ g/kg _Halib
Flieles 300 µ g/kg Bajd
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
1.2.9.1.
Penethamate
Benzylpenicillin Ovini 50 µ g/kg
4 µ g/kg
Fwied, milsa, 
muskolu, xa_ham
_Halib
Majjal 50 µ g/kg Fwied, milsa, 
muskolu, xa_ham
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.1.1.1.
Febantel
Total ta’ fdalijiet 
ta’ oxfendazole, 
oxfendazole 
sulfone u fenben-
dazole
Kull spe_ci li jip-
produ_ci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa_ham
_Halib
Provdimenti o_hra: 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_ci li jip-
produ_ci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa_ham
_Halib
Provdimenti o_hra: 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_ci li jip-
produ_ci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xa_ham
_Halib
Provdimenti o_hra: Kull MRL ikopri kull fdal ta’ febantel, fenbendazole u oxfendazole
2.1.1.4.
Albendazole
Total ta’ alben-
dazole u metabo-
lites li ji_gu 
mi_zurati b_hala 2-
amino-benzimi-
dazole sulphone
Bovini, Ovini 100 µ g/kg
500 µ g/kg
1000 µ g/kg
Muskolu, xa_ham, 
_halib
Milsa
Fwied
16 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
2.2.  A_genti li ja_gixxu 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_ham, 
_halib
2.1.1.6.
Triclabendazole
Total ta’ fdalijiet 
estraibbli li 
jistg_hu ji_gu oxi-
dized g_hal 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_ham
2.1.1.8.
Oxibendazole
Oxibendazole Bovini, Ovini, 
majjal, equidae
100 µ g/kg Muskolu, fwied, 
milsa, xa_ham
Bovini, ovini 50 µ g/kg _Halib
2.1.1.9.
Netobimin
Total ta’ neto-
bimin u albenda-
zole u 
metabolites ta’ 
albendazole 
mi_zurati b_hala 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_ham
_Halib
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.2.1.1.
Amitraz
Total ta’ amitraz 
u metabolites 
mi_zurati b_hala 
2.4-dimethyl-
aniline
Bovini 200 µ g/kg
10 µ g/kg
Milsa, fwied, 
xa_ham
_Halib
Ovini 400 µ g/kg
200 µ g/kg
Xa_ham
Milsa, fwied
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.2.2.1.
Azamethiphos
Azamethiphos Salmonidae 100 µ g/kg Muskolu u _gilda 
fi proprozjoni-
jiet naturali
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.2.3.1.
Cymiazole
Cymiazole Na_hal 1000 µ g/kg G_hasel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 17
2.3. A_genti li ja_gixxu kontra endo- u ectoparasiti
2.3.1. Avermectins
3. A_genti li ja_gixxu fuq is-sistema nervu_z
3.1. A_genti li ja_gixxu fuq is-sistema nervu_z _centrali
3.1.1. Butyrophenone tranquillizers
3.2. A_genti li ja_gixxu fuq is-sistema nervu_z awtomatiku
3.2.1. ß 2 sympathomimetic agents
4. Corticoids
4.1. Glucocorticoids
5. A_genti anti-infjammatorji
5.1. A_genti anti-inflammatorji nonsteroidali
5.1.1. Arylpropionic acid derivative
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
2.3.1.1.
Moxidectin
Moxidectin Bovini, ovini 200 µ g/kg
20 µ g/kg
Xa_ham
Milsa, fwied
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
3.1.1.1.
Azaperone
Azaperol  Kull spe_ci li jip-
produ_ci l-ikel
100 µ g/kg
50 µ g/kg
Milsa
Fwied, muskolu, 
xa_ham
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci ta’annimali MRLs Target tissues
3.2.1.1.
Clenbuterol 
hydrochloride
Clenbuterol  Bovini
(Indikazzjoni: 
biss g_hal 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
_Halib
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_cewtika-
ment attivi
Marker residue Spe_ci 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 _Halib
Sustanza/i 
farma_cewtika-
ment attivi
Marker residue Spe_ci 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 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
IR-RABA SKEDA
(Regolament 6)
Lista ta’ sustanzi farmakolo_gikament attivi li dwarhom ma jistg_hux ji_gu stabbiliti 
livelli massimi
1. Nitrofurans minbarra furazolidone
2. Ronidazole
3. Dapsone
4. Chloramphenicol
5. Furazolidone
6. Dimetridazole
7. Colchicine
8. Avoparcin
IL-_HAMES SKEDA
(Regolament 8)
Tag_hrif u partikolaritajiet li g_handhom jidda_h_hlu f’applikazzjoni sabiex ji_gi stabbilit 
x’ikun il-limitu ta’ fdal massimu g_hal sustanza farmakolo_gikament attiva li ti_gi u_zata 
fi prodotti medi_cinali veterinarji
Partikolaritajiet amministrattivi
1) Isem jew isem tal-korp _guridiku u indirizz permanenti ta’ min japplika.
2) Isem tal-prodott medicinali veterinarju.
3) G_hamla kwalitattiva u kwantitattiva skond il-prin_cipali attivi, b’tismija ta’ l-
isem internazzjonali mhux kummer_cjali rakkomandat mill-G_haqda Dinija g_has-
Sa_h_ha (WHO), meta jkun hemm isem b_hal dak.
4) Awtorizzazzjoni dwar il-manifattura, jekk ikun hemm.
5) Awtorizzazzjonijiet dwar il-kummer_cjar, jekk ikun hemm.
6) Su_c_cint tal-karatteristi_ci ta’ prodott(i) medi_cinali veterinarju/i.
A) Dokumentazzjoni dwar is-sigurt_a  g_has-sa_h_ha tal-prodott
A.0 Rapport peritali
A.l) Identifikazzjoni pre_ci_za tas-sustanza msemmija fl-applikazzjoni
5.1.1.2.
Carprofen
Carprofen Bovini 1000 µ g/kg
500 µ g/kg
Fwied, milsa
Muskolu, xa_ham
Equidae 1000 µ g/kg
50 µ g/kg
100 µ g/kg
Fwied, milsa
Muskolu
Xa_ham
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI _g L.S.231.34 19
1.1) Isem internazzjonali mhux kummer_cjali.
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_giku.
1.5) Sinonimi u abbrevjazzjonijiet.
1.6) Formola strutturali.
1.7) Formola molekulari.
1.8) Pi_z molekulari.
1.9) Grad ta’ impurit_a .
1.10) G_hamla kwalitattiva u kwantitattiva ta’ impuritajiet.
1.11) Deskrizzjoni ta’ proprjetajiet fi_zi_ci:
- grad ta’ fu_zjoni
- temperatura meta jag_hli
- pressjoni tal-fwar
- solubilit_a  fl-ilma u solventi organi_ci espressi b_hala g/l,
b’indikazzjoni tat-temperatura
- densit_a
- indi_ci refrattiv, rotazzjoni, e_c_c.
A.2) Studji farmakolo_gi_ci relevanti
2.1) Farmakodinamika.
2.2) Farmakokinetika.
A.3) Studji tossolo_gi_ci
3.1) Tossi_cit_a  ta’ do_za wa_hda.
3.2) Tossi_cit_a  ta’ do_zi ripetuti.
3.3) Tolleranza fl-ispe_ci ta’ annimal target.
3.4) Tossi_cit_a  riproduttiva, inklu_za terato_geni_cita.
3.4.1) Studji ta’ l-effetti fuq ir-riproduzzjoni.
3.4.2) Embrijotossi_cit_a /fetotossi_cit_a , inklu_za terato_geni_cit_a .
3.5) Muta_geni_cit_a .
3.6) Kar_cino_geni_cit_a .
A.4) Studji ta’ effetti o_hra
4.1) Immunotossi_cit_a .
4.2) Proprjetajiet ta’ fdalijiet mikrobijolo_gi_ci.
4.2.1) fuq il-flora ta’ l-imsaren tal-bniedem;
4.2.2) fuq l-organi_zmi u l-mikro-organi_zmi li jintu_zaw g_hall-
ippro_cessar ta’ l-ikel industrijali.
4.3) Osservazzjonijiet fil-bniedem.
20 L.S.231.34 _h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDI_CINALI VETERINARJI
B) Dokumentazzjoni dwar fdalijiet
B.0) Rapport peritali
B.l) Identifikazzjoni pre_ci_za tas-sustanza msemmija fl-applikazzjoni
Is-sustanza msemmija g_handha ti_gi identifikata skond il-partita A.l.
Madankollu, meta l-applikazzjoni jkollha x’taqsam ma’ prodott medi_cinali
veterinarju wie_hed jew aktar, il-prodott innifsu g_handu ji_gi identifikat fid-dettal,
inklu_zi:
- l-g_hamla kwalitattiva u kwantitattiva;
- il-purit_a ;
- l-identifikazzjoni tal-lot tal-manifattura li jintu_za fl-istudji;
- affinit_a  mal-prodott finali;
- attivit_a  spe_cifika u radio-purit_a  ta’ sustanzi tikkettjati;
- po_zizzjoni 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_hall-kxif ta’ fdalijiet
3.1) Deskrizzjoni tal-metodu.
3.2 Validement tal-metodu.
3.2.1) spe_cifi_cit_a ;
3.2.2) akkuratezza, inklu_za sensitivit_a ;
3.2.3) pre_cizjoni;
3.2.4) limiti ta’ tkixxif;
3.2.5) limitu ta’ kwaliflkazzjoni;
3.2.6) prattikabilit_a  u applikabilit_a  ta_ht kondizzjonijiet tal-
laboratorju normali;
3.2.7) suxxettibilt_a  g_hal interferenza.
