LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 1
LEGISLAZZJONI SUSSIDJARJA 231.34
REGOLAMENTI DWAR LIMITI MASSIMI TA’ 
FDALIJIET FI PRODOTTI MEDICINALI 
VETERINARJI
1 ta’ Ottubru, 1998
L-Avviz Legali 162 ta’ l-1998.
Titolu.
Limiti Massimi ta’ Fdalijiet fi Prodotti Medicinali Veterinarji.
Tifsir.
ma tehtiegx xort’ohra -
"Direttur" tfisser id-Direttur tas-Servizz Veterinarju;
"fdalijiet ta’ prodotti medicinali veterinarji" tfisser is-sustanzi
kollha farmakologikament attivi, sew principali attivi, prodotti
eccipjenti jew ta’ degradazzjoni, u l-metaboliti taghhom li jifdal
f’oggetti ta’ l-ikel maghmula minn annimali li lilhom ikun inghata
l-prodott medicinali veterinarju involut;
"limitu ta’ fdal massimu" jew "MRL" tfisser l-koncentrazzjoni
ta’ fdal massimu li tirrizulta mill-uzu ta’ prodott medicinali
veterinarju (espressa f’mg/Kg jew u/Kg fuq bazi ta’ piz frisk) li
tista’ legalment tigi permessa jew rikonoxxuta bhala li tkun
accettabbli fl-ikel. Dan il-limitu jew jigi bazat fuq it-tip u l-ammont
ta’ fdal meqjus bhala li mhux ta’ periklu tossologiku ghas-sahha
tal-bniedem kif espress bil-konsum ta’ kuljum accettabbli (ADI),
jew fuq il-bazi ta’ ADI temporanja li tutilizza fattur ta’ sigurta
ghall-bniedem addizzjonali. Sabiex jigi kalkolat dan il-limitu
ghandhom jitqiesu wkoll riskji ohra relevanti ta’ sahha pubblika kif
ukoll aspetti ta’ teknologija ta’ l-ikel. Meta jkun qed jigi stabbilit
limitu ta’ fdal massimu ghandhom jitqiesu wkoll fdalijiet li jinsabu
f’ikel li jorigina mill-pjanti jew li jinkisbu mill-ambjent. Iktar minn
hekk, MRL jista’ jitnaqqas b’mod li jkun konsistenti ma’ kull
prattika tajba fl-uzu ta’ medicinali veterinarji u sal-limitu ta’
disponibbilta  ta’ metodi analitici prattici.
(2) Dawn ir-regolamenti m’ghandhomx japplikaw ghal
principali attivi ta’ origini biologika li jkunu mahsuba biex
jipproducu immunita  attiva jew passiva jew biex issir dijanjosi ta’
stat ta’ immunita  uzat fi prodotti medicinali veterinarji immologici.
Sustanzi suggetti 
ghal MRL.
3. Il-lista ta’ sustanzi farmakologikament attivi uzati fi
prodotti medicinali veterinarji li dwarhom ikunu gew stabbiliti
limiti ta’ fdalijiet massimi huma dawk li hemm fl-Ewwel Skeda.
 Sustanzi li mhux 
suggetti ghal MRL.
4. Meta, wara li ssir evalwazzjoni ta’ xi sustanza
farmakologikament attiva li tkun uzata fi prodotti medicinali
veterinarji, jkun jidher li din ma tkunx mehtiega ghall-harsien tas-
sahha pubblika sabiex jigi stabbilit limitu ta’ fdal massimu, dik is-
sustanza ghandha tigi inkluza f’lista li hemm fit-Tieni Skeda.
 Sustanzi suggetti 
ghal MRL 
provizorju.
5. Il-lista ta’ sustanzi farmakologikament attivi li jintuzaw fi
prodotti medicinali veterinarji li dwarhom ikunu gew stabbiliti l-
2 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
limiti ta’ fdal massimu provizorji huma dawk li hemm fit-Tielet
Skeda.
Sustanzi fejn ma 
jistax jigi stabbilit 
MRL.
6. (1) Meta jkun jidher li ma jistax jigi stabbilit limitu ta’ fdal
massimu dwar xi sustanza farmakologikament attiva li tintuza fi
prodotti medicinali veterinarji minhabba fil-fatt li l-fdalijiet tas-
sustanzi involuti, f’liema livell ikun, f’oggetti ta’ l-ikel li joriginaw
mill-annimali jkunu jikkostitwixxu periklu ghas-sahha tal-
konsumatur, dik is-sustanza ghandha tkun inkluza f’lista li hemm
fir-Raba’ Skeda.
(2) Ghandu jkun projbit l-ghoti tas-sustanzi fil-lista li hemm
fir-Raba’ Skeda lil annimali li jipproducu l-ikel.
Kif jigi stabbilit 
MRL.
7. (1) Sabiex jigu stabbiliti l-limiti ta’ fdal massimu ta’
prodotti medicinali veterinarji uzati f’oggetti ta’ l-ikel ta’ origini
mill-annimali ikun mehtieg li jigi specifikat l-ispeci ta’ l-annimal
fejn dawk il-fdalijiet jistghu jkunu prezenti, il-livelli li jistghu
jkunu prezenti f’kull wiehed mit-tessuti tal-laham relevanti
miksubin mill-annimal ikkurat (target tissue) u x-xorta tal-fdal li
jkun relevanti ghas-sorveljar ta’ fdalijiet (marker residue).
(2) Sabiex isir kontroll dwar il-fdalijiet, il-limiti ta’ fdal
massimu ghandhom jigu stabbiliti ghat-target tissue tal-fwied jew
tal-kilwa; izda, billi l-fwied u l-kilwa ta’ spiss jitnehhew mill-
karkassi li jinbieghu f’kummerc internazzjonali, il-limiti ta’ fdal
massimi ghandhom ghaldaqstant dejjem jigu stabbiliti ghal tessuti
muskolari jew xahmin.
(3) Fil-kaz ta’ prodotti medicinali veterinarji mahsuba ghall-
uzu fuq tajr li jbid, annimali tal-halib jew nahal tal-ghasel, il-limiti
ta’ fdal massimi ghandhom ukoll jigu stabbiliti ghall-bajd, halib,
jew ghasel.
Tqeghid ta’ 
prodotti fuq il-listi.
8. (1) Sustanza farmakologikament attiva gdida, mahsuba
biex tintuza fi prodotti medicinali veterinarji li jinghataw lil
annimali li jipproducu l-halib, jistghu biss jigu inkluzi fl-Ewwel,
fit-Tieni u fit-Tielet Skedi jekk min ikun responsabbli ghat-tqeghid
taghhom fis-suq jaghmel applikazzjoni dwar dan lid-Direttur. Dik
l-applikazzjoni ghandu jkun fiha t-taghrif u l-partikolaritajiet
imsemmija fil-Hames Skeda.
(2) Id-Direttur jista’, wara li jifli t-taghrif gdid jew wara li
jerga’ jifli t-taghrif li jkollu, jemenda kull disposizzjoni li hemm fl-
Ewwel, fit-Tieni, fit-Tielet u fir-Raba’ Skedi jekk dan ikun mehtieg
li jsir ghall-harsien tas-sahha tal-bniedem jew ta’ l-annimali.
(3) Id-Direttur ma jistax jipprojbixxi jew izomm il-kummerc
ta’ oggetti ta’ l-ikel li joriginaw mill-annimali u li jkunu gejjin
minn pajjizi ohra minhabba f’li jkun fihom fdalijiet ta’ prodotti
medicinali veterinarji jekk il-kwantita  ta’ fdal ma tkunx teccedi l-
limitu ta’ fdal massimu li hemm fl-Ewwel Skeda jew fit-Tielet
Skeda, jew inkella jekk dik is-sustanza tkun qeghda fil-lista li
hemm fit-Tieni Skeda.
Annimali li 
jipproducu l-ikel.
9. L-ghoti lil annimali li jipproducu l-ikel ta’ prodtti
medicinali veterinarji li jkun fihom sustanzi attivi farmakologici li
ma jkunux imsemmija fl-Ewwel, fit-Tieni jew fit-Tielet Skedi
ghandhu jkun projbit, hlief fil-kaz ta’ provi klinici li jkunu accettati
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 3
mill-awtoritajiet kompetenti u sakemm l-oggetti ta’ l-ikel li
jinkisbu minn bhejjem li jintuzaw f’dawk il-provi ma jkunx fihom
fdalijiet li jkunu ta’ periklu ghas-sahha tal-bniedem.
Riserva.
L.S.231.32
10. Ebda haga f’dawn ir-regolamenti m’ghandha tmur kontra
d-disposizzjonijiet tar-Regolamenti dwar Fdalijiet fil-Laham, li
jipprojbixxu l-uzu, fit-trobbija tal-bhejjem, ta’ certi sustanzi li
ghandhom azzjoni ormonika.
4 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
L-EWWEL SKEDA
(Regolament 3)
Lista ta’ sustanzi farmakologikament attivi li dwarhom ikunu gew stabbilit limiti ta’ fdalijiet 
massimi
l. Agenti anti-infettivi
1.1. Kemoterapewtici
1.1.1.  Sulfonamides
1.2. Antibiotics
1.2.1. Penicillins
1.2.2 Cephalosporins
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
Is-sustanzi kollha 
li jappartjenu 
ghas-sulfona-
mide group
Parent drug Kull speci li jip-
produci l-ikel
100 µ g/kg Muskolu, fwied, 
milsa, xaham
Bovini, Ovini, 
Kaprini
100 µ g/kg Halib
Provdimenti ohra: Il-fdalijiet totali kombinati ta’ kull sustanza fis-sulfonamide group 
m’ghandhomx jeccedu 100 µ g/kg
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.1.1.
Benzylpenicillin
Benzylpenicillin Kull speci li jip-
produci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xaham
4 µ g/kg Halib
1.2.1.2.
Ampicillin
Ampicillin Kull speci li jip-
produci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xaham
4 µ g/kg Halib
1.2.1.3.
Amoxicillin
Amoxicillin Kull speci li jip-
produci l-ikel
50 µ g/kg Muskolu, fwied, 
milsa, xaham
4 µ g/kg Halib
1.2.1.4.
Oxacillin
Oxacillin Kull speci li jip-
produci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xaham
30 µ g/kg Halib
1.2.1.5.
Cloxacillin
Cloxacillin Kull speci li jip-
produci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xaham
30 µ g/kg Halib
1.2.1.6.
Dicloxacillin
Dicloxacillin Kull speci li jip-
produci l-ikel
300 µ g/kg Muskolu, fwied, 
milsa, xaham
30 µ g/kg Halib
1.2.1.7.
Penethamate
Benzylpenicillin Bovini 50 µ g/kg Muskolu, fwied, 
milsa, xaham
4 µ g/kg Halib
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI 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,
Xaham
Halib
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci 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 xaham
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 xaham
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci 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, xaham
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, 
xaham
Muskolu
Halib
Flieles 400 µ g/kg
300 µ g/kg
200 µ g/kg
Fwied
Gilda u xaham
Muskolu
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.5.1.
Florfenicol
Total ta’ Florfen-
icol u metabo-
lites relattivi 
mizurati bhala 
Florfenicolamine
Bovini 200 µ g/kg
300 µ g/kg
3000 µ g/kg
Muskolu
Milsa
Fwied
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
6 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
2. Agenti anti-parasitici
2.1. Agenti li jagixxu kontra endoparasiti
2.1.1. Avermectins
2.1.2. Salicylanilides
2.l.3. Tetra-hydro-imidazoles (imidazolthiazoles)
2.2. Agenti li jagixxu kontra ectoparasiti
1.2.6.1.
Tetracycline
Total ta’ parent 
drug u 4-epimer 
relattivi
Kull speci li jip-
produci 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 speci li jip-
produci 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 speci li jip-
produci 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-
kologikament 
attivi
Marker residue Speci 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
Xaham
Majjal, ovini, 
equidae
15 µ g/kg
20 µ g/kg
Fwied
Xaham
2.1.1.2.
Abamectin
Avermectin B 1a Bovini 20 µ g/kg
10 µ g/kg
Fwied
Xaham
2.1.1.3.
Doramectin
Doramectin Bovini 15 µ g/kg
25 µ g/kg
Fwied
Xaham
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.1.2.1.
Closantel
Closantel Bovini 1000 µ g/kg
3000 µ g/kg
Muskolu, fwied
Milsa, xaham
Ovini 1500 µ g/kg
5000 µ g/kg
2000 µ g/kg
Muskolu, fwied
Milsa
Xaham
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci 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, 
xaham
Fwied
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 7
2.2.1. Organophosphates
2.2.2. Formamidines
3. Agenti li jagixxu fuq is-sistema nervuz
3.1. Agenti li jagixxu fuq is-sistema nervuz awtomatiku
3.1.1. Anti-adrenergics
IT-TIENI SKEDA
(Regolament 4)
Lista ta’ sustanzi mhux suggetti ghal-limiti ta’ fdalijiet massimi
1. Kimici inorganici
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.2.1.1.
Diazinon
Diazinon Bovini, ovini 700 µ g/kg
20 µ g/kg
Xaham
Milsa, fwied
muskolu
Bovini, ovini, 
kaprini
20 µ g/kg Halib
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.2.2.1.
Amitraz
Total ta’ amitraz 
u metabolites 
kollha bi 2,4-
DMA moeity, 
espressa bhala 
amitraz
Majjal 400 µ g/kg
200 µ g/kg
Xaham u gilda
Milsa, fwied
Sustanza/i farma-
kologikament 
attivi
Marker residue Speci ta’annimali MRLs Target tissues
3.1.1.1.
Carazolol
Carazolol Majjal 25 µ g/kg
5 µ g/kg
Fwied,milsa 
Muskolu, xaham 
u gilda
Sustanza/i farmakologikament attivi Speci ta’ annimali
1.1. Hydrogen peroxide Kull speci li jipproduci l-ikel
1.2. Sulpur Bovini, majjal, ovini, kaprini, equidae
1.3. Iodine u iodine inorganic compounds 
inkluzi: Kull speci li jipproduci l-ikel
- Sodium u potassium-iodide
- Sodium u potassium-iodate
- Iodophors inkluzi Polyvinyl-pyrro-
lidone-iodine
1.4. Sodium chlorite Bovini (ghal uzu topikali biss)
1.5. Calcium acetate Kull speci li jipproduci l-ikel
Calcium benzoate
8 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI 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 speci li jipproduci l-ikel (ghal uzu 
bhala eccipjent)
1.7. Sodioum dichloroisocyanurate Bovini, ovini, kaprini (ghal uzu topikali 
biss)
1.8. Boric acid u borates Kull speci li jipproduci l-ikel
1.9. Magnesium Kull speci li jipproduci l-ikel
1.10. Magnesium sulphate Kull speci li jipproduci l-ikel
1.11. Magnesium hydroxide Kull speci li jipproduci l-ikel
1.12. Magnesium stearate Kull speci li jipproduci l-ikel
1.13. Magnesium glutamate Kull speci li jipproduci l-ikel
1.14. Magnesium orotate Kull speci li jipproduci l-ikel
1.15. Magnesium aluminium silicate Kull speci li jipproduci l-ikel
1.16. Magnesium oxide Kull speci li jipproduci l-ikel
1.17. Magnesium carbonate Kull speci li jipproduci l-ikel
1.18. Magnesium phosphate Kull speci li jipproduci l-ikel
1.19. Magnesium glycerophosphate
1.20. Magnesium aspartate
1.21. Magnesium citrate
1.22. Magnesium acetate
1.23. Magnesium trisilicate
2. Komposti Organici
Sustanza/i farmakologikament attivi Speci 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 speci li jipproduci l-ikel
2.6. Melatonin Ovini, kaprini
2.7. Iodine organic compounds Kull speci li jipproduci l-ikel
- Iodoform
2.8. Acetyl cysteine Kull speci li jipproduci l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 9
2.9. Gonadotrophin releasing hormone Kull speci li jipproduci l-ikel
2.10. Pregnant Mare Serum
Gonadotrophin Kull speci li jipproduci l-ikel
2.11. 17ß -Oestradiol Kull mammal li jipproduci l-ikel (ghal uzu 
terapewtiku u zootekniku biss)
2.12. Romifidine Equidae (ghal uzu terapewtiku biss)
2.13. Detomidine Bovini, Equidae (ghal uzu
terapewtiku biss)
2.14. Brotizolam Bovini, (ghal uzu terapewtiku biss)
2.1.5. Human chorion gonadotrophin (HCG) Kull speci li jipproduci l-ikel
2.16. Oxytocin Kull mammal li jipproduci l-ikel
 2.17. Lecirelin Bovini, equidae, fenek
2.18. Dinoprost tromethamine Kull speci mammarju
2.19. Malic acid Kull speci li jipproduci l-ikel (biex jintuza 
bhala eccipjent)
2.20. L-tartaric acid u mono- u di-basic salt 
relattiv ta’ sodium potassium u calcium
Kull speci li jipproduci l-ikel (biex jintuza 
bhala eccipjent)
2.21. Benzylalcohol Kull speci li jipproduci l-ikel (biex jintuza 
bhala eccipjent)
2.22. Ethanol Kull speci li jipproduci l-ikel (biex jintuza 
bhala eccipjent)
2.23. N-butanol Kull speci li jipproduci l-ikel (biex jintuza 
bhala eccipjent)
2.24. Mineral hydrocarbons, b’viskosita  minn 
baxxa sa gholja inkluzi micro cristalline 
waxes, approx. C10-C60; aliphatic, 
branched aliphatic u alicyclic com-
pounds
Kull speci li jipproduci l-ikel (eskluzi kom-
posti aromatici u mhux saturati)
2.25. Buserelin Kull speci li jipproduci l-ikel
2.26. Ketoprofen Bovini, equidae
2.27. Caffeine Kull speci li jipproduci l-ikel
2.28. Theophylline Kull speci li jipproduci l-ikel
2.29. Theobromine Kull speci li jipproduci l-ikel
2.30. Ketoprofen Majjal
2.31. Propane Kull speci li jipproduci l-ikel
2.32. n-butane Kull speci li jipproduci l-ikel
2.33. Isobutane Kull speci li jipproduci l-ikel
2.34. Polysulphated
glycosaminoglycan Equidae
2.35. Rifaximin Bovini (ghal uzu intramammarju - hlief 
jekk is-sider jista’ jintuza bhala ikel ghal 
konsum tal-bniedem - u uzu intrauterin 
biss)
2.36. Tau fluvalinate Nahal ta’ l-ghasel
2.37. Phenol Kull speci li jipproduci l-ikel
2.38. Papaverine Bovini (ghoggiela tat-twelid biss)
2.39. Policresulene Kull speci li jipproduci l-ikel (ghal uzu 
topikali biss)
10 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
2.40. Papain Kull speci li jipproduci l-ikel
2.41. Dimethyl phtalate Kull speci li jipproduci l-ikel
2.42. Diethyl phatalate Kull speci li jipproduci l-ikel
2.43. Ethyl lactate Kull speci li jipproduci l-ikel
2.44. Heptaminol Kull speci li jipproduci l-ikel
2.45. Menthol Kull speci li jipproduci l-ikel
2.46. Phloroglucinol Kull speci li jipproduci l-ikel
2.47. Trimethylphloroglucinol Kull speci li jipproduci l-ikel
2.48. Peracetic acid Kull speci li jipproduci l-ikel
2.49. Carbetocin Kull speci mammarju li jipproduci l-ikel
2.50. Quillaia saponins Kull speci li jipproduci l-ikel
2.51. Butyl 4-hydroxybenzoate Kull speci li jipproduci l-ikel
2.52. Sodium butyl 4-hydroxybenzoate Kull speci li jipproduci l-ikel
2.53. Sodium benzyl 4-hydroxybenzoate Kull speci li jipproduci l-ikel
2.54. Cetrimide Kull speci li jipproduci l-ikel
2.55. Lobeline Kull speci li jipproduci l-ikel
2.56. Pancreatin Kull speci mammarju li jipproduci l-ikel 
(ghal uzu topikali biss)
2.57. Chlorocresol Kull speci li jipproduci l-ikel
2.58. Thymol Kull speci li jipproduci l-ikel
2.59. Dembrexine Equidae
2.60. Diclazuril Ovini (ghal uzu fil-hrief biss)
2.61. Etamiphylline camsylate Kull speci li jipproduci l-ikel
3. Sustanzi generalment maghrufin bhala siguri ghas-sahha
Sustanza/i farmakologikament attivi Speci ta’ annimali
 3.1. Absinthium extract Kull speci li jipproduci l-ikel
3.2. Acetylmethionine Kull speci li jipproduci l-ikel
3.3. Aluminium hydroxide Kull speci li jipproduci l-ikel
3.4.  luminium monostearate Kull speci li jipproduci l-ikel
3.5. Ammonium sulfate Kull speci li jipproduci l-ikel
 3.6. Benzoyl benzoate Kull speci li jipproduci l-ikel
3.7. Benzyl p-hydroxybenzoate Kull speci li jipproduci l-ikel
3.8. Calcium borogluconate Kull speci li jipproduci l-ikel
3.9. Calcium citrate Kull speci li jipproduci l-ikel
3.10. Camphor Kull speci li jipproduci l-ikel (uzu estern 
biss)
 3.11. Cardamon extract Kull speci li jipproduci l-ikel
3.12. Diethyl sebacate Kull speci li jipproduci l-ikel
 3.13. Dimethicone Kull speci li jipproduci l-ikel
3.14. Dimethyl acetamide Kull speci li jipproduci l-ikel
3.15. Dimethyl sulphoxide Kull speci li jipproduci l-ikel
 3.16. Ethylenediaminetetraacetic acid and 
salts Kull speci li jipproduci l-ikel
 3.17. Eucalyptol Kull speci li jipproduci l-ikel
3.18. Epinephrine Kull speci li jipproduci l-ikel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 11
3.19. Ethyl oleate Kull speci li jipproduci l-ikel
3.20. Formaldehyde Kull speci li jipproduci l-ikel
3.21. Formic acid Kull speci li jipproduci l-ikel
 3.22. Follicle stimulating hormone (natural 
FSH from all species and their synthetic 
analogues) Kull speci li jipproduci l-ikel
3.23. Glutaraldehyde Kull speci li jipproduci l-ikel
3.24. Guaiacol Kull speci li jipproduci l-ikel
3.25. Heparin u l-imluha tieghu Kull speci li jipproduci l-ikel
 3.26. Human chorionic gonadotropin (natural 
HCG and its synthetic analogues) Kull speci li jipproduci l-ikel
3.27. Iron ammonium citrate Kull speci li jipproduci l-ikel
 3.28. Iron dextran Kull speci li jipproduci l-ikel
3.29. Iron glucoheptonate Kull speci li jipproduci l-ikel
3.30. Isopropanol Kull speci li jipproduci l-ikel
3.31. Lanolin Kull speci li jipproduci l-ikel
 3.32. Luteinizing hormone (natural LH from 
all species and their synthetic ana-
logues) Kull speci li jipproduci l-ikel
3.33. Magnesium chloride Kull speci li jipproduci l-ikel
3.34. Magnesium gluconate Kull speci li jipproduci l-ikel
3.35. Magnesium hypophosphite Kull speci li jipproduci l-ikel
3.36. Mannitol Kull speci li jipproduci l-ikel
3.37. Montanide Kull speci li jipproduci l-ikel
3.38. Methylbenzonate Kull speci li jipproduci l-ikel
 3.39. Monothioglycerol Kull speci li jipproduci l-ikel
 3.40. Myglyol Kull speci li jipproduci l-ikel
3.41. Orgotein Kull speci li jipproduci l-ikel
3.42. Poloxalene Kull speci li jipproduci l-ikel
3.43. Poloxamer Kull speci li jipproduci l-ikel
3.44. Polyethylene glycol 200 Kull speci li jipproduci l-ikel
 3.45. Polyethylene glycol 400 Kull speci li jipproduci l-ikel
3.46. Polyethylene glycol 600 Kull speci li jipproduci l-ikel
3.47. Polyethylene glycol 3500 Kull speci li jipproduci l-ikel
3.48. Polysorbate 80 Kull speci li jipproduci l-ikel
3.49. Serotonin Kull speci li jipproduci l-ikel
 3.50. Sodium chloride Kull speci li jipproduci l-ikel
3.51. Sodium cromoglycate Kull speci li jipproduci l-ikel
3.52. Sodium dioctylsulphosuccinate Kull speci li jipproduci l-ikel
3.53. Sodium formaldehydesulphoxylate Kull speci li jipproduci l-ikel
3.54. Sodium lauryl sulphate Kull speci li jipproduci l-ikel
 3.55. Sodium pyrosulphite Kull speci li jipproduci l-ikel
3.56. Sodium stearate Kull speci li jipproduci l-ikel
3.57. Sodium thiosulphate Kull speci li jipproduci l-ikel
 3.58. Tragacanth Kull speci li jipproduci l-ikel
3.59. Urea Kull speci li jipproduci l-ikel
12 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
IT-TIELET SKEDA
(Regolament 5)
  Lista ta’ sustanzi farmakologikament attivi uzati fi prodotti medici veterinarji li dwarhom 
ikunu gew stabbiliti l-limiti ta’ fdal massimu provizorji
l.  Agenti anti-infettivi
1.1. Kemoterapewtici
1.1.1. Diamino pyrimidine derivates
1.1.2. Benzenesulphonamides
3.60. Zine sulphate Kull speci li jipproduci l-ikel
3.61. Zinc oxide Kull speci li jipproduci l-ikel
3.62. Polyethylene glycols (piz molekolari 
bejn 200 u 10000) Kull speci li jipproduci l-ikel
4. Sustanzi uzati fi prodotti medicinali veterinarji homeopatici
Sustanza/i farmakologikament attivi Speci ta’ annimali
4.1. Kull sustanza li tintuza fi prodotti 
medicinali veterinarji homeopatici 
sakemm il-koncentrazzjoni taghhom fil-
prodott ma tkunx teccedi parti wahda 
ghal kull ghaxart elef
Kull speci li jipproduci l-ikel
5. Sustanzi uzati bhal addittivi ta’ l-ikel f oggetti ta’ l-ikel ghall-konsum tal- bniedem
Sustanza/i farmakologikament attivi  Speci ta’ annimali
5.l. Sustanzi b’E number Kull speci li jipproduci l-ikel (sustanzi biss 
li jkunu approvati bhala addittivi f’oggetti 
ta’ l-ikel ghall-konsum tal-bniedem).
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.1.1.1.
Trimethoprim
Trimethoprim Kull speci li jip-
produci l-ikel
50 µ g/kg Muskolu,fwied
Milsa, xaham, 
halib
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci 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
Xaham
Halib
Majjal 50 µ g/kg
40 µ g/kg
Fwied, milsa
Xaham u gilda
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI 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 
farmacewtika-
ment attivi
Marker residue Speci 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
Xaham
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, xaham
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, 
xaham
Bajd
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.3.1.
Thiamphenicol
Thiamphenicol Bovini, pullam 40 µ g/kg Muskolu, fwied, 
milsa, xaham
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.4.1.
Ceftiofur
Total tal-fdali-
jiet kollha li 
ghandhom l-
istruttura ta’ 
betalactam 
espressa bhala 
desfuroylceftio-
fur
Bovini 2000 µ g/kg
200 µ g/kg
600 µ g/kg
100 µ g/kg
Milsa, fwied
Muskolu
Xaham
Halib
Majjal 4000 µ g/kg
3000 µ g/kg
500 µ g/kg
600 µ g/kg
Milsa
Fwied
Muskolu
Xaham
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci 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
Xaham
Bovini 200 µ g/kg Halib
14 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI 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, 
xaham
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, 
xaham
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, xaham
Bovini 100 µ g/kg Halib
1.2.5.5.
Neomycin
(inkluzi framyce-
tin)
Neomycin Bovini, ovini, 
kaprini, majjal, 
flieles, dundjani, 
papri
5000 µ g/kg
500 µ g/kg
Milsa
Muskolu, fwied, 
xaham
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 
farmacewtika-
ment attivi
Marker residue Speci 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
Xaham
Flieles 1200 µ g/kg
600 µ g/kg
300 µ g/kg
Fwied, milsa
Gilda u xaham
Muskolu
1.2.6.2.
Decoquinate
Decoquinate Bovini, ovini 500 µ g/kg Muskolu, fwied, 
milsa, xaham
1.2.6.4.
Marbofloxacin
Marbofloxacin Bovini 150 µ g/kg
75 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
Halib
Xaham
Majjal 150 µ g/kg
50 µ g/kg
Muskolu, fwied, 
milsa
Xaham u gilda
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.6.1.
Rifaximin
Rifaximin Bovini 600 µ g/kg Halib
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 15
1.2.8. Polymyxins
1.2.9. Penicillins
2. Agenti antiparasitici
2.1. Agenti li jagixxu kontra endo-parasiti
2.1.1. Benzimidazoles u pro-benzimidazoles
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci 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, 
xaham
Bovini, ovini 50 µ g/kg Halib
Flieles 300 µ g/kg Bajd
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
1.2.9.1.
Penethamate
Benzylpenicillin Ovini 50 µ g/kg
4 µ g/kg
Fwied, milsa, 
muskolu, xaham
Halib
Majjal 50 µ g/kg Fwied, milsa, 
muskolu, xaham
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.1.1.1.
Febantel
Total ta’ fdalijiet 
ta’ oxfendazole, 
oxfendazole 
sulfone u fenben-
dazole
Kull speci li jip-
produci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xaham
Halib
Provdimenti ohra: 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 speci li jip-
produci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xaham
Halib
Provdimenti ohra: 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 speci li jip-
produci l-ikel
1000 µ g/kg
10 µ g/kg
10 µ g/kg
Fwied
Muskolu, milsa, 
xaham
Halib
Provdimenti ohra: Kull MRL ikopri kull fdal ta’ febantel, fenbendazole u oxfendazole
2.1.1.4.
Albendazole
Total ta’ alben-
dazole u metabo-
lites li jigu 
mizurati bhala 2-
amino-benzimi-
dazole sulphone
Bovini, Ovini 100 µ g/kg
500 µ g/kg
1000 µ g/kg
Muskolu, xaham, 
halib
Milsa
Fwied
16 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
2.2.  Agenti li jagixxu 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, xaham, 
halib
2.1.1.6.
Triclabendazole
Total ta’ fdalijiet 
estraibbli li 
jistghu jigu oxi-
dized ghal 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, xaham
2.1.1.8.
Oxibendazole
Oxibendazole Bovini, Ovini, 
majjal, equidae
100 µ g/kg Muskolu, fwied, 
milsa, xaham
Bovini, ovini 50 µ g/kg Halib
2.1.1.9.
Netobimin
Total ta’ neto-
bimin u albenda-
zole u 
metabolites ta’ 
albendazole 
mizurati bhala 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, xaham
Halib
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.2.1.1.
Amitraz
Total ta’ amitraz 
u metabolites 
mizurati bhala 
2.4-dimethyl-
aniline
Bovini 200 µ g/kg
10 µ g/kg
Milsa, fwied, 
xaham
Halib
Ovini 400 µ g/kg
200 µ g/kg
Xaham
Milsa, fwied
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci 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 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.2.3.1.
Cymiazole
Cymiazole Nahal 1000 µ g/kg Ghasel
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 17
2.3. Agenti li jagixxu kontra endo- u ectoparasiti
2.3.1. Avermectins
3. Agenti li jagixxu fuq is-sistema nervuz
3.1. Agenti li jagixxu fuq is-sistema nervuz centrali
3.1.1. Butyrophenone tranquillizers
3.2. Agenti li jagixxu fuq is-sistema nervuz awtomatiku
3.2.1. ß 2 sympathomimetic agents
4. Corticoids
4.1. Glucocorticoids
5. Agenti anti-infjammatorji
5.1. Agenti anti-inflammatorji nonsteroidali
5.1.1. Arylpropionic acid derivative
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
2.3.1.1.
Moxidectin
Moxidectin Bovini, ovini 200 µ g/kg
20 µ g/kg
Xaham
Milsa, fwied
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
3.1.1.1.
Azaperone
Azaperol  Kull speci li jip-
produci l-ikel
100 µ g/kg
50 µ g/kg
Milsa
Fwied, muskolu, 
xaham
Sustanza/i 
farmacewtika-
ment attivi
Marker residue Speci ta’annimali MRLs Target tissues
3.2.1.1.
Clenbuterol 
hydrochloride
Clenbuterol  Bovini
(Indikazzjoni: 
biss ghal 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 
farmacewtika-
ment attivi
Marker residue Speci 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 
farmacewtika-
ment attivi
Marker residue Speci 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 
MEDICINALI VETERINARJI
IR-RABA SKEDA
(Regolament 6)
Lista ta’ sustanzi farmakologikament attivi li dwarhom ma jistghux jigu 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)
Taghrif u partikolaritajiet li ghandhom jiddahhlu f’applikazzjoni sabiex jigi stabbilit 
x’ikun il-limitu ta’ fdal massimu ghal sustanza farmakologikament attiva li tigi uzata 
fi prodotti medicinali veterinarji
Partikolaritajiet amministrattivi
1) Isem jew isem tal-korp guridiku u indirizz permanenti ta’ min japplika.
2) Isem tal-prodott medicinali veterinarju.
3) Ghamla kwalitattiva u kwantitattiva skond il-principali attivi, b’tismija ta’ l-
isem internazzjonali mhux kummercjali rakkomandat mill-Ghaqda Dinija ghas-
Sahha (WHO), meta jkun hemm isem bhal dak.
4) Awtorizzazzjoni dwar il-manifattura, jekk ikun hemm.
5) Awtorizzazzjonijiet dwar il-kummercjar, jekk ikun hemm.
6) Succint tal-karatteristici ta’ prodott(i) medicinali veterinarju/i.
A) Dokumentazzjoni dwar is-sigurta  ghas-sahha tal-prodott
A.0 Rapport peritali
A.l) Identifikazzjoni preciza tas-sustanza msemmija fl-applikazzjoni
5.1.1.2.
Carprofen
Carprofen Bovini 1000 µ g/kg
500 µ g/kg
Fwied, milsa
Muskolu, xaham
Equidae 1000 µ g/kg
50 µ g/kg
100 µ g/kg
Fwied, milsa
Muskolu
Xaham
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI g L.S.231.34 19
1.1) Isem internazzjonali mhux kummercjali.
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
- farmakologiku.
1.5) Sinonimi u abbrevjazzjonijiet.
1.6) Formola strutturali.
1.7) Formola molekulari.
1.8) Piz molekulari.
1.9) Grad ta’ impurita .
1.10) Ghamla kwalitattiva u kwantitattiva ta’ impuritajiet.
1.11) Deskrizzjoni ta’ proprjetajiet fizici:
- grad ta’ fuzjoni
- temperatura meta jaghli
- pressjoni tal-fwar
- solubilita  fl-ilma u solventi organici espressi bhala g/l,
b’indikazzjoni tat-temperatura
- densita
- indici refrattiv, rotazzjoni, ecc.
A.2) Studji farmakologici relevanti
2.1) Farmakodinamika.
2.2) Farmakokinetika.
A.3) Studji tossologici
3.1) Tossicita  ta’ doza wahda.
3.2) Tossicita  ta’ dozi ripetuti.
3.3) Tolleranza fl-ispeci ta’ annimal target.
3.4) Tossicita  riproduttiva, inkluza teratogenicita.
3.4.1) Studji ta’ l-effetti fuq ir-riproduzzjoni.
3.4.2) Embrijotossicita /fetotossicita , inkluza teratogenicita .
3.5) Mutagenicita .
3.6) Karcinogenicita .
A.4) Studji ta’ effetti ohra
4.1) Immunotossicita .
4.2) Proprjetajiet ta’ fdalijiet mikrobijologici.
4.2.1) fuq il-flora ta’ l-imsaren tal-bniedem;
4.2.2) fuq l-organizmi u l-mikro-organizmi li jintuzaw ghall-
ipprocessar ta’ l-ikel industrijali.
4.3) Osservazzjonijiet fil-bniedem.
20 L.S.231.34 h
LIMITI MASSIMI TA’ FDALIJIET FI PRODOTTI 
MEDICINALI VETERINARJI
B) Dokumentazzjoni dwar fdalijiet
B.0) Rapport peritali
B.l) Identifikazzjoni preciza tas-sustanza msemmija fl-applikazzjoni
Is-sustanza msemmija ghandha tigi identifikata skond il-partita A.l.
Madankollu, meta l-applikazzjoni jkollha x’taqsam ma’ prodott medicinali
veterinarju wiehed jew aktar, il-prodott innifsu ghandu jigi identifikat fid-dettal,
inkluzi:
- l-ghamla kwalitattiva u kwantitattiva;
- il-purita ;
- l-identifikazzjoni tal-lot tal-manifattura li jintuza fl-istudji;
- affinita  mal-prodott finali;
- attivita  specifika u radio-purita  ta’ sustanzi tikkettjati;
- pozizzjoni 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 ghall-kxif ta’ fdalijiet
3.1) Deskrizzjoni tal-metodu.
3.2 Validement tal-metodu.
3.2.1) specificita ;
3.2.2) akkuratezza, inkluza sensitivita ;
3.2.3) precizjoni;
3.2.4) limiti ta’ tkixxif;
3.2.5) limitu ta’ kwaliflkazzjoni;
3.2.6) prattikabilita  u applikabilita  taht kondizzjonijiet tal-
laboratorju normali;
3.2.7) suxxettibilta  ghal interferenza.
