Maximum Levels of Unavoidable Carry-Over of Coccidiostats or Histomonostats in Non-Target Feed Rules, 2009 (L.N. 257 of 2009)

B 2969VERŻJONI ELETTRONIKA A.L. 257 tal-2009 ATT DWAR IS-SERVIZZI VETERINARJI (KAP. 437) Regoli tal-2009 dwar il-Livelli Massimi Inevitabbli ta’ Koċċidijostati jew Istomonostati li Jistgħu Jibqgħu Jidhru f’Għalf Mhux Immirat għall-Użu b’Dawn Il-Mediċini BIS-SAĦĦA tas-setgħat mogħtija bl-artikolu 10 ta’ l-Att dwar is-Servizzi Veterinarji, il-Ministru għar-Riżorsi u Affarijiet Rurali wara konsultazzjoni mal-Ministru għall-Politika Soċjali, għamel dawn ir-regoli li ġejjin: 1. (1) It-titolu ta’ dawn ir-regoli hu Regoli ta’ l-2009 dwar il-Livelli Massimi Inevitabbli ta’ Koċċidijostati jew Istomonostati li Jistgħu Jibqgħu Jidhru f’Għalf Mhux Immirat għall-Użu b’Dawn il-Mediċini. (2) L-iskop ta’ dawn ir-regoli hu li jittrasponu u jimplimentaw id-Direttiva 2009/8/KE tal-Kummissjoni Ewropea li temenda l-Ewwel Anness li jinsab mad-Direttiva 2002/32/KE tal Parlament Ewropew u tal-Kunsill dwar sustanzi mhux mixtieqa fl ikel ta’ l-annimali kif emendata l-aħħar bid-Direttiva 2008/76/KE u li jistabbilixxu livelli massimi ta’ koċċidijostati jew istomonostati meta dawn is-sustanzi mhux mixtieqa jitrażmettu ruħhom b’mod inevitabbli fl-ikel jew fl-għalf ta’ l-annimali. (3) Dawn ir-regoli għandhom jitqiesu li daħlu fis-seħħ fl-1 ta’ Lulju, 2009. 2. (1) Kemm il-darba ma jiġix stabbilit xort’oħra f’dawn ir-regoli, it-tifsiriet mogħtija fl-Att għandhom japplikaw. (2) Għall-fini ta’ dawn ir-regoli u kemm il-darba r-rabta tal-kliem ma tkunx teħtieġ xort’oħra: “addittivi” għandu jkollha l-istess tifsira mogħtija lilha fl-Artikolu 2(a) ta’ l-Ordni tad-Direttiva tal-Kunsill 70/524/ KEE; Titolu, skop u bidu fis-seħħ. Tifsir. Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 18,489, 2 ta’ Ottubru, 2009 Taqsima B B 2970 VERŻJONI ELETTRONIKA “annimali” tfisser annimali li kontinwament jipproduċu l-ikel u għandha tinkludi wkoll annimali li jkunu jappartjenu għal speċi u, jew għal kategorija li normalment ikunu jingħataw l-ikel u jkunu jinżammu jew ikunu ttieklu mill bniedem; “l-Att” tfisser l-Att dwar is-Servizzi Veterinarji; “l-Awtorità kompetenti” tfisser l-Awtorità dwar is Servizzi Veterinarji kif imwaqqfa bl-Att; “awtorizzazzjoni għall-addittivi” tfisser awtorizzazzjoni li tinħareg mill-awtorità kompetenti biex jiġi awtorizzat l-użu ta’ koċċidijostati u ta’ istomonostati fl-għalf ta’ l-annimali meta dawk is-sustanzi jkunu jintużaw bħala addittivi awtorizzati fl-għalf; “għalf mhux fil-mira” tfisser għalf li fih ma jkunx awtorizzat l-użu ta’ koċċidijostati jew ta’ istomonostati, bħala għalf maħsub għal speċi jew kategoriji ta’ annimali li m’hemmx dispożizzjoni dwarhom fl-awtorizzazzjoni għall addittivi; “ikel” jew “għalf” tfisser prodotti li jkunu joriġinaw minn ħxejjex jew mill-annimali, fl-istat naturali tagħhom, li jkunu friski jew preservati, u prodotti derivanti mill ipproċessar industrijali ta’ l-istess, u sustanzi organiċi jew mhux organiċi, kemm jekk użati waħedhom kemm f’taħlitiet, u kemm jekk ikollhom addittivi kemm jekk le, għall-għalf orali ta’ l-annimali; “ikel kumplimentari” tfisser taħlitiet ta’ ikel b’kontenut għoli ta’ ċerti sustanzi u li, minħabba l-kompożizzjoni tagħhom, huma suffiċjenti bħala porzjon ta’ kuljum biss jekk użati flimkien ma’ ikel ieħor; “koċċidijostati u istomonostati” tfisser sustanzi maħsuba biex joqtlu jew ixekklu l-protożoa li jistgħu, inter alia, jkunu awtorizzati għall-użu bħala addittivi fl-għalf skond ir regolamenti dwar l-addittivi għall-użu fl-għalf ta’ l-annimali; “il-Komunità” tfisser il-Komunità Ewropea; “konsumatur aħħari” tfisser persuna li tixtri prodotti nutrittivi partikolari li jkunu prodotti minn annimali għall-użu personali tagħha; B 2971VERŻJONI ELETTRONIKA “il-Kummissjoni” tfisser il-Kummissjoni ta’ l-Unjoni Ewropea; “il-Kunsill” tfisser il-Kunsill ta’ l-Unjoni Ewropea; “livelli massimi” tfisser dawk il-livelli li l-Awtorità kompetenti għandha tistabbilixxi għall-użu ta’ koċċidijostati u istomonostati, meta dawn is-sustanzi jistgħu iħallu traċċi inevitabbli ta’ prodott li matul il-proċess ta’ produzzjoni jew ta’ manifattura, jkunu spiċċaw fi prodott ieħor ta’ l-għalf u li dawn il-livelli huma elenkati fl-Iskeda li tinsab ma’ dawn ir regoli; “limiti massimi ta’ residwi” tfisser dawk il-limiti li ma jistgħux jinqabżu stabbiliti permezz tal-komunità dwar il-massimu ta’ residwu ta’ prodotti mediċinali veterinarji awtorizzat fi prodotti ta’ l-ikel ta’ oriġini mill-annimali; “materjali ta’ l-għalf” tfisser prodotti varji li joriġinaw minn ħxejjex jew mill-annimali, fl-istat naturali tagħhom, friski jew preservati, kif ukoll prodotti derivanti mill ipproċessar industrijali ta’ l-istess, u sustanzi organiċi jew mhux organiċi, kemm jekk ikollhom addittivi kemm jekk le, li jkunu ntiżi għall-għalf orali ta’ l-annimali, kemm direttament bħala tali kemm wara l-ipproċessar tagħhom; “operatur tal-kummerċ” tfisser u tinkludi kull persuna li tkun tipproduċi medda wiesgħa ta’ għalf fi stabbiliment wieħed u li tkun timmanifattura tipi differenti ta’ prodotti wara xulxin fl-istess linja ta’ produzzjoni; “porzjon ta’ kuljum” tfisser il-kwantità totali medja ta’ ikel, kalkolata fuq kontentut ta’ umdità ta’ 12%, li tkun meħtieġa kuljum minn annimali ta’ speċi, età u daqs partikolari, biex jiġu milħuqa l-bżonnjiet kollha tagħhom; “provditur awtorizzat” tfisser persuna awtorizzata mill Awtorità biex timporta, tbiegħ bl-ingrossa jew bl-imnut sustanzi jew prodotti għall-għalf ta’ l-annimali skond dawn ir-regoli; “sustanza mhux mixtieqa” tfisser kull sustanza jew prodott minbarra aġenti patoġeniċi, li tkun tinsab fuq jew fil prodott intiż għall-għalf ta’ l-annimali u li tkun toffri periklu potenzjali għas-saħħa ta’ l-annimal jew tal-bniedem, jew lill B 2972 VERŻJONI ELETTRONIKA ambjent, jew li tkun tista’ tikkawża ħsara lill-produzzjoni tal bhejjem; “trażmissjoni jew transkontaminazzjoni” tfisser trasferiment minn minn lott ta’ produzzjoni għal ieħor li jista’ jseħħ meta l-koċċidijostati u l-istomonostati jkunu jintużaw bħala addittivi awtorizzati fl-għalf u li dak it trasferiment jista’ jirriżulta fil-kontaminazzjoni tal-għalf prodott b’mod sussegwenti minħabba l-preżenza ta’ traċċi ta’ dawk is-sustanzi fl-għalf mhux fil-mira li huma teknikament inevitabbli. Din it-transkontaminazzjoni inevitabbli tista’ sseħħ fl-istadji kollha tal-produzzjoni u l-ipproċessar tal-għalf u anke tul il-ħżin u t-trasport tal-għalf; u “withdrawal feed” tfisser għalf li jintuża fil-perjodu ta’ qabel il-qatla. 3. (1) Dawn ir-regoli għandhom japplikaw għal dawk il livelli massimi f’għalf mhux fil-mira elenkati fl-Iskeda li tinsab ma’ dawn ir-regoli biex tiġi evitata t-transkontaminazzjoni inevitabbli ta’ sustanzi mhux mixtieqa li sseħħ matul il-proċess tal-produzzjoni jew manifattura minn prodott għall-ieħor, biex tiġi żgurata konformità mal-ħtiġiet ta’ dawn ir-regoli fin-negozji ta’ l-għalf ta’ l-annimali matul il-proċess tal-produzzjoni u għalhekk biex tiġi nfurzata funzjoni xierqa tas-suq intern u biex tiġi mħarsa s-saħħa pubblika u dik ta’ l-annimali. (2) L-Awtorità kompetenti għandha tistabbilixxi u għandha tapplika dawk il-miżuri amministrattivi kollha meħtieġa skond ma’ jeħtieġu dawn ir-regoli biex tiżgura li ma jkunx hemm ksur ta’ dawn ir-regoli kif ukoll biex tnaqqas ir-riskju għal konsumaturi aħħara u kull riskju addizzjonali għall-annimali u għall-ambjent skond ma jipprovdu d-dispożizzjonijiet stabbiliti fl Iskeda li tinsab ma’ dawn ir-regoli. Il-miżuri stabbiliti f’dawn ir regoli għandhom ikunu konformi ma’ u skond il-ħtiġiet tal-katina alimentari u s- saħħa ta’ l-annimali. (3) Dawn il-miżuri għandhom jinkludu l-konfiskazzjoni diretta tal-prodott, is-sospensjoni ta’ l-attivitajiet imwettqa mill provditur awtorizzat meta dawn ikunu qed joħolqu riskju għal konsumaturi aħħara u għall-ambjent, u l-applikazzjoni ta’ multi amministrattivi. 4 . L -awto r i zzazz jon i j i e t għa l l -koċċ id i jo s t a t i u l-istomonostati bħala addittivi fl-għalf għandhom jistabbilixxu Applikabbiltà. Kundizzjonijiet ta’ awtorizzazzjonijiet. B 2973VERŻJONI ELETTRONIKA dawk il-kundizzjonijiet kollha speċifiċi għall-użu, bħal speċi jew kategoriji ta’ l-annimali bil-għan li l-addittivi huma maħsuba għalihom. 5. (1) L-operaturi konċernati għandhom jieħdu l-miżuri kollha xierqa fir-rigward tal-faċilitajiet u t-tagħmir, produzzjoni, ħżin u trasport, biex tiġi evitata kull transkontaminazzjoni, u dan skond l-obbligi stabbiliti mir-Regolament tal-Komunità Ewropeja li jistabbilixxi l-ħtiġiet għall-iġene ta’ l-għalf kif ukoll ħtiġiet speċifiċi għal negozji ta’ l-għalf li jużaw il-koċċidijostati u l-istomonostati fil-produzzjoni ta’ l-għalf. (2) L-istabbiliment tal-livelli massimi mill-Awtorità kompetenti tat-trażmissjoni inevitabbli tal-koċċidijostati u l-istomonostati fl-għalf mhux fil-mira skond ir-Regoli ta’ l-2009 dwar Sustanzi mhux Mixtieqa fl-Ikel ta’ l-Annimali, għandu japplika mingħajr preġudizzju għall-obbligu ewlieni ta’ l-operaturi ekonomiċi li japplikaw prattiċi tajba tal-manifattura bil-għan li tiġi evitata t-transkontaminazzjoni, u għalhekk l-Awtorità għandha tiżgura li l-ħtieġa ta’ sforz kontinwu mill-operaturi konċernati għandu jibqa japplika biex jevitaw il-preżenza ta’ dawk is-sustanzi mhux mixtieqa fl-għalf ta’ l-annimali. 6. (1) L-Awtorità kompetenti għandha tistabbilixxi, flimkien mat-twettiq ta’ prattiċi tajba tal-manifattura, il livelli massimi tat-trażmissjoni inevitabbli tal-koċċidijostati u l-istomonostati f’għalf li mhux fil-mira skond il-prinċipju “baxx kemm jista’ jkun raġonevolment possibbli”. (2) Il-manifattur ta’ l-għalf għandu jiġi provdut b’kull għajnuna possibli biex ikun jista’ jimmaniġġja t-trażmissjoni inevitabbli msemmija fis-subregola (1) ta’ din ir-regola, u għalhekk l-Awtorità kompetenti għandha tikkunsidra rata ta’ trażmissjoni ta’ madwar 3 % meta mqabbla mal-kontenut massimu awtorizzat ta’ sustanzi fir-rigward ta’ l-għalf mhux fil-mira għal speċi ta’ annimali li huma inqas sensittivi, filwaqt li għandha tinżamm ir rata ta’ trażmissjoni ta’ madwar 1 % meta mqabbla mal-kontenut massimu awtorizzat fir-rigward ta’ sustanzi għall-għalf mhux fil mira magħmul għal speċi ta’ annimali li huma sensittivi u għal “withdrawal feed”, meta dan ta’ l-aħħar ikun ser jingħata lill annimali li jkunu ser jintużaw għal konsum tal-bniedem jew għall użu tal-konsumatur aħħari. (3) Ir-rata tat-trażmissjoni ta’ 1 % għandha titqies ukoll għat-transkontaminazzjoni ta’ għalf ieħor fil-mira għal speċi Miżuri li għandhom jiġu addottati minn operaturi. A.L. 105 ta’ l-2009. Stabbiliment ta’ livelli massimi. B 2974 VERŻJONI ELETTRONIKA ta’ annimali li miegħu ma jkunu żdiedu ebda koċċidijostati u istomonostati, u fir-rigward ta’ l-għalf mhux fil-mira, għal annimali li kontinwament jipproduċu l-ikel, bħal ma huma l-baqar tal ħalib jew it-tiġieġ li jbidu, fejn ikun jidher li hemm evidenza ta’ trażmissjoni inevitabbli ta’ kontaminazzjoni mill-għalf għall-ikel ta’ oriġini mill-annimali. (4) Jekk il-materjali ta’ l-għalf jiġu mitmugħa b’mod dirett lill-annimali jew jekk ikun intuża l-għalf kumplimentari, dak l-użu fil-porzjon ta’ kuljum m’għandux iwassal għal livell ogħla ta’ koċċidijostati jew istomonostati li l-annimal ikun espost għalih minn livelli massimi korrispondenti li l-annimali jkunu esposti għalihom meta jkun intuża biss għalf sħiħ fil-porzjon ta’ kuljum. 7. (1) It-trażmissjoni inevitabbli f’għalf mhux fil-mira ta’ sustanzi attivi li jkunu jinsabu fil-koċċidijostati u l-istomonostati awtorizzati għandha titqies mill-Awtorità kompetenti bħala sustanzi mhux mixtieqa fl-għalf ta’ l-annimali skond ma jipprovdu ir-Regoli ta’ l-2009 dwar Sustanzi mhux mixtieqa fl-Ikel ta’ l-Annimali u l-preżenza tagħhom m’għandhiex tqiegħed fil-periklu b’kull mod ikun li jkun is-saħħa ta’ l-annimali, s-saħħa tal-bniedem jew ta’ l-ambjent. (2) Għall-fini tas-subregola (1) ta’ din ir-regola, livelli massimi għal dawn is-sustanzi fl-għalf ta’ l-annimali għandhom jiġu stabbiliti skond l-Iskeda li tinsab ma’ dawn ir-regoli biex jiġu evitati effetti ta’ ħsara u effetti mhux mixtieqa. 8. Meta l-Awtorità kompetenti tadotta dawk il-limiti massimi tal-koċċidijostati jew istomonostati fl-għalf mhux fil-mira stabbiliti fl-Iskeda li tinsab ma’ dawn ir-regoli, l-istess Awtorità kompetenti għandha tiżgura li jkun hemm konformità ma’ dawk id-dispożizzjonijiet li jistabbilixxu proċedura għal dawk il-limiti massimi ta’ residwi ta’ prodotti mediċinali veterinarji fi prodotti ta’ l-ikel ta’ oriġini mill-annimali. 9. (1) Il-livelli massimi elenkati fl-Iskeda I li tinsab ma’ dawn ir-regoli għandhom jiġu addattati mill-Awtorità kompetenti b’mod kontinwu għall-kundizzjonijiet ta’ użu stabbiliti fl awtorizzazzjonijiet tal-koċċidijostati u l-istomonostati bħala additivi ta’ l-għalf. ( 2 ) M e t a j i n ħ o l o q p e r j o d u t a ’ ż m i e n b e j n l-awtorizzazzjoni nnifisha, jew xi bidla, u, jew sospensjoni, u, jew revoka ta’ dik l-awtorizzazzjoni ta’ koċċidijostati jew istomonostati Trażmissjoni inevitabbli f’għalf mhux fil-mira. Limiti massimi ta’ residwi ta’ prodotti mediċinali veterinarji. Addattament ta’ livelli massimi għal awtorizzazzjonijiet. B 2975VERŻJONI ELETTRONIKA bħala addittivi fl-ikel u l-addattament sussegwenti għal-livelli massimi kif stabbiliti fl-Iskeda li tinsab ma’ dawn ir-regoli, dak l-addattament għandu jitqies mingħajr preġudizzju għal-livelli ta’ koċċidijostati jew istomonostati awtorizzati bħala addittivi fl-ikel, stabbiliti taħt kull liġi oħra jew regolamenti oħrajn. 10. Meta tkun teżisti l-preżenza tal-koċċidijostati jew ta’ l-istomonostati awtorizzati bħala addittivi ta’ l-għalf f’ikel jew għalf mhux fil-mira fuq livelli li jirriżultaw minn trażmissjoni jew transkontaminazzjoni inevitabbli u jkunu ttieħdu dawk il-miżuri kollha meħtieġa ta’ prevenzjoni skond dawn ir-regoli, m’għandux ikun daqshekk probabbli li dik il-preżenza tkun tirriżulta f’effetti ta’ ħsara għas-saħħa ta’ l-annimali u li għalhekk ir-riskju għas saħħa tal-konsumaturi mill-inġestjoni tar-residwi fi prodotti minn annimali li jkunu ġew esposti għal għalf ikkontaminat għandu jitqies li mhux konformi ma dawn ir-regoli, kif ukoll għandu jitqies bħala negliġibbli. 11. (1) Kull persuna li tonqos milli tħares dawn ir-regoli għandha tinsab ħatja ta’ reat skond dawn ir-regoli u skond l-Att, u għandhom ikunu japplikaw dwarha d-disposizzjonijiet tar-regola 3(2) u (3). (2) Kull dritt mogħti lill-Awtorità kompetenti taħt dawn ir-regoli u taħt l-Att biex tapplika dawk il-miżuri kollha meħtieġa msemmija fis-subregola (1) ta’ din ir-regola, għandu jiġi mogħti lill-Awtorità mingħajr preġudizzju għal proċeduri kriminali oħrajn li jistgħu jittieħdu taħt l-Att meta persuna twettaq xi reat billi tonqos mill tikkonforma ruħha ma’ dawn ir-regoli. Preżenza awtorizzata ta’ addittivi ta’ l-ikel. Reati u pieni. B 2976 VERŻJONI ELETTRONIKA 1 SKEDA Regoli 1, 2, 3, 8 u 9 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 1. Arseniku 2. omb Materjal ta’ l-ikel bl-eezzjoni ta’: ikel magmul mill-axix, minn xnien niexef u minn silla niexfa, u l-polpa tal-kanna taz-zokkor imnixxfa u polpa tal-bitt fosfati u galf miksub mill-ipproessar ta’ ut jew annimali marini ora Galf komplut b’eezzjoni ta’: galf komplut gal ut Galf kumplimentari bl-eezzjoni ta’: galf minerali Materjal ta’ l-ikel bl-eezzjoni ta’: silla adra fosfati lamtu 2 4 10 2 4 4 12 10 40 30 5 B 2977VERŻJONI ELETTRONIKA 2 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 3. Fluworin(*) Galf komplut Galf kumplimentari bl-eezzjoni ta’: galf minerali Materjali ta’ l-galf bl-eezzjoni ta’: galf ta’ l-annimali li joriina mill-annimali bl-eezzjoni ta’ krustaji tal-baar bal frott tal-baar krustaji tal-baar bal frott tal-baar fosfati karbunat tal-kalju ossidu tal-manjesju alka tal-baar kalkarja Vermikulit (E 561) Galf ta’ l-annimali kumplimentari li fihom inqas jew daqs 4% fosfru li fihom aktar minn 4% fosfru 5 10 30 150 500 3 000 2 000 350 600 1 000 3 000(**) 500 125 gal kull 1% fosfru B 2978 VERŻJONI ELETTRONIKA 3 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% Galf ta’ l-annimali komplut bl-eezzjoni ta’: galf ta’ l-annimali komplut gal annimali ta’ l-ifrat, naga u mogo fit-treddieg orajn galf ta’ l-annimali komplut gall-nieer galf ta’ l-annimali komplut gat-tjur galf ta’ l-annimali komplut gall-flieles galf ta’ l-annimali komplut gall-ut 150 30 50 100 350 250 350 (*) Il-livelli massimi jirreferu gal determinazzjoni analitika ta’ l-fluworin, fejn l-estrazzjoni ssir bl-aidu idrokloriku 1 N gal 20 minuta f’temperatura ambjentali. Proeduri ta’ estrazzjoni ekwivalenti jistgu jiu applikati fejn jista’ jintwera li l-proedura ta’ estrazzjoni wata gandha l-istess effijenza ta’ estrazzjoni. (**)Livelli riveduti sal-31 ta’ Diembru 2008 bl-gan li jitnaqqsu l-livelli massimi. 4. Merkurju Materjal ta’ l-ikel bl-eezzjoni ta’: galf prodott mill-ipproessar tal-ut jew annimali ora tal-baar. 0.1 0.5 B 2979VERŻJONI ELETTRONIKA 4 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 5. Nitrati 6. Kadmijum Galf komplut bl-eezzjoni ta’: galf komplut gal klieb u qtates Galf kumplimentari bl-eezzjoni ta’: galf kumplimentari gal klieb u qtates Ikel tal-ut Galf komplut minn barra: galf inti gal annimali domestii minbarra gasafar u ut ta’ l-akwarju Materjali ta’ l-ikel li joriinaw mill-axix Materjali ta’ l-ikel li joriinaw mill-annimali, minbarra: galf gal annimali domestii Fosfati Galf komplut gal baqar, naga u mogo bl-eezzjoni ta’: galf komplut gal gool, rief u giddi 0.1 0.4 0.2 60 (espress bala sodium nitrate) 15 (espress bala sodium nitrate) 1 2 10(1) 1 B 2980 VERŻJONI ELETTRONIKA 5 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 7. Aflatoxin B1 Galf komplut ieor bl-eezzjoni ta’: galf gal annimali domestii Galf minerali Galf kumplimentari ieor gal baqar, naga u mogo Materjali ta’ l-ikel bl-eezzjoni ta’: karawett, kopra, il-qalba tal-palma, erriega tal-qoton, babassu, qam ir-run u prodotti miksuba mill-ipproessar ta’: Galf komplut gal baqar, naga u mogo bl-eezzjoni ta’: baqar li jailbu l-alib goiela u rief Galf komplut gal nieer u t-tjur (minbarra annimali gar) Galf ieor komplut Galf kumplimentari gal baqar, naga u mogo (minbarra galf kumplimentari gal annimali, goiela u rief li jagmlu l-alib) 0.5 5(2) 0.5 0.05 0.02 0.05 0.005 0.01 0.02 0.01 0.05 B 2981VERŻJONI ELETTRONIKA 6 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 8. Aidu idroiniku 9. Gossipol ieles Galf kumplimentari gal nieer u tjur (minbarra annimali gar) Galf kumplimentari ieor Materjali ta’ l-ikel bl-eezzjoni ta’: erriega tal-kittien torti ta-erriega ta’ l-kittien prodotti tal-manjoka u torti tal-lew Galf komplut bl-eezzjoni ta’: galf komplut gall-flieles Materjali ta’ l-ikel bl-eezzjoni ta’: torti ta-erriega tal-qoton Galf komplut bl-eezzjoni ta’: galf komplut gal baqar, naga u mogo galf komplut gal tjur (minbarra tiie li jbidu) u gool galf komplut gal fniek u nieer (minbarra nieer gar) 0.03 0.005 50 250 350 100 50 10 20 1 200 20 500 100 60 B 2982 VERŻJONI ELETTRONIKA 7 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 10. Theobromine 11. ejt tal-mustarda volatili 12. Vinal thiooxazolidone (Vinyloxazolidine thione) 13. Rye ergot (Claviceps purpurea) Galf komplut bl-eezzjoni ta’: galf komplut gal baqar adulti Materjali ta’ l-ikel bl-eezzjoni ta’: gana ta-erriega tal-kolza Galf komplut bl-eezzjoni ta’: galf komplut gal baqar, naga u mogo (minbarra annimal gar) galf komplut gal nieer (minbarra nieer gar) u tjur Gal komplut gal tjur bl-eezzjoni ta’: galf komplut gal tiie li jbidu L-galf kollu li fihom ereali ta’ tat l-art 300 700 100 4 000 (espress bala ally1 isothiocyanate) 150 (espress bala ally1 isothiocyanate) 1 000 (espress bala ally1 isothiocyanate) 500 (espress bala ally1 isothiocyanate) 1 000 500 1 000 B 2983VERŻJONI ELETTRONIKA 8 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 14. erriega tal-axix ain u frott mhux mitun u mhux magsur li fih alkalojdi, glucosides jew sustanzi tossii ora separatament jew flimkien inklui. Datura stramonium L. 15. Castor oil paint – Ricinus communis L. 16. Crotalaria spp. 17. Aldrin wadu || Jew kombinat espress || 18. Dieldrin bala dieldrin 19. Camphechlor (toxaphene) Chlordane (somma ta’ is-u transisomers u ta’ oxychlordane, espressi bala chlordane) L-galf kollu ta’ l-annimali L-galf kollu L-galf kollu L-galf kollu bl-eezzjoni ta’: xamijiet L-galf kollu L-galf kollu bl-eezzjoni ta’: xamijiet 3 000 1 000 10 (espressi f’termini ta’ qoxra tar-rignuwa) 100 0.01 0.02 0.1 0.02 0.05 ,.. >- > ., I-' B 2984 VERŻJONI ELETTRONIKA 9 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm)meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 20. DDT (total ta’ DDT DDD-(jew TDE-) u DDE-iomeri, espressi bala DDT) 21. Endosulfan (somma ta’ alpha- u beta isomers u ta’ endosulfansulphate espressi bala endosulfan) 22. Endrin (somma ta’ endrin u ta’ delta ketoi-endrin, espressi bala endrin) 23. Heptachlor (somma ta’ heptachlor u ta’ heptachlorepoxide, espress bala heptachlor) 24. Hexachlorobenzene (HCB) L-galf kollu ta’ l-annimali bl-eezzjoni ta’: xamijiet u jut L-galf kollu bl-eezzjoni ta’: qamirrun erriega ta-ejt galf komplut gal ut Galf kollu bl-eezzjoni ta’: xamijiet L-galf kollu bl-eezzjoni ta’: xamijiet L-galf kollu bl-eezzjoni ta’: xamijiet 0.05 0.5 0.1 0.2 0.5 0.005 0.01 0.05 0.01 0.2 0.01 0.2 B 2985VERŻJONI ELETTRONIKA 10 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 26. Hexachlorocyclo hexane (HCH) 26.1 alpha-isomers 26.2 beta-isomers 26.3 gamma-isomers 27. Dioxin (somma ta’ PCDD u PCDF), espressa f’ekwivalenti internazzjonali tossii L-galf kollu bl-eezzjoni ta’: xamijiet Galf kompost bl-eezzjoni ta’: galf gal baqar li jailbu Materjali ta’ l-ikel bl-eezzjoni ta’: xamijiet L-galf kollu bl-eezzjoni ta’: xamijiet Polpa ta-itru 0.02 0.2 0.01 0.005 0.01 0.1 0.2 2.0 500 pg I –TEQ/kg (limitu t’garfien ta’ fuq) (3) B 2986 VERŻJONI ELETTRONIKA 11 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 28. ew tal-fagu mingajr qoxra Fagus silvatica L. 29. Mowrah, Bassia, Madhuca – Madhuca longifolia (L.) Macbr. (= Bassia longifolia L. = Illiped malabromm Engl.) Madhuca indica Gmelin (= Bassia latifolia Roxb.) = Illipe latifolia (Roscb.) F. Mueller) 30. Purghera – Jatropha curcas L. 31. Croton – Croton tiglium L. 32. Mustarda Indjana – Brassica juncea (L.) Czern. u Coss. ssp. Intergrifolia (West.) Thell 33. Mustarda sareptian – Brassica juncea (L.) Czern. u Coss. ssp. Juncea 34. Mustarda inia – Brassica juncea (L.) Czern. u Coss. ssp. Juncea var. lutea Batalin 35. Mustarda sewda – Brassica nigra (L.) Koch L-galf kollu erriega u frott ta’ l-ispei ta’ pjanti mnila faata kif ukoll id-derivati proessati taghom jistgu ikunu preenti fl-galf f’ammonti ta’ trai li ma jistgux ikunu determinati kwantitivament. \ \ B 2987VERŻJONI ELETTRONIKA 12 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali Il-kontenut massimu f’mg/kg(ppm) meta mqabbel m’galf b’kontenut imxarrab ta’ 12% 36. Mustarda Etijopjana mustard – Brassica carinata A. Braun L-galf kollu. erriega u frott ta’ l-ispei ta’ pjanti mnila faata kif ukoll id-derivati proessati taghom jistgu ikunu preenti fl-galf f’ammonti ta’ trai li ma jistgux ikunu determinati kwantitivament. (1) L-Istati Membri jistgu ukoll jippreskrivu kontenut massimu ta’ kadmijun ta’ 0.5 mg kull 1% fosfru. (2) L-Istati Membri jistgu ukoll jippreskrivu kontenut massimu ta’ kadmijum ta’ 0.75 mg kull 1% fosforu. (3) Konentrazzjonijiet ta’ fuq huma kalkulati bl-assumzjoni li l-valuri kollha tal congeners differenti u tnei l-limitu ta’ tisjib huma ugwali gal limitu ta’ tisjib. B 2988 VERŻJONI ELETTRONIKA 13 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 37. Lasalocid sodium 38. Narasin Materjali gall-galf Galf kompost gal: klieb, goiela, fniek, spei ekwini, annimali tal-alib, gasafar li jbidu, dundjani (>12 -il imga) u tiie imrobbija biex ibidu (>16 -il imga); tiie gat-tismin, tiie imrobbija biex ibidu (<16 -il imga) u dundjani (<12 -il imga) gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu tal-lasalocid sodium (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl-galf fejn mhux awtorizzat l-uu tal-lasalocid sodium. Materjali gall-galf Galf kompost gal: 1.25 1.25 1.25 3.75 (**) 0.7 B 2989VERŻJONI ELETTRONIKA 14 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 39. Salinomycin sodium dundjani, fniek, spei ekwini, gasafar li jbidu, u tiie imrobbija biex ibidu (>16 -il imga); tiie gat-tismin gall-perjodu qabel il-qatla fejn mhux permess l-uu tan-narasin (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl-galf fejn mhux awtorizzat l-uu tan-narasin. Materjali gall-galf Galf kompost gal: spei ekwini, dundjani, gasafar li jbidu, u tiie imrobbija biex ibidu (>12 -il imga) tiie gat-tismin, tiie imrobbija biex ibidu (<12 -il imga) u fniek 0.7 0.7 2.1 (**) 0.7 0.7 0.7 B 2990 VERŻJONI ELETTRONIKA 15 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 40. Monensin sodium gat-tismin gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu ta’ salinomycin sodium (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl-galf fejn mhux awtorizzat l-uu tas-salinomycin sodium. Materjali gall-galf Galf kompost gal: spei ekwini, klieb, annimali gar li jixtarru, naga u mogo, papri, bovini, bhejjem tal alib, gasafar li jbidu, tiie imrobbija biex ibidu (>16 -il imga) u dundjani (>16 -il imga); tiie gat-tismin, tiie imrobbija biex ibidu (<16 -il imga) u dundjani (<16 -il imga) gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu tal-monensin 2.1 (**) 1.25 1.25 1.25 B 2991VERŻJONI ELETTRONIKA 16 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 41. Semduramicin sodium 42. Maduramicin ammonium alpha sodium (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tal-monensin sodium. Materjali gall-galf Galf kompost gal: gasafar li jbidu u tiie imrobbija biex ibidu (>16 -il imga); tiie gat-tismin gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu tas semduramicin sodium (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tas-semduramicin sodium. Materjali gall-galf Galf kompost gal: 3.75 (**) 0.25 0.25 0.25 0.75 (**) 0.05 B 2992 VERŻJONI ELETTRONIKA 17 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 43. Robenidine hydrochloride spei ekwini, fniek, dundjani (>16 -il imga), gasafar li jbidu, u tiie imrobbija biex ibidu (>16 -il imga); tiie gat-tismin u dundjani (<16 -il imga) gall perjodu ta’ qabel il qatla fejn m’huwiex permess l-uu tal maduramicin ammonium alpha (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tal-maduramicin ammonium alpha. Materjali gall-galf Galf kompost gal: gasafar li jbidu u tiie imrobbija biex ibidu (>16-il imga); tiie gat-tismin, fniek gat-tismin u gat-tgammir u dundjani gall perjodu qabel il qatla fejn m’huwiex 0.05 0.05 0.15 (**) 0.7 0.7 0.7 B 2993VERŻJONI ELETTRONIKA 18 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 44. Decoquinate permess l-uu tar robenidine hydrochloride (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tar-robenidine hydrochloride. Materjali gall-galf Galf kompost gal: gasafar li jbidu u tiie imrobbija biex ibidu (>16 -il imga); tiie gat-tismin gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu tad decoquinate (withdrawal feed); spei ta’ annimali ora. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tad-decoquinate. 2.1 (**) 0.4 0.4 0.4 1.2 (**) B 2994 VERŻJONI ELETTRONIKA 19 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 45. Halofuginone hydrobromide 46. Nicarbazin Materjali gall-galf Galf kompost gal: gasafar li jbidu, u tiie imrobbija biex ibidu (>16 -il imga) u dundjani (>12 -il imga); tiie gat-tismin u dundjani (<12 -il imga) gall perjodu ta’ qabel il qatla fejn m’huwiex permess l-uu tal halofuginone hydrobromide (withdrawal feed); spei ta’ annimali ora lief it-tiie imrobbija biex ibidu (<16 -il imga). Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tal-halofuginone hydrobromide. Materjali gall-galf Galf kompost gal: spei ekwini, gasafar li jbidu, u tiie imrobbija biex ibidu (>16 -il imga); 0.03 0.03 0.03 0.09 (**) 0.5 0.5 B 2995VERŻJONI ELETTRONIKA 20 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% 47. Diclazuril tiie gat-tismin gall-perjodu ta’ qabel il-qatla fejn m’huwiex permess l-uu tan-nicarbazin (imallat man narasin) (withdrawal feed); spei ta’ annimali. Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tan-nicarbazin (imallat man-narasin). Materjali gall-galf Galf kompost gal: gasafar li jbidu, u tiie imrobbija biex ibidu (>16 -il imga) u dundjani gat-tismin (>12 -il imga); fniek gat-tismin u gat-tgammir gall-perjodu qabel il-qatla fejn m’huwiex permess l-uu tad-diclazuril (withdrawal feed); spei ta’ annimali ora lief it-tiie imrobbija biex ibidu (<16 -il imga), tiie gat-tismin u 0.5 1.5 (**) 0.01 0.01 0.01 0.03 B 2996 VERŻJONI ELETTRONIKA 21 Sustanzi mhux mixtieqa Prodotti ntii gal galf ta’ l-annimali (*) Livelli massimi f’mg/kg (ppm) meta mqabbel ma’ galf b’kontenut ta’ umdita’ ta’ 12% u dundjani gat tismin (<12 -il imga) Pretalitiet gall-uu fl galf fejn mhux awtorizzat l-uu tad-diclaruzil. (**) (*) Bla sara gal-livelli awtorizzati fil-qafas tar-Regolament (KE) Nru 1831/2003 tal Parlament Ewropew u tal-Kunsill tat-22 ta’ Settembru 2003 fuq l-addittivi gall-uu fl-galf tal-annimali. (**) Il-livell massimu tas-sustanza fil-pretalitiet huwa l-konentrazzjoni li ma tirriultax fil-livell tas-sustanza ogla minn 50% tal-livelli massimi stabbiliti meta jiu segwiti l-istruzzjonijiet gall-uu tal-pretalitiet. B 2997VERŻJONI ELETTRONIKA L.N. 257 of 2009 VETERINARY SERVICES ACT (CAP. 437) Maximum Levels of Unavoidable Carry-Over of Coccidiostats or Histomonostats in Non-Target Feed Rules, 2009 IN exercise of the powers conferred by article 10 of the Veterinary Services Act, the Minister for Resources and Rural Affairs, after consultation with the Minister for Social Policy, has made the following rules: 1. (1) The title of these rules is Maximum Levels of Unavoidable Carry-Over of Coccidiostats or Histomonostats in Non-Target Feed Rules, 2009. (2) The scope of these regulations is to transpose and implement Directive 2009/8/EC of the European Commission which amends the First Annex to Directive 2002/32/EC of the European Parliament and the Council regarding undesirable substances in animal feed as last amended by Directive 2008/76/ EC and which establish maximum levels of coccidiostats or histomonostats when these undesirable substances transmit themselves in an unavoidable manner in animal feed. (3) These rules shall be deemed to have come into force on the 1st of July, 2009. 2. (1) Unless otherwise stated in these rules, the definitions prescribed in the Act shall apply. (2) For the purpose of these rules and unless the context otherwise requires: “the Act” means the Veterinary Services Act; “additives” shall have the same meaning as defined in Article 2(a) of Council Directive Order 70/524/EEC; “animals” means continuous food-producing animals and shall also include animals which belong to species and, or categories normally fed and kept or consumed by man; “authorisation for additives” means an authorisation Title, scope and commencement. Interpretation. B 2998 VERŻJONI ELETTRONIKA issued by the competent authority in order to authorise the use of coccidiostats and histomonostats in animal feed when such substances are used as authorised feed additives; “authorised provider” means a person authorised by the Authority to import, wholesale or retail substances or products for animal feed in terms of these rules; “business operators” means and includes any person who produces, within one establishment, a broad range of feeds and different types of products may have to be manufactured after each other in the same production line; “carry over or cross-contamination” means the transfer from one production lot to another which may occur when the coccidiostats and histomonostats are used as authorised feed additives and which transfer may result in the contamination of feed produced subsequently by the presence of technically unavoidable traces of such substances in non-target feed. Such unavoidable cross-contamination may occur at all stages of production and processing of feed and also during storage and transport of feed; “coccidiostats and histomonostats” means substances intended to kill or inhibit protozoa, which may, inter alia, be authorised for use as feed additives in accordance with the regulations on additives for use in animal feeds; “the Commission” means the Commission of the European Union; “the Community” means the European Community; “the competent Authority” means the Veterinary Services Authority as established by the Act; “complementary feeding stuffs” means mixtures of feeding stuffs which have a high content of certain substances and which, by reason of their composition, are sufficient for a daily portion only if used in combination with other feeding stuffs; “the Council” means the Council of the European Union; B 2999VERŻJONI ELETTRONIKA “daily portion” means the average total quantity of feeding stuffs, calculated on a moisture content of 12%, required daily by an animal of a given species, age class and yield, to satisfy all its needs; “feed materials” means various products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, whether containing additives or not, which are intended for use in oral animal feeding either directly as such or after the processing thereof; “feeding stuffs” means products of vegetable or animal origin, in their natural state, fresh or preserved, and products derived from the industrial processing thereof, and organic or inorganic substances, used singly or in mixtures, whether containing additives or not, for oral animal feeding; “final consumer” means a person who buys particular nutritive products produced by animals for one’s own personal use; “maximum leve l s” means such leve l s which the competent Authority shall establish for the use of coccidiostats and histomonostats when these substances may leave unavoidable traces of a product which, in the process of production or manufacturing, end up in another feed product and which levels are listed in the Schedule to these rules; “maximum residue limits” means such limits which cannot be exceeded and as established by the Community regarding the maximum residue of veterinary medical products authorised in products of animal origin; “non-target feed” means feed for which the use of coccidiostats or histomonostats are not authorised, such as feed intended for animal species or categories not provided for in the authorisation for additives; “undesirable substance” means any substance or product, with the exception of pathogenic agents, which is present in, or on the product intended for animal feed and which presents a potential danger to animal or human health or to the environment or which could adversely affect livestock production; and B 3000 VERŻJONI ELETTRONIKA “withdrawal feed” means feed used for the period before slaughter. 3. (1) These rules shall apply to such maximum levels in non-target feed listed in the Schedule hereto to prevent unavoidable carry-over of undesirable substances which occur during the process of production or manufacture from one product to another, in order to ensure conformity with the requirements of these rules in the business of animal feeding stuffs during the production process and thus to enforce a proper functioning of the internal market and to safeguard public health and animal health. (2) The competent Authority shall establish and apply all such necessary administrative measures according to the requirements of these rules to ensure that there is no breach of these rules and also to reduce the risk for final consumers and any additional risk to animals and to the environment in terms of the provisions established in the Schedule to these rules. The measures established in these rules shall conform with and be in accordance with the requirements of the food chain and animal health. (3) These measures shal l include the d i rect confiscation of the product, the suspension of the activities carried out by the authorised provider when these are creating a risk to final consumers and to the environment, and the application of administrative fines. 4. The authorisations for coccidiostats and histomonostats as feed additives shall establish all such specific conditions for use, such as the target animal species or categories for which the additives are intended. 5. (1) The operators concerned shall take all appropriate measures with regard to facilities and equipment, production, storage and transport, to prevent any cross-contamination, and this in accordance with the obligations established by the European Community Regulation which establishes requirements for feed hygene and also specific requirements for feed businesses which use coccidiostats and histomonostats in the production of feed. (2) The establishment of maximum levels by the competent Authority of unavoidable carry-over of coccidiostats and histomonostats in non-target feed according to Undesirable Substances in Animal Feed Rules, 2009 shall apply without prejudice to the primary obligation of economic operators to Applicability. Conditions of authorisation. Measures which shall be adopted by operators. L.N. 105 of 2009. B 3001VERŻJONI ELETTRONIKA apply good manufacturing practices with the aim of preventing cross-contamination, and thus the Authority shall ensure that the requirement of a continuous effort by the operators concerned shall continue to apply to prevent the presence of such undesirable substances in animal feed. 6. (1) The competent Authority shall establish together with the carrying out of good manufacturing practices, the maximum levels of unavoidable carry-over of coccidiostats and histomonostats in non-target feed according to the principal ‘As Low As Reasonably Achievable’. (2) The feed manufacturer shall be provided with any possible aid to be able to manage the unavoidable carry over mentioned in sub-rule (1) hereof, and thus the competent authority shall consider a carry-over rate of approximately 3 % when compared to the maximum authorised content of substances regarding non-target feed for animal species which are less sensitive, while a carry-over rate of approximately 1 % shall be retained when compared to the maximum authorised content of substances for non-target feed made for animal species which are sensitive and for “withdrawal feed”, when the latter is to be given to animals to be used for human consumption or for the use of final consumers. (3) The carry-over rate of 1 % shall also be taken into consideration for the cross-contamination of other target feed for species to which no coccidiostats or histomonostats have been added, and with regard to non-target feed, for continuous producing animals, such as dairy cows and laying hens, where there is evidence of unavoidable carry-over of contamination from feed to food of animal origin. (4) If feed materials are fed directly to animals or if complementary feeding-stuffs has been used, such use in a daily portion shall not lead to the animal being exposed to a higher level of coccidiostat or histomonostat than the corresponding maxium levels to which animals are exposed where only complete feedingstuffs are used in a daily portion. 7. (1) The unavoidable carry-over in non-target feed of active substances contained in authorised coccidiostats and histomonostats shall be considered by the competent Authority as undesirable substances in animal feed in terms of the Undesirable Substances in Animal Feed Rules, 2009 and their presence shall Establishment of maximum levels. Unavoidable carry over in non-target feed. B 3002 VERŻJONI ELETTRONIKA not, in any manner whatsoever endanger animal health, human health or the environment. (2) For the purpose of sub-rule (1) hereof, maximum levels for these substances in animal feed shall be established in terms of the Schedule to these rules in order to prevent harmful and undesirable effects. 8. When the competent Authority adopts such mamimum limits of coccidiostats or histomonostats in non-target feeds established in the Schedule to these rules, the same competent Authority shall ensue that there is conformity with such provisions which establish the procedure for such maximum residue limits of veterinary medical products in feed products of animal origin. 9. (1) The maximum levels listed in Schedule 1 to these rules shall be continuously adapted to the conditions of use provided for in the authorisations of coccidiostats and histomonostats as feed additives. (2) When a period of time occurs between the authorisation itself and, or any modification, and, or suspension and, or revocation of such authorisation of coccidiostats or histomonostats as feed additive and the subsequent adjustment to the maximum levels as established in the Schedule to these rules, such adjustment shall be considered as being without prejudice to the levels of coccidiostats or histomonostats authorised as feed additives under any other law or regulations. 10. When there exists the authorised presence of coccidiostats and histomonostats as feed additives in non-target feed on levels which result from unavoidable carry-over or cross contamination and all such necessary precautionary measures have been taken according to these rules, it shall be very unlikely that such presence results in adverse animal health effects and thus the risk to consumers’ health from the ingestion of residues in products from animals exposed to cross-contaminated feed shall be considered as not being in conformity with these rules, and shall also be considered as negligible. 11. (1) Any person who fails to abide by these rules shall be guilty of an offence in terms of these rules in terms of the Act and the provisions of rule 3(2) and (3) shall apply to it. Maximum residue limits of veterinary medical products. Adjustment of maximum levels for authorisations. Authorised presence of feed additives. Offences and penalties. B 3003VERŻJONI ELETTRONIKA (2) Any right given to the competent Authority under these rules to apply all such necessary measures prescribed in sub rule (1) hereof, shall be given to the Authority without prejudice to other criminal procedures which may be taken under any other law when a person commits an offence by failing to abide by these rules. B 3004 VERŻJONI ELETTRONIKA 11 SCHEDULE Rules 1, 2, 3, 8 and 9 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 1. Arsenic 2. Lead Feed materials with the exception of: meal made from grass, from dried Lucerne and from dried clover, and dried sugar beet pulp and dried molasses sugar beet pulp phosphates and feeding stuffs obtained from the processing of fish or other marine animals Complete feeding stuffs with the exception of: complete feeding stuffs for fish Complementary feeding stuffs with the exception of: mineral feeding stuffs Feed materials with the exception of: green fodder phosphates 2 4 10 2 4 4 12 10 40 30 B 3005VERŻJONI ELETTRONIKA 12 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 3. Fluorine (*) yeasts Complete feeding stuffs Complementary feeding stuffs with the exception of: mineral feeding stuffs Feed materials with the exception of: feeding stuffs of animal origin with the exception of marine crustaceans such as marine krill marine crustaceans such as marine krill phosphates calcium carbonate magnesium oxide calcareous marine algae Vermiculite (E 561) Complementary feeding stuffs containing 4% or less phosphorous containing more than 4% phosphorous 5 5 10 30 150 500 3 000 2 000 350 600 1 000 3 000 (**) 500 125 per 1% phosphorous B 3006 VERŻJONI ELETTRONIKA 13 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% Complete feeding stuffs with the exception of: complete feeding stuffs for cattle sheep and goats in lactation other complete feeding stuffs for pigs complete feeding stuffs for poultry complete feeding stuffs for chicks complete feeding stuffs for fish 150 30 50 100 350 250 350 (*) Maximum levels refer to an analytical determination of fluorine, whereby extraction is performed with hydrochloric acid 1 N for 20 minutes at ambient temperature. Equivalent extraction procedures can be applied for which it can be demonstrated that the used extraction procedure has an equal extraction efficiency. (**) Levels being reviewed by 31 st December 2008 with the aim of reducing the maximum levels. 4. Mercury Feed materials with the exception of: feeding stuffs produced by the processing of fish or other marine animals Complete feeding stuffs with the exception of: complete feeding stuffs for dogs and cats 0.1 0.5 0.1 0.4 B 3007VERŻJONI ELETTRONIKA 14 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 5. Nitrites 6. Cadmium Complementary feeding stuffs except: complementary feeding stuffs for dogs and cats Fish meal Complete feeding stuffs excluding: feeding stuffs intended for pets except birds and aquarium fish Feed materials of vegetable origin Feed materials of animal origin except: feeding stuffs for pets Phosphates Complete feeding stuffs for cattle, sheep and goats except: complete feeding stuffs for calves, lambs and kids Other complete feeding stuffs except: 0.2 60 (expressed as sodium nitrate) 15 (expressed as sodium nitrate) 1 2 10( 1 ) 1 0.5 B 3008 VERŻJONI ELETTRONIKA 15 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 7. Aflatoxin B1 feeding stuffs for pets Mineral feeding stuffs Feed materials with the exception of: ground nut, copra, palm-kernel, cotton seed, babassu, maize and products derived from the processing thereof Complete feeding stuffs for cattle, sheep and goats with the exception of: dairy cattle calves and lambs Complete feeding stuffs for pigs and poultry (except young animals) Other complete feeding stuffs Complementary feeding stuffs for cattle, sheep and goats (except complementary feeding stuffs for dairy animals, calves and lambs) Complementary feeding stuffs for pigs and poultry (except young animals) 5( 2 ) 0.05 0.02 0.05 0.005 0.01 0.02 0.01 0.05 0.03 B 3009VERŻJONI ELETTRONIKA 16 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 8. Hydrocyanic acid 9. Free gossypol Other complementary feeding stuffs Feed materials with the exception of: linseed linseed cakes manioc products and almond cakes Complete feeding stuffs with the exception of: complete feeding stuffs for chicks Feed materials with the exception of: cotton-seed cakes Complete feeding stuffs with the exception of: complete feeding stuffs for cattle, sheep and goats complete feeding stuffs for poultry (except laying hens) and calves complete feeding stuffs for rabbits and pigs (except piglets) 0.005 50 250 350 100 50 10 20 1 200 20 500 100 60 B 3010 VERŻJONI ELETTRONIKA 17 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 10. Theobromine 11. Volatile mustard oil 12. Vinal thiooxazolidone (Vinyloxazolidine thione) Complete feeding stuffs with the exception of: complete feeding stuffs for adult cattle Feed materials with the exception of: rapseed cakes Complete feeding stuffs with the exception of: complete feeding stuffs for cattle, sheep and goats (except young animals) complete feeding stuffs for pigs (except piglets) and poultry Complete feeding stuffs for poultry with the exception of: complete feeding stuffs for laying hens 300 700 100 4 000 (expressed as ally1 isothiocyanate) 150 (expressed as ally1 isothiocyanate) 1 000 (expressed as ally1 isothiocyanate) 500 (expressed as ally1 isothiocyanate) 1 000 500 B 3011VERŻJONI ELETTRONIKA 18 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 13. Rye ergot (Claviceps purpurea) 14. Weed seeds and ungrounded and uncrushed fruits containing alkaloids, glucosides or other toxic substances separately or in combination including Datura stramonium L. 15. Castor oil plant – Ricinus communis L. 16. Crotalaria spp. 17. Aldrin || Singly or combined expressed as dieldrin || 18. Dieldrin 19. Camphechlor (toxaphene) All feeding stuffs containing ungrounded cereals All feeding stuffs All feeding stuffs All feeding stuffs All feeding stuffs with the exception of: fats All feeding stuffs 1 000 3 000 1 000 10 (expressed in terms of castor-oil plants husks) 100 0.01 0.2 0.1 "' "' > > ., B 3012 VERŻJONI ELETTRONIKA 19 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 20. Chlordane (sum of cis- and transisomers and of oxychlordane, expressed as chlordane) 21. DDT (sum of DDT-, DDD-, (or TDE-) and DDE- isomers, expressed as DDT) 22. Endosulfan (sum of alpha- and beta isomers and of endosulfansulphate expressed as endosulfan) 23. Endrin (sum of endrin and of delta ketoi-endrin, expressed as endrin) 24. Heptachlor (sum of heptachlor and of heptachlorepoxide, expressed as heptachlor) 25. Hexachlorobenzene (HCB) All feeding stuffs with the exception of: fats All feeding stuffs with the exception of: fats and oils All feeding stuffs with the exception of: maize oilseeds complete feeding stuffs for fish All feeding stuffs with the exception of: fats All feeding stuffs with the exception of: fats All feeding stuffs with the exception of: fats 0.02 0.05 0.05 0.5 0.1 0.2 0.5 0.005 0.01 0.05 0.01 0.2 0.01 0.2 B 3013VERŻJONI ELETTRONIKA 20 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 26. Hexachlorocyclo hexane (HCH) alpha-isomer beta-isomers 26.3 gamma-isomers 27. Dioxin (sum of PCDD and PCDF), expressed in international toxic equivalent All feeding stuffs with the exception of: fats Compound feeding stuffs with the exception of: feeding stuffs for daily cattle Feed materials with the exception of: fats All feeding stuffs with the exception of: fats Citrus pulp 0.02 0.2 0.01 0.05 0.01 0.1 0.2 2.0 500pg I-TEQ/kg (upper bound detection limit) ( 3 ) B 3014 VERŻJONI ELETTRONIKA 21 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 28. Unhusked beech mast — Fagus silvatica L. 29. Mowrah, Bassia, Madhuca – Madhuca longfolia (L.) Macbr. (= Bassia longifolia L. = Illiped malabrorum Engl.) Madhuca indica Gmelin (= Bassia latifolia Roxb.) = Illipe latifolia (Roscb.) F. Mueller) 30. Purgghera – Jatropha curcas L. 31. Croton – Croton tiglium L. 32. Indian mustard Brassica juncea(L.) Czern. And Coss. ssp intergrfolia (West.) Thell. 33. Sareptian mustard – Brassica juncea (L.) Czern. And Coss. ssp. juncea 34. Chinese mustard – Brassica juncea (L.) Czern. And Coss. ssp. juncea var. lutea Batalin All feeding stuffs Seeds and fruit of the plant species listed opposite as well as their processed derivates may only be present in feeding stuffs in trace amounts not quantitatively determinable B 3015VERŻJONI ELETTRONIKA 22 Undesirable substances Products intended for animal feed Maximum content in mg/kg(ppm) relative to a feeding stuff with a moisture content of 12% 35. Black mustard – Brassica nigra (L.) Koch 36. Ethiopian mustard – Brassica carinata A. Braun All feeding stuffs Seeds and fruit of the plant species listed opposite as well as their processed derivates may only be present in feeding stuffs in trace amounts not quantitatively determinable ( 1 ) Member States may also prescribe a maximum cadmium content of 0.5 per 1% phosphorus. ( 2 ) Member States may also prescribe a maximum cadmium content of 0.75 per 1% phosphorus. ( 3 ) Upper bound concentrations are calculated assuming that all values of the different congeners less than the limit of detection are equal to the limit of detection. ' 'I > > B 3016 VERŻJONI ELETTRONIKA 23 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 37. Lasalocid sodium 38. Narasin Feed materials Compound feed for Dogs, calves, rabbits, equine species, dairy animals, laying birds, turkeys (>12 weeks) and chickens reared for laying (>16weeks); Chickens for fattening, chickens reared for laying (<16weeks) and turkeys (<12weeks) for the period before slaughter in which the use of lasalocid sodium is prohibited (withdrawal feed); Other animal species Premixtures for use in feed in which the use of lasalocid sodium is not authorised. Feed materials Compound feed for Turkeys, rabbits, equine species, laying birds and chickens reared for laying (>16weeks); 1,25 1,25 1,25 3,75 (**) 0,7 0,7 B 3017VERŻJONI ELETTRONIKA 24 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 39. Salinomycin sodium Chickens for fattening for the period before slaughter in which the use of narasin is prohibited (withdrawal feed); Other animal species Premixtures for use in feed in which the use of narasin is not authorised. Feed materials Compound feed for Equine species, turkeys, laying birds and chickens reared for laying (>12weeks) Chickens for fattening, chickens reared for laying (<12 weeks) and rabbits for fattening for the period before slaughter in which the use of salinomycin sodium is prohibited (withdrawal feed); Other animal species. 0,7 2,1 (**) 0,7 0,7 0,7 2,1 B 3018 VERŻJONI ELETTRONIKA 25 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 40. Monensin sodium Premixtures for use in feed in which the use of salinomycin sodium is not authorised. Feed materials Compound feed for Equine species, dogs, small ruminants (sheep and goat) ducks, bovine, dairy cattle, laying birds, chickens reared for laying (>16weeks) and turkeys (>16weeks); Chickens for fattening, chickens reared for laying (<16weeks) and turkeys (<16weeks) for the period before slaughter in which the use of monensin sodium is prohibited (withdrawal feed); Other animal species Premixtures for use in feed in which the use of monensin sodium is not authorised. (**) 1,25 1,25 1,25 3,75 (**) B 3019VERŻJONI ELETTRONIKA 26 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 41. Semduramicin sodium 42. Maduramicin ammonium alpha Feed materials Compound for feed Laying birds and chickens reared for laying (>16weeks) Chickens for fattening for the period before slaughter in which the use of semduramicin sodium is prohibited (withdrawal feed); Other animal species. Premixtures for use in feed in which the use of semduramicin sodium is not authorised. Feed materials Compound feed for Equine species, rabbits, turkeys (>16weeks), laying birds and chickens reared for laying (>16weeks) 0,25 0,25 0,25 0,75 (**) 0,05 0,05 B 3020 VERŻJONI ELETTRONIKA 27 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 43. Robenidine hydrochloride Chickens for fattening and turkeys (<16weeks) for the period before slaughter in which the use of maduramicin ammonium alpha is prohibited (withdrawal feed); Other animal species Premixtures for use in feed in which the use of maduramicin ammonium alpha is not authorised. Feed materials Compound feed for Laying birds and chickens reared for laying (>16weeks); Chickens for fattening, rabbits for fattening and breeding and turkeys for the period before slaughter in which the use of robenidine hydrochloride is prohibited (withdrawal feed); Other species. 0,05 0,15 (**) 0,7 0,7 0,7 2,1 B 3021VERŻJONI ELETTRONIKA 28 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 44. Decoquinate 45. Halofuginone hydrobromide Premixtures for use in feed in which the use of robenidine hydrochloride is not authorised. Feed materials Compound feed for Laying birds and chickens reared for laying (>16weeks) Chickens for fattening for the period before slaughter in which the use of decoquinate is prohibited (withdrawal feed); Other animal species. Premixtures for use in feed in which the use of decoquinate is not authorised. Feed materials Compound feed for Laying birds, chickens reared for laying (>16weeks) and turkeys(>12weeks); (**) 0,4 0,4 0,4 1,2 (**) 0,03 0,03 B 3022 VERŻJONI ELETTRONIKA 29 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 46. Nicarbazin Chickens for fattening and turkeys (<12weeks) for the period before slaughter in which the use of halofuginone hydrobromide is prohibited (withdrawal feed); Other animal species other than chickens reared for laying (<16weeks). Premixtures for use in feed in which the use of halofuginone hydrobromide is not authorised. Feed materials Compound feed for Equine species, laying birds and chickens reared for laying (>16weeks); Chickens for fattening for the period before slaughter in which the use of nicarbazin (in combination with narasin) is prohibited (withdrawal feed); 0,03 0,09 (**) 0,5 0,5 0,5 B 3023VERŻJONI ELETTRONIKA 30 Undesirable substances Products intended for animal feed (*) Maximum Content in mg/kg (ppm) relative to a feeding stuff with a moisture content of 12% 47. Diclazuril Other animal species Premixtures for use in feed in which the use of nicarbazin (in combination with narasin) is not authorised. Feed materials Compound feed for Laying birds, chickens reared for laying (>16weeks) and turkeys for fattening (>12weeks); Rabbits for fattening and breeding for the period before slaughter in which the use of diclazuril is prohibited (withdrawal feed); Other animal species other than chickens reared for laying (<16weeks), chickens for fattening and turkeys for fattening (<12weeks). Premixtures for use in feed in which the use of diclazuril is not authorised. 1,5 (**) 0,01 0,01 0,01 0,03 (**) B 3024 VERŻJONI ELETTRONIKA 31 (*) Without prejudice to the authorised levels in the frame of Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. (**) The maximum level of the substance in the premixture is the concentration which shall not result in a level of the substance higher than 50% of the maximum levels established in the feed when the instructions for use of the premixture are followed. Ippubblikat mid-Dipartiment tal-Informazzjoni (doi.gov.mt) — Valletta — Published by the Department of Information (doi.gov.mt) — Valletta Mitbugħ fl-Istamperija tal-Gvern fuq karta riċiklata — Printed at the Government Printing Press on recycled paper Prezz/Price €2.61