Products used in animal nutrition Rules, 2005 (L.N. 89 of 2005)

B 1241 Suppliment tal-Gazzetta tal-Gvern ta’ Malta, Nru. 17,748, 1 ta’ April, 2005 Taqsima B A.L. 89 ta’ l-2005 ATT TA’ L-2001 DWAR IS-SERVIZZI VETERINARJI (ATT NRU. XXIII TA’ L-2001) Regoli ta’ l-2005 dwar Prodotti li Jintu]aw fl-G[alf ta’ l-Annimali BIS-SA{{A tas-setg[a mog[tija bl-artikoli 24 u 25 ta’ l-Att ta’ l-2001 dwar is-Servizzi Veterinarji, il-Ministru ta’ l-Affarijiet Rurali u l-Ambjent, wara konsultazzjoni mal-Ministru tas-Sa[[a, Anzjani u Kura Komunitarja, g[amel dawn ir-regoli li ;ejjin> 1. (1) It-titolu ta’ dawn ir-regoli hu Regoli ta’ l-2005 dwar Prodotti li jintu]aw fl-G[alf ta’ l-Annimali (2) L-iskop ta’ dawn ir-regoli huwa l-implimentazzjoni tar regoli li hemm fid-Direttiva tal-Kunsill ta’ l-Unjoni Ewropeja 82#471#KEE tat-30 ta’ :unju, 1982, dwar çerti prodotti li jikkonsistu f’sors dirett jew indirett ta’ proteini, li huma manufatturati skond çerti proçessi tekniçi u li jitqeg[du fis-suq b[ala g[alf ta’ l-annimali jew fl g[alf skond l-artikoli 24 u 25 tal-Att dwar is-Servizzi Veterinarji. (3) Dawn ir-regoli ma g[andhomx ikunu ta’ pre;udizzju g[ar-regoli o[ra dwar> (a) addittivi fl-g[alf< (b) l-iffissar ta’ livelli massimi ta’ sustanzi jew prodotti mhux desiderabbli fl-g[alf< (ç) l-iffissar ta’ livelli massimi ta’ fdalijiet ta’ pestiçidi fuq jew fil-prodotti intenzjonati g[all-u]u fl-ikel tal-bniedem jew ta’ l-annimali< (d) it-tqeg[id fis-suq ta’ g[alf kompost, mikro-organi]mi pato;eniçi fl-g[alf< g[alf intenzjonat g[all-nutriment partikolari< i-irkolazzjoni ta’ materjal u]at fl-g[alf. 2. G[all-iskop ta’ dawn ir-regoli, g[andhom japplikaw id definizzjonijiet li ;ejjin> Titolu u skop. Tifsir. B 1242 “addittivi” tfisser sustanzi li meta ji;u inkorporati ma’ l-g[alf dawn jistg[u jibdlu l-karatteristiçi ta’ l-g[alf jew tal-produzzjoni tal-bhejjem< “g[alf” tfisser sustanzi organiçi jew inorganiçi, u]ati we[edhom jew fit-ta[litiet, li g[andhom jew li ma g[andhomx addittivi, biex jittiekel mill-annimali< “g[alf komplet” tfisser ta[lita ta’ g[alf li min[abba l kompo]izzjoni tag[ha li bi]]ejjed g[ar razzjon ta’ kuljum< “g[alf supplimentari” tfisser ta[litiet ta’ g[alf li g[andhom kontenut g[oli ta’ çertu sustanzi u li min[abba l-kompozizzjoni tag[hom, huma bi]]ejjed g[ar-razzjon ta’ kuljum biss jekk ikunu im[allta ma’ g[alf ie[or< “razzjon ta’ kuljum” tfisser il-kwantità medja tat-total tal g[alf, ikkalkulat fuq il-kontentut niedi ta’ 12%, li hu me[tie; kuljum minn annimal ta’ speçi, età u tkabbir speçifiçi, biex ji;u sodisfatti l-b]onnijiet kollha tieg[u< “ta[litiet li jsiru minn qabel” tfisser addittivi konçentrati intenzjonati g[all-manifattura industrijali ta’ g[alf kompost. 3. (1) G[alf li jaqa’ ta[t xi wie[ed mill-gruppi ta’ prodotti mni]]la fl-Iskeda li tinsab ma’ dawn ir-Regoli jew li fih dawn prodotti, jista’ jitqeg[du fis-suq biss jekk> (a) il-prodott innifsu ikun imni]]el fl-iskeda< (b) kull kondizzjoni imnizzla hemmhekk tkun sodisfatta. (2) L-awtoritajiet kompetenti jistg[u, g[al skopijiet ta’ riçerka jew dawk xjentifiçi, jag[mlu derogi minn dak li hu mni]]el f’subregola (1), basta ssir ispezzjoni uffiçjali adegwata. (3) Prodotti msemmija f’ Kapitolu I.1 (a) tad-Direttiva tal Kunsill 95#69#KE tat-22 ta’ Diçembru, 1995 li tistabbilixxi l kondizzjonijiet u l-arran;amenti g[all-approvazzjoni u r-re;istrazzjoni ta’ çerti stabbilimenti u intermedjarji li ja[dmu fil-qasam ta’ l-g[alf, jistg[u biss jitqeg[du fis-suq minn stabbilimenti jew intermedjarji li jissodisfaw il-kondizzjonijiet imni]]la f’ Artiklu 2 jew Artiklu 3 ta’ dik id-Direttiva, skond kif japplika. (4) Subregola (3) g[andu japplika ming[ajr pre;udizzju g[all-Artiklu 4 (2) tad-Direttiva tal-Kunsill 95#69#KE. Tqeg[id fis-suq ta’ g[alf. B 1243 4. (1) Ming[ajr pre;udizzju g[all-mi]uri dwar it-tikkettjar li japplikaw g[all-g[alf wa[du jew kompost, il-prodotti mni]]la fl-Iskeda ma jistg[ux jitqeg[du is-suq b[ala g[alf jew ji;u mi]juda ma’ l-g[alf, sakemm xi partikolaritajiet imni]]la fl-Iskeda ma jidhrux fuq il-pakkett jew il-kontenitur, jew fuq tabella imwa[[la fuqhom. (2) G[all-materjali mibjug[a bl-ingrossa, il-partikolaritajiet imsemmija f’subregola (1) g[andhom jidhru fuq id-dokument li jimxi mag[hom. 5. (1) Fl-Iskeda g[andhom ji;u osservati dawn il-prinçipji li ;ejjin> (a) Prodott ma g[andux ji;i imni]]el fl-Iskeda sakemm> (i) ma jkollux valur nutrittiv g[all-annimali g[ax ikun fih in-nitro;enu, jew (ii) meta jintu]a sew ma jkollu ebda effett detrimentali fuq is-sa[[a tal-bniedem jew ta’ l-annimali jew fuq l-ambjent, u ma jkunx iwe;;a’ lill-konsumatur billi jfixkel il-karatteristiçi distintivi tal-prodotti mill-annimali, jew (iii) ikun jista’ ji;i monitorjat fl-g[alf. (b) Prodott g[andu ji;i mne[[i mill-Iskeda meta xi wa[da mill-kundizzjonijiet imposti f’paragrafu (a) ma ti;ix sodisfatta. (2) Il-kriterji li jag[mluha possibbli li ji;u definiti l-prodotti mni]]la f’dawn ir-regoli, b’mod partikolari il-kriterji tal-kompo]izzjoni, il-purità, u l-proprjetajiet fi]jokimiçi u batterjolo;içi, jistg[u ji;u stabbiliti skond tag[rif xjentifiku u tekniku. 6. (1) Sabiex ji;i ]gurat li l-prodotti mni]]la fis-sezzjonijiet 1.1 u 1.2 ta’ l-Iskeda, jissodisfaw il-prinçipji imni]]la f’regola 5 (1), id dossier, preparat skond id-disposizzjonijiet ta’ subregola (2) ta’ dawn ir-regoli, ji;i mibg[ut uffiçjalment lill-Istati Membri, lill-organizazzjoni internazzjonali rilevanti u, jekk ikun hemm b]onn li ji;u konsultati, ’l kumitati xjentifiçi neçessarji. (2) L-awtoritajiet kompetenti u r-riçevituri l-o[ra tad-dossier imsemmi f’subregola (1) g[andhom ji]guraw, jekk mitluba minn applikant g[al xi ra;uni valida, li kull informazzjoni li jekk din ti;i mikxufa tista’ tolqot drittijiet ta’ proprjetà industrijali jew kummerjali, tin]amm kunfidenzjali. Is-segretezza industrijali u kummerçjali ma g[andiex tapplika g[al> Il-partikolaritajiet li japplikaw g[andhom jidhru fuq it-tikketta eçç. Prinçipji osservati fl-Iskeda. Konformità tal prodott. B 1244 (a) Ismijiet u l-kompo]izzjoni ta’ prodott, u kull informazzjoni dwar proprjetajiet tas-substrate u mikrobijolo;ika, (b) Il-proprjetajiet fi]jokimiçi u batterjoli;içi tal-prodott, (ç) L-interpretazzjoni tad-data farmakolo;ika, tossikolo;ika u ekotossikolo;ika, (d) Il-metodi analitiçi sabiex ji;i monitorjat il-prodott fl g[alf. 7. Jekk, abba]i ta’ ra;unijiet dettaljati min[abba data ;dida jew evalwazzjoni ;dida ta’ data esistenti li saret evidenti minn meta ;ew adottati r-regoli konernati, l-awtoritajiet kompetenti jsibu li wie[ed mill prodotti mni]]la fl-Iskeda jew l-u]u tieg[u ta[t kull kundizzjoni li jinsab fiha, jirrappre]enta periklu g[as-sa[[a tal-bniedem jew ta’ l-annimali avolja jil[aq il-kundizzjonijiet ta’ dawn ir-regoli, dawn jistg[u temporanjament jissospendu jew inaqqsu l-applikazzjoni ta’ dawk ir regoli. Huma g[andhom immedjatament jinformaw lill-Istati Membri l-o[ra u lill-organizzazzjonijiet internazzjonali rilevanti, u jag[tu r ra;unijiet g[al dik id-deçi]joni. 8. F’dak li g[andu x’jaqsam ma’ kummerç bejn Malta u l-Istati Membri l-o[ra, il-partikolaritajiet imsemmija f’regola 4 g[andhom jing[ataw g[al ta’ l-anqas, f’lingwa wa[da uffiçjali tal-pajji] tad destinazzjoni. 9. Sa fejn g[andu x’jaqsam mal-pre]enza u t-tikkettjar ta’ prodotti mni]]la fl-Iskeda, g[alf li jkun konformi mal-kundizzjonijiet imposti minn dawn ir-regoli hu so;;ett biss g[al dawk ir-restrizzjonijiet dwar it-tqeg[id fis-suq b[alma huma mni]]la f’dawn ir-regoli. 10. Il-prodotti ta’ l-annimali ma jkunu so;;etti g[al ebda restrizzjoni dwar it-tqeg[id fis-suq b[ala ri]ultat ta’ l-applikazjoni ta’ dawn ir-regoli. 11. L-awtoritajiet kompetenti g[andhom jie[du kull mi]ura neçessarja sabiex uffiçjalment jimmonitorjaw li l-g[alf ikun konformi mal-kundizzjonijiet imni]]la f’dawn ir-regoli, g[al ta’ l-anqas billi jittie[du kampjuni waqt li dan ikun qieg[ed ji;i mqieg[ed fis-suq. Sospensjoni temporanja eçç ta’ l-applikazzjoni tal-provvedimenti. Il-partikolaritajiet g[andhom jing[ataw bil lingwa uffiçjali. Restrizzjonijiet dwar tqeg[id fis suq. Prodotti ta’ l annimali mhux so;;etti g[al restrizzjonijiet. Sorveljanza fuq kemm l-g[alf ikun konformi. B 1245 SK E D A 1 2 3 4 5 6 7 Is em ta l gr up p ta l pr od ot t Is em ta l pr od ot t X 'in hu il p ri nċ ip ju nu tr itt iv je w il m ik ro or ga ni żm u C ul tu re s ub st ra te (s pe ċi fi ka zz jo ni jie t, je kk h em m ) K ar at te ri st iċ i ta l ko m po żi zz jo ni ta l pr od ot t. Sp eċ i t a' l an ni m al i R eg ol i s pe ċj al i 1. P ro te in i m eħ ud a m in n da w n il gr up pi ta ' m ik ro o rg an iż m i 1. 1. B at te rj a 1. 1. 1. B at te rj a kk ul tiv at a fi l m et ha no l 1. 1. 1. 1. P ro do tt pr ot ei ni ku m in n fe rm en ta zz jo ni m ik su b m it tk ab bi r t a' M et hy lo ph ilu s M et hy lo tr op hu s fu q il m et ha no l M et hy lo ph ilu s m et hy lo tr op hu s N C IB st ra in 1 0. 51 5 M et ha no l p ro te in i m hu x m aħ du m a m in . 68 % In di ċi ri fl et tiv ta ' l an qa s 50 m aj ja li għ oġ ġi el a tju r ħu t D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t p ro te in i m hu x m aħ du m a i rm ie d m hu x m aħ du m x aħ am m hu x m aħ du m k on te nu t t a' u m di tà i st ru zz jo ni jie t g ħa ll uż u D ik ja ra zz jo ni ta l kl ie m 'Ix xo m m ux n um ru a pp ro va t D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f; a m m on t t al p ro do tt li fi h l għ al f' 1. 1. 2 B at te rj a kk ul tiv at a fu q ga ss na tu ra li 1. 1. 2. 1 Pr od ot t pr ot ei ni ku m in n fe rm en ta zz jo ni o tte nu t m in n ga ss n at ur al i b it tk ab bi r t a' : M et hy lo co cu s M et hy lo co cu s ca ps ul at us (B at h) N C IM B s tr ai n 11 13 2 A lc al ig en es ac id ov or an s N C IM B st ra in 1 23 87 B ac ill us G as s na tu ra li: (a pp ro x. 9 1% m et ha ne , 5 % e th an e, 2% p ro pa ne , 0 , 5 % is ob ut an e, 0 , 5 % nb ut an e, 1 % Pr ot ei ni m hu x m aħ du m a: m in . 6 5% M aj ja li għ as s im na m in n 2 5 sa 6 0 kg G ħo ġġ ie la m in n 80 k g 'il fu q S al am un D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t " Pr od ot t p ro te in ik u m in n B 1246 ca ps ul at us (B at h) , A lc al ig en es ac id ov or an s, B ac ill us br ev is e t B ac ill us fir m us , u ċ ċ el lo li li ġe w m aq tu la br ev is N C IM B s tr ai n 13 28 8 B ac ill us fi rm us N C IM B s tr ai n 13 28 0 ko m po ne nt i o ħr aj n) , am m on ia m in er al sa lts fe rm en ta zz jo ni o tte nu t m in n ga ss n at ur al i b it tk ab bi r t a' : M et hy lo co cu s ca ps ul at us (B at h) , A lc al ig en es a ci do vo ra ns , B ac ill us b re vi s et B ac ill us fir m us " p ro te in i m hu x m aħ du m a i rm ie d m hu x m aħ du m x aħ am m hu x m aħ du m k on te nu t t a' u m di tà i st ru zz jo ni jie t g ħa ll uż u r at a m as si m a ta ' in ko rp or az zj on i 8 % m aj ja li għ as s im na 8 % g ħo ġġ ie la 1 9% s al am un (i lm a ħe lu ) 3 3% s al am un (i lm a ba ħa r) D ik ja ra zz jo ni ta l kl ie m 'Ix xo m m ux ' n um ru a pp ro va t D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f; l i se m : "P ro do tt pr ot ei ni ku ot te nu t m ill fe rm en ta zz jo ni b at te ri ka ta l ga ss n at ur al i" a m m on t t al p ro do tt li fi h l għ al f. 1. 2. Y ea st s 1. 2. 1. Y ea st s Il y ea st s ko llh a m ik su bi n m ill m ik ro Sa cc ha ro m yc es ce re vi si ae , M ol as se s, re si dw i t a' di st ill er ija , ċ er ej al i u L i sp eċ i k ol lh a ta ' l an ni m al i B 1247 ik ku lti va t f uq su bs tr at es ta ' o ri ġi ni an ni m al i j ew v eġ et al i or ga ni ċi je w su bs tr at es li h um a m ni żż la fu l ko lo nn i 3 je w 4 ri sp et tiv am en t l i ċ ċ el lo li ta għ ho m ġe w m aq tu la Sa cc ha ro m yc es ca rl sb er gi en si s, K lu yv er om yc es la ct is , K lu yv er om yc es fr ag ili s pr od ot ti li għ an dh om il la m tu , m er aq ta ' fr ot t m ag ħs ur , x għ ir (w he y) , l ac tic a dd , fi br i v eġ et al i hy dr ol yz ed 1. 2. 2. Y ea st s ik ku lti va ti fu q su bs tr at es b ar ra d aw k im se m m ija f' 1 .2 .1 1. 3. A lk a 1. 4. L ow er fu ng i 1. 4. 1. P ro do tti m ill pr od uz zj on i t a' an tib ijo tiċ i b il fe rm en ta zz jo ni 1. 4. 1. 1. M yc el iu m , w et b yp ro du ct m ill pr od uz zj on i t al pe ni ci lli n, e ns ile d pe rm ez z ta ' la ct ob ac ill us b re vi s, pl an ta ru n, s ak e, co lle no id u st re pt oc oc cu s la ct is bi ex m a jħ al lix li ll pe ni ci lli n ja ħd em u ttr at ta t b is s ħa na N itr og en ou s co m po un d P en ic ill iu m ch ry so ge nu m A TC C 48 27 1 So rs i d if fe re nt i t a' ka rb oi dr at i u l hy dr ol ys at es ta għ ho m N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a: m in . 7 % M aj ja li li jir għ u D ik ja ra zz jo ni li g ħa nd ha ss ir fu q it tik ke tta je w fu q l ip pa kk ja r t al p ro do tt: l i se m : "M yc el iu m s ila ge m ill pr od uz zj on i t al p en ic ill in " N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a i rm ie d m hu x m aħ du m u m di tà s pe ċi ta ' a nn im al i j ew ka te go ri ja D ik ja ra zz jo ni li g ħa nd ha ss ir fu q it tik ke tta je w l ip pa kk ja r t a' x i p ro do tti fi h l għ al f; l i se m : "M yc el iu m s ila ge m ill B 1248 pr od uz zj on i t al p en ic ill in " 2. K om po ne nt i t an ni tr oġ en u li m a hu m ie x pr ot ei ni 2. 1. U ri na u d d er iv at i ta għ ha 2. 1. 1. U ri na te kn ik am en t p ur a C O (N H 2) 2 U ri na : M in im u 97 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu 2. 1. 2. B iu re t, te kn ik am en t p ur a (C O N H 2) 2 N H B iu re t: M in im u 9 7% 2. 1. 3. U re ap ho sp ha te , te kn ik am en t p ur a C O (N H 2) 2 H 3P O 4 N itr oġ en u: M in im u 16 , 5 % fo sf ru : m in im u 18 % D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: l i se m 'U ri na ', 'B iu re t', ' U rc ap ho sp ha te ' j ew ' D iu re id oi so bu ta ne s ko nd il ka ż l iv el l t a' n itr oġ en u u ad di zz jo na li m al p ro do tt 2. 1. 3, il l iv el l t a' fo sf or u, B 1249 2. 1. 4. D iu re id oi so bu ta ne , te kn ik am en t p ur a (C H 3) 2 (C H ) 2 (N H C O N H 2) 2 N itr oġ en u: M in im u 30 % Is ob ut yr al de hy d e: m in im u 35 % l i sp eċ i t a' l an ni m al i u l ka te go ri ja n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f: l i se m : ' U ri na ', 'B iu re t', 'U re ap ho sp ha te ' j ew 'D iu re id oi so bu ta ne ' s ko nd il ka ż a m m on t t al p ro do tt li fi h l għ al f, p er ċe nt aġ ġ m it to ta l t a' ko m po ne nt i t an n itr oġ en u li m a hu m ie x pr ot ei ni i nd ik az zj on i, fl is tr uz zj on i g ħa ll uż u, ta l liv el l t ot al i t a' n itr oġ en u m a hu w ie x ġe j m ill pr ot ei ni li m a għ an du x jiġ i m og ħt i f l ik la ta ' ku lju m ta ' k ul l s pe ċi je w ka te go ri ja ta ' a nn im al i. 2. 2. A m m on iu m s al ts 2. 2. 1. A m m on iu m la ct at e, m ag ħm ul m ill f er m en ta zz jo ni m a' L ac to ba ci llu s bu lg ar ic us C H 3C H O H C O O N H 4 X għ ir (W he y) N itr oġ en u ta ħt il fo rm a ta ' pr ot ei ni m hu x m aħ du m a: M in im u 44 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t 'A m m on iu m la ct at e m in n fe rm en ta zz jo ni ', N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a i rm ie d m hu x m aħ du m u m di tà s pe ċi ta ' a nn im al i j ew B 1250 ka te go ri ja n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f: l i se m 'A m m on iu m la ct at e m in n fe rm en ta zz jo ni ', a m m on t t a' p ro do tt fl għ al f, p er ċe nt aġ ġ m it to ta l t a' ko m po ne nt i t an n itr oġ en u li m a hu m ie x pr ot ei ni i nd ik az zj on i, fl is tr uz zj on i g ħa ll uż u, ta l liv el l t ot al i t a' n itr oġ en u m a hu w ie x ġe j m ill pr ot ei ni li m a għ an du x jiġ i m og ħt i f l ik la ta ' ku lju m ta ' k ul l s pe ċi je w ka te go ri ja ta ' a nn im al i. 2. 2. 2. A m m on iu m ac et at e f' a qu eu ou s so lu tio n C H 3C O O N H 4 A m m on iu m ac et at e m in . 5 5 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i l kl ie m : A m m on iu m a ce ta te , k on te nu t t an n itr oġ en u u ta l um di tà , s pe ċi je w k at eg or ija ta ' an ni m al i n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' B 1251 xi p ro do tti fi h l għ al f: i l kl ie m : A m m on iu m a ce ta te l a m m on t t al p ro do tt fl għ al f, p er ċe nt aġ ġ m it to ta l t a' ko m po ne nt i t an n itr oġ en u li m a hu m ie x pr ot ei ni i nd ik az zj on i, fl is tr uz zj on i g ħa ll uż u, ta l liv el l t ot al i t a' n itr oġ en u m a hu w ie x ġe j m ill pr ot ei ni li m a għ an du x jiġ i m og ħt i f l ik la ta ' ku lju m ta ' k ul l s pe ċi je w ka te go ri ja ta ' a nn im al i.' 2. 2. 3 A m m on iu m su lfa te f' a qu eo us so lu tio n (N H 4) 2 SO 4 A m m on iu m su lfa te : m in im u 35 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i l kl ie m ; A m m on iu m s ul fa te , k on te nu t t an n itr oġ en u u ta l um di tà s pe ċi ta ' a nn im al i n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f: i l kl ie m : "A m m on iu m s ul fa te ", l a m m on t t al p ro do tt fl għ al f, p er ċe nt aġ ġ m it to ta l t a' ko m po ne nt i t an n itr oġ en u B 1252 li m a hu m ie x pr ot ei ni i nd ik az zj on i, fl is tr uz zj on i g ħa ll uż u, ta l liv el l t ot al i t a' n itr oġ en u m a hu w ie x ġe j m ill pr ot ei ni li m a għ an du x jiġ i m og ħt i f l ik la ta ' ku lju m ta ' k ul l s pe ċi je w ka te go ri ja ta ' a nn im al i.' , f il ka ż ta ' a nn im al i l i jir għ u zg ħa r, l ik la ta ' ku lju m m a tis ta x itk un m iż ju da b ' a kt ar m in n in 0, 5 % 2. 3. B y P ro du ct s m ill pr od uz zj on i t a' a m in o aċ id i b il fe rm en ta zz jo ni 2. 3. 1. B y P ro du ct s lik w id i k on ċe nt ra ti m ill p ro du zz jo ni ta ' Lg lu ta m ic a ci d bi l fe rm en ta zz jo ni b il C or yn eb ac te ri um m el as se co la A m m on iu m s al ts u pr od ot ti oħ ra m ag ħm ul a m in ni tr oġ en u Su cr os e, m ol as se s, st ar ch p ro du ct s u hy dr ol ys at es ta għ ho m N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a: m in im u 48 % um di tà : m as si m u 28 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t ' B y P ro du ct s m ill p ro du zz jo ni ta ' Lg lu ta m ic a ci d' fi l ka ż ta ' p ro do tt 2. 3. 1; 'B y P ro du ct s ta ' L Ly si ne ' fi l ka ż ta ' 2 .3 .2 , N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a i rm ie d m hu x m aħ du m u m di tà s pe ċi ta ' a nn im al i j ew ka te go ri ja n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f: B 1253 l i se m 'B y P ro du ct s m ill p ro du zz jo ni ta ' Lg lu ta m ic a ci d' fi l ka ż ta ' pr od ot t 2 .3 .1 ; 'B y P ro du ct s m ill pr od uz zj on i t a' L L ys in e' fi l ka ż ta ' p ro do tt 2. 3. 2, p er ċe nt aġ ġ m it to ta l t a' ko m po ne nt i t an n itr oġ en u li m a hu m ie x pr ot ei ni i nd ik az zj on i, fl is tr uz zj on i g ħa ll uż u, ta l liv el l t ot al i t a' n itr oġ en u m a hu w ie x ġe j m ill pr ot ei ni li m a għ an du x jiġ i m og ħt i f l ik la ta ' ku lju m ta ' k ul l s pe ċi je w ka te go ri ja ta ' a nn im al i.' 2. 3. 2. B y P ro du ct s lik w id i k on ċe nt ra ti m ag ħm ul a m ill pr od uz zj on i t a' L Ly si ne m on oh yd ro ch lo ri de bi l fe rm en ta zz jo ni ta ' vi ba ct er iu m la ct of er m en tu m A m m on iu m s al ts u pr od ot ti oħ ra m ag ħm ul a m in ni tr oġ en u Su cr os e, m ol as se s, st ar ch p ro du ct s u hy dr ol ys at es ta għ ho m N itr oġ en u es pr es s bħ al a pr ot ei ni m hu x m aħ du m a: m in im u 45 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu 3. A m in o A ċi di u s Sa lts ta għ ho m 3. 1. M et hi on in e 3. 1. 1. D L M et hi on in e, te kn ik am en t p ur C H 3S (C H 2) 2 C H (N H 2) C O O H D L M et hi on in e: m in im u 98 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r B 1254 3. 1. 2. D ih yd ra te d ca lc iu m s al t o f N hy dr ox y m et hy l D L M et hi on in e, te kn ik am en t p ur [C H 3S (C H 2) 2 C H (N H H 2O H ) C O O ]2 C a. 2H 2O D L M et hi on in e: m in im u 67 % F or m al de hy de : m as si m u 14 % K al ċj um : m in im u 9% 3. 1. 3. M et hi on in ez in c, te kn ik am en t p ur [C H 3S (C H 2) 2 C H (N H 2) C O O ]2 Z n D L M et hi on in e: m in im u 80 % Z n: m as si m u 18 , 5 % A nn im al i l i j ir għ u m ill bi du li b de w ji rg ħu ta l pr od ot t: i se m ta l pr od ot t " D L L m et hi on in e, fi l ka ż ta ' pr od ot t 3 .1 .1 , " D ih yd ra te d ca lc iu m s al t t a' N hy dr ox y m et hy lD L M et hi on in e" fi l ka ż ta ' p ro do tt 3. 1. 2, "Z in cm et hi on in e" , f il ka ż ta ' p ro do tt 3. 1. 3, D L M et hi on in e u l ko nt en ut ta ' l u m di tà s pe ċi je w k at eg or ija ta ' an ni m al i f il ka ż ta ' pr od ot ti 3. 1. 2 an d 3. 1. 3, n um ru ta ' a pp ro va zz jo ni 3. 1. 4. C on ce nt ra te d liq ui d so di um D L M et hi on in e te kn ik am en t p ur (C H 3S (C H 2) 2 C H (N H 2) C O O ) N a D L M et hi on in e: m in im u 40 , 0 % So di um : m in im u 6, 2 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t 'c on ce nt ra te d liq ui d so di um D L M et hi on in e' k on te nu t t a' D L M et hi on in e k on te nu t t a' u m di tà n um ru ta ' a pp ro va zz jo ni 3. 1. 5 D L M et hi on in e, te kn ik am en t p ur pr ot et t b ' co po ly m er vi ny lp yr id i n el st yr en e C H 3S (C H 2) 2 C H (N H 2) C O O H D L M et hi on in e: M in im u 65 % co po ly m er vi ny lp yr id in e/ st yr en e: M as si m u 3 % B aq ar li ja ħi lb u D ik ja ra zz jo ni jie tl i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: " P ro te ct ed m et hi on in e w ith c op ol ym er vi ny lp yr id in e/ st yr en e" D L M et hi on in e u B 1255 ko nt en ut ta ' u m di tà s pe ċi ta ' a nn im al n um ru ta ' a pp ro va zz jo ni 3. 2. L ys in e 3. 2. 1. L L ys in e, te kn ik am en t p ur N H 2 ( C H 2) 4 C H (N H 2) C O O H L Ly si ne : m in im u 98 % 3. 2. 2. L L ys in e (b as e) lik w id u ko nċ en tr at N H 2 ( C H 2) 4 C H (N H 2) C O O H Sa cc ha ro se , m ol as se s, st ar ch p ro du ct s u hy dr ol ys at es ta għ ho m L Ly si ne : m in im u 60 % 3. 2. 3. L Ly si ne m on oh yd ro ch lo ri de , t ek ni ka m en t p ur N H 2 ( C H 2) 4 C H (N H 2) C O O H .H C l L Ly si ne : m in im u 78 % 3. 2. 4. L Ly si ne m on oh yd ro ch lo ri de li kw id u ko nċ en tr at N H 2 ( C H 2) 4 C H (N H 2) C O O H .H C l Sa cc ha ro se , m ol as se s, st ar ch p ro du ct s u hy dr ol ys at es ta għ ho m L Ly si ne : m in im u 22 , 4 % 3. 2. 5. L Ly si ne su lp ha te m ag ħm ul b ' fe rm en ta zz jo ni b il C or yn eb ac te ri um gl ut am ic um [N H 2 ( C H 2) 4 C H (N H 2) C O O H ] 2 H 2S O 4 Su ga r sy ru p, m ol as se s, ċ er ej al i, st ar ch p ro du ct s u hy dr ol ys at es ta għ ho m L Ly si ne : m in im u 40 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t " L Ly si ne " fi l ka ż ta l pr od ot t 3. 2. 1, " C on ce nt ra te d liq ui d L Ly si ne b as e" fi l ka ż ta l pr od ot t 3 .2 .2 , " L Ly si ne m on oh yd ro ch lo ri de " fi l ka ż ta l pr od ot t 3 .2 .3 , "C on ce nt ra te d liq ui d L Ly si ne m on oh yd ro ch lo ri de " fi l ka ż ta l pr od ot t 3 .2 .4 , " L Ly si ne s ul ph at e u l B y P ro du ct s tie għ u m ill fe rm en ta zz jo ni " , f il ka ż ta l pr od ot t 3 .2 .5 , L L ys in e u l ko nt en ut ta ' um di tà n um ru ta ' a pp ro va zz jo ni 3. 2. 6. L Ly si ne ph os ph at e u l B y P ro du ct s ta għ ha m ag ħm ul a b' fe rm en ta zz jo ni b il B re vi ba ct er iu m la ct of er m en tu m N R R L B 11 47 0 [N H 2 ( C H 2) 4 C H (N H 2) C O O H ] Su cr os e am m on ia u so lu bl es ta l ħu t L Th re on in e m in im u 98 % L Ly si ne : m in . 3 5 % fo sf ru : m in . 4 , 3 % T ju r u ħ ni eż er D ik ja ra zz jo ni jie tl i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: " L Ly si ne u l ko nt en ut ta ' u m di tà n um ru ta ' a pp ro va zz jo ni 3. 2. 7 T aħ lit a ta ': (a ) L N H 2 ( C H 2) 4 C H (N H 2) C O O H H C l L Ly si ne + D L M et hi on in e B aq ar li ja ħi lb u D ik ja ra zz jo ni jie tl i għ an dh om is ir u fu q it B 1256 Ly si ne m on oh yd ro ch lo ri de , t ek ni ka m en t p ur u, ( b) D L M et hi on in e, te kn ik am en t p ur pr ot et t b il co po ly m er vi ny lp yr id in e/ s ty re ne C H 3S (C H 2) 2 C H (N H 2) C O O H m in im u 50 % (i nk lu ż D L M et hi on in e m in im u 15 % ) C op ol ym er vi ny lp yr id in e/ st yr en e m as si m u 3 % tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t " ta ħl ita ta ' U ly si ne m on oh yd ro ch lo ri de u D L M et hi on in e pr ot et t b il co po ly m er vi ny lp yr id in e/ st yr en e" L L ys in e, D Lr ne th io ni ne u l ko nt en ut ta ' u m di tà s pe ċi ta ' a nn im al i n um ru ta ' a pp ro va zz jo ni 3. 3. T hr eo ni ne 3. 3. 1. L T hr eo ni ne , te kn ik am en t p ur C H 3C H (O H ) C H (N H 2) C O O H L Th re on in e: m in im u 98 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t " L Th re on in e" L T hr eo ni ne u k on te nu t ta ' u m di tà n um ru ta ' a pp ro va zz jo ni 3. 4. T ry pt op ha n 3. 4. 1. L T ry pt op ha n, te kn ik am en t p ur (C 8H 5N H ) C H 2C H (N H 2) C O O H L Tr yp to ph an : m in im u 98 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t "L T ry pt op ha n" L T ry pt op ha n u ko nt en ut ta ' u m di tà n um ru ta ' a pp ro va zz jo ni 3. 4. 2. D L Tr yp to ph an , te kn ik am en t p ur (C , H , N H ) C H , C H (N H ,) C O O H D L Tr yp to ph an : m in im u 98 % K ul l s pe ċi ta ' an ni m al i D ik ja ra zz jo ni jie tl i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: i se m ta l pr od ot t B 1257 "L T ry pt op ha n" L T ry pt op ha n u ko nt en ut ta ' u m di tà n um ru ta ' a pp ro va zz jo ni 4. S im ili ta ' a m in o aċ id i 4. 1. A na lo gi ta l m et hi on in e 4. 1. 1 H yd ro xy an al og ue ta ' m et hi on in e C H 3S (C H 2) 2 C H (O H ) C O O H T ot al ta ' a ċi di : m in im u 85 % aċ du M on om er : m in im u 65 % 4. 1. 2 Sa lt ta l ka lċ ju m ta ' h yd ro xy s im ili għ al l m et hi on in e [C H 3S (C H 2) 2 C H (O H ) C O O ]2 C a A ċd u M on om er : m in im u 83 % K al ċj um : m in im u 12 % K ul l s pe ċi ta ' a nn im al i D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r ta l pr od ot t: j ek k ap pr op ja t l i se m (k ol on na 2 ), a ċi du m on om er u to ta l ta ' k on te ni tu ri a ċi du żi fi l ka ż ta l pr od ot t 4 .1 .1 u aċ id u m on om er fi l ka ż ta ' pr od ot t 4 .1 .2 , k on te nu t t a' u m di tà , s pe ċi ta ' a nn im al i n um ru ta ' a pp ro va zz jo ni D ik ja ra zz jo ni jie t l i għ an dh om is ir u fu q it tik ke tta je w l ip pa kk ja r t a' xi p ro do tti fi h l għ al f: : j ek k ap pr op ja t l i se m (k ol on na 2 ), a ċi du m on om er u to ta l ta ' k on te ni tu ri a ċi du żi fi l ka ż ta l pr od ot t 4 .1 .1 u aċ id u m on om er fi l ka ż ta ' pr od ot t 4 .1 .2 , l a m m on t t al p ro do tt fi l għ al f. Il k on te nu ti m ni żż la je w li g ħa nd ho m ji ġu d ik ja ra ti sk on d il ko lo nn i 5 u 7 ji rr ef er u għ al l pr od ot t b ħa la ta li. B 1258 L.N. 89 of 2005 VETERINARY SERVICES ACT (CAP. 437) Products Used in Animal Nutrition Rules, 2005 IN exercise of the powers conferred by articles 24 and 25 of the Veterinary Services Act, the Minister for Rural Affairs and the Environment, after consultation with the Minister of Health, the Elderly and Community Care, has made the following rules> 1. (1) The title of these rules is the Products Used in Animal Nutrition Rules, 2005. (2) The scope of these rules is to implement the rules found under European Union Council Directive 82#471#EEC of the 30th June, 1982 on certain products which act as direct or indirect protein sources, are manufactured by certain technical processes and are put into circulation as feedingstuffs or in feedingstuffs in accordance with articles 24 and 25 of the Veterinary Services Act. (3) These rules shall be without prejudice to other provisions concerning> (a) additives in feedingstuffs< (b) the fixing of maximum levels for undesirable substances and products in feedingstuffs< (c) the fixing of maximum levels for pesticide residues on and in products intended for human or animal nutrition< (d) the marketing of compound feedingstuffs, pathogenic micro-organisms in feedingstuffs, feedingstuffs for particular nutritional purposes, the circulation of feed materials. 2. For the purpose of these rules, the following definitions shall apply> “additives” means substances which, when incorporated in feeding-stuffs, are likely to affect their characteristics or livestock production< Title and scope. Interpretation. B 1259 “complete feeding-stuffs” means mixtures of feedingstuffs which, by reason of their composition, are sufficient for a daily ration< “daily ration” 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 category and yield, to satisfy all its needs< “feeding-stuffs” means organic or inorganic substances, used singly or in mixtures, whether or not containing additives, for oral animal feeding< “premixtures” means additive concentrates intended for the industrial manufacture of compound animal feeding-stuffs< “supplementary 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 ration only if they are used in combination with other feeding-stuffs. 3. (1) Feedingstuffs belonging to one of the product groups listed in the Schedule or containing such products may be marketed only if> (a) the product in question appears in the Schedule. (b) any conditions laid down therein are fulfilled. (2) Competent authorities may, for experimental or scientific purposes, provide for derogations from the provisions of sub-rule (1), provided that an adequate official inspection is carried out. (3) Products referred to in Chapter I. 1 (a) of Council Directive 95#69#EC of 22 December 1995 laying down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector may be put into circulation only by establishments or intermediaries which meet the conditions laid down in Article 2 or Article 3 of that Directive, as appropriate. (4) Sub-rule (3) shall apply without prejudice to Article 4 (2) of Council Directive 95#69#EC. Marketing of feedingstuffs. B 1260 4. (1) Without prejudice to the labelling provisions applicable to straight and compound feedingstuffs, the products listed in the Schedule may not be marketed as feedingstuffs or incorporated in feedingstuffs unless any particulars laid down in the Schedule appear in the package or container or on a label attached thereto. (2) For material marketed in bulk the particulars referred to in sub-rule (1) appear on an accompanying document. 5. (1) In the Schedule, the following principles are observed> (a) A product shall not be included in the Schedule unless> (i) it has nutritional value for animals because it provides nitrogen,or (ii) when used sensibly it has no detrimental effect on human or animal health or on the environment and does not harm the consumer by impairing the distinctive features of animal products, or (iii) it can be monitored in feedingstuffs. (b) A product shall be deleted from the Schedule if one of the conditions listed in paragraph (A) is not satisfied. (2) Criteria making it possible to define the products included in these rules, particularly the criteria of composition and purity and the physicochemical and biological properties, may be set in the light of scientific and technical knowledge. 6. (1) In order to ensure that the products referred to in sections 1.1 and 1.2 of the Schedule comply with the principles set out in rule 5 (1), the dossier, prepared in accordance with the provisions of sub-rule (2) hereof, is sent officially to the Member States, to the relevant international organisation and, if it is requested that they be consulted, to the necessary scientific committees. (2) The competent authorities and the other recipients of the dossier referred to in sub-rule (1) shall ensure, if requested on good grounds by an applicant, that information whose disclosure could adversely affect industrial or commercial property rights is kept confidential. Industrial and commercial secrecy shall not apply to> (a) The names and composition of the product, and any information concerning the substrate and the micro-organism, Applicable particulars to appear on label etc. Principles observed in Schedule. Product conformity. B 1261 (b) The physicochemical and biological properties of the product, (c) The interpretation of the pharmacological, toxicological and ecotoxicological data, (d) The analytical methods for monitoring the product in the feedingstuffs. 7. If, on the basis of detailed grounds due to new data or a new evaluation of existing data that have become evident since the adoption of the provisions in question, the competent authorities find that one of the products listed in the Schedule or its use under any conditions that have been set represents a danger to human or animal health even though it complies with the provisions of these rles, they may temporarily suspend or restrict the application of those provisions. They shall immediately inform the other Member States and the relevant international organisation thereof, giving the reasons for its decision. 8. With regard to marketing between Malta and other Member States, the particulars referred to in rule 4 shall be given in at least one of the official languages of the country of destination. 9. As far as the presence and labelling of the products listed in the Schedule is concerned, feedingstuffs that comply with the provisions of these rules are subject only to the marketing restrictions contained in these rules. 10. Animal products are not subject to any marketing restriction as a result of the application of these rules. 11. The competent authorities shall take all necessary measures to ensure that the compliance of feedingstuffs with the requirements of these rules is officially monitored, at least by sampling during marketing. Temporary suspension etc. of applications provisions. Particulars to be given in official language. Marketing restrictions. Animal products not subject to marketing restrictions. Monitoring of compliance of feedingstuffs. B 1262 SC H E D U L E 1 2 3 4 5 6 7 N am e of p ro du ct gr ou p N am e of p ro du ct D es ig na tio n of nu tr iti ve p ri nc ip le o r id en tit y of m ic ro or ga ni sm C ul tu re s ub st ra te (s pe ci fi ca tio ns , i f a ny ) C om po si tio n ch ar ac te ri st ic s of p ro du ct A ni m al s pe ci es Sp ec ia l p ro vi si on s 1. P ro te in s ob ta in ed fr om th e fo llo w in g gr ou ps o f m ic ro or ga ni sm s 1. 1. B ac te ri a 1. 1. 1. B ac te ri a cu lti va te d on m et ha no l 1. 1. 1. 1. P ro te in pr od uc t o f fe rm en ta tio n ob ta in ed by c ul tu re o f M et hy lo ph ilu s M et hy lo tr op hu s on m et ha no l M et hy lo ph ilu s m et hy lo tr op hu s N C IB st ra in 1 0. 51 5 M et ha no l C ru de p ro te in m in . 6 8 % R ef le ct an ce in de x at le as t 5 0 P ig s C al ve s – Po ul tr y F is h D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: n am e of th e pr od uc t c ru de p ro te in , c ru de a sh , c ru de fa t, m oi st ur e co nt en t, i ns tr uc tio ns fo r u se , D ec la ra tio n of th e w or ds 'A vo id in ha la tio n. a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s: a m ou nt o f t he p ro du ct co nt ai ne d in th e fe ed in gs tu ff .' 1. 1. 2 B ac te ri a cu lti va te d on n at ur al ga s 1. 1. 2. 1 pr ot ei n pr od uc t o f fe rm en ta tio n fr om na tu ra l g as o bt ai ne d by c ul tu re o f: M et hy lo co cu s ca ps ul at us (B at h) N C IM B s tr ai n 11 13 2 A lc al ig en es ac id ov or an s N C IM B N at ur al g as : ( ap pr ox . 91 % m et ha ne , 5 % et ha ne , 2 % p ro pa ne , 0, 5 % is ob ut an e, 0 , 5% n bu ta ne , 1 % o th er cr ud e pr ot ei n: m in . 6 5% P ig s fo r f at te ni ng fr om 2 5 to 6 0 kg C al ve s fr om 8 0 kg o n S al m on D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am es : "P ro te in p ro du ct o f B 1263 M et hy lo co cu s ca ps ul at us (B at h) , A lc al ig en es ac id ov or an s, B ac ill us br ev is e t B ac ill us fi rm us , a nd th e ce lls of w hi ch h av e be en ki lle d st ra in 1 23 87 B ac ill us br ev is N C IM B s tr ai n 13 28 8 B ac ill us fi rm us N C IM B s tr ai n 13 28 0 co m po ne nt s) , am m on ia m in er al sa lts fe rm en ta tio n fr om n at ur al ga s ob ta in ed b y cu ltu re o f M et hy lo co cu s ca ps ul at us (B at h) , A lc al ig en es ac id ov or an s, B ac ill us br ev is e t B ac ill us fi rm us " c ru de p ro te in c ru de a sh c ru de fa t m oi st ur e co nt en t i ns tr uc tio ns fo r u se m ax im um in co rp or at io n ra te in 8 % p ig s fo r f at te ni ng 8 % c al ve s 1 9% s al m on (f re sh w at er ) 3 3% s al m on (s ea w at er ) d ec la ra tio n of th e w or ds : "a vo id in ha la tio n" . a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s : T he n am e: "P ro te in p ro du ct o bt ai ne d by b ac te ri al fe rm en ta tio n of n at ur al g as " a m ou nt o f t he p ro du ct co nt ai ne d in th e fe ed in gs tu ff . 1. 2. Y ea st s 1. 2. 1. Y ea st s cu lti va te d on su bs tr at es o f a ni m al A ll ye as ts o bt ai ne d fr om th e m ic ro o rg an is m s an d su bs tr at es li st ed in Sa cc ha ro m yc es ce re vi si ae , Sa cc ha ro m yc es ca rl sb er gi en si s, M ol as se s, d is til le ry re si du es , c er ea ls a nd pr od uc ts c on ta in in g st ar ch , f ru it ju ic e, A ll an im al s pe ci es B 1264 or v eg et ab le o ri gi n co lu m ns 3 a nd 4 re sp ec tiv el y t he c el l o f w hi ch ha ve b ee n ki lle d K lu yv er om yc es la ct is , K lu yv er om yc es fr ag ili s w he y, la ct ic a dd , hy dr ol yz ed v eg et ab le fi br es 1. 2. 2. Y ea st s cu lti va te d on su bs tr at es o th er th an th os e gi ve n in 1 .2 .1 1. 3. A lg ae 1. 4. L ow er fu ng i 1. 4. 1. P ro du ct s fr om pr od uc tio n of an tib io tic s by fe rm en ta tio n 1. 4. 1. 1. M yc el iu m , w et b yp ro du ct fr om th e pr od uc tio n of pe ni ci lli n, e ns ile d by m ea ns o f l ac to ba ci llu s br ev is , p la nt ar un , sa ke , c ol le no id a nd st re pt oc oc cu s la ct is to in ac tiv e th e pe ni ci lli n an d he at tr ea te d N itr og en ou s co m po un d Pe ni ci lli um ch ry so ge nu m A T C C 48 27 1 D if fe re nt s ou rc es o f ca rb oh yd ra te s an d th ei r h yd ro ly sa te s N itr og en ex pr es se d as cr ud e pr ot ei n: m in . 7 % R um in an ts p ig s D ec la ra tio n to b e m ad e on th e la be l o r p ac ka gi ng o f th e pr od uc t: t he n am e: "M yc el iu m s ila ge fr om th e pr od uc tio n of pe ni ci lli n" N itr og en e xp re ss ed a s cr ud e pr ot ei n c ru de a sh m oi st ur e a ni m al s pe ci es o r ca te go ry D ec la ra tio n to b e m ad e on th e la be l o r pa ck ag in g of th e co m po un d fe ed in gs tu ff : t he n am e: "M yc el iu m s ila ge fr om th e pr od uc tio n of pe ni ci lli n" B 1265 2. N on p ro te in ni tr og en ou s co m po un ds 2. 1. U re a an d its de ri va tiv es 2. 1. 1. U re a, te ch ni ca lly p ur e C O (N H 2) 2 U re a: m in im um 9 7% R um in an ts fr om th e be gi nn in g of ru m in at io n 2. 1. 2. B iu re t, te ch ni ca lly p ur e (C O N H 2) 2 N H B iu re t: m in im um 9 7% 2. 1. 3. U re ap ho sp ha te , te ch ni ca lly p ur e C O (N H 2) 2 H 3P O 4 N itr og en : m in im um 1 6, 5% P ho sp ho ru s: m in im um 1 8 % 2. 1. 4. D iu re id oi so bu ta ne , te ch ni ca lly p ur e (C H 3) 2 (C H ) 2 (N H C O N H 2) 2 N itr og en : m in im um 3 0% Is ob ut yr al de hy d e: m in im um 3 5 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e 'U re a' , ' B iu re t', ' U rc ap ho sp ha te ' o r' D iu re id oi so bu ta ne ', as th e ca se m ay b e, n itr og en le ve l; an d in a dd iti on fo r pr od uc t 2 .1 .3 , p ho sp ho ru s le ve l, a ni m al s pe ci es o r ca te go ry , a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s: t he n am e 'U re a' , ' B iu re t', 'U re ap ho sp ha te ' o r 'D iu re id oi so bu ta ne ' a s th e ca se m ay b e, a m ou nt o f t he p ro du ct co nt ai ne d in th e fe ed in gs tu ff , p er ce nt ag e of th e to ta l cr ud e pr ot ei n pr ov id ed b y no n pr ot ei n ni tr og en , i nd ic at io n, in th e in st ru ct io ns fo r u se , o f t he le ve l o f t ot al n on p ro te in ni tr og en w hi ch s ho ul d no t be e xt en de d in th e da ily ra tio n of e ac h an im al sp ec ie s or c at eg or y. B 1266 2. 2. A m m on iu m s al ts 2. 2. 1. A m m on iu m la ct at e, p ro du ce d by fe rm en ta tio n w ith L ac to ba ci llu s bu lg ar ic us C H 3C H O H C O O N H 4 W he y N itr og en ex pr es se d as cr ud e pr ot ei n: m in im um 4 4 % R um in an ts fr om th e be gi nn in g of ru m in at io n D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e 'A m m on iu m la ct at e fr om fe rm en ta tio n' , n itr og en e xp re ss ed a s cr ud e pr ot ei n, c ru de a sh , m oi st ur e, a ni m al s pe ci es o r ca te go ry , a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s: t he n am e 'A m m on iu m la ct at e fr om fe rm en ta tio n' , a m ou nt o f p ro du ct co nt ai ne d in th e fe ed in gs tu ff p er ce nt ag e of th e to ta l c ru de p ro te in pr ov id ed b y no n pr ot ei n ni tr og en , i nd ic at io n, in th e in st ru ct io ns fo r u se , o f t he le ve l o f t ot al n on p ro te in ni tr og en w hi ch s ho ul d no t be e xc ee de d in th e da ily ra tio n of e ac h an im al sp ec ie s or c at eg or y. 2. 2. 2. A m m on iu m ac et at e in a qu eu ou s so lu tio n C H 3C O O N H 4 A m m on iu m ac et at e m in . 5 5 % R um in an ts , f ro m th e st ar t o f r um in at io n D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he w or ds : A m m on iu m a ce ta te , B 1267 n itr og en a nd m oi st ur e co nt en ts , a ni m al s pe ci es o r ca te go ry , a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s: t he w or ds : A m m on iu m a ce ta te t he a m ou nt o f t he pr od uc t c on ta in ed in th e fe ed in gs tu ff , p er ce nt ag e of th e to ta l cr ud e pr ot ei n pr ov id ed b y no n pr ot ei n ni tr og en , i nd ic at io n in th e in st ru ct io ns fo r u se o f t he le ve l o f t ot al n on p ro te in ni tr og en w hi ch s ho ul d no t be e xc ee de d in th e da ily ra tio n of e ac h an im al sp ec ie s or c at eg or y. ' 2. 2. 3 A m m on iu m su lf at e in a qu eo us so lu tio n (N H 4) 2 SO 4 A m m on iu m su lf at e: m in im um 3 5% R um in an ts fr om th e st ar t o f r um in at io n D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he w or ds : A m m on iu m s ul fa te , n itr og en a nd m oi st ur e co nt en ts , a ni m al s pe ci es , a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d B 1268 fe ed in gs tu ff s: t he w or ds : "A m m on iu m s ul fa te ", t he a m ou nt o f t he pr od uc t c on ta in ed in th e fe ed in gs tu ff , p er ce nt ag e of th e to ta l cr ud e pr ot ei n pr ov id ed b y no n pr ot ei n ni tr og en , i nd ic at io n in th e in st ru ct io ns fo r u se o f t he le ve l o f t ot al n on p ro te in ni tr og en w hi ch s ho ul d no t be e xc ee de d in th e da ily ra tio n of e ac h an im al sp ec ie s, i n th e ca se o f y ou ng ru m in at s, th e in co rp or at io n ra te in th e da ily ra tio n m ay n ot ex ce ed 0 , 5 % 2. 3. B y Pr od uc ts fr om th e pr od uc tio n of am in o ac id s by fe rm en ta tio n 2. 3. 1. C on ce nt ra te d liq ui d B y Pr od uc ts fr om th e pr od uc tio n of L gl ut am ic a ci d by fe rm en ta tio n w ith C or yn eb ac te ri um m el as se co la A m m on iu m s al ts a nd ot he r n itr og en ou s co m po un ds Su cr os e, m ol as se s, st ar ch p ro du ct s an d th ei r h yd ro ly sa te s N itr og en ex pr es se d as cr ud e pr ot ei n: m in im um 4 8 % M oi st ur e: m ax im um 2 8% R um in an ts fr om th e be gi nn in g of ru m in at io n D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e 'B y Pr od uc ts fr om th e pr od uc tio n of L gl ut am ic a ci d' in th e ca se o f p ro du ct 2 .3 .1 ; 'B y Pr od uc ts o f L L ys in e' in th e ca se o f p ro du ct 2. 3. 2, n itr og en , e xp re ss ed a s cr ud e pr ot ei n, c ru de a sh , m oi st ur e, B 1269 a ni m al s pe ci es o r ca te go ry , a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in gs tu ff s: t he n am e 'B y Pr od uc ts fr om th e pr od uc tio n of L gl ut am ic a ci d' in th e ca se o f p ro du ct 2 .3 .1 ; 'B y Pr od uc ts fr om th e pr od uc tio n of L L ys in e' in th e ca se o f p ro du ct 2 .3 .2 , p er ce nt ag e of th e to ta l cr ud e pr ot ei n pr ov id ed b y no n pr ot ei n ni tr og en , i nd ic at io n, in th e in st ru ct io ns fo r u se , o f t he le ve l o f t ot al n on p ro te in ni tr og en w hi ch s ho ul d no t be e xc ee de d in th e da ily ra tio n of e ac h an im al sp ec ie s or c at eg or y. 2. 3. 2. C on ce nt ra te d liq ui d B y Pr od uc ts fr om th e pr od uc tio n of L L ys in e m on oh yd ro ch lo ri de by fe rm en ta tio n w ith B re vi ba ct er iu m la ct of er m en tu m A m m on iu m s al ts a nd ot he r n itr og en ou s co m po un ds Su cr os e, m ol as se s, st ar ch p ro du ct s an d th ei r h yd ro ly sa te s N itr og en ex pr es se d as cr ud e pr ot ei n: m in im um 4 5 % R um in an ts fr om th e be gi nn in g of ru m in at io n 3. A m in o ac id s an d th ei r s al ts 3. 1. M et hi on in e 3. 1. 1. D L M et hi on in e, te ch ni ca lly p ur e C H 3S (C H 2) 2 C H (N H 2) C O O H D L M et hi on in e: A ll an im al s pe ci es m in im um 9 8 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: B 1270 3. 1. 2. D ih yd ra te d ca lc iu m s al t o f N hy dr ox y m et hy l D L M et hi on in e, te ch ni ca lly p ur e [C H 3S (C H 2) 2 C H (N H H 2O H ) C O O ]2 C a. 2H 2O D L M et hi on in e: m in im um 6 7% Fo rm al de hy de : m ax im um 1 4% C al ci um : m in im um 9 % 3. 1. 3. M et hi on in ez in c, te ch ni ca lly p ur e [C H 3S (C H 2) 2 C H (N H 2) C O O ]2 Z n D L M et hi on in e: m in im um 8 0% Z n: m ax im um 1 8, 5 % R um in an ts fr om th e be gi nn in g of ru m in at io n t he n am e "D L L m et hi on in e, in th e ca se o f pr od uc ts 3 .1 .1 , "D ih yd ra te d ca lc iu m s al t of N hy dr ox y m et hy lD L M et hi on in e" in th e ca se o f pr od uc t 3 .1 .2 , "Z in cm et hi on in e" , i n th e ca se o f p ro du ct 3 .1 .3 , D L M et hi on in e an d m oi st ur e co nt en ts , a ni m al s pe ci es o r ca te go ry in th e ca se o f pr od uc ts 3 .1 .2 a nd 3 .1 .3 , a pp ro va l n um be r 3. 1. 4. C on ce nt ra te d liq ui d so di um D L M et hi on in e te ch ni ca lly p ur e (C H 3S (C H 2) 2 C H (N H 2) C O O ) N a D L M et hi on in e: A ll an im al s pe ci es m in im um 4 0, 0 % S od iu m : m in im um 6 , 2 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e 'c on ce nt ra te d liq ui d so di um D L M et hi on in e' D L M et hi on in e co nt en t m oi st ur e co nt en t a pp ro va l n um be r 3. 1. 5 D L M et hi on in e, te ch ni ca lly p ur e pr ot ec te d w ith co po ly m er v in yl py ri di ne ls ty re ne C H 3S (C H 2) 2 C H (N H 2) C O O H D L M et hi on in e: D ai ry c ow s m in im um 6 5 % co po ly m er vi ny lp yr id in e/ st yr en e: m ax im um 3 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: " Pr ot ec te d m et hi on in e w ith c op ol ym er vi ny lp yr id in e/ st yr en e" D L M et hi on in e an d m oi st ur e co nt en ts a ni m al s pe ci es a pp ro va l n um be r B 1271 3. 2. L ys in e 3. 2. 1. L L ys in e, te ch ni ca lly p ur e N H 2 ( C H 2) 4 C H (N H 2) C O O H L L ys in e: m in im um 9 8% 3. 2. 2. C on ce nt ra te d liq ui d L L ys in e (b as e) N H 2 ( C H 2) 4 C H (N H 2) C O O H Sa cc ha ro se , m ol as se s, st ar ch p ro du ct s an d th ei r h yd ro ly sa te s L L ys in e: m in im um 6 0% 3. 2. 3. L L ys in em on oh yd ro ch l or id e, te ch ni ca lly p ur e N H 2 ( C H 2) 4 C H (N H 2) C O O H .H C l L L ys in e: m in im um 7 8% 3. 2. 4. C on ce nt ra te d liq ui d L L ys in em on oh yd ro ch l or id e N H 2 ( C H 2) 4 C H (N H 2) C O O H .H C l Sa cc ha ro se , m ol as se s, st ar ch p ro du ct s an d th ei r h yd ro ly sa te s L L ys in e: m in im um 2 2, 4% 3. 2. 5. L L ys in es ul ph at e pr od uc ed b y fe rm en ta tio n w ith C or yn eb ac te ri um gl ut am ic um [N H 2 ( C H 2) 4 C H (N H 2) C O O H ] 2 H 2S O 4 Su ga r s yr up , m ol as se s, c er ea ls , st ar ch p ro du ct s an d th ei r h yd ro ly sa te s L L ys in e: m in im um 4 0% A ll an im al s pe ci es D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e "L L ys in e" in th e ca se o f p ro du ct 3 .2 .1 , "C on ce nt ra te d liq ui d L L ys in e ba se " in th e ca se of p ro du ct 3 .2 .2 , " L L ys in em on oh yd ro ch lo ri de " in th e ca se o f p ro du ct 3. 2. 3, " C on ce nt ra te d liq ui d L L ys in e m on oh yd ro ch lo ri de " in th e ca se o f p ro du ct 3 .2 .4 , "L L ys in e su lp ha te a nd it s B y Pr od uc ts fr om fe rm en ta tio n" , i n th e ca se of p ro du ct 3 .2 .5 , L L ys in e an d m oi st ur e co nt en ts a pp ro va l n um be r 3. 2. 6. L L ys in e ph os ph at e an d its B y Pr od uc ts p ro du ce d by fe rm en ta tio n w ith B re vi ba ct er iu m la ct of er m en tu m N R R L B 11 47 0 [N H 2 ( C H 2) 4 C H (N H 2) C O O H ] Su cr os e am m on ia a nd fi sh s ol ub le s L T hr eo ni ne nl in im um 9 8 % L L ys in e: m in . 3 5 % Ph os ph or us : m in . 4 , 3 % Po ul tr y, p ig s D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: " L L ys in e an d m oi st ur e co nt en t a pp ro va l n um be r 3. 2. 7 M ix tu re s of : N H 2 ( C H 2) 4 C H (N H 2) C O O H H C l C H 3S (C H 2) 2 C H (N H 2) C O O H (a ) L L ys in em on oh yd ro ch l or id e, te ch ni ca lly p ur e an d, (b ) D L M et hi on in e, te ch ni ca lly p ur e L L ys in e + D L M et hi on in e m in im um 5 0 % (i nc lu di ng D L M et hi on in e m in im um 1 5 % ) C op ol ym er D ai ry c ow s D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e "m ix tu re o f U ly si ne m on oh yd ro ch lo ri de a nd D L M et hi on in e pr ot ec te d B 1272 pr ot ec te d w ith co po ly m er vi ny lp yr id in e/ s ty re ne vi ny lp yr id in e/ st yr en e m ax im um 3 % w ith c op ol ym er vi ny lp yr id in e/ st yr en e" L L ys in e, D L rn et hi on in e an d m oi st ur e co nt en ts a ni m al s pe ci es a pp ro va l n um be r 3. 3. T hr eo ni ne 3. 3. 1. L T hr eo ni ne , te ch ni ca lly p ur e C H 3C H (O H ) C H (N H 2) C O O H L T hr eo ni ne : A ll an im al s pe ci es m in im um 9 8% D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e "L T hr eo ni ne " L T hr eo ni ne a nd m oi st ur e co nt en ts a pp ro va l n um be r 3. 4. T ry pt op ha n 3. 4. 1. L T ry pt op ha n, te ch ni ca lly p ur e (C 8H 5N H ) C H 2C H (N H 2) C O O H L T ry pt op ha n: A ll an im al s pe ci es m in im um 9 8 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e: "L T ry pt op ha n" L T ry pt op ha n an d m oi st ur e co nt en ts a pp ro va l n um be r 3. 4. 2. D L T ry pt op ha n, te ch ni ca lly p ur e, (C , H , N H ) C H , C H (N H ,) C O O H D L T ry pt op ha n: A ll an im al sp ec ie s m in im um 9 8 % D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: t he n am e: "L T ry pt op ha n" L T ry pt op ha n an d m oi st ur e co nt en ts a pp ro va l n um be r 4. A na lo gu es o f am in o ac id s B 1273 4. 1. A na lo gu es o f m et hi on in e 4. 1. 1 H yd ro xy an al og ue o f m et hi on in e C H 3S (C H 2) 2 C H (O H ) C O O H T ot al o f a ci ds : m in im um 8 5 % M on om er a ci d: m in im um 6 5 % 4. 1. 2 C al ci um s al t o f hy dr ox y an al og ue o f m et hi on in e [C H 3S (C H 2) 2 C H (O H ) C O O ]2 C a M on om er ac id : m in im um 8 3 % C al ci um : m in im um 1 2 % A ll an im al s pe ci es D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of th e pr od uc t: i f a pp ro pr ia te , t he n am e (c ol um n 2) , m on om er a ci d an d to ta l ac id s co nt en ts in th e ca se of p ro du ct 4 .1 .1 a nd m on om er a ci d co nt en t i n th e ca se o f p ro du ct 4 .1 .2 , m oi st ur e co nt en t, a ni m al s pe ci es a pp ro va l n um be r D ec la ra tio ns to b e m ad e on th e la be l o r p ac ka gi ng of c om po un d fe ed in g St uf fs : i f a pp ro pr ia te , t he n am e (c ol um n 2) , m on om er a ci d an d to ta l ac id s co nt en ts in th e ca se of p ro du ct 4 .1 .1 a nd m on om er a ci d co nt en t i n th e ca se o f p ro du ct 4 .1 .2 , a m ou nt o f t he p ro du ct co nt ai ne d in th e fe ed in gs tu ff . T he c on te nt s la id d ow n or to b e de cl ar ed in a cc or da nc e w ith c ol um ns 5 a nd 7 re fe r t o th e pr od uc t a s su ch . B 1274 Ippubblikat mid-Dipartiment ta’ l-Informazzjoni (doi.gov.mt) Valletta - Published by the Department of Information - (doi.gov.mt) - Valletta Mitbug] fl-Istamperija tal-Gvern - Printed at the Government Printing Press Prezz 68` - Price 68c