isifinyezo
IKHOMISHINI YAseYurophu,
Ngokuphathelene neSivumelwano sokuSebenza kwe-European Union,
Ngokubheka i-Regulation (EU) 2015/2283 yePhalamende laseYurophu kanye noMkhandlu, kaNovemba 25, 2015, mayelana nokudla okunoveli, okuguqula i-Regulation (EU) no. 1169/2011 yePhalamende laseYurophu kanye noMkhandlu kanye nokuchithwa kweRegulation (EC) no. 258/97 wePhalamende LaseYurophu kanye NoMkhandlu Nomthetho (CE) n. 1852/2001 weKhomishana (1), kuhlanganise ikakhulukazi ku-athikili 12,
Uma kucatshangelwa okulandelayo:
- (1) Umthethonqubo (EU) 2015/2283 uhlinzeka ngokuthi ukudla okusha kuphela okugunyaziwe futhi okufakwe ohlwini lweNyunyana okungamakethwa kuNyunyana.
- (2) Ngokulandela Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) yamukelwa, ukusungula uhlu Unit sika ogunyaziwe ukudla inoveli.
- (3) Ngomhla zizi-4 kuNhlangulana wezi-2020, inkampani i-Pharmanutra SpA (umfakisicelo) yathumela kuKhomishana, ngokulandela Isigaba 10(1) Somthethonqubo (EU) 2015/2283, isicelo sokumaketha ama-acids anamafutha kuNyunyana afakwe cetylated njengokudla okusha. Umfakisicelo uphinde wacela ukuthi ama-asidi anamafutha ane-cetylated azosetshenziswa ezithasiselweni zokudla, njengoba kuchazwe kuMyalelo 2002/46/EC wePhalamende LaseYurophu kanye noMkhandlu (3) Isicelo sicacise ukuthi izithasiselo zokudla zihloselwe ukusetshenziswa abantu abadala. ngezinga eliphezulu lokusetshenziswa lika-2,1 g ngosuku.
- (4) Umfakisicelo futhi uthumela isicelo sokuvikela ulwazi lobunikazi kuKhomishana mayelana nemininingwane ehlukahlukene ethunyelwe ukweseka isicelo, okuwukuthi ukuhlehliswa kokuhlolwa koguquko kumagciwane (4); ukuhlolwa kwe-in vitro micronucleus (5); isifundo sobuthi sinezinsuku eziyi-14 kumagundane (6); isifundo sobuthi sinamasonto angu-13 kumagundane (7); Ithebula elifingqiwe lokubhekwa kwezibalo ezibalulekile ezifundweni zobuthi (8); izitifiketi zokuhlaziya, izivivinyo ze-batch nezindlela zokuhlaziya (9); idatha yokuzinza (10).
- (5) Ngokuvumelana ne-Article 10(3) ye-Regulation (EU) 2015/2283, ngomhla zingama-20 kuJulayi 2020 iKhomishana yabonisana ne-European Food Safety Authority (Authority) futhi wayicela ukuthi ikhiphe umbono wesayensi wangaphambili Ukuhlolwa kwama-cetylated fatty acids njenge ukudla inoveli.
- . (ishumi nanye). Lo mbono uhambisana nezidingo ze-athikili 6 ye-Regulation (EU) 26/2021.
- (7) Ngamazwi aso, isigungu seziPhathimandla siphetha ngokuthi ukudla okuyinoveli, okunamafutha acid ane-cetylated, kuphephile ngezinga lokudla lika-1.6 g ngosuku kubantu abadala. Leli zinga eliphephile lokuthatha lingaphansi kwezinga eliphezulu lokudla lika-2,1 g elihlongozwe ngumfakisicelo. Njengoba kukhonjiswe Isiphathimandla, umthamo ophakeme kakhulu ofundwe ocwaningweni lobuthi obungadluli isikhathi eside uthathwe njengeNoa Observed Adverse Effect Level (NOAEL). Ukusebenzisa isici sokungaqiniseki esimisiwe kanye nesisindo somzimba esimisiwe kubantu abadala, lokhu kubangela ukuthi badle u-1,6 g ngosuku.
- (8) Ngakho-ke, umbono wesigungu seziPhathimandla uyisizathu esanele sokuthola ukuthi ama-asidi ane-cetylated, asetshenziswa ezithasiselweni zokudla kubantu abadala anesilinganiso esiphezulu esingu-1.6 g ngosuku, ahlangabezana nezimfuneko zokumaketha ngokuhambisana neSigaba 12, isigaba. 1, Womthethonqubo (EU) 2015/2283.
- (9) Izithako zokudla eziqukethe ama-asidi ane-cetylated akumele zisetshenziswe abantu abangaphansi kweminyaka eyishumi nesishiyagalombili ubudala, ngakho-ke imfuneko yamalebula kufanele isungulwe ukuze yazise abathengi ngokufanele mayelana nalokhu.
- (10) Ngokombono waso, iSigungu seziPhathimandla siphinde saphetha ngokuthi ukuhlolwa kokuguquka kwezakhi zofuzo kumagciwane, ukuhlolwa kwe-in vitro micronucleus, ucwaningo lwamasonto ayi-13 lobuthi emagundeni, ithebula lesifinyezo lokubhekwa okubalulekile kwezibalo ezifundweni zobuthi, izitifiketi zokuhlaziya, inqwaba. izivivinyo nezindlela zokuhlaziya kanye nedatha yokuzinza esetshenziswe njengesisekelo sokunquma ukuphepha kokudla kwenoveli. Isiphathimandla siphinde siqinisekise ukuthi besingeke sikwazi ukufinyelela esiphethweni saso ngaphandle kwale datha, umfakisicelo aqinisekisa ukuthi ingeyakhe.
- (11) IKhomishana icele umfakisicelo ukuthi acaciselwe okwengeziwe ngezizathu ezinikeziwe maqondana nesicelo sayo sobunikazi bale datha futhi icacise isimangalo sayo sokuthi inelungelo elikhethekile lokuyidlulisela kubo, ngokuhambisana neSigaba 26(2), incwadi. b), we-Regulation (EU) 2015/2283.
- (12) Umfakisicelo uyasho ukuthi, ngesikhathi sokufakwa kwesicelo, unamalungelo obunikazi kanye namalungelo akhethekile okubhekisela kule datha ngaphansi komthetho kazwelonke nokuthi, ngakho-ke, akukho muntu wesithathu ongayisebenzisa noma afinyelele noma ayidlulisele kuyo. .ngokomthetho
- (13) IKhomishana ihlole lonke ulwazi oluhlinzekwe ngumfakisicelo futhi yabheka ukuthi umfakisicelo ubonise ngokwanele ukuhambisana nezidingo ezibekwe ku-Article 26(2) yoMthethonqubo (EU) 2015/2283. Ngakho-ke, i-bacterial reverse mutation assay (12), i-in vitro micronucleus assay (13), isifundo seviki le-13 sobuthi kumagundane (14), ithebula lesifinyezo lokubhekwa okubalulekile kwezibalo ezifundweni zobuthi (15), izitifiketi. Ukuhlaziya, ukuhlolwa kweqoqo kanye nezindlela zokuhlaziya (16) kanye nedatha yokuzinza (17) equkethwe efayeleni lomfakisicelo akumele isetshenziswe Isigungu seziPhathimandla ukuze kuzuze noma yimuphi umfakisicelo olandelayo.Isikhathi esiyiminyaka emihlanu kusukela ngosuku lokuqalisa ukusebenza. walo Mtheshwana. Ngakho-ke, phakathi naleso sikhathi, ukugunyazwa kokumaketha kwama-acids ane-cetylated ku-Union kufanele kukhawulelwe kumfakisicelo.
- (14) Nokho, ukukhawulela ukugunyazwa kwamafutha ane-cetylated fatty acid ekusetshenzisweni komfakisicelo kuphela kanye nelungelo lokubhekisela kulabo abafakwe kudosi yabo akuvimbeli abanye abafake izicelo ukuthi bathumele izicelo zokugunyazwa ukumaketha ukudla okuyinoveli efanayo uma isicelo sabo ngokusekelwe olwazini olutholwe ngokomthetho oluvumela ukugunyazwa ngokuhambisana noMthethonqubo (EU) 2015/2283.
- (15) Ngakho-ke, inqubo yokuchibiyela isijobelelo SokuQalisa Umthethonqubo (EU) 2017/2470 ngokufanele.
- (16) Izinyathelo ezihlinzekwe kulo Mthethonqubo zihambisana nombono weKomidi Elimisiwe LeZimila, Izilwane, Ukudla Nokuphakelayo,
WAMKELELA LE IMITHETHO:
Isigaba 1
1. Amafutha acid ane-cetylated ashiwo kusijobelelo salo Mtheshwana azofakwa ohlwini lweYunithi yokudla okunoveli okugunyaziwe okusungulwe ku-Implementing Regulation (EU) 2017/2470.
2. Isikhathi esiyizinyanga ezinhlanu kusukela osukwini lokuqala ukusebenza kwalo Mthethonqubo, ofake isicelo sokuqala kuphela:
inkampani: Pharmanutra SpA,
Ikheli: Via Delle Lenze 216/b, 56122 Pisa, Italy
bagunyazwe ukumaketha eNhlanganweni ukudla okuyinoveli okukhulunywe ngakho endimeni 1, ngaphandle uma umfakisicelo olandelayo ethola ukugunyazwa kwalokhu kudla kwenoveli ngaphandle kokubhekisela kudatha evikelwe ngokuhambisana nezinhlinzeko zeSigaba 2 salo Mthethonqubo, noma ngesivumelwano Inkampani Pharmanutra S.p.A
3. Ohlwini lweNyunyana okukhulunywe ngayo esigabeni 1, okufakiwe kuzobandakanya imibandela yokusebenzisa kanye nezidingo zokulebula ezishiwo eSithasiselweni salo Mtheshwana.
Isigaba 2
Izifundo eziqukethwe efayeleni lesicelo lapho iSiphathimandla sihlaziye khona ukudla kwenoveli okukhulunywe ngakho esihlokweni soku-1, izifundo umfakisicelo athi ziyindawo yakhe futhi ngaphandle kwalokho ukudla kwenoveli bekungeke kugunyazwe, ngeke kusetshenziswe. womfakisicelo olandelayo isikhathi esiyiminyaka emihlanu kusukela osukwini lokuqala ukusebenza kwale Mithethonqubo ngaphandle kwesivumelwano se-Pharmanutra SpA.
Isigaba 4
Lo Mthethonqubo uzoqala ukusebenza ezinsukwini ezingamashumi amabili ngemva kokushicilelwa kwawo ku-Official Journal of the European Union.
Lo Mthethonqubo uyobophezela kuzo zonke izici zawo futhi usebenze ngokuqondile kulelo nalelo zwe eliyiLungu.
Kwenziwe e-Brussels, ngoFebhuwari 10, 2022.
OkweKhomishini
umongameli
Ursula VON DER LEYEN
OKUnamathiselwe
ISijobelelo Somthethonqubo Wokusebenzisa (EU) 2017/2470 silungiswa ngale ndlela elandelayo:
- 1) Kuthebula loku-1 (ukudla kwenoveli okugunyaziwe) kufakwe lokhu okulandelayo okufakiwe [OP, faka enguqulweni yeSpanishi ngokulandelana kwezinhlamvu]: Ukudla kwenoveli egunyaziwe Imibandela lapho ukudla kwenoveli kungasetshenziswa ngaphansi kwazo Izidingo ezengeziwe zokulebula eziqondile Ezinye izidingo Ukuvikelwa kwedatha amafutha ane-cetylated ama-acids Isigaba esithile sokudla Okuqukethwe okuphezulu
1.-Igama lokudla okusha ekulebulani kwezithako zokudla ezikuqukethe kufanele kube “ukulungiswa kwe-asidi enamafutha”.
2.-Ekubhalweni kwezithako zokudla eziqukethe ukudla okusha, isitatimende kufanele sifakwe esicacisa ukuthi lezi zithako zokudla akufanele zisetshenziswe abantu abangaphansi kweminyaka engu-18 ubudala.
Igunyazwe ngomhla ka-3 Mashi 2022. Lokhu kufakwa kusekelwe ebufakazini bobunikazi besayensi nedatha yesayensi evikelwe ngokuvumelana ne-Article 26 of Regulation (EU) 2015/2283.
Umfakisicelo: Pharmanutra SpA, Via Delle Lenze 216/b, 56122 Pisa, Italy. Phakathi nesikhathi sokuvikelwa kokwaziswa, i-Pharmanutra SpA kuphela egunyazwe ukumaketha ukudla okusha okunamafutha acid ane-cetylated ophikweni, inqobo nje uma umfakisicelo olandelayo ethola ukugunyazwa kokudla okusha ngaphandle kokubhekisela ebufakazini besayensi obuncike kumalungelo obunikazi noma idatha yesayensi evikelwe ngokuhambisana ne-athikili 26 ye-Regulation (EU) 2015/2283, noma ngemvume ye-Pharmanutra SpA
Idethi ukuphela kokuvikelwa kwedatha: Mashi 3, 2027.
Izithako zokudla, njengoba kuchazwe ku-Directive 2002/46/EC, ezihloselwe abantu abadala abangu-1,6 g/ngosuku.
- 2) Kuthebula lesi-2 (Izincazelo), okufakiwe okulandelayo kufakwe: Ukudla kwenoveli okugunyaziwe Imininingwane ama-cetylated fatty acids
Incazelo/Incazelo:
Ukudla kwenoveli kuqukethe ikakhulukazi ingxube ye-cetylated mystic acid kanye ne-cetylated oleic acid ehlanganiswe ku-cetyl alcohol, myrstic acid ne-oleic acid, futhi, ngokwezinga elincane, amanye ama-cetylated fatty acids nezinye izinhlanganisela zikawoyela we-olive.
Izici/ukwakheka:
Okuqukethwe kwe-Ester: 70-80%, okuthi: cetyl oleate: 22-30%, cetyl myristate: 41-56%
I-Triglycerides: 22-25%
inani le-asidi (mg KOH/g): ≤ 5
inani le-saponification (mg KOH/g): 130-150
Imibandela ye-Microbiological:
Isamba sesibalo se-aerobic microbiological: ≤ 1.000 CFU/g
Imvubelo nesikhunta: ≤ 100 CFU/g
I-KOH: i-potassium hydroxide
I-CFU: amayunithi okwenza ikholoni
