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Ngaphandle kokuba kuphawulwe ngenye indlela, olu papasho luhanjiswa phantsi kweLayisensi yoRhulumente oVulekileyo v3.0.Ukujonga eli phepha-mvume, ndwendwela nationalarchives.gov.uk/doc/open-government-licence/version/3 okanye ubhalele kuMgaqo-nkqubo woLwazi, ooVimba beSizwe, eKew, eLondon TW9 4DU, okanye i-imeyile: psi@nationalarchives.i-gov.IUNITED KINGDOM.
Ukuba siye sazi malunga naluphi na ulwazi lwelungelo lokushicilela lesithathu, kuya kufuneka ufumane imvume kumnini welungelo lokushicilela.
Olu papasho luyafumaneka ku- https://www.gov.uk/government/publications/uknhcc-scientific-opinion-white-mulberry-leaf-extract-and-blood-glucose-levels/scientific-opinion-for-the-substantiation .ukufumana-amabango-ezempilo-kwicandelo-enye-ukusuka-white-mulberry-extract-and-healthy-bl
I-UKNHCC Code of Conduct ithi ababukeli abasemthethweni baya kwiintlanganiso ze-UKNHCC ukubonelela ngolwazi lwangoku malunga nemiba yangoku yesayensi kunye nomgaqo-nkqubo kumazwe abo ngelixa behlonipha ukuzimela kwe-UKNHCC.
I-UKNHCC (i-UK Nutrition and Health Claims Council), i-2023 i-Reserved Scientific Opinion (EC) No 1924 / 2006, iMimiselo yeZondlo (Izilungiso njl.) (Ukushiya i-EU) kunye neMimiselo yeZondlo (Izilungiso njl.)) (ukuhoxiswa kwi-EU) 2020 njengoko ulungisiwe.
Olu luvo alukho kwaye alufanele luthathwe njengesigunyaziso sentengiso yesicatshulwa se-mulberry leaf, uvavanyo oluhle lokhuseleko lwalo, kwaye ayisigwebo malunga nokuba isicatshulwa seqabunga le-mulberry sihlelwa njengemveliso yokutya.Kufuneka kuqatshelwe ukuba olu hlobo lommiselo alubonelelwanga phantsi koKutya (Ulungiso, njl.) (Ukushiya i-EU) Ummiselo we-2019 kunye noMthetho woLondolozo lokuTya (uLungiso) (EC) No 1924/2006 [umbhalo osemazantsi we-1], njl. .) (Ukushiya i-EU) Ummiselo we-2020
Kufuneka kwakhona kugxininiswe ukuba umda, amagama acetywayo amabango kunye nemiqathango yokusetyenziswa ecetywayo nguMenzi-sicelo zinokutshintshwa phambi kokuba kugqitywe inkqubo yegranti ebonelelwe kwiSiqendu 18(4) soMmiselo weSavings Regulation (EC) Akukho 1924 / 2006 [umbhalo osemazantsi 1] Njengoko uhlonyelwe, ngoKutya (Ulungiso, njl.) (Ukushiya i-EU) Imigaqo ye-2019 kunye noKutya (Izilungiso, njl.) (Ukushiya i-EU) Imigaqo ye-2020.
Izicelo zafunyanwa yi-UKNHCC ngomhla we-5 Agasti 2022 kwaye inkqubo yokuhlola isayensi yaqala ngokukhawuleza.
Ngomhla we-19 ka-Agasti 2022, uvavanyo lwezenzululwazi lwanqunyanyiswa emva kwenkqubo “yokumisa iwotshi” efuna abafaki-zicelo banike ulwazi olongezelelweyo.
Ngomhla we-4 Septemba 2022, i-UKNHCC ifumene ulwazi olongezelelweyo kwaye iphinda iqalise uvavanyo lwesayensi ngokuhambelana neSiqendu 16 (1) soMgaqo-nkqubo (EC) No 1924 / 2006.
Igunya lokwenza amabango ezempilo phantsi kweSiqendu 14(1)(a) Surviving Regulation (EC) No 1924/20061 njengoko ihlonyelwe yiNutrition (Amendment, etc.) Regulation (ukuhoxiswa kwi-European Union) 2019 kwaye ikhutshwe yi-UK igunya elinobuchule. .Igunya kwisicelo se-Ascarit UK.Kwi- Nutrition (Ulungiso, njl.) (Ukushiya i-EU) Imigaqo ye-2020, i-UK Nutrition and Health Claims Committee (UKNHCC) yacelwa ukuba inike izimvo malunga nesiseko sesayensi kumabango ezempilo e-mulberry (M. alba) amaqabunga.Izicatshulwa "zingqinwe ngokweklinikhi ukunceda ukugcina amanqanaba eswekile yegazi esempilweni."
Kwaphakanyiswa ukuba ububanzi besicelo buxhomekeke kwiimfuno zempilo ezinxulumene nokunciphisa ingozi yesifo, kubandakanywa nesicelo sokukhusela ubumfihlo, esaye sarhoxiswa.
Imveliso yesondlo ekuthiwa isempilweni yincindi yecandelo elinye lamagqabi e-M. alba (white mulberry).
Ngokombono weKomiti, isicatshulwa sesondlo samaqabunga e-M. alba ayibonakali ngokwaneleyo kumabango acetywayo.
Ibango lomfaki-sicelo lelokuba isicatshulwa segqabi le-M. alba “singqinwe ngokwezonyango ukunceda ukugcina amanqanaba eswekile esegazini esempilweni.”Umngcipheko wokubeka umngcipheko wawunyukile iswekile yegazi kunye nomngcipheko ohambelana nomngcipheko wawuhlobo lwe-2 yeswekile.Iqela elicetywayo ekujoliswe kulo "yizigulane ezinesifo sikashukela sohlobo lwe-2".Iziphumo ezibangwayo ezinjalo zingaphandle kwendawo yeSiqendu 14(1) (a) samabango ezempilo.Njengoko kuchazwe kwiSiqendu 2 (6) soMgaqo-nkqubo (EC) No 1924/2006, "ibango lokunciphisa umngcipheko wezifo" naliphi na ibango lezempilo elithi, licebisa okanye lithetha ukusetyenziswa kodidi lokutya, ukutya okanye enye yamacandelo ayo.Ukunciphisa kakhulu umngcipheko wokuphuhliswa kwezifo zabantu.Ngokutsho kwePhaneli yeDiet, Nutrition and Allergy (NDA) ye-European Food Safety Authority (EFSA), iKhomishoni ikholelwa ukuba amabango ezempilo kufuneka abhekiselele kubantu ngokubanzi (abanempilo).IKomiti iphinde yaqwalasela ukuba ukuba ibango lezempilo lihambelana nomsebenzi okanye umphumo onokuthi udibaniswe nesifo, izifundo ezinesifo azikho abantu ekujoliswe kubo kwibango (EFSA, 2021).
IKomiti yayingayazi indlela esetyenzisiweyo kuphononongo loncwadi olungeniswe ngumfaki-sicelo kwaye ngoko ke ayikwazanga ukuvavanya ukuba ngaba bonke ubungqina buthunyelwe ukuba buqwalaselwe.Umfaki-sicelo uchonge upapasho olupheleleyo lwe-13 akholelwa ukuba lufanelekile kumabango, kubandakanywa:
Kubungqina obunikwe nguMfaki-sicelo, i-2 RCTs (Lown et al. 2017; Thondre et al. 2021) ayizange ihlolisise ubungqina obuxhasa eli bango.Ulingo olulawulwa ngokungahleliwe (u-Mudra et al., 2007) yayiyingxelo eshwankathelayo kwaye yayicatshangelwa ukuba inomngcipheko ophezulu wokungakhethi.Uphononongo olungalawulwayo (i-Chatterji kunye neFogel, i-2018) ayizange ihlolisise ubungqina bokuxhasa eli bango.Iimpapasho ezintlanu (uBensky, 1993; Asano et al., 2001; Saudek et al., 2008; Gomyo et al., 2004; NIH, 2008) ayizange ichaze iimveliso zokutya kunye / okanye iziphumo ezibango.Iimpapasho ezintathu (i-Lown, i-2017; i-Drugs.com, i-2022; i-Gordon-Seymour, i-2021) yayiyimibhalo engekho yesayensi.Enye ipapasho (Thaipitakwong et al., 2018) yayiyinqaku lokuphonononga amagqabi e-mulberry kunye nefuthe lawo elinokubakho kumngcipheko we-cardiometabolic.Ngokoluvo lweKomiti, akukho zigqibo zinokuthathwa kolu papasho ukuxhasa le nkcazo.
Ngokusekelwe kulwazi olunikeziweyo, iKomiti yagqiba ukuba ubudlelwane be-causal phakathi kokusetyenziswa kweqabunga leqabunga le-M. alba kunye neziphumo ezibangwayo azikwazi ukusekwa.Ikomiti iphinde yagqiba ukuba akukho bungqina obunikezelweyo bobudlelwane phakathi kweempembelelo ezibangwayo kunye nomngcipheko wokuphuhlisa uhlobo lwe-2 yeswekile.
Isicelo siqulethe isicelo sokukhuselwa kwedatha eyimfihlo, eyathi yarhoxiswa emva koko.
Ukutya okwakungumxholo webango lezempilo yi-M. alba (i-mulberry emhlophe), eyayibalelwa kwi-50% ye-roundworm content.
Ubukho be-mulberry bunciphise kakhulu inani le-glucose ukusuka kwinqanaba lokulawula ukuya kwinqanaba eliphantsi kwaye linyuse kakhulu izinga le-insulin xa kuthelekiswa nenqanaba lokulawula.Kuphononongo lweklinikhi, iintshulube ezijikelezayo zavavanywa amandla azo okwehlisa amanqanaba eglucose.Uphononongo longenelelo olulindelekileyo lweziko elinye lwenziwa kwaSirayeli.
Umfaki-sicelo uphakamisa la magama alandelayo kwibango lenzuzo yezempilo: "Ingqinwe ngokwezonyango ukunceda ukugcina amanqanaba eswekile yegazi esempilweni."
Umfaki-sicelo akazange acebise iimeko ezithile zokusetyenziswa kokutya kwe-M. alba ngumxholo wesibhengezo.Imimiselo yokusetyenziswa ephakanyisiweyo ibonelelwe kwi-Ascarit supplement.Iqela elicetywayo ekujoliswe kulo lizigulane ezinesifo sikashukela sohlobo lwe-2.
Ngokungqinelana neNqaku le-14(1)(a) loMmiselo (EC) No 1924/2006 [umbhalo osemazantsi 1] Uhlengahlengiso ngebango lesondlo (isilungiso) malunga namabango ezempilo esicatshulwa semulberry leaf kunye nokugcinwa kwamanqanaba eswekile esempilweni, njl njl. d.) (I-EU Rejection) Ummiselo we-2019 kunye neMithetho yoKutya (Izilungiso, njl.) (Ukushiya i-EU) Ummiselo we-2020 ye-ID yesicelo: 002UKNHCC.Inikezelwe ngu Ascarit UK.
1.1 Ekuphenduleni isicelo se-UKNHCC sokucaciswa kwemveliso yokutya eyintloko yebango lezempilo, umfaki-sicelo uqinisekisile ukuba imveliso yokutya isicatshulwa se-M. alba (iqabunga le-mulberry elimhlophe).Umfaki-sicelo akazange anike iinkcukacha malunga nokwakheka, ukuguquguquka kwe-batch-to-batch, okanye izifundo zozinzo lwe-M. alba leaf extract.
1.2 Umfaki-sicelo unike isishwankathelo senkqubo yokwenziwa kwe-Ascarite echazwe njenge-multi-component additive equlethe:
Amagqabi kunye neentyatyambo ziyacocwa kwaye zilungiswe ngokutsha (okt ukugcina umbala wazo wokuqala, ukumila, kunye nokudumba) ngendibaniselwano yokusikwa, ukucofa, kunye nokutsalwa kobushushu kunye nokusetyenzwa kotywala ukuze kwandiswe ukubuyiswa kweemveliso zezityalo, kubandakanywa ne-sheet latex.Emva koko, i-liquid ipholile ngokukhawuleza ukuya kwi-20-30 degrees Celsius, kwaye ihlulwe.Amalungu engcambu kunye namagxolo ahlanjululwa, emva koko acutshungulwe ngokususa ubushushu kunye nokupholisa.Isisombululo esixubileyo siqulethe (njengepesenti ngobunzima bobunzima besisombululo) 50% Morus, 20% Artemisia, 10% Urtica, 10% Cinnamon kunye ne-10% Taraxacum.
Umfaki-sicelo ucele ukuba ubunini be-Ascarit yokwakheka kunye nenkqubo yokuvelisa igcinwe, kodwa kamva wayirhoxisa le mfuneko.
1.3 Ngokombono weKomiti, i-nutrition extract yamagqabi e-M. alba, eyona nto ibango lezempilo, ayizange ibonakaliswe ngokwaneleyo malunga nemiphumo yebango elicetywayo.
2.1 Umenzi-sicelo uthi uhlobo lwe-2 yeswekile sisifo se-metabolic esibonakaliswa ngamanqanaba aphezulu eglucose yegazi.Ekuphenduleni isicelo se-UKNHCC sobungqina obubonisa ubudlelwane phakathi komngcipheko wokubeka (i-glucose yegazi ephakamileyo) kunye nomngcipheko wesifo esichaphazelekayo (uhlobo lwe-2 yeswekile), umfaki-sicelo ungenise izifundo ze-3 (DCCT, 1995; Rohlfing et al., 2002) ; Sveta, 2014).Zombini i-Diabetes Control and Complications Trial (DCCT) iqela lokufunda (1995) kunye noRolfing et al.(2002) ingxelo ye-DCCTs kuquka izigulane ezine-insulin ezixhomekeke kwi-insulin (uhlobo lwe-1) kodwa kungekhona nge-2 yeswekile.uhlobo (isifo esifunekayo ukunciphisa umngcipheko).).I-Swetha (i-2014) ibala ulungelelwaniso phakathi kwe-HbA1c (i-glycosylated hemoglobin) kunye neziphumo ezahlukahlukeneyo (ukuzila ukutya, i-postprandial kunye ne-glucose yokuphumla) ukuvavanya ukusetyenziswa kwazo ekubekeni iliso kwi-glycemic control kwizigulane zesifo sikashukela.Ngokombono wekomiti, abafaki-zicelo abazange babonelele ubungqina bobudlelwane be-causal phakathi kwamanqanaba aphezulu e-glucose yegazi kunye nomngcipheko wokuphuhlisa uhlobo lwe-2 yeswekile, okanye ukuba amanqanaba aphezulu e-glucose yegazi yi-predictor ezimeleyo yohlobo lwe-2 yeswekile.
2.2 Umfaki-sicelo unikezele ngolwazi olongezelelweyo ekuphenduleni isicelo se-UKNHCC solwazi malunga nesiphumo, iziphumo eziguquguqukayo kunye nongenelelo olucetywayo lokuvavanya izinto ezinobungozi kwizifundo zabantu.Nangona kunjalo, ngokusekelwe kwingcaciso enikeziweyo, akucaci kwiKomiti ukuba zeziphi iziphumo eziphakanyiswa ngabafaki-zicelo kunye nendlela abaya kuvavanywa ngayo.
2.3 Isiphumo esibango somfaki-sicelo “singqinwe ngokonyango ukunceda ukugcina amanqanaba eswekile esempilweni”.Iqela ekujoliswe kulo elicetywayo ngumfaki-sicelo zizigulane ezinesifo sikashukela sohlobo lwe-2.
2.4 IKomiti iphawula ukuba iqela elicetywayo lezigulane ezinesifo sikashukela sohlobo lwe-2 alikho phantsi kwamabango ezempilo phantsi kweSiqendu 14 (1) (a) soMgaqo-nkqubo (EC) No 1924/2006.Njengoko kuchazwe kwiSiqendu 2 (6) soMgaqo-nkqubo (EC) No 1924/2006, "ibango lokunciphisa umngcipheko wezifo" naliphi na ibango lezempilo elithi, licebisa okanye lithetha ukusetyenziswa kodidi lokutya, ukutya okanye enye yamacandelo ayo.Ukunciphisa kakhulu umngcipheko wokuphuhliswa kwezifo zabantu.Ngokutsho kwePhaneli yeDiet, Nutrition and Allergy (NDA) ye-European Food Safety Authority (EFSA), iKhomishoni ikholelwa ukuba amabango ezempilo kufuneka abhekiselele kubantu ngokubanzi (abanempilo).IKomiti iphinde yaqwalasela ukuba ukuba ibango lezempilo lihambelana nomsebenzi okanye umphumo onokuthi udibaniswe nesifo, izifundo ezinesifo azikho abantu ekujoliswe kubo kwibango (EFSA, 2021).
2.5 Ukufezekisa isiphumo esibangwayo, umenzi-sicelo ucebisa ukuba athathe ii-capsules ze-roundworm ezi-2 ngamanzi imizuzu engama-30 ngaphambi kokutya amaxesha amathathu ngosuku.Abafaki-zicelo abacebisi ukugxila, umthamo okanye ixesha lokusetyenziswa.
2.6 IKomiti yaqaphela ukuba ukunciphisa impendulo ye-glycemic ye-postprandial inokuthathwa njengenzuzo kubantu abasele benengxaki yokunyamezela i-glucose ukunyamezela, kodwa iKomiti ithathele ingqalelo ukuba igama elicetywayo alizange lihlangabezane neendlela zokuqwalasela kwiSiqendu 14 (1) (a) , kwaye ayizange ithethe ngeengenelo zempilo Iikhrayitheriya zabemi ekunokwenziwa ngazo amabango okuncitshiswa kwengozi yesifo.
3.1 Xa becelwa yi-UKNHCC, abafaki-zicelo bayacelwa ukuba banike iinkcukacha zokuphononongwa koncwadi, kubandakanywa nobubhali, iinjongo, imigaqo yokufaneleka, isicwangciso esipheleleyo sokukhangela kunye nedatha nganye ekhangelweyo.Ulwazi olunikiweyo lwalunqongophele kangangokuba iKomiti ayizange ikwazi ukuvavanya ukuba ngaba bonke ubungqina buthunyelwe ukuba buqwalaselwe.
3.2 Umfaki-sicelo uchonge upapasho olupheleleyo lwe-13 akholelwa ukuba lufanelekile kumabango, kubandakanywa:
IKomiti ibona ukuba akukho zigqibo zinokuthathwa kolu papasho njengoko kungekho bungqina buqinisekisiweyo bokuxhasa eli bango.
3.4 Iqulethe ikhonkco lencwadi yamayeza esintu aseTshayina (uBensky, 1993).Akukho nkcazelo yesahluko, iinombolo zamaphepha, okanye izicatshulwa zale ncwadi zangeniswa kwikomiti ukuze ziqwalaselwe, ngoko ke azinakuhlelwa.
3.5 Uxwebhu lwenyaniso (i-NIH, 2008) lushwankathela izifundo malunga nokulawulwa kwesifo seswekile kunye neengxaki kunye nezifundo zokulandelela, kodwa aluvavanyi ubungqina obuxhasa eli bango, ngoko akukho zigqibo zinokuthathwa kolu papasho.
Uphononongo lwebhubhoratri (u-Asano et al., 2001) uchaze ukukhululwa kwe-M. alba alkaloids kunye nefuthe labo lokuthintela kwi-glycosidases, kodwa ubungqina bokuxhasa eli bango abuzange buhlolwe.IKomiti ibona ukuba akukho zigqibo zinokuthathwa kolu papasho.
3.7 Kwii-RCT ezintathu (Lown et al., 2017; Thondre et al., 2021; Mudra et al., 2007), abathathi-nxaxheba babelwa ngokungenamkhethe ukuba bafumane i-mulberry leaf extract.Lown et al.(2017) kunye noThondre et al.(I-2021) yayiyi-double-blind blind, i-randomized, imilinganiselo ephindaphindiweyo, izilingo ze-crossover ezivavanya ukusetyenziswa okanye ukusetyenziswa kwe-extract ye-mulberry leaf extract (i-Reducose®) ngokubhekiselele kwi-placebo kwizifundo eziphilileyo iimpendulo ze-glycemic zabathathi-nxaxheba kumngeni we-carbohydrate.Ngokoluvo lweKomiti, akukho zigqibo zinokuthathwa kolu papasho kuba abakhange bavavanye ubungqina obuxhasa eli bango.U-Mudra et al.(2007) yingxelo yesishwankathelo esishwankathela uphando lwe-crossover oluvavanya umphumo we-mulberry leaf extract okanye i-placebo kwimpendulo ye-glucose yegazi yabathathi-nxaxheba abaphilileyo (abathathi-nxaxheba be-10) kunye nezigulane ezinesifo sikashukela sohlobo lwe-2 (abantu abayi-10).IKomiti iqwalasele ukuba uphando lunokuba lusengozini enkulu yokuxhatshazwa ngenxa yokungabikho kolwazi malunga nenkqubo ye-randomization, i-bias enokubakho ehambelana nokungenelela okujoliswe kuyo, kunye ne-bias enokubakho ekukhethweni kweziphumo ezixeliweyo.
I-3.8 Uphononongo olungalawulwayo (i-Chatterji kunye ne-Fogel, i-2018) yayiquka izigulane ezine-type 2 yeswekile.I-Chatterji kunye neFogel (2018) ivavanye umphumo we-herbal composition SR2004 (ebandakanya amaqabunga e-M. alba, amaqabunga e-U. dioica, i-cinnamon bark, i-A. dracunculus leaf extracts kunye ne-T. officinale root extracts) kumanqanaba e-HbA1c kanye ngeveki kwiintsuku ze-12 .iiveki kunye neeveki ezingama-24.Ngokombono weKomidi, akukho zigqibo ezinokuthi zithathwe kulolu cwaningo olungalawulwayo, olungazange luhlolisise ubungqina obuxhasa amabango.
3.9 Ngoko ke iKomiti ibona ukuba akukho zigqibo zinokuthathwa kubungqina obunikwe ngummangali malunga nefuthe le-albaflora leaf extract kwi-blood glucose concentrations.
4.1 Ekuphononongeni ubungqina, ikomiti yaqwalasela i-1 isilingo esilawulwa ngokungahleliwe (i-Mudra et al., 2007) apho kunokuthi kwenziwe izigqibo.
4.2 IKomiti yagqiba ukuba, ngokusekelwe kubungqina obunikeziweyo, kwakungenakwenzeka ukuseka ubudlelwane be-causal phakathi kokusetyenziswa kwe-Albiflora leaf extract kunye neziphumo ezibangwayo.Ikomiti iphinde yagqiba ukuba akukho bungqina obunikezelweyo bobudlelwane phakathi kweempembelelo ezibangwayo kunye nomngcipheko wokuphuhlisa uhlobo lwe-2 yeswekile.
Morus Alba (Muscus alba) Isicatshulwa seLeaf Umba womxholo wamabango ezempilo acetywayo awuchazwanga ngokwaneleyo ngokunxulumene neziphumo zamabango.
Amabango empembelelo kwizigulane ezine-2 yeswekile ayihambelani nemigaqo echazwe kwi-Regulation (EC) No 1924/2006.ngokungqinelana neCandelo 14(1)(a).
Ubudlelwane be-causal phakathi kokusetyenziswa kwe-mulberry leaf extract kunye neziphumo ezibangwayo azikwazanga ukusekwa, kwaye akukho bungqina bobudlelwane phakathi kweziphumo ezibangwayo kunye nomngcipheko wokuphuhlisa uhlobo lwe-2 yeswekile.
Ixesha lokuposa: Jan-29-2023