Sainzi Maonero ekutsigira Hutano Zvikumbiro zveIngredient Mulberry Leaf Extract uye Rubatsiro Kuchengeta Hutano Hweshuga Yeropa

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Bhuku iri rinowanikwa pa https://www.gov.uk/government/publications/uknhcc-scientific-opinion-white-mulberry-leaf-extract-and-blood-glucose-levels/scientific-opinion-for-the-substantiation .kuwana-zvinoda-zveutano-pane-chimwe-chikamu-kubva-white-mulberry-extract-and-help-healthy-bl
UKNHCC Code of Conduct inotaura kuti vataridzi vepamutemo vanopinda misangano yeUKNHCC kuti vape ruzivo rwemazuva ano nezvenyaya dzesainzi uye dzemitemo munyika dzavo vachiremekedza rusununguko rweUKNHCC.
UKNHCC (UK Nutrition and Health Claims Council), 2023 Reserved Scientific Opinion (EC) No 1924/2006, Nutritional Regulations (Amendments etc.) (Kusiya EU) uye Nutritional Regulations (Amendments etc.)) (kubviswa muEU) 2020 sezvakagadziriswa.
Maonero aya haasi uye haafanire kutorwa semvumo yekushambadzira yekubvisa shizha remurubheri, ongororo yakanaka yekuchengetedzwa kwayo, uye haisi mutongo wekuti shizha remurubheri rakatorwa sechikafu chekudya.Izvo zvinofanirwa kucherechedzwa kuti rudzi urwu rwemutemo haruna kupihwa pasi peChikafu (Amendment, nezvimwewo) (Kusiya EU) Regulation 2019 uye Food Preservation (Amendment) Regulation (EC) No 1924/2006 [muzasi 1], nezvimwe. (Kusiya EU) Regulation 2020
Izvo zvinofanirwawo kusimbiswa kuti chiyero, mazwi akatsanangurwa ezvichemo uye mamiriro ekushandiswa akatsanangurwa neMunyoreri anogona kushanduka kusati kwapedzwa nzira yekupihwa inopihwa muChinyorwa 18 (4) cheSavings Regulation (EC) Kwete 1924/2006 [chinyorwa chepasi 1] Sezvakagadziridzwa, neChikafu (Amendment, nezvimwewo) (Kusiya EU) Regulations 2019 uye Chikafu (Amendments, etc.) (Kusiya EU) Regulations 2020.
Zvikumbiro zvakagamuchirwa neUKNHCC musi wa5 Nyamavhuvhu 2022 uye maitiro ekuongorora sainzi akatanga pakarepo.
Musi waNyamavhuvhu 19, 2022, kuongororwa kwesainzi kwakamiswa mushure mekuita "kumira-kumira" kwaida kuti vanonyorera vape rumwe ruzivo.
Musi wa4 Gunyana 2022, UKNHCC yakagamuchira rumwe ruzivo uye yakatangazve ongororo yesainzi zvinoenderana neChinyorwa 16 (1) cheMutemo (EC) No 1924/2006.
Mvumo yekuita zvichemo zvehutano pasi peChinyorwa 14 (1) (a) Surviving Regulation (EC) No 1924/20061 sezvakagadziridzwa neNutrition (Amendment, nezvimwewo) Regulation (kubviswa kubva kuEuropean Union) 2019 uye yakapihwa neUK ine masimba masimba. .Chiremera pane Ascarit UK application.MuNutrition (Amendment, etc.) (Kusiya EU) Regulations 2020, UK Nutrition uye Health Claims Committee (UKNHCC) yakakumbirwa kuti itaure pamusoro pehwaro hwesainzi hwezvichemo zvehutano zvemulberry (M. alba) mashizha.maextracts "anoratidzwa nekiriniki kubatsira kuchengetedza hutano hwehuga hweropa."
Zvakarongwa kuti chiyero chechikumbiro chive pasi pezvinodiwa zvehutano zvine chekuita nekuderedza njodzi yechirwere, kusanganisira chikumbiro chekuchengetedzwa kwekuvanzika, icho chakazobviswa.
Chigadzirwa chinovaka muviri chinonzi chine hutano chikamu chimwe chete cheM. alba (white mulberry) mashizha.
Mukuona kweKomiti, chikafu chekudya cheM. alba mashizha hachina kukwana zvakakwana kune zvakataurwa.
Zvinotaurwa nemunyoreri ndezvekuti M. alba shizha rinotorwa “rakapupurirwa nekiriniki kuti rinobatsira kuchengetedza hutano hweshuga yemuropa.Iyo putative risk factor yaive yakasimudzwa shuga yeropa uye yakabatana nenjodzi yekusagadzikana yaive Type 2 chirwere cheshuga.Iro boka rinotarisirwa "varwere vane chirwere cheshuga chechipiri".Mamiriro akadaro ari kunze kwechikamu cheChinyorwa 14 (1) (a) zvichemo zvehutano.Sezvinotsanangurwa muChikamu chechipiri (6) cheMutemo (EC) No 1924/2006, "chirevo chekuderedza njodzi yechirwere" chero chirevo chehutano chinoti, chinokurudzira kana chinoreva kudyiwa kwechikamu chekudya, chikafu kana chimwe chezvikamu zvacho.Zvakanyanya kuderedzwa njodzi zvinhu pakukura kwezvirwere zvevanhu.Sekureva kweDiet, Nutrition and Allergy (NDA) Panel yeEuropean Food Safety Authority (EFSA), Komisheni inotenda kuti zvichemo zvehutano zvinofanirwa kureva huwandu hwevanhu (vane hutano).Komiti yakaonawo kuti kana chirevo chehutano chine chekuita nebasa kana mhedzisiro inogona kuve yakabatana nechirwere, vanhu vane chirwere ichi havasi ivo vanotarisirwa kuverengerwa (EFSA, 2021).
Komiti yakanga isingazivi nzira yakashandiswa mukuongorora mabhuku akaunzwa nemunhu anenge akakumbira uye naizvozvo haana kukwanisa kuongorora kana humbowo hwose hwakaendeswa kuti huongorore.Iye Munyoreri aratidza huwandu hwezvinyorwa zve13 izvo zvaanotenda kuti zvine chekuita nezvikumbiro, zvinosanganisira:
Pahumbowo hwakapihwa neMunyoreri, 2 RCTs (Lown et al. 2017; Thondre et al. 2021) havana kuongorora humbowo hunotsigira chirevo ichi.The randomized controlled trial (Mudra et al., 2007) yaiva pfupiso yeshumo uye yaionekwa seine ngozi yakawanda yekusarura.Chidzidzo chisingadzoreki (Chatterji naFogel, 2018) havana kuongorora humbowo hwekutsigira ichi chirevo.Zvinyorwa zvishanu (Bensky, 1993; Asano et al., 2001; Saudek et al., 2008; Gomyo et al., 2004; NIH, 2008) havana kuudza zvigadzirwa zvekudya uye / kana zvakakonzerwa.Mabhuku matatu (Lown, 2017; Drugs.com, 2022; Gordon-Seymour, 2021) aive asiri esainzi zvinyorwa.Rimwe bhuku (Thaipitakwong et al., 2018) chaive chinyorwa chekuongorora nezvemashizha emuhabhurosi uye kukanganisa kwavo panjodzi yemoyo.Sekuona kweKomiti, hapana mhedziso dzinogona kutorwa kubva muzvinyorwa izvi kutsigira kutaura uku.
Kubva pane ruzivo rwakapiwa, Komiti yakagumisa kuti hukama hunokonzera pakati pekudyiwa kweM.Komiti iyi yakagumisawo kuti hapana humbowo hwakapihwa hwekubatana pakati pezvaitaurwa uye njodzi yekuva nechirwere cheshuga cherudzi rwechipiri.
Chikumbiro chaive nechikumbiro chekuchengetedzwa kwedata rakavanzika, iro rakazobviswa.
Zvokudya izvo zvaive nyaya yehutano hunoti M. alba (white mulberry), iyo yakaverengera 50% yezvinyorwa zveroundworm.
Kuvapo kwemurubheri kwakaderedza zvakanyanya kuwanda kweglucose kubva padanho rekutonga kusvika kune yakaderera uye zvakanyanya kuwedzera mwero we insulin uchienzaniswa nedanho rekutonga.Muchidzidzo chekiriniki, makonye akaedzwa kuti akwanise kuderedza mazinga eglucose.Imwe-centre yakavhurika inotarisirwa kupindira kudzidza yakaitwa muIsrael.
Iye Munyoreri anopa anotevera mazwi echipo chekubatsira hutano: "Yakasimbiswa nekiriniki kubatsira kuchengetedza hutano hwehuga hweropa."
Munyoreri haana kurongedzera mamiriro chaiwo ekushandiswa kweM. alba chikafu icho chiri musoro wekuzivisa.Mamiriro ekushandisa akakurudzirwa anopihwa kune iyo Ascarit yekuwedzera.Boka rinotarisirwa rinotarisirwa varwere vane Type 2 chirwere cheshuga.
Zvinoenderana neChinyorwa 14(1)(a) cheRegulation (EC) No 1924/2006 [chinyorwa chepasi 1] Yakagadziriswa nekudya kunovaka muviri (kugadzirisa) maererano nezvehutano hwekutorwa kweshizha remurubheri uye kuchengetedzwa kwemazinga eshuga eropa, nezvimwewo d.) (EU Rejection) Regulation 2019 uye Food Regulations (Amendments, etc.) (Kusiya EU) Regulation 2020 Application ID: 002UKNHCC.Yakapihwa naAscarit UK.
.Munyoreri haana kupa ruzivo rwekuumbwa, batch-to-batch musiyano, kana zvidzidzo zvekugadzikana kweM. alba shizha rinotorwa.
1.2 Iye Munyoreri akapa mhedziso yeAscarite yekugadzira nzira inotsanangurwa seyakawanda-chikamu chekuwedzera chine:
Mashizha nemaruva zvinocheneswa uye zvichangobva kugadziriswa (kureva kuchengetedza ruvara rwazvo, chimiro, uye kuzvimba) nemusanganiswa wekucheka, kudzvanya, nekubvisa kupisa nekubika doro kuti zviwedzere kudzoreredzwa kwezvirimwa, kusanganisira sheet latex.Mushure maizvozvi, mvura yacho inokurumidza kunyoroveswa kusvika ku20-30 degrees Celsius, uye yozopepetwa.Midzi uye bark zvikamu zvinocheneswa, zvino zvinogadziriswa uchishandisa kubvisa kupisa uye kutonhora.Mushonga wakavhenganiswa une (sechikamu chehuremu hwehuwandu hwehuwandu hwemhinduro) 50% Morus, 20% Artemisia, 10% Urtica, 10% Cinnamon uye 10% Taraxacum.
Munyoreri akakumbira kuti hunhu hwekuumbwa kweAscarit uye nzira yekugadzira zvichengetedzwe, asi gare gare akabvisa ichi chinodiwa.
1.3 Mukuona kweKomiti, kudya kunovaka muviri kwemashizha eM. alba, iyo inyaya yehutano hwehutano, haisati yanyatsozivikanwa maererano nezvinorehwa nezvinodiwa.
2.1 Munyoreri anoti Type 2 chirwere cheshuga chirwere chemetabolism chinoratidzwa nekukwira kweglucose yeropa.Mukupindura chikumbiro cheUKNHCC chehumbowo hunoratidza hukama pakati peiyo putative risk factor (yakakwira yeglucose yeropa) uye njodzi yechirwere chakabatana (Type 2 chirwere cheshuga), munyoreri akapa 3 zvidzidzo (DCCT, 1995; Rohlfing et al., 2002) Sveta, 2014).Ose ari maviri Diabetes Control and Complications Trial (DCCT) boka rekudzidza (1995) uye Rolfing et al.(2002) yakashuma DCCTs kusanganisira varwere vane insulin-inotenderera chirwere cheshuga (rudzi rwe1) asi kwete nechirwere cheshuga 2.rudzi (chirwere chinoda kuderedza njodzi).)Swetha (2014) akaverenga kuwirirana pakati peHbA1c (glycosylated hemoglobin) nemigumisiro yakasiyana-siyana (kutsanya, postprandial uye kuzorora glucose) kuti vaongorore kubatsira kwavo pakuongorora glycemic control muvarwere vane chirwere cheshuga.Sekuona kwekomiti iyi, vanyoreri havana kupa humbowo hwehukama huri pakati pemazinga eglucose akakwira uye njodzi yekuva nechirwere cheshuga cherudzi rwechipiri, kana kuti mazinga eglucose eropa akakwira anozvimiririra emhando ye2 chirwere cheshuga.
2.2 Munyoreri akapa rumwe ruzivo rwekupindura chikumbiro cheUKNHCC cheruzivo pamusoro pemhedzisiro, mhedzisiro yemhedzisiro uye kupindira kwakarongwa kwekuongorora njodzi muzvidzidzo zvevanhu.Nekudaro, zvichibva paruzivo rwakapihwa, hazvina kujeka kuKomiti kuti ndedzipi mhinduro dziri kutaurwa nevanyoreri uye kuti vachaongororwa sei.
2.3 Zvinoitwa nemunyoreri “zvinotaridzwa nekiriniki kuti zvinobatsira kuchengetedza hutano hweshuga yemuropa”.Boka rinonangwa rakakurudzirwa neanonyorera varwere vane Type 2 chirwere cheshuga.
2.4 Komiti inocherechedza kuti boka rinotarisirwa revarwere vane chirwere cheshuga chechipiri harisi pasi pehutano hwehutano pasi peChitsauko 14 (1) (a) cheMutemo (EC) No 1924 / 2006.Sezvinotsanangurwa muChikamu chechipiri (6) cheMutemo (EC) No 1924/2006, "chirevo chekuderedza njodzi yechirwere" chero chirevo chehutano chinoti, chinokurudzira kana chinoreva kudyiwa kwechikamu chekudya, chikafu kana chimwe chezvikamu zvacho.Zvakanyanya kuderedzwa njodzi zvinhu pakukura kwezvirwere zvevanhu.Sekureva kweDiet, Nutrition and Allergy (NDA) Panel yeEuropean Food Safety Authority (EFSA), Komisheni inotenda kuti zvichemo zvehutano zvinofanirwa kureva huwandu hwevanhu (vane hutano).Komiti yakaonawo kuti kana chirevo chehutano chine chekuita nebasa kana mhedzisiro inogona kuve yakabatana nechirwere, vanhu vane chirwere ichi havasi ivo vanotarisirwa kuverengerwa (EFSA, 2021).
2.5 Kuti uwane zvazvinoreva, munyoreri anokurudzira kutora 2 roundworm capsules nemvura 30 maminetsi vasati vadya katatu pazuva.Vanyoreri havaratidze kutarisisa, dosi kana nguva yekushandiswa.
2.6 Komiti yakaona kuti kuderedzwa kweiyo postprandial glycemic mhinduro inogona kunzi inobatsira kune vanhu vanenge vatotambura nekusagadzikana kweglucose kushivirira, asi Komiti yakaona kuti mazwi akarongwa haana kusangana nemaitiro ekuongororwa muChikamu 14 (1) (a) , uye harina kutaura pamusoro pezvibatsiro zvehutano Mamiriro ehuwandu hwehuwandu hwehuwandu hunogona kutaurwa nezvekuderedzwa kwengozi yechirwere.
3.1 Kana vakumbirwa neUKNHCC, vanyoreri vanokumbirwa kuti vape humbowo hweongororo yemabhuku, kusanganisira kuve munyori, zvinangwa, nzira dzekukodzera, nzira yekutsvaga yakazara uye dhatabhesi yega yega yakatsvakwa.Ruzivo rwakapihwa rwakanga rushoma zvekuti Komiti haina kukwanisa kuongorora kana humbowo hwese hwakaendeswa kuti hutariswe.
3.2 Iye Munyoreri aratidza huwandu hwezvinyorwa zve13 izvo zvaanotenda kuti zvine chekuita nezvichemo, kusanganisira:
Komiti inoona kuti hapana mhedziso dzinogona kutorwa kubva muzvinyorwa izvi sezvo pasina humbowo hwakabatiswa hunotsigira izvi.
3.4 Rine chinongedzo kubhuku remishonga yemakwenzi yekuChina (Bensky, 1993).Hapana mashoko echitsauko, nhamba dzepeji, kana kuti zvikamu zvebhuku zvakatumirwa kukomiti kuti zvionekwe, saka hazvina kurongwa.
3.5 The fact sheet (NIH, 2008) inopfupikisa zvidzidzo pamusoro pekutonga kwechirwere cheshuga uye matambudziko uye zvidzidzo zvekutevera, asi haiongorore uchapupu hunotsigira izvi, saka hapana mhedziso inogona kutorwa kubva mubhuku rino.
Chidzidzo che laboratory (Asano et al., 2001) yakatsanangura kusunungurwa kweM. alba alkaloids uye inhibitory effect pa glycosidases, asi uchapupu hunotsigira chirevo ichi hahuna kuongororwa.Komiti inoona kuti hapana mhedziso dzinogona kutorwa kubva muzvinyorwa izvi.
3.7 Mune matatu maRCTs (Lown et al., 2017; Thondre et al., 2021; Mudra et al., 2007), vatori vechikamu vakapihwa zvisina tsarukano kuti vagamuchire mulberry mashizha anotorwa.Lown et al.(2017) uye Thondre et al.(2021) dzaive mbiri-mapofu, randomized, akadzokororwa zviyero, crossover miedzo yekuongorora kushandiswa kana kusashandiswa kweiyo proprietary mulberry leaf extract (Reducose®) inopesana ne placebo mune zvidzidzo zvine hutano vatori vechikamu 'glycemic responses kune dambudziko recarbohydrate.Sekuona kweKomiti, hapana mhedziso dzinogona kutorwa kubva muzvinyorwa izvi nekuti havana kuongorora humbowo hunotsigira chirevo ichi.Mudra et al.(2007) ishumo inopfupisa inopfupisa chidzidzo checrossover chakasarudzika chakaongorora mhedzisiro yemashizha emurubheri kana kuti placebo pamhinduro yeglucose yeropa yevatori vechikamu vane hutano (10 vatori vechikamu) uye varwere vane Type 2 chirwere cheshuga (10 vanhu).Komiti yakafunga kuti chidzidzo chacho chingave chiri pangozi yakakura yekusarura nekuda kwekushayikwa kweruzivo pamusoro pemaitiro e randomisation, zvingave zvakasarudzwa zvinosanganiswa nezvinodiwa kupindira, uye zvingave zvakasarudzwa pakusarudzwa kwemigumisiro yakashumwa.
3.8 Chidzidzo chisingadzoreki (Chatterji naFogel, 2018) chaisanganisira varwere vane chirwere cheshuga chechipiri.Chatterji and Fogel (2018) vakaongorora kushanda kwemishonga yemishonga SR2004 (inosanganisira M. alba mashizha, U. dioica mashizha, sinamoni bark, A. dracunculus mashizha emashizha uye T. officinale midzi yemidzi) pamazinga eHbA1c kamwe chete pavhiki kwemazuva gumi nemaviri. .mavhiki uye ipapo pamavhiki makumi maviri nemana.Mukuona kweKomiti, hapana mhedziso dzinogona kutorwa kubva kuchidzidzo ichi chisingadzoreki, icho chisina kuongorora humbowo hunotsigira zvirevo.
3.9 Saka Komiti inoona kuti hapana mhedziso inogona kutorwa kubva kune humbowo hwakapihwa nemumhan'ari pamusoro pemhedzisiro yealbaflora shizha rinobvisa pahuwandu hweglucose yeropa.
4.1 Mukuongorora humbowo, komiti yakafunga 1 randomized controlled trial (Mudra et al., 2007) kubva pane izvo zvinogona kutorwa.
4.2 Komiti yakagumisa kuti, zvichibva pauchapupu hwakaratidzwa, zvakanga zvisingabviri kusimbisa hukama hunokonzera pakati pekushandiswa kweAlbiflora mashizha emashizha uye zvinokonzerwa nemigumisiro.Komiti iyi yakagumisawo kuti hapana humbowo hwakapihwa hwekubatana pakati pezvaitaurwa uye njodzi yekuva nechirwere cheshuga cherudzi rwechipiri.
Morus Alba (Muscus alba) Leaf Extract.
Mhedzisiro yezvirevo zvevarwere vane Type 2 chirwere cheshuga haizadzise maitiro akaiswa muRegulation (EC) No 1924/2006.maererano neChikamu 14(1)(a).
Hukama hwechikonzero pakati pekudyiwa kwemurubheri shizha rabviswa uye zvaitaurwa hazvina kukwanisa kusimbiswa, uye pakanga pasina humbowo hwekubatana pakati pezvaitaurwa uye njodzi yekuva nechirwere cheshuga cherudzi rwechipiri.


Nguva yekutumira: Jan-29-2023