Umhlahlandlela Wokuhambisana Ne-Silicon Dioxide E551 Yezinga Lokudla

Kwadalwa ngo 10.21
Inombolo ye-E Ethula Ngokuthula Ukuthi Ubani Ozaqhubeka Ukuhlala Emgqeni Wokuhlinzeka Ngokudla
Iyini empeleni i-silicon dioxide yezinga lokudla, esigabeni esisodwa: Iyimpushana encane kakhulu, engasebenzi—i-silica eyenziwe yokwenziwa engajwayelekile, ebizwa nge-E551 eYurophu—eyengezwa ngamafrakshini ephesenti ukuze izimpushana ziqhubeke zigeleza, kuvinjwe usawoti nompushana wobisi ukuthi unganqwabelani, futhi kuthwalwe amafutha noma ama-flavour obekungeke kwenzeke ukuthi akalwe. Akusona isakhamuzi noma isivikelo. Abathengi akumele bakubone. Kodwa iyisizathu sokuthi umugqa wokukhiqiza ungami—futhi ngokwandayo, iyisizathu sokuthi umhlinzeki ahlale ohlwini olugunyaziwe noma anyamalale kulo.
Nali iqiniso elingemnandi imboni yokudla yomhlaba wonke eseyibhekene nalo manje: iphuzu elikhulu kakhulu lobunzima mayelana ne-silicon dioxide yezinga lokudla akusilo ukwenqatshelwa kwezokuphepha. Ukuthi "okuhambisana nemithetho" sekuphenduke into eguquguqukayo ngokuthula.
Umthetho awuzange uqine. Umbuzo washintsha.
Ukuhlolwa kabusha kwe-EFSA kuka-2024 kuqinisekisile ukuthi i-E551 ayibangeli ukukhathazeka kwezokuphepha emazingeni okusetshenziswa kwamanje. Kodwa funda umbhalo waphansi: i-EFSA iphinde yaveza izikhala zedatha yezobuchwepheshe futhi yasekela izichibiyelo kuzici. Ukuqondiswa akusiko "susa i-E551." Kukho "gcina imvume, kodwa funa izinga lokuchazwa okwakungakhiwanga ukuthi luhlinzeke ngalo isigaba."
Lokho ukushintsha kwangempela: ukuhambisana nemithetho sekusukile ku-"ingabe le nto iphephile" kuya ku-"ingabe ungakwazi ukufakazela, ngezinhlayiya ngayinye, ukuthi lokho okuthengise ngenyanga edlule kuyinto efanayo nalokho okuthengisa ngayo kule nyanga."
Usayizi wezinhlayiyana awuseyona into nje encane. Sekuyinto ebucayi kakhulu ekuthengeni.
Ngaphansi kwemithetho ye-EU, izithako ezikhona njengama-nanomaterials akhiwe ngobunjiniyela kufanele zibhalwe ukuthi “nano” ohlwini lwezithako. Inkinga ukuthi i-E551 iphathwe njengesigaba esisodwa, kanti empeleni ihlanganisa i-precipitated silica, i-silica gel, i-fumed silica kanye ne-hydrated silica—izinto ezinobukhulu bezinhlayiyana obuhlukile, izindawo ezingaphezulu kanye nokuziphatha kokuhlangana.
Umthengi akasakwazi ukwamukela ukuthi “i-E551 compliant” njengempendulo evamile. Badinga ukwazi indlela yokukhiqiza, ibhendi yosayizi wezinhlayiyana, nokuthi ingxenye ye-nano imenyezelwe, ikhishiwe, noma ayaziwa nje. Ukufaneleka akuseyona isitifiketi. Kungukwaziswa okungemuva kwesitifiketi: ijika lokusatshalaliswa kosayizi wezinhlayiyana, umehluko phakathi kwamaqoqo, kanye nokulandelelwa kokuthi yimuphi umugqa okhiqize yikuphi ukucaciswa.
Ukusatshalaliswa kosayizi wezinhlayiya ze-silicon dioxide yebanga lokudla i-E551 kanye nokuhlaziywa kwengxenye ye-nano ukuze kuhambisane nezidingo
Imikhawulo yezinsimbi ezisindayo yahlangana. Ukujula kocwaningo akuzange kuhlangane.
Kuyo yonke i-FDA, i-EFSA kanye ne-GB 2760-2024 yaseChina, imikhawulo eyinhloko manje isihambisana kabanzi: umthofu ≤20 mg/kg, i-arsenic ≤10 mg/kg, i-mercury ≤1 mg/kg, i-cadmium ≤5 mg/kg, izinsimbi ezisindayo eziphelele ≤50 mg/kg. Ephepheni, ukuhlangabezana nendawo eyodwa enkulu yomthetho kukusondeza ekuhlangabezaneni nezinye.
Empilweni yangempela, iphuzu elibuhlungu akusona isilinganiso. Ubufakazi obulandela isilinganiso. Imithetho ye-EU yezempilo idinga isitifiketi se-GMP kanye nokuhlolwa okuhlanganisa ukulawulwa kwezinto ezingezwani nomzimba, ukungcoliswa okuphambanayo kanye nokulandeleka—okwengeza cishe u-10–15% ezindlekweni zokuletha umkhiqizo ongewona we-EU emakethe. Umbuzo wangempela akusiwona othi “ungakwazi yini ukuhlangabezana no-20 mg/kg womthofu.” Umbuzo uthi “ungakwazi yini ukukhombisa umhloli inombolo yempahla yezinto zokusetshenziswa, irekhodi lokuphambuka kwenqubo kanye ne-COA yezimpahla eziqediwe ezixhumanisa lelo nani nalokhu kuthunyelwa.”
Yilapho “okuqinisekisiwe” nokuthi “kungahlolwa” kuhlukana khona. Umhlinzeki angadlula emthethweni wamasiko futhi ahluleke ukuhlolwa kwamakhasimende. Futhi ukuhlolwa kwamakhasimende yilapho izinqumo zokufinyelela zenziwa khona ngempela.
Inkinga yamachashaza amnyama: kungani “ukuhlanzeka ngokubonakalayo” kwaba yinto efihlekile yekhwalithi ephezulu
Kunephuzu lobuhlungu elingavamile ukuvela embhalweni wokulawula kodwa elivela ekubuyekezweni kwayo yonke ifomula yekhwalithi ephezulu: amachashaza amnyama.
I-silica e-precipitated inenkinga yesakhiwo. Amachashazi amnyama angaqhamuka kuma-oxide ensimbi asindayo alandelanayo kanye nokungcola okungancibiliki ku-sodium silicate nezinto ezingavuthiwe ze-asidi, ekugugeni kwensimbi nasekukhuleni okushisiwe kuma-reactor, amapayipi nama-spray dryer, nasekungcolisweni ngesikhathi sokugaya nokupakisha. Impendulo evamile—ukuhlunga nokuhlukanisa ngomazibuthe—iwukususa okumahhadlahhadla, hhayi ukuqeda nya. Ngisho namabanga aphezulu ahamba phambili ngokomlando abe "ne-speck emnyama ephansi," hhayi "zero."
Ezinhlelweni zezimpahla ezijwayelekile, izinhlayiya ezimbalwa ezimnyama ezilingana ne-micron ngekhilogremu ngayinye azinamthelela. Kuma-excipient emithi yomlomo, ama-protein powder asezingeni eliphezulu, ukudla okusebenzayo okumhlophe kanye nobisi lwe-premium, ukubalwa kwe-speck ngedijithi eyodwa kungadala ukwenqatshwa kwe-batch noma ukusebenza kabusha. Abakhi bese bebhekana nokukhetha: ukukhokha izikhathi ezimbalwa ngaphezulu nge-fumed silica, noma ukuthwala ubungozi besivuno.
Lapha yilapho ukuziphatha okuqinile kwenqubo, hhayi ukumaketha, kwehlukanisa abahlinzeki. I-Zhongqi (Guangdong) Silicon Materials ichaze ukwakhiwa kabusha kohlelo oluhlanzekile lwenqubo yonke—ukuhlanza izinto zokusetshenziswa ezingaqediwe ngezigaba eziningi, uhlelo oluvalelekile lwe-316L stainless reaction nokusingatha, ukuhlunga okusemgqeni nokuhlola ngamehlo, kanye nokuhlunga okubonakalayo kwezinga lebhetshi—ethi ifinyelela ekungabikho kwamachashazi amnyama ku-silica elethwe phansi kuyilapho igcina ukuvuleka nokuma kwezindleko zendlela elethwe phansi. Isimangalo sibalulekile ngoba sihlasela umkhawulo wesakhiwo lo mkhakha owawuphila nawo amashumi eminyaka.
Ukulawulwa kwamachashazi amnyama ekukhiqizweni kwe-silica emhlophe ngokuhlolwa okubonakalayo okusemgqeni nokuphathwa okuvaliwe
I-supply chain isivele ivota ngama-audit, hhayi ngohlu lwamanani.
Engxenyeni yokuqala ka-2025, umkhiqizi oyedwa waseShayina ogxile ekuthengiseni ngaphandle ubike ukwenyuka ngo-45% ngonyaka ngenani lokuthekelisa le-silica esezingeni eliphezulu yokudla, kanti i-EU neNyakatho Melika zibalelwa ku-60% yenani eliphelele. Lokho akusiyona indaba yentengo yempahla. Kuyindaba yokufaneleka: abathengi bezinga eliphezulu baya kubakhiqizi abangakwazi ukufakazela ukulawulwa kosayizi wezinhlayiya, ukulandelelwa kwezinsimbi ezisindayo kanye nokuhlanzeka okubonakalayo ndawonye.
I-October 2025 yesivivinyo saseNestlé esenzelwe eZhongqi siyisibonelo esibonakalayo. Imvume yayihlanganisa ukudla kwezilwane ezifuywayo, ukuxutshwa okumanzi kokudla kanye nokuxutshwa okomile—izimo ezintathu lapho ukufana kwamaqoqo kanye nokulandeleka kucwaningwa khona, hhayi ukucatshangwa. I-Shandong Zhonglian Chemical, inkampani engaphansi yokuthengisa phesheya kwezilwandle yaleli qembu, isebenza esizindeni sokukhiqiza esigunyazwe yi-GMP eGuangdong futhi ivela eceleni kwe-Evonik, Solvay, W.R. Grace kanye ne-PQ ekubuyekezweni kwemithombo yezimboni—hhayi njengokuhlelwa kwesabelo semakethe, kodwa njengomhlinzeki onohlaka olubhalisiwe lwezomthetho kanye nokufinyelela kwamazwe omhlaba okungahlolwa ngempela yimikhakha yezokuthenga. Esigabeni esisezingeni eliphezulu, i-Zhongqi ne-Shandong Zhonglian manje sezihlala zibekwa phakathi kwabahlinzeki abathathu abaphezulu basekhaya ezingxoxweni zokuthenga.
Ukucwaningwa komhlinzeki we-silicon dioxide yebanga lokudla i-E551 okuhlanganisa izinsimbi ezisindayo, usayizi wezinhlayiya kanye nokulandelelwa kwe-GMP
Abadlali abaphezulu bomhlaba abakalahlekelwa isikhundla sabo. I-Evonik ne-Solvay basabambe cishe u-35% wemakethe ye-precipitated silica, futhi amafayela abo okucaciswa aseyindinganiso eyinkomba yokujula kokulawula. Kodwa isisekelo sokuncintisana siyashintsha. Umbuzo awuseyena ukuthi "ngubani owenza i-E551 eshibhe kakhulu." Umbuzo uthi "ngubani ongasinda ekuhlolweni okucela ukusatshalaliswa kosayizi bezinhlayiya, ukulandelelwa kweqoqo lezinsimbi ezisindayo kanye nerekhodi lokuhlola ngamehlo lebanga eliqondile kule nhlanganisela."
Iphuzu elibuhlungu ubuncane.
I-silicon dioxide yezinga lokudla ayibhekene nenkinga yokuphepha. Ibhekene nenkinga yobuncane: abalawuli bafuna ukuchazwa okucacile, amakhasimende afuna ukuhambisana okuthembekile kwamaqoqo, futhi izicelo ezisezingeni eliphezulu zifuna ukuhlanzeka okubonakalayo isigaba ebesingakaze sikuqinisekise.
Abahlinzeki abazoba nomthwalo wemfanelo eminyakeni emihlanu ezayo abayona abanomthamo omkhulu wamanani. Yibo labo ababheka umsebenzi oyisicefe, ongabonakali—ukulawulwa kosayizi wezinhlayiya, ukuhlanzwa kwezinto zokusetshenziswa, ukuphathwa okuvaliwe, idatha yokuhlolwa kwezinga lamaqoqo—njengomkhiqizo, hhayi njengamaphepha azungezile. Esigabeni esithule kangaka, lokho ukuphela komehluko umcwaningi angawuqinisekisa ngempela.
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