I-EFSA E551 I-Silicon Dioxide

I-Silica Ekhishwe Ngokujwayelekile Yezinjongo Ezijwayelekile Izinga elilodwa kuzo zonke izinto zokudla, ukunakekelwa komlomo, imithi kanye nezimonyo — ilungiselelwe iBrazil neLatin America Uhlobo olulodwa lwezinga lezimboni eziningi lwe-silica ehlanzekile kakhulu enamanzi, ekhiqizwa ngokuhlehla okulawulwayo. Yakhelwe ukuhlangabezana nezilinganiso zekhwalithi zamazwe ngamazwe futhi, ngasikhathi sinye, nemibhalo abalawuli baseBrazil abayilindele — ukuze umakhi wemithi akwazi ukuqinisekisa into eyodwa esikhundleni ezine. Izinga lisebenza imikhakha emine eyinhloko: ukukhiqizwa kokudla, ukunakekelwa komlomo, izithako zemithi kanye nezimonyo zokunakekela umuntu. Ukusetshenziswa kwezimboni nokwengeza ekudleni kwesekelwa njengezinhlelo zokusetshenziswa zesibili. Usayizi wezinhlayiyana, ukwakheka kwezimbobo kanye namazinga okungcola konke kuyalungiseka, ngakho abathengi akudingeki ukuthi bathole futhi baqinisekise i-silica ehlukile kumugqa ngamunye wokukhiqiza. Kubakhiqizi nabanikazi bamabhrendi eBrazil nakulo lonke elaseLatin America, umphumela ongokoqobo ukuncipha kwama-SKU, ukuphathwa kwempahla okulula kanye nomsebenzi omncane wokuqinisekisa. Umkhiqizi I-Zhongqi Shandong Silicon Material Co., Ltd. ikhiqiza i-silica ekhishwe ngokujwayelekile yezinjongo ezijwayelekile enezinga eliphezulu eShandong, eChina. Inkampani iyibhizinisi likazwelonke lobuchwepheshe obuphezulu futhi inamalungelo obunikazi azimele ayisishiyagalombili ahlanganisa ubuchwepheshe bokukhiqiza i-silica. Imigqa yokukhiqiza ezenzekelayo eyisithupha inika umthamo wonyaka ongaphezu kwamathani angu-80,000, okusekela ukunikezwa okuqhubekayo kwamanani amakhulu. I-silica yezinjongo ezijwayelekile isebenza ngaphansi kokuphathwa okusekelwe ku-GMP. Imikhiqizo yezinga lokudla neyemithi yenziwa endaweni evaliwe ukuvimbela ukungcola okuhlanganayo. Ukulandelelwa kuhlanganisa ukungeniswa kwezinto zokusetshenziswa, ukusabela, ukuhlolwa komkhiqizo ophelile, ukupakisha nokuthunyelwa. I-batch ngayinye inekhodi yayo, futhi amarekhodi okukhiqiza nawokuhlolwa angemuva kwaleyo khodi agcinwa ukuze ahlolwe. Kubathengi baseBrazil sinikeza i-Technical Data Sheet (TDS), i-Material Safety Data Sheet (MSDS), i-Certificate of Analysis (COA) kanye nemibiko yokuqinisekiswa kwezindlela. Ithimba lethu lobuchwepheshe lisekela amadokhumenti okubhalisa e-ANVISA kanye nezimemezelo zokuhambisana nokungenisa, futhi lingahlela ukugunyazwa kwemibhalo nokuqinisekiswa kwamanxusa lapho indlela yokubhalisa ikudinga — umsebenzi ovamise ukususa umgoqo wemibhalo ohlelweni lokwethula. Impahla isivele inikezwa eYurophu, eNyakatho Melika naseNingizimu-mpumalanga Asia, futhi izici zilungiselelwe izimo zokusetshenziswa nezomthetho zaseBrazil. Usayizi wezinhlayiyana, indawo ekhonjisiwe yomhlaba kanye nokumuncwa kukawoyela kuyalungiseka. Abathengi bahlanganisa amaqembu amakhulu e-FMCG asebenza eBrazil kanye nabaholi bendawo kwezokudla, ukunakekelwa komlomo, imithi, izimonyo, ukudla kwezilwane nokucubungula kwezimboni. Izici zobuchwepheshe — izinga elijwayelekile lomhlaba wonke Amanani ajwayelekile ngezansi. Ipharamitha ngayinye ingalungiseka ngokusho kohlelo lokusetshenziswa kanye nokwakheka. Into Izinga Amanothi Okuqukethwe kwe-SiO₂ (isisekelo esishisiwe) ≥ 97.5% Isakhiwo esinamanzi esingenakho ukwakheka; akukho silica ecwebezelayo etholakele nge-X-ray diffraction Ukulahlekelwa ngokushiswa (1000 °C, ihora eli-1) ≤ 8.0% Okuqukethwe kwamanzi aboshiwe nokuzinza kokushisa Umswakama (njengoba kupakishiwe, 105 °C, amahora ama-2) 3.0 – 5.5% Kubekelwe ukunciphisa ukunqwabelana nokwakheka kwe-static I-pH (i-5% yokumiswa kwamanzi) 6.5 – 7.3 Ecishe ibe phakathi; ihambisana nezinhlelo eziningi zokwakheka Ukuminyana kwesamba 0.20 – 0.28 g/cm³ Kuyalungiseka kumishini ehlukene yokudla nokuxuba Ukumuncwa kukawoyela kwe-DBP 80 – 120 cm³/100 g Kubekelwe umsebenzi wokuqina, ukumuncwa noma ukuvimbela ukunqwabelana Usayizi wezinhlayiyana ophakathi (D50) 10 – 15 μm Kuyalungiseka kusuka ku-2 μm kuya ku-25 μm Indawo yomhlaba ye-BET 100 – 140 m²/g Isakhiwo sezimbobo silungiselelwe umsebenzi wokuthwala nokumuncwa Ukumhlophe (CIE L*) ≥ 97.5 Inani le-RDA (ukunakekelwa komlomo) 120 – 150 Kuyalungiseka ngamazinga ahlukene okumhlophe; ngaphansi kwezinga le-RDA elingu-250 lokuhola kukho ukwelashwa kwamazinyo kwansuku zonke (ISO 11609) Izinsimbi ezisindayo i-As ≤ 1 ppm, i-Pb ≤ 2 ppm, i-Hg ≤ 0.5 ppm Imikhawulo ibekelwe ukusetshenziswa kokudla, ukunakekelwa komlomo nemithi; imiphumela ye-batch ibikwa ku-COA Inani eliphelele le-aerobic plate ≤ 50 cfu/g Kuhlangabezana nezidingo ze-microbial zokusetshenziswa kokudla, imithi nezimonyo Into eyinhloko I-silica ekhishwe ngokujwayelekile enamanzi I-chemically inert futhi izinzile ekwakheni; ukuhlukaniswa kwengozi ngokwe-SDS yomkhiqizo Ukupakisha okujwayelekile Isikhwama sephepha le-kraft elingangenisi amanzi lezinga lokuthumela ngaphandle lika-10 / 15 / 20 kg eline-PE ngaphakathi Ukupakisha okukhethekile nokulebula kwangasese kuyatholakala Imigomo yokuhweba I-FOB Qingdao / CIF Santos / CFR Rio de Janeiro / DDP emadolobheni amakhulu aseBrazil Izixazululo eziguquguqukayo zezinhlelo ezahlukene zokungenisa Izitifiketi nemibhalo yomthetho Zonke izitifiketi zikhishwa izikhungo zezinye izinhlangano futhi zivuselelwa ngokuhlolwa konyaka kokugada. Zisekela ukukhishwa kwempahla emakhasini, ukufinyelela emakethe kanye namadokhumenti okubhalisa e-silica engeniswa eBrazil. 1.I-USP/NF Silicon Dioxide monograph — ikhiqizwe ngokwe-United States Pharmacopeia monograph; isebenza ekusetshenzisweni kwezithako zemithi nezinga lokudla, futhi isekela ukubhalisa kwemithi nokudla kwe-ANVISA. 2.I-ISO 22000:2018 — uhlelo lokuphathwa kokuphepha kokudla olusetshenziswa kuyo yonke inqubo yokukhiqiza. 3.I-GMP yezinto zokusetshenziswa zezimonyo nemithi — ukuphathwa kwendawo yokusebenza kuhlangabezana nezidingo ze-GMP zokukhiqiza imithi nezimonyo. 4.I-ISO 9001:2015 — isitifiketi sokuphathwa kwekhwalithi kwenqubo ephelele. 5.I-SHC HALAL — isitifiketi se-halal semakethe yokudla nezimonyo ye-halal yaseBrazil. 6.I-OU KOSHER — isitifiketi se-kosher sokukhiqiza kokudla nezimonyo kwe-kosher. 7.I-FDA 21 CFR ukuhambisana nokudla — kuhambisana nezidingo ze-US FDA 21 CFR zezinto ezithinta ukudla, ezamukelwa kabanzi njengesisekelo sokuhambisana nokusetshenziswa okuthinta ukudla eBrazil. 8.I-FAMI-QS — ihambisana nohlelo lwekhwalithi lwe-EU lokwengeza ekudleni; isekela ukubhalisa kwe-MAPA kwezithako zokudla kwezilwane. 9.Amalungelo obunikazi kazwelonke ayisishiyagalombili okukhiqiza i-silica ekhishwe ngokujwayelekile — impahla yobuhlakani ezimele ehlanganisa ubuchwepheshe bokukhiqiza. 10.Ibhizinisi Likazwelonke Lobuchwepheshe Obuphezulu (eChina) — ukuqashelwa okusemthethweni kwekhono le-R&D. Izici eziyinhloko zomkhiqizo 1. Ukuhlanzeka nokulawulwa kokungcola Ukuhlanzeka kufinyelela ku-≥ 97.5% SiO₂ ngesisekelo esishisiwe ngokusebenzisa ukuhlolwa kwezinto zokusetshenziswa, ukuhlanza okwamazinga amaningi nokukhiqiza okuvaliwe. I-Arsenic, i-lead ne-mercury zibanjwa emikhawulweni etafuleni elingenhla, futhi izibalo ze-microbial zilawulwa zokusetshenziswa kokudla, ukunakekelwa komlomo nezimonyo. I-batch ngayinye ihlolwa ngokuphelele ngaphambi kokuthunyelwa, futhi irekhodi lokuhlolwa lihamba ne-lot — okuyikho okuvumela impahla ukuthi isetshenziswe emikhiqizweni engaphansi kwezidingo zezempilo nokuphepha ze-ANVISA. 2. Ukuzinza kwamakhemikhali nokuhambisana kokwakheka I-silica ekhishwe ngokujwayelekile enamanzi izinzile ngamakhemikhali futhi ayisebenzi ngaphansi kwezimo eziphakathi noma ezincane ze-asidi noma ze-alkaline, futhi ayisabeli nezithako ezisebenzayo nezinto eziyisisekelo ezivame ukusetshenziswa kulezi zinhlelo. Ihambisana nezinhlelo ze-fluoride (i-sodium fluoride, i-sodium monofluorophosphate) ekunakekelweni komlomo, nama-API ezinhlotsheni zomthamo oqinile, namavithamini nezithako ekudleni, kanye nama-emollient, izilondolozi nezinto ezisebenzayo ezimonyweni. Ukumuncwa kwezinto ezisebenzayo kuphansi ekusetshenzisweni okujwayelekile; sisatusa ukuhlolwa okufushane kokuhambisana kufomula yekhasimende ngokwalo ngaphambi kokukhulisa. 3. Amapharamitha alungisekayo nezinga elikhethekile Amathimba ethu e-R&D nawobuchwepheshe alungisa ukusatshalaliswa kosayizi wezinhlayiyana, ukwakheka kwezimbobo, ukumuncwa kukawoyela, ukuminyana kwesamba kanye nenani le-RDA ukuze kuhambisane nokusetshenziswa kanye nokuma komkhiqizo ophelile. Lokho kuhlanganisa umuthi wokuxubha wokumhlophe okuhlanza kakhulu odinga amandla okuhlanza, amazinga okudla okuvimbela ukunqwabelana adinga ukugeleza, ama-glidant emithi adinga imibhalo ephelele yokuphepha, kanye namazinga ezimonyo okufiphaza adinga umuzwa wesikhumba. Ukusekelwa kusuka ekuhlolweni kwesampula kuya ekuqinisekisweni kokukhulisa. 4. Ukuhambisana kwe-batch ne-batch Usayizi wezinhlayiyana, i-pH nokumhlophe kuqashwa ku-inthanethi ngesikhathi sokukhiqiza, futhi ukulawulwa kwekhwalithi kusuka ezintweni ezingenayo kuya ezimpahleni eziphelile. Ukuphambuka phakathi kwama-lot kubanjwa ngaphakathi kwebhendi elincane, ngakho abathengi akudingeki ukuthi baphinde balungise amafomula njalo lapho kufika i-batch entsha. Lokho kwehlisa izindleko zokulungisa futhi kusekela ukukhiqiza okukhulu okuqhubekayo. Kungani leli zinga lifanele imakethe yaseBrazil 1. Izinga elilodwa eliqinisekisiwe emikhakheni emine Ukudla, ukunakekelwa komlomo, imithi nezimonyo kwabelana ngento efanayo eyisisekelo, kanti ukusetshenziswa kwezimboni nokudla kwezilwane kusekelwa eceleni. Kumaqembu aseBrazil aqhuba amabhizinisi amaningi, ukuqinisekisa okukodwa kuhlanganisa ukuthuthukiswa komhlinzeki, ukuhlolwa okungenayo nokuhlelwa kwempahla yemigqa eminingi yomkhiqizo — futhi kunciphisa inani lama-SKU aphethwe. 2. Ukusekelwa kwemibhalo yokungena emakethe Isethi yesitifiketi yamukelwa kabanzi eBrazil, futhi silungisa idokhumenti eliphelele elidingekayo ekubhaliseni kwe-ANVISA nokubhalisa kwe-MAPA kwemikhiqizo yokudla kwezilwane. Sisekela futhi ukugunyazwa kwemibhalo nokuqinisekiswa kwamanxusa lapho indlela ikudinga, futhi siphendula imibuzo yobuchwepheshe ngesikhathi sokubuyekezwa. Ukubhalisa eBrazil kuphethwe yinkampani yokungenisa yendawo; indima yethu ukunikeza iphakethe lobuchwepheshe nelamadokhumenti elisekela isicelo. 3. Izinhlelo zokusetshenziswa ezilungiselelwe imikhuba yendawo Ukunakekelwa komlomo kulinganiswa ngokumelene namabala akhona ekusetshenzisweni kwansuku zonke kwaseBrazil — ikhofi, i-chimarrão nogwayi. Amazinga okudla ahambisana nezinongo eziyimpuphu zendawo nezilungiselelo eziyimpuphu. Amazinga ezimonyo afanele isidingo sendawo sokulawula uwoyela namafomula e-sunscreen ane-UV ephezulu. 4. Iphakethe eliphelele lobuchwepheshe I-TDS, i-MSDS, i-COA nemibiko yokuqinisekiswa kwezindlela, kanye namafomula ayireferensi nemihlahlandlela yokusetshenziswa. Ithimba lethu lobuchwepheshe linikeza ukuxazulula kwezinkinga zamafomula kude, okunciphisa umsebenzi wokuthuthukisa ohlangothini lwekhasimende. 5. Ukunikezwa okuzinzile kwamanani amakhulu Umthamo wonyaka ongaphezu kwamathani angu-80,000, nesitoko sokuphepha esigcinwe ezicini ezijwayelekile. Samukela ama-oda ohlaka lonyaka nokulethwa ngezigaba, futhi sihlela ukukhiqiza ngaphambi kohlelo lwesidingo sekhasimende ukuze simunce ukuhamba okude kolwandle kusuka eChina kuya emachwebeni aseBrazil. 6. I-Logistics eyakhelwe iBrazil I-FOB Qingdao, i-CIF noma i-CFR Santos neRio de Janeiro, kanye nokulethwa kwe-DDP eminyango emadolobheni angaphakathi ahlanganisa iSão Paulo. Siphethe imibhalo yokukhishwa kwempahla yokungenisa yaseBrazil futhi sisebenza nomthumeli oqokiwe wekhasimende. Imihlahlandlela yokusetshenziswa Ukuphathwa okujwayelekile 1.Ukulandelana kokudla — engeza i-silica powder ngesikhathi sokuxuba kwempuphu eyomile. Xuba ngokulinganayo nezinye izingxenye zempuphu kuqala, bese wethula izingxenye eziwuketshezi isinyathelo ngesinyathelo; ukuxhumana okuqondile namanzi amaningi kubangela ukuhlangana. 2.Ukusabalalisa — vumela isikhathi esanele sokuxuba kanye ne-shear efanele yohlelo lokwakheka, ukuze izinhlayiyana zisabalale ngokulinganayo futhi izinga lisebenze njengoba kuchaziwe. 3.Imvelo — gcina izindawo zokukhiqiza nokugcina zomile futhi umswakama ohlobene ube ngaphakathi kwebanga elilawulwayo ukuvimbela ukuthatha umswakama nokunqwabelana. Umthamo onconywayo ngomkhakha Ukunakekelwa komlomo (i-abrasive yomuthi wokuxubha): 18% – 25% kumafomula omuthi wokuxubha wokumhlophe; lungisa ngokumelene ne-RDA eqondiwe nokusebenza kokuhlanza okudingekayo. Ukudla (ukuvimbela ukunqwabelana / usizo lokugeleza / umthwali): ngokujwayelekile 0.5% – 5%. Izinga langempela kufanele lihlale ngaphakathi kwemikhawulo yezithako i-ANVISA eyibekela isigaba sokudla esithile — i-silicon dioxide ibalwe njenge-INS 551, futhi ingxenye esebenzayo kufanele ihlolwe ngohlobo ngalunye lomkhiqizo. Izithako zemithi (i-glidant / i-anti-adherent): 0.1% – 3% ezinhlotsheni zomthamo oqinile womlomo njengamaphilisi namacapsule; lungisa ngokwezidingo zenqubo. Izimonyo nokunakekela umuntu: 2% – 15% yokuqina, ukufiphaza nokumuncwa kukawoyela kumakhrimu, ama-lotion, ama-scrub nemikhiqizo yempuphu; lungisa ngokokuthungwa okuqondiwe nokusebenza kahle. Ukugcina Gcina emaphaketheni okuqala avaliwe, endaweni epholile, eyomile, enomoya, kude nomswakama nokungcola okuguquguqukayo. Isikhathi sokuphila yizinyanga ezingama-24 emaphaketheni okuqala angavulwanga ngaphansi kwezimo zokugcina ezishiwo. Vala futhi usebenzise ngokushesha ngemuva kokuvula futhi usebenzise esikhathini esifushane ukuvimbela ukuthatha umswakama nokungcola kwe-microbial. Ububanzi bokusetshenziswa Imikhakha eyinhloko 1. Ukunakekelwa komlomo nomuthi wokuxubha Kufanele iningi lamafomula okunakekelwa komlomo, kokubili ukuhlanza kwe-abrasive kanye nezinga lokuqina: Umuthi wokuxubha wokumhlophe — ususa ibala langaphandle futhi upholisha i-enamel, uhloselwe ukungcola kwekhofi, i-chimarrão nogwayi okuvamile eBrazil, ne-RDA ngaphakathi kwebanga elamukelwa umhlaba wonke. Umuthi wokuxubha wansuku zonke wokuhlanza ngokujulile — ususa i-plaque futhi upholisha indawo yezinyo; uhambisana nezinhlelo zokunambitheka kwe-mint nezithelo ezisetshenziswa emakethe yaseBrazil. Umuthi wokuxubha ocacile — izici zihambisana ne-refractive index yesisekelo, ukuze kube nokucaca okuphezulu kwe-paste nokuhlanza okumnene nokuqina. I-powder yamazinyo ne-paste yokupholisha yobungcweti — ukugeleza okuhle kwempuphu nokusebenza kokupholisha kwezimpuphu zamazinyo nama-paste okuzivikela kobungcweti. 2. Ukukhiqizwa kokudla Kusetshenziswa njengesithako sokudla esivunyelwe, i-silicon dioxide (E551 / INS 551): Ukuvimbela ukunqwabelana ekudleni okuyimpuphu — izinongo eziyimpuphu, ikhofi elisheshayo, impuphu ye-chimarrão, impuphu yobisi, i-creamer, usawoti odliwayo kanye noshukela we-icing; kuvimbela ukuthatha umswakama nokunqwabelana futhi kuthuthukisa ukugeleza. Usizo lokucubungula kubhiya neziphuzo — usizo lokucacisa olumunca i-protein ne-polyphenol haze, kuthuthukisa ukucaca futhi kwandise isikhathi sokuphila. Umthwali wezithako zokudla — umthwali wokumuncwa wezinambitheka eziwuketshezi, ama-sweetener nezithako zokondla, ukuziguqula zibe yimpuphu egelezayo ngokukhululekile. Izinhlelo zokusetshenziswa ezithinta ukudla — kuhlangabezana nezidingo zezinto ezithinta ukudla, kuhlanganisa ama-sachet e-desiccant nezinye izindlela zokusetshenziswa okungaqondile. 3. Izithako zemithi Kukhiqizwa ngokwe-USP/NF monograph futhi kusetshenziswa ezinhlotsheni zomthamo oqinile womlomo: Amaphilisi namacapsule — i-glidant ne-anti-adherent; kuthuthukisa ukugeleza kwempuphu, kunciphisa ukungqubuzana nama-punch nama-die, kuthuthukisa ukunemba kwesisindo nokuqedwa kwendawo, futhi kuvimbela ukunamathela. Ama-powder nama-granule — usizo lokugeleza nomthwali; kuthuthukisa ukufana kwezinto ezisebenzayo zomthamo ophansi nokuzinza kokulungiselela. Ukusekelwa kokubhalisa — idatha yobuchwepheshe edingekayo ekubhaliseni imithi eBrazil inikezwa nempahla. 4. Izimonyo nokunakekela umuntu Ukuqina, ukulawula i-rheology, ukufiphaza, ukumuncwa kukawoyela nokusebenza kwe-soft-focus: Ukunakekela isikhumba — amakhrimu, ama-lotion, ama-serum nama-scrub; kulungisa ukuthungwa, kuthuthukisa ukuzinza, kunika umuzwa ocwebezelayo, futhi kunikeza ukuxubha okumnene kumafomethi e-scrub. Izimonyo — impuphu ekhululekile necindezelwe, i-foundation ne-primer; umphumela we-soft-focus, kufiphaza izimbobo nemigqa emincane, kumunca uwoyela owedlulele futhi kwandise isikhathi sokugqoka. I-sunscreen — kuthuthukisa ukusabalala, kunciphisa ukugcwele kwamafutha futhi kuthuthukisa umuzwa wangemuva. Ukunakekela izinwele — i-shampoo eyomile nemikhiqizo yokulawula uwoyela; kumunca uwoyela wesikhumba futhi kwengeza umthamo. Imikhakha yesibili Izimboni Isigcwalisi esisebenzayo esingajwayelekile se-inorganic sokusetshenziswa: Ama-coatings nama-inki — i-agent yokufiphaza, i-agent yokuvimbela ukuhla nokuthuthukisa ukumelana nokuklwebheka ezinhlelweni ezithwelwe ngamanzi nezithwelwe nge-solvent. I-silicone rubber — isigcwalisi esiqinisayo esithuthukisa amandla okudonsa nokumelana nokudabuka. Iphepha nezinye izimboni — isigcwalisi sephepha, i-adsorbent yezimboni nomthwali we-catalyst. Izithako zokudla kwezilwane Isitifiketi se-FAMI-QS, sihambisana nezidingo zokuphepha kokudla kwezilwane zaseBrazil: I-agent yokuvimbela ukunqwabelana nosizo lokugeleza kwe-premix, i-concentrate nezithako zokudla kwezilwane eziyimpuphu. Umthwali wezinto ezincane, amavithamini nezinye izithako zokondla, kuthuthukisa ukuzinza nokusabalalisa. Imibhalo yobuchwepheshe namasampula ayatholakala uma uceliwe.