i-Brazil EFSA E551 I-Silicon Dioxide

I-Silica Ekhishwe Ngokujwayelekile Yezinjongo Ezihlukahlukene Izinga elilodwa kuzo zonke izinto zokudla, ukunakekelwa komlomo, imithi kanye nezimonyo — ilungiselelwe iBrazil neLatin America Izinga elilodwa lezimboni eziningi le-silica ehlanzekile kakhulu enamanzi, ekhiqizwa ngokuhlehla okulawulwayo. Yakhelwe ukuhlangabezana nezilinganiso zamazwe ngamazwe zekhwalithi 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 kanye nokwengeza emfuyweni kusekelwa 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 nakuyo yonke iLatin America, umphumela ongokoqobo ukuncipha kwama-SKU, ukugcinwa kwempahla okulula kanye nomsebenzi omncane wokuqinisekisa. Umkhiqizi I-Zhongqi Shandong Silicon Material Co., Ltd. ikhiqiza i-silica ekhishwe ngokujwayelekile yokusebenza okuphezulu eShandong, eChina. Inkampani iyibhizinisi likazwelonke lobuchwepheshe obuphezulu futhi inamalungelo obunikazi azimele ayisishiyagalombili amboza ubuchwepheshe bokukhiqiza i-silica. Imigqa yokukhiqiza ezenzakalelayo eyisithupha inika umthamo wonyaka ongaphezu kwamathani angu-80,000, okusekela ukunikezwa okungaguquki komthamo omkhulu. I-silica yezinjongo ezijwayelekile isebenza ngaphansi kokuphathwa okusekelwe ku-GMP. Imikhiqizo yezinga lokudla neyemithi yenziwa endaweni evaliwe ukuvimbela ukungcola okuhlanganayo. Ukulandelelwa kumboza ukungeniswa kwezinto zokusetshenziswa, ukusabela, ukuhlolwa komkhiqizo ophelile, ukupakisha kanye nokuthunyelwa. I-batch ngayinye inekhodi yayo, futhi amarekhodi okukhiqiza nawokuhlola angemuva kwaleyo khodi agcinwa ukuze ahlolwe. Kumakhasimende aseBrazil 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 kanye nokuqinisekiswa kwamanxusa lapho indlela yokubhalisa ikudinga — umsebenzi ovamise ukususa umgoqo wemibhalo ohlelweni lokwethula. Impahla isivele inikezwa eYurophu, eNyakatho Melika naseNingizimu-mpumalanga Asia, futhi izicaciso zilungiselelwe izimo zokusetshenziswa zaseBrazil kanye nezomthetho. Usayizi wezinhlayiyana, indawo ekhonjisiwe yomhlaba kanye nokumuncwa kukawoyela kuyalungiseka. Amakhasimende ahlanganisa amaqembu amakhulu e-FMCG asebenza eBrazil kanye nabaholi bendawo kwezokudla, ukunakekelwa komlomo, imithi, izimonyo, imfuyo kanye nokucubungula kwezimboni. Izicaciso zobuchwepheshe — izinga elijwayelekile lomhlaba wonke Amanani ajwayelekile ngezansi. Ipharamitha ngayinye ingalungiselelwa uhlelo 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 kanye nokuzinza kokushisa Ukomisa (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 nezinqubo 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 lomhlahlandlela womuthi wokuxubha wansuku zonke (ISO 11609) Izinsimbi ezisindayo i-As ≤ 1 ppm, i-Pb ≤ 2 ppm, i-Hg ≤ 0.5 ppm Imikhawulo ibekelwe ukusetshenziswa kokudla, ukunakekelwa komlomo kanye nemithi; imiphumela ye-batch ibikwa ku-COA Inani eliphelele le-aerobic plate ≤ 50 cfu/g Kuhlangabezana nezidingo ze-microbial zokusetshenziswa kokudla, imithi kanye 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 elingangeni amanzi lezinga lokuthumela ngaphandle lika-10 / 15 / 20 kg eline-PE inner liner Ukupakisha okwezifiso kanye 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 yezomthetho Zonke izitifiketi zikhishwa izikhungo zezinye izinhlangano futhi zivuselelwa ngokuhlolwa konyaka kokugada. Zisekela ukukhishwa kwempahla emthethweni, 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 kanye nezinga lokudla, futhi isekela ukubhalisa kwe-ANVISA kwezemithi nokudla. 2.I-ISO 22000:2018 — uhlelo lokuphathwa kokuphepha kokudla olusetshenziswa kuyo yonke inqubo yokukhiqiza. 3.I-GMP yezinto zokusetshenziswa zezimonyo nemithi — ukuphathwa kwendawo yokusebenzela kuhlangabezana nezidingo ze-GMP zokukhiqiza imithi nezimonyo. 4.I-ISO 9001:2015 — isitifiketi sokuphathwa kwekhwalithi kwayo yonke inqubo. 5.I-SHC HALAL — isitifiketi se-halal semakethe yokudla neyezimonyo ye-halal yaseBrazil. 6.I-OU KOSHER — isitifiketi se-kosher sokukhiqiza kokudla neyezimonyo kwe-kosher. 7.I-FDA 21 CFR yokuhambisana nokuxhumana nokudla — ihambisana nezidingo ze-US FDA 21 CFR zezinto ezixhumana nokudla, ezamukelwa kabanzi njengesisekelo sokuhambisana nokusetshenziswa kokuxhumana nokudla eBrazil. 8.I-FAMI-QS — ihambisana nohlelo lwekhwalithi lwe-EU lwezithako zemfuyo; isekela ukubhalisa kwe-MAPA kwezithako zemfuyo. 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 eziyisisekelo zomkhiqizo 1. Ukuhlanzeka nokulawulwa kokungcola Ukuhlanzeka kufinyelela ku-≥ 97.5% SiO₂ ngesisekelo esishisiwe ngokuhlolwa kwezinto zokusetshenziswa, ukuhlanzwa okunezigaba kanye nokukhiqiza okuvaliwe. I-Arsenic, i-lead ne-mercury zibanjwa emikhawulweni esethebula elingenhla, futhi izibalo ze-microbial zilawulwa zokusetshenziswa kokudla, ukunakekelwa komlomo kanye nezimonyo. I-batch ngayinye ihlolwa ngokuphelele ngaphambi kokuthunyelwa, futhi irekhodi lokuhlola lihamba ne-lot — okuyikho okwenza into ikwazi ukusetshenziswa emikhiqizweni engaphansi kwezidingo zezempilo nokuphepha ze-ANVISA. 2. Ukuzinza kwamakhemikhali nokuhambisana kokwakheka I-silica ekhishwe ngokujwayelekile enamanzi izinzile ngamakhemikhali futhi i-inert ngaphansi kwezimo eziphakathi nendawo nezinomuncu kancane noma ezinobuthi obuncane, 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 zokudla, kanye nama-emollient, izilondolozi nezinto ezisebenzayo kwezimonyo. Ukumuncwa kwezinto ezisebenzayo kuphansi ekusetshenzisweni okujwayelekile; sisatusa ukuhlolwa okufushane kokuhambisana kufomula yekhasimende ngaphambi kokukhulisa. 3. Amapharamitha alungisekayo nezinga lezifiso 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 ogugayo ophezulu odinga amandla okuhlanza, amazinga okudla avimbela ukunqwabelana adinga ukugeleza, ama-glidant emithi adinga imibhalo ephelele yokuphepha, kanye namazinga ezimonyo okumisa adinga umuzwa wesikhumba. Ukusekelwa kusuka ekuhlolweni kwesampula kuya ekuqinisekisweni kokukhulisa. 4. Ukungaguquki kwe-batch kuya ku-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 amakhasimende akudingeki ukuthi aphinde alungise amafomula njalo lapho kufika i-batch entsha. Lokho kwehlisa izindleko zokulungisa futhi kusekela ukukhiqiza okukhulu okungaguquki. Kungani leli zinga lifanele imakethe yaseBrazil 1. Izinga elilodwa eliqinisekisiwe emikhakheni emine Ukudla, ukunakekelwa komlomo, imithi kanye nezimonyo kwabelana ngento efanayo eyisisekelo, kanti ukusetshenziswa kwezimboni nemfuyo kusekelwa eceleni. Kumaqembu aseBrazil aqhuba amabhizinisi amaningi, ukuqinisekiswa okukodwa kumboza ukuthuthukiswa komhlinzeki, ukuhlolwa okungenayo kanye nokuhlelwa kwempahla yemigqa eminingi yomkhiqizo — futhi kunciphisa inani lama-SKU aphethwe. 2. Ukusekelwa kwemibhalo kokungena emakethe Isethi yesitifiketi yamukelwa kabanzi eBrazil, futhi silungisa idokhumenti ephelele edingekayo yokubhalisa kwe-ANVISA nokubhalisa kwe-MAPA kwemikhiqizo yemfuyo. Sisekela futhi ukugunyazwa kwemibhalo nokuqinisekiswa kwamanxusa lapho indlela ikudinga, futhi siphendula imibuzo yobuchwepheshe ngesikhathi sokubuyekezwa. Ukubhalisa eBrazil kuphethwe yinkampani yasekhaya engenisa impahla; 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 kanye nogwayi. Amazinga okudla ahambisana nezinongo zendawo eziyimpuphu kanye namalungiselelo ayimpuphu. 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 okukhulu okungaguquki Umthamo wonyaka ongaphezu kwamathani angu-80,000, nesitoko sokuphepha esigcinwe ezicacisweni 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 ngokulingana nezinye izingxenye zempuphu kuqala, bese wethula izingxenye eziwuketshezi isinyathelo ngesinyathelo; ukuxhumana okuqondile nomthamo omkhulu woketshezi kubangela ukunqwabelana. 2.Ukusabalalisa — vumela isikhathi esanele sokuxuba kanye ne-shear efanele uhlelo lokwakheka, ukuze izinhlayiyana zisabalale ngokulingana futhi izinga lisebenze njengoba kucacisiwe. 3.Indawo — 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 kanye nokusebenza kokuhlanza okudingekayo. Ukudla (ukuvimbela ukunqwabelana / usizo lokugeleza / umthwali): ngokujwayelekile 0.5% – 5%. Izinga langempela kufanele lihlale ngaphakathi kwemikhawulo yezithako ezibekwe yi-ANVISA yesigaba sokudla esithile — i-silicon dioxide ifakwe ohlwini njenge-INS 551, futhi ingxenye esebenzayo kufanele ihlolwe uhlobo 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, ukumisa nokumuncwa kukawoyela kumakhrimu, amalothoni, ama-scrub nemikhiqizo eyimpuphu; lungisa ngokokuthungwa okuqondiwe nokusebenza kahle. Ukugcinwa Gcina emaphaketheni okuqala avaliwe, endaweni epholile, eyomile, enomoya, kude nomswakama nokungcola okuguquguqukayo. Isikhathi sokuphila siyizinyanga ezingama-24 emaphaketheni okuqala angavulwanga ngaphansi kwezimo zokugcina ezicacisiwe. Phinda uvale 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 okugugayo kanye nezinga elithile lokuqina: Umuthi wokuxubha wokumhlophe — isusa ibala langaphandle futhi ipholisha i-enamel, ihloselwe ukungcola kwekhofi, i-chimarrão nogwayi okuvamile eBrazil, ne-RDA ngaphakathi kwebanga elamukelwa umhlaba wonke. Umuthi wokuxubha wansuku zonke wokuhlanza okujulile — isusa i-plaque futhi ipholisha ubuso bezinyo; ihambisana nezinhlelo zokunambitheka kwe-mint nezithelo ezisetshenziswa emakethe yaseBrazil. Umuthi wokuxubha ocacile — izicaciso zihambisana ne-refractive index yesisekelo, ukuze kube nokucaca okuphezulu kwe-paste nokuhlanza okumnene nokuqina. I-powder yamazinyo ne-paste yokupolisha yobungcweti — ukugeleza okuhle kwempuphu nokusebenza kokupolisha kwezimpuphu zamazinyo nama-paste e-prophylaxis yobungcweti. 2. Ukukhiqizwa kokudla Kusetshenziswa njengesithako sokudla esivunyelwe, i-silicon dioxide (E551 / INS 551): Ukuvimbela ukunqwabelana kokudla okuyimpuphu — izinongo eziyimpuphu, ikhofi elisheshayo, i-powder ye-chimarrão, ubisi oluyimpuphu, 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, luthuthukisa ukucaca futhi lwandisa isikhathi sokuphila. Umthwali wezithako zokudla — umthwali wokumuncwa wezinongo eziwuketshezi, ama-sweetener nezithako zokondla, eziziguqula zibe yimpuphu egelezayo ngokukhululekile. Izinhlelo zokusetshenziswa ezixhumana nokudla — kuhlangabezana nezidingo zezinto ezixhumana nokudla, kuhlanganisa ama-sachet e-desiccant nezinye izinhlelo zokusetshenziswa zokuxhumana 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 kobuso, futhi kuvimbela ukunamathela. Ama-powder nama-granule — usizo lokugeleza nomthwali; kuthuthukisa ukulingana kwezinto ezisebenzayo zomthamo ophansi nokuzinza kokulungiselela. Ukusekelwa kokubhalisa — idatha yobuchwepheshe edingekayo yokubhalisa imithi eBrazil inikezwa nento. 4. Izimonyo nokunakekela umuntu Ukuqina, ukulawula i-rheology, ukumisa, ukumuncwa kukawoyela nokusebenza kwe-soft-focus: Ukunakekela isikhumba — amakhrimu, amalothoni, ama-serum nama-scrub; kulungisa ukuthungwa, kuthuthukisa ukuzinza, kunika umuzwa ocishe ube njengesilika, futhi kunikeza ukuxubha okumnene kumafomathi e-scrub. Izimonyo — i-powder ekhululekile necindezelwe, i-foundation ne-primer; umphumela we-soft-focus, kufiphalisa izimbobo nemigqa emincane, kumunca uwoyela owedlulele futhi kwandisa isikhathi sokugqoka. I-sunscreen — kuthuthukisa ukusabalala, kunciphisa ukugcwele kwamafutha futhi kuthuthukisa umuzwa wangemuva. Ukunakekela izinwele — i-shampoo eyomile nemikhiqizo yokulawula uwoyela; kumunca uwoyela wekhanda futhi kwengeza umthamo. Imikhakha yesibili Izimboni Isigcwalisi esisebenzayo esingajwayelekile se-inorganic sokusetshenziswa: Ama-coatings nama-inki — i-agent yokumisa, i-agent yokuvimbela ukuhla kanye nomthuthukisi wokumelana nokuklwebheka ezinhlelweni ezithwalwa ngamanzi nezithwalwa nge-solvent. I-silicone rubber — isigcwalisi esiqinisayo esithuthukisa amandla okudonsa nokumelana nokudabuka. Iphepha nezinye izimboni — isigcwalisi sephepha, i-adsorbent yezimboni kanye nomthwali we-catalyst. Izithako zemfuyo Kuqinisekiswe nge-FAMI-QS, kuhambisana nezidingo zokuphepha kwemfuyo zaseBrazil: I-agent evimbela ukunqwabelana nosizo lokugeleza lwe-premix, i-concentrate nezithako zemfuyo eziyimpuphu. Umthwali wezinto ezincane, amavithamini nezinye izithako zokondla, kuthuthukisa ukuzinza nokusabalala. Imibhalo yobuchwepheshe namasampula kuyatholakala uma kuceliwe.