I-US FDA iphakamisa ukuhlolwa kwe-asbestos okuphoqelekile kwezimonyo eziqukethe i-talc powder

Ngomhla zingama-26 kuZibandlela 2024, i-US Food and Drug Administration (FDA) ihlongoze isiphakamiso esibalulekile esidinga abakhiqizi bezimonyo ukuthi benze ukuhlolwa kwe-asbestos okuyimpoqo emikhiqizweni equkethe i-talc ngokuvumelana nezinhlinzeko ze-2022 Cosmetic Regulatory Modernization Act (MoCRA). Lesi siphakamiso sizoba nomthelela omkhulu embonini yezimonyo, ikakhulukazi emakethe yezimonyo ye-talcum powder.

Izindlela zokuthola ezihlongozwayo ze-FDA ngokuyinhloko zifaka izinhlobo ezimbili: i-polarized light microscopy (PLM): le ndlela ingahlaziya inani elikhulu lamasampuli futhi ihlonze i-asbestos ngokubheka izici ze-optical crystallographic (ezifana nombala, imibala eminingi, inkomba ye-refractive, i-birefringence, njll. ) kanye ne-particle morphology. I-Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selective Electron Diffraction (TEM/EDS/SAED): Le ndlela ingakwazi ukubona imicu emincane futhi ihlonze i-asbestos ngokuhlaziya ukwakheka kwe-elemental, ukwakheka kwekristalu, kanye ne-particle morphology.

I-FDA ithe ukuhlanganisa lezi zindlela ezimbili kungakhulisa ukutholwa kwe-asbestos. Nakuba i-PLM inokukhuliswa okuphansi, ingahlaziya inani elikhulu lamasampula; Futhi i-TEM/EDS/SAED ingathola imicu emincane. Lezi zindlela ezimbili ziyaphelelisana, zithuthukisa ukunemba nokuhlanganisa kokutholwa.

Isiphakamiso sokungaguquguquki kwezinga lamazwe ngamazwe sihambisana namazinga omhlaba. I-European Union, Canada, kanye ne-Japan basungule imithetho eqinile efanayo ukuze baqinisekise ukuthi imikhiqizo ye-talc ayikuqukethe ukungcoliswa kwe-asbestos. Amasu ama-Microscopic afana ne-PLM ne-TEM asetshenziswa kabanzi emhlabeni wonke ukuthola ngokunembile i-asbestos. Leli zinga elihlanganisiwe alisizi nje kuphela ukuvikela impilo yabathengi, kodwa futhi likhuthaza uhwebo lwamazwe ngamazwe futhi likhulise ukuzethemba kwabathengi ekuphepheni kwemikhiqizo ye-talc yomhlaba wonke.

Isiphakamiso se-FDA sisho ngokusobala ukuthi uma i-asbestos itholwa kuzimonyo noma i-talc esetshenziswa kuzimonyo, umkhiqizo uzobhekwa njengowonakele futhi wephule umthetho we-Federal Food, Drug, and Cosmetic. Lo mthethonqubo uhlinzeka ngesisekelo esicacile esingokomthetho sokugcinwa komthetho.

Inhloso eyinhloko yalesi siphakamiso ukunciphisa ingozi yokuchayeka kwabathengi ku-asbestos nokuvimbela izifo ezihlobene. Ngesikhathi esifanayo, kuzosiza futhi abakhiqizi behlise imvamisa yokukhumbula umkhiqizo futhi banciphise ubungozi bokusebenza.

Ukwengeza, lesi siphakamiso sigcwalisa izikhala ezithile kuzinkombandlela ze-MoCRA, ikakhulukazi mayelana nokungaqondi kahle kwamazinga okuhlola ukuphepha kwezimonyo ngamabhizinisi amancane naphakathi nendawo. I-FDA manje isizichaze ngokucacile izindlela zokuhlola i-asbestos ku-talc, ihlinzeka ngesiqondiso esicacile embonini.

I-FDA ivule isikhathi sokubuyekeza umphakathi ukuze umphakathi ubambe iqhaza kanye nezinyathelo ezilandelayo, nomnqamulajuqu wangoMashi 27, 2025. Lokhu kunikeza ithuba imboni nomphakathi ukuthi ubambe iqhaza enqubweni yokulawula. Uma ekugcineni uphasiswa, lo mthethonqubo omusha uzothuthukisa kakhulu ukuphepha kwe-talc equkethe izimonyo futhi unikeze ukuvikeleka okunamandla kwempilo yabathengi.

Isiphakamiso se-FDA sibonisa ukugcizelela okuphezulu kweziphathimandla ezilawulayo ekuphepheni kwezimonyo, ikakhulukazi ekutholweni kwe-asbestos, i-carcinogen eyaziwayo. Ngokunikezwa kwesiphakamiso esisha se-FDA, i-Bureau Veritas incoma ukuthi abakhiqizi bezimonyo baqale ukuhlola nokubuyekeza izinqubo zabo zokulawula ikhwalithi kusenesikhathi, ikakhulukazi emikhiqizweni equkethe i-talc. Amabhizinisi afanelekile kufanele afune usizo olufika ngesikhathi kuma-ejensi okuhlola ezinkampani zangaphandle, aqeqeshe abasebenzi abafanelekile, futhi asungule uhlelo lokulawula uchungechunge lokuhlinzekwa kwempahla ukuze aqinisekise ukuthobelana nezidingo zokulawula ezintsha, alondoloze isithunzi somkhiqizo, nokwethenjwa kwabathengi.

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