Ngaba izithambiso zifuna ukubhaliswa kwe-FDA?

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Ngaba izithambiso zifuna ukubhaliswa kwe-FDA?

Ubhaliso lwe-FDA1

Kutshanje, i-FDA ikhuphe izikhokelo zokugqibela zokudweliswa kwezixhobo zokuthambisa kunye neemveliso, kwaye yazisa iphothali yezithambiso entsha ebizwa ngokuba yi-'Cosmetic Direct'. Kwaye, i-FDA ibhengeze iimfuno ezisisinyanzelo zobhaliso lweziko lokuthambisa kunye noluhlu lwemveliso ukuqala nge-1 kaJulayi, 2024, ukuqinisekisa ukuba amashishini alawulwayo anexesha elaneleyo lokulungiselela kunye nokungenisa ulwazi.

1. Imigaqo
1)UMthetho wokuLawulwa kweZithambiso zale mihla ka-2022, (i-MoCRA)
2)UMthetho woKutya, iChiza kunye neCosmetic Act (FD&C Act)
3)UMthetho wokuPakisha ngokuFanelekileyo kunye nokuFakwa kweLebhile (FPLA)

2. Ubungakanani besicelo
Ngokomthetho wase-US, izinto zokuthambisa zichazwa njengezinto eziqatywayo, ezisasazwayo, ezitshizwayo, okanye ezisetyenziswa emzimbeni womntu ukucoca, ukuhombisa, ukwenza umtsalane okanye ukutshintsha inkangeleko.
Ngokukodwa, ibandakanya i-moisturizer yolusu, i-perfume, i-lipstick, i-nail polish, amehlo kunye nezithambiso zobuso, i-shampoo yokucoca, i-perm, idayi yeenwele kunye ne-deodorant, kunye nayo nayiphi na into esetyenziswa njengesithako sokuthambisa. Isepha asiyonto yokuthambisa.

3. Ukuhlelwa
Ngokutsho kwe-MoCRA, i-FDA yezothambiso yaseMelika ihlela izinto zokuthambisa ngokwezi ndidi zilandelayo:
-Iimveliso zomntwana: kubandakanya ishampu yomntwana, umgubo wetalcum wokunyamekela ulusu, ukhilimu wobuso, ioyile kunye nolwelo.
-Imveliso yokuhlamba: kubandakanywa ityuwa yokuhlamba, ioli, iyeza, i-agent ye-foam, i-gel yokuhlamba, njl.
-Izithambiso zamehlo: ezinje ngepensile yeshiya, i-eyeliner, isithunzi samehlo, ukuhlamba amehlo, ukususa izithambiso zamehlo, amehlo amnyama, njl.
Izithambiso ezineziphumo ezikhethekileyo, ezifana nokushwabana, ukuqaqamba, ukuncipha komzimba, njl., kufuneka zibhaliswe njengamachiza e-OTC ngaxeshanye. Kufuneka kuqatshelwe ukuba le migaqo mitsha isebenza kwizinto zokuthambisa ezithunyelwa ngaphandle kwimarike yase-US.

Ubhaliso lwe-FDA2

Ukubhaliswa kwe-FDA

I-MoCRA ayongezanga nje ezi mfuno zintsha zilandelayo, kubandakanywa ukusekwa kwenkqubo yomntu onoxanduva lokuthambisa, ukunika ingxelo enyanzelekileyo yeziphumo ezibi kakhulu, ukuthotyelwa kweGood Manufacturing Practice (GMP), ubhaliso loncedo lwefektri kunye nokubhaliswa koluhlu lwemveliso, ukubonelela ngezatifikethi zokhuseleko ezaneleyo, kodwa. Ikwafuna ukuba ileyibhile imakishwe ngolwazi lomntu onoxanduva, i-essence allergener, ukusetyenziswa kobuchwephesha beengxelo zemveliso, uphuhliso kunye nokukhutshwa kweendlela zokubona i-asbestos kwizinto zokuthambisa ezine-talcum powder, kunye novavanyo lomngcipheko wokhuseleko kunye novavanyo lokuphuma kwezilwanyana kwi-PFAS kwizinto zokuthambisa. .

Phambi kokuphunyezwa kwe-MOCRA, abavelisi/abapakishi bezinto zokuthambisa banokubhalisa amaziko abo efektri kwi-FDA ngeNkqubo yoBhaliso yeZithambiso yokuzithandela yase-US ye-FDA's (VCRP), kwaye i-FDA ayinazo iimfuno ezisinyanzelo zoku.

Kodwa ngokuphunyezwa kwe-MOCRA kunye nomhla wokugqibela ofunekayo, zonke iinkampani ezithengisa izimonyo e-United States kufuneka zibhalise amaziko azo okuvelisa kunye ne-FDA kwaye zihlaziye ulwazi lwabo lokubhalisa rhoqo emva kweminyaka emibini, kubandakanywa igama, ulwazi loqhagamshelwano, njl. Amazwe nawo ayafuneka ukuba anike ulwazi kunye neenkcukacha zoqhagamshelwano zeearhente ngaphakathi eUnited States. Kukwakho nolunye ulwazi olongezelelweyo ekufuneka luzaliswe, olufana neenkcukacha zenkampani engumzali, uhlobo lweshishini, imifanekiso yokupakishwa, amakhonkco ephepha lewebhu lemveliso, nokuba zizithambiso zobungcali, ikhowudi yeDun&Bradstreet yomntu onoxanduva, njl. njl. Akunyanzelekanga ukugcwalisa. in. Izibonelelo zokuthambisa ezikhoyo kufuneka zibhalise kwi-FDA kwisithuba sonyaka omnye emva kokuba imimiselo emitsha ikhutshiwe, kwaye ixesha lokubhalisa kwizibonelelo ezitsha zokuthambisa lingaphakathi kweentsuku ezingama-60 zokubandakanyeka ekusetyenzweni nasekuveliseni izithambiso.

ILebhu yoVavanyo lwe-BTF, inkampani yethu ineelabhoratri ezihambelanayo ne-electromagnetic, imimiselo yokhuseleko ILabhoratri, iLebhu yerediyo engenazingcingo, iLebhu yebhetri, iLebhu yeekhemikhali, iLabhoratri yeSAR, iLabhoratri ye-HAC, njl. I-VCCI, njl. Ukuba unovavanyo olufanelekileyo kunye neemfuno zesatifikethi, ungaqhagamshelana ngokuthe ngqo nabasebenzi bethu boVavanyo ukuze ufumane iikowuti zeendleko ezineenkcukacha kunye nolwazi lomjikelo!

Ubhaliso lwe-FDA3

Ingxelo yovavanyo lwe-FDA


Ixesha lokuposa: Aug-21-2024