Amavuta yo kwisiga arasaba kwiyandikisha kwa FDA?

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Amavuta yo kwisiga arasaba kwiyandikisha kwa FDA?

Kwiyandikisha FDA1

Vuba aha, FDA yasohoye umurongo ngenderwaho wanyuma wurutonde rwibikoresho byo kwisiga nibicuruzwa, inashyira ahagaragara umuyoboro mushya wo kwisiga witwa 'Cosmetic Direct'. Kandi, FDA yatangaje ibyangombwa bisabwa kugirango yandike ibikoresho byo kwisiga no gutondekanya ibicuruzwa guhera ku ya 1 Nyakanga 2024, kugirango ubucuruzi bugenzurwa bugire igihe gihagije cyo gutegura no gutanga amakuru.

1. Amabwiriza
1) Kuvugurura amategeko agenga amavuta yo kwisiga yo muri 2022, (MoCRA)
2) Amategeko y’ibiribwa, ibiyobyabwenge n’amavuta yo kwisiga (Itegeko rya FD&C)
3) Amategeko yo gupakira no kuranga neza (FPLA)

2. Igipimo cyo gusaba
Dukurikije amategeko y’Amerika, kwisiga bisobanurwa nkibintu bikoreshwa, gukwirakwizwa, gutera, cyangwa ubundi buryo bukoreshwa kumubiri wumuntu kugirango bisukure, byiza, byongere ubwiza, cyangwa guhindura isura.
By'umwihariko, ikubiyemo uruhu rwogeza uruhu, parufe, lipstick, imisumari yimisumari, kwisiga mumaso no mumaso, koza shampoo, perm, gusiga irangi umusatsi na deodorant, hamwe nibintu byose bikoreshwa mubintu byo kwisiga. Isabune ntabwo ari iy'amavuta yo kwisiga.

3. Ibyiciro
Nk’uko MoCRA ibivuga, amavuta yo kwisiga yo muri Amerika FDA ashyira amavuta yo kwisiga mu byiciro bikurikira:
-Ibicuruzwa byabana: harimo shampoo yumwana, ifu yita kuruhu rwa talcum, cream yo mumaso, amavuta namazi.
-Ibicuruzwa byogejwe: birimo umunyu woge, amavuta, imiti, umukozi wa furo, gel gel, nibindi.
-Kosmeti y'amaso: nk'ikaramu y'ijisho, ijisho, igicucu cy'amaso, koza amaso, gukuramo amaso, umukara w'amaso, n'ibindi.
Amavuta yo kwisiga afite ingaruka zidasanzwe, nka anti inkinko, kwera, guta ibiro, nibindi, agomba kwandikwa nkimiti ya OTC icyarimwe. Twabibutsa ko aya mabwiriza mashya akoreshwa mu kwisiga byoherezwa ku isoko ry’Amerika.

Kwiyandikisha kwa FDA2

Kwiyandikisha kwa FDA

MoCRA ntabwo yongeyeho gusa ibisabwa bishya bikurikira, harimo gushyiraho uburyo bwo kwisiga bushinzwe uburyo bwo kwisiga, gutanga raporo ku buryo bukabije bw’ingaruka mbi, kubahiriza uburyo bwiza bwo gukora ibicuruzwa (GMP), iyandikwa ry’ibikorwa by’uruganda no kwiyandikisha ku bicuruzwa, gutanga ibyemezo bihagije by’umutekano, ariko yasabye kandi ikirango gushyirwaho amakuru yumuntu ubishinzwe, essence allergens, gukoresha ubuhanga bwibicuruzwa, guteza imbere no gusohora uburyo bwo gutahura asibesitosi mu mavuta yo kwisiga arimo ifu ya talcum, hamwe n’isuzuma ry’umutekano w’umutekano hamwe n’icyiciro cy’inyamaswa ikizamini cya PFAS mu kwisiga. .

Mbere y’ishyirwa mu bikorwa rya MOCRA, abakora amavuta yo kwisiga / abapakira barashobora kwandikisha ibikoresho byabo by’uruganda muri FDA binyuze muri gahunda yo kwiyandikisha ku bushake bwo kwisiga yo muri Amerika FDA (VCRP), kandi FDA ntabwo isabwa kubisabwa.

Ariko hamwe n’ishyirwa mu bikorwa rya MOCRA n’igihe ntarengwa cyegereje, amasosiyete yose agurisha amavuta yo kwisiga muri Amerika agomba kwandikisha ibikoresho by’inganda muri FDA kandi akavugurura amakuru y’iyandikisha buri myaka ibiri, harimo izina, amakuru y’itumanaho, n'ibindi. Ibikoresho biri hanze y’Ubumwe Ibihugu birasabwa kandi gutanga amakuru nibisobanuro byabakozi muri Amerika. Hariho kandi amakuru yinyongera agomba kuzuzwa, nkamakuru yisosiyete yababyeyi, ubwoko bwibigo, amashusho yo gupakira, guhuza ibicuruzwa byurubuga, niba ari amavuta yo kwisiga yabigize umwuga, code ya Dun & Bradstreet ushinzwe, nibindi ntabwo ari itegeko kuzuza .

Laboratwari ya BTF, isosiyete yacu ifite laboratoire ihuza amashanyarazi, amabwiriza yumutekano Laboratoire, Laboratoire idafite umurongo wa Laboratoire, Laboratoire ya laboratoire, Laboratoire y’imiti, Laboratoire ya SAR, Laboratoire ya HAC, nibindi. Twabonye impamyabumenyi nuburenganzira nka CMA, CNAS, CPSC, A2LA, VCCI, nibindi. Isosiyete yacu ifite itsinda ryinzobere mu buhanga bwa tekinike kandi zumwuga, zishobora gufasha ibigo gukemura ikibazo. Niba ufite ibizamini bikenewe hamwe nimpamyabumenyi, urashobora guhamagara abakozi bacu bashinzwe ibizamini kugirango ubone ibiciro birambuye hamwe namakuru yizunguruka!

Kwiyandikisha kwa FDA3

Raporo y'ibizamini bya FDA


Igihe cyo kohereza: Kanama-21-2024