Kodi Ogulitsa Zinthu Zakunja Ayenera Kudziwa Chiyani Kulembetsa Zodzoladzola za FDA?

Lamulo la Modernization of Cosmetics Regulation Act la 2022 (MoCRA) likuyimira kukulitsa kwakukulu kwa ulamuliro wa US Food and Drug Administration (FDA) wolamulira zodzoladzola kuyambira pomwe Federal Food, Drug, and Cosmetic Act (FD&C) Act idaperekedwa mu 1938. Kwa ogulitsa zinthu zodzoladzola omwe amabweretsa zinthu zodzoladzola ku United States, kumvetsetsa zofunikira zatsopanozi ndikofunikira kuti apewe kuchedwa kutumiza, chindapusa, ndi ziletso zolowera pamsika. Bukuli limapereka chithunzithunzi chokwanira cha zomwe ogulitsa zinthu ayenera kudziwa zokhudza kulembetsa zodzoladzola za FDA pansi pa MoCRA.

Kodi MoCRA ndi Chiyani Ndipo N’chifukwa Chiyani Ndi Yofunika kwa Ogulitsa Zinthu Zakunja?

MoCRA inasintha malamulo okhudza zodzoladzola mwa kusintha njira yakale yolembetsera mwaufulu ndi zofunikira zofunika. MoCRA isanayambe, Pulogalamu Yolembetsa Zodzoladzola Yodzipereka ya FDA (VCRP) inali ndi malo olembetsedwa 5,176 okha ndi zinthu 35,102 zomwe zalembedwa. Pofika pa Januware 1, 2025, FDA inanena kuti yawonjezeka pafupifupi nthawi 20, ndi malo olembetsedwa 9,528 ogwira ntchito komanso malo olembetsedwa 589,762 apadera a zinthu zodzoladzola.

Kwa otumiza kunja, kusinthaku kumatanthauza kuti kutsatira malamulo sikulinso kosankha. Zodzoladzola zochokera kunja ziyenera kutsatira malamulo ndi malangizo omwewo omwe amagwira ntchito pazinthu zopangidwa m'dziko. Kutumiza kosatsatira malamulo kungaletsedwe kulowa, kuchedwetsedwa, kapena kukakamizidwa.

Zofunikira Zazikulu za MoCRA kwa Otumiza Kunja

1. Kulembetsa Malo

Malinga ndi MoCRA, malo aliwonse opanga kapena kukonza zinthu zodzikongoletsera kuti zigawidwe ku United States ayenera kulembetsa ndi FDA. Izi zikuphatikizapo malo akunja omwe amatumiza kunja ku US. Kulembetsa kuyenera kukonzedwanso zaka ziwiri zilizonse (zaka ziwiri zilizonse).

Zofunika kwa Ogulitsa Zinthu Zakunja:

·Kulembetsa kuyenera kumalizidwa kudzera pa tsamba lotumizira la FDA's Cosmetics Direct.

Chipinda chilichonse chimafunika nambala ya FDA Establishment Identifier (FEI)

· Chidziwitso cholembetsa chiyenera kusinthidwa mkati mwa masiku 60 kuchokera pamene kusintha kulikonse kwachitika.

·Masiku okonzanso amachokera pa tsiku loyamba lolembetsa (monga, ngati adalembetsa pa February 20, 2024, kukonzanso kudzayenera kuchitika pofika February 20, 2026)

2. Mndandanda wa Zogulitsa

"Munthu wodalirika"—wotchedwa wopanga, wonyamula katundu, kapena wogawa yemwe dzina lake limawonekera pa chizindikiro cha malonda—ayenera kulemba chilichonse chodzikongoletsera chomwe chikugulitsidwa ku FDA. Izi zikuphatikizapo kupereka zosakaniza za malonda ndikusintha zambiri chaka chilichonse.

Mfundo Zofunika Kwambiri kwa Ogulitsa Zinthu Zakunja:

Mndandanda wa zinthu uyenera kukhala ndi nambala ya FEI ya malo aliwonse omwe chinthucho chimapangidwa kapena kukonzedwa.

Mndandanda uyenera kutumizidwa kudzera mu Cosmetics Direct

Zosintha ziyenera kuchitika chaka chilichonse kapena pamene chidziwitso cha malonda chikusintha

3. Kusaloledwa ku Mabizinesi Ang'onoang'ono

MoCRA imachotsa mabizinesi ena ang'onoang'ono ku zofunikira zolembetsa malo ndi kulemba zinthu. Bizinesi imayenerera kukhala "bizinesi yaying'ono" ngati malonda ake apakati pachaka ku United States pazaka zitatu zapitazi ndi ochepera $1,000,000.

Zoletsa Zofunika:

Chikhululukirochi sichikugwira ntchito ku malo omwe amapanga kapena kukonza zinthu zina zodzikongoletsera, kuphatikizapo zomwe zimakhudzana ndi nembanemba ya diso nthawi zonse, zinthu zomwe zimalowetsedwa m'thupi, kapena zinthu zomwe zimagwiritsidwa ntchito mkati.

Mabizinesi ang'onoang'ono akuyembekezekabe kutsatira miyezo yofunika kwambiri yachitetezo ndi kutsatira malamulo

Chikhululukirochi chimagwira ntchito polembetsa ndi kulembetsa kokha—zofunikira zina monga chitsimikizo cha chitetezo zikugwiranso ntchito

4. Kutsimikizira Chitetezo

MoCRA imafuna kuti munthu wodalirika akhale ndi chitsimikizo chokwanira cha chitetezo pa chinthu chilichonse chokongoletsera. Ngakhale kuti FDA sipereka njira inayake, imafuna umboni wotsimikizira chitetezo cha chinthucho pansi pa mikhalidwe yachizolowezi kapena yodziwikiratu yogwiritsira ntchito.

Kwa Otumiza Zinthu Kunja:

Zolemba zoyesera ziyenera kusungidwa ndikupezeka kuti ziwunikidwe ndi FDA

Zowonjezera za utoto zimafuna kuvomerezedwa msika usanayambe

Zinthu zomwe zili ndi talc zimafuna ziphaso zoyesera asbestos

5. Malipoti Oipa a Zochitika

Munthu wodalirika ayenera kunena za mavuto aakulu okhudzana ndi kugwiritsa ntchito zinthu zodzoladzola ku United States kwa FDA mkati mwa masiku 15 ogwira ntchito.

Tanthauzo la Chochitika Choipa Kwambiri:
Chochitika choipa kwambiri ndi chomwe chimabweretsa imfa, kudwala kwambiri, kugonekedwa m'chipatala, kulumala kosalekeza kapena kwakukulu, matenda obadwa nawo, matenda, kapena kupunduka kwakukulu (kuphatikizapo ziphuphu zoopsa komanso zosatha, kupsa kwachiwiri kapena kwachitatu, kutayika kwa tsitsi kwakukulu, kapena kusintha kosatha kapena kwakukulu kwa mawonekedwe).

6. Chofunikira cha Ofesi ya US

Maofesi akunja ayenera kusankha ndi kusunga Wothandizira wa ku US yemwe ali ndi udindo wolankhulana ndi FDA, zolemba zotsata malamulo, komanso kugwirizanitsa zochitika zoyipa. Wothandizira uyu ndi malo olumikizirana ndi FDA pa malo akunja ndipo ayenera kupezeka nthawi yantchito.

Zimene Ogulitsa Zinthu Zakunja Sayenera Kuchita

Ndikofunikira kumvetsetsa zomwe MoCRA sikufuna:

·Zogulitsa zodzikongoletsera ndi zosakaniza sizifuna kuvomerezedwa ndi FDA isanayambe kugulitsa, kupatulapo zowonjezera za utoto

·Makampani omwe amatumiza zinthu zomwe zimaonedwa kuti ndi zodzoladzola zokha sakuyenera kulembetsa ndi FDA—chofunikira cholembetsa chimagwira ntchito kwa opanga ndi opanga, osati ogulitsa okha.

Komabe, otumiza zinthu kunja ayenera kuonetsetsa kuti opanga omwe amagwira nawo ntchito alembetsedwa bwino komanso kuti zinthuzo zalembedwa bwino.

Njira Zotumizira Zinthu Kunja ndi Kutsatira Malamulo a Kasitomu

FDA imagwira ntchito limodzi ndi US Customs and Border Protection (CBP) kuti iwunikire zodzoladzola zomwe zatumizidwa kunja. Zodzoladzola zomwe zatumizidwa kunja ziyenera kufufuzidwa ndi CBP panthawi yolowera.

Zofunikira Zazikulu Zokhudza Kayendetsedwe ka Zinthu:

· Kutumiza zinthu zodzikongoletsera kumafuna chidziwitso cha FDA pasadakhale kudzera mu dongosolo la ACE

·Kunyamula katundu wa pandege ndi panyanja kuyenera kukhala ndi zikalata za MoCRA zotsimikizira kuti katunduyo wachotsedwa pa msonkho.

·HS code 3304 (zogulitsa zokongoletsera) imagwirizana ndi macheke a FDA

·Malembo ayenera kukhala m'Chingerezi kwa otumiza kunja ku US

Zolakwa Zofala Zoyenera Kupewa:

· Kulephera kulembetsa malo musanatumize

· Mndandanda wosakwanira wa zosakaniza

· Kunyalanyaza mayeso a chitetezo cha zodzoladzola zachinsinsi

·Sindinadziwitsidwepo kale za katundu wa pandege

·Malembo akale opanda chidziwitso cha MoCRA

Zofunikira pa Zolemba Pansi pa MoCRA

Malamulo atsopano okhudza kulemba zilembo amafuna kuti zinthu zitsatidwe bwino kuti zitsatidwe ndi kasitomu:

· Lembani nambala yolembetsera malo pa zilembo

· Lembani momveka bwino zinthu zomwe zimayambitsa ziwengo monga zonunkhira

·Kuchuluka konse ndi tsatanetsatane wa wopanga ndizofunikira

·Malembo achingerezi amafunika pazinthu zonse zotumizidwa kunja

· Machenjezo okhudza zoopsa za talc, lead, kapena asbestos

Kukakamiza ndi Zilango

Bungwe la FDA lakulitsa kwambiri mphamvu zake zokakamiza anthu pansi pa MoCRA:

·Kuyimitsa kulembetsa malo ngati zinthuzo zingayambitse mavuto aakulu pa thanzi

·Ulamuliro wokakamiza wobweza katundu ngati munthu wodalirika akana kubweza katundu mwaufulu

·Akuluakulu opezera zolemba kuti ayang'anenso zolemba zachitetezo

Ngati kulembetsa kwa malo osungiramo zinthu kwayimitsidwa, kugawa kapena kugulitsa zinthu zodzikongoletsera kuchokera ku malo osungiramo zinthu ku United States ndi lamulo loletsedwa.

Bungwe la FDA lawonjezera mwamphamvu zochita zokakamiza anthu kuti achitepo kanthu, kuphatikizapo machenjezo, kubweza zinthu, ndi kupempha njira zowongolera mwachangu. Kusanthula kwa 2024 kunawonetsa kuti 48% ya zodzoladzola zomwe zimagulitsidwa m'masitolo 25 apamwamba ku America sizinali kutsatira zofunikira zolembetsa ndi kulemba mndandanda wa MoCRA, zomwe zikugogomezera kufunika kotsatira malamulo mwachangu.

Njira Zothandiza kwa Ogulitsa Zinthu Zakunja

Kuonetsetsa kuti malamulo akutsatira malamulo komanso kuti malonda alowe bwino pamsika:

· Tsimikizirani kulembetsa kwa wopanga wanu - Onetsetsani kuti ogwira nawo ntchito opanga zinthu zakunja alembetsedwa ndi FDA ndipo ali ndi manambala ovomerezeka a FEI

· Tsimikizirani mndandanda wa zinthu - Tsimikizirani kuti munthu wodalirika walemba zinthu zonse mu FDA

· Sankhani Woyimira wa ku US - Ngati mukugwira ntchito ndi opanga akunja, onetsetsani kuti ali ndi Woyimira wa ku US wogwira ntchito

·Unikani zolemba - Onetsetsani kuti zilembo zonse zikukwaniritsa zofunikira za MoCRA, kuphatikiza Chingerezi ndi kuulula koyenera kwa zinthu zomwe zimayambitsa allergen

· Sungani zikalata zachitetezo - Sungani zolemba zotsimikizira chitetezo ndi ziphaso zoyesera zomwe zilipo mosavuta

·Kukhazikitsa njira zofotokozera zochitika zoyipa - Onetsetsani kuti pali njira yofotokozera zochitika zoyipa zazikulu mkati mwa masiku 15 ogwira ntchito

·Gwirani ntchito ndi ogwira ntchito mogwirizana ndi malamulo okhudza kayendetsedwe ka katundu - Phatikizani zikalata za MoCRA mu zikalata zonyamula katundu kuti mupewe kuchedwa kwa misonkho

Mapeto

MoCRA ikuyimira nthawi yatsopano yoyang'anira malamulo okhudza zodzoladzola zomwe zimalowetsedwa ku United States. Kwa ogulitsa ochokera kunja, kumvetsetsa ndikutsatira zofunikira izi ndikofunikira kuti tipewe kuchedwa kokwera mtengo, chindapusa, ndi zoletsa zolowera pamsika. Mwa kugwira ntchito ndi ogwira nawo ntchito opanga zinthu mogwirizana ndi malamulo, kusunga zikalata zoyenera, komanso kukhala ndi chidziwitso chokhudza zosintha zamalamulo, ogulitsa kunja amatha kuyenda bwino m'malo atsopanowa ndikuwonetsetsa kuti zinthu zawo zikufika kwa ogula aku US popanda kusokonezedwa.

Bungwe la FDA likupitiliza kusintha malangizo ake ndi njira zake zamagetsi zotumizira katundu, kotero oitanitsa katundu ayenera kuyang'ana nthawi zonse tsamba la FDA's Cosmetics Direct ndikufunsa akatswiri olamulira kuti azikhala ndi zofunikira zatsopano.

• Chaka Chokhazikitsidwa
  --
• Mtundu Wabizinesi
  --
• Dziko / dera
  --
• Makampani Amitundu Yaikulu
  --
• Zogulitsa zazikulu
  --
• Enterprise Wovomerezeka Munthu
  --
• Ogwira ntchito zonse
  --
• Mtengo Wopanda Pachaka
  --
• Msika wogulitsa
  --
• Makasitomala Ogwirizana
  --