Nigute Wokwemeza FDA hamwe nubumwe bwibihugu byi Burayi Ibiribwa-Twandikire Impapuro zitumizwa mu mahanga

Ku bayobozi bashinzwe gutanga amasoko, abayobozi bashinzwe ubwishingizi bufite ireme, hamwe n’abashinzwe kubahiriza ubucuruzi mpuzamahanga, gutumiza ibicuruzwa biva mu mahanga bisaba kumenya neza ibijyanye no kubahiriza umutekano w’ibiribwa. Ifu ya aluminiyumu, ububiko bwa lacqued, hamwe na fayili yabanje gusiga amavuta bigomba kuba byujuje ibisabwa mbere yo kwinjira mumasoko yo muri Amerika y'Amajyaruguru cyangwa Uburayi.

Kwishingikiriza kubatanga ibicuruzwa rusange cyangwa ibyemezo bitemewe byerekana abinjira mu mahanga kwangwa na gasutamo, kwibutsa ibicuruzwa, ihazabu ikabije, hamwe nuburyozwe. Kugenzura Ibicuruzwa bitumizwa mu mahanga bya aluminiyumu FDA hamwe n’ubumwe bw’ibihugu by’Uburayi kubahiriza ibisabwa bisaba kugenzura buri gihe gahunda yo gupima protocole, kwemerera laboratoire, no gutangaza byemewe n'amategeko.

Amabwiriza yubahirizwa ningirakamaro kubatumiza ibicuruzwa mu mahanga

Inzego zishinzwe umutekano ku biribwa ku isi zikurikiranira hafi ibikoresho bipfunyika bitumizwa mu mahanga kugira ngo hirindwe uburozi bw’imiti yinjira mu munyururu.

Igiciro Cyinshi cyo Kutubahiriza: Ifatira rya gasutamo, ihazabu, n’ibyangiritse

Abayobozi ba gasutamo (nka US CBP / FDA cyangwa ibiro by’ubugenzuzi bw’umupaka w’ubumwe bw’ibihugu by’Uburayi) bagenzura ibicuruzwa byinjira kugira ngo hubahirizwe ibiryo. Ibicuruzwa bidafite ibyangombwa byujuje ibyangombwa bihita byangwa byinjira, gusenya byanze bikunze, cyangwa imipaka ihenze.

Gutandukanya Raw Substrate Ubwiza v

Umutekano wo guhuza ibiryo ukurikizwa kuri buri cyiciro cyahinduwe:

Bare Metal Substrate: Isuzumirwa kumyanda iremereye (gurş, kadmium, arsenic, mercure).

Amavuta yo kwisiga & Coatings: Yasuzumwe kwimuka ryimiti, ibinyabuzima kama bihindagurika (VOC), hamwe nibice bivamo resin.

Intambwe ku yindi Kugenzura Urwego rwo kugenzura: FDA na EU Inyandiko

Nigute wagenzura uruganda rwamahanga rwa tekiniki yubahiriza Dossier

Abatumiza mu mahanga bagomba gukora igenzura ryibice bitatu mbere yo gutanga ibicuruzwa:

Ibibazo

Q1: Niyihe nyandiko imwe yingenzi ikenewe mu kwinjiza ibiryo bya aluminiyumu ifata muri EU?

Igisubizo: Itangazo ryubahiriza amategeko (DoC) ryateganijwe n’amabwiriza (EC) No 1935/2004 n’amabwiriza (EU) No 10/2011. Ninyandiko yemewe n'amategeko yashyizweho umukono nuwabikoze yemeza ko ibikoresho byujuje ibyimuka by’ubumwe bw’ibihugu by’Uburayi.

Q2: Nigute uwatumije mu mahanga ashobora kugenzura niba raporo y'ibizamini bya SGS cyangwa Intertek itanga ukuri?

Igisubizo: Menyesha laboratoire itanga binyuze kumurongo wabo wo kugenzura cyangwa kumurongo wa serivisi zabakiriya, utange numero ya raporo nitariki yatanzwe. Laboratwari zemewe zemewe kubika amakuru ashakishwa kugirango igenzure raporo yikizamini.

Q3: Ese ibyatanga isoko rusange bisaba 'FDA Yemejwe ' byemewe n'amategeko byemewe na gasutamo?

Igisubizo: Oya. FDA ntabwo 'yemeza ' ibikoresho byo gupakira muburyo butaziguye. Abatumiza mu mahanga bagomba gukora raporo y'ibizamini byihariye byerekana kubahiriza ibice bya CFR bijyanye (urugero, 21 CFR 175.300 yo gutwikira cyangwa 21 CFR 178.3910 yo gusiga amavuta) yatanzwe na laboratoire yemewe ya ISO 17025.

Ikibazo cya 4: Ni ubuhe buryo bwo gupima ibiryo bisabwa kugira ngo ifu ikoreshwe n'ibiryo bya aside?

Igisubizo: Munsi y’ubumwe bw’ibihugu by’Uburayi No 10/2011, gupima ibiryo birimo aside bisaba guhura n’ibiribwa Simulant B ( 3% $ Acide Acide) mu gihe cy’ubushyuhe n’ibihe byateganijwe kugira ngo bapime icyuma cyimuka n’imiti.

Q5: Nigute Changzhou Dingang Metal Material Co., Ltd. (Ubushinwa) ifasha abatumiza ibicuruzwa kubahiriza gasutamo?

Igisubizo: Dingang Metal Material Co., Ltd. itanga dosiye yuzuye igenzurwa na buri byoherejwe, harimo Amatangazo yashyizweho umukono, ISO 17025 yemewe na SGS / Intertek raporo y'ibizamini, FDA 21 CFR ibyemezo byubahirizwa, hamwe nibisobanuro bya CoA.

Umwanzuro

Kuzana ibicuruzwa bipfunyika mumasoko yo muri Amerika na EU bisaba kugenzura neza. Mugenzuzi ya dosiye yubuhanga, gusaba raporo yikizamini cy’abandi bantu bemewe, no kwemeza ko urwego rwakurikiranwa, abatumiza ibicuruzwa mu mahanga barashobora gukumira gasutamo, kwirinda inshingano, no kubaka urwego rwizewe kandi rwiza ku isi.