Ni ibihe byemezo bisabwa kugira ngo ibiryo byo mu rwego rwo mu bwoko bwa Aluminiyumu byoherezwa mu bihugu by’Uburayi n’amasoko yo muri Amerika y'Amajyaruguru mu cyubahiro? Nibihe Bizamini Bipimwa na FDA na EU 10/2011?
Uri hano: Murugo » Blog » Ni ibihe byemezo bisabwa kugira ngo Ibiribwa byo mu rwego rwo mu bwoko bwa Aluminiyumu byoherezwa mu bihugu by’Uburayi n’amasoko yo muri Amerika y'Amajyaruguru mu cyubahiro? Nibihe Bizamini Bipimwa na FDA na EU 10/2011?

Ni ibihe byemezo bisabwa kugira ngo ibiryo byo mu rwego rwo mu bwoko bwa Aluminiyumu byoherezwa mu bihugu by’Uburayi n’amasoko yo muri Amerika y'Amajyaruguru mu cyubahiro? Nibihe Bizamini Bipimwa na FDA na EU 10/2011?

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Intangiriro

Ibiciro by'ibiribwa bisize aluminiyumu bikoreshwa cyane mubipfunyika ibiryo, ibyokurya, ibikoresho, ibiryo n'ibikoni. Iyo byoherejwe mu bihugu by’Uburayi n’amasoko yo muri Amerika ya Ruguru, kubahiriza umutekano w’ibiribwa ni itegeko. Igipfundikizo nicyo kintu cyingenzi mugupima ibiryo, nubwo substrate ari aluminium. Abaguzi benshi nababikora bitiranya ibyangombwa byemeza nibizamini hagati ya FDA na (EU) No 10/2011. Iyi ngingo itondekanya ibyangombwa byubahirizwa byubumwe bw’ibihugu by’Uburayi na Amerika ya Ruguru, ikanasobanura neza ibizamini byuzuye munsi ya FDA 21 CFR na EU 10/2011 kuri aluminiyumu isize amabara.

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Impamyabumenyi Ziteganijwe & Inyandiko zubahiriza Isoko rya EU

Amabwiriza yibanze

Amabwiriza (EC) No 1935/2004: Amabwiriza ngenderwaho kubikoresho byose byo guhuza ibiryo hamwe ningingo zo muri EU, bikubiyemo ibara ryometse kuri aluminiyumu igizwe (aluminium substrate + coating organic). Irasaba gukurikiranwa, nta kurekura ibintu byangiza no kuyikora Itangazo ryubahiriza (DoC).

Amabwiriza (EU) No 10/2011: Igipimo nyamukuru cyibikoresho byo gutwikisha plastike hejuru yubutaka bwicyuma, kugenga monomers, inyongeramusaruro, pigment nimbibi zimuka ziterwa na organic.

Amabwiriza (EU) No 2023/2006: Uburyo bwiza bwo gukora (GMP) kubikoresho byo guhuza ibiryo.

Ibisabwa Bishyigikira

1.Itangazo ryubahirizwa (DoC): Kwiyitirira ubwabyo bitangwa nuwabikoze, gutondekanya ibikoresho, ibishushanyo mbonera, ibisubizo byikizamini cyimuka hamwe nuburyo bwo guhuza ibiryo. Ni itegeko mbere yo gushyira ibicuruzwa ku isoko rya EU.

2. Raporo y'ibizamini bya laboratoire ya gatatu ya EU 10/2011, uhereye muri laboratoire yemewe nka SGS, TÜV, Intertek.

3.Ibintu bifatika byerekana ko bisize: resin, pigment, imiti ikiza ninyongeramusaruro bigomba gushyirwa kurutonde rwibintu byiza byuburayi.

4.Byifuzo ariko bikunze gusabwa: Raporo yikizamini cya LFGB (Ubudage busabwa guhuza ibiryo byigihugu), EN ibipimo bya aluminium substrate (EN 601 / EN 602).

Impamyabumenyi Ziteganijwe & Inyandiko zubahiriza Isoko ryo muri Amerika y'Amajyaruguru (USA & Kanada)

Amerika FDA Ibisabwa

FDA ntabwo itanga ibicuruzwa 'ibyemezo '. Abatanga isoko batanga ibyangombwa bya FDA hiyongereyeho raporo y'ibizamini bya laboratoire yemewe kugirango berekane ibara ryuzuye aluminiyumu ryujuje Umutwe 21 CFR.

  • 21 CFR Igice cya 175.300: Ibiryo byongeweho ibiryo bitaziguye - ibishishwa bya resinous na polymeric (ingingo ikoreshwa cyane mubyiciro byibiribwa bitwikiriye aluminium).

  • Ingingo zijyanye: 21 CFR Igice cya 177 kubikoresho bya polymer, 21 CFR 178.3297 kubiryo-bihuza amabara.

Ibisabwa muri Kanada

Kanada Ubuzima Bwibiryo Byubuzima Ibikoresho byoherejwe: amabara asize aluminiyumu agomba kwerekana ibisubizo byikuramo kandi biremereye ugereranije nibipimo bya FDA. Raporo yikizamini cyibiryo byabandi basabwa nabatumiza hanze.

Impamyabumenyi Yinyongera Yamasoko Yombi

  • ISO 9001 Sisitemu yo gucunga neza

  • ISO 22000 / HACCP yo kugenzura umusaruro wibiribwa

  • RoHS (bidashoboka, akenshi bisabwa nabaguzi kugenzura ibyuma biremereye)

Ibintu Byuzuye Byibizamini bya EU (EU) No 10/2011 kubiribwa byo mu cyiciro cyibara ryuzuye Aluminium

1. Muri rusange Ikizamini cyo Kwimuka

Muri rusange ingamba zo kwimuka zifata ihererekanyabubasha ryibintu byose bidahindagurika biva mubitereko byibiribwa.

  • Abigana:

Simulant A: 10% Ethanol (ibiryo byo mu mazi, inzoga)

Simulant B: 3% acide acike (ibiryo bya acide nkumutobe wimbuto, isosi y'inyanya)

Simulant D2: Amavuta ya elayo (ibiryo binuze / amavuta)

  • Imipaka: ≤10 mg / dm² cyangwa 60 mg / kg

  • Ubushyuhe bwikizamini & igihe: byatoranijwe ukurikije imikoreshereze yabigenewe (ububiko bukonje, icyumba cyicyumba, guteka / guteka ubushyuhe bwo hejuru)

2. Ikizamini cyihariye cyo kwimuka (SML, Imipaka yihariye yo kwimuka)

Gerageza intego yagabanijwe hamwe ntarengwa ntarengwa:

  • Ibyuma biremereye: Isasu (Pb), Cadmium (Cd), Mercure (Hg), Chromium Hexavalent Cr (VI)

  • Bisphenol A (BPA) n'ibikomoka kuri Bisphenol

  • Formaldehyde

  • Phthalates (DEHP, DBP, BBP nibindi)

  • Abandi ba monomers ninyongera byanditswe muri EU 10/2011 Umugereka

3. Ibigize Ibikoresho & Kugenzura Ibikoresho

Reba niba coating resin, monomer, pigment, inyongera zashyizwe kurutonde rwiza rwa EU

Kugenzura / kubuzwa kugenzura ibintu: PFAS, inyongeramusaruro zimwe na zimwe

4. Kugenzura no Kugenzura

Impumuro, uburyohe, inenge yatwikiriye, gukuramo, gusibanganya ibara nyuma yo kwibizwa mu buryo bumwe.

Icyitonderwa: Umuryango w’ubumwe bw’ibihugu by’Uburayi 10/2011 wibasiye ibikoresho bya pulasitiki, ariko bireba ibice bya pulasitiki kama ya plastike kuri aluminiyumu, ibyo bikaba ari ibara ry’ibiribwa ryuzuye ibara rya aluminiyumu. Icyuma cya aluminiyumu gikurikira EC 1935/2004 hamwe n’inama y’Uburayi ikemura ibyuma.

FDA 21 CFR Ibintu Byipimisha Ibiribwa Byiciro Byibara Byuzuye Aluminium (Ahanini 21 CFR 175.300)

1. Ibikururwa / Ikizamini cyimuka munsi ya FDA Simulants

FDA ikoresha ibintu bitatu bisanzwe bivamo ubwoko bwibiryo bigenewe nubushyuhe bukoreshwa:

  • Amazi yamenetse (bigana ibiryo byamazi)

  • 8% Ethanol (ibiryo birimo inzoga)

  • n-Heptane (bigana ibiryo binuze, amavuta)

Ubushyuhe bwikizamini hamwe nigihe bimara bihuye nibisabwa nyabyo: kubika ubushyuhe bwicyumba, gukonjesha, kubika ubukonje, guteka ubushyuhe bwo hejuru / gushyushya.

Ibikururwa byose bidahindagurika bigomba kuba byujuje imipaka yasobanuwe muri 21 CFR 175.300.

2. Kugenzura Ibyuma Biremereye

Kurongora, kadmium nibindi byuma biremereye biva mubitereko munsi ya acide.

3. Kugenzura Impamyabushobozi Yibikoresho Kugenzura

  • Ibisigarira, imiti ikiza, pigment, inyongeramusaruro bigomba kuba byemewe na FDA byemewe

  • Pigment zubahiriza 21 CFR 178.3297

  • Kugenzura uburyo bwo gukiza ibintu: gukira kutuzuye bizatera gukuramo monomer birenze

4. Ibizamini byubufasha bwibikorwa (Umuguzi Akenshi Asaba)

Gufata neza, kurwanya ruswa, kwihanganira kubira, kurwanya ibishishwa (ntabwo ari itegeko rya FDA riteganijwe, ariko birakenewe cyane kubipakira no guteka).

Itandukaniro ryibanze hagati yuburayi 10/2011 na FDA 21 CFR kuri Aluminiyumu Yuzuye

  • Intego yibanze: EU 10/2011 ifite SML isobanutse kubintu amagana yibintu; FDA yibanze kubikuramo byose hiyongereyeho urutonde rwiza rwo kwemeza ibikoresho bibisi.

  • Ifishi yemewe: EU isaba DoC imenyekanisha + ikizamini cyimuka; FDA yishingikiriza kurutonde rwibikoresho no gukuramo ikizamini nta cyemezo cyemewe.

  • Sisitemu ya Simulant: EU ikoresha 10% Ethanol, 3% acide acike, amavuta ya elayo; FDA ikoresha amazi, 8% Ethanol na n-heptane.

  • Amategeko y'ibyuma biremereye: Umuryango w'ubumwe bw’ibihugu by’Uburayi ushyiraho imipaka ntarengwa yo kwimuka ku byuma biremereye; FDA igenzura ibyuma biremereye ikoresheje ibizamini bivanwa.

Impanuro zifatika zohereza hanze kubiribwa byo mu cyiciro cyibara ryuzuye Aluminium

  • Emeza amaherezo-gukoresha ibintu byambere: gupakira ubukonje gusa cyangwa guteka ubushyuhe bwo hejuru, kugirango uhitemo ubushyuhe bwikigereranyo hamwe na simulant. Ikizamini kitari cyo kizatesha agaciro raporo.

  • Icyitegererezo cyikigereranyo kigomba gukoresha formula imwe yo gutwikira, gutwikira ubunini hamwe no gukiza nkibikorwa byinshi.

  • Tegura dosiye yuzuye ya tekiniki: icyemezo cya alloy, coating material raw MSDS, raporo yikizamini, DoC (EU), inyandiko zerekana neza.

  • Kubicuruzwa bibiri-byoherejwe (EU + USA), kora ibizamini byombi EU10 / 2011 na FDA 21 CFR muri laboratoire imwe yemewe kugirango ugabanye igiciro nigihe cyo kuyobora.

Umwanzuro

Kohereza ibicuruzwa byo mu rwego rwibiribwa bisize aluminiyumu muri EU no muri Amerika ya ruguru bikenera uduce twihariye two kubahiriza. Umuryango w'ubumwe bw’ibihugu by’Uburayi urasaba EC1935 / 2004, EU10 / 2011 ibizamini byo kwimuka hamwe nuwabikoze DoC. Amerika y'Amajyaruguru (USA) ikurikira FDA 21 CFR Igice cya 175.300 ikizamini gishobora gukururwa no kwemeza ibikoresho fatizo. Gusobanukirwa n'ibizamini byuzuye bya EU10 / 2011 na FDA bifasha abayikora kwirinda ifungwa rya gasutamo, kwanga ibicuruzwa ndetse n’inshingano z’umutekano w’ibiribwa, kandi ishyigikira ubufatanye buhamye hamwe n’ibipfunyika ibiryo, ibikoresho byo mu gikoni hamwe n’abaguzi b’ibiribwa ku isi.

Twandikire

Mugisha inama kugirango tubone igisubizo cya Aluminium yihariye

Turagufasha kwirinda imitego yo gutanga ubuziranenge no guha agaciro aluminiyumu ukeneye, ku gihe no kuri bije.

Ibicuruzwa

Gusaba

Ihuza ryihuse

Dukurikire

Twandikire

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