Gusobanukirwa iyubahirizwa ry'amategeko agenga ibiribwa ku mifuka ifunze neza

Mu guhitamo ibipfunyika by'ibiribwa, ibipfunyika akenshi bibanda ku kuntu ibiribwa bipfunyika, kuramba, igihe bizamara, n'igiciro cyabyo. Ariko, ku bipfunyika n'abacuruzi b'ibiribwa mpuzamahanga, kimwe mu bintu by'ingenzi ni ukumenya niba ibipfunyika byubahiriza amabwiriza agenga ibiribwa ku isoko ry'ibicuruzwa.

Agafuka ko hasi gafite ibara rirambuye gakoreshwa cyane mu ikawa, utuntu two kurya, ibiryo by’amatungo, ibiryo byumye, imbuto z’intete, uruganda rw’ibiryo biryoshye, n’ibindi biryo kuko gatanga uburyo bwiza bwo kubika ibintu, ahantu hanini ho gucapa, kandi gafite imiterere myiza. Ariko, inyuma y’igishushanyo mbonera gikurura hari imiterere igoye cyane igomba kuzuza ibisabwa mu buryo bukomeye ku mutekano.

Agafuka ko hasi gafite ingano y’ibiribwa ntigasobanurwa gusa n’ibikoresho bikoreshwa mu gice cy’imbere. Imiterere yuzuye y’ibipfunyika, harimo firime icapa, urwego rw’inzitizi, kole, wino, n’urwego rufunga ubushyuhe, bigomba gusuzumwa kugira ngo harebwe ko ibice byose bikwiriye gukora ku biryo mu buryo butaziguye cyangwa butaziguye.

Ku bicuruzwa bicuruzwa bya PACKMIC ku isi yose, gusobanukirwa amabwiriza agenga FDA na EU yo gupakira ibiribwa ni ngombwa. Agafuka kubahiriza amabwiriza yo ku isoko rimwe gashobora kutagera ku bisabwa mu rindi soko mu buryo bwikora.

Ku bakiriya b'i Burayi, Itangazo ry'Iyubahirizwa ry'Amategeko (DoC) ni inyandiko y'ingenzi isabwa kugira ngo hemezwe kandi harebwe neza ibicuruzwa bipfunyitse mu biribwa. Ritanga amakuru asobanutse neza ku bijyanye no kumenya niba ibyo bipfunyitse bikurikiza amabwiriza agenga ibiribwa byo mu muryango w'Ubumwe bw'u Burayi ndetse niba bikwiriye gukoreshwa mu buryo buteganyijwe.

Itangazo ryuzuye ry’Ishyirahamwe ry’Ubumwe bw’u Burayi rikunze kuba rikubiyemo ibisobanuro birambuye nk’amabwiriza agenga ipaki, ibikoresho bikoreshwa mu miterere y’ipaki, ubwoko bw’ibiryo byagenewe, n’uburyo byitezwe bwo gukoreshwa, harimo ubushyuhe n’igihe bizamara. Rigomba kandi kwerekana ibisubizo by’ibizamini by’ubwimukira no kugaragaza ibintu bibujijwe cyangwa ibisabwa byihariye bigomba kwitabwaho.

Ni ngombwa kumva ko raporo y'ikizamini cyo kwimuka n'Itangazo ry'Iyubahirizwa ry'amategeko bigira intego zitandukanye. Raporo y'ikizamini cyo kwimuka itanga ibisubizo by'ikizamini hashingiwe ku ngero runaka, mu gihe DoC ari itangazo ryemewe ry'amategeko ritangwa hashingiwe ku isuzuma rusange ry'ibikoresho byo gupfunyika, inzira yo gukora, n'ibisabwa n'amategeko. Kubwibyo, raporo y'ikizamini cyo kwimuka yonyine ntishobora gusimbura Itangazo ryuzuye ry'Iyubahirizwa ry'amategeko.

Ku bakiriya b'i Burayi, Itangazo ry'Iyubahirizwa ry'Amategeko (DoC) ni inyandiko y'ingenzi isabwa kugira ngo hemezwe kandi harebwe neza ibicuruzwa bipfunyitse mu biribwa. Ritanga amakuru asobanutse neza ku bijyanye no kumenya niba ibyo bipfunyitse bikurikiza amabwiriza agenga ibiribwa byo mu muryango w'Ubumwe bw'u Burayi ndetse niba bikwiriye gukoreshwa mu buryo buteganyijwe.

Itangazo ryuzuye ry’Ishyirahamwe ry’Ubumwe bw’u Burayi rikunze kuba rikubiyemo ibisobanuro birambuye nk’amabwiriza agenga ipaki, ibikoresho bikoreshwa mu miterere y’ipaki, ubwoko bw’ibiryo byagenewe, n’uburyo byitezwe bwo gukoreshwa, harimo ubushyuhe n’igihe bizamara. Rigomba kandi kwerekana ibisubizo by’ibizamini by’ubwimukira no kugaragaza ibintu bibujijwe cyangwa ibisabwa byihariye bigomba kwitabwaho.

Ni ngombwa kumva ko raporo y'ikizamini cyo kwimuka n'Itangazo ry'Iyubahirizwa ry'amategeko bigira intego zitandukanye. Raporo y'ikizamini cyo kwimuka itanga ibisubizo by'ikizamini hashingiwe ku ngero runaka, mu gihe DoC ari itangazo ryemewe ry'amategeko ritangwa hashingiwe ku isuzuma rusange ry'ibikoresho byo gupfunyika, inzira yo gukora, n'ibisabwa n'amategeko. Kubwibyo, raporo y'ikizamini cyo kwimuka yonyine ntishobora gusimbura Itangazo ryuzuye ry'Iyubahirizwa ry'amategeko.

Urugero, amabwiriza agenga gupakira ibiryo muri Leta Zunze Ubumwe za Amerika agenzurwa cyane cyane n’Ikigo gishinzwe ibiribwa n’imiti muri Amerika (FDA) hakurikijwe Umutwe wa 21 w’amategeko agenga ubucuruzi bwa leta (21 CFR). Mu Burayi, ibikoresho byo guhuza ibiryo bigenzurwa cyane cyane binyuze mu Mabwiriza (EC) No. 1935/2004 n’Amabwiriza (EU) No. 10/2011.

Nk’uruganda rw’ibipfunyika rwabigize umwuga, PACKMIC ikorana n’ibirango by’ibiribwa ku isi yose kugira ngo itange udufuka tw’ibiryo dukozwe mu buryo bwihariye twujuje ibisabwa ku rwego mpuzamahanga, dushyigikiwe n’inyandiko zerekana ko ibiryo byujuje ibisabwa, ibyemezo by’ubuziranenge, n’uburyo umusaruro ukurikiranwa.

Ni iki gituma ibiryo bihinduka mu gakapu gafite ibara ry'umuhondo?

Ijambo "urwego rw'ibiribwa" rikunze gukoreshwa mu nganda zipakira, ariko abaguzi benshi ntibamenya icyo risobanura mu by'ukuri ukurikije ikoranabuhanga.

Ibikoresho byo gupfunyikamo ibiryo ntibiba bigikoreshwa burundu. Mu gihe cyo kubika, cyane cyane mu gihe hari ubushyuhe, ubushuhe, cyangwa igihe kirekire, ibintu bike biva mu bikoresho byo gupfunyikamo bishobora kwimukira mu biribwa.

Iyi nzira izwi nka "kwimuka".

Imiryango igenzura ibicuruzwa hirya no hino ku isi ishyiraho imipaka yo kugenzura ukwimuka kw'ibicuruzwa no kwemeza ko gupakira ibiryo bitagira ingaruka mbi ku mutekano w'ibiribwa, ubwiza bw'ibicuruzwa, uburyohe, cyangwa ubuzima bw'abaguzi.

Ku bijyanye no gupakira ibintu byoroshye, kwimuka bishobora guturuka mu bice bitandukanye by'inyubako, harimo:

Filimi yo hanze icapishijwe, itanga ikirango n'uburinzi bwa mekanike.

Urusobe rw'inkingo, nk'urupapuro rwa aluminiyumu cyangwa PET yakozwe mu byuma, rurinda ibintu bya ogisijeni, ubushuhe n'urumuri.

Urupapuro rw'ubukorikori, ruhuza ibikoresho bitandukanye hamwe mu gihe cyo gusimbuza.

Urupapuro rw'imbere rufunga, ubusanzwe PE cyangwa CPP, rukora ku gicuruzwa gipakiye.

Buri gikoresho cyakozwe hakurikijwe ibisabwa n'ibicuruzwa. Urugero, ikawa ikenera ogisijeni nyinshi n'impumuro nziza, mu gihe ibyo kurya bishobora kwibanda cyane ku kudahumeka no gukomera kwa mashini.

Ariko, kubahiriza amategeko ntibigenwa gusa n'ibikoresho byihariye.

Igikunze kutumvikana ni uko niba buri gapira gakoreshwa mu gakapu gakurikiza amategeko y’ibiryo, agakapu ka nyuma gakurikiza amategeko y’ibiryo. Mu by’ukuri, imiterere ya laminated igomba no gusuzumwa kuko kole, wino, n’imiterere y’uburyo bwo gutunganya ibintu bishobora kugira ingaruka ku mikorere ya nyuma yo gupakira.

Bityo rero, abakora umwuga wo gupakira bagomba kugenzura inzira yose kuva ku guhitamo ibikoresho fatizo kugeza ku gucapa, gusiga amavuta, gusiga amavuta, gukora imifuka, no kugenzura bwa nyuma.

Ibisabwa na FDA ku mifuka y'ibiribwa

Ku bicuruzwa bigurishwa muri Leta Zunze Ubumwe za Amerika, ibikoresho byo gupfunyikamo ibiryo bigenzurwa n’Ikigo gishinzwe Ibiribwa n’Imiti muri Amerika (FDA).

Amabwiriza y'ingenzi agenga uburyo bwo gupfunyika ibintu byoroshye ari mu Gice cya 21 CFR, cyane cyane Ibice bya 174 kugeza 177.

Aya mabwiriza agena ibintu bishobora gukoreshwa mu gukoresha ibiryo mu buryo bunyuranyije n'ibyo kurya n'igihe bigeze.

FDA 21 CFR Igice cya 174 gitanga ibisabwa rusange ku biryo biryo byifashishwa mu buryo butaziguye.

Igice cya 175 cya FDA 21 CFR kivuga ku mavuta n'udupira dushobora gukoreshwa mu gupfunyika ibiryo.

Igice cya 177 cya FDA 21 CFR kivuga kuri polimeri na pulasitiki bikunze gukoreshwa mu gupfunyika.

Ibikoresho byinshi byoroshye byo gupfunyika bikoreshwa mu mifuka irambuye yo hasi bigengwa n'amabwiriza ya polimeri mu Gice cya 177.

Urugero, polyethylene, ikoreshwa cyane nk'urwego rwo gufunga ubushyuhe bw'ibiryo, ikunze kuvugwa muri FDA 21 CFR 177.1520.

Ibikoresho bitandukanye bishobora kugira ubuvuzi butandukanye bwa FDA bitewe n'imiterere yabyo n'uburyo bikoreshwa.

Ku bigo bigura amapaki ku bacuruzi bo mu mahanga, ni ngombwa gusaba inyandiko zirambuye zerekana ko amategeko yubahirizwa aho kwemera gusa inyandiko zivuga ngo “Byemejwe na FDA.”

Mu nganda zikora ibipfunyika, FDA ntiyemera imifuka irangiye nk'uko abaguzi bashobora kubyumva. Ahubwo, amabwiriza ya FDA yemerera ibikoresho n'ibindi bintu byihariye gukoreshwa mu buryo bwihariye ku biribwa.

Umutanga serivisi w’inzobere agomba kuba ashoboye gutanga:

Ibisobanuro by'amategeko agenga FDA

Imbonerahamwe 21 za CFR zikurikizwa

Amakuru y'ingenzi

Uburyo bwo gukurikirana umusaruro

Gushyigikira raporo z'ibizamini byo kwimuka igihe bibaye ngombwa

Muri PACKMIC, dutegura inyandiko zijyanye na FDA hakurikijwe ibisabwa ku isoko ry'abakiriya n'uburyo ibicuruzwa bikoreshwa, bigafasha abakiriya mpuzamahanga koroshya inzira yo kwemeza ibyo bapakira.

Amabwiriza agenga uburyo bwo guhuza ibiribwa n'ibiryo by'i Burayi ku mifuka

Umuryango w’Ubumwe bw’u Burayi ufite bumwe mu buryo burambuye bwo kugenzura uburyo ibiryo bipfunyikwa ku isi.

Ku bijyanye no gupfunyika mu buryo bworoshye, amabwiriza abiri ni ingenzi cyane:

Itegeko Nshinga (EC) No. 1935/2004

Iri tegeko ritanga urwego rusange rw'ibikoresho byose byo guhuza ibiryo.

Bisaba ko ibikoresho byo gupfunyika:

Ntugakure ibintu bishobora gushyira ubuzima bw'abantu mu kaga.

Ntugatere impinduka zidakwiye ku miterere y'ibiryo.

Ntugire ingaruka mbi ku buryohe bw'ibiryo, impumuro yabyo, cyangwa uko bigaragara.

Iri tegeko ntirireba gusa ibipfunyika bya pulasitiki ahubwo rireba n'ibindi bikoresho bifatanye n'ibiribwa.

Amabwiriza (EU) No. 10/2011 – Amabwiriza agenga ibikoresho bya pulasitiki

Ku bijyanye no gupfunyika pulasitiki, Itegeko Nshinga (EU) No. 10/2011 ni ryo tegeko ry'ingenzi.

Ishyiraho ibisabwa kuri:

Ibintu byemewe bikoreshwa mu bikoresho bya pulasitiki.

Uburyo bwo gupima abimukira.

Ibikoresho bipima ibiryo.

Ubushyuhe n'igihe.

Imipaka yihariye yo kwimuka ku bintu bimwe na bimwe.

Iri tegeko rishyiraho umupaka rusange w’ibicuruzwa bishobora kuva mu bipaki bijya mu biribwa.

Umupaka ukunze kuvugwaho ni:

10 mg kuri desimetero kare imwe y'ubuso bw'ibiryo.

Mu mibare imwe n'imwe, ibi bingana na mg 60 kuri kilo y'ibiribwa.

Uretse kwimuka muri rusange, hari ibintu bimwe na bimwe bifite amategeko agenga kwimuka ku giti cyabyo azwi nka Specific Migration Limits (SML).

Kubwibyo, kubahiriza amategeko y’Umuryango w’Ubumwe bw’u Burayi bisaba ibirenze guhitamo firime ya pulasitiki irinda ibiryo gusa. Imiterere yose y’ibipfunyika igomba gusuzumwa hakurikijwe ikoreshwa ryabyo.

Impamvu Itangazo ry’Iyubahirizwa ry’Amategeko ari ingenzi mu gupakira ibiryo by’Umuryango w’Ubumwe bw’u Burayi

Ku bakiriya b'i Burayi, Itangazo ry'Iyubahirizwa ry'Amategeko (DoC) ni inyandiko y'ingenzi isabwa kugira ngo hemezwe kandi harebwe neza ibicuruzwa bipfunyitse mu biribwa. Ritanga amakuru asobanutse neza ku bijyanye no kumenya niba ibyo bipfunyitse bikurikiza amabwiriza agenga ibiribwa byo mu muryango w'Ubumwe bw'u Burayi ndetse niba bikwiriye gukoreshwa mu buryo buteganyijwe.

Itangazo ryuzuye ry’Ishyirahamwe ry’Ubumwe bw’u Burayi rikunze kuba rikubiyemo ibisobanuro birambuye nk’amabwiriza agenga ipaki, ibikoresho bikoreshwa mu miterere y’ipaki, ubwoko bw’ibiryo byagenewe, n’uburyo byitezwe bwo gukoreshwa, harimo ubushyuhe n’igihe bizamara. Rigomba kandi kwerekana ibisubizo by’ibizamini by’ubwimukira no kugaragaza ibintu bibujijwe cyangwa ibisabwa byihariye bigomba kwitabwaho.

Ni ngombwa kumva ko raporo y'ikizamini cyo kwimuka n'Itangazo ry'Iyubahirizwa ry'amategeko bigira intego zitandukanye. Raporo y'ikizamini cyo kwimuka itanga ibisubizo by'ikizamini hashingiwe ku ngero runaka, mu gihe DoC ari itangazo ryemewe ry'amategeko ritangwa hashingiwe ku isuzuma rusange ry'ibikoresho byo gupfunyika, inzira yo gukora, n'ibisabwa n'amategeko. Kubwibyo, raporo y'ikizamini cyo kwimuka yonyine ntishobora gusimbura Itangazo ryuzuye ry'Iyubahirizwa ry'amategeko.

Raporo y'ikizamini itanga ibisubizo bya laboratwari, mu gihe DoC ari itangazo ryemewe rihuza ibicuruzwa bipfunyitse n'amabwiriza arigenga.

Muri PACKMIC, dutanga impapuro zijyanye no gupfunyika ibiryo hashingiwe ku byo abakiriya bakeneye, harimo Itangazo ry’Ubumwe bw’u Burayi ry’Iyubahirizwa ry’Amategeko, inyandiko zijyanye no kubahiriza amategeko ya FDA, raporo z’ibizamini byo kwimuka, n’inyandiko zigaragaza uko umusaruro uboneka.