Imiti yica udukoko igira uruhare runini mu gukumira no kurwanya indwara z’ubuhinzi n’amashyamba, kuzamura umusaruro w’ingano no kuzamura ubwiza bw’ingano, ariko gukoresha imiti yica udukoko byanze bikunze bizana ingaruka mbi ku bwiza n’umutekano w’ibicuruzwa by’ubuhinzi, ubuzima bw’abantu n’umutekano w’ibidukikije.Amategeko mpuzamahanga agenga imicungire y’imiti yica udukoko, yatanzwe ku bufatanye n’umuryango w’ibiribwa n’ubuhinzi w’umuryango w’abibumbye n’umuryango w’ubuzima ku isi, arasaba inzego z’igihugu zishinzwe kurwanya udukoko gushyiraho uburyo bwo kongera kwiyandikisha kugira ngo zisuzume buri gihe kandi zisuzume ibicuruzwa byica udukoko twanduye.Menya neza ko ingaruka nshya zagaragaye mugihe gikwiye kandi hafatwa ingamba zifatika zo kugenzura.
Kugeza ubu, Umuryango w’ubumwe bw’ibihugu by’Uburayi, Amerika, Kanada, Mexico, Ositaraliya, Ubuyapani, Koreya yepfo na Tayilande byashyizeho uburyo bwo gukurikirana ibyago nyuma yo kwiyandikisha no kongera gusuzuma isuzuma hakurikijwe imiterere yabo.
Kuva ishyirwa mu bikorwa rya gahunda yo kwandikisha imiti yica udukoko mu 1982, ibisabwa mu makuru yo kwandikisha imiti yica udukoko byakorewe ubugororangingo butatu, kandi ibisabwa bya tekiniki n’ibipimo ngenderwaho mu isuzuma ry’umutekano byatejwe imbere ku buryo bugaragara, kandi ibicuruzwa by’imiti yica udukoko byanditswe mbere ntibishobora kuba byujuje byuzuye ibisabwa byo gusuzuma umutekano muri iki gihe.Mu myaka yashize, binyuze mu guhuza umutungo, gutera inkunga imishinga n’izindi ngamba, Minisiteri y’ubuhinzi n’ibikorwa by’icyaro yakomeje kongera imicungire y’umutekano yo kwandikisha imiti yica udukoko, kandi ikurikirana kandi isuzuma amoko menshi y’udukoko twangiza kandi twangiza cyane.Kurugero, kubibazo byangiza ibiyobyabwenge bya metsulfuron-methyl, ingaruka z’ibidukikije bya flubendiamide hamwe n’ubuzima bw’abantu bwa paraquat, tangira ubushakashatsi bwihariye, kandi utangire ingamba zibujijwe mu gihe gikwiye;Ibindi byiciro bya phorate, isofenphos-methyl, isocarbophos, ethoprophos, omethoate, karbofuran mu 2022 na 2023 Imiti umunani yica udukoko twangiza cyane nka methomyl na aldicarb, yagabanije umubare w’imiti yica udukoko twangiza cyane kugeza munsi ya 1% yumubare wica udukoko twanduye. , kugabanya neza ingaruka z'umutekano zo gukoresha imiti yica udukoko.
Nubwo Ubushinwa bwateje imbere buhoro buhoro no gusuzuma ubushakashatsi ku ikoreshwa ry’imiti n’udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko twangiza udukoko, inshingano ntisobanutse, kandi haracyari icyuho kinini ugereranije nibihugu byateye imbere.Kubwibyo rero, kwigira ku cyitegererezo gikuze n'ubunararibonye by’Umuryango w’ubumwe bw’ibihugu by’Uburayi na Amerika, ugasobanura neza uburyo bwo gushyira mu bikorwa n’ibisabwa kugira ngo hongere kwandikwa imiti yica udukoko mu Bushinwa, no kubaka uburyo bushya bwo gucunga imiti yica udukoko duhuza isuzuma ry’iyandikisha, kongera gusuzuma no gukomeza kwiyandikisha ni an ibikubiye mu micungire yingenzi kugirango harebwe byimazeyo umutekano wokoresha imiti yica udukoko niterambere rirambye ryinganda.
1 Ongera usuzume icyiciro cyumushinga
1.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
1.1.1 gusubiramo gahunda yubwoko bwa kera
Mu 1993, Komisiyo y’Uburayi (yitwa “Komisiyo y’Uburayi”) hashingiwe ku biteganywa n’Amabwiriza 91/414, ibikoresho bigera ku 1.000 byica udukoko twangiza udukoko twandikiwe gukoreshwa ku isoko mbere ya Nyakanga 1993 byasuzumwe mu byiciro bine.Muri Werurwe 2009, isuzuma ryarangiye ahanini, kandi ibikoresho bigera kuri 250, cyangwa 26%, byongeye kwiyandikisha kubera ko byujuje ubuziranenge bw’umutekano;67% by'ibikoresho bikora byavuye ku isoko kubera amakuru atuzuye, nta gusaba imishinga cyangwa gukuramo ibikorwa.Ibindi 70 cyangwa 7% byibikoresho byakuweho kubera ko bitujuje ibisabwa mu isuzuma rishya ry’umutekano.
1.1.2 gusubiramo ibyemezo
Ingingo ya 21 y’itegeko rishya ryo kurwanya imiti yica udukoko 1107/2009 iteganya ko Komisiyo y’Uburayi ishobora igihe icyo ari cyo cyose gutangira kongera gusuzuma ibiyigize byanditse, ni ukuvuga kongera gusuzuma.Gusaba kongera gusuzumwa n’ibihugu bigize uyu muryango hashingiwe ku bushakashatsi bushya bwa siyansi na tekiniki hamwe n’amakuru yo gukurikirana bigomba kwitabwaho na Komisiyo yo gutangiza isuzuma ryihariye.Niba Komisiyo ibona ko ikintu gikora kitagishoboye kuzuza ibisabwa kugira ngo yiyandikishe, bizamenyesha ibihugu bigize uyu muryango, ikigo cy’ibihugu by’Uburayi gishinzwe umutekano w’ibiribwa (EFSA) n’isosiyete ikora inganda kandi bigashyiraho igihe ntarengwa kugira ngo isosiyete itange itangazo.Komisiyo irashobora gusaba inama cyangwa ubufasha bwa siyansi na tekiniki mu bihugu bigize Umuryango na EFSA mu gihe cy'amezi atatu uhereye igihe baboneye inama cyangwa ubufasha bwa tekiniki, kandi EFSA igatanga ibitekerezo cyangwa ibyavuye mu mirimo yayo mu gihe cy'amezi atatu uhereye kuri itariki yakiriyeho icyifuzo.Niba hemejwe ko ikintu gikora kitagishoboye kubahiriza ibyangombwa byo kwiyandikisha cyangwa ko andi makuru yasabwe atatanzwe, Komisiyo izatanga icyemezo cyo gukuraho cyangwa guhindura iyandikwa ry’ibikoresho bikora hakurikijwe amategeko abigenga.
1.1.3 kuvugurura kwiyandikisha
Gukomeza kwandikisha ibicuruzwa byica udukoko mu bihugu by’Uburayi bihwanye no gusuzuma buri gihe mu Bushinwa.Mu 1991, Umuryango w’ubumwe bw’ibihugu by’Uburayi washyize ahagaragara amabwiriza ya 91/414 / EEC, ateganya ko igihe cyo kwiyandikisha cy’ibiti byica udukoko twangiza udukoko kidashobora kurenza imyaka 10, kandi kigomba kongera gusaba kwiyandikisha igihe kirangiye, kandi gishobora kongerwa nyuma yujuje ubuziranenge bwo kwiyandikisha. .Mu 2009, Umuryango w’ubumwe bw’ibihugu by’i Burayi washyizeho itegeko rishya rigenga imiti yica udukoko 1107/2009, risimbuza 91/414 / EEC.Itegeko 1107/2009 riteganya ko ibiyigize n’imyiteguro y’imiti yica udukoko bigomba gusaba kwiyandikisha nyuma yo kurangira, kandi igihe ntarengwa cyo kwagura iyandikwa ry’ibikorwa gikomoka ku bwoko bwacyo no ku bisubizo: igihe cyo kwagura ibintu byangiza imiti yica udukoko. muri rusange ntabwo irenze imyaka 15;Igihe cy'umukandida uzasimburwa ntikirenza imyaka 7;Ibikoresho bifatika bikenewe mu kurwanya udukoko twangiza n’indwara zidahuye n’ibipimo byandikwa muri iki gihe, nka kanseri yo mu cyiciro cya 1A cyangwa 1B, uburozi bw’imyororokere yo mu cyiciro cya 1A cyangwa 1B, ibintu bifatika bifite imitunganyirize ya endocrine bishobora gutera ingaruka mbi ku bantu n'ibinyabuzima bidafite intego, ntibishobora kongerwa imyaka irenze 5.
1.2 Amerika
1.2.1 kwandikisha ubwoko bwa kera
Mu 1988, itegeko ry’udukoko twica udukoko, Fungicide, na Rodenticide (FIFRA) ryarahinduwe kugira ngo risubire gusuzuma ibiyigize mu miti yica udukoko twanditswe mbere y’itariki ya 1 Ugushyingo 1984. Kugira ngo hubahirizwe ubumenyi bwa siyansi ndetse n’ibipimo ngenderwaho.Muri Nzeri 2008, Ikigo cyo muri Amerika gishinzwe kurengera ibidukikije (EPA) cyarangije gusuzuma ibizamini 1150 bikora (bigabanijwe ku ngingo 613) binyuze muri gahunda ya Old Variety Re-kwiyandikisha, muri byo hakaba haremejwe ingingo 384, cyangwa 63%.Hariho ingingo 229 zijyanye no kwiyandikisha, bingana na 37%.
1.2.2
Muri FIFRA hamwe n’amategeko ngengamikorere ya Leta (CFR), hashobora gutangizwa isuzuma ryihariye mugihe ibimenyetso byerekana ko imiti yica udukoko yujuje kimwe muri ibi bikurikira:
1) Irashobora gukomeretsa bikabije abantu cyangwa amatungo.
2) Irashobora kuba kanseri, teratogenic, genotoxique, uburozi bwinda, uburozi bwimyororokere cyangwa uburozi bwatinze kubantu.
3) Urwego rusigaye mu binyabuzima bidafite intego mu bidukikije birashobora kuba bingana cyangwa birenze urugero rw’ingaruka z’ubumara bukabije cyangwa karande, cyangwa birashobora kugira ingaruka mbi ku myororokere y’ibinyabuzima bitagamije.
4) irashobora guteza ibyago gukomeza kubaho kw'ibinyabuzima bigenda byangirika cyangwa byugarijwe nk'uko byagenwe n'amategeko agenga ibinyabuzima.
5) Birashobora kuvamo gusenya ahantu h'ingenzi h’ibinyabuzima bigenda byangirika cyangwa byugarijwe cyangwa izindi mpinduka mbi.
6) Hashobora kubaho ingaruka ku bantu cyangwa ku bidukikije, kandi ni ngombwa kumenya niba inyungu zo gukoresha imiti yica udukoko zishobora gukuraho ingaruka mbi z’imibereho, ubukungu n’ibidukikije.
Isubiramo ryihariye risanzwe ririmo gusuzuma byimbitse ingaruka imwe cyangwa nyinshi zishobora kubaho, intego nyamukuru yo kugabanya ibyago byica udukoko twifashishije gusuzuma amakuru ariho, kubona amakuru mashya no / cyangwa gukora ibizamini bishya, gusuzuma ingaruka zagaragaye no kumenya ingaruka zikwiye. ingamba zo kugabanya.Nyuma yo gusubiramo bidasanzwe birangiye, EPA irashobora gutangiza ibikorwa byemewe byo gukuraho, guhakana, gutandukanya, cyangwa guhindura iyandikwa ryibicuruzwa bireba.Kuva mu myaka ya za 70, EPA yakoze isuzuma ryihariye ry’imiti yica udukoko irenga 100 kandi irangiza ibyinshi muri byo.Kugeza ubu, hategerejwe gusubiramo ibintu byinshi bidasanzwe: aldicarb, atrazine, propazine, simazine, na Ethyleneoxide.
1.2.3 gusubiramo kwiyandikisha
Urebye ko gahunda ishaje yo kwiyandikisha itandukanye yarangiye kandi isubiramo ridasanzwe ryatwaye imyaka myinshi, EPA yahisemo gutangiza iryo vugurura nka gahunda izasimbura iyandikwa ryubwoko butandukanye ndetse no kwisubiramo bidasanzwe.isuzuma ryubu rya EPA rihwanye nisuzuma ryigihe cyose mubushinwa, kandi ishingiro ryaryo ni itegeko ryo kurengera ubuziranenge bwibiribwa (FQPA), ryasabye ko hasuzumwa buri gihe imiti yica udukoko ku nshuro ya mbere mu 1996, ikanahindura FIFRA.EPA isabwa buri gihe gusuzuma buri muti wica udukoko wanditse byibuze rimwe mumyaka 15 kugirango harebwe ko buri muti wica udukoko wanditswemo ukomeza kubahiriza ibipimo biriho mugihe urwego rwo gusuzuma ingaruka rugenda rwiyongera kandi politiki igahinduka.
Mu 2007, FIFRA yatanze ubugororangingo kugira ngo itangire ku mugaragaro isubirwamo, isaba EPA kurangiza isuzuma ry’imiti yica udukoko 726 yanditswe mbere y’itariki ya 1 Ukwakira 2007, kugeza ku ya 31 Ukwakira 2022. Mu rwego rwo gufata icyemezo cyo gusuzuma, EPA igomba no kubahiriza inshingano zayo mu Ibinyabuzima bigenda byangirika bigamije gufata ingamba zo kugabanya ingaruka ziterwa n’ibinyabuzima bigenda byangirika.Ariko, kubera icyorezo cya COVID-19, gutinda gutanga amakuru kubasabye hamwe no gusuzuma bigoye, imirimo ntiyarangiye ku gihe.Mu 2023, EPA yasohoye gahunda nshya y’imyaka 3 yo kongera gusuzuma, izavugurura igihe ntarengwa cyo kuvugurura imiti yica udukoko 726 yanditswe mbere y’itariki ya 1 Ukwakira 2007, n’imiti yica udukoko 63 yanditswe nyuma yiyo tariki kugeza ku ya 1 Ukwakira 2026. Ni ngombwa kumenya ko, hatitawe ku kuba umuti wica udukoko wongeye gusubirwamo, EPA izafata ingamba zikwiye zo kugenzura igihe igennye ko imiti yica udukoko itera ingaruka zihutirwa ku bantu cyangwa ku bidukikije bisaba ko byihutirwa kwitabwaho.
2 Inzira zijyanye
Nkuko Umuryango w’ubumwe bw’ibihugu by’Uburayi wasuzumye ibintu bitandukanye, Leta zunze ubumwe z’Amerika zongeye kwiyandikisha ndetse n’imishinga idasanzwe yo kuvugurura ibintu byarangiye, kuri ubu, Umuryango w’ubumwe bw’ibihugu by’Uburayi binyuze mu kwagura abiyandikisha, Amerika ahanini binyuze mu mushinga wo kongera gusuzuma kugira ngo hakorwe isuzuma ry’umutekano ryanditswe. imiti yica udukoko, ihwanye cyane nisuzuma ryigihe mubushinwa.
2.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
Gukomeza kwiyandikisha muri EU bigabanyijemo intambwe ebyiri, icya mbere ni ugukomeza kwandikisha ibintu bifatika.Ibikoresho bikora birashobora kuvugururwa niba byemejwe ko umwe cyangwa benshi bahagarariye gukoresha ibikoresho bikora kandi byibuze igicuruzwa kimwe cyo gutegura kirimo ibintu bifatika byujuje ibyangombwa byo kwiyandikisha.Komisiyo irashobora guhuza ibintu bisa n’ibikorwa kandi igashyiraho ibyihutirwa na gahunda z’akazi hashingiwe ku ngaruka zabyo ku buzima bw’abantu n’inyamaswa ndetse n’umutekano w’ibidukikije, hitawe ku bishoboka, hagomba kubaho uburyo bunoze bwo kugenzura no kurwanya intego.Porogaramu igomba kuba ikubiyemo ibi bikurikira: inzira zo gutanga no gusuzuma ibyifuzo byo kuvugurura kwiyandikisha;Amakuru agomba gutangwa, harimo ingamba zo kugabanya ibizamini byinyamaswa, nko gukoresha ingamba zo gupima ubwenge nko muri vitro yerekana;Igihe ntarengwa cyo gutanga amakuru;Amategeko mashya yo gutanga amakuru;Isuzuma n'ibihe byo gufata ibyemezo;Kugenera isuzuma ryibikoresho bikora mubihugu bigize uyu muryango.
2.1.1
Ibikoresho bifatika byinjira mugihe gikurikira cyo kuvugurura imyaka 3 mbere yuko igihe cy’icyemezo cyo kwiyandikisha kirangira, kandi abifuza gusaba kongererwa kwiyandikisha (baba babisabye mugihe cyemewe bwa mbere cyangwa abandi babisabye) bagomba gutanga ibyifuzo byabo imyaka 3 mbere yuko icyemezo cyo kwiyandikisha kirangira.Isuzuma ryamakuru yerekeranye no gukomeza kwiyandikisha ryibigize bikorwa bikorwa ku bufatanye n’igihugu cy’abanyamuryango ba raporo (RMS) hamwe n’ibihugu bigize umuryango w’ubufatanye (Co-RMS), EFSA n’ibindi bihugu bigize Umuryango.Ukurikije ibipimo byashyizweho n’amabwiriza abigenga, umurongo ngenderwaho n’amabwiriza, buri gihugu cy’abanyamuryango kigena ibihugu bigize Umuryango bifite ubushobozi n’ubushobozi bukenewe (abakozi, kuzuza akazi, nibindi) nkigihugu kiyobora.Bitewe nimpamvu zinyuranye, Leta iyobora hamwe n’igihugu kiyobora hamwe n’ibindi bihugu bishobora kongera gutandukana na Leta yanditswemo bwa mbere.Ku ya 27 Werurwe 2021, Amabwiriza 2020/1740 ya Komisiyo y’Uburayi yatangiye gukurikizwa, agaragaza ibibazo byihariye byo kuvugurura iyandikwa ry’ibikoresho byangiza imiti yica udukoko, bikoreshwa ku bintu bifatika igihe cyo kwiyandikisha kiri ku ya 27 Werurwe 2024. Kugira ngo gikore ibirungo birangira mbere yitariki ya 27 Werurwe 2024, Amabwiriza 844/2012 azakomeza gukurikizwa.Inzira yihariye yo kuvugurura kwiyandikisha muri EU nuburyo bukurikira.
2.1.1.1 Mbere yo gusaba Kumenyesha no gutanga ibitekerezo
Mbere yo gusaba kongererwa igihe cyo kwiyandikisha, uruganda ruzabanza gushyikiriza EFSA imenyesha ry’imanza ziburanisha ruteganya gukora mu rwego rwo gushyigikira iyandikwa ry’iyandikisha, kugira ngo EFSA ibashe gutanga inama zuzuye kandi ikore inama rusange. menya neza ko ibigeragezo bireba bikorwa mu gihe gikwiye kandi cyumvikana.Abashoramari barashobora gusaba inama muri EFSA igihe icyo aricyo cyose mbere yo kuvugurura ibyifuzo byabo.EFSA iramenyesha Leta iyobora hamwe na / cyangwa Leta ifatanya kuyobora imenyekanisha ryatanzwe n’ikigo kandi igatanga icyifuzo rusange gishingiye ku gusuzuma amakuru yose ajyanye n’ibikoresho bikora, harimo amakuru yo kwiyandikisha mbere cyangwa gukomeza amakuru yo kwiyandikisha.Niba abasaba benshi icyarimwe bashakira inama kubijyanye no kuvugurura kwiyandikisha kubintu bimwe, EFSA ibagira inama yo gutanga icyifuzo cyo kuvugurura hamwe.
2.1.1.2 Gutanga ibyifuzo no kwemerwa
Usaba agomba gusaba kongererwa igihe cya elegitoroniki mu gihe kitarenze imyaka 3 mbere yuko irangira ry’ibikorwa byinjira binyuze muri sisitemu nkuru yo gutanga ibyashyizweho n’Umuryango w’ubumwe bw’ibihugu by’Uburayi, aho Leta iyobora, ibihugu bifatanya kuyobora, ibindi bihugu bigize Umuryango, EFSA na Komisiyo irashobora kumenyeshwa.Igihugu kiyobora kiramenyesha uwasabye, Leta ifatanije na Leta, Komisiyo na EFSA, mu gihe cy'ukwezi kumwe uhereye igihe yatangiriye gusaba, umunsi yakiriyeho kandi ko yemeye gusaba kongererwa igihe.Niba ikintu kimwe cyangwa byinshi bibuze mubikoresho byatanzwe, cyane cyane iyo amakuru yuzuye yikizamini atatanzwe nkuko bisabwa, igihugu kiyobora kimenyesha uwasabye ibintu byabuze mugihe cyukwezi kumwe uhereye igihe yakiriye ibisabwa, kandi bigasaba gusimburwa mugihe cyiminsi 14, niba ibikoresho byabuze bitatanzwe cyangwa ntampamvu zifatika zitangwa birangiye, gusaba kongererwa ntibizemerwa.Igihugu kiyobora kimenyesha bidatinze uwasabye, Leta ifatanije na Perezida, Komisiyo, ibindi bihugu bigize Umuryango na EFSA ku cyemezo n'impamvu zitemerwa.Mbere yigihe ntarengwa cyo gukomeza gusaba, Igihugu gihuriweho n’igihugu kizemeranya ku bikorwa byose byo gusuzuma no gutanga akazi.
2.1.1.3 Gusubiramo amakuru
Niba gusaba gukomeza byakiriwe, Leta iyobora izasuzuma amakuru yingenzi kandi ishake ibitekerezo rusange.EFSA igomba, mugihe cyiminsi 60 uhereye umunsi yatangarijweho gusaba gukomeza, kwemerera abaturage gutanga ibitekerezo byanditse kumakuru yo gusaba gukomeza kandi hariho andi makuru cyangwa ubushakashatsi bufite akamaro.Leta iyobora hamwe na Leta ifatanya kuyobora noneho ikora isuzuma ryigenga, rifite intego kandi rinyuze mu mucyo niba ibiyigize bikora byujuje ibyangombwa bisabwa kugira ngo umuntu yiyandikishe, ashingiye ku bushakashatsi bwakozwe na siyansi hamwe n’inyandiko zikoreshwa mu kuyobora, asuzuma amakuru yose yakiriwe ku cyifuzo cyo kuvugurura, mbere yatanze amakuru yo kwiyandikisha hamwe nimyanzuro yisuzuma (harimo umushinga wabanje gusuzuma) nibitekerezo byanditse byakiriwe mugihe cyinama rusange.Amakuru yatanzwe nabasabye ibirenze icyifuzo, cyangwa nyuma yigihe ntarengwa cyo gutanga, ntabwo azasuzumwa.Igihugu kiyobora gishyikiriza Komisiyo na EFSA umushinga wa raporo y’isuzuma rishya (dRAR) mu gihe cy’amezi 13 uhereye igihe wasabye kongererwa igihe.Muri iki gihe, Leta iyobora irashobora gusaba amakuru yinyongera kubasabye kandi igashyiraho igihe ntarengwa cy’amakuru y’inyongera, irashobora kandi kugisha inama EFSA cyangwa igasaba andi makuru y’ubumenyi n’ubuhanga mu bindi bihugu bigize Umuryango, ariko ntishobora gutuma igihe cy’isuzuma kirenga byagenwe amezi 13.Umushinga wo gusuzuma iyagurwa rya raporo yo kwandikisha ugomba kuba ukubiyemo ibintu byihariye bikurikira:
1) Ibyifuzo byo gukomeza kwiyandikisha, harimo ibisabwa byose nibisabwa.
2) Ibyifuzo byuko niba ingirakamaro ikora igomba gufatwa nkibintu “bishobora kuba bike”.
3) Ibyifuzo byerekana niba ingirakamaro zigomba gufatwa nkumukandida uzasimburwa.
4) Ibyifuzo byo gushiraho imipaka ntarengwa isigaye (MRL), cyangwa impamvu zo kutagira uruhare muri MRL.
5) Ibyifuzo byo gutondekanya, kwemeza cyangwa gutandukanya ibintu bifatika.
6) Kugena ibigeragezo mumibare yo gukomeza kwiyandikisha bifitanye isano nisuzuma.
7) Ibyifuzo ku bice bigize raporo bigomba kugishwa inama ninzobere.
8) Iyo bibaye ngombwa, Leta ihuriweho n’ibihugu ntibemeranya n’ingingo z’isuzuma ry’igihugu kiyobora, cyangwa ingingo zumvikanyweho hagati y’ibihugu bigize uyu muryango bigize akanama gihuriweho n’ibihugu biyobora.
9) Ibyavuye mu nama nyunguranabitekerezo nuburyo bizitabwaho.
Igihugu kiyobora kigomba kuvugana bidatinze n’inzego zishinzwe kugenzura imiti kandi, vuba aha, kigashyikiriza icyifuzo ikigo cy’ibihugu by’Uburayi gishinzwe imiti (ECHA) mu gihe cyo gutanga umushinga wa raporo y’isuzuma ry’ibikomeza kugira ngo byibuze byashyirwe mu byiciro by’ubumwe bw’ibihugu by’Uburayi, Kwandika no gupakira amabwiriza kubintu hamwe nuruvange.Ibikoresho bikora ni ibintu biturika, uburozi bukabije, kwangirika kwuruhu / kurakara, gukomeretsa bikabije amaso / kurakara, guhumeka cyangwa uruhu, allergie selile selile, kanseri yica imyororokere, uburozi bwimyororokere, ubumara bwihariye bwibihimba biterwa no guhura rimwe na rimwe, hamwe no gushyira mubyiciro bimwe. ku bidukikije byo mu mazi.Leta iburanisha igomba kwerekana bihagije impamvu zituma ibigize ingirakamaro bitujuje ibyiciro byashyizwe mu cyiciro kimwe cyangwa byinshi mu byiciro by’akaga, kandi ECHA irashobora gutanga ibisobanuro ku bitekerezo by’igihugu kiburanisha.
2.1.1.4 Ibitekerezo kumushinga wa raporo yo gukomeza gusuzuma
EFSA izasuzuma niba umushinga wa raporo yo gukomeza isuzuma ukomeza ikubiyemo amakuru yose ajyanye no kuyigeza ku babisabye ndetse no mu bindi bihugu bigize Umuryango bitarenze amezi 3 nyuma yo kubona raporo.Akimara kubona umushinga wa raporo yo gusuzuma ibizakomeza, usaba arashobora, mu byumweru bibiri, gusaba EFSA kubika amakuru amwe mu ibanga, kandi EFSA ikazashyira ahagaragara umushinga wa raporo y’isuzuma ry’ibikomeza, usibye amakuru y’ibanga yemewe, hamwe n’ibivugururwa; gukomeza gusaba amakuru.EFSA izemerera abaturage gutanga ibitekerezo byanditse mugihe cyiminsi 60 uhereye umunsi byatangarijweho umushinga wa raporo ikomeza isuzumwa no kubohereza, hamwe nibitekerezo byabo bwite, kubihugu biyobora, Igihugu gihuriweho hamwe cyangwa itsinda ry’ibihugu bigize uyu muryango. gufatanya kuyobora.
2.1.1.5 Urungano rusubiramo no gutanga ibyemezo
EFSA itegura impuguke (impuguke z’igihugu kiyobora n’impuguke z’ibindi bihugu bigize uyu muryango) kugira ngo zisuzume urungano, zungurane ibitekerezo ku isuzuma ry’igihugu kiyobora ndetse n’ibindi bibazo by’ingenzi, rishyireho imyanzuro ibanza n’inama nyunguranabitekerezo, hanyuma rishyikirize imyanzuro n’ibyemezo kuri Komisiyo y’Uburayi ishinzwe kwemeza no kurekurwa.Niba, kubwimpamvu zidashobora kugenzurwa nuwabisabye, isuzuma ryibintu bikora bitarangiye mbere yitariki yo kurangiriraho, Umuryango w’ubumwe bw’ibihugu by’Uburayi uzatanga icyemezo cyo kongera agaciro k’ibikorwa by’ibikorwa kugira ngo ivugurura ry’iyandikisha rirangire neza. .
2.1.2 Imyiteguro
Ufite icyemezo cyabigenewe agomba kwiyandikisha, mu gihe cy'amezi 3 uhereye igihe cyo kuvugurura iyandikwa ry'ibikoresho bikora, ashyikiriza icyifuzo cyo kuvugurura iyandikwa ry'ibicuruzwa bikomoka ku miti mu bihugu bigize Umuryango wabonye iyandikwa ry'ibicuruzwa bikoreshwa mu bya farumasi; .Niba ufite kwiyandikisha asabye kongererwa iyandikwa ry’ibicuruzwa bimwe bikoreshwa mu bya farumasi mu turere dutandukanye, amakuru yose abisaba agomba kumenyeshwa ibihugu byose bigize Umuryango kugira ngo byoroherezwe guhana amakuru hagati y’ibihugu bigize Umuryango.Mu rwego rwo kwirinda ibizamini byigana, usaba agomba, mbere yo gukora ibizamini cyangwa ibizamini, gusuzuma niba ibindi bigo byabonye iyandikwa ry’ibicuruzwa bimwe, kandi bigafata ingamba zose zifatika mu buryo buboneye kandi buboneye kugira ngo bagere ku masezerano yo kugabana ibizamini na raporo y'ibizamini. .
Mu rwego rwo gushyiraho uburyo bunoze kandi bunoze bwo gukora, Umuryango w’ubumwe bw’ibihugu by’Uburayi ushyira mu bikorwa gahunda yo kwiyandikisha mu karere mu myiteguro, igabanijwemo uturere dutatu: Amajyaruguru, Hagati n’Amajyepfo.komite nyobozi ya zone (zonal SC) cyangwa ibihugu bihagarariye ibihugu byayo bizasaba abafite ibyemezo byose byo kwandikisha ibicuruzwa niba basaba kongererwa igihe cyo kwiyandikisha kandi mukarere ki, Igena kandi ibihugu bigize raporo y’akarere (RMS zonal).Kugira ngo hategurwe mbere, Leta iyobora akarere igomba gushyirwaho neza mbere yo gutanga icyifuzo cyo gukomeza ibicuruzwa by’ibiyobyabwenge, muri rusange bikaba bisabwa gukorwa mbere yuko EFSA itangaza imyanzuro y’isuzuma ry’ibigize.Ni inshingano za Leta iyobora akarere kwemeza umubare wabasabye batanze ibyifuzo byo kuvugurura, kumenyesha abasabye iki cyemezo no kurangiza isuzuma mu izina ry’ibindi bihugu byo mu karere (isuzuma rikomeza ku gukoresha imiti imwe n'imwe ibicuruzwa rimwe na rimwe bikorwa nigihugu cyabanyamuryango badakoresheje sisitemu yo kwiyandikisha muri zone).Igihugu gikora isuzuma ryibikoresho birasabwa kurangiza kugereranya amakuru yimikorere ikomeza hamwe namakuru yo gukomeza ibiyobyabwenge.Igihugu kiyobora akarere kizasoza isuzuma ryamakuru akomeje kwitegura bitarenze amezi 6 ikohereza mubihugu bigize uyu muryango n’abasaba ibisobanuro.Buri gihugu cy’abanyamuryango kizarangiza kwemeza ibicuruzwa byabigenewe mu gihe cy’amezi atatu.Igikorwa cyose cyo kuvugurura ibyateganijwe kigomba kurangira mugihe cyamezi 12 uhereye igihe ibikorwa byo kwiyandikisha bibaye ngombwa.
2.2 Amerika
Muri gahunda yo kongera gusuzuma, EPA yo muri Amerika irasabwa gukora isuzuma ry’ingaruka, kumenya niba umuti wica udukoko wujuje ibyangombwa byo kwiyandikisha kwa FIFRA, no gutanga icyemezo cyo gusuzuma.Ikigo gishinzwe kugenzura imiti yica udukoko cya EPA kigizwe n’ibice birindwi, ibice bine bigenga, n’ibice bitatu byihariye.Serivisi ishinzwe kwandika no gusuzuma ni ishami rishinzwe kugenzura, kandi Gerefiye ishinzwe porogaramu nshya, imikoreshereze n'impinduka mu miti yica udukoko twangiza imiti;Serivise ishinzwe gusuzuma isuzuma nyuma yo kwiyandikisha kwa pesticide zisanzwe.Ishami ry’ingaruka ku buzima, Ishami rishinzwe imyitwarire n’ibidukikije hamwe n’ishami rishinzwe isesengura ry’ibinyabuzima n’ubukungu, ariryo shami ryihariye, bashinzwe cyane cyane gusuzuma tekiniki amakuru yose ajyanye no kwandikisha imiti yica udukoko no gusuzuma nyuma yo kwiyandikisha, no kurangiza ingaruka isuzuma.
Igabana ry'insanganyamatsiko
Ingingo yo kwisubiramo igizwe nibintu bimwe cyangwa byinshi bikora hamwe nibicuruzwa byose birimo ibyo bintu bikora.Iyo imiterere yimiti nibiranga toxicologique yibintu bitandukanye bikora bifitanye isano ya hafi, kandi igice cyangwa amakuru yose asabwa kugirango isuzumabumenyi rishobora gusaranganywa, birashobora guhurizwa mumutwe umwe;Ibicuruzwa byica udukoko birimo ibintu byinshi bikora nabyo bigengwa ningingo yo gusubiramo buri kintu cyose gikora.Iyo amakuru mashya cyangwa amakuru abonetse, EPA irashobora kandi guhindura impinduka kumutwe wongeye gusuzuma.Niba isanze ibintu byinshi bikora mubintu bidasa, EPA irashobora kugabanya ingingo mubice bibiri cyangwa byinshi byigenga, cyangwa irashobora kongeraho cyangwa kuvanaho ibintu bifatika mumutwe wongeye gusuzuma.
2.2.2 Gutegura ingengabihe
Buri ngingo yo gusubiramo ifite itariki shingiro, niyo itariki yambere yo kwiyandikisha cyangwa itariki yo kongera kwiyandikisha kubicuruzwa byica udukoko byanditswe bwa mbere mumutwe (itariki yo kongera kwiyandikisha bivuga itariki icyemezo cyo kongera kwiyandikisha cyangwa icyemezo cyagateganyo. yashyizweho umukono), muri rusange icyaricyo cyose nyuma.EPA mubisanzwe ishingira gahunda yayo yo kwisubiramo kuriki gihe cyibanze cyangwa gusubiramo vuba aha, ariko irashobora kandi gusubiramo ingingo nyinshi zingirakamaro icyarimwe kugirango zikore neza.EPA izashyira dosiye yisuzuma, harimo itariki y'ibanze, kurubuga rwayo kandi igumane gahunda yo kongera gusuzuma umwaka yatangarijweho kandi byibuze imyaka ibiri yakurikiyeho.
2.2.3 Isubiramo riratangira
2.2.3.1 gufungura dock
EPA itangira kwisubiramo ikora dossier rusange kuri buri ngingo yo gusuzuma imiti yica udukoko no gusaba ibitekerezo.Ariko, niba EPA igennye ko umuti wica udukoko wujuje ibisabwa kugirango FIFRA yandikwe kandi nta yandi mananiza asabwa, irashobora gusimbuka iyi ntambwe ikanatangaza icyemezo cyayo cya nyuma binyuze muri rejisitiri nkuru.Buri dosiye dosiye izakomeza gufungura mugihe cyo gusubiramo kugeza igihe hafashwe icyemezo cya nyuma.Dosiye ikubiyemo, ariko ntabwo igarukira gusa kuri ibi bikurikira: incamake yimiterere yumushinga wo kongera gusuzuma;Urutonde rwabiyandikishije hamwe nabiyandikishije, integuza iyo ari yo yose ya Federal Register yerekeye iyandikwa ritegereje, imipaka isigaye cyangwa yigihe gito;Inyandiko zo gusuzuma ingaruka;Bibliografiya yigitabo kiriho;Incamake yamakuru yimpanuka;N'andi makuru yose afatika cyangwa amakuru.Dosiye ikubiyemo kandi gahunda ibanza yakazi ikubiyemo amakuru y’ibanze EPA ifite kuri ubu yerekeye imiti yica udukoko igomba kugenzurwa n’uburyo izakoreshwa, hamwe n’isuzuma ryateganijwe ry’ingaruka, ibikenewe mu makuru, na gahunda yo gusuzuma.
2.2.3.2 Igitekerezo rusange
EPA itangaza itangazo muri rejisitiri nkuru kugirango itange ibisobanuro kumugaragaro kuri dosiye isubirwamo na gahunda y'akazi ibanza mugihe kitarenze iminsi 60.Muri iki gihe, abafatanyabikorwa barashobora kubaza ibibazo, gutanga ibitekerezo cyangwa gutanga amakuru afatika.Gutanga ayo makuru bigomba kuba byujuje ibisabwa bikurikira.
1) Amakuru afatika agomba gutangwa mugihe cyagenwe cyagenwe, ariko EPA nayo izasuzuma, mubushake bwayo, niba yakira amakuru cyangwa amakuru yatanzwe nyuma.
2) Amakuru agomba gutangwa muburyo busomeka kandi bukoreshwa.Kurugero, ibikoresho byose bitari mucyongereza bigomba guherekezwa nubusobanuro bwicyongereza, kandi amakuru yose yatanzwe mumajwi cyangwa amashusho agomba kuba aherekejwe ninyandiko yanditse.Inyandiko zanditse zishobora gutangwa mu mpapuro cyangwa muburyo bwa elegitoronike.
3) Utanga agomba kwerekana neza inkomoko yamakuru yatanzwe cyangwa amakuru.
4) Subfiler irashobora gusaba ko EPA yakongera gusuzuma amakuru yanze mubisubiramo, ariko igomba gusobanura impamvu zo kongera gusuzuma.
Ukurikije amakuru yakiriwe mugihe cyibitekerezo no kubisuzuma mbere, EPA itegura kandi igatanga gahunda yanyuma yakazi ikubiyemo ibisabwa byamakuru kuri gahunda, ibitekerezo byakiriwe, nincamake y'ibisubizo bya EPA.
Niba imiti yica udukoko idafite ibyangombwa byanditse, cyangwa ibicuruzwa byose byanditswe byavanyweho, EPA ntizongera gusuzuma imiti yica udukoko.
2.2.3.3 Uruhare rwabafatanyabikorwa
Kugirango hongerwe gukorera mu mucyo no kwishora hamwe no gukemura ibibazo bidashidikanywaho bishobora kugira ingaruka ku isuzuma ry’imiti yica udukoko no gufata ibyemezo byo gucunga ibyago, nko gushyira ikimenyetso ku buryo budasobanutse cyangwa kubura amakuru y’ikigereranyo, EPA irashobora gukora inama yibanze hamwe n’abafatanyabikorwa ku ngingo zizaza cyangwa zikomeje gusubirwamo.Kugira amakuru ahagije hakiri kare birashobora gufasha EPA kugabanya isuzuma ryibice bikeneye kwitabwaho.Kurugero, mbere yo gutangira kwisubiramo, EPA irashobora kugisha inama nyir'icyemezo cyo kwiyandikisha cyangwa ukoresha imiti yica udukoko ku bijyanye no gukoresha no gukoresha ibicuruzwa, kandi mugihe cyo kongera gusuzuma, EPA irashobora kugisha inama nyir'icyemezo cyo kwiyandikisha, ukoresha imiti yica udukoko cyangwa ibindi bijyanye abakozi kugirango bafatanyirize hamwe gahunda yo kurwanya ingaruka zica udukoko.
2.2.4 Kongera gusuzuma no gushyira mubikorwa
2.2.4.1 Suzuma impinduka zabaye kuva isubiramo ryanyuma
EPA izasuzuma impinduka iyo ari yo yose mu mabwiriza, politiki, uburyo bwo gusuzuma ingaruka, cyangwa ibisabwa mu makuru byabaye kuva isuzuma ryanyuma ryiyandikisha, rigena akamaro k'izo mpinduka, kandi rumenye niba imiti yica udukoko twongeye gusuzuma yujuje ibisabwa na FIFRA.Muri icyo gihe, subiramo amakuru yose mashya cyangwa amakuru kugira ngo umenye niba isuzuma rishya rishobora kugerwaho cyangwa isuzuma rishya rishobora kugerwaho.
2.2.4.2 Kora isuzuma rishya nkuko bikenewe
Niba hemejwe ko isuzuma rishya rikenewe kandi amakuru asanzwe ariho arahagije, EPA izongera gukora isuzuma ryibyago cyangwa isuzuma ryibyago / inyungu.Niba amakuru cyangwa amakuru ariho atujuje ibyangombwa bisabwa byo gusuzuma, EPA izatanga itangazo ryo guhamagara amakuru kubafite ibyemezo byiyandikishije bijyanye n'amabwiriza ya FIFRA.Ufite icyemezo cyo kwiyandikisha asabwa gusubiza mugihe cyiminsi 90 kugirango yumvikane na EPA kumakuru agomba gutangwa nigihe cyo kurangiza gahunda.
2.2.4.3 Gusuzuma ingaruka ku moko yangiritse
Iyo EPA yongeye gusuzuma imiti yica udukoko mu kongera gusuzuma, itegekwa kubahiriza ibiteganywa n’itegeko ry’ibinyabuzima bigenda byangirika kugira ngo hirindwe kwangirika kw’ibinyabuzima byugarijwe cyangwa byugarijwe na federasiyo hamwe n’ingaruka mbi ku buturo bwagenwe.Nibiba ngombwa, EPA izagisha inama ikigo gishinzwe amafi n’ibinyabuzima muri Amerika hamwe n’ikigo cy’igihugu gishinzwe uburobyi bwo mu nyanja.
2.2.4.4 Uruhare rwabaturage
Niba isuzuma rishya ryakozwe, EPA izatangaza itangazo muri rejisitiri nkuru itanga umushinga wo gusuzuma ibyago kugirango bisuzumwe kandi bitangwe ibitekerezo, hamwe nibitekerezo byibuze iminsi 30 kandi mubisanzwe iminsi 60.EPA izashyiraho kandi raporo ivuguruye yo gusuzuma ingaruka zavuguruwe muri rejisitiri nkuru, ibisobanuro byimpinduka zose zahinduwe ku nyandiko yatanzwe, nigisubizo kubitekerezo rusange.Niba isuzuma ry’ibyago byavuguruwe ryerekana ko hari ingaruka ziterwa nimpungenge, igihe cyo gutanga ibitekerezo byibuze iminsi 30 gishobora gutangwa kugirango abaturage batange ibindi byifuzo byingamba zo kugabanya ingaruka.Niba isuzuma ryambere ryerekana urwego ruto rwo gukoresha / gukoresha imiti yica udukoko, ingaruka nke ku bafatanyabikorwa cyangwa ku baturage, ibyago bike, kandi hagomba gukenerwa ingamba nke zo kugabanya ingaruka, EPA ntishobora gukora ibisobanuro rusange ku mushinga wo gusuzuma ingaruka, ariko ahubwo kora umushinga uboneka kugirango usuzumwe rusange hamwe nicyemezo cyo gusubiramo.
2.2.5 icyemezo cyo gusuzuma
Icyemezo cyo kongera gusuzuma ni icyemezo cya EPA cyo kumenya niba umuti wica udukoko wujuje ibyangombwa byemewe n'amategeko, ni ukuvuga ko usuzuma ibintu nkibirango byibicuruzwa, ibikoresho bikora hamwe nugupakira kugirango hamenyekane niba imiti yica udukoko izakora imirimo yagenewe idateye ingaruka mbi zidafite ishingiro kubantu. ubuzima cyangwa ibidukikije.
2.2.5.1 yatanze igitekerezo cyo gusuzuma iyandikwa cyangwa icyemezo cyagateganyo
Niba EPA isanze isuzumabumenyi rishya ridakenewe, rizatanga icyemezo cyasubiwemo gisubirwamo hakurikijwe amabwiriza ("Icyemezo cyatanzwe");Iyo bisuzumwe by'inyongera, nk'isuzuma ry’ibinyabuzima bigenda byangirika cyangwa gusuzuma endocrine, bisabwa, icyemezo cy'agateganyo gishobora gutangwa.Icyemezo giteganijwe kizatangazwa binyuze muri rejisitiri nkuru kandi kizaboneka kubaturage mugihe cyo gutanga ibitekerezo byibuze iminsi 60.Icyemezo giteganijwe gikubiyemo ahanini ibi bikurikira:
1) Vuga imyanzuro yatanzwe ku ngingo ngenderwaho zo kwiyandikisha kwa FIFRA, harimo n'ibyavuye mu nama nyunguranabitekerezo y’ibinyabuzima bigenda byangirika, kandi werekane ishingiro ry’imyanzuro yatanzwe.
2) Menya ingamba ziteganijwe zo kugabanya ingaruka cyangwa ubundi buryo bukenewe kandi ubyemeze.
3) Erekana niba hakenewe amakuru yinyongera;Niba bikenewe, vuga ibisabwa bisabwa hanyuma umenyeshe abafite ikarita yo kwiyandikisha bahamagaye.
4) Kugaragaza icyifuzo icyo aricyo cyose cyahinduwe.
5) Shiraho igihe ntarengwa cyo kurangiza buri gikorwa gisabwa.
2.2.5.2 icyemezo cyo gusuzuma by'agateganyo icyemezo cyo gusuzuma
Nyuma yo gusuzuma ibisobanuro byose ku cyemezo cy’agateganyo cyatanzwe, EPA irashobora, ku bushake bwayo, gutanga icyemezo cy’agateganyo binyuze muri rejisitiri nkuru mbere yo kurangiza isuzuma.Icyemezo cy'agateganyo gikubiyemo ibisobanuro ku mpinduka iyo ari yo yose yatanzwe ku cyemezo cy’agateganyo cyatanzwe mbere no gusubiza ku bitekerezo by'ingenzi, kandi icyemezo cy'agateganyo gishobora kandi: gusaba ingamba nshya zo kugabanya ingaruka cyangwa gushyira mu bikorwa ingamba zo kugabanya ingaruka z'agateganyo;Gusaba kohereza ibirango bigezweho;Sobanura amakuru yamakuru akenewe kugirango arangize isuzuma na gahunda yo gutanga (imenyesha ryo guhamagara amakuru rishobora gutangwa mbere, icyarimwe cyangwa nyuma yicyemezo cyo gusubiramo by'agateganyo gitanzwe).Niba ufite icyemezo cyo kwiyandikisha ananiwe gufatanya nibikorwa bisabwa mu cyemezo cyo gusubiramo by'agateganyo, EPA irashobora gufata ibyemezo bikwiye.
2.2.5.3 icyemezo cya nyuma
EPA izatanga umwanzuro wanyuma nurangiza gusuzuma isuzumabumenyi ryose, harimo, aho bibaye ngombwa, gusuzuma no kugisha inama amoko yanditse ku rutonde rw’ibinyabuzima by’ibinyabuzima byugarijwe n’iterabwoba, ndetse no gusuzuma gahunda yo gusuzuma ibibazo bya endocrine.Niba ufite icyemezo cyo kwiyandikisha ananiwe gufatanya nibikorwa bisabwa mu cyemezo cyo gusubiramo, EPA irashobora gufata ibyemezo bikwiye muri FIFRA.
3 Andika icyifuzo cyo gukomeza
3.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
Kuvugurura Umuryango w’ubumwe bw’ibihugu by’Uburayi wifashisha imiti yica udukoko ni isuzuma ryuzuye rihuza amakuru ashaje kandi mashya, kandi abasaba bagomba gutanga amakuru yuzuye nkuko bisabwa.
3.1.1
Ingingo ya 6 y’amabwiriza 2020/1740 yerekeye kuvugurura iyandikwa ryerekana amakuru agomba gutangwa kugirango yongere kwiyandikisha kwingirakamaro, harimo:
1) Izina na aderesi byabasabye bafite inshingano zo gukomeza gusaba no kuzuza inshingano ziteganijwe n’amabwiriza.
2) Izina na aderesi byabasabye hamwe nizina ryishyirahamwe ryabaproducer.
3) Uburyo bwerekana uburyo bwo gukoresha byibuze ibicuruzwa birinda ibihingwa birimo ingirakamaro ku gihingwa cyatewe cyane muri buri karere, kandi gihamya ko ibicuruzwa byujuje ibyangombwa byo kwiyandikisha bivugwa mu ngingo ya 4 y’amabwiriza No 1107/2009.
“Uburyo bwo gukoresha” buvuzwe haruguru bukubiyemo uburyo bwo kwiyandikisha no gusuzuma mu gukomeza kwiyandikisha.Nibura kimwe mubicuruzwa birinda ibihingwa hamwe nuburyo bwavuzwe haruguru bwo gukoresha bigomba kuba bitarimo ibindi bintu bikora.Niba amakuru yatanzwe nuwasabye adakubiyemo ibice byose birimo, cyangwa bidakuze cyane muri kariya gace, impamvu igomba gutangwa.
4) amakuru akenewe hamwe n ibisubizo byo gusuzuma ingaruka, harimo: i) kwerekana impinduka mubisabwa n'amategeko n’amabwiriza kuva byemejwe kwandikisha ibintu bifatika cyangwa kuvugurura kwiyandikisha vuba aha;ii) kwerekana impinduka muri siyansi n'ikoranabuhanga kuva byemejwe kwandikisha ibintu bifatika cyangwa kuvugurura kwiyandikisha vuba aha;iii) kwerekana impinduka mu mikoreshereze y'abahagarariye;iv) yerekana ko kwiyandikisha bikomeje guhinduka kuva kwiyandikisha kwambere.
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6) inyandiko yuzuye ya buri kigeragezo cyangwa raporo yubushakashatsi hamwe nibisobanuro byayo nkigice cyamakuru yambere yo kwiyandikisha cyangwa amakuru yo kwiyandikisha nyuma, ukurikije ibisabwa byo gutegura ibiyobyabwenge.
7) Ibimenyetso byerekana ko ari ngombwa gukoresha ibintu bifatika bitujuje ubuziranenge bwo kwiyandikisha kugirango wirinde udukoko twangiza ibihingwa.
8) Kugirango umwanzuro wa buri kizamini cyangwa ubushakashatsi burimo intangangabo, vuga ingamba zafashwe kugirango wirinde kwipimisha ku nyababyeyi.Amakuru yo kwagura kwiyandikisha ntashobora kuba arimo raporo yikizamini yerekana gukoresha nkana ibintu bifatika kubantu cyangwa gukoresha ibicuruzwa birimo ibintu bifatika.
9) Kopi yo gusaba MRLS yatanzwe hakurikijwe ingingo ya 7 y’amabwiriza (EC) No 396/2005 y’Inteko Ishinga Amategeko y’Uburayi n’Inama Njyanama.
10) Icyifuzo cyo gutondekanya cyangwa gutondekanya ibintu bikora hakurikijwe Amabwiriza 1272/2008.
11) Urutonde rwibikoresho bishobora kwerekana ubwuzuzanye bwa porogaramu ikomeza, kandi ushireho amakuru mashya yatanzwe muri iki gihe.
12) Dukurikije ingingo ya 8 (5) y’amabwiriza No 1107/2009, incamake n’ibisubizo by’urungano rwasuzumwe n’ubuvanganzo rusange bwa siyansi.
13) Suzuma amakuru yose yatanzwe ukurikije uko siyansi n'ikoranabuhanga bigezweho, harimo no kongera gusuzuma amwe mu makuru yambere yo kwiyandikisha cyangwa amakuru yo gukomeza kwiyandikisha.
14) Kuzirikana no gusaba ingamba zose zikenewe kandi zikwiye zo kugabanya ingaruka.
15) Dukurikije ingingo ya 32b y’amabwiriza 178/2002, EFSA irashobora gutanga ibizamini bya siyansi bikenewe kugira ngo ikorwe n’ikigo cy’ubushakashatsi cyigenga cya siyansi kandi kigeza ibyavuye mu bizamini Inteko ishinga amategeko y’Uburayi, Komisiyo n’ibihugu bigize Umuryango.Izo manda zirakinguye kandi ziragaragara, kandi amakuru yose ajyanye no kumenyeshwa iburanisha agomba gushyirwa mubisabwa byo kwagura kwiyandikisha.
Niba amakuru yambere yo kwiyandikisha aracyujuje ibyangombwa bisabwa hamwe nibipimo ngenderwaho, birashobora gukomeza gukoreshwa muri uku kwagura, ariko bigomba kongera gutangwa.Usaba agomba gukoresha imbaraga ze zose kugirango abone kandi atange amakuru yumwimerere yo kwiyandikisha cyangwa amakuru ajyanye no gukomeza kwiyandikisha nyuma.Niba usaba kongererwa kwiyandikisha atari we usaba kwiyandikisha kwambere kwingirakamaro (ni ukuvuga, usaba adafite amakuru yatanzwe bwa mbere), birakenewe kubona uburenganzira bwo gukoresha kwiyandikisha bihari amakuru yibikoresho bikora binyuze mubasabye kwiyandikisha bwa mbere cyangwa ishami ryubuyobozi bwigihugu gishinzwe gusuzuma.Niba usaba kongererwa kwiyandikisha atanga ibimenyetso byerekana ko amakuru ajyanye ataboneka, Leta iyobora cyangwa EFSA yakoze isuzuma ryabanje kandi / cyangwa nyuma yo kuvugurura bizagerageza gutanga ayo makuru.
Niba amakuru yambere yo kwiyandikisha atujuje ibyangombwa bisabwa, ibizamini bishya na raporo nshya bigomba gukorwa.Usaba agomba kumenya no gutondekanya ibizamini bishya bizakorwa n'ingengabihe yabyo, harimo urutonde rwihariye rw'ibizamini bishya ku nyababyeyi zose, hitawe ku bitekerezo byatanzwe na EFSA mbere yo kuvugurura porogaramu.Raporo y'ibizamini bishya igomba gushyirwaho neza, isobanura impamvu n'ibikenewe.Kugirango habeho gufungura no gukorera mu mucyo no kugabanya kwigana ibizamini, ibizamini bishya bigomba gushyikirizwa EFSA mbere yo gutangira, kandi ibizamini bidatsinzwe ntibizemerwa.Usaba arashobora gutanga ibyifuzo byo kurinda amakuru kandi agatanga verisiyo y'ibanga kandi itari ibanga yaya makuru.
3.1.2 Imyiteguro
Gukomeza kwandikisha ibicuruzwa bya farumasi bishingiye kubintu bifatika byarangiye.Dukurikije ingingo ya 43 (2) y’amabwiriza No 1107/2009, gusaba gukomeza imyiteguro bikubiyemo:
1) Kopi y'icyemezo cyo kwiyandikisha.
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3) Impamvu zo gutanga amakuru mashya: ibisabwa bishya byamakuru, umurongo ngenderwaho nubuziranenge ntibyakurikizwaga mugihe cyo kwandikisha ibicuruzwa;Cyangwa guhindura uburyo bwo gukoresha ibicuruzwa.
4) Kwemeza ko ibicuruzwa byujuje ibyangombwa byo kwiyandikisha byongeweho byingirakamaro mubikorwa byamabwiriza (harimo nibibuza).
5) Niba ibicuruzwa byakurikiranwe, raporo yamakuru yo gukurikirana igomba gutangwa.
6) Iyo bibaye ngombwa, amakuru yo gusuzuma igereranya agomba gutangwa hakurikijwe amabwiriza abigenga.
3.1.2.1 Guhuza amakuru yibikoresho bikora
Iyo usabye gukomeza kwandikisha ibicuruzwa bikoreshwa mu bya farumasi, usaba agomba, akurikije umwanzuro w’isuzuma ry’ibikoresho bikora, atanga amakuru mashya ya buri kintu gikora kigomba kuvugururwa bitewe n’imihindagurikire y’ibisabwa n’ibipimo, guhindura no kunoza amakuru ajyanye nibicuruzwa bya farumasi, kandi akore isuzuma ryibyago akurikije amabwiriza mashya nindangagaciro zanyuma kugirango harebwe ko ibyago bikiri murwego rwemewe.Guhuza amakuru yibikorwa bisanzwe mubisanzwe ni inshingano zigihugu kiyobora gukora isuzuma rihoraho ryiyandikisha ryibintu.Usaba arashobora gutanga amakuru yingirakamaro yingirakamaro mugihugu cyagenwe kiyobora mugutanga imenyekanisha ko amakuru yingirakamaro ari mugihe kitarinzwe, gihamya yuburenganzira bwo gukoresha ayo makuru, imenyekanisha ko imyiteguro isonewe gutanga an amakuru yingirakamaro yamakuru, cyangwa mugusaba gusubiramo ikizamini.Kwemeza amakuru yo gusaba kugirango akomeze kwandikisha imyiteguro arashobora gusa gushingira kumiti imwe yumwimerere yujuje ubuziranenge bushya, kandi mugihe ubwiza bwibihinduka byavuzwe mbere byibiyobyabwenge (harimo nibirimo byinshi byanduye), usaba arashobora gutanga ibitekerezo bifatika. ko ibiyobyabwenge byumwimerere byakoreshejwe birashobora gufatwa nkibingana.
3.1.2.2 Guhindura imikorere myiza yubuhinzi (GAP)
Usaba agomba gutanga urutonde rwimikoreshereze yibicuruzwa, harimo itangazo ryerekana ko nta mpinduka nini zigeze zigaragara muri GAP muri kariya gace kuva igihe cyo kwiyandikisha, hamwe nurutonde rwihariye rwakoreshejwe muburyo bwa GAP muburyo bwagenwe; .Gusa impinduka zikomeye muri GAP zikenewe kugirango hubahirizwe impinduka mugusuzuma ibice bikora (indangagaciro nshya zanyuma, kwemeza amabwiriza mashya, ibisabwa cyangwa ibibujijwe mumabwiriza yo kuvugurura iyandikwa) biremewe, mugihe uwasabye atanze amakuru yose akenewe.Ihame, nta fomu ihambaye ya dosiye ishobora guhinduka mugukomeza gusaba
3.1.2.3
Kugirango bigerweho, usaba agomba kugena no kwemeza gutanga amakuru mashya yikizamini.Niba impinduka ya GAP iterwa nigiciro gishya cyanyuma, umurongo ngenderwaho mushya, amakuru yikigereranyo cya GAP nshya agomba gutangwa, bitabaye ibyo, gusa amakuru yo kurwanya agomba gutangwa kugirango akomeze gusaba.
3.2 Amerika
Ibyifuzo bya EPA muri Amerika kugirango bisubirwemo imiti yica udukoko bihujwe no kwandikisha imiti yica udukoko, guhindura iyandikwa, no kongera kwiyandikisha, kandi nta mabwiriza atandukanye.Icyifuzo kigenewe amakuru ashingiye kubikenewe byo gusuzuma ibyago mugusubiramo, ibitekerezo byakiriwe mugihe cyinama rusange, nibindi, bizatangazwa muburyo bwa gahunda yanyuma yakazi no kumenyesha guhamagara amakuru.
4 Ibindi bibazo
4.1 Gusaba hamwe
4.1.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
Dukurikije ingingo ya 5, Igice cya 3 cy’amabwiriza 2020/1740, iyo abasabye barenze umwe basabye kongererwa iyandikwa ry’ibintu bimwe bikora, abasaba bose bagomba gufata ingamba zose zifatika zo gutanga amakuru hamwe.Ishyirahamwe ryagenwe nuwasabye arashobora gusaba guhuriza hamwe mwizina ryabasabye, kandi abashobora gusaba bose barashobora kuvugana nicyifuzo cyo gutanga amakuru hamwe.
Abasaba gusaba kandi gutanga amakuru yuzuye ukwayo, ariko bagomba gusobanura impamvu mumakuru.Icyakora, dukurikije ingingo ya 62 y’amabwiriza 1107/2009, ibizamini bisubirwamo ku binyabuzima by’inyamabere ntibyemewe, bityo abashobora gusaba kandi bafite amakuru y’uruhushya babigenewe bagomba gukora ibishoboka byose kugira ngo ibisubizo by’ibizamini by’inyamabere n’ubushakashatsi birimo bisangwe.Kugirango havugururwe ibikorwa byiyandikisha birimo abasaba byinshi, amakuru yose agomba gusuzumirwa hamwe, kandi imyanzuro na raporo bigomba gukorwa nyuma yisesengura ryuzuye.
4.1.2 Amerika
EPA irasaba ko abasaba gusangira amakuru yo gusuzuma, ariko nta cyangombwa gisabwa.Dukurikije itangazo ryo guhamagara amakuru, ufite icyemezo cyo kwiyandikisha cyibigize imiti yica udukoko ashobora guhitamo niba gutanga amakuru hamwe nabandi babisabye, gukora ubushakashatsi butandukanye, cyangwa kuvanaho kwiyandikisha.Niba ibigeragezo bitandukanye nabasabye batandukanye bivamo ingingo ebyiri zanyuma, EPA izakoresha amaherezo yanyuma.
4.2 Isano iri hagati yo kuvugurura kwiyandikisha no kwiyandikisha gushya
4.2.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
Mbere yo gutangira kuvugurura iyandikwa ryibikoresho bikora, ni ukuvuga, mbere yuko ibihugu bigize Umuryango byakira ivugurura ry’ibikorwa by’ibikoresho byiyandikisha, usaba ashobora gukomeza gutanga ibyangombwa byo kwandikisha imiti y’imiti bijyanye n’ibihugu bigize Umuryango (akarere) ;Nyuma yo gutangira kuvugurura ibikorwa bifatika byiyandikisha, usaba ntashobora kongera gutanga ibyangombwa byo kwandikisha imyiteguro ijyanye n’ibihugu bigize Umuryango, kandi agomba gutegereza itangwa ry’icyemezo kijyanye no kuvugurura iyandikwa ry’ibikoresho mbere yo kubitanga. ukurikije ibisabwa bishya.
4.2.2 Amerika
Niba iyandikwa ryiyongereye (urugero, gutegura dosiye nshya) ridatera isuzuma rishya ryibyago, EPA irashobora kwemera iyandikwa ryinyongera mugihe cyo gusubiramo;Ariko, niba kwiyandikisha gushya (nkurwego rushya rwo gukoresha) rushobora gukurura isuzuma rishya ryibyago, EPA irashobora gushyira ibicuruzwa mugusuzuma ibyago byo gusuzuma ibyago cyangwa gukora isuzuma ryibyago bitandukanye kubicuruzwa no gukoresha ibisubizo mugusuzuma.Ihinduka rya EPA riterwa n’uko ibice bitatu byihariye by’ishami ry’ingaruka z’ubuzima, Ishami rishinzwe imyitwarire n’ibidukikije, n’ishami rishinzwe isesengura ry’ibinyabuzima n’ubukungu rishyigikira imirimo y’iyandikisha n’ishami rishinzwe gusuzuma, kandi rishobora kubona byose amakuru yo kwiyandikisha no gusubiramo icyarimwe.Kurugero, mugihe reevaluation yafashe icyemezo cyo guhindura ikirango, ariko ntikiratangwa, niba isosiyete itanze icyifuzo cyo guhindura ikirango, rejisitiri izayitunganya hakurikijwe icyemezo cyo kongera gusuzuma.Ubu buryo bworoshye butuma EPA ihuza neza umutungo kandi igafasha ibigo kwiyandikisha kare.
4.3 Kurinda amakuru
4.3.1 Umuryango w’ubumwe bw’ibihugu by’i Burayi
Igihe cyo kurinda amakuru mashya yingirakamaro hamwe namakuru yo gutegura akoreshwa mu kuvugurura kwiyandikisha ni amezi 30, guhera ku munsi ibicuruzwa byateguwe byandikwa bwa mbere kugirango bivugururwe muri buri gihugu cy’abanyamuryango, itariki yihariye iratandukanye gato n’ibihugu bigize Umuryango n’ibindi.
4.3.2 Amerika
Amakuru yatanzwe yongeye gusubirwamo afite igihe cyo kurinda amakuru yimyaka 15 uhereye igihe yatangiriye, kandi iyo usaba yerekeza ku makuru yatanzwe n’ikindi kigo, agomba kwerekana ko indishyi zahawe nyir'amakuru cyangwa uruhushya rwabonetse.Niba uruganda rukora ibikorwa byo kwandikisha ibiyobyabwenge rwemeje ko rwatanze amakuru asabwa kugirango rwongere rusuzumwe, ibicuruzwa bitegura byakozwe hakoreshejwe imiti ikora byabonye uruhushya rwo gukoresha amakuru y’ibiyobyabwenge bikora, bityo birashobora kugumana iyandikwa rishingiye ku gusubiramo umwanzuro wibiyobyabwenge bikora, utongeyeho amakuru yinyongera, ariko biracyakenewe gufata ingamba zo kugenzura ingaruka nko guhindura ikirango nkuko bisabwa.
5. Incamake n'ibyiringiro
Muri rusange, Umuryango w’ubumwe bw’ibihugu by’Amerika na Amerika bifite intego imwe mu gukora isuzuma ry’ibicuruzwa byica udukoko byanditswe: kugira ngo ubushobozi bw’isuzuma ry’ibyago butere imbere na politiki bihinduke, imiti yica udukoko twanduye ishobora gukomeza gukoreshwa neza kandi ntibiteza ingaruka zidafite ishingiro ku buzima bw’abantu. n'ibidukikije.Ariko, hariho itandukaniro muburyo bwihariye.Icya mbere, bigaragarira mu isano iri hagati yo gusuzuma ikoranabuhanga no gufata ibyemezo.Kwiyongera kw’ubumwe bw’ibihugu by’Uburayi bikubiyemo isuzuma rya tekiniki n’ibyemezo byanyuma byo kuyobora;Kuvugurura muri Reta zunzubumwe zamerika bifata gusa imyanzuro yo gusuzuma tekiniki nko guhindura ibirango no gutanga amakuru mashya, kandi ufite icyemezo cyo kwiyandikisha agomba gufata iya mbere kugirango akore akurikije umwanzuro kandi asabe ibyifuzo bijyanye kugirango ashyire mubikorwa ibyemezo byubuyobozi.Icya kabiri, uburyo bwo gushyira mubikorwa buratandukanye.Kwagura kwiyandikisha muri EU bigabanijwemo intambwe ebyiri.Intambwe yambere nukwagura ibikorwa bifatika kwiyandikisha kurwego rwa EU.Nyuma yo kwagura ibikorwa bifatika byiyandikishije byemejwe, kwagura iyandikwa ryibicuruzwa bikoreshwa mu bya farumasi bikorwa mu bihugu bigize uyu muryango.Kuvugurura ibintu bikora nibicuruzwa byakozwe muri Amerika bikorwa icyarimwe.
Kwemeza kwiyandikisha no kongera gusuzuma nyuma yo kwiyandikisha ni ibintu bibiri byingenzi kugirango umutekano wokoresha imiti yica udukoko.Muri Gicurasi 1997, Ubushinwa bwatangaje “Amabwiriza agenga imicungire y’udukoko”, kandi nyuma y’imyaka irenga 20 y’iterambere, hashyizweho uburyo bwuzuye bwo kwandikisha imiti yica udukoko hamwe n’uburyo bwo gusuzuma.Kugeza ubu, Ubushinwa bumaze kwandika amoko arenga 700 yica udukoko hamwe n’ibicuruzwa birenga 40.000 byo gutegura, kimwe cya kabiri cyabyo kikaba kimaze imyaka irenga 20 cyanditswe.Igihe kirekire, kinini kandi kinini cyo gukoresha imiti yica udukoko bizabura byanze bikunze kwiyongera kw’ibinyabuzima bigamije kurwanya, kwiyongera kw’ibidukikije, no kwiyongera kw’umutekano w’abantu n’inyamaswa.Kongera gusuzuma nyuma yo kwiyandikisha nuburyo bwiza bwo kugabanya ingaruka zigihe kirekire zo gukoresha imiti yica udukoko no kumenya uburyo bwose bwo gucunga imiti yica udukoko, kandi ninyongera muburyo bwo kwiyandikisha no kubyemeza.Icyakora, Ubushinwa bwo kongera gusuzuma imiti yica udukoko bwatangiye bitinze, kandi “Ingamba zo gucunga iyandikwa ry’imiti yica udukoko” yatangajwe mu 2017 yerekanye ku nshuro ya mbere kuva ku rwego rw’amabwiriza ko ubwoko bw’imiti yica udukoko bwanditswe mu myaka irenga 15 bugomba gutegurwa kugira ngo butware hanze isuzuma ryigihe ukurikije umusaruro nogukoresha uko ibintu bimeze no guhindura politiki yinganda.NY / T2948-2016 "Ibisobanuro bya tekiniki yo kuvugurura imiti yica udukoko" byatanzwe mu 2016 bitanga amahame shingiro nuburyo bwo gusuzuma uburyo bwo kongera gusuzuma ubwoko bw’udukoko twangiza udukoko twangiza, kandi bugasobanura ingingo zijyanye, ariko kubishyira mu bikorwa ni bike nkurwego rusabwa.Kubijyanye nakazi keza ko gucunga imiti yica udukoko mu Bushinwa, ubushakashatsi nisesengura rya sisitemu yo kuvugurura imikorere y’ubumwe bw’ibihugu by’Uburayi na Amerika birashobora kuduha ibitekerezo bikurikira no kumurikirwa.
Ubwa mbere, tanga gukina byuzuye inshingano nyamukuru zabafite icyemezo cyo kwiyandikisha mugusubiramo isuzuma ryimiti yica udukoko.Inzira rusange yo kongera kwica udukoko twangiza udukoko tw’ubumwe bw’ibihugu by’Uburayi na Amerika ni uko ishami rishinzwe imicungire y’iyandikisha ritegura gahunda y’akazi, rigashyira ahagaragara ubwoko butandukanye bwo kuvugurura no guhangayikishwa n’ingaruka zishobora guterwa, kandi ufite nyir'icyemezo cyo kwandikisha udukoko atanga amakuru nk'uko bisabwa muri igihe cyagenwe.Ubushinwa bushobora gukura amasomo ku byabaye, bugahindura imitekerereze y’ishami rishinzwe kwandikisha imiti yica udukoko kugira ngo dukore ibizamini byo kugenzura no kurangiza imirimo rusange yo kuvugurura imiti yica udukoko, bikarushaho gusobanura inshingano nyamukuru y’abafite icyemezo cyo kwandikisha udukoko mu gukora isuzuma no kugenzura umutekano w’ibicuruzwa, no kunoza uburyo bwo gushyira mu bikorwa imiti yica udukoko mu Bushinwa.
Iya kabiri ni ishyirwaho rya sisitemu yo kurinda amakuru yica udukoko.Amabwiriza agenga imicungire y’udukoko n’amabwiriza ayashyigikira asobanura neza uburyo bwo kurinda ubwoko bushya bw’udukoko twangiza udukoko mu Bushinwa n’ibisabwa kugira ngo umuntu yemererwe kwandikisha imiti yica udukoko, ariko ibisabwa byo kongera gusuzuma amakuru no gutanga uburenganzira ntibisobanutse.Kubwibyo, abafite ibyemezo byo kwandikisha imiti yica udukoko bagomba gushishikarizwa kugira uruhare rugaragara mubikorwa byo gusubiramo, kandi uburyo bwo kurinda amakuru bugasubirwamo bugomba gusobanurwa neza, kugirango abafite amakuru yambere bashobore gutanga amakuru kubandi basaba indishyi, kugabanya ibizamini bisubirwamo, kandi kugabanya umutwaro ku mishinga.
Icya gatatu nukubaka sisitemu yo gusuzuma nyuma yo kwiyandikisha mugukurikirana ingaruka ziterwa nudukoko, kongera gusuzuma no gukomeza kwiyandikisha.Mu 2022, Minisiteri y’ubuhinzi n’ibikorwa by’icyaro yasohoye vuba aha “Amabwiriza yerekeye imicungire y’ikurikiranwa ry’isuzuma ry’isuzuma ry’imiti yica udukoko (Umushinga w’ibitekerezo)”, byerekana ko Ubushinwa bwiyemeje kohereza gahunda kandi buri gihe mu micungire y’imiti yica udukoko.Mu bihe biri imbere, dukwiye kandi gutekereza neza, gukora ubushakashatsi bwimbitse, no kwigira kuri byinshi, hanyuma tugashyiraho buhoro buhoro gahunda yo gucunga umutekano w’imiti yica udukoko nyuma y’iyandikisha ry’imiti yica udukoko ijyanye n’imiterere y’igihugu cy’Ubushinwa binyuze mu gukurikirana, kongera gusuzuma no kwandikisha ibyago byo gukoresha imiti yica udukoko, kugirango bigabanye rwose ingaruka zose z’umutekano zishobora guterwa no gukoresha imiti yica udukoko, no kurinda neza umusaruro w’ubuhinzi, ubuzima rusange n’umutekano w’ibidukikije.
Igihe cyo kohereza: Gicurasi-27-2024