Amabwiriza y’ubumwe bw’ibihugu by’Uburayi n’ibisabwa mu kohereza ibicuruzwa by’ubuvuzi

Ku ya 25 Gicurasi 2017, Amabwiriza y’ubuvuzi bw’ibihugu by’Uburayi (Amabwiriza ya MDR (EU) 2017/745)byatangajwe ku mugaragaro,hamwe ninzibacyuho yimyaka itatu. Mu ntangiriro byari biteganijwe ko bizakurikizwa byuzuye guhera ku ya 26 Gicurasi 2020. Kugirango duhe inganda igihe kinini cyo guhuza n'amabwiriza mashya no kwemeza ko ibicuruzwa byujuje ibisabwa. Komisiyo y’Uburayi yemeje icyifuzo cyo kongera igihe cy’inzibacyuho ku ya 6 Mutarama 2023.Nkurikije iki cyifuzo, igihe cy’inzibacyuho cy’ibikoresho bishobora guteza ibyago byinshi kizongerwa kuva ku ya 26 Gicurasi 2024 kugeza ku ya 31 Ukuboza 2027; igihe cyinzibacyuho kubikoresho bito n'ibiciriritse bishobora kwongerwa kugeza 31 Ukuboza 2028; Icyiciro cya III cyimikorere gakondo Igihe cyinzibacyuho cyibikoresho kizongerwa kugeza 26 Gicurasi 2026.

 

Kugirango usobanukirwe nubushakashatsi bwibikoresho bya EU byubuvuzi bwa MDR, ugomba kubanza kubyumvaIbintu bya CMR na EDCs.

Ibintu bya CMRCMR ni impfunyapfunyo ya Carcinogenic carcinogenic, Mutagenic gene mutagenic hamwe nuburozi bwa reprotoxic. Kubera ko ibintu bya CMR bifite ingaruka zidakira, bigomba kugenzurwa no kubuzwa. Ibihumbi n’ibintu bya CMR byatangajwe kugeza ubu, kandi umubare uzakomeza kwiyongera mu bihe biri imbere. Ukurikije ibyago byabo, bigabanijwemo ibyiciro bitatu bikurikira:

CMR: 1A—— Byemejwe ko bifite ingaruka ziterwa na kanseri, mutagenic nimyororokere kubantu

CMR: 1B——Byemejwe nubushakashatsi bwinyamaswa ko bushobora gutera ingaruka eshatu zavuzwe haruguru kumubiri wumuntu

CMR: 2——Bimwe mubitabo byerekana ko bishobora gutera ingaruka eshatu zavuzwe haruguru kumubiri wumuntu. Ikintu cya CMR gishobora kuba kirimo kimwe cyangwa byinshi biranga ibyago bya CMR. Iyo irimo ibiranga byinshi bya CMR ibyago, bizashyirwa mubikorwa ukurikije buri kiranga ibyago, Urugero:

Benzene ni kanseri ya 1A hamwe na teratogenic 1B; (Carc. Injangwe. 1A, Muta. Injangwe. 1B)

Chromate iyobora (II) ni kanseri 1B, uburozi bwimyororokere 1A ibintu; (Carc. Cat. 1B, Rep. Cat. 1A)

Dibutyltin dichloride nicyiciro cya teratogenic icyiciro cya 2, uburozi bwimyororokere icyiciro cya 1B; (Muta. Cat. 2, Rep. Cat. 1B)

Benzo (a) pyrene ni kanseri 1B, teratogenic 1B, n'uburozi bw'imyororokere 1B; (Carc. Injangwe. 1B, Muta. Injangwe. 1B, Rep.Ibintu bya EDCsIbintu bya EDCs ni Endocrine-Ihagarika Imiti Endocrine ihagarika ibintu bya shimi, bivuga ibintu bya chimique bishobora kubangamira imikorere ya endocrine yumuntu biva hanze. Iyi miti yakozwe n'abantu irashobora kwinjira mumubiri wumuntu cyangwa izindi nyamaswa binyuze murwego rwibiryo (indyo) cyangwa guhura, kandi bigira ingaruka kumyororokere yabo. Bazabangamira synthesis, kurekura, kugenda, metabolism, hamwe no guhuza ibintu bisanzwe bisohoka mumubiri, gukora cyangwa kubuza sisitemu ya endocrine, bityo bikangiza uruhare rwayo mukubungabunga umutekano no kugenzura umubiri.

Amabwiriza y’ibikoresho by’ubuvuzi bya EUMDR

MDR ni ihame ryo kugera kubikoresho byubuvuzi byinjira ku isoko ry’Uburayi. Intego yacyo nyamukuru ni ukurinda umutekano n’ibikorwa by’ibikoresho by’ubuvuzi mu gihe cy’ubuzima bwose, no gucunga ibikoresho by’ubuvuzi bigurishwa ku isoko ry’ubumwe bw’ibihugu by’Uburayi mu buryo bunoze bwo kurinda abaturage. Ubuzima n’umutekano w’abarwayi. Itangizwa ryaya mabwiriza risobanura kandi ko amabwiriza yambere yubuvuzi bukora (AIMD, 90/385 / EEC) hamwe nubuyobozi bwibikoresho byubuvuzi byoroshye (MDD, 93/42 / EEC) bizasimburwa buhoro buhoro. Bitandukanye n’amabwiriza yabanjirije iyi, birasabwa muri MDR Ingingo ya 52 n’Umutwe wa II Umugereka wa I 10.4.1 ko ibintu bya CMR / ECDs bigomba kwirindwa ku bikoresho n’ibigize cyangwa ibikoresho bifite ibimenyetso bikurikira:

01 Kwinjira, no guhura muburyo butaziguye numubiri wumuntu, nkimikorere ya orthopedic, imitwe ya termometero yipimisha, nibindi.;

02 ikoreshwa mu kugeza ibiyobyabwenge, amazi yumubiri cyangwa ibindi bintu (harimo na gaze) mumubiri wumuntu, nkumuyoboro uhumeka, nibindi.;

03 ikoreshwa mu gutwara cyangwa kubika kugirango itangwe Ibiyobyabwenge, amazi yumubiri cyangwa ibintu (harimo na gaze) mumubiri wumuntu, nkibikoresho byo gushiramo, nibindi.

Amabwiriza y’ibikoresho by’ubuvuzi bya EU (MDR)Ibibujijwe n'ibisabwa

Dukurikije amabwiriza ya MDR, birakenewe kwemeza ibikoresho byubuvuzi nibigize nibikoresho, kandi twirinde kwibanda kubintu bikurikira birenga 0.1 (W / W)%: 1) Ibintu byangiza kanseri, mutagen cyangwa imyororokere (CMR): icyiciro 1A cyangwa 1B, dukurikije Imbonerahamwe 3.1 y Igice cya 3 cy Umugereka wa VI w’amabwiriza No 1272/2008 y’Inteko Ishinga Amategeko y’Uburayi n’Inama Njyanama (Amabwiriza ya CLP). ) . Niba ubunini bwibintu bya CMR / EDCs burenze 0.1%, uwakoze ibikoresho agomba kwerekana ko ibyo bintu biri kubikoresho ubwabyo ndetse no gupakira kwa buri gice, kandi bigatanga urutonde rurimo amazina yibintu hamwe nubunini bwabyo. Niba gukoresha ibikoresho nk'ibi birimo kuvura abana, abagore batwite cyangwa bonsa, n'andi matsinda y'abarwayi bafatwa nk'abashobora kwibasirwa cyane n'ibintu nk'ibi cyangwa / cyangwa ibikoresho, amabwiriza yo gukoresha agomba kuvuga ko ayo matsinda y'abarwayi ashobora guhura nabyo ibyago bisigaye, hamwe nubwitonzi bukwiye, niba bishoboka.

RoHS-Kubuzayo gukoresha ibintu bimwe bishobora guteza akaga ibikoresho byamashanyarazi na elegitoroniki

Niba ibisabwa byo gusuzuma no gusuzuma RoHS, REACH nandi mabwiriza byujujwe, turacyakeneye ibisubizo byikizamini cyibintu bya chimique bisabwa na MDR? Amabwiriza ya EU RoHS ni itegeko riteganijwe. Kugenzura ibicuruzwa bya elegitoroniki n’amashanyarazi nibice bifitanye isano bigomba kuba munsi yibisabwa kubintu bibujijwe. Nubuyobozi bugomba kwitabwaho mugihe cyohereza ibikoresho byubuvuzi bya elegitoronike muri EU.

Amabwiriza ya REACH yibanze cyane kubisabwa bibiri bikurikira mubikoresho byubuvuzi byo kugenzura no kubimenyeshwa(Ingingo 7) , mubindi bintu, birashobora kandi kuba bikubiyemo ibisabwa kugirango wohereze amakuru kumurongo wo gutanga. Ibintu bibujijwe kandi bibujijwe (Ingingo ya 67): Kubikoresho byihariye byo gukoresha cyangwa mugihe ibicuruzwa birimo ibintu bibujijwe kandi bibujijwe kurenza imipaka, kubikora no kubikoresha birabujijwe.

Gupakira no gupakira imyanda Amabwiriza-Amabwiriza 94/62 / EC (PPW)Amabwiriza yo Gupakira no Gupakira Amabwiriza (Amabwiriza yo Gupakira no Gupakira Imyanda) ateganya cyane cyane ibyuma bine biremereye mubikoresho byo gupakira no kugabanya imipaka hamwe no gupakira imyanda. Dukurikije ingingo ya 22 (i) y’iri tegeko, ibihugu bigize Umuryango w’ubumwe bw’ibihugu by’Uburayi bigomba kwemeza ko guhera ku ya 30 Kamena 2001, ibikoresho bipfunyika cyangwa bipfunyika bidashobora kuba birimo ibyuma bine biremereye (kadmium, chromium hexavalent, gurş, mercure) hamwe n’ubushakashatsi bwabo bwose. Igiteranyo ntigomba kurenga 100 ppm. Umuryango w’ubumwe bw’ibihugu by’i Burayi wasohoye Amabwiriza 2013/2 / EU ku 2013.02.08 kugira ngo avugurure ibikoresho byo gupakira hamwe n’amabuye y’imyanda (Amabwiriza 94/62 / EC, PPW). Amabwiriza mashya agumana ibisabwa bine byose bisabwa kubintu byangiza mubikoresho byo gupakira: gurş, kadmium, mercure, na chromium ya hexavalent, kandi biracyagarukira kuri 100ppm, guhera ku ya 30 Nzeri 2013. Ukurikije ibisabwa na PPW, ibicuruzwa bipakira ibicuruzwa. yuwabikoze agomba kuba yujuje ibyangombwa bitagira ingaruka, kongera gupakira, gutunganya ibikoresho bipakira imyanda nubundi buryo bwo kuvugurura, no kugabanya guta burundu. Inyandiko zateguwe zitwa ibikoresho byo gupakira. Raporo yo gusuzuma ibipimo byubahirizwa / kugenzura.

Ibikoresho byubuvuzi byishyurwa na EU bigomba kubahiriza amabwiriza atatu ya MDR, RoHS na REACH

Ibisabwa kubahiriza MDR, RoHS na REACH birasa. Ibikoresho byubuvuzi bizima byashyizwe kumasoko yuburayi bigomba kubahiriza ibisabwa naya mabwiriza atatu, mugihe ibikoresho byubuvuzi byigenga bitagengwa namabwiriza ya RoHS. Muri byo, amabwiriza ya REACH na RoHS niyo shingiro, kandi kubikoresho byubuvuzi byujuje ibisobanuro bya MDR Umugereka wa I 10.4.1, hagomba gukorwa ibizamini bya chimique CMR / EDCs. Byongeye kandi, ibikoresho byubuvuzi bigomba kubahiriza ibisabwa n’amabwiriza ya MDR ntabwo byujuje gusa ibisabwa n’amabwiriza ya RoHS na REACH, ahubwo binashyira mu byiciro buri kintu cy’imiti gishingiye ku gukora ibikoresho n’ingaruka zabyo mu gihe cyo guhitamo uburyo bukwiye bwo gusuzuma kugira ngo harebwe ko ibikoresho byubuvuzi bibereye ibikoresho bitandukanye bipimwa kugirango bisuzumwe neza.