NgoMeyi 17, 2024, i-Official Journal of the European Union (EU) yashicilela (EU) 2024/1328, ibuyekeza into engu-70 yohlu lwezinto ezikhawulelwe ku-Annex XVII yomthetho we-REACH ukuze kukhawulelwe i-octamethylcyclotetrasiloxane (D4), decamethylcyclopentasiloxane (D) , kanye ne-dodecylhexasiloxane (D6) ezintweni noma izingxube. Izimo ezintsha zokumaketha zokugeza izimonyo eziqukethe i-D6 nezimonyo zezakhamuzi eziqukethe i-D4, i-D5, ne-D6 zizoqala ukusebenza ngomhla ka-6 Juni 2024.
Ngokomthethonqubo we-REACH owaphasiswa ngo-2006, imithethonqubo emisha ikhawulela ngokuqinile ukusetshenziswa kwamakhemikhali amathathu alandelayo kuzimonyo ezingezona i-gonococcal neminye imikhiqizo yabathengi nephrofeshinali.
I-Octamethylcyclotetrasiloxane (D4)
Inombolo ye-CAS 556-67-2
EC No 209-136-7
·I-Decamethylcyclopentasiloxane (D5)
Inombolo ye-CAS 541-02-6
I-EC No 208-764-9
I-Dodecyl Cyclohexasiloxane (D6)
Inombolo ye-CAS 540-97-6
EC No 208-762-8
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401328
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Imikhawulo emisha ethile imi kanje:
1. Ngemuva kukaJuni 6, 2026, ngeke ifakwe emakethe: (a) njengento ngokwayo; (b) Njengengxenye yezinye izinto; Noma (c) enhlanganisweni, ukugxila kuyalingana noma kukhulu kuno-0.1% wesisindo sento ehambisanayo;
2. Ngemuva kukaJuni 6, 2026, ngeke isetshenziswe njengesinyibilikisi esomile sendwangu, isikhumba, noboya.
3. Njengokukhululwa:
(a) Ku-D4 kanye ne-D5 kuzimonyo eziwashiwe, iphuzu 1 (c) kufanele lisebenze ngemva komhla zingama-31 kuJanuwari, 2020. Mayelana nalokhu, "izimonyo ezihlanzeka ngamanzi" zibhekisela kuzimonyo njengoba kuchazwe ku-Athikili 2 (1) (a) yoMthethonqubo ( EC) No 1223/2009 wePhalamende LaseYurophu kanye NoMkhandlu, okuthi ngaphansi kwezimo ezijwayelekile zokusetshenziswa, agezwe ngamanzi ngemva kokusetshenziswa;
(b) Zonke izimonyo ngaphandle kwalezo ezishiwo endimeni 3 (a), isigaba 1 sizosebenza ngemva kukaJuni 6, 2027;
(c) Okwamadivaysi (ezokwelapha) njengoba kuchazwe ku-Article 1 (4) ye-Regulation (EU) 2017/745 kanye ne-Article 1 (2) ye-Regulation (EU) 2017/746 yePhalamende laseYurophu kanye noMkhandlu, isigaba sokuqala kufanele faka isicelo ngemuva kukaJuni 6, 2031;
(d) Ezidakamizweni ezichazwe ku-Athikili 1, iphuzu 2 leSiqondiso 2001/83/EC kanye nezidakamizwa zezilwane ezichazwe ku-Athikili 4 (1) Yomthethonqubo (EU) 2019/6, isigaba 1 sizosebenza ngemva komhla ka-6 Juni 2031;
(e) Ku-D5 njengesinyibilikisi sendwangu yokuhlanza okomile, isikhumba, noboya, izigaba 1 no-2 zizosebenza ngemva kukaJuni 6, 2034.
4. Njengokukhululwa, isigaba 1 asisebenzi kokuthi:
(a) Faka imikhiqizo ye-D4, i-D5, ne-D6 emakethe ukuze isetshenziswe ezimbonini ezilandelayo: - njengama-monomers okukhiqizwa kwama-polymers e-organosilicon, - njengeziphakathi zokukhiqiza ezinye izinto ze-silicon, - njengama-monomers ku-polymerization, - ukuze kwenziwe noma (kabusha) ukupakishwa kwezingxube- Isetshenziselwa ukukhiqiza izimpahla- Ayisetshenziselwa ukwelapha indawo yensimbi;
(b) Beka i-D5 ne-D6 emakethe ukuze isetshenziswe njengamadivayisi (ezokwelapha) njengoba kuchazwe ku-Athikili 1 (4) ye-Regulation (EU) 2017/745, yokwelashwa nokunakekelwa kwezibazi namanxeba, ukuvimbela izilonda, nokunakekelwa. i-stomas;
(c) Beka i-D5 emakethe ukuze ochwepheshe bahlanze noma babuyisele ubuciko nezinto zakudala;
(d) Yethula i-D4, i-D5, ne-D6 emakethe njengama-reagents aselabhorethri ukuze enze ucwaningo nokuthuthukisa imisebenzi ngaphansi kwezimo ezilawulwayo.
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5. Njengokukhululwa, iphuzu (b) lesigaba 1 alisebenzi ku-D4, i-D5, kanye ne-D6 ebekwe emakethe: - njengezingxenye ze-organosilicon polymers - njengezingxenye zama-organosilicon polymers kuzingxube ezishiwo esigabeni 6.
6. Njengokukhululwa, iphuzu (c) lesigaba 1 alisebenzi kuzingxube eziqukethe i-D4, i-D5, noma i-D6 njengezinsalela zama-polymers e-organosilicon abekwe emakethe ngaphansi kwalezi zimo ezilandelayo:
(a) Ukugxila kwe-D4, D5 noma i-D6 ilingana noma ngaphansi kuka-1% wesisindo sento ehambisanayo enhlanganisweni, esetshenziselwa ukuhlanganisa, ukuvala, ukunamathisela nokuphonsa;
(b) Ingxube yezingubo zokuzivikela (kuhlanganise nezingubo zomkhumbi) ezinezingxube ze-D4 ezilingana noma ngaphansi kuka-0.5% ngesisindo, noma ukuhlushwa kwe-D5 noma i-D6 elingana noma ngaphansi kuka-0.3% ngesisindo;
(c) Ukuqoqwa kwe-D4, D5 noma i-D6 ilingana noma ngaphansi kuka-0.2% wesisindo sento ehambisanayo enhlanganisweni, futhi isetshenziswa njengempahla (yezokwelapha) njengoba kuchazwe ku-Athikili 1 (4) Yomthethonqubo (EU). ) 2017/745 kanye ne-Article 1 (2) ye-Regulation (EU) 2017/746, ngaphandle kwempahla eshiwo esigabeni 6 (d);
(d) Ukugxiliswa kwe-D5 okulingana noma ngaphansi kuka-0.3% ngesisindo sengxube noma ukugxiliswa kwe-D6 okulingana noma ngaphansi kuka-1% ngesisindo sengxube, okusetshenziswe njengethuluzi elichazwe ku-Athikili 1 (4) Yomthethonqubo (EU) 2017 /745 kokuvela kwamazinyo;
(e) Ukugxila kwe-D4 kungxube ilingana noma ingaphansi kuka-0.2% ngesisindo, noma ukugxiliswa kwe-D5 noma i-D6 kunoma iyiphi into esengxubeni ilingana noma ingaphansi kuka-1% ngesisindo, esetshenziswa njengama-silicon insoles noma izicathulo zamahhashi zamahhashi;
(f) Ukugxila kwe-D4, i-D5 noma i-D6 ilingana noma ngaphansi kuka-0.5% wesisindo sento ehambisanayo kungxube, esetshenziswa njengomgqugquzeli wokunamathela;
(g) Ukugxiliswa kwe-D4, i-D5 noma i-D6 ilingana noma ngaphansi kuka-1% wesisindo sento ehambisanayo kungxube, esetshenziselwa ukuphrinta kwe-3D;
(h) Ukugxila kwe-D5 engxubeni ilingana noma ingaphansi kuka-1% ngesisindo, noma ukugxila kwe-D6 engxubeni kulingana noma ngaphansi kuka-3% ngesisindo, esetshenziselwa ukwenza i-prototyping ngokushesha kanye nokwenza isikhunta, noma izicelo ezisebenza kahle kakhulu eziqiniswe izigcwalisi ze-quartz;
(i) Ukugxiliswa kwe-D5 noma i-D6 kulingana noma ngaphansi kuka-1% wesisindo sanoma iyiphi into esengxubeni, esetshenziselwa ukuphrinta amaphedi noma ukukhiqiza; (j) Ukugxiliswa kwe-D6 kulingana noma ngaphansi kuka-1% wesisindo sengxube, esetshenziselwa ukuhlanza okuphrofeshinali noma ukubuyisela ubuciko nezinto zakudala.
7. Njengokukhululwa, izigaba 1 no-2 azisebenzi ekubekweni emakethe noma ukusetshenziswa kwe-D5 njenge-solvent kumasistimu okuhlanza okomile avaliwe alawulwa ngokuqinile ezindwangu, isikhumba, noboya, lapho i-solvent yokuhlanza igaywa kabusha noma ishiswa.
Lo mthethonqubo uyoqala ukusebenza ngosuku lwama-20 kusukela osukwini lokushicilelwa kwawo ku-Official Journal of the European Union, futhi uzoba namandla abophezelayo futhi usebenze ngokuqondile kuwo wonke amazwe angamalungu e-EU.
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Isifinyezo:
Ngenxa yokuthi i-D4, i-D5, ne-D6 ziyizinto ezikhathazayo kakhulu (SVHC), zibonisa ukuphikelela okuphezulu kanye ne-bioaccumulation (vPvB). I-D4 iphinda yaziwa ngokuthi iyaphikelela, i-bioaccumulative, kanye ne-toxic (PBT), futhi uma i-D5 ne-D6 iqukethe u-0.1% noma ngaphezulu we-D4, zibuye ziqashelwe njengezinezici ze-PBT. Uma kucatshangelwa ukuthi ubungozi bemikhiqizo ye-PBT ne-vPvB abukalawulwa ngokugcwele, imikhawulo iyindlela yokuphatha efaneleke kakhulu.
Ngemva kokuvinjelwa nokulawulwa kwemikhiqizo yokuwasha equkethe i-D4.D5 ne-D6, ukulawulwa kwemikhiqizo engawashi equkethe i-D4.D5 ne-D6 kuzoqiniswa. Ngesikhathi esifanayo, uma kucatshangelwa izimo zamanje zohlelo olubanzi, imikhawulo ekusetshenzisweni kwe-D5 ezindwangu, isikhumba, noboya bokuhlanza okomile, kanye nemikhawulo ekusetshenzisweni kwe-D4.D5 ne-D6 emithini yemithi nemithi yezilwane, izohlehliswa. .
Uma kubhekwa ukusetshenziswa okukhulu kwe-D4.D5 ne-D6 ekukhiqizeni i-polydimethylsiloxane, ayikho imingcele efanele kulokhu kusetshenziswa. Ngesikhathi esifanayo, ukuze kucaciswe ingxube ye-polysiloxane equkethe izinsalela ze-D4, i-D5, ne-D6, imikhawulo yokuhlushwa ehambisanayo nayo ihlinzekwe ngezingxube ezahlukene. Izinkampani ezifanele kufanele zifunde ngokucophelela izigatshana ezifanele ukuze zigweme ukuthi umkhiqizo ungaphansi kwemibandela evimbelayo.
Sekukonke, imikhawulo ku-D4.D5 ne-D6 inomthelela omncane kakhulu embonini yasekhaya ye-silicone. Izinkampani zingahlangabezana nemikhawulo eminingi ngokucabangela izinkinga ezisele ze-D4.D5 ne-D6.
Ilebhu yokuhlola ye-BTF, inkampani yethu inamalabhorethri ahambisana nogesi, izimiso zokuphepha Ilabhorethri, Ilabhorethri yefrikhwensi yomsakazo, Ilabhorethri yebhethri, Ilabhorethri yamakhemikhali, I-SAR Laboratory, I-HAC Laboratory, njll. Sithole iziqu nokugunyazwa okufana ne-CMA, CNAS, CPSC, A2LA, I-VCCI, njll. Inkampani yethu inethimba lobunjiniyela bezobuchwepheshe abanolwazi nochwepheshe, elingasiza amabhizinisi ukuxazulula inkinga. Uma unezidingo ezifanele zokuhlola nezitifiketi, ungathintana ngqo nabasebenzi bethu bokuhlola ukuze uthole amakhotheshini anemininingwane yezindleko kanye nolwazi lomjikelezo!
Isikhathi sokuthumela: Jul-31-2024
