isifinyezo
IKHOMISHINI YAseYurophu,
Ngokuphathelene neSivumelwano sokuSebenza kwe-European Union,
Uma kubhekwa uMthethonqubo (CE) n. 1107/2009 wePhalamende laseYurophu kanye noMkhandlu, wangomhla zingama-21 kuMfumfu, 2009, mayelana nokumakethwa kwemikhiqizo yokuvikela izitshalo nalapho kuchithwa khona Iziqondiso 79/117/CEE kanye 91/414/CEE zoMkhandlu (1), kanye ikakhulukazi isihloko sayo sama-20, isigaba 1, incwadi a),
Uma kucatshangelwa okulandelayo:
- (1) Umyalelo Wekhomishini 2005/58/EC (2) uhlanganisa i-bifenazate njengento esebenzayo kuSijobelelo I seSiqondiso soMkhandlu 91/414/EEC (3) .
- (2) Izinto ezisebenzayo ezifakwe kuSijobelelo I seSiqondiso 91/414/CEE sivunyiwe kucatshangelwa ukuthotshelwa koMthethonqubo (CE) n. 1107/2009 ivela engxenyeni A yesithasiselo soMtheshwana Wokusebenza (EU) n. 540/2011 weKhomishini (4) .
- (3) Ukugunyazwa kwento esebenzayo ye-bifenazate, eyayisohlwini lwengxenye A yesithasiselo SokuQalisa Umthethonqubo (EU) no. 540/2011, iphelelwa yisikhathi ngoJulayi 31, 2022.
- (4) Ngokuvumelana ne-Article 1 YokuQalisa Umthethonqubo (EU) no. 844/2012 weKhomishana (5), Izwe eliyiLungu le-rapporteur lithole isicelo sokuvuselela ukugunyazwa kwento esebenzayo ye-bifenazate phakathi nesikhathi esihlinzekwe kuleso sihloko.
- (5) Umfakisicelo uhambisa amafayela engeziwe adingekayo ngokuhambisana nesihloko sesi-6 soMthethonqubo WokuQalisa (EU) n. 844/2012. Izwe eliyilungu le-rapporteur libona ukuthi isicelo siqediwe.
- (6) Izwe eliyiLungu elinombiko lilungiselele ukuhlolwa kokuvuselela okusalungiswa okunolwazi ngokuxoxisana neZwe eliyiLungu le-reporteur futhi likuthumele ku-European Food Safety Authority (Isiphathimandla) nakuKhomishana zingama-29 kuMasingana wezi-2016.
- (7) Isigungu seziPhathimandla senze isifinyezo sefayela elihambisanayo latholakala emphakathini. Isiphathimandla siphinde sasabalalisa umbiko wokuhlola wokuvuselela okusalungiswa kumfakisicelo kanye naMazwe Angamalungu ukuze aphawule, futhi sethula ukubonisana nomphakathi ngawo. Isiphathimandla sidlulisela imibono eyamukelwe kuKhomishana.
- (8) Ngomhla zizi-4 kuMasingana, 2017, isiGungu seziPhathimandla sazisa iKhomishana ngesiphetho saso (6) mayelana nokuthi i-bifenazate ingalindelwa yini ukuhlangabezana nemibandela yokugunyazwa esungulwe ku-Article 4 yoMthethonqubo (EC) No. 1107/2009; kuyo, i-EFSA ithola ubungozi obubangelwa izinyoni ezingahlosiwe, izilwane ezincelisayo kanye nezilwane ezincelisayo ngokuphathelene nabo bonke abasebenzisi abamele futhi, ngaphezu kwalokho, ingozi ebangelwa abaqhubi nabasebenzi ngokuphathelene nabasebenzisi abakhulu kunabo bonke. Ngaphezu kwalokho, ayikwazanga ukuqedela ukuhlolwa kwengozi ekhona ezintweni eziphila emanzini nakubathengi.
- (9) Mhla ziyi-17 kuNovemba 2020, iKhomishana yagunyaza i-EFSA ukuthi ihlole ubungozi obuvela ekusetshenzisweni kwe-bifenazate kanye ngonyaka ngethamo eliphansi kakhulu elethulwe kudosi. Izwe eliyilungu le-reporteur libuyekeza umbiko waso wokuhlaziya wokuvuselela ngokufanele futhi Isiphathimandla sibuyekeza isiphetho saso zingama-30 Agasti 2021 (7); kuyo, thola ubungozi obuphakeme ezinyonini uma kwenzeka zichayeka isikhathi eside ku-bifenazate kukho konke ukusetshenziswa kommeleli. Ngaphezu kwalokho, ayikwazanga ukuqedela ukuhlolwa kwengozi ekhona kubathengi. Ikhomishana ibika ngokuvuselelwa kwe-bifenazate eKomidini Elimisiwe Lezitshalo, Izilwane, Ukudla Nesiphakeli ngoJulayi 19, 2017 kanye no-Okthoba 22, 2021, kanye nohlaka lwalo Mthethonqubo ngoDisemba 1, 2021.
- (10) IKhomishana imema umfakisicelo ukuthi alethe imibono yayo eziphethweni ezimbili zesiGungu seziPhathimandla futhi, ngokuhambisana neSigaba 14(1), isigatshana sesithathu, sokuSebenzisa Umthethonqubo (EU) No. 844/2012 (8), mayelana nombiko ophusile wokuvuselela. Umfakisicelo uthumela imibono yakhe, ecutshungulwa ngokucophelela.
- (11) Kunqunyiwe, maqondana nokusetshenziswa okukodwa noma ngaphezulu kokumelayo okungenani komkhiqizo owodwa wokuvikela isitshalo oqukethe into esebenzayo i-bifenazate, ukuthi imibandela yokugunyaza ebekwe ku-Article 4 of Regulation (EC) No. 1107/2009.
- (12) Ngakho-ke kufanelekile ukuvuselela ukugunyazwa kwe-bifenazate.
- (13) Nokho, ngokuhambisana nezinhlinzeko zeSigaba 14(1) soMthethonqubo (EC) No. 1107/2009, maqondana ne-athikili yayo yesi-6, futhi kucatshangelwa ulwazi lwamanje lwesayensi nobuchwepheshe, kuyadingeka ukufaka izimo ezithile nemikhawulo. Qhubeka, ikakhulukazi, ukukhawulela ukusetshenziswa kwemikhiqizo yokuvikela izitshalo equkethe i-bifenazate engadliwayo etshalwe ezindlini zokugcina izithombo unomphela futhi ucele ulwazi olwengeziwe oluqinisekisayo.
- (14) Ukukhawulelwa kokusetshenziswa kwezitshalo ezingadliwa akuhlanganisi ukuchayeka kwabathengi ngokudla, okuholela ekukhokheni ngoba ukuhlolwa kwerayisi kubathengi akuqedwa. Njengoba kunikezwe ukuthi ithola ubungozi obukhulu ezinyoni uma kwenzeka zichayeka isikhathi eside ku-bifenazate, umkhawulo wokusetshenziswa kwayo ezindaweni zokugcina izithombo, njengoba kuchazwe ku-athikili 3 yoMthethonqubo (EC) no. 1107/2009, iqinisekisa ukuthi izinyoni azivezwa ku-l. Ngaphezu kwalokho, uma kubhekwa ukuthi, ngokusekelwe kudatha etholakalayo, iSiphathimandla sithola ubungozi obukhulu ezilwaneni ezincelisayo maqondana nokusetshenziswa okuthile okumelayo kanye nobungozi obungamahlalakhona bezinyosi, ukuvinjelwa kokusetshenziswa kuphela ezindlini zokugcina izithombo nakho kuvimbela ukuchayeka kwalezo zilwane okungezona okuhlosiwe. , njengokuba khona kwayo emanzini okuphuza.
- (15) Ngokuqondene nemibandela yokunquma izakhiwo eziphazamisayo ze-endocrine ezethulwe yi-Commission Regulation (EU) 2018/605 (9), ngokusekelwe olwazini olutholakalayo lwesayensi olufingqiwe esiphethweni sesiGungu, Ikhomishana icabange ukuthi i-bifenazate ayinazo izakhiwo ze-endocrine eziphazamisayo.
- (16) Ukuze kuqiniswe ukuzethemba esiphethweni sokuthi i-bifenazate ayinazo izakhiwo ze-endocrine eziphazamisayo, umfakisicelo, ngokuhambisana nephuzu 2.2, incwadi b), yesiThasiselo II kuMthethonqubo (EC) No. 1107/2009, kumele yethule ukuhlolwa okubuyekeziwe kwemibandela esungulwe kumaphuzu 3.6.5 no-3.8.2 weSijobelelo II soMthethonqubo (EC) no. 1107/2009, futhi senze lokho ngokuvumelana neziqondiso zokutholwa kweziphazamisi ze-endocrine (10) .
- (17) Ukuhlolwa kwengozi yokuvuselelwa kokugunyazwa kwento esebenzayo i-bifenazate kusekelwe ekusetshenzisweni kommeleli njenge-acaricide. Ngenxa yalokhu kuhlolwa kwengozi, akudingekile ukugcina umkhawulo wokusetshenziswa okukhethekile njenge-acaricide.
- (18) Ngakho-ke kufanelekile ukuchibiyela Umthethonqubo Wokusebenzisa (EU) No. 540/2011 ngokufanele.
- (19) Nge-Commission Execution Regulation (EU) 2021/745 (11) inwebe isikhathi sokugunyazwa se-bifenazate kuze kube ngumhla zingama-31 kuJulayi, 2022 ukuze ibone inqubo yokuvuselela ngaphambi kokuphela kwesikhathi sokugunyazwa kwento esebenzayo eshiwo. Nokho, njengoba isinqumo sokuvuselela sithathwe ngaphambi kwalolo suku olunwetshiwe lokuphelelwa yisikhathi, lo Mthethonqubo kufanele usebenze ngokushesha okukhulu.
- (20) Izinyathelo ezihlinzekwe kulo Mthethonqubo zihambisana nombono weKomidi Elimisiwe LeZimila, Izilwane, Ukudla Nokuphakelayo,
WAMKELELA LE IMITHETHO:
I-athikili 1 Ukuvuselelwa kokugunyazwa kwento esebenzayo
Ukugunyazwa komuthi osebenzayo we-bifenazate, njengoba kucaciswe kusijobelelo I, kuvuselelwa ngokuvumelana nemibandela nemikhawulo esungulwe kusijobelelo esishiwo.
I-athikili 2 Ukuguqulwa Komthethonqubo Wokusayinwa (EU) n. 540/2011
Isijobelelo soMthethonqubo Wokubulala (EU) n. 540/2011 ishintshiwe ngokuvumelana nezinhlinzeko zeSijobelelo II salo Mtheshwana.
Isigaba 3 Ukuqala ukusebenza kanye nosuku lokufaka isicelo
Lo Mthethonqubo uzoqala ukusebenza ezinsukwini ezingamashumi amabili ngemva kokushicilelwa kwawo ku-Official Journal of the European Union.
Izosebenza kusukela ngomhlaka-1 Julayi 2022.
Lo Mthethonqubo uyobophezela kuzo zonke izici zawo futhi usebenze ngokuqondile kulelo nalelo zwe eliyiLungu.
Kwenziwe e-Brussels, ngoMeyi 3, 2022.
OkweKhomishini
umongameli
Ursula VON DER LEYEN
ISIQEPHU I
Igama elivamile nezinombolo zesibonakaliso I-IUPAC Igama elithi Purity (12) Usuku lokugunyazwa Ukuphelelwa yisikhathi kokugunyazwa Imibandela ethile
Bifenazate
149877-41-8
736
I-isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate
980g / kg
I-toluene iyinkinga ye-toxicological futhi akufanele idlule ku-0,7 g/kg ezintweni zobuchwepheshe.
Julayi 1, 2022 Juni 30, 2037
Kugunyazwe ukusetshenziswa ezitshalweni ezingadliwa kuphela ezindlini zokugcina izithombo unomphela.
Ukuze kusetshenziswe izimiso ezifanayo okukhulunywe ngazo ku-athikili 29, isigaba 6, soMthethonqubo (EC) no. 1107/2009, ibheka iziphetho zombiko wokuvuselela i-bifenazate futhi, ikakhulukazi, kwizijobelelo zawo I kanye no-II.
Kulokhu kuhlola kukonke, Amazwe Angamalungu kufanele anake kakhulu lezi zici ezilandelayo:
--ukuvikelwa kwabaqhubi nabasebenzi, ukuqinisekisa ukuthi izimo zokusebenzisa zihlanganisa ukusetshenziswa kwezinto ezanele zokuvikela umuntu,
--ubungozi bezinyosi nezinyosi ezikhishelwa ukuvuthwa kwempova ezindaweni zokugcina izithombo.
Imibandela yokusebenzisa kumele ifake, lapho kufanele, izinyathelo zokunciphisa ubungozi.
Kungakadluli umhla zingama-24 kuNhlaba wezi-2024, umfakisicelo uzohambisa ulwazi oluqinisekisayo kuKhomishana, Amazwe Angamalungu kanye Nesigungu Seziphathimandla mayelana namaphuzu 3.6.5 kanye no-3.8.2 eSijobelelo II soMthethonqubo (EC) No. 1107/2009, elungiswe yi-Regulation (EU) 2018/605, ikakhulukazi ukuhlolwa okubuyekeziwe kolwazi oluvezwe ngenhla futhi, kulokhu, ulwazi olwengeziwe lokuqinisekisa ukungabikho komsebenzi we-endocrine.
ISITHASISELO II
Isijobelelo soMthethonqubo Wokubulala (EU) n. 540/2011 ilungiswe kanje:
- 1) Engxenyeni A, okufakiwe 109, okuhlobene ne-bifenazate, kuyasuswa. LE0000455592_20220501
- 2) Engxenyeni B, okufakiwe okulandelayo kuyatholakala: Inombolo yegama okungelona elobunikazi kanye nezinombolo zesibonakaliso IUPAC igama elithi Purity (13) Usuku lokugunyaza Ukuphelelwa yisikhathi kokugunyazwa Imibandela ethile152
Bifenazate
149877-41-8
736
I-isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate
980g / kg
I-toluene iyinkinga ye-toxicological futhi akufanele idlule ku-0,7 g/kg ezintweni zobuchwepheshe.
Julayi 1, 2022 Juni 30, 2037
Kugunyazwe ukusetshenziswa ezitshalweni ezingadliwa kuphela ezindlini zokugcina izithombo unomphela.
Ukuze kusetshenziswe izimiso ezifanayo okukhulunywe ngazo ku-athikili 29, isigaba 6, soMthethonqubo (EC) no. 1107/2009, ibheka iziphetho zombiko wokuvuselela i-bifenazate futhi, ikakhulukazi, kwizijobelelo zawo I kanye no-II.
Kulokhu kuhlola kukonke, Amazwe Angamalungu kufanele anake kakhulu lezi zici ezilandelayo:
--ukuvikelwa kwabaqhubi nabasebenzi, ukuqinisekisa ukuthi izimo zokusebenzisa zihlanganisa ukusetshenziswa kwezinto ezanele zokuvikela umuntu,
--ubungozi bezinyosi nezinyosi ezikhishelwa ukuvuthwa kwempova ezindaweni zokugcina izithombo.
Imibandela yokusebenzisa kumele ifake, lapho kufanele, izinyathelo zokunciphisa ubungozi.
Kungakadluli umhla zingama-24 kuNhlaba wezi-2024, umfakisicelo uzohambisa ulwazi oluqinisekisayo kuKhomishana, Amazwe Angamalungu kanye Nesigungu Seziphathimandla mayelana namaphuzu 3.6.5 kanye no-3.8.2 eSijobelelo II soMthethonqubo (EC) No. 1107/2009, elungiswe yi-Regulation (EU) 2018/605, ikakhulukazi ukuhlolwa okubuyekeziwe kolwazi oluvezwe ngenhla futhi, kulokhu, ulwazi olwengeziwe lokuqinisekisa ukungabikho komsebenzi we-endocrine.
LE0000455592_20220501
