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eiteocsaquin
ethoxyquin
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#2154557
EATOCSACUIN
ETHOXYQUIN
#2353230
Eatocsacuin
Ethoxyquin
#2497321
Mar sin léirítear leis an measúnú ar eatocsacuin nach gcomhlíontar na coinníollacha údaraithe, dá bhforáiltear in Airteagal 5 de Rialachán (CE) Uimh. 1831/2003, agus dá réir sin ba cheart údarú eatocsacuine mar bhreiseán beathaithe a bhaineann leis an bhfeidhmghrúpa “frithocsaídeoirí” a dhiúltú.
The assessment of ethoxyquin thus shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are not satisfied and accordingly, the authorisation of ethoxyquin as a feed additive belonging to the functional group ‘antioxidants’ should be denied.
#1935657
lena leasaítear Rialachán Cur Chun Feidhme (AE) 2017/962 a mhéid a bhaineann leis an athbhreithniú ar údarú eatocsacuine mar bhreiseán beathaithe a chur ar fionraí
amending Implementing Regulation (EU) 2017/962 as regards the review of the suspension of the authorisation of ethoxyquin as a feed additive
#1935672
In aon chas, ba cheart athbhreithniú a dhéanamh ar an mbeart fionraíochta i gcás ina nglacfaidh an tÚdarás tuairim neamhfhabhrach maidir le sábháilteacht nó éifeachtúlacht an bhreiseáin eatocsacuin, le linn an phróisis measúnaithe.
In any event, the suspension measure should be reviewed where, during the assessment process, the Authority adopts a non-favourable opinion on the safety or efficacy of the additive ethoxyquin.
#2497291
maidir le húdarú eatocsacuine a dhiúltú mar bhreiseán beathaithe a bhaineann leis an bhfeidhmghrúpa frithocsaídeoirí agus lena n-aisghairtear Rialachán Cur Chun Feidhme (AE) 2017/962
concerning the denial of authorisation of ethoxyquin as a feed additive belonging to the functional group of antioxidants and repealing Implementing Regulation (EU) 2017/962
#2497299
Le Treoir 70/524/CEE údaraíodh eatocsacuin, gan teorainn ama, mar bhreiseán beathaithe lena húsáid le haghaidh gach speicis ainmhíoch.
Ethoxyquin was authorised without a time limit by Directive 70/524/EEC as a feed additive for use for all animal species.
#2497304
Go háirithe, níorbh fhéidir teacht ar an gconclúid nach raibh ann do ghéineatocsaineacht i leith na meitibilíte eatocsacuin cuineon imín, agus cuireadh ábhair imní in iúl maidir le só-ghineacht an eisíontais p-feineitidín.
In particular, no conclusion was possible on the absence of genotoxicity of the metabolite ethoxyquin quinone imine and concerns were raised as to the possible mutagenicity of the impurity p-phenetidine.
#2497305
Dá thoradh sin, níor suíodh nach bhfuil éifeacht dhíobhálach ag an mbreiseán eatocsacuin ar shláinte ainmhithe, ar shláinte an duine ná ar an gcomhshaol.
Consequently, it had not been established that the additive ethoxyquin does not have an adverse effect on animal health, human health and the environment.
#2497306
Dá bhrí sin, cuireadh an t-údarú atá ann cheana maidir leis an mbreiseán eatocsacuin ar fionraí le Rialachán Cur Chun Feidhme (AE) 2017/962 ón gCoimisiún.
Therefore, the existing authorisation of the additive ethoxyquin was suspended by Commission Implementing Regulation (EU) 2017/962.
#2497315
Ina theannta sin, in éagmais sonraí faoi iarmhair i mbainne, ní raibh an tÚdarás in ann teacht ar chonclúid maidir le sábháilteacht eatocsacuine do thomhaltóirí, nuair a úsáidtear é i mbeatha le haghaidh ainmhithe táirgthe bainne.
In addition, in the absence of residue data in milk, the Authority could not conclude on the consumers’ safety of ethoxyquin, when used in feed for milk-producing animals.
#2497317
Maidir le sábháilteacht an chomhshaoil, dúirt an tÚdarás go mbeadh gá le sonraí forlíontacha chun teacht ar chonclúid maidir le sábháilteacht eatocsacuine don urrann talún nuair a thugtar mar bheatha d’ainmhithe talún í.
Regarding the safety for the environment, the Authority stated that supplementary data would be needed to conclude on the safety of ethoxyquin for the terrestrial compartment when fed to terrestrial animals.
#2497319
Thairis sin, tháinig an tÚdarás ar an gconclúid nach bhféadfaí riosca a chur as an áireamh i gcás eatocsacuin a úsáidtear i gcaighin mhara le haghaidh orgánaigh a chónaíonn ar dhríodair mhuirí.
Furthermore, the Authority concluded that a risk could not be excluded for ethoxyquin used in sea-cages for marine sediment-dwelling organisms.
#2497327
Diúltaítear údarú eatocsacuine (E 324) mar bhreiseán beathaithe a bhaineann leis an gcatagóir breiseán “breiseáin theicneolaíocha” agus leis an bhfeidhmghrúpa “frithocsaídeoirí”.
The authorisation of ethoxyquin (E 324) as an additive in animal nutrition belonging to the additive category ‘technological additives’ and to the functional group ‘antioxidants’, is denied.
#1935663
Le Rialachán Cur Chun Feidhme (AE) 2017/962 ón gCoimisiún cuireadh ar fionraí údarú an bhreiseáin eatocsacuin ar bhonn thuairim an Údaráis Eorpaigh um Shábháilteacht Bia (“an tÚdarás”) an 21 Deireadh Fómhair 2015, ar tuairim í nach bhféadfadh teacht ar aon chonclúid maidir le sábháilteacht agus éifeachtúlacht an bhreiseáin mar gheall ar easpa sonraí ar an iomlán a bheith curtha isteach ag an iarratasóir faoi chuimsiú an nós imeachta maidir le húdarú.
Commission Implementing Regulation (EU) 2017/962 suspended the authorisation of the additive ethoxyquin on the basis of the opinion of the European Food Safety Authority (‘the Authority’) of 21 October 2015, which could not conclude on the safety and efficacy of the additive due to an overall lack of data submitted by the applicant in the framework of the authorisation procedure.
#1935664
Cuireadh údarú an bhreiseáin eatocsacuin ar fionraí go dtí go gcuirfeadh an t-iarratasóir sonraí forlíontacha isteach agus go mbeadh measúnú déanta orthu, i gcomhréir le sceideal ama ina liostaítear in ord tosaíochta na staidéir atá le déanamh i ndiaidh a chéile.
The authorisation of the additive ethoxyquin was suspended pending the submission and assessment of supplementary data to be produced by the applicant, in accordance with a time schedule listing in order of priority the studies to be carried out successively.
#1935667
Cé gur chuir an t-iarratasóir isteach pacáistí sonraí forlíontacha comhleanúnacha, tharla moilleanna móra ar shraith sonraí a ghiniúint, go háirithe i dtaca le léiriú maidir le sábháilteacht an bhreiseáin eatocsacuin i dtaobh an chomhshaoil.
While the applicant has submitted successive packages of supplementary data, major delays occurred in the generation of a series of data, in particular concerning the demonstration of the safety of the additive ethoxyquin for the environment.
#1935669
I bhfianaise a bhfuil luaite roimhe seo, ba cheart am leordhóthanach a thabhairt don Údarás chun an próiseas measúnaithe a chur i gcrích maidir leis an bhfaisnéis agus na sonraí forlíontacha go léir a chuir an t-iarratasóir isteach nó an fhaisnéis agus na sonraí sin atá fós le cur isteach aige chun sábháilteacht agus éifeachtúlacht an bhreiseáin eatocsacuin a léiriú.
In view of the above, the Authority should be granted sufficient time to complete the assessment process of all supplementary information and data submitted or still to be submitted by the applicant in order to demonstrate the safety and efficacy of the additive ethoxyquin.
#1935682
Athbhreithneofar an Rialachán seo faoin 31 Nollaig 2022 ar a dhéanaí agus in aon chás tar éis don Údarás tuairim neamhfhabhrach a ghlacadh maidir le sábháilteacht agus éifeachtúlacht an bhreiseáin eatocsacuin.”.
This Regulation shall be reviewed by 31 December 2022 at the latest and in any event after the adoption by the Authority of a non-favourable opinion on the safety and efficacy of the additive ethoxyquin.’.
#1935691
Rialachán Cur Chun Feidhme (AE) 2017/962 ón gCoimisiún an 7 Meitheamh 2017 lena gcuirtear ar fionraí údarú eatocsacuine mar bhreiseán beathaithe le haghaidh gach speicis agus catagóir ainmhíoch (IO L 145, 8.6.2017, lch. 13).
Commission Implementing Regulation (EU) 2017/962 of 7 June 2017 suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories (OJ L 145, 8.6.2017, p. 13).
#2497301
I gcomhréir le hAirteagal 10(2) de Rialachán (CE) Uimh. 1831/2003 i gcomhar le hAirteagal 7 de, cuireadh isteach iarratas chun athmheastóireacht a dhéanamh ar eatocsacuin mar bhreiseán beathaithe le haghaidh gach speicis ainmhíoch, ar iarratas é ina n-iarradh go n-aicmeofaí an breiseán sa chatagóir breiseán “breiseáin teicneolaíocha”.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of ethoxyquin as a feed additive for all animal species, requesting the additive to be classified in the category ‘technological additives’.
#2497303
Thug an tÚdarás Eorpach um Shábháilteacht Bia (“an tÚdarás”) dá aire sa tuairim uaidh an 21 Deireadh Fómhair 2015 nach raibh sé in ann teacht ar chonclúid maidir le héifeachtúlacht agus sábháilteacht an bhreiseáin bia eatocsacuin i leith ainmhithe, tomhaltóirí ná an comhshaoil, mar gheall ar easpa sonraí ar an iomlán a bheith curtha isteach ag an iarratasóir.
The European Food Safety Authority (‘the Authority’) noted in its opinion of 21 October 2015 that it could not conclude on the efficacy and safety of the additive ethoxyquin for animals, consumers and the environment, due to an overall lack of data submitted by the applicant.
#2497307
Cuireadh údarú an bhreiseáin eatocsacuin ar fionraí go dtí go gcuirfeadh an t-iarratasóir sonraí forlíontacha isteach agus go ndéanfaí measúnú orthu, i gcomhréir le sceideal ama ina liostaítear na staidéir riachtanacha.
The authorisation of the additive ethoxyquin was suspended pending the submission and assessment of supplementary data to be produced by the applicant, in accordance with a time schedule listing the necessary studies to be carried out.
#2497309
I gcomhréir le Rialachán Cur Chun Feidhme (AE) 2017/962, athbhreithneofar an beart fionraíochta faoin 31 Nollaig 2022 agus in aon chás tar éis don Údarás tuairim neamhfhabhrach a ghlacadh maidir le sábháilteacht agus éifeachtúlacht an bhreiseáin eatocsacuin.
In accordance with Implementing Regulation (EU) 2017/962, the suspension measure is to be reviewed by 31 December 2022 and in any event after the adoption by the Authority of a non-favourable opinion on the safety and efficacy of the additive ethoxyquin.
#2497312
An 27 Eanáir 2022, ghlac an tÚdarás tuairim tar éis measúnú a dhéanamh ar na sonraí forlíontacha a chuir an t-iarratasóir isteach, agus é ag cur san áireamh go háirithe sonraíochtaí modhnaithe an bhreiseáin eatocsacuin, inar laghdaíodh cion an eisíontais p-feineitidín go leibhéal is ísle ná 2,5 ppm, agus i bhfianaise an leibhéil 50 mg den bhreiseán in aghaidh an kg a beartaíodh a chur i mbeatha iomlán.
On 27 January 2022, the Authority adopted an opinion following the assessment of the supplementary data submitted by the applicant, taking into account in particular the modified specifications of the additive ethoxyquin, in which the content of the impurity p-phenetidine was reduced to a level lower than 2,5 ppm, and considering the proposed inclusion level of 50 mg of the additive per kg in complete feed.
#2497313
Sa tuairim uaidh, ní raibh an tÚdarás in ann teacht ar chonclúid maidir le sábháilteacht an bhreiseáin eatocsacuin ar aon leibhéal le haghaidh ainmhithe fadré agus atáirgthe, ós rud é go bhfuil p-feineitidín sa bhreiseán, substaint atá aitheanta mar só-ghineach féideartha agus a fhanann ina eisíontas sa bhreiseán, ach nár chuir an t-iarratasóir faisnéis bhreise ar fáil ina leith maidir leis an gcúis imní sábháilteachta sin.
In its opinion, the Authority could not conclude on the safety of the additive ethoxyquin at any level for long-living and reproductive animals, considering that the additive contains p-phenetidine, a recognised possible mutagen which remains as an impurity in the additive, but in regards to which the applicant did not provide additional information addressing this safety concern.
#2497314
Maidir le sábháilteacht úsáid eatocsacuin do thomhaltóirí, níorbh fhéidir teacht ar aon chonclúid de dheasca p-feineitidín a bheith ann agus in éagmais sonraí maidir le hiarmhair p-feineitidíne i bhfíocháin agus i dtáirgí de bhunadh ainmhíoch.
Concerning the safety of the use of ethoxyquin for the consumers, no conclusion could be drawn due to the presence of p-phenetidine and in the absence of data on the residues of p-phenetidine in tissues and products of animal origin.
#2497320
Dá bhrí sin, léirítear leis an tuairim ón Údarás an 27 Eanáir 2022 nár suíodh nach bhfuil éifeacht dhíobhálach ag eatocsacuin ar shláinte ainmhithe, ar shláinte an duine ná ar an gcomhshaol nuair a úsáidtear í mar bhreiseán beatha san fheidhmghrúpa “frithocsaídeoirí”.
The Authority’s opinion of 27 January 2022 shows, therefore, that it has not been established that ethoxyquin does not have an adverse effect on animal health, human health or the environment, when used as a feed additive in the functional group ‘antioxidants’.
#2497341
Rialachán Cur Chun Feidhme (AE) 2017/962 ón gCoimisiún an 7 Meitheamh 2017 lena gcuirtear ar fionraí údarú eatocsacuine mar bhreiseán beathaithe le haghaidh gach speicis agus catagóir ainmhíoch (IO L 145, 8.6.2017, lch. 13).
Commission Implementing Regulation (EU) 2017/962 of 7 June 2017 suspending the authorisation of ethoxyquin as a feed additive for all animal species and categories (OJ L 145, 8.6.2017, p. 13).
#2777437
Rialachán Cur Chun Feidhme (AE) 2022/1375 ón gCoimisiún an 5 Lúnasa 2022 maidir le húdarú eatocsacuine a dhiúltú mar bhreiseán beathaithe a bhaineann leis an bhfeidhmghrúpa frithocsaídeoirí agus lena n-aisghairtear Rialachán Cur Chun Feidhme (AE) 2017/962, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2022/1375 of 5 August 2022 concerning the denial of authorisation of ethoxyquin as a feed additive belonging to the functional group of antioxidants and repealing Implementing Regulation (EU) 2017/962 is to be incorporated into the EEA Agreement.
#2777456
Rialachán Cur Chun Feidhme (AE) 2022/1375 ón gCoimisiún an 5 Lúnasa 2022 maidir le húdarú eatocsacuine a dhiúltú mar bhreiseán beathaithe a bhaineann leis an bhfeidhmghrúpa frithocsaídeoirí agus lena n-aisghairtear Rialachán Cur Chun Feidhme (AE) 2017/962 (IO L 206, 8.8.2022, lch. 39).
Commission Implementing Regulation (EU) 2022/1375 of 5 August 2022 concerning the denial of authorisation of ethoxyquin as a feed additive belonging to the functional group of antioxidants and repealing Implementing Regulation (EU) 2017/962 (OJ L 206, 8.8.2022, p. 39).
#3093089
Rialachán Cur Chun Feidhme (AE) 2021/412 ón gCoimisiún an 8 Márta 2021 lena leasaítear Rialachán Cur Chun Feidhme (AE) 2017/962 a mhéid a bhaineann leis an athbhreithniú ar údarú eatocsacuine mar bhreiseán beathaithe a chur ar fionraí, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2021/412 of 8 March 2021 amending Implementing Regulation (EU) 2017/962 as regards the review of the suspension of the authorisation of ethoxyquin as a feed additive is to be incorporated into the EEA Agreement.