"sd": "1" (i gcás cúrsa vacsaínithe phríomhúil 1-dáileoige)
"sd": "2" (in case of a 2-dose primary vaccination series or for an additional dose following a 1-dose primary vaccination course) "sd": "3" (e.g. in case of additional doses following a 2-dose primary vaccination series) v/dt Date of vaccination The date when the described dose was received, in the format YYYY-MM-DD (full date without time). Other formats are not supported.
(2) I gcomhréir le hAirteagal 7 de Rialachán (CE) Uimh. 1831/2003, cuireadh isteach iarratas ar údarú ullmhóide d’ion-1,4-béite-xiolanáis arna táirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis (ar a dtugtar freisin ‘subtilisin’) arna táirgeadh ag Bacillus subtilis ATCC SD-2107 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease (also known as ‘subtilisin’) produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525.
(3) Baineann an t-iarratas sin le húdarú ullmhóide d’ion-1,4-béite-xiolanáis arna táirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis ATCC SD-2107 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 mar bhreiseán beatha le haghaidh sicíní lena ramhrú, sicíní a thógtar le bheith ina mbéaróga, béaróga agus mionspeicis éanlaithe clóis, atá le haicmiú sa chatagóir ‘breiseáin zóiteicniúla’ agus sa ghrúpa feidhme ‘feabhsaitheoirí díleáiteachta’.
(3) That application concerns the authorisation of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 as a feed additive for chickens for fattening, chickens reared for laying, laying hens and minor poultry species, to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’.
(4) Níorbh fhéidir leis an Údarás Eorpach um Shábháilteacht Bia (‘an tÚdarás’) teacht ar chonclúid, ina thuairim an 25 Bealtaine 2020, ar shábháilteacht na hullmhóide d’ion-1,4-béite-xiolanáis arna táirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis ATCC SD-2107 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 do na spriocspeicis, do thomhaltóirí, d’úsáideoirí agus don chomhshaol.
(4) The European Food Safety Authority (‘the Authority’) could not conclude, in its opinion of 25 May 2020, on the safety of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis ATCC SD-2107 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for the target species, consumers, users and the environment.
Mar sin féin, ina thuairim ina dhiaidh sin an 6 Eanáir 2023, thuairiscigh an tÚdarás gur chuir an t-iarratasóir faisnéis nua isteach chun aghaidh a thabhairt ar chuid de na teorainneacha a aithníodh i dtuairim an 25 Bealtaine 2020 agus gur dhearbhaigh sé athrú ar thréithchineáil táirgeachta na próitéáise, ag cur Bacillus subtilis ATCC SD-2107 in ionad Bacillus subtilis CBS 148232, agus bhain sé de thátal as, faoi na coinníollacha úsáide a bhí beartaithe, nach bhfuil drochthionchar ag an ullmhóid d’ion-1,4-béite-xiolanáis arna táirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 ar shláinte ainmhithe, ar shábháilteacht tomhaltóirí ná ar an gcomhshaol.
However, in its subsequent opinion of 6 January 2023, the Authority reported that the applicant submitted new information to address some of the limitations identified in the opinion of 25 May 2020 and declared a change in the production strain of the protease, substituting Bacillus subtilis ATCC SD-2107 for Bacillus subtilis CBS 148232, and concluded that, under the proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 does not have adverse effects on animal health, consumer safety or the environment.
Cuirtear taifeach SD ar fáil do na cineálacha teoranta taispeána nach féidir glacadh le caighdeáin níos airde ná caighdeáin níos airde a thaispeáint.
SD resolution is made available for the limited types of display that cannot accept or display higher resolution standards.
“SD” soláthar ceoil, scannán agus cluichí, lena n-áirítear cluichí áidh agus cluichí cearrbhachais, agus craolachán agus imeachtaí polaitiúla, cultúrtha, ealaíonta, spórtúla, eolaíochta agus siamsaíochta;
«SD» supply of music, films and games, including games of chance and gambling games, and of political, cultural, artistic, sporting, scientific and entertainment broadcasts and events;
Féach an t-airteagal faoi chuideachta Zhiguang Communication ar shuíomh gréasáin oifigiúil Shandong Dazhong an 7 Lúnasa 2019: https://sd.dzwww.com/sdnews/201908/t20190807_19032401.htm (ar breathnaíodh air go deireanach an 7 Aibreán 2021).
See article about the Zhiguang Communication company on the official Shandong Dazhong website of 7 August 2019: https://sd.dzwww.com/sdnews/201908/t20190807_19032401.htm (last viewed on 7 April 2021).
maidir le monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 a údarú mar bhreiseán beathaithe le haghaidh gach speicis ainmhíoch seachas iasc eite
concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish
Tuarascáil Deiridh. dar teideal, 13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study.
13-week repeated oral toxicity study of T/08/041 in CD ISG (SD) rats with concominant recovery study.
e. Ó dheas: 4.2km siar siar ó thuaidh de chrosbhealach 356th Street agus SD Highway 44.
e. South: 4.2km west northwest from the intersection of 356th Street and SD Highway 44.
f. Siar ó dheas: 6.3km soir ó thuaidh de chrosbhealach 348th Avenue agus SD Highway 44.
f. Southwest: 6.3km northeast from the intersection of 348th Avenue and SD Highway 44.
Glacfar gurb é 25 mm íosluach thiús an fheire (Sd) do thrastomhas rotha D ≥ 840 mm.
The minimum value of thickness of the flange (Sd) for wheel diameter D ≥ 840 mm shall be taken as 25 mm.
(1) an nós imeachta maidir le scrúdú cineáil (Modúl SB) don chéim dearaidh agus forbartha in éineacht leis an nós imeachta um chóras bainistíochta cáilíochta táirgthe (Modúl SD) don chéim táirgthe; nó
(1) the type-examination procedure (Module SB) for the design and development phase in combination with the production quality management system procedure (Module SD) for the production phase; or
(2) an nós imeachta maidir le scrúdú cineáil (Modúl SB) don chéim dearaidh agus forbartha in éineacht leis an nós imeachta um chóras bainistíochta cáilíochta táirgthe (Modúl SD) don chéim táirgthe; nó
(2) the type-examination procedure (Module SB) for the design and development phase in combination with the production quality management system procedure (Module SD) for the production phase; or
PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 le gníomhaíocht íosta de:
PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 with a minimum activity of:
maidir le diúltú d’údarú ullmhóide de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine mar bhreiseán beathaithe le haghaidh bradán agus breac.
concerning the denial of authorisation of a preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) as a feed additive for salmon and trout
any or all of them as to the sd Psident & ffellows & their Successors or to the Vicepsident & ffellows in the absence of the Psident or the major pte of them as aforesd shall seeme reasonable & fitting”.
any or all of them as to the sd Psident & ffellows & their Successors or to the Vicepsident & ffellows in the absence of the Psident or the major pte of them as aforesd shall seeme reasonable & fitting".
Chun críoch an doiciméid seo, cumhdaítear le córas cumarsáide agus faisnéise (CCF) an trealamh ar fad a úsáidtear chun FRAE a láimhseáil, a stóráil agus a tharchur, lena n-áirítear stáisiúin oibre, printéirí, gléasanna cóipeála, meaisíní facs, freastalaithe, córais bainistíochta líonra, rialaitheoirí líonra agus rialaitheoirí cumarsáide, ríomhairí glúine, ríomhairí táibléid, fóin chliste agus gairis stórála inbhainte amhail mearóga USB, CDanna, cártaí SD, etc.
For the purpose of this document, a communication and information system (CIS) covers all equipment used to handle, store and transmit EUCI, including workstations, printers, copiers, fax machines, servers, network management systems, network controllers and communications controllers, laptops, notebooks, tablet PCs, smart phones and removable storage devices such as USB-sticks, CDs, SD-cards, etc.
ní mór flaischuimhne (e.g. méaróga USB, cártaí SD, tiomántáin soladstaide, tiomántáin chrua hibrideacha) a fhorscríobh trí huaire ar a laghad agus ansin iad a fhíorú lena áirithiú nach féidir an t-ábhar bunaidh a aisghabháil, nó ní mór í a scriosadh trí úsáid a bhaint as bogearraí scriosta formheasta;
flash memory (e.g. USB sticks, SD cards, solid state drives, hybrid hard drives) must be overwritten at least three times and then verified to ensure that the original content cannot be recovered, or be deleted using approved deletion software;
Maidir le gach ceann de na córais chumhachtaithe UUT a chumhdaítear thíos, déanfar an chumhacht SDR a thomhas sa ghnáthchumraíocht, trí úsáid a bhaint as an leagan ardghléine den chomhad 10 nóiméad ‘tástáil dhinimiciúil físchumhachta SDR’, mura rud é go bhfuil comhoiriúnacht comhartha ionchuir teoranta do SD.
For each of the UUT powering systems covered below, SDR power shall be measured in the normal configuration, using the HD version of the 10 minute “SDR dynamic video power test” file, unless input signal compatibility is restricted to SD.
I gcomhréir le hAirteagal 7 de Rialachán (CE) Uimh. 1831/2003, cuireadh isteach iarratas maidir le monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 chun an t-údarú a bhaineann lena húsáid mar bhreiseán beathaithe d’iasc eite a leathnú ionas go gcumhdóidh sé gach speiceas ainmhíoch.
In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species.
Baineann an t-iarratas le monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 chun an t-údarú a bhaineann lena húsáid mar bhreiseán beathaithe d’iasc eite a leathnú ionas go gcumhdóidh sé gach speiceas ainmhíoch, rud atá le haicmiú sa chatagóir breiseán “breiseáin chothaitheacha”, san fheidhmghrúpa “aimíonaigéid, a salainn agus a n-analóga”, agus sa chatagóir breiseán “breiseáin chéadfacha”, san fheidhmghrúpa “comhdhúile blaistithe”.
The application concerns the authorisation of the extension of use of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive from finfish to all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’.
Chinn an tÚdarás Eorpach um Shábháilteacht Bia (“an tÚdarás”) ina thuairim an 5 Bealtaine 2021 nach bhfuil tionchar díobhálach ag monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 ar shláinte ainmhithe, ar shábháilteacht an tomhaltóra ná ar an gcomhshaol, faoi na coinníollacha úsáide atá beartaithe.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 5 May 2021 that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 does not have an adverse effect on animal health, consumers safety or the environment.
An measúnú ar mhonaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268, léiríonn sin go gcomhlíontar na coinníollacha maidir le húdarú dá bhforáiltear in Airteagal 5 de Rialachán (CE) Uimh. 1831/2003.
The assessment of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
An tsubstaint monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 a shonraítear san Iarscríbhinn, substaint a bhaineann leis an gcatagóir breiseán “breiseáin chothaitheacha” agus leis an bhfeidhmghrúpa “aimíonaigéid, a salainn agus a n-analóga”, údaraítear í mar bhreiseán beathaithe i gcothú ainmhithe, faoi réir na gcoinníollacha a leagtar síos san Iarscríbhinn sin.
The substance L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.
An tsubstaint monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 a shonraítear san Iarscríbhinn, substaint a bhaineann leis an gcatagóir breiseán “breiseáin chéadfacha” agus leis an bhfeidhmghrúpa “comhdhúile blaistithe”, údaraítear í mar bhreiseán beathaithe i gcothú ainmhithe, faoi réir na gcoinníollacha a leagtar síos san Iarscríbhinn sin.
The substance L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.
Rialachán Cur Chun Feidhme (AE) 2021/2080 ón gCoimisiún an 26 Samhain 2021 maidir le monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 a údarú mar bhreiseán beathaithe le haghaidh gach speicis ainmhíoch seachas iasc eite, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2021/2080 of 26 November 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish is to be incorporated into the EEA Agreement.
32021 R 2080: Rialachán Cur Chun Feidhme (AE) 2021/2080 ón gCoimisiún an 26 Samhain 2021 maidir le monaihiodráit mhonaihidreaclóiríde L-histidín arna táirgeadh trí choipeadh le Escherichia coli NITE SD 00268 a údarú mar bhreiseán beathaithe le haghaidh gach speicis ainmhíoch seachas iasc eite (IO L 426, 29.11.2021, lch. 23).
32021 R 2080: Commission Implementing Regulation (EU) 2021/2080 of 26 November 2021 concerning the authorisation of L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE SD 00268 as a feed additive for all animal species except finfish (OJ L 426, 29.11.2021, p. 23).
Rialachán Cur Chun Feidhme (AE) 2019/454 ón gCoimisiún an 20 Márta 2019 maidir le húdarú ullmhóidí alfaimileáise ó Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, nó Aspergillus oryzae ATCC SD-5374, mar aon le húdarú ullmhóide ion-1,4-béite-ghlúcanáise ó Trichoderma reesei ATCC PTA-10001 mar bhreiseáin sadhlais le haghaidh gach speicis ainmhíoch, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species is to be incorporated into the EEA Agreement.
32019 R 0454: Rialachán Cur Chun Feidhme (AE) 2019/454 ón gCoimisiún an 20 Márta 2019 maidir le húdarú ullmhóidí alfaimileáise ó Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, nó Aspergillus oryzae ATCC SD-5374, mar aon le húdarú ullmhóide ion-1,4-béite-ghlúcanáise ó Trichoderma reesei ATCC PTA-10001 mar bhreiseáin sadhlais le haghaidh gach speicis ainmhíoch (IO L 79, 21.3.2019, lch. 4).’
32019 R 0454: Commission Implementing Regulation (EU) 2019/454 of 20 March 2019 concerning the authorisation of preparations of alpha-amylase from Bacillus amyloliquefaciens DSM 9553, Bacillus amyloliquefaciens NCIMB 30251, or Aspergillus oryzae ATCC SD-5374, as well as a preparation of endo-1,4-beta-glucanase from Trichoderma reesei ATCC PTA-10001 as silage additives for all animal species (OJ L 79, 21.3.2019, p. 4).’
Rialachán Cur Chun Feidhme (AE) 2022/1470 ón gCoimisiún an 5 Meán Fómhair 2022 maidir le húdarú in-1,4-béite-xiolanáise arna táirgeadh ag Trichoderma longibrachiatum CBS 139997 agus alfa-galachtóisíodáise arna táirgeadh ag Aspergillus tubingensis ATCC SD 6740 mar bhreiseán beathaithe le haghaidh sicíní lena ramhrú, sicíní a thógtar le bheith ina mbéaróga, mionspeicis éanlaithe clóis lena ramhrú agus a thógtar le bheith ina mbéaróga, agus éin ornáideacha (sealbhóir an údaraithe Industrial Técnica Pecuaria S.A.), tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2022/1470 of 5 September 2022 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds (holder of the authorisation Industrial Técnica Pecuaria S.A.) is to be incorporated into the EEA Agreement.
32022 R 1470: Rialachán Cur Chun Feidhme (AE) 2022/1470 ón gCoimisiún an 5 Meán Fómhair 2022 maidir le húdarú in-1,4-béite-xiolanáise arna táirgeadh ag Trichoderma longibrachiatum CBS 139997 agus alfa-galachtóisíodáise arna táirgeadh ag Aspergillus tubingensis ATCC SD 6740 mar bhreiseán beathaithe le haghaidh sicíní lena ramhrú, sicíní a thógtar le bheith ina mbéaróga, mionspeicis éanlaithe clóis lena ramhrú agus a thógtar le bheith ina mbéaróga, agus éin ornáideacha (sealbhóir an údaraithe Industrial Técnica Pecuaria S.A.) (IO L 231, 6.9.2022, lch. 109).’
32022 R 1470: Commission Implementing Regulation (EU) 2022/1470 of 5 September 2022 concerning the authorisation of endo-1,4-beta-xylanase produced by Trichoderma longibrachiatum CBS 139997 and alpha-galactosidase produced by Aspergillus tubingensis ATCC SD 6740 as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species for fattening and reared for laying, and ornamental birds (holder of the authorisation Industrial Técnica Pecuaria S.A.) (OJ L 231, 6.9.2022, p. 109).’
(3) I gcomhréir le hAirteagal 15 agus 16 de Rialachán Cur Chun Feidhme (AE) 2018/545 agus le Cinneadh 2010/713/AE agus trí mhodúil SB, SD/SF nó SH1 a chur i bhfeidhm maidir leis an bhfíorú CE, agus más ábhartha i gcomhréir le hAirteagal 15(5) de Threoir (AE) 2016/797, cuirfidh an t-eintiteas a bhainistíonn an t-athrú comhlacht a dtugtar fógra dó ar an eolas faoi gach athrú a rachaidh i gcion ar chomhréireacht an fhochórais le ceanglais STI (STInna) ábhartha lena n-éileofar go ndéanfaidh an comhlacht á dtugtar fógra dó seiceálacha nua.
(3) In accordance with Articles 15 and 16 of Implementing Regulation (EU) 2018/545 and Decision 2010/713/EU and by application of modules SB, SD/SF or SH1 for the EC verification, and if relevant in accordance with Article 15(5) of Directive (EU) 2016/797, the entity managing the change shall inform a notified body of all changes affecting the conformity of the subsystem with requirements of the relevant TSI(s) requiring new checks by a notified body.
Maidir le rothaí istigh bogaithe 3 acastóir, nach mbaineann le treoir riain, ceadaítear teorainnluachanna níos ísle do thoisí geoiméadracha na rothaí ná na cinn a cheanglaítear i dTábla 1 agus i dTábla 2 do thiús an fheire (Sd) agus don toise tosaigh (SR).
For the inner wheels of 3-axle bogies, that are not involved in track guidance, lower limit values of the wheels geometrical dimensions than those required in Table 1 and in Table 2 are permitted for the thickness of the flange (Sd) and for the front to front dimension (SR).
(2) Cuirfidh an t-eintiteas a bhainistíonn an t-athrú Comhlacht faoina dtugtar fógra ar an eolas faoi gach athrú a dhéanann difear do chomhréireacht an fhochórais le ceanglais na STI(anna) ábhartha a éilíonn seiceálacha nua, i gcomhréir le hAirteagal 15 agus le hAirteagal 16 de Rialachán Cur Chun Feidhme (AE) 2018/545 agus Cinneadh 2010/713/AE agus trí mhodúil SB, SD/SF nó SH1 a chur i bhfeidhm maidir le fíorú CE, agus más ábhartha i gcomhréir le hAirteagal 15 (5) de Threoir (AE) 2016/797.
(2) The entity managing the change shall inform a Notified Body of all changes affecting the conformity of the subsystem with the requirements of the relevant TSI(s) requiring new checks, in accordance with Articles 15 and 16 of Implementing Regulation (EU) 2018/545 and Decision 2010/713/EU and by application of modules SB, SD/SF or SH1 for the EC verification, and if relevant Article 15(5) of Directive (EU) 2016/797.
(a) sa chás go ndéantar an t-athrú mar gheall ar earráid táirge: Déantar an t-athrú faoi chóras bainistíochta cáilíochta arna fhormheas ag comhlacht faoina dtugtar fógra (e.g de réir mhodúil CH1, SH1, CD, SD).
(a) in the case where the change is made due to a product error: The change is performed under a quality management system approved by a notified body (e.g. according to modules CH1, SH1, CD, SD).
(2) Bhí an ullmhóid d’ion-1,4-béite-xiolanáise arna tháirgeadh ag Trichoderma reesei CBS 143953 (a aithníodh go tacsanomaíoch roimhe seo mar ATCC PTA-5588) agus ion-1,3(4)-béite-ghlúcanáise arna dtáirgeadh ag Trichoderma reesei CBS 143945 (a aithníodh go tacsanomaíoch roimhe seo mar ATCC SD-2106) údaraithe ar feadh 10 mbliana mar bhreiseán beatha d’éanlaith chlóis, bainbh scoite agus muca lena ramhrú le Rialachán (AE) Uimh. 337/2011 ón gCoimisiún, agus le haghaidh cránacha ag tál agus mionspeicis mhucúla (bainbh scoite, muca lena ramhrú agus cránacha ag tál) le Rialachán Cur Chun Feidhme (AE) 2016/997 ón gCoimisiún.
(2) The preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei CBS 143953 (previously taxonomically identified as ATCC PTA-5588) and endo-1,3(4)-beta-glucanase produced by Trichoderma reesei CBS 143945 (previously taxonomically identified as ATCC SD-2106) was authorised for 10 years as a feed additive for poultry, weaned piglets and pigs for fattening by Commission Regulation (EU) No 337/2011, and for lactating sows and minor porcine species (weaned piglets, pigs for fattening and lactating sows) by Commission Implementing Regulation (EU) 2016/997.
[3] Rialachán Cur Chun Feidhme (AE) 2016/997 ón gCoimisiún an 21 Meitheamh 2016 maidir le húdarú d’ion-1,4-béite-xiolanáise EC 3.2.1.8 arna tháirgeadh ag Trichoderma reesei (ATCC PTA 5588) agus ion-1,3(4)-béite-ghlúcanáise EC 3.2.1.6 arna dtáirgeadh ag Trichoderma reesei (ATCC SD 2106) mar bhreiseán beatha le haghaidh cránacha ag tál agus mionspeicis mhucúla (sealbhóir údaraithe Danisco (UK) Ltd, ag trádáil mar Danisco Animal Nutrition agus arna ionadú ag Genencor International BV) (IO L 164, 22.6.2016, lch. 4).
[3] Commission Implementing Regulation (EU) 2016/997 of 21 June 2016 concerning the authorisation of endo-1,4-beta-xylanase EC 3.2.1.8 produced by Trichoderma reesei (ATCC PTA 5588) and endo-1,3(4)- beta-glucanase EC 3.2.1.6 produced by Trichoderma reesei (ATCC SD 2106) as a feed additive for lactating sows and minor porcine species (holder of authorisation Danisco (UK) Ltd, trading as Danisco Animal Nutrition and represented by Genencor International B.V.) (OJ L 164, 22.6.2016, p. 4).
maidir le húdarú ullmhóide d’ion-1,4-béite-xiolanáis arna tháirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 le haghaidh sicíní lena ramhrú, sicíní a thógtar le bheith ina mbéaróga agus mionspeicis éanlaithe clóis (sealbhóir údaraithe: Danisco (UK) Ltd arna ionadú san Aontas ag Genencor International B.V.)
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 for chickens for fattening, chickens reared for laying and minor poultry species (holder of authorisation: Danisco (UK) Ltd represented in the Union by Genencor international B.V.)
Tháinig an tÚdarás ar an gconclúid freisin ina thuairim an 6 Eanáir 2023 ag tagairt dá thuairim an 25 Bealtaine 2020 go raibh ullmhóid ullmhóid d’ion-1,4-béite-xiolanáis arna táirgeadh ag Trichoderma reesei ATCC PTA-5588, próitéáis arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 éifeachtach i sicíní lena ramhrú, i sicíní a thógtar le bheith ina mbéaróga agus i mionspeicis éanlaith chlóis suas go dtí an pointe beirthe, ach níorbh fhéidir teacht ar chonclúid maidir lena éifeachtúlacht maidir le béaróga.
The Authority also concluded in its opinion of 6 January 2023 with reference to its opinion of 25 May 2020 that the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 is efficacious in chickens for fattening, chickens reared for laying and minor poultry species up to the point of lay, but could not conclude on its efficacy for laying hens.
(6) Léirítear leis an measúnú ar an ullmhóid ion-1,4-béite-xiolanáise arna táirgeadh ag Trichoderma reesei ATCC PTA-5588 agus próitéáis arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis arna táirgeadh ag Bacillus lichenformis ATCC SD-6525 go bhfuil na coinníollacha údaraithe, dá bhforáiltear in Airteagal 5 de Rialachán (CE) Uimh. 1831/2003, á gcomhlíonadh.
(6) The assessment of the preparation of endo-1,4-beta-xylanase produced by Trichoderma reesei ATCC PTA-5588, protease produced by Bacillus subtilis CBS 148232 and alpha-amylase produced by Bacillus licheniformis ATCC SD-6525 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
PTA-5588, próitéáis (EC 3.4.21.62, ar a dtugtar freisin ‘subtilisin’) arna táirgeadh ag Bacillus subtilis CBS 148232 agus alfaimileáis (EC 3.2.1.1) arna táirgeadh ag Bacillus lichenformis ATCC SD-6525.
PTA-5588, protease (EC 3.4.21.62, also known as ‘subtilisin’) produced by Bacillus subtilis CBS 148232 and alpha-amylase (EC 3.2.1.1) produced by Bacillus licheniformis ATCC SD-6525
Ullmhóid de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine, údaraíodh í ar feadh 4 bliana i gcomhréir le Treoir 70/524/CEE mar bhreiseán beathaithe a bhaineann leis an ngrúpa ‘datháin, lena n-áirítear líocha’ lena húsáid le haghaidh bradán agus breac faoin uimhir bhreiseáin E 161y.
A preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) was authorised for four years in accordance with Directive 70/524/EEC as a feed additive belonging to the group ‘colourants, including pigments’ for use for salmon and trout with the additive number E 161y.
I gcomhréir le hAirteagal 10(2) de Rialachán (CE) Uimh. 1831/2003, i gcomhar le hAirteagal 7 de, cuireadh isteach iarratas maidir le húdarú ullmhóide de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine mar bhreiseán beathaithe le haghaidh bradán agus breac, iarratas inar iarradh go n-aicmeofaí an breiseán sin sa chatagóir ‘breiseáin chéadfacha’ agus san fheidhmghrúpa ‘datháin: (ii) substaintí a chuireann dathanna ar bhia de bhunadh ainmhíoch nuair a úsáidtear in ábhar beatha d’ainmhithe iad’.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted for the authorisation of a preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) as a feed additive for salmon and trout, requesting that additive to be classified in the category ‘sensory additives’ and in the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’.
Eascraíonn sé ón tuairim ón Údarás an 27 Eanáir 2022 nár suíodh nach bhfuil éifeacht dhíobhálach ag an ullmhóid de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine ar shláinte ainmhithe ná ar shláinte an duine, ná go bhfuil sé éifeachtúil nuair a úsáidtear í mar bhreiseán beathaithe le haghaidh bradán agus breac sa chatagóir breiseán ‘breiseáin chéadfacha’ agus san fheidhmghrúpa ‘datháin: (ii) substaintí a chuireann dathanna ar bhia de bhunadh ainmhíoch nuair a úsáidtear in ábhar beatha d’ainmhithe iad’.
It derives from the Authority’s opinion of 27 January 2022 that it has not been established that the preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) does not have an adverse effect on animal health and human health, and that it is efficacious when used as a feed additive for salmon and trout in the additive category ‘sensory additives’ and the functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’.
I bhfianaise an mhéid thuas, ní féidir a mheas go gcomhlíonann an ullmhóid de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine na coinníollacha maidir le húdarú, dá bhforáiltear in Airteagal 5 de Rialachán (CE) Uimh. 1831/2003.
In view of the above, it cannot be considered that the preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) satisfies the conditions for the authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003.
Dá bhrí sin, ba cheart an ullmhóid de Phaffia rhodozyma (ATCC SD-5340) ar chuid mhór astaxaintine agus beatha ina bhfuil sí a tharraingt siar ón margadh a luaithe is féidir a mhéid a bhaineann lena húsáid le haghaidh bradán agus breac.
Therefore, the preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) and feed containing it should be withdrawn from the market as soon as possible as far as the use for salmon and trout is concerned.
Diúltaítear údarú na hullmhóide de Phaffia rhodozyma (ATCC SD-5340) (E 161y) ar chuid mhór astaxaintine mar bhreiseán i gcothú ainmhithe a bhaineann leis an gcatagóir ‘breiseáin chéadfacha’, san fheidhmghrúpa ‘datháin: (ii) substaintí a chuireann dathanna ar bhia de bhunadh ainmhíoch nuair a úsáidtear in ábhar beatha d’ainmhithe iad’ lena húsáid le haghaidh bradán agus breac.
The authorisation of the preparation of astaxanthin-rich Phaffia rhodozyma (ATCC SD-5340) (E 161y) as an additive in animal nutrition belonging to the category ‘sensory additives’, functional group ‘colourants: (ii) substances which, when fed to animals, add colours to food of animal origin’ for use for salmon and trout, is denied.