#2123172
Akeso Biomedical, Inc. SAM, atá á ionadú san Aontas ag Pen & Tec Consulting SLU
Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU
Scag na torthaí
Bailiúcháin
20 toradh in 7 ndoiciméad
#2357630
Asahi Biocycle Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.
Asahi Biocycle Co. Ltd, represented in the Union by Pen & Tec Consulting S.L.U.
#2009267
Cuireadh éisteachtaí ar siúl le Decora S.A., Airoldi (i gcomhar le O. Wilms GmbH, Amari Miotal BV agus Alpha Metall GmbH), Bash-tec GmbH, STAKO Sp. z o.o. agus Haomei Group.
Hearings took place with Decora S.A., Airoldi (joined by O. Wilms GmbH, Amari Metals BV and Alpha Metall GmbH), Bash-tec GmbH, STAKO Sp. z o.o. and Haomei Group.
#2009464
Tar éis an nochta deiridh, thug beirt úsáideoirí eile (Decora agus Bash tec) le fios gur cheart na táirgí a allmhairíonn siad a eisiamh ón imscrúdú i ngeall ar a saintréithe sonracha, i ngeall ar easpa nó easpa soláthair ó tháirgeoirí an Aontais nó i ngeall ar phraghsanna arda ó tháirgeoirí an Aontais.
Following final disclosure two other users (Decora and Bash tec) indicated that the products they import should be excluded from the investigation because of their specific characteristics, a lack or absence of supply by Union producers or high prices from Union producers.
#2010376
Tar éis an nochta deiridh, rinne ceithre úsáideoir aighneachtaí (Decora S.A., Bash-tec GmbH, Stako Sp. z o.o. agus Mat Inter) chun léiriú a thabhairt ar na bearta tionchair a bheadh acu ar a gcuideachtaí agus ar na hinfheistíochtaí a rinneadh, agus chun a chur in iúl nach raibh siad in ann táirgeoir de chuid an Aontais a aithint chun táirgí a bhí ag teastáil uathu a sholáthar.
Following final disclosure four users made submissions (Decora S.A., Bash-tec GmbH, Stako Sp. z o.o. and Mat Inter) to indicate the impact measures would have on their companies and on the investments made, and to point out that they had not been able to identify a Union producer to supply products they needed.
#2123126
maidir le húdarú chrágaigh ciotráite iarainn(III) mar bhreiseán beathaithe le haghaidh bainbh agus mionspeicis mhucúla (sealbhóir an údaraithe: Akeso Biomedical, Inc. USA, atá á ionadú san Aontas ag Pen & Tec Consulting SLU)
concerning the authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species (holder of the authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU)
#2357540
maidir le húdarú ullmhóid Bacillus velezensis DSM 15544 mar bhreiseán beathaithe a athnuachan le haghaidh bainbh scoite, an ullmhóid sin a údarú le haghaidh gach speicis agus catagóire éan, lena leasaítear Rialachán Cur Chun Feidhme (AE) 2016/897, Rialachán Cur Chun Feidhme (AE) 2017/2312 agus Rialachán Cur Chun Feidhme (AE) 2018/1081 agus lena aisghairtear Rialachán (AE) Uimh. 333/2010, Rialachán (AE) Uimh. 184/2011 agus Rialachán Cur Chun Feidhme (AE) 2019/893 (sealbhóir an údaraithe: Asahi Biocycle Co. Ltd., arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.)
concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.)
#2357559
An 2 Nollaig 2020, an t-iarratasóir, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U., chuir sé isteach sonraí tacaíochta ábhartha a bhain le hathrú ainm shealbhóir an údaraithe i gcomhréir le hAirteagal 13(3) de Rialachán (CE) Uimh. 1831/2003.
On 2 December 2020, the applicant, represented in the Union by Pen & Tec Consulting S.L.U., submitted relevant supporting data concerning a change of the name of the holder of authorisation in accordance with Article 13(3) of Regulation (EC) No 1831/2003.
#2357610
Rialachán (AE) Uimh. 333/2010 ón gCoimisiún an 22 Aibreán 2010 maidir le húdarú úsáide nua Bacillus subtilis C-3102 (DSM 15544) mar bhreiseán beathaithe le haghaidh bainbh scoite (sealbhóir an údaraithe Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 102, 23.4.2010, lch. 19).
Commission Regulation (EU) No 333/2010 of 22 April 2010 concerning the authorisation of a new use of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for weaned piglets (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (OJ L 102, 23.4.2010, p. 19).
#2357611
Rialachán (AE) Uimh. 184/2011 ón gCoimisiún an 25 Feabhra 2011 maidir le húdarú Bacillus subtilis C-3102 (DSM 15544) mar bhreiseán beathaithe le haghaidh sicíní a thógtar le bheith ina mbéaróga, turcaithe, mionspeicis éanúla, agus éin ornáideacha agus éin ghéim eile (sealbhóir an údaraithe Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 53, 26.2.2011, lch. 33).
Commission Regulation (EU) No 184/2011 of 25 February 2011 concerning the authorisation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for chickens reared for laying, turkeys, minor avian species and other ornamental and game birds (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (OJ L 53, 26.2.2011, p. 33).
#2357612
Rialachán Cur Chun Feidhme (AE) 2016/897 ón gCoimisiún an 8 Meitheamh 2016 maidir le húdarú ullmhóid Bacillus subtilis (C-3102) (DSM 15544) mar bhreiseán beathaithe le haghaidh béaróg agus éisc ornáideacha (sealbhóir an údaraithe Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) agus lena leasaítear Rialacháin (CE) Uimh. 1444/2006, (AE) Uimh. 333/2010 agus (AE) Uimh. 184/2011 a mhéid a bhaineann le sealbhóir an údaraithe (IO L 152, 9.6.2016, lch. 7).
Commission Implementing Regulation (EU) 2016/897 of 8 June 2016 concerning the authorisation of a preparation of Bacillus subtilis (C-3102) (DSM 15544) as a feed additive for laying hens and ornamental fish (holder of authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) and amending Regulations (EC) No 1444/2006, (EU) No 333/2010 and (EU) No 184/2011 as regards the holder of the authorisation (OJ L 152, 9.6.2016, p. 7).
#2357613
Rialachán Cur Chun Feidhme (AE) 2017/2312 ón gCoimisiún an 13 Nollaig 2017 maidir le húdarú úsáide nua Bacillus subtilis C-3102 (DSM 15544) mar bhreiseán beathaithe le haghaidh cránacha, bainbh diúil agus madraí (sealbhóir an údaraithe Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 331, 14.12.2017, lch. 41).
Commission Implementing Regulation (EU) 2017/2312 of 13 December 2017 concerning the authorisation of a new use of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for sows, suckling piglets and dogs (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (OJ L 331, 14.12.2017, p. 41).
#2357614
Rialachán Cur Chun Feidhme (AE) 2018/1081 ón gCoimisiún an 30 Iúil 2018 maidir le húdarú ullmhóid Bacillus subtilis C-3102 (DSM 15544) mar bhreiseán beathaithe le haghaidh muc lena ramhrú (sealbhóir an údaraithe Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 194, 31.7.2018, lch. 17).
Commission Implementing Regulation (EU) 2018/1081 of 30 July 2018 concerning the authorisation of the preparation of Bacillus subtilis C-3102 (DSM 15544) as a feed additive for pigs for fattening (holder of the authorisation Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (OJ L 194, 31.7.2018, p. 17).
#2357615
Rialachán Cur Chun Feidhme (AE) 2019/893 ón gCoimisiún an 28 Bealtaine 2019 maidir le húdarú Bacillus subtilis DSM 15544 mar bhreiseán beathaithe a athnuachan le haghaidh sicíní lena ramhrú agus lena n-aisghairtear Rialachán (CE) Uimh. 1444/2006 (Asahi Calpis Wellness Co. Ltd, arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 142, 29.5.2019, lch. 60).
Commission Implementing Regulation (EU) 2019/893 of 28 May 2019 concerning the renewal of the authorisation of Bacillus subtilis DSM 15544 as a feed additive for chickens for fattening and repealing Regulation (EC) No 1444/2006 (Asahi Calpis Wellness Co. Ltd, represented in the European Union by Pen & Tec Consulting S.L.U.) (OJ L 142, 29.5.2019, p. 60).
#2376852
Tá Rialachán Cur Chun Feidhme (AE) 2021/1412 ón gCoimisiún an 27 Lúnasa 2021 maidir le húdarú chrágaigh ciotráite iarainn (III) mar bhreiseán beathaithe le haghaidh bainbh agus mionspeicis mhucúla (sealbhóir an údaraithe: Akeso Biomedical, Inc. USA, atá á ionadú san Aontas ag Pen & Tec Consulting SLU) le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2021/1412 of 27 August 2021 concerning the authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species (holder of the authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU) is to be incorporated into the EEA Agreement.
#2376873
32021 R 1412: Rialachán Cur Chun Feidhme (AE) 2021/1412 ón gCoimisiún an 27 Lúnasa 2021 maidir le húdarú chrágaigh ciotráite iarainn (III) mar bhreiseán beathaithe le haghaidh bainbh agus mionspeicis mhucúla (sealbhóir an údaraithe: Akeso Biomedical, Inc. USA, atá á ionadú san Aontas ag Pen & Tec Consulting SLU) (IO L 304, 30.8.2021, lch. 14).
32021 R 1412: Commission Implementing Regulation (EU) 2021/1412 of 27 August 2021 concerning the authorisation of Iron(III) citrate chelate as a feed additive for piglets and minor porcine species (holder of the authorisation: Akeso Biomedical, Inc. USA, represented in the Union by Pen & Tec Consulting SLU) (OJ L 304, 30.8.2021, p. 14).
#2660724
Rialachán Cur Chun Feidhme (AE) 2022/703 ón gCoimisiún an 5 Bealtaine 2022 maidir le húdarú ullmhóid Bacillus velezensis DSM 15544 mar bhreiseán beathaithe a athnuachan le haghaidh bainbh scoite, an ullmhóid sin a údarú le haghaidh gach speicis agus catagóire éan, lena leasaítear Rialachán Cur Chun Feidhme (AE) 2016/897, Rialachán Cur Chun Feidhme (AE) 2017/2312 agus Rialachán Cur Chun Feidhme (AE) 2018/1081 agus lena aisghairtear Rialachán (AE) Uimh. 333/2010, Rialachán (AE) Uimh. 184/2011 agus Rialachán Cur Chun Feidhme (AE) 2019/893 (sealbhóir an údaraithe: Asahi Biocycle Co. Ltd., arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2022/703 of 5 May 2022 concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.) is to be incorporated into the EEA Agreement.
#2735509
maidir le hullmhóid d’ion-1,4-béite-xiolanáis arna táirgeadh ag Komagataella phaffii DSM 33574 a údarú mar bhreiseán beathaithe le haghaidh gach speicis éanlaithe clóis lena ramhrú agus gach speicis éanlaithe clóis a thógtar le haghaidh breithe agus a thógtar le haghaidh pórúcháin (sealbhóir an údaraithe: BioResource International, Inc. arna ionadú san Aontas ag Pen & Tec Consulting, S.L.U.)
concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Komagataella phaffii DSM 33574 as a feed additive for all poultry species for fattening and all poultry species reared for laying and reared for breeding (holder of authorisation: BioResource, international, Inc. represented in the Union by Pen & Tec Consulting, S.L.U.)
#2945719
Sanntar na scóir ‘Uirlisí (cineál)’ (Ti) le haghaidh gach páirt tosaíochta i (TBAT, TDA, TBC, TFFC, TRFC, TEC, TBUT, TMIC, TSPK agus TFM) de réir chastacht agus infhaighteacht na n-uirlisí is gá lena n-athsholáthar.
The ‘Tools (type)’ scores (Ti) for each priority part i (TBAT, TDA, TBC, TFFC, TRFC, TEC, TBUT, TMIC, TSPK and TFM) are assigned according to the complexity and availability of the tools needed for its replacement.
#2660745
32022 R 0703: Rialachán Cur Chun Feidhme (AE) 2022/703 ón gCoimisiún an 5 Bealtaine 2022 maidir le húdarú ullmhóid Bacillus velezensis DSM 15544 mar bhreiseán beathaithe a athnuachan le haghaidh bainbh scoite, an ullmhóid sin a údarú le haghaidh gach speicis agus catagóire éan, lena leasaítear Rialachán Cur Chun Feidhme (AE) 2016/897, Rialachán Cur Chun Feidhme (AE) 2017/2312 agus Rialachán Cur Chun Feidhme (AE) 2018/1081 agus lena aisghairtear Rialachán (AE) Uimh. 333/2010, Rialachán (AE) Uimh. 184/2011 agus Rialachán Cur Chun Feidhme (AE) 2019/893 (sealbhóir an údaraithe: Asahi Biocycle Co. Ltd., arna ionadú san Aontas ag Pen & Tec Consulting S.L.U.) (IO L 132, 6.5.2022, lch. 5).’
32022 R 0703: Commission Implementing Regulation (EU) 2022/703 of 5 May 2022 concerning the renewal of the authorisation of a preparation of Bacillus velezensis DSM 15544 as a feed additive for weaned piglets, the authorisation for all avian species and categories, amending Implementing Regulation (EU) 2016/897, Implementing Regulation (EU) 2017/2312 and Implementing Regulation (EU) 2018/1081 and repealing Regulation (EU) No 333/2010, Regulation (EU) No 184/2011 and Implementing Regulation (EU) 2019/893 (holder of the authorisation: Asahi Biocycle Co. Ltd., represented in the Union by Pen & Tec Consulting S.L.U.) (OJ L 132, 6.5.2022, p. 5).’