#297523
ÉISC EITE EILE
OTHER FIN FISH
ÉISC EITE EILE
OTHER FIN FISH
ÉISC EITE EILE
OTHER FIN FISH
Iasc Eite
Fin Fish
Iasc Eite
Fin fish
Salmainidí agus gach iasc eite eile seachas éisc ornáideacha
Salmonids and other fin fish except ornamental fish
agus gach iasc eite eile
and all other fin fish
13,5 mg le haghaidh salmainidí agus mionéisc eite
13,5 mg for salmonids and minor fin fish
Gach bia-speiceas seachas éisc eite
All food producing species except fin fish
Measann an Ghníomhaireacht gurb iomchuí na MRLanna imíodaclóipride le haghaidh Salmonidae a úsáid i gcás gach éisc eite.
The Agency has considered that the extrapolation of the MRL for imidacloprid from Salmonidae to all fin fish is appropriate.
I bhfianaise na tuairime ón nGníomhaireacht, an MRL a mholtar le haghaidh iasc eite, is iomchuí é a bhunú.
In view of the opinion of the Agency, it is appropriate to establish the recommended MRL for fin fish.
Laonna (bainne púdrach), caoirigh, gabhair, athchogantaigh eile lena ramhrú, capaill, salmainidí agus gach iasc eite eile: 400 mg;
Calves (milk replacer), sheep, goats, other ruminants for fattening, horses, salmonids and all other fin fish: 400 mg;
I gcomhréir le hAirteagal 3 de Rialachán (CE) Uimh. 470/2009, an 27 Iúil 2021, chuir VETHELLAS AEBE iarraidh faoi bhráid na Gníomhaireachta Leigheasra Eorpaí (‘an Ghníomhaireacht’) maidir leis an iontráil atá ann cheana maidir le prasacuainteil a leathnú chun iasc eite a chumhdach.
In accordance with Article 3 of Regulation (EC) No 470/2009, on 27 July 2021, VETHELLAS AEBE submitted a request to the European Medicines Agency (‘Agency’) for the extension of the existing entry for praziquantel to fin fish.
An 8 Meán Fómhair 2022, tháinig an Ghníomhaireacht ar an gconclúid, trí thuairim an Choiste um Tháirgí Íocshláinte d’Úsáid Tréidliachta, gurbh iomchuí MRL a bhunú le haghaidh prasacuainteil in iasc eite, i ndáil le matáin agus craiceann i gcoibhneasa nádúrtha.
On 8 September 2022, the Agency, through the opinion of the Committee for Medicinal Products for Veterinary Use, concluded that the establishment of an MRL for praziquantel in fin fish, in relation to muscle and skin in natural proportions, was appropriate.
I bhfianaise na tuairime ón nGníomhaireacht, measann an Coimisiún gurb iomchuí MRL a bhunú le haghaidh prasacuainteile in iasc eite, i ndáil le matáin agus craiceann i gcoibhneasa nádúrtha agus an t-aicmiú ‘níl gá le huasteorainn iarmhar’ a bhunú le haghaidh prasacuainteile i ngach athchogantach seachas na bó-ainmhithe.
In view of the opinion of the Agency, the Commission considers it appropriate to establish an MRL for praziquantel in fin fish, in relation to muscle and skin in natural proportions and to establish the recommended ‘no MRL required’ classification for praziquantel in all ruminants except bovine species.
Ina dhiaidh sin, tharraing an t-iarratasóir siar an t-iarratas ar údarú tintiúr ceadharlaigh ó Gentiana Lutea L. maidir le gach speiceas agus catagóir ainmhíoch ach amháin: speicis ainmhithe lena ramhrú (seachas each-ainmhithe) agus salmainidí agus mionéisc eite seachas stoc goir.
Subsequently, the applicant withdrew the application for authorisation of gentian tincture from Gentiana Lutea L. for all animal species and categories except: animal species for fattening (other than Equidae) and salmonids and minor fin fish other than brood stock.
I bhfianaise an mhéid thuas, measann an Coimisiún go gcomhlíonann tintiúr ceadharlaigh ó Gentiana lutea L. na coinníollacha dá bhforáiltear in Airteagal 5 de Rialachán (CE) Uimh. 1831/2003, a mhéid a bhaineann le speicis ainmhithe lena ramhrú (seachas each-ainmhithe), salmainidí agus éisc eite seachas stoc goir, agus ar choinníoll go háirithe nach n-úsáidtear an breiseán in éineacht le breiseáin eile ina bhfuil geintisin, isigeintisin agus geintipiocróisíd.
In view of the above, the Commission considers that gentian tincture from Gentiana lutea L. satisfies the conditions provided for in Article 5 of Regulation (EC) No 1831/2003, as regards animal species for fattening (except Equidae), salmonids and fin fish except brood stock, and provided in particular that the additive is not used in combination with other additives containing gentisin, isogentisin and gentiopicroside.