Le tocsain Shiga a tháirgeann Escherichia coli (STEC), áirítear inter alia enterohaemorrhagic E. coli (EHEC), véaratocsain a tháirgeann E. coli (VTEC) nó véaraicíteatocsain a tháirgeann E. coli (VTEC).
Shiga toxin producing Escherichia coli (STEC) includes inter alia enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
Le tocsain Shiga a tháirgeann Escherichia coli (STEC), áirítear inter alia enterohaemorrhagic E. coli (EHEC), véaratocsain a tháirgeann E. coli (VTEC) nó véaraicíteatocsain a tháirgeann E. coli (VTEC).
Shiga toxin producing Escherichia coli (STEC) includes inter alia enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
Le tocsain Shiga a tháirgeann Escherichia coli (STEC), áirítear inter alia enterohaemorrhagic E. coli (EHEC), véaratocsain a tháirgeann E. coli (VTEC) nó véaraicíteatocsain a tháirgeann E. coli (VTEC).
Shiga toxin producing Escherichia coli (STEC) includes inter alia enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
Le tocsain Shiga a tháirgeann Escherichia coli (STEC), áirítear inter alia enterohaemorrhagic E. coli (EHEC), véaratocsain a tháirgeann E. coli (VTEC) nó véaraicíteatocsain a tháirgeann E. coli (VTEC).
Shiga toxin producing Escherichia coli (STEC) includes inter alia enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytotoxin producing E. coli (VTEC).
E.coli veireatocsaigineach
Verotoxigenic E. coli
E. coli veireatocsaigineach
Verotoxigenic E. coli
Ainmneacha eile ar Escherichia coli (STEC) is ea E. coli eintrea-fhuilreatha (EHEC) nó E. coli a tháirgeann véaraicíteatocsain (VTEC).
Shiga toxin producing Escherichia coli (STEC) is also known as enterohaemorrhagic E. coli (EHEC) or verocytotoxin producing E. coli (VTEC).
Escherichia coli (E. coli) agus baictéir dhrólannacha (EN ISO 9308-1 nó EN ISO 9308-2);
Escherichia coli (E. coli) and coliform bacteria (EN ISO 9308-1 or EN ISO 9308-2);
E. coli: < 10 CFU/g
E. coli: < 10 CFU/g
(arna tháirgeadh le tréithchineálacha díorthacha E. coli BL21(DE3))
(produced by derivative strains of E. coli BL21(DE3))
(arna tháirgeadh ag tréithchineál díorthach de E. Coli BL21(DE3))
(produced by a derivative strain of E. coli BL21(DE3))
(arna tháirgeadh ag tréithchineál díorthach de E. coli BL21(DE3))
(produced by derivative strains of E. coli BL21(DE3))
E. coli:< 3 MPN/g
E. coli: < 3 MPN/g
(arna tháirgeadh ag tréithchineálacha díorthacha de E. coli BL21(DE3))
(produced by derivative strains of E. coli BL21(DE3))
E. coli: nár aimsíodh in 10 g
E. coli: not detected in 10 g
(arna tháirgeadh ag tréithchineálacha díorthacha de E. coli BL21(DE3))
(produced by derivative strains of E. coli BL21(DE3))
(arna tháirgeadh ag tréithchineál díorthach de E. coli K-12 DH1)
(produced by derivative strain of E. coli K-12 DH1)
(arna tháirgeadh le tréithchineál díorthach E. coli W (ATCC 9637))
(produced by derivative strain of E. coli W (ATCC 9637))
(arna tháirgeadh le tréithchineál díorthach E. coli W (ATCC 9637)) Tuairisc:
‘6′ -Sialyllactose (6′-SL) sodium salt
tá na luachanna a léirítear do E. coli, Legionella spp. agus néimeatóidí stéigeacha comhlíonta in 90 % nó níos mó de na samplaí; ní bhíonn aon cheann de na luachanna os cionn na teorann uasta diallais d’aon aonad loga amháin ón luach a léirítear do E. coli agus Legionella spp. agus 100 % den luach a léirítear do néimeatóidí stéigeacha;
the indicated values for E. coli, Legionella spp. and intestinal nematodes are met in 90 % or more of the samples; none of the values of the samples exceed the maximum deviation limit of 1 log unit from the indicated value for E. coli and Legionella spp. and 100 % of the indicated value for intestinal nematodes;
Escherichia coli (E. coli), eintreacocas stéigeach, baictéir dhrólannacha, áireamh coilíneachtaí ag 22 °C, dath, moirtiúlacht, blas, boladh, pH agus seoltacht;
Escherichia coli (E. coli), intestinal enterococci, coliform bacteria, colony count 22 °C, colour, turbidity, taste, odour, pH and conductivity;
Ba cheart LNT arna thairgeadh le tréithchineálacha díorthacha E. coli BL21(DE3) a áireamh i liosta an Aontais de bhianna núíosacha a leagtar amach i Rialachán Cur Chun Feidhme (AE) 2017/2470.
LNT produced with derivative strains of E. coli BL21(DE3) should be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
Údaraítear lachta-N-teatra-ós a tháirgtear le tréithchineálacha díorthacha E. coli BL21(DE3) a chur ar an margadh laistigh den Aontas.
Lacto-N-tetraose produced with derivative strains of E. coli BL21(DE3) is authorised to be placed on the market within the Union.
Áireofar lachta-N-teatra-ós arna thairgeadh le tréithchineálacha díorthacha E. coli BL21(DE3) i liosta an Aontais de bhianna núíosacha a leagtar amach i Rialachán Cur Chun Feidhme (AE) 2017/2470.
Lacto-N-tetraose produced with derivative strains of E. coli BL21(DE3) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
3-Fúcaishiollachtós arna tháirgeadh le tréithchineál díorthach de E. coli BL21(DE3), údaraítear é a chur ar an margadh laistigh den Aontas.
3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) is authorised to be placed on the market within the Union.
3-FL arna tháirgeadh le tréithchineál díorthach de E. coli BL21(DE3), áireofar é i liosta an Aontais de bhianna núíosacha a leagtar amach i Rialachán Cur Chun Feidhme (AE) 2017/2470.
3-Fucosyllactose produced with a derivative strain of E. coli BL21(DE3) shall be included in the Union list of novel foods set out in Implementing Regulation (EU) 2017/2470.
Salann sóidiam 3′-Siailiol-lachtóis arna tháirgeadh le tréithchineálacha díorthacha de E. coli BL21(DE3), údaraítear é a chur ar an margadh laistigh den Aontas.
3′-Sialyllactose sodium salt produced with derivative strains of E. coli BL21(DE3) is authorised to be placed on the market within the Union.
3-Fúcaishiollachtós arna tháirgeadh le tréithchineál díorthach de E. coli K-12 DH1, údaraítear é a chur ar an margadh laistigh den Aontas.
3-Fucosyllactose produced with a derivative strain of E. coli K-12 DH1 is authorised to be placed on the market within the Union.
Chun íosmhéadú a dhéanamh ar na hiarmhairtí don tsláinte poiblí ó bhagairtí sláinte trasteorann amhail a leagtar amach i gCinneadh Uimh 1082/2013/AE ó Pharlaimint na hEorpa agus ón gComhairle [7], a d'fhéadfadh dul ó olléilliú i ngeall ar theagmhais cheimiceacha go paindéimí, amhail na cinn a thig le déanaí as E. coli, fliú de chineál H1N1 nó SARS (géarshiondróm trom riospráide) nó éifeachtaí sláinte a thagann as gluaiseachtaí daonra atá ag dul i méid, ba cheart don Chlár rannchuidiú le sásraí agus uirlisí láidre a chruthú agus a chothabháil chun mórbhagairtí sláinte trasteorann a bhrath, a mheasúnú agus a bhainistiú.
In order to minimise the public health consequences of cross-border threats to health as set out in Decision No 1082/2013/EU of the European Parliament and of the Council [7], which could range from mass contamination caused by chemical incidents to pandemics, like those unleashed recently by E. coli, influenza strain H1N1 or SARS (severe acute respiratory syndrome), or health effects resulting from increasing population movements, the Programme should contribute to the creation and maintenance of robust mechanisms and tools to detect, assess and manage major cross-border health threats.
Glactar leis gur “croípharaiméadair” iad Escherichia coli (E. coli) agus eintreacocas stéigeach agus ní thiocfaidh laghdú ar mhinicíochtaí an fhaireacháin a dhéantar orthu mar gheall ar mheasúnú riosca ar an gcóras soláthair i gcomhréir le hAirteagal 9 agus Cuid C den Iarscríbhinn seo.
Escherichia coli (E. coli) and intestinal enterococci are considered ‘core parameters’ and their monitoring frequencies shall not be the subject of a reduction due to a risk assessment of the supply system in accordance with Article 9 and Part C of this Annex.
Is iad na miocrorgánaigh tháscacha atá roghnaithe ná E. coli le haghaidh baictéir phataigineacha, baictéarafagaigh dhrólannacha F-shonracha, baictéarafagaigh shómatacha dhrólannacha nó baictéarafagaigh dhrólannacha le haghaidh víris phataigineacha, agus spóir de Clostridium perfringens nó baictéir sulfáitlaghdaithe spórdhéanta le haghaidh protozoa.
The indicator microorganisms selected are E. coli for pathogenic bacteria, F-specific coliphages, somatic coliphages or coliphages for pathogenic viruses, and Clostridium perfringens spores or spore-forming sulfate-reducing bacteria for protozoa.
An 22 Deireadh Fómhair 2020, ghlac an tÚdarás a thuairim eolaíoch “Sábháilteacht lachta-N-neoiteatrós (LNnT) arna tháirgeadh ag tréithchineálacha díorthacha de E. Coli BL21 mar bhia núíosach de bhun Rialachán (AE) 2015/2283”.
On 22 October 2020, the Authority adopted its scientific opinion ‘Safety of lacto-N-neotetraose (LNnT) produced by derivative strains of E. coli BL21 as a novel food pursuant to Regulation (EU) 2015/2283’.
I mí an Mheithimh 2021, rinne an t-iarratasóir athbhreithniú ar a iarratas agus d’iarr sé go ndéanfaí tiontú einsíme ar ribidióisíd A nó steibhióisíd ó eastócáin duilleog Stevia chuig ribidióisídí M agus D agus ribidióisíd AM faoi seach, ag úsáid einsímí arna dtáirgeadh ag miocrorgánaigh ghéinmhodhnaithe a dhíorthaítear ó thréithchineálacha E. coli K-12, lena n-úsáid mar phróiseas táirgthe malartach le haghaidh E 960c.
On June 2021, the applicant revised its application and requested enzymatic conversion of highly purified rebaudioside A or stevioside from Stevia leaf extracts to, respectively, rebaudiosides M and D and rebaudioside AM, using enzymes produced by genetically modified microorganisms derived from strains of E. coli K-12, to be used as an alternative production process for E 960c.
Táirgtear ribidióisíd M trí thiontú einsíme a dhéanamh ar eastóscáin ribidióisíd A ghliocóisíde steibhióil ardíonaithe (95 % gliocóisídí steibhióil) a fhaightear ó phlanda Bertoni Stevia rebaudiana ag baint úsáide as UDP-glúcaisioltraisfearáis agus einsímí siontáise siúcróise a tháirgtear leis na tréithchineálacha géinmhodhnaithe de E. coli (pPM294, pFAF170 agus pSK401) a éascaíonn aistriú glúcóis ó shiúcrós agus UDP-glúcóis go gliocóisídí steibhióil trí nascanna gliocóisídeacha.
Rebaudioside M is produced via enzymatic conversion of highly purified steviol glycoside rebaudioside A extracts (95 % steviol glycosides) obtained from Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified strains of E. coli (pPM294, pFAF170 and pSK401) that facilitate the transfer of glucose from sucrose and UDP-glucose to steviol glycosides via glycosidic bonds.
Tar éis na heinsímí a bhaint trí dheighilt sholadach-leachtach agus trí chóireáil teasa, is éard atá i gceist leis an íonú ribidióisíd M a thiúchan trí asú roisín, agus athchriostalú a dhéanamh ar na gliocóisídí steibhióil ina dhiaidh sin as a dtiocfaidh táirge deiridh ina mbeidh rud nach lú ná 95 % de ribidióisíd M. Ní bhraithfear cealla inmharthana de E. coli (pPM294, pFAF170 agus pSK401) agus a gcuid DNA sa bhreiseán bia.
After removal of the enzymes by solid-liquid separation and heat treatment, the purification involves concentration of the rebaudioside M by resin adsorption, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95 % of rebaudioside M. Viable cells of E. coli (pPM294, pFAF170 and pSK401) and their DNA shall not be detected in the food additive.
Táirgtear ribidióisíd D trí thiontú einsíme a dhéanamh ar eastóscáin ribidióisíd A ghliocóisíde steibhióil ardíonaithe (95 % gliocóisídí steibhióil) a fhaightear ó phlanda Bertoni Stevia rebaudiana ag baint úsáide as UDP-glúcaisioltraisfearáis agus einsímí siontáise siúcróise a tháirgtear leis na tréithchineálacha géinmhodhnaithe de E. coli (pPM294, pFAF170 agus pSK401) a éascaíonn aistriú glúcóis ó shiúcrós agus UDP-glúcóis go gliocóisídí steibhióil trí nascanna gliocóisídeacha.
Rebaudioside D is produced via enzymatic conversion of highly purified steviol glycoside rebaudioside A extracts (95 % steviol glycosides) obtained from Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified strains of E. coli (pPM294, pFAF170 and pSK401) that facilitate the transfer of glucose from sucrose and UDP-glucose to steviol glycosides via glycosidic bonds.
Tar éis na heinsímí a bhaint trí dheighilt sholadach-leachtach agus trí chóireáil teasa, is éard atá i gceist leis an íonú ribidióisíd D a thiúchan trí asú roisín, agus athchriostalú a dhéanamh ar na gliocóisídí steibhióil ina dhiaidh sin as a dtiocfaidh táirge deiridh ina mbeidh rud nach lú ná 95 % de ribidióisíd D agus ribidióisíd A. Ní bhraithfear cealla inmharthana de E. coli (pPM294, pFAF170 agus pSK401) agus a gcuid DNA sa bhreiseán bia.
After removal of the enzymes by solid-liquid separation and heat treatment, the purification involves concentration of the rebaudioside D by resin adsorption, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95 % of rebaudioside D and rebaudioside A. Viable cells of E. coli (pPM294, pFAF170 and pSK401) and their DNA shall not be detected in the food additive.
Táirgtear ribidióisíd AM trí thiontú einsíme a dhéanamh ar eastóscáin steibhióisíde ghliocóisíde steibhióil ardíonaithe (95 % gliocóisídí steibhióil) a fhaightear ó phlanda Bertoni Stevia rebaudiana ag baint úsáide as UDP-glúcaisioltraisfearáis agus einsímí siontáise siúcróise a tháirgtear leis na tréithchineálacha géinmhodhnaithe de E. coli (pPM294, pFAF170 agus pSK401) a éascaíonn aistriú glúcóis ó shiúcrós agus UDP-glúcóis go gliocóisídí steibhióil trí nascanna gliocóisídeacha.
Rebaudioside AM is produced via enzymatic conversion of highly purified steviol glycoside stevioside extracts (95 % steviol glycosides) obtained from Stevia rebaudiana Bertoni plant using UDP-glucosyltransferase and sucrose synthase enzymes produced by the genetically modified strains of E. coli (pPM294, pFAF170 and pSK401) that facilitate the transfer of glucose from sucrose and UDP-glucose to steviol glycosides via glycosidic bonds.
Tar éis na heinsímí a bhaint trí dheighilt sholadach-leachtach agus trí chóireáil teasa, is éard atá i gceist leis an íonú ribidióisíd AM a thiúchan trí asú roisín, agus athchriostalú a dhéanamh ar na gliocóisídí steibhióil ina dhiaidh sin as a dtiocfaidh táirge deiridh ina mbeidh rud nach lú ná 95 % de ribidióisíd AM. Ní bhraithfear cealla inmharthana de E. coli (pPM294, pFAF170 agus pSK401) agus a gcuid DNA sa bhreiseán bia.
After removal of the enzymes by solid-liquid separation and heat treatment, the purification involves concentration of the rebaudioside AM by resin adsorption, followed by recrystallisation of the steviol glycosides resulting in a final product containing not less than 95 % of rebaudioside AM. Viable cells of E. coli (pPM294, pFAF170 and pSK401) and their DNA shall not be detected in the food additive.
Go traidisiúnta, tagann an fhoinse uisce ó fhuaráin nádúrtha doimhne ar mhórán mianraí nó ó thollhpoill trí shreafaí nádúrtha nó caidéalaithe, ach tá foinsí eile inghlactha freisin má tá cáilíocht mhicribhitheolaíoch ard oiriúnach ag baint leo (sprioc maidir le E. coli nialasach, lamháltas, 100cfu/100ml; sprioc maidir le listéire nialasach, lamháltas 100cfu/100ml, Salmonella nialasach, STEC nialasach) agus má tá siad saor ó éilliú uisce dromchla.
Traditionally the source of water has been from deep mineral rich natural springs or boreholes by either natural flows or pumped, however other sources are acceptable if of a suitably high microbiological quality (target zero Ecoli, tolerance,100cfu/100ml; target zero listeria, tolerance 100cfu/100ml, zero Salmonella, zero STEC) and free from surface water contamination.
Le Rialachán Cur Chun Feidhme (AE) 2020/484 ón gCoimisiún údaraíodh Lachta-N-teatra-ós a fhaightear trí choipeadh miocróbach trí úsáid á baint as an tréithchineál géinmhodhnaithe K12 DH1 Escherichia coli (“E. Coli”) a chur ar mhargadh an Aontais mar bhia núíosach faoi Rialachán (AE) 2015/2283.
Commission Implementing Regulation (EU) 2020/484 authorised the placing on the Union market of Lacto-N-tetraose obtained by microbial fermentation using the genetically modified strain K12 DH1 of Escherichia coli (‘E. coli’) as a novel food under Regulation (EU) 2015/2283.
An 22 Bealtaine 2020, chuir an chuideachta Chr. Hansen A/S (“an t-iarratasóir”) iarratas ar údarú faoi bhráid an Choimisiúin i gcomhréir le hAirteagal 10(1) de Rialachán (AE) 2015/2283 chun lachta-N-teatra-ós (“LNT”), a fhaightear trí choipeadh miocróbach trí úsáid á baint as dhá thréithchineál ghéinmhodhnaithe (tréithchineál táirgthe agus tréithchineál díghrádúcháin roghnach) a dhíorthaítear ón tréithchineál óstach E. coli BL21(DE3), a chur ar mhargadh an Aontais mar bhia núíosach.
On 22 May 2020, the company Chr. Hansen A/S (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place lacto-N-tetraose (‘LNT’), obtained by microbial fermentation using two genetically modified strains (a production strain and an optional degradation strain) derived from the host strain E. coli BL21(DE3), on the Union market as a novel food.
An 27 Eanáir 2021 d’iarr an Coimisiún ar an Údarás Eorpach um Shábháilteacht Bia (“an tÚdarás”) measúnú a dhéanamh ar LNT a fhaightear trí choipeadh miocróbach trí úsáid a bhaint as dhá thréithchineál ghéinmhodhnaithe (cineál táirgthe agus tréithchineál díghrádúcháin roghnach) a dhíorthaítear ón tréithchineál óstach Escherichia coli (“E. coli”) BL21(DE3), mar bhia núíosach, i gcomhréir le hAirteagal 10(3) de Rialachán (AE) 2015/2283.
On 27 January 2021, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of LNT obtained by microbial fermentation using two genetically modified strains (a production strain and an optional degradation strain) derived from the host strain Escherichia coli (‘E. coli’) BL21(DE3), as a novel food, in accordance with Article 10(3) of Regulation (EU) 2015/2283.
An 23 Márta 2022, ghlac an tÚdarás a thuairim eolaíoch dar teideal ‘Safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283’ [Sábháilteacht lachta-N-teatra-óis arna tháirgeadh le tréithchineálacha díorthacha E. coli BL21(DE3) mar bhia núíosach de bhun Rialachán (AE) 2015/2283] i gcomhréir le hAirteagal 11 de Rialachán (AE) 2015/2283.
On 23 March 2022, the Authority adopted its scientific opinion on the ‘Safety of lacto-N-tetraose (LNT) produced by derivative strains of Escherichia coli BL21(DE3) as a novel food pursuant to Regulation (EU) 2015/2283’ in accordance with the requirements of Article 11 of Regulation (EU) 2015/2283.
Is iomchuí go mbeadh an fhaisnéis dá dtagraítear in Airteagal 9(3) de Rialachán (AE) 2015/2283 san iontráil a bhaineann le LNT arna thairgeadh le tréithchineálacha díorthacha E. coli BL21(DE3) ar liosta an Aontais de bhianna núíosacha.
It is appropriate that the inclusion of LNT produced with derivative strains of E. coli BL21(DE3) as a novel food in the Union list of novel foods contains the information referred to in Article 9(3) of Regulation (EU) 2015/2283.
Le Rialachán Cur Chun Feidhme (AE) 2021/2029 ón gCoimisiún údaraíodh 3-Fúcaishiollachtós, rud a fhaightear trí choipeadh miocróbach agus úsáid á baint as an tréithchineál géinmhodhnaithe K12 MG1655 de Escherichia coli (“E. coli”), a chur ar mhargadh an Aontais mar bhia núíosach faoi Rialachán (AE) 2015/2283.
Commission Implementing Regulation (EU) 2021/2029 authorised the placing on the Union market of 3-Fucosyllactose obtained by microbial fermentation using the genetically modified strain K12 MG1655 of Escherichia coli (‘E. coli’) as a novel food under Regulation (EU) 2015/2283.
An 17 Márta 2020, chuir an chuideachta Chr. Hansen A/S (“an t-iarratasóir”) iarratas ar údarú faoi bhráid an Choimisiúin i gcomhréir le hAirteagal 10(1) de Rialachán (AE) 2015/2283 chun 3-fúcaishiollachtóis (“3-FL”), rud a fhaightear trí choipeadh miocróbach agus úsáid á baint as an tréithchineál géinmhodhnaithe amháin de E. coli BL21(DE3), a chur ar mhargadh an Aontais mar bhia núíosach.
On 17 March 2020, the company Chr. Hansen A/S (‘the applicant’) submitted an application for an authorisation to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 to place 3-fucosyllactose (‘3-FL’) obtained by microbial fermentation using one genetically modified strain of E. coli BL21(DE3), on the Union market as a novel food.
An 23 Meán Fómhair 2020, d’iarr an Coimisiún ar an Údarás Eorpach um Shábháilteacht Bia (“an tÚdarás”) measúnú a dhéanamh ar 3-Fúcaishiollachtós a fhaightear trí choipeadh miocróbach agus úsáid á baint as tréithchineál táirgthe géinmhodhnaithe a dhíorthaítear ó thréithchineál óstach E. coli BL21(DE3), mar bhia núíosach i gcomhréir le hAirteagal 10(3) de Rialachán (AE) 2015/2283.
On 23 September 2020, the Commission requested the European Food Safety Authority (‘the Authority’) to carry out an assessment of 3-Fucosyllactose obtained by microbial fermentation using a genetically modified production strain derived from the host strain E. coli BL21(DE3), as a novel food in accordance with Article 10(3) of Regulation (EU) 2015/2283.
Dá réir sin, níor cheart ach an t-iarratasóir a údarú chun 3-fúcaishiollachtós a tháirgtear le tréithchineál díorthach de E. coli BL21(DE3) a chur ar an margadh laistigh den Aontas ar feadh tréimhse cúig bliana ó theacht i bhfeidhm an Rialacháin seo.
Accordingly, only the applicant should be authorised to place 3-fucosyllactose produced with a derivative strain of E. coli BL21(DE3) on the market within the Union during a period of five years from the entry into force of this Regulation.
Mar sin féin, srianadh an údaraithe i leith 3-FL a tháirgtear le tréithchineál díorthach de E. coli BL21(DE3) agus tagairt do na staidéir agus na sonraí eolaíocha atá i gcomhad an iarratasóra ionas gur ag an iarratasóir amháin atá an ceart sin, ní rud é lena gcuirtear cosc ar iarratasóirí eile cur isteach ina dhiaidh sin ar údarú chun an bia núíosach céanna a chur ar an margadh, ar choinníoll go mbeidh a n-iarratas bunaithe ar fhaisnéis a fuarthas go dlíthiúil agus atá ina taca leis an údarú sin.
However, restricting the authorisation of 3-FL produced with a derivative strain of E. coli BL21(DE3) and the reference to the scientific studies and data contained in the applicant’s file for the sole use by them does not prevent subsequent applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting such an authorisation.