#2051034
GC- nó LC-MS/MS
GC- or LC-MS/MS
GC- nó LC-MS/MS
GC- or LC-MS/MS
LC-MS-MS — crómatagrafaíocht leachta in éineacht le mais-speictriméadracht thrí-cheathairpholach
LC-MS-MS – Liquid chromatography (tandem) triple quadrupole mass spectrometry
LC-MS-MS/ESI — crómatagrafaíocht leachta in éineacht le mais-speictriméadracht thrí-cheathairpholach le hianúchán leictreasprae deimhneach
LC-MS-MS/ESI – Liquid chromatography (tandem) triple quadrupole mass spectrometry with positive electrospray ionisation
crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS)
high performance liquid chromatography coupled to tandem mass spectrometry (LC- MS/MS)
an modh aitheantais anailíseach (e.g. ELISA, LC-MS/MS, AAS);
the analytical method identification (e.g. ELISA, LC-MS/MS, AAS);
Crómatagrafaíocht Leachta Ardfheidhmíochta mar aon le mais-speictriméadracht sraithe (LC-MS/MS) – EN 17299
High Performance Liquid Chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299
— crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS)
— high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)
crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS) – EN 17299.
high performance liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) – EN 17299.
Crómatagrafaíocht Leachta Ardfheidhmíochta in éineacht le mais-speictriméadracht sraithe (LC-MS/MS) — EN 17299.
High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) – EN 17299.
Maidir le hidreabróimíd halafúigionóin i bhfíócháin a chinneadh: crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS).
For the determination of halofuginone hydrobromide in tissues: high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS).
EN 17504 Beatha ainmhithe: Modhanna samplála agus anailíse. Gosapól i síol cadáis agus in ábhar beatha a chinneadh trí LC-MS/MS
EN 17504 Animal feeding stuffs: Methods of sampling and analysis – Determination of gossypol in cotton seed and feeding stuff by LC-MS/MS
Ina theannta sin, d’fhíoraigh an tÚdarás an tuarascáil maidir leis an modh chun anailís a dhéanamh ar an mbreiseán beathaithe arna cur isteach ag an tSaotharlann Tagartha a bunaíodh le Rialachán (CE) Uimh. 1831/2003, lena n-áirítear an t-aguisín a soláthraíodh an 23 Eanáir 2023, inar moladh modh nua ilanailíte a chur leis bunaithe ar chrómatagrafaíocht leachtach mar aon le mais-speictriméadracht (LC-MS/MS) chun sóidiam lasalocid A i mbeatha cumaisc a dhearbhú.
In addition, the Authority verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003, including the addendum produced on 23 January 2023, recommending the addition of a new multi-analyte method based on liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) for the determination of lasalocid A sodium in compound feed.
An modh anailíse dá bhforáiltear le EN 17299 Beatha ainmhithe: Modhanna samplála agus anailíse – Scagthástáil agus cinneadh ar choicideastait údaraithe ar leibhéal breiseáin agus ar leibhéal traséillithe 1 % agus 3 %, agus ar choicideastait neamhchláraithe agus ar antaibheathach amháin ar leibhéil fo-bhreiseáin, i mbeatha chumaisc trína mbrath trí Chrómatagrafaíocht Leachta Ardfheidhmíochta in éineacht le Mais-Speictriméadracht Tandaim (LC-MS/MS), Nó
the method of analysis provided for by EN 17299 Animal feeding stuffs: Methods of sampling and analysis – Screening and determination of authorized coccidiostats at additive and 1 % and 3 % cross-contamination level, and of non-registered coccidiostats and of one antibiotic at sub-additive levels, in compound feed with High Performance Liquid Chromatograpy – Tandem Mass Spectrometry detection (LC-MS/MS), or
an modh anailíse dá bhforáiltear le EN 17299 Beatha ainmhithe: Modhanna samplála agus anailíse – Scagthástáil agus cinneadh ar choicideastait údaraithe ar leibhéal breiseáin agus ar leibhéal traséillithe 1 % agus 3 %, agus ar choicideastait neamhchláraithe agus ar antaibheathach amháin ar leibhéil fo-bhreiseáin, i mbeatha chumaisc trína mbrath trí Chrómatagrafaíocht Leachta Ardfheidhmíochta in éineacht le Mais-Speictriméadracht (LC-MS/MS), nó
the method of analysis provided for by EN 17299 Animal feeding stuffs: Methods of sampling and analysis – Screening and determination of authorized coccidiostats at additive and 1 % and 3 % cross-contamination level, and of non-registered coccidiostats and of one antibiotic at sub-additive levels, in compound feed with High Performance Liquid Chromatography – Tandem Mass Spectrometry detection (LC-MS/MS), or
EN 17194: Beatha ainmhithe: Modhanna samplála agus anailíse – Dé-ocsainiviléanól, Aflatocsain B1, Fúmainisin B1 & B2, tocsainí T-2 & HT-2, Searailionón agus Ócratocsain A a chinneadh in ábhair bheatha agus i mbeatha chumaisc trí LC-MS/MS
EN 17194: Animal feeding stuffs: Methods of sampling and analysis – Determination of Deoxynivalenol, Aflatoxin B1, Fumonisin B1 & B2, T-2 & HT-2 toxins, Zearalenone and Ochratoxin A in feed materials and compound feed by LC-MS/MS
An 26 Márta 2021, chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin ar chosaint staidéar eolaíoch agus sonraí dílseánaigh, is iad sin, staidéir ar chrómatagrafaíocht leachta ardfheidhmíochta in éineacht le mais-speictriméadracht le hianúchán leictreasprae (‘LC-MS/MS’), athshondas maighnéadach núicléach (‘AMN’) agus crómatagrafaíocht ardfheidhmíochta leachta in éineacht le brath aerasól luchtaithe (‘HPLC-CAD’) maidir le haitheantas 6-FL’-SL a chinneadh; tuairisc ar thréithchineál táirgthe salainn sóidiam 6′-SL géinmhodhnaithe; tuairisc mhionsonraithe ar an bpróiseas táirgthe; tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; tástáil micreanúicléis in vivo i gcealla mamach le salann sóidiam 6′-SL; tástáil micreanúicléis in vivo i gcealla mamach le salann sóidiam 3’-Siailiol-lachtóis (‘3′-SL’); tástáil bhaictéarach ais-sócháin le salann sóidiam 3′-SL; staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; staidéar anailíse bithfhaisnéisíochta ar ghéanóm E. coli W (ATCC 9637) chun seichimh heitrealógacha a aimsiú lena bhféadfaí ailléirginí féideartha a ionchódú; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL, arna chur isteach mar thaca leis an iarratas.
On 26 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data, namely, liquid chromatography-mass spectrometry (‘LC-MS/MS’), nuclear magnetic resonance (‘NMR’) and a high-performance liquid chromatography – charged aerosol detection (‘HPLC-CAD’) studies for the determination of the identity of 6′-SL; a description of the genetically modified 6′-SL sodium salt production strain; a detailed description of the production process; a bacterial reverse mutation test with 6′-SL sodium salt; an in vitro mammalian cell micronucleus test with 6′-SL sodium salt; an in vivo mammalian cell micronucleus test with 6′-SL sodium salt; an in vivo mammalian cell micronucleus test with 3′-Sialyllactose (‘3′-SL’) sodium salt; a bacterial reverse mutation test with 3′-SL sodium salt; a 90-day oral toxicity study in rats with 3′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and, a 90-day oral toxicity study in rats with 6′-SL sodium salt, submitted in support of the application.
Sa tuairim eolaíoch uaidh, thug an tÚdarás dá aire go raibh a chonclúid maidir le sábháilteacht an bhia núíosaigh bunaithe ar staidéir agus sonraí eolaíocha ó staidéir ar LC-MS/MS, AMN agus HPLC-CAD maidir le haitheantas 6′-SL a chinneadh; an tuairisc ar thréithchineál táirgthe salainn sóidiam 6′-SL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an tástáil micreanúicléis in vivo i gcealla mamach le salann sóidiam 6′-SL; staidéar anailíse bithfhaisnéisíochta ar ghéanóm E. coli W (ATCC 9637) chun seichimh heitrealógacha a aimsiú lena bhféadfaí ailléirginí féideartha a ionchódú; staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′-SL, atá ann i gcomhad an iarratasóra agus nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach ná teacht ar a chonclúid dá uireasa.
In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on scientific studies and data from namely, LC-MS/MS, NMR and HPLC-CAD studies for the determination of the identity of 6′-SL; the description of the genetically modified 6′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the in vivo mammalian cell micronucleus test with 6′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; a 90-day oral toxicity study in rats with 6′-SL sodium salt, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.
Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na staidéir eolaíocha agus na sonraí eolaíocha, is iad sin, staidéir ar LC-MS/MS, AMN agus HPLC-CAD maidir le haitheantas 6′-SL a chinneadh; an tuairisc ar thréithchineál táirgthe salainn sóidiam 6′-SL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an tástáil micreanúicléis in vivo i gcealla mamach le salann sóidiam 6′-SL; staidéar anailíse bithfhaisnéisíochta ar ghéanóm E. coli W (ATCC 9637) chun seichimh heitrealógacha a aimsiú lena bhféadfaí ailléirginí féideartha a ionchódú; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salainn sóidiam 6′-SL, faoin dlí náisiúnta an tráth a chuir sé an t-iarratas isteach, agus nach féidir le tríú páirtithe rochtain dhlíthiúil a fháil ar na sonraí ná na staidéir sin, iad a úsáid ná tagairt a dhéanamh dóibh.
The applicant declared that it held proprietary and exclusive rights of reference to the scientific studies and data, namely, LC-MS/MS, NMR and HPLC-CAD studies for the determination of the identity of 6′-SL; the description of the genetically modified 6′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the in vivo mammalian cell micronucleus test with 6′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and, the 90-day oral toxicity study in rats with 6′-SL sodium salt, under national law at the time they submitted the application and that third parties cannot lawfully access, use or refer to those data and studies.
Dá bhrí sin, na staidéir eolaíocha agus na sonraí a chuirtear isteach chun tacú leis an iarratas, is iad sin, staidéir LC-MS/MS, AMN agus HPLC-CAD maidir le haitheantas 6′-SL a chinneadh; an tuairisc ar thréithchineál táirgthe salainn sóidiam 6′-SL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an tástáil micreanúicléis in vivo i gcealla mamach le salann sóidiam 6′-SL; staidéar anailíse bithfhaisnéisíochta ar ghéanóm E. coli W (ATCC 9637) chun seichimh heitrealógacha a aimsiú lena bhféadfaí ailléirginí féideartha a ionchódú; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′-SL, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.
Therefore, the scientific studies and data submitted in support of the application, namely, LC-MS/MS, NMR and HPLC-CAD studies for the determination of the identity of 6′-SL; the description of the genetically modified 6′-SL sodium salt production strain; the detailed description of the production process; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the in vivo mammalian cell micronucleus test with 6′-SL sodium salt; a bioinformatics analysis study on the genome of the E. coli W (ATCC 9637) to detect heterologous sequences that could encode possible allergens; and, the 90-day oral toxicity study in rats with 6′-SL sodium salt, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.