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GC- nó LC-MS/MS
GC- or LC-MS/MS
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#2403430
HPLC-MS-MS — crómatagrafaíocht leachta ardfheidhmíochta in éineacht le mais-speictriméadracht thrí-cheathairpholach
HPLC-MS-MS – High-performance liquid chromatography (tandem) triple quadrupole mass spectrometry
#2403431
LC-MS-MS — crómatagrafaíocht leachta in éineacht le mais-speictriméadracht thrí-cheathairpholach
LC-MS-MS – Liquid chromatography (tandem) triple quadrupole mass spectrometry
#2403433
UPLC-MS-MS — crómatagrafaíocht leachta ultra-ardfheidhmíochta in éineacht le mais-speictriméadracht thrí-cheathairpholach
UPLC-MS-MS – Ultra-performance liquid chromatography (tandem) triple quadrupole mass spectrometry
#2480532
crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS)
high performance liquid chromatography coupled to tandem mass spectrometry (LC- MS/MS)
#2563501
an modh aitheantais anailíseach (e.g. ELISA, LC-MS/MS, AAS);
the analytical method identification (e.g. ELISA, LC-MS/MS, AAS);
#2846730
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
#2960598
— crómatagrafaíocht leachta ardfheidhmíochta cúpláilte le mais-speictriméadracht sraithe (LC-MS/MS)
— high performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)
#3123859
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.
#3190556
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.
#3234516
I gcás GC-MS/MS:
For GC-MS/MS:
#3234645
Crómatagrafaíocht gháis/Brath leictreonghabhála (GC-ECD), GC-LRMS, GC-MS/MS, GC-HRMS nó modhanna coibhéiseacha.
Gas chromatography / Electron Capture Detection (GC-ECD), GC-LRMS, GC-MS/MS, GC-HRMS or equivalent methods.
#1933186
(HPLC-MS/MS) modh bunaithe ar chainníochtú ar an aigéad trícharbaillileach a scaoiltear de bharr gníomhaíochta einsíme ar fhúmainisin B1 ag pH 8,0 agus ag 30 °C.
(HPLC-MS/MS) method based on the quantification of the tricarballylic acid released from the action of the enzyme on fumonisin B1 at pH 8,0 and 30 °C.
#2403432
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
#3123769
Maidir le sanguineairín (marcóir fiticheimiceach) i réamh-mheascáin agus i mbeatha chumaisc a chinneadh: leachtchrómatagrafaíocht ardfheidhmíochta phas-aisiompaithe cúpláilte le brath mais-speictriméadrachta (HPLC-MS/MS).
Determination of sanguinarine (phytochemical marker) in premixtures and compound feed: reversed phase high performance liquid chromatography coupled to mass spectrometry detection (HPLC-MS/MS).
#3190557
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).
#3234356
Le modhanna den sórt sin, úsáidtear crómatagrafaíocht gháis in éineacht le mais-speictriméadracht ardtaifeach (GC-HRMS) nó crómatagrafaíocht gháis in éineacht le mais-speictriméadracht sraithe (GC-MS/MS).
Such methods utilise gas chromatography/high resolution mass spectrometry (GC-HRMS) or gas chromatography/tandem mass spectrometry (GC-MS/MS).
#3234398
Chun comhlíontacht nó neamhchomhlíontacht leis an uasleibhéal a chinneadh, is féidir GC-MS/MS a úsáid freisin.
For confirming compliance or non-compliance with the maximum level, also GC-MS/MS can be used.
#3234653
dhá mháthair-ian shonracha ar a laghad, a mbeidh ian táirge trasdula comhfhreagrach sonrach amháin ag gach ceann díobh le haghaidh MS-MS.
two specific precursor ions, each with one specific corresponding transition product ion for for MS-MS.
#3234692
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
#2846658
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.
#3007802
Dá bhrí sin, na staidéir eolaíocha agus na sonraí maidir le HPLC-ESI-MS/MS, speictriméadracht NMR, agus bailíochtú modhanna HPAEC-PAD agus na torthaí maidir le haitheantas 3-FL a chinneadh; an tuairisc mhionsonraithe ar thréithchineál táirgthe 3-FL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an anailís mhionsonraithe ar chomhdhéanamh agus torthaí tástála cobhsaíochta; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh le 3-F; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.
Therefore, the scientific studies and data on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.
#3233702
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
#3233847
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
#3234690
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
#3007793
An 25 Márta 2021, rinne an t-iarratasóir iarraidh ar an gCoimisiún freisin ar chosaint staidéar eolaíoch agus sonraí dílseánaigh a cuireadh isteach chun tacú leis an iarratas, is iad sin, bailíochtú modhanna crómatagrafaíochta leachta ardfheidhmíochta in éineacht le mais-speictriméadracht le hianúchán leictreasprae (‘HPLC-ESI-MS/MS’), an athshondais mhaighnéadaigh núicléach (‘AMN’) agus na crómatagrafaíochta ainianmhalartúcháin ardfheidhmíochta le haimpéarméadrach bíogach braite (‘HPAEC-PAD’) agus na torthaí maidir le aitheantas 3-FL; tuairisc mhionsonraithe ar thréithchineál táirgthe 3-FL géinmhodhnaithe; tuairisc mhionsonraithe ar an bpróiseas táirgthe; anailís mhionsonraithe ar chomhdhéanamh agus torthaí tástála cobhsaíochta; tástáil bhaictéarach ais-sócháin le 3-FL; tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL; agus, staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL.
On 25 March 2021, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data submitted in support of the application, namely, high performance liquid chromatography-electrospray ionisation-mass spectrometry (‘HPLC-ESI-MS/MS’), nuclear magnetic resonance (‘NMR’) spectroscopy, and high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 3-FL; a detailed description of the genetically modified 3-FL production strain; a detailed description of the production process; detailed composition analysis and stability test results; a bacterial reverse mutation test with 3-FL; an in vitro mammalian cell micronucleus test with 3-FL; a 14-day dose range finding oral toxicity study in rats with 3-FL; and, a 90-day oral toxicity study in rats with 3-FL.
#3007798
Sa tuairim eolaíoch uaidh, mheas an tÚdarás nach bhféadfadh sé teacht ar a chonclúidí maidir le sábháilteacht an 3-FL arna tháirgeadh ag tréithchineál díorthach de E. coli K-12 DH1 gan na staidéir eolaíocha agus na sonraí maidir le HPLC-ESI-MS/MS, speictriméadracht AMN, agus bailíochtú modhanna HPAEC-PAD agus na torthaí maidir le haitheantas 3-FL a chinneadh; an tuairisc mhionsonraithe ar thréithchineál táirgthe 3-FL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an anailís mhionsonraithe ar chomhdhéanamh agus torthaí tástála cobhsaíochta; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh le 3-F; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL.
In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL produced by a derivative strain of E. coli K-12 DH1 without the scientific studies and data on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL.
#3007800
Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na staidéir eolaíocha agus na sonraí eolaíocha maidir le HPLC-ESI-MS/MS, speictriméadracht AMN, agus bailíochtú modhanna HPAEC-PAD agus na torthaí maidir le haitheantas 3-FL a chinneadh; an tuairisc mhionsonraithe ar thréithchineál táirgthe 3-FL géinmhodhnaithe; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; an anailís mhionsonraithe ar chomhdhéanamh agus torthaí tástála cobhsaíochta; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh le 3-F; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL, 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 on the HPLC-ESI-MS/MS, NMR spectroscopy, and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL; the detailed description of the genetically modified 3-FL production strain; the detailed description of the production process; the detailed composition analysis and stability test results; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 14-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL, under national law at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data and studies.
#3008232
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.
#3008237
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.
#3008239
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.
#3008241
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.