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  1. #1915903

    An 31 Eanáir 2019, d’iarr an t-iarratasóir ar an gCoimisiún sonraí dílseánaigh le haghaidh roinnt staidéar a cuireadh isteach mar thaca leis an iarratas a chosaint, eadhon na tuarascála anailíseacha dílseánaigh ar an gcomparáid struchtúir trí athshondas maighnéadach núicléach (“AMN”) 6’-SL arna tháirgeadh trí choipeadh baictéarach 6’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 6’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 6’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 6’-SL; tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6’-SL; tástáil micreanúicléis in vitro i gcealla mamach leis an gcomhdhúil ghaolta salann sóidiam 3’-siailiol-lachtóis (“3’-SL”); tástáil bhaictéarach ais-sócháin le salann sóidiam 6’-SL; tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL; staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de; staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de.

    On 31 January 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 6’-SL intake assessment reports; an in vitro mammalian cell micronucleus test with 6’-SL sodium salt; an in vitro mammalian cell micronucleus test with the related compound 3’-sialyllactose (‘3’-SL’) sodium salt; a bacterial reverse mutation test with 6’-SL sodium salt; a bacterial reverse mutation test with 3’-SL sodium salt; a 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; a 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations; a 14-day oral toxicity study in the neonatal rat with 3’-SL sodium salt; and a 90-day oral toxicity study in the neonatal rat with 3’-SL sodium salt, including the summary table of the statistically significant observations.

    Commission Implementing Regulation (EU) 2021/82 of 27 January 2021 authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  2. #1918710

    An 28 Feabhra 2019, d’iarr an t-iarratasóir ar an gCoimisiún sonraí dílseánaigh le haghaidh roinnt staidéar a cuireadh isteach mar thaca leis an iarratas a chosaint, eadhon na tuarascála anailíseacha dílseánaigh ar an gcomparáid struchtúir trí athshondas maighnéadach núicléach (“AMN”) 3’-SL arna tháirgeadh trí choipeadh baictéarach 3’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéarachaagus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 3’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 3’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 3’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3’-SL; an tástáil micreanúicléis in vitro i gcealla mamach leis an gcomhdhúil ghaolta salann sóidiam 6’-siailiol-lachtóis (“6’-SL”); an tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6’-SL; an staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL; an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de, staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL, agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de.

    On 28 February 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the proprietary analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; an in vitro mammalian cell micronucleus test with 3'-SL sodium salt; an in vitro mammalian cell micronucleus test with the related compound 6'-sialyllactose (‘6'-SL’) sodium salt; a bacterial reverse mutation test with 3'-SL sodium salt; a bacterial reverse mutation test with 6'-SL sodium salt; a 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; a 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt including the summary table of the statistically significant observations, a 14-day oral toxicity study in the neonatal rat with 6'-SL sodium salt, and a 90-day oral toxicity study in the neonatal rat with 6'-SL sodium salt, including the summary table of the statistically significant observations.

    Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  3. #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.

    Commission Implementing Regulation (EU) 2023/2215 of 23 October 2023 authorising the placing on the market of 6'-Sialyllactose sodium salt produced by derivative strain of Escherichia coli W (ATCC 9637) as a novel food and amending Implementing Regulation (EU) 2017/2470

  4. #2170869

    Ina theannta sin, chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin ar chosaint sonraí dílseánaigh i gcás roinnt sonraí a cuireadh isteach mar thaca lena iarratas, eadhon, tuairisc mhionsonraithe ar an bpróiseas táirgthe,; modhanna anailíse; deimhnithe anailíse; tuarascáil ar chobhsaíocht; measúnú ar iontógáil bóróin chothaithigh; staidéar tocsainchinéiteach; tástáil cúlsócháin bhaictéaraigh; tástáil micreanúicléis in vitro i gcealla na mamach; staidéar 90 lá ar thocsaineacht i bhfrancaigh; anailís ar cháithníní de réir méide; modh anailíse ar cháithníní de réir méide; anailís ar fhruchtós; anailís ar aimíonaigéid; anailís ar mhiocrorgánaigh; cobhsaíocht fhisiceimiceach; cobhsaíocht fruchtóis sa bhia núíosach; iontógáil cúlra bóróin chothaithigh; díthiomsú bóróin ag pH éagsúla.

    The applicant also submitted a request to the Commission for the protection of proprietary data for a number of data submitted in support of the application, namely, detailed description of the production process; methods of analysis; certificates of analysis; stability report; dietary boron intake assessment; toxicokinetic study; bacterial reverse mutation test; in vitro mammalian micronucleus assay; 90-day toxicity study in rats; particle size analysis; particle size method of analysis; fructose analysis; amino acid analysis; microorganisms analysis; physiochemical stability; stability of fructose in the novel food; background dietary boron intakes; boron dissociation under varying pH.

    Commission Implementing Regulation (EU) 2021/2129 of 2 December 2021 authorising the placing on the market of calcium fructoborate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  5. #2170881

    Dá réir sin, seo tuairisc mhionsonraithe ar an bpróiseas táirgthe; modhanna anailíse; deimhnithe anailíse; tuarascáil ar chobhsaíocht; staidéar tocsainchinéiteach; tástáil cúlsócháin bhaictéaraigh; tástáil micreanúicléis in vitro i gcealla na mamach; staidéar 90 lá ar thocsaineacht i bhfrancaigh; anailís ar cháithníní de réir méide; modh anailíse ar cháithníní de réir méide; anailís ar fhruchtós; anailís ar aimíonaigéid; anailís ar mhiocrorgánaigh; cobhsaíocht fhisiceimiceach; cobhsaíocht fruchtóis sa bhia núíosach; díthiomsú bóróin ag pH éagsúla atá i gcomhad an iarratasóra, ar ar bhunaigh an tÚdarás a chonclúid maidir le sábháilteacht an bhia núíosaigh, agus nach bhféadfadh an tÚdarás measúnú a dhéanamh ar an mbia núíosach dá n-uireasa, níor cheart don Údarás na sonraí sin a úsáid chun tairbhe aon iarratasóra ina dhiaidh sin ar feadh tréimhse 5 bliana ó dháta theacht i bhfeidhm an Rialacháin seo.

    Therefore, detailed description of the production process; methods of analysis; certificates of analysis; stability report; toxicokinetic study; bacterial reverse mutation test; in vitro mammalian micronucleus assay; 90-day toxicity study in rats; particle size analysis; particle size method of analysis; fructose analysis; amino acid analysis; microorganisms analysis; physiochemical stability; stability of fructose in the novel food; boron dissociation under varying pH contained in the applicant’s file, on which the Authority based its conclusion on the safety of the novel food and without which it could not have assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of 5 years from the date of entry into force of this Regulation.

    Commission Implementing Regulation (EU) 2021/2129 of 2 December 2021 authorising the placing on the market of calcium fructoborate as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  6. #2298677

    An 24 Deireadh Fómhair 2019, d’iarr an t-iarratasóir ar an gCoimisiún sonraí dílseánaigh le haghaidh roinnt staidéar a cuireadh isteach mar thaca leis an iarratas a chosaint, eadhon, tástáil bhaictéarach ais-sócháin, tástáil micreanúicléis in vitro i gcealla mamaigh, staidéar raon dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh, staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh, sonraí tocsaineachta foilsithe, staidéar bailíochtaithe ar chítiméadracht sreibhe, agus staidéar ar fhrithsheasmhacht fhrithmhiocróbach.

    On 24 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, a bacterial reverse mutation test, an in vitro mammalian cell micronucleus test, a 14-day dose ranging oral toxicity study in rats, a 90-day oral toxicity study in rats, the published toxicity data, a flow cytometry validation study, and an antimicrobial resistance study.

    Commission Implementing Regulation (EU) 2022/168 of 8 February 2022 authorising the placing on the market of pasteurised Akkermansia muciniphila as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  7. #2298682

    Ina thuairim eolaíoch, thug an tÚdarás dá aire go raibh a chonclúid ar shábháilteacht an bhia núíosaigh bunaithe ar na sonraí ón tástáil bhaictéarach ais-sócháin, ón tástáil micreanúicléis in vitro i gcealla mamaigh, ón staidéar raon dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh, ón staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh, ón staidéar bailíochtaithe modha le haghaidh na hanailíse foirmlithe don staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh, agus ón staidéar ar fhrithsheasmhacht fhrithmhiocróbach.

    In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the method validation study for the formulation analysis for the 90-day oral toxicity study in rats, and the antimicrobial resistance study.

    Commission Implementing Regulation (EU) 2022/168 of 8 February 2022 authorising the placing on the market of pasteurised Akkermansia muciniphila as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  8. #2298684

    Na sonraí ón tástáil bhaictéarach ais-sócháin, ón tástáil micreanúicléis in vitro i gcealla mamaigh, ón staidéar raon dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh, ón staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh, ó na sonraí tocsaineachta foilsithe, ón staidéar bailíochtaithe ar chítiméadracht sreibhe, agus ón staidéar ar fhrithsheasmhacht fhrithmhiocróbach, dhearbhaigh an t-iarratasóir go raibh na cearta dílseánaigh agus eisiacha tagartha acu ar na sonraí sin nuair a chuir siad an t-iarratas isteach agus dá bhrí sin níorbh fhéidir le tríú páirtithe rochtain a fháil go dleathach ar na staidéir sin ná úsáid a bhaint astu.

    The applicant declared that they held proprietary and exclusive rights of reference to the data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study at the time they submitted the application and therefore third parties could not lawfully have access to or use those studies.

    Commission Implementing Regulation (EU) 2022/168 of 8 February 2022 authorising the placing on the market of pasteurised Akkermansia muciniphila as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  9. #2298686

    Dá bhrí sin, na sonraí ón tástáil bhaictéarach ais-sócháin, ón tástáil micreanúicléis in vitro i gcealla mamaigh, ón staidéar raon dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh, ón staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh, ó na sonraí tocsaineachta foilsithe, ón staidéar bailíochtaithe ar chítiméadracht sreibhe, agus ón staidéar ar fhrithsheasmhacht fhrithmhiocróbach, atá i gcomhad an iarratasóra ar ar bhunaigh an tÚdarás a chonclúid maidir le sábháilteacht an bhia núíosaigh agus nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach dá n-uireasa, níor cheart don Údarás na sonraí sin a úsáid chun tairbhe aon iarratasóra ina dhiaidh sin ar feadh tréimhse 5 bliana ó dháta theacht i bhfeidhm an Rialacháin seo.

    Therefore, the data from the bacterial reverse mutation test, the in vitro mammalian cell micronucleus test, the 14-day dose ranging oral toxicity study in rats, the 90-day oral toxicity study in rats, the published toxicity data, the flow cytometry validation study, and the antimicrobial resistance study contained in the applicant’s file on which the Authority based its conclusion on the safety of the novel food and without which it could have not assessed the novel food, should not be used by the Authority for the benefit of any subsequent applicant for a period of five years from the date of entry into force of this Regulation.

    Commission Implementing Regulation (EU) 2022/168 of 8 February 2022 authorising the placing on the market of pasteurised Akkermansia muciniphila as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  10. #2462932

    An 22 Eanáir 2020, rinne an t-iarratasóir iarraidh don Choimisiún ar chosaint sonraí dílseánaigh maidir leis na sonraí anailíseacha, maidir le tástáil bhaictéarach ais-sócháin, maidir le measúnacht micreanúicléis in vitro, maidir le staidéar 90 lá ar thocsaineacht fho-ainsealach bhéil agus maidir le measúnacht scagthástála ar thocsaineacht atáirgthe/fhorbarthach i gcreimirí a cuireadh isteach mar thaca lena iarratas.

    On 22 January 2020, the applicant also made a request to the Commission for the protection of proprietary data for the analytical data, a bacterial reverse mutation test, an in vitro micronucleus assay, a 90-day oral sub-chronic toxicity study and a reproduction/developmental toxicity screening test in rodents, submitted in support of the application.

    Commission Implementing Regulation (EU) 2022/961 of 20 June 2022 authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  11. #2462938

    Sa tuairim uaidh, thug an tÚdarás dá aire go raibh a chonclúid maidir le sábháilteacht an bhia núíosaigh bunaithe ar na sonraí anailíseacha, ar an tástáil bhaictéarach ais-sócháin, ar an measúnacht micreanúicléis in vitro, ar an staidéar 90 lá ar thocsaineacht fho-ainsealach bhéil agus ar an measúnacht scagthástála ar thocsaineacht atáirgthe/fhorbarthach i gcreimirí a bhí i gcomhad an iarratasóir, agus nach mbeadh an tÚdarás in ann an bia núíosach a mheasúnú ná teacht ar a chonclúid gan an comhad sin.

    In its scientific opinion, the Authority noted that its conclusion on the safety of the novel food was based on the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

    Commission Implementing Regulation (EU) 2022/961 of 20 June 2022 authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  12. #2462940

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha tagartha ar na sonraí anailíseacha, ar an tástáil bhaictéarach ais-sócháin, ar an measúnacht micreanúicléis in vitro, ar an staidéar 90 lá ar thocsaineacht fho-ainsealach bhéil agus ar an measúnacht scagthástála ar thocsaineacht atáirgthe/fhorbarthach i gcreimirí ina sheilbh aige an tráth a chuir sé an t-iarratas isteach, agus nach mbeadh tríú páirtithe in ann rochtain dhlíthiúil a fháil ar na sonraí sin, iad a úsáid ná tagairt a dhéanamh do na sonraí sin ach oiread.

    The applicant declared that they held proprietary and exclusive rights of reference to the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, at the time they submitted the application, and that third parties cannot lawfully access, use or refer to those data.

    Commission Implementing Regulation (EU) 2022/961 of 20 June 2022 authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  13. #2462942

    Dá bhrí sin, na sonraí anailíseacha, an tástáil bhaictéarach ais-sócháin, an measúnacht micreanúicléis in vitro, an staidéar 90 lá ar thocsaineacht fho-ainsealach bhéil agus an measúnacht scagthástála ar thocsaineacht atáirgthe/fhorbarthach i gcreimirí, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the analytical data, the bacterial reverse mutation test, the in vitro micronucleus assay, and the 90-day oral sub-chronic toxicity study and the reproduction/developmental toxicity screening test in rodents, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2022/961 of 20 June 2022 authorising the placing on the market of tetrahydrocurcuminoids as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  14. #2584004

    An 22 Iúil 2020 chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin chun go gcosnófaí staidéir agus sonraí eolaíocha dílseánaigh arna gcur isteach chun tacú leis an iarratas, is é sin tástáil bhaictéarach ais-sócháin; measúnacht micreanúicléis in vitro le limficítí daonna; staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh; staidéar 90 lá ar thocsaineacht fho-ainsealach béil i bhfrancaigh; na torthaí ó anailísí ar chomhdhéanamh agus na deimhnithe anailíseacha le haghaidh 23 bhaisc bhreise den bhia núíosach agus 20 baisc d’aonraíoch próitéine meidhg tráchtála; agus na torthaí ó anailísí ar áireamh coilíneachtaí an bhia núíosaigh agus a ndeimhnithe.

    On 22 July 2020, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data and submitted in support of the application, namely, a bacterial reverse mutation test; an in vitro micronucleus assay with human lymphocytes; a 14-day range-finding oral toxicity study in rodents; a 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and 20 batches of commercial whey protein isolate; and, the results of total microbial plate count analyses of the novel food and their certificates.

    Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorising the placing on the market of bovine milk beta-lactoglobulin (ß-lactoglobulin) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  15. #2584009

    Sa tuairim eolaíoch uaidh, thug an tÚdarás dá aire freisin go raibh a chonclúid maidir le sábháilteacht an bhia núíosaigh bunaithe ar na staidéir agus sonraí eolaíochta ar an tástáil bhaictéarach ais-sócháin; ar an measúnacht micreanúicléis in vitro le limficítí daonna; ar an staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh; ar an staidéar 90 lá ar thocsaineacht fho-ainsealach béil i bhfrancaigh; ar na torthaí ó anailísí ar chomhdhéanamh; agus ar na deimhnithe anailíseacha le haghaidh 23 bhaisc bhreise den bhia núíosach agus 20 baisc d’aonraíoch próitéine meidhg tráchtála, agus ar na torthaí ó anailísí ar áireamh coilíneachtaí an bhia núíosaigh agus a ndeimhnithe, nithe atá ann i gcomhad an iarratasóra agus nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach ná teacht ar a chonclúid dá n-uireasa.

    In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the scientific studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses; and, the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate and the results of total microbial plate count analyses of the novel food and their certificates, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

    Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorising the placing on the market of bovine milk beta-lactoglobulin (ß-lactoglobulin) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  16. #2584011

    Dhearbhaigh an t-iarratasóir go raibh cearta tagartha dílseánaigh agus eisiacha acu ar na sonraí eolaíocha ar an tástáil bhaictéarach ais-sócháin; ar an measúnacht micreanúicléis in vitro le limficítí daonna; ar an staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh; ar an staidéar 90 lá ar thocsaineacht fho-ainsealach béil i bhfrancaigh; Ar na torthaí ó anailísí ar chomhdhéanamh agus na deimhnithe anailíseacha le haghaidh 23 bhaisc bhreise den bhia núíosach agus na 20 baisc d’aonraíoch próitéine meidhg tráchtála; agus ar na torthaí ó anailísí ar áireamh coilíneachtaí an bhia núíosaigh agus a ndeimhnithe, tráth a chuir siad an t-iarratas isteach, agus dhearbhaigh sé freisin nach féidir le tríú páirtithe rochtain dhlíthiúil a fháil ar na sonraí sin ná iad a úsáid ná tagairt a dhéanamh dóibh.

    The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate; and, the results of total microbial plate count analyses of the novel food and their certificates, at the time they submitted the application and that third parties cannot lawfully access, use or refer to those data.

    Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorising the placing on the market of bovine milk beta-lactoglobulin (ß-lactoglobulin) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  17. #2584013

    Dá bhrí sin, na staidéir agus na sonraí eolaíocha ar an tástáil bhaictéarach ais-sócháin; an mheasúnacht micreanúicléis in vitro le limficítí daonna; an staidéar raoin dáileoige 14 lá ar thocsaineacht bhéil i bhfrancaigh; an staidéar 90 lá ar thocsaineacht fho-ainsealach béil i bhfrancaigh; na torthaí ó anailísí ar chomhdhéanamh agus na deimhnithe anailíseacha le haghaidh 23 bhaisc bhreise den bhia núíosach agus na 20 baisc d’aonraíoch próitéine meidhg tráchtála; agus na torthaí ó anailísí ar áireamh coilíneachtaí an bhia núíosaigh agus a ndeimhnithe, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the scientific studies and data on the bacterial reverse mutation test; the in vitro micronucleus assay with human lymphocytes; the 14-day range-finding oral toxicity study in rodents; the 90-day oral sub-chronic toxicity study in rodents; the results of compositional analyses and the analytical certificates for 23 additional batches of the novel food and the 20 batches of commercial whey protein isolate; and, the results of total microbial plate count analyses of the novel food and their certificates, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2022/2534 of 21 December 2022 authorising the placing on the market of bovine milk beta-lactoglobulin (ß-lactoglobulin) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  18. #2749702

    Dá bhrí sin, na staidéir agus na sonraí ar thástálacha athshondais mhaighnéadaigh núicléach (“NMR”) chun aitheantas 2′-FL a chinneadh; an tuairisc ar na hanailísí ar sheicheamh géiniteach an tréithchineáil táirgthe ghéinmhodhnaithe 2′-FL; torthaí na n-anailísí chun neamhláithreacht cealla inmharthana den tréithchineál díorthach de Corynebacterium glutamicum ATCC 13032 a dheimhniú; an tástáil bhaictéarach ais-sócháin le 2′-FL, an tástáil saofa crómasóim in vitro le 2′-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 2′-FL; an tástáil micreanúicléis in vitro i limficít dhaonna le 2′-FL; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 2′-FL, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the studies and data on the nuclear magnetic resonance (‘NMR’) tests for the determination of the identity of 2′-FL; the genetic sequence analyses description of the genetically modified 2′-FL production strain; the results of analyses to confirm the absence of viable cells of the derivative strain of Corynebacterium glutamicum ATCC 13032; the bacterial reverse mutation test with 2′-FL, the in vitro chromosome aberration test with 2′-FL; the in vitro mammalian cell micronucleus test with 2′-FL; the in vitro human lymphocyte micronucleus test with 2′-FL; and, the 90-day oral toxicity study in rats with 2′-FL, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

  19. #2817594

    An 7 Deireadh Fómhair 2019 chuir an t-iarratasóir iarratas faoi bhráid an Choimisiúin freisin ar chosaint sonraí dílseánaigh, is é sin staidéar cógaschinéiteach i bhfrancaigh, tástáil bhaictéarach ais-sócháin, tástáil saofa crómasóim in vitro i mamaigh, tástáil micreanúicléis ar eiritricítí mamacha i lucha, staidéar 90 lá ar thocsaineacht ildáileog bhéil i bhfrancaigh, tástáil intuaslagthachta, tástáil micreanúicléis in vitro agus tástáil tocsaineachta ainsealaí aon bhliain amháin.

    On 7 October 2019, the applicant also made a request to the Commission for the protection of proprietary data, namely, pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test.

    Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  20. #2817601

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha tagartha aige ar an staidéar cógaschinéiteach i bhfrancaigh, an tástáil bhaictéarach ais-sócháin, an tástáil saofa crómasóim in vitro i mamaigh, an tástáil micreanúicléis ar eiritricítí mamacha i lucha, an staidéar 90 lá ar thocsaineacht ildáileog bhéil i bhfrancaigh, an tástáil intuaslagthachta, an tástáil micreanúicléis in vitro agus an tástáil tocsaineachta ainsealaí aon bhliain amháin tráth a chuir sé an t-iarratas isteach, agus nach féidir le tríú páirtithe rochtain a fháil ar na sonraí sin ná iad a úsáid ná tagairt a dhéanamh dóibh go dleathach.

    The applicant declared that it held proprietary and exclusive rights of reference to the pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test at the time it submitted the application, and that third parties cannot lawfully access, use or refer to those data.

    Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  21. #2817603

    Dá bhrí sin, an staidéar cógaschinéiteach i bhfrancaigh, an tástáil bhaictéarach ais-sócháin, an tástáil saofa crómasóim in vitro i mamaigh, an tástáil micreanúicléis ar eiritricítí mamacha i lucha, an staidéar 90 lá ar thocsaineacht ildáileog bhéil i bhfrancaigh, an tástáil intuaslagthachta, an tástáil micreanúicléis in vitro agus an tástáil tocsaineachta ainsealaí aon bhliain amháin, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, pharmacokinetic study in rats, bacterial reverse mutation test, in vitro mammalian chromosome aberration test, mammalian erythrocyte micronucleus test in mice, repeated dose (90 days) oral toxicity study in rats, solubility test, in vitro micronucleus test and one year chronic toxicity test should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2023/972 of 10 May 2023 authorising the placing on the market of aqueous ethanolic extract of Labisia pumila as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  22. #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.

    Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation (EU) 2017/2470

  23. #1915908

    Ina thuairim eolaíoch, mheas an tÚdarás nach mbeadh sé in ann teacht ar a chuid conclúidí maidir le sábháilteacht salainn sóidiam 6’-SL murach na sonraí ó na tuarascála anailíseacha dílseánaigh ar an gcomparáid struchtúir trí AMN 6’-SL arna tháirgeadh trí choipeadh baictéarach le 6’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 6’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 6’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne, na tuarascálacha measúnachta ar iontógáil 6’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6’-SL; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6’-SL; an staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de.

    In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 6’-SL sodium salt without the data from the proprietary analytical reports on the structure comparison via NMR of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates, the 6’-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 6’-SL sodium salt; the bacterial reverse mutation test with 6’-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations.

    Commission Implementing Regulation (EU) 2021/82 of 27 January 2021 authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  24. #1915909

    Tar éis dó an tuairim eolaíoch ón Údarás a fháil, d’iarr an Coimisiún ar an iarratasóir soiléiriú breise a thabhairt maidir leis an réasúnú a cuireadh ar fáil i dtaca lena n-éileamh dílseánaigh ar na tuarascála anailíseacha ar an gcomparáid struchtúir trí athshondas maighnéadach núicléach (“AMN”) 6’-SL arna tháirgeadh trí choipeadh baictéarach 6’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 6’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 6’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 6’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6’-SL; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6’-SL; an staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 6’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de, agus soiléiriú a thabhairt maidir lena n-éileamh ar an gceart eisiach ar an tagairt do na staidéir, dá dtagraítear in Airteagal 26(2)(b) de Rialachán (AE) 2015/2283.

    Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the analytical reports on the structure comparison via nuclear magnetic resonance NMR of 6’-SL produced by bacterial fermentation with 6’-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 6’-SL sodium salt batches; the analytical methods and validation reports; the 6’-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 6’-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 6’-SL sodium salt; the bacterial reverse mutation test with 6’-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 6’-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 6’-SL sodium salt, including the summary table of the statistically significant observations, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2021/82 of 27 January 2021 authorising the placing on the market of 6’-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  25. #1918715

    Ina thuairim eolaíoch, mheas an tÚdarás nach mbeadh sé in ann teacht ar a chuid conclúidí maidir le sábháilteacht salainn sóidiam 3’-SL murach na sonraí ó na tuarascála anailíseacha dílseánaigh ar an gcomparáid struchtúir trí AMN 3’-SL arna tháirgeadh trí coipeadh baictéarach le 3’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála, na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 3’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 3’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 3’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3’-SL; an tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; an staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL, lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de.

    In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3'-SL sodium salt without the data from the proprietary analytical reports on the structure comparison via NMR of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids, the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations.

    Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  26. #1918716

    Tar éis dó an tuairim eolaíoch ón Údarás a fháil, d’iarr an Coimisiún ar an iarratasóir soiléiriú breise a thabhairt maidir leis an réasúnú a cuireadh ar fáil i dtaca lena n-éileamh dílseánaigh ar na tuarascála anailíseacha ar an gcomparáid struchtúir trí athshondas maighnéadach núicléach (“AMN”) 3’-SL arna tháirgeadh trí choipeadh baictéarach 3’-SL atá i mbainne daonna go nádúrtha; na sonraí tréithrithe mionsonraithe ar tháirgeadh tréithchineálacha baictéaracha agus a ndeimhnithe; na sonraíochtaí le haghaidh na n-amhábhar agus na n-áiseanna próiseála; na deimhnithe anailísí ar bhaisceanna éagsúla salainn sóidiam 3’-SL; na modhanna anailíse agus na tuarascálacha bailíochtaithe; na tuarascálacha ar chobhsaíocht salainn sóidiam 3’-SL; an tuairisc mhionsonraithe ar an bpróiseas táirgthe; na deimhnithe creidiúnaithe saotharlainne; na tuarascálacha measúnachta ar iontógáil 3’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3’-SL; an tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; an staidéar 14 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh nuabheirthe le salann sóidiam 3’-SL lena n-áirítear tábla achoimre na mbarúlacha atá suntasach ó thaobh staitistice de, agus soiléiriú a thabhairt maidir lena éileamh ar an gceart eisiach ar an tagairt do na staidéir, dá dtagraítear in Airteagal 26(2)(b) de Rialachán (AE) 2015/2283.

    Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the analytical reports on the structure comparison via nuclear magnetic resonance (‘NMR’) of 3'-SL produced by bacterial fermentation with 3'-SL naturally present in human milk; the detailed characterisation data on the production bacterial strains and their certificates; the specifications for the raw materials and processing aids; the certificates of analyses of the various 3'-SL sodium salt batches; the analytical methods and validation reports; the 3'-SL sodium salt stability reports; the detailed description of the production process; the laboratory accreditation certificates; the 3'-SL intake assessment reports; the in vitro mammalian cell micronucleus test with 3'-SL sodium salt; the bacterial reverse mutation test with 3'-SL sodium salt; the 14-day oral toxicity study in the neonatal rat with 3'-SL sodium salt; and the 90-day oral toxicity study in the neonatal rat with 3'-SL sodium salt, including the summary table of the statistically significant observations, and to clarify their claim to an exclusive right of reference to these studies, as referred to in Article 26(2)(b) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2021/96 of 28 January 2021 authorising the placing on the market of 3'-sialyllactose sodium salt as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  27. #2157834

    Ina theannta sin, an 1 Deireadh Fómhair 2019, d’iarr an t-iarratasóir ar an gCoimisiún go gcosnófaí sonraí dílseánaigh i gcás roinnt staidéar a cuireadh isteach mar thaca leis an iarratas, eadhon na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.

    On 1 October 2019, the applicant also made a request to the Commission for the protection of proprietary data for a number of studies submitted in support of the application, namely, the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via nuclear magnetic resonance (‘NMR’) of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.

    Commission Implementing Regulation (EU) 2021/2029 of 19 November 2021 authorising the placing on the market of 3-Fucosyllactose (3-FL) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  28. #2157839

    Sa tuairim eolaíoch ón Údarás, mheas sé nach bhféadfadh sé teacht ar a chuid conclúidí maidir le sábháilteacht 3-FL gan na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (“NMR”) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil micreanúicléis in vitro ar lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar 3 seachtaine tocsaineachta béil ar bhainbh nuabheirthe.

    In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3-FL without the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.

    Commission Implementing Regulation (EU) 2021/2029 of 19 November 2021 authorising the placing on the market of 3-Fucosyllactose (3-FL) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  29. #2157840

    Tar éis dó tuairim eolaíoch an Údaráis a fháil, d’iarr an Coimisiún ar an iarratasóir soiléiriú breise a thabhairt maidir leis an réasúnú a cuireadh ar fáil i dtaca lena éileamh dílseánaigh ar na sonraí ó na sonraí tréithrithe mionsonraithe maidir le tréithchineál baictéarach an táirgthe; próiseas táirgthe an bhia núíosaigh; na hanailísí ar na baisceanna éagsúla 3-FL; na tuarascálacha anailíseacha maidir le tréithriú 3-FL trí athshondas maighnéadach núicléach (‘NMR’) agus an 3-FL atá i mbainne an duine go nádúrtha; na tuarascálacha maidir le cobhsaíocht 3-L; na tuarascálacha measúnachta maidir le hiontógáil 3-FL; tástáil bhaictéarach ais-sócháin; tástáil mhicreanúicléis in vitro i lucha; tástáil mhicreanúicléis in vitro ar chealla ubhagáin an hamstair Shínigh; tástáil in vitro saobhadh crómasóim i gcealla mamach, tástáil a rinneadh ar limficítí daonna; tástáil géarthocsaineachta béil ar fhrancaigh; staidéar tocsaineachta béil 90 lá ar fhrancaigh, lena n-áirítear anailís séirim agus fuail; staidéar tocsaineachta béil 6 lá ar bhainbh; agus staidéar tocsaineachta béil 3 seachtaine ar bhainbh nuabheirthe.

    Following the receipt of the Authority’s scientific opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data from the detailed characterisation data on the production bacterial strain; the novel food production process; the analyses of the various 3-FL batches; the analytical reports on the characterisation via NMR of 3-FL and of the 3-FL naturally present in human milk; the 3-FL stability reports; the 3-FL intake assessment reports; a bacterial reverse mutation test; an in vitro mouse micronucleus test; an in vitro micronucleus test with Chinese hamster ovary cells; an in vitro mammalian cell chromosomal aberration test in human lymphocytes; an acute oral toxicity test in rats; a 90-day oral toxicity study in the rat including serum and urine analysis; a 6-day oral toxicity study in piglets; and a 3-week oral toxicity study in neonatal piglets.

    Commission Implementing Regulation (EU) 2021/2029 of 19 November 2021 authorising the placing on the market of 3-Fucosyllactose (3-FL) as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  30. #2694121

    An 22 Bealtaine 2020 chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiún go gcosnófaí na staidéir agus na sonraí eolaíocha dílseánaigh arna gcur isteach mar thaca leis ar iarratas, is é sin, bailíochtú modha mais-speictriméadrachta (“MS”), athshondais mhaighnéadaigh núicléach (“NMR”) agus crómatagrafaíochta ainianmhalartúcháin ardfheidhmíochta le haimpéarméadrach bíogach braite (“HPAEC-PAD”) agus na torthaí a bhaineann le haitheantas LNT agus seachtháirgí carbaihiodráite (lachta-N-trí-ós II (“LNT2”), para-lachta-N-heicsea-ós (“pLNH”), lachtós, agus glúcós/galachtós) atá ann sa bhia núíosach a chinneadh; tuairisc ar thréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus lachta-N-neoiteatra-óis (“LNnT”); deimhnithe deascaidh na dtréithchineálacha táirgthe agus na dtréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (“qPCR”) agus tuarascálacha maidir le bailíochtú modha le haghaidh tréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha LNT agus LNnT; tástáil bhaictéarach ais-sócháin le LNT; tástáil micreanúicléis in vitro i gcealla mamach le LNT; staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le LNT; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le LNT.

    On 22 May 2020, the applicant also made a request to the Commission for the protection for the protection of proprietary scientific studies and data submitted in support of the application, namely, mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of LNT and of the carbohydrate by-products (lacto-N-triose II (‘LNT2’), para-lacto-N-hexaose (‘pLNH’), lactose, and glucose/galactose) present in the novel food; a description of the genetically modified LNT and lacto-N-neotetraose (‘LNnT’) production and optional degradation strains; certificates of deposition of genetically modified LNT and LNnT production and optional degradation strains; real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified LNT and LNnT production and optional degradation strains; a bacterial reverse mutation test with LNT; an in vitro mammalian cell micronucleus test with LNT; a 7-day dose range finding oral toxicity study in rats with LNT;, and a 90-day oral toxicity study in rats with LNT.

    Commission Implementing Regulation (EU) 2023/7 of 3 January 2023 authorising the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  31. #2694126

    Sa tuairim eolaíoch uaidh, thug an tÚdarás dá aire freisin go raibh a chonclúid i ndáil le sábháilteacht an bhia núíosaigh bunaithe ar na staidéir agus sonraí eolaíocha agus na staidéir ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus ar na torthaí a bhaineann le haitheantas LNT agus seachtháirgí carbaihiodráite LNT2, pLNH, lachtóis, agus glúcóis/galachtóis atá ann sa bhia núíosach a chinneadh; ar an tuairisc ar thréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; ar dheimhnithe deascaidh na dtréithchineálacha táirgthe agus na dtréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; ar an gcóras qPCR agus ar thuarascálacha maidir le bailíochtú modha le haghaidh tréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha LNT agus LNnT; ar an tástáil bhaictéarach ais-sócháin le LNT; ar an tástáil micreanúicléis in vitro i gcealla mamach le LNT; ar an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le LNT; agus ar an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le LNT, nithe nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach ná teacht ar a chonclúid dá n-uireasa.

    In its scientific opinion, the Authority also noted that its conclusion on the safety of the novel food was based on the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of LNT and of the carbohydrate by-products LNT2, pLNH, lactose, and glucose/galactose present in the novel food; the description of the genetically modified LNT and LNnT production and optional degradation strains; the certificates of deposition of genetically modified LNT and LNnT production and optional degradation strains; the qPCR system and method validation reports for the genetically modified LNT and LNnT production and optional degradation strains; the bacterial reverse mutation test with LNT; the in vitro mammalian cell micronucleus test with LNT; the 7-day dose range finding oral toxicity study in rat with LNT; and, the 90-day oral toxicity study in rats with LNT, without which it could not have assessed the novel food and reached its conclusion.

    Commission Implementing Regulation (EU) 2023/7 of 3 January 2023 authorising the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  32. #2694128

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha tagartha aige ar na staidéir agus na sonraí ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí a bhaineann le haitheantas LNT agus seachtháirgí carbaihiodráite LNT2, pLNH, lachtóis, agus glúcóis/galachtóis atá ann sa bhia núíosach a chinneadh; ar an tuairisc ar thréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; ar dheimhnithe deascaidh na dtréithchineálacha táirgthe agus na dtréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; ar an gcóras qPCR agus ar thuarascálacha maidir le bailíochtú modha le haghaidh tréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha LNT agus LNnT; ar an tástáil bhaictéarach ais-sócháin e LNT; ar an tástáil micreanúicléis in vitro i gcealla mamach le LNT; ar an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le LNT; agus ar an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le LNT, agus dhearbhaigh siad go bhfuil na cearta sin aige faoin dlí náisiúnta tráth a chuir siad an t-iarratas isteach agus nach féidir le tríú páirtithe na sonraí agus na staidéir sin a úsáid ná tagairt a dhéanamh dóibh.

    The applicant declared that they held proprietary and exclusive rights of reference to the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of LNT and of the carbohydrate by-products LNT2, pLNH, lactose, and glucose/galactose present in the novel food; the description of the genetically modified LNT and LNnT production and optional degradation strains; the certificates of deposition of genetically modified LNT and LNnT production and optional degradation strains; the qPCR system and method validation reports for the genetically modified LNT and LNnT production and optional degradation strains; the bacterial reverse mutation test with LNT; the in vitro mammalian cell micronucleus test with LNT; the 7-day dose range finding oral toxicity study in the rat with LNT; and, the 90-day oral toxicity study in the rat with LNT, under national law at the time they submitted the application and that third parties cannot use or refer to those data and studies.

    Commission Implementing Regulation (EU) 2023/7 of 3 January 2023 authorising the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  33. #2694130

    Dá bhrí sin, na staidéir agus na sonraí eolaíocha ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí a bhaineann le haitheantas LNT agus seachtháirgí carbaihiodráite LNT2, pLNH, lachtóis, agus glúcóis/galachtóis atá ann sa bhia núíosach a chinneadh; an tuairisc ar thréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; deimhnithe deascaidh na dtréithchineálacha táirgthe agus na dtréithchineálacha díghrádúcháin roghnacha géinmhodhnaithe LNT agus LNnT; an córas qPCR agus tuarascálacha maidir le bailíochtú modha le haghaidh tréithchineálacha táirgthe agus tréithchineálacha díghrádúcháin roghnacha LNT agus LNnT; an tástáil bhaictéarach ais-sócháin le LNT; an tástáil micreanúicléis in vitro i gcealla mamach le LNT; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le LNT; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le LNT, ba cheart iad sin a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of LNT and of the carbohydrate by-products LNT2, pLNH, lactose, and glucose/galactose present in the novel food; the description of the genetically modified LNT and LNnT production and optional degradation strains; the certificates of deposition of genetically modified LNT and LNnT production and optional degradation strains; the qPCR system and method validation reports for the genetically modified LNT and LNnT production and optional degradation strains; the bacterial reverse mutation test with LNT; the in vitro mammalian cell micronucleus test with LNT; the 7-day dose range finding oral toxicity study in the rat with LNT; and, the 90-day oral toxicity study in the rat with LNT, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2023/7 of 3 January 2023 authorising the placing on the market of Lacto-N-tetraose produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  34. #2694334

    An 17 Márta 2020, rinne an t-iarratasóir iarraidh ar an gCoimisiún freisin ar chosaint staidéir eolaíocha agus sonraí dílseánaigh a cuireadh isteach chun tacú leis an iarratas, is iad sin, bailíochtú modhanna na mais-speictriméadrachta (“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 agus fotháirgí carbaihiodráite a chinneadh; tuairisc ar thréithchineál táirgthe 3-FL géinmhodhnaithe; deimhniú deascaidh thréithchineál táirgthe 3-FL géinmhodhnaithe; córas imoibriú slabhrúil polaiméaráise cúl-trascrioptáise cainníochtúil fíor-ama (“qPCR”) agus tuarascálacha bailíochtaithe modha maidir le tréithchineál táirgthe 3-FL géinmhodhnaithe; tástáil bhaictéarach ais-sócháin le 3-FL; tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 3-FL.

    On 17 March 2020, 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, the mass spectrometry (‘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 and carbohydrate by-products; a description of the genetically modified 3-FL production strain; a certificate of deposition of the genetically modified 3-FL production strain; real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 3-FL production strain; a bacterial reverse mutation test with 3-FL; an in vitro mammalian cell micronucleus test with 3-FL; a 7-day dose range finding oral toxicity study in rats with 3-FL; and, a 90-day oral toxicity study in rats with 3-FL.

    Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  35. #2694339

    Sa tuairim eolaíoch uaidh, mheas an tÚdarás nach bhféadfadh sé teacht ar a chonclúidí maidir le sábháilteacht 3-FL gan na staidéir agus na sonraí eolaíocha ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí maidir le haitheantas 3-FL agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar thréithchineál táirgthe 3-FL géinmhodhnaithe; deimhniú deascaidh thréithchineál táirgthe ghéinmhodhnaithe 3-fúcaishiollachtóis; an córas qPCR agus an tuarascáil bhailíochtaithe modha maidir le tréithchineál táirgthe géinmhodhnaithe 3-FL; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 7 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 without the scientific studies and data on the MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-fucosyllactose production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in rats with 3-FL; and, the 90-day oral toxicity study in rats with 3-FL.

    Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  36. #2694341

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na staidéir agus na sonraí eolaíocha i dtaca le bailíochtú modha MS, NMR agus HPAEC-PAD agus leis na torthaí maidir le haitheantas 3-FL agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar thréithchineál táirgthe 3-FL géinmhodhnaithe; deimhniú deascaidh an tréithchineáil táirgthe ghéinmhodhnaithe 3-FL; an córas qPCR agus an tuarascáil bhailíochtaithe modha maidir le tréithchineál táirgthe géinmhodhnaithe 3-FL; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 7 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 they held proprietary and exclusive rights of reference to the scientific studies and data on MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-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 they submitted the application, and that third parties cannot lawfully access, use or refer to those data and studies.

    Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  37. #2694343

    Dá bhrí sin, na staidéir agus na sonraí eolaíocha ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí maidir le haitheantas 3-FL agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar thréithchineál táirgthe 3-FL géinmhodhnaithe; deimhniú deascaidh an tréithchineáil táirgthe ghéinmhodhnaithe 3-FL; an córas qPCR agus an tuarascáil bhailíochtaithe modha maidir le tréithchineál táirgthe géinmhodhnaithe 3-FL; an tástáil bhaictéarach ais-sócháin le 3-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 3-FL; staidéar raoin dáileoige 7 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 MS, NMR and HPAEC-PAD method validation and the results for the determination of the identity of 3-FL and of the carbohydrate by-products present in the novel food; the description of the genetically modified 3-FL production strain; the certificate of deposition of the genetically modified 3-FL production strain; the qPCR system and method validation report for the genetically modified 3-FL production strain; the bacterial reverse mutation test with 3-FL; the in vitro mammalian cell micronucleus test with 3-FL; the 7-day dose range finding oral toxicity study in the rat with 3-FL; and, the 90-day oral toxicity study in the rat with 3-FL, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2023/52 of 4 January 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  38. #2705493

    An 13 Bealtaine 2020, chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin freisin go gcosnófaí staidéir agus sonraí eolaíocha dílseánaigh arna gcur isteach mar thaca leis an iarratas, is iad sin, mais-speictriméadracht (“MS”), athshondas maighnéadach núicléach (“NMR”) agus crómatagrafaíocht mhalartaithe anian ardfheidhmíochta le bailíochtú mhodh an bhrath amperoiméadrachta bhíogaigh (“HPAEC-PAD”) agus na torthaí chun aitheantas 3′-SL agus fotháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; tuairisc ar tháirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus na tréithchineálacha díghrádúcháin roghnacha agus na deimhnithe deascaidh a bhaineann leo; córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (“qPCR”) agus tuarascálacha maidir le bailíochtú modha le haghaidh tréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 3′-SL agus tréithchineálacha díghrádúcháin roghnacha; tástáil bhaictéarach ais-sócháin le salann sóidiam 3′-SL; tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3′-SL; staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; agus, an staidéar cliniciúil maidir le naíonáin lánaibí chun meastóireacht a dhéanamh ar an gcobhsaíocht chothaitheach agus an infhulaingtheacht a bhaineann le bainne foirmle do naíonáin ina bhfuil meascán d’olagaishiúicrídí bainne atá comhionann leo sin a fhaightear i mbainne daonna.

    On 13 May 2020, 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, mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 3′-SL and of the carbohydrate by-products present in the novel food; a description and certificates of deposition of the genetically modified 3′-SL sodium salt production and optional degradation strains; real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 3′-SL sodium salt production and optional degradation strains; a bacterial reverse mutation test with 3′-SL sodium salt; an in vitro mammalian cell micronucleus test with 3′-SL sodium salt; a 7-day dose range finding oral toxicity study in rats with 3′-SL sodium salt; a 90-day oral toxicity study in rats with 3′-SL sodium salt; and, the clinical study with term infants to evaluate the nutritional suitability and tolerability of an infant formula containing a mixture of human identical milk oligosaccharides.

    Commission Implementing Regulation (EU) 2023/113 of 16 January 2023 authorising the placing on the market of 3'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  39. #2705498

    Ina thuairim eolaíoch uaidh, mheas an tÚdarás nach bhféadfadh sé teacht ar a chonclúidí maidir le sábháilteacht salainn sóidiam 3′-SL gan na staidéir agus na sonraí eolaíocha maidir le bailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí chun aitheantas 3′-SL agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar tháirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus na tréithchineálacha díghrádúcháin roghnacha agus na deimhnithe deascaidh a bhaineann leo; an córas qPCR agus tuarascálacha maidir le bailíochtú modha le haghaidh táirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus tréithchineálacha díghrádúcháin roghnacha; an tástáil bhaictéarach ais-sócháin le salann sóidiam 3’-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; agus, an staidéar cliniciúil maidir le naíonáin lánaibí chun meastóireacht a dhéanamh ar an gcobhsaíocht chothaitheach agus an infhulaingtheacht a bhaineann le bainne foirmle do naíonáin ina bhfuil meascán d’olagaishiúicrídí bainne atá comhionann leo sin a fhaightear i mbainne daonna.

    In its scientific opinion, the Authority considered that it could not have reached its conclusions on the safety of the 3′-SL sodium salt without the scientific studies and data on the MS, NMR, and HPAEC-PAD method validation and the results for the determination of the identity of 3′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 3′-SL sodium salt production and optional degradation strains; the qPCR system and method validation reports for the genetically modified 3′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 3′-SL sodium salt; the 90-day oral toxicity study in rats with 3′-SL sodium salt; and, the clinical study with term infants to evaluate the nutritional suitability and tolerability of an infant formula containing a mixture of human identical milk oligosaccharides.

    Commission Implementing Regulation (EU) 2023/113 of 16 January 2023 authorising the placing on the market of 3'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  40. #2705500

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na staidéir agus na sonraí eolaíocha i dtaca le bailíochtú modha MS, NMR agus HPAEC-PAD agus leis na torthaí maidir le haitheantas 3′-S agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar tháirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus na tréithchineálacha díghrádúcháin roghnacha agus na deimhnithe deascaidh a bhaineann leo; an córas qPCR agus tuarascálacha maidir le bailíochtú modha le haghaidh táirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus tréithchineálacha díghrádúcháin roghnacha; an tástáil bhaictéarach ais-sócháin le salann sóidiam 3′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; agus, an staidéar cliniciúil maidir le naíonáin lánaibí chun meastóireacht a dhéanamh ar an gcobhsaíocht chothaitheach agus an infhulaingtheacht a bhaineann le bainne foirmle do naíonáin ina bhfuil meascán d’olagaishiúicrídí bainne atá comhionann leo sin a fhaightear i mbainne daonna, 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 they held proprietary and exclusive rights of reference to the scientific studies and data on the MS, NMR, and HPAEC-PAD method validation and the results for the determination of the identity of 3′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 3′-SL sodium salt production and optional degradation strains; the qPCR system and method validation reports for the genetically modified 3′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 3′-SL sodium salt; the 90-day oral toxicity study in rats with 3′-SL sodium salt; and, the clinical study with term infants to evaluate the nutritional suitability and tolerability of an infant formula containing a mixture of human identical milk oligosaccharides, 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.

    Commission Implementing Regulation (EU) 2023/113 of 16 January 2023 authorising the placing on the market of 3'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  41. #2705502

    Dá bhrí sin, na staidéir agus na sonraí eolaíocha ar bhailíochtú modha MS, NMR agus HPAEC-PAD agus na torthaí maidir le haitheantas 3′-SL agus na seachtháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar tháirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus na tréithchineálacha díghrádúcháin roghnacha agus na deimhnithe deascaidh a bhaineann leo; an córas qPCR agus tuarascálacha maidir le bailíochtú modha le haghaidh táirgeadh salainn sóidiam ghéinmhodhnaithe 3′-SL agus tréithchineálacha díghrádúcháin roghnacha; an tástáil bhaictéarach ais-sócháin le salann sóidiam 3′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 3′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 3′SL; agus, an staidéar cliniciúil maidir le naíonáin lánaibí chun meastóireacht a dhéanamh ar an gcobhsaíocht chothaitheach agus an infhulaingtheacht a bhaineann le bainne foirmle do naíonáin ina bhfuil meascán d’olagaishiúicrídí bainne atá comhionann leo sin a fhaightear i mbainne daonna, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the scientific studies and data on the MS, NMR, and HPAEC-PAD method validation and the results for the determination of the identity of 3′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 3′-SL sodium salt production and optional degradation strains; the qPCR system and method validation reports for the genetically modified 3′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 3′-SL sodium salt; the in vitro mammalian cell micronucleus test with 3′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 3′-SL sodium salt; the 90-day oral toxicity study in rats with 3′-SL sodium salt; and, the clinical study with term infants to evaluate the nutritional suitability and tolerability of an infant formula containing a mixture of human identical milk oligosaccharides, should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2023/113 of 16 January 2023 authorising the placing on the market of 3'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  42. #2749693

    An 7 Iúil 2020 chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin freisin go gcosnófaí staidéir agus sonraí eolaíocha dílseánaigh maidir le tástálacha athshondais mhaighnéadaigh núicléach (“AMN”) chun aitheantas 2′-FL a chinneadh; tuairisc ar na hanailísí ar sheicheamh géiniteach an tréithchineáil táirgthe ghéinmhodhnaithe 2′-FL; torthaí na n-anailísí chun neamhláithreacht cealla inmharthana den tréithchineál díorthach de Corynebacterium glutamicum ATCC 13032 a dheimhniú; tástáil bhaictéarach ais-sócháin le 2′-FL; tástáil saofa crómasóim in vitro le 2′-FL; tástáil micreanúicléis in vitro i gcealla mamach le 2′-FL; tástáil micreanúicléis in vitro i limficít dhaonna le 2′-FL; staidéar ar ghéarthocsaineacht bhéil i bhfrancaigh; agus, staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 2′-FL, a cuireadh isteach mar thaca leis an iarratas.

    On 7 July 2020, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data on nuclear magnetic resonance (‘NMR’) tests for the determination of the identity of 2′-FL; a genetic sequence analyses description of the genetically modified 2′-FL production strain; results of analyses to confirm the absence of viable cells of the derivative strain of Corynebacterium glutamicum ATCC 13032; a bacterial reverse mutation test with 2′-FL; an in vitro chromosome aberration test with 2′-FL; an in vitro mammalian cell micronucleus test with 2′-FL; an in vitro human lymphocyte micronucleus test with 2′-FL; an acute oral toxicity study in rats; and, a 90-day oral toxicity study in rats with 2′-FL, submitted in support of the application.

    Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

  43. #2749698

    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 thástálacha athshondais mhaighnéadaigh núicléach (“AMN”) chun aitheantas 2′-FL a chinneadh; an tuairisc ar na hanailísí ar sheicheamh géiniteach an tréithchineáil táirgthe ghéinmhodhnaithe 2′-FL; torthaí na n-anailísí chun neamhláithreacht cealla inmharthana den tréithchineál díorthach de Corynebacterium glutamicum ATCC 13032 a dheimhniú; an tástáil bhaictéarach ais-sócháin le 2′-FL; an tástáil saofa crómasóim in vitro le 2′-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 2′-FL, an tástáil micreanúicléis in vitro i limficít dhaonna le 2′-FL; agus an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 2′-FL, atá i gcomhad an iarratasóra, nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach ná a chonclúid a bhaint amach dá n-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 the nuclear magnetic resonance (‘NMR’) tests for the determination of the identity of 2′-FL; the genetic sequence analyses description of the genetically modified 2′-FL production strain; the results of analyses to confirm the absence of viable cells of the derivative strain of Corynebacterium glutamicum ATCC 13032; the bacterial reverse mutation test with 2′-FL; the in vitro chromosome aberration test with 2′-FL; the in vitro mammalian cell micronucleus test with 2′-FL, the in vitro human lymphocyte micronucleus test with 2′-FL; and the 90-day oral toxicity study in rats with 2′-FL, contained in the applicant’s file, without which it could not have assessed the novel food and reached its conclusion.

    Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

  44. #2749700

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha tagartha aige i leith na staidéar agus na sonraí eolaíocha ar thástálacha athshondais mhaighnéadaigh núicléach (“AMN”) chun aitheantas 2′-FL a chinneadh, an tuairisc ar sheicheamh géiniteach an tréithchineáil táirgthe ghéinmhodhnaithe 2′-FL; torthaí na n-anailísí chun neamhláithreacht cealla inmharthana den tréithchineál díorthach de Corynebacterium glutamicum ATCC 13032 a dheimhniú; an tástáil bhaictéarach ais-sócháin le 2′-FL; an tástáil saofa crómasóim in vitro le 2′-FL; an tástáil micreanúicléis in vitro i gcealla mamach le 2′-FL; an tástáil micreanúicléis in vitro i limficít dhaonna le 2′-FL; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le 2′-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 they held proprietary and exclusive rights of reference to the scientific studies and data on the nuclear magnetic resonance (‘NMR’) tests for the determination of the identity of 2′-FL the genetic sequence analyses description of the genetically modified 2′-FL production strain; the results of analyses to confirm the absence of viable cells of the derivative strain of Corynebacterium glutamicum ATCC 13032; the bacterial reverse mutation test with 2′-FL; the in vitro chromosome aberration test with 2′-FL; the in vitro mammalian cell micronucleus test with 2′-FL; the in vitro human lymphocyte micronucleus test with 2′-FL; and, the 90-day oral toxicity study in rats with 2′-FL, 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.

    Commission Implementing Regulation (EU) 2023/859 of 25 April 2023 amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food 2’-Fucosyllactose (microbial source) to authorise its production by a derivative strain of Corynebacterium glutamicum ATCC 13032 (Text with EEA relevance)

  45. #2810652

    An 15 Bealtaine 2020, chuir an t-iarratasóir iarraidh faoi bhráid an Choimisiúin freisin go gcosnófaí staidéir agus sonraí eolaíocha dílseánaigh, is iad sin, mais-speictriméadracht (‘MS’), athshondas maighnéadach núicléach (‘NMR’) agus crómatagrafaíocht mhalartaithe anian ardfheidhmíochta le bailíochtú mhodh an bhraite aimpéarméadraigh bhíogaigh (‘HPAEC-PAD’) agus na torthaí chun aitheantas 6′-SL agus fotháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; tuairisc ar na tréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus ar na tréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach, agus na deimhnithe deascaidh a bhaineann leo; córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (‘qPCR’) agus tuarascálacha maidir le bailíochtú modha le haghaidh na dtréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na dtréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach; tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL; agus staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL, arna chur isteach mar thaca leis an iarratas.

    On 15 May 2020, the applicant also made a request to the Commission for the protection of proprietary scientific studies and data, namely, mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 6′-SL and of the carbohydrate by-products present in the novel food; a description and certificates of deposition of the genetically modified 6′-SL sodium salt production and optional degradation strains; real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 6′-SL sodium salt production and optional degradation strains; a bacterial reverse mutation test with 6′-SL sodium salt; an in vitro mammalian cell micronucleus test with 6′-SL sodium salt; a 7-day dose range finding oral toxicity study in rats with 6′-SL sodium salt; and, a 90-day oral toxicity study in rats with 6′-SL sodium salt, submitted in support of the application.

    Commission Implementing Regulation (EU) 2023/948 of 12 May 2023 authorising the placing on the market of 6'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  46. #2810657

    Sa tuairim eolaíoch uaidh, thug an tÚdarás dá aire go raibh an chonclúid uaidh i ndáil le sábháilteacht an bhia núíosaigh bunaithe ar staidéir agus sonraí eolaíocha ón mais-speictriméadracht (‘MS’), ón athshondas maighnéadach núicléach (‘NMR’) agus ón gcrómatagrafaíocht mhalartaithe anian ardfheidhmíochta le bailíochtú mhodh an bhraite aimpéarméadraigh bhíogaigh (‘HPAEC-PAD’) agus na torthaí chun aitheantas 6′-SL agus na fotháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar na tréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na tréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach, agus na deimhnithe deascaidh a bhaineann leo; an córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (‘qPCR’) agus tuarascálacha maidir le bailíochtú modha le haghaidh na dtréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na dtréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL; agus, an staidéar 90 lá ar thocsaineacht bhéil i bhfrancaigh le salainn 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 the mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 6′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 6′-SL sodium salt production and optional degradation strains; the real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 6′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 6′-SL sodium salt; and, the 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.

    Commission Implementing Regulation (EU) 2023/948 of 12 May 2023 authorising the placing on the market of 6'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  47. #2810659

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na staidéir agus sonraí eolaíocha dílseánaigh arna gcur isteach mar thaca leis an iarratas, is iad sin, mais-speictriméadracht (‘MS’), athshondas maighnéadach núicléach (‘NMR’) agus crómatagrafaíocht mhalartaithe anian ardfheidhmíochta le bailíochtú mhodh an bhraite aimpéarméadraigh bhíogaigh (‘HPAEC-PAD’) agus na torthaí chun aitheantas 6′-SL agus fotháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar na tréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na tréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach, agus na deimhnithe deascaidh a bhaineann leo; an córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (‘qPCR’) agus tuarascálacha maidir le bailíochtú modha le haghaidh na dtréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na dtréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL; 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 they held proprietary and exclusive rights of reference to the scientific studies and data submitted in support of the application, namely, mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 6′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 6′-SL sodium salt production and optional degradation strains; the real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 6′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 6′-SL sodium salt; 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.

    Commission Implementing Regulation (EU) 2023/948 of 12 May 2023 authorising the placing on the market of 6'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  48. #2810661

    Dá bhrí sin, na staidéir agus sonraí eolaíocha dílseánaigh arna gcur isteach mar thaca leis an iarratas, is iad sin, mais-speictriméadracht (‘MS’), athshondas maighnéadach núicléach (‘NMR’) agus crómatagrafaíocht mhalartaithe anian ardfheidhmíochta le bailíochtú mhodh an bhraite aimpéarméadraigh bhíogaigh (‘HPAEC-PAD’) agus na torthaí chun aitheantas 6′-SL agus fotháirgí carbaihiodráite atá sa bhia núíosach a chinneadh; an tuairisc ar na tréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na tréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach, agus na deimhnithe deascaidh a bhaineann leo; an córas um imoibriú slabhrúil polaiméaráise cainníochtúil fíor-ama (‘qPCR’) agus tuarascálacha maidir le bailíochtú modha le haghaidh na dtréithchineálacha táirgthe salainn sóidiam ghéinmhodhnaithe 6′-SL agus na dtréithchineálacha díghrádúcháin salainn sóidiam ghéinmhodhnaithe 6′-SL atá roghnach; an tástáil bhaictéarach ais-sócháin le salann sóidiam 6′-SL; an tástáil micreanúicléis in vitro i gcealla mamach le salann sóidiam 6′-SL; an staidéar raoin dáileoige 7 lá ar thocsaineacht bhéil i bhfrancaigh le salann sóidiam 6′SL; 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, mass spectrometry (‘MS’), nuclear magnetic resonance (‘NMR’) and a high-performance anion-exchange chromatography with pulsed amperometric detection (‘HPAEC-PAD’) method validation and the results for the determination of the identity of 6′-SL and of the carbohydrate by-products present in the novel food; the description and certificates of deposition of the genetically modified 6′-SL sodium salt production and optional degradation strains; the real time quantitative polymerase chain reaction (‘qPCR’) system and method validation reports for the genetically modified 6′-SL sodium salt production and optional degradation strains; the bacterial reverse mutation test with 6′-SL sodium salt; the in vitro mammalian cell micronucleus test with 6′-SL sodium salt; the 7-day dose range finding oral toxicity study in rats with 6′-SL sodium salt; 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.

    Commission Implementing Regulation (EU) 2023/948 of 12 May 2023 authorising the placing on the market of 6'-Sialyllactose sodium salt produced by derivative strains of Escherichia coli BL21(DE3) as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  49. #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.

    Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation (EU) 2017/2470

  50. #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.

    Commission Implementing Regulation (EU) 2023/2210 of 20 October 2023 authorising the placing on the market of 3-Fucosyllactose produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food and amending Implementing Regulation (EU) 2017/2470