#293829
- tástáil shaobhadh crómasóim smeara i mamaigh;
- mammalian bone marrow chromosome aberration test;
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#293834
- tástáil shaobhadh crómasóim speirmeatógónaigh i mamaigh;
- mammalian spermatogonial chromosome aberration test;
#293843
- tástáil shaobhadh crómasóim in vitro i mamaigh;
- in vitro mammalian chromosome aberration test;
#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.
#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.
#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.
#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.
#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.
#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.
#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.