Cuirfidh an monaróir ar fáil don údarás cineálcheadaithe a dheonaigh an cineálcheadú feithicle ina hiomláine an deimhniú comhréireachta i bhformáid leictreonach atá i gcomhréir le formáid agus struchtúr na sonraí agus na dteachtaireachtaí caighdeánaithe a leagtar amach in Airteagal 2 trí aon phointe rochtana náisiúnta den Chóras Eorpach Faisnéise maidir le feithiclí agus ceadúnais tiomána (EUCARIS) san Aontas.
The manufacturer shall make available an electronic version of the certificate of conformity in accordance with the format and structure of the data elements and standardised messages set out in Article 2 through any national access point of the European Vehicle and Driving Licence Information System (EUCARIS) in the Union to the type-approval authority that has granted the whole-vehicle type-approval.
#1920289
Bainfidh an t-údarás ceadaithe úsáid as EUCARIS mar mhodh chun sonraí an deimhnithe comhréireachta a mhalartú mar shonraí struchtúraithe i bhformáid leictreonach dá dtagraítear i bpointe (c) d’Airteagal 37(8) de Rialachán (AE) 2018/858.
The approval authority shall use EUCARIS as the means of exchange of data of the certificate of conformity as structured data in electronic format referred to in point (c) of Article 37(8) of Regulation (EU) 2018/858.
#1976864
Beidh gá le struchtúr sonraí comhchoiteann agus comhaontú ar bhrí bheartaithe gach réimse sonraí i ndáil leis an bpálasta agus a luachanna féideartha ionas go mbeifí in ann Deimhniú Digiteach COVID AE a léamh agus a thuiscint.
The ability to read and interpret the EU Digital COVID Certificate requires a common data structure and agreement on the intended meaning of each data field of the payload and its possible values.
#1976897
Leagtar amach in Iarscríbhinn I na sonraíochtaí teicniúla i ndáil le Deimhniú Digiteach COVID AE lena leagtar síos an struchtúr cineálach sonraí, na sásraí ionchódaithe agus an sásra ionchódaithe iompair i bhformáid optúil atá inléite ag meaisín.
The technical specifications for the EU Digital COVID Certificate laying down the generic data structure, the encoding mechanisms, and the transport encoding mechanism in a machine-readable optical format are set out in Annex I.
#1977177
Ba cheart comhoiriúnacht droim ar ais a áirithiú: ní mór do Bhallstáit a athraíonn struchtúr a n-aitheantóirí thar am (laistigh den phríomhleagan, atá socruithe ag v1 faoi láthair) a áirithiú go léiríonn aon dá aitheantóir atá díreach mar an gcéanna an deimhniú/dearbhú vacsaínithe céanna.
Backwards-compatibility should be ensured: Member States that over time change the structure of their identifiers (within the main version, currently set at v1) must ensure that any two identifiers that are identical represent the same vaccination certificate/assertion.
#1992527
Áiritheofar comhoiriúnacht droim ar ais: áiritheoidh na Ballstáit a athraíonn struchtúr a n-aitheantóirí thar am (laistigh den phríomhleagan, atá socruithe ag v1 faoi láthair) go léiríonn aon dá aitheantóir atá díreach mar an gcéanna an deimhniú/dearbhú vacsaínithe céanna.
Backwards-compatibility shall be ensured: Member States that over time change the structure of their identifiers (within the main version, currently set at v1) shall ensure that any two identifiers that are identical represent the same vaccination certificate/assertion.
#2006709
Maidir le haon mhodhnú ar na cineálacha feithiclí a liostaítear san Aguisín le deimhniú ar chineálcheadú AE maidir leis an gcóras cosanta tosaigh, atá chun tosaigh ar a A-philéir nó ar an gcóras cosanta tosaigh féin, a bhfuil tionchar aige ar an struchtúr, ar na príomh-thoisí, ar ábhair dhromchlaí seachtracha na feithicle nó an chórais cosanta tosaigh, ar na modhanna daingnithe nó ar shocrú na gcomhpháirteanna seachtracha nó inmheánacha, agus a d’fhéadfadh tionchar nach beag a imirt ar thorthaí na dtástálacha, measfar gur leasú é de bhun Airteagal 33 de Rialachán (AE) 2018/858 agus dá bharr sin, éileofar cineálcheadú nua ón Aontas maidir leis an gcóras cosanta tosaigh.
Any modification of the vehicle types that are listed in the Appendix to the EU type-approval certificate of the frontal protection system, forward of their A-pillars or of the frontal protection system itself, which affects either the structure, the main dimensions, the materials of the outer surfaces of the vehicle or the frontal protection system, the fixing methods or the external or internal component arrangement, and which may have a significant influence on the results of the tests, shall be regarded as an amendment pursuant to Article 33 of Regulation (EU) 2018/858 and thus require a new EU type-approval with regard to the frontal protection system.
#2302134
Rialachán Cur Chun Feidhme (AE) 2021/133 ón gCoimisiún an 4 Feabhra 2021 lena gcuirtear chun feidhme Rialachán (AE) 2018/858 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le formáid bhunúsach, struchtúr agus modh malartaithe shonraí an deimhnithe comhréireachta i bhformáid leictreonach (IO L 42, 5.2.2021, lch.1)
Commission Implementing Regulation (EU) 2021/133 of 4 February 2021 implementing Regulation (EU) 2018/858 of the European Parliament and of the Council as regards the basic format, structure and the means of exchange of the data of the certificate of conformity in electronic format (OJ L 42, 5.2.2021, p. 1).
#2374286
Rialachán Cur Chun Feidhme (AE) 2021/133 ón gCoimisiún an 4 Feabhra 2021 lena gcuirtear chun feidhme Rialachán (AE) 2018/858 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le formáid bhunúsach, struchtúr agus modh malartaithe shonraí an deimhnithe comhréireachta i bhformáid leictreonach, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2021/133 of 4 February 2021 implementing Regulation (EU) 2018/858 of the European Parliament and of the Council as regards the basic format, structure and the means of exchange of the data of the certificate of conformity in electronic format is to be incorporated into the EEA Agreement.
#2374291
32021 R 0133: Rialachán Cur Chun Feidhme (AE) 2021/133 ón gCoimisiún an 4 Feabhra 2021 lena gcuirtear chun feidhme Rialachán (AE) 2018/858 ó Pharlaimint na hEorpa agus ón gComhairle a mhéid a bhaineann le formáid bhunúsach, struchtúr agus modh malartaithe shonraí an deimhnithe comhréireachta i bhformáid leictreonach (IO L 42, 5.2.2021, lch. 1).”
32021 R 0133: Commission Implementing Regulation (EU) 2021/133 of 4 February 2021 implementing Regulation (EU) 2018/858 of the European Parliament and of the Council as regards the basic format, structure and the means of exchange of the data of the certificate of conformity in electronic format (OJ L 42, 5.2.2021, p. 1).’
#2801237
Is díol sásaimh don Chomhairle go bhfuil sé ar intinn ag an gCoimisiún comhoibriú go dlúth le EDS chun an líonra deimhniúcháin sláinte dhigitigh domhanda a fhorbairt, lena gcuirfear ar chumas EDS an creat iontaoibhe, na prionsabail agus na teicneolaíochtaí oscailte maidir le Deimhniú Digiteach COVID an Aontais a ghlacadh ina struchtúr féin, ar bhonn na sonraíochtaí teicniúla a leagadh síos roimhe seo i gCinneadh Cur Chun Feidhme (AE) 2021/1073.
The Council welcomes the Commission’s intention to closely cooperate with the WHO in the development of the global digital health certification network, enabling the WHO to take up the EU Digital COVID Certificate trust framework, principles and open technologies into its own structure, on the basis of the technical specifications previously laid down in Implementing Decision (EU) 2021/1073.
#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.
#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.
#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.
#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.
#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.
#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.