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8 results in 5 documents

  1. #2911248

    Léiríonn arbhar Indiach géinmhodhnaithe MON-ØØØ21-9 an ghéin epsps, géin a thugann frithsheasmhacht in aghaidh luibhicídí atá bunaithe ar ghliofosáit, agus léiríonn arbhar Indiach géinmhodhnaithe ACS-ZMØØ3-2 an ghéin pat, géin a thugann frithsheasmhacht in aghaidh luibhicídí glúfosanáit-amóiniam.

    Genetically modified maize MON-ØØØ21-9 expresses the epsps gene, which confers tolerance to glyphosate-based herbicides and genetically modified maize ACS-ZMØØ3-2 expresses the pat gene, which confers tolerance to glufosinate-ammonium herbicides.

    Commission Implementing Decision (EU) 2023/2132 of 13 October 2023 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize GA21 × T25 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2023) 6735)

  2. #2512377

    Meastar géin frithsheasmhachta frithmhiocróbaí a bheith intreach má tá sí suite ar chrómasóm in éagmais eilimint ghéiniteach shoghluaiste agus má tá sí ag tromlach thréithchineálacha fiáine an speicis chéanna;

    An antimicrobial resistance gene is considered intrinsic if it is located on a chromosome in the absence of mobile genetic element and shared by the majority of wild type strains of the same species;

    Commission Regulation (EU) 2022/1439 of 31 August 2022 amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms (Text with EEA relevance)

  3. #2513969

    Meastar géin frithsheasmhachta frithmhiocróbaí a bheith intreach má tá sí suite ar chrómasóm in éagmais eilimint ghéiniteach shoghluaiste agus má tá sí ag tromlach thréithchineálacha fiáine an speicis chéanna;

    An antimicrobial resistance gene is considered intrinsic if it is located on a chromosome in the absence of mobile genetic element and shared by the majority of wild type strains of the same species;

    Commission Regulation (EU) 2022/1441 of 31 August 2022 amending Regulation (EU) No 546/2011 as regards specific uniform principles for evaluation and authorisation of plant protection products containing micro-organisms (Text with EEA relevance)

  4. #3167210

    Léiríonn arbhar Indiach géinmhodhnaithe SYN-IR6Ø4-5 géin cry3A mhodhnaithe, lena dtugtar cosaint in aghaidh lotnaidí coiléipteireacha áirithe.

    The genetically modified maize SYN-IR6Ø4-5 expresses a modified cry3A gene, which provides protection against certain coleopteran pests.

    Commission Implementing Decision (EU) 2024/391 of 26 January 2024 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and thirty sub-combinations, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 434)

  5. #2497084

    An 21 Feabhra 2020, d’iarr an t-iarratasóir ar an gCoimisiún freisin go gcosnófaí sonraí dílseánaigh le haghaidh tástáil micreanúicléis in vitro i gcealla mamach, tástáil sócháin géine in vitro i gcealla mamach ina n-úsáidtear an géin cionáise tímidíne, agus staidéar 90 lá ar thocsaineacht bhéil i gcreimirí, a cuireadh isteach mar thaca leis an iarratas.

    On 21 February 2020, the applicant also made a request to the Commission for the protection of proprietary data for an in vitro mammalian cell micronucleus test, an in vitro mammalian cell gene mutation test using the thymidine kinase gene, and a 90-day oral toxicity study in rodents, submitted in support of the application.

    Commission Implementing Regulation (EU) 2022/1373 of 5 August 2022 authorising the placing on the market of iron hydroxide adipate tartrate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  6. #2497102

    Sa tuairim eolaíoch uaidh, thug an tÚdarás dá aire go raibh a chonclúid maidir le sábháilteacht an bhia núíosaigh bunaithe ar shonraí eolaíocha ón tástáil micreanúicléis in vitro i gcealla mamach, ón tástáil sócháin géine in vitro i gcealla mamach ina n-úsáidtear an géin cionáise tímidíne, agus ón staidéar 90 lá ar thocsaineacht bhéil i gcreimirí, atá i gcomhad an iarratasóra, agus nach bhféadfadh sé measúnú a dhéanamh ar an mbia núíosach agus 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 data from the in vitro mammalian cell micronucleus test, the in vitro mammalian cell gene mutation test using the thymidine kinase gene, and the 90-day oral toxicity study 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) 2022/1373 of 5 August 2022 authorising the placing on the market of iron hydroxide adipate tartrate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  7. #2497104

    Dhearbhaigh an t-iarratasóir go raibh cearta dílseánaigh agus eisiacha aige chun tagairt a dhéanamh do na sonraí eolaíocha ón tástáil micreanúicléis in vitro i gcealla mamach, ón tástáil sócháin géine in vitro i gcealla mamach ina n-úsáidtear an géin cionáise tímidíne, agus ón staidéar 90 lá ar thocsaineacht bhéil i gcreimirí tráth a chuir siad an t-iarratas isteach, agus 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 it held proprietary and exclusive rights of reference to the scientific data from the in vitro mammalian cell micronucleus test, the in vitro mammalian cell gene mutation test using the thymidine kinase gene, and the 90-day oral toxicity study 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) 2022/1373 of 5 August 2022 authorising the placing on the market of iron hydroxide adipate tartrate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)

  8. #2497106

    Dá bhrí sin, na sonraí eolaíocha ón tástáil micreanúicléis in vitro i gcealla mamach, ón tástáil sócháin géine in vitro i gcealla mamach ina n-úsáidtear an géin cionáise tímidíne agus ón staidéar 90 lá ar thocsaineacht bhéil i gcreimirí, ba cheart iad a chosaint i gcomhréir le hAirteagal 27(1) de Rialachán (AE) 2015/2283.

    Therefore, the scientific data from the in vitro mammalian cell micronucleus test, the in vitro mammalian cell gene mutation test using the thymidine kinase gene and the 90-day oral toxicity study in rodents should be protected in accordance with Article 27(1) of Regulation (EU) 2015/2283.

    Commission Implementing Regulation (EU) 2022/1373 of 5 August 2022 authorising the placing on the market of iron hydroxide adipate tartrate as a novel food and amending Implementing Regulation (EU) 2017/2470 (Text with EEA relevance)