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3 results in 2 documents

  1. #2329727

    Comhlíonann an tsubstaint ghníomhach sin na coinníollacha a leagtar síos i bpointe 5.2.1 d’Iarscríbhinn II a ghabhann le Rialachán (CE) Uimh. 1107/2009 toisc nár léirigh sí, ar leibhéal tréithchineáil, il-fhrithsheasmhacht in aghaidh ábhair fhrithmhiocróbacha a úsáidtear in íocshláinte an duine nó in íocshláinte tréidliachta.

    That active substance fulfils the conditions set in point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 because, at strain level, it has not demonstrated multiple resistance to anti-microbials used in human or veterinary medicine.

    Commission Implementing Regulation (EU) 2022/383 of 4 March 2022 renewing the approval of the low-risk active substance Metarhizium brunneum strain Ma 43 (formerly Metarhizium anisopliae var. anisopliae strain BIPESCO 5/F52) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

  2. #2512094

    Le pointe 5.2.1 d’Iarscríbhinn II a ghabhann le Rialachán (CE) Uimh. 1107/2009 leagtar amach na critéir lena measfar substaintí gníomhacha ar miocrorgánaigh iad mar shubstaintí gníomhacha íseal-riosca agus faoi láthair tagraíonn an pointe sin don il-fhrithsheasmhacht in aghaidh frithmhiocróbach a d’fhéadfadh teacht chun cinn.

    Point 5.2.1 of Annex II to Regulation (EC) No 1107/2009 sets out the criteria for considering active substances that are micro-organisms as low-risk active substances and currently refers to the possible occurrence of multiple resistance to antimicrobials.

    Commission Regulation (EU) 2022/1438 of 31 August 2022 amending Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards specific criteria for the approval of active substances that are micro-organisms (Text with EEA relevance)

  3. #2512097

    Mar sin féin, leis an il-fhrithsheasmhacht in aghaidh roinnt frithmhiocróbach a d’fhéadfadh teacht chun cinn mar a leagtar amach faoi láthair i bpointe 5.2.1 maidir leis an líon roghanna cóireála éifeachtacha bunaithe ar fhrithmhiocróbaigh atá ar fáil.

    However, the possible occurrence of multiple resistance to some antimicrobials as currently outlined in point 5.2.1 does not clarify the number of effective treatment options based on antimicrobials which are available.

    Commission Regulation (EU) 2022/1438 of 31 August 2022 amending Annex II to Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards specific criteria for the approval of active substances that are micro-organisms (Text with EEA relevance)