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  1. #2512758

    le haghaidh miocrorgánaigh a bhfuil modh gníomhaíochta pataigineach acu nó le haghaidh víreas (e.g. einteómapataiginigh) a mheastar a leathfaidh go suntasach sa chomhshaol tar éis leata, d’fhéadfadh údar a bheith leis an dáileog bhéil a thugtar sna staidéir bunaithe ar an bhfaisnéis a chuirtear isteach faoi phointí 7.1.1 agus 7.1.2.

    for micro-organisms with pathogenic mode of action or viruses (e.g. entomopathogens) that are expected to proliferate significantly in the environment following an application, the oral dose administered in the studies may be justified based on the information submitted under points 7.1.1 and 7.1.2.

    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)

  2. #2512772

    Déanfar staidéir ábhartha ar éifeachtaí pataigineacha/ionfhabhtaíocha ar algaí agus ar an ráta fáis más eol go bhfuil modh gníomhaíochta luibhicídeach ag an miocrorgánach nó más eol go bhfuil dlúthbhaint aige le pataigin planda, mura léiríonn an t-iarratasóir, trí chur chuige thromachar na fianaise, ceann de na cásanna seo a leanas:

    Relevant studies on pathogenic/infective effects on algae growth and growth rate shall be performed if the micro-organism is known to have an herbicidal mode of action or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

    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. #2512777

    Déanfar staidéir ábhartha ar éifeachtaí pataigineacha/ionfhabhtaíocha ar mhacraifítí uisceacha más eol go bhfuil modh gníomhaíochta luibhicídeach ag an miocrorgánach nó más eol go bhfuil dlúthbhaint aige le pataigin planda, mura léiríonn an t-iarratasóir, trí chur chuige thromachar na fianaise, ceann de na cásanna seo a leanas:

    Relevant studies on pathogenic/infective effects on aquatic macrophytes shall be performed if the micro-organism is known to have an herbicidal mode of action, or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

    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)

  4. #2512801

    Déanfar staidéir ábhartha ar éifeachtaí pataigineacha/ionfhabhtaíocha ar phlandaí talún nach spriocphlandaí talún iad más eol go bhfuil modh gníomhaíochta luibhicídeach ag an miocrorgánach nó más eol go bhfuil dlúthbhaint aige le pataigin planda, mura léiríonn an t-iarratasóir, trí chur chuige thromachar na fianaise, ceann de na cásanna seo a leanas:

    Relevant studies on pathogenic/infective effects on non-target terrestrial plants shall be performed if the micro-organism is known to have an herbicidal mode of action or to be closely related to a plant pathogen, unless the applicant demonstrates, by following a weight of evidence approach, that:

    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)

  5. #2512832

    Le staid reatha an eolais eolaíoch maidir le táirgí cosanta plandaí a bhfuil miocrorgánaigh iontu, is féidir cur chuige níos fearr agus níos sonraí a ghlacadh i leith measúnú a dhéanamh orthu, rud atá bunaithe ar an modh gníomhaíochta agus ar shaintréithe éiceolaíocha na speiceas faoi seach agus, i gcás inarb infheidhme, na dtréithchineál miocrorgánach faoi seach.

    The current state of scientific knowledge on plant protection products containing micro-organisms allows for a better and more specific approach for their assessment, which is based on the mode of action and ecological characteristics of the respective species and, where applicable, the respective strains of micro-organisms.

    Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Text with EEA relevance)

  6. #2513149

    Cuirfear ar fáil faisnéis bhreise maidir leis an modh gníomhaíochta ar an spriocorgánach i gcás ina bhféadfadh éifeacht ábhartha a bheith ag na comhpháirteanna ceimiceacha (e.g. comhfhoirmligh) ar éifeachtacht, ar shláinte an duine nó ar shláinte ainmhithe nó ar an gcomhshaol.

    Additional information on the mode of action on the target organism shall be provided in case the chemical components (e.g. co-formulants) may have a relevant effect on efficacy, human and animal health or the environment.

    Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Text with EEA relevance)

  7. #2513248

    Nuair a iarrann an t-údarás inniúil é, cuirfear isteach tuarascálacha achoimre ar réamhthástálacha, lena n-áireofar staidéir i saotharlanna, staidéir i dtithe gloine agus staidéir allamuigh, a úsáidtear chun measúnú a dhéanamh ar ghníomhaíocht bhitheolaíoch, ar mhodh gníomhaíochta agus ar raon dáileoige an táirge cosanta plandaí agus na substainte gníomhaí/na substaintí gníomhacha atá ann.

    When requested by the competent authority, summary reports of preliminary tests shall be submitted, including laboratory, greenhouse and field studies, used to assess the biological activity, mode of action and dose-range finding of the plant protection product and the active substance(s) it contains.

    Commission Regulation (EU) 2022/1440 of 31 August 2022 amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms (Text with EEA relevance)

  8. #2513506

    Leis an eolas eolaíoch atá ar fáil faoi láthair maidir le táirgí cosanta plandaí a bhfuil miocrorgánaigh iontu, is féidir cur chuige níos fearr agus níos sonraí a ghlacadh i leith measúnú a dhéanamh orthu, rud atá bunaithe ar an modh gníomhaíochta agus ar shaintréithe éiceolaíocha na speiceas faoi seach agus, i gcás inarb infheidhme, na dtréithchineál miocrorgánach.

    The currently available scientific knowledge on plant protection products containing micro-organisms allows for a better and more specific approach for their assessment, which is based on the mode of action and the ecological characteristics of the respective species and, where applicable, the respective strains of micro-organisms.

    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)

  9. #2513976

    is iad airíonna bitheolaíocha agus modh gníomhaíochta miocrorgánaigh an chéad chéim agus an chéim ríthábhachtach sa phróiseas meastóireachta, toisc go sainíonn siad na gnéithe agus na heilimintí ábhartha ar cheart díriú orthu sa mheastóireacht, agus freisin na gnéithe nach bhfuil ábhartha le haghaidh cinnteoireacht láidir fheasach,

    the biological properties and the mode of action of a micro-organism are the first and crucial step in the evaluation process, because they define which are the relevant aspects and elements on which the evaluation should focus, and also which aspects are not relevant for a robust informed decision making,

    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)

  10. #2514001

    Déanfaidh na Ballstáit meastóireacht ar fhaisnéis maidir leis an modh gníomhaíochta ar na spriocorgánaigh don táirge cosanta plandaí chun rioscaí ionchasacha agus feidhm na substainte gníomhaí ar miocrorgánach í a shainaithint de réir na gcoinníollacha úsáide atá beartaithe.

    Member States shall evaluate information on the mode of action on the target organisms for the plant protection product to identify potential risks and function of the active substance that is a micro-organism according to the proposed conditions of use.

    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)

  11. #2514134

    Áireofar sa mheasúnú riosca sin breithniú ar mhodh gníomhaíochta, mar shampla, airíonna fisiceacha agus ceimiceacha an mhiocrorgánaigh agus comhpháirteanna eile sa táirge cosanta plandaí, amhail meitibilítí arb údar imní iad, teorantóirí, sineirgígh agus eisíontais ábhartha.

    This risk assessment shall include consideration of e.g. mode of action, physical and chemical properties of the micro-organism and other components in the plant protection product, such as metabolites of concern, safeners, synergists and relevant impurities.

    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)

  12. #2514332

    Má tá modh gníomhaíochta luibhicídeach ag an miocrorgánach nó má tá dlúthbhaint aige le pataigin is eol a bheith ann, agus má tá an fhéidearthacht ann go nochtfaí plandaí talún ar an miocrorgánach de réir an bhreithnithe a rinneadh faoi phointe 1.6, ní dheonófar aon údarú má tá an miocrorgánach pataigineach do phlandaí talún nó má tá éifeachtaí tocsaineacha ag an táirge cosanta plandaí ar phlandaí talún.

    If the micro-organism has an herbicidal mode of action or it is closely related to a known plant pathogen, and there is a possibility of terrestrial plants being exposed to the micro-organism according to the consideration done under point 1.6, no authorisation shall be granted if the micro-organism is pathogenic to, or the plant protection product has toxic effects on, terrestrial plants.

    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)

  13. #3175521

    Faoi láthair, tá sé shubstaint ghníomhacha ann le haghaidh creimiricídí a bhfuil modh gníomhaíochta acu atá difriúil ó mhodh gníomhaíochta creimiricídí antaithéachtacha (alfaclóralós, foisfín lena scaoiltear foisfíd alúmanaim, dé-ocsaíd charbóin, ciainíd hidrigine, coba arbhair Indiaigh púdraithe agus colacailciféaról).

    There are currently six active substances for rodenticides with a mode of action different from that of anticoagulant rodenticides (alphachloralose, aluminium phosphide releasing phosphine, carbon dioxide, hydrogen cyanide, powdered corn cob and cholecalciferol).

    Commission Implementing Decision (EU) 2024/816 of 5 March 2024 addressing questions regarding the second comparative assessment of anticoagulant rodenticide biocidal products in accordance with Article 23(5) of Regulation (EU) No 528/2012 of the European Parliament and of the Council

  14. #3187310

    I gcás nochtadh do theaglaim substaintí a bhfuil an modh gníomhaíochta céanna acu nó a dhíríonn ar na spriocorgáin, spriocfhíocháin nó sprioc-chealla céanna, ba cheart an riosca a mheasúnú ar bhonn na teaglama substaintí sin.

    In the case of exposure to a combination of substances that have the same mode of action or act at the same target organs, tissues or cells, the risk should be assessed on the basis of that combination of substances.

    Directive (EU) 2024/869 of the European Parliament and of the Council of 13 March 2024 amending Directive 2004/37/EC of the European Parliament and of the Council and Council Directive 98/24/EC as regards the limit values for lead and its inorganic compounds and for diisocyanates

  15. #3190702

    Sa tuairim eolaíoch uaidh an 29 Meitheamh 2022, rinne an tÚdarás meastóireacht ar na sonraí a cuireadh isteach agus tháinig sé ar an gconclúid gur spreag substaint ionadaíoch an ghrúpa, 2-Feiniolcrotónaildéad (FL Uimh. 05.062), modh gníomhaíochta aineoigineachta.

    In its scientific opinion of 29 June 2022, the Authority evaluated the submitted data and concluded that the representative substance of the group, 2-Phenylcrotonaldehyde (FL No 05.062), induced an aneugenicity mode of action.

    Commission Regulation (EU) 2024/238 of 15 January 2024 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the introduction of restrictions on the use of certain flavouring substances