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lena ndeonaítear údarú Aontais le haghaidh an táirge bhithicídigh aonair “Aero-Sense Aircraft Insecticide ASD”
granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’
lena ndeonaítear údarú Aontais le haghaidh an táirge bhithicídigh aonair “Aero-Sense Aircraft Insecticide ASD”
granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’
Aontaíonn an Coimisiún le tuairim na Gníomhaireachta agus measann sé dá réir sin gur iomchuí údarú Aontais le haghaidh “Aero-Sense Aircraft Insecticide ASD” a dheonú.
The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Aero-Sense Aircraft Insecticide ASD’.
An 2 Feabhra 2018, chuir Aero-Sense NV iarratas isteach i gcomhréir le hAirteagal 43(1) de Rialachán (AE) Uimh. 528/2012 ar údarú ar tháirge bithicídeach aonair ar a dtugtar “Aero-Sense Aircraft Insecticide ASD” den chineál táirge 18, de réir mar a thuairiscítear in Iarscríbhinn V a ghabhann leis an Rialachán sin, lenar tugadh deimhniú i scríbhinn gur chomhaontaigh údarás inniúil na Beilge meastóireacht a dhéanamh ar an iarratas.
On 2 February 2018, Aero-Sense NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘Aero-Sense Aircraft Insecticide ASD’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application.
Is é 1R-tras feinitrin an tsubstaint ghníomhach in “Aero-Sense Aircraft Insecticide ASD”; tá an tsubstaint sin san áireamh ar liosta an Aontais de na de shubstaintí gníomhacha formheasta dá dtagraítear in Airteagal 9(2) de Rialachán (AE) Uimh. 528/2012.
‘Aero-Sense Aircraft Insecticide ASD’ contains 1R-trans phenothrin, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.
An 2 Iúil 2020, chuir an Ghníomhaireacht tuairim, an dréacht-achoimre ar shaintréithe an táirge bhithicídigh ( ‘SPC’) atá ag “Aero-Sense Aircraft Insecticide ASD” agus an tuarascáil mheasúnaithe deiridh ar an táirge bithicídeach aonair faoi bhráid an Choimisiúin i gcomhréir le hAirteagal 44(3) de Rialachán (AE) Uimh. 528/2012.
On 2 July 2020, the Agency submitted to the Commission an opinion, the draft summary of the biocidal product characteristics ( ‘SPC’) of ‘Aero-Sense Aircraft Insecticide ASD’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012.
Is é conclúid na tuairime gur táirge bithicídeach é “Aero-Sense Aircraft Insecticide ASD”, go bhfuil sé incháilithe d’údarú Aontais i gcomhréir le hAirteagal 42(1) Rialachán (AE) Uimh. 528/2012 agus, faoi réir chomhlíonadh an dréacht-SPC, go gcomhlíonann sé na coinníollacha a leagtar síos in Airteagal 19(1) den Rialachán sin.
The opinion concludes that ‘Aero-Sense Aircraft Insecticide ASD’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.
Deonaítear údarú Aontais a bhfuil an uimhir údaraithe EU-0024297-0000 aige do Aero-Sense NV chun an táirge bithicídeach aonair “Aero-Sense Aircraft Insecticide ASD” a chur ar fáil ar an margadh agus a úsáid i gcomhréir leis an achoimre ar thréithe an táirge bhithicídigh a leagtar amach san Iarscríbhinn.
A Union authorisation with authorisation number EU-0024297-0000 is granted to Aero-Sense NV for the making available on the market and use of the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
Tuairim ECHA an 17 Meitheamh 2020 maidir le húdarú Aontais le haghaidh an táirge bithicídeach “Aero-Sense Aircraft Insecticide ASD” (ECHA/BPC/262/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation
ECHA opinion of 17 June 2020 on the Union authorisation of the biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ (ECHA/BPC/262/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation