#2394411
Imréiteach airgeadais: ceartú earráidí aitheanta (Fiachas – Beartais ADI 2007-13 seiceáil 5 bliana)
Financial clearance: correction of known errors (Créances - Mesures DJA 2007-13 contrôle à 5 ans)
Scag na torthaí
Bailiúcháin
39 toradh in 16 doiciméad
#2512282
leibhéal iontógála laethúla inghlactha (ADI) a leagan síos, i gcás inarb ábhartha, do dhaoine;
establish, where relevant, an acceptable daily intake (ADI) level for humans;
#2513707
cinneadh maidir le hiontógáil laethúil inghlactha (ADI),
the determination of an acceptable daily intake (ADI),
#2968036
EFmix = (Σ ADi · NCVi · EFi + EmFGC) / (Σ ADi · NCVi) (Cothromóid 36) I gcás inarb amhlaidh an méid seo a leanas:
EFmix = (Σ ADi · NCVi · EFi + EmFGC)/(Σ ADi · NCVi) (Equation 36)
#2968767
Is é ADi
ADi
#2122065
In 2017, tháinig an Coimisiún ar an eolas freisin faoi fhianaise eolaíoch nua a chuir oibreoirí gnólachtaí isteach le linn an chomhairliúcháin phoiblí faoin dréacht-Rialachán Cur Chun Feidhme lena mbunaítear liosta an Aontais de bhianna núíosacha údaraithe, fianaise a léiríonn ADI i bhfad níos airde le haghaidh astaxaintine ná an ADI a bhunaigh an tÚdarás roimhe sin.
The Commission also became aware of new scientific evidence in 2017, submitted by business operators during the public consultation of the draft Implementing Regulation establishing the Union list of authorised novel foods, pointing to a considerably higher ADI for astaxanthin than the one previously established by the Authority.
#2873256
Agus Iontógáil Laethúil Inghlactha (‘ADI’) astaxaintine de 0,2 mg/kg de mheáchan coirp in aghaidh an lae agus iontógálacha astaxaintine ón aiste bia ginearálta mar a leagtar síos i dtuairim ón údarás a foilsíodh in 2020 á gcur san áireamh, bheadh iontógálacha astaxaintine nach mó ná an ADI mar thoradh ar iontógáil astaxaintine a thagann ó fhorbhianna mar atá molta ag an iarratasóir.
Taking into account the Acceptable Daily Intake (‘ADI’) of astaxanthin of 0,2 mg/kg body weight per day and the intakes of astaxanthin from the background diet as set out in the opinion of the authority published in 2020, the intake of astaxanthin from food supplements as proposed by the applicant would result in overall intakes of astaxanthin that do not exceed the ADI.
#2999188
Maidir le níotráití, choinnigh an tÚdarás ADI de 3,7 mg ian níotráite/kg bw in aghaidh an lae agus mheas sé nár sháraigh an teagmháil a d’eascair as a úsáid mar bhreiseán bia an ADI sin.
For nitrates, the Authority maintained an ADI of 3,7 mg nitrate ion/kg bw per day and estimated that the exposure resulting from its use as a food additive did not exceed this ADI.
#307884
3.6.1. I gcás inarb ábhartha, déanfar ADI, AOEL agus ARfD bhunú.
3.6.1. Where relevant, an ADI, AOEL and ARfD shall be established.
#307950
- gurb ísle go suntasach a ADI, ARfD nó AOEL ná mar is amhlaidh i gcás thromlach na substaintí gníomhacha formheasta laistigh de ghrúpaí substaintí/catagóirí úsáide,
- its ADI, ARfD or AOEL is significantly lower than those of the majority of the approved active substances within groups of substances/use categories,
#2122063
Tráth a bunaíodh liosta an Aontais de bhianna núíosacha atá údaraithe in 2017 agus ar bhonn dhá thuairim roimhe sinin 2014 ón Údarás Eorpach um Shábháilteacht Bia (“an tÚdarás”), tuairim amháin acu maidir le húsáid astaxaintine i mbreiseáin bheathaithe mar a shainmhínítear i Rialachán (CE) Uimh. 1831/2003 ó Pharlaimint na hEorpa agus ón gComhairle maidir le breiseáin bheathaithe le haghaidh cothú ainmhithe, inar leagadh síos Iontógáil Laethúil Inghlactha (“ADI”) 0,034 mg/kg in aghaidh an mheáchain coirp in aghaidh an lae le haghaidh astaxaintine, agus an tuairim eile maidir le sábháilteacht na hastaxaintine mar chomhábhar bia núíosaigh, mheas an Coimisiún go bhféadfadh iontógáil na hastaxaintine ó fhorbhianna ina bhfuil an t-uasleibhéal údaraithe de 8,0 mg in aghaidh an lae bainte amach , go bhféadfadh sí sin dul thar an ADI agus gan bheith i gcomhréir leis na coinníollacha a leagtar amach in Airteagal 7 de Rialachán (AE) 2015/2283.
At the time of the establishment of the Union list of authorised novel foods in 2017, the Commission considered that, based on previous two opinions, of 2014 of the European Food Safety Authority (‘the Authority’), one on the use of astaxanthin in feed additives as defined in Regulation (EC) No 1831/2003 of the European Parliament and the Council on feed additives for animal nutrition, that established an Acceptable Daily Intake (‘ADI’) of 0,034 mg/kg body weight per day for astaxanthin, and one on the safety of astaxanthin as a novel food ingredient, the intake of astaxanthin from food supplements containing the maximum authorised use levels of up to 8,0 mg per day, may exceed the ADI and may not be in accordance with the conditions set out in Article 7 of Regulation (EU) 2015/2283.
#2469922
Sa tuairim ón Údarás a glacadh an 4 Bealtaine 2021, leagadh síos iontógáil laethúil inghlactha (“ADI”) 10 mg/kg de mheáchan coirp (bw) in aghaidh an lae.
In the Authority’s opinion adopted on 4 May 2021, an acceptable daily intake (‘ADI’) of 10 mg/kg bw per day was established.
#2513884
Ag cur san áireamh gach úsáid chláraithe, ní údarófar an úsáid atá beartaithe má sháraíonn an meastachán is fearr is féidir ar nochtadh cothúcháin an ADI.
Taking into account all registered uses, the proposed use shall not be authorised if the best possible estimate of dietary exposure exceeds the ADI.
#2514350
I gcás nach bhfuil ADI ar fáil le haghaidh meitibilíte arb údar imní í, tá feidhm ag an luach réamhshocraithe 0.1 μg/l.
Where the ADI is not available for a metabolite of concern, the default value of 0.1 μg/l applies.
#2712683
Mhol an tÚdarás, ar bhonn na staidéar ar néarthocsaineacht fhorbarthach, gur cheart iontógáil laethúil inghlactha níos ísle (ADI) agus géardháileog thagartha (ARfD) níos ísle a leagan síos.
The Authority proposed, based on the developmental neurotoxicity studies, that a lower acceptable daily intake (ADI) and acute reference dose (ARfD) should be established.
#2968117
EFEl = (Σ ADi · NCVi · EFi + EmFGC)-/-Elprod (Cothromóid 47) I gcás inarb amhlaidh an méid seo a leanas:
EFEl = (Σ ADi · NCVi · EFi + EmFGC)/Elprod (Equation 47)
#2999181
Maidir le nítrítí, fuair an tÚdarás Iontógáil Laethúil Inghlactha (ADI) de 0,07 mg ian nítríte/kg bw in aghaidh an lae.
For nitrites, the Authority derived an Acceptable Daily Intake (ADI) of 0,07 mg nitrite ion/kg bw per day.
#2999189
Dá ndéanfaí gach foinse teagmhála le níotráit chothaithe a mheas le chéile, shárófaí an ADI do gach aoisghrúpa ag an meán-nochtadh agus ag an teagmháil is airde.
If all sources of dietary nitrate exposure were considered together, the ADI would be exceeded for all age groups at the mean and the highest exposure.
#307861
Beidh san áireamh sna sainchomhaid a thíolactar de bhun Airteagal 7(1) an fhaisnéis is gá chun an Iontógáil Laethúil Inghlactha (ADI), Leibhéal Inghlactha i dtaca leis an Oibreoir a bheith faoi lé na Substainte (AOEL) agus an Ghéardháileog Thagartha (ARfD) a shuíomh más ábhartha.
The dossiers submitted pursuant to Article 7(1) shall contain the information needed to establish, where relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL) and Acute Reference Dose (ARfD).
#2100723
Thairis sin, chinn sé gur féidir an Iontógáil Laethúil Inghlactha (ADI) de 4 mg/kg de mheáchan coirp in aghaidh an lae a chur i bhfeidhm freisin maidir le ribidióisíd M a tháirgtear trí mhodhnú einsíme ar ghliocóisídí steibhióil.
Furthermore, it concluded that the existing Acceptable Daily Intake (ADI) of 4 mg/kg bw per day can also be applied to rebaudioside M produced via enzyme modification of steviol glycosides.
#2122069
Sa tuairim eolaíoch ón Údarás, tháinig sé ar an gconclúid, ar bhonn na fianaise nua, gurb é 0,2 mg/kg ina aghaidh an mheáchain coirp an ADI le haghaidh astaxaintine in aghaidh an lae.
In its scientific opinion, the Authority concluded that on the basis of the new evidence, the ADI for astaxanthin is 0,2 mg/kg body weight per day.
#2122070
Agus ADI na hastaxaintine agus iontógáil na hastaxaintine ón ngnáth-aiste bhia araon á gcur san áireamh, tháinig an tÚdarás ar an gconclúid go bhfuil iontógáil na n-uasleibhéil údaraithe faoi láthair d’astaxaintin, is é sin suas le 8,0 mg in aghaidh an lae, as forbhianna ina bhfuil oiléaroisín ar chuid mhór astaxaintine ó algaí Haematococcus pluvialis, go bhfuil an iontógáil sin sábháilte do dhaoine fásta agus do dhéagóirí os cionn 14 bliain d’aois.
Taking into account the astaxanthin ADI and the intake of astaxanthin from the normal diet, the Authority concluded that the intake of the maximum currently authorised levels of up to 8,0 mg/day astaxanthin from food supplements containing astaxanthin-rich oleoresin from Haematococcus pluvialis algae is safe for adults and adolescents above 14 years old.
#2281130
Mar sin féin, mhol an tÚdarás tástáil thocsaineolaíoch bhreise, staidéar sínithe 90 lá nó staidéar tocsaineachta ar atáirgeadh ilghlúine nó staidéar tocsaineachta sínithe ar atáirgeadh aonghlúine i gcomhréir le treoirlínte ECFE atá ann faoi láthair, chun go bhféadfar luach treoraíochta atá bunaithe ar an tsláinte (iontógáil laethúil inghlactha - ADI) a bhunú le haghaidh dé-ocsaíd tíotáiniam (E 171).
Nevertheless, the Authority recommended additional toxicological testing, an extended 90-day study or a multigeneration or extended-one generation reproduction toxicity study according to the current OECD guidelines, in order to be able to establish a health-based guidance value (acceptable daily intake – ADI) for titanium dioxide (E 171).
#2463768
An iontógáil d’eistir astaxaintine a bheidh ann de bharr mhéadú na n-eistear astaxaintine in olaí ó Calanus finmarchicus i bhforbhianna atá ceaptha do ghrúpaí daonra is sine ná 14 bliana d’aois, ionas gur ≤ 0,25 % a bheidh i gceist seachas < 0,1 %, meastar nach sáróidh an iontógáil sin agus an iontógáil d’astaxaintin ón ngnáthréim bhia i bhfochair a chéile, nach sáróidh siad an iontógáil laethúil inghlactha (“ADI”) athbhreithnithe atá leagtha síos ag an Údarás, mar atá 0,2 mg d’astaxaintin/kg de mheáchain coirp.
The increase in the astaxanthin esters in oil from Calanus finmarchicus from < 0,1 % to ≤ 0,25 % in food supplements intended for population groups older than 14 years is expected to result in intakes of astaxanthin esters which, in combination with the intake of astaxanthin from the normal diet, are not expected to exceed the revised Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg bw, established by the Authority.
#2463770
Tá údar le naíonáin agus leanaí óga a eisiamh mar an iontógáil iomlán d’eistir astaxaintine a mheastar a bheidh ann, idir a dtiocfaidh ó fhorbhianna ina bhfuil ola Calanus finmarchicus dar leibhéal < 0,1 % d’eistir astaxaintine agus a dtiocfaidh ón ngnáthréim bhia, meastar nach sáróidh an iontógáil sin an iontógáil laethúil inghlactha (“ADI”) athbhreithnithe atá leagtha síos ag an Údarás maidir leis na grúpaí sin de thomhaltóirí, mar atá 0,2 mg d’astaxaintin/kg de mheáchain coirp.
The exclusion of infants and young children is justified because the anticipated combined intake of astaxanthin esters from food supplements containing Calanus finmarchicus oil with levels of < 0,1 % astaxanthin esters and from the normal diet is expected to exceed the revised Acceptable Daily Intake (‘ADI’) of 0,2 mg astaxanthin/kg of body weight established by the Authority for these groups of consumers.
#2469923
Thug an tÚdarás dá aire go bhfuil an meastachán nochta is airde, 3,1 mg/kg bw i lapadáin, laistigh den ADI atá leagtha síos, agus tháinig sé ar an gconclúid nach ábhar imní é ó thaobh sábháilteachta de an nochtadh do ghlicilipidí a bhaineann leis na húsáidí agus na leibhéil úsáide atá beartaithe ag an iarratasóir.
The Authority noted that the highest estimate of exposure of 3,1 mg/kg bw per day, in toddlers, is within the established ADI and concluded that the exposure to glycolipids does not raise a safety concern at the uses and use levels proposed by the applicant.
#2513893
anuastiúchan a leagtar síos agus an tsubstaint ghníomhach á formheas i gcomhréir le Rialachán (CE) Uimh. 1107/2009, ar bhonn sonraí iomchuí, go háirithe sonraí tocsaineolaíocha, nó, i gcás nár leagadh síos an tiúchan sin, an tiúchan a fhreagraíonn don deichiú cuid den ADI a leagadh síos nuair a formheasadh an tsubstaint ghníomhach i gcomhréir le Rialachán (CE) Uimh. 1107/2009,
the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, on the basis of appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,
#2514167
I gcásanna nach léiríonn an meastachán ar leibhéil iarmhar riosca inghlactha do thomhaltóirí, déanfaidh na Ballstáit an mheastóireacht a bheachtú, bunaithe ar shonraí a ghintear trí thrialacha iarmhar, nó ar thocsaineacht na meitibilítí arb údar imní iad trí chríochphointe tocsaineolaíoch a chinneadh, amhail an iontógáil laethúil inghlactha (ADI), nó, i gcás inarb iomchuí, luach na Tairsí Imní Tocsaineolaíochta (TTC) ag féachaint don fhaisnéis shonrach a chuirtear ar fáil i gcomhréir le pointe 6.2 de Chuid B den Iarscríbhinn a ghabhann le Rialachán (AE) Uimh. 283/2013.
In cases where the estimation of residue levels does not demonstrate acceptable risk to consumers, Member States shall refine the evaluation, either based on data generated through residues trials, or on toxicity of metabolites of concern through determination of a toxicological endpoint, such as the acceptable daily intake (ADI), or, where appropriate, the Threshold of Toxicological Concern (TTC) value having regard to the specific information provided in accordance with point 6.2 of Part B of the Annex to Regulation (EU) No 283/2013.
#2514311
an uastiúchan a leagtar síos agus an tsubstaint ghníomhach á formheas i gcomhréir le Rialachán (CE) Uimh. 1107/2009, bunaithe ar shonraí iomchuí, go háirithe sonraí tocsaineolaíocha, nó, i gcás nár leagadh síos an tiúchan sin, an tiúchan a fhreagraíonn don deichiú cuid den ADI a leagadh síos nuair a formheasadh an tsubstaint ghníomhach i gcomhréir le Rialachán (CE) Uimh. 1107/2009,
the maximum concentration laid down when approving the active substance in accordance with Regulation (EC) No 1107/2009, based on appropriate data, in particular toxicological data, or, where that concentration has not been laid down, the concentration corresponding to one tenth of the ADI laid down when the active substance was approved in accordance with Regulation (EC) No 1107/2009,
#2527751
Mheas an tÚdarás nach mbeidh nochtadh do ribidióisíd AM (arna sloinneadh mar choibhéis steibhióil) níos airde ná an nochtadh do ghliocóisídí steibhióil (E 960ú), dá gcuirfí ribidióisíd AM ina n-ionad. Tháinig an tÚdarás ar an gconclúid freisin go bhfuil feidhm ag ADI 4 mg/kg bw in aghaidh an lae a bhfuil feidhm aige maidir leis an 60 gliocóisídí steibhióil a liostaítear in Aguisín A a ghabhann leis an tuairim a glacadh an 24 Márta 2020, arna sloinneadh mar choibhéis steibhióil, maidir le ribidióisíd M, D agus AM a fhaightear ón tiontú einsíme atá i gceist.
The Authority considered that exposure to rebaudioside AM (expressed as steviol equivalent) will not be higher than the exposure to steviol glycosides (E 960a), if those would be replaced by rebaudioside AM. The Authority further concluded that the ADI of 4 mg/kg bw per day that applies to the 60 steviol glycosides listed in Appendix A to the opinion adopted on 24 March 2020, expressed as steviol equivalent, also applies to the rebaudioside M, D and AM obtained by the enzymatic bioconversion in question.
#2712684
An 3 Feabhra 2021, agus i gcomhréir le hAirteagal 43 de Rialachán (CE) Uimh. 396/2005, d’iarr an Coimisiún ar an Údarás tuairim réasúnaithe a sholáthar ina ndéanfaí measúnú ar na rioscaí a bhféadfadh baint a bheith acu le MRLanna áirithe atá ann faoi láthair le haghaidh abaimeictine, i bhfianaise an ADI agus an ARfD níos ísle a luaitear thuas.
On 3 February 2021 and in accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion assessing the risks on certain existing MRLs for abamectin that may pose to consumers in light of the lower ADI and ARfD.
#2750867
Beidh údarú go fóill ag sealbhóirí rátáil Amharc Rialaithe Aeradróim (ADV), nach bhfuil rátáil Ionstraim Rialaithe Aeradróim (ADI) acu, chun seirbhís rialaithe aerthráchta a sholáthar do thrácht aeradróim ag aeradróm nach bhfuil aon nósanna imeachta tagtha nó imeachta ionstraime foilsithe acu, ar choinníoll go gcothaítear bailíocht an fhormhuinithe aonaid a bhaineann leis an rátáil ADV.”;
Holders of the Aerodrome Control Visual (ADV) rating, who do not hold an Aerodrome Control Instrument (ADI) rating, shall continue to be authorised to provide air traffic control service to aerodrome traffic at an aerodrome that has no published instrument approach or departure procedures, provided that the validity of the unit endorsement related to the ADV rating is maintained.’;
#2750871
Athróidh na húdaráis inniúla ainm na rátála Ionstraim Rialaithe Aeradróim (ADI) arna n-eisiúint roimh an 4 Lúnasa 2024 go Rialú Aeradróim (ADC) tráth nach déanaí ná an 4 Lúnasa 2027 ar mhodh a bhunóidh an t-údarás inniúil.
The competent authorities shall change the name of the Aerodrome Control Instrument (ADI) rating issued before 4 August 2024 into Aerodrome Control (ADC) no later than 4 August 2027 in a manner established by the competent authority..
#2750875
Má bhíonn feidhmiú phribhléidí an tsealbhóra teoranta do rialú aeir nó rialú talún amháin, tabharfar le fios é sin san fhormhuiniú aonaid, i gcomhréir le pointe ATCO.B.020(d) d’Iarscríbhinn I, tráth a athraíonn ainm an rátáil Ionstraim Rialaithe Aeradróim (ADI) ina Rialú Aeradróim (ADC) i gcomhréir le mír 1 den Airteagal seo.
If the exercise of the privileges of the holder is limited to air control or ground control only, this shall be indicated in the unit endorsement, in accordance with point ATCO.B.020(d) of Annex I, at the time of the change of name of the Aerodrome Control Instrument (ADI) rating into Aerodrome Control (ADC) in accordance with paragraph 1 of this Article.
#2750877
Athróidh na húdaráis inniúla ainm an fhormhuinithe rátála Rialaithe Radar Aeradróim (RAD) arna eisiúint roimh an 4 Lúnasa 2024 chuig formhuiniú rátála Faireachas Rialaithe Aeradróim (SUR), tráth a athraíonn ainm an rátáil Ionstraim Rialaithe Aeradróim (ADI) ina Rialú Aeradróim (ADC) i gcomhréir le mír 1 den Airteagal seo.
The competent authorities shall change the name of the Aerodrome Radar Control (RAD) rating endorsement issued before 4 August 2024 into the Aerodrome Control Surveillance (SUR) rating endorsement at the time of the change of name of the Aerodrome Control Instrument (ADI) rating into Aerodrome Control (ADC) in accordance with paragraph 1 of this Article.
#2999182
Níor sháraigh an teagmháil mheasta a d’eascair as a úsáid mar bhreiseán bia an ADI seo don daonra i gcoitinne, ach amháin i gcás sárú beag i leanaí ag an gcéatadán is airde agus b’ionann é agus thart ar 17 % den teagmháil fhoriomlán cothúcháin.
The estimated exposure resulting from its use as a food additive did not exceed this ADI for the general population, except for a slight exceedance in children at the highest percentile and it represented approximately 17 % of the overall dietary exposure.
#2999183
Dá ndéanfaí gach foinse teagmhála cothúcháin a mheas le chéile (breiseáin bhia, láithreacht nádúrtha agus éilliú), shárófaí an ADI i naíonáin, leanaí óga agus leanaí ag an meánteagmháil agus shárófaí é i ngach aoisghrúpa ag an teagmháil is airde.
If all sources of dietary exposure were considered together (food additives, natural presence and contamination), the ADI would be exceeded in infants, toddlers and children at the mean exposure and for all age groups at the highest exposure.
#3211004
I gcomhthéacs an nós imeachta chun formheas na substainte gníomhaí iondocsacarb a athnuachan i gcomhréir le Rialachán (CE) Uimh. 1107/2009 ó Pharlaimint na hEorpa agus ón gComhairle, d’fhoilsigh an tÚdarás Eorpach um Shábháilteacht Bia (‘an tÚdarás’) conclúid maidir leis an athbhreithniú piaraí ar an measúnú riosca ar an tsubstaint ghníomhach sin, lena mbunaítear iontógáil laethúil inghlactha (‘ADI’) níos ísle agus géardháileog thagartha níos ísle (ARfD).
In the context of the procedure for the renewal of the approval of indoxacarb in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, the European Food Safety Authority (‘the Authority’) published a conclusion on the peer review of the risk assessment of that active substance, establishing a lower acceptable daily intake (‘ADI’) and a lower acute reference dose (‘ARfD’).
#3211007
I gcomhréir le hAirteagal 43 de Rialachán (CE) Uimh. 396/2005, d’iarr an Coimisiún ar an Údarás tuairim réasúnaithe a sholáthar maidir leis na rioscaí a bhféadfadh baint a bheith acu leis na MRLanna atá ann faoi láthair le haghaidh iondocsacarb atá bunaithe ar lamháltais allmhairiúcháin agus ar uasteorainneacha iarmhar Codex (‘CXLanna’) i bhfianaise an ADI agus an ARfD níos ísle.
In accordance with Article 43 of Regulation (EC) No 396/2005, the Commission requested the Authority to provide a reasoned opinion on the risks that the current MRLs for indoxacarb based on import tolerances and Codex maximum residue limits (‘CXLs’) may pose to consumers in light of the lower ADI and ARfD.