#2032396
Uasleibhéil DHA
Maximum levels of DHA
Uasleibhéil DHA
Maximum levels of DHA
Aigéad docaisiheicséanóch (DHA): ≥ 32,0 %
Docosahexaenoic acid (DHA): ≥ 32,0 %
Uasleibhéil DHA
Maximum levels of DHA
Aigéad docaisiheicséanóch (DHA): ≥ 32,0 %
Docosahexaenoic acid (DHA): ≥ 32,0 %
Aigéad docaisiheicséanóch (DHA): > 4,0 %
Docosahexaenoic acid (DHA): > 4,0 %
“Ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch
‘Schizochytrium sp. oil rich in DHA and EPA
Uasleibhéil aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch le chéile
Maximum levels of DHA and EPA combined
Uasleibhéil aigéid dhocaisiheicséanóch
Maximum levels of DHA
Cion DHA: ≥ 35,0 %
DHA content: ≥ 35,0 %
‘Ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch
‘Schizochytrium sp. oil rich in DHA and EPA
An cion aigéid dhocaisiheicséanóch: ≥ 15 %
DHA content: ≥ 15 %
Uasleibhéil DHA
Maximum levels of DHA
Cion DHA: ≥ 35,0 %
DHA content: ≥ 35,0 %
Mar sin féin, sa tuairim eolaíoch ón Údarás in 2012 maidir le Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA) [Uasleibhéal iontógála is inghlactha an aigéid icisipeintéanóch (EPA), an aigéid docaisiheicséanóch (DHA) agus aigéid docaisipeintéanóch (DPA)], tháinig sé ar an gconclúid sé nach cúis imní sábháilteachta don phobal i gcoitinne é iontógáil fhorlíontach DHA amháin suas le 1 g in aghaidh an lae.
However, the Authority in its 2012 scientific opinion on the ‘Tolerable Upper Intake Level of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and docosapentaenoic acid (DPA)’ concluded that supplemental intakes of DHA alone up to about 1 g/day do not raise safety concerns for the general population.
Mar thoradh ar an leathnú úsáide a iarradh, beidh iontógáil ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch, i dteannta na n-iontógálacha ó úsáidí údaraithe an bhia núíosaigh faoi láthair, inchomparáide leis na hiontógálacha a mheas an tÚdarás a bheith sábháilte agus lenar tacaíodh le leathnú úsáid ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch le Cinneadh Cur Chun Feidhme (AE) 2015/546.
The requested extension of use will result in intakes of Schizochytrium sp. oil rich in DHA and EPA which, combined with the intakes from the currently authorised uses of the novel food, are comparable with the intakes assessed by the Authority as safe and which supported the authorisation of an extension of use of Schizochytrium sp. oil rich in DHA and EPA by Implementing Decision (EU) 2015/546.
An t-athbhreithniú sin ar na sonraíochtaí le haghaidh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch, baineann sé le hathrú ar aon pharaiméadar amháin, is é sin an leibhéal aigéid dhocaisiheicséanóch, agus ní athraítear paraiméadair eile na sonraíochtaí.
This revision of the specifications for Schizochytrium sp. oil rich in DHA and EPA concerns the change of only one parameter, the level of DHA, while the other parameters of the specifications remain unchanged.
CEST (An Coiste Eolaíoch um Shábháilteacht Tomhaltóirí), Tuairim maidir le Déhiodrocsaicéatón - DHA, 3-4 Márta 2020, SCCS/1612/19.
SCCS (Scientific Committee on Consumer Safety), Opinion on Dihydroxyacetone – DHA, 3-4 March 2020, SCCS/1612/19.
lena leasaítear Rialachán Cur Chun Feidhme (AE) 2017/2470 a mhéid a bhaineann le coinníollacha úsáide ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch
amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA
Ar liosta an Aontais a leagtar amach san Iarscríbhinn a ghabhann le Rialachán Cur Chun Feidhme (AE) 2017/2470 áirítear ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch mar bhia núíosach údaraithe.
The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Schizochytrium sp. oil rich in DHA and EPA as an authorised novel food.
Rinne Cinneadh Cur Chun Feidhme (AE) 2015/546 ón gCoimisiún leasú ar choinníollacha úsáide ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch.
Commission Implementing Decision (EU) 2015/546 amended the conditions of use of Schizochytrium sp. oil rich in DHA and EPA.
Dá bhrí sin, is iomchuí coinníollacha úsáide an bhia núíosaigh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch a leasú trína úsáid a leathnú chuig analóga éisc agus analóga feola.
Therefore, it is appropriate to amend the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA by extending its use to fish analogues and meat analogues.
Tuairim Eolaíoch maidir le leathnú úsáide le haghaidh ola algach atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch ó Schizochytrium sp. mar chomhábhar Bia Núíosaigh (Iris EFSA 2014;12(10):3843).
Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient (EFSA Journal 2014;12(10):3843).
Cuirtear an méid seo a leanas in ionad na hiontrála ‘ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch’ i dTábla 1 (Bia núíosacha údaraithe) den Iarscríbhinn a ghabhann le Rialachán Cur Chun Feidhme (AE) 2017/2470:
In Table 1 (Authorised novel foods) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for ‘Schizochytrium sp. oil rich in DHA and EPA’ is replaced by the following:
Maidir leis an mbia núíosach a ainmniú ar lipéadú na n-earraí bia ina bhfuil sé, is é ‘Ola ón miocralga Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch’ an t-ainmniú a bheidh air.”
The designation of the novel food on the labelling of the foodstuffs containing it shall be “DHA and EPA-rich oil from the microalgae Schizochytrium sp.” ’
lena leasaítear Rialachán Cur Chun Feidhme (AE) 2017/2470 a mhéid a bhaineann le sonraíochtaí an bhia núíosaigh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch
amending Implementing Regulation (EU) 2017/2470 as regards the specifications of the novel food Schizochytrium sp. oil rich in DHA and EPA
Airítear ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch mar bhia núíosach údaraithe i liosta an Aontais a leagtar amach san Iarscríbhinn a ghabhann le Rialachán Cur Chun Feidhme (AE) 2017/2470.
The Union list set out in the Annex to Implementing Regulation (EU) 2017/2470 includes Schizochytrium sp. oil rich in docosahexaenoic acid (‘DHA’) and eicosapentaenoic acid (‘EPA’) as an authorised novel food.
D’iarr an t-iarratasóir go laghdófaí an leibhéal údaraithe reatha le haghaidh aigéad docaisiheicséanóch ó leibhéal atá cothrom le 22,5 % nó níos mó ná sin go dtí leibhéal atá cothrom le 15,0 % nó níos mó ná sin.
The applicant requested to lower the levels of DHA from the current authorised level of equal or greater than 22,5 % to equal or greater than 15,0 %.
Chuir an t-iarratasóir in iúl nach ndéanann an t-athrú a iarradh ar shonraíochtaí ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch difear do shábháilteacht an bhia núíosaigh.
The applicant also indicated that the requested change of the specifications of Schizochytrium sp. oil rich in DHA and EPA does not affect the safety of the novel food.
Baineann an t-athrú ar na sonraíochtaí a iarradh le leibhéil aigéid dhocaisiheicséanóch atá níos ísle ná na leibhéil a mheas an tÚdarás a bheith sábháilte roimhe seo.
The requested change of the specifications concerns lower levels of DHA than previously assessed by the Authority as safe.
Tuairim Eolaíoch maidir le húsáid ola algaí atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch ó Schizochytrium sp. mar chomhábhar Bia Núíosaigh a leathnú (Iris EFSA 2014;12(10):3843).
Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient (EFSA Journal 2014;12(10):3843).
I dtábla 2 (Sonraíochtaí) den Iarscríbhinn a ghabhann le Rialachán Cur Chun Feidhme (AE) 2017/2470, cuirtear an méid seo a leanas in ionad na hiontrála a bhaineann le hola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch:
In Table 2 (Specifications) of the Annex to Implementing Regulation (EU) 2017/2470, the entry for Schizochytrium sp. oil rich in DHA and EPA is replaced by the following:
Cobhsaíocht ocsaídiúcháin: Ba cheart cobhsaíocht ocsaídiúcháin a léiriú trí mhodheolaíocht tástála náisiúnta nó idirnáisiúnta atá iomchuí agus aitheanta (e.g. Comhlachas na gCeimiceoirí Anailíseacha Oifigiúla) i gcás na dtáirgí uile ina bhfuil ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch
Oxidative stability: All food products containing Schizochytrium sp. oil rich in DHA and EPA should demonstrate oxidative stability by appropriate and recognised national/international test methodology (e.g. AOAC)
An 18 Eanáir 2018, fuair an Coimisiún agus na Ballstáit an tuairim eolaíoch ón Údarás, inar thángthas ar an gconclúid, ar bhonn na sonraí a cuireadh i láthair, nár suíodh ceangal “cúis agus éifeacht” idir NWT-02, teaglaim sheasta lúitéine, shéacsaintine agus DHA i mbuíocán a chaitheamh agus teip amhairc a laghdú.
On 18 January 2018, the Commission and the Member States received the scientific opinion from the Authority, which concluded that, on the basis of the data presented, a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and DHA in egg yolk and a reduction of the loss of vision.
Maidir leis an iarratas a bhaineann leis na forbhianna, mheas an tÚdarás nár leor na sonraí a chuir an t-iarratasóir ar fáil chun teacht ar chonclúid faoi shábháilteacht an bhia núíosaigh i ndáil leis na húsáidí atá beartaithe (3 g DHA in aghaidh an lae i bhforbhianna do dhaoine fásta, gan mná torracha ná mná atá ag lachtadh a áireamh).
With regard to the application concerning the food supplements, the Authority considered that the data provided by the applicant were not sufficient to conclude on the safety of the novel food at the proposed uses (3 g DHA/day in food supplements for adults, excluding pregnant and lactating women).
De bhun Airteagal 4(2) de Rialachán (CE) Uimh. 258/97 ó Pharlaimint na hEorpa agus ón gComhairle, údaraíodh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch le cur ar an margadh mar bhia núíosach le húsáid i roinnt bianna.
Pursuant to Article 4(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council, Schizochytrium sp. oil rich in DHA and EPA has been authorised to be placed on the market as a novel food to be used in a number of foods.
Go háirithe, leathnaíodh úsáid ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch chuig bianna breise, is iad sin, forbhianna mar a shainmhínítear i dTreoir 2002/46/CE ó Pharlaimint na hEorpa agus ón gComhairle.
In particular, the use of Schizochytrium sp. oil rich in DHA and EPA has been extended to additional foods, namely, food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council.
An 8 Nollaig 2021, chuir an chuideachta DSM Nutritional Products (“an t-iarratasóir”) iarratas faoi bhráid an Choimisiúin i gcomhréir le hAirteagal 10(1) de Rialachán (AE) 2015/2283 chun coinníollacha úsáide an bhia núíosaigh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch a leasú.
On 8 December 2021, the company DSM Nutritional Products (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for an amendment of the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA.
D’iarr an t-iarratasóir úsáid ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch a leathnú chun analóga éisc agus analóga feola ag leibhéil 300 mg/100 g agus 300 mg/100 g faoi seach, atá beartaithe don phobal i gcoitinne.
The applicant requested to extend the use of Schizochytrium sp. oil rich in DHA and EPA to fish analogues and meat analogues at levels 300 mg/100 g and 300 mg/100 g respectively, intended for the general population.
Cinneadh Cur Chun Feidhme (AE) 2015/546 ón gCoimisiún an 31 Márta 2015 lena n-údaraítear leathnú ar úsáid ola atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch ón miocralgaí Schizochytrium sp. mar chomhábhar bia núíosach faoi Rialachán (CE) Uimh. 258/97 ó Pharlaimint na hEorpa agus ón gComhairle (IO L 90, 2.4.2015, lch. 11).
Commission Implementing Decision (EU) 2015/546 of 31 March 2015 authorising an extension of use of DHA and EPA-rich oil from the micro-algae Schizochytrium sp. as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 90, 2.4.2015, p. 11).
Rialachán Cur Chun Feidhme (AE) 2022/1365 ón gCoimisiún an 4 Lúnasa 2022 lena leasaítear Rialachán Cur Chun Feidhme (AE) 2017/2470 a mhéid a bhaineann le coinníollacha úsáide an bhia núíosaigh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch, tá sé le hionchorprú i gComhaontú LEE.
Commission Implementing Regulation (EU) 2022/1365 of 4 August 2022 amending Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food Schizochytrium sp. oil rich in DHA and EPA is to be incorporated into the EEA Agreement.
De bhun Airteagal 4(2) de Rialachán (CE) Uimh. 258/97 ó Pharlaimint na hEorpa agus ón gComhairle, tá ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch údaraithe lena cur ar an margadh mar bhia núíosach atá le húsáid i roinnt bianna.
Pursuant to Article 4(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council, Schizochytrium sp. oil rich in DHA and EPA has been authorised to be placed on the market as a novel food to be used in a number of foods.
An 30 Eanáir 2024 chuir an chuideachta DSM Nutritional Products Ltd. (‘an t-iarratasóir’) iarratas faoi bhráid an Choimisiúin i gcomhréir le hAirteagal 10(1) de Rialachán (AE) 2015/2283 chun sonraíochtaí an bhia núíosaigh ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch a athrú.
On 30 January 2024, the company DSM Nutritional Products Ltd. (‘the applicant’) submitted an application to the Commission in accordance with Article 10(1) of Regulation (EU) 2015/2283 for a change of the specifications of the novel food Schizochytrium sp. oil rich in DHA and EPA.
An laghdú dá thoradh sin ar leibhéil aigéid dhocaisiheicséanóch sa táirge, bhí sé beartaithe agus bhí coinne leis, agus tá sé mar thoradh ar fheabhsú agus barrfheabhsú an táirgthe a bhaineann go príomha le mionathruithe ar chéim an choipthe, gan aon athrú ar na céimeanna próiseála eile.
The resulting decrease of the levels of DHA in the product was intended and expected, and is the result of production improvements and optimisation, mainly due to minor adjustments in the fermentation phase, while other processing steps remain the same.
An nuashonrú a iarradh ar liosta an Aontais maidir leis an athrú ar shonraíochtaí ola Schizochytrium sp. atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch, mar ata beartaithe ag an iarratasóir, measann an Coimisiún nach dócha go mbeidh tionchar aige ar shláinte an duine agus nach gá don Údarás Eorpach um Shábháilteacht Bia (‘an tÚdarás’) meastóireacht sábháilteachta a dhéanamh i gcomhréir le hAirteagal 10(3) de Rialachán (AE) 2015/2283.
The Commission considers that the requested update of the Union list concerning the change of the specifications of Schizochytrium sp. oil rich in DHA and EPA as proposed by the applicant is not liable to have an effect on human health and that a safety evaluation by the European Food Safety Authority (‘the Authority’) in accordance with Article 10(3) of Regulation (EU) 2015/2283 is not necessary.
Maidir leis na hathruithe ar shonraíochtaí an bhia núíosaigh, is leor an foras atá le fáil san fhaisnéis a sholáthraítear san iarratas agus sa ‘Tuairim Eolaíoch maidir le húsáid ola algach atá saibhir in aigéad docaisiheicséanóch agus in aigéad icisipeintéanóch ó Schizochytrium sp. mar chomhábhar Bia Núíosaigh a leathnú’ ón Údarás chun a shuí go bhfuil na hathruithe sin i gcomhréir le coinníollacha Airteagal 12 de Rialachán (AE) 2015/2283 agus gur cheart iad a fhormheas.
The information provided in the application and the Authority’s ‘Scientific Opinion on the extension of use for DHA and EPA-rich algal oil from Schizochytrium sp. as a Novel Food ingredient’ gives sufficient grounds to establish that the changes to the specifications of the novel food are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
Thug an tÚdarás dá aire, toisc go bhfuil na leibhéil úsáide atá beartaithe i gcomhréir le Rialachán (AE) Uimh. 609/2013 agus lena rialachán forlíontach, Rialachán Cur Chun Feidhme (AE) 2016/127, go bhfuil an iontógáil aigéid dhocaisiheicséanóigh (DHA) ó bhainne foirmle do naíonáin agus ó bhainne foirmle leantach do naíonáin, bainní a bhfuil an bia núíosach iontu ag na leibhéil úsáide atá beartaithe, laistigh den raon feidhme arna thuar ag an Rialachán sin.
The Authority noted, that as the proposed use levels are in accordance with Regulation (EU) No 609/2013 and its supplementing Commission Delegated Regulation (EU) 2016/127, the intake of docosahexaenoic acid (DHA) from infant formula and follow on formula containing the novel food at the proposed use levels is within the range foreseen by that Regulation.