#1888395
deimhniú ar chineál na nguaiseacha, lena n-áirítear, i gcás inarb iomchuí, an caidreamh atá bainteach le dáileogacht;
confirmation of the nature of the hazards, including, where relevant, the dose-response relationship;
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#294031
Is gá na sonraí ar na críochphointí seo, má tá siad ar fáil, a mheas maidir lena dtábhacht statistiúil nó bhitheolaíoch agus a ngaolmhaireacht idir dáileog agus freagairt.
Data on these end points, if available, need to be evaluated in light of their statistical or biological significance and dose response relationship.
#517731
27. Maidir le tocsaineacht ildáileog agus le tocsaineacht atáirgeach déanfar an ghaolmhaireacht idir dáileog agus freagairt a mheasúnú i gcás gach substainte gníomhaí agus i gcás substainte ar údar imní í agus, nuair is féidir, sainaithneofar NOAEL.
27. For repeated dose toxicity and reproductive toxicity the dose-response relationship shall be assessed for each active substance or substance of concern and, where possible, a NOAEL identified.
#517767
Is féidir breathnú ar ghnéithe breise chomh maith le haghaidh fachtóirí measúnaithe, lena n-áirítear tocsainchinéitic agus tocsaindinimic, cineál agus déine na héifeachta, daonraí agus fodhaonraí daonna, dialltaí risíochta idir torthaí staidéir agus risíocht an duine ó thaobh minicíochta agus fad ama, eachtarshuíomh a bhaineann le fad ama staidéir (e.g. fo-ainsealach go hainsealach) caidreamh idir dáileog agus freagairt agus cáilíocht fhoriomlán an phacáiste maidir le sonraí tocsaineachta.
Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.
#517895
Déanfaidh an comhlacht meastóireachta sonraí faoi fhreagairt do dháileog a mheas, ar sonraí iad a gineadh i dtástálacha iomchuí (nach mór rialú neamhchóireáilte a bheith ar áireamh iontu) a raibh rátaí dáileoige níos lú ná an ráta molta i gceist leo, d’fhonn a mheasúnú an é an t-íosmhéid is gá chun an éifeacht inmhianaithe a fháil atá sa dáileog bheartaithe.
The evaluating body shall evaluate dose-response data generated in appropriate trials (which must include an untreated control) involving dose rates lower than the recommended rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect.
#620292
Ar bhonn na hoibre atá an Eagraíocht Dhomhanda Sláinte á déanamh faoi láthair maidir leis an modheolaíocht chun na himpleachtaí sláinte a bhaineann le tionchair an torainn a mheas, tá sé ar intinn ag an gCoimisiún Iarscríbhinn III a ghabhann le Treoir 2002/49/CE (tionchar an torainn ar an tsláinte a mheas, cuair dáileoige is freagartha) a athbhreithniú."
Based on work the World Health Organisation is currently undertaking regarding the methodology to assess health implications of the noise impact, the Commission intends to revise Annex III to Directive 2002/49/ EC (estimation of health impact, dose response curves)."
#631872
Bunaithe ar obair atá an Eagraíocht Dhomhanda Sláinte a dhéanamh faoi láthair maidir leis an modheolaíocht chun na himpleachtaí sláinte a bhaineann le tionchair an torainn a mheas, tá sé ar intinn ag an gCoimisiún Iarscríbhinn III a ghabhann le Treoir 2002/49/CE (tionchar an torainn ar an tsláinte a mheas, cuair dáileoige is freagartha) a athbhreithniú.”
Based on work the WHO is currently undertaking regarding the methodology to assess health implications of the noise impact, the Commission intends to revise Annex III to Directive 2002/49/ EC (estimation of health impact, dose response curves).’
#1656746
Bunaithe ar obair atá an Eagraíocht Dhomhanda Sláinte á déanamh faoi láthair maidir leis an modheolaíocht chun na himpleachtaí sláinte a bhaineann le tionchair an torainn a mheas, tá sé ar intinn ag an gCoimisiún Iarscríbhinn III a ghabhann le Treoir 2002/49/CE (tionchar an torainn ar an tsláinte a mheas, cuair dáileoige is freagartha) a athbhreithniú.
Based on work the WHO is currently undertaking regarding the methodology to assess health implications of the noise impact, the Commission intends to revise Annex III to Directive 2002/49/ EC (estimation of health impact, dose response curves).
#1732423
Déanfar athbhreithniú leanúnach ar na teorainnluachanna atá bunaithe sa Treoir seo i bhfianaise chur chun feidhme Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle agus tuairimí an dá choiste de chuid na Gníomhaireachta Eorpaí Ceimiceáin (ECHA) (an Coiste um Measúnú Riosca (RAC) agus an Coiste um Anailís Shocheacnamaíoch (SEAC)), go háirithe chun an idirghníomhaíocht idir teorainnluachanna atá bunaithe i dTreoir 2004/37/CE agus gaolmhaireachtaí idir dáileog agus freagairt, faisnéis nochta iarbhír, agus, i gcás ina mbeidh siad ar fáil, DNELanna (Leibhéil Dhíorthaithe gan Éifeacht) a dhíorthaítear do cheimiceáin ghuaiseacha i gcomhréir leis an Rialachán sin a chur san áireamh d'fhonn cosaint éifeachtach a thabhairt d'oibrithe.
The limit values established in this Directive will be kept under review in light of the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council and of the opinions of two committees of the European Chemicals Agency (ECHA) (the Committee for Risk Assessment (RAC) and the Committee for Socioeconomic Analysis (SEAC)), in particular to take account of the interaction between limit values established in Directive 2004/37/EC and dose-response relations, actual exposure information, and, where available, DNELs (Derived No Effect Levels) derived for hazardous chemicals in accordance with that Regulation in order to protect workers effectively.
#2567864
Thug an tÚdarás dá aire na sonraí teoranta atá ann maidir le gaolmhaireachtaí idir dáileog agus freagairt idir dáileoga (-)-eipeagallacaitéicín-3-galláite agus paraiméadair ae mhínormálta is gá chun measúnú a dhéanamh ar dháileog (-)-eipeagallacaitéicín-3-galláite nach mbeadh éifeacht aici ar pharaiméadair ae.
The Authority noted the limited data on dose–response relationships between doses of (-)-epigallocatechin-3-gallate and abnormal liver parameters, which is needed for the assessment of a dose of (-)-epigallocatechin-3-gallate that would not cause an effect on liver parameters.
#2567871
I bhfianaise na n-éiginnteachtaí a leag an tÚdarás amach sa tuairim uaidh an 14 Márta 2018 agus sa mholadh uaidh gur cheart staidéir a dhéanamh chun dáileog agus freagairt heipiteatocsaineachta caiteiciní tae ghlais a chinneadh agus scrúdú a dhéanamh ar an athraitheacht idir speicis agus laistigh díobh, faoi Airteagal 8(4) de Rialachán (CE) Uimh. 1925/2006 féadfaidh páirtithe leasmhara na sonraí is gá chun sábháilteacht úsc tae ghlais i gcomhréir le hAirteagal 5 de Rialachán Cur Chun Feidhme (AE) Uimh. 307/2012 a léiriú a chur isteach.
Considering the uncertainties outlined by the Authority in its 14 March 2018 opinion and its recommendation that studies should be performed to determine a dose–response of hepatotoxicity of green tea catechins and examine inter and intra species variability, interested parties may submit, under Article 8(4) of Regulation (EC) No 1925/2006, the data necessary to demonstrate the safety of green tea extracts in accordance with Article 5 of Implementing Regulation (EU) No 307/2012.
#1759393
(15)Coinneofar na teorainnnluachanna a bhunaítear sa Treoir seo faoi athbhreithniú i bhfianaise chur chun feidhme Rialachán (CE) Uimh. 1907/2006, ó Pharlaimint na hEorpa agus ón gComhairle an 18 Nollaig 2006, maidir le maidir le Clárú, Meastóireacht, Údarú agus Srianadh Ceimiceán (REACH), lena mbunaítear Gníomhaireacht Eorpach um Cheimiceáin, lena leasaítear Treoir 1999/45/CE agus lena naisghairtear Rialachán (CEE) Uimh. 793/93 ón gComhairle agus Rialachán (CE) Uimh. 1488/94 ón gCoimisiún chomh maith le Treoir 76/769/CEE ón gComhairle agus Treoracha 91/155/CEE, 93/67/CEE, 93/105/CE agus 2000/21/CE ón gCoimisiún 58 agus tuairimí Choiste Measúnaithe Riosca (RAC) an ECHA agus an Choiste um Anailís Socheacnamaíoch (SEAC), go háirithe chun an idirghníomhaíocht idir teorainnluachanna a bhunaítear i dTreoir 2004/37/CE agus gaolmhaireachtaí idir dáileog agus freagairt, faisnéis nochta iarbhír, agus, nuair a bhíonn fáil orthu, DNELanna (Leibhéil Dhíorthaithe gan Éifeacht) a dhíorthaítear do cheimiceáin ghuaiseacha i gcomhréir leis an Rialachán sin.
(15)The limit values established in this Directive will be kept under review in the light of the implementation of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 58 and of the opinions of the ECHA Risk Assessment Committee (RAC) and Socio-economic Analysis Committee (SEAC), in particular to take account of the interaction between limit values established in Directive 2004/37/EC and dose-response relations, actual exposure information, and, where available, DNELs (Derived No Effect Levels) derived for hazardous chemicals in accordance with that Regulation.