'substance' — Parallel English-Irish Corpus of Legislation

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#633731

Duine atá bunaithe laistigh den Aontas a mhonaraíonn nó a allmhairíonn substaint ábhartha, inti féin nó i dtáirgí bithicídeacha, (‘an soláthraí substainte’) nó a mhonaraíonn nó a chuireann táirge bithicídeach ar fáil ar an margadh, táirge arb é an tsubstaint ábhartha sin atá ann, a bhfuil an tsubstaint ábhartha sin ann, nó a ngintear an tsubstaint ábhartha as, (‘an soláthraí táirge’), féadfaidh sé uair ar bith sainchomhad iomlán substainte don tsubstaint ábhartha sin, litir rochtana ar an sainchomhad iomlán substainte sin, nó uimhir tagartha don sainchomhad sin a bhfuil na tréimhsí cosanta sonraí go léir ina leith imithe in éag a thíolacadh don Ghníomhaireacht.

A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (“the substance supplier”) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (“the product supplier”), may at any time submit to the Agency either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired.

Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market Text with EEA relevance
#307110

Chun críche mhír 2 go mír 6, is é atá i substaint ghníomhach ná substaint bhunata:

For the purpose of paragraphs 2 to 6, a basic substance is an active substance which:

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
#307929

Is é atá i substaint vPvB ná aon substaint a chomhlíonann an dá chritéar sna pointí anseo thíos.

A substance that fulfils both of the criteria of the points below is a vPvB substance.

Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC
#343297

ciallaíonn "substaint blaistithe" substaint cheimiceach shainmhínithe a bhfuil airíonna blaistithe aici;

"flavouring substance" shall mean a defined chemical substance with flavouring properties;

Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC
#439185

ciallaíonn “caitheamh” i ndáil le substaint shícighníomhach, an tsubstaint a chaitheamh (cibé acu a rinneadh an tsubstaint lena mbaineann a thuaslagadh nó a scaipeadh in aon substaint eile, nó a chaolú nó a mheascadh léi)—

“consumption”, in relation to a psychoactive substance, means to consume the substance (whether or not the substance concerned has been dissolved or dispersed in or diluted or mixed with any other substance)—

CRIMINAL JUSTICE (PSYCHOACTIVE SUBSTANCES) ACT 2010
#439563

ciallaíonn “caitheamh” i ndáil le substaint shícighníomhach, an tsubstaint a chaitheamh (cibé acu a rinneadh an tsubstaint lena mbaineann a thuaslagadh nó a scaipeadh in aon substaint eile, nó a chaolú nó a mheascadh léi)—

“consumption”, in relation to a psychoactive substance, means to consume the substance (whether or not the substance concerned has been dissolved or dispersed in or diluted or mixed with any other substance)—

CRIMINAL JUSTICE (PSYCHOACTIVE SUBSTANCES) ACT 2010
#517722

- aon airíonna speisialta eile de chuid na substainte gníomhaí nó de chuid na substainte ar údar imní í,

- any other special properties of the active substance or substance of concern,

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance
#675345

ciallaíonn “substaint íne” substaint nár úsáideadh roimhe sin;

‘virgin substance’ means a substance which has not previously been used;

Regulation (EU) No 517/2014 of the European Parliament and of the Council of 16 April 2014 on fluorinated greenhouse gases and repealing Regulation (EC) No 842/2006 Text with EEA relevance
#888946

(2) Pé uair a déanfar ordú fén alt so á dhearbhú gan aon dleacht do bheith ar shubstaint áirithe no ar shaghas áirithe substainte, ansan, d'ainneoin éinní atá san Acht so ní bheidh aon dleacht iníoctha ná ionbhainte amach fén gCuid seo den Acht so ar an substaint sin no ar an saghas san substainte (pe'ca aca é) maidir le haon mhí thosnóidh tar éis an dáta luadhfar chuige sin san ordú san agus faid a leanfaidh an t-ordú san i bhfeidhm maidir leis an substaint sin no leis an saghas san substainte (pe'ca aca é) agus ní bheidh aon mhí den tsórt san ina dhleacht-mhí chun crícheanna na Coda so den Acht so.

(2) Whenever an order under this section declaring that there shall be no levy on a particular substance or class of substance has been made, then, notwithstanding anything contained in this Act, no levy shall be payable or recoverable under this Part of this Act on the said substance or class of substance (as the case may be) in respect of any month which begins after the end of the levy month specified in that behalf in such order and while such order remains in force in respect of such substance or class of substance (as the case may be), and no such month shall be a levy month for the purposes of this Part of this Act

Number 21 of 1935: DAIRY PRODUCE (PRICE STABILISATION) ACT, 1935
#889145

(2) Pé uair a déanfar ordú fén alt so á dhearbhú gan aon deolchaire do bheith iníoctha ar shubstaint áirithe no ar shaghas áirithe substainte, ansan, d'ainneoin éinní atá san Acht so, ní bheidh aon deolchaire iníoctha fén gCuid seo den Acht so ar aon chuid den tsubstaint sin no den tsaghas san substainte (pe'ca aca é) a heasportálfar o Shaorstát Éireann tar éis an dáta luadhfar chuige sin san ordú san agus faid a leanfaidh an t-ordú san i bhfeidhm maidir leis an substaint no leis an saghas san substainte.

(2) Whenever an order under this section declaring that no bounty shall be payable on a particular substance or class of substance has been made, then, notwithstanding anything contained in this Act, no bounty shall be payable under this Part of this Act on any of the said substance or class of substance (as the case may be) exported from Saorstát Eireann after the date specified in that behalf in such order and while such order remains in force in respect of such substance or class of substance.

Number 21 of 1935: DAIRY PRODUCE (PRICE STABILISATION) ACT, 1935
#953466

cialluíonn an abairt “substaint mhianrúil” aon tsubstaint is cosúil ina nádúir le haon mhianra sceidealta;

the expression "mineral substance" means any substance of a similar nature to any scheduled mineral;

Number 31 of 1940: MINERALS DEVELOPMENT ACT, 1940
#1009477

—(1) San Acht seo, ciallaíonn an abairt “substaint toirmiscthe” substaint—

—(1) In this Act the expression "prohibited substance" means a substance which—

Number 27 of 1947: CLEAN WOOL ACT, 1947
#1911838

le haghaidh na substainte gníomhaí nó ábhar tosaigh, nó imoibrí nó idirmheánach den chuid na substainte gníomhaí;

for the active substance or a starting material, reagent or intermediate of the active substance;

Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
#1911978

Ní substaint bhitheolaíoch ná substaint imdhíoneolaíoch a bheidh sa tsubstaint ghníomhach.

The active substance shall not be a biological or immunological substance.

Commission Implementing Regulation (EU) 2021/17 of 8 January 2021 establishing a list of variations not requiring assessment in accordance with Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
#1915820

Ní fhormheastar an tsubstaint dé-ocsaíd charbóin (E 290) mar shubstaint bhunúsach.

The substance carbon dioxide (E 290) is not approved as a basic substance.

Commission Implementing Regulation (EU) 2021/80 of 27 January 2021 concerning the non-approval of carbon dioxide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#1945331

substaint neamhghníomhach/substaintí neamhghníomhacha (i.e. substaint/substaintí ar údar imní í/iad) agus,

non-active substance(s) (i.e. substance(s) of concern); and

Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
#1945340

substaint neamhghníomhach/substaintí neamhghníomhacha (i.e. substaintí ar údar imní í/iad),

non-active substance(s) (i.e. substance(s) of concern);

Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (Text with EEA relevance)
#2051410

an tsubstaint nó na grúpaí substaintí atá le scrúdú;

substance or substance groups for examination;

Commission Implementing Regulation (EU) 2021/808 of 22 March 2021 on the performance of analytical methods for residues of pharmacologically active substances used in food-producing animals and on the interpretation of results as well as on the methods to be used for sampling and repealing Decisions 2002/657/EC and 98/179/EC (Text with EEA relevance)
#2125260

An tsubstaint suilfíd démheitile, ní fhormheastar í mar shubstaint bhunúsach.

The substance dimethyl sulphide is not approved as a basic substance.

Commission Implementing Regulation (EU) 2021/1451 of 3 September 2021 concerning the non-approval of dimethyl sulphide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#2148127

Thug an tÚdarás dá aire freisin gur substaint í FL Uimh. 16.133 ag a bhfuil airíonna a mhodhnaíonn an blaistiú.

The Authority also noted that substance FL No 16.133 is a substance with flavouring modifying properties.

Commission Regulation (EU) 2021/1917 of 3 November 2021 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the inclusion of 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-(thiophen-2-ylmethyl)acetamide in the Union list of flavourings (Text with EEA relevance)
#2277458

beidh substaint ghníomhach aon-náisiúnta ina substaint ghníomhach ilnáisiúnta.

a mono-national active substance becomes a multi-national active substance.

Commission Implementing Regulation (EU) 2022/20 of 7 January 2022 laying down rules for the application of Regulation (EU) No 536/2014 of the European Parliament and of the Council as regards setting up the rules and procedures for the cooperation of the Member States in safety assessment of clinical trials (Text with EEA relevance)
#2514465

An tsubstaint próipianáit chailciam, ní fhormheastar í mar shubstaint bhunúsach.

The substance calcium propionate is not approved as a basic substance.

Commission Implementing Regulation (EU) 2022/1443 of 31 August 2022 concerning the non-approval of calcium propionate as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#2514508

An tsubstaint gallúnach dhubh E470a, ní fhormheastar í mar shubstaint bhunúsach.

The substance black soap E470a is not approved as a basic substance.

Commission Implementing Regulation (EU) 2022/1444 of 31 August 2022 concerning the non-approval of black soap E470a as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#2713083

Ní fhormheastar an tsubstaint bláthola líomóide (bláthola Citrus limon) mar shubstaint bhunata.

The substance lemon essential oil (Citrus limon essential oil) is not approved as a basic substance.

Commission Implementing Regulation (EU) 2023/200 of 30 January 2023 concerning the non-approval of lemon essential oil (Citrus limon essential oil) as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#3221881

ciallaíonn ‘substaint íon’ substaint nár úsáideadh roimhe sin;

‘virgin substance’ means a substance which has not previously been used;

Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014
#3221999

ainm na substainte nó an mheascáin ina bhfuil substaint den sórt sin;

name of the substance or mixture containing such substance;

Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014
#3224174

ciallaíonn ‘substaint íon’ substaint nár úsáideadh roimhe sin;

‘virgin substance’ means a substance which has not previously been used;

Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete the ozone layer, and repealing Regulation (EC) No 1005/2009
#3224297

ainm na substainte ídithe ózóin nó an mheascáin ina bhfuil substaint den sórt sin;

name of the ozone-depleting substance or mixture containing such substance;

Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete the ozone layer, and repealing Regulation (EC) No 1005/2009
#3243366

Áirítear an tsubstaint salaicioláit sóidiam sa tábla sin mar shubstaint cheadaithe.

The substance sodium salicylate is included in that table as an allowed substance.

Commission Implementing Regulation (EU) 2024/859 of 18 March 2024 amending Regulation (EU) No 37/2010 as regards the classification of the substance sodium salicylate with respect to its maximum residue limit in foodstuffs of animal origin
#1481409

(c) cibé bearta a dhéanamh is gá lena chinntiú go gcuirfear ar fáil do dhaoine dá soláthraíonn an duine sin an tsubstaint faisnéis leordhóthanach ar aon phriacal do shábháilteacht nó do shláinte a d'fhéadfadh a bheith ann mar gheall ar airíonna nádúrtha na substainte, ar thorthaí aon tástálacha ábhartha a bheidh déanta ar an tsubstaint nó i dtaca léi agus ar aon choinníollacha is gá lena chinntiú go mbeidh an tsubstaint sábháilte agus gan phriacal don tsláinte nuair a bheidh sí á húsáid nó á diúscairt.

( c ) to take such steps as are necessary to ensure that persons supplied by that person with the substance are provided with adequate information about any risk to safety or health to which the inherent properties of the substance may give rise, about the results of any relevant tests which have been carried out on or in connection with the substance and about any conditions necessary to ensure that the substance will be safe and without risk to health when the substance is being used or being disposed of.

Number 7 of 1989: SAFETY, HEALTH AND WELFARE AT WORK ACT, 1989
#153991

(1) Ní dhéanfaidh coinsíneoir substainte sceidealta an tsubstaint sceidealta a chur nó a iompar nó a sheachadadh lena hiompar de bhóthar ach amháin i gcás-

(1) A consignor of a scheduled substance shall not send or carry the scheduled substance or deliver the scheduled substance for carriage by road unless—

Statutory Instruments: 1980
#1915813

Tá sonraíocht chéannacht na substainte san iarratas ar fhormheas mar shubstaint bhunúsach comhionann le ceann na substainte gníomhaí formheasta.

The specification of the substance identity in the application for approval as a basic substance is identical to that of the approved active substance.

Commission Implementing Regulation (EU) 2021/80 of 27 January 2021 concerning the non-approval of carbon dioxide as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)
#2104207

Go deimhin, sa mheasúnú nua níor deimhníodh dianseasmhacht na substainte, rud a fhágann nach gcomhlíonann an tsubstaint sin dhá cheann de na critéir atá ann chun a mheas gur substaint PBT í.

Indeed, the new assessment did not confirm the persistency of the substance, which lead to that substance no longer meeting two of the criteria to be considered as a PBT substance.

Commission Implementing Regulation (EU) 2021/1177 of 16 July 2021 amending Implementing Regulation (EU) 2015/408 as regards the deletion of propoxycarbazone from the list of active substances to be considered as candidates for substitution (Text with EEA relevance)
#3222758

Σ (Substaint X % x acmhainneacht téimh dhomhanda) + (Substaint Y % x acmhainneacht téimh dhomhanda) + … (Substaint N % x acmhainneacht téimh dhomhanda), i gcás inarb ionann % agus an t-ionchur de réir meáchain le lamháltas meáchain +/– 1 %.

Σ (Substance × % × GWP) + (Substance Y % × GWP) + … (Substance N % × GWP), where % is the contribution by weight with a weight tolerance of +/– 1 %.

Regulation (EU) 2024/573 of the European Parliament and of the Council of 7 February 2024 on fluorinated greenhouse gases, amending Directive (EU) 2019/1937 and repealing Regulation (EU) No 517/2014
#291851

1. Maidir le sainteorainneacha tiúchana agus teorainneacha tiúchana cineálacha, is teorainneacha iad a shanntar do shubstaint lena luaitear tairseach ar a mbeidh, nó thar a mbeidh, láithreacht na substainte sin i substaint eile nó i meascán mar eisíontas sainaitheanta, mar bhreiseán nó mar chomhábhar leithleach ina cúis le haicmiú na substainte nó an mheascáin mar shubstaint ghuaiseach nó mar mheascán guaiseach.

1. Specific concentration limits and generic concentration limits are limits assigned to a substance indicating a threshold at or above which the presence of that substance in another substance or in a mixture as an identified impurity, additive or individual constituent leads to the classification of the substance or mixture as hazardous.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
#291966

1. Féadfaidh monaróir, allmhaireoir nó úsáideoir foghabhálach substainte i meascán iarratas a chur faoi bhráid na Gníomhaireachta chun ainm ceimiceach malartach a úsáid a thagróidh do shubstaint i meascán trí bhíthin ainm lena sainaithnítear na feidhmghrúpaí ceimiceacha is tábhachtaí nó trí bhíthin ainm mhalartaigh, i gcás ina gcomhlíonfaidh an tsubstaint na critéir a leagtar amach i gCuid 1 d'Iarscríbhinn I agus i gcás ina bhféadfaidh sé a léiriú go gcuirfí cineál rúnda a ghnó, go háirithe a chearta maoine intleachtúla, i mbaol dá nochtfaí céannacht cheimiceach na substainte sin ar an lipéad nó ar an mbileog sonraí sábháilteachta.

1. The manufacturer, importer or downstream user of a substance in a mixture may submit a request to the Agency to use an alternative chemical name which refers to that substance in a mixture either by means of a name that identifies the most important functional chemical groups or by means of an alternative designation, where the substance meets the criteria set out in Part 1 of Annex I and where he can demonstrate that disclosure on the label or in the safety data sheet of the chemical identity of that substance puts the confidential nature of his business, in particular his intellectual property rights, at risk.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006
#517283

8.7.2.Trí ionanálúIs iomchuí an tástáil trí ionanálú más dócha go mbeidh risíocht an duine trí ionanálú agus an méid seo a leanas á chur san áireamh:galbhrú na substaine (tá ag substaint shoghalaithe galbhrú > 1 × 10–2 Pa ag 20 °C) agus/nóis púdair é an tsubstaint ghníomhach ina bhfuil cion suntasach (e.g. 1 % de réir meáchain) de cháithníní le méid cáithnín MMAD < 50 micriméadar nócuimsítear an tsubstaint ghníomhach i dtárgí ar púdair iad nó a úsáidtear ar bhealach trína ngintear risíocht le haerasóil, le cáithníní nó le braoiníní ar de mhéid in-ionanálaithe iad (MMAD < 50 micriméadar)is é an Modh Aicmeach Géarthocsaineach an modh de rogha chun an críochphointe sin a bhrath

8.7.2.By inhalationTesting by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account:the vapour pressure of the substance (a volatile substance has vapour pressure > 1 × 10–2 Pa at 20 °C) and/orthe active substance is a powder containing a significant proportion (e.g. 1 % on a weight basis) of particles with particle size MMAD < 50 micrometers orthe active substance is included in products that are powders or are applied in a manner that generates exposure to aerosols, particles or droplets of an inhalable size (MMAD < 50 micrometers)the Acute Toxic Class Method is the preferred method for the determination of this endpoint

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products Text with EEA relevance
#567314

I gcás ina bhfuil forais réasúnacha ag Ballstát le creidiúint go bhféadfaí substaint shonrach nach bhfuil liostaithe sna hIarscríbhinní a úsáid chun pléascáin a mhonarú go haindleathach, féadfaidh sé cur ar fáil, sealbhú agus úsáid na substainte sin a shrianadh nó a thoirmeasc nó cur ar fáil, sealbhú agus úsáid aon mheascáin nó aon substainte a bhfuil an tsubstaint sin ann nó inti a shrianadh nó a thoirmeasc, nó féadfaidh sé foráil a dhéanamh go mbeidh an tsubstaint sin faoi réir thuairisciú idirbheart amhrasach i gcomhréir le hAirteagal 9.

Where a Member State has reasonable grounds for believing that a specific substance not listed in the Annexes could be used for the illicit manufacture of explosives, it may restrict or prohibit the making available, possession and use of that substance, or of any mixture or substance containing it, or it may provide that the substance be subject to the reporting of suspicious transactions in accordance with Article 9.

Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the marketing and use of explosives precursors Text with EEA relevance
#633601

Thairis sin, i gcás nach bhfuil monaróir ná allmhaireoir substainte ar bith liostaithe do shubstaint a bhfuil sainchomhad iomlán substainte curtha isteach di, ba cheart an fhéidearthacht a bheith ann go mbeadh cead ag duine eile táirgí bithicídeacha a bhfuil an tsubstaint sin iontu a chur ar an margadh, faoi réir sainchomhad nó litir rochtana ar shainchomhad ón duine sin, nó ó mhonaróir nó ó allmhaireoir an táirge bhithicídigh a chur isteach.

Furthermore, where no substance manufacturer or importer is listed for a substance for which a complete substance dossier has been submitted, the possibility should be allowed for another person to place biocidal products containing that substance on the market, subject to the submission of a dossier, or a letter of access to a dossier, by that person or the manufacturer or importer of the biocidal product.

Regulation (EU) No 334/2014 of the European Parliament and of the Council of 11 March 2014 amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products, with regard to certain conditions for access to the market Text with EEA relevance
#853652

(d) gurb é bheidh ag iomportáil na substainte sin ná dochtúir leighis cláruithe agus go dtabharfaidh an dochtúir sin d'oifigeach custum agus máil, le linn na substainte sin do bheith á hiomportáil, dearbhú i scríbhinn fé n-a láimh á rá go bhfuil an tsubstaint sin ag teastáil go práinneach i gcóir duine dá othair féin agus nárbh fhéidir do toisc cúrsaí áirithe (a luadhfar sa dearbhú san) cead iomportála chun na substainte sin d'iomportáil d'fháil luath go leor.

( d ) such substance is imported by a registered medical practitioner and such practitioner at the time of importing such substance delivers to an officer of customs and excise a declaration in writing signed by him to the effect that such substance is urgently required for one of his own patients and that circumstances (to be specified in such declaration) did not permit of his obtaining in sufficient time an import permit to import such substance.

Number 25 of 1932: THERAPEUTIC SUBSTANCES ACT, 1932
#1073460

(5) Ní déanfar aon táthú, prásáil ná lionntáthú, ná aon ghearradh a n-úsáidtear teas chuige, ar aon ghléasra, dabhach, ná soitheach ina bhfuil, nó ina raibh, aon tsubstaint phléascach nó lasúil go dtí go mbeidh gach beart is féidir déanta chun an tsubstaint agus aon mhúchanna aisti a thabhairt chun siúil, nó chun iad a dhéanamh neamhphléascach nó neamhlasúil, agus má rinneadh aon oibríocht mar adúradh ar aon ghléasra, dabhach nó soitheach, ní ligfear aon tsubstaint phléascach ná lasúil isteach sa ghléasra, sa dabhach ná sa soitheach go dtí go mbeidh an miotal chomh fuar sin nach bhfuil baol ar bith go n-adhanfar an tsubstaint.

(5) Any plant, tank or vessel which contains or has contained any explosive or inflammable substance shall not be subjected to any welding, brazing or soldering operation or to any cutting operation which involves the application of heat, until all practicable steps have been taken to remove the substance and any fumes arising therefrom, or to render them non-explosive or non-inflammable, and if any plant, tank, or vessel has been subjected to any such operation as aforesaid, an explosive or inflammable substance shall not be allowed to enter the plant, tank or vessel until the metal has cooled sufficiently to prevent any risk of igniting the substance.

Number 10 of 1955: FACTORIES ACT, 1955
#1323184

(2) Féadfaidh an Rialtas, le hordú, a dhearbhú gur druga rialaithe chun críocha an Achta seo aon substaint, táirge nó ullmhóid (nach substaint, táirge nó ullmhóid a shonraítear sa Sceideal a ghabhann leis an Acht seo) agus, fad a bheidh ordú faoin bhfo-alt seo i bhfeidhm, beidh éifeacht ag an Acht seo maidir le haon substaint, táirge nó ullmhóid a shonrófar san ordú amhail is dá mbeadh an tsubstaint, an táirge nó an ullmhóid sonraithe sa Sceideal sin.

(2) The Government may by order declare any substance, product or preparation (not being a substance, product or preparation specified in the Schedule to this Act) to be a controlled drug for the purposes of this Act and so long as an order under this subsection is in force, this Act shall have effect as regards any substance, product or preparation specified in the order as if the substance, product or preparation were specified in the said Schedule.

Number 12 of 1977: MISUSE OF DRUGS ACT, 1977
#1735588

Le haghaidh substaint ghníomhach, féadfaidh monaróir na substainte gníomhaí nó an t-iarratasóir a shocrú go gcuirfidh monaróir na substainte gníomhaí an fhaisnéis seo a leanas ar fáil i ndoiciméad ar leithligh go díreach do na húdaráis inniúla mar Mháistirchomhad maidir le Substaintí Gníomhacha:

For a well-defined active substance, the active substance manufacturer or the applicant may arrange for the following information to be supplied in a separate document directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File:

Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (Text with EEA relevance)
#1809539

ciallaíonn “réamhtheachtaí pléascán rialáilte” substaint atá liostaithe in Iarscríbhinn I nó II lena n-áirítear meascán nó substaint eile ina bhfuil substaint a liostaítear sna hIarscríbhinní sin seachas meascáin aonchineálacha le níos mó ná 5 chomhábhar ina bhfuil tiúchan gach ceann de na substaintí a liostaítear in Iarscríbhinn I nó II faoi bhun 1 % w/w;

‘regulated explosives precursor’ means a substance listed in Annex I or II including a mixture or another substance in which a substance listed in those Annexes is present, excluding homogeneous mixtures of more than 5 ingredients in which the concentration of each substance listed in Annex I or II is below 1 % w/w;

Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (Text with EEA relevance)
#1809647

I gcás ina bhfuil forais réasúnacha ag Ballstát lena chreidiúint go bhféadfaí substaint shonrach nach bhfuil liostaithe in Iarscríbhinn I ná II a úsáid chun pléascáin a mhonarú go haindleathach, féadfaidh sé cur ar fáil, tabhairt isteach, sealbhú agus úsáid na substainte sin a shrianadh nó a thoirmeasc nó cur ar fáil, tabhairt isteach, sealbhú agus úsáid aon mheascáin nó aon substainte a bhfuil an tsubstaint sin ann nó inti a shrianadh nó a thoirmeasc, nó féadfaidh sé foráil a dhéanamh go mbeidh an tsubstaint sin faoi réir oibleagáidí tuairiscithe i gcomhréir le hAirteagal 9.

Where a Member State has reasonable grounds for believing that a specific substance that is not listed in Annex I or II could be used for the illicit manufacture of explosives, it may restrict or prohibit the making available, introduction, possession and use of that substance, or of any mixture or substance containing it, or provide that the substance be subject to reporting obligations in accordance with Article 9.

Regulation (EU) 2019/1148 of the European Parliament and of the Council of 20 June 2019 on the marketing and use of explosives precursors, amending Regulation (EC) No 1907/2006 and repealing Regulation (EU) No 98/2013 (Text with EEA relevance)
#1982795

Ós rud é go gcomhlíonann heicseaflumúrón na critéir maidir le bheith ina shubstaint mharthanach, bhithcharnach agus thocsaineach (substaint PBT) agus ina shubstaint an-mharthanach agus an-bhithcharnach (substaint vPvB) de réir Iarscríbhinn XIII a ghabhann le Rialachán (CE) Uimh. 1907/2006 ó Pharlaimint na hEorpa agus ón gComhairle, comhlíonann sé na critéir eisiaimh a leagtar amach in Airteagal 5(1), pointe (e), de Rialachán (AE) Uimh. 528/2012.

As hexaflumuron meets the criteria for being a persistent, bioaccumulative and toxic substance (PBT substance), and a very persistent and very bioaccumulative substance (vPvB substance) according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, it meets the exclusion criteria set out in Article 5(1), point (e), of Regulation (EU) No 528/2012.

Commission Implementing Decision (EU) 2021/1299 of 4 August 2021 postponing the expiry date of approval of hexaflumuron for use in biocidal products of product-type 18 (Text with EEA relevance)
#2049609

Le haghaidh substaint ghníomhach neamhbhitheolaíoch, féadfaidh an t-iarratasóir a shocrú go soláthróidh monaróir na substainte gníomhaí an fhaisnéis ar an tsubstaint ghníomhach i bpointe (2) go díreach do na húdaráis inniúla mar Mháistirchomhad maidir le Substaintí Gníomhacha.

For a non-biological active substance, the applicant may arrange for the information on active substance in point (2) to be supplied directly to the competent authorities by the manufacturer of the active substance as an Active Substance Master File.

Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council (Text with EEA relevance)
#2362600

Tar éis don Ghníomhaireacht Eorpach Ceimiceán cuireadh oscailte a fhoilsiú chun ról an rannpháirtí a ghlacadh i leith teaglamaí áirithe de shubstaintí gníomhacha/cineálacha táirgí a chumhdaítear faoin aitheantas substainte atá ann cheana, ach nach gcumhdaítear faoin aitheantas substainte nua, ba cheart teaglamaí de shubstaintí gníomhacha/cineálacha táirgí a dtugtar fógra ina leith de bhun Airteagal 14(1), pointe (b) agus a mheastar a bheith i gcomhréir le hAirteagal 17(2) de Rialachán Tarmligthe (AE) Uimh. 1062/2014 a áireamh in Iarscríbhinn II a ghabhann leis an Rialachán sin de bhun Airteagal 18 den Rialachán sin.

Following the publication by the European Chemicals Agency (‘the Agency’) of an open invitation to take over the role of participant for certain active substance/product-type combinations covered by the existing substance identity but not by the new substance identity, substance/product-type combinations notified pursuant to Article 14(1), point (b), and found by the Agency to be compliant with Article 17(2) of Delegated Regulation (EU) No 1062/2014 should be included in Annex II to that Regulation pursuant to Article 18 of that Regulation.

Commission Delegated Regulation (EU) 2022/825 of 17 March 2022 amending Annex II to Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
#286614

(a) má aithnítear éifeacht dhíobhálach ar an tsláinte, déanfar an tsubstaint agus/nó an comhábhar ina bhfuil an tsubstaint:

(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall:

Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods
#291574

Agus a bhfreagrachtaí faoin Rialachán seo á gcomhall acu, ba cheart go gceadófaí d'úsáideoirí foghabhálacha an t-aicmiú ar shubstaint nó ar mheascán arna dhíorthú ag gníomhaí sa slabhra soláthair i gcomhréir leis an Rialachán seo a úsáid le haghaidh substainte nó meascáin, ar an gcoinníoll nach n-athróidh siad comhdhéanamh na substainte nó an mheascáin, agus ba cheart go gceadófaí do dháileoirí an t-aicmiú ar shubstaint nó ar mheascán arna dhíorthú ag gníomhaí sa slabhra soláthair i gcomhréir leis an Rialachán seo a úsáid.

In fulfilling their responsibilities downstream users should be allowed to use the classification of a substance or mixture derived in accordance with this Regulation by an actor in the supply chain, provided that they do not change the composition of the substance or mixture, and distributors should be allowed to use the classification of a substance or mixture derived in accordance with this Regulation by an actor in the supply chain.

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006

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