natgillin/translations-raw huggingface dataset:
Waste which contains one or more substances classified as aquatic chronic 1, 2 or 3 assigned to the hazard statement code(s) H410, H411 or H412 in accordance with Regulation (EC) No 1272/2008, and the sum of the concentrations of all substances classified as aquatic chronic 1 (H410) multiplied by 100 added to the sum of the concentrations of all substances classified as aquatic chronic 2 (H411) multiplied by 10 added to the sum of the concentrations of all substances classified as aquatic chronic 3 (H412) equals or exceeds the concentration limit of 25 %.
otpad koji sadržava jednu ili više tvari koje su razvrstane kao kronično toksične u vodenom okolišu 1., 2. ili 3. kategorije te im je dodijeljena jedna ili više šifri oznaka upozorenja H410, H411 ili H412 u skladu s Uredbom (EZ) br. 1272/2008, a zbroj koncentracija svih tvari koje su razvrstane kao kronično toksične u vodenom okolišu 1. kategorije (H410) pomnožen sa 100, dodan zbroju koncentracija svih tvari koje su razvrstane kao kronično toksične u vodenom okolišu 2. kategorije (H411) pomnoženom sa 10 i dodan zbroju koncentracija svih tvari koje su razvrstane kao kronično toksične u vodenom okolišu 3. kategorije (H412) jednak je graničnoj vrijednosti koncentracije od 25 % ili je premašuje.
A cut-off value of 0,1 % applies to substances classified as H410 and a cut-off value of 1 % applies to substances classified as H411 or H412.
Gornja granična vrijednost od 0,1 % primjenjuje se na tvari koje su razvrstane kao H410 i gornja granična vrijednost od 1 % primjenjuje se na tvari koje su razvrstane kao H411 ili H412.
Waste which contains one or more substances classified as aquatic chronic 1, 2, 3 or 4 assigned the hazard statement code(s) H410, H411, H412 or H413 in accordance with Regulation (EC) No 1272/2008, and the sum of the concentrations of all substances classified as aquatic chronic equals or exceeds the concentration limit of 25 %.
otpad koji sadržava jednu ili više tvari koje su razvrstane kao kronično toksične u vodenom okolišu 1., 2., 3. ili 4. kategorije te im je dodijeljena jedna ili više šifri oznaka upozorenja H410, H411, H412 ili H413 u skladu s Uredbom (EZ) br. 1272/2008, a zbroj koncentracija svih tvari koje su razvrstane kao kronično toksične u vodenom okolišu jednak je graničnoj vrijednosti koncentracije od 25 % ili je premašuje.
A cut-off value of 0,1 % applies to substances classified as H410 and a cut-off value of 1 % applies to substances classified as H411, H412 or H413.
Gornja granična vrijednost od 0,1 % primjenjuje se na tvari koje su razvrstane kao H410 i gornja granična vrijednost od 1 % primjenjuje se na tvari koje su razvrstane kao H411, H412 ili H413.
Where: Σ = sum and c = concentrations of the substances.
Pri čemu je: Σ = zbroj i c = koncentracije tvari.
the note below the entry for HP 15 is deleted.
Napomena ispod unosa za HP 15 briše se.
Commission Implementing Regulation (EU) 2017/998
Provedbena uredba Komisije (EU) 2017/998
amending for the 268th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
o 268. izmjeni Uredbe Vijeća (EZ) br. 881/2002 o uvođenju određenih posebnih mjera ograničavanja protiv određenih osoba i subjekata povezanih s organizacijama ISIL-om (Da'esh) i Al-Qaidom
On 7 June 2017, the Sanctions Committee of the United Nations Security Council decided to amend one entry in its list of persons, groups and entities to whom the freezing of funds and economic resources should apply.
Odbor za sankcije Vijeća sigurnosti Ujedinjenih naroda odlučio je 7. lipnja 2017. izmijeniti jedan unos na popisu osoba, skupina i subjekata na koje se primjenjuje zamrzavanje financijskih sredstava i gospodarskih izvora.
The identifying data for the entry ‘Al-Nusrah Front for the People of the Levant (alias (a) the Victory Front; (b) Jabhat al-Nusrah; (c) Jabhet al-Nusra; (d) Al-Nusrah Front; (e) Al-Nusra Front; (f) Ansar al-Mujahideen Network); (g) Levantine Mujahideen on the Battlefields of Jihad). Other information: (a) Operates in Syria; (b) Previously listed between 30 May 2013 and 13 May 2014 as an aka of Al-Qaida in Iraq. Date of designation referred to in Article 2a(4)(b): 14.5.2014.’ under the heading ‘Legal persons, groups and entities’ in Annex I to Regulation (EC) No 881/2002 is replaced by the following:
Podaci za potrebe identifikacije u unosu „Fronta obrane naroda Levanta Al-Nusrah (također poznata kao (a) Fronta pobjede; (b) Jabhat al-Nusrah; (c) Jabhet al-Nusra; (d) Al-Nusrah Front; (e) Al-Nusra Front; (f) Mreža Ansar al-Mujahideen); (g) Levantski mudžahedini na bojištima džihada). Ostali podaci: (a) djeluje u Siriji; (b) prethodno uvrštena između 30. svibnja 2013. i 13. svibnja 2014. i također poznata kao Al-Qaida u Iraku. Datum uvrštenja na popis iz članka 2.a stavka 4. točke (b): 14.5.2014.” pod naslovom „Pravne osobe, skupine i subjekti” u Prilogu I. Uredbi (EZ) br. 881/2002 zamjenjuje se sljedećim:
‘Al-Nusrah Front for the People of the Levant (alias (a) the Victory Front; (b) Jabhat al-Nusrah; (c) Jabhet al-Nusra; (d) Al-Nusrah Front; (e) Al-Nusra Front; (f) Ansar al-Mujahideen Network); (g) Levantine Mujahideen on the Battlefields of Jihad; (h) Jabhat Fath al Sham; (i) Jabhat Fath al-Sham; (j) Jabhat Fatah al-Sham; (k) Jabhat Fateh Al-Sham; (l) Fatah al-Sham Front; (m) Fateh al-Sham Front); (n) Conquest of the Levant Front; (o) The Front for the Liberation of al Sham; (p) Front for the Conquest of Syria/the Levant; (q) Front for the Liberation of the Levant; (r) Front for the Conquest of Syria. Other information: (a) Operates in Syrian Arab Republic (b) Iraq; (c) Previously listed between 30 May 2013 and 13 May 2014 as an aka of Al-Qaida in Iraq. Date of designation referred to in Article 7d(2)(i): 14.5.2014.’
„Al-Nusrah Front for the People of the Levant (alias (a) the Victory Front; (b) Jabhat al-Nusrah; (c) Jabhet al-Nusra; (d) Al-Nusrah Front; (e) Al-Nusra Front; (f) Ansar al-Mujahideen Network); (g) Levantine Mujahideen on the Battlefields of Jihad; (h) Jabhat Fath al Sham; (i) Jabhat Fath al-Sham; (j) Jabhat Fatah al-Sham; (k) Jabhat Fateh Al-Sham; (l) Fatah al-Sham Front; (m) Fateh al-Sham Front); (n) Conquest of the Levant Front; (o) The Front for the Liberation of al Sham; (p) Front for the Conquest of Syria/the Levant; (q) Front for the Liberation of the Levant; (r) Front for the Conquest of Syria. Ostali podaci: (a) djeluje u Sirijskoj Arapskoj Republici (b) u Iraku; (c) prethodno uvrštena od 30. svibnja 2013. do 13. svibnja 2014. kao drugo ime za Al-Qaidu u Iraku. Datum uvrštenja u skladu s člankom 7.d stavkom 2. točkom (i): 14.5.2014.”
Commission Regulation (EU) 2017/999
Uredba Komisije (EU) 2017/999
amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
o izmjeni Priloga XIV. Uredbi (EZ) br. 1907/2006 Europskog parlamenta i Vijeća o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH)
Having regard to 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 [1], and in particular Articles 58 and 131 thereof,
uzimajući u obzir Uredbu (EZ) br. 1907/2006 Europskog parlamenta i Vijeća od 18. prosinca 2006. o registraciji, evaluaciji, autorizaciji i ograničavanju kemikalija (REACH) i osnivanju Europske agencije za kemikalije te o izmjeni Direktive 1999/45/EZ i stavljanju izvan snage Uredbe Vijeća (EEZ) br. 793/93 i Uredbe Komisije (EZ) br. 1488/94 kao i Direktive Vijeća 76/769/EEZ i direktiva Komisije 91/155/EEZ, 93/67/EEZ, 93/105/EZ i 2000/21/EZ [1], a posebno njezine članke 58. i 131.,
The substance 1-bromopropane (n-propyl bromide) meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 of the European Parliament and the Council [2] and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar 1-brompropan (n-propil-bromid) ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 Europskog parlamenta i Vijeća [2] te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance diisopentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar diizopentilftalat ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar 1,2-benzendikarboksilna kiselina, di-C6-8-razgranati alkilesteri, s velikim udjelom C7, ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar 1,2-benzendikarboksilna kiselina, di-C7-11-razgranati i linearni alkilesteri, ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance 1,2-benzenedicarboxylic acid, dipentylester, branched and linear, meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar 1,2-benzendikarboksilna kiselina, dipentilester, razgranati i linearni, ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance bis(2-methoxyethyl) phthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar bis(2-metoksietil)ftalat ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance dipentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar dipentilftalat ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
The substance N-pentyl-isopentylphthalate meets the criteria for classification as toxic for reproduction (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(c) of that Regulation.
Tvar n-pentil-izopentilftalat ispunjuje kriterije prema kojima se tvari razvrstavaju kao reproduktivno toksične (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (c) te Uredbe.
When containing a certain percentage of benzo[a]pyrene, the substance anthracene oil meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation.
Kad sadržava određeni postotak benzo[a]pirena, tvar antracensko ulje ispunjuje kriterije prema kojima se tvari razvrstavaju kao kancerogene (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (a) te Uredbe.
The substance is also persistent, bioaccumulative and toxic, as well as very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meets the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(d) and (e) of that Regulation.
Tvar je i postojana, bioakumulativna i otrovna, pa i vrlo postojana i vrlo bioakumulativna, u skladu s kriterijima iz Priloga XIII. Uredbi (EZ) br. 1907/2006 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. toj Uredbi utvrđene u članku 57. točkama (d) i (e) te Uredbe.
The substance pitch, coal tar, high temp. meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and therefore meets the criteria for inclusion in Annex XIV to Regulation (EC) No 1907/2006 set out in Article 57(a) of that Regulation.
Tvar smola, ugljeni katran, visokotemperaturni, ispunjuje kriterije prema kojima se tvari razvrstavaju kao kancerogene (kategorija 1.B) u skladu s Uredbom (EZ) br. 1272/2008 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. Uredbi (EZ) br. 1907/2006 utvrđene u članku 57. točki (a) te Uredbe.
The substance is also persistent, bioccumulative and toxic, as well as very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 and therefore meets the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(d) and (e) of that Regulation.
Tvar je i postojana, bioakumulativna i otrovna, pa i vrlo postojana i vrlo bioakumulativna, u skladu s kriterijima iz Priloga XIII. Uredbi (EZ) br. 1907/2006 te stoga ispunjuje kriterije za uvrštenje u Prilog XIV. toj Uredbi utvrđene u članku 57. točkama (d) i (e) te Uredbe.
The substance group 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (covering well-defined substances and substances of unknown or variable composition, complex reaction products or biological materials (‘UVCB substances’), polymers and homologues) are substances which through their degradation have endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment.
Skupina tvari 4-(1,1,3,3-tetrametilbutil)fenol, etoksiliran (obuhvaćajući točno definirane tvari i tvari nepoznatog ili promjenjivog sastava, kompleksne reakcijske produkte ili biološki materijal („UVCB tvari”), polimere i homologne tvari), tvari su koje uslijed razgradnje imaju svojstva endokrine disrupcije za koja postoje znanstveni dokazi o vjerojatnim ozbiljnim učincima na okoliš.
As such, they give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) of Article 57 of Regulation (EC) No 1907/2006 and, therefore, meet the criteria for inclusion in Annex XIV to that Regulation set out in Article 57(f) of that Regulation.
Kao takve one uzrokuju jednakovrijednu razinu zabrinutosti kao druge tvari iz točaka od (a) do (e) članka 57. Uredbe (EZ) br. 1907/2006 te stoga ispunjuju kriterije za uvrštenje u Prilog XIV. toj Uredbi utvrđene u članku 57. točki (f) te Uredbe.
The substance group 4-nonylphenol, branched and linear, ethoxylated (including substances with a linear and/or branched alkyl chain with a carbon number of 9 covalently bound in position 4 to phenol, ethoxylated covering UVCB- and well-defined substances, polymers and homologues, which include any of the individual isomers and/or combinations thereof), are substances which through their degradation have endocrine disrupting properties for which there is scientific evidence of probable serious effects to the environment.
Skupina tvari 4-nonilfenol, razgranati i linearni, etoksiliran (uključujući tvari s linearnim i/ili razgranatim alkilnim lancem s brojem atoma ugljika 9 u kovalentnoj vezi na poziciji 4 s fenolom, etoksiliranim, obuhvaćajući UVCB tvari i točno definirane tvari, polimere i homologne tvari, koje uključuju bilo koji pojedinačni izomer i/ili njegove kombinacije), tvari su koje uslijed razgradnje imaju svojstva endokrine disrupcije za koja postoje znanstveni dokazi o vjerojatnim ozbiljnim učincima na okoliš.
Those substances have been identified and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006.
Te su tvari identificirane i uvrštene na popis tvari predloženih za uvrštenje u skladu s člankom 59. Uredbe (EZ) br. 1907/2006.
They have furthermore been prioritised for inclusion in Annex XIV to Regulation (EC) No 1907/2006 by the European Chemicals Agency (‘the Agency’) in its recommendations of 6 February 2014 [3] and 1 July 2015 [4], in accordance with Article 58 of that Regulation.
Nadalje, u svojim preporukama od 6. veljače 2014. [3] i 1. srpnja 2015.
In addition, the Commission has received information on socioeconomic impacts provided in the numerous stakeholder submissions after receipt of the Agency's fifth recommendation or provided through a public consultation conducted in parallel with the Agency's public consultation on its draft sixth recommendation.
Europska agencija za kemikalije (dalje u tekstu „Agencija”) preporučila je prioritetno uvrštenje tih tvari u Prilog XIV. Uredbi (EZ) br. 1907/2006 u skladu s člankom 58. te Uredbe. Osim toga, Komisija je primila informacije o socioekonomskim učincima koje su joj dostavile brojne zainteresirane strane po primitku Pete preporuke Agencije ili tijekom javnog savjetovanja koje se održalo usporedno s javnim savjetovanjem Agencije o njezinu nacrtu Šeste preporuke.
Notwithstanding the information received, it is appropriate to include those substances in that Annex.
Neovisno o primljenim informacijama te je tvari primjereno uvrstiti u taj Prilog.
It is appropriate to indicate the dates referred to in Article 58(1)(c)(ii) of Regulation (EC) No 1907/2006 in line with the Agency's recommendations of 6 February 2014 and of 1 July 2015.
Primjereno je navesti datume iz članka 58. stavka 1. točke (c) podtočke ii. Uredbe (EZ) br. 1907/2006 u skladu s preporukama Agencije od 6. veljače 2014. i 1. srpnja 2015.
Those dates have been identified on the basis of the estimated time that would be required to prepare an application for the authorisation, taking into account the information available on the different substances and the information received during the public consultation carried out in accordance with Article 58(4) of Regulation (EC) No 1907/2006.
Ti su datumi utvrđeni na temelju predviđenog vremena potrebnog za pripremu zahtjeva za autorizaciju, uzimajući u obzir dostupne informacije o različitim tvarima i informacije dobivene tijekom javnog savjetovanja provedenog u skladu s člankom 58. stavkom 4. Uredbe (EZ) br. 1907/2006.
To that purpose, the Agency's capacity to handle applications in the time provided for in Regulation (EC) No 1907/2006 should also been taken into account, as provided in Article 58(3) of that Regulation.
U tu svrhu u obzir bi trebalo uzeti i sposobnost Agencije da obradi zahtjeve u roku predviđenom Uredbom (EZ) br. 1907/2006, kako je predviđeno člankom 58. stavkom 3. te Uredbe.
For each of those substances listed in the Annex to this Regulation there are no reasons why the date referred to in Article 58(1)(c)(i) of Regulation (EC) No 1907/2006 should be set later than 18 months after the date referred to in Article 58(1)(c)(ii) of that Regulation.
Ni za jednu tvar navedenu u Prilogu toj Uredbi nema razloga da se za datum iz članka 58. stavka 1. točke (c) podtočke i. Uredbe (EZ) br. 1907/2006 odredi datum koji je za više od 18 mjeseci veći od datuma iz članka 58. stavka 1. točke (c) podtočke ii. te Uredbe.
Article 58(1)(e) in conjunction with Article 58(2) of Regulation (EC) No 1907/2006 provides for the possibility of exemptions of uses or categories of uses in cases where specific Union legislation imposes minimum requirements relating to the protection of human health or the environment ensuring proper control of the risks.
Člankom 58. stavkom 1. točkom (e) u vezi s člankom 58. stavkom 2. Uredbe (EZ) br. 1907/2006 predviđa se mogućnost izuzimanja uporaba ili kategorija uporaba u slučajevima u kojima su minimalni zahtjevi u pogledu zaštite zdravlja ljudi ili okoliša posebno propisani zakonodavstvom Unije, čime se osigurava odgovarajuća kontrola rizika.
In accordance with the information currently available it is not appropriate to set exemptions based on those provisions.
U skladu s trenutačno dostupnim informacijama nije primjereno utvrditi izuzeća na temelju tih odredaba.
On the basis of the information currently available it is not appropriate to set exemptions for product and process orientated research and development.
Na temelju trenutačno dostupnih informacija nije primjereno utvrditi izuzeća za istraživanje i razvoj usmjerene na proizvod i proces.
On the basis of the information currently available it is not appropriate to set review periods for certain uses.
Na temelju trenutačno dostupnih informacija nije primjereno utvrditi razdoblja preispitivanja za određene uporabe.
In accordance with Article 60(8) of Regulation (EC) No 1907/2006 review periods are to be determined on a case-by-case basis taking into account, inter alia, the risks posed by the uses of the substance, the socioeconomic benefits arising from its use and the analysis of alternatives or any substitution plan submitted for uses for which authorisation is requested.
U skladu s člankom 60. stavkom 8. Uredbe (EZ) br. 1907/2006 razdoblja preispitivanja određuju se za svaki slučaj posebno uzimajući u obzir, među ostalim, rizike do kojih dolazi zbog uporabe tvari, socioekonomske koristi koje proizlaze iz njezine uporabe te analizu alternativa ili zamjenskih planova podnesenih za uporabe za koje se traži autorizacija.
In instances where there is no suitable alternative, the risks posed by the use are limited by appropriate and effective risk management measures, and when the benefits arising from the use are expected to be high, as could be the case for uses in the production of medicinal products or medical devices, review periods could be long.
Ako ne postoje odgovarajuće alternative, ako su rizici do kojih dolazi zbog uporabe tvari ograničeni odgovarajućim i učinkovitim mjerama upravljanja rizicima te kada se očekuje da će koristi koje proizlaze iz uporabe biti velike, što bi mogao biti slučaj za uporabe u proizvodnji lijekova ili medicinskih uređaja, razdoblja preispitivanja mogu biti duga.