natgillin/translations-raw huggingface dataset:
As a prerequisite for recognition, the regulatory regime of the third country in which the CCP is authorised must be deemed ‘sufficiently equivalent’, in relation to the degree of protection from systemic risk and level of effectiveness and fairness of services it achieves, to the Australian regulatory regime for comparable domestic CCPs.
Kao preduvjet za priznavanje regulatorni se sustav treće zemlje u kojoj CCP ima odobrenje mora smatrati „dovoljno istovrijednim” u odnosu na stupanj zaštite od sistemskog rizika te razinu učinkovitosti i pravednosti pruženih usluga koji vrijedi u regulatornom sustavu Australije za usporedive domaće CCP-ove.
The assessment of ‘sufficient equivalence’ involves similar considerations as those assessed under Regulation (EU) No 648/2012.
Ocjenom „dovoljne istovrijednosti” obuhvaćena su slična razmatranja kao i ona koja se ocjenjuju na temelju Uredbe (EU) br. 648/2012.
The establishment of cooperation arrangements between the Australian authorities and the relevant foreign supervisory authorities is also required to grant an overseas CCP licence.
Za dodjelu prekomorske licencije za CCP-ove potrebno je uspostaviti mehanizme suradnje između tijela Australije i nadležnih stranih nadzornih tijela.
It should therefore be considered that the legal and supervisory arrangements of Australia provide for an effective equivalent system for the recognition of third country CCPs.
Stoga se treba smatrati da se pravnim i nadzornim sustavima Australije osigurava učinkovit istovrijedan sustav za priznavanje CCP-ova trećih zemalja.
The conditions laid down in Article 25(6) of Regulation (EU) No 648/2012 can therefore be considered to be met by the legal and supervisory arrangements of Australia regarding CCPs authorised therein and those legal and supervisory arrangements should be considered to be equivalent to the requirements laid down in Regulation (EU) No 648/2012.
Stoga se može smatrati da pravni i nadzorni sustavi Australije u pogledu CCP-ova koji ondje imaju odobrenje ispunjuju uvjete iz članka 25. stavka 6. Uredbe (EU) br. 648/2012 te da bi se ti pravni i nadzorni sustavi trebali smatrati istovrijednima zahtjevima iz Uredbe (EU) br. 648/2012.
The Commission, informed by ESMA, should continue monitoring the evolution of the Australian legal and supervisory framework for CCPs and the fulfilment of the conditions on the basis of which this decision has been taken.
Potrebno je da Komisija, koju obavješćuje ESMA, nastavi pratiti razvoj pravnog i nadzornog okvira Australije u pogledu CCP-ova te ispunjivanje uvjeta na temelju kojih je donesena ova Odluka.
For the purposes of Article 25 of Regulation (EU) No 648/2012, the legal and supervisory arrangements of Australia applicable to CCPs authorised therein, consisting of Part 7.3 of the Corporations Act 2001 and the Corporations Regulations 2001, as explained under Regulatory Guidance 211 ‘Clearing and settlement facilities: Australian and overseas operators’, and the Financial Stability Standards for Central Counterparties, shall be considered to be equivalent to the requirements laid down in Regulation (EU) No 648/2012.
Za potrebe članka 25. Uredbe (EU) br. 648/2012 pravni i nadzorni sustavi Australije u pogledu CCP-ova koji ondje imaju odobrenje, koji su sastavljeni od dijela 7.3 Zakona o trgovačkim društvima od 2001. („Corporations Act 2001”) i Pravila o trgovačkim društvima od 2001. („Corporations Regulations 2001”) kako su obrazložena regulatornom smjernicom 211 „Instrumenti poravnanja i namire: australski i prekomorski operateri” („Clearing and settlement facilities: Australian and overseas operators”) te Standarda financijske stabilnosti za središnje druge ugovorne strane (Financial Stability Standards for Central Counterparties), smatraju se istovrijednima zahtjevima utvrđenima Uredbom (EU) br. 648/2012.
Other than certain sub-standards, which came into effect on 31 March 2014, the FSS became effective in March 2013.
Ne računajući određene podstandarde koji su stupili na snagu 31. ožujka 2014., FSS je stupio na snagu u ožujku 2013.
The FSS are to be complied with by all licensed CCPs.
FSS moraju poštovati svi licencirani CCP-ovi.
concerning restrictions of the authorisations of biocidal products containing IPBC and propiconazole notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
o ograničenjima odobrenja biocidnih proizvoda koji sadržavaju IPBC i propikonazol koje je prijavila Njemačka u skladu s Direktivom 98/8/EZ Europskog parlamenta i Vijeća
(notified under document C(2014) 7909)
(priopćeno pod brojem dokumenta C(2014) 7909)
Having regard to 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 [1], and in particular Article 36(3) thereof,
uzimajući u obzir Uredbu (EU) br. 528/2012 Europskog parlamenta i Vijeća od 22. svibnja 2012. o stavljanju na raspolaganje na tržištu i uporabi biocidnih proizvoda [1], a posebno njezin članak 36. stavak 3.,
Annex I to Directive 98/8/EC of the European Parliament and of the Council [2] contained the list of active substances approved at Union level for inclusion in biocidal products.
Prilog I. Direktivi 98/8/EZ Europskog parlamenta i Vijeća [2] sadržavao je popis aktivnih tvari koje su na razini Unije odobrene za uvrštavanje u biocidne proizvode.
Commission Directives 2008/78/EC [3] and 2008/79/EC [4] added the active substances propiconazole and IPBC, respectively, for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.
Direktivama Komisije 2008/78/EZ [3] i 2008/79/EZ [4] dodane su aktivne tvari propikonazol i IPBC za uporabu u proizvodima koji pripadaju vrsti proizvoda 8, sredstvima za zaštitu drva, kako je utvrđeno u Prilogu V. Direktivi 98/8/EZ.
By virtue of Article 86 of Regulation (EU) No 528/2012, those substances are therefore approved active substances included in the list referred to in Article 9(2) of that Regulation.
Na temelju članka 86. Uredbe (EU) br. 528/2012 te su tvari stoga odobrene aktivne tvari uvrštene u popis iz članka 9. stavka 2. te Uredbe.
In accordance with Article 8 of Directive 98/8/EC, the company Janssen PMP submitted applications to the United Kingdom for authorisation of three wood preservative biocidal products containing IPBC and propiconazole (‘the contested products’).
U skladu s člankom 8. Direktive 98/8/EZ poduzeće Janssen PMP podnijelo je zahtjeve Ujedinjenoj Kraljevini za odobrenje tri biocidna proizvoda za zaštitu drva koji sadržavaju IPBC i propikonazol (dalje u tekstu: „sporni proizvodi”).
The product authorisations granted by the United Kingdom covered different application methods, including automated dipping for industrial use and spraying (indoors and outdoors) for professional and non-professional use.
Odobrenja proizvoda koja je izdala Ujedinjena Kraljevina obuhvaćala su različite metode primjene, uključujući automatizirano uranjanje za industrijsku uporabu i raspršivanje (u zatvorenom i na otvorenom) za profesionalnu i neprofesionalnu uporabu.
A number of Member States have subsequently authorised the contested products through mutual recognition.
Neke države članice naknadno su odobrile sporne proizvode međusobnim priznavanjem.
Janssen PMP (‘the applicant’) submitted complete applications to Germany for mutual recognition of the authorisations of the contested products granted by the United Kingdom.
Poduzeće Janssen PMP (dalje u tekstu: „podnositelj zahtjeva”) podnijelo je Njemačkoj potpune zahtjeve za međusobno priznavanje odobrenja spornih proizvoda koje je izdala Ujedinjena Kraljevina.
Germany notified the Commission, the other Member States and the applicant on 28 August 2013 of its proposal to restrict the authorisations in accordance with Article 4(4) of Directive 98/8/EC.
Njemačka je 28. kolovoza 2013. obavijestila Komisiju, druge države članice i podnositelja zahtjeva o svojem prijedlogu za ograničavanje odobrenja u skladu s člankom 4. stavkom 4. Direktive 98/8/EZ.
Germany considers that the contested products do not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to human health and the environment.
Njemačka smatra da sporni proizvodi ne ispunjavaju zahtjeve iz članka 5. stavka 1. Direktive 98/8/EZ u pogledu zdravlja ljudi i okoliša.
According to Germany, the authorisation of the application method by spraying outdoors was not appropriately assessed by the United Kingdom in terms of environmental risks.
Po mišljenju Njemačke, Ujedinjena Kraljevina nije primjereno ocijenila odobrenje metode primjenom raspršivanja na otvorenom s obzirom na rizike za okoliš.
The assessment performed by Germany for the three products concluded in unacceptable risks for the distant soil compartment.
Njemačkom procjenom za tri proizvoda zaključeno je da je riječ o neprihvatljivim rizicima za udaljena tla.
Germany also considers that for one of the products, the application by automated dipping should be limited to systems with a sufficiently high degree of automation due to unacceptable risks for the health of professional users.
Njemačka također smatra da bi za jedan od proizvoda primjena automatiziranim uranjanjem trebala biti ograničena na sustave s dovoljno visokim stupnjem automatizacije zbog neprihvatljivih rizika za zdravlje profesionalnih korisnika.
The Commission invited the other Member States and the applicant to submit comments to the notifications in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC.
Komisija je pozvala druge države članice i podnositelja zahtjeva da u roku od 90 dana u pismenom obliku dostave primjedbe na obavijesti u skladu s člankom 27. stavkom 1. Direktive 98/8/EZ.
Comments were submitted within that deadline by Germany, the United Kingdom and the applicant.
U tom roku primjedbe su dostavile Njemačka, Ujedinjena Kraljevina i podnositelj zahtjeva.
The notification was also discussed between the Commission and Member States' Competent Authorities for biocidal products on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012.
Komisija i nadležna tijela država članica za biocidne proizvode raspravljali su o obavijesti 24. rujna 2013. na sastanku koordinacijske skupine osnovane na temelju članka 35. Uredbe (EU) br. 528/2012.
With regard to the risks for the environment, from those discussions and comments it follows that the conclusions of the environmental assessment carried out by the United Kingdom were based on the relevant scenario of the Series on Emission Scenario Documents of the Organisation for Economic Co-operation and Development (OECD) [5] available at the time of the evaluation.
S obzirom na rizike za okoliš, iz tih rasprava i primjedbi slijedi da su zaključci procjene utjecaja na okoliš koju je provela Ujedinjena Kraljevina temeljeni na relevantnom scenariju iz serije dokumenata Organizacije za gospodarsku suradnju i razvoj (OECD) o scenarijima emisija [5], dostupnom u vrijeme procjene.
It also follows that the conclusions from Germany are based on a revised scenario of the OECD Series on Emission Scenario Documents [6], available since the authorisations were granted by the United Kingdom and also since the notification made by Germany.
Također slijedi da se zaključci Njemačke temelje na revidiranom scenariju serije dokumenata OECD-a o scenarijima emisija [6], dostupnom otkad je Ujedinjena Kraljevina izdala odobrenja te otkad je Njemačka izdala obavijest.
In addition, according to agreed guidance by the 47th meeting of representatives of Members States Competent Authorities for the implementation of Directive 98/8/EC concerning the placing of biocidal products on the market [7], new guidance can only be taken into consideration if it was available before the date of submission of the application for product authorisation, unless scientific progress shows that the reliance on old guidance gives rise to serious concern.
Nadalje, prema dogovorenim smjernicama s 47. sastanka predstavnika nadležnih tijela država članica za provedbu Direktive 98/8/EZ o stavljanju biocidnih pripravaka na tržište [7], nove se smjernice mogu uzeti u obzir jedino ako su bile dostupne prije datuma podnošenja zahtjeva za odobrenje proizvoda, osim ako znanstveni napredak pokazuje da je oslanjanje na stare smjernice razlog za ozbiljnu zabrinutost.
This guidance further establishes that a serious concern would trigger revision of existing authorisations.
U tim se smjernicama dalje utvrđuje da bi ozbiljna zabrinutost pokrenula reviziju postojećih odobrenja.
However, neither the United Kingdom nor the other Member States having approved the products through mutual recognition considered that the concern was such as to justify a revision of existing authorisations.
Međutim, ni Ujedinjena Kraljevina ni druge države članice koje su proizvode odobrile međusobnim priznavanjem nisu smatrale da je zabrinutost takva da bi opravdala reviziju postojećih odobrenja.
In the light of the above comments, the Commission supports the conclusions of the evaluation carried out by the United Kingdom and the other Member States having approved the products through mutual recognition, considering that the contested products fulfil the requirements set by Article 5(1) of Directive 98/8/EC with regard to the environment.
S obzirom na navedene argumente Komisija podupire zaključke ocjene koju su provele Ujedinjena Kraljevina i druge države članice koje su odobrile proizvode međusobnim priznavanjem te smatra da sporni proizvodi ispunjavaju zahtjeve iz članka 5. stavka 1. Direktive 98/8/EZ u pogledu okoliša.
The Commission therefore considers that the request by Germany to restrict the authorisations cannot be justified on the grounds put forward.
Komisija stoga smatra da zahtjev Njemačke za ograničenje odobrenja ne može biti opravdan na temelju navedenih razloga.
With regard to the application by automated dipping, the Commission considers that the contested product should be subject to the provisions established by a previous Commission Decision [8] addressing the protection of the health of professional users when applying IPBC containing products by this application method.
Uzimajući u obzir primjenu automatiziranim uranjanjem, Komisija smatra da bi sporni proizvod trebao podlijegati odredbama utvrđenima prethodnom Odlukom Komisije [8] o zaštiti zdravlja profesionalnih korisnika prilikom primjene proizvoda koji sadržavaju IPBC tom metodom.
Consequently, the contested product should be authorised subject to instructions on the label restricting the use to fully automated dipping processes and the product authorisation should be amended accordingly.
Stoga bi sporni proizvod trebalo odobriti prema uputama na deklaraciji kojima se njegova uporaba ograničava na postupke potpuno automatiziranog uranjanja, a odobrenje proizvoda trebalo bi odgovarajuće izmijeniti.
Regulation (EU) No 528/2012 applies to the contested product in accordance with the provisions of Article 92(2) of that Regulation.
Uredba (EU) br. 528/2012 primjenjuje se na sporni proizvod u skladu s odredbama članka 92. stavka 2. te Uredbe.
Since the legal basis for this Decision is Article 36(3) of that Regulation, this Decision should be addressed to all Member States by virtue of Article 36(4) of that Regulation.
Budući da je pravna osnova ove Odluke članak 36. stavak 3. te Uredbe, ovu Odluku treba uputiti svim državama članicama u skladu s člankom 36. stavkom 4. te Uredbe.
This Decision applies to products identified by the following application reference numbers in the Reference Member State, as provided for by the Register for Biocidal Products:
Ova se odluka primjenjuje na proizvode navedene u zahtjevima sa sljedećim referentnim brojevima u referentnoj državi članici, kako je predviđeno Registrom biocidnih proizvoda:
The proposal by Germany not to authorise the biocidal products referred to in Article 1 for spraying outdoors, is rejected.
Odbija se prijedlog Njemačke da se ne odobre biocidni proizvodi iz članka 1. za raspršivanje na otvorenom.
Where used for automated dipping, authorisations of biocidal products identified by the application reference number 2010/2709/7626/UK/AA/8666 shall include a condition that the label of the products contains the following instruction:
Odobrenja biocidnih proizvoda navedenih u zahtjevu s referentnim brojem 2010/2709/7626/UK/AA/8666 uključuju uvjet da se na deklaraciji proizvoda navedu sljedeće upute:
‘Product (insert name of the product) must only be used in fully automated dipping processes where all steps in the treatment and drying process are mechanised and no manual handling takes place, including when the treated articles are transported through the dip tank to the draining/drying and storage (if not already surface dry before moving to storage). Where appropriate, the wooden articles to be treated must be fully secured (e.g. via tension belts or clamping devices) prior to treatment and during the dipping process, and must not be manually handled until after the treated articles are surface dry.’
„Proizvod (umetnuti naziv proizvoda) se može upotrebljavati jedino u potpuno automatiziranim postupcima uranjanja kada su svi koraci postupka tretiranja i sušenja mehanizirani i ne uključuju ručno prenošenje, uključujući kada se tretirani proizvodi prenose kroz spremnik za uranjanje na cijeđenje/sušenje i pohranu (ako se površina prije prenošenja u pohranu nije već osušila). Ako je to primjenjivo, drveni proizvodi koji se tretiraju moraju biti potpuno učvršćeni (npr. zateznim remenima ili stegama) prije tretiranja i tijekom postupka uranjanja te se ne smiju prenositi ručno dok se površina tretiranih proizvoda ne osuši.”
Commission Directive 2008/78/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include propiconazole as an active substance in Annex I thereto (OJ L 198, 26.7.2008, p. 44).
Direktiva Komisije 2008/78/EZ od 25. srpnja 2008. o izmjeni Direktive 98/8/EZ Europskog parlamenta i Vijeća radi uvrštavanja propikonazola kao aktivne tvari u njezin Prilog I. (SL L 198, 26.7.2008., str. 44.).
Commission Directive 2008/79/EC of 28 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include IPBC as an active substance in Annex I thereto (OJ L 200, 29.7.2008, p. 12).
Direktiva Komisije 2008/79/EZ od 28. srpnja 2008. o izmjeni Direktive 98/8/EZ Europskog parlamenta i Vijeća radi uvrštenja IPBC-a kao aktivne tvari u njezin Prilog I. (SL L 200, 29.7.2008., str. 12.).
See Emission scenarios for outdoor treatments from Part II of OECD Emission Scenario Document (ESD) for Wood Preservatives (2003), available on the website http://echa.europa.eu/documents/10162/16908203/pt8_wood_preservatives_2_en.pdf
Vidjeti scenarije emisija za tretiranje na otvorenom iz Dijela II. Dokumenta OECD-a o scenarijima emisija (ESD) za sredstva za zaštitu drva (2003.), dostupne na internetskoj stranici http://echa.europa.eu/documents/10162/16908203/pt8_wood_preservatives_2_en.pdf
See Outdoor spraying emission scenario from OECD Revised Emission Scenario Document for Wood Preservatives (ENV/JM/MONO(2013)21), available on the website http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2013)21&doclanguage=en
Vidjeti scenarij emisije vanjskog raspršivanja iz Revidiranog dokumenta OECD-a o scenarijima emisija za sredstva za zaštitu drva (ENV/JM/MONO(2013)21) dostupan na internetskoj stranici http://search.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/jm/mono(2013)21&doclanguage=en
See document CA-July12-Doc.6.2d — Final on Relevance of new guidance becoming available during the process of authorisation and mutual recognition of authorisations of biocidal products, available on the website https://circabc.europa.eu/w/browse/03bce60b-cf04-49aa-8172-e9c6a75205a7
Vidjeti dokument CA-July 12-Doc.6.2d – završna verzija o relevantnosti novih smjernica koje postaju dostupne za vrijeme postupka odobrenja i uzajamnog priznavanja biocidnih proizvoda, dostupan na internetskoj stranici https://circabc.europa.eu/w/browse/1960acce-3e3b-4dea-9a97-b9a044f68317
Commission Implementing Decision 2014/402/EU of 25 June 2014 regarding restrictions of authorisations of biocidal products containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council (OJ L 188, 27.6.2014, p. 85).
Provedbena odluka Komisije 2014/402/EU od 25. lipnja 2014. o ograničenju odobrenja za biocidne proizvode koji sadržavaju IPBC, o čemu je obavijestila Njemačka u skladu s Direktivom 98/8/EZ Europskog parlamenta i Vijeća (SL L 188, 27.6.2014., str. 85.).
concerning restrictions of the authorisation of a biocidal product containing IPBC notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
o ograničenjima odobrenja biocidnog proizvoda koji sadržava IPBC koji je prijavila Njemačka u skladu s Direktivom 98/8/EZ Europskog parlamenta i Vijeća
(notified under document C(2014) 7914)
(priopćeno pod brojem dokumenta C(2014) 7914)
Annex I to Directive 98/8/EC of the European Parliament and of the Council [2] contained the list of active substances approved at Union level for inclusion in biocidal products.
Prilog I. Direktivi 98/8/EZ Europskog parlamenta i Vijeća [2] sadržavao je popis aktivnih tvari koje su odobrene na razini Unije za uporabu u biocidnim proizvodima.
Commission Directive 2008/79/EC [3] added the active substance IPBC for use in products belonging to product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.
Direktivom Komisije 2008/79/EZ [3] dodana je aktivna tvar IPBC za uporabu u proizvodima koji pripadaju vrsti proizvoda 8, sredstvima za zaštitu drva, kako je utvrđeno u Prilogu V. Direktivi 98/8/EZ.
By virtue of Article 86 of Regulation (EU) No 528/2012, this substance is therefore an approved active substance included in the list referred to in Article 9(2) of that Regulation.
Na temelju članka 86. Uredbe (EU) br. 528/2012, ta je tvar stoga odobrena aktivna tvar uvrštena u popis iz članka 9. stavka 2. te Uredbe.
In accordance with Article 8 of Directive 98/8/EC, the company ISP Cologne Holding GmbH submitted on 22 December 2010 an application to Denmark for authorisation of a wood preservative biocidal product containing IPBC (‘the contested product’).
U skladu s člankom 8. Direktive 98/8/EZ, poduzeće ISP Cologne Holding GmbH podnijelo je 22. prosinca 2010. zahtjev Danskoj za odobravanje biocidnog proizvoda za zaštitu drva, koji sadržava IPBC (dalje u tekstu: „sporni proizvod”).
Denmark authorised the contested product on 19 December 2011 for Use classes 2 and 3 of the treated wood, as described in the Technical Notes for Guidance on Product Evaluation [4].
Danska je odobrila sporni proizvod 19. prosinca 2011. za razrede uporabe 2 i 3 tretiranog drva, kako je opisano u Tehničkim bilješkama s uputama za ocjenjivanje proizvoda [4].
The product authorisation covers different application methods, including automated dipping for professional use.
Odobravanje proizvoda obuhvaća različite metode primjene, uključujući automatizirano uranjanje za profesionalnu uporabu.
Two Member States have subsequently authorised the contested product through mutual recognition.
Dvije države članice zatim su odobrile sporni proizvod međusobnim priznavanjem.
ISP Cologne Holding GmbH (‘the applicant’) submitted on 20 February 2012 a complete application to Germany for mutual recognition of the authorisation of the contested product granted by Denmark.
Poduzeće ISP Cologne Holding GmbH (dalje u tekstu: „podnositelj zahtjeva”). 20. veljače 2012. podnijelo je Njemačkoj potpuni zahtjev za međusobno priznavanje odobrenja spornog proizvoda koje je izdala Danska.
Germany has notified the Commission, the other Member States and the applicant on 30 August 2013 of its proposal to restrict the authorisation in accordance with Article 4(4) of Directive 98/8/EC.
Njemačka je 30. kolovoza 2013. obavijestila Komisiju, druge države članice i podnositelja zahtjeva o svojem prijedlogu za ograničavanje odobrenja u skladu s člankom 4. stavkom 4. Direktive 98/8/EZ.