natgillin/translations-raw huggingface dataset:
Germany considers that the contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the human health and the environment.
Njemačka smatra da sporni proizvod ne ispunjava zahtjeve iz članka 5. stavka 1. Direktive 98/8/EZ u pogledu zdravlja ljudi i okoliša.
According to Germany, the assessment performed by Denmark did not appropriately address the environmental concerns raised by the contested product.
Po mišljenju Njemačke procjenom Danske nije na odgovarajući način obrađena potencijalna opasnost spornog proizvoda za okoliš.
The environmental risk assessment performed by Germany of the service life of treated wood under Use Class 3 conditions concluded in an unacceptable risk for the soil compartment at day 30 (‘time 1’) regardless of the application method.
Procjenom rizika za okoliš Njemačke u pogledu životnog vijeka tretiranog drva u skladu s uvjetima razreda uporabe 3 zaključeno je da je riječ o neprihvatljivom riziku za tlo nakon tridesetog dana („vrijeme 1”) bez obzira na metodu primjene.
As a result, Germany proposes not to authorise the use of wood treated with the contested product under Use class 3 conditions.
Zbog toga Njemačka predlaže odbijanje odobravanja uporabe drva tretiranog spornim proizvodom na temelju uvjeta razreda uporabe 3.
Germany also considers that the application by automated dipping should be limited to systems with a sufficiently high degree of automation due to unacceptable risks on the human health of professional users.
Njemačka također smatra da bi primjena proizvoda 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 notification 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, Denmark and the applicant.
U tom roku primjedbe su dostavile Njemačka, Danska 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.
O obavijesti su Komisija i nadležna tijela država članica za biocidne proizvode raspravljali 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 evaluation carried out by Denmark is compatible with current guidance [5].
Uzimajući u obzir rizike za okoliš, iz tih rasprava i primjedbi proizlazi da je ocjena Danske u skladu s trenutačnim smjernicama [5].
Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated wood under Use classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the service life is deemed acceptable.
Ako je rizik u vremenu 1 utvrđen kao rezultat pretpostavljenog najgoreg razvoja događaja, može se smatrati da je uporaba tretiranog drva u skladu s uvjetima razreda uporabe 2 i 3 sigurna kada se rizik za okoliš na kraju radnoga vijeka smatra prihvatljivim.
The Commission also notes that cases where an unacceptable risk is identified at time 1 are currently under discussion at Union level in order to establish a harmonised approach.
Komisija napominje i da se o slučajevima kada je u vremenu 1 utvrđen neprihvatljiv rizik trenutačno raspravlja na razini Unije kako bi se uspostavio usklađen pristup.
Against this background the Commission considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested product by the Denmark should be considered as valid until the renewal of the product authorisation.
U tom kontekstu Komisija smatra da bi se, dok se takav pristup službeno ne donese, zaključci Ujedinjene Kraljevine nakon procjene spornog proizvoda trebali smatrati valjanima do obnove odobrenja proizvoda.
In the light of those comments, the Commission supports the conclusions of the evaluation carried out by Denmark and the other Member States having approved the product through mutual recognition, considering that the contested product fulfils the requirements set by Article 5(1) of Directive 98/8/EC with regard to the environment.
U svjetlu tih argumenata Komisija podupire zaključke ocjene koju su provele Danska i druge države članice koje su odobrile proizvod međusobnim priznavanjem te smatra da sporni proizvod ispunjava 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 authorisation cannot be justified on the grounds put forward.
Komisija stoga smatra da zahtjev Njemačke za ograničavanje 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 [6] addressing the protection of the health of professional users when applying IPBC containing products by this application method.
Uzimajući u obzir primjenu proizvoda automatiziranim uranjanjem, Komisija smatra da bi sporni proizvod trebao podlijegati odredbama utvrđenima prethodnom Odlukom Komisije [6] u kojoj se obrađuje zaštita 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 trebao biti odobren podložno uputama na deklaraciji kojima se njegova uporaba ograničava na postupke automatiziranog uranjanja, a odobrenje proizvoda trebalo bi odgovarajuće izmijeniti.
This Decision applies to products identified by the following application reference number in the Reference Member State, as provided for by the Register for Biocidal Products:
Odluka se primjenjuje na proizvode navedene u zahtjevu pod sljedećim referentnim brojem u referentnoj državi članici, kako je predviđeno Registrom biocidnih proizvoda:
The proposal by Germany to restrict the authorisation granted by Denmark on 19 December 2011 of the products referred to in the Article 1, is rejected.
Prijedlog Njemačke za ograničavanje odobrenja koje je Danska 19. prosinca 2011. izdala za proizvod naveden u članku 1. odbacuje se.
Where used for automated dipping, authorisations of biocidal products identified by the application reference number listed in Article 1 shall include a condition that the label of the products contains the following instruction:
Odobrenja biocidnih proizvoda navedenih u zahtjevu pod referentnim brojem iz članka 1. 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) može se koristiti jedino u potpuno automatiziranim postupcima uranjanja kada su svi koraci postupka tretiranja i sušenja mehanizirani i ne uključuju rukovanje, 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 primjenjivo, drveni proizvodi koji se tretiraju moraju biti potpuno osigurani (npr. zateznim remenima ili stegama) prije tretiranja i tijekom postupka uranjanja te se njima ne smije rukovati dok se površina tretiranih proizvoda ne osuši.”
Available on the website http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
Dostupno na internetskoj stranici http://echa.europa.eu/documents/10162/16960215/bpd_guid_tnsg-product-evaluation_en.pdf
Report of leaching workshop (Arona, Italy, 13-14 June 2005), available on the website http://ihcp.jrc.ec.europa.eu/our_activities/public-health/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/file
Izvješće s radionice o procjeđivanju (Arona, Italija, 13. – 14. lipnja 2005.), dostupno na internetskoj stranici http://ihcp.jrc.ec.europa.eu/our_activities/public-health/risk_assessment_of_Biocides/doc/ESD/ESD_PT/PT_08/PT_8_Leaching_Workshop_2005.pdf/at_download/file
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 ograničenjima odobrenja biocidnih proizvoda koji sadržavaju IPBC, koje je prijavila Njemačka u skladu s Direktivom 98/8/EZ Europskog parlamenta i Vijeća (SL L 188, 27.6.2014., str. 85.).
rejecting the refusal of the authorisation of a biocidal product notified by Germany in accordance with Directive 98/8/EC of the European Parliament and of the Council
o odbacivanju odbijanja odobrenja za biocidni proizvod koji je prijavila Njemačka u skladu s Direktivom 98/8/EZ Europskog parlamenta i Vijeća
(notified under document C(2014) 7915)
(priopćeno pod brojem dokumenta C(2014) 7915)
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] sadržava popis aktivnih tvari koje su odobrene na razini Unije za uporabu u biocidnim proizvodima.
Commission Directives 2008/78/EC [3], 2008/79/EC [4] and 2008/86/EC [5] added the active substances propiconazole, IPBC and tebuconazole, 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], 2008/79/EZ [4] i 2008/86/EZ [5] dodane su aktivne tvari propikonazol, IPBC i tebukonazol 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, these 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 na popis iz članka 9 stavka 2. te Uredbe.
In accordance with Article 8 of Directive 98/8/EC, the company Arch Timber Protection Ltd submitted on 2 April 2010 an application to The United Kingdom for authorisation of a wood preservative biocidal product containing propiconazole, IPBC and tebuconazole (‘the contested product’).
U skladu s člankom 8. Direktive 98/8/EZ poduzeće Arch Timber Protection Ltd. podnijelo je 2. travnja 2010. zahtjev Ujedinjenoj Kraljevini za odobravanje biocidnog proizvoda za zaštitu drva, koji sadržava propikonazol, IPBC i tebukonazol (dalje u tekstu: „sporni proizvod”).
The United Kingdom authorised the contested product on 7 June 2012 for industrial use and temporary protection of freshly sawn/felled wood and unseasoned timber only, also indicating that wood treated with this product can be used for Use Classes 2 and 3 as described in the Technical Notes for Guidance on Product Evaluation [6].
Ujedinjena Kraljevina odobrila je sporni proizvod 7. lipnja 2012. samo za industrijsku uporabu i privremenu zaštitu svježe ispiljenog/posječenog i sirovog drva, navodeći pritom da se drvo tretirano tim proizvodom može upotrebljavati za razrede uporabe 2 i 3 kako je opisano u Tehničkim bilješkama s uputama za ocjenjivanje proizvoda [6].
The product consists of two packs to be mixed and diluted at industrial premises depending on site-specific application conditions by dipping or enclosed deluge.
Proizvod se sastoji od dva pakiranja čiji se sadržaj miješa i razrjeđuje u industrijskim pogonima uranjanjem ili potapanjem, ovisno o uvjetima primjene na posebnim lokacijama.
Ten Member States have subsequently authorised the contested product through mutual recognition.
Deset država članica zatim je odobrilo sporni proizvod međusobnim priznavanjem.
Arch Timber Protection Ltd (‘the applicant’) submitted on 16 July 2012 a complete application to Germany for mutual recognition of the authorisation of the contested product granted by the United Kingdom.
Poduzeće Arch Timber Protection Ltd. (dalje u tekstu: „podnositelj zahtjeva”) 16. srpnja 2012. podnijelo je Njemačkoj potpuni zahtjev za međusobno priznavanje odobrenja spornog proizvoda koji je odobrila Ujedinjena Kraljevina.
Germany notified the Commission, the other Member States and the applicant on 19 August 2013 of its proposal to refuse the authorisation in accordance with Article 4(4) of Directive 98/8/EC.
Njemačka je 19. kolovoza 2013. obavijestila Komisiju, druge države članice i podnositelja zahtjeva o svojem prijedlogu za odbijanje odobrenja u skladu s člankom 4. stavkom 4. Direktive 98/8/EZ.
Germany considered that the contested product does not meet the requirements of Article 5(1) of Directive 98/8/EC with regard to the environment.
Njemačka je smatrala da sporni proizvod ne ispunjava zahtjeve iz članka 5. stavka 1. Direktive 98/8/EZ u pogledu okoliša.
According to Germany, the authorisation did not reflect well that the product was intended for temporary wood protection and the product was not appropriately assessed by the United Kingdom in terms of environmental risks.
Po mišljenju Njemačke odobrenjem se ne odražava na odgovarajući način činjenica da je proizvod namijenjen za privremenu zaštitu drva te ga Ujedinjena Kraljevina nije prikladno procijenila u smislu rizika za okoliš.
The assessment performed by Germany concluded in an unacceptable risk for the environment at day 30 following the application of the product (‘time 1’), which also raised concerns regarding the potential use of wood treated with the contested product under Use Classes 2 and 3 conditions.
Procjenom Njemačke zaključeno je da je riječ o neprihvatljivom riziku za okoliš tridesetog dana nakon primjene proizvoda („vrijeme 1”), što je izazvalo zabrinutost u pogledu moguće uporabe drva tretiranog spornim proizvodom na temelju uvjeta razreda uporabe 2 i 3.
Germany also considered that, since the ratio of the active substances and non-active substances in the working solutions of the product is variable, the product does not meet the definition of biocidal products in Article 2(a) of Directive 98/8/EC and should have been authorised as a frame formulation as defined by Article 2(j) of Directive 98/8/EC.
Njemačka također smatra da, budući da je omjer aktivnih i neaktivnih tvari u radnoj otopini proizvoda promjenjiv, proizvod ne odgovara definiciji biocidnih pripravaka iz članka 2. točke (a) Direktive 98/8/EZ i trebao je biti odobren kao okvirna formulacija kako je definirano člankom 2. točkom (j) Direktive 98/8/EZ.
The Commission invited other Member States and the applicant to submit comments to the notification 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 pisanom obliku dostave primjedbe na obavijest 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 on 24 September 2013 in the meeting of the coordination group established under Article 35 of Regulation (EU) No 528/2012.
O obavijesti se raspravljalo i 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 evaluation carried out by the United Kingdom, in the absence of an agreed model for temporary wood protection, followed the best guidance available at the time [7], which is based on models for treated wood to be placed on the market under Use Classes 2 and 3 conditions.
Uzimajući u obzir rizike za okoliš, iz tih rasprava i primjedbi proizlazi da je Ujedinjena Kraljevina pri provedbi ocjene, u nedostatku dogovorenog modela za privremenu zaštitu drva, slijedila tadašnje najbolje smjernice [7] koje se temelje na modelima za tretirano drvo koje se stavlja na tržište u skladu s uvjetima razreda uporabe 2 i 3.
The assessment was also based on a worst-case assumption of a complete release of the active substances at time 1.
Procjena je temeljena i na pretpostavljenom najgorem razvoju događaja u smislu potpunog otpuštanja aktivne tvari u vremenu 1.
It also follows that the evaluation performed by the United Kingdom following those models is compatible with current guidance [8].
Također proizlazi da je ocjena koju je provela Ujedinjena Kraljevina slijedeći te modele u skladu s trenutačnim smjernicama [8].
Where a risk is identified at time 1 as a result of a worst-case assumption, safe use of treated wood under Use Classes 2 and 3 conditions can be assumed when the risk for the environment at the end of the service life is considered acceptable.
Ako je rizik u vremenu 1 utvrđen kao rezultat pretpostavljenog najgoreg razvoja događaja, može se smatrati da je uporaba tretiranog drva u skladu s uvjetima razreda uporabe 2 i 3 sigurna kada se rizik za okoliš na kraju radnoga vijeka smatra prihvatljivim.
Against this background the Commission considers that, until such an approach is formally adopted, the conclusions of the assessment of the contested product by the United Kingdom should be considered as valid until the renewal of the product authorisation.
U tom kontekstu Komisija smatra da bi se, dok se takav pristup službeno ne donese, zaključci Ujedinjene Kraljevine nakon procjene spornog proizvoda trebali smatrati valjanima do obnove odobrenja proizvoda.
With regard to the identity of the product, from those discussions and comments it follows that the contested product, in the form in which it is supplied to the industrial users, has specific fixed concentrations of the active and non-active substances.
U odnosu na identitet proizvoda, iz tih rasprava i primjedbi proizlazi da sporni proizvod, u obliku u kojem se dostavlja industrijskim korisnicima, ima specifične fiksne koncentracije aktivnih i neaktivnih tvari.
The Commission considers that the fact that industrial users can prepare different solutions of the product at the work place, which are process dependant, cannot be interpreted in a way as if the authorisation holder was placing on the market a group of different biocidal products as referred to in Article 2(j) of Directive 98/8/EC.
Komisija smatra da se činjenica da industrijski korisnici mogu pripremiti različite otopine proizvoda na radnome mjestu, koje ovise o postupku, ne može tumačiti kao da je nositelj odobrenja stavio na tržište skupinu različitih biocidnih proizvoda kako je navedeno u članku 2. točki (j) Direktive 98/8/EZ.
In the light of those arguments, the Commission supports the conclusions of the evaluation carried out by the United Kingdom and the other Member States having approved the product through mutual recognition, considering that the contested product meets the definition in Article 2(a) of Directive 98/8/EC and fulfils the requirements set by Article 5(1) of that Directive with regard to the environment.
U svjetlu tih argumenata Komisija podupire zaključke ocjene koju su provele Ujedinjena Kraljevina i druge države članice koje su odobrile proizvod međusobnim priznavanjem te smatra da sporni proizvod odgovara definiciji iz članka 2. točke (a) Direktive 98/8/EZ i zadovoljava uvjete utvrđene člankom 5. stavkom 1. te Direktive u pogledu okoliša.
The Commission therefore considers that the request by Germany to refuse the authorisation cannot be justified on the grounds put forward.
Komisija stoga smatra da zahtjev Njemačke za odbijanje odobrenja ne može biti opravdan navedenim razlozima.
Finally, on the basis of the discussions held, it appears necessary to explicitly mention in the product authorisation that the use of the product is for temporary wood protection and to ensure, as a condition for the authorisation, that specific instructions for use of the product are provided to industrial users taking into consideration the characteristics of the industrial sites where the product is to be used.
Konačno, na temelju održanih rasprava, u odobrenju proizvoda potrebno je izričito napomenuti da je on namijenjen privremenoj zaštiti drva i, kao uvjet za odobrenje, osigurati da se industrijskim korisnicima dostave posebne upute za uporabu proizvoda u kojima se uzimaju u obzir značajke industrijskih područja u kojima će se proizvod upotrebljavati.
The proposal by Germany to refuse the authorisation granted by the United Kingdom on 7 June 2012 of the products referred to in Article 1, is rejected.
Prijedlog Njemačke za odbijanje odobrenja koje je Ujedinjena Kraljevina izdala 7. lipnja 2012. za proizvod naveden u članku 1. odbacuje se.
The intended use described in the product authorisation shall be amended as follows:
Predviđena uporaba opisana u odobrenju proizvoda mijenja se kako slijedi:
‘For temporary wood protection use against wood staining fungi and surface moulds on freshly sawn/felled wood and unseasoned timber only. Wood treated with this product can be used for Use Classes 2 and 3 (i.e. timbers not in ground contact, either continually exposed to the weather or protected from the weather but subject to frequent wetting).’ .
„Za privremenu zaštitu drva od gljivica koje uzrokuju promjenu boje i površinskih plijesni na svježe ispiljenom/posječenom i sirovom drvu. Drvo tretirano tim proizvodom može se upotrebljavati za razrede uporabe 2 i 3 (tj. drvo koje nije u kontaktu s tlom, trajno izloženo vremenskim uvjetima ili zaštićeno od njih, ali izloženo čestom močenju).”
The following condition for authorisation is imposed to the products referred to in Article 1:
Za proizvode navedene u članku 1. uvodi se sljedeći uvjet za odobrenje:
‘As a condition of the authorisation, the authorisation holder must ensure that detailed instructions for use of the product, taking into account the characteristics of the industrial site where the product is to be used, are provided to users at the site of application.’ .
„Kao uvjet za odobrenje, nositelj odobrenja mora osigurati da se detaljne upute za uporabu proizvoda, uzimajući u obzir značajke industrijskog područja u kojem će se proizvod upotrebljavati, dostave korisnicima na mjestu primjene.”
Commission Directive 2008/86/EC of 5 September 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include tebuconazole as an active substance in Annex I thereto (OJ L 239, 6.9.2008, p. 9).
Direktiva Komisije 2008/86/EZ od 5. rujna 2008. o izmjeni Direktive 98/8/EZ Europskog parlamenta i Vijeća radi uvrštenja tebukonazola kao aktivne tvari u njezin Prilog I. (SL L 239, 6.9.2008., str. 9.).
See OECD Emission Scenario Documents (EDS) for Wood Preservatives:
Vidjeti dokumente OECD-a o scenarijima emisija za sredstva za zaštitu drva:
Part 1 — 4 (2003), available on the website http://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents
Dio 1. – 4. (2003.), dostupan na internetskoj stranici http://echa.europa.eu/guidance-documents/guidance-on-biocides-legislation/emission-scenario-documents