natgillin/translations-raw huggingface dataset:
PHMB (1415; 4.7) is approved as an active substance for use in biocidal products of product-types 2 and 4, subject to the specifications and conditions set out in the Annex.
Prije odobrenja aktivne tvari zainteresiranim stranama trebalo bi omogućiti primjereno razdoblje za poduzimanje pripremnih mjera potrebnih za ispunjavanje novih zahtjeva.
Done at Brussels, 20 April 2018.
PHMB (1415; 4.7) se odobrava kao aktivna tvar za uporabu u biocidnim proizvodima vrsta 2 i 4, podložno specifikacijama i uvjetima iz Priloga.
OJ L 167, 27.6.2012, p. 1.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
Commission Delegated Regulation (EU) No 1062/2014 of 4 August 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 (OJ L 294, 10.10.2014, p. 1).
Sastavljeno u Bruxellesu 20. travnja 2018.
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 (OJ L 396, 30.12.2006, p. 1).
Za Komisiju
Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
Predsjednik
ANNEX
SL L 167, 27.6.2012., str. 1.
Common Name
Delegirana uredba Komisije (EU) br. 1062/2014 оd 4. kolovoza 2014. o programu rada za sustavni pregled svih postojećih aktivnih tvari sadržanih u biocidnim proizvodima iz Uredbe (EU) br. 528/2012 Europskog parlamenta i Vijeća (SL L 294, 10.10.2014., str. 1.).
IUPAC Name
Uredba (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 (SL L 396, 30.12.2006., str. 1.).
Identification Numbers
Uredba (EZ) br. 1935/2004 Europskog parlamenta i Vijeća od 27. listopada 2004. o materijalima i predmetima koji dolaze u dodir s hranom i stavljanju izvan snage direktiva 80/590/EEZ i 89/109/EEZ (SL L 338, 13.11.2004., str. 4.).
Minimum degree of purity of the active substance
PRILOG
Specific conditions
Najmanji stupanj čistoće aktivne tvari
PHMB (1415; 4.7) (polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7)
Datum odobrenja
CoPoly(bisiminoimidocarbonyl, hexamethylene hydrochloride),(iminoimidocarbonyl, hexamethylene hydrochloride)
Vrsta proizvoda
EC No: not available
Posebne odredbe
CAS No: 32289-58-0 and 1802181-67-4
PHMB (1415; 4.7) (poliheksametilen bigvanid hidroklorid s općim prosjekom molekulne mase (Mn) od 1415 i prosječnom polidisperznošću (PDI) od 4.7)
943g/kg (calculated dry weight specification).
Kemijski naziv prema IUPAC-u:
The active substance as manufactured is an aqueous solution of 20 % w/w of PHMB (1415; 4.7)
Kopoli(bisiminoimidokarbonil, heksametilen hidroklorid), (iminoimidokarbonil, heksametilen hidroklorid)
1 November 2019
EZ br.: nije dostupan
31 October 2026
CAS br.: 32289-58-0 i 1802181-67-4
PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
943 g/kg (izračunana specifikacija suhe tvari).
The authorisations of biocidal products are subject to the following conditions:
Aktivna tvar kako je proizvedena vodena je otopina s 20 % masenog udjela PHMB-a (1415; 4.7)
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance;
1. studenoga 2019.
in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:
31. listopada 2026.
professional users;
PHMB (1415; 4.7) se smatra potencijalnom tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (d) Uredbe (EU) br. 528/2012.
non-professional users;
Odobrenja za biocidne proizvode podliježu sljedećim uvjetima:
secondary exposure of the general public and toddlers;
Pri ocjeni proizvoda posebna se pozornost posvećuje izloženosti, rizicima i učinkovitosti povezanima sa svim uporabama na koje se odnosi zahtjev za odobrenje, a koje nisu proučene u okviru procjene rizika za aktivnu tvar na razini Unije.
environment: surface water, sediment and soil.
S obzirom na rizike utvrđene za ocijenjene uporabe, pri ocjeni proizvoda posebna se pozornost posvećuje sljedećem:
The placing on the market of treated articles is subject to the following condition:
profesionalnim korisnicima;
The person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1415; 4.7) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
neprofesionalnim korisnicima;
PHMB (1415; 4.7) is considered a candidate for substitution in accordance with point (d) of Article 10(1) Regulation (EU) No 528/2012.
sekundarnoj izloženosti šire javnosti i male djece;
secondary exposure of the general public;
zaštiti okoliša: površinskim vodama, sedimentima i tlu.
environment: surface water, sediment and soil;
Stavljanje tretiranih proizvoda na tržište podliježe sljedećem uvjetu:
for products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded;
Osoba odgovorna za stavljanje na tržište proizvoda koji je tretiran PHMB-om (1415; 4.7) ili ga sadržava mora osigurati da su na oznaci tog tretiranog proizvoda navedene informacije iz članka 58. stavka 3. drugog podstavka Uredbe (EU) br. 528/2012.
products shall not be incorporated in materials and articles intended to come into contact with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004, unless the Commission has established specific limits on the migration of PHMB (1415; 4.7) into food or it has been established pursuant to that Regulation that such limits are not necessary.
PHMB (1415; 4.7) se smatra potencijalnom tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (d) Uredbe (EU) br. 528/2012.
the person responsible for the placing on the market of a treated article treated with or incorporating PHMB (1415; 4.7) shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
sekundarnoj izloženosti šire javnosti;
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
zaštiti okoliša: površinskim vodama, sedimentima i tlu.
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Za proizvode čiji se ostaci mogu nalaziti u hrani ili hrani za životinje treba provjeriti je li potrebno odrediti nove ili izmijeniti postojeće maksimalne razine ostataka (MRO-i) u skladu s Uredbom (EZ) br.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p.
470/2009 Europskog parlamenta i Vijeća ili Uredbom (EZ) br.
11).
396/2005 Europskog parlamenta i Vijeća te poduzeti sve odgovarajuće mjere za smanjenje rizika kako bi se osiguralo da se ne prekorače primjenjivi MRO-i.
approving azoxystrobin as an active substance for use in biocidal products of product-types 7, 9 and 10
o odobrenju azoksistrobina kao postojeće aktivne tvari za uporabu u biocidnim proizvodima vrsta 7, 9 i 10
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, and in particular Article 9(1)(a) 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, a posebno njezin članak 9. stavak 1. točku (a),
The United Kingdom received on 13 April 2014 an application for the approval of the active substance azoxystrobin for use in biocidal products of product-type 7, film preservatives, product-type 9, fibre, leather, rubber and polymerised materials preservatives, and product-type 10, construction material preservatives, as described in Annex V to Regulation (EU) No 528/2012.
Ujedinjena Kraljevina primila je 13. travnja 2014. zahtjev za odobrenje aktivne tvari azoksistrobin za uporabu u biocidnim proizvodima vrste 7, „Sredstva za zaštitu površine”, vrste 9, „Sredstva za zaštitu vlakana, kože, gume i polimeriziranih materijala”, i vrste 10, „Sredstva za zaštitu građevinskih materijala”, kako su utvrđene u Prilogu V. Uredbi (EU) br. 528/2012.
The United Kingdom submitted the assessment reports together with its recommendations on 1 December 2016 in accordance with Article 8(1) of Regulation (EU) No 528/2012.
Ujedinjena Kraljevina podnijela je 1. prosinca 2016. izvješća o ocjeni zajedno sa svojim preporukama, u skladu s člankom 8. stavkom 1.
The opinions of the European Chemicals Agency were formulated on 3 October 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.
Uredbe (EU) br. 528/2012.
According to those opinions, biocidal products of product-types 7, 9 and 10 containing azoxystrobin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.
Odbor za biocidne proizvode 3. listopada 2017. sastavio je mišljenja Europske agencije za kemikalije, uzimajući u obzir zaključke nadležnog ocjenjivačkog tijela.
It is therefore appropriate to approve azoxystrobin for use in biocidal products of product-types 7, 9 and 10, subject to compliance with certain specifications and conditions.
U skladu s tim mišljenjima može se očekivati da će biocidni proizvodi vrsta 7, 9 i 10 koji sadržavaju azoksistrobin ispuniti zahtjeve iz članka 19. stavka 1. točke (b) Uredbe (EU) br. 528/2012 ako se zadovolje određene specifikacije i uvjeti koji se odnose na njihovu uporabu.
The opinions conclude that azoxystrobin meets the criteria for being a very persistent (vP) and toxic (T) substance according to Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council.
Stoga je primjereno odobriti azoksistrobin za uporabu u biocidnim proizvodima vrsta 7, 9 i 10 podložno određenim specifikacijama i uvjetima.
Azoxystrobin therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.
U mišljenjima je navedeno da azoksistrobin ispunjava kriterije za vrlo postojane (vP) i otrovne (T) tvari u skladu s Prilogom XIII.
Since azoxystrobin meets the criteria for being very persistent (vP) according to Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating azoxystrobin should be appropriately labelled when placed on the market.
Azoksistrobin stoga ispunjuje uvjete iz članka 10. stavka 1. točke (d) Uredbe (EU) br. 528/2012 i trebalo bi ga se smatrati potencijalnom tvari za zamjenu.
A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.
U skladu s člankom 10. stavkom 4. te uredbe, odobrenje aktivne tvari koja se smatra potencijalnom tvari za zamjenu trebalo bi biti za razdoblje od najviše sedam godina.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Budući da azoksistrobin ispunjuje kriterije kao vrlo postojan (vP) u skladu s Prilogom XIII.
HAS ADOPTED THIS REGULATION:
Uredbi (EZ) br. 1907/2006, tretirane proizvode koji su tretirani azoksistrobinom ili ga sadržavaju trebalo bi na prikladan način označiti pri stavljanju na tržište.
Article 1
Prije odobrenja aktivne tvari zainteresiranim stranama trebalo bi omogućiti primjereno razdoblje za poduzimanje pripremnih mjera potrebnih za ispunjavanje novih zahtjeva.
Azoxystrobin is approved as an active substance for use in biocidal products of product-types 7, 9 and 10, subject to the specifications and conditions set out in the Annex.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za biocidne proizvode,
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Azoksistrobin se odobrava kao aktivna tvar za uporabu u biocidnim proizvodima vrsta 7, 9 i 10, podložno specifikacijama i uvjetima iz Priloga.
Done at Brussels, 20 April 2018.
Članak 2.
OJ L 167, 27.6.2012, p. 1.
Sastavljeno u Bruxellesu 20. travnja 2018.
Common Name
SL L 167, 27.6.2012., str. 1.
Minimum degree of purity of the active substance
Uobičajeni naziv
Product type
Najmanji stupanj čistoće aktivne tvari
Azoxystrobin
Datum isteka odobrenja
Methyl(E)-2-2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl-3-methoxyacrylate
Posebne odredbe
EC No: not available
Azoksistrobin
CAS No: 131860-33-8
Kemijski naziv prema IUPAC-u:
1 November 2018
Metil(E)-2-2[6-(2-cijanofenoksi)pirimidin-4-iloksi]fenil-3-metoksiakrilat
31 October 2025
EZ br.: nije dostupan
Azoxystrobin is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.
CAS br.: 131860-33-8
The authorisations of biocidal products are subject to the following condition:
1. studenoga 2018.
The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
31. listopada 2025.
The placing on the market of treated articles is subject to the following condition:
Azoksistrobin se smatra potencijalnom tvari za zamjenu u skladu s člankom 10. stavkom 1. točkom (d) Uredbe (EU) br.
The person responsible for the placing on the market of a treated article treated with or incorporating azoxystrobin shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.
528/2012.
Azoxystrobin is considered a candidate for substitution in accordance with Article 10(1)(d) of Regulation (EU) No 528/2012.
Odobrenja za biocidne proizvode podliježu sljedećem uvjetu:
The purity indicated in this column was the minimum degree of purity of the active substance evaluated.
Pri ocjeni proizvoda posebna se pozornost posvećuje izloženosti, rizicima i učinkovitosti povezanima sa svim uporabama na koje se odnosi zahtjev za odobrenje, a koje nisu proučene u okviru procjene rizika za aktivnu tvar na razini Unije.
The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Stavljanje tretiranih proizvoda na tržište podliježe sljedećem uvjetu:
supplementing Regulation (EU) 2017/1001 of the European Parliament and of the Council on the European Union trade mark, and repealing Delegated Regulation (EU) 2017/1430
o dopuni Uredbe (EU) 2017/1001 Europskog parlamenta i Vijeća o žigu Europske unije i o stavljanju izvan snage Delegirane uredbe (EU) 2017/1430
Having regard to Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark, and in particular Article 48, Article 49(3), Article 65, Article 73, Article 96(4), Article 97(6), Article 98(5), Article 100(2), Article 101(5), Article 103(3), Article 106(3), Article 121, Article 168, Article 194(3) and Article 196(4) thereof,
uzimajući u obzir Uredbu (EU) 2017/1001 Europskog parlamenta i Vijeća od 14. lipnja 2017. o žigu Europske unije, a posebno njezin članak 48., članak 49. stavak 3., članak 65., članak 73., članak 96. stavak 4., članak 97. stavak 6., članak 98. stavak 5., članak 100. stavak 2., članak 101. stavak 5., članak 103. stavak 3., članak 106. stavak 3., članak 121., članak 168., članak 194. stavak 3. i članak 196. stavak 4.,
Council Regulation (EC) No 40/94, which was codified as Council Regulation (EC) No 207/2009, created a system specific to the Union for the protection of trade marks to be obtained at the level of the Union on the basis of an application to the European Union Intellectual Property Office (‘the Office’).
Uredbom Vijeća (EZ) br. 40/94, koja je kodificirana kao Uredba Vijeća (EZ) br. 207/2009, stvoren je za Europsku uniju specifičan sustav zaštite žigova koji se stječu na razini Unije na temelju prijave koja se podnosi Uredu Europske unije za intelektualno vlasništvo („Ured”).
Regulation (EU) 2015/2424 of the European Parliament and of the Council amending Regulation (EC) No 207/2009 aligned the powers conferred therein upon the Commission with Articles 290 and 291 of the Treaty on the Functioning of the European Union.
Uredbom (EU) 2015/2424 Europskog parlamenta i Vijeća o izmjeni Uredbe Vijeća (EZ) br. 207/2009 uskladile su se ovlasti dodijeljene Komisiji s člancima 290. i 291.
In order to conform with the new legal framework resulting from that alignment, Commission Delegated Regulation (EU) 2017/1430 and Commission Implementing Regulation (EU) 2017/1431 were adopted.
Ugovora o funkcioniranju Europske Unije.
Regulation (EC) No 207/2009 was codified as Regulation (EU) 2017/1001.
Radi prilagodbe novom pravnom okviru proizašlom iz tog usklađivanja, donesene su Delegirana uredba Komisije (EU) 2017/1430 i Provedbena uredba Komisije (EU) 2017/1431.
For reasons of clarity and simplification, the references contained in a Delegated Regulation should reflect the renumbering of articles resulting from such a codification of the relevant basic act.
Uredba (EZ) br. 207/2009 kodificirana je kao Uredba (EU) 2017/1001.
Delegated Regulation (EU) 2017/1430 should therefore be repealed and the provisions of that Delegated Regulation should be laid down, with updated references to Regulation (EU) 2017/1001, in this Regulation.
Radi jasnoće i pojednostavnjenja, upućivanja iz Delegirane uredbe trebala bi odražavati novo brojčano označivanje članaka koje je rezultat te kodifikacije relevantnog osnovnog akta.
The procedural rules on opposition should ensure an effective, efficient and expeditious examination and registration of EU trade mark applications by the Office using a procedure which is transparent, thorough, fair and equitable.
Stoga bi Delegirana uredba (EU) 2017/1430 trebala biti stavljena izvan snage, a odredbe te delegirane uredbe s ažuriranim upućivanjima na Uredbu (EU) 2017/1001 trebale bi biti propisane u ovoj Uredbi.
In order to enhance legal certainty and clarity, those opposition rules should take account of the extended relative grounds for refusal laid down in Regulation (EU) 2017/1001, in particular as regards the requirements for admissibility and substantiation of opposition proceedings, and be adjusted to better reflect the case-law of the Court of Justice of the European Union and to codify the practice of the Office.
Pravilima o postupku povodom prigovora trebalo bi se osigurati da Ured učinkovito, djelotvorno i brzo obavlja ispitivanje i registraciju prijava žiga EU-a primjenom transparentnog, podrobnog, pravičnog i ravnopravnog postupka.
In order to allow for a more flexible, consistent and modern trade mark system in the Union, while ensuring legal certainty, it is appropriate to reduce the administrative burden for the parties in inter partes proceedings by relaxing the requirements for the substantiation of earlier rights in cases where the content of the relevant evidence is accessible online from a source recognised by the Office, as well as the requirement of submitting evidence in the language of the proceedings.
U cilju povećanja pravne sigurnosti i jasnoće, tim pravilima o postupku povodom prigovora trebali bi se uzeti u obzir prošireni relativni razlozi za odbijanje propisani u Uredbi (EU) 2017/1001, posebno u pogledu zahtjeva za dopuštenost i potkrjepljenje postupaka povodom prigovora, i prilagoditi kako bi se više temeljili na sudskoj praksi Suda Europske unije i radi kodifikacije prakse Ureda.
According to settled case-law of the Court of Justice, unless otherwise provided, the Office enjoys discretionary powers when examining belated evidence, submitted for the purpose of either substantiating an opposition or proving genuine use of the earlier mark in the context of opposition or invalidity proceedings.
Nadalje, zahtjevi za prijenos žiga EU-a registriranog na ime neovlaštenog zastupnika trebali bi se rješavati u istom postupku kao i postupci za proglašavanje ništavosti koji u praksi služe kao alternativa za poništenje žiga.
In order to ensure legal certainty the relevant boundaries of such discretion should be accurately reflected in the rules governing opposition proceedings or proceedings for the declaration of invalidity of EU trade marks.
U skladu s utvrđenom sudskom praksom Suda EU-a, ako nije predviđeno drugačije, Ured ima diskrecijske ovlasti u postupku ispitivanja zakašnjelih dokaza koji su podneseni radi potkrjepljenja prigovora ili radi dokazivanja stvarne uporabe ranijeg žiga u kontekstu postupka povodom prigovora ili postupka za proglašavanje ništavosti.
In order to allow for an effective, efficient and, within the scope of the appeal defined by the parties, complete review of decisions taken by the Office in the first instance by means of a transparent, thorough, fair and impartial appeal procedure suited to the specific nature of intellectual property law and taking into account the principles laid down in Regulation (EU) 2017/1001, it is appropriate to reinforce legal certainty and predictability by clarifying and specifying the procedural rules and the parties' procedural guarantees, in particular where a defendant makes use of the right to file a cross appeal.
Kako bi se osigurala pravna sigurnost, odgovarajuće granice te diskrecijske ovlasti trebale bi biti točno utvrđene u pravilima koja se primjenjuju na postupak povodom prigovora ili postupak za proglašavanje ništavosti žigova EU-a.