natgillin/translations-raw huggingface dataset:
By way of derogation from paragraph 1, for each authorised plant protection product containing bixafen as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 30 September 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation.
Z odstopanjem od odstavka 1 države članice znova ocenijo vsako registrirano fitofarmacevtsko sredstvo, ki vsebuje biksafen kot edino aktivno snov ali kot eno od več aktivnih snovi, vključenih v Prilogo k Izvedbeni uredbi (EU) št. 540/2011, najpozneje do 30. septembra 2013 po enotnih načelih iz člena 29(6) Uredbe (ES) št. 1107/2009, na podlagi dokumentacije, ki izpolnjuje zahteve iz Priloge III k Direktivi 91/414/EGS, in ob upoštevanju stolpca o posebnih določbah iz Priloge I k tej uredbi.
in the case of a product containing bixafen as the only active substance, where necessary, amend or withdraw the authorisation by 31 March 2015 at the latest; or
če sredstvo vsebuje biksafen kot edino aktivno snov, po potrebi spremenijo ali prekličejo registracijo najpozneje do 31. marca 2015 ali
in the case of a product containing bixafen as one of several active substances, where necessary, amend or withdraw the authorisation by 31 March 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
če sredstvo vsebuje biksafen kot eno od več aktivnih snovi, registracijo po potrebi spremenijo ali prekličejo najpozneje do 31. marca 2015 ali do datuma, določenega za tako spremembo ali preklic v ustreznih aktih, s katerimi so bile zadevne snovi dodane v Prilogo I k Direktivi 91/414/EGS oziroma s katerimi so bile zadevne snovi odobrene, pri čemer se upošteva poznejši datum.
CAS No 581809-46-3
št. CAS 581809-46-3
CIPAC No 819
št. CIPAC 819
For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
Za izvajanje enotnih načel iz člena 29(6) Uredbe (ES) št. 1107/2009 se upoštevajo ugotovitve iz poročila o pregledu biksafena ter zlasti dodatkov I in II h končni različici poročila, ki jo je Stalni odbor za prehranjevalno verigo in zdravje živali pripravil 15. marca 2013.
the residues of bixafen and of its metabolites in rotational crops;
ostanke biksafena in njegovih metabolitov v kmetijskih rastlinah, ki sledijo v kolobarju;
the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;
zaščito podtalnice, kadar se aktivna snov uporablja na območjih z občutljivimi tlemi in/ali neugodnimi podnebnimi razmerami;
the risk to soil and sediment-dwelling organisms.
tveganje za organizme, ki živijo v tleh in usedlinah.
In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC [2] is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011.
V skladu s členom 80(1)(a) Uredbe (ES) št. 1107/2009 ter ob upoštevanju postopka in pogojev za odobritev je treba Direktivo Sveta 91/414/EGS [2] uporabljati za aktivne snovi, v zvezi s katerimi je bila pred 14. junijem 2011 sprejeta odločitev v skladu s členom 6(3) navedene direktive.
For bixafen the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2009/700/EC [3].
Z Odločbo Komisije 2009/700/ES [3] je bilo potrjeno, da biksafen izpolnjuje pogoje iz člena 80(1)(a) Uredbe (ES) št. 1107/2009.
Commission Implementing Regulation (EU) No 351/2013
Izvedbena uredba Komisije (EU) št. 351/2013
Commission Implementing Regulation (EU) No 352/2013
Izvedbena uredba Komisije (EU) št. 352/2013
on the issue of licences for the import of garlic in the subperiod from 1 June 2013 to 31 August 2013
o izdaji uvoznih dovoljenj za česen v podobdobju od 1. junija 2013 do 31. avgusta 2013
The quantities for which ‘A’ licence applications have been lodged by traditional importers and by new importers during the first seven working days of April 2013, pursuant to Article 10(1) of Regulation (EC) No 341/2007 exceed the quantities available for products originating in China.
Količine, za katere so tradicionalni uvozniki in novi uvozniki vložili zahtevke za izdajo dovoljenj „A“ v prvih sedmih dneh meseca aprila 2013 v skladu s členom 10(1) Uredbe (ES) št. 341/2007, presegajo količine, ki so na voljo za proizvode s poreklom iz Kitajske.
Therefore, in accordance with Article 7(2) of Regulation (EC) No 1301/2006, it is now necessary to establish the extent to which the ‘A’ licence applications sent to the Commission by 14 April 2013 can be met in accordance with Article 12 of Regulation (EC) No 341/2007.
Zato je v skladu s členom 7(2) Uredbe (ES) št. 1301/2006 treba določiti, v kolikšni meri je možno ob uporabi člena 12 Uredbe (ES) št. 341/2007 ugoditi zahtevkom za izdajo dovoljenj „A“, poslanim Komisiji najpozneje do štirinajstega v mesecu aprilu 2013.
Applications for ‘A’ import licences lodged pursuant to Article 10(1) of Regulation (EC) No 341/2007 during the first seven working days of April 2013 and sent to the Commission by 14 April 2013 shall be met at a percentage rate of the quantities applied for as set out in the Annex to this Regulation.
Zahtevkom za izdajo uvoznih dovoljenj „A“, ki so bili vloženi v skladu s členom 10(1) Uredbe (ES) št. 341/2007 v prvih sedmih dneh meseca aprila 2013 in poslani Komisiji do štirinajstega v mesecu aprilu 2013, se ugodi po odstotni stopnji zaprošenih količin, določenih v Prilogi k tej uredbi.
Commission Implementing Regulation (EU) No 353/2013
Izvedbena uredba Komisije (EU) št. 353/2013
amending Implementing Regulation (EU) No 543/2011 as regards the trigger levels for additional duties on cucumbers, cherries, other than sour, apricots, tomatoes, plums, peaches, including nectarines, and table grapes
o spremembi Izvedbene uredbe (EU) št. 543/2011 glede sprožitvenih ravni za dodatne dajatve za kumare, češnje razen višenj, marelice, paradižnik, slive, breskve, vključno z breskvami sorte brugnon in nektarinami, ter namizno grozdje
For the purposes of Article 5(4) of the Agreement on Agriculture [4] concluded during the Uruguay Round of multilateral trade negotiations and in the light of the latest data available for 2010, 2011 and 2012, the trigger levels for additional duties on cucumbers and cherries, other than sour, should be amended with effect from 1 May 2013, whilst those on apricots, tomatoes, plums, peaches, including nectarines, and table grapes should be amended with effect from 1 June 2013.
Za namene uporabe člena 5(4) Sporazuma o kmetijstvu [4], sklenjenega v okviru urugvajskega kroga večstranskih trgovinskih pogajanj, in glede na najnovejše razpoložljive podatke za leta 2010, 2011 in 2012 bi bilo treba spremeniti sprožitvene ravni za dodatne dajatve za kumare in češnje razen višenj od 1. maja 2013 dalje ter za marelice, paradižnike, slive, breskve, vključno z breskvami sorte brugnon in nektarinami, ter namizno grozdje od 1. junija 2013 dalje.
Mandarins (including tangerines and satsumas); wilkings and similar citrus hybrids
Mandarine (vključno s tangerinami in mandarinami satsuma); Mandarine wilking in podobni hibridi agrumov
Commission Implementing Regulation (EU) No 354/2013
Izvedbena uredba Komisije (EU) št. 354/2013
on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
o spremembah biocidnih proizvodov, za katere je bilo izdano dovoljenje v skladu z Uredbo (EU) št. 528/2012 Evropskega parlamenta in Sveta
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 51 thereof,
ob upoštevanju Uredbe (EU) št. 528/2012 Evropskega parlamenta in Sveta z dne 22. maja 2012 o dostopnosti na trgu in uporabi biocidnih proizvodov [1] ter zlasti člena 51 Uredbe,
In order to ensure a harmonised approach, it is appropriate to adopt provisions for changes of biocidal products in respect of any of the information submitted in relation to the initial application for the authorisation or registration of biocidal products and biocidal product families authorised or registered in accordance with Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [2] and Regulation (EU) No 528/2012.
Da bi zagotovili usklajen pristop, je primerno sprejeti določbe za spremembe biocidnih proizvodov v zvezi z informacijami, predloženimi v zvezi s prvotno vlogo za izdajo dovoljenja ali registracijo za biocidne proizvode in družine biocidnih proizvodov, za katere je izdano dovoljenje ali so registrirani v skladu z Direktivo 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [2] in Uredbo (EU) št. 528/2012.
Proposed changes of biocidal products should be classified in different categories, taking into account the extent to which they require a reassessment of the risk for human or animal health or the environment and of the efficacy of the biocidal product or biocidal product family.
Predlagane spremembe biocidnih proizvodov bi bilo treba razvrstiti v različne kategorije ob upoštevanju tega, ali je zanje potrebna ponovna ocena tveganja za zdravje ljudi in živali ali okolje ali ponovna ocena učinkovitosti biocidnega proizvoda ali družine biocidnih proizvodov.
It is appropriate to establish the criteria to be used for classifying a change of a product in one of the categories referred to in Article 50(3) of Regulation (EU) No 528/2012.
Primerno je določiti merila, ki se uporabljajo za razvrščanje spremembe proizvoda v eno od kategorij iz člena 50(3) Uredbe (EU) št. 528/2012.
In order to bring further predictability, the European Chemicals Agency (hereinafter ‘the Agency’) should issue opinions on the classification of changes of products.
Da bi omogočili večjo predvidljivost, bi morala Evropska agencija za kemikalije (v nadaljnjem besedilu: Agencija) izdati mnenja o razvrstitvi sprememb proizvodov.
The Agency should also issue guidelines on the details of the various categories of changes.
Poleg tega bi Agencija morala izdati smernice o podrobnostih posameznih kategorij sprememb.
Those guidelines should be regularly updated in the light of scientific and technical progress.
Te smernice bi bilo treba redno posodabljati glede na napredek na znanstvenem in tehničnem področju.
It is necessary to clarify the procedure which will lead to a decision by the Commission in accordance with the first subparagraph of Article 50(2) of Regulation (EU) No 528/2012 and, where relevant, Article 44(5) thereof.
Potrebno je pojasniti postopek, na podlagi katerega bo Komisija sprejela odločitev v skladu s prvim pododstavkom člena 50(2) Uredbe (EU) št. 528/2012 in po potrebi členom 44(5) Uredbe.
In order to reduce the overall number of possible applications and to enable Member States, the Agency and the Commission to focus on those changes that have a genuine impact on the properties of biocidal products, an annual reporting system should be introduced for certain changes of an administrative nature.
Da bi zmanjšali skupno število možnih vlog in državam članicam, Agenciji in Komisiji omogočili, da se osredotočijo na spremembe, ki resnično vplivajo na lastnosti biocidnih proizvodov, bi bilo treba za nekatere spremembe upravne narave uvesti letni sistem poročanja.
Such changes should not require any prior agreement and should be notified within 12 months following implementation.
Za takšne spremembe predhodno soglasje ne bi bilo potrebno, priglasiti pa bi jih bilo treba v dvanajstih mesecih po začetku izvajanja.
However, other types of changes of an administrative nature, whose immediate reporting and prior examination is necessary for the continuous supervision of the biocidal product concerned should not be subject to the annual reporting system.
Za druge vrste sprememb upravne narave, pri katerih sta za stalni nadzor nad zadevnim biocidnim proizvodom potrebna takojšnje poročanje in predhodni pregled, letni sistem poročanja ne bi smel veljati.
Each change should require a separate submission.
Za vsako spremembo bi morala biti potrebna ločena vloga.
Grouping of changes should nevertheless be allowed in certain cases, in order to facilitate the review of the changes and reduce the administrative burden.
V nekaterih primerih pa bi bilo treba dovoliti združevanje sprememb v skupine, da bi olajšali pregled sprememb in zmanjšali upravno obremenitev.
Provisions should be introduced regarding the role of the coordination group established under Regulation (EU) No 528/2012 to increase cooperation between Member States and allow for the settlement of disagreements in the evaluation of certain changes.
Uvesti bi bilo treba določbe glede vloge koordinacijske skupine, ustanovljene na podlagi Uredbe (EU) št. 528/2012 za večje sodelovanje med državami članicami in možnost reševanja sporov pri ocenjevanju nekaterih sprememb.
This Regulation should clarify when the authorisation holder is allowed to implement a given change, as such clarification is essential for economic operators.
Ta uredba bi morala pojasniti, kdaj sme imetnik dovoljenja izvesti določeno spremembo, saj je takšna pojasnitev bistvena za gospodarske subjekte.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke –
This Regulation lays down provisions concerning changes of biocidal products sought in accordance with Article 50(2) of Regulation (EU) No 528/2012 with regard to any of the information submitted in relation to the initial application for the authorisation of biocidal products or biocidal product families in accordance with Directive 98/8/EC and Regulation (EU) No 528/2012 (hereinafter ‘changes of products’).
Ta uredba vsebuje določbe glede sprememb biocidnih proizvodov, zahtevanih v skladu s členom 50(2) Uredbe (EU) št. 528/2012 glede vseh informacij, predloženih v zvezi s prvotno vlogo za izdajo dovoljenja za biocidne proizvode ali družine biocidnih proizvodov v skladu z Direktivo 98/8/ES in Uredbo (EU) št. 528/2012 (v nadaljnjem besedilu: spremembe proizvodov).
Classification of changes of products
Razvrstitev sprememb proizvodov
Changes of products are classified in accordance with the criteria laid down in the Annex to this Regulation.
Spremembe proizvodov so razvrščene v skladu z merili, določenimi v Prilogi k tej uredbi.
Certain categories of changes are listed in the tables of the Annex.
Nekatere kategorije sprememb so navedene v razpredelnicah v Prilogi.
The holder of an authorisation may request the Agency to provide an opinion on the classification in accordance with the criteria laid down in the Annex to this Regulation of a change not listed in one of the tables of that Annex.
Imetnik dovoljenja lahko od Agencije zahteva, da v skladu z merili iz Priloge k tej uredbi predloži mnenje glede razvrstitve spremembe, ki ni navedena v razpredelnicah iz navedene priloge.
The opinion shall be delivered within 45 days following receipt of the request and payment of the fee referred to in Article 80(1)(a) of Regulation (EU) No 528/2012.
Mnenje se predloži v 45 dneh po prejemu zahteve in plačila pristojbine iz člena 80(1)(a) Uredbe (EU) št. 528/2012.
The Agency shall publish the opinion after deletion of all information of commercial confidential nature.
Agencija mnenje objavi po odstranitvi vseh informacij z značajem poslovne tajnosti.
Guidelines on classification
Smernice glede razvrstitve
The Agency shall, after consulting the Member States, the Commission and interested parties, draw up guidelines on the details of the various categories of changes of products.
Agencija po posvetovanju z državami članicami, Komisijo in zainteresiranimi stranmi pripravi smernice o podrobnostih posameznih kategorij sprememb proizvodov.
Those guidelines shall be regularly updated, taking into account the opinions taken in accordance with Article 2(2), contributions from Member States as well as scientific and technical progress.
Smernice se redno posodabljajo, pri čemer se upoštevajo mnenja, pridobljena v skladu s členom 2(2), prispevki držav članic ter napredek na znanstvenem in tehničnem področju.
Grouping of changes
Razvrstitev sprememb v skupine
Where several changes of products are sought, a separate notification or application shall be submitted in respect of each change sought.
Kadar je zahtevanih več sprememb proizvodov, se za vsako zahtevano spremembo predloži ločeno obvestilo ali vloga.
By way of derogation from paragraph 1, the following rules shall apply:
Z odstopanjem od odstavka 1 veljajo naslednja pravila:
a single notification may cover a series of proposed administrative changes affecting different products in the same manner;
enotno obvestilo se lahko nanaša na niz predlaganih upravnih sprememb, ki vplivajo na različne proizvode na enak način;
a single notification may cover a series of proposed administrative changes affecting the same product;
enotno obvestilo se lahko nanaša na niz predlaganih upravnih sprememb, ki vplivajo na isti proizvod;
a single application may cover more than one proposed change of the same product in the following cases:
enotna vloga se lahko nanaša na več kot eno predlagano spremembo istega proizvoda v naslednjih primerih:
one of the proposed changes in the group is a major change of the product; all other proposed changes in the group are a direct consequence of that change;
ena od predlaganih sprememb v skupini je večja sprememba proizvoda, vse druge predlagane spremembe v skupini so neposredne posledice zadevne spremembe;
one of the proposed changes in the group is a minor change; all other proposed changes in the group are a direct consequence of that change;
ena od predlaganih sprememb v skupini je manjša sprememba, vse druge predlagane spremembe v skupini so neposredne posledice zadevne spremembe;
all changes in the group are a direct consequence of a new classification of the active substance(s) or non-active substance(s) contained in the product or of the product itself;
vse spremembe v skupini so neposredna posledica nove razvrstitve aktivnih ali neaktivnih snovi, vsebovanih v proizvodu, ali samega proizvoda;
all changes in the group are a direct consequence of a specific condition of the authorisation;
vse spremembe v skupini so neposredna posledica posebnega pogoja pridobitve dovoljenja;
a single application may cover more than one proposed change if the Member State evaluating the application in accordance with Article 7(4) or 8(4), or, in the case of a change of a Union authorisation, the Agency, confirms that it is practically feasible to handle those changes in the same procedure.
enotna vloga se lahko nanaša na več kot eno predlagano spremembo, če država članica, ki ocenjuje vlogo v skladu s členom 7(4) ali 8(4), ali, v primeru spremembe dovoljenja Unije, Agencija potrdi, da se zadevne spremembe praktično lahko obravnavajo v istem postopku.
The single applications referred to in points (c) and (d) of the first subparagraph shall be made in accordance with Article 7 or 12 where at least one of the proposed changes is a minor change of the product and none of the proposed changes is a major change of the product, and with Article 8 or 13 where at least one of the proposed changes is a major change of the product.
Enotne vloge iz točk (c) in (d) prvega pododstavka se predložijo v skladu s členom 7 ali 12, kadar je vsaj ena od predlaganih sprememb manjša sprememba proizvoda in nobena od predlaganih sprememb ni večja sprememba proizvoda, ter v skladu s členom 8 ali 13, kadar je vsaj ena od predlaganih sprememb večja sprememba proizvoda.
An application submitted in accordance with Article 50(2) of Regulation (EU) No 528/2012 shall contain the following:
Vloga, predložena v skladu s členom 50(2) Uredbe (EU) št. 528/2012, vsebuje naslednje:
the relevant filled application form as available from the Register for Biocidal Products, which shall contain:
Ustrezno izpolnjen obrazec vloge, ki je na voljo v registru biocidnih proizvodov in vsebuje naslednje informacije:
a list of all the authorisations affected by the proposed change(s);
seznam vseh dovoljenj, na katera vplivajo predlagane spremembe;
a list indicating all the Member States in which the product is authorised and the changes are sought (hereinafter the ‘Member States concerned’);
seznam z navedbo vseh držav članic, v katerih je proizvod odobren in v katerih se zahtevajo spremembe (v nadaljnjem besedilu: zadevne države članice);
for products authorised by national authorisation, the Member State which evaluated the initial application for authorisation of the biocidal product or, if the changes are not sought in that Member State, the Member State having been chosen by the applicant together with written confirmation that that Member State agrees to be reference Member State (hereinafter referred to as the ‘reference Member State’);
za proizvode z nacionalnim dovoljenjem, država članica, ki je ocenila prvotno vlogo za izdajo dovoljenja za biocidni proizvod, če pa v tej državi članici spremembe niso zahtevane, država članica, ki jo je vlagatelj izbral, skupaj s pisnim potrdilom, da ta država članica privoli, da je referenčna država članica (v nadaljnjem besedilu: referenčna država članica);
for major changes of products authorised by Union authorisation, the Member State who evaluated the initial application for authorisation of the biocidal product or, if the changes are not sought in that Member State, the Member State having been chosen by the applicant together with written confirmation that that Member State agrees to evaluate the application of the change;
za večje spremembe proizvodov z dovoljenjem Unije, država članica, ki je ocenila prvotno vlogo za izdajo dovoljenja za biocidni proizvod, če pa v tej državi članici spremembe niso zahtevane, država članica, ki jo je vlagatelj izbral, skupaj s pisnim potrdilom, da ta država članica privoli, da bo ocenila vlogo za spremembo;
where relevant, a draft revised summary of the biocidal product characteristics in, as appropriate,
po potrebi osnutek revidiranega povzetka značilnosti biocidnega proizvoda v
for products authorised by national authorisation, the official language(s) of all the Member States concerned;
uradnih jezikih vseh zadevnih držav članic za proizvode z nacionalnim dovoljenjem;
for products authorised by Union authorisation, one of the official languages of the Union, which in case of major changes must be a language accepted by the Member State referred to in point (c) at the time of application;
enem od uradnih jezikov Unije, ki mora biti v primeru večjih sprememb jezik, ki je za državo članico iz točke (c) ob predložitvi vloge sprejemljiv, za proizvode z dovoljenjem Unije.
a description of all the changes sought;
Opis vseh zahtevanih sprememb.
where a change leads to or is the consequence of other changes of the terms of the same authorisation, a description of the relation between these changes;
Kadar sprememba povzroči ali je posledica drugih sprememb pogojev istega dovoljenja, opis razmerja med temi spremembami.