natgillin/translations-raw huggingface dataset:
EFSA Journal 2012;10(1):2511.
(Review of the existing maximum residue levels (MRLs) for trinexapac, according to Article 12 of Regulation (EC) No 396/2005.) EFSA Journal 2012; 10(1):2511.
The columns for acetamiprid, isoproturon, picoxystrobin and pyrimethanil are replaced by the following:
stolpci za acetamiprid, izoproturon, pikoksistrobin in pirimetanil se nadomestijo z naslednjim:
Acetamiprid - code 1000000 except 1040000: Sum of acetamiprid and N-desmethyl-acetamiprid (IM-2-1), expressed as acetamiprid
acetamiprid – oznaka 1000000 razen 1040000: vsota acetamiprida in N-desmetil-acetamiprida (IM-2-1), izražena kot acetamiprid.
When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 5 February 2016 or, if that information is not submitted by that date, the lack of it.
Pri pregledu mejne vrednosti ostanka bo Komisija upoštevala informacije iz prvega stavka, če bodo predložene do 5. februarja 2016, če pa navedene informacije do navedenega datuma ne bodo predložene, bo upoštevala, kot da jih ni.
(+) The European Food Safety Authority identified some information on analytical methods as unavailable.
(+) Evropska agencija za varnost hrane je za nekatere informacije o analitskih metodah navedla, da niso na voljo.
(+) The European Food Safety Authority identified some information on livestock metabolism and feeding studies as unavailable.
(+) Evropska agencija za varnost hrane je za nekatere informacije o metabolizmu pri živini in študijah o krmljenju navedla, da niso na voljo.
(+) The European Food Safety Authority identified some information on analytical methods on liver and kidneys as unavailable.
(+) Evropska agencija za varnost hrane je za nekatere informacije o analitskih metodah za jetra in ledvice navedla, da niso na voljo.
Pyrimethanil - code 1020000: Sum of pyrimethanil and 2-anilino-4.6-dimethylpyrimidine-5-ol, expressed as pyrimethanil
pirimetanil (R) – oznaka 1020000: vsota pirimetanila in 2-anilino-4,6-dimetilpirimidin-5-ola, izražena kot pirimetanil.
Pyrimethanil - codes 1011000/1012000/1013000/1014000/1015000/1017000: Sum of pyrimethanil and 2-(4-hydroxyanilino)-4.6-dimethylpyrimidine, expressed as pyrimethanil.
Pirimetanil – oznake 1011000/1012000/1013000/1014000/1015000/1017000: vsota pirimetanila in 2-(4-hidroksianilino)-4,6-dimetilpirimidina, izražena kot pirimetanil.
(+) The European Food Safety Authority identified some information on crop metabolism with seed treatment as unavailable.
(+) Evropska agencija za varnost hrane je za nekatere informacije o vplivu tretiranja semena na metabolizem v kmetijski rastlini navedla, da niso na voljo.
The following columns for chlorotoluron and trinexapac are added:
dodata se naslednja stolpca za klorotoluron in trineksapak:
(+) The European Food Safety Authority identified some information on storage stability, analytical methods, crop metabolism and residue trials as unavailable.
(+) Evropska agencija za varnost hrane je za nekatere informacije o obstojnosti pri shranjevanju, analitskih metodah, metabolizmu v kmetijski rastlini in o preskusih za ugotavljanje ostankov navedla, da niso na voljo.
Trinexapac (sum of trinexapac (acid) and its salts, expressed as trinexapac)
Trineksapak (vsota trineksapaka (kisline) in njegovih soli, izražena kot trineksapak)
The column for daminozide is deleted.
stolpec za daminozid se črta;
In part A the columns for butralin, chlorotoluron and trinexapac are deleted;
v delu A se črtajo stolpci za butralin, klorotoluron in trineksapak;
In part B the columns for acetamiprid, daminozide, isoproturon, picoxystrobin, and pyrimethanil are deleted.
v delu B se črtajo stolpci za acetamiprid, daminozid, izoproturon, pikoksistrobin in pirimetanil;
In Annex V the following columns for butralin and daminozide are added:
v Prilogi V se dodata naslednja stolpca za butralin in daminozid:
Daminozide (sum of daminozide and 1,1-dimethyl-hydrazine (UDHM), expressed as daminozide)
Daminozid (vsota daminozida in 1,1-dimetilhidrazina (UDHM), izražena kot daminozid)
The non-inclusion of butralin in Annex I to Directive 91/414/EEC is provided for in Commission Decision No 2008/819/EC [5] and Member States were authorized to grant a period of grace expiring no later than 20 April 2010.
Nevključitev butralina v Prilogo I k Direktivi 91/414/EGS je določena v Odločbi Komisije 2008/819/ES [5], države članice pa so lahko odobrile podaljšanje roka najpozneje do 20. aprila 2010.
All existing authorisations for plant protection products containing the active substance butralin have been revoked.
Vse obstoječe registracije fitofarmacevtskih sredstev, ki vsebujejo aktivno snov butralin, so bile razveljavljene.
Commission Implementing Regulation (EU) No 88/2014
Izvedbena uredba Komisije (EU) št. 88/2014
specifying a procedure for the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products
o določitvi postopka za spremembo Priloge I k Uredbi (EU) št. 528/2012 Evropskega parlamenta in Sveta o dostopnosti na trgu in uporabi biocidnih proizvodov
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 28(5) 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 28(5) Uredbe,
Categories 1, 2, 3, 4 and 5 of Annex I to Regulation (EU) No 528/2012 are well defined so as to allow certain presumptions as regards the properties of the substances falling therein.
Kategorije 1, 2, 3, 4 in 5 iz Priloge I k Uredbi (EU) št. 528/2012 so natančno določene, da omogočajo nekatere domneve glede lastnosti vključenih snovi.
The inclusion in category 6 of that Annex requires the submission of a data package allowing a full risk assessment for the intended use.
Za vključitev v kategorijo 6 navedene priloge je potrebna predložitev paketa podatkov, ki omogoča popolno oceno tveganja za predvideno uporabo.
The procedure for amending one of those categories upon request in order to include therein active substances, or modifying the restrictions therein, should be transparent and equal for all applicants.
Postopek za spremembo ene od navedenih kategorij na zahtevo, da bi se vanjo vključile aktivne snovi, ali za spremembo omejitev, ki jih vsebuje, bi moral biti pregleden in enak za vse vlagatelje.
It is therefore appropriate to further specify it.
Zato ga je primerno podrobneje določiti.
The data required for inclusion of an active substance in Annex I to Regulation (EU) No 528/2012 should be sufficient to evidence that the substance does not give rise to concern within the meaning of Article 28(2) of Regulation (EU) No 528/2012.
Podatki, potrebni za vključitev aktivne snovi v Prilogo I k Uredbi (EU) št. 528/2012, bi morali zadostovati za dokaz, da snov ne vzbuja zaskrbljenosti v smislu člena 28(2) Uredbe (EU) št. 528/2012.
In order to be consistent, the procedure for submission and validation of an application for inclusion of an active substance in Annex I to Regulation (EU) No 528/2012 should be identical to that for submission and validation of an application for approval of an active substance.
Da se zagotovi skladnost, bi moral biti postopek za vložitev in validacijo vlog za vključitev aktivne snovi v Prilogo I k Uredbi (EU) št. 528/2012 enak postopku za vložitev in validacijo vlog za odobritev aktivne snovi.
However, where the former may require less data to be submitted, the evaluation procedure should be adapted accordingly.
Kadar se za postopek za vložitev in validacijo vlog za vključitev aktivne snovi lahko predloži manj podatkov, pa bi bilo treba postopek ocenjevanja ustrezno prilagoditi.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products referred to in Article 82(1) of Regulation (EU) No 528/2012,
Ukrepi iz te uredbe so v skladu z mnenjem Stalnega odbora za biocidne pripravke iz člena 82(1) Uredbe (EU) št. 528/2012 –
This Regulation lays down the procedures to be followed for the purpose of amending, at the request of an applicant, Annex I to Regulation (EU) No 528/2012 in order to:
Ta uredba določa postopke, ki jih je treba upoštevati pri spremembi Priloge I k Uredbi (EU) št. 528/2012 na zahtevo vlagatelja, da:
include active substances in category 1, 2, 3, 4, 5 or 6 of that Annex in accordance with Article 28(1) of that Regulation; or
bi se v kategorije 1, 2, 3, 4, 5 ali 6 iz navedene priloge vključile aktivne snovi v skladu s členom 28(1) navedene uredbe, ali
make amendments of the relevant restrictions in those categories.
da bi se spremenile ustrezne omejitve, ki jih vsebujejo navedene kategorije.
An application for an inclusion or an amendment referred to in Article 1 shall include the information specified in the Annex to this Regulation.
Vloga za vključitev ali spremembo iz člena 1 vključuje podatke, ki so določeni v Prilogi k tej uredbi.
The procedure laid down in Article 7(1) and (2), the third subparagraph of Article 7(3), and Article 7(6) of Regulation (EU) No 528/2012 shall apply for the submission of applications for inclusions or amendments referred to in Article 1 of this Regulation.
Postopek, določen v členu 7(1) in (2), tretjem pododstavku člena 7(3) in členu 7(6) Uredbe (EU) št. 528/2012, se uporablja za vložitev vlog za vključitve ali spremembe iz člena 1 te uredbe.
Where the application concerns category 6 of Annex I to Regulation (EU) No 528/2012, the first and second subparagraphs of Article 7(3) and Article 7(4) and (5) of that Regulation shall apply for the validation of the application.
Kadar se vloga nanaša na kategorijo 6 iz Priloge I k Uredbi (EU) št. 528/2012, se za validacijo vloge uporabijo prvi in drugi pododstavek člena 7(3) ter člen 7(4) in (5) navedene uredbe.
The evaluating competent authority shall evaluate whether there is evidence that the substance does not give rise to concern in accordance with Article 28(2) of Regulation (EU) No 528/2012 and, where relevant, to which restrictions its use should be subject.
Ocenjevalni pristojni organ oceni, ali obstaja dokaz, da snov ne vzbuja zaskrbljenosti v skladu s členom 28(2) Uredbe (EU) št. 528/2012, in, po potrebi, katere omejitve bi morale veljati za njeno uporabo.
It shall send an assessment report and the conclusions of its evaluation to the European Chemicals Agency set up under Regulation (EC) No 1907/2006 of the European Parliament and of the Council [2] (‘the Agency’).
Evropski agenciji za kemikalije, ustanovljeni z Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta [2] (v nadaljnjem besedilu: Agencija), pošlje poročilo o oceni in ugotovitve ocenjevanja.
Where the application concerns inclusion in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012, the assessment report and the conclusions shall be submitted within 180 days of the payment of the fees referred to in the third subparagraph of Article 7(3) of that Regulation.
Kadar se vloga nanaša na vključitev v kategorije 1, 2, 3, 4 ali 5 iz Priloge I k Uredbi (EU) št. 528/2012, se poročilo o oceni in ugotovitve predložijo v roku 180 dni od plačila pristojbin iz tretjega pododstavka člena 7(3) navedene uredbe.
The evaluating competent authority shall take due account of those comments when finalising its evaluation.
Ocenjevalni pristojni organ navedene pripombe ustrezno upošteva pri končni oceni.
Where it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall request that the applicant submit such information within a specified time limit, and shall inform the Agency accordingly.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, ocenjevalni pristojni organ od vlagatelja zahteva, da te predloži v določenem roku, in o tem obvesti Agencijo.
The periods referred to in paragraph 1 of this Article shall be suspended from the date of issue of that request until the date the information is received.
Obdobji iz odstavka 1 tega člena se prekineta od dneva, ko se navedena zahteva pošlje, do dneva prejema informacij.
The suspension shall not exceed 180 days in total unless it is justified by the nature of the data requested or by exceptional circumstances.
Prekinitev skupno ne presega 180 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izjemnih okoliščin.
An application concerning inclusion of an active substance in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012, which, following a request for additional data pursuant to paragraph 2, complies fully with Article 6 of Regulation (EU) No 528/2012 shall, where the applicant so requests,
Vloga za vključitev aktivne snovi v kategorije 1, 2, 3, 4 ali 5 iz Priloge I k Uredbi (EU) št. 528/2012, ki je po zahtevi po predložitvi dodatnih podatkov v skladu z odstavkom 2 v celoti skladna s členom 6 Uredbe (EU) št. 528/2012, se na zahtevo vlagatelja:
be considered as an application for inclusion in category 6 of Annex I to that Regulation; and
šteje za vlogo za vključitev v kategorijo 6 iz Priloge I k navedeni uredbi in
be subject to validation pursuant to Article 3(2).
validira v skladu s členom 3(2).
The Agency shall, having regard to the conclusions of the evaluating competent authority, prepare and submit to the Commission the opinion referred to in Article 28 of Regulation (EU) No 528/2012 within 270 days of receipt of the conclusions of the evaluation in the case of an application for inclusion in category 6 of Annex I to Regulation (EU) No 528/2012, and within 180 days of that receipt in the case of an application for inclusion in category 1, 2, 3, 4 or 5 of Annex I to that Regulation.
Agencija ob upoštevanju ugotovitev ocenjevalnega pristojnega organa pripravi in Komisiji predloži mnenje iz člena 28 Uredbe (EU) št. 528/2012 v roku 270 dni od prejema ugotovitev ocenjevanja, kadar gre za vlogo za vključitev v kategorijo 6 iz Priloge I k Uredbi (EU) št. 528/2012, in v roku 180 dni od navedenega prejema, kadar gre za vlogo za vključitev v kategorije 1, 2, 3, 4 ali 5 iz Priloge I k navedeni uredbi.
Agency opinions eligible to form the basis for a Commission decision
Mnenja Agencije, ki se upoštevajo kot podlaga za sklep Komisije
Provided that there is evidence that an active substance does not give rise to concern within the meaning of Article 28(1) of Regulation (EU) No 528/2012, the Commission may adopt a decision pursuant to that Article amending Annex I to that Regulation in the sense referred to in Article 1 of this Regulation where the Agency has submitted an opinion pursuant to:
Če obstajajo dokazi, da aktivna snov ne vzbuja zaskrbljenosti v smislu člena 28(1) Uredbe (EU) št. 528/2012, lahko Komisija sprejme odločitev v skladu z navedenim členom o spremembi Priloge I k navedeni uredbi v smislu iz člena 1 te uredbe, kadar Agencija predloži mnenje v skladu:
Article 4(4) of this Regulation;
s členom 4(4) te uredbe;
Article 8(4) of Regulation (EU) No 528/2012; or
s členom 8(4) Uredbe (EU) št. 528/2012 ali
one of the acts provided for by Article 89(1) of Regulation (EU) No 528/2012.
enim od aktov iz člena 89(1) Uredbe (EU) št. 528/2012.
Data requirements for the inclusion of an active substance in Annex I to Regulation (EU) No 528/2012
Zahteve glede podatkov za vključitev aktivne snovi v Prilogo I k Uredbi (EU) št. 528/2012
Data for inclusion in category 1, 2, 3, 4 or 5
Podatki za vključitev v kategorijo 1, 2, 3, 4 ali 5
An application for inclusion of an active substance in category 1, 2, 3, 4 or 5 of Annex I to Regulation (EU) No 528/2012 shall specify the relevant category, the identity of the substance and the intended uses of the products for which authorisation will be sought, and contain conclusive evidence to demonstrate the following:
V vlogi za vključitev aktivne snovi v kategorijo 1, 2, 3, 4 ali 5 iz Priloge I k Uredbi (EU) št. 528/2012 se določijo ustrezna kategorija, identiteta snovi in predvidene uporabe proizvodov, v zvezi s katerimi se pošlje vloga za dovoljenje, vsebuje pa tudi prepričljive dokaze, da:
that the substance complies with the description of the relevant category; and
je snov skladna z opisom ustrezne kategorije, in
that there is a robust consensus of expert opinion that the substance does not give rise to concern in accordance with Article 28(2) of that Regulation.
obstaja trdno soglasje glede strokovnega mnenja, da snov ne vzbuja zaskrbljenosti v skladu s členom 28(2) navedene uredbe.
The evidence referred to in point (b) shall include all relevant published literature data regarding the substance in question and all relevant data on the substance generated by the applicant.
Dokazi iz točke (b) vključujejo vse podatke o ustrezni objavljeni literaturi v zvezi z zadevno snovjo in vse pomembne podatke o snovi, ki jih predloži vložnik.
It may also include read-across from chemical analogues/homologues, (Q)SAR predictions, data from existing studies, in vitro studies, historical human data, or conclusions from other regulatory authorities or frameworks.
Vključujejo lahko tudi navzkrižno branje v zvezi s kemijskimi analogi/homologi, napovedi (Q)SAR, podatke iz obstoječih študij, študije in vitro, historične podatke, ki se nanašajo na človeka, ali ugotovitve drugih regulativnih organov ali okvirov.
By way of derogation from paragraph 1(b), where there is no conclusive evidence of a robust consensus of expert of opinion regarding one or more endpoints, an application shall contain all additional data necessary to show that the substance does not give rise to concern in accordance with Article 28(2) of Regulation (EU) No 528/2012.
Kadar ni prepričljivih dokazov o trdnem soglasju glede strokovnega mnenja v zvezi z eno ali več končnimi točkami, vloga z odstopanjem od odstavka 1(b) vsebuje vse dodatne podatke, ki so potrebni za dokaz, da snov ne vzbuja zaskrbljenosti v skladu s členom 28(2) Uredbe (EU) št. 528/2012.
Data for inclusion in category 6
Podatki za vključitev v kategorijo 6
An application for inclusion of an active substance in category 6 of Annex I to Regulation (EU) No 528/2012 shall contain the data referred to in Article 6 of that Regulation to allow a state-of-the-art risk assessment.
Vloga za vključitev aktivne snovi v kategorijo 6 iz Priloge I k Uredbi (EU) št. 528/2012 vsebuje podatke iz člena 6 navedene uredbe, da se omogoči z zadnjim stanjem skladna ocena tveganja.
Where the application concerns inclusion in category 6 of Annex I to Regulation (EU) No 528/2012, the assessment report and the conclusions shall be submitted within 365 days of validation of that application. Prior to submitting its conclusions to the Agency, the evaluating competent authority shall give the applicant the opportunity to provide written comments on the assessment report and on the conclusions of the evaluation within 30 days.
Kadar se vloga nanaša na vključitev v kategorijo 6 iz Priloge I k Uredbi (EU) št. 528/2012, se poročilo o oceni in ugotovitve predložijo v roku 365 dni od validacije navedene vloge.Preden ocenjevalni pristojni organ svoje ugotovitve predloži Agenciji, ponudi vlagatelju možnost, da v 30 dneh predloži pisne pripombe glede poročila o oceni in ugotovitev ocenjevanja.
Commission Implementing Regulation (EU) No 89/2014
Izvedbena uredba Komisije (EU) št. 89/2014
approving bis(N-cyclohexyl-diazenium-dioxy)-copper (Cu-HDO) as an existing active substance for use in biocidal products for product-type 8
o odobritvi bis(N-cikloheksil-diazen-dioksi)-bakra (Cu-HDO) kot obstoječe aktivne snovi za uporabo v biocidnih proizvodih 8. vrste proizvodov
That list includes bis(N-cyclohexyl-diazenium-dioxy)-copper (Cu-HDO).
Navedeni seznam vključuje bis(N-cikloheksil-diazen-dioksi)-baker (Cu-HDO).
Cu-HDO has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to that Directive, which corresponds to product-type 8 as defined in Annex V to Regulation (EU) No 528/2012.
V skladu s členom 11(2) Direktive 98/8/ES je bila opravljena presoja Cu-HDO glede uporabe v 8. vrsti proizvodov, sredstva za zaščito lesa, kot je opredeljena v Prilogi V k navedeni direktivi, ki ustreza 8. vrsti proizvodov, kot je opredeljena v Prilogi V k Uredbi (EU) št. 528/2012.
Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 25 February 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Avstrija, ki je bila imenovana za državo članico poročevalko, je 25. februarja 2008 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 Komisiji poslala poročilo pristojnega organa in priporočilo.
In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 13 December 2013, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile ugotovitve pregleda na sestanku Stalnega odbora za biocidne pripravke 13. decembra 2013 vključene v poročilo o oceni.
It appears from that report that biocidal products used for product-type 8 and containing Cu-HDO may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Iz navedenega poročila je razvidno, da je za biocidne proizvode, ki se uporabljajo kot proizvodi v 8. vrsti proizvodov in vsebujejo Cu-HDO, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to approve Cu-HDO for use in biocidal products for product-type 8.
Zato je primerno odobriti Cu-HDO za uporabo v biocidnih proizvodih 8. vrste proizvodov.
Bis(N-cyclohexyl-diazenium-dioxy)-copper (Cu-HDO) shall be approved as an active substance for use in biocidal products for product-type 8, subject to the specifications and conditions set out in the Annex.
Bis(N-cikloheksil-diazen-dioksi)-baker (Cu-HDO) se odobri kot aktivna snov za uporabo v biocidnih proizvodih 8. vrste proizvodov, pri čemer se upoštevajo specifikacije in pogoji iz Priloge.
IUPAC Name Identification Numbers
Ime po IUPAC Identifikacijske številke
Expiry date of approval
Datum prenehanja veljavnosti odobritve
bis(N-cyclohexyl-diazenium-dioxy)-copper
bis(N-cikloheksil-diazen-dioksi)-baker
EC no: N/A
Št. ES: ni relevantno
CAS no: 312600-89-8
Št. CAS: 312600-89-8
Appropriate risk mitigation measures shall be taken to protect the terrestrial compartment.
Sprejmejo se ustrezni ukrepi za zmanjšanje tveganja za varovanje kopenskega ekosistema.
In particular, labels and, where provided, safety data sheets of products authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.
Zlasti na oznakah in, če so na voljo, varnostnih listih dovoljenih pripravkov se navede, da industrijska uporaba poteka na zaprtem območju ali na neprepustni trdni podlagi z ogrado, da se sveže obdelani les po obdelavi hrani pod zaščitno streho in/ali na neprepustni trdni podlagi, s čimer se prepreči neposredno izlivanje pripravkov v tla ali vodo, ter da se izgube pri uporabi pripravkov zbirajo za ponovno uporabo ali odstranjevanje.
Commission Implementing Regulation (EU) No 90/2014
Izvedbena uredba Komisije (EU) št. 90/2014
approving decanoic acid as an existing active substance for use in biocidal products for product-types 4, 18 and 19
o odobritvi dekanojske kisline kot obstoječe aktivne snovi za uporabo v biocidnih pripravkih 4., 18. in 19. vrste proizvodov
That list includes decanoic acid.
Navedeni seznam vključuje dekanojsko kislino.