natgillin/translations-raw huggingface dataset:
When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication.
Države članice se v sprejetih odločbah sklicujejo na to direktivo ali pa sklic nanjo navedejo ob njihovi uradni objavi.
Germany delivered its draft reassessment report on 27 July 2009.
Nemčija je 27. julija 2009 predstavila osnutek poročila o ponovni oceni.
The European Food Safety Authority then performed a peer review which was finalised on 30 April 2010.
Evropska agencija za varnost hrane je nato izvedla strokoven pregled, ki je bil zaključen 30. aprila 2010.
Commission Directive 2010/71/EU
Direktiva Komisije 2010/71/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include metofluthrin as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev metoflutrina kot aktivne snovi v Prilogo I k Direktivi
The United Kingdom received on 23 December 2005 an application from Sumitomo Chemical (UK) Plc, in accordance with Article 11(1) of Directive 98/8/EC, for the inclusion of the active substance metofluthrin in its Annex I for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC.
Združeno kraljestvo je 23. decembra 2005 od družbe Sumitomo Chemical (UK) Plc v skladu s členom 11(1) Direktive 98/8/ES prejelo vlogo za vključitev aktivne snovi metoflutrin v Prilogo I za uporabo v vrsti pripravkov 18, insekticidi, akaricidi in pripravki za nadzor drugih členonožcev, kot je opredeljeno v Prilogi V k Direktivi 98/8/ES.
Metofluthrin was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as an active substance of a biocidal product.
Metoflutrin na datum iz člena 34(1) Direktive 98/8/ES še ni bil v prometu kot aktivna snov biocidnega pripravka.
After carrying out an evaluation, the United Kingdom submitted its evaluation report, together with a recommendation, to the Commission on 19 June 2008.
Po opravljeni oceni je Združeno kraljestvo 19. junija 2008 Komisiji poslalo poročilo o oceni skupaj s priporočilom.
The report was reviewed by the Member States and the Commission within the Standing Committee on Biocidal Products on 27 May 2010, and the findings of the review were incorporated in an assessment report.
Poročilo so 27. maja 2010 pregledale države članice in Komisija v Stalnem odboru za biocidne pripravke, ugotovitve pregleda pa so bile vključene v poročilo o oceni.
It appears from the examinations made that biocidal products used as insecticides, acaricides and products to control other arthropods and containing metofluthrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot insekticidi, akaricidi in pripravki za nadzor drugih členonožcev ter vsebujejo metoflutrin, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include metofluthrin in Annex I to that Directive.
Zato je primerno vključiti metoflutrin v Prilogo I k navedeni direktivi.
Not all potential uses have been evaluated at the European level.
Na evropski ravni ni bila opravljena ocena vseh možnosti uporabe.
It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the European level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno, da države članice ocenijo tiste možnosti uporabe oziroma tiste scenarije izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na evropski ravni, ter da pri izdaji dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance metofluthrin and to facilitate the proper operation of the biocidal market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da se zagotovi enako ravnanje z biocidnimi pripravki na trgu, ki vsebujejo aktivno snov metoflutrin, in da se omogoči ustrezno delovanje trga biocidnih pripravkov na splošno.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States to bring into force the laws, regulations and administrative provisions necessary to comply with this Directive.
Pred vključitvijo aktivne snovi v Prilogo I je treba zagotoviti ustrezno obdobje, ki bo omogočilo državam članicam, da sprejmejo zakone ter druge predpise in določbe, potrebne za uskladitev s to direktivo.
Member States shall adopt and publish, by 30 April 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice najpozneje do 30. aprila 2011 sprejmejo in objavijo zakone ter druge predpise in določbe, potrebne za uskladitev s to direktivo.
They shall apply those provisions from 1 May 2011.
Navedene določbe uporabljajo od 1. maja 2011.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication.
Ko države članice sprejmejo navedene določbe, se te sklicujejo na to direktivo ali pa se sklic nanjo navede ob njihovi uradni objavi.
In Annex I to Directive 98/8/EC, the following entry for the substance metofluthrin is added:
V Prilogi I k Direktivi 98/8/ES se doda snov metoflutrin:
Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances)
Rok za uskladitev s členom 16(3) (razen za pripravke, ki vsebujejo več kot eno aktivno snov, za katere je rok za uskladitev s členom 16(3) enak roku, določenemu v zadnji odločbi o vključitvi njegovih aktivnih snovi)
RTZ isomer:
Izomer RTZ
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl-(1R,3R)-2,2-dimethyl-3-(Z)-(prop-1-enyl)cyclopropanecarboxylate
2,3,5,6-tetrafluoro-4-(metoksimetil)benzil-(1R,3R)-2,2-dimetil-3-(Z)-(prop-1-enil)ciklopropankarboksilat
EC No: n.a.
Št. ES: ni podatkov
CAS No: 240494-71-7
Št. CAS: 240494-71-7
Sum of all isomers:
Vsota izomerov
2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1SR,3SR)-2,2-dimethyl-3-prop-1-enylcyclopropanecarboxylate
2,3,5,6-tetrafluoro-4-(metoksimetil)benzil (EZ)-(1RS,3RS;1SR,3SR)-2,2-dimetil-3-prop-1-enilciklopropankarboksilat
CAS No: 240494-70-6
Št. CAS: 240494-70-6
The active substance shall comply with both the following minimum purities:
Aktivna snov je v skladu z obema naslednjima vrednostma čistosti:
1 May 2011
maj 2011
30 April 2021
april 2021
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the European level risk assessment.’
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vloge za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo tiste scenarije uporabe ali izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na evropski ravni.“
Commission Directive 2010/72/EU
Direktiva Komisije 2010/72/EU
amending Directive 98/8/EC of the European Parliament and of the Council to include spinosad as an active substance in Annex I thereto
o spremembi Direktive 98/8/ES Evropskega parlamenta in Sveta za vključitev spinosada kot aktivne snovi v Prilogo I k Direktivi
That list includes spinosad.
Navedeni seznam vključuje spinosad.
Pursuant to Regulation (EC) No 1451/2007, spinosad has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.
Na podlagi Uredbe (ES) št. 1451/2007 je bila v skladu s členom 11(2) Direktive 98/8/ES opravljena presoja spinosada glede uporabe v 18. vrsti izdelkov, insekticidih, akaricidih in pripravkih za nadzor drugih členonožcev, kot je opredeljena v Prilogi V k navedeni direktivi.
The Netherlands were designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 1 April 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.
Nizozemska, ki je bila imenovana za državo članico poročevalko, je 1. aprila 2008 v skladu s členom 14(4) in (6) Uredbe (ES) št. 1451/2007 poslala Komisiji 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 27 May 2010, in an assessment report.
V skladu s členom 15(4) Uredbe (ES) št. 1451/2007 so bile 27. maja 2010 ugotovitve pregleda vključene v Stalnem odboru za biocidne pripravke v poročilo o oceni.
It appears from the examinations made that biocidal products used as insecticides, acaricides or to control other arthropods and containing spinosad may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
Preiskave so pokazale, da je za biocidne pripravke, ki se uporabljajo kot insekticidi, akaricidi ali pripravki za nadzor drugih členonožcev ter vsebujejo spinosad, mogoče pričakovati, da izpolnjujejo zahteve iz člena 5 Direktive 98/8/ES.
It is therefore appropriate to include spinosad in Annex I to that Directive.
Zato je primerno vključiti spinosad v Prilogo I k navedeni direktivi.
It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to the compartments and populations that have not been representatively addressed in the EU level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.
Zato je primerno, da države članice ocenijo tiste možnosti uporabe oziroma tiste scenarije izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni EU, ter da pri izdaji dovoljenj za pripravke zagotovijo, da se sprejmejo ustrezni ukrepi ali naložijo posebni pogoji za zmanjšanje ugotovljenih tveganj na sprejemljivo raven.
In the light of the findings of the assessment report, it is appropriate to require that risk mitigation measures are applied at product authorisation level.
Glede na ugotovitve poročila o oceni je primerno zahtevati, da se na ravni izdaje dovoljenja za pripravek uporabijo ukrepi za zmanjšanje tveganja.
In particular, in the light of the identified adverse health effects for the unprotected professional user during application by spraying of biocidal products containing spinosad, it is appropriate to require at product authorisation level that products intended for professional use by spraying be used with appropriate personal protective equipment, unless it can be demonstrated that risks for industrial or professional users can be reduced by other means.
Glede na ugotovljene škodljive učinke na zdravje nezaščitenega poklicnega uporabnika med razprševanjem biocidnih pripravkov, ki vsebujejo spinosad, je zlasti primerno na ravni izdaje dovoljenja za pripravke zahtevati, da se pripravki, namenjeni poklicni uporabi z razprševanjem, uporabljajo z ustrezno osebno zaščitno opremo, razen če se lahko dokaže, da je tveganje za industrijske ali poklicne uporabnike mogoče zmanjšati z drugimi sredstvi.
Furthermore, in the light of the findings relating to possible indirect human exposure via consumption of food, it is appropriate to require, where relevant, verification of the need to set new or amended existing maximum residue levels (MRLs) and adoption of measures ensuring that the applicable MRLs are not exceeded.
Poleg tega je na podlagi izsledkov, povezanih z možno posredno izpostavljenostjo ljudi prek uživanja hrane, po potrebi primerno zahtevati, da se preveri potreba po določitvi novih ali spremembi obstoječih zgornjih mejnih vrednosti ostankov (MRLs – maximum residue levels) in da se sprejmejo ukrepi, ki zagotavljajo, da se veljavne zgornje mejne vrednosti ostankov ne prekoračijo.
It is important that the provisions of this Directive be applied simultaneously in all the Member States in order to ensure equal treatment of biocidal products on the market containing the active substance spinosad and also to facilitate the proper operation of the biocidal products market in general.
Pomembno je, da se določbe te direktive uporabljajo hkrati v vseh državah članicah, da bi bilo tako zagotovljeno enako ravnanje z biocidnimi pripravki, ki vsebujejo aktivno snov spinosad, na trgu in omogočeno ustrezno delovanje trga biocidnih pripravkov na splošno.
A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.
Pred vključitvijo aktivne snovi v Prilogo I je treba zagotoviti ustrezno obdobje, ki bo omogočilo državam članicam in zainteresiranim stranem, da se pripravijo na izpolnjevanje novih s tem povezanih zahtev, in prijaviteljem, ki so pripravili dokumentacijo, da lahko povsem izkoristijo desetletno obdobje za varstvo podatkov, ki se v skladu s členom 12(1)(c)(ii) Direktive 98/8/ES začne z dnem vključitve.
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.
Po vključitvi morajo države članice imeti na voljo razumno dolgo obdobje za izvedbo člena 16(3) Direktive 98/8/ES.
Member States shall adopt and publish, by 31 October 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
Države članice sprejmejo in objavijo zakone in druge predpise, potrebne za uskladitev s to direktivo, najpozneje do 31. oktobra 2011.
They shall apply those provisions from 1 November 2012.
Navedene predpise uporabljajo od 1. novembra 2012.
Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Države članice sporočijo Komisiji besedila glavnih predpisov nacionalne zakonodaje, ki jih sprejmejo na področju, ki ga ureja ta direktiva.
In Annex I to Directive 98/8/EC, the following entry for the substance spinosad is added:
V Prilogi I k Direktivi 98/8/ES se doda naslednji vnos za snov spinosad:
EC No: 434-300-1
Št. ES: 434-300-1
CAS No: 168316-95-8
Št. CAS: 168316-95-8
Spinosad is a mixture of 50-95 % spinosyn A and 5-50 % spinosyn D.
Spinosad je zmes 50–95 % spinosina A in 5–50 % spinosina D.
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-60-7
(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-[(6-deoksi-2,3,4-tri-O-metil-α-L-manopiranosil)oksi]-13-[[(2R,5S,6R)-5-(dimetilamino)tetrahidro-6-metil-2H-piran-2-il]oksi]-9-etil-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradekahidro-14-metil-1H-as-indaceno[3,2-d]oksaciklododecin-7,15-dion Št. CAS: 131929-60-7
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyl)oxy]-13-[[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methyl-2H-pyran-2-yl]oxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecin-7,15-dione CAS No: 131929-63-0
(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-[(6-deoksi-2,3,4-tri-O-metil-α-L-manopiranosil)oksi]-13-[[(2R,5S,6R)-5-(dimetilamino)tetrahidro-6-metil-2H-piran-2-il]oksi]-9-etil-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradekahidro-4,14-dimetil-1H-as-indaceno[3,2-d]oksaciklododecin-7,15-dion Št. CAS: 131929-63-0
31 October 2022
oktober 2022
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, when relevant for the particular product, those uses or exposure scenarios and those risks to compartments and populations that have not been representatively addressed in the EU level risk assessment.
Kadar je za določen pripravek to potrebno, države članice pri ocenjevanju vloge za izdajo dovoljenja za pripravek v skladu s členom 5 in Prilogo VI ocenijo tiste možnosti uporabe ali scenarije izpostavljenosti ter tista tveganja za predele in prebivalce, ki niso bili reprezentativno obravnavani v oceni tveganja na ravni EU.
Authorisations shall be subject to appropriate risk mitigation measures.
Pogoj za izdajo dovoljenja so ustrezni ukrepi za zmanjševanje tveganja.
In particular, products authorised for professional use by spraying shall be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by others means.
Zlasti se pripravki, za katere je izdano dovoljenje za poklicno uporabo z razprševanjem, uporabljajo z ustrezno osebno zaščitno opremo, razen če je v vlogi za izdajo dovoljenja dokazano, da se tveganja za poklicne uporabnike lahko zmanjšajo na sprejemljivo raven z drugimi sredstvi.
For products containing spinosad that may lead to residues in food or feed, Member States shall verify the need to set new and/or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 and/or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded.’
Za proizvode, ki vsebujejo spinosad in zaradi katerih se lahko pojavijo ostanki v hrani ali krmi, države članice preverijo potrebo po določitvi novih in/ali spremembi obstoječih zgornjih mejnih vrednosti ostankov v skladu z Uredbo (ES) št. 470/2009 in/ali Uredbo (ES) št. 396/2005 ter sprejmejo morebitne ustrezne ukrepe za zmanjševanje tveganj, s katerimi zagotovijo, da se veljavne zgornje mejne vrednosti ostankov ne prekoračijo.“
Directive 2010/73/EU of the European Parliament and of the Council
Direktiva 2010/73/EU Evropskega parlamenta in Sveta
amending Directives 2003/71/EC on the prospectus to be published when securities are offered to the public or admitted to trading and 2004/109/EC on the harmonisation of transparency requirements in relation to information about issuers whose securities are admitted to trading on a regulated market
o spremembah direktiv 2003/71/ES o prospektu, ki se objavi ob javni ponudbi ali sprejemu vrednostnih papirjev v trgovanje, in 2004/109/ES o uskladitvi zahtev v zvezi s preglednostjo informacij o izdajateljih, katerih vrednostni papirji so sprejeti v trgovanje na reguliranem trgu
Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 50 and 114 thereof,
ob upoštevanju Pogodbe o delovanju Evropske unije, zlasti členov 50 in 114 Pogodbe,
The European Council agreed, at its meeting on 8 and 9 March 2007, that administrative burdens on companies should be reduced by 25 % by the year 2012 in order to enhance the competitiveness of companies in the Union.
Evropski svet se je na zasedanju dne 8. in 9. marca 2007 strinjal, da je treba administrativne obremenitve družb zmanjšati za 25 % do leta 2012, da bi se izboljšala konkurenčnost družb v Uniji.
Some of the obligations provided for in Directive 2003/71/EC of the European Parliament and of the Council [4] have been identified by the Commission as appearing to be excessively burdensome on companies.
Komisija je nekatere izmed obveznosti iz Direktive 2003/71/ES Evropskega parlamenta in Sveta [4] opredelila kot morebiti pretirano obremenjujoče za družbe.
Those obligations need to be reviewed in order to reduce the burdens weighing on companies within the Union to the necessary minimum without compromising the protection of investors and the proper functioning of the securities markets in the Union.
Te obveznosti je treba pregledati, da se obremenitve, ki pritiskajo na gospodarske družbe v Uniji, zmanjšajo na potrebni minimum, ne da bi pri tem ogrozili varstvo vlagateljev in ustrezno delovanje trgov z vrednostnimi papirji v Uniji.
Directive 2003/71/EC requires the Commission to make an assessment of the application of that Directive 5 years after the date of its entry into force and to present, where appropriate, proposals for its review.
Direktiva 2003/71/ES zahteva, da Komisija pripravi oceno njene uporabe pet let po začetku njene veljavnosti in predstavi predloge sprememb, kadar je to potrebno.
That assessment has revealed that certain elements of Directive 2003/71/EC should be amended in order to simplify and improve its application, increase its efficiency and enhance the international competitiveness of the Union, thereby contributing to the reduction of administrative burdens.
Ta ocena je pokazala, da je treba nekatere določbe Direktive 2003/71/ES spremeniti, da bi se poenostavila in izboljšala njena uporaba, povečala njena učinkovitost in okrepila mednarodna konkurenčnost Unije, kar bi prispevalo k zmanjšanju administrativnih obremenitev.
Following the conclusions of the report of the High-Level Group on Financial Supervision in the EU (the ‘de Larosière report’), the Commission put forward concrete legislative proposals on 23 September 2009 in order to establish a European System of Financial Supervisors comprising a network of national financial supervisors working in tandem with new European supervisory authorities.
V skladu s priporočili iz poročila visoke skupine za finančni nadzor v EU („poročilo de Larosière“) je Komisija 23. septembra 2009 predstavila konkretne zakonodajne predloge za vzpostavitev evropskega sistema finančnih nadzornih organov, vključujoč mrežo nacionalnih finančnih nadzornih organov, ki delujejo skupaj z novimi evropskimi nadzornimi organi.
One of those new authorities, the European Supervisory Authority (European Securities and Markets Authority), is to replace the Committee of European Securities Regulators.
Eden od teh novih organov, Evropski nadzorni organ (Evropski organ za vrednostne papirje in trge), je nadomestil Odbor evropskih zakonodajalcev za vrednostne papirje.
The way limits of maximum offering amounts are calculated in Directive 2003/71/EC should be clarified for reasons of legal certainty and efficiency.
Zaradi pravne varnosti in učinkovitosti je treba pojasniti, kako so v Direktivi 2003/71/ES izračunane meje najvišjih zneskov ponudb.
The total consideration for certain offers referred to in that Directive should be computed on a Union-wide basis.
Skupno vrednost nekaterih ponudb iz navedene direktive je treba izračunati za celotno Unijo.