natgillin/translations-raw huggingface dataset:
In order to ensure that no unnecessary administrative burden is placed on parties to data-sharing agreements that already exist on the date of entry into force of this Regulation, those parties should be allowed to waive the obligation to include a reimbursement mechanism if all parties to the agreement consent.
Da se prepreči nepotrebno upravno breme za pogodbenice sporazumov o souporabi podatkov, ki že obstajajo na dan začetka veljavnosti te uredbe, bi navedenim pogodbenicam moralo biti dovoljeno, da opustijo obveznost vključitve mehanizma za povračilo, če se s tem strinjajo vse pogodbenice sporazuma.
In the case of such agreements, potential registrants who intend to join the existing agreement should be allowed to request the inclusion of a reimbursement mechanism.
V primeru takšnih sporazumov bi potencialnim registracijskim zavezancem, ki se nameravajo pridružiti obstoječemu sporazumu, moralo biti dovoljeno, da zahtevajo vključitev mehanizma za povračilo.
In the interest of providing legal certainty, it should be clarified that in accordance with Article 50(4) of Regulation (EC) No 1907/2006, the costs associated with a substance evaluation decision may also apply to registrants who have already ceased their activities pursuant to paragraph 2 or 3 of Article 50 of that Regulation.
Zaradi zagotavljanja pravne varnosti bi bilo treba pojasniti, da se v skladu s členom 50(4) Uredbe (ES) št. 1907/2006 stroški, povezani s sklepom o evalvaciji snovi, lahko nanašajo tudi na registracijske zavezance, ki so že prenehali opravljati svoje dejavnosti v skladu z odstavkom 2 ali 3 člena 50 navedene uredbe.
The principle of ‘one substance, one registration’, which underpins the operation of Titles II and III of Regulation (EC) No 1907/2006, should be reinforced by emphasising the role of the Agency in ensuring that all submissions of information regarding the same substance are part of the same registration under that Regulation.
Načelo „ena snov, ena registracija“, ki podpira operacije iz naslovov II in III Uredbe (ES) št. 1907/2006, bi bilo treba okrepiti tako, da se poudari vloga Agencije pri zagotavljanju, da so vse predložene informacije, ki zadevajo isto snov, del iste registracije v skladu z navedeno uredbo.
Where tests on vertebrate animals are not required for the purposes of a party's registration under Regulation (EC) No 1907/2006, it should be clarified that that party is not obliged to share data with other registrants of the same substance and may choose to submit separately the information referred to in Article 10(a) in accordance with Article 11(3) or 19(2) of that Regulation.
Kadar za namene registracije pogodbenice v skladu z Uredbo (ES) št. 1907/2006 niso potrebni poskusi na vretenčarjih, bi bilo treba pojasniti, da navedena pogodbenica ni zavezana k souporabi podatkov z drugimi registracijskimi zavezanci za isto snov in da lahko informacije iz člena 10(a) predloži ločeno v skladu s členom 11(3) ali 19(2) navedene uredbe.
In order to ensure consistency with the principle of ‘one substance, one registration’, the Agency should ensure that a separate submission of the information referred to in Article 10(a), justified under Article 11(3) or 19(2) of Regulation (EC) No 1907/2006, is still part of the existing registration for that substance.
Za zagotovitev skladnosti z načelom „ena snov, ena registracija“ bi morala Agencija zagotoviti, da je ločena predložitev informacij iz člena 10(a), utemeljena na podlagi člena 11(3) ali 19(2) Uredbe (ES) št. 1907/2006, še vedno vključena v obstoječo registracijo za navedeno snov.
In order to promote the development and use of alternative methods for the assessment of hazards of substances and to minimise animal testing, this Regulation encourages the sharing of relevant (animal and non-animal) studies that are conducted on a substance which is structurally similar to the substance being registered (grouping or read-across).
Da bi spodbudila razvoj in uporabo alternativnih metod za ocenjevanje nevarnosti snovi in omejila preskuse na živalih na najmanjšo možno mero, ta uredba spodbuja souporabo ustreznih študij (z živalmi in brez njih), ki se izvajajo na snovi, strukturno podobni snovi, ki je v postopku registracije (združevanje v skupine ali navzkrižno branje).
This Regulation lays down specific duties and obligations for parties to agreements where the sharing of information and associated costs are required under Regulation (EC) No 1907/2006.
Ta uredba določa posebne dolžnosti in obveznosti za pogodbenice sporazumov, kadar se v skladu z Uredbo (ES) št. 1907/2006 zahtevata souporaba informacij in delitev z njimi povezanih stroškov.
Where multiple registrants of the same substance or participants in a Substance Information Exchange Forum (SIEF) are obliged to share information in accordance with their duties under Regulation (EC) No 1907/2006, they shall make every effort to reach an agreement on the sharing of the information.
Kadar je več registracijskih zavezancev za isto snov ali udeležencev foruma za izmenjavo informacij o snoveh (SIEF) zavezanih k souporabi informacij v skladu s svojimi dolžnostmi na podlagi Uredbe (ES) št. 1907/2006, morajo storiti vse za dosego sporazuma o souporabi informacij.
This data-sharing agreement, which involves only persons or entities subject to that Regulation, shall be clear and comprehensible to all parties and shall include the following sections:
Ta sporazum o souporabi podatkov, ki vključuje le osebe ali subjekte, za katere velja navedena uredba, je jasen in razumljiv za vse pogodbenice ter zajema naslednje oddelke:
the itemisation of the data to be shared, including the cost of each data item, a description indicating the information requirements in Regulation (EC) No 1907/2006 to which each cost corresponds and a justification of how the data to be shared satisfies the information requirement;
razčlenitev podatkov, ki so predvideni za souporabo, vključno s stroški vsake podatkovne postavke, opis z navedbo zahtev po informacijah iz Uredbe (ES) št. 1907/2006, ki jim ustrezajo posamezni stroški, in utemeljitev, kako podatki, predvideni za souporabo, izpolnjujejo zahtevo po informacijah;
the itemisation and justification of any cost of creating and managing the data-sharing agreement and the joint submission of information between registrants of the same substance as required by Regulation (EC) No 1907/2006 (hereinafter referred to as ‘administrative costs’) applicable for that data-sharing agreement;
razčlenitev in utemeljitev vseh stroškov vzpostavitve in upravljanja sporazuma o souporabi podatkov in skupne predložitve informacij med registracijskimi zavezanci, ki registrirajo isto snov, kot je določeno z Uredbo (ES) št. 1907/2006 (v nadaljnjem besedilu: upravni stroški), ki se uporablja za navedeni sporazum o souporabi podatkov;
a cost-sharing model, which shall include a reimbursement mechanism.
model delitve stroškov, ki vključuje mehanizem za povračilo.
Where a data-sharing agreement already exists on the date of entry into force of this Regulation, parties to that agreement may, by unanimous consent, waive their obligation to itemise the data as described in points (a) and (b) of paragraph 1.
Kadar sporazum o souporabi podatkov že obstaja na dan začetka veljavnosti te uredbe, lahko pogodbenice navedenega sporazuma soglasno opustijo svojo obveznost razčlenitve podatkov, kot je opisana v točkah (a) in (b) odstavka 1.
A potential registrant of a substance for which a data-sharing agreement has already been reached by previous registrants, who requests a study or set of studies to be shared in accordance with Articles 27 and 30 of Regulation (EC) No 1907/2006 shall not be bound by an existing waiver, unless he provides his signed consent to it to the previous registrants, and shall have the right to request itemisation as described in points (a) and (b) of paragraph 1.
Potencialni registracijski zavezanec za snov, za katero so predhodni registracijski zavezanci že dosegli sporazum o souporabi podatkov, ki zahteva souporabo študije ali niza študij v skladu s členoma 27 in 30 Uredbe (ES) št. 1907/2006, ni zavezan k obstoječi opustitvi obveznosti, razen če predhodnim registracijskim zavezancem predloži podpisano soglasje k njej, in ima pravico zahtevati razčlenitev iz točk (a) in (b) odstavka 1.
Where such a request is made, the previous registrants shall:
Kadar je taka zahteva vložena, predhodni registracijski zavezanci:
itemise all relevant costs incurred after the date of entry into force of this Regulation as described in points (a) and (b) of paragraph 1;
razčlenijo vse ustrezne stroške, ki so nastali po datumu začetka veljavnosti te uredbe, kot je opisano v točkah (a) in (b) odstavka 1;
provide proof of the cost of any study, completed before the date of entry into force of this Regulation, that is requested in accordance with Article 30(1) of Regulation (EC) No 1907/2006;
predložijo dokazila o stroških za vse študije, dokončane pred datumom začetka veljavnosti te uredbe, ki se zahtevajo v skladu s členom 30(1) Uredbe (ES) št. 1907/2006;
make every effort to provide itemisation of all other relevant costs, including administrative costs and study costs not covered in point (b), incurred before the date of entry into force of this Regulation as described in points (a) and (b) of paragraph 1.
storijo vse, kar je v njihovi moči, da se zagotovi razčlenitev vseh drugih ustreznih stroškov, vključno z upravnimi stroški in stroški študij, ki niso zajeti v točki (b), ki so nastali pred datumom začetka veljavnosti te uredbe, kot je opisano v točkah (a) in (b) odstavka 1.
The itemisation of costs shall be provided to the potential registrant without undue delay.
Razčlenitev stroškov se da na razpolago potencialnemu registracijskemu zavezancu brez nepotrebnega odlašanja.
Where registrants of the same substance have shared information and submitted it jointly in accordance with Regulation (EC) No 1907/2006, they shall document yearly any further costs incurred in relation to the operation of their data-sharing agreement.
Kadar imajo registracijski zavezanci za isto snov informacije v souporabi in so jih predložili skupaj v skladu z Uredbo (ES) št. 1907/2006, letno dokumentirajo vse dodatne stroške, ki nastanejo v zvezi z izvajanjem njihovega sporazuma o souporabi podatkov.
The annual documentation shall contain the sections indicated in paragraph 1 and include, for the purposes of the reimbursement mechanism, a record of any compensation received from new registrants.
Letna dokumentacija vsebuje oddelke, navedene v odstavku 1, in za namene mehanizma za povračilo vključuje evidenco vseh povračil, prejetih od novih registracijskih zavezancev.
In the absence of detailed documentation of costs incurred or compensation received before the entry into force of this Regulation, parties to an agreement shall make every effort to collate proof, or to make the best approximation, of such costs and compensation for each year since the commencement of that agreement.
Če ni podrobne dokumentacije nastalih stroškov oziroma prejetih povračil iz obdobja pred začetkom veljavnosti te uredbe, si pogodbenice sporazuma prizadevajo zbrati dokaze ali doseči najboljši približek takih stroškov in povračil za vsako leto od začetka veljavnosti navedenega sporazuma.
Such annual documentation shall be kept by the registrants for a minimum of 12 years following the latest submission of a study and shall be made available free of charge upon request from any party to the data-sharing agreement concerned within reasonable time and in full consideration of the requirements related to applicable registration deadlines.
Takšno letno dokumentacijo registracijski zavezanci hranijo najmanj 12 let po zadnji predložitvi študije, na voljo pa je brezplačno na zahtevo katere koli pogodbenice zadevnega sporazuma o souporabi podatkov, v razumnem času in ob popolnem upoštevanju zahtev v zvezi z roki za registracijo.
One substance, one registration
Ena snov, ena registracija
Without prejudice to Articles 11(3) and 19(2) of Regulation (EC) No 1907/2006, the Agency shall ensure that all registrants of the same substance are part of the same registration under that Regulation.
Brez poseganja v določbe členov 11(3) in 19(2) Uredbe (ES) št. 1907/2006 Agencija zagotovi, da so vsi registracijski zavezanci za isto snov del iste registracije v skladu z navedeno uredbo.
Where the Agency permits a potential registrant of a substance that has already been registered to refer to requested information in accordance with Articles 27(6) and 30(3) of Regulation (EC) No 1907/2006, the Agency shall ensure that any subsequent submission of information by that potential registrant is part of the existing joint submission for that substance.
Kadar Agencija potencialnemu registracijskemu zavezancu za snov, ki je že bila registrirana, dovoli sklicevanje na zahtevane informacije v skladu s členoma 27(6) in 30(3) Uredbe (ES) št. 1907/2006, Agencija zagotovi, da so kakršne koli nadaljnje informacije, ki jih predloži navedeni potencialni registracijski zavezanec, del obstoječe skupne predložitve za navedeno snov.
Where a potential registrant has complied with his obligations under Articles 26 or 29 of Regulation (EC) No 1907/2006 and has ascertained that he is not required to share tests on vertebrate animals for the purposes of his registration, he may decide to invoke Articles 11(3) or 19(2) in order to submit separately all or part of the relevant information in Article 10(a) of that Regulation.
Kadar je potencialni registracijski zavezanec izpolnil svoje obveznosti iz člena 26 ali 29 Uredbe (ES) št. 1907/2006 in ugotovil, da mu za namene svoje registracije ni treba dati v souporabo podatkov o preskusih na vretenčarjih, se lahko odloči za sklicevanje na člen 11(3) ali 19(2) in ločeno, v celoti ali delno, predloži ustrezne informacije iz člena 10(a) navedene uredbe.
In such cases, the potential registrant shall inform any previous registrants of that substance of his decision.
V takih primerih potencialni registracijski zavezanec o svoji odločitvi obvesti vse predhodne registracijske zavezance za zadevno snov.
He shall also inform the Agency which shall ensure that this separate submission, made in accordance with Article 11(3) or 19(2) of Regulation (EC) No 1907/2006, remains part of the existing registration for that substance in accordance with paragraph 1.
Prav tako obvesti Agencijo, ki zagotovi, da je ta ločena predložitev, ki je izvršena v skladu s členom 11(3) ali 19(2) Uredbe (ES) št. 1907/2006, še vedno del obstoječe registracije za zadevno snov v skladu z odstavkom 1.
Fairness and non-discrimination
Poštenost in nediskriminacija
Pursuant to Articles 27(3) and 30(1) of Regulation (EC) No 1907/2006, any registrant of a substance shall only be required to share the costs of information that such registrant is obliged to submit to the Agency to satisfy his registration requirements under that Regulation.
V skladu s členoma 27(3) in 30(1) Uredbe (ES) št. 1907/2006 se od katerega koli registracijskega zavezanca samo enkrat zahteva delitev stroškov informacij, ki jih je ta registracijski zavezanec zavezan predložiti Agenciji za izpolnitev svojih registracijskih obveznosti v skladu z navedeno uredbo.
This condition applies also to administrative costs.
Ta pogoj se uporablja tudi za upravne stroške.
The cost-sharing model referred to in Article 2(1)(c) shall apply to all registrants of that substance, including the possibility of future registrants joining the data-sharing agreement at a later stage.
Model delitve stroškov iz člena 2(1)(c) se uporablja za vse registracijske zavezance za zadevno snov, vključno z morebitnimi prihodnjimi registracijskimi zavezanci, ki se pridružijo sporazumu o souporabi podatkov pozneje.
The cost-sharing model shall include for all registrants of a particular substance provisions for sharing any costs resulting from a potential substance evaluation decision.
Model delitve stroškov vsebuje določbe, ki veljajo za vse registracijske zavezance za določeno snov, o delitvi vseh stroškov, ki izhajajo iz morebitnega sklepa o evalvaciji snovi.
The following factors shall also be considered in agreeing on a particular cost-sharing model:
Pri dogovarjanju o določenem modelu delitve stroškov se upoštevata tudi naslednja dejavnika:
In the event that a cost-sharing model includes the possibility to cover the costs of future additional information requirements for that substance, other than those resulting from a potential substance evaluation decision, this possibility shall be justified and indicated separately from other costs in the data-sharing agreement.
Če se udeleženci sporazuma o souporabi podatkov ne morejo dogovoriti o takšnem modelu delitve stroškov, v skladu s členoma 27 in 30 Uredbe (ES) št. 1907/2006 vsak udeleženec plača enak delež stroškov, potrebnih za njegovo udeležbo.
Compiling information for the purposes of establishing substance sameness should not be the subject of any cost sharing between previous registrants and potential registrants.
Povračilo dela takih plačanih stroškov se še vedno izvede, kot če bi bil na podlagi prvega pododstavka odstavka 4 dogovorjen mehanizem za povračilo.
Pursuant to Articles 27 and 30 of Regulation (EC) No 1907/2006, if the participants to a data-sharing agreement cannot agree to such a cost-sharing model, each participant shall pay an equal share of the costs required for their participation.
Mehanizem za povračilo iz člena 2(1)(c) se določi v vsakem modelu delitve stroškov in vključuje metodo sorazmernega povračila deleža plačanih stroškov vsem udeležencem, kadar se v prihodnosti zadevnemu sporazumu pridruži potencialni registracijski zavezanec.
Reimbursement of part of such costs paid shall still occur as if a reimbursement mechanism has been agreed subject to the first subparagraph of paragraph 4.
V mehanizmu za povračilo se upoštevata tudi naslednja dejavnika:
The reimbursement mechanism referred to in Article 2(1)(c) shall be envisaged in every cost-sharing model and shall include a method of proportional redistribution to each participant of their share of costs paid where a potential registrant joins that agreement in the future.
Kadar sporazum o souporabi podatkov že obstaja na dan začetka veljavnosti te uredbe, lahko pogodbenice tega sporazuma soglasno opustijo svojo obveznost vključitve mehanizma za povračilo v svoj model delitve stroškov.
The reimbursement mechanism shall also take account of the following factors:
Potencialni registracijski zavezanec, ki namerava sodelovati v obstoječem sporazumu o souporabi podatkov, ni zavezan k obstoječi opustitvi obveznosti, razen če predhodnim registracijskim zavezancem predloži podpisano soglasje k njej, in ima pravico doseči vključitev mehanizma za povračilo v model delitve stroškov v skladu s to uredbo.
Where a data-sharing agreement already exists on the date of entry into force of this Regulation, parties to that agreement may, by unanimous consent, waive their obligation to include a reimbursement mechanism in their cost-sharing model.
Reševanje sporov
A potential registrant who intends to participate in an existing data-sharing agreement shall not be bound by an existing waiver unless he provides his signed consent to it to the previous registrants and shall have the right to obtain the inclusion of a reimbursement mechanism in the cost-sharing model in accordance with this Regulation.
Pri reševanju sporov v zvezi s souporabo podatkov v skladu s členoma 27(5) in 30(3) Uredbe (ES) št. 1907/2006, Agencija upošteva, ali pogodbenice izpolnjujejo obveznosti iz členov 2, 3 in 4 te uredbe.
Any registrant who has ceased his activities pursuant to paragraph 2 or 3 of Article 50 of Regulation (EC) No 1907/2006 may still be required to share costs resulting from a substance evaluation decision in accordance with Article 50(4) of that Regulation.
Ta uredba se uporablja brez poseganja v polno in neomejeno uporabo konkurenčnega prava Evropske unije.
Dispute Resolution
Začetek veljavnosti
When settling a data-sharing dispute pursuant to Articles 27(5) and 30(3) of Regulation (EC) No 1907/2006, the Agency shall take account of the parties' compliance with the obligations set out in Articles 2, 3 and 4 of this Regulation.
Ta uredba začne veljati dvajseti dan po objavi v Uradnem listu Evropske unije.
This Regulation operates without prejudice to the full and complete application of the Union competition law.
Ta uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.
Article 6
V Bruslju, 5. januarja 2016
This Regulation shall be binding in its entirety and directly applicable in all Member States.
UL L 396, 30.12.2006, str. 1.
Done at Brussels, 5 January 2016.
ocenjeno število potencialnih registracijskih zavezancev za zadevno snov in možnost prihodnjih zahtev po dodatnih informacijah za zadevno snov, razen tistih, ki izhajajo iz morebitnega sklepa o evalvaciji snovi.
For the Commission
možnost prihodnjih dodatnih zahtev za registracijo zadevne snovi, razen tistih, ki izhajajo iz morebitnega sklepa o evalvaciji snovi in ekonomska upravičenost določenih povračil, kadar so stroški povračila višji od zneska, ki ga je treba vrniti.
Commission Implementing Regulation (EU) 2016/10
Izvedbena uredba Komisije (EU) 2016/10
Commission Implementing Regulation (EU) 2016/12
Izvedbena uredba Komisije (EU) 2016/12
of 6 January 2016
z dne 6. januarja 2016
terminating the partial interim review of the anti-dumping and countervailing measures applicable to imports of crystalline silicon photovoltaic modules and key components (i.e. cells) originating in or consigned from the People's Republic of China
o zaključku delnega vmesnega pregleda protidampinških in izravnalnih ukrepov, ki se uporabljajo za uvoz fotonapetostnih modulov iz kristalnega silicija in njihovih ključnih sestavnih delov (tj. celic) s poreklom iz Ljudske republike Kitajske ali ki so od tam poslani
Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community [1] (‘the basic anti-dumping Regulation’), and in particular Article 11(3) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 1225/2009 z dne 30. novembra 2009 o zaščiti proti dampinškemu uvozu iz držav, ki niso članice Evropske skupnosti [1] („osnovna protidampinška uredba“), in zlasti člena 11(3) Uredbe,
Having regard to Council Regulation (EC) No 597/2009 of 11 June 2009 on protection against subsidised imports from countries not members of the European Community [2] (‘the basic anti-subsidy Regulation’), and in particular Article 19(3) thereof,
ob upoštevanju Uredbe Sveta (ES) št. 597/2009 z dne 11. junija 2009 o zaščiti proti subvencioniranemu uvozu iz držav, ki niso članice Evropske skupnosti [2] („osnovna protisubvencijska uredba“), in zlasti člena 19(3) Uredbe,
By Regulation (EU) No 513/2013 [3], the European Commission (‘the Commission’) imposed a provisional anti-dumping duty on imports into the European Union (‘the Union’) of crystalline silicon photovoltaic modules (‘modules’) and key components (i.e. cells and wafers) originating in or consigned from the People's Republic of China (‘China’).
Evropska komisija („Komisija“) je z Uredbo (EU) št. 513/2013 [3] določila začasne protidampinške dajatve na uvoz v Evropsko unijo („Unija“) fotonapetostnih modulov iz kristalnega silicija („modulov“) in njihovih ključnih sestavnih delov (tj. celic in rezin) s poreklom iz Ljudske republike Kitajske („Kitajska“) ali ki so od tam poslani.
The exporting producers gave a mandate to the China Chamber of Commerce for Import and Export of Machinery and Electronic Products (‘the CCCME’) to submit a price undertaking on their behalf to the Commission, which they did.
Skupina proizvajalcev izvoznikov je kitajsko gospodarsko zbornico za uvoz in izvoz strojev in elektronskih izdelkov („CCCME“) pooblastila, naj v njihovem imenu Komisiji predloži cenovno zavezo, kar se je tudi zgodilo.