natgillin/translations-raw huggingface dataset:
In the case of non phase-in substances, the Agency shall prepare a draft decision in accordance with Article 40(3) within 180 days of receiving a registration or downstream user report containing a testing proposal.
Pri snoveh, ki niso v postopnem uvajanju, Agencija pripravi osnutek odločitve v skladu s členom 40(3) v 180 dneh po prejemu registracije ali poročila nadaljnjega uporabnika, ki vsebuje predlog za testiranje.
In the case of phase-in substances, the Agency shall prepare the draft decisions in accordance with Article 40(3):
Pri snoveh v postopnem uvajanju pripravi Agencija osnutek odločitev v skladu s členom 40(3):
by 1 December 2012 for all registrations received by 1 December 2010 containing proposals for testing in order to fulfil the information requirements in Annexes IX and X;
do 1. decembra 2012 za vse registracije, prejete do 1. decembra 2010, ki vsebujejo predloge za testiranje za izpolnitev zahtev po informacijah iz prilog IX in X;
by 1 June 2016 for all registrations received by 1 June 2013 containing proposals for testing in order to fulfil the information requirements in Annex IX only;
do 1. junija 2016 za vse registracije, prejete do 1. junija 2013, ki vsebujejo predloge za testiranje za izpolnitev zahtev po informacijah samo iz Priloge IX;
by 1 June 2022 for any registrations containing testing proposals received by 1 June 2018.
do 1. junija 2022 za vse registracije, prejete do 1. junija 2018, ki vsebujejo predloge za testiranje.
The list of registration dossiers being evaluated under Article 40 shall be made available to Member States.
Seznam registracijske dokumentacije, ki se evalvira v skladu s členom 40, je na razpolago državam članicam.
Substance evaluation
Evalvacija snovi
Criteria for substance evaluation
Kriteriji za evalvacijo snovi
In order to ensure a harmonised approach, the Agency shall in cooperation with the Member States develop criteria for prioritising substances with a view to further evaluation.
Za zagotovitev usklajenega pristopa Agencija v sodelovanju z državami članicami pripravi kriterije za določitev prednostnega seznama snovi za nadaljnjo evalvacijo.
Prioritisation shall be on a risk-based approach.
Prednostni seznam se določi na podlagi pristopa, utemeljenega na tveganju.
The criteria shall consider:
Kriteriji bodo upoštevali:
hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
informacije o nevarnostih, na primer strukturne podobnosti snovi z znanimi snovmi, ki vzbujajo skrb, ali snovmi, ki so obstojne in se lahko kopičijo v organizmih, kar kaže na to, da ima snov ali eden ali več njenih proizvodov pretvorbe lastnosti, ki vzbujajo skrb, ali da so obstojni in se lahko kopičijo v organizmih;
exposure information;
informacije o izpostavljenosti;
tonnage, including aggregated tonnage from the registrations submitted by several registrants.
tonažo, vključno s skupno tonažo iz registracij, ki jih predloži več registracijskih zavezancev.
The Agency shall use the criteria in paragraph 1 for the purpose of compiling a draft Community rolling action plan which shall cover a period of three years and shall specify substances to be evaluated each year.
Agencija bo oblikovala osnutek tekočega akcijskega načrta Skupnosti, ki zajema obdobje treh let, in opredelila snovi, ki morajo biti vsako leto evalvirane, ob uporabi kriterijev iz odstavka 1.
Substances shall be included if there are grounds for considering (either on the basis of a dossier evaluation carried out by the Agency or on the basis of any other appropriate source, including information in the registration dossier) that a given substance constitutes a risk to human health or the environment.
Snovi so v načrt vključene, če obstajajo pomisleki (na podlagi evalvacije dokumentacije, ki jo izvede Agencija, ali katerega koli drugega ustreznega vira, vključno z informacijami v registracijski dokumentaciji) o tem, ali določena snov ne pomeni tveganja za zdravje ljudi ali okolje.
The Agency shall submit the first draft rolling action plan to the Member States by 1 December 2011.
Agencija državam članicam predloži prvi osnutek tekočega akcijskega načrta do 1. decembra 2011.
The Agency shall submit draft annual updates to the rolling action plan to the Member States by 28 February each year.
Agencija državam članicam predloži osnutek letnih dopolnitev tekočega akcijskega načrta do 28. februarja vsako leto.
The Agency shall adopt the final Community rolling action plan on the basis of an opinion from the Member State Committee set up under Article 76(1)(e) (hereinafter referred to as the Member State Committee) and shall publish the plan on its website, identifying the Member State who will carry out the evaluation of the substances listed therein as determined according to Article 45.
Agencija sprejme končni tekoči akcijski načrt Skupnosti na podlagi mnenja Odbora držav članic, ustanovljenega v skladu s členom 76(1)(e) (v nadaljnjem besedilu „Odbor držav članic“), in ga objavi na svoji spletni strani, z opredelitvijo države članice, ki bo opravila evalvacijo snovi s seznama v načrtu, kot je določeno v skladu s členom 45.
The Agency shall be responsible for coordinating the substance evaluation process and ensuring that substances on the Community rolling action plan are evaluated.
Odgovornost Agencije je, da usklajuje proces evalvacije snovi in da zagotovi, da so snovi iz tekočega akcijskega načrta Skupnosti evalvirane.
In doing so, the Agency shall rely on the competent authorities of Member States.
Pri tem se Agencija sklicuje na pristojne organe držav članic.
In carrying out an evaluation of a substance, the competent authorities may appoint another body to act on their behalf.
Pristojni organi lahko imenujejo drug organ, ki bo evalvacijo snovi opravil v njihovem imenu.
A Member State may choose (a) substance(s) from the draft Community rolling action plan, with the aim of becoming a competent authority for the purposes of Articles 46, 47 and 48.
Država članica lahko iz osnutka tekočega akcijskega načrta Skupnosti izbere določeno snov (snovi), da tako postane pristojni organ za namene členov 46, 47 in 48.
In the event of a substance from the draft Community rolling action plan not being chosen by any Member State, the Agency shall ensure that the substance is evaluated.
V primeru, da snovi iz osnutka tekočega akcijskega načrta Skupnosti ne izbere nobena država članica, Agencija zagotovi, da je snov evalvirana.
In cases where two or more Member States have expressed an interest in evaluating the same substance and they cannot agree who should be the competent authority, the competent authority for the purposes of Articles 46, 47 and 48 shall be determined in accordance with the following procedure.
Če dve ali več držav članic izrazi zanimanje za evalvacijo iste snovi in se ne morejo dogovoriti o pristojnem organu, se pristojni organ za namene členov 46, 47 in 48 določi v skladu z naslednjim postopkom.
The Agency shall refer the matter to the Member State Committee, in order to agree which authority shall be the competent authority, taking into account the Member State in which the manufacturer(s) or importer(s) is located, the respective proportions of total Community gross domestic product, the number of substances already being evaluated by a Member State and the expertise available.
Agencija zadevo predloži Odboru držav članic, da se dogovori, kateri organ bo pristojni organ, ob upoštevanju, iz katere države članice proizvajalec(-ci) ali uvoznik(-i) prihaja(-jo), posamičnih deležev skupnega bruto domačega proizvoda, števila snovi, ki se v državi članici že evalvirajo, ter razpoložljivega strokovnega znanja.
If, within 60 days of the referral, the Member State Committee reaches unanimous agreement, the Member States concerned shall adopt substances for evaluation accordingly.
Če Odbor držav članic doseže soglasje v 60 dneh po tem, ko mu je bila zadeva predložena, zadevne države članice v skladu s tem sprejmejo snovi za evalvacijo.
If the Member State Committee fails to reach a unanimous agreement, the Agency shall submit the conflicting opinions to the Commission, which shall decide which authority shall be the competent authority, in accordance with the procedure referred to in Article 133(3), and the Member States concerned shall adopt substances for evaluation accordingly.
Če Odbor držav članic soglasja ne doseže, Agencija nasprotujoča si mnenja predloži Komisiji, ki odloči, kateri organ bo pristojni organ v skladu s postopkom iz člena 133(3), zadevne države članice pa v skladu s tem sprejmejo snovi za evalvacijo.
The competent authority identified in accordance with paragraphs 2 and 3 shall evaluate the allocated substances in accordance with this Chapter.
Pristojni organ, določen v skladu z odstavkoma 2 in 3, evalvira dodeljene snovi v skladu s tem poglavjem.
A Member State may notify the Agency at any time of a substance not on the Community rolling action plan, whenever it is in possession of information which suggests that the substance is a priority for evaluation.
Država članica lahko kadar koli uradno obvesti Agencijo o snovi, ki je ni v tekočem akcijskem načrtu Skupnosti, če razpolaga z informacijami, ki kažejo na to, da snov v postopku evalvacije spada med prednostne.
The Agency shall decide whether to add this substance to the Community rolling action plan on the basis of an opinion from the Member State Committee.
Agencija se o tem, ali bo to snov dodala v tekoči akcijski načrt Skupnosti, odloči na podlagi mnenja Odbora držav članic.
If the substance is added to the Community rolling action plan, the proposing Member State, or another Member State who agrees, shall evaluate that substance.
Če se snov doda tekočemu akcijskemu načrtu Skupnosti, jo evalvira država članica, ki je snov predlagala, ali druga država članica, ki se s predlogom strinja.
Requests for further information and check of information submitted
Zahteve po dodatnih informacijah in preverjanje predloženih informacij
If the competent authority considers that further information is required, including, if appropriate, information not required in Annexes VII to X, it shall prepare a draft decision, stating reasons, requiring the registrant(s) to submit the further information and setting a deadline for its submission.
Če so po mnenju pristojnega organa potrebne dodatne informacije, če je ustrezno, vključno z informacijami, ki se ne zahtevajo v prilogah VII do X, pristojni organ pripravi osnutek odločitve, ki od registracijskega(-ih) zavezanca(-ev) zahtevajo predložitev dodatnih informacij in določitev roka za predložitev.
A draft decision shall be prepared within 12 months of the publication of the Community rolling action plan on the Agency's website for substances to be evaluated that year.
Osnutek odločitve o snoveh, ki se bodo evalvirale v tem letu, bo pripravljen v 12 mesecih po objavi tekočega akcijskega načrta Skupnosti na spletni strani Agencije.
The decision shall be taken in accordance with the procedure laid down in Articles 50 and 52.
Odločitev se sprejme v skladu s postopkom iz členov 50 in 52.
The competent authority shall examine any information submitted, and shall draft any appropriate decisions in accordance with this Article, if necessary, within 12 months of the information being submitted.
Pristojni organ preveri vse informacije ter po potrebi pripravi ustrezne osnutke odločitev v skladu s tem členom v 12 mesecih po predložitvi informacij.
The competent authority shall finish its evaluation activities within 12 months of the start of the evaluation of the substance or within 12 months of the information being submitted under paragraph 2, and notify the Agency accordingly.
Pristojni organ zaključi svojo evalvacijo snovi v 12 mesecih po začetku evalvacije ali v 12 mesecih po predložitvi informacij v skladu z odstavkom 2 ter o tem obvesti Agencijo.
If this deadline is exceeded, the evaluation shall be deemed to be finished.
Če se ta rok preseže, se evalvacija šteje za končano.
Coherence with other activities
Usklajenost z drugimi dejavnostmi
An evaluation of a substance shall be based on all relevant information submitted on that particular substance and on any previous evaluation under this Title.
Evalvacija snovi se opira na vse ustrezne informacije, predložene v zvezi s to posebno snovjo, in na predhodne evalvacije v skladu s tem naslovom.
Where information on intrinsic properties of a substance has been generated by reference to structurally related substance(s), the evaluation may also cover these related substances.
Evalvacija lahko v primerih, ko so bile informacije o intrinzičnih lastnostih snovi pridobljene s sklicevanjem na strukturno sorodne snovi, zajema tudi te sorodne snovi.
In cases where a decision on an evaluation has been previously taken in accordance with Article 51 or Article 52, any draft decision requiring further information under Article 46 may be justified only by a change of circumstances or acquired knowledge.
Če je bila odločitev o evalvaciji predhodno sprejeta v skladu s členom 51 ali 52, se vsak osnutek odločitve, ki zahteva dodatne informacije v skladu s členom 46, lahko utemelji samo s spremembo okoliščin ali novimi spoznanji.
In order to ensure a harmonised approach to requests for further information, the Agency shall monitor draft decisions under Article 46 and shall develop criteria and priorities.
Da se zagotovi usklajen pristop k zahtevanju dodatnih informacij, Agencija spremlja osnutke odločitev v skladu s členom 46 ter določi kriterije in prednostne naloge.
Where appropriate, implementing measures shall be adopted in accordance with the procedure referred to in Article 133(3).
Kjer je ustrezno, se sprejmejo izvedbeni ukrepi v skladu s postopkom iz člena 133(3).
Follow-up to substance evaluation
Nadaljnja evalvacija snovi
Once the substance evaluation has been completed, the competent authority shall consider how to use the information obtained from this evaluation for the purposes of Article 59(3), Article 69(4) and Article 115(1).
Po zaključeni evalvaciji snovi pristojni organi razmislijo, kako uporabiti informacije, pridobljene s to evalvacijo, za namene členov 59(3), 69(4) in 115(1).
The competent authority shall inform the Agency of its conclusions as to whether or how to use the information obtained.
Pristojni organ obvesti Agencijo o svojih sklepih glede tega, ali naj se pridobljene informacije uporabijo in na kakšen način.
The Agency shall in turn inform the Commission, the registrant and the competent authorities of the other Member States.
Agencija pa nato obvesti Komisijo, registracijskega zavezanca ter pristojne organe drugih držav članic.
Evaluation of intermediates
Evalvacija intermediatov
Further information on on-site isolated intermediates
Dodatne informacije o na mestu izoliranih intermediatih
For on-site isolated intermediates that are used in strictly controlled conditions, neither dossier nor substance evaluation shall apply.
Za na mestu izolirane intermediate, ki se uporabljajo pod strogo nadzorovanimi pogoji, se ne uporablja niti evalvacija dokumentacije niti snovi.
However, where the competent authority of the Member State in whose territory the site is located considers that a risk to human health or the environment, equivalent to the level of concern arising from the use of substances meeting the criteria in Article 57, arises from the use of an on-site isolated intermediate and that risk is not properly controlled, it may:
Če se lahko dokaže, da tveganje za zdravje ljudi ali okolje zaradi uporabe na mestu izoliranega intermediata povzroča zaskrbljenost, enakovredno zaskrbljenosti, ki jo povzroča uporaba snovi, ki izpolnjujejo kriterije iz člena 57, in da to tveganje ni primerno nadzorovano, lahko pristojni organ države članice, na ozemlju katere je to mesto:
require the registrant to submit further information directly related to the risk identified.
od registracijskega zavezanca zahteva, da predloži nadaljnje informacije, neposredno povezane z ugotovljenim tveganjem.
This request shall be accompanied by a written justification;
Tej zahtevi je treba priložiti pisno utemeljitev;
examine any information submitted and, if necessary, recommend any appropriate risk reduction measures to address the risks identified in relation to the site in question.
preuči vse predložene informacije in po potrebi priporoči ustrezne ukrepe za zmanjšanje tveganj, ugotovljenih v zvezi z zadevnim mestom.
The procedure provided for in the first paragraph may be undertaken only by the competent authority referred to therein.
Postopek iz prvega odstavka lahko izvede samo v njem navedeni pristojni organ.
The competent authority shall inform the Agency of the results of such an evaluation, which shall then inform the competent authorities of the other Member States and make the results available to them.
Pristojni organ obvesti Agencijo o rezultatih takšne evalvacije, slednja pa potem obvesti pristojne organe drugih držav članic ter jim da te rezultate na razpolago.
Registrants' and downstream users' rights
Pravice registracijskih zavezancev in nadaljnjih uporabnikov
The Agency shall notify any draft decision under Articles 40, 41 or 46 to the registrant(s) or downstream user(s) concerned, informing them of their right to comment within 30 days of receipt.
Agencija vse osnutke odločitev v skladu s členi 40, 41 ali 46 uradno sporoči zadevnemu(-im) registracijskemu(-im) zavezancu(-em) ali nadaljnjemu(-im) uporabniku(-om) in ga (jih) obvesti o njegovi (njihovi) pravici, da v 30 dneh po prejemu obvestila predloži(-jo) svoje pripombe.
If the concerned registrant(s) or downstream user(s) wish to comment, they shall provide their comments to the Agency.
Če zadevni registracijski zavezanec(-ci) ali nadaljnji uporabnik(-i) pripombe želijo predložiti, jih posredujejo Agenciji.
The Agency in turn shall inform the competent authority of the submission of the comments without delay.
Agencija pa nato o predložitvi pripomb takoj obvesti pristojni organ.
The competent authority (for decisions taken under Article 46) and the Agency (for decisions taken under Articles 40 and 41) shall take any comments received into account and may amend the draft decision accordingly.
Pristojni organ (za odločitve, sprejete v skladu s členom 46) in Agencija (za odločitve, sprejete v skladu s členoma 40 in 41) upoštevata vse prejete pripombe in lahko v skladu z njimi spremenita osnutek odločitve.
If a registrant has ceased the manufacture or import of the substance, or the production or import of an article, or the downstream user the use, he shall inform the Agency of this fact with the consequence that the registered volume in his registration, if appropriate, shall be put to zero and no further information may be requested with respect to that substance, unless the registrant notifies the restart of the manufacture or import of the substance or the production or import of the article, or the downstream user notifies the restart of the use.
Če je registracijski zavezanec prenehal proizvajati ali uvažati snov ali izdelovati ali uvažati izdelek, nadaljnji uporabnik pa ju je prenehal uporabljati, o tem obvesti Agencijo, pri čemer se registrirana količina v njegovi registraciji po potrebi spremeni na nič in v zvezi s to snovjo se ne more več zahtevati dodatnih informacij, razen če registracijski zavezanec ne prijavi ponovnega zagona proizvodnje ali uvoza snovi ali izdelovanja ali uvoza izdelka, nadaljnji uporabnik pa ne prijavi ponovne uporabe.
The Agency shall inform the competent authority of the Member State in which the registrant or downstream user is located.
Agencija obvesti pristojni organ države članice, v kateri ima registracijski zavezanec ali nadaljnji uporabnik sedež.
The registrant may cease the manufacture or import of the substance or the production or import of the article, or the downstream user the use, upon receipt of the draft decision.
Registracijski zavezanec lahko po sprejetju osnutka odločitve preneha proizvajati ali uvažati snov ali izdelovati ali uvažati izdelek, nadaljnji uporabnik pa ju preneha uporabljati.
In such cases, the registrant, or downstream user, shall inform the Agency of this fact with the consequence that his registration, or report, shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration or report.
V takšnih primerih registracijski zavezanec ali nadaljnji uporabnik obvesti o tem Agencijo, kar ima za posledico prenehanje veljavnosti njegove registracije ali prijave in da se v zvezi s to snovjo ne more več zahtevati dodatnih informacij, razen če ne predloži nove registracije ali prijave.
Notwithstanding paragraphs 2 and 3, further information may be required in accordance with Article 46 in either or both of the following cases:
Ne glede na odstavka 2 in 3 se dodatne informacije lahko zahtevajo v skladu s členom 46 v enem ali obeh naslednjih primerih:
where the competent authority prepares a dossier in accordance with Annex XV concluding that there is a potential long-term risk to human health or the environment justifying the need for further information;
če pristojni organ pripravi dokumentacijo v skladu s Prilogo XV, pri čemer ugotovi možno dolgoročno tveganje za zdravje ljudi ali okolje, ki upravičuje potrebo po dodatnih informacijah;
where the exposure to the substance manufactured or imported by the registrant(s), or to the substance in the article produced or imported by the registrant(s), or to the substance used by the downstream user(s) contributes significantly to that risk.
če izpostavljenost snovi, ki jo izdeluje(-jo) ali uvaža(-jo) zadevni registracijski zavezanec(-ci), ali snovi v izdelku, ki ga izdeluje(-jo) ali uvaža(-jo) zadevni registracijski zavezanec(-ci), ali snovi, ki jo uporablja(-jo) nadaljnji uporabnik(-i), bistveno prispeva k temu tveganju.
The procedure in Articles 69 to 73 shall apply mutatis mutandis.
Smiselno se uporablja postopek iz členov 69 do 73.
Adoption of decisions under dossier evaluation
Sprejetje odločitev med evalvacijo dokumentacije
The Agency shall notify its draft decision in accordance with Articles 40 or 41, together with the comments of the registrant, to the competent authorities of the Member States.
Agencija svoj osnutek odločitve, skupaj s pripombami registracijskega zavezanca, v skladu s členom 40 ali 41 uradno sporoči pristojnim organom držav članic.
Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency.
Države članice lahko v 30 dneh po tem, ko je bila dokumentacija razposlana, Agenciji predlagajo spremembe osnutka odločitve.
If the Agency does not receive any proposals, it shall take the decision in the version notified under paragraph 1.
Če Agencija ne prejme nobenih predlogov, odločitev sprejme v različici iz odstavka 1.
If the Agency receives a proposal for amendment, it may modify the draft decision.
Če Agencija prejme predlog spremembe, lahko spremeni osnutek odločitve.
The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in paragraph 2.
Agencija osnutek odločitve skupaj s predlaganimi spremembami predloži Odboru držav članic v 15 dneh po poteku 30-dnevnega roka iz odstavka 2.
The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days.
Agencija vsak predlog spremembe takoj sporoči vsem zadevnim registracijskim zavezancem ali nadaljnjim uporabnikom in jim omogoči, da v 30 dneh predložijo svoje pripombe.
The Member State Committee shall take any comments received into account.
Odbor držav članic upošteva vse prejete pripombe.
If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly.
Če Odbor držav članic doseže soglasje o osnutku odločitve v 60 dneh po tem, ko mu je bila zadeva predložena, Agencija v skladu s tem sprejme odločitev.