natgillin/translations-raw huggingface dataset:
The Agency shall make available on its web-site broad information on uses, taking into account Articles 118 and 119 on access to information, for which applications have been received and for reviews of authorisations, with a deadline by which information on alternative substances or technologies may be submitted by interested third parties.
Ob upoštevanju členov 118 in 119 o dostopu do informacij da Agencija na razpolago na svoji spletni strani splošne informacije o uporabah, za katere je prejela vloge ter za preverjanje avtorizacij, pri čemer navede roke, do katerih zainteresirane tretje strani lahko predložijo informacije o alternativnih snoveh ali tehnologijah.
In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes all the information specified in Article 62 that is relevant to its remit.
Pri pripravi svojega mnenja oba odbora iz odstavka 1 najprej preverita, ali vloga vključuje vse informacije iz člena 62, ki jih potrebujeta za izvedbo svoje naloge.
If necessary, the Committees shall, in consultation with each other, make a joint request to the applicant for additional information to bring the application into conformity with the requirements of Article 62.
Po potrebi odbora v posvetovanju drug z drugim vlagatelja pozoveta k predložitvi dodatnih informacij, da se vloga uskladi z zahtevami iz člena 62.
The Committee for Socio-economic Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time period, additional information on possible alternative substances or technologies.
Odbor za socialno-ekonomsko analizo lahko, če meni, da je to potrebno, od vlagatelja ali tretjih strani zahteva, da v določenem roku predloži dodatne informacije o alternativnih snoveh ali tehnologijah.
Each Committee shall also take into account any information submitted by third parties.
Oba odbora upoštevata tudi informacije, ki jih predložijo tretje strani.
The draft opinions shall include the following elements:
Osnutek mnenja vsebuje naslednje elemente:
Committee for Risk Assessment: an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives;
Odbor za oceno tveganja: oceno tveganja za zdravje ljudi in/ali okolje, ki izhaja iz uporabe (uporab) snovi skupaj z ustreznostjo in učinkovitostjo ukrepov za obvladovanje tveganja, kot je (so) opisana(-e) v vlogi, in če je ustrezno, oceno tveganj, ki izhajajo iz morebitnih alternativ;
Committee for Socio-economic Analysis: an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, when an application is made in accordance with Article 62 and of any third party contributions submitted under paragraph 2 of this Article.
Odbor za socialno-ekonomsko analizo: oceno socialno-ekonomskih dejavnikov ter razpoložljivost, primernost in tehnično izvedljivost drugih možnosti, povezanih z uporabo(-ami) snovi, kot je (so) opisana(-e) v vlogi, če se ta predloži v skladu s členom 62, ali vseh prispevkov zainteresiranih tretjih strani iz odstavka 2 tega člena.
The Agency shall send these draft opinions to the applicant by the end of the deadline set out in paragraph 1.
Agencija pošlje osnutka obeh mnenj vlagatelju do konca roka iz odstavka 1.
Within one month of receipt of the draft opinion, the applicant may provide written notice that he wishes to comment.
V enem mesecu po prejemu osnutka mnenja lahko vlagatelj pisno izrazi željo po predložitvi pripomb.
The draft opinion shall be deemed to have been received seven days after the Agency has sent it.
Osnutek mnenja se šteje kot prejet sedem dni po tem, ko ga je Agencija poslala.
If the applicant does not wish to comment, the Agency shall send these opinions to the Commission, the Member States and the applicant, within 15 days of the end of the period within which the applicant may comment or within 15 days of receipt of notice from the applicant that he does not intend to comment.
Če vlagatelj ne želi predložiti pripomb, Agencija ti mnenji pošlje Komisiji, državam članicam in vlagatelju v 15 dneh po poteku roka, v katerem lahko vlagatelj predloži pripombe, ali v 15 dneh po prejemu obvestila vlagatelja, da ne namerava predložiti pripomb.
If the applicant wishes to comment, he shall send his written argumentation to the Agency within two months of the receipt of the draft opinion.
Če vlagatelj želi predložiti pripombe, jih pošlje Agenciji v pisni obliki v dveh mesecih po prejemu osnutka mnenja.
The Committees shall consider the comments and adopt their final opinions within two months of receipt of the written argumentation, taking this argumentation into account where appropriate.
Odbora preučita pripombe in v dveh mesecih po njihovem prejemu v pisni obliki sprejmeta vsak svoje dokončno mnenje, pri čemer jih ustrezno upoštevata.
Within a further 15 days the Agency shall send the opinions, with the written argumentation attached, to the Commission, the Member States and the applicant.
V nadaljnjih 15 dneh Agencija pošlje mnenji s priloženimi pisnimi pripombami Komisiji, državam članicam in vlagatelju.
The Agency shall determine in accordance with Articles 118 and 119 which parts of its opinions and parts of any attachments thereto should be made publicly available on its website.
Agencija določi v skladu s členoma 118 in 119, kateri deli njenih mnenj in kateri deli prilog k tem mnenjem naj bi bili na razpolago javnosti na njeni spletni strani.
In cases covered by Article 63(1), the Agency shall treat the applications together, provided the deadlines for the first application can be met.
V primerih iz člena 63(1) Agencija obravnava vloge skupaj, če se lahko izpolnijo roki za prvo vlogo.
The Commission shall prepare a draft authorisation decision within three months of receipt of the opinions from the Agency.
Komisija pripravi osnutek odločitve o avtorizaciji v treh mesecih po prejemu mnenj Agencije.
A final decision granting or refusing the authorisation shall be taken in accordance with the procedure referred to in Article 133(3).
Dokončna odločitev o izdaji ali zavrnitvi avtorizacije se sprejme v skladu s postopkom iz člena 133(3).
Summaries of the Commission decisions, including the authorisation number and the reasons for the decision, in particular where suitable alternatives exist, shall be published in the Official Journal of the European Union and shall be made publicly available in a database established and kept up to date by the Agency.
Povzetki odločitev Komisije, vključno s številko dovoljenja, ter razlogi za odločitev, zlasti če obstajajo primerne alternative, se objavijo v Uradnem listu Evropske unije in v zbirki podatkov, ki jo vzpostavi in sproti dopolnjuje Agencija.
In cases covered by Article 63(2), the deadline set out in paragraph 1 of this Article shall be shortened to five months.
V primerih iz člena 63(2) se rok iz odstavka 1 tega člena skrajša na pet mesecev.
Authorisations in the supply chain
Avtorizacije v dobavni verigi
Obligation of holders of authorisations
Obveznost imetnikov avtorizacije
Holders of an authorisation, as well as downstream users referred to in Article 56(2) including the substances in a preparation, shall include the authorisation number on the label before they place the substance or a preparation containing the substance on the market for an authorised use without prejudice to Directive 67/548/EEC and Directive 1999/45/EC.
Imetniki avtorizacije kakor tudi nadaljnji uporabniki iz člena 56(2), ki vključujejo snovi v pripravke, vključijo številko avtorizacije na etiketo, preden dajo snov ali pripravek, ki snov vsebuje, v promet za dovoljeno uporabo brez poseganja v direktivi 67/548/EGS in 1999/45/ES.
This shall be done without delay once the authorisation number has been made publicly available in accordance with Article 64(9).
To se naredi takoj, ko je številka avtorizacije objavljena v skladu s členom 64(9).
Downstream users
Nadaljnji uporabniki
Downstream users using a substance in accordance with Article 56(2) shall notify the Agency within three months of the first supply of the substance.
Nadaljnji uporabniki, ki uporabljajo snov v skladu s členom 56(2), o tem obvestijo Agencijo v treh mesecih po prvi dostavi snovi.
The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1.
Agencija vzpostavi in sproti dopolnjuje register nadaljnjih uporabnikov, ki so poslali obvestilo v skladu z odstavkom 1.
The Agency shall grant access to this register to the competent authorities of the Member States.
Agencija zagotovi dostop do tega registra pristojnim organom držav članic.
RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES
OMEJITVE ZA PROIZVODNJO, DAJANJE V PROMET IN UPORABO NEKATERIH NEVARNIH SNOVI, PRIPRAVKOV IN IZDELKOV
General issues
Splošna vprašanja
A substance on its own, in a preparation or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
Snov kot taka, v pripravku ali izdelku, za katero vsebuje Priloga XVII omejitev, se ne sme proizvajati, dajati v promet ali uporabljati, če ne izpolnjuje pogojev iz te omejitve.
This shall not apply to the manufacture, placing on the market or use of a substance in scientific research and development.
To ne velja za proizvodnjo, dajanje v promet ali uporabo snovi za znanstvene raziskave in razvoj.
Annex XVII shall specify if the restriction shall not apply to product and process orientated research and development, as well as the maximum quantity exempted.
V Prilogi XVII je natančno navedeno, če se omejitev ne uporablja za v proizvod in proces usmerjeno raziskavo in razvoj, kakor tudi največja količina, ki je izvzeta.
Paragraph 1 shall not apply to the use of substances in cosmetic products, as defined by Directive 76/768/EEC, with regard to restrictions addressing the risks to human health within the scope of that Directive.
Odstavek 1 se ne uporablja za uporabo snovi v kozmetičnih izdelkih, kot je opredeljeno v Direktivi 76/768/EGS, v zvezi z omejitvami, ki se nanašajo na tveganja za zdravje ljudi na področju uporabe te direktive.
Until 1 June 2013, a Member State may maintain any existing and more stringent restrictions in relation to Annex XVII on the manufacture, placing on the market or use of a substance, provided that those restrictions have been notified according to the Treaty.
Države članice lahko do 1. junija 2013 ohranijo vse obstoječe in strožje omejitve v zvezi s Prilogo XVII glede proizvodnje, dajanja v promet ali uporabe snovi, pod pogojem, da so bile te omejitve priglašene v skladu s Pogodbo.
The Commission shall compile and publish an inventory of these restrictions by 1 June 2009.
Komisija do 1. junija 2009 izdela in objavi popis teh omejitev.
Restrictions process
Postopek za omejitve
Introducing new and amending current restrictions
Uvedba novih in sprememba veljavnih omejitev
When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73.
Če iz proizvodnje snovi, njene uporabe ali dajanja v promet izhaja nesprejemljivo tveganje za zdravje ljudi ali okolje, ki jo je treba obravnavati v celi Skupnosti, se Priloga XVII spremeni v skladu s postopkom iz člena 133(4), tako da se sprejmejo nove omejitve ali spremenijo veljavne omejitve iz Priloge XVII za proizvodnjo, uporabo ali dajanje v promet snovi kot take, v pripravkih ali izdelkih v skladu s postopkom iz členov 69 do 73.
Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives.
Vsaka takšna odločitev upošteva socialno-ekonomski vpliv omejitve, vključno z razpoložljivostjo drugih možnosti.
The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate.
Prvi pododstavek se ne uporablja za uporabo snovi kot na mestu izoliranega intermediata.
For a substance on its own, in a preparation or in an article which meets the criteria for classification as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, and could be used by consumers and for which restrictions to consumer use are proposed by the Commission, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4).
Za snovi kot take, v pripravku ali v izdelku, ki izpolnjujejo kriterije za razvrstitev kot rakotvorne, mutagene ali strupene za razmnoževanje iz skupine 1 ali 2 in ki bi jih lahko potrošniki uporabili ter za katere je Komisija predlagala omejitve potrošniške uporabe, se Priloga XVII spremeni v skladu s postopkom iz člena 133(4).
Articles 69 to 73 shall not apply.
Členi 69 do 73 se ne uporabljajo.
Preparation of a proposal
Priprava predloga
If the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XV.
Če po mnenju Komisije pomeni proizvodnja, dajanje v promet ali uporaba snovi kot take, v pripravku ali izdelku tveganje za zdravje ljudi ali okolje, ki ni ustrezno nadzorovano in bi ga bilo treba obravnavati, Komisija zaprosi Agencijo, da pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XV.
After the date referred to in Article 58(1)(c)(i) for a substance listed in Annex XIV, the Agency shall consider whether the use of that substance in articles poses a risk to human health or the environment that is not adequately controlled.
Agencija po datumu iz člena 58(1)(c)(i) za snov iz Priloge XIV preuči, ali uporaba te snovi v izdelkih pomeni tveganje za zdravje ljudi ali okolje, ki ni ustrezno nadzorovano.
If the Agency considers that the risk is not adequately controlled, it shall prepare a dossier which conforms to the requirements of Annex XV.
Če Agencija meni, da to tveganje ni ustrezno nadzorovano, pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XV.
Within 12 months of the receipt of the request from the Commission in paragraph 1 and if this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.
V 12 mesecih po prejemu zahteve Komisije v odstavku 1 in če se s to dokumentacijo dokaže, da je tveganje nesprejemljivo in da je zato treba poleg že uvedenih ukrepov sprejeti ukrepe na ravni celotne Skupnosti, Agencija predlaga omejitve, da sproži postopek za določitev omejitev.
If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed it shall notify the Agency that it proposes to prepare a dossier which conforms to the requirements of the relevant sections of Annex XV.
Če po mnenju Komisije pomeni proizvodnja, dajanje v promet ali uporaba snovi kot take, v pripravku ali izdelku tveganje za zdravje ljudi ali okolje, ki ni ustrezno nadzorovano in bi ga bilo treba obravnavati, Komisija uradno obvesti Agencijo, da predlaga, naj pripravi dokumentacijo, ki je v skladu z zahtevami iz ustreznih oddelkov iz Priloge XV.
If the substance is not on the list maintained by the Agency referred to in paragraph 5 of this Article, the Member State shall prepare a dossier which conforms to the requirements of Annex XV within 12 months of the notification to the Agency.
Če ta snov ni na seznamu iz odstavka 5 tega člena, država članica v 12 mesecih po uradnem obvestilu Agenciji pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XV.
If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XV, in order to initiate the restrictions process.
Če se s to dokumentacijo dokaže, da je treba poleg že uvedenih ukrepov sprejeti ukrepe na ravni celotne Skupnosti, država članica to dokumentacijo predloži Agenciji v obliki iz Priloge XV, da sproži postopek za določitev omejitev.
The Agency or Member States shall refer to any dossier, chemical safety report or risk assessment submitted to the Agency or Member State under this Regulation.
Agencija ali države članice upoštevajo dokumentacijo, poročila o kemijski varnosti ali ocene tveganja, predložene Agenciji ali državi članici v skladu s to uredbo.
The Agency or Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives.
Agencija in države članice upoštevajo tudi ustrezne ocene tveganja, predložene za namene drugih uredb ali direktiv Skupnosti.
To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency or Member State concerned on request.
Zato na zahtevo zagotovijo informacije zadevni državi članici ali Agenciji drugi organi, kot so agencije, ustanovljene na podlagi zakonodaje Skupnosti, ki izvajajo podobne naloge.
The Committee for Risk Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XV.
Odbor za oceno tveganja in Odbor za socialno-ekonomsko analizo preverita, ali je predložena dokumentacija v skladu z zahtevami iz Priloge XV.
Within 30 days of receipt, the respective Committee shall inform the Agency or the Member State suggesting restrictions, as to whether the dossier conforms.
V 30 dneh po prejemu posamezni odbor Agencijo ali državo članico, ki je predlagala omejitve, obvesti o tem, ali je dokumentacija po mnenju odborov v skladu z zahtevami.
If the dossier does not conform, the reasons shall be given to the Agency or the Member State in writing within 45 days of receipt.
Če dokumentacija ni v skladu z zahtevami, se Agencijo ali državo članico o tem pisno obvesti v 45 dneh po prejemu in pri tem navede razloge.
The Agency or the Member State shall bring the dossier into conformity within 60 days of the date of receipt of the reasons from the Committees, otherwise the procedure under this Chapter shall be terminated.
Agencija ali država članica dokumentacijo uskladi z zahtevami v 60 dneh po prejemu obvestila odborov o razlogih, sicer se postopek iz tega poglavja zaključi.
The Agency shall publish without delay the intention of the Commission or of a Member State to instigate a restriction procedure for a substance and shall inform those who submitted a registration for that substance.
Agencija takoj objavi, da namerava Komisija ali država članica sprožiti postopek za omejitev snovi, ter obvesti tiste, ki so predložili registracijo za to snov.
The Agency shall maintain a list of substances for which a dossier conforming to the requirements of Annex XV is planned or underway by either the Agency or a Member State for the purposes of a proposed restriction.
Agencija vodi seznam snovi, za katere Agencija ali država članica načrtuje dokumentacijo ali pa takšna dokumentacija nastaja, za namene predloga o omejitvi in ki je v skladu z zahtevami iz Priloge XV.
If a substance is on the list, no other such dossier shall be prepared.
Če je snov na seznamu, se ne pripravi nobena druga takšna dokumentacija.
If it is proposed by either a Member State or the Agency that an existing restriction listed in Annex XVII should be re-examined a decision on whether to do so shall be taken in accordance with the procedure referred to in Article 133(2) based on evidence presented by the Member State or the Agency.
Če država članica ali Agencija predlaga, da bi bilo treba obstoječo omejitev iz Priloge XVII ponovno preučiti, se odločitev o tem sprejme v skladu s postopkom iz člena 133(2) na podlagi dokazil, ki jih predstavi država članica ali Agencija.
Without prejudice to Articles 118 and 119, the Agency shall make publicly available on its website all dossiers conforming with Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of this Article without delay, clearly indicating the date of publication.
Agencija brez poseganja v člena 118 in 119 vso dokumentacijo, ki je v skladu s Prilogo XV, vključno z omejitvami, predlaganimi v skladu z odstavkoma 3 in 4 tega člena, takoj objavi na svoji spletni strani in pri tem jasno navede datum objave.
The Agency shall invite all interested parties to submit individually or jointly within six months of the date of publication:
Agencija pozove vse zainteresirane strani, da v 6 mesecih po datumu objave posamezno ali skupno predložijo:
comments on dossiers and the suggested restrictions;
pripombe k dokumentaciji in predlaganim omejitvam;
a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions.
socialno-ekonomsko analizo predlaganih omejitev ali informacije, ki se lahko uporabijo za takšno analizo, s katero se preučijo prednosti in slabosti predlaganih omejitev.
It shall conform to the requirements in Annex XVI.
Biti mora v skladu z zahtevami iz Priloge XVI.
Agency opinion: Committee for Risk Assessment
Mnenje Agencije: Odbor za oceno tveganja
Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier.
V devetih mesecih po datumu objave iz člena 69(6) Odbor za oceno tveganja na podlagi preučitve ustreznih delov dokumentacije oblikuje mnenje o tem, ali so predlagane omejitve primerne za zmanjševanje tveganja za zdravje ljudi in/ali okolje.
This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in Article 69(6)(a).
Pri tem mnenju upošteva dokumentacijo države članice ali dokumentacijo, ki jo na zahtevo Komisije pripravi Agencija, in stališča zainteresiranih strani iz točke (a) člena 69(6).
Agency opinion: Committee for Socio-economic Analysis
Mnenje Agencije: Odbor za socialno-ekonomsko analizo
Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact.
V dvanajstih mesecih po datumu objave iz člena 69(6) Odbor za socialno-ekonomsko analizo na podlagi preučitve ustreznih delov dokumentacije in socialno-ekonomskega vpliva oblikuje mnenje o predlaganih omejitvah.
It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to Article 69(6)(b), if there are any.
Pripravi osnutek mnenja o predlaganih omejitvah in njihovem socialno-ekonomskem vplivu, pri čemer upošteva analize ali informacije v skladu s točko (b) člena 69(6), če so bile predložene.
The Agency shall publish the draft opinion on its website without delay.
Agencija osnutek mnenja takoj objavi na svoji spletni strani.