natgillin/translations-raw huggingface dataset:
(e) a decision in accordance with points (a), (b) or (c), if several registrants or downstream users of the same substance have submitted proposals for the same test, giving them the opportunity to reach an agreement on who will perform the test on behalf of all of them and to inform the Agency accordingly within 90 days.
(e) odločitev v skladu s točko (a), (b) ali (c), če je več registracijskih zavezancev ali nadaljnjih uporabnikov za isto snov predložilo predloge za isti test; omogoči se jim, da lahko sklenejo dogovor o tem, k dobo opravil test v imenu vseh drugih in Agencijo ustrezno obvestil v 90 dneh.
Compliance check of registrations
Preverjanje skladnosti registracij lahko preuči vsako registracijo, da preveri
The Agency may examine any registration in order to verify any of the following:
Agencija naslednje:
The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance.
Agencija preuči vse predloge za testiranje iz registracije ali poročila nadaljnjega uporabnika za pridobitev informacijo snovi iz prilog IX in X.
(a) that the information in the technical dossier(s) submitted pursuant to Article 10 complies with the requirements of Articles 10, 12 and 13 and with Annexes III and VI to X;
(a) ali informacije iz tehnične dokumentacije, predložene v skladu s členom 10, izpolnjujejo zahteve iz členov 10, 12 in 13 ter prilogI II in VI do X;
(b) that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes VII to X and with the general rules set out in Annex XI;
(b) ali prilagoditve zahtev za standardne informacije in utemeljitve zanje iz tehnične dokumentacije upoštevajo pravila, ki urejajo takšne prilagoditve iz prilog VII do X, in splošna pravila iz Priloge XI;
(c) that any required chemical safety assessment and chemical safety report comply with the requirements of Annex I and that the proposed risk management measures are adequate;
(c) ali vse zahtevane ocene kemijske varnosti in poročila o kemijski varnosti izpolnjujejo zahteve iz Priloge I in ali so predlagani ukrepi za obvladovanje tveganja ustrezni;
The Agency shall publish on its website the name of the substance, the hazard endpoint for which vertebrate testing is proposed, and the date by which any third party information is required.
Agencija na svoji domači strani objavi ime snovi, končno točko nevarnosti, za katerega se predlaga test, in datum, do katerega mora vsaka tretja stran predložiti ustrezne informacije.
It shall invite third parties to submit, using the format provided by the Agency, scientifically valid information and studies that address the relevant substance and hazard endpoint, addressed by the testing proposal, within 45 days of the date of publication.
Agencija tretje strani pozove, naj v 45 dneh po objavi na obrazcih Agencije predložijo znanstveno veljavne informacije in študije, ki obravnavajo zadevno snov in končno točko nevarnosti, kar obravnava predlog za test.
(d) that any explanation(s) submitted in accordance Article 11(3) or Article 19(2) have an objective basis.
(d) ali ima(-jo) razlaga(-e), predložene v skladu s členom 11(3) ali 19(2), objektivno osnovo.
(a) a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the study summary, or the robust study summary if required by Annex I;
(a) odločitev, ki od zadevnega(-ih) registracijskega(-ih) zavezanca(-ev) ali nadaljnjega(-ih) uporabnika(-ov) zahteva, da izvede(-jo) predlagani test, in vsebuje rok za predložitev povzetka študije ali grobega povzetka študije, če to zahteva Priloga I;
(b) a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;
(b) odločitev v skladu s točko (a), vendar ob spremenjenih pogojih, pod katerimi naj bi se izvedel test;
The registrant shall submit the information required to the Agency by the deadline set.
Registracijski v določenem roku.
(d) a decision rejecting the testing proposal;
(c) odločitev v skladu s točko (a), (b) ali (d), vendar ob zahtevi, da registracijski zavezanec(-ci) ali nadaljnji uporabnik(-i) opravi(-jo) enega ali več dodatnih testov v primeru neskladnosti predloga za testiranje s prilogami IX, X in XI;
The Agency shall give priority, but not exclusively, to dossiers meeting at least one of the following criteria:
Agencija da prednost, vendar ta prednostni izključna, dokumentaciji, ki izpolnjuje vsaj enega od naslednjih kriterijev:
(a) the dossier contains information in Article 10(a)(iv), (vi) and/or (vii) submitted separately as per Article 11(3); or
(a) dokumentacija vsebuje informacije iz člena 10(a)(iv), (vi) in/ali (vii), ki so predložene ločeno v skladu s členom 11(3); ali
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 osnutek odločitev v skladu s členom 40(3):
(b) the dossier is for a substance manufactured or imported in quantities of one tonne or more per year and does not meet the requirements of Annex VII applying under either Article 12(1)(a) or (b), as the case may be; or
(b) dokumentacija se nanaša na snov, ki se proizvede ali uvozi v količini 1 tone ali več na leto in ne izpolnjuje zahtev iz Priloge VII, ki se uporablja glede na člen 12(1)(a) ali (b), odvisno od posameznega primera; ali
(a) 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;
(a) 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;
(c) the dossier is for a substance listed in the Community rolling action plan referred to in Article 44(2).
(c) dokumentacija je pripravljena za snov, navedeno v tekočem akcijskem načrtu Skupnosti iz člena 44(2).
(b) 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;
(b) 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;
The Commission may, after consulting with the Agency, take a decision to vary the percentage of dossiers selected and amend or include further criteria in paragraph 5 in accordance with the procedure referred to in Article 133(4).
Komisija se lahko po posvetovanju z Agencijo odloči, da bo spremenila odstotek izbrane dokumentacije ter dopolnila ali vključila nadaljnje kriterijev odstavku 5 v skladu s postopkom iz člena 133(4).
(a) hazard information, for instance structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bioaccumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
(a) 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;
(b) exposure information;
(b) informacije o izpostavljenosti;
(c) tonnage, including aggregated tonnage from the registrations submitted by several registrants.
(c) tonažo, vključno s skupno tonažo iz registracij, ki jih predloži več registracijskih zavezancev.
Once the dossier evaluation is completed, the Agency shall notify the Commission and the competent authorities of the Member States of the information obtained and any conclusions made.
Ko je evalvacija dokumentacije končana, Agencija uradno obvesti Komisijo ter pristojne organe držav članico pridobljenih informacijah in posledičnih zaključkih.
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 potem, ko mu je bila zadeva predložena, zadevne države članice v skladu s tem sprejmejo snovi za evalvacijo.
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 there in 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.
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, daje snov evalvirana.
(b) 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.
(b) preuči vse predložene informacije in po potrebi priporoči ustrezne ukrepe za zmanjšanje tveganj, ugotovljenih v zvezi z zadevnim mestom.
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 čene predloži nove registracije ali prijave.
(a) 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;
(a) 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;
(b) 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.
(b) 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.
Where registrants or downstream users are required to perform a test as a result of a decision taken under this Title, those registrants or downstream users shall make every effort to reach an agreement as to who is to carry it out on behalf of the other registrants or downstream users and to inform the Agency accordingly within 90 days.
Registracijski zavezanci ali nadaljnji uporabniki, ki so po odločitvi v skladu s tem naslovom zavezani opraviti test, si po svojih najboljših močeh prizadevajo, da bi se dogovorili o tem, k do naj opravi test v imenu vseh drugih registracijskih zavezancev ali nadaljnjih uporabnikov, ter Agencijo o tem ustrezno obvestijo v 90 dneh.
Within 30 days of circulation, the Member States may propose amendments to the draft decision to the Agency.
Države članice lahko v 30 dneh potem, ko je bila dokumentacija razposlana, Agenciji predlagajo spremembe osnutka odločitve.
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.
Agencija vsak predlog spremembe takoj sporoči vsem zadevnim registracijskim zavezancem ali nadaljnjim uporabnikom in jim omogoči, da v 30 dneh predložijo svoje pripombe.
(a) uses in plant protection products within the scope of Directive 91/414/EEC;
(a) uporabe v fitofarmacevtskih sredstvih na področju uporabe Direktive 91/414/EGS;
(b) uses in biocidal products within the scope of Directive 98/8/ EC;
(b) uporabe v biocidnih proizvodih na področju uporabe Direktive 98/8/ES;
To this end all manufacturers, importers and downstream users applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and economic feasibility of substitution.
Namen tega naslova je, da se zagotovi dobro delovanje notranjega trga ter hkrati, da se tveganja, izhajajoča iz snovi, ki so vzrok za veliko zaskrbljenost, ustrezno nadzirajo in da se te snovi postopno zamenjajo z ustreznimi alternativnimi snovmi ali tehnologijami, kjer so te ekonomsko in tehnično izvedljive.
(c) use as motor fuels covered by Directive 98/70/EC of the European Parliament and of the Council of 13 October
Vsi proizvajalci, uvozniki in nadaljnji uporabniki, ki prosijo za avtorizacijo, v ta namen preučijo, ali so na voljo druge alternative, ocenijo njihovo tveganje in ali je nadomestitev tehnično in ekonomsko izvedljiva.
1998 relating to the quality of petrol and diesel fuels (
1 ); o kakovosti motornega bencina in dizelskega goriva (
(d) uses as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems.
(d) uporabe izdelkov iz mineralnih olj kot gorivo za premične ali stacionarne kurilne naprave in uporabo kot gorivo v zaprtih sistemih.
(a) uses in cosmetic products within the scope of Directive 76/768/EEC;
(a) uporabe v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS;
(a) the use(s) of that substance on its own or in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with Articles 60 to 64; or
(a) je bilo za uporabo(-e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(e) se snov daje v promet ali za katero(e) jo sam uporablja, izdano dovoljenje v skladu s členi 60 do 64; ali
(b) uses in food contact materials within the scope of Regulation (EC) No 1935/2004.
(b) uporabe v materialih za stik z živili na področju uporabe Uredbe (ES) št. 1935/2004.
(b) the use(s) of that substance on its own or in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIV itself in accordance with Article 58(2); or
(b) je (so) bila(-e) uporaba(-e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(e) je bila snov dana v promet ali za katero(e) jo sam uporablja, izvzeta iz zahteve za pridobitev avtorizacije iz Priloge XIV v skladu s členom 58(2); ali
(a) for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w);
(a) snovi iz člena 57(d), (e) in (f), katerih koncentracija ne presega mejne vrednosti 0,1 % mas. m/m;
(c) the date referred to in Article 58(1)(c)(i) has not been reached; or
(d) če je bil datum iz člena 58(1)(c)(i) že dosežen in je 18 mesecev pred tem datumom oddal vlogo, odločitev glede iz daje avtorizacije v skladu s to vlogo pa še ni bila sprejeta; ali
(b) for all other substances, below the lowest of the concentration limits specified in Directive 1999/45/EC or in Annex I to Directive 67/548/EEC which result in the classification of the preparation as dangerous.
(b) vse druge snovi, katerih koncentracija ne presega najnižje mejne vrednosti iz Direktive 1999/45/ES ali Priloge I k Direktivi 67/548/EGS in se zato pripravki iz njih razvrstijo kot nevarni.
(d) the date referred to in Article 58(1)(c)(i) has been reached and he made an application 18 months before that date but a decision on the application for authorisation has not yet been taken; or
(e) je bila za snovi, dane v promet, avtorizacija zato uporabo izdana njegovemu neposrednemu nadaljnjemu uporabniku te snovi.
Article 57
Člen 57 vlagatelj nadaljevati uporabo ali dajanje snovi v promet za določene uporabe po datumu(-ih) poteka; te nadaljnje uporabe se dovolijo po datumu poteka do sprejetja odločitve glede predložene avtorizacije;
(d) review periods for certain uses, if appropriate;
(e) uporabe ali kategorije uporab, ki so izvzete iz zahtev avtorizacije, če obstajajo, in pogoje za takšne izjeme, če obstajajo.
(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
(a) snovi, ki izpolnjujejo kriterije za razvrstitev kot rakotvorne iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
(b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
(b) snovi, ki izpolnjujejo kriterije za razvrstitev kot mutagene iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
(c) substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
(c) snovi, ki izpolnjujejo kriterije za razvrstitev kot strupene za razmnoževanje iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
Uses or categories of uses may be exempted from the authorisation requirement provided that, on the basis of the existing specific Community legislation imposing minimum requirements relating to the protection of human health or the environment for the use of the substance, the risk is properly controlled.
Uporabe ali kategorije uporab so lahko izvzete iz zahtev avtorizacije pod pogojem, daje na podlagi veljavne posebne zakonodaje Skupnosti, ki določa za uporabo snovi v zvezi z varovanjem zdravja ljudi ali okolja minimalne zahteve, tveganje pod primernim nadzorom.
(e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
(d) snovi, ki so v skladu s kriteriji iz Priloge XIII te uredbe obstojne, strupene in se lahko kopičijo v organizmih;
Prior to a decision to include substances in Annex XIV, the Agency shall, taking into account the opinion of the Member State Committee, recommend priority substances to be included specifying for each substance the items set out in paragraph 1.
Pred odločitvijo o vključitvi snovi v Prilogo XIV Agencija ob upoštevanju mnenja Odbora držav članic priporoči prednostne snovi, ki jih je treba vključiti, in pri tem za vsako snov navede podatke iz odstavka 1. Običajno se da prednost snovem, ki:
(a) PBT or vPvB properties; or
(a) imajo lastnosti PBT ali vPvB; ali
(f) substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
(f) snovi – kot so snovi, ki so po svojih lastnostih endokrini motilci, ali snovi, ki so po svojih lastnostih obstojne, se kopičijo v organizmih in so strupene ali zelo obstojne in se zelo lahko kopičijo v organizmih, ne izpolnjujejo kriterijev iz točke (d) ali (e) – in za katere je za vsak primer posebej v skladu s postopkom iz člena 59 znanstveno dokazano, da imajo lahko resne učinke na zdravje ljudi ali okolje, ki so enakovredni učinkom snovi iz točk (a) do (e).
(b) wide dispersive use; or
(b) široko razširjeno uporabo; ali
The Agency shall make its first recommendation of priority substances to be included in Annex XIV by 1 June 2009.
Agencija svoje prvo priporočilo prednostnih snovi, ki jih je treba vključiti v Prilogo XIV, iz da do 1. junija 2009.
The Agency shall make further recommendations at least every second year with a view to including further substances in Annex XIV.
Nadaljnja priporočila za vključitev dodatnih snovi v Prilogo XIV Agencija iz da vsaj vsako drugo leto.
(a) the identity of the substance as specified in Section 2 of Annex VI;
(a) podatke o snovi, kakor je določeno v oddelku 2 Priloge VI;
Before the Agency sends its recommendation to the Commission it shall make it publicly available on its website, clearly indicating the date of publication, taking into account Articles 118 and 119 on access to information.
Preden Agencija pošlje svoje priporočilo Komisiji, gada najprej na razpolago javnosti na svoji spletni strani, pri čemer jasno navede datum objave, ob upoštevanju členov 118 in 119 o dostopu do informacij.
(i) the date(s) from which the placing on the market and the use of the substance shall be prohibited unless an authorisation is granted (hereinafter referred to as the sunset date) which should take into account, where appropriate, the production cycle specified for that use;
(i) datum(-e), s katerim(-i) se prepove dajanje v promet in uporaba snovi, če se ne pridobi avtorizacija( v nadaljevanju „datum poteka“), ki morajo po potrebi upoštevati poseben proizvodni ciklus zato uporabo;
Within 60 days of circulation, the other Member States or the Agency may comment on the identification of the substance in relation to the criteria in Article 57 in the dossier to the Agency.
V 60 dneh potem, ko je bila dokumentacija razposlana, lahko druge države članice ali Agencija v dokumentaciji predložijo pripombe v zvezi z dokumentacijo snovi glede na kriterije iz člena 57.
A substance listed in Annex XIV may be subjected to new restrictions under the procedure outlined in Title VIII covering the risks to human health or the environment from the presence of the substance in (an) article(s).
Za snovi z Priloge XIV se lahko sprejmejo nove omejitve v skladu s postopkom iz naslova VIII za nadzorovanje tveganj za zdravje ljudi ali okolja zaradi prisotnosti snovi v izdelku(-ih).
When comments are made or received, the Agency shall refer the dossier to the Member State Committee within 15 days of the end of the 60-day period referred to in paragraph 5.
Potem, ko so pripombe podane ali prejete, Agencija predloži dokumentacijo Odboru držav članic v 15 dneh po poteku 60-dnevnega roka iz odstavka 5.
The Agency shall make this dossier available within 30 days of receipt to the other Member States.
Agencija to dokumentacijo v 30 dneh po prejemu dana razpolago drugim državam članicam.
Without prejudice to paragraph 3, an authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from the intrinsic properties specified in Annex XIV is adequately controlled in accordance with Section 6.4 of Annex I and as documented in the applicant's chemical safety report, taking into account the opinion of the Committee for Risk Assessment referred to in Article 64(4) (a).
Avtorizacija se brez poseganja v odstavek 3 dodeli, če je tveganje za zdravje ljudi ali okolje, ki izhaja iz uporabe snovi zaradi njenih intrinzičnih lastnosti iz Priloge XIV, pod ustreznim nadzorom v skladu z oddelkom 6.4 Priloge I, kar vlagatelj dokumentira s poročilom o kemijski varnosti, pri čemer se upošteva mnenje Odbora za oceno tveganja iz člena 64(4)(a).
The Agency shall publish on its website a notice that an Annex XV dossier has been prepared for a substance.
Agencija na svoji spletni strani objavi obvestilo, daje bila za snov pripravljena dokumentacija iz Priloge XV.
L 136/47 into account the appropriateness and effectiveness of risk management measures;
L 136/47 in učinkovitost ukrepov za obvladovanje ustreznost tveganja;