natgillin/translations-raw huggingface dataset:
The technical dossier referred to in Article 10(a) shall include under points (vi) and (vii) of that provision all physicochemical, toxicological and ecotoxicological information that is relevant and available to the registrant and as a minimum the following:
Tehnična dokumentacija iz člena 10(a) mora v zvezi s točkama (vi) in (vii) navedene določbe vključevati vse pomembne in za registracijskega zavezanca razpoložljive fizikalno-kemijske, toksikološke in ekotoksikološke podatke ter vsaj:
the information specified in Annex VII for non-phase-in substances, and for phase-in substances meeting one or both of the criteria specified in Annex III, manufactured or imported in quantities of one tonne or more per year per manufacturer or importer;
informacije iz Priloge VII za snovi, ki niso v postopnem uvajanju, ter za snovi v postopnem uvajanju, ki izpolnjujejo enega ali več kriterijev iz Priloge III in se proizvedejo ali uvozijo v količini, ki znaša eno tono ali več na leto na proizvajalca ali uvoznika;
the information on physicochemical properties specified in Annex VII, section 7 for phase-in substances manufactured or imported in quantities of one tonne or more per year per manufacturer or importer which do not meet either of the criteria specified in Annex III;
informacije o fizikalno-kemijskih lastnostih iz oddelka 7 Priloge VII za snovi v postopnem uvajanju, ki se proizvedejo ali uvozijo v količini, ki znaša eno tono ali več na leto na proizvajalca ali uvoznika in ne izpolnjujejo nobenega izmed kriterijev iz Priloge III;
the information specified in Annexes VII and VIII for substances manufactured or imported in quantities of 10 tonnes or more per year per manufacturer or importer;
informacije iz prilog VII in VIII za snovi, ki se proizvedejo ali uvozijo v količini, ki znaša 10 ton ali več na leto na proizvajalca ali uvoznika;
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annex IX for substances manufactured or imported in quantities of 100 tonnes or more per year per manufacturer or importer;
informacije iz prilog VII in VIII ter predloge testov za pridobitev informacij iz Priloge IX glede snovi, ki se proizvedejo ali uvozijo v količini, ki znaša 100 ton ali več na leto na proizvajalca ali uvoznika;
the information specified in Annexes VII and VIII and testing proposals for the provision of the information specified in Annexes IX and X for substances manufactured or imported in quantities of 1000 tonnes or more per year per manufacturer or importer.
informacije iz prilog VII in VIII ter predloge za testiranje za pridobitev informacij iz prilog IX in X glede snovi, ki se proizvedejo ali uvozijo v količini, ki znaša 1000 ton ali več na leto na proizvajalca ali uvoznika.
As soon as the quantity of a substance per manufacturer or importer that has already been registered reaches the next tonnage threshold, the manufacturer or importer shall inform the Agency immediately of the additional information he would require under paragraph 1.
Takoj ko količina že registrirane snovi na proizvajalca ali uvoznika doseže naslednji količinski prag, proizvajalec ali uvoznik Agencijo nemudoma obvesti o dodatnih informacijah, ki jih zahteva v skladu z odstavkom 1.
Article 26(3) and (4) shall apply adapted as necessary.
Uporablja se po potrebi prilagojeni člen 26(3) in (4).
This Article shall apply to producers of articles adapted as necessary.
Ta člen se uporablja za izdelovalce izdelkov in se po potrebi prilagodi.
General requirements for generation of information on intrinsic properties of substances
Splošne zahteve za pridobitev informacij o intrinzičnih lastnostih snovi
Information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.
Informacije o intrinzičnih lastnostih snovi se lahko pridobijo tudi na druge načine in ne samo s testi, če so izpolnjeni pogoji iz Priloge XI.
In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods, for example, in vitro methods or qualitative or quantitative structure-activity relationship models or from information from structurally related substances (grouping or read-across).
Informacije, zlasti o toksičnosti za ljudi, se pridobijo, kadar koli je mogoče, tudi na druge načine in ne samo s testi na vretenčarjih, z uporabo alternativnih metod, kot so metode in vitro, ali kvalitativnih in kvantitativnih modelov razmerja med strukturo in aktivnostjo snovi ali iz informacij o strukturno sorodnih snoveh (združevanje v skupine ali navzkrižno branje).
Testing in accordance with Annex VIII, Sections 8.6 and 8.7, Annex IX and Annex X may be omitted where justified by information on exposure and implemented risk management measures as specified in Annex XI, section 3.
Testiranja v skladu z oddelkoma 8.6 in 8.7 Priloge VIII, Prilogo IX in Prilogo X se lahko izpustijo, kjer to utemeljujejo informacije o izpostavljenosti in ukrepi za obvladovanje tveganj, izvedeni, kot je določeno v oddelku 3 Priloge XI.
These methods shall be regularly reviewed and improved with a view to reducing testing on vertebrate animals and the number of animals involved.
Te metode se redno pregledujejo in izboljšujejo, da se zmanjša število testiranj na vretenčarjih in število udeleženih živali.
The Commission, following consultation with relevant stakeholders, shall, as soon as possible, make a proposal, if appropriate, to amend the Commission Regulation on test methods adopted in accordance with the procedure referred to in Article 133(4), and the Annexes of this Regulation, if relevant, so as to replace, reduce or refine animal testing.
Komisija čim prej in po posvetu z ustreznimi interesnimi skupinami po potrebi pripravi predlog spremembe uredbe Komisije o testnih metodah, sprejetih v skladu s postopkom iz člena 133(4), in predlog spremembe prilog te uredbe, da se nadomesti, zmanjša in izboljša testiranje na živalih.
Amendments to that Commission Regulation shall be adopted in accordance with the procedure specified in paragraph 3 and amendments to the Annexes of this Regulation shall be adopted in accordance with the procedure referred to in Article 131.
Predlogi sprememb navedene uredbe Komisije se sprejmejo v skladu s postopkom iz odstavka 3, predlogi sprememb prilog te uredbe pa v skladu s postopkom iz člena 131.
Where tests on substances are required to generate information on intrinsic properties of substances, they shall be conducted in accordance with the test methods laid down in a Commission Regulation or in accordance with other international test methods recognised by the Commission or the Agency as being appropriate.
Če se za pridobitev informacij o intrinzičnih lastnostih snovi zahtevajo testi, se ti izvedejo v skladu s testnimi metodami iz uredbe Komisije ali v skladu z drugimi mednarodnimi testnimi metodami, ki jih Komisija ali Agencija priznava kot enakovredne.
The Commission shall adopt that Regulation, designed to amend the non-essential elements of this Regulation by supplementing it, in accordance with the procedure referred to in Article 133(4).
Komisija sprejme navedeno uredbo, namenjeno spremembi nebistvenih določb te uredbe, z njeno dopolnitvijo v skladu s postopkom iz člena 133(4).
Information on intrinsic properties of substances may be generated in accordance with other test methods provided that the conditions set out in Annex XI are met.
Informacije o intrinzičnih lastnostih snovi se lahko pridobijo v skladu z drugimi testnimi metodami, če so izpolnjeni pogoji iz Priloge XI.
Ecotoxicological and toxicological tests and analyses shall be carried out in compliance with the principles of good laboratory practice provided for in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency and with the provisions of Directive 86/609/EEC, if applicable.
Ekotoksikološki in toksikološki testi ter analize se opravijo v skladu z načeli dobre laboratorijske prakse iz Direktive 2004/10/ES ali drugih mednarodnih standardov, ki jih Komisija ali Agencija priznava kot enakovredne, in ob upoštevanju določb Direktive 86/609/EGS, če je primerno.
If a substance has already been registered, a new registrant shall be entitled to refer to the study summaries or robust study summaries, for the same substance submitted earlier, provided that he can show that the substance that he is now registering is the same as the one previously registered, including the degree of purity and the nature of impurities, and that the previous registrant(s) have given permission to refer to the full study reports for the purpose of registration.
Če je bila snov že registrirana, se novi registracijski zavezanec lahko sklicuje na povzetke študij ali grobe povzetke študij, ki so bili za enako snov že prej predloženi, če lahko dokaže, da je snov, ki jo želi registrirati, enaka predhodno registrirani snovi, vključno s stopnjo čistot in vrsto nečistot, ter če mu je (so mu) predhodni registracijski zavezanec(-ci) dovolil(-i) sklicevanje na celovito poročilo o študiji za namene registracije.
A new registrant shall not refer to such studies in order to provide the information required in Section 2 of Annex VI.
Novi registracijski zavezanec se na takšne študije ne sklicuje pri zagotavljanju informacij iz oddelka 2 Priloge VI.
Chemical safety report and duty to apply and recommend risk reduction measures
Poročilo o kemijski varnosti ter obvezna uporaba in priporočilo ukrepov za zmanjšanje tveganja
Without prejudice to Article 4 of Directive 98/24/EC, a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in accordance with this Chapter in quantities of 10 tonnes or more per year per registrant.
Brez poseganja v člen 4 Direktive 98/24/ES se izvede ocena kemijske varnosti in pripravi poročilo o kemijski varnosti za vse snovi, ki jih je treba registrirati v skladu s tem poglavjem, v količini 10 ton ali več na leto na registracijskega zavezanca.
The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex I for either each substance on its own or in a preparation or in an article or a group of substances.
Poročilo o kemijski varnosti dokumentira oceno kemijske varnosti, ki se izvede v skladu z odstavki 2 do 7 ter Prilogo I za vsako snov kot tako ali v pripravku ali izdelku ali za skupino snovi.
A chemical safety assessment in accordance with paragraph 1 need not be performed for a substance which is present in a preparation if the concentration of the substance in the preparation is less than the lowest of any of the following:
Ocene kemijske varnosti v skladu z odstavkom 1 ni treba opraviti za snov v pripravku, če je njena koncentracija v pripravku nižja od naslednjih vrednosti:
the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
veljavnih koncentracij iz tabele člena 3(3) Direktive 1999/45/ES;
the concentration limits given in Annex I to Directive 67/548/EEC;
mejnih koncentracij iz Priloge I k Direktivi 67/548/EGS;
the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
mejnih koncentracij iz dela B Priloge II k Direktivi 1999/45/ES;
the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
mejnih koncentracij iz dela B Priloge III k Direktivi 1999/45/ES;
the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XI of this Regulation;
mejnih koncentracij, podanih pod dogovorjeno rubriko v popisu razvrstitev in označitev iz naslova XI te uredbe;
0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII of this Regulation.
0,1 % mas. m/m, če snov izpolnjuje kriterije iz Priloge XIII te uredbe.
A chemical safety assessment of a substance shall include the following steps:
Ocena kemijske varnosti snovi zajema naslednje faze:
human health hazard assessment;
oceno nevarnosti za zdravje ljudi;
physicochemical hazard assessment;
oceno nevarnosti fizikalno-kemijskih lastnosti;
environmental hazard assessment;
oceno nevarnosti za okolje;
persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
oceno obstojni, bioakumulativni, strupeni (PBT) ter zelo obstojni, zelo bioakumulativni (vPvB).
If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps:
Če registracijski zavezanec na podlagi izvedenih faz (a) do (d) odstavka 3 ugotovi, da snov izpolnjuje kriterije za razvrstitev kot nevarna v skladu z Direktivo 67/548/EGS ali da gre za PBT ali vPvB, je treba v oceno kemijske varnosti vključiti še naslednje dodatne faze:
exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;
oceno izpostavljenosti, vključno s pripravo scenarija(-ev) izpostavljenosti (ali, če je to primerno, opredelitev ustrezne kategorije uporabe in izpostavljenosti) ter oceno izpostavljenosti;
risk characterisation.
opredelitev tveganja.
The exposure scenarios (where appropriate the use and exposure categories), exposure assessment and risk characterisation shall address all identified uses of the registrant.
V scenarijih izpostavljenosti (po potrebi kategorije za uporabo in izpostavljenost), oceni izpostavljenosti in opredelitvi tveganja je treba obravnavati vse navedene uporabe registracijskega zavezanca.
The chemical safety report need not include consideration of the risks to human health from the following end uses:
V poročilu o kemijski varnosti ni treba upoštevati nevarnosti, ki jo za zdravje ljudi pomenijo naslednje končne uporabe:
in food contact materials within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food [39];
v materialih za stik z živili na področju uporabe Uredbe (ES) št. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili [39];
in cosmetic products within the scope of Directive 76/768/EEC.
v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS.
Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies in accordance with Article 31.
Vsak registracijski zavezanec določi in uporablja primerne ukrepe za ustrezno nadzorovanje tveganja iz ocene kemijske varnosti in jih, če je ustrezno, priporoči v varnostnih listih, ki jih priskrbi v skladu s členom 31.
Any registrant required to conduct a chemical safety assessment shall keep his chemical safety report available and up to date.
Vsak registracijski zavezanec, ki mora opraviti oceno kemijske varnosti, da svoje poročilo o kemijski varnosti, ki ga sproti dopolnjuje, na voljo drugim.
Substances regarded as being registered
Snovi, ki se štejejo za registrirane
Substances in plant protection and biocidal products
Snovi v fitofarmacevtskih sredstvih in biocidnih proizvodih
Active substances and co-formulants manufactured or imported for use in plant protection products only and included either in Annex I to Council Directive 91/414/EEC [40] or in Commission Regulation (EEC) No 3600/92 [41], Commission Regulation (EC) No 703/2001 [42], Commission Regulation (EC) No 1490/2002 [43], or Commission Decision 2003/565/EC [44] and for any substance for which a Commission Decision on the completeness of the dossier has been taken pursuant to Article 6 of Directive 91/414/EEC shall be regarded as being registered and the registration as completed for manufacture or import for the use as a plant protection product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.
Aktivne snovi in pomožne snovi v formulaciji, proizvedene ali uvožene izključno za uporabo v fitofarmacevtskih sredstvih, ki so vključene v Prilogo I Direktive Sveta 91/414/EGS [40] ali v Uredbo Komisije (EGS) št. 3600/92 [41], Uredbo Komisije (ES) št. 703/2001 [42], Uredbo Komisije (ES) št. 1490/2002 [43] ali v Odločbo Komisije 2003/565/ES [44], ter snovi, za katere je Komisija v skladu s členom 6 Direktive 91/414/EGS sprejela odločitev o popolnosti dokumentacije, se štejejo, da so bile registrirane in da je njihova registracija zaključena za proizvodnjo ali uvoz za uporabo kot fitofarmacevtsko sredstvo ter tako izpolnjujejo zahteve iz poglavij 1 in 5 tega naslova.
Active substances manufactured or imported for use in biocidal products only and included either in Annexes I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market [45] or in Commission Regulation (EC) No 2032/2003 [46]on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC, until the date of the decision referred to in the second subparagraph of Article 16(2) of Directive 98/8/EC, shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of this Title.
Aktivne snovi, proizvedene ali uvožene izključno za uporabo v biocidnih proizvodih, ki so bile vključene v priloge I, IA ali IB k Direktivi 98/8/ES Evropskega parlamenta in Sveta z dne 16. februarja 1998 o dajanju biocidnih pripravkov v promet [45] ali v Uredbo Komisije (ES) št. 2032/2003 [46] o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES do datuma odločitve iz drugega pododstavka člena 16(2) Direktive 98/8/ES, se štejejo, da so bile registrirane za proizvodnjo ali uvoz za uporabe iz takšne vključitve ter tako izpolnjujejo zahteve iz poglavij 1 in 5 tega naslova.
Duties of the Commission, the Agency and registrants of substances regarded as being registered
Naloge Komisije, Agencije in registracijskega zavezanca za registrirane snovi
The Commission or the relevant Community body shall make information equivalent to that required by Article 10 available to the Agency for substances regarded as registered according to Article 15.
Komisija ali ustrezni organ Skupnosti da Agenciji na voljo informacije, enakovredne tistim, ki so zahtevane na podlagi člena 10, za snovi, za katere velja, da so registrirane v skladu s členom 15.
The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008.
Agencija te informacije ali sklicevanje nanje vključi v svojo podatkovno zbirko in o tem obvesti pristojne do 1. decembra 2008.
Articles 21, 22 and 25 to 28 shall not apply to uses of substances regarded as registered according to Article 15.
Členi 21, 22 in 25 do 28 se ne uporabljajo za uporabe snovi, za katere velja, da so registrirane v skladu s členom 15.
Obligation to register and information requirements for certain types of isolated intermediates
Obvezno registriranje in zahtevane informacije za določene vrste izoliranih intermediatov
Registration of on-site isolated intermediates
Registracija na mestu izoliranih intermediatov
Any manufacturer of an on-site isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the on-site isolated intermediate.
Vsak proizvajalec, ki proizvede na mestu izolirane intermediate v količini, ki znaša eno tono ali več na leto, pri Agenciji predloži registracijo za registracijo na mestu izoliranega intermediata.
A registration for an on-site isolated intermediate shall include all the following information, to the extent that the manufacturer is able to submit it without any additional testing:
Registracijska dokumentacija na mestu izoliranega intermediata vsebuje vse naslednje informacije v obsegu, ki proizvajalcu omogoči, da jo lahko predloži brez dodatnega testiranja:
the identity of the manufacturer as specified in Section 1 of Annex VI;
podatke o proizvajalcu, kakor je določeno v oddelku 1 Priloge VI;
the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;
identiteto intermediata, kakor je določeno v oddelkih 2.1 do 2.3.4 Priloge VI;
the classification of the intermediate as specified in Section 4 of Annex VI;
razvrstitev intermediata, kakor je določeno v oddelku 4 Priloge VI;
any available existing information on physicochemical, human health or environmental properties of the intermediate.
vse razpoložljive obstoječe informacije o fizikalno-kemijskih lastnostih intermediata ter o njihovem vplivu na zdravje ljudi in okolje.
Where a full study report is available, a study summary shall be submitted;
Kjer je na voljo celovito poročilo o študiji, se predloži povzetek študije;
a brief general description of the use, as specified in Section 3.5 of Annex VI;
kratek splošni opis uporabe, kakor je določeno v oddelku 3.5 Priloge VI;
details of the risk management measures applied.
podrobnosti o ukrepih, uporabljenih za obvladovanje tveganja.
Except in cases covered under Article 25(3), Article 27(6) or Article 30(3), the registrant shall be in legitimate possession of or have permission to refer to the full study report summarised under (d) for the purpose of registration.
Razen v primerih iz členov 25(3), 27(6) ali 30(30) registracijski zavezanec zakonito razpolaga s celovitim poročilom o študiji ali ima dovoljenje za sklicevanje na celovito poročilo o študiji, povzeto v točki (d) za namene registracije.
The registration shall be accompanied by the fee required in accordance with Title IX.
Ob registraciji se plača pristojbina v skladu z naslovom IX.
Paragraph 2 shall apply only to on-site isolated intermediates if the manufacturer confirms that the substance is only manufactured and used under strictly controlled conditions in that it is rigorously contained by technical means during its whole lifecycle.
Odstavek 2 se za na mestu izolirane intermediate uporablja le, če proizvajalec potrdi, da se snov proizvaja in uporablja le pod strogo nadzorovanimi pogoji, in sicer, da je snov v svojem celotnem življenjskem ciklusu dosledno nadzorovana s tehničnimi sredstvi.
Control and procedural technologies shall be used to minimise emission and any resulting exposure.
Postopki in tehnologije nadzora se uporabljajo za zmanjšanje emisije in izpostavljenosti zaradi te na najmanjšo mero.
If these conditions are not fulfilled, the registration shall include the information specified in Article 10.
Če ti pogoji niso izpolnjeni, se v registracijsko dokumentacijo vključijo informacije iz člena 10.
Registration of transported isolated intermediates
Registracija transportiranih izoliranih intermediatov
Any manufacturer or importer of a transported isolated intermediate in quantities of one tonne or more per year shall submit a registration to the Agency for the transported isolated intermediate.
Vsak proizvajalec ali uvoznik transportiranega izoliranega intermediata v količini, ki znaša eno tono ali več na leto, Agenciji predloži registracijo transportiranega izoliranega intermediata.
A registration for a transported isolated intermediate shall include all the following information:
Registracijska dokumentacija za transportiran izolirani intermediat vsebuje vse naslednje informacije:
the identity of the manufacturer or importer as specified in Section 1 of Annex VI;
podatke o proizvajalcu ali uvozniku, kakor je določeno v oddelku 1 Priloge VI;
information on risk management measures applied and recommended to the user in accordance with paragraph 4.
podrobnosti o ukrepih, uporabljenih za obvladovanje tveganja in priporočenih uporabniku v skladu z odstavkom 4.