natgillin/translations-raw huggingface dataset:
(d) 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;
(d) 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;
(a) it would be disproportionately costly for him to submit this information jointly; or
(a) bi bilo zanj nesorazmerno drago, če bi te informacije predložil skupaj; ali
(b) submitting the information jointly would lead to disclosure of information which he considers to be commercially sensitive and is likely to cause him substantial commercial detriment; or
(b) bi predložitev teh informacij skupaj vodila k razkritju informacij, za katere meni, da so poslovno občutljive in bi mu njihovo razkritje lahko povzročilo znatno poslovno škodo; ali
(e) 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 1 000 tonnes or more per year per manufacturer or importer.
(e) 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 1 000 ton ali več na leto na proizvajalca ali uvoznika.
(c) he disagrees with the lead registrant on the selection of this information.
(c) z glavnim registracijskim zavezancem ne soglaša glede izbire teh informacij.
If points (a), (b) or (c) apply, the registrant shall submit, along with the dossier, an explanation as to why the costs would be disproportionate, why disclosure of information was likely to
Če se točke (a), (b) ali (c) uporabljajo, registracijski zavezanec skupaj z dokumentacijo predloži razlago, zakaj bi bili stroški
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, daje 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.
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 informacijo strukturno sorodnih snoveh (združevanje v skupine ali navzkrižno branje).
The chemical safety report shall document the chemical safety assessment which shall be conducted in accordance with paragraphs 2 to 7 and with Annex If or 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: iz tabele člena
(a) the applicable concentrations defined in the table of Article 3(3) of Directive 1999/45/EC;
(a) veljavnih koncentracij 1999/45/ES;
(b) the concentration limits given in Annex I to Directive 67/548/EEC;
(b) mejnih koncentracij iz Priloge I k Direktivi 67/548/EGS;
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 informacijo 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.
(c) the concentration limits given in Part B of Annex II to Directive 1999/45/EC;
(c) mejnih koncentracij 1999/45/ES;
(d) the concentration limits given in Part B of Annex III to Directive 1999/45/EC;
(d) mejnih koncentracij izdela B Priloge III k Direktivi 1999/45/ES;
(e) the concentration limits given in an agreed entry in the classification and labelling inventory established under Title XI of this Regulation;
(e) mejnih koncentracij iz sporazumno določenih vrednosti v popisu razvrstitev in označitev, vzpostavljenim v skladu z naslovom XI te uredbe;
(f) 0,1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII of this Regulation.
(f) 0,1 % mas. m/m, če snov izpolnjuje kriterije iz Priloge XIII te uredbe.
(a) human health hazard assessment;
(a) oceno nevarnosti za zdravje ljudi;
(b) physicochemical hazard assessment;
(b) oceno nevarnosti fizikalno-kemijskih lastnosti;
(c) environmental hazard assessment;
(c) oceno nevarnosti za okolje;
(d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.
(d) oceno obstojni, bioakumulativni, strupeni (PBT) ter zelo obstojni, zelo bioakumulativni (vPvB).
Commission Regulation (EEC) No 3600/92 (
Snovi v fitofarmacevtskih sredstvih in biocidnih proizvodih
(a) exposure assessment including the generation of exposure scenario(s) (or the identification of relevant use and exposure categories if appropriate) and exposure estimation;
(a) oceno izpostavljenosti, vključno s pripravo scenarija(-ev) izpostavljenosti (ali, če je to primerno, opredelitev ustrezne kategorije uporabe in izpostavljenosti) ter oceno izpostavljenosti;
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.
v Odločbo Komisije 2003/565/ES (6), 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 daje njihova registracija zaključena za proizvodnjo ali uvoz za uporabo kot fitofarmacevtsko sredstvo ter tako izpolnjujejo zahteve iz poglavij 1 in 5 tega naslova.
(a) 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
(a) 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 (1);
(b) in cosmetic products within the scope of Directive 76/768/EEC.
(b) v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS.
) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).
) Direktiva Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet (UL L 230, 19.8.1991, str. 1).
Directive as last amended by Commission Directive 2006/136/EC (OJ L 349, 12.12.2006, p. 42). )
Direktiva, kakor je bila nazadnje spremenjena z Direktivo Komisije 2006/136/ES (UL L 349, 12.12.2006, str. 42). )
Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L 259, 13.10.2000, p. 27). )
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 2266/2000 (UL L 259, 13.10.2000, str. 27). )
Commission Regulation (EC) No 703/2001 of 6 April 2001 laying down the active substances of plant protection products to be assessed in the second stage of the work programme referred to in Article 8(2) of Council Directive 91/414/EEC and revising the list of Member States designated as rapporteurs for those substances (OJ L 98, 7.4.2001, p. 6). )
Uredba Komisije (ES) št. 703/2001 z dne 6. aprila 2001 o določitvi aktivnih snovi v fitofarmacevtskih sredstvih, ki bodo ocenjeni v drugi fazi delovnega programa iz člena 8(2) Direktive Sveta 91/414/EGS, in o reviziji seznama imenovanih držav članic poročevalk za te snovi (UL L 98, 7.4.2001, str. 6). )
Regulation as last amended by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23). )
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1744/2004 (UL L 311, 8.10.2004, str. 23). )
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
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 (1) ali v Uredbo Komisije (ES) št. 2032/
(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;
(e) kratek splošni opis uporabe, kakor je določeno v oddelku 3.5 Priloge VI; o ukrepih, uporabljenih za obvladovanje
(f) details of the risk management measures applied.
(f) podrobnosti tveganja.
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.
2003 (2) 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.
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(3) 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.
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 uporabljale pod strogo nadzorovanimi pogoji, in sicer, daje snov v svojem celotnem življenjskem ciklusu dosledno nadzorovana s tehničnimi sredstvi.
The Agency shall include this information or a reference thereto in its databases and notify the competent authorities thereof by 1 December 2008.
Členi 21, 22 in 25 do 28 se ne uporabljajo za uporabe snovi, za katere velja, da so registrirane v skladu s členom 15.
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.
Registracijska dokumentacija na mestu izoliranega intermediata vsebuje vse naslednje informacije v obsegu, ki proizvajalcu omogoči, dajo lahko predloži brez dodatnega testiranja:
(a) the identity of the manufacturer or importer as specified in Section 1 of Annex VI;
(a) podatke o proizvajalcu ali uvozniku, kakor je določeno v oddelku 1 Priloge VI;
(b) the identity of the intermediate as specified in Sections 2.1 to 2.3.4 of Annex VI;
(b) identiteto intermediata, kakor je določeno v oddelkih 2.1 do 2.3.4 Priloge VI;
(a) the identity of the manufacturer as specified in Section 1 of Annex VI;
(b) identiteto intermediata, kakor je določeno v oddelkih 2.1 do 2.3.4 Priloge VI;
(c) the classification of the intermediate as specified in Section 4 of Annex VI;
(c) razvrstitev intermediata, kakor je določeno v oddelku 4 Priloge VI;
(d) any available existing information on physicochemical, human health or environmental properties of the intermediate.
(d) vse razpoložljive obstoječe informacije o fizikalno-kemijskih lastnostih intermediata ter o njihovem vplivu na zdravje ljudi in okolje.
(e) a brief general description of the use, as specified in Section 3.5 of Annex VI;
(e) kratek splošni opis uporabe, kakor je določeno v oddelku 3.5 Priloge VI;
(f) information on risk management measures applied and recommended to the user in accordance with paragraph 4.
(f) podrobnosti o ukrepih, uporabljenih za obvladovanje tveganja in priporočenih uporabniku v skladu z odstavkom 4.
Community by one or more manufacturers and/or imported by one or more importers, the following shall apply.
Informacije, navedene v členu 17(2)(c) in (d) in členu 18(2)(c) in (d), ob upoštevanju odstavka 2 tega člena, najprej predloži proizvajalec ali uvoznik, ki deluje na podlagi skupnega dogovora z drugim(-i) proizvajalcem(-i) ali uvoznikom(-i) (v nadaljevanju „glavni registracijski zavezanec“).
Subject to paragraph 2 of this Article, the information specified in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first be submitted by one manufacturer or importer acting with the agreement of the other assenting manufacturer(s) or importer(s) (hereinafter referred to as ‘the lead registrant’).
Vsak registracijski zavezanec kasneje ločeno predloži informacije iz člena 17(2)(a), (b), (e) in (f) ter člena 18(2)(a), (b), (e) in (f).
A registration for a transported isolated intermediate in quantities of more than 1 000 tonnes per year per manufacturer or importer shall include the information specified in Annex VII in addition to the information required under paragraph 2.
Registracijska dokumentacija za transportiran izolirani intermediat v količini, ki znaša več kot 1 000 ton na leto na proizvajalca ali uvoznika, mora poleg informacij iz odstavka 2 vključevati še informacije iz Priloge VII.
Paragraphs 2 and 3 shall apply only to transported isolated intermediates if the manufacturer or importer confirms himself or states that he has received confirmation from the user that the synthesis of (an)other substance(s) from that intermediate takes place on other sites under the following strictly controlled conditions:
Odstavka 2 in 3 se za transportirane izolirane intermediate uporabljata samo, če proizvajalec ali uvoznik sam potrdi ali izjavi, daje prejel potrdilo uporabnika, da sinteza druge(-ih) snovi iz tega intermediata poteka na drugih mestih pod naslednjimi strogo nadzorovanimi pogoji:
(a) the substance is rigorously contained by technical means during its whole lifecycle including manufacture, purification, cleaning and maintenance of equipment, sampling, analysis, loading and unloading of equipment or vessels, waste disposal or purification and storage;
(a) snov je v svojem celotnem življenjskem ciklusu dosledno nadzorovana s tehničnimi sredstvi, vključno s proizvodnjo, očiščevanjem, čiščenjem in vzdrževanjem opreme, vzorčenjem, analiziranjem, polnjenjem in praznjenjem opreme ali posod, odstranjevanjem ali čiščenjem odpadkov in skladiščenjem;
(b) procedural and control technologies shall be used that minimise emission and any resulting exposure;
(b) uporaba postopkov in tehnologij nadzora, ki zmanjšajo emisijo in izpostavljenost zaradi te na najmanjšo mero;
(d) in the case of cleaning and maintenance works, special procedures such as purging and washing are applied before the system is opened and entered;
(d) pri čiščenju in vzdrževanju se uporabijo posebni procesi, kot sta prepihavanje in spiranje, preden se sistem odpre ali se vanj vstopi;
(e) in cases of accident and where waste is generated, procedural and/or control technologies are used to minimise emissions and the resulting exposure during purification or cleaning and maintenance procedures;
(e) v primeru nesreče ali če se proizvajajo odpadki, se uporabijo procesi in/ali tehnologije nadzora za zmanjšanje emisij in izpostavljenosti zaradi njih med procesi očiščevanja ali čiščenja in vzdrževanja na najmanjšo mero;
(f) substance-handling procedures are well documented and strictly supervised by the site operator.
(f) procesi za ravnanje s snovjo so dobro dokumentirani in pod strogim nadzorom upravljavca mesta.
Joint submission of data onisolated intermediates by multiple registrants
Skupna predložitev podatkov o izoliranih intermediatih s strani več registracijskih zavezancev
When an on-site isolated intermediate or transported isolated intermediate is intended to be manufactured in the
Agencija preveri popolnost posameznih registracij, da preveri, ali so bili predloženi vsi sestavni deli, ki se zahtevajo v skladu s členoma 10 in 12 ali členoma 17 ali 18, ter ali je bila plačana pristojbina za registracijo iz člena 6(4), člena 7(1) in (5), člena 17(2) ali člena 18(2).
The completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.
Če naj bi na mestu izolirani intermediat ali transportirani intermediat v Skupnosti proizvajal eden ali več proizvajalcev in/ali uvažal eden ali več uvoznikov, se uporabi naslednje.
If a registration is incomplete, the Agency shall inform the registrant, before expiry of the three-week or three-month period referred to in the second subparagraph, as to what further information is required in order for the registration to be complete, while setting a reasonable deadline for this.
Če je registracija nepopolna, Agencija pred potekom roka treh tednov ali treh mesecev iz drugega pododstavka obvesti registracijskega zavezanca o nadaljnjih informacijah, ki so potrebne za popolno registracijo, ter zato določi razumen rok.
(a) the registration dossier together with the submission or registration number;
(a) registracijska dokumentacija, skupaj s številko predložitve ali registracije;
(b) the submission or registration date;
(b) datum predložitve ali registracije;
In the case of an update of a registration according to Article 22 a registrant may continue the manufacture or import of the substance, or the production or import of the article, if there is no indication to the contrary from the Agency in accordance with Article 20(2) within the three weeks after the update date, without prejudice to Article 27(8).
V primeru dopolnitve registracije v skladu s členom 22 lahko registracijski zavezanec nadaljuje s proizvajanjem ali uvažanjem snovi ali z izdelavo ali uvažanjem izdelka, če Agencija v skladu s členom 20(2) v treh tednih po datumu dopolnitve ne navede drugače in tone posega v člen 27(8).
(d) any request for further information and deadline set in accordance with the third subparagraph of paragraph 2.
(d) vse zahteve za dodatne informacije in rok, določen v skladu s tretjim pododstavkom odstavka 2.
If the Agency has informed the registrant that he is to submit further information in accordance with the third subparagraph of Article 20(2), the registrant may start the manufacture or import of a substance or production or import of an article if there is no indication to the contrary from the Agency within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to Article 27(8).
Če je Agencija registracijskega zavezanca obvestila, da mora predložiti dodatne informacije v skladu s tretjim pododstavkom člena 20(2), lahko registracijski zavezanec, če Agencija ne navede drugače in brez poseganja v člen 27(8), proizvodnjo ali uvoz snovi ali izdelovanje ali uvoz izdelka začne tri tedne potem, ko Agencija prejme dodatne informacije, potrebne za dopolnitev njegove registracije.
(b) any change in the composition of the substance as given in Section 2 of Annex VI;
(a) sprememba njegovega statusa, kot je proizvajalec, uvoznik ali izdelovalec izdelkov, ali sprememba njegovih podatkov, kot je ime ali naslov;
(c) changes in the annual or total quantities manufactured or imported by him or in the quantities of substances present in articles produced or imported by him if these result in a change of tonnage band, including cessation of manufacture or import;
(c) sprememba letnih ali skupnih količin, ki jih proizvede ali uvozi, ali količin snovi v izdelkih, ki jih izdela ali uvozi, če imajo za posledico spremembo količinskega razpona, vključno s prenehanjem proizvodnje ali uvoza;
(d) new identified uses and new uses advised against as in Section 3.7 of Annex VI for which the substance is manufactured or imported;
(d) nove določene uporabe in nove priporočene uporabe oddelka 3.7 Priloge VI, za katere se snov proizvaja ali uvaža;
(e) new knowledge of the risks of the substance to human health and/or the environment of which he may reasonably be expected to have become aware which leads to changes in the safety data sheet or the chemical safety report;
(a) snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene kot rakotvorne, mutagene ali strupene za razmnoževanje v skupino 1 ali 2 in so bile vsaj enkrat po 1. juniju 2007 v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala eno tono ali več na leto na proizvajalca ali uvoznika;
(a) phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, category 1 or 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching one tonne or more per year per manufacturer or per importer, at least once after 1 June 2007;
(e) nova spoznanja glede tveganj snovi za zdravje ljudi in/ali okolje, za katera se lahko upravičeno pričakuje, daje z njimi seznanjen in ki vodijo k spremembam varnostnega lista ali poročila o kemijski varnosti;
(f) any change in the classification and labelling of the substance;
(f) vsaka sprememba v razvrstitvi in označitvi snovi;
(g) any update or amendment of the chemical safety report or Section 5 of Annex VI;
(g) vsaka posodobitev ali sprememba poročila o kemijski varnosti ali oddelka 5 Priloge VI;
(b) phase-in substances classified as very toxic to aquatic organisms which may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC, and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once after 1 June 2007;
(b) snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene kot zelo strupene za vodne organizme, ki lahko povzročijo dolgoročne neugodne posledice v vodnem okolju (R50/53), in so bile vsaj enkrat po 1. juniju 2007 v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika;