natgillin/translations-raw huggingface dataset:
Where any of the substances exists in one or more nanoforms and data from one form are used in demonstration of the safe use of other forms, in accordance with the general rules set out in Annex XI, a scientific justification shall be given on how, applying the rules for grouping and read-across, the data from a specific test or other information (e.g. methods, results or conclusions) can be used for the other forms of the substance.
Če katera koli snov obstaja v eni ali več nanooblikah in se podatki iz ene oblike uporabijo pri dokazovanju varne uporabe drugih oblik v skladu s splošnimi pravili iz Priloge XI, se navede znanstvena utemeljitev, kako se na podlagi pravil o združevanju v skupine in navzkrižnem branju podatki iz določenega testa ali druge informacije (npr. metode, rezultati ali sklepne ugotovitve) lahko uporabijo za druge oblike snovi.
Similar considerations apply to exposure scenarios and risk management measures.’;
Podobno velja za scenarije izpostavljenosti in ukrepe za obvladovanje tveganja.“;
The last paragraph in subsection 0.5. is replaced by the following:
zadnji odstavek pododdelka 0.5 se nadomesti z naslednjim:
‘If the manufacturer or importer considers that further information is necessary for producing his chemical safety report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary and record this in the chemical safety report under the appropriate heading.
„Če proizvajalec ali uvoznik meni, da za izdelavo poročila o kemijski varnosti potrebuje dodatne informacije in da je te informacije mogoče pridobiti samo z izvajanjem testov v skladu s Prilogo IX ali X, vloži predlog za strategijo testiranja, v katerem razloži, zakaj so po njegovem mnenju potrebne dodatne informacije, in to pod ustreznim naslovom evidentira v poročilu o kemijski varnosti.
Where considered necessary, the proposal for a testing strategy may concern several studies addressing respectively different forms of the same substance for the same information requirement.
Po potrebi se lahko predlog za strategijo testiranja nanaša na več študij, v katerih se za isto zahtevo po informacijah obravnavajo različne oblike iste snovi.
While waiting for results of further testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim risk management measures that he has put in place and those he recommends to downstream users intended to manage the risks being explored.
Med čakanjem na rezultate dodatnih testov v svojem poročilu o kemijski varnosti evidentira in v pripravljeni scenarij izpostavljenosti vključi prehodne ukrepe za obvladovanje tveganj, ki jih je uvedel, in ukrepe, ki jih priporoča nadaljnjim uporabnikom v zvezi z obvladovanjem tveganj, ki so predmet raziskovanja.
The exposure scenarios and interim risk management measures recommended shall address all nanoforms that are covered by the registration.’;
V scenarijih izpostavljenosti in prehodnih ukrepih za obvladovanje tveganj se obravnavajo vse nanooblike, ki so zajete v registraciji.“;
Point 0.6.3 is replaced by the following:
točka 0.6.3 se nadomesti z naslednjim:
‘0.6.3.
„0.6.3
Where as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or, when applicable, nanoforms thereof fulfils the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB, the chemical safety assessment shall also include steps 5 and 6 in accordance with Sections 5 and 6 of this Annex:
Če proizvajalec ali uvoznik na podlagi opravljenih faz 1 do 4 ugotovi, da snov ali, kadar je ustrezno, njene nanooblike izpolnjujejo kriterije za razvrstitev v enega od naslednjih razredov nevarnosti oziroma eno od kategorij iz Priloge I k Uredbi (ES) št. 1272/2008 ali da gre za PBT ali vPvB, mora ocena kemijske varnosti v skladu z oddelkoma 5 in 6 te priloge obsegati tudi fazi 5 in 6:
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9, and 3.10;
razredi nevarnosti 3.1 do 3.6, 3.7 (škodljivi učinki na spolno delovanje in plodnost ali razvoj), 3.8 (učinki, ki niso narkotični učinki), 3.9 in 3.10;
hazard class 5.1.’;
razred nevarnosti 5.1.“;
After subsection 0.11. the following subsection 0.11.bis is added:
za pododdelkom 0.11 se doda naslednji pododdelek 0.11a:
When nanoforms are covered by the chemical safety assessment, an appropriate metric for the assessment and presentation of the results in steps 1-6 of the chemical safety assessment under 0.6.1 and 0.6.2 shall be considered, with the justification included in the chemical safety report and summarised in the safety data sheet.
Kadar so v poročilu o kemijski varnosti zajete nanooblike, se upošteva ustrezna meritev za oceno in predstavitev rezultatov v fazah 1 do 6 poročila o kemijski varnosti na podlagi točk 0.6.1 in 0.6.2, pri čemer se utemeljitev vključi v poročilo o kemijski varnosti in povzame v varnostnem listu.
A multiple metric presentation, including mass metric information, is preferable.
Zaželena je predstavitev z več meritvami, vključno z informacijami o meritvi mase.
When possible, a method for reciprocal conversion shall be indicated.’;
Po možnosti se navede metoda za vzajemno pretvorbo.“;
The following sentence is added after the first paragraph of section 1.0.3:
za prvim odstavkom točke 1.0.3 se doda naslednji stavek:
‘The assessment shall address all nanoforms that are covered by the registration.’;
„V oceni se obravnavajo vse nanooblike, ki so zajete v registraciji.“;
The second paragraph of point 1.3.1. is replaced by the following:
drugi odstavek točke 1.3.1 se nadomesti z naslednjim:
‘The assessment should always include a statement as to whether the substance or, when applicable, nanoforms thereof fulfils or does not fulfil the criteria given in Regulation (EC) No 1272/2008 for classification in the hazard class carcinogenicity category 1A or 1B, in the hazard class germ cell mutagenicity category 1A or 1B or in the hazard class reproductive toxicity category 1A or 1B.’;
„V oceno je treba vedno vključiti izjavo, ali snov ali, kadar je ustrezno, njene nanooblike izpolnjujejo kriterije iz Uredbe (ES) št. 1272/2008 za razvrstitev v razred nevarnosti rakotvornost kategorije 1A ali 1B, razred nevarnosti mutagenost za zarodne celice kategorije 1A ali 1B ali razred nevarnosti strupenost za razmnoževanje kategorije 1A ali 1B.“;
Point 1.3.2. is replaced by the following:
točka 1.3.2 se nadomesti z naslednjim:
‘1.3.2.
„1.3.2
If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrants shall indicate and justify the action or decision he has taken as a result.’;
Če se na podlagi informacij ni mogoče odločiti, ali je treba snov ali, kadar je ustrezno, njene nanooblike razvrstiti v določen razred ali kategorijo nevarnosti, registracijski zavezanec navede in utemelji ukrep ali odločitev, ki jo je zaradi tega sprejel.“;
The second paragraph of subsection 2.2. is replaced by the following:
drugi odstavek pododdelka 2.2 se nadomesti z naslednjim:
‘If the information is inadequate to decide whether a substance or, when applicable, nanoforms thereof should be classified for a particular hazard class or category, the registrant shall indicate and justify the action or decision he has taken as a result.’;
„Če se na podlagi informacij ni mogoče odločiti, ali je treba snov ali, kadar je ustrezno, njene nanooblike razvrstiti v določen razred ali kategorijo nevarnosti, registracijski zavezanec navede in utemelji ukrep ali odločitev, ki jo je zaradi tega sprejel.“;
The following sentence is added at the end of point 3.0.2.:
na koncu točke 3.0.2 se doda naslednji stavek:
Point 3.2.1. is replaced by the following:
točka 3.2.1 se nadomesti z naslednjim:
The appropriate classification developed in accordance with the criteria in Regulation (EC) No 1272/2008 shall be presented and justified.
Navede in utemelji se ustrezna razvrstitev v skladu s kriteriji iz Uredbe (ES) št. 1272/2008.
Any M-factor resulting from the application of Article 10 of Regulation (EC) No 1272/2008 shall be presented and, if it is not included in Part 3 of Annex VI to Regulation (EC) No 1272/2008, justified.
Navede se vsak M-faktor, ki izvira iz uporabe člena 10 Uredbe (ES) št. 1272/2008, ter utemelji, če ni vključen v del 3 Priloge VI k Uredbi (ES) št. 1272/2008.
The presentation and justification is applied to all nanoforms covered by the registration.’;
Navedba in utemeljitev se uporabita za vse nanooblike, zajete v registraciji.“;
Point 3.2.2. is replaced by the following:
točka 3.2.2 se nadomesti z naslednjim:
‘3.2.2.
„3.2.2
Point 4.0.2. is replaced by the following:
točka 4.0.2 se nadomesti z naslednjim:
‘4.0.2.
„4.0.2
The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report.
korak 1
The assessment shall address all nanoforms that are covered by the registration:
primerjava s kriteriji
Step 1
korak 2
Comparison with the Criteria.
opredelitev emisij
Step 2
Ocenjevanje se povzame tudi v varnostnem listu pod naslovom 12.“;
Emission Characterisation.
pododdelek 4.2 se nadomesti z naslednjim:
The assessment shall also be summarised in the Safety Data Sheet under heading 12.’;
korak 2: Opredelitev emisij
Subsection 4.2. is replaced by the following:
Če snov izpolnjuje kriterije ali če je v registracijski dokumentaciji obravnavana kot PBT ali vPvB, se izvede opredelitev emisij, ki zajema ustrezne dele ocenjevanja izpostavljenosti, kot je opisano v oddelku 5.
Step 2: Emission Characterisation
Zlasti mora vsebovati oceno količine snovi, izpuščene v različne dele okolja med vsemi dejavnostmi, ki jih je izvedel proizvajalec ali uvoznik, in ob vseh opredeljenih uporabah, ter opredelitev verjetnih načinov izpostavljenosti ljudi in okolja snovi.
If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5.
V oceni se obravnavajo vse nanooblike, ki so zajete v registraciji.“;
In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance.
prvi odstavek pododdelka 5.0 se nadomesti z naslednjim:
The estimation shall address all nanoforms that are covered by the registration.’;
„Cilj ocenjevanja izpostavljenosti je priprava kvantitativne in kvalitativne ocene odmerka/koncentracije snovi, ki so ji oziroma so ji lahko izpostavljeni ljudje in okolje.
The first paragraph of subsection 5.0. is replaced by the following:
V oceni se upoštevajo vse stopnje življenjskega cikla snovi, kot izhajajo iz proizvodnje in opredeljenih uporab, in so vsebovane vse izpostavljenosti, ki se lahko nanašajo na nevarnosti iz oddelkov 1 do 4.
‘The objective of the exposure assessment shall be to make a quantitative and qualitative estimate of the dose/concentration of the substance to which humans and the environment are or may be exposed.
V oceni se obravnavajo vse nanooblike, ki so zajete v registraciji.
The assessment shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and shall cover any exposures that may relate to the hazards identified in Sections 1 to 4.
Ocena izpostavljenosti zajema naslednja dva koraka, ki se sicer jasno opredelita v poročilu o kemijski varnosti:“;
The assessment shall address all nanoforms that are covered by the registration.
na koncu točke 5.2.2 se doda naslednji stavek:
The exposure assessment shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:’;
„Kadar so v registraciji zajete nanooblike, se v oceni emisij zanje, kjer je ustrezno, upoštevajo primeri, ko so izpolnjeni pogoji iz točke (c) pododdelka 3.2 Priloge XI.“;
The following sentence is added at the end of point 5.2.2.:
točka 5.2.3 se nadomesti z naslednjim:
‘When nanoforms are covered by the registration, the emission estimation for these shall, where relevant, take account of situations when the conditions outlined in Annex XI section 3.2 point (c) are fulfilled.’;
„5.2.3
Point 5.2.3. is replaced by the following:
Izvede se opredelitev možnih procesov razkroja, pretvorbe ali reakcijskih procesov ter ocena razširjenosti in usode v okolju.
‘5.2.3.
Kadar so v registraciji zajete nanooblike, se vključi opredelitev sprememb hitrosti raztapljanja, agregacije delcev, aglomeracije delcev in površinske kemije delcev.“.
A characterisation of possible degradation, transformation, or reaction processes, and an estimation of environmental distribution and fate shall be performed.
Priloga III k Uredbi (ES) št. 1907/2006 se nadomesti z naslednjim:
When nanoforms are covered by the registration, a characterisation of the dissolution rate, the particle aggregation, the agglomeration and of the particle surface chemistry changes shall be included.’
„KRITERIJI ZA SNOVI, KI SO REGISTRIRANE V KOLIČINAH MED 1 IN 10 TONAMI
Annex III to Regulation (EC) No 1907/2006 is replaced by the following:
Kriteriji za snovi in, kadar je ustrezno, njihove nanooblike, ki so registrirane v količinah med 1 in 10 tonami glede na člen 12(1)(a) in (b):
‘CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES
snovi, za katere je predvideno (tj. z uporabo (Q)SAR ali drugih dokazov), da bodo verjetno izpolnjevale kriterije za razvrstitev v kategorijo 1A ali 1B rakotvornosti, mutagenosti za zarodne celice ali strupenosti za razmnoževanje, ali kriterije iz Priloge XIII;
Criteria for substances and, when applicable, for nanoforms thereof, registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):
snovi:
substances for which it is predicted (i.e. by the application of (Q)SARs or other evidence) that they are likely to meet the criteria for category 1A or 1B classification in the hazard classes carcinogenicity, germ cell mutagenicity or reproductive toxicity or the criteria in Annex XIII;
z razširjenimi ali razpršenimi uporabami, zlasti kadar se te snovi uporabljajo v zmeseh za potrošnike ali so vsebovane v izdelkih za potrošnike, in
substances:
za katere je predvideno (tj. z uporabo (Q)SAR ali drugih dokazov), da bodo verjetno izpolnjevale kriterije za razvrstitev v enega od razredov nevarnosti ali razločevanja za zdravje ali okolje po Uredbi (ES) št. 1272/2008, ali za snovi z nanooblikami, razen če so te nanooblike topne v bioloških in okoljskih medijih.“
with dispersive or diffuse use(s) particularly where such substances are used in consumer mixtures or incorporated into consumer articles; and
Priloga VI k Uredbi (ES) št. 1907/2006 se spremeni:
for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classification criteria for any health or environmental hazard classes or differentiations under Regulation (EC) No 1272/2008 or for substances with nanoforms, unless those nanoforms are soluble in biological and environmental media.’
podnaslov in uvodno besedilo pod podnaslovom „Navodilo o izpolnjevanju zahtev iz prilog VI do XI“ se nadomestita z naslednjim:
Annex VI to Regulation (EC) No 1907/2006 is amended as follows:
„OPOMBA GLEDE IZPOLNJEVANJA ZAHTEV IZ PRILOG VI DO XI
The subtitle and the introductory text under the current subtitle ‘Guidance note on fulfilling the requirements of annexes VI to XI’ are replaced by the following:
Priloge VI do XI določajo informacije, ki se za namene registracije in evalvacije predložijo v skladu s členi 10, 12, 13, 40, 41 in 46.
‘NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI
V Prilogi VII so navedene standardne zahteve za najnižjo raven tonaže; vsakič, ko je dosežena nova raven tonaže, je treba dodati zahteve ustrezne priloge.
Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to Articles 10, 12, 13, 40, 41 and 46.
Za vsako registracijo se bodo natančne zahteve po informacijah razlikovale glede na tonažo, uporabo in izpostavljenost.
For the lowest tonnage level, the standard requirements are in Annex VII, and every time a new tonnage level is reached, the requirements of the corresponding Annex have to be added.
Priloge se zato obravnavajo kot celota in v povezavi s skupnimi zahtevami po registraciji, evalvaciji in dolžnosti skrbnega ravnanja.
For each registration the precise information requirements will differ, according to tonnage, use, and exposure.
Snov je opredeljena v skladu s členom 3(1) in se identificira v skladu z oddelkom 2 te priloge.
The Annexes shall thus be considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.
Snov se vedno proizvaja ali uvaža v vsaj eni obliki.
A substance is defined in accordance with Article 3(1) and identified in accordance with section 2 in this Annex.
Pojavlja se lahko tudi v več kot eni obliki.
A substance is always manufactured or imported in at least one form.
Za vse nanooblike, ki so zajete v registraciji, se navedejo nekatere posebne informacije.
A substance can also occur in more than one form.
Nanooblike se opredelijo, kot je določeno v tej prilogi.
For all nanoforms covered by the registration certain specific information items shall be provided.
Registracijski zavezanec utemelji, zakaj so informacije, predložene v skupni registraciji, ki izpolnjujejo zahteve po informacijah za registrirane snovi z nanooblikami, ustrezne za ocenjevanje nanooblik.
Nanoforms shall be characterised as provided for in this Annex.
Informacije, ki so ustrezne za izpolnjevanje zahtev po informacijah za tako snov, lahko posamezni registracijski zavezanci predložijo tudi ločeno, če je to upravičeno v skladu s členom 11(3).
The registrant shall justify why the information provided in the joint registration, covering the information requirements for the registered substances with nanoforms, is adequate for assessing the nanoforms.
Kadar obstajajo bistvene razlike pri lastnostih, pomembnih za oceno in obvladovanje nevarnosti, izpostavljenosti in tveganja za nanooblike, bo morda za eno ali več zahtev po informacijah potreben več kot en sklop podatkov.
Information relevant to cover information requirements for such a substance can also be submitted separately by individual registrants, where justified in accordance with Article 11(3).
Informacije se navedejo tako, da je jasno, katere informacije v skupni predložitvi se nanašajo na katero nanoobliko snovi.
More than one dataset may be required for one or more information requirements whenever there are significant differences in the properties relevant for the hazard, exposure and risk assessment and management of nanoforms.
Kadar se dve ali več oblik snovi ‚združijo v skupino‘ za namene ene, več ali morebiti vseh zahtev po informacijah, se v registracijski dokumentaciji, če je to tehnično in znanstveno utemeljeno, uporabijo metodologije iz pododdelka 1.5 Priloge XI.
The information shall be reported in such a manner that it is clear which information in the joint submission pertains to which nanoform of the substance.
Zahteve, ki so specifične za nanooblike snovi, se uporabljajo brez poseganja v zahteve, ki veljajo za druge oblike snovi.
Where technically and scientifically justified, the methodologies set out in Annex XI.1.5 shall be used within a registration dossier when two or more forms of a substance are “grouped” for the purposes of one, more or possibly all the information requirements.
Opredelitev nanooblike in skupine podobnih nanooblik:
The requirements specific to nanoforms apply without prejudice to requirements applicable to other forms of a substance.
Na podlagi Priporočila Komisije z dne 18. oktobra 2011 o opredelitvi nanomateriala nanooblika pomeni obliko naravne ali umetne snovi, ki vsebuje delce v nevezanem stanju ali v obliki agregatov ali aglomeratov in pri kateri je ena ali več zunanjih dimenzij – za 50 % ali več delcev pri razporeditvi snovi po velikosti glede na število – v razponu velikosti od 1 nm do 100 nm ter ki na podlagi odstopanja vključuje tudi fulerene, plasti grafena in enoplastne ogljikove nanocevke z eno ali več zunanjimi merami pod 1 nm.
Definition of a nanoform and a set of similar nanoforms:
Za ta namen ‚delec‘ pomeni zelo majhen del snovi, ki ima opredeljene fizične meje; ‚aglomerat‘ pomeni skupek šibko povezanih delcev ali agregatov, katerega zunanja površina je podobna vsoti površin posameznih sestavnih delov, in ‚agregat‘ pomeni delec, sestavljen iz močno povezanih ali zlitih delcev.
On the basis of the Commission Recommendation of 18 October 2011 on the definition of nanomaterial, a nanoform is a form of a natural or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm, including also by derogation fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm.
Nanooblika je opredeljena v skladu s pododdelkom 2.4.
For this purpose, “particle” means a minute piece of matter with defined physical boundaries; “agglomerate” means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components and “aggregate” means a particle comprising of strongly bound or fused particles.
Snov ima lahko eno ali več različnih nanooblik glede na razlike v parametrih iz točk 2.4.2 do 2.4.5.
A nanoform shall be characterised in accordance with section 2.4 below.
‚Skupina podobnih nanooblik‘ je skupina nanooblik, opredeljenih v skladu s pododdelkom 2.4, pri čemer jasno opredeljene mejne vrednosti parametrov iz točk 2.4.2 do 2.4.5 za posamezne nanooblike iz skupine še vedno dopuščajo sklepanje, da je mogoče ocenjevanje nevarnosti, izpostavljenosti in tveganja za te nanooblike izvesti skupaj.
A substance may have one or more different nanoforms, based on differences in the parameters in points 2.4.2 to 2.4.5.
Z dokazom se utemelji, da odstopanje v teh mejah ne vpliva na ocene nevarnosti, izpostavljenosti in tveganja za podobne nanooblike v skupini.
A “set of similar nanoforms” is a group of nanoforms characterised in accordance with section 2.4 where the clearly defined boundaries in the parameters in the points 2.4.2 to 2.4.5 of the individual nanoforms within the set still allow to conclude that the hazard assessment, exposure assessment and risk assessment of these nanoforms can be performed jointly.
Nanooblika lahko pripada le eni skupini podobnih nanooblik
A justification shall be provided to demonstrate that a variation within these boundaries does not affect the hazard assessment, exposure assessment and risk assessment of the similar nanoforms in the set.
Izraz ‚nanooblika‘, kadar se navaja v drugih prilogah, se nanaša na nanoobliko ali skupino podobnih nanooblik, če je bila opredeljena, kot je opredeljeno v tej prilogi.“;
A nanoform can only belong to one set of similar nanoforms
korak 1 se nadomesti z naslednjim:
The term “nanoform”, when it is referred to in the other Annexes, shall refer to a nanoform or a set of similar nanoforms, when one has been defined, as defined in this Annex.’;
„KORAK 1 – ZBIRANJE IN SOUPORABA OBSTOJEČIH INFORMACIJ
Step 1 is replaced by the following:
Registracijski zavezanec naj zbere vse obstoječe in razpoložljive podatke o testih snovi, ki jo je treba registrirati; to vključuje iskanje ustreznih informacij o snovi v literaturi.
‘STEP 1 — GATHER AND SHARE EXISTING INFORMATION
Kjer je to mogoče, naj se registracije predložijo skupaj, v skladu s členom 11 ali 19.