natgillin/translations-raw huggingface dataset:
The registrant should gather all existing available test data on the substance to be registered, this would include a literature search for relevant information on the substance.
To bo omogočilo souporabo podatkov o testih; na ta način bi se izognili nepotrebnim testom in zmanjšali stroške.
Wherever practicable, registrations should be submitted jointly, in accordance with Articles 11 or 19.
Registracijski zavezanec naj prav tako zbere vse druge razpoložljive in ustrezne informacije o snovi, tudi o vseh nanooblikah snovi, ki so zajete v registraciji, ne glede na to, ali se testiranje za določeno končno točko pri določenih ravneh tonaže zahteva ali ne.
This will enable test data to be shared, thereby avoiding unnecessary testing and reducing costs.
To naj vključuje informacije iz alternativnih virov (npr. iz (Q)SAR, navzkrižnega branja iz drugih snovi, testiranja in vivo ter in vitro, epidemioloških podatkov), ki lahko pomagajo pri opredelitvi prisotnosti ali odsotnosti nevarnih lastnosti snovi in ki lahko v določenih primerih nadomestijo rezultate testiranj na živalih.
The registrant should also collect all other available and relevant information on the substance including on all nanoforms of the substance that are covered by the registration, regardless whether testing for a given endpoint is required or not at the specific tonnage level.
Poleg tega je treba zbrati informacije o izpostavljenosti, uporabi in ukrepih za obvladovanje tveganja v skladu s členom 10 in to prilogo.
This should include information from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiological data) which may assist in identifying the presence or absence of hazardous properties of the substance and which can in certain cases replace the results of animal tests.
Registracijski zavezanec bo ob upoštevanju vseh teh informacij skupaj lahko določil potrebo po pridobitvi nadaljnjih informacij.“;
In addition, information on exposure, use and risk management measures in accordance with article 10 and this Annex should be collected.
korak 3 se nadomesti z naslednjim:
Considering all this information together, the registrant will be able to determine the need to generate further information.’;
„KORAK 3 – OPREDELITEV INFORMACIJSKIH VRZELI
Step 3 is replaced by the following:
Registracijski zavezanec nato primerja potrebe po informacijah za snov z informacijami, ki so že na voljo, in obsegom, v katerem je mogoče trenutno razpoložljive informacije uporabiti za vse nanooblike, zajete v registraciji, ter opredeli vrzeli.
‘STEP 3 — IDENTIFY INFORMATION GAPS
Na tej stopnji je treba zagotoviti, da so razpoložljivi podatki primerni in zadovoljive kakovosti za izpolnjevanje zahtev.“;
The registrant shall then compare the information needs for the substance with the information already available and the extent to which currently available information can be applied to all nanoforms covered by the registration and identify where there are gaps.
korak 4 se nadomesti z naslednjim:
It is important at this stage to ensure that the available data is relevant and has sufficient quality to fulfil the requirements.’;
„KORAK 4 – PRIDOBIVANJE NOVIH PODATKOV/PREDLAGANJE STRATEGIJE TESTIRANJA
Step 4 is replaced by the following:
V nekaterih primerih novih podatkov ne bo treba pridobiti.
‘STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY
Kadar pa obstaja informacijska vrzel, ki jo je treba zapolniti, se, odvisno od tonaže, pridobijo novi podatki (prilogi VII in VIII) ali predlaga strategija testiranja (prilogi IX in X).
In some cases it will not be necessary to generate new data.
Novi testi na vretenčarjih se izvedejo ali predlagajo le kot zadnja možnost, ko so bili izčrpani vsi drugi viri podatkov.
However, where there is an information gap that needs to be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X), depending on the tonnage.
Zgornji pristop se uporabi tudi, če obstaja vrzel v razpoložljivih informacijah za eno ali več nanooblik snovi, vključenih v skupno predloženo registracijsko dokumentacijo.
New tests on vertebrates shall only be conducted or proposed as a last resort when all other data sources have been exhausted.
V nekaterih primerih lahko pravila iz prilog VII do XI zahtevajo, da se določeni testi izvedejo pred standardnimi zahtevami ali dodatno k tem zahtevam.
The above approach shall also apply if there is a gap of available information for one or more nanoforms of the substance included in the jointly submitted registration dossier.
OPOMBE
In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addition to the standard requirements.
Opomba 1: Če posredovanje informacij tehnično ni mogoče ali če se ne zdi znanstveno potrebno, se razlogi v skladu z ustreznimi določbami jasno navedejo.
NOTES
Opomba 2: Registracijski zavezanec sme navesti, da so nekatere informacije v registracijski dokumentaciji poslovno občutljive in bi mu njihovo razkritje lahko poslovno škodovalo.
Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons shall be clearly stated, in accordance with the relevant provisions.
V takem primeru navede postavke in zagotovi utemeljitev.“;
Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially sensitive and its disclosure might harm him commercially.
uvodno besedilo v oddelku 2 „Identifikacija snovi“ se nadomesti z naslednjim:
If this is the case, he shall list the items and provide a justification.’;
„Informacije, navedene v tem oddelku, zadostujejo za identifikacijo vsake snovi in opredelitev različnih nanooblik.
The introductory text in Section 2 Identification of the substance is replaced by the following:
Če posredovanje informacij tehnično ni mogoče ali če se posredovanje informacij o eni ali več točkah, ki so navedene spodaj, ne zdi znanstveno potrebno, se razlogi jasno navedejo.“;
‘For each substance, the information given in this section shall be sufficient to enable each substance to be identified and the different nanoforms to be characterised.
pododdelek 2.3 se nadomesti z naslednjim:
If it is not technically possible or if it does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.’;
Sestava vsake snovi.
Subsection 2.3. is replaced by the following:
Kadar registracija zajema eno ali več nanooblik, se te nanooblike opredelijo v skladu s pododdelkom 2.4 te priloge.
Composition of each substance.
Stopnja čistote (%)
Where a registration covers one or more nanoforms, these nanoforms shall be characterised pursuant to section 2.4 of this Annex.
Vrsta nečistot, vključno z izomeri in stranskimi proizvodi
Degree of purity (%)
Odstotek (pomembnih) glavnih nečistot
Nature of impurities, including isomers and by-products
Vrsta in red velikosti (… ppm, … %) vseh dodatkov (npr. stabilizatorjev ali inhibitorjev)
Percentage of (significant) main impurities
Spektralni podatki (npr. ultravijolični, infrardeči, jedrska magnetna resonanca ali masni spekter)
Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)
Visokotlačni tekočinski kromatogram, plinski kromatogram
Spectral data (e.g. ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)
Opis analitičnih metod ali primernih bibliografskih referenc za identifikacijo snovi in, kjer je to primerno, za identifikacijo nečistot in dodatkov.
High-pressure liquid chromatogram, gas chromatogram
Te informacije zadostujejo za ponovljivost metod.
Description of the analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives.
Opredelitev nanooblik snovi: za kateri koli opredelitveni parameter se lahko predložene informacije uporabljajo za posamezno nanoobliko ali skupino podobnih nanooblik, pod pogojem, da so mejne vrednosti skupine jasno opredeljene.
This information shall be sufficient to allow the methods to be reproduced.
Informacije iz točk 2.4.2 do 2.4.5 se jasno pripišejo različnim nanooblikam ali skupinam podobnih nanooblik, opredeljenim v točki 2.4.1.
Characterisation of nanoforms of a substance: For each of the characterisation parameters, the information provided may be applicable to either an individual nanoform or a set of similar nanoforms provided that the boundaries of the set are clearly specified.
Imena ali drugi identifikatorji nanooblik ali skupin podobnih nanooblik snovi
The information in points 2.4.2 – 2.4.5 shall be clearly assigned to the different nanoforms or sets of similar nanoforms identified in point 2.4.1.
Številska porazdelitev velikosti delcev z navedbo številskega deleža sestavnih delcev v razponu velikosti med 1 nm in 100 nm
Names or other identifiers of the nanoforms or sets of similar nanoforms of the substance
Opis površinske funkcionalizacije ali obdelave in identifikacija vsakega sredstva, vključno z imenom IUPAC in številko CAS ali ES
Number based particle size distribution with indication of the number fraction of constituent particles in the size range within 1 nm – 100 nm.
Oblika, razmerje med višino in širino ter druge morfološke značilnosti: kristaliničnost, informacije o strukturi sestave, vključno z npr. školjkastimi ali votlimi strukturami, če je ustrezno
Description of surface functionalisation or treatment and identification of each agent including IUPAC name and CAS or EC number.
Površina (specifična površina glede na prostornino, specifična površina glede na maso ali oboje)
Shape, aspect ratio and other morphological characterisation: crystallinity, information on assembly structure including e.g. shell like structures or hollow structures, if appropriate
Opis analitičnih metod ali primernih bibliografskih referenc za elemente informacij v tem pododdelku.
Surface area (specific surface area by volume, specific surface area by mass or both)
Te informacije zadostujejo za ponovljivost metod.“;
Description of the analytical methods or the appropriate bibliographical references for the information elements in this sub-section.
v oddelku 3 se za naslovom „INFORMACIJE O PROIZVODNJI IN UPORABI(-AH) SNOVI“ doda naslednje uvodno besedilo:
This information shall be sufficient to allow the methods to be reproduced.’;
„Kadar se snov, ki se registrira, proizvaja ali uvaža v eni ali več nanooblikah, informacije o proizvodnji in uporabi iz pododdelkov 3.1 do 3.7 vključujejo ločene informacije o različnih nanooblikah ali skupinah podobnih nanooblik, kot so opredeljene v pododdelku 2.4.“;
In section 3, the following introductory text is added after the title ‘INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)’:
v oddelku 5 se uvodno besedilo nadomesti z naslednjim:
‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information on manufacture and use under 3.1-3.7 shall include separate information on the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4.’;
„Te informacije so skladne z informacijami v varnostnem listu, kadar se tak varnostni list zahteva v skladu s členom 31 te uredbe.
In section 5, the introductory text is replaced by the following:
Kadar se snov, ki je v postopku registracije, proizvaja ali uvaža tudi v eni ali več nanooblikah, se informacije v skladu s tem oddelkom nanašajo na različne nanooblike ali skupine podobnih nanooblik, kot so opredeljene v pododdelku 2.4, kjer je to ustrezno.“;
‘This information shall be consistent with that in the Safety Data Sheet where such a Safety Data Sheet is required according to Article 31.
v oddelku 6 se za naslovom „INFORMACIJE O IZPOSTAVLJENOSTI ZA SNOVI, KI SO REGISTRIRANE V KOLIČINAH MED 1 IN 10 TONAMI NA LETO NA PROIZVAJALCA ALI UVOZNIKA“ doda naslednje uvodno besedilo:
Where a substance being registered is also manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 where relevant.’;
„Kadar se snov, ki se registrira, proizvaja ali uvaža v eni ali več nanooblikah, se informacije v skladu s tem oddelkom nanašajo na različne nanooblike ali skupine podobnih nanooblik, kot so posebej opredeljene v pododdelku 2.4.“
In section 6, the following introductory text is added after the title ‘INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES PER YEAR PER MANUFACTURER OR IMPORTER’:
Priloga VII k Uredbi (ES) št. 1907/2006 se spremeni:
‘Where a substance being registered is manufactured or imported in one or several nanoforms, the information pursuant to this Section shall address the different nanoforms or sets of similar nanoforms as characterised in subsection 2.4 separately.’
v uvodnem besedilu se za tretjim odstavkom doda naslednje besedilo:
Annex VII to Regulation (EC) No 1907/2006 is amended as follows:
„Brez poseganja v informacije, predložene za druge oblike, vse ustrezne fizikalno-kemijske, toksikološke in ekotoksikološke informacije vključujejo opredelitev testirane nanooblike in pogojev testiranja.
In the introductory text, the following text is added after the third paragraph:
Kadar se uporabijo modeli QSAR ali se dokazi pridobijo drugače kot s testiranjem, se zagotovita utemeljitev in opis obsega značilnosti/lastnosti nanooblik, za katere se dokazi lahko uporabijo.“;
‘Without prejudice to the information submitted for other forms, any relevant physicochemical, toxicological and ecotoxicological information shall include characterisation of the nanoform tested and test conditions. A justification shall be provided where QSARs are used or evidence is obtained by means other than testing, as well as a description of the range of the characteristics/properties of the nanoforms to which the evidence can be applied.’;
pododdelek 7.7 se nadomesti z naslednjim:
Subsection 7.7 is replaced by the following:
Topnost v vodi
Water solubility
Za nanooblike se dodatno upošteva testiranje hitrosti raztapljanja v vodi ter v ustreznih bioloških in okoljskih medijih.
For nanoforms, in addition the testing of dissolution rate in water as well as in relevant biological and environmental media shall be considered.
Študije ni treba izvesti, če:
The study does not need to be conducted if:
je snov hidrolitsko nestabilna pri vrednostih pH 4, 7 in 9 (razpolovna doba je krajša od 12 ur) ali
the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours), or
snov v vodi takoj oksidira.
the substance is readily oxidisable in water.
Če se snov zdi ‚netopna‘ v vodi, se izvede mejni test do meje zaznavnosti analitične metode.
If the substance appears “insoluble” in water, a limit test up to the detection limit of the analytical method shall be performed.
Za nanooblike se pri izvajanju študije oceni morebitni zavajajoči učinek disperzije.“
For nanoforms the potential confounding effect of dispersion shall be assessed when conducting the study.’;
pododdelek 7.8 se nadomesti z naslednjim:
Subsection 7.8 is replaced by the following:
Porazdelitveni koeficient n-oktanol/voda
Partition coefficient n-octanol/water
Študije ni treba izvesti, če je snov anorganska.
The study does not need to be conducted if the substance is inorganic.
Če testa ni mogoče izvesti (npr. snov razpade, ima visoko površinsko aktivnost, med izvajanjem testa burno reagira ali se v vodi ali oktanolu ne raztopi, ali ni mogoče pridobiti dovolj čiste snovi), se zagotovijo izračunana vrednost za log P in podrobnosti metode izračunavanja.
If the test cannot be performed (e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure substance), a calculated value for log P as well as details of the calculation method shall be provided.
Za nanooblike se pri izvajanju študije oceni morebitni zavajajoči učinek disperzije v oktanolu in vodi.
For nanoforms the potential confounding effect of dispersion in octanol and water shall be assessed when conducting the study.
Za nanooblike anorganskih ali organskih snovi, za katere se ne uporablja porazdelitveni koeficient n-oktanol/voda, se namesto tega upoštevajo raziskave disperzijske stabilnosti.“
For nanoforms, whether of inorganic or organic substances, for which the partition coefficient n-octanol/water is not applicable the study of dispersion stability shall be considered instead.’;
za pododdelkom 7.14 se doda naslednje:
After subsection 7.14., the following is added:
„7.14a
‘7.14bis
Prašenje
Dustiness
Za nanooblike
For nanoforms
7.14a Študije ni treba izvesti, če je mogoče izključiti izpostavljenost zrnati obliki snovi med njenim življenjskim ciklom.“
bis.
točka 8.4.1 se nadomesti z naslednjim:
The study does not need to be conducted if exposure to granular form of the substance during its life-cycle can be excluded.’;
Študija genske mutacije in vitro pri bakterijah
Point 8.4.1. is replaced by the following:
Študije nanooblik ni treba izvesti, če to ni ustrezno.
In vitro gene mutation study in bacteria
V tem primeru se zagotovijo druge študije, ki vključujejo eno ali več študij mutagenosti in vitro v celicah sesalcev (točki 8.4.2 in 8.4.3 Priloge VIII ali druge mednarodno priznane metode in vitro).“
The study does not need to be conducted for nanoforms where it is not appropriate.
točka 8.5.1 se nadomesti z naslednjim:
In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.’;
Pri zaužitju
Point 8.5.1 is replaced by the following:
Študije ni treba izvesti, če
By oral route
je na voljo študija o akutni strupenosti pri vdihavanju (8.5.2).
The study need not be conducted if
Pri nanooblikah se študija z zaužitjem nadomesti s študijo z vdihavanjem (8.5.2), razen če izpostavljenost ljudi pri vdihavanju ni verjetna ob upoštevanju možnosti izpostavljenosti aerosolom, delcem ali kapljicam, ki jih je mogoče vdihniti.“
a study on acute toxicity by the inhalation route (8.5.2) is available.
točka 9.1.1 se nadomesti z naslednjim:
For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.’;
Preskušanje kratkodobne strupenosti za nevretenčarje (najprimernejša vrsta Daphnia)
Point 9.1.1. is replaced by the following:
Registracijski zavezanec lahko upošteva testiranje dolgodobne namesto kratkodobne strupenosti.
Short-term toxicity testing on invertebrates (preferred species Daphnia)
olajševalni dejavniki kažejo na majhno verjetnost pojava strupenosti za vodno okolje, na primer, če je snov zelo slabo topna v vodi ali ni verjetno, da bo snov prešla biološke membrane.
The registrant may consider long-term toxicity testing instead of short-term.
je na voljo študija dolgodobne strupenosti za vodno okolje za nevretenčarje ali
there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes,
so na voljo ustrezne informacije za razvrščanje in označevanje z vidika nevarnosti za okolje.
a long-term aquatic toxicity study on invertebrates is available, or
Pri nanooblikah študije ni mogoče opustiti zgolj na podlagi visoke netopnosti v vodi.
adequate information for environmental classification and labelling is available.
Študija dolgodobne strupenosti za vodno okolje za vrsto Daphnia (Priloga IX, 9.1.5) se upošteva, če je snov slabo topna v vodi, ali pri nanooblikah, če imajo majhno hitrost raztapljanja v ustreznih testnih medijih.“
For nanoforms, the study may not be waived on the basis of high insolubility in water alone.
točka 9.1.2 se nadomesti z naslednjim:
The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5.) shall be considered if the substance is poorly water soluble, or for nanoforms if they have low dissolution rate in the relevant test media.’;
„9.1.2
Growth inhibition study aquatic plants (algae preferred)
Pri nanooblikah študije ni mogoče opustiti zgolj na podlagi visoke netopnosti v vodi.“
The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely to cross biological membranes.
Priloga VIII k Uredbi (ES) št. 1907/2006 se spremeni:
For nanoforms, the study may not be waived on the basis of high insolubility in water alone.’;
v uvodnem besedilu se za prvim odstavkom doda naslednje besedilo:
Annex VIII to Regulation (EC) No 1907/2006 is amended as follows:
vstavi se nov oddelek:
In the introductory text, the following text is added after the first paragraph:
INFORMACIJE O FIZIKALNO-KEMIJSKIH LASTNOSTIH SNOVI
A new section is inserted:
Samo za nanooblike
INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE
Registracijski zavezanec razmisli o dodatnem testiranju za nanooblike, zajete v registraciji, ali pa tako testiranje zahteva Agencija v skladu s členom 41, če obstajajo znaki, da posebne dodatne lastnosti delcev bistveno vplivajo na nevarnost navedenih nanooblik ali izpostavljenost tem nanooblikam.“
7.14ter.
pododdelek 8.5 se nadomesti z naslednjim:
Further information on physicochemical properties
Akutna strupenost
Only for nanoforms
Študij običajno ni treba izvesti, če:
Further testing for nanoforms covered by the registration shall be considered by the registrant or may be required by the Agency in accordance with Article 41, if there is an indication that specific additional particle properties significantly influence the hazard of or the exposure to those nanoforms.’;
je snov razvrščena kot jedka za kožo.
Subsection 8.5. is replaced by the following:
Za snovi razen plinov se poleg informacij o izpostavljenosti pri zaužitju (8.5.1) ali pri vdihavanju (8.5.2) za nanooblike zagotovijo tudi informacije iz točk 8.5.1 do 8.5.3 o vsaj še enem načinu izpostavljenosti.
Acute toxicity
Izbira drugega načina je odvisna od narave snovi in verjetnega načina izpostavljenosti ljudi.
The study/ies do(es) not generally need to be conducted if:
Če obstaja le en način izpostavljenosti, je treba zagotoviti informacije zgolj za ta način.“
the substance is classified as corrosive to the skin.
točka 8.6.1 se nadomesti z naslednjim:
In addition to the oral route (8.5.1.) or to the inhalation route (8.5.2) for nanoforms, for substances other than gases, the information mentioned under 8.5.1. to 8.5.3. shall be provided for at least one other route.
Študija kratkodobne strupenosti pri ponovljenih odmerkih (28 dni), ena vrsta, moški in ženski spol, najprimernejši način vnosa, ob upoštevanju verjetnega načina izpostavljenosti ljudi.
The choice for the second route will depend on the nature of the substance and the likely route of human exposure.
Študije kratkodobne strupenosti (28 dni) ni treba izvesti, če:
If there is only one route of exposure, information for only that route needs to be provided.’;
je na voljo zanesljiva študija subkronične (90 dni) ali kronične strupenosti, pod pogojem, da so bile uporabljene ustrezne vrste, odmerek, topilo in način vnosa, ali
Point 8.6.1 is replaced by the following:
snov takoj razpade in je na voljo dovolj podatkov o produktih razpada, ali
Short-term repeated dose toxicity study (28 days), one species, male and female, most appropriate route of administration, having regard to the likely route of human exposure.
je mogoče izključiti izpostavljenost ljudi v skladu z oddelkom 3 Priloge XI.
The short-term toxicity study (28 days) does not need to be conducted if:
Ustrezen način se izbere na podlagi naslednjega:
a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate species, dosage, solvent and route of administration were used, or
Testiranje v stiku s kožo je ustrezno, če: