natgillin/translations-raw huggingface dataset:
‘The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.’;
Upoštevajo se pretekli podatki, ki se nanašajo na človeka, kot na primer epidemiološke študije na izpostavljenih populacijah, podatki o nezgodni ali poklicni izpostavljenosti ter klinične študije.
Point 1.1.3. is replaced by the following:
Zahtevnost podatkov za posebne učinke za zdravje ljudi je med drugim odvisna od vrste analize, zajetih parametrov, obsega in specifičnosti odziva ter posledično od predvidljivosti učinkov.
‘1.1.3.
Kriteriji za ocenjevanje primernosti podatkov vključujejo:
Historical human data
pravilno izbiro in opredelitev izpostavljenih in kontrolnih skupin;
Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.
primerno opredelitev izpostavljenosti;
The strength of the data for a specific human health effect depends, among other things, on the type of analysis and on the parameters covered and on the magnitude and specificity of the response and consequently the predictability of the effect.
zadostno trajanje spremljanja pojavnosti bolezni;
Criteria for assessing the adequacy of the data include:
veljavno metodo za opazovanje učinka;
the proper selection and characterisation of the exposed and control groups;
pravilno obravnavanje pristranskosti in zavajajočih dejavnikov ter
adequate characterisation of exposure;
sprejemljivo statistično zanesljivost za utemeljitev sklepa.
sufficient length of follow-up for disease occurrence;
Vedno se zagotovi primerna in zanesljiva dokumentacija.
valid method for observing an effect;
Kadar so v registraciji zajete nanooblike, se v zgornjem pristopu obravnavajo ločeno.“;
proper consideration of bias and confounding factors; and
pododdelek 1.2 se nadomesti z naslednjim:
a reasonable statistical reliability to justify the conclusion.
Zanesljivost dokazov
In all cases adequate and reliable documentation shall be provided.
Iz več neodvisnih virov podatkov je morda mogoče dovolj zanesljivo domnevati/sklepati, da ima snov določene nevarne lastnosti ali pa teh nima, medtem ko se informacije samo iz vsakega posameznega vira štejejo kot nezadostne za podporo tega mnenja.
When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’;
Dokazi iz uporabe novih testnih metod, ki še niso vključene med testne metode iz člena 13(3), ali mednarodne testne metode, ki jo kot enakovredno priznava Komisija ali Agencija, lahko dovolj zanesljivo kažejo na prisotnost ali odsotnost posebne nevarne lastnosti v snovi.
Subsection 1.2. is replaced by the following:
Kadar je na voljo dovolj zanesljivih dokazov za prisotnost ali odsotnost določene nevarne lastnosti:
Weight of evidence
se za to lastnost opusti nadaljnje testiranje na vretenčarjih,
There may be sufficient weight of evidence from several independent sources of information leading to the assumption/conclusion that a substance has or has not a particular dangerous property, while the information from each single source alone is regarded insufficient to support this notion.
se lahko opusti nadaljnje testiranje, ki ne vključuje vretenčarjev.
There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the test methods referred to in Article 13(3) or from an international test method recognised by the Commission or the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous property.
pododdelek 1.3 se nadomesti z naslednjim:
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
Kvalitativno in kvantitativno razmerje med strukturo in aktivnostjo ((Q)SAR)
further testing on vertebrate animals for that property shall be omitted,
Rezultati, pridobljeni iz veljavnih kvalitativnih ali kvantitativnih modelov razmerja med strukturo in aktivnostjo ((Q)SAR), lahko kažejo na prisotnost ali odsotnost določene nevarne lastnosti.
further testing not involving vertebrate animals may be omitted.
Rezultati iz (Q)SAR se lahko uporabijo namesto testiranja, če so izpolnjeni naslednji pogoji:
Subsection 1.3. is replaced by the following:
rezultati so izpeljani iz modela (Q)SAR s potrjeno znanstveno veljavnostjo;
Qualitative or Quantitative structure-activity relationship ((Q)SAR)
za snov velja področje uporabe modela (Q)SAR;
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property.
rezultati so primerni za razvrščanje in označevanje ter/ali oceno tveganja in
Results of (Q)SARs may be used instead of testing when the following conditions are met:
zagotovljena je primerna in zanesljiva dokumentacija uporabljene metode.
results are derived from a (Q)SAR model whose scientific validity has been established,
Agencija v sodelovanju s Komisijo, državami članicami in zainteresiranimi stranmi oblikuje in zagotovi smernice za oceno, kateri model (Q)SAR bo izpolnil te pogoje, ter zagotovi primere.
the substance falls within the applicability domain of the (Q)SAR model,
zadnji odstavek pododdelka 1.4 se nadomesti z naslednjim:
results are adequate for the purpose of classification and labelling and/or risk assessment, and
„Ta potrditev se lahko opusti, če so izpolnjeni naslednji pogoji:
adequate and reliable documentation of the applied method is provided.
rezultati izhajajo iz metode in vitro, katere znanstvena veljavnost je bila potrjena z validacijsko študijo v skladu z mednarodno dogovorjenimi načeli validacije;
The Agency in collaboration with the Commission, Member States and interested parties shall develop and provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.
rezultati so primerni za razvrščanje in označevanje ter/ali oceno tveganja in
The last paragraph in Section 1.4 is replaced by the following:
Kadar so v registraciji zajete nanooblike, se v zgornjem pristopu iz točk 1 do 3 obravnavajo ločeno.“;
‘Such confirmation may be waived if the following conditions are met:
prvi odstavek pododdelka 1.5 se nadomesti z naslednjim:
results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;
„Snovi, katerih fizikalno-kemijske, toksikološke ali ekotoksikološke lastnosti so lahko podobne ali sledijo urejenemu vzorcu kot rezultat strukturne podobnosti, se lahko upoštevajo kot skupina ali ‚kategorija‘ snovi.
results are adequate for the purpose of classification and labelling and/or risk assessment; and
Uporaba koncepta skupine zahteva, da je mogoče fizikalno-kemijske lastnosti, učinke za zdravje ljudi in učinke za okolje ali usodo v okolju napovedati iz podatkov za referenčno snov znotraj skupine z interpolacijo na druge snovi v skupini (pristop navzkrižnega branja).
When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.’;
Na ta način se izogne potrebi po testiranju vsake snovi za vsako končno točko.
The first paragraph in Section 1.5 is replaced by the following:
Agencija bo po posvetovanju z ustreznimi interesnimi skupinami in drugimi zainteresiranimi stranmi izdala navodila za tehnično in znanstveno utemeljeno metodologijo za združevanje snovi v skupine, in sicer dovolj zgodaj pred prvim rokom za registracijo snovi v postopnem uvajanju.
‘Substances whose physicochemical, toxicological and eco-toxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or “category” of substances.
Kadar so v registraciji zajete nanooblike, se v zgornjem pristopu obravnavajo ločeno.
Application of the group concept requires that physicochemical properties, human health effects and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).
Združevanja različnih nanooblik iste snovi v skupine ni mogoče utemeljiti zgolj na podlagi podobnosti molekulske strukture.
This avoids the need to test every substance for every endpoint.
Če se nanooblike, zajete v registraciji, združijo v skupino ali vključijo v ‚kategorijo‘ z drugimi oblikami snovi v isti registraciji, vključno z drugimi nanooblikami, se zgoraj navedene obveznosti uporabljajo enako.“
The Agency, after consulting with relevant stakeholders and other interested parties, shall issue guidance on technically and scientifically justified methodology for the grouping of substances sufficiently in advance of the first registration deadline for phase-in substances.
Priloga XII k Uredbi (ES) št. 1907/2006 se spremeni:
When nanoforms are covered by the registration the above approach shall address the nanoforms separately.
uvodno besedilo se nadomesti z naslednjim:
For grouping different nanoforms of the same substance the molecular structural similarities alone cannot serve as a justification.
„UVOD
If nanoforms covered by a registration are grouped or placed in a “category” with other forms, including other nanoforms, of the substance in the same registration the obligations above shall apply in the same manner.’
Namen te priloge je določiti, kako morajo nadaljnji uporabniki oceniti in dokumentirati, da so tveganja, izhajajoča iz snovi, ki jih uporabljajo, pod primernim nadzorom med njihovo uporabo, in sicer za uporabo, ki ni vključena v varnostni list, ki so ga prejeli, ter da drugi uporabniki v nadaljevanju dobavne verige lahko ustrezno nadzorujejo tveganja.
Annex XII to Regulation (EC) No 1907/2006 is amended as follows:
Ocena zajema življenjski krog snovi od prejema nadaljnjega uporabnika za njegove lastne uporabe in opredeljene uporabe v nadaljevanju dobavne verige.
The introductory text is replaced by the following:
Ocena upošteva uporabo snovi samostojno, v zmesi ali izdelku.
‘INTRODUCTION
Utemeljitve in zaključki, sprejeti na podlagi ocene morajo biti ustrezni za nanooblike od prejema s strani nadaljnjega uporabnika za njegove lastne uporabe in njegove opredeljene uporabe v nadaljevanju dobavne verige.
The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet supplied to them and that other users further down the supply chain can adequately control the risks.
Nadaljnji uporabnik pri pripravi ocene kemijske varnosti in izdelavi poročila o kemijski varnosti upošteva informacije, ki jih je prejel od dobavitelja kemikalije v skladu s členoma 31 in 32 te uredbe.
The assessment shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identified uses further down the supply chain.
Kadar so v njegovi lastni uporabi ali njegovih opredeljenih uporabah v nadaljevanju dobavne verige zajete nanooblike snovi, se upošteva ustrezna meritev za oceno in predstavitev rezultatov v fazah 1 do 6 ocene kemijske 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.
The assessment shall consider the use of the substance on its own, in a mixture or in an article.
Zaželena je predstavitev z več meritvami, ki zagotavlja razpoložljivost informacij o meritvi mase.
Justifications and conclusions drawn from the assessment shall be relevant to the nanoforms, from their receipt by the downstream user, for his own uses and for his identified uses further down the supply chain.
Pri oceni kemijske varnosti se, kadar je to na voljo in primerno, upošteva ocena, pripravljena v skladu z zakonodajo Skupnosti (npr. ocene tveganj, opravljene v skladu z Uredbo (EGS) št. 793/93), ki se odraža tudi v poročilu o kemijski varnosti.
In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this Regulation.
Odstopanja od takšnih ocen se utemeljijo.
When nanoforms of the substance are covered by his own use or his identified uses down the supply chain, 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.
Prav tako se lahko upoštevajo ocene, izvedene v skladu z drugimi mednarodnimi in nacionalnimi programi.
A multiple metric presentation is preferable, ensuring availability of mass metric information.
Postopek, ki ga opravi nadaljnji uporabnik pri pripravi ocene kemijske varnosti in poročila o kemijski varnosti, sestoji iz treh korakov:“;
Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and be reflected in the Chemical Safety Report.
pri koraku 2 se za prvim odstavkom doda naslednje besedilo:
Deviations from such assessments shall be justified.
„Kadar so v njegovi lastni uporabi ali njegovih opredeljenih uporabah v nadaljevanju dobavne verige zajete nanooblike snovi, ocena zajema oceno nevarnosti, PBT in vPvB nanooblik, kot se uporabljajo.“;
‘In those cases where the downstream user considers that information, in addition to that provided by the supplier, is necessary for producing his Chemical Safety Report, the downstream user shall gather this information.
Pri zgoraj navedenem evidentiranju se obravnavajo vse nanooblike, ki so zajete z njegovimi lastnimi uporabami ali njegovimi opredeljenimi uporabami v nadaljevanju dobavne verige.
Commission Implementing Regulation (EU) 2018/1882
Izvedbena uredba Komisije (EU) 2018/1882
on the application of certain disease prevention and control rules to categories of listed diseases and establishing a list of species and groups of species posing a considerable risk for the spread of those listed diseases
o uporabi nekaterih pravil za preprečevanje in obvladovanje bolezni za kategorije bolezni s seznama ter o oblikovanju seznama vrst in skupin vrst, ki predstavljajo znatno tveganje za širjenje navedenih bolezni s seznama
Having regard to Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (‘Animal Health Law’), and in particular Articles 8(2) and 9(2) thereof,
ob upoštevanju Uredbe (EU) 2016/429 Evropskega parlamenta in Sveta z dne 9. marca 2016 o prenosljivih boleznih živali in o spremembi ter razveljavitvi določenih aktov na področju zdravja živali („Pravila o zdravju živali“) ter zlasti člena 8(2) in člena 9(2) Uredbe,
Regulation (EU) 2016/429 lays down rules for the prevention and control of diseases which are transmissible to animals or humans, including rules for the prioritisation and categorisation of listed diseases that are of concern at Union level.
Uredba (EU) 2016/429 določa pravila za preprečevanje in obvladovanje bolezni, ki se prenašajo na živali ali na ljudi, vključno s pravili za določitev prednostnega seznama bolezni, ki zadevajo Unijo, in njihovo razvrščanje.
Article 5 of Regulation (EU) 2016/429 provides that disease-specific rules for the prevention and control of diseases apply to the listed diseases, as referred to in that Article and in Annex II to that Regulation.
Člen 5 Uredbe (EU) 2016/429 določa, da se posebna pravila za preprečevanje in obvladovanje posameznih bolezni uporabljajo za bolezni s seznama iz navedenega člena in Priloge II k navedeni uredbi.
Annex II to Regulation (EU) 2016/429 was amended by Commission Delegated Regulation (EU) 2018/1629, and those amendments apply from 21 April 2021.
Priloga II k Uredbi (EU) 2016/429 je bila spremenjena z Delegirano uredbo Komisije (EU) 2018/1629, navedene spremembe pa se uporabljajo od 21. aprila 2021.
Rules for the prevention and control of listed diseases should only apply to species and groups of species which can transmit such listed diseases, by virtue of either being susceptible to them or by acting as vectors.
Pravila za preprečevanje in obvladovanje bolezni s seznama bi bilo treba uporabljati samo za vrste in skupine vrst, ki lahko prenašajo te bolezni s seznama, ker so dovzetne zanje ali delujejo kot njihovi vektorji.
Listed diseases require different types of management measures, as set out in the disease prevention and control rules provided for in Article 9 of Regulation (EU) 2016/429, and having regard to the potential seriousness of their impact on public or animal health, the economy, society or on the environment.
Za bolezni s seznama so potrebne različne vrste ukrepov za upravljanje, kot so določeni v pravilih za preprečevanje in obvladovanje bolezni iz člena 9 Uredbe (EU) 2016/429 in pri katerih se upošteva morebitna resnost njihovega vpliva na javno zdravje ali zdravje živali, gospodarstvo, družbo ali okolje.
Those measures range from basic responsibilities and obligations, such as reporting and the notification of the occurrence or suspicion of a listed disease and eradication programmes, to in–depth Union–wide disease-specific surveillance and eradication measures, as well as measures related to the movement of animals and products of animal origin in the Union and their entry into the Union.
Navedeni ukrepi zajemajo tako osnovne odgovornosti in obveznosti, kot so poročanje in obveščanje o pojavu ali sumu bolezni s seznama ter programi izkoreninjenja bolezni, kot tudi podrobne ukrepe za spremljanje in izkoreninjenje posameznih bolezni za celotno Unijo ter ukrepe v zvezi s premiki živali in proizvodov živalskega izvora v Uniji ter njihovim vstopom v Unijo.
Certain criteria are laid down in Articles 8(2) and (3) and 9(1) and (2) of Regulation (EU) 2016/429 and in Annex IV thereto, for the purpose of listing specific species or groups of species subject to the disease prevention and control rules laid down in that Regulation, as well as the methods of applying the disease prevention and control rules to the listed diseases.
Nekatera merila so določena v členu 8(2) in (3) ter členu 9(1) in (2) Uredbe (EU) 2016/429 ter v Prilogi IV k Uredbi, in sicer za uvrstitev določenih vrst ali skupin vrst, za katere veljajo pravila za preprečevanje in obvladovanje bolezni iz navedene uredbe, na seznam ter za metode uporabe pravil za preprečevanje in obvladovanje bolezni za bolezni s seznama.
The Commission, with the assistance of the European Food Safety Authority (EFSA) and with the benefit of scientific knowledge provided by the EU Animal Health Reference Laboratories, carried out a systematic assessment of listed diseases which require Union intervention.
Komisija je s pomočjo Evropske agencije za varnost hrane (EFSA) in ob upoštevanju znanstvenih spoznanj, ki so jih zagotovili referenčni laboratoriji EU za zdravje živali, izvedla sistematično oceno bolezni s seznama, za katere je potrebno posredovanje Unije.
It also took into account available information from the World Organisation for Animal Health.
Upoštevala je tudi razpoložljive informacije Svetovne organizacije za zdravje živali.
The systematic assessment by the Commission also took into account various factors, such as the species susceptible to certain listed diseases, disease reservoirs and disease vectors, and whether or not the listed disease is currently present in the Union, and how the listed disease is transmitted between animals, and from animals to humans, and its potential impact on animal and human health, including its morbidity and mortality rates.
Pri sistematični oceni Komisije so se upoštevali tudi različni dejavniki, kot so vrste, dovzetne za določene bolezni s seznama, rezervoarji in vektorji bolezni, dejstvo, ali je bolezen s seznama trenutno prisotna v Uniji ali ne, način prenosa bolezni s seznama med živalmi in z živali na ljudi ter njen morebitni vpliv na zdravje živali in ljudi, vključno s stopnjo obolevnosti in umrljivosti.
The systematic assessment also considered the wider impact of these listed diseases, such as their impact on the economy, society, animal welfare, the environment and biodiversity.
Pri sistematični oceni se je upošteval tudi širši vpliv teh bolezni s seznama, na primer na gospodarstvo, družbo, dobrobit živali, okolje in biotsko raznovrstnost.
For the purposes of the systematic assessment, EFSA delivered scientific opinions on infection with Brucella abortus, B. melitensis and B. suis, infection with Mycobacterium tuberculosis complex (M. bovis, M. caprae and M. tuberculosis), infection with bluetongue virus (serotypes 1-24), anthrax, surra (Trypanosoma evansi), Ebola virus disease, paratuberculosis, Japanese encephalitis, West Nile fever, infection with Mycoplasma mycoides subsp. mycoides SC (Contagious bovine pleuropneumonia), infectious bovine rhinotracheitis/infectious pustular vulvovaginitis, bovine viral diarrhoea, bovine genital campylobacteriosis, trichomonosis, enzootic bovine leukosis, contagious caprine pleuropneumonia, ovine epididymitis (Brucella ovis), Venezuelan equine encephalomyelitis, equine encephalomyelitis (Eastern and Western), infection with Aujeszky's disease virus, infection with porcine reproductive and respiratory syndrome virus, avian mycoplasmosis (Mycoplasma gallisepticum and M. meleagridis), infection with Salmonella Pullorum, S. Gallinarum and S. arizonae, infection with low pathogenic avian influenza viruses, infestation with Varroa spp.
Za namene sistematične ocene je EFSA pripravila znanstvena mnenja o okužbi z Brucella abortus, B. melitensis in B. suis, okužbi s kompleksom Mycobacterium tuberculosis (M. bovis, M. caprae in M. tuberculosis), okužbi z virusom modrikastega jezika (serotipi 1–24), vraničnem prisadu, tripanosomiazi (Trypanosoma evansi), eboli, paratuberkulozi, japonskem encefalitisu, mrzlici Zahodnega Nila, okužbi z Mycoplasma mycoides subsp. mycoides SC (pljučno kugo govedi), infekcioznem bovinem rinotraheitisu/infekcioznem pustularnem vulvovaginitisu, goveji virusni diareji, goveji genitalni kampilobakteriozi, trihomonozi, enzootski goveji levkozi, nalezljivi plevropnevmoniji koz, ovčjem epididimitisu (Brucella ovis), venezuelskem encefalomielitisu enoprstih kopitarjev, encefalitisu enoprstih kopitarjev (vzhodnem in zahodnem), okužbi z virusom bolezni Aujeszkega, okužbi z virusom prašičjega reprodukcijskega in respiratornega sindroma, aviarni mikoplazmozi (Mycoplasma gallisepticum in M. meleagridis), okužbi s Salmonella pullorum, S. gallinarum in S. arizonae, okužbi z virusi nizkopatogene aviarne influence, infestaciji z Varroa spp.
(Varroosis), infection with Batrachochytrium salamandrivorans and Koi herpes virus disease in accordance with Article 8(3) of the Regulation (EU) 2016/429 and Annex IV thereto, and it followed the method set out in its Scientific Opinion, adopted on 5 April 2017, on an ad hoc method for the assessment on listing and categorisation of animal diseases within the framework of the Animal Health Law.
(varoozo), okužbi z Batrachochytrium salamandrivorans in bolezni koi herpes virusa v skladu s členom 8(3) Uredbe (EU) 2016/429 in Prilogo IV k Uredbi, pri čemer je sledila metodi iz znanstvenega mnenja, ki ga je sprejela 5. aprila 2017, in ad hoc metodi za oceno uvrstitve bolezni živali na seznam in njihovega razvrščanja v okviru pravil o zdravju živali.
As Regulation (EU) 2016/429 applies from 21 April 2021, the measures provided for in this Regulation should also apply from that date.
Ker se Uredba (EU) 2016/429 uporablja od 21. aprila 2021, bi bilo treba ukrepe iz te uredbe prav tako uporabljati od navedenega datuma.