natgillin/translations-raw huggingface dataset:
A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the Agency in accordance with Articles 40 or 41 if the frequency and duration of human exposure indicates that a longer term study is appropriate and one of the following conditions is met:
Bioakumulacija u vodenim vrstama, po mogućnosti ribama
serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study for which the available evidence is inadequate for toxicological evaluation or risk characterisation, or
tvar ima nizak bioakumulacijski potencijal (npr. log Kow ≤ 3) i/ili nizak potencijal prolaska kroz biološke membrane, ili
effects shown in substances with a clear relationship in molecular structure with the substance being studied were not detected in the 28-day or 90-day study, or
nije vjerojatna izravna ili neizravna izloženost vodenog segmenta.
the substance may have a dangerous property that cannot be detected in a 90-day study.
Za nanooblike uporaba bilo kojeg fizikalno-kemijskog svojstva (npr. koeficijent raspodjele oktanol/voda, brzina otapanja, stabilnost disperzije) kao razloga za odustajanje od istraživanja mora uključivati odgovarajuće obrazloženje važnosti tog svojstva za niski potencijal bioakumulacije ili nevjerojatnosti izravne ili neizravne izloženosti vodenog segmenta.
If nanoforms are covered by the registration, physicochemical characteristics, in particular particle size, shape and other morphological parameters, surface functionalisation and surface area, as well as molecular structure shall be taken into consideration when determining if one of the conditions above are met.’;
Dodatne informacije o adsorpciji/desorpciji ovisno o rezultatima istraživanja koje se zahtijeva u Prilogu VIII.
Annex XI to Regulation (EC) No 1907/2006 is amended as follows:
na temelju fizikalno-kemijskih svojstava tvari može se očekivati da tvar ima nizak potencijal adsorpcije (npr. tvar ima nizak koeficijent raspodjele oktanol/voda), ili
In the introductory text, the following text is added after the last paragraph:
tvar i njezini proizvodi razgradnje brzo se raspadaju.
‘The requirements specific to nanoforms in this Annex are without prejudice to requirements applicable to other forms of a substance.’;
Za nanooblike uporaba bilo kojeg fizikalno-kemijskog svojstva (npr. koeficijent raspodjele oktanol/voda, brzina otapanja, stabilnost disperzije) kao razloga za odustajanje od istraživanja mora uključivati odgovarajuće obrazloženje važnosti tog svojstva za niski potencijal adsorpcije.”;
Point 1.1.3. is replaced by the following:
pododjeljak 9.4. zamjenjuje se sljedećim:
‘1.1.3.
Učinci na kopnene organizme ƒ9.4.
Historical human data
Ta istraživanja nije potrebno provoditi ako izravna ili neizravna izloženost segmenta tla nije vjerojatna.
Historical human data, such as epidemiological studies on exposed populations, accidental or occupational exposure data and clinical studies, shall be considered.
Ako podaci o toksičnosti za organizme tla nisu raspoloživi, opasnost za te organizme može se procijeniti metodom ravnotežne raspodjele.
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.
Primjena metode ravnotežne raspodjele na nanooblike mora biti znanstveno opravdana.
Criteria for assessing the adequacy of the data include:
Izbor ispitivanja ovisi o rezultatima procjene kemijske sigurnosti.
the proper selection and characterisation of the exposed and control groups;
Posebno za tvari s visokim potencijalom adsorpcije na tlo ili vrlo postojane tvari podnositelj registracije razmatra mogućnost ispitivanja dugoročne umjesto kratkoročne toksičnosti.”
adequate characterisation of exposure;
7.
sufficient length of follow-up for disease occurrence;
Prilog X. Uredbi (EZ) br. 1907/2006 mijenja se kako slijedi:
valid method for observing an effect;
točka 8.6.3. zamjenjuje se sljedećim:
proper consideration of bias and confounding factors; and
„8.6.3.
a reasonable statistical reliability to justify the conclusion.
Podnositelj registracije može predložiti, a Agencija može u skladu s člankom 40. ili člankom 41. zahtijevati istraživanje dugoročne toksičnosti nakon ponavljane primjene (≥ 12 mjeseci) ako učestalost i trajanje izlaganja ljudi ukazuju na potrebu za dugotrajnijim istraživanjem i ispunjen je jedan od sljedećih uvjeta:
In all cases adequate and reliable documentation shall be provided.
tijekom 28-dnevnog ili 90-dnevnog istraživanja opaženi su posebno zabrinjavajući toksični učinci s ozbiljnim ili teškim posljedicama, a raspoloživi podaci nisu dostatni za toksikološku evaluaciju ili karakterizaciju rizika, ili
When nanoforms are covered by the registration the above approach shall address the nanoforms separately.’;
tijekom 28-dnevnog ili 90-dnevnog istraživanja nisu otkriveni učinci koji se opažaju u tvari koje pokazuje jasnu srodnost u molekularnoj strukturi s tvari koja se istražuje, ili
Subsection 1.2. is replaced by the following:
tvar možda ima opasno svojstvo koje se ne može otkriti 90-dnevnim istraživanjem.
Weight of evidence
Ako su registracijom obuhvaćeni nanooblici, pri utvrđivanju jesu li navedeni uvjeti ispunjeni uzet će se u obzir fizikalno-kemijska svojstva, posebno veličina i oblik čestica te drugi morfološki parametri, površinska funkcionalizacija i površina te molekularna struktura.”
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.
8.
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.
Prilog XI.
Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:
Uredbi (EZ) br. 1907/2006 mijenja se kako slijedi:
further testing on vertebrate animals for that property shall be omitted,
u uvodnom tekstu nakon posljednjeg stavka dodaje se sljedeći tekst:
further testing not involving vertebrate animals may be omitted.
„Zahtjevima u ovom Prilogu koji su specifični za nanooblike ne dovode se u pitanje zahtjevi koji se primjenjuju na druge oblike tvari.”;
Subsection 1.3. is replaced by the following:
točka 1.1.3. zamjenjuje se sljedećim:
Qualitative or Quantitative structure-activity relationship ((Q)SAR)
„1.1.3.
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property.
Postojeći podaci dobiveni na ljudima
Results of (Q)SARs may be used instead of testing when the following conditions are met:
Uzimaju se u obzir postojeći podaci dobiveni na ljudima, kao što su epidemiološke studije o izloženim populacijama, podaci o slučajnoj ili profesionalnoj izloženosti i kliničke studije.
results are derived from a (Q)SAR model whose scientific validity has been established,
Uvjerljivost podataka o određenom učinku na zdravlje ljudi ovisi, između ostalog, o vrsti analize i obuhvaćenim parametrima, o jačini i specifičnosti odgovora te, prema tomu, predvidljivosti učinka.
the substance falls within the applicability domain of the (Q)SAR model,
Prikladnost podataka procjenjuje se na temelju sljedećih kriterija:
results are adequate for the purpose of classification and labelling and/or risk assessment, and
pravilan odabir i karakterizacija izloženih i kontrolnih skupina;
adequate and reliable documentation of the applied method is provided.
prikladna karakterizacija izloženosti;
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.
dovoljno dugo razdoblje praćenja koje omogućuje da se utvrdi moguća pojava bolesti;
The last paragraph in Section 1.4 is replaced by the following:
valjana metoda promatranja učinka;
‘Such confirmation may be waived if the following conditions are met:
uzimanje u obzir pristranosti i zbunjujućih čimbenika; i
results are derived from an in vitro method whose scientific validity has been established by a validation study, according to internationally agreed validation principles;
statistička pouzdanost koja je potrebna da se opravda zaključak.
results are adequate for the purpose of classification and labelling and/or risk assessment; and
U svakom slučaju treba dostaviti prikladnu i pouzdanu dokumentaciju.
When nanoforms are covered by the registration the above approach in points (1) to (3) shall address the nanoforms separately.’;
Ako su registracijom obuhvaćeni nanooblici, navedeni pristup primjenjuje se zasebno na nanooblike.”;
The first paragraph in Section 1.5 is replaced by the following:
pododjeljak 1.2. zamjenjuje se sljedećim:
‘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.
Dokazna snaga
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).
Informacije iz više neovisnih izvora na temelju kojih se može pretpostaviti/zaključiti da tvar ima ili nema određeno opasno svojstvo mogu imati dostatnu dokaznu snagu čak i ako informacije iz svakog od tih izvora zasebno nisu dovoljne da potkrijepe takav zaključak/pretpostavku.
This avoids the need to test every substance for every endpoint.
Informacije na temelju kojih se može zaključiti da tvar ima ili nema određeno opasno svojstvo mogu imati dostatnu dokaznu snagu i ako su dobivene uporabom novih ispitnih metoda koje još nisu uključene u ispitne metode iz članka 13. stavka 3. ili međunarodnom ispitnom metodom koju Komisija odnosno Agencija priznaje kao istovrijednu.
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.
Ako informacije koje ukazuju na prisutnost ili odsutnost određenog opasnog svojstva imaju dostatnu dokaznu snagu:
When nanoforms are covered by the registration the above approach shall address the nanoforms separately.
odustaje se od daljnjih ispitivanja tog svojstva na kralježnjacima,
For grouping different nanoforms of the same substance the molecular structural similarities alone cannot serve as a justification.
može se odustati od daljnjih ispitivanja u kojima ne sudjeluju kralježnjaci.
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.’
pododjeljak 1.3. zamjenjuje se sljedećim:
Annex XII to Regulation (EC) No 1907/2006 is amended as follows:
Kvalitativni ili kvantitativni odnos strukture i djelovanja ((Q)SAR)
The introductory text is replaced by the following:
Rezultati dobiveni iz valjanih modela kvalitativnog ili kvantitativnog odnosa strukture i djelovanja ((Q)SAR) mogu ukazati na prisutnost ili odsutnost određenog opasnog svojstva.
‘INTRODUCTION
Rezultati (Q)SAR-ova mogu se upotrebljavati umjesto ispitivanja ako su ispunjeni sljedeći uvjeti:
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.
rezultati su dobiveni na temelju znanstveno utemeljenog modela (Q)SAR,
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.
tvar spada u područje primjene modela (Q)SAR,
The assessment shall consider the use of the substance on its own, in a mixture or in an article.
rezultati su dostatni za razvrstavanje i označivanje i/ili procjenu rizika, i
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.
dostavljena je prikladna i pouzdana dokumentacija o primijenjenoj metodi.
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.
Agencija u suradnji s Komisijom, državama članicama i zainteresiranim stranama izrađuje i daje smjernice za procjenu (Q)SAR-ova koji ispunjavaju te uvjete i navodi odgovarajuće primjere.
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.
posljednji stavak pododjeljka 1.4. zamjenjuje se sljedećim:
A multiple metric presentation is preferable, ensuring availability of mass metric information.
„Od te se potvrde može odustati ako su ispunjeni sljedeći uvjeti:
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.
rezultati su dobiveni in vitro metodom čija je znanstvena utemeljenost potvrđena validacijskom studijom u skladu s međunarodno dogovorenim načelima validacije;
Deviations from such assessments shall be justified.
rezultati su dostatni za razvrstavanje i označivanje i/ili procjenu rizika; i
‘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.
Agencija nakon savjetovanja s relevantnim dionicima i drugim zainteresiranim stranama na vrijeme izdaje smjernice za tehnički i znanstveno utemeljenu metodologiju grupiranja tvari uzimajući u obzir prvi rok za registraciju tvari u postupnom uvođenju.
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,
uzimajući u obzir Uredbu (EU) 2016/429 Europskog parlamenta i Vijeća od 9. ožujka 2016. o prenosivim bolestima životinja te o izmjeni i stavljanju izvan snage određenih akata u području zdravlja životinja („Zakon o zdravlju životinja”), a posebno njezin članak 8. stavak 2. i članak 9. stavak 2.,
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.
Uredbom (EU) 2016/429 utvrđena su pravila o sprečavanju i suzbijanju bolesti koje su prenosive na životinje ili ljude, uključujući pravila za utvrđivanje prioriteta i kategorizaciju bolesti s popisa koje izazivaju zabrinutost na razini Unije.
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.
Člankom 5.
Annex II to Regulation (EU) 2016/429 was amended by Commission Delegated Regulation (EU) 2018/1629, and those amendments apply from 21 April 2021.
Uredbe (EU) 2016/429 predviđeno je da se na bolesti s popisa navedene u tom članku i u Prilogu II. toj uredbi primjenjuju posebna pravila za sprečavanje i suzbijanje bolesti.
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.
Prilog II.
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.
Uredbi (EU) 2016/429 izmijenjen je Delegiranom uredbom Komisije (EU) 2018/1629, a te se izmjene primjenjuju od 21. travnja 2021.
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.
Pravila za sprečavanje i suzbijanje bolesti s popisa trebala bi se primjenjivati samo na vrste i skupine vrsta koje mogu prenositi takve bolesti s popisa tako što su podložne tim bolestima ili djeluju kao vektori.
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.
Bolesti s popisa zahtijevaju različite vrste mjera upravljanja, kako je utvrđeno u pravilima o sprečavanju i suzbijanju bolesti iz članka 9.
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.
Uredbe (EU) 2016/429, i uzimajući u obzir potencijalnu ozbiljnost njihova utjecaja na javno zdravlje ili zdravlje životinja, gospodarstvo, društvo ili okoliš.
It also took into account available information from the World Organisation for Animal Health.
Te mjere sežu od osnovnih odgovornosti i obveza, kao što su izvješćivanje i obavješćivanje o pojavi ili sumnji na pojavu bolesti s popisa i programi iskorjenjivanja bolesti, do sveobuhvatnih posebnih mjera nadzora i iskorjenjivanja bolesti koje se provode na razini Unije te mjera koje se odnose na kretanje životinja i proizvoda životinjskog podrijetla u Uniji te njihov ulazak u Uniju.
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.
U članku 8. stavcima 2. i 3. i članku 9. stavcima 1. i 2.
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.
Uredbe (EU) 2016/429 i Prilogu IV. toj uredbi utvrđeni su određeni kriteriji za uvrštavanje na popis određenih vrsta ili skupina vrsta na koje se primjenjuju pravila za sprečavanje i suzbijanje bolesti utvrđena u toj uredbi, kao i metoda primjene pravila za sprečavanje i suzbijanje bolesti na bolesti s popisa.
As Regulation (EU) 2016/429 applies from 21 April 2021, the measures provided for in this Regulation should also apply from that date.
U sustavnoj procjeni Komisije u obzir su uzeti i razni čimbenici, kao što su vrste prijemljive na određene bolesti s popisa, izvorišta bolesti i vektori bolesti, je li bolest s popisa trenutačno prisutna u Uniji, kako se bolest s popisa prenosi među životinjama i sa životinja na ljude te njezin potencijalni utjecaj na zdravlje životinja i ljudi, uključujući stope obolijevanja i smrtnosti.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
U sustavnoj je procjeni razmotren i širi utjecaj tih bolesti s popisa na gospodarstvo, društvo, dobrobit životinja, okoliš i bioraznolikost.
HAS ADOPTED THIS REGULATION:
Budući da se Uredba (EU) 2016/429 primjenjuje od 21. travnja 2021., mjere predviđene ovom Uredbom također bi se trebale primjenjivati od tog datuma.
For the purposes of this Regulation, the following definitions apply:
DONIJELA JE OVU UREDBU:
‘category A disease’ : means a listed disease that does not normally occur in the Union and for which immediate eradication measures must be taken as soon as it is detected, as referred to in Article 9(1)(a) of Regulation (EU) 2016/429;
Članak 1.
‘category B disease’ : means a listed disease which must be controlled in all Member States with the goal of eradicating it throughout the Union, as referred to in Article 9(1)(b) of Regulation (EU) 2016/429;
Za potrebe ove Uredbe, primjenjuju se sljedeće definicije:
‘category C disease’ : means a listed disease which is of relevance to some Member States and for which measures are needed to prevent it from spreading to parts of the Union that are officially disease-free or that have eradication programmes for the listed disease concerned, as referred to in Article 9(1)(c) of Regulation (EU) 2016/429;
„bolest kategorije A” : znači bolest s popisa koja se inače ne pojavljuje u Uniji i za koju se moraju poduzeti hitne mjere iskorjenjivanja čim je otkrivena, kako je navedeno u članku 9. stavku 1. točki (a) Uredbe (EU) 2016/429;
‘category D disease’ : means a listed disease for which measures are needed to prevent it from spreading on account of its entry into the Union or movements between Member States, as referred to in Article 9(1)(d) of Regulation (EU) 2016/429;
„bolest kategorije B” : znači bolest s popisa koja se mora suzbijati u svim državama članicama s ciljem njezina iskorjenjivanja diljem Unije, kako je navedeno u članku 9. stavku 1. točki (b) Uredbe (EU) 2016/429;
‘category E disease’ : means a listed disease for which there is a need for surveillance within the Union, as referred to in Article 9(1)(e) of Regulation (EU) 2016/429.
„bolest kategorije C” : znači bolest s popisa koja je relevantna za neke države članice i za koju su potrebne mjere kako bi se spriječilo njezino širenje u dijelove Unije koji su službeno slobodni od bolesti ili u kojima postoje programi iskorjenjivanja dotične bolesti s popisa, kako je navedeno u članku 9. stavku 1. točki (c) Uredbe (EU) 2016/429;
Article 2
„bolest kategorije D” : znači bolest s popisa za koju su potrebne mjere kako bi se spriječilo njezino širenje zbog njezina ulaska u Uniju ili premještanja između država članica, kako je navedeno u članku 9. stavku 1. točki (d) Uredbe (EU) 2016/429;
The disease prevention and control rules for listed diseases referred to in Article 9(1) of Regulation (EU) 2016/429 shall apply to the categories of listed diseases for the listed species and groups of listed species referred to in the table set out in the Annex to this Regulation.
„bolest kategorije E” : znači bolest s popisa koju je unutar Unije potrebno nadzirati, kako je navedeno u članku 9. stavku 1. točki (e) Uredbe (EU) 2016/429.