natgillin/translations-raw huggingface dataset:
Regulation (EC) No 999/2001 lays down rules for the monitoring of transmissible spongiform encephalopathies in bovine, ovine and caprine animals and for eradication measures to be carried out following confirmation of a transmissible spongiform encephalopathy (TSE) in ovine and caprine animals.
Uredba (ES) št. 999/2001 določa predpise za spremljanje transmisivnih spongiformnih encefalopatij pri govedu, ovcah in kozah ter ukrepe za izkoreninjenje bolezni, ki se izvajajo po potrditvi transmisivne spongiformne encefalopatije (TSE) pri ovcah in kozah.
Annex VII to Regulation (EC) No 999/2001 lays down the eradication measures to be carried out following confirmation of an outbreak of TSE in ovine and caprine animals.
Priloga VII k Uredbi (ES) št. 999/2001 določa ukrepe za izkoreninjenje, ki se izvajajo po potrditvi izbruha TSE pri ovcah in kozah.
Although TSE has been known to be present in ovine and caprine animals for over two hundred years, there is no evidence of any relationship between outbreaks of TSE in those animals and outbreaks of TSE in humans.
Čeprav je znano, da je TSE pri ovcah in kozah prisotna že več kot dvesto let, ni dokazov o kakršni koli povezavi med izbruhi TSE pri navedenih živalih in izbruhi TSE pri ljudeh.
Nevertheless, in 2000 the Commission introduced a comprehensive set of measures for the monitoring, prevention, control and eradication of TSE in ovine and caprine animals, on the basis of the limited scientific knowledge available at that time, and in order to ensure that sourcing from ovine and caprine animals’ materials is as safe as possible.
Kljub temu je Komisija leta 2000 uvedla celovit sklop ukrepov za spremljanje, preprečevanje, nadzor in izkoreninjenje TSE pri ovcah in kozah na podlagi takrat razpoložljivih omejenih znanstvenih spoznanj, da se zagotovi čim varnejše pridobivanje iz materialov ovc in koz.
Those measures are aimed at gathering as much data as possible on the prevalence of TSE other than bovine spongiform encephalopathy (BSE) in ovine and caprine animals, and on possible links with BSE and transmissibility to humans.
Cilj navedenih ukrepov je zbrati čim več podatkov o prevalenci TSE, razen goveje spongiformne encefalopatije (BSE), pri ovcah in kozah ter možni povezavi z BSE in prenosljivosti na ljudi.
The measures are also aimed at reducing as much as possible the occurrence of TSE.
Cilj ukrepov je tudi čim bolj zmanjšati pogostost TSE.
The measures include the removal of specified risk materials, an extensive active monitoring programme, measures applicable to flocks infected with TSE and voluntary breeding schemes to increase resistance to TSE in the ovine population.
Ukrepi vključujejo odstranitev snovi s specifičnim tveganjem, obsežen aktivni program spremljanja, ukrepe za črede, okužene s TSE, ter prostovoljne vzrejne programe za povečanje odpornosti na TSE pri ovcah.
Since the introduction of such measures and with the information obtained from active surveillance programmes carried out in the Member States, no epidemiological link has ever been established between TSE, other than BSE, in ovine and caprine animals and TSE in humans.
Od uvedbe takšnih ukrepov in glede na informacije, dobljene v okviru aktivnih nadzornih programov v državah članicah, ni bila ugotovljena nobena epidemiološka povezava med TSE, razen BSE, pri ovcah in kozah ter TSE pri ljudeh.
Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2] provides that in specific circumstances where, following an assessment of available information, the possibility of harmful effects on health is identified but scientific uncertainty persists, provisional risk management measures necessary to ensure a high level of health protection may be adopted, pending further scientific information for a more comprehensive risk assessment.
Člen 7 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [2], določa, da se v nekaterih primerih, kadar je po oceni razpoložljivih informacij ugotovljena možnost neželenih učinkov na zdravje, obstaja pa znanstvena negotovost, lahko sprejmejo začasni ukrepi za obvladovanje tveganja za zagotovitev visoke ravni varovanja zdravja, dokler niso na voljo nadaljnje znanstvene informacije za bolj izčrpno oceno tveganja.
It also stipulates that such measures must be proportionate and no more restrictive of trade than is required to achieve the high level of health protection sought, regard being had to technical and economic feasibility and other factors regarded as legitimate in the matter under consideration.
Prav tako določa, da morajo biti takšni ukrepi v sorazmerju in ne smejo ovirati trgovine bolj, kakor je potrebno za doseganje visoke ravni varovanja zdravja, ob upoštevanju tehnične in gospodarske izvedljivosti in drugih dejavnikov, pomembnih za obravnavano zadevo.
The measures are to be reviewed within a reasonable period of time.
Ukrepi se ponovno pregledajo v primernem roku.
On 8 March 2007 the European Food Safety Authority (EFSA) adopted an opinion on certain aspects related to the risk of TSE in ovine and caprine animals [3].
Evropska agencija za varnost hrane (EFSA) je 8. marca 2007 sprejela mnenje o nekaterih vidikih v zvezi s tveganjem za TSE pri ovcah in kozah [3].
In that opinion, EFSA concluded that ‘there is no evidence for an epidemiological or molecular link between classical and/or atypical scrapie and TSEs in humans.
EFSA v mnenju navaja sklep, da „ni dokazov za epidemiološko ali molekularno povezavo med klasičnim in/ali atipičnim praskavcem in TSE pri ljudeh.
The BSE agent is the only TSE agent identified as zoonotic.
Povzročitelj BSE je edini povzročitelj TSE, opredeljen kot povzročitelj zoonoz.
However, at the current stage of scientific knowledge, neither their diagnostic sensitivity nor their specificity can be assumed to be perfect’.
Vendar pa na trenutni stopnji znanstvenih spoznanj ni mogoče domnevati, da sta njihova diagnostična občutljivost in njihova specifičnost popolni“.
Following that opinion and in the framework of the Communication from the Commission — TSE Road map of 15 July 2005 [4], and in line with the SANCO work programme 2006-07 on TSEs of 21 November 2006 [5], Commission Regulation (EC) No 727/2007 of 26 June 2007 amending Annexes I, III, VII and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies [6] was adopted.
Na podlagi navedenega mnenja in v okviru Sporočila Komisije o časovnem načrtu za TSE z dne 15. julija 2005 [4] in v skladu z delovnim programom SANCO za obdobje 2006–2007 o TSE z dne 21. novembra 2006 [5] je bila sprejeta Uredba Komisije (ES) št. 727/2007 z dne 26. junija 2007 o spremembi prilog I, III, VII in X k Uredbi (ES) št. 999/2001 Evropskega parlamenta in Sveta o določitvi predpisov za preprečevanje, nadzor in izkoreninjenje nekaterih transmisivnih spongiformnih encefalopatij [6].
The amendments made to Regulation (EC) No 999/2001 by Regulation (EC) No 727/2007 were aimed at adjusting the measures initially taken as regards TSE in ovine and caprine animals, to take account of updated scientific evidence.
Cilj sprememb Uredbe (ES) št. 999/2001 z Uredbo (ES) št. 727/2007 je bil prilagoditi ukrepe, prvotno sprejete v zvezi s TSE pri ovcah in kozah, da se upoštevajo posodobljeni znanstveni dokazi.
Regulation (EC) No 999/2001, as amended by Regulation (EC) No 727/2007, therefore discontinued the obligation to cull the entire flock and provided for certain alternative measures to culling in the event of confirmation of an outbreak of TSE in a holding of ovine or caprine animals and where the presence of bovine spongiform encephalopathy (BSE) had been excluded.
Uredba (ES) št. 999/2001, kakor je bila spremenjena z Uredbo (ES) št. 727/2007, je zato ukinila obvezo do izločitve celotne črede in uvedla nekatere alternativne ukrepe za izločitev v primeru potrditve izbruha TSE na kmetijskem gospodarstvu z ovcami in kozami in ob izključitvi goveje spongiformne encefalopatije (BSE).
In particular, taking into account the fact that the sector for ovine and caprine animals is different across the Community, Regulation (EC) No 999/2001, as amended by Regulation (EC) No 727/2007, introduced the possibility for Member States to apply alternative policies, as laid down in Regulation (EC) No 727/2007, depending on the specific characteristics of the sector in each Member State.
Ob upoštevanju dejstva, da se sektor za ovce in koze po vsej Skupnosti razlikuje, je bila z Uredbo (ES) št. 999/2001, kakor je bila spremenjena z Uredbo (ES) št. 727/2007, uvedena možnost za države članice, da uporabijo alternativne politike, kakor je določeno v Uredbi (ES) št. 727/2007, odvisno od posebnih značilnosti sektorjev v vsaki državi članici.
On 17 July 2007, in Case T-257/07, France brought an action against the European Commission before the Court of First Instance of the European Communities, applying for the partial annulment of point 2.3(b)(iii), point 2.3(d) and point 4 of Chapter A of Annex VII to Regulation (EC) No 999/2001, as amended by Regulation (EC) No 727/2007, in particular regarding the measures to be applied to TSE-affected flocks, or alternatively the entire annulment of that Regulation.
Francija je 17. julija 2007 z zadevo T-257/07 na Sodišču prve stopnje Evropskih skupnosti sprožila postopek proti Evropski komisiji, pri čemer je zahtevala delno razveljavitev točke 2.3(b)(iii), točke 2.3(d) in točke 4 poglavja A Priloge VII k Uredbi (ES) št. 999/2001, kakor je bila spremenjena z Uredbo (ES) št. 727/2007, zlasti v zvezi z ukrepi za črede, okužene s TSE, ali namesto tega razveljavitev celotne navedene uredbe.
In its Order of 28 September 2007 [7], the Court suspended the application of those provisions pending delivery of a final judgment.
Sodišče je v Odredbi z dne 28. septembra 2007 [7] začasno odložilo uporabo navedenih določb do izreka končne sodbe.
In the Order of 28 September 2007, the Commission’s assessment of the available scientific data on the possible risks was questioned.
V Odredbi z dne 28. septembra 2007 je bil izražen dvom v oceno Komisije o razpoložljivih znanstvenih podatkih o možnih tveganjih.
Accordingly, the Commission subsequently asked EFSA to assist it in clarifying the two main premises on which Regulation (EC) No 727/2007 was based.
Zato je Komisija naknadno zaprosila EFSA, da ji pomaga pojasniti osnovni načeli, na katerih temelji Uredba (ES) št. 727/2007.
Firstly, the absence of any scientific evidence demonstrating that any TSE agent, other than BSE, may be considered to be a zoonotic agent.
Prvič, odsotnost vsakršnih znanstvenih dokazov o tem, da se povzročitelj TSE, razen BSE, lahko obravnava kot povzročitelj zoonoz.
Secondly, the possibility to distinguish through molecular and biological tests between BSE and other animal TSE in ovine and caprine animals.
Drugič, možnost razločevanja med BSE in drugimi živalskimi oblikami TSE pri ovcah in kozah prek molekularnih in bioloških preskusov.
On 24 January 2008, EFSA adopted the scientific and technical clarification [8], as regards the interpretation of some facets of the conclusions of its Opinion of 8 March 2007, which had been taken into account for the adoption of Regulation (EC) No 727/2007.
EFSA je 24. januarja 2008 sprejela znanstveno in tehnično pojasnilo [8] v zvezi z razlago nekaterih vidikov sklepov iz njenega mnenja z dne 8. marca 2007, ki je bilo upoštevano pri sprejetju Uredbe (ES) št. 727/2007.
As regards the transmissibility of TSE, EFSA confirmed that:
EFSA je v zvezi s prenosljivostjo TSE potrdila:
in ovine animals, no TSE agents other than those causing Classical Scrapie and Atypical Scrapie have been identified,
da pri ovcah niso bili opredeljeni nobeni povzročitelji TSE, razen povzročiteljev klasičnega praskavca in atipičnega praskavca,
in caprine animals, no TSE agents other than those causing BSE, Classical Scrapie and Atypical Scrapie have been identified,
da pri kozah niso bili opredeljeni nobeni povzročitelji TSE, razen povzročiteljev BSE, klasičnega praskavca in atipičnega praskavca,
the operational term ‘BSE’ covers a TSE of bovine animals that could be caused by at least three distinct TSE agents with heterogeneous biological properties,
da operativni termin „BSE“ zajema TSE pri govedu, ki bi jo lahko povzročili vsaj trije različni povzročitelji TSE z raznovrstnimi biološkimi lastnostmi,
the operational term ‘Classical Scrapie’ covers a TSE of ovine and caprine animals caused by several TSE agents with heterogeneous biological properties,
da operativni termin „klasični praskavec“ zajema TSE pri ovcah in kozah, ki jo povzroča več povzročiteljev TSE z raznovrstnimi biološkimi lastnostmi,
the operational term ‘Atypical Scrapie’ covers a TSE of ovine and caprine animals that differs from Classical Scrapie.
operativni termin „atipični praskavec“ zajema TSE pri ovcah in kozah, ki se razlikuje od klasičnega praskavca.
Currently, it is a subject for debate whether it is caused by one or more TSE agents.
Vprašanje, ali jo povzroča eden ali več povzročiteljev TSE, je trenutno predmet razprave.
However, EFSA cannot exclude transmissibility to humans of other TSE agents other than BSE as:
Vendar pa EFSA ne more izključiti prenosljivosti povzročiteljev TSE, razen BSE, na ljudi:
experimental transmissions to primate and to transgenic mouse models expressing the human PrP gene are currently used to evaluate the potential capacity of a TSE agent to cross the human species barrier,
saj se za ovrednotenje možne zmogljivosti povzročitelja TSE, da prestopi mejo človeške vrste, trenutno uporabljajo poskusi prenosljivosti na primate in transgene miši z izraženim človeškim genom za PrP,
TSE agents other than the Classical BSE agent from three field TSE cases (two Classical Scrapie cases and one L type BSE case) have been demonstrated to cross the modelled human species barrier,
saj je bilo v treh primerih TSE na terenu (dva primera klasičnega praskavca in en primer BSE tipa L) dokazano, da so povzročitelji TSE, razen povzročiteljev klasične BSE, prestopili model meje človeške vrste,
some limitations to these models have to be considered, including the uncertainty of how well they represent the human species barrier and the uncertainty of how well the experimental inoculation route employed represents exposure under natural conditions.
saj je treba upoštevati nekatere omejitve za te modele, vključno z negotovostjo o tem, kako dobro predstavljajo mejo človeške vrste, in negotovostjo o tem, kako dobro uporabljena poskusna inokulacija predstavlja izpostavljenost pod naravnimi pogoji.
It appears from EFSA’s clarifications that the biodiversity of the disease agents in ovine and caprine animals is an important element which does not make it possible to exclude transmissibility to humans and that that diversity increases the likelihood of one of the TSE agents being transmissible.
Iz pojasnil EFSA je razvidno, da je biotska raznovrstnost povzročiteljev bolezni pri ovcah in kozah pomemben element, ki ne omogoča izključitve prenosljivosti na ljudi, in da navedena raznovrstnost povečuje verjetnost prenosljivosti enega od povzročiteljev TSE.
However, EFSA acknowledges that there is no scientific evidence of any direct link between TSE in ovine and caprine animals, other than BSE, and TSE in humans.
Vendar EFSA priznava, da ni nobenih znanstvenih dokazov o neposredni povezavi med TSE pri ovcah in kozah, razen BSE, ter TSE pri ljudeh.
The EFSA viewpoint that transmissibility to humans of TSE agents in ovine or caprine animals cannot be excluded is based on experimental studies on human species barrier and animal models (primates and mice).
Stališče EFSA, da prenosljivosti povzročiteljev TSE pri ovcah ali kozah na ljudi ni mogoče izključiti, temelji na poskusnih študijah na modelih meje človeške vrste in na živalih (primatih in miših).
Those models, however, do not take into account genetic characteristics of humans which have a major influence on relative susceptibility to prion diseases.
Vendar navedeni modeli ne upoštevajo genetskih značilnosti ljudi, ki močno vplivajo na relativno občutljivost na prionske bolezni.
They also have limitations when extrapolating results to natural conditions, in particular regarding how well they represent the human species barrier and the uncertainty of how well the experimental inoculation route employed represents exposure under natural conditions.
Ravno tako obstajajo omejitve za te modele pri ekstrapolaciji rezultatov na naravne pogoje, zlasti glede negotovosti o tem, kako dobro predstavljajo mejo človeške vrste, in negotovosti o tem, kako dobro uporabljena poskusna inokulacija predstavlja izpostavljenost pod naravnimi pogoji.
On that basis, it may be considered that although a risk of transmissibility to humans of TSE agents in ovine or caprine animals cannot be excluded, that risk would be extremely low, taking into account the fact that the evidence of transmissibility is based on experimental models which do not represent the natural conditions related to the real human species barrier and the real routes of infection.
Na podlagi tega je mogoče domnevati, da bi bilo tveganje prenosljivosti povzročiteljev TSE pri ovcah ali kozah na ljudi izjemno nizko, čeprav se ga ne da izključiti, ob upoštevanju dejstva, da dokazi o prenosljivosti temeljijo na poskusnih modelih, ki ne predstavljajo naravnih pogojev, povezanih z dejansko mejo človeške vrste in dejanskimi načini okužbe.
As regards the discriminatory tests, EFSA confirmed that:
EFSA je v zvezi z ločevalnimi preskusi potrdila:
based on the limited data available, the discriminatory tests as implemented at European Union level are practicable tools for screening of field TSE cases, as referred to in point 3.2(c) of Chapter C of Annex X to Regulation (EC) No 999/2001, fulfilling the objective of rapid and reproducible identification of TSE cases that have a signature compatible with Classical BSE agent,
da so na podlagi omejenih razpoložljivih podatkov ločevalni preskusi, kakor se izvajajo na ravni Evropske unije, praktična orodja za presejanje terenskih primerov TSE, kot je določeno v točki 3.2(c) Poglavja C Priloge X Uredbe (ES) št. 999/2001, kar izpolnjuje cilj hitrega in ponovljivega opredeljevanja primerov TSE, ki so združljivi s povzročiteljem klasične BSE,
those discriminatory tests cannot be considered to be perfect because of the current lack of understanding of both the true biodiversity of TSE agents in ovine and caprine animals and how the agents interact in case of co-infection.
da se navedeni ločevalni preskusi ne morejo obravnavati kot popolni zaradi trenutnega pomanjkanja razumevanja dejanske biotske raznovrstnosti povzročiteljev TSE pri ovcah in kozah ter načina, kako povzročitelji medsebojno vplivajo v primeru sočasne okužbe.
Following a request by the Commission for clarification as to whether the absence of statistically sufficient data on the performance of the tests is compensated by the procedure in place, which includes a ring trial with additional molecular testing methods in different laboratories and an evaluation by an expert panel chaired by the Community Reference Laboratory for TSEs, EFSA explained that:
Na zahtevo Komisije za pojasnilo, ali pomanjkljivost statističnih podatkov o rezultatih preskusov nadomesti uveden postopek, ki zajema primerjalni test z metodami dodatnih molekularnih preskusov v različnih laboratorijih in ovrednotenje odbora strokovnjakov, ki mu predseduje referenčni laboratorij Skupnosti za TSE, je EFSA razložila:
despite consistent performance in ring trials employing samples from experimental ovine BSE cases, there is uncertainty on about their performance in the field because of the lack of detection of natural BSE in ovine or caprine animals,
da kljub trdnim rezultatom primerjalnih testov, pri katerih se uporabljajo vzorci iz poskusnih primerov BSE pri ovcah, obstaja negotovost o njihovih rezultatih na terenu, ker naravna BSE pri ovcah ali kozah do sedaj še ni bila odkrita,
TSE positive cases go through the full discriminatory process, including bioassay, only when biochemical discriminatory testing is compatible with BSE signature; therefore, data obtained through this process cannot be used for the evaluation of the sensitivity or the specificity of the discriminatory tests,
da se pri pozitivnih primerih TSE izvede celoten ločevalni postopek, vključno z biološkimi poskusi, samo kadar je biokemični ločevalni poskus združljiv s povzročiteljem BSE; zato se podatki, dobljeni med tem postopkom, ne morejo uporabiti za vrednotenje občutljivosti ali specifičnosti ločevalnih preskusov,
increasing the number of negative results during TSE discriminatory testing of ovine or caprine animals cannot compensate for the absence of statistically sufficient data on the performance of the tests.
da povečanje števila negativnih rezultatov med ločevalnimi preskusi za TSE pri ovcah ali kozah ne more nadomestiti pomanjkljivih statističnih podatkov o rezultatih preskusov.
EFSA acknowledged that the discriminatory tests established in Regulation (EC) No 999/2001 are practicable tools fulfilling the objective of rapid and reproducible identification of TSE cases that have a signature compatible with the classical BSE agent.
EFSA je potrdila, da so ločevalni preskusi iz Uredbe (ES) št. 999/2001 praktična orodja, ki izpolnjujejo cilj hitrega in ponovljivega opredeljevanja primerov TSE, ki so združljivi s povzročiteljem klasične BSE.
Given the absence of scientific evidence of co-infection of BSE and other TSE agents in ovine or caprine animals in natural conditions, and given that the prevalence of BSE in ovine, if present, or caprine animals is very low and therefore the possibility of co-infection would be even lower, the number of BSE cases missed in ovine and caprine animals would be extremely low.
Glede na odsotnost znanstvenih dokazov o sočasni okužbi z BSE in drugimi povzročitelji TSE pri ovcah in kozah pod naravnimi pogoji ter glede na to, da je prevalenca BSE pri ovcah, če je prisotna, ali kozah zelo nizka in je zato možnost sočasne okužbe še manjša, je število neodkritih primerov BSE pri ovcah in kozah izjemno nizko.
Therefore, although the discriminatory tests cannot be considered to be perfect, it is appropriate to consider them as a suitable tool for the purposes of the TSE eradication objectives pursued by Regulation (EC) No 999/2001.
Zato je ločevalne preskuse, čeprav jih ni mogoče obravnavati kot popolne, ustrezno obravnavati kot primerna orodja za namene izkoreninjenja TSE, kot je določeno v Uredbi (ES) št. 999/2001.
In its Opinion of 25 January 2007 [9], EFSA gave an estimation of the likely prevalence of BSE in ovine animals.
EFSA je v mnenju z dne 25. januarja 2007 [9] navedla oceno verjetne prevalence BSE pri ovcah.
The Authority concluded that in high-risk countries there is a rate of less than 0,3 to 0,5 cases of BSE per 10000 healthy slaughtered animals.
Agencija je sklepala, da v državah z visokim tveganjem obstaja stopnja, nižja od 0,3 do 0,5 primerov BSE na 10000 zdravih zaklanih živali.
Since the introduction in 2005 of the discriminatory tests procedure, as set out in point 3.2(c) of Chapter C of Annex X to Regulation (EC) No 999/2001, 2798 discriminatory tests have been carried out in TSE-affected ovine animals and 265 discriminatory tests have been carried out in TSE-affected caprine animals and none of them have been confirmed as BSE-like.
Od uvedbe ločevalnih preskusov leta 2005, kakor je določeno v točki 3.2(c) Poglavja C Priloge X k Uredbi (ES) št. 999/2001, je bilo izvedenih 2798 ločevalnih preskusov na ovcah, okuženih s TSE, in 265 ločevalnih preskusov na kozah, okuženih s TSE, za noben primer pa ni bilo potrjeno, da je podoben BSE.
A high level of protection of human life and health is assured in the pursuit of Community policies.
Pri izvajanju politik Skupnosti je treba zagotoviti visoko raven varovanja življenja in zdravja ljudi.