natgillin/translations-raw huggingface dataset:
amending Regulation (EU) No 206/2010 as regards the entry for the United States in the list of third countries, territories or parts thereof authorised for the introduction of live ungulates into the Union, the model veterinary certificate ‘POR-X’ and the protocols for testing for vesicular stomatitis
o spremembi Uredbe (EU) št. 206/2010 glede vnosa za Združene države na seznam tretjih držav, njihovih ozemelj ali delov, iz katerih se odobri vnos živih kopitarjev v Unijo, glede vzorca veterinarskega spričevala „POR-X“ in protokolov testiranja za prisotnost vezikularnega stomatitisa
Having regard to Council Directive 2004/68/EC of 26 April 2004 laying down animal health rules for the importation into and transit through the Community of certain live ungulate animals, amending Directives 90/426/EEC and 92/65/EEC and repealing Directive 72/462/EEC [1], and in particular the first and second subparagraphs of Article 3(1), the first subparagraph of Article 6(1), Article 7(e), Article 9 and Article 13(1)(e) thereof,
ob upoštevanju Direktive Sveta 2004/68/ES z dne 26. aprila 2004 o določitvi predpisov v zvezi z zdravstvenim varstvom živali za uvoz v Skupnost in tranzit skozi Skupnost nekaterih živih parkljarjev, o spremembi direktiv 90/426/EGS in 92/65/EGS ter razveljavitvi Direktive 72/462/EGS [1], zlasti prvega in drugega pododstavka člena 3(1), prvega pododstavka člena 6(1), člena 7(e), člena 9 in člena 13(1)(e) Direktive,
Directive 2004/68/EC lays down the animal health requirements for the importation into and transit through the Union of certain live ungulates.
Direktiva 2004/68/ES določa zahteve glede zdravstvenega varstva živali za uvoz v Unijo in tranzit skozi Unijo nekaterih živih kopitarjev.
It provides that specific provisions, including model veterinary certificates, may be laid down for the import into the Union of live ungulates of the species listed in Annex I thereto from authorised third countries.
Določa, da se lahko določijo posebne določbe, vključno z vzorci veterinarskih spričeval, za uvoz v Unijo vrst živih kopitarjev, navedenih v Prilogi I k Direktivi, iz odobrenih tretjih držav.
Commission Regulation (EU) No 206/2010 of 12 March 2010 laying down lists of third countries, territories or parts thereof authorised for the introduction into the European Union of certain animals and fresh meat and the veterinary certification requirements [2] lays down amongst others the veterinary certification requirements for the introduction into the Union of certain consignments of live cloven-hoofed animals of the species listed in Annex I to Directive 2004/68/EC.
Uredba Komisije (EU) št. 206/2010 z dne 12. marca 2010 o seznamih tretjih držav, njihovih ozemelj ali delov, iz katerih se odobri vnos nekaterih živali in svežega mesa v Evropsko unijo, ter o zahtevah za izdajo veterinarskih spričeval [2] med drugim določa zahteve za izdajo veterinarskih spričeval za vnos v Unijo nekaterih pošiljk vrst živih parkljarjev, ki so navedene v Prilogi I k Direktivi 2004/68/ES.
Annex I to Regulation (EU) No 206/2010 sets out a list of third countries, territories or parts thereof from which such consignments may be introduced into the Union.
Priloga I k Uredbi (EU) št. 206/2010 določa seznam tretjih držav, njihovih ozemelj ali delov, iz katerih se lahko take pošiljke vnašajo v Unijo.
It also provides models of veterinary certificates to accompany those consignments.
Določa tudi vzorce veterinarskih spričeval, ki spremljajo navedene pošiljke.
Currently, ungulates can only be imported into the Union from third countries, or in case of regionalisation parts of third countries, that are free of vesicular stomatitis for at least six months prior to dispatch of the animals.
Trenutno je uvoz kopitarjev v Unijo dovoljen le iz tretjih držav ali, v primeru regionalizacije, iz delov tretjih držav, ki so prosti vezikularnega stomatitisa vsaj šest mesecev pred odpremo živali.
The United States requested to be authorised for imports into the Union of live pigs for breeding and production.
Združene države so zaprosile za dovoljenje za uvoz v Unijo živih prašičev za vzrejo in proizvodnjo.
Outbreaks of vesicular stomatitis have been notified by the United States.
Združene države so EU obvestile o izbruhih vezikularnega stomatitisa.
However those outbreaks are sporadic and limited to certain areas.
Vendar pa so navedeni izbruhi občasni in omejeni na nekatera področja.
The risk of introduction into the Union of vesicular stomatitis via imports of live pigs from that third country is negligible, if the biosecurity measures which are described in Chapter 8.15.6 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE) are applied including confinement of the pigs during the pre-export residence period in premises free of the disease, vector protection during pre-export quarantine and transport to the place of loading and testing of all animals to be exported.
Tveganje za vnos vezikularnega stomatitisa v Unijo z uvozom živih prašičev iz navedene tretje države je zanemarljiv, če se izvajajo ukrepi za biološko varnost, opisani v poglavju 8.15.6 Zoosanitarnega kodeksa za kopenske živali Mednarodne organizacije za zdravje živali (OIE), vključno z osamitvijo prašičev v obdobju njihovega bivanja v prostorih, prostih bolezni, pred izvozom, zaščito pred vektorji v obdobju karantene pred izvozom ter prevozom do kraja natovarjanja in testiranja vseh živali za izvoz.
Part 1 of Annex I to Regulation (EU) No 206/2010 should therefore be amended to add the United States to the list of third countries, territories or parts thereof from which consignments of live ungulates may be introduced into the Union indicating the appropriate guarantees as regards testing for vesicular stomatitis.
Del 1 Priloge I k Uredbi (EU) št. 206/2010 bi bilo zato treba spremeniti, da se na seznam tretjih držav, njihovih ozemelj ali delov, iz katerih je dovoljen vnos pošiljk živih kopitarjev v Unijo, dodajo Združene države z ustreznimi jamstvi glede testov za prisotnost vezikularnega stomatitisa.
The implementation of those guarantees should be confirmed in the veterinary certificate for live pigs for breeding and production accompanying the animals at the time of introduction into the Union.
Izvajanje teh jamstev bi bilo treba potrditi v veterinarskem spričevalu za žive prašiče za vzrejo in proizvodnjo, ki spremlja živali ob vstopu v Unijo.
The model veterinary certificate for the import of live domestic porcine animals, ‘POR-X’, set out in Part 2 of Annex I to Regulation (EU) No 206/2010, should therefore be amended accordingly to introduce the conditions for pre-export residence and quarantine as well as the laboratory test requirements.
Vzorec veterinarskega spričevala za uvoz živih domačih prašičev „POR-X“ iz dela 2 Priloge I k Uredbi (EU) št. 206/2010 bi bilo zato treba ustrezno spremeniti, da se uvedejo pogoji glede bivanja in karantene pred izvozom ter zahteve za laboratorijske teste.
In addition, Article 5 of Regulation (EU) No 206/2010 provides that where sampling and testing is required by the veterinary certificates set out in Annex I to that Regulation, they are to be carried out in conformity with the protocols for the standardisation of materials and testing procedures set out in Part 6 of that Annex.
Poleg tega člen 5 Uredbe (EU) št. 206/2010 določa, da se vzorčenje in testiranje, če sta potrebna v skladu z veterinarskimi spričevali iz Priloge I k navedeni uredbi, izvajata v skladu s protokoli za standardizacijo snovi in postopki testiranja iz dela 6 navedene priloge.
It is therefore necessary to amend Part 6 of Annex I to Regulation (EU) No 206/2010 in order to add the relevant protocol and testing procedure for vesicular stomatitis.
Zato je treba del 6 Priloge I k Uredbi (EU) št. 206/2010 spremeniti, da se doda zadevni protokol in postopek testiranja za prisotnost vezikularnega stomatitisa.
The test should be carried out and interpreted in accordance with the protocols for serological tests for vesicular stomatitis prescribed for international trade in Chapter 2.1.19 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
Test bi bilo treba izvesti in rezultate razlagati v skladu s protokoli za serološke teste za vezikularni stomatitis, ki so določeni za mednarodno trgovino v poglavju 2.1.19 Priročnika diagnostičnih testov in cepiv za kopenske živali OIE.
Annex I to Regulation (EU) No 206/2010 is amended in accordance with the Annex to this Regulation.
Priloga I k Uredbi (EU) št. 206/2010 se spremeni v skladu s Prilogo k tej uredbi.
in Part 1, the following entry for the United States is added:
v del 1 se doda naslednji vnos za Združene države:
‘US – United States
„US – Združene države
the text concerning ‘POR-X’ is replaced by the following:
besedilo, ki se nanaša na „POR-X“, se nadomesti z naslednjim:
Model of veterinary certificate for domestic porcine animals (Sus scrofa) intended for breeding and/or production after importation or intended for transit through the Union from one third country to another third country.’
vzorec veterinarskega spričevala za domače prašiče (Sus scrofa), namenjene za vzrejo in/ali proizvodnjo po uvozu ali namenjene za tranzit skozi Unijo iz ene tretje države v drugo tretjo državo.“
in the list of SG (Supplementary guarantees), the following text is added:
na seznam PJ (Posebna jamstva) se doda naslednje besedilo:
guarantees regarding vesicular stomatitis test on animals certified according to the model of veterinary certificate POR-X (point II.2.1(b)).’
jamstva glede testa za prisotnost vezikularnega stomatitisa pri živalih, certificiranega v skladu z vzorcem veterinarskega spričevala POR-X (točka II.2.1(b)).“
the model veterinary certificate ‘POR-X’ is replaced by the following:
vzorec veterinarskega spričevala „POR-X“ se nadomesti z naslednjim:
‘Model POR-X
„Vzorec POR-X
oestrogenic, androgenic, gestagenic or β-agonist substances for purposes other than therapeutic or zootechnic treatment (as defined in Directive 96/22/EC).
estrogenih, androgenih, gestagenih snovi ali beta-agonistov za druge namene, razen v terapevtske ali zootehnične namene (kakor je opredeljeno v Direktivi 96/22/ES).
they come from the territory with code: … (1) which, at the date of issuing this certificate:
prihajajo z ozemlja z oznako: … (1) ki je na dan izdaje tega spričevala:
either [(a) has been free for 24 months from foot-and-mouth disease, for 12 months from rinderpest, African swine fever, classical swine fever, swine vesicular disease and vesicular exanthema, and]
bodisi [(a) zadnjih 24 mesecev prosto slinavke in parkljevke, 12 mesecev goveje kuge, afriške prašičje kuge, klasične prašičje kuge, vezikularne bolezni prašičev in vezikularnega eksantema in]
or [(a) (i) has been free [for 24 months from foot-and-mouth disease] (2), for 12 months from rinderpest, African swine fever, vesicular exanthema, [classical swine fever] (2) and [swine vesicular disease] (2), and
ali [(a) (i) [24 mesecev] prosto [slinavke in parkljevke] (2), 12 mesecev goveje kuge, afriške prašičje kuge, vezikularnega eksantema, [klasične prašičje kuge] (2)in [vezikularne bolezni prašičev] (2), in
has been considered free from [foot-and-mouth disease] (2), [classical swine fever] (2) and [swine vesicular disease] (2), since … (dd/mm/yyyy), without having had cases/outbreaks from that date, and authorised to export these animals by Commission Regulation (EU) No …/… of … (dd/mm/yyyy), and]
se šteje, da je prosto [slinavke in parkljevke] (2),[klasične prašičje kuge] (2)in [vezikularne bolezni prašičev] (2), od … (dd/mm/llll), brez primerov/izbruhov po navedenem datumu, ter ima dovoljenje za izvoz teh živali na podlagi Uredbe Komisije EU št. …/… z dne … (dd/mm/llll) in]
either [(b) for 6 months from vesicular stomatitis, and]
bodisi [(b) 6 mesecev prosto vezikularnega stomatitisa in]
or [(b) the animals have been kept for the 21 days, or since birth if younger than 21 days of age, prior to entering the pre-export quarantine in a holding in which no case of vesicular stomatitis was officially reported during that period and during the pre-export quarantine of not less than 30 days prior to shipment in a quarantine station protected from vector insects where they were subjected with negative results at a serum dilution of 1 in 32 to a virus neutralisation test for vesicular stomatitis carried out as referred to in Part 6 of Annex I to Regulation (EU) No 206/2010 on samples taken at least 21 days after commencement of the quarantine; and]
ali [(b) so živali 21 dni ali, če so mlajše od 21 dni, od rojstva pred vstopom v predizvozno karanteno bivale na gospodarstvu, na katerem ni bil uradno prijavljen noben primer vezikularnega stomatitisa v tem obdobju in v obdobju vsaj 30-dnevne predizvozne karantene pred odpremo, in sicer v karantenski postaji, zaščiteni pred vektorskimi insekti, kjer je bil na vzorcih teh živali, odvzetih vsaj 21 dni po začetku karantene, izveden test nevtralizacije virusa za ugotavljanje vezikularnega stomatitisa z negativnim rezultatom pri razredčitvi seruma 1 : 32 v skladu z delom 6 Priloge I k Uredbi (EU) št. 206/2010; in]
they have remained in the territory described under point II.2.1 since birth, or for at least the last six months before dispatch to the Union and without contact with imported cloven-hoofed animals for the last 30 days;
so bivale na ozemlju, opisanem v točki II.2.1, od rojstva ali vsaj zadnjih šest mesecev pred odpremo v Unijo in v zadnjih 30 dneh niso bile v stiku z uvoženimi parkljarji;
A they are not animals to be killed under a national programme for the eradication of diseases, nor have they been vaccinated against the diseases referred to in point II.2.1;
A navedene živali niso namenjene za usmrtitev po nacionalnem programu za izkoreninjenje bolezni in niso bile cepljene proti boleznim iz točke II.2.1;
B they have been subjected within the past 30 days to a test for swine vesicular disease antibodies and a test for classical swine fever antibodies with negative results in both cases;]
B so bile v zadnjih 30 dneh pregledane s testom za ugotavljanje protiteles proti vezikularni bolezni prašičev in s testom za ugotavljanje protiteles proti klasični prašičji kugi, v obeh primerih z negativnimi rezultati;]
C they have been subjected within the past 30 days to a buffered Brucella antigen test for porcine brucellosis with negative results;]
C so bile v zadnjih 30 dneh pregledane s testom s puferiranim antigenom za dokazovanje bruceloze pri prašičih z negativnimi rezultati;]
they come from herds which are not restricted under the national brucellosis eradication programme;
prihajajo iz čred, za katere ne veljajo omejitve po nacionalnem programu za izkoreninjenje bruceloze;
or [to the officially authorised assembly centre described under box reference I.13 situated within the territory described under point II.2.1,]
ali [v uradno priznani zbirni center iz rubrike I.13, ki je na ozemlju, opisanem v točki II.2.1,]
they were not at any place where, or around which within a 10 km radius, during the previous 40 days there has been a case/outbreak of any of the diseases referred to in point II.2.1, and
niso bile v nobenem kraju ali v njegovi okolici na območju s polmerom 10 km od kraja, v katerem je bil v zadnjih 40 dneh ugotovljen primer/izbruh katere koli bolezni iz točke II.2.1, in
in the case the country has not been free for 6 months of vesicular stomatitis, they were transported to the place of loading protected from vector insects;
če država ni bila prosta 6 mesecev vezikularnega stomatitisa, so bile v kraj natovarjanja pripeljane zaščitene pred vektorskimi insekti;
they have been loaded for dispatch to the Union on … (dd/mm/yyyy) (5) in the means of transport described under box reference I.15 that were cleaned and disinfected before loading with an officially authorised disinfectant and so constructed that faeces, urine, litter or fodder could not flow or fall out of the vehicle or container during transportation.
so bile natovorjene za odpremo v Unijo dne … (dd/mm/llll)( (5) na prevozno sredstvo, opisano v rubriki I.15, pred natovarjanjem očiščeno in razkuženo z uradno odobrenim razkužilom, in konstruirano tako, da onemogoča iztekanje ali izpadanje fekalij, urina, nastilja ali krme iz vozila ali kontejnerja med prevozom.
according to official information, no clinical, pathological or serological evidence of Aujeszky’s disease has been recorded for the last 12 months in the holding(s) of origin referred to in box reference I.11., and in those holdings situated in its vicinity within 5 km;
v skladu z uradnimi podatki niso bili evidentirani nobeni klinični, patološki ali serološki dokazi o prisotnosti bolezni Aujeszkega v zadnjih 12 mesecih na gospodarstvih izvora iz rubrike I.11 ter na gospodarstvih v okolici do 5 km;
prior to dispatch for exportation, have remained since birth in the holding(s) of origin referred to in box reference I.11. or they have remained in this(ese) holdings(s) for the last 3 months and in others of equivalent status since birth,
so pred odpremo za izvoz od rojstva bivale na gospodarstvih izvora, navedenih v rubriki I.11, ali so bivale na teh gospodarstvih zadnje 3 mesece ali od rojstva na drugih gospodarstvih z enakovrednim zdravstvenim statusom;
have been isolated in accommodation approved by the competent authority for the last 30 days immediately prior to dispatch for export, without direct or indirect contact with other Suidae animals,
so bile izolirane v nastanitvenih prostorih, ki jih je odobril pristojni organ, v zadnjih 30 dneh neposredno pred odpremo za izvoz in niso bile v neposrednem ali posrednem stiku z drugimi živalmi iz družine prašičev (Suidae);
have been subjected to an ELISA test for the presence of Ig (7) on sera taken at least 21 days after entry into isolation, with negative results; and, all animals in isolation have also given negative results to this test, and
so bile pregledane s testom ELISA za ugotavljanje prisotnosti Ig (7) na serumih, odvzetih vsaj 21 dni po namestitvi v prostorih za izolacijo, z negativnimi rezultati, vse živali v prostoru za izolacijo pa so negativno reagirale na ta test, ter
(further requirements and/or tests) …]
(dodatni pogoji in/ali testi) …]
After importation the animals must be conveyed without delay to the holding of destination where they shall remain for a minimum period of 30 days before further movement outside the holding, except in the case of animals dispatched directly to a slaughterhouse or of animals transiting the Union from one third country to another third country.
Po uvozu je treba živali nemudoma prepeljati na namembno gospodarstvo, na katerem morajo bivati vsaj 30 dni pred nadaljnjimi premiki z omenjenega gospodarstva, razen v primeru neposredne odpreme v klavnico ali v primeru tranzita živali skozi Unijo iz ene tretje države v drugo tretjo državo.
Box reference I.8: Provide the code of territory as appearing in Part 1 of Annex I to Regulation (EU) No 206/2010.
Rubrika I.8: Navesti oznako ozemlja, kakor je navedena v delu 1 Priloge I k Uredbi (EU) št. 206/2010.
Box reference I.13: The assembly centre, if any, must fulfil the conditions for its approval, as laid down in Part 5 of Annex I to Regulation (EU) No 206/2010.
Rubrika I.13: Če obstaja zbirni center, mora izpolnjevati pogoje za dovoljenje, kot je navedeno v delu 5 Priloge I k Uredbi (EU) št. 206/2010.
Box reference I.15: Registration number (railway wagons or container and lorries), flight number (aircraft) or name (ship) is to be provided.
Rubrika I.15: Navesti registrsko številko (železniških vagonov ali kontejnerjev in tovornjakov), številko leta (letala) ali ime (ladje).
Box reference I.23: For containers or boxes, the container number and the seal number (if applicable) should be included.
Rubrika I.23: Za kontejnerje ali škatle navesti številko kontejnerja in številko zalivke (če je primerno).
Box reference I.28.: Identification system: the animals must bear:
Rubrika I.28: Sistem identifikacije: živali morajo imeti:
Box reference I.28: Age: months.
Rubrika I.28: Starost: v mesecih.
Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘B’.
Navesti posebna jamstva, če so zahtevana v stolpcu 5 ,PJ‘ dela 1 Priloge I k Uredbi (EU) št. 206/2010, z vnosom ‚B‘.
Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘C’.
Navesti posebna jamstva, če so zahtevana v stolpcu 5 ,PJ‘ dela 1 Priloge I k Uredbi (EU) št. 206/2010, z vnosom ‚C‘.
When required by the EU Member State of destination or Switzerland, in accordance with Decision 2008/185/EC and the Agreement between the Community and the Swiss Confederation on trade in agricultural products (OJ L 114, 30.4.2002, p. 132) except for those countries with ‘IX’ in column 6 ‘Specific conditions’ of Part 1 of Annex I to Regulation (EU) No 206/2010.
Če to zahteva namembna država članica EU ali Švica v skladu z Odločbo 2008/185/ES in v skladu s Sporazumom med Skupnostjo in Švicarsko konfederacijo o trgovini s kmetijskimi proizvodi (UL L 114, 30.4.2002, str. 132), razen za države z vnosom ‚IX‘ v stolpcu 6 ‚Posebni pogoji‘ dela 1 Priloge I k Uredbi (EU) št. 206/2010.
Supplementary guarantees to be provided when required in column 5 ‘SG’ of Part 1 of Annex I to Regulation (EU) No 206/2010, with the entry ‘D’.
Navesti posebna jamstva, če so zahtevana v stolpcu 5 ,PJ‘ dela 1 Priloge I k Uredbi (EU) št. 206/2010, z vnosom ‚D‘.
in Part 6, the following text is added:
v del 6 se doda naslednji vnos:
‘Vesicular stomatitis (VS)
„Vezikularni stomatitis (VS)
The virus neutralisation (VN) test shall be carried out in accordance with the testing protocols for vesicular stomatitis set out in Chapter 2.1.19 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.
Test za nevtralizacijo virusa se izvaja v skladu s protokoli testiranja na prisotnost vezikularnega stomatitisa iz poglavja 2.1.19 Priročnika diagnostičnih testov in cepiv za kopenske živali OIE.
Sera that prevent cytopathic effect (CPE) at dilutions of 1 in 32 or greater shall be considered to contain antibodies to the vesicular stomatitis virus.’
Za serume, ki preprečujejo citopatski učinek (CPE) v razredčitvah 1: 32 ali več, se šteje, da vsebujejo protitelesa proti virusu vezikularnega stomatitisa.“
Commission Implementing Regulation (EU) No 103/2013
Izvedbena uredba Komisije (EU) št. 103/2013
amending Regulation (EC) No 786/2007 as regards the name of the holder of the authorisation of a preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell)
o spremembi Uredbe (ES) št. 786/2007 glede imena imetnika dovoljenja za pripravek endo-1,4-beta-mananaze ES 3.2.1.78 (Hemicell)
ChemGen Corp. has submitted an application under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Regulation (EC) No 786/2007 [2] concerning the 10 year authorisation of a preparation of endo-1,4-beta-mannanase EC 3.2.1.78 (Hemicell), belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’.
Družba ChemGen Corp. je v skladu s členom 13(3) Uredbe (ES) št. 1831/2003 vložila vlogo s predlogom za spremembo imena imetnika dovoljenja iz Uredbe Komisije (ES) št. 786/2007 [2] o izdaji dovoljenja za pripravek endo-1,4-beta-mananaze ES 3.2.1.78 (Hemicell), ki spada v kategorijo dodatkov „zootehnični dodatki“ in funkcionalno skupino „pospeševalci prebavljivosti“, za deset let.
The applicant claims that, with effect from 10 February 2012, ChemGen Corp. was acquired by Eli Lilly and Company Ltd which now owns the marketing rights for that additive.
Vlagatelj trdi, da je družba Eli Lilly and Company Ltd z 10. februarjem 2012 pripojila družbo ChemGen Corp. in je zdaj lastnik pravic trženja za navedeni dodatek.
The applicant has submitted relevant data supporting its request.
Vlagatelj je predložil ustrezne podatke, ki podpirajo njegovo zahtevo.
To allow Eli Lilly and Company Ltd to exploit its marketing rights it is necessary to change the terms of the authorisation.
Da bi se družbi Eli Lilly and Company Ltd omogočilo, da izkorišča svoje pravice trženja, je treba spremeniti pogoje dovoljenja.