natgillin/translations-raw huggingface dataset:
The competent authority shall keep approvals of establishments granted in accordance with Articles 97 and 99 under review, at appropriate intervals based on the risk involved.
Kadar pristojni organ ugotovi resne nepravilnosti v obratu glede skladnosti z zahtevami iz člena 97(1) in pravil, sprejetih na podlagi člena 97(2), izvajalec dejavnosti v tem obratu pa ne more zagotoviti ustreznih jamstev, da bodo te nepravilnosti odpravljene, pristojni organ sproži postopek za odvzem odobritve obrata.
Where a competent authority identifies serious deficiencies in an establishment as regards compliance with the requirements laid down in Article 97(1) and the rules adopted pursuant to Article 97(2), and the operator of that establishment is not able to provide adequate guarantees that those deficiencies will be eliminated, the competent authority shall initiate procedures to withdraw the approval of the establishment.
Vendar lahko pristojni organ odobritev obrata zgolj začasno prekliče in je ne odvzame, kadar izvajalec dejavnosti lahko zagotovi, da bodo te nepravilnosti odpravljene v razumnem roku.
However, the competent authority may merely suspend, rather than withdraw, approval of an establishment where the operator can guarantee that it will eliminate those deficiencies within a reasonable period of time.
Odobritev se po odvzemu izda oziroma po začasnem preklicu obnovi v skladu z odstavkom 2 šele po tem, ko pristojni organ ugotovi, da obrat v celoti izpolnjuje vse zahteve iz te uredbe za to vrsto obrata.
Approval shall only be granted after withdrawal or restored after suspension in accordance with paragraph 2 when the competent authority is satisfied that the establishment fully complies with all the requirements of this Regulation appropriate for that type of establishment.
Registri pristojnega organa
Registers of the competent authority
Člen 101
Article 101
Registri, ki jih vodi pristojni organ
Registers to be kept by the competent authority
Vsak pristojni organ vzpostavi in posodablja registre:
Each competent authority shall establish and keep up to date registers of:
vseh obratov in izvajalcev dejavnosti, ki jih registrira na podlagi člena 93;
all establishments and operators registered with it pursuant to Article 93;
vseh obratov, ki jih odobri v skladu s členoma 97 in 99.
all establishments approved by it in accordance with Articles 97 and 99.
Registre iz točk (a) in (b) prvega pododstavka da na voljo Komisiji in pristojnim organom drugih držav članic, če vsebujejo informacije, pomembne za premike gojenih kopenskih živali in njihovega zarodnega materiala med državami članicami.
It shall make the registers referred to in points (a) and (b) of the first subparagraph available to the Commission and to the competent authorities of other Member States in so far as the information contained therein is relevant for movements of kept terrestrial animals and germinal products thereof between Member States.
Register vseh odobrenih obratov iz točke (b) prvega pododstavka da na voljo javnosti, če vsebuje informacije, pomembne za premike gojenih kopenskih živali in njihovega zarodnega materiala med državami članicami.
It shall make the register of approved establishments as referred to in point (b) of the first subparagraph available to the public in so far as the information contained therein is relevant for movements of kept terrestrial animals and germinal products thereof between Member States.
Pristojni organ lahko – kadar je to potrebno in ustrezno – združi registracijo iz točke (a) prvega pododstavka odstavka 1 in odobritev iz točke (b) prvega pododstavka odstavka 1 z registracijo za druge namene.
Where appropriate and relevant, a competent authority may combine the registration referred to in point (a) of the first subparagraph of paragraph 1 and the approvals referred to in point (b) of the first subparagraph of paragraph 1 with registration for other purposes.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 264 v zvezi s podrobnimi informacijami, ki se navedejo v registrih, kot je določeno v točkah (a) in (b) prvega pododstavka odstavka 1, ter v zvezi z javno dostopnostjo registra, kot je določeno v točki (b) prvega pododstavka odstavka 1.
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning the detailed information to be included in the registers provided for in points (a) and (b) of the first subparagraph of paragraph 1, and the availability to the public of the register provided for in point (b) of the first subparagraph of paragraph 1.
Vodenje evidenc
Record-keeping
Člen 102
Article 102
Obveznost izvajalcev dejavnosti v obratih, ki niso obrati z zarodnim materialom, da vodijo evidence
Record-keeping obligations of operators of establishments other than germinal products establishments
Izvajalci dejavnosti v obratih, ki jih je treba registrirati v skladu s členom 93 ali odobriti v skladu s členom 97(1), vodijo in vzdržujejo evidence, ki vsebujejo vsaj naslednje informacije:
Operators of establishments subject to the requirement of registration in accordance with Article 93, or approval in accordance with Article 97(1), shall keep and maintain records containing at least the following information:
vrste, kategorije, število in, kjer je to ustrezno, identifikacijo gojenih kopenskih živali v njihovem obratu;
the species, categories, number and, where applicable, identification of kept terrestrial animals on their establishment;
premike gojenih kopenskih živali v njihov obrat in iz njega, pri čemer se ustrezno navede:
movements of kept terrestrial animals into and out of their establishment, stating as appropriate:
njihov kraj izvora ali namembni kraj;
their place of origin or destination;
datum takih premikov;
the date of such movements;
dokumente, ki morajo spremljati gojene kopenske živali ob prihodu v obrat ali odhodu iz njega v skladu s točko (b) člena 112, točko (b) člena 113(1), točko (c) člena 114(1), točko (b) člena 115, točko (b) člena 117, členom 143(1) in (2), členom 164(2) ter pravili, sprejetimi na podlagi členov 118 in 120 ter točk (b) in (c) člena 144(1);
the documents required to accompany kept terrestrial animals arriving at or leaving their establishment in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);
umrljivost gojenih kopenskih živali v njihovem obratu;
mortality of kept terrestrial animals on their establishment;
ukrepi za biološko zaščito, spremljanje, zdravljenja, rezultate testov in druge relevantne informacije, kot je primerno, za:
biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for:
vrste in kategorije gojenih kopenskih živali v obratu;
the species and categories of kept terrestrial animals in the establishment;
vrsto in velikost obrata;
the type and size of the establishment;
rezultati vseh veterinarskih obiskov, ki se zahtevajo v skladu s členom 25(1).
the results of any animal health visits required in accordance with Article 25(1).
Evidence se vodijo in vzdržujejo v papirni ali elektronski obliki.
The records shall be kept and maintained in paper or electronic form.
Zadevna država članica lahko obrate, ki predstavljajo majhno tveganje za širjenje bolezni s seznama ali porajajočih se bolezni, izvzame iz zahteve, da vodijo evidence v zvezi z vsemi ali nekaterimi informacijami, naštetimi v odstavku 1.
Establishments presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
Izvajalci dejavnosti v obratih evidence iz odstavkov 1 in 2 vodijo v svojem zadevnem obratu in jih:
Operators of establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment concerned and shall:
dajo takoj na voljo pristojnemu organu na zahtevo;
make them immediately available to the competent authority on request;
hranijo vsaj tako dolgo, kot predpiše pristojni organ, kar pa ne sme biti manj kot tri leta.
retain them for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Z odstopanjem od odstavka 3 se izvajalci dejavnosti lahko izvzamejo iz obveznosti vodenja evidenc za nekatere ali vse informacije iz odstavka 1, če ima zadevni izvajalec dejavnosti:
By way of derogation from paragraph 3, operators may be exempted from the obligation to keep records of some or all of the matters provided for in paragraph 1 when the operator concerned:
dostop do računalniške zbirke podatkov iz člena 109 za zadevne vrste in zbirka podatkov že vsebuje informacije, ki jih je treba vključiti v evidence, ter
has access to the computerised database referred to in Article 109 for the relevant species and the database already contains the information to be included in the records; and
posodobljene informacije, ki so bile neposredno vnesene v računalniško zbirko podatkov.
has the up–to–date information entered directly into the computerised database.
Člen 103
Article 103
Obveznost obratov z zarodnim materialom, da vodijo evidence
Record-keeping obligations of germinal product establishments
Izvajalci dejavnosti v obratih z zarodnim materialom vodijo in vzdržujejo evidence, ki vsebujejo vsaj naslednje informacije:
Operators of germinal product establishments shall keep and maintain records containing at least the following information:
pasmo, starost, identifikacijo in zdravstveni status živali darovalk, ki se uporabljajo pri pridobivanju zarodnega materiala;
the breed, age, identification and health status of donor animals used for the production of germinal products;
čas in kraj odvzema ter priprave in shranjevanja zarodnega materiala, ki se odvzame, pridobi ali pripravi;
the time and place of collection, and the processing and storage, of germinal products collected, produced or processed;
identifikacijo zarodnega materiala, skupaj s podrobnostmi o njegovem namembnem kraju, če je znan;
the identification of the germinal products together with details of their place of destination, if known;
dokumente, ki morajo spremljati zarodni material ob prihodu v zadevni obrat ali odhodu iz njega v skladu s členom 162 in členom 164(2) ter pravili, sprejetimi na podlagi člena 162(3) in (4);
the documents required to accompany germinal products arriving at or leaving the establishment in question in accordance with Article 162 and Article 164(2) and any rules adopted pursuant to Article 162(3) and (4);
rezultate kliničnih in laboratorijskih preiskav, kadar je to ustrezno;
where relevant, the results of clinical and laboratory tests;
uporabljene laboratorijske tehnike.
laboratory techniques used.
Izvajalci dejavnosti v obratih z zarodnim materialom evidence iz odstavkov 1 in 2 vodijo v svojem obratu in jih:
Operators of germinal product establishments shall keep the records provided for in paragraphs 1 and 2 on their establishment and:
Člen 104
Article 104
Obveznost prevoznikov, da vodijo evidence
Record-keeping obligations of transporters
Prevozniki vodijo in vzdržujejo evidence, ki vsebujejo vsaj naslednje informacije:
Transporters shall keep and maintain records containing at least the following information:
obrate, ki so jih obiskali;
the establishments visited by them;
kategorije, vrste in število gojenih kopenskih živali, ki jih prevažajo;
the categories, species and number of kept terrestrial animals transported by them;
čiščenje, razkuževanje in dezinfestacija prevoznih sredstev, ki jih uporabljajo;
the cleaning, disinfection and disinfestation of the means of transport used;
podrobnosti dokumentov, ki spremljajo zadevne živali, vključno s številkami dokumentov.
details of the documents accompanying the animals in question, including their document numbers.
Zadevne države članice lahko prevoznike, ki predstavljajo majhno tveganje za širjenje bolezni s seznama ali porajajočih se bolezni, izvzamejo iz zahteve, da vodijo evidence v zvezi z vsemi ali nekaterimi informacijami, naštetimi v odstavku 1.
Transporters presenting a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
Prevozniki vodijo evidence iz odstavkov 1 in 2:
Transporters shall keep the records provided for in paragraphs 1 and 2:
na način, da je lahko nemudoma na voljo pristojnemu organu na zahtevo;
in such a manner that they can be made immediately available to the competent authority on request;
vsaj tako dolgo, kot predpiše pristojni organ, kar pa ne sme biti manj kot tri leta.
for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Člen 105
Article 105
Obveznost izvajalcev dejavnosti, ki izvajajo dejavnosti zbiranja, da vodijo evidence
Record-keeping obligations of operators conducting assembly operations
Izvajalci dejavnosti, ki izvajajo dejavnosti zbiranja, za katere velja obveznost registracije iz člena 93, vodijo in vzdržujejo evidence, ki vsebujejo vsaj naslednje informacije:
Operators conducting assembly operations subject to the registration requirement laid down in Article 93 shall keep and maintain records containing at least the following information:
vrste, kategorije, število in identifikacijo gojenih kopenskih živali, za katere so odgovorni;
the species, categories, numbers and identification of kept terrestrial animals under their responsibility;
premike gojenih kopenskih živali, za katere so odgovorni, pri čemer se ustrezno navede:
movements of kept terrestrial animals under their responsibility, stating as appropriate:
njihov kraj izvora in namembni kraj;
their place of origin and destination;
dokumente, ki morajo spremljati gojene kopenske živali pri premikih, za katere so odgovorni, v skladu s točko (b) člena 112, točko (b) člena 113(1), točko (c) člena 114(1), točko (b) člena 115, točko (b) člena 117, členom 143(1) in (2), členom 164(2) ter vsemi pravili, sprejetimi na podlagi členov 118 in 120 ter točk (b) in (c) člena 144(1);
the documents required to accompany kept terrestrial animals moved under their responsibility in accordance with point (b) of Article 112, point (b) of Article 113(1), point (c) of Article 114(1), point (b) of Article 115, point (b) of Article 117, Article 143(1) and (2), Article 164(2) and any rules adopted pursuant to Articles 118 and 120 and points (b) and (c) of Article 144(1);
umrljivost gojenih kopenskih živali, za katere so odgovorni;
mortality of kept terrestrial animals under their responsibility; and
ukrepe za biološko zaščito, spremljanje, zdravljenja, rezultate testov in druge relevantne informacije, kot je primerno, za vrste in kategorije gojenih kopenskih živali, za katere so odgovorni.
biosecurity measures, surveillance, treatments, test results and other relevant information as appropriate for the species and categories of kept terrestrial animals under their responsibility.
Zadevne države članice lahko izvajalce dejavnosti, ki predstavljajo majhno tveganje za širjenje bolezni s seznama ali porajajočih se bolezni, izvzamejo iz zahteve, da vodijo evidence v zvezi z vsemi ali nekaterimi informacijami, naštetimi v odstavku 1.
Operators whose activities present a low risk of spreading listed or emerging diseases may be exempted by the Member State concerned from the requirement to keep records of all or some of the information listed in paragraph 1.
dajo evidence iz odstavka 1 na voljo pristojnemu organu na zahtevo;
make the records referred to in paragraph 1 available to the competent authority on request;
hranijo te evidence vsaj tako dolgo, kot predpiše pristojni organ, kar pa ne sme biti manj kot tri leta.
retain those records for a minimum period to be prescribed by the competent authority, which may not be less than three years.
Člen 106
Article 106
Prenos pooblastil glede vodenja evidenc
Delegation of powers concerning record-keeping
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 264 v zvezi s pravili za dopolnitev zahtev za vodenje evidenc iz členov 102, 103, 104 in 105 glede:
The Commission shall be empowered to adopt delegated acts in accordance with Article 264 concerning rules supplementing the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:
informacij, ki jih je treba evidentirati poleg informacij, določenih v členih 102(1), 103(1), 104(1) in 105(1);
information to be recorded in addition to that provided for in Articles 102(1), 103(1), 104(1) and 105(1);
dodatnih zahtev za vodenje evidenc glede zarodnega materiala, ki je bil odvzet, pridobljen ali pripravljen v obratu z zarodnim materialom, potem ko ta obrat preneha delovati.
additional requirements for record-keeping in respect of germinal products collected, produced or processed in a germinal products establishment after that establishment ceased its activities.
Pri oblikovanju pravil, ki se določijo v delegiranih aktih iz odstavka 1, Komisija ta pravila utemelji na naslednjih zadevah:
When establishing the rules to be laid down in delegated acts as provided for in paragraph 1, the Commission shall base those rules on the following matters:
tveganjih, ki jih predstavlja posamezna vrsta obrata ali dejavnosti;
the risks posed by each type of establishment or activity;
vrstah in kategorijah gojenih kopenskih živali ali zarodnega materiala v zadevnem obratu ali ki se prevažajo v ta obrat ali iz njega;
the species and categories of kept terrestrial animals or germinal products in the establishment concerned, or transported to or from that establishment;
vrsti proizvodnje v obratu ali vrsti dejavnosti;
the type of production on the establishment or the type of activity;
značilnih vzorcih premikov in kategorijah zadevnih živali;
the typical movement patterns and categories of the animals concerned;
številu gojenih kopenskih živali v obratu ali količini zarodnega materiala, za katere je odgovoren zadevni izvajalec dejavnosti.
the number of kept terrestrial animals or volume of germinal products under the responsibility of the operator concerned.
Člen 107
Article 107
Izvedbena pooblastila glede izvzetij od zahtev za vodenje evidenc
Implementing powers concerning exemptions from the record-keeping requirements
Komisija lahko z izvedbenimi akti določi pravila glede vrst obratov in izvajalcev dejavnosti, ki jih države članice lahko izvzamejo od zahtev za vodenje evidenc iz členov 102, 103, 104 in 105, kar zadeva:
The Commission may, by means of implementing acts, lay down rules concerning the types of establishments and operators that may be exempted by Member States from the record-keeping requirements provided for in Articles 102, 103, 104 and 105, as regards:
obrate, ki gojijo majhno število kopenskih živali ali hranijo majhno količino zarodnega materiala, ali izvajalce dejavnosti, ki ravnajo z majhnim številom gojenih kopenskih živali ali majhno količino zarodnega materiala ali jih prevažajo;
establishments keeping, or operators handling or transporting, a small number of kept terrestrial animals or a small volume or number of germinal products;
vrste ali kategorije gojenih kopenskih živali ali zarodnega materiala.
species or categories of kept terrestrial animals or germinal products.
Pri sprejemanju teh izvedbenih aktov Komisija te akte utemelji na merilih iz člena 106(2).
When adopting those implementing acts, the Commission shall base those acts on the criteria laid down in Article 106(2).
Zahteve za sledljivost gojenih kopenskih živali in zarodnega materiala
Traceability requirements for kept terrestrial animals and germinal products
Gojene kopenske živali
Kept terrestrial animals
Člen 108
Article 108
Odgovornost držav članic, da vzpostavijo sistem za identifikacijo in registracijo gojenih kopenskih živali
Member States' responsibility for establishing a system for the identification and registration of kept terrestrial animals
Države članice vzpostavijo sistem za identifikacijo in registracijo tistih vrst gojenih kopenskih živali, za katere je tak sistem obvezen na podlagi te uredbe in pravil, sprejetih na njeni podlagi.
Member States shall have in place a system for the identification and registration of those species of kept terrestrial animals for which such a system is required by this Regulation and by any rules adopted pursuant to it.
Tak sistem po potrebi določa evidentiranje premikov takih živali.
Such a system shall, when appropriate, provide for the recording of the movements of such animals.
Države članice pri vzpostavitvi sistema iz odstavka 1 upoštevajo:
When establishing the system referred to in paragraph 1, Member States shall take into account:
vrste ali kategorije zadevnih gojenih kopenskih živali;
the species or categories of kept terrestrial animals concerned;
tveganje, ki ga predstavlja ta vrsta ali kategorija.
the risk posed by that species or category.
Sistem iz odstavka 1 vključuje naslednje elemente:
The system provided for in paragraph 1 shall include the following elements:
sredstva za posamično ali skupinsko identifikacijo gojenih kopenskih živali;
the means to identify kept terrestrial animals individually or in groups;
identifikacijske dokumente, dokumente o premiku ter druge dokumente za identifikacijo in sledenje gojenih kopenskih živali iz člena 110;
identification documents, movement documents and other documents for identifying and tracing kept terrestrial animals as referred to in Article 110;
posodobljene evidence v obratih, kot je določeno v točkah (a) in (b) člena 102(1);
up–to–date records in establishments as provided for in points (a) and (b) of Article 102(1);
računalniško zbirko podatkov o gojenih kopenskih živalih, kot je določena v členu 109(1).
a computer database of kept terrestrial animals as provided for in Article 109(1).
Sistem iz odstavka 1 se oblikuje na način, da:
The system provided for in paragraph 1 shall be designed in such a manner that it:
zagotavlja učinkovito izvajanje ukrepov za preprečevanje in obvladovanje bolezni iz te uredbe;
ensures the efficient application of the disease prevention and control measures provided for in this Regulation;
olajša sledljivost gojenih kopenskih živali in njihovih premikov znotraj države članice in med državami članicami ter njihovega vstopa v Unijo;
facilitates the traceability of kept terrestrial animals and their movements within and between Member States and their entry into the Union;
zagotavlja učinkovito interoperabilnost, integracijo in združljivost elementov tega sistema;
ensures the efficient interoperability, integration and compatibility of the elements of that system;
zagotavlja, da je sistem, kolikor je to primerno, prilagojen:
ensures that the system, to the extent appropriate, is adapted to:
računalniško podprtemu informacijskemu sistemu za prijavljanje in poročanje na ravni Unije, kot je določen v členu 22;
the computerised information system for Union notification and reporting provided for in Article 22;
sistemu TRACES;
TRACES;
zagotavlja skladen pristop glede različnih živalskih vrst, ki jih zajema sistem.
ensures a coherent approach in respect of the different animal species covered by the system.
Države članice lahko, kadar je to primerno:
Member States may when appropriate:
uporabijo celoten sistem ali del sistema iz odstavka 1 za namene, ki niso navedeni v točkah (a) in (b) odstavka 4;
use the whole or part of the system provided for in paragraph 1 for purposes other than those referred to in points (a) and (b) of paragraph 4;
vključijo identifikacijske dokumente, dokumente o premiku in druge dokumente iz člena 110 v veterinarska spričevala ali lastne deklaracijske dokumente iz člena 143(1) in (2), člena 151(1) ter vseh pravil, sprejetih na podlagi točk (b) in (c) člena 144(1) ter členov 151(3) in (4);