natgillin/translations-raw huggingface dataset:
I, the undersigned official, declare that I have read and understood Regulation (EC) No 1069/2009 of the European Parliament and of the Council (1a) and in particular Articles 8 and 10 thereof, and Commission Regulation (EU) No 142/2011 (1b), and in particular Annex XIV, Chapter II thereof, and certify that the photographic gelatine described above:
Podpisana uradna oseba izjavljam, da sem prebral in razumel Uredbo (ES) št. 1069/2009 Evropskega parlamenta in Sveta (1a) zlasti člena 8 in 10 Uredbe, in Uredbo Komisije (EU) št. 142/2011 (1b), zlasti poglavje II Priloge XIV k Uredbi, ter potrjujem, da zgoraj opisana fotografska želatina:
consists exclusively of photographic gelatine for photographic uses and is not intended for any other purpose;
vsebuje izključno fotografsko želatino za fotografsko uporabo in ni namenjena nobeni drugi vrsti uporabe;
has been prepared and stored in a plant registered and supervised by the competent authority in accordance with Article 23 of Regulation (EC) No 1069/2009, which does not produce gelatine for food, feed or other uses intended for dispatch to the European Union;
je bila pripravljena in skladiščena v obratu, ki ga je odobril in validiral ter ga nadzoruje pristojni organ v skladu s členom 23 Uredbe (ES) št. 1069/2009 ter v katerem se ne proizvaja želatina za uporabo v živilih, krmi ali za druge uporabe, namenjena odpremi v Evropsko unijo;
has been prepared with Category 3 animal by-products and/or bovine vertebral column classified as Category 1 material;
je bila pripravljena iz živalskih stranskih proizvodov kategorije 3 in/ali hrbtenice goveda, uvrščene med snovi kategorije 1;
has been wrapped, packaged in new containers, stored and transported in sealed, leak-proof labelled containers in a vehicle under satisfactory hygiene conditions;
je bila embalirana, zapakirana v nove kontejnerje, skladiščena in se je prevažala v zatesnjenih, neprepustnih in označenih kontejnerjih v vozilu v zadovoljivih higienskih razmerah;
either treated by pressure sterilisation as referred to in definition No 19 of Article 3 of Regulation (EC) No 1069/2009 (2);
bodisi obdelana s sterilizacijo pod pritiskom, kot je opredeljena v točki 19 člena 3 Uredbe (ES) št. 1069/2009 (2);
or subjected to:
ali obdelana:
treatment with acid for at least two days, washing with water and treatment with an alkaline solution for at least 20 days; the pH must be adjusted and the material purified by means of filtration and sterilised at 138-140 °C for 4 seconds; or
z uporabo kisline vsaj dva dni, spiranjem z vodo in uporabo alkalne raztopine vsaj 20 dni; pH mora biti uravnan in snov je prečiščena s filtriranjem ter 4 sekunde sterilizirana pri 138–140 °C; ali
treatment with alkali for at least two days, washing with water and treatment with an acid solution for 10-12 hours; the pH must be adjusted and the material purified by means of filtration and sterilised at 138-140 °C for 4 seconds.
z uporabo luga vsaj dva dni, spiranjem z vodo in uporabo kisle raztopine 10–12 ur; pH mora biti uravnan in snov je prečiščena s filtriranjem ter 4 sekunde sterilizirana pri 138–140 °C;
has been wrapped and packaged in wrappings and packages carrying the words ‘PHOTOGRAPHIC GELATINE FOR THE PHOTOGRAPHIC INDUSTRY ONLY’.
je bila embalirana in zapakirana v ovojnini in pakiranjih, na katerih je natisnjeno besedilo „FOTOGRAFSKA ŽELATINA LE ZA FOTOGRAFSKO INDUSTRIJO“.
Box reference I.5: The intended destination of the photographic gelatine can only be the Czech Republic, the Netherlands or the United Kingdom.
Rubrika I.5: namembni kraj fotografske želatine je lahko le Češka, Nizozemska ali Združeno kraljestvo.
Box reference I.9: Country of destination: only applicable for the Czech Republic, the Netherlands or the United Kingdom.
Rubrika I.9: namembna država: primerno le za Češko, Nizozemsko ali Združeno kraljestvo.
Box reference I.23: Identification of container/seal number: only where applicable.
Rubrika I.23: navedba številke kontejnerja/zalivke: samo kadar je primerno.
Pressure sterilisation (method 1) is also referred to in Chapter III of Annex IV to Regulation (EU) No 142/2011 as follows:
Sterilizacija pod pritiskom (metoda 1) je navedena tudi v poglavju III Priloge IV k Uredbi (EU) št. 142/2011:
‘Reduction
„Drobljenje
Note for the person responsible for the load in the European Union: this certificate is only for veterinary purposes and has to accompany the consignment until it reaches the factory of destination from the border inspection post.
Opomba za odgovorno osebo za natovarjanje v Evropski uniji: to spričevalo se izdaja le v veterinarske namene in mora spremljati pošiljko, dokler z mejne kontrolne točke ne prispe v namembni industrijski obrat.
Declaration for the import from third countries and for the transit through the European Union of intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics and laboratory reagents
Izjava za uvoz iz tretjih držav in tranzit skozi Evropsko unijo vmesnih proizvodov za uporabo v proizvodnji zdravil, zdravil za uporabo v veterinarski medicini, medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov in laboratorijskih reagentov
Intermediate products to be used for the manufacture of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics and laboratory reagents
Vmesni proizvodi za uporabo v proizvodnji zdravil, zdravil za uporabo v veterinarski medicini, medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov in laboratorijskih reagentov
I, the undersigned, declare that the intermediate product referred to above is intended to be imported by me into the Union and satisfy the definition provided for in point 35 of Annex I of Commission Regulation (EU) No 142/2011 (1a), and in particular that:
Podpisani izjavljam, da nameravam zgoraj opisani vmesni proizvod uvoziti v Unijo in da izpolnjuje opredelitev iz točke 35 Priloge I k Uredbi Komisije (EU) št. 142/2011 (1a) ter zlasti da:
it is intended for the manufacture of:
je namenjen za proizvodnjo:
either [- medicinal products,]
bodisi [- zdravil,]
and/or [- veterinary medicinal products,]
in/ali [- zdravil za uporabo v veterinarski medicini,]
and/or [- medical devices,]
in/ali [- medicinskih pripomočkov,]
and/or [- active implantable medical devices,]
in/ali [- aktivnih medicinskih pripomočkov za vsaditev,]
and/or [- in vitro diagnostic medical devices,]
in/ali [- in vitro diagnostičnih medicinskih pripomočkov,]
and/or [- laboratory reagents;]
in/ali [- laboratorijskih reagentov;]
its design, transformation and manufacturing stages have been sufficiently completed in order to qualify the material directly or as a component of a product intended for that purpose, except for the fact that it requires further handling or transformation such as mixing, coating, assembling, packaging or labelling to make it suitable for placing on the market or putting into service as medicinal products, veterinary medicinal products, active implantable medical device, medical devices or in vitro diagnostic medical device in accordance with the Union legislation (1b) applicable to those products or as laboratory reagents;
faze oblikovanja, transformacije in proizvodnje so se ustrezno zaključile, da lahko snov neposredno ustreza proizvodu za navedeni namen ali njegovemu delu, razen če zahteva nadaljnjo obdelavo ali transformacijo, kot so mešanje, premazovanje, sestavljanje, pakiranje ali označevanje, da bo ustrezal za dajanje na trg ali dajanje v uporabo kot zdravilo, zdravilo za uporabo v veterinarski medicini, aktivni medicinski pripomoček za vsaditev, medicinski pripomoček ali in vitro diagnostični medicinski pripomoček v skladu z zakonodajo Unije (1b), ki se uporablja za navedene proizvode, ali laboratorijski reagent;
it has been derived from the following material which may have originated from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Council Directive 96/22/EC or Article 2(b) of Council Directive 96/23/EC (2):
pridobljen je bil iz naslednjih snovi, ko so lahko izvirale iz živali, ki so bile predmet nezakonite uporabe, kot je opredeljena v členu 1(2)(d) Direktive Sveta 96/22/ES ali členu 2(b) Direktive Sveta 96/23/ES (2):
and/or [- products derived from or generated by:
in/ali [- proizvodov, ki se pridobijo ali nastanejo iz:
aquatic animals, and parts of such animals, except sea mammals, which did not show any signs of disease communicable to humans or animals,
vodnih živali in delov takšnih živali, razen morskih sesalcev, ki niso kazale nobenih znakov bolezni, prenosljivih na ljudi ali živali,
aquatic or terrestrial invertebrates other than species pathogenic to humans or animals,
vodnih ali kopenskih nevretenčarjev, razen patogenih vrst za ljudi ali živali,
animals and parts thereof of the zoological orders of Rodentia and Lagomorpha, except Category 1 material as referred to in Article 8(a)(iii), (iv) and (v) and Category 2 material as referred to in Article 9(a) to (g) of Regulation (EC) No 1069/2009;]
živali in delov teh živali, ki spadajo v živalski red Rodentia in Lagomorpha, razen snovi kategorije 1 iz člena 8(a)(iii), (iv) in (v) in snovi kategorije 2 iz člena 9(a) do (g) Uredbe (ES) št. 1069/2009;]
and/or [- animals and parts of animals, other than those referred to in Article 8 or Article 10 of Regulation (EC) No 1069/2009,
in/ali [- živali in delov živali, razen tistih, navedenih v členu 8 ali členu 10 Uredbe (ES) št. 1069/2009,
that die other than by being slaughtered or killed for human consumption, including animals killed for disease control purposes;
ki niso umrle zaradi zakola ali usmrtitve za prehrano ljudi, vključno z živalmi, usmrčenimi za namene nadzora bolezni;
foetuses;
fetusi;
oocytes, embryos and semen which are not destined for breeding purposes; and
jajčne celice, zarodki in seme, ki niso namenjeni razplodu, ter
dead-in-shell poultry;]
mrtva perutnina v jajčni lupini;]
and/or [- animal by-products other than Category 1 material or Category 3 material;]
in/ali [- živalski stranski proizvodi, razen snovi kategorije 1 ali 3;]
its outer packaging is labelled ‘FOR MEDICINAL PRODUCTS/VETERINARY MEDICINAL PRODUCTS/MEDICAL DEVICES/ACTIVE IMPLANTABLE MEDICAL DEVICES/IN VITRO DIAGNOSTIC MEDICAL DEVICES/LABORATORY REAGENTS ONLY’ and it is not intended to be diverted at any stage within the Union for any other use;
zunanje pakiranje je označeno z „LE ZA ZDRAVILA / ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI / MEDICINSKE PRIPOMOČKE / AKTIVNE MEDICINSKE PRIPOMOČKE ZA VSADITEV / IN VITRO DIAGNOSTIČNE MEDICINSKE PRIPOMOČKE / LABORATORIJSKE REAGENTE“, proizvodi pa niso namenjeni za preusmeritev na kateri koli stopnji za katero koli drugo vrsto uporabe v Uniji;
the consignment will be transported directly to the place of destination as indicated under point I.12 of this declaration, that is:
pošiljka bo prepeljana neposredno v namembni kraj iz točke I.12. te izjave, ki je:
an establishment or plant for the production of medicinal products, veterinary medicinal products, medical devices, in vitro diagnostics or laboratory reagents, which has been registered in accordance with Article 23 of Regulation (EC) No 1069/2009,
obrat ali objekt za proizvodnjo zdravil, zdravil za uporabo v veterinarski medicini, medicinskih pripomočkov, in vitro diagnostičnih medicinskih pripomočkov ali laboratorijskih reagentov, registriranih v skladu s členom 23 Uredbe (ES) št. 1069/2009;
an establishment or plant which has been approved in accordance with Article 24(1)(i) of Regulation (EC) No 1069/2009, from where they shall only be dispatched to an establishment or plant referred to in the preceding subpoint of (5).
obrat ali objekt, odobren v skladu s členom 24(1)(i) Uredbe (ES) št. 1069/2009, od koder bodo proizvodi poslani v obrat ali objekt in prejšnje podtočke v točki (5).
Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001), Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) and Directive 98/79/EC of the European Parliament and the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1), as appropriate.
Direktiva 2001/82/ES Evropskega parlamenta in sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini (UL L 311, 28.11.2001), Direktiva 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini (UL L 311, 28.11.2001, str. 67), Direktiva Sveta 93/42/EGS z dne 14. junija 1993 o medicinskih pripomočkih (UL L 169, 12.7.1993, str. 1) in Direktiva Evropskega parlamenta in Sveta 98/79/ES z dne 27. oktobra 1998 o in vitro diagnostičnih medicinskih pripomočkih (UL L 331, 7.12.1998, str. 1).
OFFICIAL CONTROLS IN PROCESSING PLANTS
URADNI NADZOR V PREDELOVALNIH OBRATIH
Supervision of the production
Nadzor proizvodnje
The competent authority shall supervise processing plants to ensure compliance with the requirements of Regulation (EC) No 1069/2009 and with this Regulation.
Pristojni organ nadzira predelovalne obrate zaradi zagotovitve skladnosti z zahtevami iz Uredbe (ES) št. 1069/2009 in te uredbe.
It shall, in particular:
Pristojni organ zlasti:
check:
preverja:
the general conditions of hygiene of the premises, equipment and staff;
splošne higienske pogoje za prostore, opremo in osebje;
the efficacy of the own checks carried out by the operator of the processing plant, in accordance with Article 28 of Regulation (EC) No 1069/2009; such checks must include an examination of the results of those checks and if necessary, the taking of samples;
učinkovitost notranje kontrole, ki jo izvaja upravljavec predelovalnega obrata v skladu s členom 28 Uredbe (ES) št. 1069/2009, takšni pregledi pa morajo vključevati preverjanje rezultatov navedenih pregledov in po potrebi odvzem vzorcev;
the effective implementation of the permanent written procedure based on the HACCP principles in accordance with Article 29(1) of Regulation (EC) No 1069/2009; such checks must include an examination of the results of this implementation and if necessary, the taking of samples;
učinkovitost izvajanja stalnega pisnega postopka, ki temelji na načelih HACCP v skladu s členom 29(1) Uredbe (ES) št. 1069/2009, takšni pregledi pa morajo vključevati preverjanje rezultatov tega izvajanja in po potrebi odvzem vzorcev;
the standards of the products after processing; the analyses and tests must be carried out in accordance with scientifically recognised methods, in particular, those laid down in Union legislation or, where no such methods are laid down in Union legislation, in accordance with recognised international standards or, in their absence, national standards; and
standarde proizvodov po predelavi; analize in teste je treba izvajati v skladu z znanstveno priznanimi metodami, zlasti tistimi iz zakonodaje Unije ali, če takšne metode niso določene v zakonodaji Unije, s priznanimi mednarodnimi standardi ali, če ne obstajajo, nacionalnimi standardi; in
the storage conditions;
pogoje skladiščenja;
take any samples required for laboratory tests; and
odvzame kakršne koli vzorce, potrebne za laboratorijske teste; ter
make any other checks it considers necessary to ensure compliance with Regulation (EC) No 1069/2009 and with this Regulation.
opravlja kakršne koli druge preglede, ki so potrebni za zagotavljanje skladnosti z Uredbo (ES) št. 1069/2009 in to uredbo.
To allow it to carry out its responsibilities under point 1, the competent authority must have free access at all times to all parts of the processing plant and to records, commercial documents and health certificates.
Da pristojni organ lahko opravlja svoje naloge iz točke 1, mora imeti vedno prost dostop do vseh delov predelovalnega obrata ter evidenc, komercialnih dokumentov in veterinarskih spričeval.
Validation procedures
Postopki validacije
Prior to issuing an approval for a processing plant, as provided for in Article 44(1) of Regulation (EC) No 1069/2009, the competent authority must check that a validation of the processing plant has been carried out by the operator in accordance with the following procedures and indicators:
Pristojni organ mora pred izdajo odobritve predelovalnemu obratu, kot je določeno v členu 44(1) Uredbe (ES) št. 1069/2009, preveriti, ali je bila opravljena validacija predelovalnega obrata, ki jo opravi upravljavec v skladu z naslednjimi postopki in kazalniki:
a description of the process by a process flow diagram;
opis procesa z diagramom poteka procesa;
an identification of critical control points (CCPs) including the material process rate for continuous systems;
določitev kritičnih kontrolnih točk (CCP), vključno s stopnjo predelave snovi za neprekinjene sisteme;
the compliance with the specific process requirements laid down by this Regulation; and
skladnost s posebnimi zahtevami procesa iz te uredbe; ter
the achievement of the following requirements:
izpolnjevanje naslednjih zahtev:
particle size for batch-pressure and continuous processes, defined by the mincer hole or the anvil gap size;
velikost delcev za procese v prekinjenem tlačnem sistemu (sistemu serij) ter neprekinjene procese, opredeljena z velikostjo odprtine mlevne priprave ali velikostjo reže drobilne priprave;
temperature, pressure, processing time and, in the case of continuous processing systems, the material processing rate, as specified in points 2 and 3.
temperatura, tlak, čas predelave in v primeru neprekinjenih sistemov stopnja predelave snovi, kot je opredeljeno v točkah 2 in 3.
In the case of a batch pressure system:
V primeru prekinjenega tlačnega sistema se:
the temperature must be monitored with a permanent thermocouple and it must be plotted against real time;
temperatura spremlja po stalnem termočlenu in izrisuje glede na dejanski čas;
the pressure stage must be monitored with a permanent pressure gauge; pressure must be plotted against real time;
stopnja tlaka spremlja po stalnem merilcu tlaka; tlak se izrisuje glede na dejanski čas;
the processing time must be shown by time/temperature and time/pressure diagrams.
čas predelave prikazuje na podlagi diagramov čas/temperatura in čas/tlak.
At least once a year the thermocouple and the pressure gauge must be calibrated.
Termočlen in merilec tlaka je treba umeriti najmanj enkrat na leto.
In the case of a continuous pressure system:
V primeru neprekinjenega tlačnega sistema:
the temperature and the pressure must be monitored with thermocouples, or an infrared temperature gun, and pressure gauges must be used at defined positions throughout the process system in such a way that temperature and pressure comply with the required conditions inside the whole continuous system or in a section of it; the temperature and pressure must be plotted against real time;
se temperatura in tlak spremljata po termočlenih ali z infrardečo temperaturno pištolo, merilci tlaka pa se morajo uporabljati na opredeljenih točkah v celotnem sistemu procesa tako, da sta temperatura in tlak skladna z zahtevanimi pogoji znotraj celotnega neprekinjenega sistema ali v posameznih delih sistema; temperatura in tlak se izrisujeta glede na dejanski čas;
measurement of the minimum transit time inside the whole relevant part of the continuous system where the temperature and pressure comply with the required conditions, must be provided to the competent authorities, using insoluble markers, such as manganese dioxide, or a method which offers equivalent guarantees.
je treba meritve najmanjšega prehodnega časa znotraj celotnega zadevnega dela v neprekinjenem sistemu, kjer sta temperatura in tlak skladna z zahtevanimi pogoji, predložiti na vpogled pristojnim organom, in v ta namen uporabiti netopne sledilne snovi, kot je manganov dioksid, ali pa metodo, ki zagotavlja enakovredno jamstvo.
Accurate measurement and control of the material process rate is essential and must be measured during the validation test in relation to a CCP that can be continuously monitored such as:
Bistvenega pomena so natančne meritve ter nadzor stopnje predelave snovi, meriti pa jih je treba med celotnim validacijskim testom glede na kritično kontrolno točko (CCP), ki jo je mogoče neprekinjeno spremljati, kakor na primer:
feed screw revolutions per minute (rev./min.);
obrati dovajalnega polža na minuto (obr./min.);
the electric power (amps at given voltage);
električna moč (amperi pri dani električni napetosti);
the evaporation/condensation rate; or
stopnja izparevanja/kondenzacije ali
the number of pump strokes per unit time.
število obratov črpalke na časovno enoto.
All measuring and monitoring equipment must be calibrated at least once a year.
Vso merilno opremo in opremo za spremljanje je treba umeriti najmanj enkrat na leto.
The competent authority must repeat the checks on the validation procedures when it considers it necessary, and in any case each time any significant alterations are made to the process, such as modifications of the machinery or changes of raw materials.
Pristojni organ mora ponavljati preverjanja postopkov validacije, če meni, da je to potrebno, in v vsakem primeru vsakokrat ob izvedbi kakršnih koli pomembnih sprememb v procesu, kot sta zamenjava strojne opreme ali uvedba novih surovin.
LISTS OF REGISTERED AND APPROVED ESTABLISHMENTS, PLANTS AND OPERATORS
SEZNAMI REGISTRIRANIH IN ODOBRENIH OBRATOV, OBJEKTOV IN UPRAVLJAVCEV
Access to lists of registered and approved establishments, plants and operators
Dostop do seznamov registriranih in odobrenih obratov, objektov in upravljavcev
In order to assist Member States in making up-to-date lists of registered and approved establishments, plants and operators available to other Member States and to the public, the Commission shall provide a website which shall contain links to the national websites provided by each Member State, as referred to in point 2(a).
Da bi Komisija pomagala državam članicam pri sestavljanju posodobljenih seznamov registriranih in odobrenih obratov, objektov in upravljavcev, ki bodo na voljo drugim državam članicam in javnosti, jim zagotovi spletno stran s povezavami na nacionalne spletne strani, za katere poskrbi vsaka država članica, kot je navedeno v točki 2(a).
Format for national websites
Oblika nacionalnih spletnih strani
Each Member State shall provide the Commission with a linking address to a single national website containing the master list of all registered and approved establishments, plants and operators on its territory (‘master list’).
Vsaka država članica pošlje Komisiji povezavo do nacionalne spletne strani z glavnim seznamom, ki zajema vse registrirane in odobrene obrate, objekte in upravljavce na njenem ozemlju („glavni seznam“).
Each master list shall consist of one sheet and shall be completed in one or more official languages of the Union.
Vsak glavni seznam je sestavljen iz enega lista in je izpolnjen v enem ali več uradnih jezikih Unije.
The layout, including the relevant information and codes, of master lists shall follow the technical specifications which are published by the Commission on its website.
Razporeditev glavnega seznama, vključno z ustreznimi informacijami in oznakami, upošteva tehnične specifikacije, ki jih Komisija objavi na svoji spletni strani.
SPECIFIC REQUIREMENTS FOR OFFICIAL CONTROLS
POSEBNE ZAHTEVE ZA URADNI NADZOR
Official controls regarding marking of derived products
Uradni nadzor glede označevanja pridobljenih proizvodov