natgillin/translations-raw huggingface dataset:
Farmed animals in holdings or herds in the feeding zone must be under the regular surveillance of an official veterinarian regarding the prevalence of TSE and of diseases transmissible to humans or animals;
Rejne živali na gospodarstvih ali v čredah na območjih krmljenja morajo biti pod rednim nadzorom uradnega veterinarja glede prevalence TSE in bolezni, ki se prenašajo na ljudi ali živali.
Feeding must be immediately suspended in the case of:
Krmljenje je treba nemudoma prekiniti v primeru:
a suspected or confirmed link to the spread of TSE in a holding or herd, until the risk can be excluded;
suma ali potrditve povezave s širjenjem TSE na gospodarstvu ali v čredi, dokler se tveganje ne izključi;
a suspected or confirmed outbreak of a serious disease transmissible to humans or animals in a holding or herd, until the risk can be excluded; or
suma ali potrditve izbruha resne bolezni, ki se prenaša na ljudi ali živali na gospodarstvu ali v čredi, dokler se tveganje ne izključi, ali
non-compliance with any of the rules provided for in this Regulation;
neskladnosti s katerim koli pravilom iz te uredbe.
The competent authority must specify in the authorisation:
Pristojni organ mora v dovoljenju določiti:
appropriate measures to prevent the transmission of TSE and of transmissible diseases from the dead animals to humans or other animals, such as measures targeted at the feeding patterns of the species to be conserved, seasonal feeding restrictions, movement restrictions for farmed animals and other measures intended to control possible risks of transmission of a disease communicable to humans or animals, such as measures relating to species present in the feeding zone for the feeding of which the animal by-products are not used;
ustrezne ukrepe za preprečevanje prenosa TSE in bolezni, ki se prenašajo z mrtvih živali na ljudi ali druge živali, kot so ukrepi, usmerjeni v vzorce hranjenja vrst, ki naj bi se ohranile, sezonske omejitve hranjenja, omejitve gibanja rejnih živali in drugi ukrepi, namenjeni nadzoru nad možnimi tveganji za prenos bolezni, ki se prenašajo na ljudi ali živali, kot so ukrepi, povezani z vrstami, ki so prisotne na območju krmljenja, za krmljenje katerih se ne uporabljajo živalski stranski proizvodi;
the responsibilities of persons or entities in the feeding zone who are assisting with the feeding or responsible for farmed animals, in relation to the measures referred to under point (i);
odgovornosti oseb ali subjektov na območju krmljenja, ki pomagajo pri krmljenju ali so odgovorni za rejne živali, v povezavi z ukrepi iz točke (i);
the conditions for the imposition of penalties as referred to in Article 53 of Regulation (EC) No 1069/2009 which are applicable to infringements of measures referred to under point (i) by the persons or entities referred to under point (ii) of this point (d);
pogoje za izrek kazni, navedenih v členu 53 Uredbe (ES) št. 1069/2009, ki se naložijo osebam ali subjektom iz točke (ii) te točke (d) za kršitve ukrepov iz točke (i).
Where the feeding is carried out without the prior collection of the dead animals, an estimate of the likely mortality rate of farmed animals in the feeding zone and of the likely feeding requirements of the wild animals must be carried out, as a basis for the assessment of the potential risks of disease transmission.
Če se krmljenje izvaja brez predhodnega zbiranja mrtvih živali, je treba opraviti oceno verjetne stopnje umrljivosti rejnih živali na območju krmljenja in verjetnih potreb prosto živečih živali po krmljenju kot podlago za oceno možnih tveganj za prenos bolezni.
Feeding of zoo animals with Category 1 material
Krmljenje živali v živalskih vrtovih s snovmi kategorije 1
The competent authority may authorise the use of Category 1 material comprising of entire bodies or parts of dead animals containing specified risk materials and the use of material derived from zoo animals, for the feeding of zoo animals under the following conditions:
Pristojni organ lahko dovoli uporabo snovi kategorije 1, ki zajemajo celotne trupe ali dele mrtvih živali, ki vsebujejo snovi s specifičnim tveganjem, in uporabo snovi, pridobljenih iz živali iz živalskih vrtov, za krmljenje živali v živalskih vrtovih pod naslednjimi pogoji:
The competent authority must have granted an authorisation to the operator responsible for the feeding.
Pristojni organ je izdal dovoljenje nosilcu dejavnosti, odgovornemu za krmljenje.
the feeding is not used as an alternative way of disposal of specified risk materials or disposal of fallen ruminant stock containing such material posing a TSE risk;
se krmljenje ne uporablja kot alternativni način odstranjevanja snovi s specifičnim tveganjem ali poginulih prežvekovalcev, ki vsebujejo take snovi, ki pomenijo tveganje TSE,
when Category 1 material comprising of entire bodies or parts of dead animals containing specified risk material, which originates from bovine animals is used, an appropriate surveillance system for TSEs as laid down in Regulation (EC) No 999/2001 is in place involving regular laboratory testing of samples for TSEs;
kadar se uporabljajo snovi kategorije 1, ki zajemajo celotne trupe ali dele mrtvih govedi, ki vsebujejo snovi s specifičnim tveganjem, je vzpostavljen ustrezen sistem za nadzor TSE, kot je določeno v Uredbi (ES) št. 999/2001, ki vključuje redno laboratorijsko testiranje vzorcev za TSE.
The authorisation granted by the competent authority must be immediately suspended in the case of:
Dovoljenje, ki ga izda pristojni organ, se nemudoma prekliče v primeru:
a suspected or confirmed link to the spread of TSEs until the risk can be excluded; or
suma ali potrditve povezave s širjenjem TSE, dokler se tveganje ne izključi, ali
store the material to be used for the feeding and carry out the feeding in an enclosed and fenced area to ensure that no carnivorous animal other than the zoo animals for which the authorisation has been granted have access to the material for the feeding;
snovi, ki naj bi se uporabile za krmljenje, skladišči in krmljenje izvaja v zaprtem in ograjenem območju, da se zagotovi, da do snovi za krmljenje nimajo dostopa mesojede živali, razen živali v živalskih vrtovih, za katere je bilo izdano dovoljenje;
ensure that ruminant animals intended to be used for feeding are included in the TSE monitoring programme carried out in accordance with Annex III to Regulation (EC) No 999/2001 and, if applicable, in accordance with a Decision adopted in accordance with the second subparagraph of Article 6(1b) of that Regulation;
zagotovi, da se prežvekovalci, ki naj bi se uporabili za krmljenje, vključijo v program spremljanja TSE, ki se izvaja v skladu s Prilogo III k Uredbi (ES) št. 999/2001 in, če je to primerno, v skladu z odločitvijo, ki se sprejme na podlagi drugega pododstavka člena 6(1b) navedene uredbe;
keep records at least of the number, nature, estimated weight and origin of the bodies of the animals used for feeding, the results of the TSE tests and the date of the feeding.
vodi evidenco vsaj o številu, naravi, ocenjeni teži in izvoru trupov živali, uporabljenih za krmljenje, rezultatih testov TSE in datumu krmljenja.
SPECIAL RULES ON COLLECTION AND DISPOSAL
POSEBNA PRAVILA ZA ZBIRANJE IN ODSTRANJEVANJE
Special disposal rules for animal by-products
Posebna pravila za odstranjevanje živalskih stranskih proizvodov
If the competent authority authorises the disposal of animal by-products on site in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, such disposal may take place:
Če pristojni organ dovoli odstranjevanje živalskih stranskih proizvodov na kraju samem v skladu s členom 19(1)(a), (b), (c) in (e) Uredbe (ES) št. 1069/2009, se tako odstranjevanje lahko izvede:
by burning or burial on the premises on which the animal by-products originate;
s sežiganjem ali zakopavanjem v obratu, iz katerega izvirajo živalski stranski proizvodi;
in an authorised landfill; or
na pooblaščenem odlagališču ali
by burning or burial at a site which minimises the risk to animal and public health and the environment, provided that the site is located within a range of distance sufficient to enable the competent authority to manage the prevention of the risk to animal and public health and the environment.
s sežiganjem ali zakopavanjem na kraju, kjer je tveganje za zdravje živali in ljudi ter za okolje najmanjše, pod pogojem, da kraj leži na razdalji, ki omogoča pristojnemu organu preprečevanje tveganja za zdravje živali in javno zdravje ter za okolje.
The burning of animal by-products on the sites referred to in Article 19(1)(b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out in such a way to ensure that they are burnt:
Sežiganje živalskih stranskih proizvodov na krajih, navedenih v členu 19(1)(b), (c) in (e) Uredbe (ES) št. 1069/2009, se mora opraviti tako, da se zagotovi sežig:
on a properly constructed pyre and the animal by-products reduced to ash;
na pravilno sestavljeni grmadi tako, da od živalskih stranskih proizvodov ostane samo pepel;
without endangering human health;
brez ogrožanja zdravja ljudi;
without using processes or methods which could harm the environment, in particular when they could result in risks to water, air, soil and plants and animals or through noise or odours;
brez uporabe postopkov ali metod, ki bi škodovali okolju, zlasti če bi lahko povzročili tveganja za vodo, zrak, prst in rastline ter živali ali zaradi hrupa ali smrada;
under conditions which ensure that any resulting ash is disposed of by burial in an authorised landfill.
pod pogoji, ki zagotavljajo, da se ves pepel, ki ostane, odstrani z zakopavanjem na pooblaščenem odlagališču.
The burial of animal by-products on the sites referred to in Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009 must be carried out to ensure that they are buried:
Zakopavanje živalskih stranskih proizvodov na krajih, navedenih v členu 19(1)(a), (b), (c) in (e) Uredbe (ES) št. 1069/2009, se mora opraviti tako, da se zagotovi zakopavanje:
in such a way that carnivorous or omnivorous animals cannot gain access to them;
na način, da do njih ne morejo priti mesojede ali vsejede živali, in
in an authorised landfill or in another site without endangering human health and using processes or methods which do not harm the environment, in particular when they could result in risks to water, air, soil and plants and animals, or through noise or odours.
na pooblaščenem odlagališču ali drugem kraju brez ogrožanja zdravja ljudi in z uporabo postopkov ali metod, ki ne škodujejo okolju, zlasti če bi lahko povzročili tveganja za vodo, zrak, prst in rastline ter živali ali zaradi hrupa ali smrada.
In the case of disposal in accordance with Article 19(1)(a), (b), (c) and (e) of Regulation (EC) No 1069/2009, the movement of the animal by-products from the place of origin to the place of disposal must be carried out under the following conditions:
V primeru odstranjevanja v skladu s členom 19(1)(a), (b), (c) in (e) Uredbe (ES) št. 1069/2009 je treba živalske stranske proizvode premakniti s kraja izvora na kraj odstranitve pod naslednjimi pogoji:
the animal by-products are transported in secure, leak-proof containers or vehicles;
se živalski stranski proizvodi prepeljejo v varnih, neprepustnih kontejnerjih ali prevoznih sredstvih;
the loading and unloading of the animal by-products is supervised by the competent authority, if appropriate;
nakladanje in razkladanje živalskih stranskih proizvodov nadzoruje pristojni organ, če je to primerno;
the vehicle wheels are disinfected upon leaving the site of origin;
se kolesa prevoznega sredstva ob odhodu z izvornega kraja razkužijo;
containers and vehicles used for transporting animal by-products are thoroughly cleansed and disinfected after unloading of the animal by-products; and
se kontejnerji in prevozna sredstva za prevoz živalskih stranskih proizvodov po razkladanju živalskih stranskih proizvodov temeljito očistijo in razkužijo ter
adequate escorts for the vehicles, leak testing and double covering are provided, if appropriate.
se za prevozna sredstva preskrbijo primerno spremstvo, preverjanje neprepustnosti in dvojna zaščita, če je to primerno.
Burning and burial of animal by-products in remote areas
Sežiganje in zakopavanje živalskih stranskih proizvodov na oddaljenih območjih
The maximum percentage as referred to in Article 19(2) of Regulation (EC) No 1069/2009 shall not exceed the following:
Največji odstotni delež, naveden v členu 19(2) Uredbe (ES) št. 1069/2009, ne presega naslednjega:
10 % of the bovine population of the Member State concerned;
10 % populacije goveda zadevne države članice;
25 % of the ovine and caprine population of the Member State concerned;
25 % populacije ovc in koz zadevne države članice;
10 % of the porcine population of the Member State concerned; and
10 % populacije prašičev zadevne države članice in
a percentage of the population of other species which is determined by the competent authority, on the basis of an assessment of the possible risks for public and animal health which arise from the disposal of animals of those species by burning or burial on site.
odstotnega deleža populacije druge živalske vrste, ki ga določi pristojni organ na podlagi ocene možnih tveganj v zvezi z javnim zdravjem in zdravjem živali zaradi odstranjevanja teh živalskih vrst s sežiganjem ali zakopavanjem na kraju samem.
Burning and burial of bees and apiculture by-products
Sežiganje in zakopavanje čebel in čebelarskih stranskih proizvodov
In the case of bees and apiculture by-products, the competent authority may authorise the disposal by burning or burial on site, as referred to in Article 19(1)(f) of Regulation (EC) No 1069/2009, provided that all necessary measures are taken to ensure that the burning or burial does not endanger animal or human health or the environment.
Glede čebel in čebelarskih stranskih proizvodov lahko pristojni organ odobri odstranjevanje s sežiganjem ali zakopavanjem na kraju samem, kot je navedeno v členu 19(1)(f) Uredbe (ES) št. 1069/2009, pod pogojem, da se sprejmejo vsi potrebni ukrepi za zagotovitev, da sežiganje ali zakopavanje ne ogroža zdravja živali ali ljudi oziroma okolja.
DISPOSAL BY OTHER MEANS
ODSTRANJEVANJE Z DRUGIMI NAČINI
By way of derogation from Article 14 of Regulation (EC) No 1069/2009, Member States may authorise the collection, transport and disposal of the Category 3 materials referred to in Article 10(f) of that Regulation by means other than burning or burial on site provided that:
Z odstopanjem od člena 14 Uredbe (ES) št. 1069/2009 lahko države članice dovolijo zbiranje, prevoz in odstranjevanje snovi kategorije 3 iz člena 10(f) navedene uredbe z načini, ki niso sežiganje ali zakopavanje na kraju samem, če:
the materials do not exceed a volume of 20 kg per week from the establishment or plant where the materials are collected, regardless of the species of origin of the materials;
snovi ne presegajo količine 20 kg na teden iz obrata ali objekta, v katerem so snovi zbrane, ne glede na živalsko vrsto izvora snovi;
the materials are collected, transported and disposed of by means which prevent the transmission of unacceptable risks to public and animal health;
se snovi zbirajo, prevažajo in odstranjujejo na način, ki preprečuje prenašanje nesprejemljivih tveganj v zvezi z javnim zdravjem in zdravjem živali;
the competent authority carries out regular checks, including checks on the records kept by operators, in the establishments or plants where the materials are collected, to ensure compliance with the provisions of this Section.
pristojni organ izvaja redne preglede, vključno s pregledi evidenc, ki jih vodijo nosilci dejavnosti, v obratih ali objektih, v katerih se snovi zbirajo, da se zagotovi skladnost z določbami tega oddelka.
Member States may decide to increase the volume referred to in point (a) to a maximum of 50 kg per week, provided that they present a detailed justification to the Commission and to the other Member States in the framework of the Standing Committee on the Food Chain and Animal Health referred to in Article 52(1) of Regulation (EC) No 1069/2009, which specifies the nature of the activities for which the volume is to be increased, the species of origin of the animal by-products concerned, and an explanation of the reasons why it is necessary to increase the volume, in view of the adequate system for the handling and disposal of animal by-products and derived products on their territory, as referred to in Article 4(4) of that Regulation.
Države članice se lahko odločijo, da bodo povečale količino iz točke (a) na največ 50 kg na teden, če Komisiji in drugim državam članicam prek Stalnega odbora za prehranjevalno verigo in zdravje živali iz člena 52(1) Uredbe (ES) št. 1069/2009 predložijo podrobno utemeljitev z navedbo vrste dejavnosti, za katero naj bi se količina povečala, živalske vrste izvora zadevnih živalskih stranskih proizvodov in razloge za povečanje obsega, ob upoštevanju ustreznega sistema za ravnanje z živalskimi stranskimi proizvodi in pridobljenimi proizvodi in njihovo odstranjevanje na svojem ozemlju, kot je navedeno v členu 4(4) navedene uredbe.
CEN TC/102 – Sterilisers for medical purposes – EN 285:2006 + A2:2009 – Sterilization - Steam Sterilisers - Large Sterilisers, reference published in OJ C 293, 2.12.2009, p. 39.
CEN TC/102 – Sterilizatorji za uporabo v medicini – EN 285:2006 + A2:2009 – Sterilizacija – Parni sterilizatorji – Veliki sterilizatorji, sklic objavljen v UL C 293, 2.12.2009, str. 39.
STANDARD FORMAT FOR APPLICATIONS FOR ALTERNATIVE METHODS
STANDARDNA OBLIKA ZA VLOGE ZA ALTERNATIVNE METODE
Applications for authorisation of an alternative method of use or disposal of animal by-products or derived products as referred to in Article 20 of Regulation (EC) No 1069/2009 (applications) shall be submitted in one of the official languages of the European Union as referred to in Article 1 of Regulation No 1 of 1958.
Vloge za izdajanje dovoljenj za alternativne metode pri uporabi ali odstranjevanju živalskih stranskih proizvodov ali pridobljenih proizvodov, navedene v členu 20 Uredbe (ES) št. 1069/2009 („vloge“), se predložijo v enem od uradnih jezikov Evropske unije, kot je določeno v členu 1 Uredbe št. 1 iz leta 1958.
Interested parties that submit such applications in a language other than English shall validate the official translation of their application, which EFSA shall provide, prior to the assessment.
Zainteresirane strani, ki take vloge predložijo v jeziku, ki ni angleški, pred ocenjevanjem potrdijo uradni prevod vloge, ki ga zagotovi EFSA.
The period referred to in Article 20(5) of Regulation (EC) No 1069/2009 shall only start once the interested party has validated the official translation of the application.
Rok iz člena 20(5) Uredbe (ES) št. 1069/2009 začne teči šele, ko je zainteresirana stran potrdila uradni prevod vloge.
Content of applications
Vsebina vlog
Applications shall contain all necessary information concerning the following points, in order to allow EFSA to assess the safety of their proposed alternative method:
Da lahko EFSA oceni varnost predlaganih alternativnih metod, morajo vloge vsebovati vse potrebne informacije v zvezi z naslednjimi točkami:
the categories of animal by-products which are intended to be submitted to the alternative method, by reference to the categories referred to in Articles 8,9, and 10 of Regulation (EC) No 1069/2009;
kategorije živalskih stranskih proizvodov, ki naj bi se vključile v alternativno metodo, s sklicevanjem na kategorije iz členov 8, 9 in 10 Uredbe (ES) št. 1069/2009;
the identification and characterisation of risk materials according to the following principles:
opredelitev in opis lastnosti snovi s tveganjem na podlagi naslednjih načel:
Significant risk materials must be identified separately.
Snovi z velikim tveganjem je treba opredeliti ločeno.
For each material, the likelihood of human and animal exposure under normal and emergency/abnormal operating conditions must be assessed.
Za vsako snov je treba oceniti verjetnost izpostavljenosti ljudi in živali pod običajnimi in izrednimi/neobičajnimi obratovalnimi pogoji.
In the case of significant exposure, the potential risk must be assessed;
V primeru velike izpostavljenosti je treba oceniti možno tveganje;
the agent risk reduction according to the following principles:
zmanjšanje tveganja zaradi povzročiteljev bolezni na podlagi naslednjih načel:
The risk reduction for human and animal health which can be achieved by the process must be estimated on the basis of direct measurements.
Zmanjšanje tveganja za zdravje ljudi in živali, ki se lahko doseže z zadevnim postopkom, je treba oceniti na podlagi neposrednih meritev.
Where no direct measurement is available, modelling or extrapolation from other processes may also be used.
Če neposredne meritve niso na voljo, se lahko uporabi tudi modeliranje ali ekstrapolacija iz drugih postopkov.
In order to demonstrate effective risk reduction, the identified hazard (such as Salmonella) must be quantified both in the input (raw) material and in the resulting output material.
Za prikaz dejanskega zmanjšanja tveganja je treba ugotovljeno nevarnost (na primer za salmonelo) količinsko opredeliti v vhodni snovi (surovini) in pridobljeni izhodni snovi.
For the purpose of this Chapter, output material comprises any end-products resulting from and by-products derived from the process.
V tem poglavju izhodni material zajema vse končne proizvode in stranske proizvode, pridobljene v postopku.
Estimates must be accompanied by evidence.
Ocenam je treba priložiti dokaze.
This includes – for measurements – information on the methodology used (sensitivity and reliability of the methods used), nature of samples which have been analysed and evidence that samples are representative (relevant real samples, number of tests performed).
V zvezi z meritvami to vključuje informacije o uporabljeni metodologiji (občutljivost in zanesljivost uporabljenih metod), narava vzorcev, ki so bili analizirani, in dokazi, da so vzorci reprezentativni (ustrezni resnični vzorci, število opravljenih preskusov).
If surrogates for prion measurement are used, an explanation should be given of their relevance.
Če se uporabijo nadomestki za merjenje prionskih bolezni, je treba obrazložiti njihovo primernost.
An evaluation of the validity with the uncertainties involved must be provided;
Predložiti je treba oceno veljavnosti s povezanimi negotovostmi;
the risk containment according to the following principles:
omejitev tveganj na podlagi naslednjih načel:
The likely effectiveness of the technical measures used to ensure that the risks are contained must be analysed.
Analizirati je treba verjetno učinkovitost tehničnih ukrepov za omejitev tveganj.
That analysis must reflect normal and abnormal/emergency operating conditions including a breakdown of the process.
Navedena analiza mora izražati običajne in neobičajne/izredne obratovalne pogoje, vključno z okvaro.
Monitoring and surveillance procedures to demonstrate containment must be specified.
Opredeliti je treba postopke spremljanja in nadzora za prikaz omejitve.
If full containment is not achievable, an assessment shall be required of any potential risk;
Če ni mogoče doseči popolne omejitve, je treba oceniti vsa možna tveganja;
the identification of interdependent processes according to the following principles:
opredelitev medsebojno odvisnih postopkov na podlagi naslednjih načel:
Possible indirect impacts which may influence the risk reduction capacity of a particular process must be evaluated.
Oceniti je treba možne posredne učinke, ki lahko vplivajo na zmožnost zadevnega postopka za zmanjšanje tveganja.
Indirect impacts may arise from transport, storage and safe disposal of end-products resulting from and by-products derived from a process;
Posredni učinki lahko nastanejo pri prevozu, skladiščenju in varnem odstranjevanju končnih proizvodov in stranskih proizvodov, pridobljenih v postopku;
the intended end use of the end products and by-products according to the following principles:
predvidena končna uporaba končnih proizvodov in stranskih proizvodov na podlagi naslednjih načel:
The intended end use of end products and by-products of a process must be specified.
Navesti je treba predvideno končno uporabo končnih proizvodov in stranskih proizvodov postopka.