natgillin/translations-raw huggingface dataset:
The exact experimental design and statistical approaches of feeding experiments in food producing animals to test the nutritional value of genetically modified feed, modified for enhanced nutritional characteristics, shall depend on the targeted animal species, type of plant trait(s) studied and the size of the expected effect.
Točen načrt poskusa in statistični pristopi k poskusom krmljenja živali za proizvodnjo živil pri testiranju hranilne vrednosti gensko spremenjenih živil, spremenjenih za povečanje hranilnih značilnosti, so odvisni od ciljnih živalskih vrst, vrste preučevanih rastlinskih lastnosti in velikosti pričakovanega učinka.
The experimental diets shall be formulated in such a way that the key measured endpoints are responsive to a difference in the quantity and/or availability of the nutrient in question.
Poskusna prehrana se oblikuje tako, da se ključni merjeni cilji odzivajo na razliko v količini in/ali razpoložljivosti zadevne hranilne snovi.
Endpoint measurements shall vary with the target species used in the study, but shall include feed intake, body weight, animal performance and bioavailability of nutrients.
Ciljne meritve se spreminjajo glede na uporabljene ciljne vrste v študiji, vendar vključujejo vnos krme, telesno maso, proizvodnost živali in biološko razpoložljivost hranilnih snovi.
The conclusion of the nutritional assessment of genetically modified food and feed shall indicate whether the genetically modified food and feed is nutritionally equivalent to its conventional counterpart, taking natural variations into account.
V sklepni ugotovitvi ocene hranilne vrednosti gensko spremenjenih živil in krme se navede, ali so gensko spremenjena živila in krma ob upoštevanju naravne variabilnosti prehransko enakovredni podobni konvencionalni vrsti.
The applicant shall evaluate the result of the nutritional assessment in the light of anticipated intake of the genetically modified food and feed (see Section 2).
Vlagatelj oceni rezultat ocene hranilne vrednosti glede na pričakovani vnos gensko spremenjenih živil in krme (glej oddelek 2).
Standardised guidelines for toxicity tests
1.7 Standardizirane smernice za teste toksičnosti
The applicant shall use for toxicity testing internationally agreed guidelines and test methods described by Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) [11] (see Tables 1 and 2).
Vlagatelj uporabi za testiranje toksičnosti mednarodno dogovorjene smernice in metode testiranja, opisane v Uredbi Komisije (ES) št. 440/2008 z dne 30. maja 2008 o določitvi testnih metod v skladu z Uredbo (ES) št. 1907/2006 Evropskega parlamenta in Sveta o registraciji, evalvaciji, avtorizaciji in omejevanju kemikalij (REACH) [11] (glej preglednici 1 in 2).
A non-exhaustive list of validated test methods which, where necessary, shall be used in a possibly adapted form for GMO toxicological testing is provided in Tables 1 and 2.The performance of test methods depends on the type of genetically modified food and feed, type of the genetic modification and resulting intended and unintended alterations, intended use and exposure/intake, and the available knowledge.
Neizčrpen seznam validiranih testnih metod, ki se po potrebi uporabi v verjetno prilagojeni obliki za toksikološki test GSO, je naveden v preglednicah 1 in 2.Uspešnost metod testiranja je odvisna od vrste gensko spremenjenih živil in krme, vrste genske spremembe in posledičnih namernih in nenamernih sprememb, nameravane uporabe in izpostavljenosti/vnosa ter razpoložljivega znanja.
Some of the tests were developed for the assessment of risks at the workplace (see Sections 1.4 and 1.5).
Nekateri testi so bili razviti za ocenjevanje tveganj na delovnem mestu (glej oddelka 1.4 in 1.5).
Non-exhaustive list of validated test methods for chemicals as provided by Regulation (EC) No 440/2008 and which may be used in a possibly adapted form for GMO toxicological testing
Neizčrpen seznam validiranih metod testiranja za kemikalije, kot je določen v Uredbi (ES) št. 440/2008 in se lahko uporablja v verjetno prilagojeni obliki za toksikološki test GSO
Reference of the method in Part B of the Annex to Regulation (EC) No 440/2008
Sklicevanje na metodo v delu B Priloge k Uredbi (ES) št. 440/2008
ACUTE TOXICITY (DERMAL)
AKUTNA TOKSIČNOST (V STIKU S KOŽO)
REPEATED-DOSE (28 DAYS) TOXICITY (ORAL)
TOKSIČNOST (PO ORALNI POTI) PRI PONAVLJAJOČIH SE ODMERKIH (28 DNI)
REPEATED-DOSE (28 DAYS) TOXICITY (DERMAL)
TOKSIČNOST (V STIKU S KOŽO) PRI PONAVLJAJOČIH SE ODMERKIH (28 DNI)
SUBCHRONIC ORAL TOXICITY TEST REPEATED-DOSE 90-DAY ORAL TOXICITY STUDY IN RODENTS
TEST SUBKRONIČNE ORALNE TOKSIČNOSTI 90-DNEVNA ŠTUDIJA ORALNE TOKSIČNOSTI S PONAVLJAJOČIMI SE ODMERKI NA GLODAVCIH
CHRONIC TOXICITY TEST
TEST KRONIČNE TOKSIČNOSTI
CARCINOGENICITY TEST
TEST RAKOTVORNOSTI
COMBINED CHRONIC TOXICITY/CARCINOGENICITY TEST
KOMBINIRANI TEST KRONIČNE TOKSIČNOSTI/RAKOTVORNOSTI
ONE-GENERATION REPRODUCTION TOXICITY TEST
TEST TOKSIČNOSTI ZA RAZMNOŽEVANJE NA ENI GENERACIJI
TWO-GENERATION REPRODUCTION TOXICITY STUDY
ŠTUDIJA DVOGENERACIJSKE REPRODUKTIVNE TOKSIČNOSTI
NEUROTOXICITY STUDY IN RODENTS
ŠTUDIJA NEVROTOKSIČNOSTI NA GLODAVCIH
Genotoxicity tests as provided by Regulation (EC) No 440/2008
Testi genotoksičnosti, kot so določeni v Uredbi (ES) št. 440/2008
MUTAGENICITY — IN VIVO MAMMALIAN BONE MARROW CHROMOSOME ABERRATION TEST
MUTAGENOST – TEST KROMOSOMSKIH ABERACIJ V KOSTNEM MOZGU SESALCEV IN VIVO
MUTAGENICITY — IN VIVO MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST
MUTAGENOST – TEST MIKRONUKLEUSOV V ERITROCITIH SESALCEV IN VIVO
MUTAGENICITY: REVERSE MUTATION TEST USING BACTERIA
MUTAGENOST – TEST POVRATNE MUTACIJE PRI BAKTERIJAH
MUTAGENICITY TESTING AND SCREENING FOR CARCINOGENICITY GENE MUTATION — SACCHAROMYCES CEREVISIAE
TEST MUTAGENOSTI IN PRESEJALNA ŠTUDIJA RAKOTVORNOSTI – GENSKA MUTACIJA – SACCHAROMYCES CEREVISIAE
MITOTIC RECOMBINATION — SACCHAROMYCES CEREVISIAE
MITOTIČNA REKOMBINACIJA – SACCHAROMYCES CEREVISIAE
MUTAGENICITY — IN VITRO MAMMALIAN CELL GENE MUTATION TEST
MUTAGENOST – TEST GENSKIH MUTACIJ V CELICAH SESALCEV IN VITRO
SISTER CHROMATID EXCHANGE ASSAY IN VITRO
TEST IZMENJAVE SESTRSKIH KROMATID IN VITRO
IN VITRO MAMMALIAN CELL TRANSFORMATION TESTS
TESTI CELIČNE TRANSFORMACIJE SESALSKIH CELIC IN VITRO
MAMMALIAN SPERMATOGONIAL CHROMOSOME ABERRATION TEST
TEST KROMOSOMSKIH ABERACIJ V SPERMATOGONIJIH SESALCEV
An estimate of the expected intake shall be an essential element in the risk assessment of genetically modified food and feed and shall also be required for the nutritional evaluation.
Ocena pričakovanega vnosa je bistveni element ocene tveganja gensko spremenjenih živil in krme in se zahteva tudi pri oceni hranilne vrednosti.
Information shall be provided by the applicant on the intended function, the dietary role, and the expected level of use of the genetically modified food and feed in the EU.
Vlagatelj predloži informacije o nameravani funkciji, vlogi prehrane in pričakovani stopnji uporabe gensko spremenjenih živil in krme v EU.
In addition, the expected range of concentrations of newly produced proteins or existing plant proteins deliberately modified in the genetically modified food(s) and feed(s) to be placed on the market shall be provided.
Predloži se tudi pričakovani obseg koncentracij novoproizvedenih beljakovin ali obstoječih rastlinskih beljakovin, namerno spremenjenih v gensko spremenjenih živilih in krmi, ki naj bi bili dani na trg.
On the basis of representative consumption data for products obtained from the respective conventional plants, the applicant shall estimate the anticipated average and maximum intake of the genetically modified food and feed.
Na podlagi reprezentativnih podatkov o porabi proizvodov, pridobljenih iz zadevnih podobnih konvencionalnih rastlin, vlagatelj oceni pričakovani povprečni in največji vnos gensko spremenjenih živil in krme.
Probabilistic methods may be used to determine ranges of plausible values rather than single values or point estimates.
Verjetnostne metode se lahko uporabljajo bolj za določitev razpona verjetnih vrednosti kakor za posamezne vrednosti ali oceno točk.
The applicant shall identify and consider particular groups of the EU population with an expected higher exposure and shall consider this higher exposure within the risk assessment.
Vlagatelj identificira in upošteva posebne skupine prebivalstva EU s pričakovano visoko izpostavljenostjo in to visoko izpostavljenost upošteva v oceni tveganja.
Any assumptions made in the exposure assessment shall be described.
Opišejo se vse predpostavke v zvezi z oceno izpostavljenosti.
Recent developments in methodologies and appropriate consumption data shall be used.
Uporabijo se podatki o najnovejšem razvoju metodologij in ustrezni podatki o porabi.
Data on import and production quantities may provide additional information for the intake assessment.
Podatki o količinah uvoza in proizvodnje lahko zagotovijo dodatne informacije pri oceni vnosa.
The applicant shall determine by appropriate methods the concentrations of the newly expressed proteins, other new constituents and endogenous food and feed constituents, of which the levels have been altered as a result of the genetic modification (for example, due to changes in metabolic pathways) in those parts of the genetically modified plant intended for food or feed use.
Vlagatelj z ustreznimi metodami določi koncentracije novoizraženih beljakovin, drugih novih sestavin ter endogenih sestavin živil in krme, katerih ravni so se spremenile zaradi genske spremembe (na primer zaradi sprememb presnovnih poti) v tistih delih gensko spremenjene rastline, ki so namenjeni za živila ali krmo.
Expected intake of these constituents shall be estimated taking into account the influences of processing, storage and expected treatment of the food and feed in question, for example, potential accumulation or reduction.
Pričakovani vnos teh sestavin se oceni ob upoštevanju vplivov predelave, shranjevanja in pričakovane obdelave zadevnih živil in krme, na primer morebitno kopičenje ali zmanjšanje.
In cases where the genetic modification has resulted in an altered level of a natural constituent, or if a new constituent occurs naturally in other food and feed products, the anticipated change in total intake of this constituent shall be assessed considering realistic as well as worst case intake scenarios.
Ko je genska sprememba posledica spremenjene ravni naravne sestavine ali če se nova sestavina pojavi naravno v drugih živilskih in krmnih proizvodih, se pričakovana sprememba skupnega vnosa te sestavine oceni ob upoštevanju realističnega pa tudi najslabšega scenarija vnosa.
The applicant shall provide information on known or anticipated human/animal intake of analogous genetically modified food and feed and on other routes of exposure to the respective new and natural constituents, including amount, frequency and other factors influencing exposure.
Vlagatelj predloži informacije o znanem ali pričakovanem vnosu podobnih gensko spremenjenih živil in krme pri ljudeh in živalih ter drugih poteh izpostavljenosti zadevnim novim in naravnim sestavinam, vključno s količino, pogostostjo in drugimi dejavniki, ki vplivajo na izpostavljenost.
Introduction
3.1 Uvod
The applicant shall base its risk characterisation of genetically modified plants and foods and feed on data from hazard identification, hazard characterisation, and on exposure/intake data.
Vlagatelj utemelji opredelitev tveganja za gensko spremenjene rastline, živila in krmo na podatkih o identifikaciji nevarnosti, opredelitvi nevarnosti in podatkih o izpostavljenosti/vnosu.
The applicant shall ensure that the risk characterisation is comprehensive by considering all the available evidence from several analysis including molecular analysis, phenotypic, agronomical and compositional analysis, toxicity and allergenicity testing.
Vlagatelj zagotovi, da je opredelitev tveganja celovita, z upoštevanjem vseh razpoložljivih dokazov iz različnih analiz, ki vključujejo molekularno, fenotipsko, agronomsko analizo, analizo sestave, testiranje toksičnosti in alergenosti.
The applicant shall consider indications resulting from the risk characterisation that may require specific activities for post-market monitoring of genetically modified food and feed.
Vlagatelj upošteva znake, ki izhajajo iz opredelitve tveganja, ki morda zahtevajo posebne dejavnosti za spremljanje po dajanju gensko spremenjenih živil in krme na trg.
In performing its risk characterisation, the applicant shall demonstrate that the hazard identification and hazard characterisation are complete.
Pri pripravi opredelitve tveganja vlagatelj dokaže, da sta identifikacija nevarnosti in opredelitev nevarnosti popolna.
The applicant shall discuss the quality of existing data and information.
Vlagatelj razpravlja o kakovosti obstoječih podatkov in informacij.
The discussion shall clearly indicate how this body of information has been taken into account in the determination of the final risk characterisation.
V razpravi jasno navede, kako so bile te informacije upoštevane pri določitvi končne opredelitve tveganja.
The applicant shall provide estimations of the uncertainties associated to each test as well as to the different stages of the risk assessment.
Vlagatelj predloži ocene negotovosti, ki so povezane z vsakim testom, pa tudi različne faze ocene tveganja.
The applicant shall quantify them to the possible extent.
Vlagatelj jih tudi čim bolj količinsko opredeli.
A distinction shall be made between uncertainties that reflect natural variations in biological parameters (including variations in susceptibility in populations), and variation amongst different species’ responses.
Razlikuje med negotovostmi, ki izražajo naravno variabilnost bioloških parametrov (vključno z variabilnostjo v dovzetnosti populacije) in variabilnost med odzivi različnih vrst.
Depending on the issue to be addressed and the available data, the applicant shall perform a qualitative and, where possible, quantitative risk characterisation.
Odvisno od vprašanja, ki se obravnava, in podatkov, ki so na voljo, vlagatelj pripravi kakovostno in, če je mogoče, količinsko opredelitev tveganja.
The conditions for the estimated risk, and associated uncertainties, shall be as precise as possible.
Razmere za ocenjevanje tveganja in povezanih negotovosti naj bodo čim podrobnejše.
Issues to be considered for risk characterisation
3.2 Vprašanja, ki se upoštevajo pri opredelitvi tveganja
When appropriate and depending on the type of genetic modification, the applicant shall carry out a risk assessment of genetically modified plants in an integrative manner in accordance with Section 3.1.
Kadar je primerno in odvisno od vrste genske spremembe, vlagatelj pripravi celovito oceno tveganja gensko spremenjenih rastlin v skladu z oddelkom 3.1.
This risk assessment shall be performed on a case-by-case basis depending on the modified plant and the type of genetic modification, the cultivation practices of the genetically modified plant and uses of the genetically modified food and feed.
Ocenjevanje tveganja se izvede za vsak primer posebej, odvisno od spremenjene rastline in vrste genske spremembe, načina pridelave gensko spremenjene rastline in uporabe gensko spremenjenih živil in krme.
The applicant shall take into account the different issues considered in hazard identification and hazard characterisation and exposure steps.
Vlagatelj upošteva različna vprašanja, ki se obravnavajo pri identifikaciji nevarnosti, opredelitvi nevarnosti ter stopnjah izpostavljenosti.
The outcomes of these issues shall be considered by the applicant together in the risk characterisation step.
Vlagatelj upošteva izide teh vprašanj skupaj s stopnjo opredelitve tveganja.
The list of issues provided in this Section shall not be exhaustive.
Seznam primerov iz tega oddelka ni izčrpen.
Molecular characterisation
3.2.1 Molekularna karakterizacija
Evaluation of the characteristics and previous use of the donor and the recipient plant shall be a key element to identify the need for specific analyses, such as the occurrence of specific toxins, or allergens in the unmodified recipient plant which may be unintentionally increased as result of the genetic modification.
Ocena značilnosti in prejšnje uporabe donorske in prejemne rastline je ključni element za ugotovitev potrebe po posebnih analizah, kot so pojavljanje posebnih toksinov ali alergenov pri nespremenjeni prejemni rastlini, ki se lahko nenamerno povečajo zaradi genske spremembe.
Transformation protocols, molecular characterisation strategies and the specificity and sensitivity of the methods used shall be discussed by the applicant in relation to the intentional and possibly unintentional insertion and expression of gene sequences.
Vlagatelj razpravlja o protokolih transformacije, strategijah molekularne karakterizacije in specifičnosti ter občutljivosti uporabljenih metod v povezavi z namernim in morda nenamernim vnosom in izražanjem zaporedij gena.
Where sequence analysis has identified a potential hazard, the applicant shall demonstrate how approaches like bioinformatic analysis, compositional/agronomical analysis and possibly animal feeding trials with the whole genetically modified food and feed contribute to the safety assessment.
Kadar analiza zaporedij ugotovi potencialno tveganje, vlagatelj dokaže, kako pristopi, kot so bioinformacijska analiza, analiza sestave, agronomska analiza in morebitni poskusi krmljenja živali s celotnimi gensko spremenjenimi živili in krmo, prispevajo k oceni varnosti.
The value of the results obtained shall be evaluated in the light of the available knowledge on the structure and function of genomic databases of the crop species in question or related species.
Vrednost pridobljenih rezultatov se oceni glede na razpoložljivo znanje o strukturi in funkciji genomskih podatkovnih zbirk o vrstah zadevne poljščine ali sorodnih vrstah.
In cases of GM plants containing stacked transformation events, the additional risks possibly arising from the combined effects of the stacked genes shall be evaluated.
Če gensko spremenjene rastline vsebujejo transformacijske dogodke z nalaganjem, se ocenijo dodatna tveganja, ki lahko izhajajo iz kombiniranih učinkov nalaganja genov.
The first goal of the comparative analysis is to identify possible differences between the GM plant and its conventional counterpart and, where appropriate, additional comparators.
Prvi cilj primerjalne analize je ugotoviti morebitne razlike med gensko spremenjeno rastlino in podobno konvencionalno vrsto ter, če je primerno, dodatnimi primerjalnimi vrstami.
The second goal of the comparative analysis is to identify possible lack of equivalences between the GM plant and its reference varieties.
Drugi cilj primerjalne analize je ugotoviti morebitno pomanjkanje enakovrednosti med gensko spremenjeno rastlino in njenimi referenčnimi sortami.
These differences and/or lack of equivalences should be assessed with respect to their possible impact on food and feed safety and nutritional properties, taking into account natural variation.
Te razlike in/ali pomanjkanje enakovrednosti je treba ob upoštevanju naravne variabilnosti oceniti glede na njihov morebitni vpliv na varnost živil in krme ter njihove prehranske lastnosti.
The estimated risk and associated uncertainties should be as precise as possible and taken into account.
Tveganje in povezane negotovosti je treba oceniti čim bolj natančno in jih upoštevati.
The applicant shall demonstrate that the comparative analysis between the genetically modified plant and its conventional counterpart with respect to agronomic, morphological and compositional characteristics has been carried out in accordance with the requirements of this Regulation.
Vlagatelj dokaže, da je bila primerjalna analiza med gensko spremenjeno rastlino in podobno konvencionalno vrsto glede agronomskih in morfoloških značilnosti ter sestave izvedena v skladu z zahtevami te uredbe.
The selection of the conventional counterpart and, where appropriate, additional comparators shall be justified.
Izbira podobne konvencionalne vrste in, če je primerno, dodatnih primerjalnih vrst se utemelji.
Food and feed safety in relation to intake
3.2.3 Varnost živil in krme glede na vnos
The applicant shall evaluate the data generated to estimate possible short-term and long-term risks to human or animal health associated with the consumption of genetically modified food or feed with respect to the expression of new proteins/metabolites, as well as significantly altered levels of original plant proteins/metabolites in genetically modified foods/feed.
Vlagatelj oceni dobljene podatke za presojo morebitnih kratko- in dolgoročnih tveganj za zdravje ljudi ali živali, povezanih s porabo gensko spremenjenih živil ali krme glede na izražene nove beljakovine/metabolite, pa tudi znatno spremenjene ravni prvotnih rastlinskih beljakovin/metabolitov v gensko spremenjenih živilih/krmi.
This evaluation shall include a thorough analysis of the relevance and limitations of each test as well as of the whole information.
Ta ocena vključuje temeljito analizo ustreznosti in omejitev vsakega testa, pa tudi celotnih informacij.
The applicant shall consider the range of levels observed for the compounds known to occur in the conventional counterpart and in reference varieties.
Vlagatelj razmisli o paleti opazovanih stopenj snovi, za katere je znano, da se pojavljajo v podobni konvencionalni vrsti in referenčnih sortah.
This variability may be caused by differences that are genotype-dependent, environmentally dependent, or caused by genotype x environment interactions.
To variabilnost lahko povzročijo razlike, ki so odvisne od genotipa ali od okolja ali pa jih povzroči medsebojno učinkovanje med genotipom in okoljem.
In addition, the range of levels observed in a broad spectrum of food and feed representative for the human and animal diet may be taken into account given that it reflects the levels of the specific compound to which consumers may be exposed.
Poleg tega se lahko upošteva paleta opazovanih stopenj v širokem izboru živil in krme, značilnih za prehrano ljudi in živali, glede na to, da izražajo ravni določene snovi, ki so ji porabniki lahko izpostavljeni.
If single constituents and/or whole genetically modified food and feed are found to induce adverse effects in specific studies, information on dose response relationships, threshold levels, delayed onset of adverse effects, risks for certain groups in the population, and use of uncertainty factors in extrapolation of animal data to humans shall be submitted.
Če je v posebnih študijah ugotovljeno, da posamezne sestavine in/ali celotno gensko spremenjeno živilo in krma sprožijo škodljive učinke, se predložijo informacije o zvezi med odmerkom in odzivom, mejnih stopnjah, zapoznelem nastopu škodljivih učinkov, tveganju za nekatere skupine prebivalstva in uporabi dejavnikov negotovosti pri prenašanju podatkov o živalih na ljudi.
The applicant shall consider data on the characteristics of the new compounds present in the genetically modified plant including potential biological effects in humans and animals.
Vlagatelj upošteva podatke o značilnostih novih snovi, navzočih v gensko spremenjeni rastlini, ki vključujejo morebitne biološke učinke pri ljudeh in živalih.
If the compounds have known adverse health effects and maximum levels for the presence of these compounds in the plant or its products were laid down in specific legislation, these maximum levels shall be taken into account.
Če imajo snovi znane škodljive učinke na zdravje in so v posebni zakonodaji določene mejne vrednosti za navzočnost teh snovi v rastlini in njenih proizvodih, je treba te najvišje ravni upoštevati.
Otherwise, reference values for acceptable or tolerable levels of intake, such as the acceptable daily intake (ADI) or tolerable upper intake level (UL), shall be considered in relation to the anticipated intake.
Drugače pa se v zvezi s pričakovanim vnosom upoštevajo referenčne vrednosti za sprejemljive ali dopustne ravni vnosa, na primer sprejemljivi dnevni vnos ali dopustna zgornja raven vnosa.