natgillin/translations-raw huggingface dataset:
characteristics for which the genetically modified plant or the genetically modified food and feed are different to the characteristics of its conventional counterpart and/or not equivalent to the reference varieties taking into account natural variation, which need further investigation;
katere značilnosti gensko spremenjene rastline ali gensko spremenjenih živil in krme so drugačne od značilnosti podobne konvencionalne vrste in/ali niso enakovredne referenčnim sortam ob upoštevanju naravne variabilnosti, ki potrebuje nadaljnjo raziskavo;
whether, in the case of transformation events stacked by conventional crossing, there are indications of interactions between the combined transformation events.
ali pri transformacijskih dogodkih z nalaganjem s konvencionalnim križanjem obstajajo znaki medsebojnega učinkovanja med kombiniranimi transformacijskimi dogodki.
The toxicological impact of any changes on the whole genetically modified food/feed resulting from the genetic modification such as the introduction of new genes, gene silencing or over-expression of an endogenous gene shall be assessed.
Oceni se toksikološki vpliv vseh sprememb, ki so posledica genskih sprememb, na celotna gensko spremenjena živila in krmo, kot so vnos novih genov, utišanje gena ali pretirano izražanje endogenega gena.
Toxicological assessment shall be performed in order to:
Toksikološka ocena se izvede, da bi:
demonstrate that the intended effect(s) of the genetic modification has no adverse effects on human and animal health;
dokazali, da predvideni učinki genske spremembe nimajo škodljivih učinkov na zdravje ljudi in živali;
demonstrate that unintended effect(s) of the genetic modification(s) identified or assumed to have occurred based on the preceding comparative molecular, compositional or phenotypic analyses, have no adverse effects on human and animal health;
dokazali, da nenamerni učinki genskih sprememb, ki so bili ugotovljeni na podlagi predhodnih primerjalnih analiz molekul, sestave ali fenotipa, ali se domneva, da so se pojavili, nimajo škodljivih učinkov na zdravje ljudi in živali.
identify potential adverse effects of new constituents and determine their highest dose level that does not result in adverse effects.
ugotovili morebitne škodljive učinke novih sestavin in določili najvišjo stopnjo odmerka, ki ne povzroča škodljivih učinkov.
From data obtained from an appropriate animal study, an acceptable daily intake (ADI) of single compounds by humans may be derived by using uncertainty or safety factors that take into account differences between test animal species and humans, and inter-individual variations among humans;
Sprejemljivi dnevni vnos posameznih snovi za človeka se lahko izračuna iz podatkov, pridobljenih v ustreznih študijah na živalih, z uporabo dejavnikov nezanesljivosti ali varnosti ob upoštevanju razlik med testno živalsko vrsto in ljudmi ter variabilnosti med posameznimi ljudmi;
identify potential adverse effects on the whole genetically modified food/feed or address remaining uncertainties through the performance of 90-day feeding studies.
ugotovili morebitne škodljive učinke v celotnem gensko spremenjenem živilu/krmi ali obravnavali preostale negotovosti z izvedbo 90-dnevnih študij o krmljenju.
The applicant shall consider the nature of toxicological testing to be conducted on new constituents and whole genetically modified food/feed based on the outcome of the molecular and comparative analysis referred to in Sections 1.2 and 1.3, namely the differences identified between the genetically modified product and its conventional counterpart, including intended as well as unintended changes.
Vlagatelj razmisli o vrsti toksikološkega testa, ki ga bo opravil na novih sestavinah in celotnem gensko spremenjenem živilu/krmi, na podlagi rezultatov molekularne in primerjalne analize, navedenih v oddelkih 1.2 in 1.3, in sicer razlik, ugotovljenih med gensko spremenjenim proizvodom in podobnim konvencionalnim proizvodom, ki vključujejo namerne pa tudi nenamerne spremembe.
The applicant shall also assess the results of the performed toxicological tests to consider the need to conduct additional testing on new constituents or on whole genetically modified food/feed as set out in Sections 1.4.4.2 and 1.4.4.3.
Vlagatelj oceni tudi rezultate opravljenih toksikoloških testov, da preuči potrebo po izvedbi dodatnih testiranj na novih sestavinah ali celotnem gensko spremenjenem živilu/krmi v skladu z oddelkoma 1.4.4.2. in 1.4.4.3.
The applicant shall take into account the presence of: newly expressed proteins, the potential presence of other new constituents and/or possible changes in the level of natural constituents beyond normal variation.
Vlagatelj upošteva navzočnost: novoizraženih beljakovin, morebitno navzočnost drugih novih sestavin in/ali možnih sprememb količine naravnih sestavin, ki presega normalno variabilnost.
The specific information requirements and testing strategies are set out in Sections 1.4.1 to 1.4.4.
Posebne zahteve glede informacij in strategij testiranja so navedene v oddelkih 1.4.1 do 1.4.4.
As regards applications of which the scope include or is restricted to genetically modified food and feed produced from genetically modified plants, toxicological studies with the processed products shall be provided except if the applicant provides a risk assessment of the genetically modified plant (or relevant parts of it) demonstrating its safety and there are no indications that the processed genetically modified food and feed would be any different from their respective conventional counterpart.
Pri vlogah na področju uporabe, ki vključuje gensko spremenjena živila in krmo, proizvedene iz gensko spremenjenih rastlin, ali je omejena nanje, se toksikološke študije na predelanih proizvodih izvedejo, razen če vlagatelj predloži oceno tveganja gensko spremenjene rastline (ali njenih ustreznih delov), ki dokazuje njeno varnost, in ni znakov, da so predelana gensko spremenjena živila in krma kaj drugačni od podobnih konvencionalnih vrst.
The applicant shall provide adequate justification in this regard.
Vlagatelj posreduje ustrezno utemeljitev v zvezi s tem.
Toxicology studies designed to evaluate risks to human and/or animal health shall complement each other.
Toksikološke študije, namenjene ocenjevanju tveganja za zdravje ljudi in/ali živali, se medsebojno dopolnjujejo.
Most studies required for the assessment of the safety of the genetically modified food are also valid for the assessment of genetically modified feed.
Večina študij, ki so potrebne za ocenjevanje varnosti gensko spremenjenih živil, velja tudi za ocenjevanje gensko spremenjene krme.
Besides the exposure of consumers and animals through intake of food and feed, any adverse effect(s) on individuals that could be due to their exposure to genetically modified food and feed material as part of their professional activities, for example, farming, seed processing, shall be reported by the applicant.
Poleg izpostavljenosti potrošnikov in živali prek uživanja živil in krme vlagatelj poroča tudi o vseh škodljivih učinkih na posameznike, ki bi lahko nastali zaradi izpostavljenosti gensko spremenjenim živilom in materialu za krmo v okviru strokovnih dejavnosti, na primer kmetovanja ali obdelave semen.
Appropriate studies shall be performed to further characterise these indications of potential adverse effects.
Za nadaljnjo opredelitev teh znakov o morebitnih škodljivih učinkih se opravijo ustrezne študije.
The applicant shall use internationally agreed protocols and test methods for toxicity testing (see Tables 1 and 2 of Section 1.7).
Vlagatelj uporabi mednarodno dogovorjene protokole in testne metode za testiranje toksičnosti (glej preglednici 1 in 2 v oddelku 1.7).
Adaptations of these protocols or use of any methods that differ from such protocols shall be justified in the application.
V vlogi se opredelijo prilagoditve teh protokolov ali uporaba vseh metod, ki se razlikujejo od teh protokolov.
The applicant shall provide an evaluation of all newly expressed proteins.
Vlagatelj predloži oceno vseh novoizraženih beljakovin.
The studies required to investigate the potential toxicity of a newly expressed protein shall be selected on a case-by-case basis, depending on the knowledge available with respect to the protein’s source, function or activity and history of human or animal consumption.
Študije, potrebne za raziskavo potencialne toksičnosti novoizražene beljakovine, se izberejo za vsak primer posebej, odvisno od znanja, ki je na voljo v zvezi v izvorom beljakovine, funkcije ali dejavnosti ter zgodovine porabe pri ljudeh ali živalih.
As regards proteins expressed in the genetically modified plant, in the case where the history of safe use for consumption as food and/or feed of both the plant and the newly expressed proteins is duly documented, specific toxicity testing as provided for in this Section shall not be required.
Ko je za beljakovine, izražene v gensko spremenjeni rastlini, dokumentirana zgodovina varne uporabe kot živilo in/ali krma, se za rastlino in novoizražene beljakovine ne zahteva posebno testiranje toksičnosti, kot je predvideno v tem oddelku.
In such case, the applicant shall provide the necessary information regarding the history of safe use of the proteins.
V tem primeru vlagatelj predloži potrebne informacije v zvezi z zgodovino varne uporabe beljakovin.
Where specific testing is required, the tested protein shall be equivalent to the newly expressed protein as it is expressed in the genetically modified plant.
Kjer je potrebno posebno testiranje, je testna beljakovina enakovredna novoizraženi beljakovini, ki je izražena v gensko spremenjeni rastlini.
If, due to the lack of sufficient amount of test materials from the plant, a protein produced by micro-organisms is used, the structural, biochemical and functional equivalence of this microbial substitute to the newly expressed plant protein shall be demonstrated.
Če se zaradi pomanjkanja zadostne količine testnih materialov iz rastline uporabi beljakovina, ki jo proizvajajo mikroorganizmi, se dokaže strukturna, biokemijska in funkcionalna enakovrednost tega mikrobnega nadomestka za novoizraženo beljakovino.
In particular, comparisons of the molecular weight, amino acid sequence, post-translational modification, immunological reactivity and, in the case of enzymes, the enzymatic activity are needed to provide evidence for the equivalence.
Za dokaze o enakovrednosti je treba zagotoviti zlasti primerjave o molekularni masi, zaporedju aminokislin, spremembi po prenosu, imunološki odzivnosti in pri encimih o encimski dejavnosti.
In case of differences between the plant expressed protein and its microbial substitute, the significance of these differences for the safety studies shall be evaluated.
Pri razlikah med rastlinsko izraženo beljakovino in njenim mikrobnim nadomestkom se oceni pomembnost teh razlik za študije varnosti.
To demonstrate the safety of newly expressed proteins, the applicant shall provide:
Da bi vlagatelj dokazal varnost novoizraženih beljakovin, zagotovi:
A molecular and biochemical characterisation of the newly expressed protein, including determination of the primary structure, molecular weight (for example using mass spectrometry), studies on post-translational modifications and a description of its function.
molekularno in biokemijsko karakterizacijo novoizražene beljakovine, vključno z določitvijo primarne strukture, molekulske mase (na primer z masno spektrometrijo), študije o spremembah po prenosu in opis funkcije.
In the case of newly expressed enzymes, information on the enzyme activities including the temperature and pH range for optimum activity, substrate specificity, and possible reaction products shall also be provided.
Pri novoizraženih encimih se zagotovijo tudi informacije o encimski dejavnosti, vključno s temperaturo in razponom pH za optimalno dejavnost, specifičnosti substrata in morebitnih reakcijskih produktih.
The potential interaction with other plant constituents shall also be evaluated.
Oceni se tudi potencialno medsebojno učinkovanje z drugimi rastlinskimi sestavinami;
An up-to-date search for homology to proteins known to cause adverse effects, such as toxic proteins.
sprotno iskanje homologije za beljakovine, za katere je znano, da povzročajo škodljive učinke, na primer toksične beljakovine.
A search for homology to proteins exerting a normal metabolic or structural function may also contribute valuable information.
Iskanje homologije za beljakovine, ki uveljavljajo normalno presnovno ali strukturno funkcijo, lahko prispeva tudi dragocene informacije.
The database(s) and the methodology used to carry out the search shall be specified.
Opredelijo se podatkovne zbirke in metodologija, uporabljene za izvajanje iskanja;
A description of the stability of the protein under relevant processing and storage conditions and the expected treatment of the food and feed.
opis stabilnosti beljakovine v ustreznih razmerah predelave in skladiščenja ter pričakovana obdelava živil in krme.
The influences of temperature and pH changes shall be examined and potential modification(s) of the proteins (such as denaturation) and/or production of stable protein fragments generated through such treatments shall be characterised.
Preučijo se vplivi temperature in sprememb pH in opredelijo morebitne spremembe beljakovin (na primer denaturacija) in/ali proizvodnja stabilnih beljakovinskih fragmentov, ki nastanejo s takimi obdelavami;
Data concerning the resistance of the newly expressed protein to proteolytic enzymes (such as pepsin), such as by in vitro investigations using appropriate and standardised tests.
podatke, ki se nanašajo na odpornost novoizražene beljakovine na proteolitične encime (kot je pepsin), na primer z raziskavami in vitro z ustreznimi in standardiziranimi testi.
Stable breakdown products shall be characterised and evaluated with regard to the potential to cause adverse health effects linked to their biological activity.
Opredelijo se stabilni razgradni produkti in ocenijo glede na možnost, da povzročijo škodljive učinke na zdravje v povezavi s svojo biološko dejavnostjo;
A repeated-dose 28-day oral toxicity study with the newly expressed protein in rodents.
nevno študijo oralne toksičnosti s ponavljajočimi se odmerki novoizražene beljakovine na glodavcih.
When appropriate depending on the outcome of the 28-day toxicity study, further targeted investigations shall be provided, including an analysis of immunotoxicity.
Kadar je primerno, odvisno od rezultata 28-dnevne študije toksičnosti, se zagotovijo nadaljnje ciljne raziskave, vključno z analizo imunotoksičnosti.
Acute toxicity testing of the newly expressed proteins of genetically modified plants is of little additional value for the risk assessment of the repeated human and animal consumption of genetically modified food and feed and shall not be provided as part of the studies performed under this point.
Testiranje akutne toksičnosti novoizraženih beljakovin gensko spremenjenih rastlin ima le malo dodatne vrednosti za oceno tveganja pri ponavljajoči porabi gensko spremenjenih živil in krme pri ljudeh in živalih ter ni predvideno kot del študij, ki se izvajajo v okviru te točke.
The applicant shall perform studies with combined administration of proteins when the genetic modification results in the expression of two or more proteins in the genetically modified plant and when, based on scientific knowledge, a possibility of synergistic or antagonistic interactions of safety concerns is identified.
Vlagatelj izvede študije s kombiniranim upravljanjem beljakovin, kadar genska sprememba povzroči izražanje dveh ali več beljakovin v gensko spremenjeni rastlini in kadar je na podlagi znanstvenih spoznanj ugotovljena možnost sinergijskega ali nasprotnega medsebojnega učinkovanja glede varnosti.
The applicant shall provide a risk assessment of identified new constituents other than proteins.
Vlagatelj predloži oceno tveganja za ugotovljene nove sestavine razen beljakovin.
This shall include, on a case-by-case basis, an evaluation of their toxic potency and of the need of toxicological testing as well as a determination of their concentration in the genetically modified food and feed.
To vključuje oceno toksične potence za vsak primer posebej in potrebe po toksikološkem testiranju ter določitvi njihove koncentracije v gensko spremenjenih živilih in krmi.
To establish the safety of new constituents having no history of safe use for consumption in food and feed, the applicant shall provide information analogous to that described in the ‘Guidance for submissions for food additive evaluations by the EFSA Panel on Food Additives and Nutrient Sources added to Food’ of 16 August 2012 [6] and Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives [7].
Zaradi določitve varnosti novih sestavin, ki nimajo zgodovine varne uporabe v živilih in krmi, vlagatelj predloži informacije, podobne tistim, ki so opisane v „Smernicah Sveta EFSA za aditive za živila in hranilne vire, dodane živilom, za predložitev informacij za ovrednotenje aditivov za živila“ z dne 16. avgusta 2012 [6] in Uredbi Komisije (ES) št. 429/2008 z dne 25. aprila 2008 o podrobnih pravilih za izvajanje Uredbe Evropskega parlamenta in Sveta (ES) št. 1831/2003 v zvezi s pripravo in predložitvijo vlog ter oceno krmnih dodatkov in izdajo dovoljenj zanje [7].
This shall include the submission of information on a core set of studies such as on metabolism/toxicokinetics, subchronic toxicity, genotoxicity, chronic toxicity, carcinogenicity and reproduction and developmental toxicity, accompanied by any other appropriate type of study.
To vključuje predložitev informacij o osnovnem sklopu študij, na primer o presnovi/toksikokinetiki, subkronični toksičnosti, genotoksičnosti, kronični toksičnosti, karcinogenosti in reprodukcijski ter razvojni toksičnosti, ki jih spremljajo morebitne druge primerne vrste študij.
For specific guidelines for animal tests, see Table 1 of Section 1.7 of this Annex.
Glede posebnih smernic za testiranje na živalih glej preglednico 1 v oddelku 1.7 te priloge.
This Section shall apply only in the case where the intended or unintended effect of the genetic modification would result in an alteration of the levels of food and feed constituents beyond the natural variation.
Ta oddelek se uporablja samo v primeru, ko bi namerni ali nenamerni učinek genske spremembe povzročil spremembo ravni sestavin živil in krme zunaj naravne variabilnosti.
To demonstrate the safety of the altered levels of food and feed constituents such as macro- and micro-nutrients, anti-nutrients, and natural toxins as well as other secondary plant metabolites, the applicant shall submit a detailed risk assessment based on the knowledge of the physiological function and/or toxic properties of these constituents.
Da bi vlagatelj dokazal varnost spremenjenih ravni sestavin živil in krme, kot so makro- in mikrohranilne snovi, protihranilne snovi in naravni strupi, pa tudi drugi sekundarni rastlinski metaboliti, predloži podrobno oceno tveganja na podlagi znanja o fiziološki funkciji in/ali toksičnih lastnostih teh sestavin.
The result of that risk assessment shall determine if, and to what extent, the applicant shall provide additional toxicological tests to the 90-day feeding study in rodents with whole genetically modified food/feed on selected food and feed constituents.
Rezultat te ocene tveganja odloči, ali in v kakšnem obsegu vlagatelj predloži dodatne toksikološke teste k 90-dnevni študiji o krmljenju na glodavcih s celotnimi gensko spremenjenimi živili/krmo na izbranih sestavinah živil in krme.
The applicant shall primarily base its risk assessment of the genetically modified food and feed on molecular characterisation, comparative agronomic, phenotypic and comprehensive compositional analysis, and the toxicological evaluation of the identified intended and unintended effects, including a 90-day feeding study in rodents with whole genetically modified food/feed as specified in Section 1.4.4.1.
Vlagatelj utemelji svojo oceno tveganja za gensko spremenjena živila in krmo predvsem z molekularno karakterizacijo, primerjalno analizo agronomskih in fenotipskih značilnosti, celovito analizo sestave ter toksikološko oceno ugotovljenih namernih in nenamernih učinkov, vključno z 90-dnevno študijo o krmljenju na glodavcih s celotnimi gensko spremenjenimi živili/krmo iz oddelka 1.4.4.1.
Under the circumstances set out in points 1.4.4.2 and 1.4.4.3 of this Section, additional specific toxicological studies with the whole genetically modified food and feed shall be carried out.
V razmerah, navedenih v točkah 1.4.4.2 in 1.4.4.3 tega oddelka, se izvedejo dodatne posebne toksikološke študije s celotnimi gensko spremenjenimi živili in krmo.
The applicant shall include a 90-day feeding study with whole food and feed in rodents for the assessment of food and feed containing, consisting of or produced from genetically modified plants with a single transformation event or with stacked transformation events which are not obtained by conventional crossing of genetically modified plants containing a single transformation event.
Vlagatelj vključi 90-dnevno študijo o krmljenju na glodavcih s celotnimi živili in krmo za ocenjevanje živil in krme, ki vsebujejo ali so sestavljeni ali proizvedeni iz gensko spremenjenih rastlin s posameznim transformacijskim dogodkom ali transformacijskimi dogodki z nalaganjem, ki niso pridobljeni s konvencionalnim križanjem gensko spremenjenih rastlin, ki vsebujejo posamezni transformacijski dogodek.
In the case of stacked transformation events obtained by conventional crossing of genetically modified plants containing one or several transformation event(s), a 90-day feeding study with whole food and feed in rodents shall be included for each of the genetically modified plant with a single transformation event which was used.
Pri transformacijskih dogodkih z nalaganjem, dobljenih s konvencionalnim križanjem gensko spremenjenih rastlin, ki vsebujejo en ali več transformacijskih dogodkov, se 90-dnevna študija o krmljenju na glodavcih s celotnimi živili in krmo vključi za vsako gensko spremenjeno rastlino s posameznim transformacijskim dogodkom, ki je bila uporabljena.
An additional 90-day feeding study with whole food and feed in rodents with the genetically modified plant with the stacked transformation events shall be included where indications of potential adverse effects are identified during the assessment of: (i) the stability of the inserts; (ii) the expression of the inserts; and (iii) the potential synergistic or antagonistic effects resulting from the combination of the transformation events.
Dodatna 90-dnevna študija o krmljenju na glodavcih s celotnimi živili in krmo z gensko spremenjeno rastlino s transformacijskimi dogodki z nalaganjem se vključi, kadar so ugotovljeni znaki o morebitnih škodljivih učinkih med ocenjevanjem (i) stabilnosti vključkov, (ii) izražanja vključkov in (iii) morebitnih sinergijskih in nasprotnih učinkov, ki izhajajo iz kombinacije transformacijskih dogodkov.
The design of the toxicity study with genetically modified food and feed should be performed according to the ‘subchronic oral toxicity test repeated-dose 90-day oral toxicity study in rodents’ (see Table 1) following an adapted protocol.
Načrt študije o toksičnosti z gensko spremenjenimi živili in krmo se mora izvesti v skladu s preskusom subkronične oralne toksičnosti v okviru 90-dnevne študije oralne toksičnosti s ponavljajočimi se odmerki na glodavcih (glej preglednico 1) ob upoštevanju sprejetega protokola.
In principle a minimum of two test doses and a negative control shall be used.
Načeloma se uporabijo najmanj dva poskusna odmerka in negativna kontrola.