natgillin/translations-raw huggingface dataset:
The highest dose shall be the maximum achievable without causing nutritional imbalance; the lowest dose shall contain the tested food and/or feed in an amount always above the anticipated human/target animal intake level.
Najvišji odmerek je največji, ki ga je mogoče doseči brez povzročitve prehranskega neravnovesja; najnižji odmerek vsebuje testirano živilo in/ali krmo v količini, ki je vedno nad pričakovano ravnjo vnosa pri ljudeh/ciljnih živalih.
The genetically modified food and feed analysed should be relevant to the product to be consumed.
Analizirana gensko spremenjena živila in krma se morajo nanašati na proizvod, ki se bo užival.
In the case of herbicide tolerant genetically modified plants, the tested material should come from the genetically modified plant exposed to the intended herbicide.
Pri gensko spremenjenih rastlinah, ki so odporne na herbicide, mora testirani material izhajati iz gensko spremenjene rastline, izpostavljene predvidenemu herbicidu.
Whenever possible, information on natural variation of test parameters shall be derived from historical background data rather than from the inclusion of reference varieties, consisting of commercially available food and feed derived from non-GM plants with a history of safe use, in the experiments.
V poskusih se po možnosti informacije o naravni variabilnosti preskusnih parametrov pridobijo iz podatkov o zgodovinskem ozadju in ne iz vključitve referenčnih sort, sestavljenih iz komercialno dostopnih živil in krme, ki izhajajo iz gensko nespremenjenih rastlin z zgodovino varne uporabe.
The statistical analysis shall focus on the detection of possible differences between the test material and its control.
Statistična analiza je usmerjena v odkrivanje morebitnih razlik med testnim materialom in njegovo kontrolo.
A power analysis to estimate a sample size capable of detecting a pre-specified biologically relevant effect size with a specified power and significance level should be used.
Za ocenitev velikosti vzorca, s katerim je mogoče zaznati vnaprej opredeljeno biološko pomembno velikost učinka z opredeljeno močjo in ravnjo pomembnosti, je treba uporabiti analizo moči.
When information required in Sections 1.4.1, 1.4.2 and 1.4.3 on the genetically modified food and feed suggest the potential for reproductive, developmental or chronic toxicity or in case of indications of adverse effects from the 90-day feeding study in rodents (such as functional and/or histological modifications of nervous, endocrine, reproductive or immunological tissues/organs), appropriate testing shall be performed.
Kadar informacije, ki se zahtevajo v oddelkih 1.4.1, 1.4.2 in 1.4.3 o gensko spremenjenih živilih in krmi, kažejo na možnost za reproduktivno, razvojno ali kronično toksičnost ali v primeru znakov o škodljivih učinkih iz 90-dnevne študije o krmljenju na glodavcih (kot so funkcionalne in/ali histološke spremembe na živčnih, endokrinih, reproduktivnih ali imunoloških tkivih/organih), se izvede ustrezno testiranje.
Protocols for reproductive, developmental and chronic toxicity testing (see Table 1 of Section 1.7) may be adapted for the purposes of testing the whole genetically modified food and feed.
Protokoli za testiranje reproduktivne, razvojne in kronične toksičnosti (glej preglednico 1 v oddelku 1.7) se lahko prilagodijo za testiranje celotnih gensko spremenjenih živil in krme.
Given that the 90-day feeding study in rodents is only designed to detect effects on adult reproductive organ weights and histopathology and that it does not detect other effects on reproduction or development, testing of the whole food and feed beyond a 90-day rodent feeding study shall be conducted where hazards in this respect have been identified.
Ker je 90-dnevna študija o krmljenju na glodavcih namenjena samo temu, da se odkrijejo učinki na težo in histopatologijo odraslega reproduktivnega organa, ter ker ne odkriva drugih učinkov na reprodukcijo ali razvoj, se testiranje celotnega živila ali krme po 90-dnevni študiji o krmljenju na glodavcih izvede samo, kadar so ugotovljene nevarnosti v tem pogledu.
Other animal studies to examine the safety and the characteristics of genetically modified food and feed (see also Sections 1.6.1 and 1.6.2)
1.4.4.3 Druge študije na živalih za preučitev varnosti in značilnosti gensko spremenjenih živil in krme (glej tudi oddelka 1.6.1 in 1.6.2)
Feeding studies with target animal species shall be submitted when indications of adverse effects are drawn from information required in Sections 1.4.1, 1.4.2 and 1.4.3 on the genetically modified food and feed or from the outcome of the 90-day feeding study in rodents.
Študije o krmljenju s ciljno živalsko vrsto se predložijo, kadar znaki o škodljivih učinkih izhajajo iz informacij, ki se zahtevajo v oddelkih 1.4.1, 1.4.2 in 1.4.3 o gensko spremenjenih živilih in krmi, ali iz rezultata 90-dnevne študije o krmljenju na glodavcih.
Their focus shall be on the safety of new constituents (newly expressed proteins and other new constituents), on the identification and characterisation of unintended effects, and on the nutritional impact of any intentional, substantial, compositional modifications of the genetically modified plant (see also Section 1.6).
Osredotočene so na varnost novih sestavin (novoizraženih beljakovin in drugih novih sestavin), na identifikacijo in opredelitev nenamernih učinkov in na vpliv na hranilno vrednost katere koli namerne, pomembne spremembe ali spremembe sestave gensko spremenjene rastline (glej tudi oddelek 1.6).
Studies of that type shall be limited to plant materials suitable for inclusion in their diets and which can be nutritionally matched to a suitable control diet.
Študije te vrste se omejijo na rastlinske materiale, ki so primerni za vključitev v prehrano in lahko prehransko ustrezajo primerno nadzorovani prehrani.
Interpretation of relevance of animal studies
1.4.4.4 Razlaga ustreznosti študij na živalih
Relevant effects observed in the animal trials shall be evaluated in order to identify potential consequences for the health of humans and animals and to assess their relevance for the safety of the genetically modified food and feed.
Ocenijo se pomembni učinki, opaženi v poskusih na živalih, da bi ugotovili morebitne posledice za zdravje ljudi in živali ter ocenili njihovo ustreznost za varnost gensko spremenjenih živil in krme.
This evaluation may be supported by additional information and considerations.
Ta ocena se lahko podpre z dodatnimi informacijami in ugotovitvami.
Attention should be paid to the fact that certain effects may be specific for the test animal, but not for humans due to interspecies differences.
Treba je biti pozoren na dejstvo, da so nekateri učinki lahko značilni za testno žival, zaradi razlik med vrstami pa ne tudi za ljudi.
The applicant shall, in particular, consider dose-response relationships in parameters that have been changed (that is to say, commensurate increases in changes at increased doses) since they provide a strong indication for an effect of the tested compound.
Vlagatelj premisli zlasti o zvezah med odmerkom in odzivom v parametrih, ki se spremenijo (se pravi o sorazmernem povečanju sprememb ob povečanih odmerkih), ker pomenijo močen znak o učinku testne snovi.
When a difference is noted only at the highest dose applied, other factors shall be considered to determine whether there is a relationship with treatment.
Kadar se razlika zazna le pri najvišjem uporabljenem odmerku, se za ugotavljanje, ali obstaja zveza z obdelavo, upoštevajo drugi dejavniki.
Information on the background variability in a given parameter may be obtained by the applicant from data from other animals of the same species/strain tested in the same or other experiments, or from internationally harmonised databases.
Informacije o variabilnosti ozadja za dani parameter lahko vlagatelj pridobi iz podatkov o drugih živalih iste vrste/sorte, testiranih v istem ali drugih poskusih ali iz mednarodno usklajenih podatkovnih zbirk.
In tests where animals of both genders are used, changes occurring in animals of one gender only may still be relevant indicators of an effect, depending on the parameter being changed and the mechanism by which the change may have been caused.
V testih, v katerih se uporabljajo živali obeh spolov, so lahko spremembe, ki se pojavljajo samo pri živalih enega spola, še vedno ustrezen kazalnik učinka, odvisno od parametra, ki se spreminja, in mehanizma, ki je morda povzročil spremembo.
For example, animals of one gender may be more or even specifically prone to changes caused by a given constituent than animals of the other gender, such as in the case of endocrine effects.
Na primer, živali enega spola so lahko posebno ali pa bolj kakor živali drugega spola nagnjene k spremembam, ki jih povzroči dana sestavina, na primer pri endokrinih učinkih.
The applicant shall also identify possible inter-relationships between observed changes in single parameters which may strengthen the indication that an effect has occurred.
Vlagatelj ugotovi tudi možne medsebojne povezave med opazovanimi spremembami pri posameznih parametrih, ki lahko okrepijo znake, da se je pojavil učinek.
For example, liver damage, which may be observed in the liver itself as a change in histopathology, gross pathology, and organ weights, may also be evident from the changed levels of certain liver-derived compounds, such as enzymes or bilirubin in serum.
Na primer, poškodba jeter, ki se lahko opazi v jetrih samih kot sprememba v histopatologiji, makroskopskih patoloških spremembah in masi organa, je lahko razvidna iz spremenjenih ravni nekaterih snovi, ki izvirajo iz jeter, kot so encimi ali serumski bilirubin.
With regard to the potential cause for an observed effect, the likelihood of causality shall be taken into account, not only for the test compound, but also for other factors that may have also influenced the outcomes (such as body weight decrease due to reduced intake of less palatable diet).
V zvezi s potencialnim vzrokom za opaženi učinek se upošteva verjetnost vzročnosti, ne samo za testno snov, temveč tudi za druge dejavnike, ki lahko vplivajo na rezultate (na primer zmanjšanje telesne mase zaradi zmanjšanega vnosa manj sprejemljive prehrane).
Supportive data for a hypothesis of causality between the test compound and effects in test animals may include, for example, predictive data for plausible effects from in vitro and in silico experiments and dose-response relationships observed in the animal test.
Spremljajoči podatki za hipotezo vzročnosti med testno snovjo in učinki pri testnih živalih lahko vključujejo na primer napovedne podatke za verjetne učinke v poskusih in vitro in in silico ter zveze med odmerkom in odzivom, opažene med testom na živalih.
The conclusion of the toxicological assessment shall indicate whether:
V sklepni ugotovitvi toksikološke ocene se navede, ali:
potential adverse effects identified in other parts of the safety assessment have been confirmed or discarded;
so bili morebitni škodljivi učinki, ugotovljeni v drugih delih ocene varnosti, potrjeni ali zavrženi;
the available information on the newly expressed protein(s) and other new constituents resulting from the genetic modification gives indications of potential adverse effects in particular, whether and at which dose levels adverse effects were identified in specific studies;
dajejo razpoložljive informacije o novoizraženih beljakovinah in drugih novih sestavinah, ki izhajajo iz genske spremembe, znake o morebitnih škodljivih učinkih, in zlasti, ali so bili v posebnih študijah ugotovljeni škodljivi učinki ter pri katerih stopnjah odmerka;
the information on natural constituents of which the levels are different from those in its conventional counterpart provides indications of potential adverse effects, in particular, whether and at which dose levels adverse effects were identified in specific studies;
dajejo informacije o naravnih sestavinah, ki nastopajo v drugačnih stopnjah kot pri podobni konvencionalni vrsti, znake o morebitnih škodljivih učinkih, in zlasti, ali so bili v posebnih študijah ugotovljeni škodljivi učinki ter pri katerih stopnjah odmerka;
adverse effects have been identified from the studies made on the whole genetically modified food and feed and at which dose levels.
so bili v študijah, opravljenih na celotnih gensko spremenjenih živilih in krmi, ugotovljeni škodljivi učinki in pri katerih stopnjah odmerka.
The applicant shall evaluate the result of the toxicological assessment in the light of anticipated intake of the genetically modified food and feed (see Section 2).
Vlagatelj oceni rezultat toksikološke ocene glede na pričakovani vnos gensko spremenjenih živil in krme (glej oddelek 2).
Food allergy is an adverse reaction to food and represents an important public health problem.
Alergija na hrano je neželeni odziv na živila in predstavlja pomemben problem javnega zdravja.
Food allergy is different from toxic reactions and intolerance.
Alergija na hrano je drugačna od toksičnih odzivov in intolerance.
Allergy is a pathological deviation of the immune response to a particular substance, which affects only some individuals where a combined effect of variations in the environment and genetic predisposition has resulted in allergic sensitisation.
Alergija je patološki odklon imunskega odziva na določeno snov, ki prizadene nekatere posameznike, pri katerih kombinirani učinek variabilnosti v okolju in genske predispozicije povzroči alergično senzibilizacijo.
In allergic individuals, sometimes minute amounts of a food that is well tolerated by the vast majority of the population can cause serious symptoms and death.
Pri alergičnih posameznikih lahko včasih že neznatne količine živila, ki ga velika večina prebivalstva dobro prenaša, povzročijo zelo resne simptome in smrt.
It is not the allergen per se, but the allergic person’s abnormal reaction to the allergen that causes the adverse health effect.
Ne gre za alergen sam po sebi, ampak za nenormalni odziv alergične osebe na alergen, ki povzroči škodljivi učinek na zdravje.
Food allergy can be caused by various immune mechanisms.
Alergijo na hrano lahko povzročijo različni imunski mehanizmi.
However, IgE-mediated food allergy represents the main form of food allergy, that causes the most severe reactions and the only form causing life-threatening reactions.
Vendar povzročajo imunoglobulini E (IgE) glavno obliko alergije na hrano z najhujšimi odzivi in je edina oblika, ki povzroča življenjsko nevarne odzive.
This IgE-mediated food allergy has been the focus in the risk assessment of allergenicity of GMOs.
Ta alergija na hrano, povezana z IgE, je središče ocenjevanja tveganja za alergenost GSO.
Importantly, food allergy consists of two separate phases: first sensitisation where no symptoms occur while the capacity of the immune system to react increases dramatically, and later elicitation (provocation) with clinical manifestations.
Značilno je, da alergijo na hrano sestavljata dve ločeni fazi: najprej se pojavi senzibilizacija, kjer ni nobenih simptomov, obenem pa se dramatično poveča zmogljivost imunskega sistema za odziv, pozneje pa elicitacijo (provokacijo) s klinično manifestacijo.
When ingested, the allergen(s), that is to say, the sensitising food or food constituent is to some extent degraded by digestive enzymes, absorbed by the gut mucosa (small amounts even by the oral mucosa), processed in specialised cells of the immune system and then presented to the reactive immune cells that produce an immune response.
Ko se alergen, torej živilo ali sestavina živila, ki povzroča senzibilizacijo, zaužije, ga do neke mere razgradijo prebavni encimi, absorbira se skozi črevesno sluznico (v manjših količinah skozi ustno sluznico), nato se predela v posebnih celicah imunskega sistema in preda reaktivnim imunskim celicam, ki ustvarijo imunski odziv.
Sensitisation can also occur if the food allergen comes into contact with the skin or is inhaled.
Do senzibilizacije lahko pride, če pride alergen v stik s kožo ali se vdiha.
The majority of the constituents that are responsible for allergenicity of foods, as well as of pollens, are proteins.
Večina sestavin, ki je odgovorna za alergenost na živila, pa tudi na cvetni prah, so beljakovine.
Some protein breakdown products, that is to say, peptide fragments, may conserve part of the allergenicity of the native protein and thus can also be considered as allergens.
Nekateri razgradni produkti beljakovin, na primer peptidni fragmenti, lahko ohranijo del alergenosti naravne beljakovine, zato se lahko prav tako štejejo za alergene.
The specific allergy risk of GMOs is associated with: (i) exposure to newly expressed protein(s) that can be present in edible parts of the plants or in the pollen; this point is related to the biological source of the transgene; and (ii) alterations to the allergenicity of the whole plant and its products, for example, due to over-expression of natural endogenous allergens as an unintended effect of the genetic modification; this point is related to the biology of the recipient plant itself.
Posebno tveganje za alergenost GSO je povezano: (i) z izpostavljenostjo novoizraženim beljakovinam, ki so lahko navzoče v užitnih delih rastlin ali v pelodu; ta točka je povezana z biološkim izvorom transgena; in (ii) s spremembami alergenosti celotne rastline in njenih proizvodov, na primer zaradi prevelike izraženosti naravnih endogenih alergenov, kot nenamerni učinek genske spremembe; ta točka je povezana z biologijo same prejemne rastline.
Allergenicity is not an intrinsic, fully predictable property of a given protein but is a biological activity requiring an interaction with individuals with a pre-disposed genetic background.
Alergenost ni intrinzična in v celoti predvidljiva lastnost dane beljakovine, temveč biološka dejavnost, ki potrebuje medsebojno učinkovanje pri posameznikih s predispozicijo genske podlage.
Allergenicity therefore depends upon the genetic diversity and variability in atopic humans.
Alergenost je torej odvisna od genske raznovrstnosti in variabilnosti pri atopikih.
Frequency, severity and specificity of allergic reactions also depend upon geographic and environmental factors.
Pogostost, resnost in specifičnost alergičnih odzivov je odvisna tudi od geografskih in okoljskih dejavnikov.
Given this lack of complete predictability, it is necessary to consider several aspects in the assessment of allergenicity to obtain a cumulative body of evidence which minimises any uncertainty with regard to the protein(s) in question.
Ker ni popolne predvidljivosti, je treba pri ocenjevanju alergenosti upoštevati več vidikov in pridobiti zbirno telo dokazov, s katerimi se zmanjša negotovost glede zadevnih beljakovin.
When studying the structural characteristics and the biological and physicochemical properties of a newly expressed protein, it is essential that the tested protein is equivalent with respect to structure and activity to the newly expressed protein in the genetically modified plant.
Pri preučevanju strukturnih značilnosti ter bioloških in fizikalno-kemijskih lastnosti novoizražene beljakovine je bistveno, da je preučevana beljakovina po strukturi in dejavnosti enakovredna novoizraženi beljakovini v gensko spremenjeni rastlini.
Studies carried out using purified target proteins prepared by expression in organisms such as Escherichia coli shall be acceptable provided that the properties of the microbial substitute protein are identical to those of the protein expressed in the plant, thus taking into account all post-translational modifications that specifically occur in the plant.
Študije, izvedene s prečiščenimi ciljnimi beljakovinami, pripravljenimi z izražanjem v organizmih, kot je Escherichia coli, so sprejemljive pod pogojem, da so lastnosti mikrobnega nadomestka beljakovine povsem enake kot lastnosti beljakovine, izražene v rastlini, in so tako upoštevane vse spremembe po prenosu, ki se konkretno pojavijo v rastlini.
The applicant shall verify whether the source of the transgene is allergenic.
Vlagatelj preveri, ali je vir transgena alergenski.
When the introduced genetic material is obtained from wheat, rye, barley, oats or related cereal grains, the applicant shall also assess the newly expressed proteins for a possible role in the elicitation of gluten-sensitive enteropathy or other enteropathies which are not IgE-mediated.
Kadar je vneseni genski material pridobljen iz pšenice, rži, ječmena, ovsa ali sorodnega žitnega zrnja, vlagatelj oceni tudi morebitno vlogo novoizraženih beljakovin pri elicitaciji glutenske enteropatije ali drugih enteropatij, ki niso povezane z IgE.
Where transformation events have been stacked, the applicant shall provide an assessment of any potential for increased allergenicity to humans and animals on a case-by-case approach.
Kjer so se transformacijski dogodki nalagali, vlagatelj predloži oceno morebitnega potenciala za povečano alergenost za ljudi in živali s pristopom, ki upošteva vsak primer posebej.
These potential effects may arise from additive, synergistic or antagonistic effects of the gene products.
Ti morebitni učinki lahko izvirajo iz aditivnih, sinergijskih in nasprotnih učinkov genskih proizvodov.
The applicant shall follow an integrated, case-by-case approach, that is to say, a weight-of-evidence approach, in the assessment of possible allergenicity of newly expressed proteins.
Pri oceni morebitne alergenosti novoizražene beljakovine vlagatelj upošteva celovit pristop za vsak primer posebej, se pravi, pristop na podlagi teže dokazov.
This approach shall include:
Ta načrt sestavljajo:
Amino acid sequence homology comparison between the newly expressed protein and known allergens
Primerjava homologije zaporedja aminokislin med novoizraženo beljakovino in znanimi alergeni
In every case, a search for sequence homologies and/or structural similarities between the expressed protein and known allergens shall be performed to identify potential IgE cross-reactivity between the newly expressed protein and known allergens.
V vsakem primeru se iskanje homologije zaporedja in/ali strukturne podobnosti med izraženo beljakovino in znanimi alergeni izvede zaradi določitve morebitne navzkrižne reaktivnosti z IgE med novoizraženo beljakovino in znanimi alergeni. Vlagatelj poskrbi, da sta kakovost in celovitost podatkovnih zbirk na najvišji ravni.
The applicant shall ensure that the quality and the comprehensiveness of the databases are state of the art. The alignment-based criterion involving 35 % sequence identity to a known allergen over a window of at least 80 amino acids is considered a minimal requirement.
Minimalna zahteva je merilo poravnave, ki vključuje 35-odstotno enakost zaporedja z znanim alergenom na vzorcu, dolgem vsaj 80 aminokislin.
All sequence alignment parameters used in the analysis shall be provided including calculation of percent identity (PID).
Zagotovijo se vsi parametri poravnave zaporedja, uporabljeni v analizi, vključno z izračunom odstotka enakosti zaporedij (PID).
The calculation of PID shall be performed on a window of 80 amino acids with gaps so that inserted gaps are treated as mismatches.
Izračun PID se izvede na vzorcu 80 aminokislin z vrzelmi, tako da se vnesene vrzeli obravnavajo kot neskladja.
In some cases, for assessing short peptidic fragments such as ORFs, a search for sequences of contiguous identical or chemically similar amino acid residue can be conducted.
V nekaterih primerih se lahko za ocenjevanje kratkih peptidnih fragmentov, na primer OBO, izvede iskanje zaporedij sosednjih enakih ali kemijsko podobnih ostankov aminokislin.
However, this search shall not be carried out routinely for the identification of potential linear IgE binding epitopes because of its poor sensitivity or specificity.
Vendar se to iskanje zaradi slabe občutljivosti ali specifičnosti ne izvaja rutinsko za ugotavljanje morebitne vezave IgE na linearne epitope.
Specific serum screening
Presejanje za specifični serum