natgillin/translations-raw huggingface dataset:
Despite the expected proportion of spurious significant differences, the applicant shall report and discuss all significant differences observed between the genetically modified crop, its conventional counterpart and, where applicable, any other test material, focusing on their biological relevance (see Section 3 on Risk Characterisation).
Kljub pričakovanemu razmerju dozdevno pomembnih razlik vlagatelj poroča in razpravlja o vseh pomembnih razlikah, ugotovljenih pri gensko spremenjeni poljščini, podobni konvencionalni vrsti in, kjer je primerno, vsakem drugem testnem materialu ter se pri tem osredotoči na njihovo biološko ustreznost (glej oddelek 3 o opredelitvi tveganja).
For reporting, full details shall be given for each endpoint analysed, listing:
Pri poročanju se podajo podrobni podatki za vsak analizirani cilj in navedejo:
the assumptions underlying the analysis;
predpostavke, ki so podlaga za analizo;
full specification of the mixed models chosen, including fixed and random effects;
celotna specifikacija izbranih mešanih modelov, vključno s fiksnimi in naključnimi učinki;
results of any test of interaction between the test materials and sites;
rezultati vsakega testa medsebojnega učinkovanja med testnimi materiali in lokacijami;
fixed effects, together with the appropriate estimated residual variation with which they are compared, and variance components for the random factors;
fiksni učinki skupaj z ustrezno ocenjeno varianco ostanka, s katero se primerjajo, in sestavni deli variance za naključne dejavnike;
estimated degrees of freedom;
ocenjene prostostne stopnje;
any other relevant statistics.
vsi drugi ustrezni statistični podatki.
A discussion on the likely impact of other growing conditions not tested in the field trial shall be provided.
Predloži se razprava o verjetnem vplivu drugih pridelovalnih razmer, ki v poskusu na prostem niso bile testirane.
Figure 1: simplified version of a graph for comparative assessment showing the seven outcome types possible for each single endpoint.
Slika 1: Poenostavljena različica grafa za primerjalno oceno, ki prikazuje sedem vrst mogočih rezultatov za vsak posamezni cilj.
After adjustment of the equivalence limits, a single confidence limit (for the difference) serves visually for assessing the outcome of both tests (difference and equivalence).
Po prilagoditvi mej enakovrednosti se ena meja zaupanja (za razliko) uporablja za vizualno ocenjevanje rezultata obeh testov (za razliko in enakovrednost).
Here, only the upper adjusted equivalence limit is considered.
Tu se upošteva le zgornja prilagojena meja enakovrednosti.
Shown are: the mean of the genetically modified crop on an appropriate scale (square); the confidence limits (whiskers) for the difference between the genetically modified crop and its conventional counterpart (bar shows confidence interval); a vertical line indicating no difference (for test of difference); and vertical lines indicating adjusted equivalence limits (for test of equivalence).
Prikazani so: srednja vrednost gensko spremenjene poljščine na ustrezni lestvici (kvadrat); meje zaupanja (zavihki) za razliko med gensko spremenjeno poljščino in podobno konvencionalno vrsto (odklonska daljica kaže interval zaupanja), navpična črta, ki označuje ničelno razliko (za test razlike), in navpični črti, ki označujeta prilagojene meje enakovrednosti (za test enakovrednosti).
For outcome types 1, 3 and 5, the null hypothesis of no difference cannot be rejected: for outcomes 2, 4, 6 and 7, the genetically modified crop is different from its conventional counterpart.
Pri rezultatih vrste 1, 3 in 5 ničelne hipoteze o tem, da ni razlike, ni mogoče zavrniti; pri rezultatih 2, 4, 6 in 7 je gensko spremenjena poljščina drugačna od podobne konvencionalne vrste.
Regarding interpretation of equivalence, four categories (i) to (iv) are identified: in category (i), the null hypothesis of non-equivalence is rejected in favour of equivalence; in categories (ii), (iii) and (iv), non-equivalence cannot be rejected.
Pri razlagi enakovrednosti so ugotovljene štiri kategorije (i) do (iv): v kategoriji (i) je ničelna hipoteza o neenakovrednosti zavrnjena v korist enakovrednosti; v kategorijah (ii), (iii) in (iv) neenakovrednosti ni mogoče zavrniti. Vrsta rezultata Zgornja prilagojena meja enakovrednosti Črta ničelne razlike Kategorije enakovrednosti Zgornja prilagojena meja enakovrednosti (i) (ii) (iii)
A. Regarding test of difference, each outcome from the graph shall be categorised as follows and the respective appropriate conclusion shall be drawn.
A. Glede testa razlike se vsak rezultat iz grafa kategorizira kot sledi in sprejmejo se ustrezni sklepi.
Outcome types 1, 3 and 5: the confidence interval bar overlaps with the line of no-difference.
Rezultati vrste 1, 3 in 5: odklonska daljica intervala zaupanja sega čez črto ničelne razlike.
The null hypothesis of no difference cannot be rejected and the appropriate conclusion is that there is insufficient evidence that the genetically modified crop and its conventional counterpart differ.
Ničelne hipoteze o tem, da ni razlike, ni mogoče zavrniti in ustrezen sklep je, da je premalo dokazov, da se gensko spremenjena poljščina in podobna konvencionalna vrsta razlikujeta.
Outcome types 2, 4, 6 and 7: the confidence interval bar does not overlap with the line of no-difference.
Rezultati vrste 2, 4, 6 in 7: odklonska daljica intervala zaupanja ne sega čez črto ničelne razlike.
The null hypothesis of no difference must be rejected and the appropriate conclusion is that the genetically modified crop is significantly different from its conventional counterpart.
Ničelna hipoteza o tem, da ni razlike, se mora zavrniti in ustrezen sklep je, da je gensko spremenjena poljščina bistveno drugačna od podobne konvencionalne vrste.
B. Regarding test of equivalence, each outcome from the graph shall be categorised as follows, and the respective appropriate conclusion shall be drawn.
B. Glede testa enakovrednosti se vsak rezultat iz grafa kategorizira in sprejmejo se ustrezni sklepi.
Outcome types 1 and 2 (category (i), Figure 1): both confidence limits lie between the adjusted equivalence limits and the null hypothesis of non-equivalence is rejected.
Rezultati vrste 1 in 2 (kategorija (i), slika 1): obe meji zaupanja ležita med prilagojenima mejama enakovrednosti in ničelna hipoteza o neenakovrednosti se zavrne.
The appropriate conclusion is that the genetically modified crop is equivalent to the set of non-genetically modified reference varieties.
Ustrezen sklep je, da je gensko spremenjena poljščina enakovredna sklopu gensko nespremenjenih referenčnih sort.
Outcome types 3 and 4 (category (ii), Figure 1): the mean of the genetically modified crop lies between the adjusted equivalence limits, but the confidence interval bar overlaps at least one of the adjusted equivalence limits on the graph.
Rezultati vrste 3 in 4 (kategorija (ii), slika 1): srednja vrednost gensko spremenjene poljščine leži med prilagojenima mejama enakovrednosti, vendar odklonska daljica intervala zaupanja sega najmanj čez eno prilagojeno mejo enakovrednosti na grafu.
Non-equivalence cannot be rejected and the appropriate conclusion is that equivalence between the genetically modified crop and the set of non-genetically modified reference varieties is more likely to be the case than lack of equivalence.
Neenakovrednosti ni mogoče zavrniti in ustrezen sklep je, da je enakovrednost med gensko spremenjeno poljščino in sklopom gensko nespremenjenih referenčnih sort verjetnejša kakor odsotnost enakovrednosti.
Outcome types 5 and 6 (category (iii), Figure 1): the mean of the genetically modified crop lies outside the adjusted equivalence limits, but the confidence interval bar overlaps with at least one of the adjusted equivalence limits.
Rezultati vrste 5 in 6 (kategorija (iii), slika 1): srednja vrednost gensko spremenjene poljščine leži zunaj prilagojenih mej enakovrednosti, vendar odklonska daljica intervala zaupanja sega najmanj čez eno prilagojeno mejo enakovrednosti.
Non-equivalence cannot be rejected and the appropriate conclusion is that lack of equivalence between the genetically modified crop and the set of non-genetically modified reference varieties is more likely to be the case than equivalence.
Neenakovrednosti ni mogoče zavrniti in ustrezen sklep je, da je pomanjkanje enakovrednosti med gensko spremenjeno poljščino in sklopom gensko nespremenjenih referenčnih sort verjetnejša kakor enakovrednost.
Outcome type 7 (category (iv), Figure 1): both confidence limits lie outside the adjusted equivalence limits.
Rezultat vrste 7 (kategorija (iv), slika 1): obe meji zaupanja ležita zunaj prilagojenih mej enakovrednosti.
The appropriate conclusion is that there is lack of equivalence between the genetically modified crop and the set of non-genetically modified reference varieties.
Ustrezen sklep je, da gre za odsotnost enakovrednosti med gensko spremenjeno poljščino in sklopom gensko nespremenjenih referenčnih sort.
In the case of significant difference and/or lack of equivalence for any particular endpoint, further statistical analysis shall be carried out to assess whether there are interactions between any of the test materials and site, possibly using a simple standard ANOVA approach.
Pri znatnih razlikah in/ali odsotnosti enakovrednosti za kateri koli poseben cilj se izvede nadaljnja statistična analiza, da se oceni, ali obstaja medsebojno učinkovanje med katerim koli testnim materialom in lokacijo, po možnosti s preprostim standardnim pristopom ANOVA.
Whatever approach is adopted, details shall be given, for each endpoint analysed, listing: (a) the assumptions underlying the analysis, and, when appropriate: (b) degrees of freedom; (c) the estimated residual variation for each source of variation, and variance components; (d) any other relevant statistics.
Ne glede na sprejeti pristop se podajo podrobni podatki za vsak analizirani cilj in navedejo: (a) predpostavke, ki so podlaga za analizo in, kadar je primerno: (b) ocenjene prostostne stopnje, (c) ocenjena varianca ostanka za vsak vir variacije in sestavni deli variance, (d) vsi drugi ustrezni statistični podatki.
These additional analyses are intended to aid the interpretation of any significant differences found and to study potential interactions between test materials and other factors.
Te dodatne analize so namenjene v pomoč pri razlagi vseh pomembnih ugotovljenih razlik in preučitvi morebitnega medsebojnega učinkovanja med testnimi materiali in drugimi dejavniki.
More detailed guidance for the application of the requirements of this Section is available in the EFSA opinion on ‘Statistical considerations for the safety evaluation of GMOs’ [4].
Podrobnejše smernice za uporabo zahtev iz tega oddelka so na voljo v mnenju EFSA o „Statističnih vidikih glede ocene varnosti GSO“ [4].
Analysis of the composition of plant material is crucial when comparing the genetically modified food and feed with its conventional counterpart.
Analiza sestave rastlinskega materiala je bistvena, ko se gensko spremenjena živila in krmo primerja s podobno konvencionalno vrsto.
The material to be used for the comparative assessment shall be selected while taking into account the uses of the genetically modified plant and the nature of the genetic modification.
Material, ki se uporabi za primerjalno oceno, se izbere ob upoštevanju uporabe gensko spremenjene rastline in narave genske spremembe.
In the case of herbicide tolerant genetically modified plants, three test materials shall be used: the genetically modified plant exposed to the intended herbicide; the conventional counterpart treated with conventional herbicide management regimes; and the genetically modified plant treated with the same conventional herbicide management regimes.
Pri gensko spremenjenih rastlinah, ki so odporne na herbicide, se uporabijo trije testni materiali: gensko spremenjena rastlina, izpostavljena predvidenemu herbicidu, podobna konvencionalna vrsta, tretirana s konvencionalnimi herbicidi, in gensko spremenjena rastlina, tretirana z istimi konvencionalnimi herbicidi.
Unless duly justified, analysis shall be carried out on the raw agricultural commodity, as this usually represents the main point of entry of the material into the food and feed production and processing chain.
Če ni druge ustrezne utemeljitve, se analiza izvede na surovi kmetijski surovini, ki ponavadi predstavlja glavno vstopno točko materiala v proizvodnjo živil in krme ter predelovalno verigo.
Additional analysis of processed products (such as food and feed, food ingredients, feed materials, food and feed additives or food flavourings) shall be conducted, where appropriate and on a case-by-case basis (see also Section 1.3.6).
Dodatna analiza predelanih proizvodov (kot so živila in krma, sestavine živil, materiali za krmo, dodatki za živila in krmo ali arome za živila) se izvede, kjer je primerno, za vsak primer posebej (glej tudi oddelek 1.3.6).
The sampling, analysis and preparation of the tested material shall be carried out according to appropriate quality standards.
Vzorčenje, analiza in priprava testnega materiala se izvedejo v skladu z ustreznimi standardi kakovosti.
In addition to the analysis on the level of the newly expressed proteins (see Section 1.2.2.3), the compositional analysis shall be carried out on an appropriate range of compounds.
Poleg analize na ravni novoizraženih beljakovin (glej oddelek 1.2.2.3) se izvede analiza sestave tudi na ustreznem sklopu snovi.
In each case, the applicant shall provide at least analysis on proximates (including moisture and total ash), key macro- and micro-nutrients, anti-nutritional compounds, natural toxins, and already identified allergens, as well as other secondary plant metabolites characteristic for specific crop plant species, as referred to in the Organisation for Economic Cooperation and Development (OECD) consensus documents on compositional considerations for new plant varieties (OECD consensus documents) [5].
Vlagatelj v vsakem primeru zagotovi najmanj analizo sestavin (vključno z vlago in surovim pepelom), ključnih makro- in mikrohranilnih snovi, protiprehranskih snovi, naravnih strupov in že ugotovljenih alergenov, pa tudi drugih sekundarnih rastlinskih metabolitov, značilnih za določene rastlinske vrste poljščin, na katere se sklicujejo dokumenti o soglasju Organizacije za ekonomsko sodelovanje in razvoj (OECD) o preudarkih glede sestave novih rastlinskih sort (dokumenti OECD o soglasju) [5].
The vitamins and minerals selected for analysis shall be those which are present at levels which are nutritionally significant and/or which make nutritionally significant contributions to the diet at the levels at which the plant is consumed.
Za analizo so izbrani vitamini in minerali, ki so navzoči v prehransko pomembnih količinah in/ali pomembno prispevajo k hranilni vrednosti prehrane v količinah, v katerih se rastlina uživa.
The specific analyses required shall depend on the plant species examined, but shall include a detailed assessment appropriate to the intended effect of the genetic modification, the considered nutritional value and use of the plant.
Posebne zahtevane analize so odvisne od preučevane rastlinske vrste, vendar vključujejo podrobno oceno, ki ustreza predvidenemu učinku genske spremembe, obravnavani hranilnih vrednosti in uporabi rastline.
The applicant shall pay particular attention to key nutrients such as proteins, carbohydrates, lipids/fats, fibre, vitamins and minerals.
Vlagatelj posveti posebno pozornost ključnim hranilnim snovem, kot so beljakovine, ogljikovi hidrati, lipidi/maščobe, vlaknine, vitamini in minerali.
For example, a fatty acid profile shall be included for oil-rich plants (main individual saturated, mono-unsaturated and poly-unsaturated fatty acids) and an amino acid profile (individual protein amino acids and main non-protein amino acids) for plants used as an important protein source.
Na primer, profil maščobnih kislin se vključi v rastline, bogate z oljem (glavne posamezne nasičene, mononenasičene in polinenasičene maščobne kisline), in profil aminokislin (posamezne proteinske aminokisline in glavne neproteinske aminokisline) v rastline, ki se uporabljajo kot pomemben beljakovinski vir.
Analysis of plant cell wall components are also required for the vegetative parts of plants used for feed purposes.
Potrebne so tudi analize sestavin v steni rastlinske celice za tiste vegetativne dele rastlin, ki se uporabljajo za krmo.
The applicant shall also provide an analysis on key toxins inherently present in the recipient plant which may adversely affect human/animal health depending on their toxic potency and levels.
Vlagatelj predloži tudi analizo ključnih strupov, ki so naravno navzoči v prejemni rastlini, kar lahko škodljivo vpliva na zdravje ljudi/živali, odvisno od zmogljivosti in količine strupa.
The concentrations of such compounds shall be assessed according to plant species and the proposed use of the food and feed product.
Koncentracije takih snovi se ocenijo glede na rastlinsko vrsto in predlagano uporabo živilskega in krmnega proizvoda.
Similarly, anti-nutritional compounds, such as digestive enzyme inhibitors, and already identified allergens shall be studied.
Podobno se preučijo protiprehranske snovi, kot so inhibitorji prebavnih encimov in že ugotovljeni alergeni.
The characteristics of the introduced trait may trigger further analysis of specific compounds including metabolites of potentially modified metabolic pathways.
Značilnosti vnesene lastnosti lahko spodbudijo nadaljnjo analizo določenih snovi, vključno z metaboliti morda spremenjenih presnovnih poti.
The applicant shall consider when appropriate, the inclusion of compounds other than the key nutrients, key toxins, anti-nutrients and allergens identified by the OECD consensus documents and justify the selection of these compounds.
Vlagatelj razmisli, kadar je primerno, o vključitvi drugih snovi poleg ključnih hranilnih snovi, ključnih strupov, protihranilnih snovi in alergenov, ugotovljenih v dokumentih OECD o soglasju, in utemelji izbiro teh snovi.
The applicant shall provide a comparison between the genetically modified plant and its conventional counterpart.
Vlagatelj predloži primerjavo med gensko spremenjeno rastlino in podobno konvencionalno vrsto.
This comparison shall enable the applicant to identify unintended effects resulting from the genetic modification and shall address also plant biology and agronomic traits, including common breeding parameters (such as yield, plant morphology, flowering time, day degrees to maturity, duration of pollen viability, response to plant pathogens and insect pests, sensitivity to abiotic stress).
Primerjava vlagatelju omogoči, da prepozna nenamerne učinke, ki so posledica genske spremembe, ter se loti tudi biologije rastline in agronomskih lastnosti, vključno s splošnimi parametri pridelave (kot so pridelek, morfologija rastline, čas cvetenja, dnevne stopinje do zrelosti, trajanje sposobnosti preživetja peloda, odziv na rastlinske patogene in škodljivi mrčes, občutljivost na abiotski stres).
The protocols of these field trials shall follow the specifications set out in Section 1.3.2.
V protokolih teh poskusov na prostem se upoštevajo specifikacije, navedene v oddelku 1.3.2.
Where transformation events are stacked by conventional crossing, there may also be changes to agronomic and phenotypic characteristics.
Kadar se transformacijski dogodki nalagajo s konvencionalnim križanjem, lahko pride tudi do sprememb agronomskih in fenotipskih značilnosti.
Possible differences in phenotypic characteristics and agronomic properties of stacked transformation events shall be assessed in field trials.
Morebitne razlike fenotipskih značilnosti in agronomskih lastnosti transformacijskih dogodkov z nalaganjem se ocenijo v poskusih na prostem.
Where appropriate, the applicant shall provide additional information on agronomic traits of the stacked transformation events from additional field trials.
Kjer je primerno, vlagatelj predloži dodatne informacije o agronomskih lastnostih transformacijskih dogodkov z nalaganjem z dodatnimi poskusi na prostem.
The applicant shall assess whether or not the processing and/or preserving technologies applied are likely to modify the characteristics of genetically modified end products compared with their respective conventional counterpart.
Vlagatelj oceni, ali je verjetno, da predelava in/ali uporabljene tehnologije konzerviranja spremenijo značilnosti gensko spremenjenih končnih proizvodov v primerjavi s podobnimi konvencionalnimi proizvodi.
The applicant shall provide a description of the different processing technologies in sufficient detail, paying special attention to the steps which may lead to significant changes in the product content, quality or purity.
Vlagatelj predloži dovolj natančen opis različnih predelovalnih tehnologij in posebno pozornost posveti korakom, ki lahko vodijo do znatnih sprememb vsebnosti, kakovosti ali čistosti proizvoda.
Genetic modification can target metabolic pathways resulting in changes in the concentration of non-protein substances or in new metabolites (such as in nutritionally enhanced foods).
Genska sprememba je lahko usmerjena v presnovne poti, kar povzroči spremembe v koncentraciji nebeljakovinskih snovi ali nove metabolite (na primer obogatena živila).
Processed products may be assessed together with the assessment of the genetically modified plant for the safety of the genetic modification, or a processed product may be assessed separately.
Varnost genske spremembe pri predelanih proizvodih se lahko ocenjuje skupaj z oceno gensko spremenjene rastline ali pa se predelani proizvod oceni posebej.
The applicant shall provide the scientific rationale for the risk assessment of these products.
Vlagatelj predloži znanstveno utemeljitev za oceno tveganja za te proizvode.
On a case-by-case basis, the submission of additional experimental data shall be considered by the applicant.
O predložitvi dodatnih rezultatov poskusa se odloči za vsak primer posebej.
When appropriate, depending on the product, information shall be necessary on the composition, level of undesirable substances, nutritional value and metabolism, as well as on the intended use.
Kadar je primerno, odvisno od proizvoda, so potrebne informacije o sestavi, stopnji nezaželenih snovi, hranilni vrednosti in presnovi, pa tudi o predvideni uporabi.
When appropriate, depending on the nature of the newly expressed protein(s), it shall be necessary to assess the extent to which the processing steps lead to the concentration or to the elimination, denaturation and/or degradation of these protein(s) in the final product.
Kadar je primerno, odvisno od narave novoizraženih beljakovin, je treba oceniti obseg, v katerem predelovalni ukrepi vodijo v koncentracijo ali odpravo, denaturacijo in/ali razgradnjo teh beljakovin v končnem proizvodu.
The conclusion of the comparative analysis shall clearly state:
V sklepni ugotovitvi primerjalne analize se jasno navede:
whether agronomic and phenotypic characteristics of the genetically modified plant are, except for the introduced trait(s), different to the characteristics of its conventional counterpart and/or equivalent to the reference varieties, taking into account natural variation;
ali so agronomske in fenotipske značilnosti gensko spremenjene rastline, razen vnesenih lastnosti, drugačne od značilnosti podobne konvencionalne vrste in/ali enakovredne referenčnim sortam ob upoštevanju naravne variabilnosti;
whether compositional characteristics of the genetically modified food and feed are, taking into account natural variation, different to the characteristics of its conventional counterpart and/or equivalent to the reference varieties, except for the introduced trait(s);
ali so značilnosti sestave gensko spremenjenih živil in krme, ob upoštevanju naravne variabilnosti, drugačne od značilnosti podobne konvencionalne vrste in/ali niso enakovredne referenčnim sortam, razen vnesenih lastnosti;