natgillin/translations-raw huggingface dataset:
In addition, the applicant may include a comparator having a closer genetic background to the genetically modified plant than the conventional counterpart (such as a negative segregant).
Poleg tega lahko vlagatelj vključi primerjalno vrsto z gensko podlago, ki je bližja gensko spremenjeni rastlini kakor podobna konvencionalna vrsta (kot je izbrani nevtralni segregant).
In the case of herbicide tolerant genetically modified plants and in order to assess whether the expected agricultural practices influence the expression of the studied endpoints, three test materials shall be compared: 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.
Da bi ocenili, ali pričakovane kmetijske prakse vplivajo na izražanje preučevanih ciljev pri gensko spremenjenih rastlinah, ki so odporne na herbicide, se primerjajo trije testni materiali: gensko spremenjena rastlina, izpostavljena predvidenemu herbicidu, podobna konvencionalna vrsta, tretirana v ureditvah upravljanja s konvencionalnimi herbicidi, in gensko spremenjena rastlina, tretirana v enakih ureditvah upravljanja s konvencionalnimi herbicidi.
In the case of stacked transformation events, it is not always possible to use a conventional counterpart with a genetic background as close to the genetically modified plant as with conventional counterpart normally used for single transformation events.
Za transformacijske dogodke z nalaganjem ni vedno mogoče uporabiti podobne konvencionalne vrste z gensko podlago, ki bi bila tako blizu gensko spremenjeni rastlini, kot je podobni konvencionalni vrsti, ki se ponavadi uporablja za posamezne transformacijske dogodke.
In such circumstances, the applicant shall provide reasoned justification on the choice of the conventional counterpart and assess its limitations for the risk assessment.
V takih razmerah vlagatelj predloži ustrezno utemeljitev za izbiro podobne konvencionalne vrste in oceni njene omejitve za oceno tveganja.
In addition, single parental genetically modified lines or genetically modified lines containing a subcombination of the stacked transformation events for which an application has been submitted or negative segregants derived from these genetically modified lines may also be included as additional comparators.
Poleg tega se lahko kot dodatne primerjalne vrste vključijo posamezne gensko spremenjene starševske linije ali gensko spremenjene linije, ki vsebujejo podkombinacijo transformacijskih dogodkov z nalaganjem, za katere je bila predložena vloga, ali izbrani nevtralni segreganti, ki so pridobljeni iz teh gensko spremenjenih vrst.
The applicant shall provide detailed information justifying the choice of additional comparators.
Vlagatelj predloži podrobne informacije, ki utemeljujejo izbiro dodatnih primerjalnih vrst.
In all cases, the applicant shall provide information on the breeding scheme (pedigree) in relation to the genetically modified plant, the conventional counterpart and, where appropriate, additional comparators together with an adequate justification of their selection.
Vlagatelj v vseh primerih zagotovi informacije o shemi pridelave (poreklu) za gensko spremenjeno rastlino, podobno konvencionalno vrsto in, če je primerno, dodatne primerjalne vrste skupaj z ustrezno utemeljitvijo svoje izbire.
The history of safe use of the conventional counterpart shall be adequately supported by both qualitative and quantitative data.
Zgodovina varne uporabe podobne konvencionalne vrste se ustrezno podpre s kakovostnimi in količinskimi podatki.
Principles of experimental design
Načela načrta poskusa
Field trials used for the production of material for the comparative analysis shall be performed in order to determine whether the genetically modified plant and/or the genetically modified food and feed is different from its conventional counterpart and/or equivalent to non-genetically modified reference varieties with a history of safe use.
Poskusi na prostem, ki se uporabljajo za proizvodnjo materiala za primerjalno analizo, se izvajajo, da bi ocenili, ali so gensko spremenjena rastlina in/ali gensko spremenjena živila in krma drugačni od podobne konvencionalne vrste in/ali enakovredni kot gensko nespremenjene referenčne sorte z zgodovino varne uporabe.
For each endpoint, the comparative analysis shall involve the following two approaches:
Primerjalna analiza vsebuje za vsak cilj naslednja pristopa:
a test of difference, to verify whether the genetically modified plant is different from its conventional counterpart and might therefore be considered a hazard depending on the type of the identified difference, and on the magnitude and type of exposure;
test razlike za preverjanje, ali je gensko spremenjena rastlina drugačna od podobne konvencionalne vrste in bi se zato lahko štela za nevarno, odvisno od vrste ugotovljene razlike, obsega in vrste izpostavljenosti;
a test of equivalence to verify whether the genetically modified plant is equivalent or not to non-genetically modified reference varieties, apart from the introduced trait(s).
test enakovrednosti za preverjanje, ali je gensko spremenjena rastlina enakovredna ali ne gensko nespremenjenim referenčnim sortam, razen vnesenih lastnosti.
In testing for difference, the null hypothesis shall be that there is no difference between the GMO and its conventional counterpart against the alternative hypothesis that a difference exists.
Ničelna hipoteza pri testiranju razlike je, da ni razlike med GSO in podobno konvencionalno vrsto, proti alternativni hipotezi, da razlika obstaja.
Where additional comparator(s) are used for the risk assessment, a test of difference shall be carried out between the genetically modified plant and each of the additional comparator(s) following the requirements set out in Section 1.3.2.2 for the test of difference between the genetically modified plant and its conventional counterpart.
Če se za oceno tveganja uporabijo dodatne primerjalne vrste, se opravi test razlik med gensko spremenjeno rastlino in vsako dodatno primerjalno vrsto v skladu z zahtevami iz oddelka 1.3.2.2 za test razlik med gensko spremenjeno rastlino in podobno konvencionalno vrsto.
In testing for equivalence, the null hypothesis shall be that the difference between the GMO and the set of reference varieties is at least as great as a specified minimum size (see Section 1.3.2.2) against the alternative hypothesis that there is no difference or a smaller difference than the specified minimum between the GMO and the set of reference varieties.
Ničelna hipoteza pri testiranju enakovrednosti je, da je razlika med GSO in sklopom referenčnih sort najmanj tako velika, kot je opredeljena najmanjša velikost (glej oddelek 1.3.2.2), proti alternativni hipotezi, da ni nobene razlike ali pa je razlika manjša od opredeljene najmanjše razlike med GSO in sklopom referenčnih sort.
Rejection of the null hypothesis shall be required in order to conclude that the GMO and the set of reference varieties are unambiguously equivalent for the endpoint considered.
Da bi ugotovili, ali sta GSO in sklop referenčnih sort nedvoumno enakovredna, je potrebna zavrnitev ničelne hipoteze obravnavanega cilja.
The equivalence limits used for the test of equivalence shall represent appropriately the range of natural variation expected for reference varieties with a history of safe use.
Meje enakovrednosti, uporabljene v testu enakovrednosti, predstavljajo primeren razpon naravne variabilnosti, ki se pričakujejo za referenčne sorte z zgodovino varne uporabe.
Specific protocols for experimental design
Posebni protokoli za načrt poskusa
Natural variation may have several sources: variation within a variety arises due to environmental factors and variation between varieties arises due to a combination of both genetic and environmental factors.
Naravna variabilnost ima lahko več virov: variabilnost znotraj sorte izhaja iz okoljskih dejavnikov in variabilnost med sortami izhaja iz kombinacije genskih in okoljskih dejavnikov.
In order to identify and estimate differences attributable only to genotypes, it is essential to control environmental variability.
Da bi ugotovili in ocenili razlike, ki se lahko pripišejo samo genotipom, je bistven nadzor nad okoljsko variabilnostjo.
Therefore, non-genetically modified reference varieties shall be included in the experimental design of the field trials and in sufficient numbers to ensure an adequate estimate of the variability required to set the equivalence limits.
Zato se gensko nespremenjene referenčne sorte vključijo v načrt poskusa s poskusi na prostem in v zadostnem številu, da se zagotovi ustrezna ocena potrebne variabilnosti za določitev mej enakovrednosti.
All test materials consisting of genetically modified plants, conventional counterpart, reference varieties and, where appropriate, additional comparator(s) shall be randomised to plots within a single field at each site, usually in a completely randomised or randomised block experimental design.
Ves testni material, ki je sestavljen iz gensko spremenjenih rastlin, podobnih konvencionalnih vrst, referenčnih sort in, kjer je primerno, dodatnih primerjalnih vrst, se naključno razporedi na parcele znotraj posameznega polja na vsaki lokaciji, ponavadi popolnoma naključno ali po načrtu poskusa z naključnimi bloki.
The different sites selected for the field trials shall reflect the different meteorological and agronomic conditions under which the crop is to be grown; the choice shall be explicitly justified.
Različne lokacije, izbrane za poskuse na prostem, izražajo različne meteorološke in agronomske razmere, v katerih naj bi se poljščina pridelovala, izbira pa se izrecno utemelji.
The choice of non-genetically modified reference varieties shall be appropriate for the chosen sites and shall be justified explicitly.
Izbira gensko nespremenjenih referenčnih sort je ustrezna za izbrane lokacije in se izrecno utemelji.
In the case the sites cover a restricted range of growing conditions, the applicant shall replicate the field trials over more than one year.
Če lokacije vključujejo omejen obseg pridelovalnih razmer, vlagatelj ponavlja poskuse na prostem več kot eno leto.
Within each site the test materials consisting of genetically modified plants, conventional counterpart and, where appropriate, additional comparator(s) shall be identical for all replicates.
Testni materiali, ki so sestavljeni iz gensko spremenjenih rastlin, podobnih konvencionalnih vrst in, kjer je primerno, dodatnih primerjalnih vrst, so na vseh lokacijah enaki za vse ponovitve.
In addition, unless there is explicit justification for not doing so, at each site there shall be at least three appropriate non-genetically modified reference varieties of the crop that have a known history of safe use, which shall also be identical between replicates.
Poleg tega so na vsaki lokaciji najmanj tri ustrezne gensko nespremenjene referenčne sorte poljščine, ki imajo znano zgodovino varne uporabe in so enake za vse ponovitve, razen če obstaja izrecna utemeljitev, da to ni potrebno.
The replication at each site is the number of results obtained for each test material; the replication should never be less than four at any site.
Ponovitve na vsaki lokaciji ustrezajo številu dobljenih rezultatov za vsak testni material; na vsaki lokaciji morajo biti najmanj štiri ponovitve.
However, if only two appropriate reference varieties are available at a particular site, then the replication shall be six at that site; if only one is available then the replication shall be eight.
Če sta na določeni lokaciji na voljo samo dve ustrezni referenčni sorti, se na tej lokaciji izvede šest ponovitev; če je na voljo samo ena, se izvede osem ponovitev.
Each field trial shall be replicated at a minimum of eight sites, chosen to be representative of the range of likely receiving environments where the plant is to be grown.
Vsak poskus na prostem se ponovi najmanj na osmih lokacijah, ki so izbrane kot reprezentativne za obseg verjetnih prejemnih okolij, v katerih naj bi se rastlina gojila.
The field trials may be conducted in a single year, or spread over multiple years.
Poskusi na prostem se lahko izvedejo v enem letu ali raztegnejo čez več let.
The non-genetically modified reference varieties may vary between sites and at least six different reference varieties shall be used over the entire set of field trials.
Gensko nespremenjene referenčne sorte se lahko med lokacijami razlikujejo in v celotnem sklopu poskusov na prostem se uporabi najmanj šest različnih referenčnih sort.
When the genetically modified plant is tested together with other genetically modified plants of the same crop species (such as Zea mays) the production of material for the comparative assessment of these different genetically modified plant may be produced simultaneously at the same site and within the same field trial by the placing of the different genetically modified plants and their appropriate comparator(s) in the same randomised block.
Ko se gensko spremenjena rastlina testira skupaj z drugimi gensko spremenjenimi rastlinami iste vrste poljščine (kot na primer Zea mays), se lahko proizvodnja materiala za primerjalno oceno teh različnih gensko spremenjenih rastlin odvija sočasno na isti lokaciji in v istem poskusu na prostem tako, da se različne gensko spremenjene rastline in njihove ustrezne primerjalne vrste namestijo v isti naključno razporejeni blok.
This shall be subject to the following two strict conditions:
Pri tem veljata naslednja stroga pogoja:
the conventional counterpart and, where appropriate, additional comparator(s) shall always occur together with the genetically modified plant in the same block;
podobna konvencionalna vrsta in, kjer je primerno, dodatne primerjalne vrste se pojavijo vedno skupaj z gensko spremenjeno rastlino v istem bloku;
all the different genetically modified plants and their comparator(s) and all the non-genetically modified reference varieties used to test equivalence with those genetically modified plants shall be fully randomised within each block.
vse različne gensko spremenjene rastline in njihove primerjalne vrste ter vse gensko nespremenjene referenčne sorte, uporabljene za testiranje enakovrednosti s temi gensko spremenjenimi rastlinami, so povsem naključno razporejene v okviru istega bloka.
If the number of plots per block required for such a field trial were to exceed 16, then a partially balanced incomplete block design may be used, to reduce the number of plots per block, by excluding some of the genetically modified plants and their appropriate comparator(s) from each block.
Če je število parcel na blok, ki so potrebne za tak poskus na prostem, večje od 16, se lahko uporabi načrt delno uravnoteženega nepopolnega bloka, da se zmanjša število parcel na blok z izločanjem nekaterih gensko spremenjenih rastlin in njihovih ustreznih primerjalnih vrst v vsakem bloku.
the conventional counterpart shall always occur together with its particular genetically modified plant in the same block;
podobna konvencionalna vrsta se pojavi vedno skupaj s svojo posebno gensko spremenjeno rastlino v istem bloku;
all of the non-genetically modified reference varieties shall appear in each of the incomplete blocks and be fully randomised with the plants and their comparator(s).
vse gensko nespremenjene referenčne sorte se pojavijo v vsakem nepopolnem bloku in so povsem naključno razporejene z rastlinami in njihovimi primerjalnimi vrstami.
The field trials shall be adequately described, giving information on important parameters such as management of the field before sowing, date of sowing, soil type, herbicide use, climatic and other cultivation/environmental conditions during growth and time of harvest, as well as the conditions during storage of the harvested material.
Poskusi na prostem se ustrezno opišejo, podajo se informacije o pomembnih parametrih, kot so urejanje polja pred sejanjem, datum setve, vrsta tal, uporaba herbicidov, klimatske in druge pridelovalne/okoljske razmere med pridelavo ter čas spravila, pa tudi razmere med shranjevanjem pobranega materiala.
Analysis of data shall be presented in a clear format, using standardised scientific units.
Analiza podatkov se predstavi v jasni obliki s standardiziranimi znanstvenimi enotami.
The raw data and the programming code used for the statistical analysis shall be given in an editable form.
Surovi podatki in programske kode, uporabljene za statistično analizo, se podajo v pregledni obliki.
Data transformation may be necessary to ensure normality and to provide an appropriate scale on which statistical effects are additive.
Morda je potrebna pretvorba podatkov, da se zagotovi normalnost in ustrezna lestvica, na kateri se statistični učinki seštevajo.
For many endpoint response variables, a logarithmic transformation is expected to be appropriate.
Za številne spremenljivke merjenega odziva je primerna logaritemska pretvorba.
In such cases, any difference between the genetically modified material and any other test material shall be interpreted as a ratio on the natural scale.
V takih primerih se vsaka razlika med gensko spremenjenim materialom in vsakim drugim testnim materialom razlaga kot količnik na naravni lestvici.
However, when logarithmic transformation does not provide appropriate results, the natural scale or another scale shall be considered.
A kadar logaritemska pretvorba ne zagotavlja primernih rezultatov, se razmisli o naravni ali drugi lestvici.
The total variability of each endpoint observed in the field trials shall be estimated and partitioned using appropriate statistical models in order to derive two sets of confidence limits and to set a lower and upper equivalence limit based on the variability observed among the reference varieties.
Skupna variabilnost vsakega opazovanega cilja v poskusih na prostem se oceni in popolnoma razdeli z ustreznimi statističnimi modeli, da bi dobili dva sklopa mej zaupanja in določili spodnjo in zgornjo mejo enakovrednosti na podlagi variabilnosti, ugotovljene med referenčnimi sortami.
One set of confidence limits shall be used in the test of difference; the other set and the equivalence limits shall be used in the test of equivalence.
En sklop mej zaupanja se uporabi v testu razlike, drugi sklop in meje enakovrednosti se uporabijo v testu enakovrednosti.
A linear mixed statistical model shall be used for calculation of the confidence limits for both tests (that is to say, the difference and equivalence tests); a slightly different model shall be used to estimate the equivalence limits to be used in the equivalence test.
Linearni mešani statistični model se uporabi za izračun mej zaupanja za oba testa (se pravi za test razlike in test enakovrednosti); nekoliko drugačen model se uporabi za oceno mej enakovrednosti, ki se uporabijo v testu enakovrednosti.
Denote by I an indicator variable (uncentered in the mixed model) such that I = 1 for a field plot having any of the non-GM reference varieties, and I = 0 otherwise.
Označite z I pojasnjevalno spremenljivko (v mešanem modelu neusredinjena), tako da je za parcelo s katero koli gensko nespremenjeno referenčno sorto I=1, sicer pa I=0.
The fixed factor for both models should have as many levels as there are test materials and represent the contrasts between the means of the test materials.
Fiksni faktor mora imeti za oba modela toliko ravni, kot je testnih materialov, in mora predstavljati nasprotja med testnimi materiali.
The test materials are as defined above: the GM plant; its conventional counterpart; the set of non-GM reference varieties; and any additional test materials.
Testni materiali so, kot so opredeljeni zgoraj: gensko spremenjena rastlina, podobna konvencionalna vrsta, sklop gensko nespremenjenih referenčnih sort in morebitni dodatni testni materiali.
The set of non-GM reference varieties is considered as a single level of the fixed factor.
Sklop gensko nespremenjenih referenčnih sort se šteje kot ena raven fiksnega faktorja.
For the difference test, the component of the fixed factor of interest is the single degree-of-freedom contrast between the GM plant and its conventional counterpart.
Pri testu razlike je kot sestavni del fiksnega faktorja pomembna razlika z eno stopinjo prostosti med gensko spremenjeno rastlino in podobno konvencionalno vrsto.
For the equivalence test, the component of the fixed factor of interest is the single degree-of-freedom contrast between the GM plant and the set of non-GM reference varieties.
Pri testu enakovrednosti je kot sestavni del fiksnega faktorja pomembna razlika z eno stopinjo prostosti med gensko spremenjeno rastlino in sklopom gensko nespremenjenih referenčnih sort.
Both the difference test and the equivalence test shall be implemented using the correspondence between hypothesis testing and the construction of confidence limits.
Oba testa, test razlike in test enakovrednosti, se izvedeta z uporabo korespondence med testiranjem hipoteze in oblikovanjem mej zaupanja.
In the case of equivalence testing, the approach used shall follow the two one-sided tests (TOST) methodology by rejecting the null hypothesis of non-equivalence when the both confidence limits fall between the equivalence limits.
Pri testiranju enakovrednosti se uporabi pristop, ki upošteva metodologijo dveh enostranskih testov z zavrnitvijo ničelne hipoteze neenakovrednosti, kadar obe meji zaupanja padeta med meji enakovrednosti.
The choice of 90 % confidence limits corresponds to the customary 95 % level for statistical testing of equivalence.
Izbira 90 % meje zaupanja ustreza običajni stopnji 95 % za statistično testiranje enakovrednosti.
The results of the difference and equivalence tests shall be represented visually for all the endpoints simultaneously, on a single graph or a few graphs.
Rezultati testov razlike in enakovrednosti se vizualno predstavijo za vse cilje hkrati na enem ali več grafih.
The graph(s) shall show the line of zero difference between the genetically modified material and its conventional counterpart, and for each endpoint: the lower and upper adjusted equivalence limits; the mean difference between the genetically modified material and its conventional counterpart; and the confidence limits for this difference (see the set of possible outcomes for a single endpoint in the graph in Figure 1).
Grafi prikažejo črto ničelne razlike med gensko spremenjenim materialom in podobno konvencionalno vrsto in za vsak cilj: spodnjo in zgornjo prilagojeno mejo enakovrednosti, srednjo vrednost razlike med gensko spremenjenim materialom in podobno konvencionalno vrsto ter meji zaupanja za to razliko (glej sklop možnih rezultatov za posamezen cilj v grafu na sliki 1).
When, in addition to the conventional counterpart, another test material is used as comparator, the mean difference between the genetically modified material and that comparator, its confidence limits and its adjusted equivalence limits shall be displayed on the graph(s), for all such additional comparators, by referring this to the same zero baseline as defined by the conventional counterpart.
Kadar se poleg podobne konvencionalne vrste kot primerjalna vrsta uporabi tudi drug testni material, se srednja vrednost razlike med gensko spremenjenim materialom in to primerjalno vrsto, njegovi meji zaupanja in prilagojeni meji enakovrednosti prikažejo na grafih za vse take dodatne primerjalne vrste s sklicevanjem na isto ničelno izhodišče, kot je opredeljeno s podobno konvencionalno vrsto.
The line of zero difference on the logarithmic scale corresponds to a multiplicative factor of unity on the natural scale.
Črta ničelne razlike na logaritemski lestvici ustreza multiplikativnemu faktorju enotnosti na naravni lestvici.
The horizontal axis shall be labelled with values that specify the change on the natural scale.
Horizontalna os se označi z vrednostmi, ki določajo spremembo na naravni lestvici.
In the case of logarithmic transformation, changes of 2x and ½x will appear equally spaced on either side of the line of zero difference.
Pri logaritemski pretvorbi se spremembi 2x in ½x pojavita v enaki oddaljenosti na vsaki strani črte ničelne razlike.