natgillin/translations-raw huggingface dataset:
The applicant shall provide comprehensive information relating to the recipient or (where appropriate) the parental plants in order to:
1.1.1 Vlagatelj predloži celovite informacije o prejemnih ali (kjer je primerno) starševskih rastlinah za:
evaluate all issues of potential concern, such as the presence of natural toxins or allergens;
oceno vseh morebitnih zaskrbljujočih vprašanj, kot sta navzočnost naravnih strupov ali alergenov;
identify the need for specific analyses.
ugotovitev potrebe po posebnih analizah.
For the purposes referred to in point 1.1.1, the applicant shall provide the following information:
1.1.2 Za namene točke 1.1.1 vlagatelj predloži naslednje informacije:
cultivar/breeding line or strain;
sorto/žlahtniteljsko linijo ali sev;
common name.
domače ime;
Geographical distribution and cultivation of the plant, including its distribution within the Union.
geografsko porazdelitev in gojenje rastline, vključno z njeno porazdelitvijo znotraj Unije;
Information on the recipient or parental plants relevant to their safety, including any known toxicity or allergenicity.
informacije o prejemnih ali starševskih rastlinah v zvezi z njihovo varnostjo, vključno s katero koli znano toksičnostjo ali alergenostjo;
Data on the past and present use of the recipient plant.
podatke o pretekli in sedanji uporabi prejemne rastline.
This information shall include the history of safe use for consumption as food or feed, information on how the plant is typically cultivated, transported and stored, whether special processing is required to make the plant safe to eat, and describe the normal role of the plant in the diet (such as which part of the plant is used as a food or feed source, whether its consumption is important in particular subgroups of the population, what important macro- or micro-nutrients it contributes to the diet).
Te informacije vključujejo zgodovino varne uporabe kot živilo ali krma, informacije o tem, kako se rastlina ponavadi goji, prevaža in shranjuje, ali je potrebna posebna obdelava, da je rastlino varno jesti, in opis normalne vloge rastline v prehrani (na primer, kateri deli rastline se uporabljajo kot vir za živila ali krmo, ali je njena poraba pomembna predvsem v podskupinah prebivalstva, katere pomembne makro- ali mikrohranilne snovi prispeva k prehrani).
The applicant shall provide sufficient information on the genetic modification:
Vlagatelj predloži dovolj informacij o genski spremembi:
to identify the nucleic acid(s) intended for transformation and related vector sequences potentially delivered to the recipient plant;
za identifikacijo nukleinskih kislin, predvidenih za transformacijo, in povezanih vektorskih zaporedjih, morda uvedenih v prejemno rastlino;
to characterise the nucleic acid(s) actually inserted in the plant.
za opredelitev nukleinskih kislin, dejansko vnesenih v rastlino.
The applicant shall provide information on the following elements:
Vlagatelj predloži informacije o naslednjih elementih:
the method of genetic transformation including relevant references;
metodi genske transformacije, vključno z ustreznimi referencami;
the recipient plant material;
materialu prejemne rastline;
the species and the strain of Agrobacterium and other microbes, if used during the genetic transformation process;
vrsti in sevu Agrobacterium ter drugih mikrobih, če se uporabijo v procesu genske transformacije;
the helper plasmids, if used during the genetic transformation process;
pomožnih plazmidih, če se uporabijo v procesu genske transformacije;
the source of carrier nucleic acid(s), if used during the genetic transformation process.
viru nosilnih nukleinskih kislin, če se uporabijo v procesu genske transformacije.
The applicant shall provide the following information:
Vlagatelj predloži naslednje informacije:
a physical map of the functional elements and other plasmid/vector components together with the relevant information needed for the interpretation of the molecular analyses (such as restriction sites, the position of primers used in polymerase chain reaction (PCR), the location of probes used in Southern analysis).
topografsko karto funkcionalnih elementov in drugih sestavnih delov plazmida/vektorja skupaj z ustreznimi informacijami, potrebnimi za razlago molekularnih analiz (kot so restrikcijska mesta, položaj začetnih oligonukleotidov, uporabljenih v verižni reakciji s polimerazo (PCR), lokacijo sond, uporabljenih v analizi Southern).
The region intended for insertion shall be clearly indicated;
Območje, predvideno za vnos, se jasno označi;
a table identifying each component of the plasmid/vector (including the region intended for insertion), its size, its origin and its intended function.
preglednico z navedbo vsakega sestavnega dela plazmida/vektorja (vključno z območjem, predvidenim za vnos), njegovo velikost, poreklo in predvideno funkcijo.
Source of nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion
1.2.1.3 Vir nukleinskih kislin, uporabljenih za transformacijo, velikost in predvidena funkcija vsakega sestavnega fragmenta v območju, predvidenem za vnos
The applicant shall provide information on the donor organism(s) and on the nucleic acid(s) sequence(s) intended to be inserted in order to determine whether the nature of the donor organism(s) or the nucleic acid sequence(s) may trigger any safety issue.
Vlagatelj predloži informacije o donorskih organizmih in zaporedjih nukleinskih kislin, predvidenih za vnos, da bi določili, ali lahko narava donorskih organizmov ali zaporedij nukleinskih kislin sproži vprašanje varnosti.
Information regarding the function of the nucleic acid region(s) intended for insertion shall comprise the following elements:
Informacije o funkciji območij nukleinskih kislin, predvidenih za vnos, zajemajo naslednje elemente:
the complete sequence of the nucleic acid(s) intended to be inserted, including information on any deliberate alteration(s) to the corresponding sequence(s) in the donor organism(s);
celotno zaporedje nukleinskih kislin, predvideno za vnos, vključno z informacijami o vsaki namerni spremembi ustreznih zaporedij donorskih organizmov;
the history of safe use of the gene product(s) arising from the regions intended for insertion;
zgodovino varne uporabe genskih proizvodov, ki izhajajo iz območij, predvidenih za vnos;
data on the possible relationship of the gene products with known toxins, anti-nutrients and allergens.
podatke o morebitni povezavi med genskimi proizvodi in znanimi strupi, protihranilnimi snovmi ter alergeni.
Information regarding each donor organism shall comprise:
Informacije o vsakem donorskem organizmu zajemajo:
taxonomic classification;
taksonomsko razvrstitev,
history of use regarding food and feed safety.
zgodovino uporabe glede varnosti živil in krme.
Information provided under this point may be limited to a general description of the introduced trait(s) and the resulting changes to the phenotype and metabolism of the plant.
Informacije v tej točki so lahko omejene na splošen opis vnesenih lastnosti in posledičnih sprememb fenotipa in metabolizma rastline.
For example, when the introduced trait is herbicide tolerance, the applicant shall provide information on the mode of action of the active substance and its metabolism in the plant.
Na primer, kadar je vnesena lastnost odpornost na herbicide, vlagatelj predloži informacije o načinu delovanja aktivne snovi ter njenem metabolizmu v rastlini.
the size and copy number of all detectable inserts, both complete and partial; this is typically determined by Southern analysis.
velikost in število kopij vseh zaznavnih vključkov, popolnih in delnih; to se ponavadi določi z analizo Southern.
Probe/restriction enzyme combinations used for this purpose shall provide complete coverage of sequences that could be inserted into the genetically modified plant, such as any parts of the plasmid/vector or any carrier or foreign nucleic acid(s) remaining in the genetically modified plant.
Kombinacije sonde/restrikcijskega encima, uporabljene v ta namen, zagotovijo celotno pokritje zaporedij, ki se lahko vnesejo v gensko spremenjeno rastlino, na primer kateri koli del plazmida/vektorja ali katere koli nosilne ali tuje nukleinske kisline, ki ostanejo v gensko spremenjeni rastlini.
The Southern analysis shall span the entire transgenic locus(i) as well as flanking sequences and include all appropriate controls.
Analiza Southern zajema celoten transgenski lokus in sosednja zaporedja ter vključuje ustrezen nadzor.
For the determination of copy number of the insert, complementary methods may also be used (such as real-time PCR);
Za določitev števila kopij vključkov se lahko uporabijo tudi dopolnilne metode (na primer PCR v realnem času);
the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format, with the aim of identifying changes in the inserted sequences compared to the sequence intended for insertion;
organizacijo in zaporedje vnesenega genskega materiala na vsakem mestu vnosa v standardizirani elektronski obliki, da se opredelijo spremembe vnesenih zaporedij v primerjavi z zaporedjem, predvidenim za vnos;
in the case of deletion(s), size and function of the deleted region(s), whenever possible;
v primeru odstranitev, če je le mogoče, velikost in funkcijo odstranjenih območij;
subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form) and methods for its/their determination;
znotrajcelično lokacijo vključkov (jedro, kloroplasti, mitohondriji ali ohranjenih v nevključeni obliki) in metode za njihovo določanje;
sequence information in a standardised electronic format for both 5’ and 3’ flanking regions at each insertion site, with the aim of identifying interruptions of known genes.
informacije o zaporedju na 5’ in 3’ koncu sosednjega območja na vsakem mestu vnosa v standardizirani elektronski obliki, da se odkrijejo prekinitve znanih genov.
Bioinformatic analyses shall be conducted using up-to-date databases with the aim of performing both intraspecies and interspecies similarity searches.
Bioinformacijske analize se izvajajo z uporabo najnovejših podatkovnih zbirk z namenom, da se poiščejo podobnosti znotraj vrste in med vrstami.
In the case of genetically modified plants containing stacked transformation events, the safety of potential interactions between any unintended modifications at each insertion site shall be assessed;
Pri gensko spremenjenih rastlinah, ki vsebujejo transformacijske dogodke z nalaganjem, se oceni varnost morebitnih medsebojnih učinkovanj med katerimi koli nenamernimi spremembami na vsakem mestu vnosa;
Open Reading Frames (hereafter referred to as ‘ORFs’ and defined as any nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame) created as a result of the genetic modification either at the junction sites with genomic DNA or due to internal rearrangements of the insert(s).
o odprtih bralnih okvirih (v nadaljnjem besedilu „OBO“, opredeljenih kot nukleotidno zaporedje, ki vsebuje niz kodonov in ni prekinjeno z navzočnostjo stop-kodona v istem bralnem okviru), ki nastanejo kot posledica genske spremembe bodisi na mestih stika z genomsko DNK bodisi zaradi notranjih prerazporeditev vključkov.
The ORFs shall be analysed between stop codons, not limiting their lengths.
OBO se analizirajo med stop-kodoni, ki ne omejujejo njihove dolžine.
Bioinformatic analyses shall be conducted to investigate possible similarities with known toxins or allergens using up-to-date databases.
Z uporabo najnovejših podatkovnih zbirk se izvedejo bioinformacijske analize, s katerimi se preučijo morebitne podobnosti z znanimi strupi ali alergeni.
The characteristics and versions of the databases shall be provided.
Navedejo se značilnosti in različice podatkovnih zbirk.
Depending on the information gathered, further analyses (such as transcription analysis) may be needed to complete the risk assessment.
Odvisno od zbranih informacij bodo za dokončanje ocene tveganja morda potrebne dodatne analize (na primer analiza transkripcije).
The applicant shall provide information:
Vlagatelj predloži informacije, s katerimi:
to demonstrate whether the inserted/modified sequence results in intended changes at the protein, RNA and/or metabolite levels;
dokaže, ali je vneseno/spremenjeno zaporedje posledica namernih sprememb beljakovine, RNA in/ali ravni metabolitov,
to characterise the potential unintended expression of new ORFs identified under point 1.2.2.2(f) as raising a safety concern.
opredeli potencialno nenamerno izražene nove OBO, ugotovljene v točki 1.2.2.2(f), ki zbujajo pomislek o varnosti.
For those purposes, the applicant shall provide the following information:
V ta namen vlagatelj predloži naslednje informacije:
The method(s) used for expression analysis together with their performance characteristics;
metode, uporabljene za analizo, skupaj z njihovimi zmogljivostnimi značilnostmi;
Information on developmental expression of the insert during the life cycle of the plant.
informacije o izražanju vključka v razvoju med življenjskim ciklom rastline.
The requirement for information on developmental expression shall be considered on a case-by-case basis taking into account the promoter used, the intended effect(s) of the modification and scope of the application;
Zahteva glede informacij o izražanju v razvoju se obravnava za vsak primer posebej ob upoštevanju uporabljenega promotorja, predvidenih učinkov na spremembo in obsega uporabe;
Parts of the plant where the insert/modified sequences are expressed;
dele rastline, v katerih so vključek/spremenjena zaporedja izražena;
Potential unintended expression of new ORFs identified under point 1.2.2.2(f) which raise a safety concern;
potencialno nenamerno izražene nove OBO, ugotovljene v točki 1.2.2.2(f), ki zbujajo pomislek o varnosti;
Protein expression data, including the raw data, obtained from field trials and related to the conditions in which the crop is grown.
podatke o izražanju beljakovine, vključno s surovimi podatki, ki se pridobijo iz poskusov na prostem in se primerjajo s pogoji, v katerih se poljščina prideluje.
Data on expression levels from those parts of the plant used for food and feed purposes shall be provided in all cases.
V vseh primerih se zagotovijo podatki o stopnjah izražanja tistih delov rastline, ki so namenjeni za živila in krmo.
In addition, information shall also be provided on the expression of target genes in other parts of the plant when tissue-specific promoters have been used and when this is relevant for the safety assessment.
Poleg tega se zagotovijo tudi informacije o izražanju ciljnih genov v drugih delih rastline, kadar so uporabljeni promotorji, specifični za tkivo, in je to pomembno za oceno varnosti.
The minimum requirement for protein expression shall be data provided from three growing sites or from one site over three seasons.
Najmanjša zahteva za izražanje beljakovine so podatki, ki se zagotovijo iz treh lokacij pridelave ali iz ene lokacije v treh sezonah.
Permutations of the sites and seasons shall be acceptable provided that the minimum requirement is met.
Kombinacije lokacij in sezon so sprejemljive pod pogojem, da je izpolnjena najmanjša zahteva.
When justified by the nature of the insert (such as silencing approaches or where biochemical pathways have been intentionally modified), specific RNA(s) or metabolite(s) shall be analysed.
Kadar to upravičuje narava vključka (na primer utiševalni pristopi ali kadar so namerno spremenjene biokemijske poti), se analizirajo specifične RNA ali metaboliti.
For silencing approaches by RNAi expression, potential ‘off target’ genes should be searched by in silico analysis to assess if the genetic modification could affect the expression of other genes which raise safety concerns;
Za utiševalne pristope z izražanjem interferenčne RNA bi bilo treba poiskati morebitne „neciljne“ gene z analizo in silico, da se oceni, ali bi genska sprememba lahko vplivala na izražanje drugih genov, ki zbujajo pomislek o varnosti;
With regard to the stacking of transformation events by conventional crossing, expression data shall be provided to assess the potential interactions between the events which may raise any additional safety concerns over protein and trait expression compared with the single transformation events.
v zvezi z nalaganjem transformacijskih dogodkov s konvencionalnim križanjem se zagotovijo podatki o izražanju za oceno morebitnih medsebojnih učinkovanj med dogodki, ki lahko zbujajo dodatne pomisleke o varnosti v zvezi z beljakovino in izražanjem lastnosti v primerjavi s posameznimi transformacijskimi dogodki.
The comparison shall be carried out with data obtained from plants grown in the same field trials.
Opravi se primerjava s podatki, dobljenimi od rastlin, ki se gojijo v istih poskusih na prostem.
On a case-by-case basis, and where concerns arise, additional information may be necessary.
V posameznih primerih in kadar se pojavi zaskrbljenost, so lahko potrebne dodatne informacije.
to demonstrate the genetic stability of the transgenic locus(i) and the phenotypic stability and inheritance pattern(s) of the introduced trait(s);
dokaže gensko stabilnost transgenskih lokusov in fenotipsko stabilnost ter dedne vzorce vnesenih lastnosti;
in case of stacked transformation events, to establish that each of the transformation events stacked in the plant has the same molecular properties and characteristics as in the plants with the single transformation events.
v primeru transformacijskih dogodkov z nalaganjem ugotovi, da ima vsak od transformacijskih dogodkov, naloženih v rastlini, enake molekularne lastnosti in značilnosti kot v rastlinah s posameznimi transformacijskimi dogodki.
For the purposes of that information, applicants shall provide data which demonstrate stability over multiple (normally five) generations or vegetative cycles for plant containing single transformation events.
Za navedene informacije vlagatelji zagotovijo podatke, ki dokazujejo stabilnost v več (ponavadi petih) generacijah ali vegetativnih ciklih za rastline s posameznimi transformacijskimi dogodki.
Data from the first and the last generations of vegetative cycles are sufficient.
Zadostujejo podatki iz prve in zadnje generacije vegetativnih ciklov.
The source of the material used for the analysis shall be specified.
Opredeli se vir materiala, uporabljenega za analizo.
Data shall be analysed using appropriate statistical methods.
Podatki se ocenijo z ustreznimi statističnimi metodami.
For stacked transformation events comparisons between the original transformation events and the stacked transformation events shall be carried out using plant materials representative of those designed for commercial production.
Za transformacijske dogodke z nalaganjem se opravijo primerjave med prvotnimi transformacijskimi dogodki in transformacijskimi dogodki z nalaganjem, pri tem pa se uporabijo rastlinski materiali, reprezentativni za rastline, namenjene za komercialno proizvodnjo.
The applicant shall provide adequate justification for the plant materials used.
Vlagatelj predloži ustrezno utemeljitev za uporabljene rastlinske materiale.
Comparisons shall include comparisons of sequences of the inserts and the flanking regions obtained from GM plants containing single events and plants containing stacked transformation events.
Primerjave vključujejo primerjave zaporedij vključkov in sosednjih območij, pridobljenih iz GS rastlin, ki vsebujejo posamezne dogodke, in rastlin, ki vsebujejo transformacijske dogodke z nalaganjem.
To assess genetic stability of the transformation event(s), applicants shall use appropriate molecular approaches referred to in Section 1.2.2.2.
Za oceno genske stabilnosti v transformacijskih dogodkih vlagatelji uporabijo ustrezne molekularne pristope iz oddelka 1.2.2.2.
The applicant shall assess the probability of horizontal gene transfer from the product to humans, animals and micro-organisms and any potential associated risk when intact and functional nucleic acid(s) remains in the genetically modified food and feed.
Vlagatelj oceni verjetnost horizontalnega prenosa gena iz proizvoda na ljudi, živali in mikroorganizme ter potencialno povezano tveganje, kadar nedotaknjene in delujoče nukleinske kisline ostanejo v gensko spremenjenih živilih in krmi.
The molecular characterisation shall provide data on the structure and expression of the insert(s), and on the stability of the intended trait(s).
Molekularna karakterizacija zagotovi podatke o strukturi in izražanju vključkov ter stabilnosti predvidenih lastnosti.
This shall also apply to situations where transformation events have been stacked by conventional breeding.
To velja tudi v primerih, ko se transformacijski dogodki nalagajo s konvencionalno pridelavo.
It shall be specifically indicated whether the molecular characterisation of the genetic modification(s) raises safety concerns with regard to the interruption of endogenous genes or regulatory sequences.
Posebej se navede, ali molekularna karakterizacija genskih sprememb zbuja pomisleke o varnosti v zvezi s prekinitvijo endogenih genov ali regulatornih zaporedij.
The molecular characterisation shall also aim to identify whether the genetic modification(s) raise(s) any issues regarding the potential for producing proteins/substances other than those intended and in particular new toxins or allergens.
Cilj molekularne karakterizacije je tudi, da ugotovi, ali genske spremembe zbujajo morebitna vprašanja v zvezi z možnostjo za proizvodnjo drugih beljakovin/snovi, razen tistih, ki so predvidene, in zlasti novih strupov ali alergenov.
The potential unintended changes identified in this Section shall be addressed in the relevant complementary part(s) of the safety assessment.
Potencialne nenamerne spremembe, ugotovljene v tem oddelku, bodo obravnavane v ustreznih dodatnih delih ocene varnosti.
The comparative analysis of composition and agronomic as well as phenotypic characteristics shall constitute, together with the molecular characterisation, the starting point to structure and conduct the risk assessment of a new genetically modified food and feed.
Primerjalna analiza sestave in agronomskih ter fenotipskih značilnosti skupaj z molekularno karakterizacijo pomeni izhodišče za strukturiranje in izvedbo ocene tveganja za nova gensko spremenjena živila in krmo.
It shall aim at identifying similarities and differences:
Njen cilj je ugotovitev podobnosti in razlik:
in composition, agronomic performance and phenotypic characteristics (intended and unintended alterations) between the genetically modified plant and its conventional counterpart;
v sestavi, agronomski učinkovitosti in fenotipskih značilnostih (namerne in nenamerne spremembe) med gensko spremenjeno rastlino in podobno konvencionalno vrsto;
in composition between the genetically modified food and feed and its conventional counterpart.
v sestavi med gensko spremenjenimi živili in krmo ter podobnimi konvencionalnimi živili in krmo.
In the case of vegetatively propagated crops, the conventional counterpart shall, in principle, be the near-isogenic variety used to generate the transgenic line.
Pri poljščinah z vegetativnim razmnoževanjem je podobna konvencionalna vrsta načeloma tista, ki je skoraj izogena sorta in se uporablja za pripravo transgene linije.
In the case of crops that reproduce sexually, the conventional counterpart shall have a genetic background comparable to the genetically modified plant.
Pri poljščinah, ki se razmnožujejo spolno, ima podobna konvencionalna vrsta primerljivo gensko podlago kot gensko spremenjena rastlina.
When the GM plant has been developed using back-crossing, a conventional counterpart with a genetic background that is as close as possible to the genetically modified plant shall be selected.
Če je bila gensko spremenjena rastlina razvita s povratnim križanjem, se izbere podobna konvencionalna vrsta z gensko podlago, ki je čim bližja gensko spremenjeni rastlini.