natgillin/translations-raw huggingface dataset:
Depending on the scope of the application, some of the requested information may not be applicable.
Odvisno od področja uporabe je mogoče, da se nekatere zahtevane informacije ne uporabijo.
The summary shall not contain parts considered to be confidential in accordance with Article 30 of Regulation (EC) No 1829/2003.
Povzetek ne sme vsebovati delov, ki se štejejo za zaupne v skladu s členom 30 Uredbe (ES) št. 1829/2003.
Details of application
1.1 Podrobnosti uporabe
Member State of application
država članica vloge;
Application number
številka vloge;
Name of the product (commercial and any other names)
ime proizvoda (komercialno in vsa druga imena);
Date of acknowledgement of valid application
datum potrditve veljavne vloge.
Applicant
1.2 Vlagatelj
Name of applicant
ime vlagatelja;
Address of applicant
naslov vlagatelja;
Name and address of the representative of the applicant established in the Union (if the applicant is not established in the Union)
ime in naslov predstavnika vlagatelja, ustanovljenega v Uniji (če vlagatelj ni ustanovljen v Uniji).
Scope of the application
1.3 Področje uporabe:
Genetically modified plants for food and feed use
gensko spremenjene rastline za živila in krmo
 Seeds and plant propagating material for cultivation in the Union
 semena in drugi razmnoževalni material za gojenje v Uniji.
Is the product or the uses of the associated plant protection product(s) already authorised or subject to another authorisation procedure within the Union?
1.4 Ali je proizvod ali uporaba pripadajočih fitofarmacevtskih sredstev že odobrena ali se obravnava v drugem postopku odobritve znotraj Unije?
(in that case, specify)
(v tem primeru opredelite)
Has the genetically modified plant been notified under Part B of Directive 2001/18/EC?
1.5 Ali je bila gensko spremenjena rastlina prijavljena v skladu z delom B Direktive 2001/18/ES?
(in that case, provide risk analysis data on the basis of the elements of Part B of Directive 2001/18/EC)
(v tem primeru zagotovite podatke o analizi tveganja na podlagi elementov dela B Direktive 2001/18/ES)
Has the genetically modified plant or derived products been previously notified for marketing in the Union under Part C of Directive 2001/18/EC?
1.6 Ali so bili gensko spremenjena rastlina ali iz nje pridobljeni proizvodi predhodno prijavljeni za trženje v Uniji v skladu z delom C Direktive 2001/18/ES?
Has the product been subject to an application and/or authorised in a third country either previously or simultaneously to this application?
1.7 Ali je bila vložena vloga za odobritev proizvoda in/ali je bil proizvod odobren v tretji državi bodisi predhodno bodisi hkrati s to vlogo?
In that case, specify the third country, the date of application and, where available, a copy of the risk assessment conclusions, the date of the authorisation and the scope of the application
(v tem primeru opredelite tretjo državo, datum vloge in, če je mogoče, kopijo sklepnih ugotovitev ocene tveganja, datum odobritve in področje uporabe)
General description of the product
1.8 Splošni opis proizvoda
Name of the recipient or parental plant and the intended function of the genetic modification
ime prejemne ali starševske rastline in predvidene funkcije genske spremembe;
Types of products planned to be placed on the market according to the authorisation applied for and any specific form in which the product must not be placed on the market (such as seeds, cut-flowers, vegetative parts) as a proposed condition of the authorisation applied for
vrste proizvodov, ki naj bi bili dani na trg v skladu z zaprošeno odobritvijo, in posebna oblika, v kateri se proizvod ne sme dati na trg (na primer semena, rezano cvetje, rastlinski deli), kot predlagani pogoj zaprošene odobritve;
Intended use of the product and types of users
predvidena uporaba proizvoda in vrste uporabnikov;
Any specific instructions and recommendations for use, storage and handling, including mandatory restrictions proposed as a condition of the authorisation applied for
vse posebne smernice in priporočila za uporabo, shranjevanje in ravnanje, vključno z obveznimi prepovedmi, predlaganimi kot pogoj zaprošene odobritve;
If applicable, geographical areas within the Union to which the product is intended to be confined under the terms of the authorisation applied for
če je primerno, geografska območja znotraj Unije, na katera naj bi bil proizvod omejen v okviru pogojev zaprošene odobritve;
Any type of environment to which the product is unsuited
vse vrste okolja, za katere proizvod ni primeren;
Any proposed packaging requirements
vse predlagane zahteve glede pakiranja;
Any proposed labelling requirements in addition to those required by other applicable EU legislation than Regulation (EC) No 1829/2003 and when necessary a proposal for specific labelling in accordance with Article 13(2) and (3), Article 25(2)(c) and (d) and Article 25(3) of Regulation (EC) No 1829/2003
vse predlagane zahteve glede označevanja poleg tistih, ki jih zahteva druga veljavna zakonodaja EU, razen Uredbe (ES) št. 1829/2003, in, kadar je potrebno, predlog za posebno označevanje v skladu s členom 13(2) in (3), členom 25(2)(c) in (d) ter členom 25(3) Uredbe (ES) št. 1829/2003.
In the case of products other than food and feed containing or consisting of genetically modified plants, a proposal for labelling which complies with the requirements of point A(8) of Annex IV to Directive 2001/18/EC must be included.
Pri proizvodih, razen živil in krme, ki vsebujejo gensko spremenjene rastline ali so iz njih sestavljeni, je treba vključiti predlog za označevanje, ki izpolnjuje zahteve točke A(8) Priloge IV k Direktivi 2001/18/ES;
Estimated potential demand
ocenjeno potencialno povpraševanje:
In the EU
v EU;
In EU export markets
na izvoznih trgih EU;
Unique identifier in accordance with Regulation (EC) No 65/2004.
posebni identifikator v skladu z Uredbo (ES) št. 65/2004.
Measures suggested by the applicant to take in the case of unintended release or misuse of the product as well as measures for its disposal and treatment
1.9 Ukrepi, ki jih predlaga vlagatelj v primeru nenamerne sprostitve ali zlorabe proizvoda, pa tudi ukrepi za njegovo odstranitev in obdelavo
INFORMATION RELATING TO THE RECIPIENT OR (WHERE APPROPRIATE) PARENTAL PLANTS
INFORMACIJE O PREJEMNIH ALI (KJER JE PRIMERNO) STARŠEVSKIH RASTLINAH
Complete name
2.1 Celotno ime
Family name
družinsko ime;
Genus
rod;
Species
vrsta;
Subspecies
podvrsta;
Cultivar/breeding line
sorta/žlahtniteljska linija;
Common name
splošno ime.
Geographical distribution and cultivation of the plant, including the distribution within the Union
2.2 Geografska porazdelitev in gojenje rastline, vključno s porazdelitvijo znotraj Unije
Information concerning reproduction (for environmental safety aspects)
2.3 Informacije v zvezi z razmnoževanjem (zaradi vidikov okoljske varnosti)
Mode(s) of reproduction
načini razmnoževanja;
Specific factors affecting reproduction
posebni dejavniki, ki vplivajo na razmnoževanje;
Generation time
generacijski čas.
Sexual compatibility with other cultivated or wild plant species (for environmental safety aspects)
2.4 Spolna združljivost s drugimi gojenimi ali prosto živečimi rastlinskimi vrstami (zaradi vidikov okoljske varnosti)
Survivability (for environmental safety aspects)
2.5 Sposobnost preživetja (zaradi vidikov okoljske varnosti)
Ability to form structures for survival or dormancy
sposobnost oblikovanja struktur za preživetje ali mirovanje;
Specific factors affecting survivability
posebni dejavniki, ki vplivajo na sposobnost preživetja.
Dissemination (for environmental safety aspects)
2.6 Razširjanje (zaradi vidikov okoljske varnosti)
Ways and extent of dissemination
poti in obseg razširjanja;
Specific factors affecting dissemination
posebni dejavniki, ki vplivajo na razširjanje.
Geographical distribution within the Union of the sexually compatible species (for environmental safety aspects)
2.7 Geografska porazdelitev spolno združljivih vrst znotraj Unije (zaradi vidikov okoljske varnosti)
In the case of plant species not normally grown in the Union description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts (for environmental safety aspects)
2.8 Če se rastlinska vrsta ponavadi ne prideluje v Uniji, opis naravnega habitata rastline, vključno z informacijami o naravnih plenilcih, zajedavcih, tekmecih in simbiontih (zaradi vidikov okoljske varnosti)
Other potential interactions, relevant to the genetically modified plant, of the plant with organisms in the ecosystem where it is usually grown, or used elsewhere, including information on toxic effects on humans, animals and other organisms (for environmental safety aspects)
2.9 Druga morebitna medsebojna učinkovanja, ki so za gensko spremenjeno rastlino pomembna, so med rastlino in organizmi v ekosistemih, kjer se ponavadi prideluje, ali drugje, vključno z informacijami o toksičnih učinkih pri ljudeh, živalih in drugih organizmih (zaradi vidikov okoljske varnosti)
MOLECULAR CHARACTERISATION
MOLEKULARNA KARAKTERIZACIJA
Nature and source of the vector used
narava in vir uporabljenega vektorja;
Description of the trait(s) and characteristics which have been introduced or modified
3.2.1 Opis lastnosti in značilnosti, ki so bile vnesene ali spremenjene
Information on the nucleic acid(s) sequences actually inserted or deleted
3.2.2 Informacije o dejansko vnesenih ali odstranjenih zaporedjih nukleinskih kislin
The copy number of all detectable inserts, both complete and partial
število kopij vseh zaznavnih vključkov, popolnih in delnih;
In the case of deletion(s), size and function of the deleted region(s)
v primeru odstranitev velikost in funkcija odstranjenih območij;
Subcellular location(s) of insert(s) (nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form) and methods for its/their determination
znotrajcelična lokacija vključkov (jedro, kloroplasti, mitohondriji ali ohranjenega v nevključeni obliki) in metode za njihovo določanje;
The organisation of the inserted genetic material at the insertion site
organizacija vnesenega genskega materiala na mestu vnosa;
In the case of modifications other than insertion or deletion, describe function of the modified genetic material before and after the modification, as well as direct changes in expression of genes as a result of the modification
v primeru sprememb, razen vnosa ali odstranitve, opis funkcije spremenjenega genskega materiala pred spremembo in po njej, pa tudi neposredne spremembe v izražanju genov kot rezultat spremembe.
Information on the expression of the insert
3.2.3 Informacije o izražanju vključka
Information on developmental expression of the insert during the life cycle of the plant
informacije o izražanju vključka v razvoju med življenjskim ciklom rastline;
Parts of the plant where the insert is expressed
deli rastline, kjer je vključek izražen.
Information (for environmental safety aspects) on how the genetically modified plant differs from the recipient plant in:
3.2.5 Informacije (zaradi vidikov okoljske varnosti) o tem, kako se gensko spremenjena rastlina razlikuje od prejemne rastline v
Mode(s) and/or rate of reproduction
načinih in/ali hitrosti razmnoževanja;
Dissemination
razširjanju;
Survivability
sposobnosti preživetja;
Other differences
drugih razlikah.
Any change to the ability of the genetically modified plant to transfer genetic material to other organisms (for environmental safety aspects)
3.2.6 Vsaka sprememba sposobnosti gensko spremenjene rastline za prenos genskega materiala na druge organizme (zaradi vidikov okoljske varnosti)
Plant to bacteria gene transfer
prenos gena z rastline na bakterijo;
Plant to plant gene transfer
prenos gena z rastline na rastlino.
COMPARATIVE ANALYSIS
PRIMERJALNA ANALIZA
Description of the experimental design (number of locations, growing seasons, geographical spread, replicates and number of commercial varieties in each location) and of the statistical analysis.
Opis načrta poskusa (število lokacij, rastne sezone, geografska porazdelitev, ponovitve in število komercialnih sort na vsaki lokaciji) ter statistične analize.
Effect of processing
4.5 Učinki predelave
TOXICOLOGY
TOKSIKOLOGIJA
Toxicological testing of newly expressed proteins
toksikološko testiranje novoizraženih beljakovin;
Information on natural food or feed constituents
informacije o naravnih sestavinah živila ali krme;
Testing of the whole genetically modified food and feed
1.4.4 Testiranje celotnega gensko spremenjenega živila ali krme
ALLERGENICITY
ALERGENOST
NUTRITIONAL ASSESSMENT
OCENA HRANILNE VREDNOSTI
EXPOSURE ASSESSMENT — ANTICIPATED INTAKE/EXTENT OF USE
OCENA IZPOSTAVLJENOSTI – PRIČAKOVANI VNOS/OBSEG UPORABE
Mechanism of interaction between the genetically modified plant and target organisms
11.1 Mehanizmi medsebojnega učinkovanja med gensko spremenjeno rastlino in ciljnimi organizmi
Potential changes in the interactions of the genetically modified plant with the biotic environment resulting from the genetic modification
11.2 Morebitne spremembe medsebojnega učinkovanja med gensko spremenjeno rastlino in biotskim okoljem, ki so posledica genske spremembe
Persistence and invasiveness
obstojnost in invazivnost;
Selective advantage or disadvantage
selektivna prednost ali pomanjkljivost;
Potential for gene transfer
potencial za prenos gena;
Interactions between the genetically modified plant and target organisms
medsebojno učinkovanje med gensko spremenjeno rastlino in ciljnimi organizmi;
Interactions of the genetically modified plant with non-target organisms
medsebojno učinkovanje med gensko spremenjeno rastlino in neciljnimi organizmi;
Effects on human health
učinki na zdravje ljudi;
Effects on animal health
učinki na zdravje živali;
Effects on biogeochemical processes
učinki na biogeokemične procese;
Impacts of the specific cultivation, management and harvesting techniques
učinki na posebne tehnike pridelave, upravljanja in spravila.
Potential interactions with the abiotic environment
11.3 Morebitna medsebojna učinkovanja z abiotskim okoljem
Risk characterisation
11.4 Opredelitev tveganja
General (risk assessment, background information)
splošno (ocena tveganja, informacije o ozadju);
Interplay between environmental risk assessment and monitoring
medsebojno učinkovanje med oceno tveganja za okolje in spremljanjem;
Case-specific genetically modified plant monitoring (approach, strategy, method and analysis)
spremljanje posameznih primerov gensko spremenjenih rastlin (pristop, strategija, metoda in analiza);
General surveillance of the impact of the genetically modified plant (approach, strategy, method and analysis)
splošen nadzor nad vplivom gensko spremenjene rastline (pristop, strategija, metoda in analiza);
Reporting the results of monitoring
poročanje o rezultatih spremljanja.
DETECTION AND IDENTIFICATION TECHNIQUES FOR THE GENETICALLY MODIFIED PLANT
TEHNIKE ODKRIVANJA IN IDENTIFIKACIJE GENSKO SPREMENJENE RASTLINE
INFORMATION RELATING TO PREVIOUS RELEASES OF THE GENETICALLY MODIFIED PLANT (FOR ENVIRONMENTAL RISK ASSESSMENT ASPECTS)
INFORMACIJE O PREJŠNJEM SPROŠČANJU GENSKO SPREMENJENE RASTLINE (ZARADI VIDIKOV OCENE TVEGANJA ZA OKOLJE)
History of previous releases of the genetically modified plant notified under Part B of Directive 2001/18/EC or under Part B of Council Directive 90/220/EEC [3] by the same notifier
14.1 Zgodovina prejšnjega sproščanja gensko spremenjene rastline, ki jo prijavi isti prijavitelj v skladu z delom B Direktive 2001/18/ES ali v skladu z delom B Direktive Sveta 90/220/EGS [3]
Notification number
številka prijave;
Conclusions of post-release monitoring
sklepne ugotovitve spremljanja po sproščanju;
Results of the release with respect to any risk to human health and the environment, submitted to the competent authority in accordance with Article 10 of Directive 2001/18/EC
rezultati sproščanja glede katerega koli tveganja za zdravje ljudi in okolje, ki se predložijo pristojnemu organu v skladu s členom 10 Direktive 2001/18/ES.
History of previous releases of the genetically modified plant carried out outside the Union by the same notifier
14.2 Zgodovina prejšnjega sproščanja gensko spremenjene rastline, ki jo je isti prijavitelj izvedel zunaj Unije
Release country
država sproščanja;
Authority overseeing the release
organ, ki je nadzoroval sproščanje;
Release site
mesto sproščanja;
Aim of the release
namen sproščanja;
Duration of the release
trajanje sproščanja;
Aim of post-releases monitoring
namen spremljanja po sproščanju;
Duration of post-releases monitoring
trajanje spremljanja po sproščanju;
Results of the release with respect to any risk to human health and the environment
rezultati sproščanja glede katerega koli tveganja za zdravje ljudi in okolje.
SCIENTIFIC REQUIREMENTS FOR THE RISK ASSESSMENT OF GENETICALLY MODIFIED FOOD AND FEED
ZNANSTVENE ZAHTEVE ZA OCENO TVEGANJA ZA GENSKO SPREMENJENA ŽIVILA IN KRMO
‘hazard identification’ means the identification of biological, chemical and physical agents capable of causing adverse health effects and which may be present in a particular food and feed or group of foods and feeds;
„identifikacija nevarnosti“ pomeni identifikacijo bioloških, kemijskih in fizikalnih dejavnikov, ki lahko povzročijo škodljive učinke na zdravje in so lahko navzoči v nekaterih vrstah ali skupinah živil ali krme;
‘hazard characterisation’ means the qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food and feed;
„opredelitev nevarnosti“ pomeni kakovostno in/ali količinsko oceno narave škodljivih učinkov na zdravje v povezavi z biološkimi, kemijskimi in fizikalnimi dejavniki, ki so lahko navzoči v živilih in krmi;
‘risk characterisation’ means the qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterisation and exposure assessment.
„opredelitev tveganja“ pomeni kakovostno in/ali količinsko oceno verjetnosti pojava in resnosti znanih ali morebitnih škodljivih učinkov na zdravje v dani populaciji, vključno s spremljajočimi negotovostmi, na podlagi identifikacije nevarnosti, opredelitve nevarnosti in ocene izpostavljenosti.
SPECIFIC CONSIDERATIONS
POSEBNE UGOTOVITVE
Insertion of marker genes and other nucleic acid(s) sequences not essential to achieve the desired trait
2.1 Vnos označevalnih genov in drugih zaporedij nukleinskih kislin, ki niso bistveni za doseganje zaželene lastnosti
In order to facilitate the risk assessment, the applicant shall endeavour to minimise the presence of inserted nucleic acid(s) sequences not essential to achieve the desired trait.
Zaradi olajšanja ocene tveganja si vlagatelj prizadeva čim bolj zmanjšati navzočnost vnesenih zaporedij nukleinskih kislin, ki niso bistvena za doseganje zaželene lastnosti.
During the process of genetic modification of plants and other organisms, marker genes are often used to facilitate the selection and identification of genetically modified cells, containing the gene of interest inserted into the genome of the host organism, among the vast majority of untransformed cells.
V procesu genske spremembe rastlin in drugih organizmov se za olajšanje izbire in identifikacijo gensko spremenjenih celic, ki vsebujejo želeni gen, vnesen v genom gostiteljskega organizma med veliko večino netransformiranih celic, pogosto uporabljajo označevalni geni.
The applicant shall carefully select such marker genes and Article 4(2) of Directive 2001/18/EC shall be respected.
Vlagatelj pazljivo izbere take označevalne gene ob upoštevanju člena 4(2) Direktive 2001/18/ES.
Against that background, the applicant shall therefore aim to develop GMOs without the use of antibiotic resistance marker genes.
Glede na navedeno ima vlagatelj torej cilj, da razvije GSO brez uporabe označevalnih genov, odpornih proti antibiotikom.
Risk assessment of genetically modified food and feed containing stacked transformation events
2.2 Ocena tveganja gensko spremenjenih živil in krme, ki vsebujejo transformacijske dogodke z nalaganjem
For the risk assessment of genetically modified food and feed containing stacked transformation events obtained by conventional crossing of genetically modified plants containing one or several transformation event(s), the applicant shall provide a risk assessment of each single transformation event or, in accordance with Article 3(6) of this Regulation, refer to already submitted application(s).
Pri oceni tveganja gensko spremenjenih živil in krme, ki vsebujejo transformacijske dogodke z nalaganjem, dobljene s konvencionalnim križanjem gensko spremenjenih rastlin, ki vsebujejo en ali več transformacijskih dogodkov, vlagatelj zagotovi oceno tveganja za vsak posamezni transformacijski dogodek ali pa se v skladu s členom 3(6) te uredbe sklicuje na že predložene vloge.
The risk assessment of genetically modified food and feed containing stacked transformation events shall also include an assessment of the following aspects:
Ocena tveganja gensko spremenjenih živil in krme, ki vsebujejo transformacijske dogodke z nalaganjem, vključuje tudi oceno naslednjih vidikov:
stability of the transformation events;
stabilnost transformacijskih dogodkov;
expression of the transformation events;
izražanje transformacijskih dogodkov;
potential synergistic or antagonistic effects resulting from the combination of the transformation events shall be subject to an assessment in accordance with Sections 1.4 (Toxicology), 1.5 (Allergenicity) and 1.6 (Nutritional assessment).
morebitne sinergijske ali nasprotne učinke, ki izhajajo iz kombinacije transformacijskih dogodkov, in so ocenjeni v skladu z oddelki 1.4 (toksikologija), 1.5 (alergenost) in 1.6 (ocena hranilne vrednosti).
For genetically modified food and feed containing, consisting of or produced from genetically modified plants, whose cultivation is associated with the production of genetically modified material containing various subcombinations of transformation events (segregating crops), the application shall include all subcombinations independently of their origin which have not yet been authorised.
Ocena tveganja za gensko spremenjena živila in krmo, ki vsebujejo gensko spremenjene rastline ali so sestavljeni ali proizvedeni iz gensko spremenjenih rastlin, pridelanih v povezavi s proizvodnjo gensko spremenjenega materiala, ki vsebuje različne podkombinacije transformacijskih dogodkov (ločene poljščine), vloga vključuje vse podkombinacije, neodvisno od njihovega porekla, ki še niso bile odobrene.
In such a case, the applicant shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations or, in the absence of such scientific rationale, provide the experimental data.
V takem primeru vlagatelj predloži znanstveno utemeljitev, ki dokazuje, da za zadevne podkombinacije ni treba zagotoviti rezultatov poskusa, če take znanstvene utemeljitve ni, pa zagotovi rezultate poskusa.
For genetically modified food and feed containing, consisting of or produced from genetically modified plants, the cultivation of which does not lead to the production of genetically modified material containing various combinations of transformation events (non-segregating crops), the application shall only cover the combination which is to be placed on the market.
Za gensko spremenjena živila in krmo, ki vsebujejo gensko spremenjene rastline ali so sestavljeni ali proizvedeni iz gensko spremenjenih rastlin, katerih pridelava ne vodi v proizvodnjo gensko spremenjenega materiala, ki bi vseboval različne kombinacije transformacijskih dogodkov (neločene poljščine), vloga vključuje samo kombinacijo, ki bo dana na trg.
The rules set out in this Section apply mutatis mutandis to transformation events which are combined by other means such as co- and retransformation.
Pravila, določena v tem oddelku, se smiselno uporabljajo za transformacijske dogodke, ki se kombinirajo z drugimi sredstvi, na primer za skupno in ponovno transformacijo.
SCIENTIFIC REQUIREMENTS
ZNANSTVENE ZAHTEVE