natgillin/translations-raw huggingface dataset:
The risk management strategies shall be described in terms of reducing the hazard or the exposure, or both, and shall be proportionate to the intended reduction of the risk, the scale and conditions of the release and the levels of uncertainty identified in the e.r.a.
V oceni tveganja in zaključkih se predlagajo tudi posebne zahteve za načrt spremljanja GSO in, kadar je ustrezno, spremljanje učinkovitosti predlaganih ukrepov za obvladovanje tveganja.
The consequent reduction in overall risk shall be quantified where possible.
Za prijave po delu C Direktive ocena tveganja vključuje tudi razlago predvidevanj iz časa OTO, narave in razsežnosti negotovosti, povezanih s tveganji, ter utemeljitev predlaganih ukrepov za obvladovanje tveganja.“;
Overall risk evaluation and conclusions
naslov in uvodni odstavek oddelka D se nadomestita z naslednjim:
A qualitative and, where possible, quantitative evaluation of the overall risk of the GMO shall be made taking into account the results of the risk characterisation, the proposed risk management strategies and the associated levels of uncertainty.
Zaključki OTO o posebnih področjih tveganja
The overall risk evaluation shall include, where applicable, the risk management strategies proposed for each identified risk.
Zaključki o možnem vplivu na okolje v zadevnih prejemnih okoljih zaradi sproščanja ali dajanja v promet GSO se pripravijo za vsako ustrezno področje tveganja iz oddelka D1 za GSO, ki niso višje rastline, ali oddelka D2 za gensko spremenjene višje rastline, in sicer na podlagi OTO, opravljene v skladu z načeli iz oddelka B in metodologijo iz oddelka C, ter na podlagi zahtevanih informacij v skladu s Prilogo III.“;
The overall risk evaluation and conclusions shall also propose specific requirements for the monitoring plan of the GMO and, where appropriate, the monitoring of the efficacy of the proposed risk management measures.
oddelek D.2 se nadomesti z naslednjim:
For notifications under Part C of the Directive, the overall risk evaluation shall also include an explanation of the assumptions made during the e.r.a. and of the nature and magnitude of uncertainties associated with the risks, and a justification of the risk management measures proposed.’
„D.2
The title and the introductory paragraph of Section D are replaced by the following:
V primeru gensko spremenjenih višjih rastlin (GSVR)
Conclusions on the specific areas of risk of the e.r.a.
„Višje rastline“ pomenijo rastline, ki sodijo v taksonomsko skupino semenk (Spermatophytae) (golosemenke (Gymnospermae) in kritosemenke (Angiospermae)).
Conclusions on the potential environmental impact in relevant receiving environments from the release or the placing on the market of GMOs shall be drawn for each relevant area of risk listed in Section D1 for GMOs other than higher plants or Section D2 for genetically modified higher plants, on the basis of an e.r.a. carried out in accordance with the principles outlined in Section B and following the methodology described in Section C, and on the basis of the information required pursuant to Annex III.’
Obstojnost in invazivnost GSVR, vključno z genskim prenosom z rastline na rastlino.
Section D.2 is replaced by the following:
Genski prenos z rastline na mikroorganizme.
‘D.2.
Medsebojno učinkovanje GSVR in ciljnih organizmov.
In the case of genetically modified higher plants (GMHP)
Medsebojno učinkovanje GSVR in neciljnih organizmov.
“Higher plants” shall mean plants which belong to the taxonomic group Spermatophytae (Gymnospermae and Angiospermae).
učinki na posebne tehnike gojenja, upravljanja in spravila
Persistence and invasiveness of the GMHP, including plant to plant gene transfer
učinki na biogeokemične procese
Plant to micro-organisms gene transfer
Učinki na zdravje ljudi in živali.“;
Interactions of the GMHP with target organisms
Priloga III se nadomesti z naslednjim:
Interactions of the GMHP with non-target organisms
PRILOGA III
Impacts of the specific cultivation, management and harvesting techniques
INFORMACIJE, ZAHTEVANE V PRIJAVI
Effects on biogeochemical processes
Prijave iz delov B in C te direktive praviloma vključujejo informacije iz Priloge III A za GSO, ki niso višje rastline, ali iz Priloge III B za gensko spremenjene višje rastline.
Effects on human and animal health.’
Določenega podniza informacij iz Priloge III A ali III B ni treba zagotoviti, kadar to ni ustrezno ali potrebno za namene ocene tveganja v kontekstu določene prijave, zlasti glede na značilnosti GSO, obseg in pogoje sproščanja ali glede na predvidene pogoje uporabe GSO.
Annex III is replaced by the following:
Ustrezna raven podrobnosti za vsak podniz informacij se prav tako lahko razlikuje glede na naravo in obseg predlaganega sproščanja.
ANNEX III
Za vsak zahtevani podniz informacij se zagotovi naslednje:
INFORMATION REQUIRED IN THE NOTIFICATION
povzetki in rezultati študij iz prijave, vključno z razlago, zakaj so relevantni za OTO, kadar je to ustrezno;
Notifications referred to in Parts B and C of this Directive shall, as a rule, include the information set out in Annex III A, for GMOs other than higher plants, or in Annex III B, for genetically modified higher plants.
za prijave iz dela C te direktive priloge s podrobnimi informacijami o navedenih študijah, vključno z opisom uporabljenih metod in materialov ali sklicem na standardizirane ali mednarodno priznane metode ter imenom organa ali organov, odgovornih za opravljanje študij.
The provision of a given subset of information listed in Annex III A or in Annex III B shall not be required where it is not relevant or necessary for the purposes of risk assessment in the context of a specific notification, in view especially of the characteristics of the GMO, of the scale and conditions of the release or of its intended conditions of use.
Nadaljnji razvoj genskega spreminjanja lahko zahteva prilagoditev te priloge tehničnemu napredku ali pripravo navodil za to prilogo.
The appropriate level of detail for each subset of information may also vary according to the nature and the scale of the proposed release.
Nadaljnje razločevanje zahtev po informacijah za različne vrste GSO, na primer za trajnice in drevesa, enocelične organizme, ribe ali insekte, ali za posebno uporabo GSO, kot je razvoj cepiv, bo mogoče, ko bo v Uniji pridobljenih dovolj izkušenj v zvezi s prijavami za sproščanje določenih GSO.
For each required subset of information, the following shall be provided:
Priloga III B se nadomesti z naslednjim:
the summaries and results of the studies referred to in the notification, including an explanation about their relevance to e.r.a., where applicable;
PRILOGA III B
for notifications referred to in Part C of this Directive, Annexes with detailed information on those studies, including a description of the methods and materials used or the reference to standardised or internationally recognised methods and the name of the body or bodies responsible for carrying out the studies.
INFORMACIJE, ZAHTEVANE V PRIJAVAH, V ZVEZI S SPROŠČANJEM GENSKO SPREMENJENIH VIŠJIH RASTLIN (GSVR) (GOLOSEMENKE – GYMNOSPERMAE IN KRITOSEMENKE – ANGIOSPERMAE)
Future developments in genetic modification may necessitate adapting this Annex to technical progress or developing guidance notes on this Annex.
I. INFORMACIJE, ZAHTEVANE V PRIJAVAH, PREDLOŽENIH V SKLADU S ČLENOMA 6 IN 7
Further differentiation of information requirements for different types of GMOs, for example perennial plants and trees, single celled organisms, fish or insects, or for particular use of GMOs like the development of vaccines, may be possible once sufficient experience with notifications for the release of particular GMOs has been gained in the Union.
A. Splošne informacije
Annex III B is replaced by the following:
Ime in naslov prijavitelja (podjetje ali inštitut)
ANNEX III B
Ime, kvalifikacije in izkušnje odgovornih znanstvenikov
INFORMATION REQUIRED IN NOTIFICATIONS CONCERNING RELEASES OF GENETICALLY MODIFIED HIGHER PLANTS (GMHPs) (GYMNOSPERMAE AND ANGIOSPERMAE)
Naslov projekta
I. INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLES 6 AND 7
Informacije o sproščanju
A. General information
Namen sproščanja
Name and address of the notifier (company or institute)
Predvideni datumi in trajanje sproščanja
Name, qualifications and experience of the responsible scientist(s)
Metoda, po kateri bo potekalo sproščanje GSVR
Title of the project
Metoda za pripravo in upravljanje mesta sproščanja pred, med in po sproščanju, vključno s praksami gojenja in metodami spravila
Information relating to the release
Približno število rastlin (ali rastlin na m2)
Purpose of the release
Informacije o mestu sproščanja
Foreseen date(s) and duration of the release
Lokacija in velikost mest sproščanja
Method by which the GMHP will be released
Opis ekosistema mesta sproščanja, vključno s podnebjem, rastlinstvom in živalstvom
Method for preparing and managing the release site, prior to, during and post release, including cultivation practices and harvesting methods
Prisotnost spolno združljivih prostoživečih sorodnikov ali gojenih rastlinskih vrst
Approximate number of plants (or plants per m2).
Neposredna bližina uradno priznanih biotopov ali zavarovanih območij, ki bi lahko bila prizadeta
Information relating to the site of release
B. Znanstvene informacije
Location and size of the release site(s).
Informacije o rastlinah prejemnicah ali, kadar je ustrezno, starševskih rastlinah
Description of the release site ecosystem, including climate, flora and fauna.
Celotno ime
Presence of sexually compatible wild relatives or cultivated plant species.
družinsko ime
Proximity to officially recognised biotopes or protected areas which may be affected.
rod
B. Scientific information
vrsta
Information relating to the recipient plant or, where appropriate, to the parental plants
podvrsta
Complete name:
kultivar ali žlahtniteljska linija
family name
domače ime
genus
Geografska razširjenost in območje gojenja rastline znotraj Unije
species
Informacije o razmnoževanju rastlin
subspecies
načini razmnoževanja
cultivar or breeding line
posebni dejavniki, ki vplivajo na razmnoževanje, če obstajajo
common name.
generacijski čas
Geographical distribution and cultivation of the plant within the Union.
Spolna združljivost z drugimi gojenimi ali prostoživečimi rastlinskimi vrstami, vključno z razširjenostjo združljivih vrst v Evropi
Information concerning reproduction:
Sposobnost preživetja
mode(s) of reproduction
sposobnost oblikovanja struktur za preživetje ali mirovanje
specific factors affecting reproduction, if any
posebni dejavniki, ki vplivajo na sposobnost preživetja, če obstajajo
generation time.
Razširjanje
Sexual compatibility with other cultivated or wild plant species, including the distribution in Europe of the compatible species.
poti in obseg razširjanja
Survivability:
posebni dejavniki, ki vplivajo na razširjanje, če obstajajo
ability to form structures for survival or dormancy
Kadar se vrsta rastlin običajno ne prideluje v Uniji, opis naravnega habitata rastline, vključno z informacijami o naravnih plenilcih, zajedavcih, tekmecih in simbiontih
specific factors affecting survivability, if any.
Možna medsebojna učinkovanja, ki so pomembna za GSVR, med rastlino in organizmi v ekosistemu, kjer se običajno prideluje ali drugje, vključno z informacijami o toksičnih učinkih pri ljudeh, živalih in drugih organizmih
Dissemination:
Molekularna karakterizacija
ways and extent of dissemination
Informacije o genski spremembi
specific factors affecting dissemination, if any.
opis uporabljenih metod za gensko spremembo
Where a plant species is not normally grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts.
narava in vir uporabljenega vektorja
Potential interactions of the plant, that are relevant to the GMHP, with organisms in the ecosystem where it is usually grown, or elsewhere, including information on toxic effects on humans, animals and other organisms.
vir nukleinskih kislin, uporabljenih za transformacijo, velikost in predvidena funkcija vsakega sestavnega fragmenta v območju, namenjenemu vnosu
Molecular characterisation
Informacije o GSVR
Information relating to the genetic modification
splošen opis lastnosti in značilnosti, ki so bile vnesene ali spremenjene
Description of the methods used for the genetic modification.
informacije o dejansko vnesenih/odstranjenih zaporedjih
Nature and source of the vector used.
velikost in število kopij vseh vključkov in metode, uporabljene za njihovo karakterizacijo
Source of the nucleic acid(s) used for transformation, size, and intended function of each constituent fragment of the region intended for insertion.
v primeru odstranitve velikost in funkcija odstranjenih območij
Information relating to the GMHP
znotrajcelične lokacije vključkov v rastlinskih celicah (vezanih v jedro, kloroplaste, mitohondrije ali ohranjenih v nevključeni obliki) ter metode za njihovo določanje
General description of the trait(s) and characteristics which have been introduced or modified.
deli rastline, kjer je vključek izražen
Information on the sequences actually inserted/deleted:
genska stabilnost vključka in fenotipska stabilnost GSVR
size and copy number of all insert(s) and methods used for its/their characterisation,
Zaključki o molekularni karakterizaciji
in case of deletion, size and function of the deleted region(s),
Informacije o posebnih področjih tveganja
subcellular location(s) of the insert(s) in the plant cells (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination.
Vse spremembe obstojnosti ali invazivnosti GSVR in njene sposobnosti prenosa genskega materiala na spolno združljive sorodnike ter zadevni škodljivi vplivi na okolje
Parts of the plant where the insert is expressed.
Vse spremembe sposobnosti GSVR, da prenese genski material na mikroorganizme, in zadevni škodljivi vplivi na okolje
Genetic stability of the insert and phenotypic stability of the GMHP.
Mehanizem medsebojnega učinkovanja med GSVR in ciljnimi organizmi (če je to ustrezno) ter zadevni škodljivi vplivi na okolje
Conclusions of the molecular characterisation
Možne spremembe v medsebojnem učinkovanju GSVR z neciljnimi organizmi, ki izhajajo iz genske spremembe, in zadevni škodljivi vplivi na okolje
Information on specific areas of risk
Možne spremembe kmetijskih praks in upravljanja GSVR zaradi genske spremembe ter zadevni škodljivi vplivi na okolje
Any change to the persistence or invasiveness of the GMHP, and its ability to transfer genetic material to sexually compatible relatives and the adverse environmental effects thereof.
Možno medsebojno učinkovanje z abiotskim okoljem in zadevni škodljivi vplivi na okolje
Any change to the ability of the GMHP to transfer genetic material to microorganisms and the adverse environmental effects thereof.
Informacije o vseh toksičnih, alergenih ali drugih škodljivih učinkih na zdravje ljudi in živali, ki izhajajo iz genske spremembe
Mechanism of interaction between the GMHP and target organisms (if applicable) and the adverse environmental effects thereof.
Zaključki o posebnih področjih tveganja
Potential changes in the interactions of the GMHP with non-target organisms resulting from the genetic modification and the adverse environmental effects thereof.
Informacije o nadzoru, spremljanju, načrtih za ravnanje po sproščanju in za ravnanje z odpadki
Potential changes in agricultural practices and management of the GMHP resulting from the genetic modification and the adverse environmental effects thereof.
Vsi sprejeti ukrepi, vključno
Potential interactions with the abiotic environment and the adverse environmental effects thereof.
s prostorsko in časovno izolacijo od spolno združljivih rastlinskih vrst, prostoživečih sorodnikov in nekultiviranih sorodnikov ter kmetijskih rastlin
Information on any toxic, allergenic or other harmful effects on human and animal health arising from the genetic modification.
z vsemi ukrepi za zmanjšanje ali preprečitev širjenja katerega koli razmnoževalnega dela GSVR
Conclusions on the specific areas of risk.
Opis metod ravnanja z mestom po sproščanju
Information on control, monitoring, post-release and waste treatment plans
Opis metod ravnanja po sproščanju za gensko spremenjeni rastlinski material, vključno z odpadki
Any measures taken, including:
Opis načrtov in tehnik spremljanja
spatial and temporal isolation from sexually compatible plant species, both wild and weedy relatives and crops;
Opis morebitnih načrtov ukrepov za primer nesreče
any measures to minimise or prevent the dispersal of any reproductive part of the GMHP.
Opis metod in postopkov za
Description of methods for post-release treatment of the site.
preprečitev ali čim večje zmanjšanje širjenja GSVR izven mesta sproščanja
Description of post-release treatment methods for the genetically modified plant material including wastes.
zaščito mesta pred vdorom nepooblaščenih oseb
Description of monitoring plans and techniques.
preprečitev ali čim večjo omejitev vstopa na mesto za druge organizme
Description of any emergency plans.
Opis tehnik odkrivanja in identifikacije GSVR
Description of the methods and procedures to:
Informacije o prejšnjih sproščanjih GSVR, če je to ustrezno
avoid or minimise the spread of the GMHPs beyond the site of release;
INFORMACIJE, ZAHTEVANE V PRIJAVAH, PREDLOŽENIH V SKLADU S ČLENOM 13
protect the site from intrusion by unauthorised individuals;
Ime in naslov prijavitelja (podjetje ali inštitut)
prevent other organisms from entering the site or minimise such entries.
Ime, kvalifikacije in izkušnje odgovornih znanstvenikov
Description of detection and identification techniques for the GMHP.
Oznaka in specifikacija GSVR
Information about previous releases of the GMHP, if applicable.
Področje uporabe iz prijave
INFORMATION REQUIRED IN NOTIFICATIONS SUBMITTED PURSUANT TO ARTICLE 13
Gojenje
Name and address of the notifier (company or institute).
Druge uporabe (opredeliti v prijavi)
Name, qualifications and experience of the responsible scientist(s).
kultivar/žlahtniteljska linija
Designation and specification of the GMHP.
Spolna združljivost z drugimi gojenimi ali prostoživečimi rastlinskimi vrstami, vključno z razširjenostjo združljivih vrst v Uniji.
Scope of the notification.
poti in obseg razširjanja
Cultivation
Informacije o gensko spremenjeni rastlini
Other uses (to be specified in the notification).
opis lastnosti in značilnosti, ki so bile vnesene ali spremenjene
cultivar/breeding line
informacije o dejansko vnesenih ali odstranjenih zaporedjih
Sexual compatibility with other cultivated or wild plant species, including the distribution in the Union of the compatible species.
velikost in število kopij vseh zaznavnih vključkov, popolnih in delnih, ter metode, uporabljene za njihovo karakterizacijo
ways and extent of dissemination;
organizacija in zaporedje vnesenega genskega materiala na vsakem mestu vnosa v standardizirani elektronski obliki
Information relating to the genetically modified plant
znotrajcelične lokacije vključkov (vezanih v jedro, kloroplaste, mitohondrije ali ohranjenih v nevključeni obliki) ter metode za njihovo določanje
Description of the trait(s) and characteristics which have been introduced or modified.
v primeru sprememb, razen vnosa ali odstranitve, funkcija spremenjenega genskega materiala pred spremembo in po njej, pa tudi neposredne spremembe v izražanju genov kot rezultat spremembe
Information on the sequences actually inserted or deleted:
informacije o zaporedju na 5′ in 3′ koncu sosednjega območja na vsakem mestu vnosa v standardizirani elektronski obliki
size and copy number of all detectable inserts, both partial and complete, and methods used for its characterisation,
bioinformacijska analiza z uporabo najnovejših podatkovnih zbirk, da se preučijo možne prekinitve znanih genov
the organisation and sequence of the inserted genetic material at each insertion site in a standardised electronic format,
bioinformacijska analiza z uporabo najnovejših podatkovnih zbirk, da se preučijo možne podobnosti med OBO in znanimi geni, ki imajo lahko škodljive učinke
subcellular location(s) of the insert(s) (integrated in the nucleus, chloroplasts, mitochondria, or maintained in a non-integrated form), and methods for its/their determination,
primarna struktura (zaporedje aminokislin) in, če je potrebno, druge strukture novoizražene beljakovine
bioinformatic analysis using up-to-date databases, to investigate possible interruptions of known genes,
metode, uporabljene za analizo, skupaj z njihovimi zmogljivostnimi značilnostmi
all Open Reading Frames, (hereafter referred to as “ORFs”) within the insert (either due to rearrangement or not) and those created as a result of the genetic modification at the junction sites with genomic DNA.
informacije o izražanju vključka v razvoju med življenjskim ciklom rastline
ORF is defined as a nucleotide sequence that contains a string of codons that is uninterrupted by the presence of a stop codon in the same reading frame,
deli rastline, v katerih je vključek/spremenjeno zaporedje izraženo
bioinformatic analysis using up-to-date databases, to investigate possible similarities between the ORFs and known genes which may have adverse effects,
potencialno nenamerno izraženi novi OBO, ugotovljeni v sedmi alinei točke (ii), ki zbujajo pomislek o varnosti
primary structure (amino acid sequence) and, if necessary, other structures, of the newly expressed protein,
podatki o izražanju beljakovine, vključno s surovimi podatki, ki se pridobijo iz študij na prostem in se primerjajo s pogoji, v katerih se kmetijska rastlina prideluje
bioinformatic analysis using up-to-date databases, to investigate possible sequence homologies and, if necessary, structural similarities between the newly expressed protein and known proteins or peptides which may have adverse effects.
Zaključki o molekularni karakterizaciji
Information on the expression of the insert:
Primerjalna analiza agronomskih in fenotipskih značilnosti in sestave
method(s) used for expression analysis together with their performance characteristics,
Izbira podobne konvencionalne vrste in dodatnih primerjalnih vrst
information on the developmental expression of the insert during the life cycle of the plant,
Izbira mest za študije na prostem
parts of the plant where the insert/modified sequence is expressed,
Načrt poskusa in statistična analiza podatkov iz poskusov na prostem za primerjalno analizo
potential unintended expression of new ORFs identified under the seventh indent of point (ii), which raise a safety concern,
opis načrta študij na prostem
protein expression data, including the raw data, obtained from field studies and related to the conditions in which the crop is grown.
opis ustreznega vidika prejemnih okolij
Conclusions of molecular characterisation
statistična analiza
Comparative analysis of agronomic and phenotypic characteristics and of composition
Izbira rastlinskega materiala za analizo, če je to ustrezno
Choice of conventional counterpart and additional comparators.
Primerjalna analiza agronomskih in fenotipskih značilnosti
Choice of sites for field studies.
Primerjalna analiza sestave, če je to ustrezno
Experimental design and statistical analysis of data from field trials for comparative analysis:
Zaključki primerjalne analize
Description of field studies design
Posebne informacije za vsako področje tveganja
Description of relevant aspect of the receiving environments
Prijavitelj za vsako od sedmih področij tveganja iz oddelka D.2 Priloge II najprej opiše pot do škode, pri čemer v vzročno-posledični verigi opiše, kako bi lahko sproščanje GSVR povzročilo škodo, ob upoštevanju tako nevarnosti kot izpostavljenosti.
Statistical analysis.
Prijavitelj predloži naslednje informacije, razen kadar to ni ustrezno glede na predvidene uporabe GSO:
Selection of plant material for analysis, if relevant.
obstojnost in invazivnost, vključno z genskim prenosom z rastline na rastlino
Comparative analysis of agronomic and phenotypic characteristics.
ocena potenciala, da GSVR postane bolj obstojna ali invazivna, ter zadevni škodljivi vplivi na okolje;