natgillin/translations-raw huggingface dataset:
The Commission shall monitor the application of this Regulation, the developments in scientific knowledge on replacement, reduction and refinement of animal use in scientific procedures and the publication of new guidance from EFSA.
Komisija spremlja uporabo te uredbe, razvoj znanstvenih spoznanj o zamenjavi, zmanjšanju in izboljšanju uporabe živali v znanstvenih postopkih in objavo novih smernic EFSA.
The Commission shall in particular monitor the outcome of the research project called GRACE (GMO Risk Assessment and Communication of Evidence) under the 2012 work programme of the seventh Framework Programme for Research (FP7).
Zlasti spremlja rezultat raziskovalnega projekta GRACE – Ocena tveganja GSO in posredovanje dokazov (GMO Risk Assessment and Communication of Evidence) v okviru delovnega programa za leto 2012 sedmega okvirnega programa za raziskave (FP7).
The Commission shall review the requirement to perform 90-day feeding studies in rodents with whole genetically modified food/feed (point 1.4.4.1 of Annex II) on the basis of new scientific information.
Komisija pregleda zahtevo za izvedbo 90-dnevnih študij o krmljenju na glodavcih s celotnimi gensko spremenjenimi živili/krmo (točka 1.4.4.1 Priloge II) na podlagi novih znanstvenih informacij.
The results of this review shall be published by 30 June 2016 at the latest.
Rezultati tega pregleda bodo objavljeni najpozneje do 30. junija 2016.
Codex Alimentarius Commission, GL 45-2003.
Komisija Codex Alimentarius, GL 45-2003.
OJ L 201, 31.7.2002, p. 48.
UL L 201, 31.7.2002, str. 48.
OJ L 10, 14.1.2004, p. 5.
UL L 10, 14.1.2004, str. 5.
OJ L 368, 23.12.2006, p. 99.
UL L 368, 23.12.2006, str. 99.
OJ L 157, 8.6.2013, p. 1.’;
UL L 157, 8.6.2013, str. 1.“;
PREPARATION AND PRESENTATION OF APPLICATIONS
PRIPRAVA IN PREDLOŽITEV VLOG
The application shall contain the following information:
Vloga vsebuje naslednje podatke:
Name and address of the applicant (company or institute).
Ime in naslov vlagatelja (podjetje ali inštitut)
Name, qualification and experience of the responsible scientist(s) and contact details of the responsible person for all dealings with the European Food Safety Authority (EFSA).
Ime, kvalifikacija in izkušnje odgovornega znanstvenika ter kontaktni podatki odgovorne osebe za vse stike z Evropsko agencijo za varnost hrane (EFSA)
Designation and specification of the genetically modified plant and its products.
Oznaka in specifikacija gensko spremenjene rastline in njenih proizvodov
Scope of the application:
Področje uporabe
Genetically modified food
gensko spremenjena živila
 Food containing or consisting of genetically modified plants
 živila, ki vsebujejo gensko spremenjene rastline ali so iz njih sestavljena
 Food produced from genetically modified plants or containing ingredients produced from genetically modified plants
 živila, ki so proizvedena iz gensko spremenjenih rastlin ali vsebujejo sestavine, proizvedene iz gensko spremenjenih rastlin
Genetically modified feed
gensko spremenjena krma
 Feed containing or consisting of genetically modified plants
 krma, ki vsebuje gensko spremenjene rastline ali je iz njih sestavljena
 Feed produced from genetically modified plants
 krma, ki je proizvedena iz gensko spremenjenih rastlin
Genetically modified plants for food or feed uses
gensko spremenjene rastline za živila in krmo:
 Products other than food and feed containing or consisting of genetically modified plants with the exception of cultivation
 proizvodi, razen živil in krme, ki vsebujejo gensko spremenjene rastline ali so iz njih sestavljeni, razen za gojenje
 Seeds and other plant propagating material for cultivation in the Union.
 semena in drugi razmnoževalni material za gojenje v Uniji.
Unique identifier.
Posebni identifikator
A proposal for a unique identifier for the genetically modified plant developed in accordance with Regulation (EC) No 65/2004.
Predlog, pripravljen v skladu z Uredbo (ES) št. 65/2004, za posebni identifikator za gensko spremenjeno rastlino.
Where applicable, a detailed description of the method of production and manufacturing.
Po potrebi podroben opis postopka pridelave in proizvodnje
This description would include, for example, a detailed description of specific methods of production of food or feed which would be due to the nature of the genetic modification or which would lead to food or feed with specific characteristics.
Ta opis naj vključuje na primer podroben opis posebnih metod, uporabljenih za proizvodnjo živil ali krme zaradi narave genske spremembe ali ki naj bi vodile do živil ali krme s posebnimi značilnostmi.
Where appropriate, the conditions for the placing on the market of the genetically modified food(s) or feed(s), including specific conditions for use and handling.
Po potrebi pogoji za dajanje na trg gensko spremenjenih živil ali krme, vključno s posebnimi pogoji za uporabo in ravnanje
Where applicable, the status of the food or feed or of related substances under other provisions of Union law.
Po potrebi status živil ali krme ali sorodnih snovi v okviru določb zakonodaje Unije
Additional authorisation requirements provided for in Union law, related to the placing on the market of the food or feed or applicable ‘maximum residue level’ (MRL) where the food or feed is likely to contain residues of plant protection products.
Dodatne zahteve za odobritev, določene v zakonodaji Unije, povezane z dajanjem živil ali krme na trg ali veljavne „mejne vrednosti ostankov“ (MRL), kadar je verjetno, da živila ali krma vsebujejo ostanke fitofarmacevtskih sredstev.
SCIENTIFIC INFORMATION
ZNANSTVENE INFORMACIJE
All the requirements of Part II shall be provided in the application except where such requirements are not justified by the scope of the application (for example, where the application is limited to food or feed produced from GMOs).
V vlogi se izpolnijo vse zahteve iz dela II, razen kadar take zahteve niso upravičene s področjem uporabe vloge (na primer, kadar je vloga omejena na živilo ali krmo, proizvedeno iz GSO).
HAZARD IDENTIFICATION AND CHARACTERISATION
IDENTIFIKACIJA IN OPREDELITEV NEVARNOSTI
Information relating to the recipient or (where appropriate) parental plants
1.1 Informacije o prejemnih ali (kjer je primerno) starševskih rastlinah
Complete name:
celotno ime;
family name;
družinsko ime;
subspecies;
podvrsto;
cultivar, breeding line;
sorta, žlahtniteljska linija;
common name;
domače ime;
Geographical distribution and cultivation of the plant within the Union;
geografska porazdelitev in gojenje rastline 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, such as history of safe use for consumption as food or feed, including information on how the plant is typically cultivated, transported and stored, whether special processing is required to make the plant safe to eat, and the plant normal role in the diet (for example, which part of the plant is used as a food source, whether its consumption is important in particular subgroups of the population, what important macro- or micro-nutrients it contributes to the diet);
podatki o pretekli in sedanji uporabi prejemne rastline, na primer zgodovina varne uporabe kot živilo ali krma, vključno z informacijami o tem, kako se rastlina ponavadi goji, prevaža ali shranjuje, ali je potrebna posebna obdelava, da je rastlino varno jesti, in normalna vloga rastline v prehrani (na primer, kateri deli rastline se uporabljajo kot prehranski vir, ali je njena poraba pomembna predvsem v podskupinah prebivalstva, katere pomembne makro- ali mikrohranilne snovi prispeva k prehrani);
Additional information relating to the recipient or parental plants required for the environmental safety aspects:
dodatne informacije o prejemnih ali starševskih rastlinah, ki so potrebne zaradi vidikov okoljske varnosti:
information concerning reproduction:
informacije o razmnoževanju:
mode(s) of reproduction;
načini razmnoževanja,
specific factors affecting reproduction (if any);
posebni dejavniki, ki vplivajo na razmnoževanje (če obstajajo),
generation time;
generacijski čas;
sexual compatibility with other cultivated or wild plant species;
spolna združljivost s drugimi gojenimi ali prosto živečimi rastlinskimi vrstami;
survivability:
sposobnost preživetja:
ability to form structures for survival or dormancy;
sposobnost oblikovanja struktur za preživetje ali mirovanje,
specific factors, if any, affecting survivability;
posebni dejavniki, če obstajajo, ki vplivajo na sposobnost preživetja;
dissemination:
razširjanje:
ways and extent of dissemination (to include, for example, an estimation of how viable pollen and/or seed declines with distance);
načini in obseg razširjanja (ki vključujejo na primer oceno, kako se možnost preživetja peloda in/ali semen zmanjšuje z razdaljo),
special factors affecting dissemination, if any;
posebni dejavniki, ki vplivajo na razširjanje, če obstajajo;
geographical distribution within the Union of the sexually compatible species;
geografska porazdelitev spolno združljivih vrst znotraj Unije;
where a plant species is not grown in the Union, a description of the natural habitat of the plant, including information on natural predators, parasites, competitors and symbionts;
kadar se rastlinska vrsta ne prideluje v Uniji, opis naravnega habitata rastline, vključno z informacijami o naravnih plenilcih, zajedavcih, tekmecih in simbiontih;
other potential interactions of the genetically modified 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.
druga morebitna medsebojna učinkovanja med gensko spremenjeno rastlino in organizmi v ekosistemih, kjer se ponavadi prideluje, ali drugje, vključno z informacijami o toksičnih učinkih pri ljudeh, živalih in drugih organizmih.
Molecular Characterisation
1.2 Molekularna karakterizacija
Information relating to the genetic modification
1.2.1 Informacije o genskem spreminjanju
Description of the methods used for the genetic modification
1.2.1.1 Opis metod, uporabljenih za gensko spremembo
Nature and source of vector used
1.2.1.2 Narava in vir uporabljenega vektorja
Source of donor nucleic acid(s) used for transformation, size and intended function of each constituent fragment of the region intended for insertion
vir donorskih nukleinskih kislin, uporabljenih za transformacijo, velikost in predvidena funkcija vsakega sestavnega fragmenta v območju, predvidenem za vnos.
Information relating to the genetically modified plant
1.2.2 Informacije o gensko spremenjeni rastlini
General description of the trait(s) and characteristics which have been introduced or modified
1.2.2.1 Splošen opis lastnosti in značilnosti, ki so bile vnesene ali spremenjene
Information on the sequences actually inserted/deleted
1.2.2.2 Informacije o dejansko vnesenih/odstranjenih zaporedjih
Information on the expression of the insert(s)
1.2.2.3 Informacije o izražanju vključkov
Genetic stability of the insert and phenotypic stability of the genetically modified plant
1.2.2.4 Genska stabilnost vključka in fenotipska stabilnost gensko spremenjene rastline
Potential risk associated with horizontal gene transfer
1.2.2.5 Potencialno tveganje, povezano s horizontalnim prenosom gena
Additional information relating to the genetically modified plant required for the environmental safety aspects
1.2.3 Dodatne informacije o gensko spremenjeni rastlini, ki so potrebne zaradi vidikov okoljske varnosti
Information on how the genetically modified plant differs from the recipient plant in reproduction, dissemination, survivability or other properties.
1.2.3.1 Informacije o tem, kako se gensko spremenjena rastlina razlikuje od prejemne rastline pri razmnoževanju, razširjanju, sposobnosti preživetja in drugih značilnostih
Any change to the ability of the genetically modified plant to transfer genetic material to other organisms, namely:
1.2.3.2 Vsaka sprememba sposobnosti gensko spremenjene rastline za prenos genskega materiala na druge organizme, in sicer:
Plant to bacteria gene transfer;
prenos gena z rastline na bakterijo;
Plant to plant gene transfer.
prenos gena z rastline na rastlino.
Conclusions of the molecular characterisation
1.2.4 Sklepne ugotovitve o molekularni karakterizaciji
Comparative analysis
3.2.2 Primerjalna analiza
Choice of the conventional counterpart and additional comparators
4.1 Izbira podobne konvencionalne vrste in dodatnih primerjalnih vrst
Experimental design and statistical analysis of data from field trials for comparative analysis
4.2 Načrt poskusa in statistična analiza podatkov iz poskusov na prostem za primerjalno analizo
Description of the protocols for the experimental design
1.3.2.1 Opis protokolov za načrt poskusa
Statistical analysis
1.3.2.2 Statistična analiza
Selection of material and compounds for analysis
1.3.3 Izbira materiala in snovi za analizo
Comparative analysis of composition
1.3.4 Primerjalna analiza sestave
Comparative analysis of agronomic and phenotypic characteristics
1.3.5 Primerjalna analiza agronomskih in fenotipskih značilnosti
Effects of processing
1.3.6 Učinki predelave
Conclusion
1.3.7 Sklepna ugotovitev
Toxicology
1.4 Toksikologija
Testing of newly expressed proteins
1.4.1 Testiranje novoizraženih beljakovin
Testing of new constituents other than proteins
1.4.2 Testiranje novih sestavin razen beljakovin
Information on natural food and feed constituents
1.4.3 Informacije o naravnih sestavinah živila in krme
Testing of the whole genetically modified food or feed
1.4.4 Testiranje celotnega gensko spremenjenega živila ali krme
ay feeding study in rodents
1.4.4.1 90-dnevna študija o krmljenju na glodavcih
Animal studies with respect to reproductive, developmental or chronic toxicity
1.4.4.2 Študije na živalih v zvezi z reproduktivno, razvojno ali kronično toksičnostjo
Other animal studies to examine the safety and the characteristics of genetically modified food and feed
1.4.4.3 Druge študije na živalih za preučitev varnosti in značilnosti gensko spremenjenih živil in krme
Conclusion of the toxicological assessment
1.4.5 Sklepna ugotovitev toksikološke ocene
Allergenicity
1.5 Alergenost
Assessment of allergenicity of the newly expressed protein
ocena alergenosti novoizražene beljakovine;
Assessment of allergenicity of the whole genetically modified plant
ocena alergenosti celotne gensko spremenjene rastline.
Conclusion of the allergenicity assessment
1.5.3 Sklepna ugotovitev ocene alergenosti
Nutritional assessment
1.6 Ocena hranilne vrednosti
Nutritional assessment of the genetically modified food
ocena hranilne vrednosti gensko spremenjenih živil;
Nutritional assessment of the genetically modified feed
ocena hranilne vrednosti gensko spremenjene krme.
Conclusion of the nutritional assessment
1.6.3 Sklepna ugotovitev ocene hranilne vrednosti
EXPOSURE ASSESSMENT — ANTICIPATED INTAKE OR EXTENT OF USE
OCENA IZPOSTAVLJENOSTI – PRIČAKOVANI VNOS ALI OBSEG UPORABE
POST-MARKET MONITORING ON THE GENETICALLY MODIFIED FOOD OR FEED
SPREMLJANJE GENSKO SPREMENJENIH ŽIVIL ALI KRME PO DAJANJU NA TRG
ENVIRONMENTAL ASSESSMENT
OKOLJSKA PRESOJA
ENVIRONMENTAL MONITORING PLAN
NAČRT SPREMLJANJA STANJA OKOLJA
ADDITIONAL INFORMATION RELATED TO THE SAFETY OF THE GENETICALLY MODIFIED FOOD OR FEED
DODATNE INFORMACIJE V ZVEZI Z VARNOSTJO GENSKO SPREMENJENIH ŽIVIL ALI KRME
A systematic review of studies published in the scientific literature and studies performed by the applicant within the period of 10 years prior to the date of submission of the dossier on the potential effects on human and animal health of the genetically modified food and feed covered by the application shall be included in the application.
V vlogo se vključi sistematičen pregled študij, objavljenih v znanstveni literaturi, in študij, ki jih je izvedel vlagatelj v obdobju 10 let pred datumom predložitve dokumentacije o morebitnih učinkih gensko spremenjenih živil in krme, zajetih v vlogi, na zdravje ljudi in živali.
This systematic review shall be carried out by taking into account the guidance of EFSA on application of systematic review methodology to food and feed safety assessments to support decision making [1].
Ta sistematičen pregled se opravi ob upoštevanju smernic EFSA o uporabi metodologije sistematičnega pregleda pri oceni varnosti živil in krme v pomoč pri odločanju [1].
Where the information obtained from those studies is not coherent with the information obtained from the studies performed in accordance with the requirements set out in Annex II, the applicant shall provide a thorough analysis of the respective studies and provide plausible explanations for the observed discrepancies.
Kadar informacije, pridobljene v teh študijah, niso v skladu z informacijami, pridobljenimi v študijah, ki so izvedene v skladu z zahtevami iz Priloge II, vlagatelj predloži temeljito analizo zadevnih študij in verodostojno razlago opaženih odstopanj.
Additional information which might influence the evaluation of the safety of the genetically modified food or feed generated following the submission of the application, as well as any information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a safety assessment shall be provided by the applicant.
Vlagatelj predloži dodatne informacije, pridobljene po predložitvi vloge, ki lahko vplivajo na oceno varnosti gensko spremenjenega živila ali krme, pa tudi vse informacije v zvezi s katero koli prepovedjo ali omejitvijo, ki jo je naložil ustrezni organ katere koli tretje države na podlagi ocene varnosti.
CARTAGENA PROTOCOL
KARTAGENSKI PROTOKOL
The application shall provide the information required under Articles 5(3)(c) and 17(3)(c) of Regulation (EC) No 1829/2003 for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity.
V vlogi se predložijo informacije, zahtevane v členu 5(3)(c) in členu 17(3)(c) Uredbe (ES) št. 1829/2003 zaradi uskladitve s Prilogo II h Kartagenskemu protokolu o biološki varnosti v okviru Konvencije o biološki raznovrstnosti.
The provided information shall contain as a minimum the information specified in Annex II to Regulation (EC) No 1946/2003 of the European Parliament and of the Council [2]:(a) The name and contact details of the applicant for a decision for domestic use;
Predložene informacije vsebujejo najmanj informacije, navedene v Prilogi II k Uredbi (ES) št. 1946/2003 Evropskega parlamenta in Sveta [2]:(a) ime in kontaktne podatke vlagatelja, ki zaprosi za odločitev o notranji uporabi;
The name and contact details of the authority responsible for the decision;
ime in kontaktne podatke organa, pristojnega za odločitev;
Name and identity of the GMO;
ime in identiteto GSO;
Description of the gene modification, the technique used, and the resulting characteristics of the GMO;
opis genske spremembe, uporabljene tehnike in posledične značilnosti GSO;
Any unique identification of the GMO;
vse enkratne identifikacije GSO;
Taxonomic status, common name, point of collection or acquisition, and characteristics of recipient organism or parental organisms related to biosafety;
taksonomski status, splošno ime, točko zbiranja ali pridobivanja ter značilnosti prejemnega organizma ali starševskih organizmov, povezane z biološko varnostjo;
Centres of origin and centres of genetic diversity, if known, of the recipient organism and/or the parental organisms and a description of the habitats where the organisms may persist or proliferate;
središča izvora ali genske raznovrstnosti, če so znana, prejemnega organizma in/ali starševskih organizmov ter opis habitatov, kjer lahko ti organizmi obstanejo ali se razmnožujejo;
Taxonomic status, common name, point of collection or acquisition, and characteristics of the donor organism or organisms related to biosafety;
taksonomski status, splošno ime, točko zbiranja ali pridobivanja ter značilnosti izvornega organizma ali donorskih organizmov, povezane z biološko varnostjo;
Approved uses of the GMO;
dovoljene vrste uporabe GSO;
A risk assessment report consistent with Annex II to Directive 2001/18/EC;
poročilo o oceni tveganja, skladno s Prilogo II k Direktivi 2001/18/ES;
Suggested methods for the safe handling, storage, transport and use, including packaging, labelling, documentation, disposal and contingency procedures, where appropriate.
predlagane metode za varno ravnanje, skladiščenje, prevoz in uporabo, skupaj s pakiranjem, označevanjem, dokumentiranjem, odlaganjem in postopki v izrednih razmerah, kadar je to primerno.
a proposal for labelling in all official languages of the Union, where a proposal for specific labelling is required in accordance with Articles 5(3)(f) and 17(3)(f) of Regulation (EC) No 1829/2003;
predlog za označevanje v vseh uradnih jezikih Unije, kadar se zahteva predlog za posebno označevanje v skladu s členom 5(3)(f) in členom 17(3)(f) Uredbe (ES) št. 1829/2003;
either a reasoned statement that the food or feed does not give rise to ethical or religious concerns or a proposal for labelling in all official languages of the Union as required by Articles 5(3)(g) and 17(3)(g) of Regulation (EC) No 1829/2003;
bodisi utemeljeno izjavo, da živilo ali krma ne vzbuja etičnih ali verskih pomislekov, bodisi predlog za označevanje v vseh uradnih jezikih Unije, kot se zahteva v členu 5(3)(g) in členu 17(3)(g) Uredbe (ES) št. 1829/2003;
when appropriate a proposal for labelling complying with the requirements of point A(8) of Annex IV to Directive 2001/18/EC.
po potrebi ustrezen predlog za označevanje v skladu z zahtevami točke A(8) Priloge IV k Direktivi 2001/18/ES.
METHODS OF DETECTION, SAMPLING AND IDENTIFICATION AND REFERENCE MATERIAL
METODE ODKRIVANJA, VZORČENJA IN IDENTIFIKACIJE REFERENČNEGA MATERIALA
The applicant shall provide methods for detection, sampling and identification, as well as samples of the food or feed and their controls samples to the European Union Reference Laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003.
Vlagatelj določi metode za odkrivanje, vzorčenje in identifikacijo, pa tudi vzorce živil ali krme in njihovih kontrolnih vzorcev za referenčni laboratorij Evropske unije (EURL), kot je navedeno v členu 32 Uredbe (ES) št. 1829/2003.
The application shall include a copy of the completed form for the submission of those samples to the EURL and proof of sending to the EURL.
Vloga vključuje kopijo izpolnjenega obrazca za predložitev navedenih vzorcev EURL in dokaz, da so bili poslani EURL.
The application shall include information as to the place where the reference material can be accessed.
Vloga vključuje informacije o kraju, kjer je na voljo referenčni material.
The applicant shall follow the instructions for the preparation and the sending of the samples provided by the EU Reference laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003.
Vlagatelj upošteva smernice za pripravo in pošiljanje vzorcev, ki jih pripravi referenčni laboratorij (EURL), kot je navedeno v členu 32 Uredbe (ES) št. 1829/2003.
These instructions are published on the following webpage: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm
Te smernice so objavljene na spletni strani: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm.
ADDITIONAL INFORMATION TO BE PROVIDED FOR GENETICALLY MODIFIED PLANTS AND/OR FOOD OR FEED CONTAINING OR CONSISTING OF GENETICALLY MODIFIED PLANTS
DODATNE INFORMACIJE, KI SE ZAGOTOVIJO ZA GENSKO SPREMENJENE RASTLINE IN/ALI ŽIVILA ALI KRMO, KI VSEBUJEJO GENSKO SPREMENJENE RASTLINE ALI SO IZ NJIH SESTAVLJENI
The information required in the notification as set out in Annex III to Directive 2001/18/EC shall be provided where it is not covered by the requirements of other parts of the application.
Informacije, ki se zahtevajo v prijavi, kot je določeno v Prilogi III k Direktivi 2001/18/ES, se pripravijo, kadar niso zajete v zahtevah za druge dele vloge.
SUMMARY OF APPLICATIONS
POVZETEK VLOG
This Part specifies the standardised form, which the summary of the application dossier must follow.
Ta del določa standardizirano obliko, ki jo je treba upoštevati za povzetek vloge.