natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1829/2003 lays down Union procedures for the authorisation and supervision of genetically modified food and feed, including rules for the labelling of such food and feed.
Uredba (ES) št. 1829/2003 določa postopke Unije za odobritev in nadzor gensko spremenjenih živil in krme, vključno s pravili za označevanje teh živil in krme.
That Regulation provides for a scientific evaluation to be carried out on the risks that the genetically modified food or feed may present for human and animal health and, as the case may be, for the environment.
Navedena uredba določa izvajanje znanstvenega ocenjevanja tveganj, ki jih lahko predstavlja gensko spremenjeno živilo ali krma za zdravje ljudi in živali ali za okolje.
It also provides that a genetically modified food or feed must not mislead the consumer or the user and must not differ from the food or feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for humans or animals.
Določa tudi, da gensko spremenjena živila in krma ne smejo zavajati potrošnika ali rejca in se ne razlikujejo od živil ali krme, ki naj bi jih nadomestilo, v takem obsegu, da bi bila njegova običajna poraba glede hranilne vrednosti neugodna za ljudi ali živali.
Regulation (EC) No 1829/2003 provides, in particular, that applications for authorisation are to adequately and sufficiently demonstrate that the genetically modified food and feed satisfy the requirements laid down in that Regulation, in respect of their proposed uses.
Uredba (ES) št. 1829/2003 zlasti določa, da vloge za odobritev ustrezno in zadovoljivo dokažejo, da gensko spremenjena živila ali krma izpolnjujejo zahteve iz navedene uredbe glede predlagane uporabe.
In the interest of consistency of Union legislation, certain definitions laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2] should also apply to this Regulation.
Zaradi doslednosti zakonodaje Unije bi se morale tudi za to uredbo uporabljati nekatere opredelitve, določene v Uredbi (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [2].
Commission Regulation (EC) No 641/2004 [3] on detailed rules for the implementation of Regulation (EC) No 1829/2003 provides for certain detailed rules concerning applications for authorisation submitted in accordance with Regulation (EC) No 1829/2003.
Uredba Komisije (ES) št. 641/2004 [3] o podrobnih pravilih za izvajanje Uredbe (ES) št. 1829/2003 določa nekatera podrobna pravila o vlogah za odobritev, predloženih v skladu z Uredbo (ES) št. 1829/2003.
To facilitate the preparation of applications and ensure that they contain all the information needed for their assessment, it is necessary to provide for more comprehensive and systematic rules concerning applications for authorisation, which should also be specific to each type of genetically modified organisms (GMO), namely plants, animals and micro-organisms.
Za olajšanje priprave vlog in zagotovitev, da vsebujejo vse informacije, ki so potrebne za njihovo ocenitev, je treba določiti celovitejša in bolj sistematična pravila o vlogah za odobritev, ki bi morala biti posebna za vsako vrsto gensko spremenjenih organizmov (GSO), namreč za rastline, živali in mikroorganizme.
The rules laid down in this Regulation should only cover applications concerning genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food or feed produced from such plants.
Pravila, določena v tej uredbi, bi morala zajemati samo vloge za gensko spremenjene rastline, namenjene živalski krmi ali človeški hrani, živila ali krmo, ki vsebujejo ali so sestavljeni iz gensko spremenjenih rastlin, ter živila ali krmo, proizvedene iz takih rastlin.
Genetically modified plants, for which sufficient experience is available to date, constitute the vast majority of current applications.
Gensko spremenjene rastline, za katere je do zdaj na voljo dovolj izkušenj, sestavljajo veliko večino sedanjih vlog.
The rules laid down in this Regulation should specify the general requirements for the presentation and preparation of applications, namely requirements to provide general and scientific information, including methods for detection, and identification, as well as reference material so as to ensure that applications comply with the conditions laid down in Articles 5, 17 and 30 of Regulation (EC) No 1829/2003.
Pravila, določena v tej uredbi, bi morala podrobno opredeliti splošne zahteve za predložitev in pripravo vlog, in sicer zahteve za zagotovitev splošnih in znanstvenih informacij, vključno s postopki odkrivanja in identifikacije, pa tudi referenčni material, tako da je zagotovljeno, da so vloge skladne s pogoji iz členov 5, 17 in 30 Uredbe (ES) št. 1829/2003.
The applicant should also take into consideration the scientific information to be provided in the application as regards the environmental risk assessment of GMOs or food and feed containing or consisting of GMOs, as set out in the principles for the environmental risk assessment in Annex II to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [4], as well as the applicable guidance published by the European Food Safety Authority (EFSA) in this regard.
Vlagatelj bi moral upoštevati tudi znanstvene informacije, ki se zagotovijo v vlogi, glede ocene tveganja za okolje v zvezi z GSO ali živili in krmo, ki vsebujejo GSO ali so sestavljeni iz njih, kot je navedeno v načelih za oceno tveganja za okolje iz Priloge II k Direktivi 2001/18/ES Evropskega parlamenta in Sveta z dne 12. marca 2001 o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS [4], pa tudi veljavne smernice, ki jih je o tem objavila Evropska agencija za varnost hrane (EFSA).
In addition to the general requirements for the presentation and preparation of applications, it is appropriate to provide for specific rules to ensure that the scientific information required in the application adequately and sufficiently demonstrates that the genetically modified food or feed satisfy the requirements laid down in Regulation (EC) No 1829/2003, in respect of their proposed uses.
Poleg splošnih zahtev za predložitev in pripravo vlog je primerno določiti posebna pravila za zagotovitev, da znanstvene informacije, ki se zahtevajo v vlogi, ustrezno in zadovoljivo dokazujejo, da gensko spremenjena živila ali krma izpolnjujejo zahteve iz Uredbe (ES) št. 1829/2003 glede predlagane uporabe.
These rules should therefore provide for a set of studies that should be included in all applications, as well as the test methods to be followed to perform such studies, whilst taking into account relevant international standards, such as the guideline of the Codex Alimentarius for the conduct of safety assessment of foods derived from the recombinant-DNA plant [5].
Zato bi morala ta pravila določiti sklop študij, ki bi jih bilo treba vključiti v vse vloge, pa tudi postopke testiranja, ki jih je treba upoštevati pri izvajanju teh študij, obenem pa upoštevati ustrezne mednarodne standarde, kot so smernice Codex Alimentarius za izvajanje ocenjevanja varnosti živil, pridobljenih iz rastlin z rekombinantno DNK [5].
In accordance with the applicable guidance of the EFSA [6], the safety assessment of the genetically modified food or feed should include studies related to new components resulting from the genetic modification, the molecular characterisation of the genetically modified plant, the comparative analysis of the composition and the phenotype of the genetically modified plant compared to its conventional counterpart.
V skladu z veljavnimi smernicami EFSA [6] bi morala ocena varnosti gensko spremenjenih živil ali krme vključevati študije o novih sestavnih delih, ki so rezultat genske spremembe, molekularno karakterizacijo gensko spremenjene rastline, primerjalno analizo sestave in fenotip gensko spremenjene rastline v primerjavi s podobno konvencionalno vrsto.
Depending on the characteristics of the genetically modified plant and on the outcome of that first set of studies, the EFSA guidance indicates that it may be necessary to perform additional studies.
Smernice EFSA določajo, da je, odvisno od značilnosti gensko spremenjene rastline in rezultata prvega sklopa študij, morda treba opraviti dodatne študije.
In that respect, the EFSA considers that notwithstanding its limitations, a 90-day feeding study in rodents with whole food or feed is, when justified, the primary additional study to address uncertainties identified in the course of the safety assessment.
EFSA v zvezi s tem meni, da je 90-dnevna študija o krmljenju s celotnimi živili ali krmo na glodavcih, če je utemeljena, primarna dodatna študija za obravnavo negotovosti, ugotovljenih med ocenjevanjem varnosti ne glede na njene omejitve.
It has, however, not been proved possible to define with the necessary precision the level of uncertainties which would require the submission of 90-day feeding studies.
Vendar ni dokazano, da je mogoče s potrebno natančnostjo opredeliti raven negotovosti, ki bi zahtevala predložitev 90-dnevnih študij o krmljenju.
In addition, some food and feed assessment bodies of Member States are of the opinion that such study should be performed in all applications for genetically modified plants containing single transformation events.
Poleg tega nekateri organi držav članic za ocenjevanje živil in krme menijo, da bi bilo treba tako študijo opraviti v vseh vlogah za gensko spremenjene rastline, ki vsebujejo posamezne transformacijske dogodke.
Considering these diverging views, as well as to improve consumer confidence, such studies should be, for the time being, requested in all applications related to genetically modified plants with single transformation events and, where appropriate, on genetically modified plants containing stacked transformation events.
Glede na ta različna mnenja in da bi izboljšali zaupanje potrošnikov, bi bilo treba zaenkrat take študije zahtevati pri vseh vlogah, ki se nanašajo na gensko spremenjene rastline s posameznimi transformacijskimi dogodki in po potrebi za gensko spremenjene rastline, ki vsebujejo transformacijske dogodke z nalaganjem.
Studies to demonstrate that a genetically modified food or feed fulfils the requirements of Regulation (EC) No 1829/2003 involving the use of laboratory animals should be carried out in accordance with Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 regarding the protection of the animals used for scientific purposes [7], and should be kept to a minimum while ensuring an adequate demonstration of the safety of the genetically modified food or feed.
Študije, ki dokazujejo, da gensko spremenjeno živilo ali krma izpolnjuje zahteve iz Uredbe (ES) št. 1829/2003, vključno z uporabo laboratorijskih živali, bi bilo treba izvajati v skladu z Direktivo 2010/63/EU Evropskega parlamenta in Sveta z dne 22. septembra 2010 o zaščiti živali, ki se uporabljajo v znanstvene namene [7], in bi jih bilo treba čim bolj omejiti, hkrati pa zagotoviti ustrezen dokaz o varnosti gensko spremenjenega živila ali krme.
The current uncertainties in relation to the need and design of 90-day feeding trials will be addressed by a large research project under the 2012 work programme of Theme 2 ‘Food, Agriculture and Fisheries, and Biotechnologies’ of the seventh Framework Programme for Research (FP7).
Sedanje negotovosti v zvezi s potrebo in načrtovanjem 90-dnevnih poskusov s krmljenjem bodo obravnavane v velikem raziskovalnem projektu v okviru delovnega programa 2012 teme 2 „Živila, kmetijstvo in ribištvo in biotehnologija“ sedmega okvirnega programa za raziskave (OP7).
While the rules laid down in this Regulation should be valid for all applications for genetically modified plants, the type and necessity of the studies to evaluate the characteristics and safety of genetically modified food or feed subject to an application may vary, depending on the nature of the genetic modification or of the product.
Medtem ko bi morala pravila iz te uredbe veljati za vse vloge za gensko spremenjene rastline, se lahko vrsta in nujnost študij za oceno značilnosti in varnosti gensko spremenjenega živila ali krme glede na vlogo spreminjata, odvisno od narave genske spremembe ali proizvoda.
For example, genetic modifications which have negligible impact on the composition of a genetically modified food or feed or highly refined products that may be proven to be identical to products produced from the conventional counterpart require different studies than a product resulting from complex genetic modification aiming to modify its nutritional characteristics.
Na primer, genske spremembe, ki imajo zanemarljiv vpliv na sestavo gensko spremenjenega živila ali krme ali visoko rafiniranih proizvodov, ki so lahko dokazano enaki kot proizvodi, proizvedeni iz podobne konvencionalne vrste, zahtevajo drugačne študije kot proizvod, ki je rezultat zapletene genske spremembe, namenjene spremembi hranilne sestave.
The requirements laid down in this Regulation regarding the studies which have to be included in an application for authorisation under Regulation (EC) No 1829/2003 should not prevent the EFSA to request, where appropriate, the applicant to supplement the particulars accompanying the application in accordance with Articles 6(2) and 18(2) of Regulation (EC) No 1829/2003.
Zahteve iz te uredbe v zvezi s študijami, ki morajo biti vključene v vlogo za odobritev na podlagi Uredbe (ES) št. 1829/2003, ne smejo preprečiti, da bi EFSA v skladu s členom 6(2) in členom 18(2) Uredbe (ES) št. 1829/2003 zahtevala, kjer je primerno, da vlagatelj dopolni podatke, priložene vlogi.
In order to ensure that studies are of high quality and documented in a transparent way, it is essential that they are performed under appropriate quality assurance systems and raw data should be provided in all cases and be in a suitable electronic format.
Za zagotovitev, da so študije kakovostne in pregledno dokumentirane, je bistveno, da so izvedene v okviru ustreznih sistemov zagotavljanja kakovosti in da se v vseh primerih zagotovijo surovi podatki v ustrezni elektronski obliki.
Toxicological studies should be performed in accordance with the quality assurance principles laid down by Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances [8].
Toksikološke študije se morajo izvesti v skladu z načeli zagotavljanja kakovosti iz Direktive 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri testih kemičnih snovi [8].
If such studies are carried out outside the Union, they should follow the state-of-the-art OECD Principles on Good Laboratory Practice (GLP).
Če so take študije izvedene zunaj Unije, morajo upoštevati najnovejša načela OECD o dobri laboratorijski praksi (DLP).
With regard to studies other than toxicological studies, they should be conducted under ISO or GLP standards.
Študije, razen toksikoloških, morajo biti izvedene v okviru standardov ISO ali DLP.
It is also necessary to define the requirements regarding the submission of additional information related to the safety of the GMO and scientific peer-reviewed literature related to the potential effects on health and on the environment of the products covered by the application.
Opredeliti je treba tudi zahteve glede predložitve dodatnih informacij v zvezi z varnostjo GSO in znanstveno strokovno pregledano literaturo v zvezi z morebitnimi učinki proizvodov, ki so zajeti v vlogi, na zdravje in okolje.
During the process of the 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 identifikacije gensko spremenjenih celic, ki vsebujejo želeni gen, vnesen v genom gostiteljskega organizma, med veliko večino netransformiranih celic pogosto uporabljajo označevalni geni.
Such marker genes should be carefully selected.
Take označevalne gene je treba pazljivo izbrati.
In addition, it is now possible to develop GMOs without the use of antibiotic resistance marker genes.
Poleg tega je zdaj mogoče razviti GSO brez uporabe označevalnih genov, odpornih proti antibiotikom.
Against this background and in accordance with Article 4(2) of Directive 2001/18/EC, the applicant should therefore aim to develop GMOs without the use of antibiotic resistance marker genes.
Glede na navedeno in v skladu s členom 4(2) Direktive 2001/18/ES bi moral biti cilj vlagatelja, da razvije GSO brez uporabe označevalnih genov, odpornih proti antibiotikom.
The harvest of segregating genetically modified plants (segregating crops) containing stacked transformation events contains various subcombinations of transformation events.
Pridelek ločenih gensko spremenjenih rastlin (ločenih poljščin), ki vsebujejo transformacijske dogodke z nalaganjem, vsebuje različne podkombinacije transformacijskih dogodkov.
In addition, current control procedures do not allow identifying the origin of combinations of transformation events.
Poleg tega s sedanjimi postopki nadzora ni mogoče določiti porekla kombinacij transformacijskih dogodkov.
Therefore, in order to ensure that authorisations are coherent with the products of which the placing on the market is unavoidable and for the feasibility of controls, the applications for genetically modified food and feed from segregating crops should include all subcombinations independently of their origin and not yet authorised.
Zato bi morale vloge za gensko spremenjena živila in krmo iz ločenih poljščin, da se zagotovita skladnost odobritev s proizvodi, katerih dajanje na trg je neizogibno, in izvedljivost kontrol, vključevati vse podkombinacije, ki še niso bile odobrene, ne glede na njihov izvor.
Regulation (EC) No 1829/2003 provides that a proposal for post-market monitoring of the use of the genetically modified food or feed shall only be submitted by the applicant where it is appropriate.
Uredba (ES) št. 1829/2003 določa, da vlagatelj predloži predlog za spremljanje uporabe gensko spremenjenih živil ali krme po dajanju na trg le, kadar je primerno.
It is therefore necessary to set out the conditions under which such a proposal should, according to the outcome of the risk assessment, accompany the application.
Zato je treba določiti pogoje, v katerih mora biti tak predlog v skladu z rezultatom ocene tveganja priložen k vlogi.
Post-market monitoring should only be considered in cases where, notwithstanding the fact that the safety of genetically modified food and feed has been demonstrated, it is appropriate to confirm the expected consumption, the application of conditions of uses or identified effects.
O spremljanju po dajanju na trg je treba razmisliti samo v primerih, ko je ne glede na dejstvo, da je bila varnost gensko spremenjenega živila in krme dokazana, primerno potrditi pričakovano porabo, pogoje uporabe ali ugotovljene učinke.
This is for example the case when the genetically modified food or feed has altered nutritional composition or when that its nutritional value differs from the conventional food or feed that it would replace or when there is a likelihood of increased allergenicity due to the genetic modification.
Tak primer je recimo, če gensko spremenjeno živilo ali krma spremeni hranilno sestavo ali če se njegova hranilna vrednost razlikuje od podobnega konvencionalnega živila ali krme, ki bi ga nadomestilo, ali če obstaja verjetnost povečanja alergenosti zaradi genske spremembe.
This Regulation should take account of the international trade commitments of the Union and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity (the Cartagena Protocol), approved by Council Decision 2002/628/EC of 25 June 2002 concerning the conclusion, on behalf of the European Community, of the Cartagena Protocol on Biosafety [9] as well as the provisions of Regulation (EC) No 1946/2003 of 15 July 2003 of the European Parliament and of the Council on transboundary movements of genetically modified organisms [10].
Ta uredba mora upoštevati obveznosti Unije v mednarodni trgovini in zahteve Kartagenskega protokola o biološki varnosti v okviru Konvencije o biološki raznovrstnosti (Kartagenski protokol), odobrenega s Sklepom Sveta 2002/628/ES z dne 25. junija 2002 o sklenitvi Kartagenskega protokola o biološki varnosti v imenu Evropske skupnosti [9], pa tudi določbe Uredbe (ES) št. 1946/2003 Evropskega parlamenta in Sveta z dne 15. julija 2003 o čezmejnem gibanju gensko spremenjenih organizmov [10].
In order to ensure that test methods included in the application are adequate to demonstrate that the food or feed complies with the requirements for authorisation set out in Regulation (EC) No 1829/2003, they should be carried out in accordance with the present Regulation, or internationally agreed guidelines such as those described by the OECD, when available.
Zaradi zagotovitve, da so metode testiranja, vključene v vlogo, ustrezne za dokazovanje, da živilo ali krma izpolnjuje zahteve za odobritev iz Uredbe (ES) št. 1829/2003, bi se morale izvajati v skladu z veljavno uredbo ali mednarodno dogovorjenimi smernicami, kot so tiste, ki jih opisuje OECD, če so na voljo.
To ensure that applications for renewal meet the same standards as regards tests methods, it is appropriate that these requirements also apply to application for renewal of authorisation of GM food and feed.
Za zagotovitev, da vloge za obnovitev izpolnjujejo enake standarde glede testnih metod, je primerno, da se te zahteve uporabljajo tudi za vloge za obnovitev odobritve gensko spremenjenih živil in krme.
In order to provide an accurate designation of the GM food or feed subject to an application under Regulation (EC) No 1829/2003, applications should include proposals for a unique identifier for each GMO concerned in accordance with Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms [11].
Zaradi zagotovitve natančne oznake gensko spremenjenega živila ali krme, ki je predmet vloge na podlagi Uredbe (ES) št. 1829/2003, bi morale vloge vključevati predlog za posebni identifikator za vsak zadevni GSO v skladu z Uredbo Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih identifikatorjev za gensko spremenjene organizme [11].
This Regulation replaces certain provisions of Regulation (EC) No 641/2004 as regards genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food or feed produced from genetically modified plants.
Ta uredba nadomešča nekatere določbe Uredbe (ES) št. 641/2004 glede gensko spremenjenih rastlin za živila in krmo, glede živil ali krme, ki vsebujejo gensko spremenjene rastline ali so iz njih sestavljeni, in glede živil ali krme, proizvedenih iz gensko spremenjenih rastlin.