natgillin/translations-raw huggingface dataset:
However, Regulation (EC) No 641/2004 should continue to apply as regards other types of genetically modified products, namely genetically modified animals and genetically modified micro-organisms.
Vendar bi se morala Uredba (ES) št. 641/2004 še naprej uporabljati za druge vrste gensko spremenjenih proizvodov, in sicer za gensko spremenjene živali in gensko spremenjene mikroorganizme.
Moreover, certain provisions of that Regulation are obsolete.
Poleg tega so nekatere določbe navedene uredbe zastarele.
Regulation (EC) No 641/2004 should therefore be amended accordingly.
Uredbo (ES) št. 641/2004 bi zato bilo treba ustrezno spremeniti.
Commission Regulation (EC) No 1981/2006 of 22 December 2006 on detailed rules for the implementation of Article 32 of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the Community reference laboratory for genetically modified organisms [12] should be amended to include references to this Regulation.
Uredbo Komisije (ES) št. 1981/2006 z dne 22. decembra 2006 o podrobnih pravilih za izvajanje člena 32 Uredbe (ES) št. 1829/2003 Evropskega Parlamenta in Sveta glede referenčnega laboratorija Skupnosti za gensko spremenjene organizme [12] bi bilo treba spremeniti tako, da bo vključevala sklicevanja na to uredbo.
Regulation (EC) No 1829/2003 provides that the Commission is to consult the EFSA before establishing implementing rules with regard to the applications for authorisation under that Regulation.
Uredba (ES) št. 1829/2003 določa, da se mora Komisija pred vzpostavitvijo izvedbenih pravil posvetovati z agencijo EFSA glede vlog za odobritev v okviru navedene uredbe.
The EFSA has been consulted on those rules accordingly.
Ustrezno posvetovanje z agencijo EFSA o teh pravilih je bilo opravljeno.
This Regulation has been drawn up on the basis of current scientific and technical knowledge.
Ta uredba je bila pripravljena na podlagi sedanjih znanstvenih in tehničnih spoznanj.
Therefore, the Commission should monitor any developments in this field and the publication of new or additional guidance by the EFSA.
Zato bi morala Komisija spremljati razvoj na tem področju in objave novih ali dodatnih smernic EFSA.
This Regulation applies to applications submitted after its entry into force.
Ta uredba se uporablja za vloge, predložene po začetku njene veljavnosti.
It is necessary to provide for transitional measures in order to enable the applicants to comply with those rules and for the current applications or the applications close to being submitted to proceed without unnecessary delays.
Predvideti je treba prehodne ukrepe, ki bodo omogočili, da se vlagatelji prilagodijo tem pravilom in da se sedanje vloge ali vloge, ki bodo kmalu vložene, nadaljujejo brez nepotrebnih zamud.
This Regulation shall apply to applications submitted under Articles 5, 11, 17 and 23 of Regulation (EC) No 1829/2003 for the authorisation of:
Ta uredba se uporablja za vloge, predložene na podlagi členov 5, 11, 17 in 23 Uredbe (ES) št. 1829/2003 za odobritev:
genetically modified plants for food or feed uses;
gensko spremenjene rastline za živila in krmo;
food or feed containing or consisting of genetically modified plants;
živila ali krmo, ki vsebujejo gensko spremenjene rastline ali so iz njih sestavljeni;
food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants.
živil, proizvedenih iz sestavin, ki so proizvedene iz gensko spremenjenih rastlin, ali jih vsebujejo, ali krme, proizvedene iz takih rastlin.
For the purposes of this Regulation, the definitions in Regulation (EC) No 1829/2003 apply.
V tej uredbi se uporabljajo opredelitve iz Uredbe (ES) št. 1829/2003.
The definitions of ‘risk’, ‘risk assessment’ and ‘hazard’ applicable for the purposes of this Regulation are those provided in Article 3 of Regulation (EC) No 178/2002.
Opredelitve pojmov „tveganje“, „ocena tveganja“ in „dejavnik tveganja“, ki se uporabljajo v tej uredbi, so določene v členu 3 Uredbe (ES) št. 178/2002.
Preparation and presentation of applications submitted under Articles 5(1) and 17(1)
Priprava in predložitev vlog, predloženih na podlagi člena 5(1) in člena 17(1)
The application submitted under Articles 5(1) and 17(1) of Regulation (EC) No 1829/2003 shall:
Vloga, predložena na podlagi člena 5(1) in člena 17(1) Uredbe (ES) št. 1829/2003:
be submitted in accordance with the requirements for the preparation and presentation of applications set out in Annex I;
se predloži v skladu z zahtevami za pripravo in predložitev vlog iz Priloge I;
contain all the information required by Annex I, in accordance with the specific requirements of Articles 4, 5 and 6.
vsebuje vse informacije, ki se zahtevajo v Prilogi I, v skladu s posebnimi zahtevami iz členov 4, 5 in 6.
The application shall include, for each of the specific requirements laid down in Articles 4, 5 and 6:
Vloga vključuje za vsako posebno zahtevo iz členov 4, 5 in 6:
the summaries and results of the studies referred to in the application;
povzetke in rezultate študij, navedenih v vlogi;
annexes where detailed information on those studies is provided.
priloge, v katerih so navedene podrobne informacije o teh študijah.
The application shall contain a checklist demonstrating that the information required under Articles 4, 5 and 6 is complete.
Vloga vsebuje kontrolni seznam, ki dokazuje, da so informacije, zahtevane v členih 4, 5 in 6, popolne.
Where an application is limited to either food or feed use, it shall contain a verifiable justification explaining why the authorisation shall not cover both uses in accordance with Article 27 of Regulation (EC) No 1829/2003.
Kadar je vloga omejena samo na uporabo za živila ali samo za krmo, vsebuje preverljivo utemeljitev, ki pojasnjuje, zakaj dovoljenje ne bo zajemalo obeh vrst uporabe v skladu s členom 27 Uredbe (ES) št. 1829/2003.
The application shall, at the time of submission, clearly state which parts of the application are claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.
V vlogi se ob predložitvi jasno navede, kateri deli vloge naj bi bili zaupni, in zagotovi preverljiva utemeljitev v skladu s členom 30 Uredbe (ES) št. 1829/2003.
Additional information submitted during the authorisation procedure shall, at the time of submission, clearly state which parts of this additional information is claimed to be confidential and provide verifiable justification in accordance with Article 30 of Regulation (EC) No 1829/2003.
V dodatnih informacijah, predloženih med postopkom odobritve, se ob predložitvi jasno navede, kateri deli teh dodatnih informacij naj bi bili zaupni, in zagotovi preverljiva utemeljitev v skladu s členom 30 Uredbe (ES) št. 1829/2003.
When studies have been already submitted to the European Food Safety Authority (EFSA) for the purposes of an application and, where relevant, to the extent that they may be used by the applicant in accordance with Article 31 of Regulation (EC) No 1829/2003, a reference to such studies and the results of the EFSA’s assessment may, with the agreement of EFSA, be made in the framework of another application.
Če so bile študije že predložene Evropski agenciji za varnost hrane (EFSA), se lahko za vlogo in, kjer je primerno, v obsegu, ki ga lahko vlagatelj uporablja v skladu s členom 31 Uredbe (ES) št. 1829/2003, sklicevanje na take študije in rezultati ocenitve EFSA s soglasjem EFSA podajo v okviru druge vloge.
Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)
Zahteve za izvajanje študij za vloge, predložene na podlagi člena 5(3) in člena 17(3)
Toxicological studies shall be conducted in facilities which comply with the:
Toksikološke študije se izvedejo v prostorih, ki izpolnjujejo:
requirements of Directive 2004/10/EC; or
zahteve iz Direktive 2004/10/ES ali
‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside the Union.
„načela OECD o dobri laboratorijski praksi (DLP)“, če se izvajajo zunaj Unije.
The applicant shall provide evidence to demonstrate such compliance.
Vlagatelj predloži dokaze o taki skladnosti.
Studies, other than toxicological studies, shall:
Študije, razen toksikoloških študij:
comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or
izpolnjujejo načela dobre laboratorijske prakse (DLP) iz Direktive 2004/10/ES ali
be conducted by organisations accredited under the relevant ISO standard.
jih izvedejo organizacije, akreditirane v okviru ustreznega standarda ISO.
Information on the study protocols and the results obtained from the studies referred to in paragraphs 1 and 2 shall be comprehensive and include the raw data in an electronic format, suitable for carrying out statistical or other analysis.
Informacije o študijskih protokolih in rezultatih, dobljenih iz študij, navedenih v odstavkih 1 in 2, so celovite in vključujejo surove podatke v elektronski obliki, primerne za izvajanje statističnih in drugih analiz.
Scientific requirements for the risk assessment of genetically modified food and feed for applications submitted under Articles 5(3) and 17(3)
Znanstvene zahteve za oceno tveganja za gensko spremenjena živila in krmo za vloge, predložene na podlagi člena 5(3) in člena 17(3)
Information, including studies, required to accompany the application as referred to in Article 5(3)(a) to (f) and (h) and in Article 17(3)(a) to (f) and (h) of Regulation (EC) No 1829/2003 shall be provided in accordance with the scientific requirements for the risk assessment of genetically modified food and feed set out in Annex II to this Regulation.
Informacije, vključno s študijami, ki morajo biti priložene vlogi, kot je navedeno v členu 5(3)(a) do (f) in (h) ter v členu 17(3)(a) do (f) in (h) Uredbe (ES) št. 1829/2003, se zagotovijo v skladu z znanstvenimi zahtevami za oceno tveganja za gensko spremenjena živila in krmo iz Priloge II k tej uredbi.
By way of derogation from paragraph 1, an application may be submitted that does not satisfy all the requirements of that paragraph provided that:
Z odstopanjem od odstavka 1 se lahko predloži vloga, ki ne izpolnjuje vseh zahtev navedenega odstavka, pod pogojem, da:
particular information is not necessary owing to the nature of the genetic modification or of the product; or
nekatere informacije niso potrebne zaradi narave genske spremembe ali proizvoda ali
it is not scientifically necessary, or technically possible to supply such information.
takih informacij znanstveno ni treba ali tehnično ni mogoče zagotoviti.
The applicant shall submit reasoned justification for the derogation.
Vlagatelj predloži podprto utemeljitev za odstopanje.
Paragraphs 1 and 2 shall not prevent the EFSA to request, where appropriate, the applicant to supplement the particulars accompanying the application as provided for in Articles 6(2) and 18(2) of Regulation (EC) No 1829/2003.
Odstavka 1 in 2 ne preprečujeta, da EFSA po potrebi zahteva od vlagatelja, da dopolni podrobne podatke, priložene vlogi, kot je določeno v členu 6(2) in členu 18(2) Uredbe (ES) št. 1829/2003.
Additional information related to the risk assessment of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
Dodatne informacije v zvezi z oceno tveganja gensko spremenjenih živil ali krme za vloge, predložene na podlagi člena 5(3) in člena 17(3)
In addition to the information required in accordance with Article 5 and Annex II, the application shall include 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.
Poleg informacij, ki se zahtevajo v skladu s členom 5 in Prilogo II, vloga vključuje sistematičen pregled študij, objavljenih v znanstveni literaturi, ter študij, ki jih je vlagatelj opravil v obdobju 10 let pred datumom predložitve dokumentacije o morebitnih učinkih gensko spremenjenih živil in krme, zajetih v vlogi, na zdravje ljudi in živali.
During the authorisation procedure, the applicant shall submit, without delay, to the EFSA additional information which might influence the risk assessment of the genetically modified food or feed generated following the submission of the application.
Med postopkom odobritve vlagatelj nemudoma predloži agenciji EFSA dodatne informacije, pridobljene po predložitvi vloge, ki lahko vplivajo na oceno tveganja za gensko spremenjeno živilo ali krmo.
In particular, the applicant shall submit to the EFSA information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a risk assessment of the genetically modified food and feed.
Vlagatelj predloži agenciji EFSA zlasti informacije v zvezi s katero koli prepovedjo ali omejitvijo, ki jo je naložil ustrezen organ katere koli tretje države na podlagi ocene tveganja za gensko spremenjeno živilo ali krmo.
Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
Zahteve za spremljanje gensko spremenjenega živila ali krme po dajanju na trg za vloge, predložene na podlagi člena 5(3) in člena 17(3)
The applicant shall submit a proposal for post-market monitoring regarding the use of the food and feed as referred to in Articles 5(3)(k) and 17(3)(k) of Regulation (EC) No 1829/2003 when the information provided in accordance with Articles 4, 5 and 6 demonstrates that the genetically modified food and feed comply with Articles 4(1) and 16(1) of Regulation (EC) No 1829/2003 and when, in accordance with the outcome of the risk assessment, it is appropriate to confirm:
Vlagatelj predloži predlog za spremljanje uporabe živila ali krme po dajanju na trg, kakor je navedeno v členu 5(3)(k) in členu 17(3)(k) Uredbe (ES) št. 1829/2003, kadar informacije, predložene v skladu s členi 4, 5 in 6, dokazujejo, da je gensko spremenjeno živilo ali krma skladno s členom 4(1) in členom 16(1) Uredbe (ES) št. 1829/2003, in, ko je v skladu z rezultatom ocene tveganja primerno, potrdi:
that specific recommendations of uses are followed by the consumer/animal owner;
da potrošnik/lastnik živali upošteva posebna priporočila za uporabo;
the predicted consumption of the genetically modified food or feed; or
napovedano porabo gensko spremenjenega živila ali krme ali
the relevance and intensity of effects and unintended effects detected during the pre-market risk assessment which can only be further characterised by post-market monitoring.
ustreznost in intenzivnost učinkov ter nenamernih učinkov, odkritih med oceno tveganja pred dajanjem na trg, ki se lahko nadalje opredeli le s spremljanjem po dajanju na trg.
The applicant shall ensure that the post-market monitoring is:
Vlagatelj zagotovi, da je spremljanje po dajanju na trg:
developed to collect reliable information with respect to one or several of the aspects set out in paragraph 1.
pripravljeno za zbiranje zanesljivih informacij v zvezi z enim ali več vidiki, navedenimi v odstavku 1.
This information shall allow the detection of indications on whether any (adverse) effect on health may be related to genetically modified food or feed consumption;
Te informacije omogočajo odkrivanje znakov o tem, ali so lahko s porabo gensko spremenjenega živila ali krme povezani kakšni (škodljivi) učinki na zdravje;
based on strategies aiming at collecting relevant information from specific stakeholders including consumers and on a reliable and validated flow of information between the different stakeholders.
utemeljeno na strategijah, usmerjenih v zbiranje ustreznih informacij pri določenih zainteresiranih straneh, vključno s potrošniki, in na zanesljivem ter validiranem toku informacij med različnimi zainteresiranimi stranmi.
More specific strategies shall be included when data on individual intakes of a specific food item or intakes of particular age groups have to be collected;
Podrobnejše strategije bodo vključene, ko bo treba zbrati podatke o posameznih vnosih določenega živila ali vnosih pri posebni starostni skupini;
accompanied by adequate justification and a thorough description of the selected methodologies for the proposed post-market monitoring including aspects related to the analysis of the collected information.
pospremljeno z ustrezno utemeljitvijo in temeljitim opisom izbranih metodologij za predlagano spremljanje po dajanju na trg, vključno z vidiki, povezanimi z analizo zbranih informacij.
Requirements concerning the methods of detection, identification and quantification and for control samples and reference material of genetically modified food or feed for applications submitted under Articles 5(3), 11(2), 17(3) and 23(2)
Zahteve glede metod odkrivanja, identifikacije in kvantifikacije ter za kontrolne vzorce in referenčni material za gensko spremenjena živila ali krmo za vloge, predložene na podlagi člena 5(3), člena 11(2), člena 17(3) in člena 23(2)
Applications submitted under Articles 5(1) and 17(1) of Regulation (EC) No 1829/2003 shall comply with the following requirements, as referred to in Article 5(3)(i) and (j) and Article 17(3)(i) and (j) of that Regulation, and set out in Annex III to this Regulation, for:
Vloge, predložene na podlagi člena 5(1) in člena 17(1) Uredbe (ES) št. 1829/2003, izpolnjujejo naslednje zahteve iz člena 5(3)(i) in (j) ter člena 17(3)(i) in (j) navedene uredbe ter Priloge III k tej uredbi za:
the methods for detection and identification of the transformation event;
metode odkrivanja in identifikacije transformacijskega dogodka;
samples of food or feed and their control samples, and information as to the place where the reference material can be accessed.
vzorce živila ali krme in njunih kontrolnih vzorcev ter informacije o kraju, kjer je na voljo referenčni material.
For applications submitted under Articles 11(1) and 23(1) of Regulation (EC) No 1829/2003, the requirements set out in Annex III to this Regulation for:
Za vloge, predložene na podlagi člena 11(1) in člena 23(1) Uredbe (ES) št. 1829/2003, se zahteve iz Priloge III k tej uredbi za:
samples of food or feed and their control samples, and information as to the place where the reference material can be accessed,
vzorce živila ali krme in njunih kontrolnih vzorcev ter informacije o kraju, kjer je na voljo referenčni material,
shall apply only for the purposes of application of Articles 11(2)(d) and 23(2)(d).
uporabljajo samo za namene uporabe člena 11(2)(d) in člena 23(2)(d).
Until 8 December 2013, applicants may choose to submit applications falling under the scope of this Regulation under Regulation (EC) No 641/2004 in the version of that Regulation in force on 8 June 2013.
Do 8. decembra 2013 se lahko vlagatelji odločijo, da predložijo vloge, ki spadajo v področje uporabe te uredbe, v okviru Uredbe (ES) št. 641/2004 v različici navedene uredbe, ki velja 8. junija 2013.
By way of derogation from Article 4(2), in the case of studies launched prior to the date of entry into force of this Regulation and conducted under quality assurance systems other than GLP and ISO, the applicant shall provide:
Z odstopanjem od člena 4(2) vlagatelj v primeru študij, ki so bile uvedene pred datumom začetka veljavnosti te uredbe in izvedene v okviru drugih sistemov zagotavljanja kakovosti, ki ni DLP ali ISO, zagotovi:
a thorough description of the quality assurance system under which such studies were performed; and
izčrpen opis sistema zagotavljanja kakovosti, v okviru katerega so bile te študije opravljene, in
comprehensive information on the protocols and the results obtained from the studies including the raw data.
celovite informacije o protokolih in rezultatih, dobljenih s temi študijami, vključno s surovimi podatki.
Amendments to Regulation (EC) No 641/2004
Spremembe Uredbe (ES) št. 641/2004
Regulation (EC) No 641/2004 is amended as follows:
Uredba (ES) št. 641/2004 se spremeni:
Article 1 is replaced by the following:
1. člen 1 se nadomesti z naslednjim besedilom:
This chapter provides detailed rules concerning applications for authorisation submitted in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 except for those applications covered by Commission Implementing Regulation (EU) No 503/2013.(2) Articles 5 to 19 are deleted.
V tem poglavju so določena podrobna pravila o vlogah za izdajo dovoljenja, predloženih v skladu s členoma 5 in 17 Uredbe (ES) št. 1829/2003, razen za tiste vloge, ki jih zajema Izvedbena uredba Komisije (EU) št. 503/2013.2. členi 5 do 19 se črtajo.
Amendments to Regulation (EC) No 1981/2006
Spremembe Uredbe (ES) št. 1981/2006
Regulation (EC) No 1981/2006 is amended as follows:
Uredba (ES) št. 1981/2006 se spremeni:
in Article 2, point (a) is replaced by the following:
1. v členu 2 se točka (a) nadomesti z naslednjim:
“full validation procedure” means:
‚popolni postopek validacije‘ je:
the assessment through a ring trial involving national reference laboratories of the method performance criteria set by the applicant as compliant with the document entitled “Definition of minimum performance requirements for analytical methods of GMO testing” referred to:
ocenjevanje s pomočjo primerjalnega testiranja meril za izvajanje metode, v katerega so vključeni nacionalni referenčni laboratoriji, pri čemer metodo določi vlagatelj kot pritožnik v skladu z dokumentom z naslovom ‚Opredelitev minimalnih zahtev za izvajanje analiznih metod testiranja GSO‘:
in the case of genetically modified plants for food or feed uses, food or feed containing or consisting of genetically modified plants and food produced from or containing ingredients produced from genetically modified plants or feed produced from genetically modified plants, in point 3.1.C.4 of Annex III to Commission Implementing Regulation (EU) No 503/2013,in all other cases, in point 1(B) of Annex I to Regulation (EC) No 641/2004;
pri gensko spremenjenih rastlinah, namenjenih živalski krmi ali človeški hrani, živilih ali krmi, ki vsebujejo ali so sestavljeni iz gensko spremenjenih rastlin, in živilih, ki vsebujejo ali so sestavljeni iz sestavin, proizvedenih iz gensko spremenjenih rastlin, ali krmi, proizvedeni iz gensko spremenjenih rastlin, iz točke 3.1.C.4 Priloge III k Izvedbeni uredbi Komisije (ES) št. 503/2013,v vseh drugih primerih iz točke 1(B) Priloge I k Uredbi (ES) št. 641/2004,
the assessment of the precision and trueness of the method provided by the applicant.
ocenjevanje natančnosti in pravilnosti metode, ki jo določi vlagatelj.
in Article 3(2), the first and second subparagraphs are replaced by the following:
2. prvi in drugi pododstavek člena 3(2) se nadomestita z naslednjim:
The CRL shall request the applicant to pay an additional contribution of EUR 60000 where a full validation procedure of a method of detection and identification for a single GMO event according to the requirements laid down in the following provisions is required:
Referenčni laboratorij Skupnosti zahteva od vlagatelja, da plača dodatni prispevek v višini 60000 EUR, kadar je potreben popolni postopek validacije metode odkrivanja in identifikacije za posamezen dogodek GSO v skladu z zahtevami iz naslednjih določb:
Annex III to Implementing Regulation (EU) No 503/2013, when the application is related to:
Priloge III k Izvedbeni uredbi (EU) št. 503/2013, kadar se vloga nanaša na:
food produced from or containing ingredients produced from genetically modified plants or feed produced from such plants; or
živila, proizvedena iz sestavin, ki so proizvedene iz gensko spremenjenih rastlin ali jih vsebujejo, ali krmo, proizvedeno iz takih rastlin, ali
point 1(B) of Annex I to Regulation (EC) No 641/2004, in all other cases.
točke 1(B) Priloge I k Uredbi (ES) št. 641/2004 v vseh drugih primerih.
That amount shall be multiplied by the number of GMO events to be fully validated.’.
Navedeni znesek se pomnoži s številom dogodkov GSO, ki jih je treba v celoti validirati.“