natgillin/translations-raw huggingface dataset:
Article 46(1) of Regulation (EC) No 1829/2003 (hereinafter referred to as the Regulation) provides that requests submitted pursuant to Article 4 of Regulation (EC) No 258/97 before the date of application of the Regulation, i.e. 18 April 2004, shall be transformed into applications pursuant to Chapter II, Section 1 of the Regulation in cases where an additional assessment report is required in accordance with Article 6(3) or (4) of Regulation (EC) No 258/97.
Člen 46(1) Uredbe (ES) št. 1829/2003 (v nadaljnjem besedilu Uredba) določa, da se vloge, ki so bile predložene v skladu s členom 4 Uredbe (ES) št. 258/97 pred začetkom uporabe Uredbe, to je pred 18. aprilom 2004, spremenijo v vloge iz oddelka I poglavja II Uredbe, kadar se zahteva dodatno poročilo o oceni v skladu s členom 6(3) ali 6(4) Uredbe (ES) št. 258/97.
The scope of Regulation (EC) No 258/97 is limited to the placing on the market, within the Community, of novel foods or novel food ingredients.
Področje uporabe Uredbe (ES) št. 258/97 je omejeno na dajanje novih živil ali novih živilskih sestavin na trg znotraj Skupnosti.
Consequently the present decision does not cover the placing on the market of feed containing, consisting of or produced from maize line 1507.
Zato ta sklep ne vključuje dajanja na trg krme, ki vsebuje koruzo sorte 1507, je iz nje sestavljena ali proizvedena.
In particular, the placing on the market of genetically modified maize line 1507 as or in some products including feed containing or consisting of this maize is subject to Commission Decision 2005/772/EC of 3 November 2005 concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests and for tolerance to the herbicide glufosinate-ammonium [3].
Dajanje na trg gensko spremenjene koruze sorte 1507 ali proizvodov, ki so iz nje sestavljeni ali proizvedeni, je zlasti predmet Odločbe Komisije 2005/772/ES z dne 3. novembra 2005 o dajanju v promet koruznega proizvoda (Zea mays L., linija 1507), gensko spremenjenega za odpornost proti nekaterim škodljivcem iz reda Lepidoptera in toleranco na herbicid glufosinat-amonij, v skladu z Direktivo 2001/18/ES Evropskega parlamenta in Sveta [3].
Feed produced from maize line 1507 has been placed on the market before the date of application of the Regulation, i.e. 18 April 2004.
Krma, proizvedena iz koruze sorte 1507, je bila dana na trg pred datumom začetka veljavnosti Uredbe, tj. 18. aprila 2004.
As a consequence, it is subject to the requirements provided for in Article 20 of the Regulation and may be placed on the market and used in accordance with the conditions laid down in the Community Register of genetically modified food and feed.
Zato zanjo veljajo zahteve iz člena 20 Uredbe, lahko se daje na trg in uporablja v skladu s pogoji iz registra Skupnosti za gensko spremenjena živila in krmo.
On 3 March 2005, the European Food Safety Authority (Authority) gave its opinion in accordance with Article 6 of the Regulation that there is no evidence to indicate that the placing on the market of the products is likely to cause adverse effects on human or animal health or the environment [4].
V mnenju z dne 3. marca 2005, ki ga je Evropska agencija za varno hrano (Agencija) podala v skladu s členom 6 Uredbe, je bilo navedeno, da ne obstajajo dokazi o tem, da bi dajanje proizvodov na trg lahko imelo škodljive posledice na zdravje ljudi, živali ali za okolje [4].
In giving its opinion, the Authority considered all specific questions and concerns raised by the Member States.
Pri izdaji mnenja je Agencija proučila vsa posebna vprašanja in pomisleke, ki so jih izrazile države članice.
Accordingly, the Authority advised that no specific labelling requirements other than those provided for in Article 13(1) of the Regulation are necessary.
Poleg tega je Agencija svetovala, da niso potrebne nobene druge zahteve za označevanje kot tiste, ki so določene v členu 13(1) Uredbe.
The Authority also advised that no specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, and no specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) of the Regulation, are required.
Agencija je prav tako svetovala, da za dajanje na trg niso potrebni nobeni posebni pogoji ali omejitve, prav tako niso potrebni za uporabo in ravnanje, vključno s spremljanjem uporabe po dajanju na trg, nobeni posebni pogoji ali omejitve niso potrebni za varstvo posebnih ekosistemov/okolja in/ali geografskih območij, kot so določeni s točko (e) člena 6(5) Uredbe.
In its opinion, the Authority concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.
Agencija je v svojem mnenju zaključila, da je načrt spremljanja okolja, ki je sestavljen iz splošnega nadzornega načrta, ki ga je predložil vlagatelj, v skladu z nameravano uporabo proizvodov.
In the light of the above considerations, authorisation should be granted.
Ob upoštevanju zgoraj navedenih vidikov je treba izdati dovoljenje.
A unique identifier should be assigned to maize line 1507 as provided for in 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 [5].
Koruzi serije 1507 je treba dodeliti enotni identifikator, kot to določa Uredba Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih identifikatorjev za gensko spremenjene organizme [5].
All information contained in the Annex to this Decision on the authorisation of the products should be entered in the Community Register of genetically modified food and feed as provided for in the Regulation.
Vse informacije o odobritvi proizvodov iz Priloge k tej direktivi je treba vnesti v register Skupnosti za gensko spremenjena živila in krmo, kot to določa Uredba.
In accordance with Article 4(2) of the Regulation, the conditions for authorisation of the product bind all persons placing it on the market.
V skladu s členom 4(2) Uredbe pogoji za odobritev proizvoda zavezujejo vse osebe, ki ga dajejo na trg.
This Decision should be notified through the Biosafety Clearing House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and to point 2(c) of Article 15 of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms [6].
O tem sklepu je treba obvestiti Urad za izmenjavo informacij o biološki varnosti in prek njega Kartagenski protokol biološke varnosti h Konvenciji o biološki raznovrstnosti v skladu s členoma 9(1) in 15(2)(c) Uredbe (ES) št. 1946/2003 Evropskega parlamenta in Sveta z dne 15. julija 2003 o čezmejnem gibanju gensko spremenjenih organizmov [6].
No opinion was delivered by the Standing Committee on the Food Chain and Animal Health; the Commission has therefore submitted a proposal to the Council on 5 October 2005 in accordance with Article 5(4) of Council Decision 1999/468/EC [7], the Council being required to act within three months.
Stalni odbor za prehranjevalno verigo in zdravje živali mnenja ni podal – Komisija je zato dne 5. oktobra 2005 predložila predlog Svetu v skladu s členom 5(4) Sklepa Sveta 1999/468/ES [7], Svet mora ukrepati v roku treh mesecev.
However, the Council has not acted within the required time limit; a Decision should now be adopted by the Commission,
Svet se ni odzval v zahtevanem roku, zato Sklep sedaj sprejme Komisija –
This Decision covers foods and food ingredients containing, consisting of, or produced from the genetically modified maize (Zea mays L.) line 1507 further specified in the Annex to this Decision (the products) and assigned the unique identifier DAS-Ø15Ø7-1, as provided for in Regulation (EC) No 65/2004.
Ta sklep pokriva živila in živilske sestavine, ki vsebujejo gensko spremenjeno koruzo sorte 1507 (Zea mays L.), so iz nje sestavljene ali proizvedene in so podrobneje določene v Prilogi k temu sklepu („proizvodi“) ter jim je dodeljen enotni identifikator DAS-Ø15Ø7-1, kot je določen z Uredbo (ES) št. 65/2004.
Placing on the market
Dajanje na trg
The placing on the market of the products, according to the conditions specified in this Decision and its Annex, is authorised for the purposes of Article 4(2) of Regulation (EC) No 1829/2003.
V skladu s pogoji, določenimi v tem sklepu in Prilogi k Sklepu, je dajanje proizvodov na trg odobreno za namene člena 4(2) Uredbe (ES) št. 1829/2003.
For the purposes of the specific labelling requirements provided for in Article 13(1) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘maize’.
Za namen posebnih zahtev za označevanje iz 13(1) Uredbe (ES) št. 1829/2003 je „ime organizma“„ koruza“.
Monitoring for environmental effects
Spremljanje vplivov na okolje
Authorisation holders shall ensure that the monitoring plan for environmental effects, as specified in the Annex to this Decision, is put in place and implemented.
Imetniki dovoljenja zagotovijo, da se načrt spremljanja vplivov na okolje, kakor je opredeljen v Prilogi k temu sklepu, pripravi in izvaja.
Authorisation holders shall submit to the Commission annual reports on the implementation and the results of the monitoring activities.
Imetniki dovoljenja Komisiji predložijo letna poročila o izvajanju in rezultatih dejavnosti spremljanja.
The reports shall clearly state those parts of the reports which are considered to be confidential, together with a verifiable justification for confidentiality in accordance with Article 30 of Regulation (EC) No 1829/2003.
V teh poročilih je jasno navedeno, kateri deli poročil so zaupni, skupaj s preverljivo utemeljitvijo zaupnosti v skladu s členom 30 Uredbe (ES) št. 1829/2003.
Confidential parts of such reports shall be submitted in separate documents.
Zaupne dele je treba predložiti v samostojnih dokumentih.
Community Register
Register Skupnosti
The information in the Annex to this Decision shall be entered in the Community Register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.
Informacije iz Priloge k temu sklepu se vnesejo v register Skupnosti za gensko spremenjena živila in krmo, kot določa člen 28 Uredbe (ES) št. 1829/2003.
Authorisation holders
Imetniki dovoljenj
The authorisation holders are:
Imetnika dovoljenja sta:
Pioneer Overseas Corporation, Belgium, representing Pioneer Hi-Bred International, United States of America; and
Pioneer Overseas Corporation, Belgija, kot predstavnik Pioneer Hi-Bred International, ZDA; in
Dow AgroSciences Europe, United Kingdom, representing Mycogen Seeds, United States of America;
Dow AgroSciences Europe, Združeno kraljestvo, kot predstavnik Mycogen Seeds, ZDA,
both of which are responsible for fulfilling the duties of authorisation holders provided for in this Decision and in Regulation (EC) No 1829/2003.
ki sta oba odgovorna za izpolnjevanje dolžnosti imetnikov dovoljenj, opredeljenih v tem sklepu in Uredbi (ES) št. 1829/2003.
This Decision shall be valid for a period of 10 years from the date of its adoption.
Ta sklep velja 10 let po datumu sprejetja.
OJ L 291, 5.11.2005, p. 42.
UL L 291, 5.11.2005, str. 42.
OJ L 287, 5.11.2003, p. 1.
UL L 287, 5.11.2003, str. 1.
Applicants and authorisation holders Name Pioneer Overseas Corporation
Vlagatelji in imetniki dovoljenja ime Pioneer Overseas Corporation
Address Avenue des Arts 44, B-1040 Brussels.
naslov Avenue des Arts 44, B-1040 Bruselj, Belgija
On behalf of Pioneer Hi-Bred International, Inc., 400 Locus Street, Suite 800, Des Moines, IA50309, United States of America
v imenu Pioneer Hi-Bred International, Inc., 400 Locus Street, Suite 800, Des Moines, IA50309, ZDA
Name Dow AgroSciences Europe Ltd
ime Dow AgroSciences Europe Ltd.
Address European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, United Kingdom.
naslov European Development Centre, 3 Milton Park, Abingdon, Oxon OX14 4RN, Združeno kraljestvo
On behalf of Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States of America
v imenu Mycogen Seeds c/o Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, ZDA
Designation and specification of the products Foods and food ingredients containing, consisting of, or produced from genetically modified maize (Zea mays L.) line 1507 as described in the application, unique identifier DAS-Ø15Ø7-1, with resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests and with tolerance to the herbicide glufosinate-ammonium.
Poimenovanje in opredelitev proizvodov Živila in živilske sestavine, ki vsebujejo gensko spremenjeno koruzo sorte 1507 (Zea mays L.), so iz nje sestavljena ali proizvedena, kot je opisana v vlogi in z enotnim identifikatorjem DAS-Ø15Ø7-1, z odpornostjo proti koruzni vešči (Ostrinia nubilalis) in nekaterim drugim škodljivim vrstam metuljev ter toleranco za herbicid glufosinat-amonij.
The genetically modified maize DAS-Ø15Ø7-1 contains the following DNA sequences in two cassettes:
Gensko spremenjena koruza DAS-Ø15Ø7-1 vsebuje naslednja zaporedja DNK v dveh kasetah:
A synthetic version of the truncated cry1F gene from Bacillus thuringiensis subsp. aizawai, which confers resistance to the European corn borer (Ostrinia nubilalis) and certain other lepidopteran pests, under the regulation of the ubiquitin promoter ubiZM1(2) from Zea mays L. and the ORF25PolyA terminator from Agrobacterium tumefaciens pTi15955;
Sintetična različica skrajšanega gena cry1F, pridobljenega iz Bacillus thuringiensis podvrste aizawai, ki povzroča odpornost proti koruzni vešči (Ostrinia nubilalis) in nekaterim drugim škodljivim vrstam metuljev, pod nadzorom promotorja ubikvitina ubiZM1(2), pridobljenega iz Zea mays L., in zaključevalnega zaporedja ORF25PolyA iz Agrobacterium tumefaciens pTi15955.
A synthetic version of the pat gene from Streptomyces viridochromogenes strain Tü494, which confers tolerance to the herbicide glufosinate-ammonium, under the regulation of the 35S promoter and terminator sequences from Cauliflower Mosaic Virus.
Sintetična različica pat gena, pridobljenega iz seva Tü494 Streptomyces viridochromogenes, ki povzroča toleranco za herbicid glufosinat-amonij, pod nadzorom promotorja 35S in zaključevalnih zaporedij iz mozaičnega virusa cvetače.
Labelling No specific requirements other than those provided pursuant to Article 13(1) of Regulation (EC) No 1829/2003.
Označevanje Drugih posebnih zahtev ni, razen tistih iz člena 13(1) Uredbe (ES) št. 1829/2003.
For the purpose of Article 13(1) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘maize’.
Za namen člena 13(1) Uredbe (ES) št. 1829/2003 je „ime organizma“„koruza“.
Method for detection Event specific real-time quantitative PCR based method for genetically modified maize DAS-Ø15Ø7-1.
Metoda odkrivanja Kvantitativna metoda za gensko spremenjeno koruzo DAS-Ø15Ø7-1, ki temelji na reakciji PCR v realnem času in glede na pojav.
Validated by the Community reference laboratory established pursuant to Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf
Potrdi jo referenčni laboratorij Skupnosti, ustanovljen v skladu z Uredbo (ES) št. 1829/2003, objavljena je na spletni strani: http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf
Reference Material: ERM®-BF418 accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Referenčni material: Referenčni material ERM®-BF418 je dostopen preko Skupnega raziskovalnega središča (JRC) Evropske komisije, Inštituta za referenčne materiale in meritve na spletni strani: http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm
Unique identifier DAS-Ø15Ø7-1
Posebni identifikator DAS-Ø15Ø7-1
Information required in accordance with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity Biosafety Clearing House, Record ID: see Decision 2006/197/EC.
Informacije, ki so potrebne v skladu s Prilogo II h Kartagenskemu protokolu biološke varnosti h Konvenciji o biološki raznovrstnosti Biosafety Clearing House (Posredovalnica informacij o biološki varnosti), številka zapisa: glej Sklep 2006/197/ES.
Conditions or restrictions on the placing on the market, use or handling of the products Not required.
Pogoji ali omejitve pri dajanju proizvodov v promet, uporabi ali ravnanju z njimi Neobvezno.
Monitoring plan Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC
Načrt spremljanja Načrt spremljanja vplivov na okolje v skladu s Prilogo VII Direktive 2001/18/ES
(Link: http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf)
[Glej: http://gmo-crl.jrc.it/detectionmethods/TC1507-WEB-Protocol-Validation.pdf]
Post market monitoring requirements for the use of the food for human consumption Not required.
Zahteve za spremljanje po dajanju v promet, kadar se uporabljajo kot živila za prehrano ljudi Neobvezno.
Note: links to relevant documents may need to be modified over time.
Opomba: povezave do ustreznih dokumentov je morda treba sčasoma spremeniti.
Those modifications will be made available to the public via the updating of the Community Register of genetically modified food and feed.
Take spremembe bodo na voljo javnosti s posodabljanjem registra Skupnosti za gensko spremenjena živila in krmo.
laying down specific conditions for imports of fishery products from the United States of America
o posebnih pogojih za uvoz ribiških proizvodov iz Združenih držav Amerike
(notified under document number C(2006) 495)
(notificirano pod dokumentarno številko C(2006) 495)
Having regard to Council Decision 98/258/EC of 16 March 1998 on the conclusion of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products [2], and in particular Article 3 thereof,
ob upoštevanju Sklepa Sveta 98/258/ES z dne 16. marca 1998 o sklenitvi Sporazuma med Evropsko skupnostjo in Združenimi državami Amerike o sanitarnih ukrepih za varovanje javnega zdravja in zdravja živali v trgovini z živimi živalmi in živalskimi proizvodi [2], in zlasti člena 3 Sklepa,
Council Directive 91/493/EEC provides that specific conditions shall be established for the imports of fishery products from each third country.
Direktiva 91/493/EGS navaja, da je treba določiti posebne pogoje za uvoz ribiških proizvodov iz vsake tretje države.
These specific import conditions shall include: the procedure for obtaining a health certificate which must accompany consignments of fish when exported to the European Community, the placing of a mark identifying the fishery products and indicating the origin and the number of the establishment, and a list of approved establishments, factory vessels, or cold stores, and a list of registered freezer vessels.
Ti posebni pogoji morajo vsebovati: postopek za pridobivanje zdravstvenih spričeval, ki morajo spremljati pošiljke rib, ko so poslane v Skupnost, nameščanje oznak za ugotavljanje identitete ribiških proizvodov z navedbo porekla in številko obrata, seznam odobrenih obratov, predelovalnih plovil ali hladilnic in seznam registriranih zamrzovalnih plovil.
Annex V to the Agreement between the European Community and the United States of America (USA) on sanitary measures to protect public and animal health in trade in live animals and animal products (the Agreement) established, inter alia, the sanitary measures for fish and fishery products and certain other animal products traded with the United States for which equivalence has been determined.
Priloga V Sporazuma med Evropsko skupnostjo in Združenimi državami Amerike (ZDA) o sanitarnih ukrepih za varovanje javnega zdravja in zdravja živali v trgovini z živimi živalmi in živalskimi proizvodi (Sporazum) med drugim določa sanitarne ukrepe za ribe in ribiške proizvode in nekatere druge proizvode živalskega izvora iz trgovine z Združenimi državami, za katere je bila določena enakovrednost.
Annex II to the Agreement established that the regulatory authorities for the control of the public health conditions for fish and fishery products in the USA are the Food and Drug Administration (FDA) and the National Marine Fisheries Service — National Oceanic & Atmospheric Administration (NMFS-NOAA).
Priloga II k Sporazumu določa, da sta regulativna organa za nadzor nad pogoji javnega zdravja na področju rib in ribiških proizvodov v ZDA „Food and Drug Administration (FDA)“ in „National Marine Fisheries Service – National Oceanic & Atmospheric Administration (NMFS-NOAA)“.
Within the scope of the agreement, the FDA and the NMFS-NOAA are responsible, in particular, for effectively verifying and controlling the implementation of the sanitary rules in force in the USA related to production and processing of fishery products, and for providing information and additional guarantees on the fishery products exported to the EC territory.
V okviru področja uporabe Sporazuma sta FDA in NMFS-NOAA odgovorni zlasti za učinkovito preverjanje in nadzorovanje izvajanja sanitarnih pravil, veljavnih v ZDA, ki se nanašajo na proizvodnjo in predelavo ribiških proizvodov, ter za informiranje in izdajo dodatnih jamstev za ribiške proizvode, izvožene v države ES.
An inspection has been carried out on behalf of the Commission in the USA to verify the conditions under which fishery products are produced, stored and dispatched to the Community.
V imenu Komisije je bil v Združenih državah Amerike opravljen inšpekcijski pregled, da bi preverili pogoje, v katerih se ribiški proizvodi proizvajajo, skladiščijo in odpošiljajo v Skupnost.
Following the results of the inspection visit, FDA and NMFS-NOAA have provided guarantees with regard to their responsibilities described above and the implementation of the specific conditions laid down by the present Decision.
Na podlagi rezultatov inšpekcijskega obiska sta FDA in NMFS-NOAA izdali jamstva v zvezi s svojimi zgoraj navedenimi odgovornostmi in izvajanjem posebnih pogojev iz te odločbe.
These guarantees concern also the controls that apply to brokers (exporters other than processors).
Ta jamstva zadevajo tudi nadzor, ki se uporablja za posrednike (izvoznike, ki niso predelovalci).
It is therefore appropriate to lay down detailed provisions concerning fishery products imported into the Community from the USA in accordance with Directive 91/493/EEC.
Zato je primerno, da se določijo podrobne določbe glede ribiških proizvodov, uvoženih v Skupnost iz ZDA v skladu z Direktivo 91/493/EGS.
It is appropriate for this Decision to be applied 45 days after its publication providing for the necessary transitional period.
Primerno je, da se ta odločba začne uporabljati 45 dni po njeni objavi, da se zagotovi potrebno prehodno obdobje.