natgillin/translations-raw huggingface dataset:
A notification (Reference C/SE/96/3501) concerning the placing on the market of a genetically modified potato product (Solanum tuberosum L. line EH92-527-1) was submitted by BASF Plant Science (formerly Amylogen HB) to the competent authority of Sweden.
BASF Plant Science (prej Amylogen HB) je pristojnemu organu Švedske predložil prijavo (sklic C/SE/96/3501) o dajanju na trg gensko spremenjenih krompirjevih proizvodov (Solanum tuberosum L. linije EH92-527-1).
The notification originally covered the placing on the market of Solanum tuberosum L. line EH92-527-1 for cultivation and processing into industrial starch, as well as use in feed in the Community.
Prijava je prvotno zajemala dajanje na trg Solanum tuberosum L. linije EH92-527-1 za gojenje in predelavo v industrijski škrob ter za uporabo v krmi v Skupnosti.
In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of Sweden prepared an assessment report, which concluded that there is no scientific evidence to indicate that the placing on the market of the Solanum tuberosum L. line EH92-527-1 poses any risk to human and animal health or the environment for the requested uses.
V skladu s postopkom iz člena 14 Direktive 2001/18/ES je pristojni švedski organ pripravil poročilo o oceni, iz katerega je razvidno, da ni znanstvenih dokazov, ki bi pričali o tem, da je dajanje Solanum tuberosum L. linije EH92-527-1 na trg v okviru zahtevane uporabe tvegano za zdravje ljudi in živali ali okolje.
The assessment report was submitted to the Commission and the competent authorities of the other Member States, which raised and maintained objections to the placing on the market of the product.
Poročilo o oceni je bilo predloženo Komisiji in pristojnim organom ostalih držav članic, ki so ugovarjali dajanju tega proizvoda na trg in pri tem vztrajali.
On 9 December 2005, BASF Plant Science informed the Swedish competent authority of its intention to exclude feed uses from the notification under Directive 2001/18/EC, limiting its scope to cultivation of the Solanum tuberosum L. line EH92-527-1 and production of starch for industrial uses.
BASF Plant Science je 9. decembra 2005 švedski pristojni organ obvestil, da namerava iz prijave na podlagi Direktive 2001/18/ES izključiti uporabo za krmo in s tem omejiti obseg uporabe na pridelavo Solanum tuberosum L. linije EH92-527-1 in proizvodnjo škroba v industrijske namene.
An application for the placing on the market of feed and food containing, consisting of, or produced from Solanum tuberosum L. line EH92-527-1 was submitted, on 25 April 2005, by BASF Plant Science under Regulation (EC) No 1829/2003 of the European Parliament and of the Council [2].
BASF Plant Science je 25. aprila 2005 v skladu z Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta [2] predložil vlogo za dajanje krme in živil na trg, ki vsebujejo Solanum tuberosum L. linije EH92-527-1, so iz njega sestavljeni ali proizvedeni.
The opinions of the European Food Safety Authority concerning the placing on the market of Solanum tuberosum L. line EH92-527-1 for cultivation and industrial starch production under Directive 2001/18/EC and feed and food under Regulation (EC) No 1829/2003, published on 24 February 2006, concluded that the product is unlikely to have an adverse effect on human and animal health or the environment in the context of its proposed uses.
Evropska agencija za varnost hrane („EFSA“) je v mnenjih, ki jih je objavila 24. februarja 2006 glede dajanja na trg Solanum tuberosum L. linije EH92-527-1 za pridelavo in proizvodnjo industrijskega škroba na podlagi Direktive 2001/18/ES ter krme in živil na podlagi Uredbe (ES) št. 1829/2003, ugotovila, da je malo verjetno, da bi proizvod v okviru predlagane uporabe škodljivo vplival na zdravje ljudi in živali ali okolje.
An examination of each of the objections maintained by the Member States in the light of Directive 2001/18/EC, of the information submitted in the notification and of the opinion of the European Food Safety Authority, discloses no evidence to believe that the placing on the market of Solanum tuberosum L. line EH92-527-1 is likely to cause adverse effects on human and animal health or the environment in the context of its proposed uses.
Preučitev vseh ugovorov držav članic na podlagi Direktive 2001/18/ES in informacij, predloženih v prijavi, ter mnenja EFSA ni razkrila nobenih dokazov, da bi dajanje Solanum tuberosum L. linije EH92-527-1 na trg v okviru predlagane uporabe škodljivo vplivalo na zdravje ljudi ali živali ali okolje.
On 26 February 2007, in the light of a report published by the World Health Organisation listing kanamycin and neomycin as ‘critically important antibacterial agents for human medicine and for risk management strategies of non-human use’, the European Medicines Agency issued a statement highlighting the therapeutic relevance of both antibiotics in human and veterinary medicine.
Ob upoštevanju poročila, ki ga je objavila Svetovna zdravstvena organizacija in uvršča kanamicin in neomicin med „nujno pomembna antibakterijska sredstva za humano medicino za strategije za obvladovanje tveganja, kadar se ne uporabljajo za ljudi“, je Evropska agencija za zdravila 26. februarja 2007 objavila poročilo, ki poudarja terapevtski pomen obeh antibiotikov v humani in veterinarski medicini.
On 13 April 2007, taking into account this statement, EFSA indicated that the therapeutic effect of the antibiotics at stake will not be compromised by the presence of the nptII gene in GM plants.
Ob upoštevanju tega poročila je EFSA 13. aprila 2007 navedla, da prisotnost gena nptII v gensko spremenjenih rastlinah ne bo ogrozila terapevtskega učinka zadevnih antibiotikov.
This is due to the extremely low probability of gene transfer from plants to bacteria and its subsequent expression and to the fact that this antibiotic resistant gene in bacteria is already widespread in the environment.
To je posledica izjemno majhne verjetnosti genskega prenosa z rastlin na bakterije in posledične ekspresije ter dejstva, da je ta na antibiotike odporen gen v bakterijah v naravi že zelo razširjen.
It thus confirmed its previous assessment of the safe use of the antibiotic resistance marker gene nptII in genetically modified organisms and their derived products for food and feed uses.
EFSA je tako potrdila svojo prejšnjo oceno o varni uporabi markerskega gena nptII za odpornost proti antibiotikom v gensko spremenjenih organizmih in proizvodih za živila in krmo, pridobljenih iz njih.
On 14 May 2008, the Commission sent a mandate to EFSA, with a request: (i) to prepare a consolidated scientific opinion taking into account the previous opinion and the statement on the use of ARM genes in GM plants intended or already authorised to be placed on the market and their possible uses for import and processing and for cultivation; (ii) to indicate the possible consequences of this consolidated opinion on the previous EFSA assessments on individual GMOs containing ARM genes.
Komisija je 14. maja 2008 pooblastila EFSA z zahtevo, (i) naj pripravi konsolidirano znanstveno mnenje ob upoštevanju prejšnjega mnenja in poročila o uporabi označevalnih genov za odpornost na antibiotike v gensko spremenjenih rastlinah, ki so namenjene ali že odobrene za dajanje na trg, ter njihovi možni uporabi za uvoz, predelavo in pridelovanje; (ii) naj navede možne učinke tega konsolidiranega mnenja na prejšnje ocene EFSA o posameznih gensko spremenjenih organizmih, ki vsebujejo označevalne gene za odpornost na antibiotike.
The mandate brought to the attention of EFSA, inter alia, letters by the Commission from Denmark and Greenpeace.
EFSA je v okviru pooblastila med drugim prejela tudi pismi, ki sta ju Komisiji predložila Danska in Greenpeace.
On 11 June 2009, EFSA published a statement on the use of ARM genes in GM plants which concludes that the previous assessment of EFSA on Solanum tuberosum L. line EH92-527-1 is in line with the risk assessment strategy described in the statement, and that no new evidence has become available that would prompt EFSA to change its previous opinion.
EFSA je 11. junija 2009 objavila poročilo o uporabi označevalnih genov za odpornost na antibiotike v gensko spremenjenih rastlinah, v kateri navaja, da je prejšnja ocena EFSA glede Solanum tuberosum L. linije EH92-527-1 v skladu s strategijo ocene tveganja, opisano v poročilu, in da ni nobenega novega dokaza, zaradi katerega bi EFSA spremenila prejšnje mnenje.
A unique identifier should be assigned to the Solanum tuberosum L. line EH92-527-1 for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [3] and 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 [4].
Za namene Uredbe (ES) št. 1830/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in krme, proizvedenih iz gensko spremenjenih organizmov, ter o spremembi Direktive 2001/18/ES [3], in Uredbe Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih identifikatorjev za gensko spremenjene organizme [4] je treba za Solanum tuberosum L. linije EH92-527-1 določiti poseben identifikator.
The proposed labelling, on a label or in an accompanying document, of products containing or consisting of Solanum tuberosum L. line EH92-527-1 should include wording to inform operators and final users that such material cannot be used for human or animal consumption.
Predlagana oznaka na etiketi ali v spremljajočem dokumentu za proizvode, ki vsebujejo Solanum tuberosum L. linije EH92-527-1 ali pa so iz njega sestavljeni, mora vključevati besedilo, ki nosilce dejavnosti in potrošnike obvešča, da se tak material ne sme uporabljati za prehrano ljudi ali živali.
Feed produced from Solanum tuberosum L. line EH92-527-1 as well as the adventitious or technically unavoidable presence of the potato in food and other feed products have been authorised under Commission Decision 2010/136/EU [5] under Regulation (EC) No 1829/2003.
Krma, proizvedena iz Solanum tuberosum L. linije EH92-527-1, ter naključna ali tehnično neizogibna navzočnost krompirja v živilih in drugih krmnih proizvodih sta bili odobreni s Sklepom Komisije 2010/136/EU [5] v skladu z Uredbo (ES) št. 1829/2003.
Member States should utilise the registers established, in accordance with Article 31(3)(b) of Directive 2001/18/EC, for recording the location of GMOs grown under Part C of the Directive, inter alia, to facilitate monitoring and general surveillance and for the purpose of inspection and control.
Države članice morajo v skladu s členom 31(3)(b) Direktive 2001/18/ES uporabljati obstoječe registre za evidentiranje mest gensko spremenjenih organizmov, ki se gojijo v skladu z delom C Direktive, med drugim za poenostavitev spremljanja in splošnega nadzora pri inšpekciji in kontroli.
In view of the opinion of EFSA, it is not necessary to establish specific conditions for the intended uses with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.
Glede na mnenje EFSA ni treba določiti posebnih pogojev za predvideno uporabo v zvezi z ravnanjem s proizvodom ali pakiranjem proizvoda ter varstvom nekaterih ekosistemov, okolij ali geografskih območij.
In order to complement existing field studies carried out in northern Europe, which indicated that the cultivation of Solanum tuberosum L. line EH92-527-1 is unlikely to have adverse effects on the environment, additional measures to monitor potato-feeding organisms in the fields and their vicinity where Solanum tuberosum L. line EH92-527-1 is commercially cultivated should be put in place as part of the monitoring programme.
Kot dopolnitev obstoječih študij na terenu v severni Evropi, ki so pokazale, da je malo verjetno, da pridelava Solanum tuberosum L. linije EH92-527-1 škodljivo vpliva na okolje, je treba na poljih, kjer se prideluje Solanum tuberosum L. linije EH92-527-1 v komercialne namene, in njihovi bližini kot del programa spremljanja sprejeti dodatne ukrepe za spremljanje organizmov, ki se hranijo s krompirjem.
Prior to the placing on the market of the Solanum tuberosum L. line EH92-527-1, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate validated detection methodology, should be applicable.
Preden se Solanum tuberosum L. linije EH92-527-1 da na trg, je treba izvesti potrebne ukrepe za zagotovitev označevanja in sledljivosti na vseh stopnjah njegovega dajanja na trg, vključno s preverjanjem z ustrezno potrjeno metodo odkrivanja.
A detection method for the Solanum tuberosum L. line EH92-527-1 has been validated by the Community Reference Laboratory as referred to in Article 32 of Regulation (EC) No 1829/2003, in accordance with Commission Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 of the European Parliament and of the Council as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation [6].
Metodo odkrivanja Solanum tuberosum L. linije EH92-527-1 je potrdil referenčni laboratorij Skupnosti, kot je določeno v členu 32 Uredbe (ES) št. 1829/2003, v skladu z Uredbo Komisije (ES) št. 641/2004 z dne 6. aprila 2004 o podrobnih pravilih za izvajanje Uredbe (ES) št. 1829/2003 Evropskega parlamenta in Sveta v zvezi z vlogo za odobritev novih gensko spremenjenih živil in krme, uradnim obvestilom o obstoječih proizvodih in naključni ali tehnično neizogibni navzočnosti gensko spremenjene snovi, ki je prejela ugodno oceno tveganja [6].
The Committee established under Article 30(1) of Directive 2001/18/EC has not delivered an opinion within the time-limit laid down by its Chairman.
Odbor, ustanovljen v skladu s členom 30(1) Direktive 2001/18/ES, ni izdal mnenja v roku, ki ga je določil njegov predsednik.
At its meeting on 16 July 2007, the Council was unable to reach a decision by qualified majority either for or against the proposal.
Na sestanku dne 16. julija 2007 Svet ni mogel sprejeti odločitve s kvalificirano večino niti za predlog niti proti njemu.
It is accordingly for the Commission to adopt the measures,
Zato mora Komisija sprejeti ukrepe –
Without prejudice to other Community legislation, in particular Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of Sweden to the placing on the market, in accordance with this Decision, of the product identified in Article 2, as notified (Reference C/SE/96/3501) by BASF Plant Science.
Brez poseganja v drugo zakonodajo Skupnosti, zlasti v Uredbo (ES) št. 1829/2003, pristojni švedski organ v skladu s tem sklepom izda pisno odobritev o dajanju na trg proizvoda iz člena 2, kakor ga je prijavil (sklic C/SE/96/3501) BASF Plant Science.
The consent shall, in accordance with Article 19(3) of Directive 2001/18/EC, explicitly specify the conditions to which the consent is subject, which are set out in Articles 3 and 4.
V skladu s členom 19(3) Direktive 2001/18/ES so v odobritvi izrecno opredeljeni pogoji, ki veljajo za odobritev in so določeni v členih 3 in 4.
The genetically modified organism to be placed on the market as or in products, hereinafter ‘the product’ is potato (Solanum tuberosum L.) modified for enhanced content of the amylopectin component of starch, which has been transformed with Agrobacterium tumefaciens, using the vector pHoxwG, resulting in line EH92-527-1.
Gensko spremenjeni organizem za dajanje na trg kot proizvod ali v proizvodu, v nadaljnjem besedilu „proizvod“, je krompir (Solanum tuberosum L.), spremenjen za povečanje vsebnosti amilopektinske komponente v škrobu z Agrobacterium tumefaciens in uporabo vektorja pHoxwG v linijo EH92-527-1.
The product contains the following DNA in two cassettes:
Proizvod vsebuje naslednje DNA sekvence v dveh kasetah:
Cassette 1:
kaseta 1:
an nptII-type kanamycin resistance gene originating from Tn5, under the regulation of a nopaline-synthase promoter for expression in plant tissue and terminated by a polyadenylation sequence from the Agrobacterium tumefaciens nopaline-synthase gene;
gen za odpornost na kanamicin tipa nptll, pridobljen iz Tn5, ki ga uravnava nopalin sintazni promotor za ekspresijo v rastlinskem tkivu s terminalnim poliadenilacijskim zaporedjem iz gena za nopalin sintazo Agrobacterium tumefaciens;
Cassette 2:
kaseta 2:
a segment of the potato gbss gene encoding for granule bound starch synthase protein inserted in reversed orientation under the control of the gbss-promoter isolated from potato, and terminated by a polyadenylation sequence from the Agrobacterium tumefaciens nopaline-synthase gene.
segment gena gbss krompirja, ki vsebuje protein za sintezo škroba, vezan v zrnca, vstavljen v obratni orientaciji, ki ga uravnava promotor gbss, izoliran iz krompirja, s terminalnim poliadenilacijskim zaporedjem iz gena za nopalin sintazo Agrobacterium tumefaciens.
The consent shall cover genetically modified Solanum tuberosum L. line EH92-527-1 as or in products.
Odobritev zajema gensko spremenjen Solanum tuberosum L. linije EH92-527-1 kot proizvod ali v proizvodu.
The product may be placed on the market for cultivation and industrial use subject to the following conditions:
Proizvod se lahko da na trg za pridelovanje in uporabo v industriji pod naslednjimi pogoji:
in accordance with Article 15(4) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date at which the consent for Solanum tuberosum L. line EH92-527-1 is issued;
v skladu s členom 15(4) Direktive 2001/18/ES je obdobje veljavnosti odobritve 10 let od datuma izdaje odobritve za Solanum tuberosum L. linije EH92-527-1;
the unique identifier of the products shall be BPS-25271-9;
posebni identifikator proizvodov je BPS-25271-9;
without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall make available positive and negative control samples of the product and its genetic materials and reference materials to the competent authorities and to inspection services of Member States as well as to the Community control laboratories on request;
brez poseganja v člen 25 Direktive 2001/18/ES da imetnik odobritve na zahtevo pristojnim organom in inšpekcijskim službam držav članic ter nadzornim laboratorijem Skupnosti na voljo pozitivne in negativne kontrolne vzorce proizvodov ter njihov genski in referenčni material;
a detection method specific to Solanum tuberosum L. line EH92-527-1, validated by the Community Reference Laboratory as referred to in the Annex to Regulation (EC) No 1829/2003 is available for the purpose of inspection and control;
za namene inšpekcije in kontrole je na voljo posebna metoda odkrivanja Solanum tuberosum L. linije EH92-527-1, ki jo je potrdil referenčni laboratorij Skupnosti, kot je navedeno v Prilogi k Uredbi (ES) št. 1829/2003;
without prejudice to specific labelling requirements provided by Regulation (EC) No 1829/2003, the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified EH92-527-1 potato’ and the words ‘not for human consumption’ shall appear either on a label or in a document accompanying the product;
brez poseganja v posebne zahteve glede označevanja, ki jih določa Uredba (ES) št. 1829/2003, je besedilo: „Ta proizvod vsebuje gensko spremenjene organizme“ ali „Ta proizvod vsebuje gensko spremenjeni krompir EH92-527-1“ in besedilo: „Ni za prehrano ljudi“ navedeno na oznaki ali v dokumentu, ki je priložen proizvodu;
it shall also be indicated on the label, or in an accompanying document, that the product contains an altered starch composition;
na oznaki ali v priloženem dokumentu je prav tako navedeno, da proizvod vsebuje sestavino spremenjenega škroba;
throughout the validity of the consent, the consent holder when placing Solanum tuberosum L. line EH92-527-1 on the market in a Member State shall directly inform operators and users on the safety and general characteristics of the product, and of the legal requirements for the placing on the market of material harvested from crops containing this line;
v času veljavnosti odobritve imetnik ob dajanju na trg Solanum tuberosum L. linije EH92-527-1, v državi članici neposredno obvešča nosilce dejavnosti in potrošnike o varnosti in splošnih značilnostih proizvoda in pravnih zahtevah za dajanje na trg materiala, pridobljenega iz pridelkov, ki vsebujejo to linijo;
in view that this Decision covers only cultivation and industrial use, the consent holder shall ensure that potato tubers of Solanum tuberosum L. line EH92-527-1 are:
ker ta sklep zajema samo pridelovanje in uporabo v industriji, imetnik odobritve zagotovi, da so krompirjevi gomolji Solanum tuberosum L. linije EH92-527-1:
physically separated from potatoes for food and feed uses during planting, cultivation, harvest, transport, storage and handling in the environment;
v času setve, pridelovanja, žetve, prevoza, skladiščenja in ravnanja v naravi fizično ločeni od krompirja za živila in krmo;
delivered exclusively to designated starch processing plants, notified to the relevant national competent authority, for processing into industrial starch within a closed system, either by time or space separation, to avoid any co-mingling with material derived from potatoes intended for food or feed.
dobavljeni izključno v določene obrate za predelavo škroba, o čemer se obvesti ustrezni nacionalni pristojni organ, za predelavo v industrijski škrob znotraj zaprtega sistema s časovnim ali krajevnim ločevanjem, da bi se izognili medsebojnemu mešanju z materialom, pridobljenim iz navadnega krompirja za živila in krmo.
Throughout the period of validity of the consent:
V obdobju veljavnosti odobritve:
the consent holder shall ensure that the monitoring plan, to monitor for any adverse effects on human and animal health or the environment arising from handling or use of the product, is put in place and implemented.
imetnik odobritve zagotovi, da je vzpostavljen in se izvaja načrt spremljanja, katerega cilj je odkrivanje škodljivih vplivov na zdravje ljudi in živali ali na okolje, ki izhajajo iz ravnanja s proizvodom ali uporabe proizvoda.
This monitoring plan includes case-specific monitoring, general surveillance and an Identity Preservation System (IPS), as contained in the notification and may be subject to further modifications as laid down in this Article;
Ta načrt spremljanja vključuje spremljanje posameznih primerov, splošni nadzor in Sistem za ohranitev lastnosti (Identity Preservation System – IPS), kot je navedeno v prijavi, ter se ga lahko nadalje spreminja, kot je določeno v tem členu;
the consent holder shall ensure that monitoring includes data as to the area of land cultivated with Solanum tuberosum L. line EH92-527-1 and the quantity of harvested material;
imetnik odobritve zagotovi, da spremljanje zajema podatke o obdelovalnih površinah Solanum tuberosum L. linije EH92-527-1 in količini pridelanega materiala;
the consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States:
imetnik odobritve je sposoben Komisiji in pristojnim organom držav članic predložiti dokaze:
that the existing monitoring networks, as specified in the monitoring plan contained in the notification, gathers the information relevant for the monitoring of the products; and
da obstoječe mreže spremljanja, kot so določene v načrtu spremljanja iz prijave, zbirajo informacije v zvezi s spremljanjem proizvodov; ter