natgillin/translations-raw huggingface dataset:
EFSA Panel on Genetically Modified Organisms (GMO), 2014.
Uredba Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih identifikatorjev za gensko spremenjene organizme (UL L 10, 16.1.2004, str. 5).
Scientific Opinion on application (EFSAGMO-NL-2009-64) for the placing on the market of herbicide-tolerant genetically modified soybean BPS-CV127-9 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from BASF Plant Science.
Uredba (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 (UL L 268, 18.10.2003, str. 24).
EFSA Journal 2014; 12(1):3505, 30 pp. doi: 10.2903/j.efsa.2014.3505.
Odločba Komisije 2009/770/ES z dne 13. oktobra 2009 o določitvi standardnih obrazcev za poročanje o rezultatih spremljanja namernega sproščanja gensko spremenjenih organizmov v okolje, kot proizvodov ali v proizvodih, namenjenih dajanju v promet, v skladu z Direktivo 2001/18/ES Evropskega parlamenta in Sveta (UL L 275, 21.10.2009, str. 9).
Commission Decision 2009/770/EC of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (OJ L 275, 21.10.2009, p. 9).
Vložnik in imetnik odobritve: Ime BASF Plant Science GmbH
Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).
Naslov Carl-Bosch-Str.
ANNEX
38, 67056 Ludwigshafen, Nemčija
Applicant and authorisation holder:
Poimenovanje in opredelitev proizvodov:
Name BASF Plant Science GmbH
soja BPS-CV127-9 v proizvodih, ki jo vsebujejo ali so iz nje sestavljeni ter se uporabljajo drugače kot proizvodi iz točk 1 in 2, razen za gojenje.
Address Carl-Bosch-Str.38, 67056 Ludwigshafen, Germany
Gensko spremenjena soja BPS-CV127-9, kot je opisana v vlogi, izraža mutirano podenoto sintaze acetohidroksi kisline Arabidopsis thaliana (AtAHAS), ki povzroča odpornost na imidazolinon herbicide.
BPS-CV127-9 soybean, in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
zaradi posebnih zahtev za označevanje iz člena 13(1) in člena 25(2) Uredbe (ES) št. 1829/2003 ter člena 4(6) Uredbe (ES) št. 1830/2003 je „ime organizma“ „soja“;
The genetically modified BPS-CV127-9 soybean, as described in the application, expresses a mutant acetohydroxyacid synthase large sub-unit of Arabidopsis thaliana (AtAHAS) which confers tolerance to the imidazolinone herbicides.
na oznaki proizvodov, ki vsebujejo sojo BPS-CV127-9 ali so iz nje sestavljeni, in v dokumentih, priloženih tem proizvodom, se navede besedilo „ni za gojenje“, z izjemo proizvodov iz člena 2(a).
For the purposes of the specific labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the ‘name of the organism’ shall be ‘soybean’.
kvantitativna, za pojav specifična metoda, ki temelji na verižni reakciji s polimerazo (PCR) v realnem času, za sojo BPS-CV127-9,
The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of BPS-CV127-9 soybean with the exception of products referred to in point (a) of Article 2.
na podlagi semen jo potrdi referenčni laboratorij EU, ustanovljen z Uredbo (ES) št. 1829/2003, objavi pa se na spletni strani http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx,
Method for detection:
referenčni material: AOCS 0911-B in AOCS 0911-D, na voljo pri združenju American Oil Chemists Society na spletni strani http://www.aocs.org/tech/crm.
Event-specific real-time PCR based method for the quantification of BPS-CV127-9 soybean.
Posebni identifikator:
Validated on seeds by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
Zahtevane informacije v skladu s Prilogo II h Kartagenskemu protokolu o biološki varnosti h Konvenciji o biološki raznovrstnosti:
Reference Material: AOCS 0911-B and AOCS 0911-D are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
Urad za izmenjavo informacij o biološki varnosti, številka vpisa: glej [izpolniti po uradnem obvestilu].
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
niso potrebne.
Biosafety Clearing-House, Record ID: see (to be completed when notified).
Načrt spremljanja:
Conditions or restrictions on the placing on the market, use or handling of the products:
načrt spremljanja učinkov na okolje v skladu s Prilogo VII k Direktivi 2001/18/ES.
Monitoring plan:
Zahteve glede spremljanja uporabe živil v prehrani ljudi po dajanju na trg:
(Link: plan published on the internet)
Take spremembe bodo na voljo javnosti s posodobljenim registrom Skupnosti za gensko spremenjena živila in krmo.
Post-market monitoring requirements for the use of the food for human consumption:
Člen 8
Note: Links to relevant documents may need to be modified over the time.
Naslovnik
Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
Odbor EFSA za gensko spremenjene organizme (GSO), 2014.
Article 8
Znanstveno mnenje o vlogi (EFSAGMO-NL-2009-64) družbe BASF Plant Science za dajanje na trg proti herbicidom odporne gensko spremenjene soje BPS-CV127-9 za uporabo v živilih in krmi, uvoz in predelavo v skladu z Uredbo (ES) št. 1829/2003.
Commission Implementing Decision (EU) 2015/692
Izvedbeni sklep Komisije (EU) 2015/692
concerning the placing on the market, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a carnation (Dianthus caryophyllus L., line 25958) genetically modified for flower colour
o dajanju nageljnov (Dianthus caryophyllus L., linija 25958), gensko spremenjenih glede barve cvetov, na trg v skladu z Direktivo 2001/18/ES Evropskega parlamenta in Sveta
(notified under document C(2015) 2765)
(notificirano pod dokumentarno številko C(2015) 2765)
Pursuant to Directive 2001/18/EC, the placing on the market of a product containing or consisting of a genetically modified organism or a combination of genetically modified organisms is subject to written consent being granted by the competent authority of the Member State that received the notification for the placing on the market of that product, in accordance with the procedure laid down in that Directive.
V skladu z Direktivo 2001/18/ES je za dajanje proizvodov, ki vsebujejo gensko spremenjene organizme ali kombinacijo gensko spremenjenih organizmov ali so sestavljeni iz njih, na trg potrebna pisna odobritev pristojnega organa države članice, ki mu je bila predložena prijava za dajanje navedenega proizvoda na trg v skladu s postopkom iz navedene direktive.
A notification concerning the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line 25958) was submitted by Florigene Ltd, Melbourne, Australia, to the competent authority of the Netherlands in March 2009.
Podjetje Florigene Ltd, Melbourne, Avstralija, je marca 2009 pristojnemu organu Nizozemske predložilo prijavo za dajanje gensko spremenjenih nageljnov (Dianthus caryophyllus L., linija 25958) na trg.
The notification covers import, distribution and retailing of cut flowers of carnation Dianthus caryophyllus L., line 25958 as for any other carnation.
Prijava zajema uvoz, distribucijo in maloprodajo rezanega cvetja nageljnov Dianthus caryophyllus L., linija 25958 kot katerih koli drugih nageljnov.
In accordance with the procedure established by Article 14 of Directive 2001/18/EC, the competent authority of the Netherlands prepared an assessment report, which concluded that no reasons have emerged on the basis of which consent for the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 25958) for ornamental use should be withheld, if specific conditions are fulfilled.
V skladu s postopkom, določenim v členu 14 Direktive 2001/18/ES, je pristojni organ Nizozemske pripravil poročilo o oceni, v katerem je ugotovil, da ni razlogov za zavrnitev odobritve za dajanje rezanega cvetja gensko spremenjenih nageljnov (Dianthus caryophyllus L., linija 25958) na trg za okrasne namene, če so izpolnjeni posebni pogoji.
In its assessment report, the competent authority of the Netherlands also concluded that the general surveillance plan submitted by the applicant is sufficient taking into account the intended uses of the product.
Pristojni organ Nizozemske je v poročilu o oceni prav tako ugotovil, da načrt splošnega nadzora, ki ga je predložil vložnik, ob upoštevanju predvidene uporabe proizvoda zadostuje.
The assessment report was submitted to the Commission and the competent authorities of the other Member States, some of which raised and maintained objections to the placing on the market of the product.
Poročilo o oceni je bilo predloženo Komisiji in pristojnim organom drugih držav članic, izmed katerih so nekateri ugovarjali dajanju tega proizvoda na trg in pri tem vztrajali.
The opinion of the European Food Safety Authority (EFSA), published on 12 December 2014, concluded, from all evidence provided, that there is no scientific reason to consider that the placing on the market of the genetically modified carnation (Dianthus caryophyllus L., line 25958) for ornamental use will cause any adverse effects on human health or the environment [2].
Evropska agencija za varnost hrane (v nadaljnjem besedilu: EFSA) je v mnenju, objavljenem 12. decembra 2014, na podlagi vseh predloženih dokazov ugotovila, da ni nobenih znanstvenih razlogov za domnevo, da bo dajanje gensko spremenjenih nageljnov (Dianthus caryophyllus L., linija 25958) na trg za okrasne namene povzročilo kakršne koli škodljive učinke na zdravje ljudi ali okolje [2].
EFSA also found that the scope of the monitoring plan provided by the notifier is in line with the intended use of the carnation.
EFSA je tudi ugotovila, da je področje uporabe načrta spremljanja, ki ga je predložil prijavitelj, v skladu s predvideno uporabo nageljnov.
An examination of the full notification, additional information provided by the notifier, specific objections maintained by the Member States in the light of Directive 2001/18/EC, and the opinion of EFSA, discloses no reason to believe that the placing on the market of cut flowers of the genetically modified carnation (Dianthus caryophyllus L., line 25958) will adversely affect human health or the environment in the context of its proposed ornamental use.
Po preučitvi celotne prijave, dodatnih informacij, ki jih je predložil prijavitelj, posebnih ugovorov držav članic na podlagi Direktive 2001/18/ES in mnenja agencije EFSA ni razloga za domnevo, da bo dajanje rezanega cvetja gensko spremenjenih nageljnov (Dianthus caryophyllus L., linija 25958) na trg za predlagane okrasne namene škodljivo učinkovalo na zdravje ljudi ali okolje.
A unique identifier has been assigned to the genetically modified carnation (Dianthus caryophyllus L., line 25958) for the purposes of Regulation (EC) No 1830/2003 of the European Parliament and of the Council [3] and Commission Regulation (EC) No 65/2004 [4].
Za namene Uredbe (ES) št. 1830/2003 Evropskega parlamenta in Sveta [3] in Uredbe Komisije (ES) št. 65/2004 [4] je bil gensko spremenjenim nageljnom (Dianthus caryophyllus L., linija 25958) dodeljen posebni identifikator.
In light of the opinion of the European Food Safety Authority, it is not necessary to establish specific conditions for the intended use with regard to the handling or packaging of the product and the protection of particular ecosystems, environments or geographical areas.
Glede na mnenje Evropske agencije za varnost hrane za predvideno uporabo ni treba določiti posebnih pogojev glede ravnanja s proizvodom ali njegovega pakiranja ter glede varstva posebnih ekosistemov, okolij ali zemljepisnih območij.
The proposed labelling, on a label or in an accompanying document, should include wording to inform operators and final users that the cut flowers of Dianthus caryophyllus L., line 25958 cannot be used for human or animal consumption nor for cultivation.
Pri predlaganem označevanju, in sicer na oznakah ali v spremljajočih dokumentih, bi moralo biti vključeno besedilo, ki obvešča izvajalce dejavnosti in končne uporabnike, da se rezano cvetje Dianthus caryophyllus L., linija 25958, ne sme uporabljati za prehrano ljudi ali živali ali za gojenje.
A detection method as required by Annex III B.D.12 of Directive 2001/18/EC, was verified and tested for the Dianthus caryophyllus L., line 25958 by the European Union Reference Laboratory in December 2012.
Metodo odkrivanja, ki se zahteva v Prilogi III B.D.12 Direktive 2001/18/ES, za Dianthus caryophyllus L., linija 25958, je decembra 2012 preveril in preizkusil referenčni laboratorij Evropske unije.
The Committee set up 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 na podlagi člena 30(1) Direktive 2001/18/ES, ni izdal mnenja v roku, ki ga je določil njegov predsednik.
An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation.
Ker je bil izvedbeni akt potreben, je predsednik odboru za pritožbe predložil osnutek izvedbenega akta v nadaljnjo obravnavo.
Written consent shall be granted by the competent authority of the Netherlands to the placing on the market, in accordance with this Decision, of the product identified in Article 2, as notified by Florigene Ltd, Melbourne, Australia (Reference C/NL/09/01).
Pristojni organ Nizozemske na podlagi tega sklepa izda pisno odobritev za dajanje proizvoda iz člena 2 na trg, v skladu s prijavo podjetja Florigene Ltd, Melbourne, Avstralija (sklic C/NL/09/01).
The genetically modified organisms to be placed on the market as product, hereinafter ‘the product’, are cut flowers of carnation (Dianthus caryophyllus L.), with modified flower colour, derived from a Dianthus caryophyllus L. cell culture, and transformed with Agrobacterium tumefaciens, strain AGL0, using the vector pCGP3366, and resulting in line 25958.
Gensko spremenjeni organizmi, ki se dajo na trg kot proizvod (v nadaljnjem besedilu: proizvod), so rezano cvetje nageljnov (Dianthus caryophyllus L.) s spremenjeno barvo cvetov, ki izhajajo iz celične kulture Dianthus caryophyllus L. in so bili transformirani z Agrobacterium tumefaciens seva AGL0 z uporabo vektorja pCGP3366, česar rezultat je linija 25958.
The product contains the following DNA in four cassettes:
Proizvod vsebuje naslednji DNK v štirih kasetah:
The petunia dfr gene encoding dihydroflavonol 4-reductase (DFR), a key enzyme in the anthocyanin biosynthetic pathway, including its own promoter and terminator.
Gen dfr petunije, ki kodira dihidroflavonol-4-reduktazo (DFR), ključni encim pri biosintezi antocianinov, vključno z njegovim promotorjem in terminatorjem.
The promoter sequence from snapdragon chalcone synthase gene, flavonoid 3′5′-hydroxylase (f3′5′h) from Viola hortensis cDNA encoding F3′5′H, a key enzyme in the anthocyanin biosynthetic pathway, and the terminator from a petunia gene encoding a phospholipid transfer protein homologue.
Promotorsko zaporedje gena navadnega odolina za halkon sintazo, flavonoid-3′5′-hidroksilaza (f3′5′h) iz cDNK Viola hortensis, ki kodira F3′5′H, ključni encim pri biosintezi antocianinov, in terminator gena petunije, ki kodira protein, homologen prenosnemu proteinu za fosfolipide.
The Cauliflower mosaic virus 35S promoter, a hairpin-forming construct consisting of a partial dihydroflavonol 4-reductase dfr sense and antisense fragment separated by a petunia dfr intron, targeted to specific, post-transcriptional down-regulation of endogenous carnation dfr, and the CaMV 35S terminator sequence.
Promotor mozaičnega virusa cvetače 35S, zankasti konstrukt iz smiselnega in protismiselnega dela delne dihidroflavonol-4-reduktaze (DFR), ločenih z intronom dfr petunije, za posebno posttranskripcijsko znižanje izražanja endogenega dfr nageljnov in terminacijsko zaporedje mozaičnega virusa cvetače 35S.
These three cassettes were inserted into the plant genome to obtain the desired flower colour.
Te tri kasete so bile vstavljene v rastlinski genom za pridobitev želene barve cvetov.
Cassette 4
Kaseta 4
The Cauliflower mosaic virus 35S promoter, the 5′untranslated region of the petunia gene coding for chlorophyll a/b binding protein, the SuRB (als) gene coding for a mutant acetolactate synthase protein (ALS) derived from Nicotiana tabacum which confers tolerance to sulfonylurea, including its own terminator.
Promotor mozaičnega virusa cvetače 35S, neprevedena regija 5′ gena petunije, ki kodira vezavni protein klorofila a/b, gen SuRB (als), ki kodira mutantni protein acetolaktat sintazo (ALS), ki izhaja iz Nicotiana tabacum, ki povzroča toleranco na sulfonilsečnino, vključno z njegovim terminatorjem.
This trait was used as a marker in the selection of transformants.
Ta lastnost je bila uporabljena kot marker pri selekciji transformant.
The consent shall cover progeny derived through vegetative reproduction of the genetically modified carnation (Dianthus caryophyllus L., line 25958).
Odobritev zajema potomce, pridobljene z vegetativno reprodukcijo gensko spremenjenih nageljnov (Dianthus caryophyllus L., linija 25958).
The product may be placed on the market for ornamental use only and its cultivation is not allowed.
Proizvod se lahko daje na trg le za okrasne namene, njegovo gojenje pa ni dovoljeno.
The product may be placed on the market subject to the following conditions:
Proizvod se lahko daje na trg pod naslednjimi pogoji:
In accordance with Article 19(3)(b) of Directive 2001/18/EC, the period of validity of the consent shall be 10 years starting from the date on which the consent is issued;
v skladu s členom 19(3)(b) Direktive 2001/18/ES odobritev velja 10 let od datuma izdaje odobritve;
The unique identifier of the product shall be IFD-25958-3;
posebni identifikator proizvoda je IFD-25958-3;
Without prejudice to Article 25 of Directive 2001/18/EC, the methodology for detecting and identifying the product, including experimental data demonstrating the specificity of the methodology as single-laboratory validated by the EU Reference Laboratory is publicly available at http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;
brez poseganja v člen 25 Direktive 2001/18/ES je metodologija za odkrivanje in identifikacijo proizvoda, vključno s poskusnimi podatki, ki kažejo specifičnost metodologije, kot jo je znotrajlaboratorijsko validiral referenčni laboratorij EU, javno dostopna na povezavi http://gmo-crl.jrc.ec.europa.eu/valid-2001-18.htm;
Without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall, whenever requested to do so, make positive and negative control samples of the product, or its genetic material, or reference materials available to the competent authorities and to inspection services of Member States as well as to EU control laboratories;
brez poseganja v člen 25 Direktive 2001/18/ES imetnik odobritve pristojnim organom in inšpekcijskim službam držav članic ter nadzornim laboratorijem EU na zahtevo omogoči dostop do pozitivnih in negativnih kontrolnih vzorcev proizvoda, njegovega genskega materiala ali referenčnih materialov;
The words ‘This product is a genetically modified organism’ or ‘This product is a genetically modified carnation’, and the words ‘not for human or animal consumption nor for cultivation’ shall appear either on a label or in a document accompanying the product.
na oznaki ali v spremljajočem dokumentu proizvoda je navedeno besedilo „Ta proizvod je gensko spremenjeni organizem.“ ali „Ta proizvod je gensko spremenjeni nagelj.“ in besedilo „Ni za prehrano ljudi ali živali niti za gojenje.“
Throughout the period of validity of the consent, the consent holder shall ensure that the monitoring plan, contained in the notification and consisting of a general surveillance plan to check for any adverse effects on human health or the environment arising from handling or use of the products, is put in place and implemented.
V obdobju veljavnosti odobritve imetnik odobritve zagotovi, da je načrt spremljanja iz prijave, ki vsebuje načrt splošnega nadzora za odkrivanje kakršnih koli škodljivih učinkov na zdravje ljudi ali na okolje, ki izhajajo iz ravnanja s proizvodi ali njihove uporabe, vzpostavljen in se izvaja.
The monitoring plan is available at [Link: plan published on the internet].
Načrt spremljanja je na voljo na povezavi: [povezava: načrt je objavljen na spletu].
The consent holder shall directly inform the operators and users concerning the safety and general characteristics of the product and of the conditions as to monitoring, including the appropriate management measures to be taken in case of accidental cultivation.
Imetnik odobritve izvajalce dejavnosti in uporabnike neposredno obvešča o varnosti in splošnih značilnostih proizvoda ter pogojih spremljanja, vključno z ustreznimi ukrepi upravljanja, ki se izvedejo v primeru nenamernega gojenja.
that the existing monitoring networks, including national botanic survey networks and plant protection services, as specified in the monitoring plan contained in the notification, gather the information relevant for the monitoring of the products; and
da obstoječe mreže za spremljanje, kot so opredeljene v načrtu spremljanja iz prijave, vključno z nacionalnimi botaničnimi mrežami za nadzor in službami za varstvo rastlin, zbirajo podatke, ki so pomembni za spremljanje proizvodov, ter
that these existing monitoring networks referred to in point (a) have agreed to make available that information to the consent holder before the date of submission of the monitoring reports to the Commission and competent authorities of the Member States in accordance with paragraph 3.
da se te obstoječe mreže za spremljanje iz točke (a) strinjajo, da dajo navedene informacije na voljo imetniku odobritve pred datumom predložitve poročil o spremljanju Komisiji in pristojnim organom držav članic v skladu z odstavkom 3.
OJ L 106, 17.4.2001, p. 1.
UL L 106, 17.4.2001, str. 1.
Scientific Opinion on a notification (reference C/NL/09/01) for the placing on the market of the genetically modified carnation IFD-25958-3 with a modified colour, for import of cut flowers for ornamental use, under Part C of Directive 2001/18/EC from Florigene.
Uredba (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 (UL L 268, 18.10.2003, str. 24).
EFSA Journal 2014;12(12):3934, 19 pp. doi:10.2903/j.efsa.2014.3934.
Uredba Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih indikatorjev za gensko spremenjene organizme (UL L 10, 16.1.2004, str. 5).
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 (OJ L 268, 18.10.2003, p. 24).
Odbor EFSA za GSO (odbor EFSA za gensko spremenjene organizme), 2014.
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 (OJ L 10, 16.1.2004, p. 5).
Znanstveno mnenje o prijavi (sklic C/NL/09/01) za dajanje gensko spremenjenih nageljnov IFD-25958-3 s spremenjeno barvo na trg za uvoz rezanega cvetja za okrasne namene na podlagi dela C Direktive 2001/18/ES s strani podjetja Florigene.