natgillin/translations-raw huggingface dataset:
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.
Na podlagi Direktive 2001/18/ES je dajanje v promet proizvodov, ki vsebujejo ali so sestavljeni iz gensko spremenjenih organizmov ali so kombinacija gensko spremenjenih organizmov, predmet pisne privolitve s strani pristojnega organa države članice, kateremu je bila predložena prijava o dajanju navedenega proizvoda v promet v skladu s postopkom iz te direktive.
A notification concerning the placing on the market of a genetically modified maize product (Zea mays L. line NK603), to be used as any other maize but not for cultivation, was submitted by Monsanto SA to the competent authority of Spain which transmitted it to the Commission and to the competent authorities of other Member States with a positive opinion.
Podjetje Monsanto S.A. je predložilo prijavo o dajanju v promet gensko spremenjenega koruznega proizvoda (Zea mays L. linija NK603), ki bi se uporabljal kot vse koruze, razen za gojenje, pristojnemu organu Španije, ki ga je posredoval Komisiji in pristojnim organom drugih držav članic s pozitivnim mnenjem.
The competent authorities of other Member States raised objections to the placing on the market of the product.
Pristojni organi drugih držav članic so podali ugovore k dajanju tega proizvoda v promet.
The opinion adopted on 25 November 2003 by the European Food Safety Authority, as established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2], concluded that Zea mays L. line NK603 is as safe as conventional maize and that its placing on the market for food, feed or processing is therefore unlikely to have an adverse effect on human or animal health or, in that context, on the environment.
Evropska agencija za varno hrano, ki je bila ustanovljena z Uredbo (ES) 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varno hrano in postopkih, ki zadevajo varno hrano [2], je v mnenju z dne 25. novembra 2003 zaključila, da je Zea mays L. linija NK603 varna kot običajna koruza in da ni verjetno, da bi dajanje takšne koruze v promet za hrano, krmo ali predelavo škodovalo zdravju ljudi ali živali oz., v tem smislu, okolju.
An examination of each of the objections 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 reason to believe that the placing on the market of Zea mays L. line NK603 will adversely affect human or animal health or the environment.
Po pregledu vsakega od vloženih ugovorov z vidika Direktive 2001/18/ES, podatkov predloženih v prijavi in mnenja Evropske agencije za varno hrano se izkaže, da ni razlogov za domnevo, da bi dajanje Zea mays L. linije NK603 v promet škodovalo zdravju ljudi, živali ali okolju.
A unique identifier should be assigned to the product for the purposes of Regulation (EC) No 1830/2003.
Proizvodu je potrebno določiti edinstven identifikator na podlagi Uredbe (ES) 1830/2003.
Adventitious or technically unavoidable traces of genetically modified organisms in products are exempted from labelling and traceability requirements in accordance with thresholds established under Directive 2001/18/EC and Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [3].
Naključni ali tehnično neizogibni sledovi gensko spremenjenih organizmov v proizvodih so izvzeti iz zahtev po označevanju in sledljivosti v skladu z vrednostmi praga, določenimi v Direktivi 2001/18/ES in Uredbi (ES) 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi [3].
Taking account of the opinion of the European Food Safety Authority, there is no reason to establish specific conditions with regard to the handling or packaging of the product and the protection of particular ecosystems/environments and/or geographical areas.
Ob upoštevanju mnenja Evropske agencije za varno hrano ne obstajajo razlogi za določitev specifičnih pogojev v zvezi z rokovanjem ali pakiranjem proizvoda ter zaščito posebnih ekosistemov/okolij in/ali geografskih področij.
Prior to the placing on the market of the product, the necessary measures to ensure its labelling and traceability at all stages of its placing on the market, including verification by appropriate detection methodology, should be applicable.
Pred dajanjem proizvoda v promet naj se izvedejo vsi potrebni ukrepi za zagotovitev označevanja in sledljivosti proizvoda v vseh stopnjah dajanja v promet, vključno z verifikacijo z ustrezno metodologijo odkrivanja.
The measures provided for in this Decision are not in accordance with the opinion of the Committee established under Article 30 of Directive 2001/18/EC and the Commission therefore submitted to the Council a proposal relating to these measures.
Ukrepi, predvideni s to odločbo, niso v skladu z mnenjem odbora, ustanovljenega na podlagi člena 30 Direktive 2001/18/ES, zato je Komisija predložila Svetu predlog v zvezi s temi ukrepi.
Since on the expiry of the period laid down in Article 30(2) of Directive 2001/18/EC the Council had neither adopted the proposed measures nor indicated its opposition to them in accordance with Article 5(6) of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission [4] the measures should be adopted by the Commission,
Ker v roku določenem v členu 30(2) Direktive 2001/18/ES, Svet ni niti sprejel predlaganih ukrepov niti ni nakazal nasprotovanja tem ukrepom v skladu s členom 5(6) Sklepa Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil [4], mora zato te ukrepe sprejeti Komisija –
Without prejudice to other Community legislation, in particular Regulation (EC) No 258/97 of the European Parliament and of the Council [5] and Regulation (EC) No 1829/2003, written consent shall be granted by the competent authority of Spain to the placing on the market, in accordance with this Decision, of the product identified in Article 2, as notified by Monsanto Europe SA (reference C/ES/00/01).The written 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.
Brez poseganja v drugo zakonodajo Skupnosti, zlasti Uredbo (ES) št. 258/97 Evropskega parlamenta in Sveta [5] ter Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta, bo pristojni organ Španije podelil v skladu s to odločbo pisno privolitev za dajanje v promet proizvoda, opredeljenega v členu 2, ki ga je prijavilo podjetje Monsanto Europe S.A. (sklicna oznaka C/ES/00/01).V tej pisni privolitvi bodo v skladu s členom 19(3) Direktive 2001/18/ES nedvoumno navedeni pogoji, ki so predvideni s to privolitvijo, in so določeni v členu 3 in 4.
The genetically modified organisms to be placed on the market as or in products, hereinafter ‘the product’, are grains of maize (Zea mays L.), with increased tolerance to the herbicide glyphosate, derived from the maize line NK603 transformation event, which has been transformed using particle acceleration technology with a MluI restriction fragment isolated from plasmid PV-ZMGT32L and which contains the following DNA sequences in two intact cassettes:
Gensko spremenjen organizem, ki se bo dal v promet kot proizvod ali v proizvodih (odslej „proizvod“), je zrnje koruze (Zea mays L.) s povečano toleranco za herbicid glifosat, ki je pridobljena s pomočjo transformacije koruzne linije NK603, transformirane s tehnologijo pospeševanja delcev z restrikcijskim fragmentom MluI, kateri je bil osamljen iz plazmida PV-ZMGT32L in ki vsebuje naslednja zaporedja DNA v dveh nedotaknjenih kasetah:
cassette 1:
Kaseta 1:
a 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of the rice actin 1 gene promoter, terminator sequences from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana;
Gen za sintazo 5-enolpiruvilšikimat-3-fosfata (epsps), ki izvira iz seva CP4 Agrobacterium sp. (CP4 EPSPS) in posreduje odpornost proti glifosatu in ki ga uravnava promotor riževega gena za aktin 1, zaključevalna zaporedja iz Agrobacterium tumefaciens ter zaporedja peptida za prehajanje kloroplasta iz gena epspsArabidopsis thaliana.
cassette 2:
Kaseta 2:
a 5-enolpyruvylshikimate-3-phosphate synthase (epsps) gene derived from Agrobacterium sp. strain CP4 (CP4 EPSPS), which imparts tolerance to glyphosate, under the regulation of an enhanced 35S promoter derived from cauliflower mosaic virus, terminator sequences from Agrobacterium tumefaciens and the chloroplast transit peptide sequence from the epsps gene of Arabidopsis thaliana.
Gen za sintazo 5-enolpiruvilšikimat-3-fosfata (epsps), ki izvira iz seva CP4 Agrobacterium sp. (CP4 EPSPS) in posreduje odpornost proti glifosatu in ki ga uravnava izboljšani promotor 35S iz mozaičnega virusa cvetače, prekinjevalna zaporedja iz Agrobacterium tumefaciens ter zaporedja peptida za prehajanje kloroplasta iz gena epsps Arabidopsis thaliana.
The MluI restriction fragment, which contains the two cassettes specified in points (a) and (b) of the first subparagraph, does not contain the neomycin phosphotransferase type II gene conferring resistance to certain aminoglycoside antibiotics or the origin of replication from Escherichia coli, although both sequences are present in the original plasmid PV-ZMGT32L.
Restrikcijski fragment MluI, ki vsebuje kaseti opredeljeni v točkah (a) in (b) prvega pododstavka, ne vsebuje gena za fosfotransferazo neomicina tipa II, ki posreduje odpornost proti določenim aminoglikozidnim antibiotikom, ali mesta začetka podvojevanja iz Escherichia coli, čeprav sta obe zaporedji prisotni v izvirnem plazmidu PV-ZMGT32L.
The unique identifier of the product is MON-00603-6.
Edinstveni identifikator proizvoda je MON-00603-6.
The consent shall cover grains from progeny derived from crosses of maize line NK603 with any traditionally bred maize as or in products.
Privolitev bo zajemala zrnje potomcev iz križanj koruzne linije NK603 s katerokoli tradicionalno vzgojeno koruzo, kot proizvod ali v proizvodih.
Conditions for placing on the market
Pogoji za dajanje v promet
The product may be used as any other maize, with the exception of cultivation and uses as or in food, and may be placed on the market subject to the following conditions:
Ta proizvod se lahko uporablja kot katerakoli druga koruza, razen za gojenje, za hrano ali v hrani, in se lahko daje v promet pod naslednjimi pogoji:
the period of validity of the written consent shall be for a period of 10 years;
časovno obdobje veljavnosti pisne privolitve bo 10 let;
the unique identifier of the product shall be MON-00603-6 in accordance with Article 2(2);
edinstveni identifikator proizvoda bo MON-00603-6 v skladu s členom 2(2);
without prejudice to Article 25 of Directive 2001/18/EC, the consent holder shall make control samples available to the competent authorities on request;
Brez poseganja v člen 25 Direktive 2001/18/ES bo imetnik privolitve na zahtevo pristojnih organov le-tem predložil na voljo kontrolne vzorce;
the words ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified maize’ shall appear either on a label or in a document accompanying the product, save where other Community legislation sets a threshold below which such information is not required;
na oznaki ali na dokumentu, ki je priložen proizvodu, bo navedba besedila „Ta proizvod vsebuje gensko spremenjene organizme“ ali „Ta proizvod vsebuje gensko spremenjeno koruzo“ razen v primerih, ko druga zakonodaja Skupnosti določa vrednost praga, pod katero takšni podatki niso zahtevani;
as long as the product has not been authorised for the placing on the market for the purpose of cultivation, the words ‘not for cultivation’ shall appear either on a label or in a document accompanying the product.
Dokler proizvod ni odobren za dajanje v promet za namene gojenja, bo na oznaki ali na dokumentu, ki je priložen proizvodu, naveden izraz „ni za gojenje“.
Throughout the period of validity of the consent, the consent holder is responsible for ensuring that the general surveillance plan, as contained in the notification, for any adverse effects on human health or the environment arising from handling or use of the product is put in place and implemented.
Ves čas trajanja veljavnosti privolitve je imetnik privoljenja odgovoren za vzpostavitev in izvajanje splošnega načrta spremljanja škodljivih učinkov na zdravje ljudi in okolje, ki bi nastali zaradi rokovanja ali uporabe proizvoda, kakršen je opredeljen v prijavi.
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 general surveillance.
Imetnik privolitve bo neposredno obvestil upravljavce in uporabnike o varnosti in splošnih lastnostih proizvoda in pogojih splošnega spremljanja.
The consent holder shall, throughout the period of validity of the consent, without prejudice to Article 20 of Directive 2001/18/EC, submit to the Commission and to competent authorities of the Member States, annual reports on the results of the general surveillance and, in the light of the results, proposals for a revised monitoring plan.
Imetnik privolitve bo ves čas veljavnosti privolitve, brez poseganja v člen 20 Direktive 2001/18/ES, Komisiji in pristojnim organom držav članic predlagal letna poročila o rezultatih splošnega spremljanja ter predloge za popravke načrta monitoringa z vidika rezultatov.
The consent holder shall be in the position to give evidence to the Commission and the competent authorities of the Member States that:
Imetnik privolitve mora Komisiji in pristojnim organom držav članic predložiti dokaze, da:
the surveillance networks, particularly those specified in table 1 of the monitoring plan contained in the notification, collect the information relevant for the general surveillance of the product; and
mreže spremljanja, zlasti tiste, navedene v tabeli 1 načrta monitoringa v prijavi, zbirajo podatke, pomembne za splošno spremljanje proizvoda ter
that these surveillance networks have agreed to make available this information to the consent holder before the date of submission of the monitoring report to the Commission and competent authorities of the Member States in accordance with paragraph 3.
da so te spremljevalne mreže privolile v posredovanje teh podatkov imetniku privolitve pred datumom oddaje poročila o monitoringu Komisiji in pristojnim organom držav članic v skladu z odstavkom 3.
This Decision shall not apply before the date of application of a Community Decision authorising the placing on the market of the products referred to in Article 1 for uses as or in food within the meaning of Regulation (EC) No 178/2002 and including a method, validated by the Community reference laboratory, for detection of those products.
Ta odločba ne začne veljati pred datumom začetka veljavnosti Odločbe Skupnosti o dovoljenju dajanja v promet proizvodov, opredeljenih v členu 1, za uporabo kot hrana ali v hrani v smislu Uredbe (ES) št. 178/2002, vključujoč metodo za odkrivanja opisanih proizvodov, ki je bila validirana v referenčnem laboratoriju Skupnosti.
This Decision is addressed to the Kingdom of Spain.
Ta odločba je naslovljena na Kraljevino Španijo.
Directive as last amended by Regulation (EC) No 1830/2003 (OJ L 268, 18.10.2003, p. 24).
Direktiva, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1830/2003 Evropskega parlamenta in Sveta (UL L 268, 18.10.2003, str. 24).
Regulation as amended by Regulation (EC) No 1642/2003 (OJ L 245, 29.9.2003, p. 4).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1642/2003 (UL L 245, 29.9.2003, str. 4).
OJ L 268, 18.10.2003, p. 1.
UL L 268, 18.10.2003, str. 1.
OJ L 43, 14.2.1997, p. 1.
UL L 43, 14.2.1997, str. 1.
Regulation as last amended by Regulation (EC) No 1882/2003 (OJ L 284, 31.10.2003, p. 1).
Uredba, kakor je bila nazadnje spremenjena z Uredbo (ES) št. 1882/2003 (UL L 284, 31.10.2003, str. 1).
adopting implementing rules concerning Regulation (EC) No 45/2001 of the European Parliament and of the Council on the protection of individuals with regard to the processing of personal data by the Community institutions and bodies and on the free movement of such data
o sprejetju izvedbenih pravil za Uredbo Evropskega parlamenta in Sveta (ES) št. 45/2001 o varstvu posameznikov pri obdelavi osebnih podatkov v institucijah in organih Skupnosti in o prostem pretoku takih podatkov
Having regard to the Treaty establishing the European Community, and in particular Article 286 thereof,
ob upoštevanju Pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 286 Pogodbe,
Having regard to Regulation (EC) No 45/2001 of the European Parliament and of the Council [1], and in particular Article 24(8) thereof,
ob upoštevanju Uredbe Evropskega parlamenta in Sveta (ES) št. 45/2001 z dne 18. decembra 2000 [1], zlasti člena 24(8) Uredbe,
Regulation (EC) No 45/2001, hereinafter referred to as the ‘Regulation’, sets out the principles and rules applicable to all Community institutions and bodies and provides for the appointment by each Community institution and Community body of the Data Protection Officer.
Uredba (ES) št. 45/2001, v nadaljnjem besedilu „Uredba“, določa načela in pravila, ki se uporabljajo za vse institucije in organe Skupnosti, in predvideva imenovanje uradne osebe za varstvo podatkov s strani vsake institucije in vsakega organa Skupnosti.
Article 24(8) of the Regulation requires that further implementing rules concerning the Data Protection Officer shall be adopted by each Community institution or body in accordance with the provisions in the Annex thereto.
Člen 24(8) Uredbe zahteva, da posamezna institucija ali organ Skupnosti v skladu z določbami iz Priloge sprejme nadaljnja izvedbena pravila v zvezi z uradno osebo za varstvo podatkov.
The implementing rules shall in particular concern the tasks, duties and powers of the Data Protection Officer.
Izvedbena pravila se nanašajo predvsem na naloge, dolžnosti in pooblastila uradne osebe za varstvo podatkov.
The implementing rules also specify the procedures for the exercise of rights of the data subjects, as well as for the fulfilment of obligations of all relevant actors within the Community institutions or bodies relating to the processing of personal data.
Z izvedbenimi pravili je treba določiti postopke za uveljavljanje pravic posameznika, na katerega se nanašajo osebni podatki, in za izpolnjevanje dolžnosti vseh ustreznih subjektov znotraj institucij ali organov Skupnosti v zvezi z obdelavo osebnih podatkov.
The implementing rules of the Regulation are without prejudice to Regulation (EC) No 1049/2001 [2], to Decision 2004/338/EC, Euratom [3], and in particular Annex II thereto, to Decision 2001/264/EC [4], and in particular Section VI of Part II of the Annex thereto, as well as to Decision of the Secretary-General of the Council/High Representative for Common Foreign and Security Policy of 25 June 2001 [5],
Izvedbena pravila Uredbe ne posegajo v Uredbo (ES) št. 1049/2001 [2], niti v Sklep Sveta 2004/338/ES, Euratom [3], in zlasti ne v Prilogo II Sklepa, v Sklep Sveta 2001/264/ES [4], in zlasti Oddelek VI Dela II Priloge, in v Sklep generalnega sekretarja Sveta/visokega predstavnika za skupno zunanjo in varnostno politiko z dne 25. junija 2001 [5] –
Subject matter and scope
Predmet in področje uporabe
This Decision lays down further implementing rules concerning Regulation (EC) No 45/2001 of the European Parliament and of the Council (hereinafter referred to as the Regulation) as regards the Council of the European Union.
S to odločbo se določijo nadaljnja izvedbena pravila za Uredbo Evropskega parlamenta in Sveta (ES) št. 45/2001 (v nadaljnjem besedilu „Uredba“) glede Sveta Evropske unije.
For the purpose of this Decision and without prejudice to the definitions provided by the Regulation:
V tej odločbi in brez poseganja v opredelitve pojmov iz Uredbe:
‘controller’ shall mean the institution, the Directorate-General, the Directorate, the Division, the Unit or any other organisational entity which alone or jointly with others determines the purposes and means of the processing of personal data, as identified in the notification to be sent to the Data Protection Officer (hereafter referred to as the DPO) in accordance with Article 25 of the Regulation;
„upravljavec“ pomeni institucijo, generalni direktorat, direktorat, oddelek, enoto ali kateri koli drugi organizacijski subjekt, ki sam ali skupaj z drugimi določa namene in sredstva obdelave osebnih podatkov, kakor je določeno v uradnem obvestilu, ki mora biti poslano uradni osebi za varstvo podatkov (v nadaljnjem besedilu „OVP“) v skladu s členom 25 Uredbe;
‘contact person’ shall mean the administrative assistant(s) of the Directorate-General or otherwise any staff member designated in consultation with the DPO by his/her Directorate-General as its representative to deal in close cooperation with the DPO with data protection issues;
„kontaktna oseba“ pomeni administrativni delavec(ci) generalnega direktorata ali kateri koli član osebja, ki ga je njegov generalni direktorat po posvetovanju z OVP imenoval za svojega predstavnika zato, da v tesnem sodelovanju z OVP obravnava vprašanja v zvezi z varstvom podatkov;
‘GSC staff’ shall mean all General Secretariat of the Council (hereafter referred to as ‘GSC’) officials and any other person covered by the Staff Regulations of officials of the European Communities and the Conditions of Employment of other servants of the European Communities laid down in Regulation (EEC, Euratom, ECSC) No 259/68 [6] (hereinafter referred to as the Staff Regulations) or working for the GSC on a contractual basis (trainees, consultants, contractors, officials seconded by Member States).
„osebje GSS“ pomeni vsi uradniki generalnega sekretariata Sveta (v nadaljnjem besedilu „GSS“) in katera koli druga oseba, ki je zajeta v Kadrovskih predpisih za uradnike Evropskih skupnosti in pogojih za zaposlovanje drugih uradnikov Evropskih skupnosti, določenih v Uredbi (EGS, Euratom, ESPJ) št. 259/68 (v nadaljnjem besedilu „kadrovski predpisi“) [6], ali pogodbeno dela za GSS (pripravniki, svetovalci, pogodbeniki, uradniki, dodeljeni s strani držav članic).
THE DATA PROTECTION OFFICER
URADNA OSEBA ZA VARSTVO PODATKOV
Appointment and status of the Data Protection Officer
Imenovanje in pravni položaj uradne osebe za varstvo podatkov
The Deputy Secretary-General of the Council appoints the DPO and registers him with the European Data Protection Supervisor (hereafter referred to as EDPS).
Namestnik generalnega sekretarja Sveta imenuje OVP in ga vpiše pri evropskem nadzorniku za varstvo podatkov (v nadaljnjem besedilu „ENVP“).
The DPO is directly attached to the Deputy Secretary-General of the Council.
OVP je neposredno podrejen namestniku generalnega sekretarja Sveta.
The term of office of the DPO shall be three years and is renewable twice.
Mandat OVP traja tri leta in se lahko dvakrat podaljša.
With respect to the performance of his/her duties, the DPO shall act in an independent manner and in cooperation with the EDPS.
OVP pri izvajanju svojih nalog ravna neodvisno in sodeluje z ENVP.