natgillin/translations-raw huggingface dataset:
ask the user to provide further information or to modify the conditions of the proposed contained use or to amend the class assigned to the contained use(s).
od uporabnika zahteva, da zagotovi dodatne informacije ali spremeni pogoje predlagane uporabe v zaprtem sistemu ali da spremeni razred, določen za uporabo(-e) v zaprtem sistemu.
In this case the competent authority may require that the contained use, if proposed, should not begin, or, if in progress, should be suspended or terminated, until the competent authority has given its approval on the basis of the further information obtained or of the modified conditions of the contained use;
V tem primeru lahko pristojni organ zahteva, da se uporaba v zaprtem sistemu, če je predlagana, ne začne, ali če že poteka, začasno ali dokončno opusti, dokler je pristojni organ ne odobri na podlagi pridobljenih dodatnih informacij ali spremenjenih pogojev uporabe v zaprtem sistemu;
limit the time for which the contained use should be permitted or subject it to certain specific conditions.
omeji časovno obdobje, v katerem naj bi bila uporaba v zaprtem sistemu dovoljena, ali pa zanjo določi nekatere posebne pogoje.
For the purpose of calculating the periods referred to in Articles 8 and 9, any period of time during which the competent authority:
Pri izračunavanju rokov iz členov 8 in 9 se ne upoštevajo obdobja, v katerih pristojni organ:
is awaiting any further information which it may have requested from the notifier in accordance with point (a) of paragraph 3; or
čaka na kakršne koli dodatne podatke, ki jih je morda zahteval od prijavitelja v skladu s točko (a) odstavka 3, ali
If the user becomes aware of relevant new information or modifies the contained use in a way which could have significant consequences in terms of the risks posed by it, the competent authority shall be informed as soon as possible and the notification pursuant to Articles 6, 8 and 9 shall be modified.
Če uporabnik izve za koristne nove podatke ali spremeni uporabo v zaprtem sistemu tako, da bi to lahko imelo znatne posledice za tveganje zaradi uporabe v zaprtem sistemu, o tem čim prej obvesti pristojni organ in spremeni prijavo iz členov 6, 8 in 9.
If information subsequently becomes available to the competent authority which could have significant consequences in terms of the risks posed by the contained use, the competent authority may require the user to modify the conditions of, or suspend or terminate, the contained use.
Če so podatki, ki bi lahko imeli znatne posledice za tveganje zaradi uporabe v zaprtem sistemu, na voljo pristojnemu organu pozneje, lahko pristojni organ zahteva od uporabnika, da spremeni pogoje uporabe v zaprtem sistemu, ali jo začasno ali dokončno opusti.
Where a Member State considers it appropriate, it may provide that the public is to be consulted on aspects of the proposed contained use, without prejudice to Article 18.
Če se državi članici zdi primerno, lahko predvidi posvetovanja z javnostjo o vidikih predlagane uporabe v zaprtem sistemu, brez poseganja v člen 18.
The competent authorities shall ensure that before a contained use commences:
Pristojni organi zagotovijo, da se pred začetkom uporabe v zaprtem sistemu:
an emergency plan is drawn up for contained uses where failure of the containment measures could lead to serious danger, whether immediate or delayed, to humans outside the premises and/or to the environment, except where such an emergency plan has been drawn up under other Community legislation;
pripravi načrt za primer nesreče za uporabe v zaprtem sistemu, pri katerih bi neuspešnost zadrževalnih ukrepov lahko povzročila takojšnjo ali kasnejšo resno nevarnost za ljudi zunaj prostorov in/ali za okolje, razen če je bil tak načrt pripravljen na podlagi druge zakonodaje Skupnosti;
information on such emergency plans, including the relevant safety measures to be applied, is supplied in an appropriate manner, and without their having to request it, to bodies and authorities liable to be affected by the accident.
organom, ki bi jih nesreča lahko prizadela, na primeren način dajo informacije o teh načrtih za primer nesreče, vključno s pomembnimi varnostnimi ukrepi, ne da bi jih ti zahtevali.
The information shall be updated at appropriate intervals.
Informacije se posodabljajo v primernih časovnih presledkih.
It shall also be made publicly available.
Prav tako morajo biti javno dostopne.
The Member States concerned shall at the same time make available to other Member States concerned, as a basis for all necessary consultation within the framework of their bilateral relations, the same information as that which is disseminated to their nationals.
Zadevne države članice istočasno dajo enake informacije, kot so jih razširile med svoje državljane, drugim zadevnim državam članicam kot podlago za vsa potrebna posvetovanja v okviru njihovih dvostranskih odnosov.
Member States shall take the necessary measures to ensure that, in the event of an accident, the user is required immediately to inform the competent authority specified in Article 10 and to provide the following information:
Države članice sprejmejo potrebne ukrepe za zagotovitev, da uporabnik ob nesreči nemudoma obvesti pristojni organ iz člena 10 in priskrbi naslednje podatke:
the circumstances of the accident;
okoliščine nesreče;
the identity and quantities of the GMMs concerned;
imena in količine zadevnih GSM;
any information necessary to assess the effects of the accident on the health of the general population and the environment;
vse potrebne informacije za presojo učinkov nesreče na zdravje prebivalstva in okolje;
the measures taken.
sprejete ukrepe.
Where information is given pursuant to paragraph 1, the Member States shall be required to:
Če države članice dobijo podatke iz odstavka 1:
ensure that any measures necessary are taken, and immediately alert any Member States which could be affected by the accident;
zagotovijo sprejetje vseh potrebnih ukrepov in nemudoma opozorijo vsako državo članico, ki bi jo nesreča lahko prizadela;
collect, where possible, the information necessary for a full analysis of the accident and, where appropriate, make recommendations to avoid similar accidents in the future and to limit the effects thereof.
če je mogoče, zberejo potrebne informacije za popolno analizo nesreče in, če je primerno, pripravijo priporočila za izognitev podobnim nesrečam v prihodnosti in omejitev njihovih učinkov.
Member States shall be required to:
Države članice so dolžne, da:
consult with other Member States likely to be affected in the event of an accident on the proposed implementation of emergency plans;
se o predlaganem izvajanju načrtov za primer nesreče posvetujejo z drugimi državami članicami, ki bi lahko bile prizadete ob nesreči;
inform the Commission as soon as possible of any accident within the scope of this Directive, giving details of the circumstances of the accident, the identity and quantities of the GMMs concerned, the response measures taken and their effectiveness and an analysis of the accident, including recommendations designed to limit its effects and to avoid similar accidents in the future.
čim prej obvestijo Komisijo o vsaki nesreči, za katero se uporablja ta direktiva, o podrobnostih okoliščin nesreče, celotnem imenu in količinah zadevnih GSM, sprejetih ukrepih za odzivanje in njihovi učinkovitosti ter o analizi nesreče, skupaj s priporočili za omejitev njenih učinkov in preprečevanje podobnih nesreč v prihodnosti.
The Commission, in consultation with the Member States, shall establish a procedure for the exchange of information pursuant to paragraph 1.
Komisija ob posvetovanju z državami članicami uvede postopek za izmenjavo informacij iz odstavka 1.
It shall also set up and keep at the disposal of the Member States a register of accidents within the scope of this Directive, including an analysis of the causes of the accidents, experience gained and measures taken to avoid similar accidents in the future.
Prav tako vzpostavi in daje na voljo državam članicam seznam nesreč, za katere se uporablja ta direktiva, skupaj z analizo vzrokov nesreč, pridobljenimi izkušnjami in sprejetimi ukrepi za preprečevanje podobnih nesreč v prihodnosti.
Member States shall ensure that the competent authority organises inspections and other control measures to ensure that users comply with this Directive.
Države članice zagotovijo, da pristojni organ organizira inšpekcijske preglede in druge nadzorne ukrepe, da zagotovi ravnanje uporabnikov v skladu s to direktivo.
Member States shall send to the Commission, at the end of each year, a summary report on class 3 and class 4 contained uses notified during that year pursuant to Article 9, including the description, purpose and risks of the contained use(s).
Države članice ob koncu vsakega leta Komisiji pošljejo zbirno poročilo o uporabah v zaprtem sistemu iz razreda 3 in razreda 4, ki so bile v tem letu prijavljene v skladu s členom 9, vključno z opisom, namenom(-i) uporab(-e) v zaprtem sistemu ter tveganji, povezanimi z njimi.
Every three years, and for the first time on 5 June 2003, Member States shall send the Commission a summary report on their experience with this Directive.
Vsaka tri leta, prvič pa 5. junija 2003, države članice Komisiji pošljejo zbirno poročilo o svojih izkušnjah s to direktivo.
Every three years, and for the first time on 5 June 2004, the Commission shall publish a summary based on the reports referred to in paragraph 2.
Vsaka tri leta, prvič pa 5. junija 2004, Komisija objavi povzetek, ki temelji na poročilih iz odstavka 2.
The Commission may publish general statistical information on the implementation of this Directive and related matters, as long as it contains no information likely to cause harm to the competitive position of a user.
Komisija lahko objavi splošne statistične informacije o izvajanju te direktive in s tem povezanih zadev, če ne vsebujejo informacij, ki bi lahko škodovale konkurenčnemu položaju uporabnika.
Where its disclosure affects one or more of the items mentioned in Article 4(2) of Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information [8], the notifier may indicate the information in the notifications submitted pursuant to this Directive that should be treated as confidential.
Če razkritje vpliva na eno ali več postavk iz člena 4(2) Direktive 2003/4/ES Evropskega parlamenta in Sveta z dne 28. januarja 2003 o javnem dostopu do okoljskih informacij [8], lahko prijavitelj označi tiste informacije v prijavi, predloženi na podlagi te direktive, ki bi jih bilo treba obravnavati kot zaupne.
Verifiable justification must be given in such cases.The competent authority shall decide, after consultation with the notifier, which information will be kept confidential and shall inform the notifier of its decision.
V takih primerih mora biti podana preverljiva utemeljitev.Po posvetovanju s prijaviteljem pristojni organ odloči, kateri podatki bodo varovani kot zaupni, in o svoji odločitvi obvesti prijavitelja.
In no case may the following information, when submitted pursuant to Articles 6, 8 or 9, be kept confidential:
V nobenem primeru ne smejo biti varovani kot zaupni naslednji podatki, če so predloženi v skladu členi 6, 8 ali 9:
the general characteristics of the GMMs, the name and address of the notifier, and the location of use;
splošne značilnosti GSM, ime in naslov prijavitelja ter kraj uporabe;
the class of contained use and the containment measures;
razred uporabe v zaprtem sistemu in zadrževalni ukrepi;
the evaluation of foreseeable effects, in particular any harmful effects on human health and the environment.
ocena predvidljivih učinkov, zlasti kakršnih koli škodljivih učinkov na zdravje ljudi in okolje.
The Commission and the competent authorities shall not divulge to third parties any information deemed to be confidential according to the second subparagraph of paragraph 1 and notified or otherwise provided pursuant to this Directive, and shall protect intellectual property rights relating to the data received.
Komisija in pristojni organi tretjim osebam ne razkrijejo nobenih podatkov, za katere je bilo v skladu z drugim pododstavkom odstavka 1 odločeno, da so zaupni, in ki so bili pridobljeni po tej direktivi v prijavah ali kako drugače, ter varujejo pravice intelektualne lastnine, povezane s prejetimi podatki.
If, for whatever reasons, the notifier withdraws the notification, the competent authority must respect the confidentiality of the information supplied.
Če prijavitelj iz kakršnih koli razlogov umakne prijavo, mora pristojni organ spoštovati zaupnost predloženih podatkov.
The measures designed to amend non-essential elements of this Directive relating to adapting Annexes II, III, IV and V to technical progress, and to adapting Annex II, Part C, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(2).
Ukrepi, namenjeni spreminjanju nebistvenih določb te direktive za prilagoditev prilog II, III, IV in V tehničnemu napredku ter za prilagoditev dela C Priloge II, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 20(2).
Directive 90/219/EEC, as amended by the acts listed in Annex VI, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time limits for transposition into national law of the Directives set out in Annex VI, Part B.
Direktiva 90/219/EGS, kakor je bila spremenjena z akti, navedenimi v delu A Priloge VI, se razveljavi brez poseganja v obveznosti držav članic glede rokov za prenos v nacionalno pravo direktiv, ki so določeni v delu B Priloge VI.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VII.
Sklicevanja na razveljavljeno direktivo se štejejo kot sklicevanja na to direktivo in se berejo v skladu s korelacijsko tabelo iz Priloge VII.
Done at Strasbourg, 6 May 2009.
V Strasbourgu, 6. maja 2009.
OJ C 162, 25.6.2008, p. 85.
UL C 162, 25.6.2008, str. 85.
Opinion of the European Parliament of 21 October 2008 (not yet published in the Official Journal) and Council Decision of 30 March 2009.
Mnenje Evropskega parlamenta z dne 21. oktobra 2008 (še ni objavljeno v Uradnem listu) in Sklep Sveta z dne 30. marca 2009.
Techniques of genetic modification referred to in point (b)(i) of Article 2 are, inter alia:
Metode genskega spreminjanja iz točke (b)(i) člena 2 so med drugim:
Recombinant nucleic acid techniques involving the formation of new combinations of genetic material by the insertion of nucleic acid molecules produced by whatever means outside an organism, into any virus, bacterial plasmid or other vector system and their incorporation into a host organism in which they do not naturally occur but in which they are capable of continued propagation.
Metode rekombinantne nukleinske kisline, vključno z oblikovanjem novih kombinacij genskega materiala z vstavitvijo molekul nukleinske kisline, pridobljene na kakršen koli način zunaj organizma, v kateri koli virus, bakterijski plazmid ali drug vektorski sistem in njihovo vključitvijo v organizem gostitelja, v katerem se spontano ne pojavljajo, vendar se lahko v njem naprej razmnožujejo.
Techniques involving the direct introduction into a micro-organism of heritable material prepared outside the micro-organism, including micro-injection, macro-injection and micro-encapsulation.
Metode, pri katerih se dednina, pripravljena izven mikroorganizma, neposredno vnese v ta mikroorganizem, vključno z mikro-injiciranjem, makro-injiciranjem in mikro-inkapsulacijo.
Cell fusion or hybridisation techniques where live cells with new combinations of heritable genetic material are formed through the fusion of two or more cells by means of methods that do not occur naturally.
Metode zlitja celic ali hibridizacije, pri katerih se žive celice z novimi kombinacijami dednine oblikujejo z zlitjem dveh ali več celic na način, ki se v naravi ne pojavlja.
Techniques referred to in point (b)(ii) of Article 2 which are not considered to result in genetic modification, on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs made by techniques/methods other than the techniques/methods excluded by Part A of Annex II:
Metode iz točke (b)(ii) člena 2, za katere se šteje, da nimajo za posledico genskih sprememb, pod pogojem, da ne vključujejo uporabe rekombinantnih molekul nukleinske kisline ali GSM, narejenih z drugimi metodami/načini in ne z metodami/načini, ki so izključeni z delom A Priloge II:
in vitro fertilisation;
oploditev in vitro;
natural processes such as: conjugation, transduction, transformation;
naravni procesi, kot so: konjugacija, transdukcija, transformacija;
polyploidy induction.
indukcija poliploidije.
Techniques or methods of genetic modification yielding micro-organisms to be excluded from this Directive on condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below:
Metode ali načini genskega spreminjanja, ki dopuščajo, da se mikroorganizmi izključijo iz te direktive, pod pogojem, da ne uporabljajo molekul rekombinantne nukleinske kisline ali GSM, razen tistih, ki so narejene z eno ali več od tu navedenih metod/načinov:
Mutagenesis.
Mutageneza.
Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes.
Zlitje celic (vključno z zlitjem protoplastov) prokariontskih vrst, ki si izmenjujejo genski material z nam znanimi fiziološkimi procesi.
Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions.
Zlitje celic (vključno z zlitjem protoplastov) katere koli evkariontske vrste, vključno s pridobivanjem hibridomov in zlitjem rastlinskih celic.
Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent), with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants.
Samokloniranje, z odstranjevanjem zaporedij nukleinskih kislin iz celic organizma, kateremu lahko sledi ali pa tudi ne ponovno vstavljanje cele ali dela te nukleinske kisline (ali sintetičnega ekvivalenta), z ali brez predhodne encimske ali mehanske stopnje, v celice iste vrste ali v celice filogenetsko ozko sorodne vrste, ki lahko izmenjujejo genski material z naravnimi fiziološkimi procesi, če ni verjetno, da bi nastali mikroorganizem povzročil bolezen pri človeku, živali ali rastlini.
Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms.
Samokloniranje lahko vključuje uporabo rekombinantnih vektorjev, ki imajo pri določenih mikroorganizmih dolgo zgodovino varne uporabe.
Criteria establishing the safety of GMMs for human health and the environment
Merila za ugotavljanje varnosti GSM za zdravje ljudi in okolje
This Annex describes in general terms the criteria to be met when establishing the safety of types of GMMs for human health and the environment and their suitability for inclusion in Part C. Technical guidance notes may be developed in accordance with the regulatory procedure referred to in Article 20(3) in order to facilitate the implementation and explanation of this Annex.
Ta priloga na splošno opisuje merila, ki jih je potrebno izpolniti, ko se dokazuje varnost vrst GSM za zdravje ljudi in okolje ter primernost za uvrstitev v del C. V skladu z regulativnim postopkom iz člena 20(3) se lahko izdelajo tehnične smernice, ki bodo v pomoč pri izvajanju in razlagi te priloge.
Types of GMMs listed in Part C in accordance with the regulatory procedure with scrutiny referred to in Article 20(2) are excluded from the scope of this Directive.
Vrste GSM, navedene v delu C, so po regulativnem postopku s pregledom iz člena 20(2) izključene iz področja uporabe te direktive.
GMMs will be added to the list on a case-by-case basis and exclusion will relate only to each clearly identified GMM.
GSM se bodo uvrščali na seznam na osnovi posameznega primera, izključevanje pa se bo nanašalo samo na vsak jasno opredeljen GSM.
This exclusion applies only when the GMM is used under conditions of contained use as defined in point (c) of Article 2.
Ta izključitev velja samo, kadar se GSM uporablja v pogojih uporabe v zaprtih sistemih v skladu s točko (c) člena 2.
It does not apply to the deliberate release of GMMs.
Ne uporablja se za namerno sproščanje GSM.
For a GMM to be listed in Part C, it must be proved that it meets the criteria given below.
Da se GSM uvrsti v del C, je treba dokazati, da izpolnjuje merila, navedena v nadaljevanju.
Strain verification/authentication
Preverjanje / avtentičnost seva
Identity of the strain must be precisely established.
Identičnost seva mora biti natančno določena.
Modification must be known and verified.
Sprememba mora biti znana in potrjena.
Documented and established evidence of safety
Dokumentirana in dokazana varnost
Documented evidence of the safety of the organism must be provided.
Zagotoviti je treba dokumentirana dokazila o varnosti organizma.
Genetic stability
Genska stabilnost
Where any instability could adversely affect safety, evidence of stability is required.
Če bi morebitna nestabilnost lahko škodljivo vplivala na varnost, je treba zagotoviti dokazila o stabilnosti.
The GMM should not be capable of causing disease or harm to a healthy human, plant or animal.
GSM ne sme biti sposoben povzročiti bolezni ali škode zdravim ljudem, rastlinam ali živalim.
Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore be:
Ker patogenost vključuje tako strupenost kot alergenost, mora biti GSM:
Non-toxigenic
Nestrupen
The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties.
Zaradi genske spremembe GSM ne sme povzročati povečane strupenosti niti ne sme biti znan po svojih strupenih lastnostih.
Non-allergenic
Nealergen
The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having, for example, allergenicity comparable in particular with that of the micro-organisms identified in Directive 2000/54/EC.
GSM zaradi genske spremembe ne sme povzročati povečane alergenosti niti ne sme biti znan alergen, kot na primer alergenost, ki je primerljiva zlasti z alergenostjo mikroorganizmov, opredeljeno v Direktivi 2000/54/ES.
No harmful adventitious agents
Nobenih škodljivih naključnih povzročiteljev
The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or inside the GMM, that could cause harm to human health and the environment.
V GSM se ne smejo nahajati znani škodljivi naključni povzročitelji, kot so drugi aktivni ali latentni mikroorganizmi, ki obstajajo vzporedno ali znotraj GSM in bi lahko škodovali zdravju ljudi in okolju.
Transfer of genetic material
Prenos genskega materiala
The modified genetic material must not give rise to harm if transferred; nor should it be self-transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism.
Spremenjen genski material ne sme povzročiti poškodb pri prenosu, niti ne sme biti samoprenosljiv ali prenosljiv s pogostnostjo, večjo kot drugi geni prejemnega ali starševskega mikroorganizma.
Safety for the environment in the event of a significant and unintended release
Varnost za okolje v primeru večjega in nenamernega sproščanja
GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur.
GSM ne smejo imeti takojšnjih ali kasnejših škodljivih vplivov na okolje, če bi prišlo do nesreče z večjim in nenamernim sproščanjem.