natgillin/translations-raw huggingface dataset:
Cilj tega postopka odobritve je zagotovitev visoke ravni zaščite življenja in zdravja ljudi, zdravja in dobrega počutja živali, okolja in interesov potrošnikov ter učinkovitega delovanja notranjega trga.
The aim of this authorisation procedure is to ensure a high level of protection of human life and health, animal health and welfare, the environment and consumer interests, whilst ensuring the effective functioning of the internal market.
(2) Na podlagi tega sklopa zakonodaje se bo za vsak GSO za gojenje posebej ocenilo tveganje, preden bo odobren za dajanje na trg Unije , ob upoštevanju neposrednih in posrednih učinkov, takojšnih učinkov, učinkov z zakasnitvijo ter kumulativnih dolgoročnih učinkov na zdravje ljudi in okolje, v skladu s prilogo II Direktive 2001/18/ES .
(2) Under this set of legislation, GMOs for cultivation shall undergo an individual risk assessment before being authorised to be placed on the Union market , taking into account, in accordance with Annex II of Directive 2001/18/EC, the direct, indirect, immediate and delayed effects, as well as the cumulative long-term effects, on human health and the environment .
Stremeti je treba k doseganju in ohranjanje enake ravni zaščite zdravja in okolja na vsem ozemlju Unije.
A uniform high level of protection of health and the environment should be achieved and maintained throughout the territory of the Union .
(2a) Komisija in države članice bi morale prednostno zagotoviti izvedbo sklepov Sveta za okolje z dne 4. decembra 2008, in sicer pravilno izvajanje pravnih zahtev iz Priloge II Direktive 2001/18/ES o oceni tveganja GSO.
(2a) The Commission and Member States should ensure, as a priority, the implementation of the Environment Council Conclusions adopted on 4 December 2008, namely a proper implementation of the legal requirements laid down in Annex II of Directive 2001/18/EC for the risk assessment of GMOs.
Strogo bi bilo treba oceniti zlasti dolgoročne vplive gensko spremenjenih pridelkov na okolje , pa tudi njihove morebitne učinke na neciljne organizme; pri tem bi bilo treba ustrezno upoštevati značilnosti prejemnih okolij in zemljepisnih območij, v katerih se gensko spremenjene rastline smejo gojiti, oceniti pa bi bilo treba tudi morebitne posledice za okolje, ki jih povzročijo spremembe v uporabi herbicidov, povezanih z na herbicide odpornimi genetsko spremenjenimi rastlinami.
In particular, the long-term environmental effects of GM crops as well as their potential effects on non-target organisms should be rigorously assessed; the characteristics of the receiving environments and the geographical areas in which GM plants may be cultivated should be duly taken into account; and the potential environmental consequences brought about by changes in the use of herbicides linked to herbicide-tolerant GM crops should be assessed.
Komisija bi morala še posebej zagotoviti sprejetje novih smernic za oceno tveganja GSO.
More specifically, the Commission should ensure that the new guidelines on GMO risk assessment are adopted.
Te ne bi smele temeljiti pretežno na načelu snovne enakovrednosti ali na primerjalni analizi varnosti in bi morale omogočiti jasno opredelitev dolgoročnih in posrednih učinkov ter znanstvenih negotovosti.
These guidelines should not be based primarily on the principle of substantial equivalence or on the concept of a comparative safety assessment, and should make it possible to clearly identify direct and indirect long-term effects, as well as scientific uncertainties.
Nove različice GSO se ne smejo odobriti, dokler se pravilno ne izvedejo določbe o oceni tveganja.
Until the risk assessment provisions are properly implemented, no new GMO variety should be authorised.
Evropska agencija za varnost hrane (EFSA) in države članice bi morale stremeti k oblikovanju široke mreže znanstvenih organizacij z vseh področij, tudi ekoloških, in bi morale sodelovati, tako da bi že v zgodnji fazi ugotovili, ali med znanstvenimi mnenji prihaja do morebitnih razhajanj, tako da bi rešili oziroma razjasnili sporna znanstvena vprašanja.
The E uropean Food Safety Authority (E FSA ) and the Member States should aim to establish an extensive network of scientific organisations representing all disciplines including those relating to ecological issues, and should cooperate to identify at an early stage any potential divergence between scientific opinions with a view to resolving or clarifying the contentious scientific issues.
Komisija in države članice bi morale zagotoviti potrebna sredstva za neodvisne raziskave o morebitnih tveganjih GSO, pa tudi, da izvrševanje pravic intelektualne lastnine ne bi onemogočalo neodvisnim raziskovalcem dostopa do zadevnega gradiva.
The Commission and the Member States should ensure that the necessary resources for independent research on the potential risks of GMOs are secured; and that the enforcement of intellectual property rights does not prevent independent researchers from accessing all relevant material.
(4a) Glede na pomembnost znanstvenih dokazov pri odločanju o odobritvi ali prepovedi GSO, bi morala Evropska agencija za varnost hrane vsako leto zbrati in objaviti rezultate raziskav glede tveganja ali dokazov o naključni prisotnosti, onesnaženju ali nevarnosti zaradi za okolje ali zdravje ljudi zaradi GSO, in sicer za vsak primer posebej.
(4a) Given the importance of scientific evidence in taking decisions on the prohibition or approval of GMOs, EFSA and the Member States should collect and publish annually the results of research regarding the risk or evidence of any accidental presence, contamination or danger to the environment or human health of GMOs, on a case - by - case basis.
Ker je posvetovanje s strokovnjaki drago, bi morale države članice spodbujati sodelovanje med raziskovalnimi ustanovami in nacionalno akademsko srenjo.
Due to the high cost of expert consultation, Member States should promote collaboration between research institutions and national academies.
GSO se ocenjujejo na podlagi podatkov, ki jih posreduje vlagatelj.
GMOs are evaluated on the basis of data submitted by the applicant.
Glede na stroške in ekonomsko omejenost Agencije za varnost hrane morajo države članice, ki odločajo, prevzeti tudi odgovornost in delo v zvezi z zbiranjem informacij in njihovim posredovanjem Evropi.
Given the cost and economic boundaries limitations of EFSA, Member States that have the capacity to decide must also take responsibility and work on collecting information and transferring it to Europe .
(5) Izkušnje kažejo, da je gojenje GSO vprašanje, ki se temeljiteje obravnava v državah članicah na nacionalni, regionalni ali lokalni ravni.
(5) Experience has shown that cultivation of GMOs is an issue which is more thoroughly addressed by Member States, either at central or at regional and local level.
V nasprotju z vprašanji pri dajanju na trg in uvozu GSO, ki jih je treba še naprej urejati na ravni EU zaradi ohranitve notranjega trga, je bilo ugotovljeno, da je gojenje GSO vprašanje z izrazito lokalno/regionalno razsežnostjo.
Contrary to issues related to the placing on the market and the import of GMOs, which should remain regulated at EU level to preserve the internal market, cultivation has been acknowledged as an issue with a strong local/regional dimension.
V skladu s členom 2(2) PDEU je zato treba državam članicam dati možnost, da sprejmejo pravila za učinkovito gojenje GSO na svojem ozemlju po tem, ko je bil GSO zakonito odobren za dajanje na trg EU.
In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt rules concerning the effective cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
Vprašanja o dajanju na trg in uvozu GSO je treba še naprej urejati na ravni EU zaradi ohranitve notranjega trga.
Issues related to the placing on the market and the import of GMOs should remain regulated at EU level to preserve the internal market.
Za gojenje GSO bi utegnila biti v nekaterih primerih potrebna večja prožnost, saj gre za vprašanje z izrazito lokalno/regionalno/teritorialno razsežnostjo , ki je še posebej pomembno za samoodločanje držav članic .
Cultivation might require more flexibility in certain instances as it is an issue with a strong local/regional/territorial dimension and an issue of particular importance for the self-determination of Member States .
Vendar prožnost ne bi smela ogrožati skupnega postopka odobritve.
The common authorisation procedure should not be adversely affected by such flexibility .
Usklajene okoljske in zdravstvene ocene tveganja morda vendarle ne bi zajele vseh možnih vplivov gojenja GSO v različnih regijah in ekosistemih.
Howev er, the harmonised environmental and health risks assessment might not address all possible impacts of GMO cultivation in different regions and local ecosystems.
V skladu s členom 2(2) PDEU je zato treba državam članicam dati možnost, da sprejmejo zavezujoče pravne predpise za učinkovito gojenje GSO na svojem ozemlju po tem, ko je bil GSO zakonito odobren za dajanje na trg EU.
In accordance with Article 2(2) TFEU Member States should therefore be entitled to have a possibility to adopt binding legislative provisions concerning the cultivation of GMOs in their territory after the GMO has been legally authorised to be placed on the EU market.
(6) Pri tem se zdi primerno, da se državam članicam v skladu z načelom subsidiarnosti prizna več svobode pri odločanju, ali želijo na svojem ozemlju gojiti gensko spremenjene pridelke ali ne, ne da se s tem spremeni sistem Unije za odobritve GSO, in neodvisno od ukrepov, ki jih lahko države članice sprejmejo na podlagi člena 26a Direktive 2001/18/ES za preprečevanje nenamerne prisotnosti GSO v drugih proizvodih.
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more freedom to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are entitled to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products.
(6) Pri tem se zdi primerno, da se državam članicam v skladu z načelom subsidiarnosti prizna več prožnosti pri odločanju, ali želijo na svojem ozemlju gojiti gensko spremenjene pridelke ali ne, ne da se s tem spremeni sistem Unije za odobritve GSO, in neodvisno od ukrepov, ki jih morajo države članice sprejeti na podlagi člena 26a Direktive 2001/18/ES za preprečevanje nenamerne prisotnosti GSO v drugih proizvodih na svojem ozemlju in območjih, ki mejijo na sosednje države članice .
(6) In this context, it appears appropriate to grant to Member States, in accordance with the principle of subsidiarity, more flexibility to decide whether or not they wish to cultivate GMO crops on their territory without changing the system of Union authorisations of GMOs and independently of the measures that Member States are required to take by application of Article 26a of Directive 2001/18/EC to avoid the unintended presence of GMOs in other products on their territory and in border areas of neighbouring Member States.
(7) Zato je treba državam članicam dovoliti, da sprejmejo ukrepe za omejitev ali prepoved gojenja vseh ali nekaterih GSO na svojem celotnem ozemlju ali njegovem delu, ter te ukrepe spremenijo, kot se jim zdi ustrezno, na vseh stopnjah odobritve ali ponovne odobritve zadevnih GSO ali njihovega umika s trga.
(7) Member States should therefore be authorised to adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs.
To je treba uporabljati tudi za gensko spremenjene sorte semen in razmnoževalnega materiala rastlin, ki se dajejo na trg v skladu z ustrezno zakonodajo o trženju semen in razmnoževalnega materiala rastlin ter zlasti v skladu z direktivama 2002/53/ES in 2002/55/ES.
This should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC.
Ukrepi se morajo nanašati le na gojenje GSO, ne pa na prosti pretok in uvoz gensko spremenjenih semen in razmnoževalnega materiala rastlin kot ločenih proizvodov ali v proizvodih ter njihovih pridelkov.
Measures should refer to the cultivation of GMOs only and not to the free circulation and import of genetically modified seeds and plant propagating material, as or in products, and of the products of their harvest.
Podobno ne smejo vplivati na gojenje gensko nespremenjenih sort semen in razmnoževalnega materiala rastlin, v katerih se ugotovijo naključne ali tehnično neizogibne sledi GSO, odobrenih v EU.
Similarly they should not affect the cultivation of non genetically modified varieties of seed and plant propagating material in which adventitious or technically unavoidable traces of EU authorised GMOs are found .
(7) Zato je treba državam članicam dovoliti, da za vsak primer posebej sprejmejo ukrepe za omejitev ali prepoved gojenja posameznih GSO , nekaterih skupin GSO ali vseh GSO na svojem celotnem ozemlju ali njegovem delu, ter te ukrepe spremenijo, kot se jim zdi ustrezno, na vseh stopnjah odobritve ali ponovne odobritve zadevnih GSO ali njihovega umika s trga.
(7) Member States should therefore be authorised to adopt , on a case - by - case basis, measures restricting or prohibiting the cultivation of particular GMOs or groups of GMOs or of all GMOs in all or part of their territory, and respectively amend those measures as they deem appropriate, at all stages of the authorisation, re-authorisation or withdrawal from the market of the concerned GMOs.
Gojenje je namreč tesno povezano z rabo zemljišč ter varstvom živalskih in rastlinskih vrst, ki sta še vedno v veliki pristojnosti držav članic.
Cultivation is closely linked to land use and the conservation of fauna and flora, areas in which the Member States retain significant powers.
Sprejemanje teh ukrepov je treba omogočiti tudi za gensko spremenjene sorte semen in razmnoževalnega materiala rastlin, ki se dajejo na trg v skladu z ustrezno zakonodajo o trženju semen in razmnoževalnega materiala rastlin ter zlasti v skladu z direktivama 2002/53/ES in 2002/55/ES.
The possibility of adopting these measures should apply as well to genetically modified varieties of seed and plant propagating material which are placed on the market in accordance with relevant legislation on the marketing of seeds and plant propagating material and, in particular, in accordance with Directives 2002/53/EC and 2002/55/EC.
Navedeni ukrepi bi morali vsem zadevnim nosilcem dejavnosti, tudi pridelovalcem, omogočiti dovolj časa za prilagajanje.
Those measures should allow all operators concerned, including growers, sufficient time to adapt.
(8) V skladu s pravnim okvirom za odobritev GSO država članica ne more spremeniti ravni zaščite zdravja ljudi ali živali in okolja v EU in tak položaj je treba ohraniti.
(8) According to the legal framework for the authorisation of GMOs, the level of protection of human/animal health and of the environment chosen in the EU cannot be revised by a Member State and this situation must not be altered.
Vendar lahko države članice ukrepe za omejitev ali prepoved gojenja vseh ali nekaterih GSO na svojem celotnem ozemlju ali njegovem delu sprejmejo na podlagi drugačnih razlogov javnega interesa , kot so že obravnavani v usklajenem sklopu pravil EU, ki že določajo postopke za upoštevanje tveganja za zdravje in okolje, ki jih lahko povzroči uporaba GSO za gojenje .
However Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds relating to the public interest other than those already addressed by the harmonised set of EU rules which already provide for procedures to take into account the risks that a GMO for cultivation may pose on health and the environment .
Poleg tega morajo biti ti ukrepi v skladu s Pogodbama, zlasti glede načela nerazlikovanja med nacionalnimi in tujimi proizvodi ter členov 34 in 36 Pogodbe o delovanju Evropske unije , in z ustreznimi mednarodnimi obveznostmi Unije, zlasti v Svetovni trgovinski organizaciji .
Those measures should furthermore be in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union, as well as with the relevant international obligations of the Union , notably in the context of the World Trade Organisation .
Vendar lahko države članice ukrepe za omejitev ali prepoved gojenja vseh ali nekaterih GSO na svojem celotnem ozemlju ali njegovem delu sprejmejo na podlagi razlogov javnega interesa.
However Member States may adopt measures restricting or prohibiting the cultivation of all or particular GMOs in all or part of their territory on the basis of grounds relating to the public interest .
Ti ukrepi lahko temeljijo na okoljskih razlogih ali drugih upravičenih dejavnikih, na primer socialno-ekonomskih vplivih, do katerih lahko pride zaradi namernega sproščanja ali dajanja GSO na trg, če ti dejavniki niso bili obravnavani v usklajenem postopku iz dela C Direktive 2001/18/ES, ali v primeru trajne znanstvene negotovosti.
Those measures may be based on grounds relating to environmental or other legitimate factors such as socio-economic impacts, which might arise from the deliberate release or the placing on the market of GMOs where those factors have not been addressed as part of the harmonised procedure provided for in Part C of Directive 2001/18/EC, or in the event of persisting scientific uncertainty.
Ukrepi morajo biti ustrezno znanstveno utemeljeni ali temeljiti na razlogih obvladovanja tveganja ali drugih upravičenih razlogih, do katerih pride zaradi namernega sproščanja ali dajanja GSO na trg.
Th ose measures should be duly justified on scientific grounds or on grounds relating to risk management or other legitimate factors which might arise from the deliberate release or the placing on the market of GMOs.
Poleg tega morajo biti ti ukrepi sorazmerni in v skladu s Pogodbama, zlasti glede načela nerazlikovanja med nacionalnimi in tujimi proizvodi ter členov 34 in 36 Pogodbe o delovanju Evropske unije.
Those measures should furthermore be proportionate and in conformity with the Treaties, in particular as regards the principle of non discrimination between national and non national products and Articles 34 and 36 of the Treaty on the Functioning of the European Union.
(8a) Omejitve ali prepovedi gojenja nekaterih GSO s strani držav članic ne smejo preprečevati ali omejevati uporabe dovoljenih GSO v drugih državah članicah, pod pogojem, da so v veljavi učinkoviti ukrepi za preprečevanje čezmejne okužbe.
(8a) Restrictions on or prohibitions of cultivation of particular GMOs by a Member State should not prevent or restrict the use of authorised GMOs by other Member States, provided effective measures are taken to prevent cross-border contamination.
(9) V skladu z načelom subsidiarnosti namen te uredbe ni usklajevanje pogojev za gojenje v državah članicah, ampak priznanje svobode državam članicam, da se pri prepovedi gojenja GSO na svojem ozemlju sklicujejo na druge razloge, kot je znanstvena ocena tveganja za okolje in zdravje .
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to invoke other grounds than scientific assessment of health and environmental risks to ban cultivation of GMOs on their territory.
Poleg tega eden od namenov Direktive 98/34/ES Evropskega parlamenta in Sveta z dne 22. junija 1998 o določitvi postopka za zbiranje informacij na področju tehničnih standardov in tehničnih predpisov, tj. da se Komisiji omogoči sprejemanje zavezujočih aktov na ravni EU, ne bi bil izpolnjen s sistematično priglasitvijo ukrepov držav članic na podlagi navedene direktive.
In addition one of the purposes of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations which is to allow the Commission to consider the adoption of binding acts at EU level would not be served by the systematic notification of Member States’ measures under that Directive.
Ker cilj ukrepov, ki jih lahko države članice sprejmejo na podlagi te uredbe, ne more biti dajanje GSO na trg, tj. ta uredba ne spreminja pogojev za dajanje na trg GSO, odobrenih na podlagi obstoječe zakonodaje, se zdi, da postopek priglasitve iz Direktive 98/34/ES ni najustreznejše sredstvo za obveščanje Komisije.
Moreover, since measures which Member States can adopt under this Regulation cannot have as a subject the placing of the market of GMOs and thus does not modify the conditions of placing on the market of GMOs authorised under the existing legislation, the notification procedure under Directive 98/34/EC does not appear the most appropriate information channel for the Commission.
Zato se z odstopanjem od Direktive 98/34/ES ne uporabljajo.
Therefore, by derogation, Directive 98/34/EC should not be applicable.
Zdi se, da je preprostejši sistem za priglasitev nacionalnih ukrepov pred njihovim sprejetjem ustreznejše orodje, s katerim se lahko Komisija seznani s temi ukrepi.
A simpler notification system of the national measures prior to their adoption appears to be a more proportionate tool for the Commission to be aware of these measures.
Ukrepi, ki jih nameravajo sprejeti države članice, se tako skupaj z razlogi zanje sporočijo Komisiji in drugim državam članicam v vednost en mesec pred sprejetjem.
Measures which Member States intend to adopt should thus be communicated together with their reasons to the Commission and to the other Member States one month prior to their adoption for information purposes.
(9) V skladu z načelom subsidiarnosti namen te uredbe ni usklajevanje pogojev za gojenje v državah članicah, ampak priznanje svobode državam članicam, da na svojem ozemlju omejijo ali prepovejo gojenje GSO na podlagi okoljskih ali drugih utemeljenih dejavnikov, ki lahko izhajajo iz namernega sproščanja GSO ali njihovega dajanja na trg in ki niso bili preučeni v usklajenem postopku, predvidenem v delu C Direktive 2001/18/ ES, ali niso bili ustrezno obravnavani .
(9) On the basis of the subsidiarity principle, the purpose of this Regulation is not to harmonize the conditions of cultivation in Member States but to grant freedom to Member States to restrict or prohibit the cultivation of GMOs on their territory on grounds relating to environmental or other legitimate factors such as socio-economic impacts, which might arise from the deliberate release or the placing on the market of GMOs where those factors have not been addressed as part of the harmonised procedure provided for in Part C of Directive 2001/18/EC or in the event o f persisting scientific uncertainty.
(9b) Omejitve ali prepovedi za gojenje GSO, ki jih uvedejo države članice, ne smejo preprečevati biotehnoloških raziskav, ki se izvajajo pod pogojem, da se pri izvajanju upoštevajo vsi potrebni varnostni ukrepi.
(9b) Restrictions or bans on cultivation of GMOs by Member States should not prevent biotechnology research from being carried out provided that, in carrying out such research, all necessary safety measures are observed.
Direktiva 2001/18/ES
Directive 2001/18/EC
Direktiva 2001/18/ES se spremeni:
Directive 2001/18/EC is amended as follows:
(-1) Člen 22 se nadomesti z naslednjim:
(-1) Article 22 is replaced by the following:
„Člen 22
‘Article 22
Prosti pretok
Free circulation