natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1829/2003 establishes a centralised system for the authorisation of GMOs (Articles 3 to 7 for genetically modified food and Article 15 to 19 for genetically modified feed).
Uredba (ES) št. 1829/2003 vzpostavlja centraliziran sistem za odobritev GSO (členi 3 do 7 za gensko spremenjena živila in členi 15 do 19 za gensko spremenjeno krmo).
Every application shall be accompanied by a dossier supplying the information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC (Articles 5(5)(a) and 17(5)(a)).
Vsaki vlogi se priloži dokumentacija, ki zagotavlja informacije v skladu s prilogama III in IV k Direktivi 2001/18/ES ter informacije in sklepe o oceni tveganja, opravljeni v skladu z načeli iz Priloge II k Direktivi 2001/18/ES (člena 5(5)(a) in 17(5)(a)).
The European Food Safety Authority (EFSA) prepares an opinion on each authorisation (Articles 6 and 18).
Evropska agencija za varnost hrane pripravi mnenje o vsaki odobritvi (člena 6 in 18).
In case of GMOs to be used as seeds or other plant-propagating materials falling within the scope of the Regulation, Articles 6(3)(c) and 18(3)(c) requires EFSA to delegate the environmental risk assessment to a national competent authority.
Če se GSO uporabi kot seme ali drug rastlinski material za razmnoževanje s področja uporabe te uredbe, mora Evropska agencija za varnost hrane v skladu s členoma 6(3)(c) in 18(3)(c) oceno tveganja za okolje poveriti pristojnemu nacionalnemu organu.
Article 8 of the Regulation lays down rules applicable to ‘existing products’ defined as food products placed on the market under Council Directive 90/220/EEC [5] before the entry into force of Regulation (EC) No 258/97 of the European Parliament and of the Council [6] or in accordance with the provisions referred to in Regulation (EC) No 258/97 or other products which have been lawfully placed on the market before the date of application of this Regulation, and for which operators responsible of the placing on the market have notified to the Commission within six months of the date of application of this Regulation that the products were placed on the market in the Community before the date of the application of this Regulation.
Člen 8 Uredbe določa pravila, ki se uporabljajo za „obstoječe proizvode“, opredeljene kot živila, dana v promet v skladu z Direktivo Sveta 90/220/EGS [5] pred začetkom veljavnosti Uredbe (ES) št. 258/97 [6] Evropskega parlamenta in Sveta ali v skladu z določbami iz Uredbe (ES) št. 258/97, ali drugi proizvodi, ki so bili zakonito dani v promet pred začetkom uporabe te uredbe in za katere nosilci dejavnosti, odgovorni za dajanje teh proizvodov v promet, obvestijo Komisijo v šestih mesecih od začetka uporabe te uredbe, da so bili proizvodi dani v promet v Skupnosti pred začetkom uporabe te uredbe.
According to the same Article 8, these products may continue to be placed on the market, used and processed under certain conditions.
V skladu z istim členom 8 se lahko ti proizvodi pod nekaterimi pogoji še naprej dajejo v promet, uporabljajo in predelujejo.
Article 20 of the Regulation sets out the same procedure for feed products which have been authorised under Directives 90/220/EEC or 2001/18/EC, including use as feed, under Directive 82/471/EEC [7], which are produced from GMO, or under Council Directive 70/524/EEC [8], which contain, consist or are produced from GMOs.
Člen 20 Uredbe določa enak postopek za krmo, dovoljeno v skladu z Direktivo 90/220/EGS ali Direktivo 2001/18/ES, vključno z uporabo za krmo, ki se proizvaja iz GSO, v skladu z Direktivo Sveta 82/471/EGS [7], ali krmo, ki vsebuje GSO ali je iz njih sestavljena ali proizvedena, v skladu z Direktivo Sveta 70/524/ES [8].
Within one year from the date of application of the Regulation, and after verification that all the information required has been submitted and examined, the products concerned entered the Community Register of genetically modified food and feed (The Register).
V enem letu od začetka uporabe te uredbe in po potrditvi, da so bile vse zahtevane informacije predložene in pregledane, se zadevni proizvodi vnesejo v register Skupnosti za gensko spremenjena živila in krmo („register“).
NATIONAL PROVISIONS NOTIFIED
PRIGLAŠENE NACIONALNE DOLOČBE
Scope of the national provisions notified.
Področje uporabe priglašenih nacionalnih določb
Poland has attached to its notification all the provisions of the draft Act.
Poljska je uradnemu obvestilu priložila vse določbe osnutka akta.
Nevertheless, according to the explanatory note submitted by Poland, the derogation to Directive 2001/18/EC would concern only points 5 and 6 of Article 111(2) of Part IV of the draft Act, which concerns the deliberate release of GMOs for experimental purposes, and its Article 172.
Vendar v skladu s pojasnjevalno opombo, ki jo je predložila Poljska, odstopanje od Direktive 2001/18/ES zadeva le člen 111(2)(5) in (6) dela IV osnutka akta, ki zadeva namerno sproščanje GSO v poskusne namene, in člen 172.
Accordingly, the assessment in the present decision will be limited to those provisions, without prejudice to other official procedures which will eventually assess the conformity of the rest of the Act — including the other provisions of Article 111 — with Community legislation.
V skladu s tem je ocena v tej odločbi omejena na te določbe, brez poseganja v druge uradne postopke, na podlagi katerih se bo nazadnje ocenila skladnost preostalega akta, vključno z drugimi določbami člena 111, z zakonodajo Skupnosti.
Article 111 (deliberate releases for experimental purposes)
Člen 111 (namerno sproščanje v poskusne namene)
Article 111 lays down the content of an application for the issuing of a decision for the deliberate release of a GMO.
Člen 111 določa vsebino vloge za izdajo odločbe za namerno sproščanje GSO.
According to Article 111(1): ‘An application for the issuing of a decision in the matter of deliberate release should contain’:
Člen 111(1) določa: „Vloga za izdajo odločbe o vprašanju namernega sproščanja mora vsebovati“:
According to Article 111(2): ‘The following shall accompany an application for the issuing of a decision in the matter of a deliberate release’:
Člen 111(2) določa: „Vlogi za izdajo odločbe o vprašanju namernega sproščanja se priloži naslednje“:
a risk assessment prepared for the genetically modified organisms being released (…);
ocena tveganja za sproščene gensko spremenjene organizme […];
documentation relating to the preparation of the risk assessment (…);
dokumentacija v zvezi s pripravo ocene tveganja […];
technical documentation of the deliberate release;
tehnična dokumentacija o namernem sproščanju;
a programme of action in the case of a risk to the health of persons or animals or the safety of the environment associated with the deliberate release;
akcijski program v primeru tveganja za zdravje ljudi ali živali ali varnost okolja, ki je povezano z namernim sproščanjem;
certification from the mayor of the municipality, town or city that in the local spatial development plan, with regard to the need to protect local environment, nature and cultural landscape of the area in question, provision is made for the possibility of deliberate release;
potrdilo župana občine, kraja ali mesta, da je v lokalnem načrtu prostorskega razvoja v skladu s potrebo po varstvu lokalnega okolja, narave in kulturne krajine zadevnega območja predvidena možnost namernega sproščanja;
written declarations from the holders of farms neighboring the location of the deliberate release that they do not object to the release;
pisne izjave lastnikov kmetij, ki mejijo na lokacijo namernega sproščanja, da ne nasprotujejo sproščanju;
notarised copy of the contract for the conduct of the deliberate release (…);
overjen izvod pogodbe za izvajanje namernega sproščanja […];
summary of the application.
povzetek vloge.
Article 172 (establishment of special zones for the cultivation of GMOs)
Člen 172 (določitev posebnih območij za gojenje GSO)
Article 172 stipulates:
Člen 172 določa:
It shall be prohibited to cultivate genetically modified plants, subject to the provisions of paragraph 2.
V skladu z določbami iz odstavka 2 je gojenje gensko spremenjenih rastlin prepovedano.
The Minister with responsibility for agriculture, in consultation with the Minister with responsibility for the environment and after seeking the opinion of the council of the municipality (gmina) in which the genetically modified plants are to be cultivated, shall issue a decision concerning the creation of a zone designated for the cultivation of genetically modified plants in a specified area situated within the territory of the municipality (zone designated for the cultivation of genetically modified plants), following the submission by the applicant mentioned in Article 4(21)(f) of an application for the issue of a decision concerning a zone designated for the cultivation of genetically modified plants.
Minister za kmetijstvo po posvetovanju z ministrom za okolje in po pridobitvi mnenja občinskega sveta (gmina) občine, v kateri se bodo gojile gensko spremenjene rastline, izda odločbo o določitvi območja za gojenje gensko spremenjenih rastlin na določenem območju na ozemlju občine (območje, namenjeno gojenju gensko spremenjenih rastlin), po predložitvi vloge za izdajo odločbe v zvezi z območjem, namenjeniem gojenju gensko spremenjenih rastlin, s strani vlagatelja iz člena 4(21)(f).
An application for the issue of a decision concerning the creation of a zone designated for the cultivation of genetically modified plants should contain:
Vloga za izdajo odločbe o določitvi območja za gojenje gensko spremenjenih rastlin, mora vsebovati:
the forename and surname or name and registered office and the address of the applicant mentioned in Article 4(21)(f);
ime in priimek ali ime in registrirani sedež ter naslov vlagatelja iz člena 4(21)(f);
the species and variety of genetically modified plant, the properties obtained as a result of the genetic modification and the unique identifier;
vrste in sorte gensko spremenjene rastline, značilnosti, pridobljene na podlagi genske spremembe, ter enotni identifikator;
the number of the cadastral parcel containing the agricultural parcel within the meaning of the regulations on the national system for keeping records of producers, records of farms and records of applications for the award of payments, the area of the agricultural parcel in hectares, the location of the agricultural parcel within the cadastral parcel, the sheet number of the cadastral map for that cadastral parcel, the name of the cadastral region and the name of the municipality and voivodship.
številko katastrske parcele, na kateri je enota rabe ali poljina, v smislu predpisov o nacionalnem sistemu vodenja evidenc proizvajalcev, evidenc kmetij in evidenc vlog za dodelitev plačil, velikost enote rabe ali poljine v hektarih, lokacijo enote rabe ali poljine na katastrski parceli, številko lista katastrske karte za to katastrsko parcelo, ime katastrske regije ter ime občine in vojvodstva.
The application shall be submitted in writing and in electronic form.
Vloga se predloži v pisni in elektronski obliki.
The application mentioned in paragraph 3 shall be accompanied by written declarations from the holders of land within the area of spatial isolation from the land on which it is planned to cultivate genetically modified plants that they do not object to the intention to create a zone designated for the cultivation of genetically modified plants.
Vlogi iz odstavka 3 se priložijo pisne izjave lastnikov zemljišč na območju prostorske izolacije od zemljišča, na katerem se načrtuje gojenje gensko spremenjenih rastlin, da ne nasprotujejo predvideni določitvi območja za gojenje gensko spremenjenih rastlin.
A copy of the application for the issue of a decision concerning a zone designated for the cultivation of genetically modified plants shall be sent, in writing and in electronic form, within five days following the date on which the application is submitted, by the Minister with responsibility for agriculture to:
Izvod vloge za izdajo odločbe o območju za gojenje gensko spremenjenih rastlin minister za kmetijstvo pošlje v pisni in elektronski obliki v petih dneh po tem, ko je bila predložena vloga:
the Minister with responsibility for the environment;
ministru za okolje;
the council of the municipality within which the genetically modified plants are to be cultivated;
občinskemu svetu občine, v kateri se bodo gojile gensko spremenjene rastline;
and these, within 45 days following the date of delivery to them of a copy of the application mentioned in paragraph 3, shall convey their position in the matter, indicating the reasons therefore, to the Minister with responsibility for agriculture.
ki v 45 dneh od dneva prejetja izvoda vloge iz odstavka 3 ministru za kmetijstvo predložita mnenje o zadevi in razloge zanj.
The Minister with responsibility for the environment shall convey to the Minister with responsibility for agriculture the position mentioned in paragraph 6(1) after seeking the opinion of the Team mentioned in Article 26(4) and the opinion of the Committee mentioned in Article 25.
Minister za okolje predloži ministru za kmetijstvo mnenje iz odstavka 6(1) po pridobitvi mnenja skupine iz člena 26(4) in mnenja odbora iz člena 25.
The council of the municipality mentioned in paragraph 6(2) shall, immediately after receiving the application, make the information contained therein publicly known in the town or village in which the zone is to be created, in the manner customarily adopted in the area in question.’
Občinski svet iz odstavka 6(2) takoj po prejetju vloge objavi informacije iz vloge v kraju ali vasi, v kateri bo vzpostavljeno območje, na način, ki je običajen na zadevnem območju.“
Poland has notified to the Commission all provisions of Article 172.
Poljska je Komisijo uradno obvestila o vseh določbah člena 172.
Without prejudice to other official procedures which will assess the conformity of the rest of the Act with Community legislation, the Commission considers that all provisions of Article 172 derogate from Directive 2001/18/EC.
Brez poseganja v druge uradne postopke, na podlagi katerih bo ocenjena skladnost preostalega akta z zakonodajo Skupnosti, Komisija meni, da vse odločbe člena 172 odstopajo od Direktive 2001/18/ES.
Impact on Community legislation of the national provisions notified
Vpliv priglašenih nacionalnih določb na zakonodajo Skupnosti
Impact of points 5 and 6 of Article 111(2)
Vpliv člena 111(2)(5) in (6)
The scope of the latter provisions, in conjunction with the explanation of the explanatory note, implies that it will primarily impact on the release of GMOs for any other purpose than for placing on the market (primarily for field trials) under Part B (Articles 5 to 11) of Directive 2001/18/EC.
Glede na področje uporabe navedenih določb, v povezavi z razlago iz pojasnjevalne opombe, bo ta člen predvsem vplival na sproščanje GSO za kateri koli drug namen, razen za dajanje v promet (predvsem za poljske poskuse), v skladu z delom B (členi 5–11) Direktive 2001/18/ES.
Impact of Article 172
Vpliv člena 172
The scope of Article 172(1) of the draft Act implies that it will primarily impact on:
Glede na področje uporabe člena 172(1) osnutka akta bo ta člen predvsem vplival na:
the cultivation of genetically modified seed varieties authorised under the provisions of part C (Articles 12 to 24) of Directive 2001/18/EC,
gojenje gensko spremenjenih sort semen, odobrenih v skladu z določbami dela C (členi 12–24) Direktive 2001/18/ES,
the cultivation of genetically modified seed varieties already approved under the provisions of Directive 90/220/EEC and now notified as existing products under Articles 8 and 20 of Regulation (EC) No 1829/2003,
gojenje gensko spremenjenih sort semen, ki so že odobrene v skladu z določbami Direktive 90/220/EGS in zdaj priglašene kot obstoječi proizvodi v skladu s členoma 8 in 20 Uredbe (ES) št. 1829/2003,
the cultivation of genetically modified seed varieties authorised under the provisions of Regulation (EC) No 1829/2003.
gojenje gensko spremenjenih sort semen, odobrenih v skladu z določbami Uredbe (ES) št. 1829/2003.
JUSTIFICATION PUT FORWARD BY POLAND
OBRAZLOŽITEV, KI JO JE PREDLOŽILA POLJSKA
Information for the draft Act, offering interpretation about the Act’s impact on and conformity with Community legislation, is provided in the submitted explanatory note on the draft Act (pages 12 and 16 and 17) and the text of the notification (pages 3 to 5).
Informacije o osnutku akta, ki pojasnjujejo vpliv akta na zakonodajo Skupnosti in skladnost z njo, so navedene v predloženi pojasnjevalni opombi k osnutku akta (strani 12 in 16–17) ter besedilu uradnega obvestila (strani 3–5).
Justifications put forward for points 5 and 6 of Article 111(2)
Predložene obrazložitve člena 111(2)(5) in (6)
According to the Polish notification (pages 3 and 4) and explanatory note (page 12), following arguments support the existence of ‘elements related to specific conditions’ in the sense of Article 95(5) EC Treaty.
V skladu z uradnim obvestilom Poljske (strani 3–4) in pojasnjevalno opombo (stran 12) obstoj „elementov, povezanih s posebnimi pogoji“ v smislu člena 95(5) Pogodbe ES, podpirajo naslednje utemeljitve:
In the drafting of the rules governing the deliberate release of genetically modified organisms into the environment for experimental purposes, the principle adopted was that a set of arrangements as strict as possible should be created for assessing the safety of a given field experiment in the context of its safety for the environment.
Pri oblikovanju pravil, ki urejajo namerno sproščanje gensko spremenjenih organizmov v okolje v poskusne namene, je bilo sprejeto načelo, da je treba oblikovati čim strožji sklop ureditev za oceno varnosti določenega poljskega poskusa v smislu njegove varnosti za okolje.
This is especially important because release is the first stage of research where the new genetically modified organism comes into contact with the environment and the experiment is conducted without such effective protective measures as are applied in closed systems.
To je predvsem pomembno, ker je sproščanje prva faza raziskave, pri kateri nov gensko spremenjeni organizem pride v stik z okoljem, poskus pa se izvaja brez takšnih učinkovitih varnostnih ukrepov, kot se uporabljajo v zaprtih sistemih.
The effect of such an organism on the environment is unknown and may be potentially harmful (this applies particularly to organisms other than genetically modified higher plants).
Vpliv takšnih organizmov na okolje ni znan in je lahko potencialno škodljiv (to velja zlasti za organizme, ki niso gensko spremenjene višje rastline).
Such action therefore requires special conditions of safety to be maintained, which is in accordance with the precautionary principle that applies in EU Member States.
Zato takšen ukrep zahteva vzpostavitev posebnih varnostnih pogojev, kar je v skladu s previdnostnim načelom, ki se uporablja v državah članicah EU.
In view of the richness of biodiversity in Poland, the introduction of genetically modified organisms into the environment may cause serious disturbances to its functioning.
Glede na bogato biološko raznovrstnost na Poljskem lahko uvajanje gensko spremenjenih organizmov v okolje povzroči resne motnje njenega delovanja.
The overriding principle was therefore adopted that there should be as strict as possible an assessment of all component elements of a given field experiment.
Zato je bilo sprejeto prevladujoče načelo, da mora biti ocena vseh sestavnih delov določenega poljskega poskusa čim strožja.
Particular emphasis was placed on the environmental conditions (soil composition, fauna, flora, presence of protected species, climatic conditions, etc.).
Poseben poudarek je bil namenjen okoljskim pogojem (sestavi tal, živalstvu, rastlinstvu, prisotnosti zaščitenih vrst, podnebnim razmeram itd.).
These proposals (namely, to condition the release to the consent of the neighbouring owners of farm parcels and the provisions of local spatial plans) place additional obligations on applicants, but they do not exclude the carrying out of work involving the deliberate release of GMOs into the environment.
Ti predlogi (namreč, da se sproščanje pogojuje s soglasjem lastnikov sosednjih kmetijskih zemljišč in določbami iz lokalnih prostorskih načrtov) vlagateljem nalagajo dodatne obveznosti, vendar ne izključujejo izvajanja dela, ki vključuje namerno sproščanje GSO v okolje.
The restrictive approach to the question of release is also linked to the structure of Polish agriculture, which is among the most fragmented in the Community.
Omejevalni pristop k vprašanju sproščanja je povezan tudi s strukturo poljskega kmetijstva, ki je med najbolj razdrobljenimi v Skupnosti.
This poses a serious problem not only for commercial growing of GM plants, but also for the safe location of field experiments.
To predstavlja resno težavo ne le za komercialno pridelavo gensko spremenjenih rastlin, ampak tudi za varno lokacijo poljskih poskusov.
The Polish authorities make no reference to any new scientific evidence since the Directive has been adopted relating to the protection of the environment.
Poljski organi se ne sklicujejo na nobena nova znanstvena spoznanja, ker je bila ta direktiva sprejeta v zvezi z varstvom okolja.
Justifications put forward for Article 172
Predložene obrazložitve člena 172
According to the Polish notification (pages 4 and 5) and explanatory note (16 and 17), the rules on commercial cultivation in the national provisions are based to a large extent on Commission Recommendation 2003/556/EC of 23 July 2003 on guidelines for the development of national strategies and best practices to ensure the coexistence of genetically modified crops with conventional and organic farming [9].
V skladu z uradnim obvestilom Poljske (strani 4–5) in pojasnjevalno opombo (16–17) pravila o komercialnem gojenju iz nacionalnih določb predvsem temeljijo na Priporočilu Komisije 2003/556/ES z dne 23. julija 2003 o smernicah za oblikovanje nacionalnih strategij in najboljših praks za zagotovitev soobstoja gensko spremenjenih pridelkov s konvencionalnim in ekološkim kmetijstvom [9].
The idea of creating zones designated for the cultivation of genetically modified plants is a development of paragraph 3.3 of the aforementioned Recommendation, which concerns cooperation between neighbouring farms.
Zamisel o določitvi območij za gojenje gensko spremenjenih rastlin se je razvila na podlagi odstavka 3.3 navedenega priporočila, ki zadeva sodelovanje med sosednjimi kmetijami.
Account was also taken of paragraph 2 and paragraph 3.3.2 (coordinated management measures), which speaks of the voluntary clustering of fields of different farms for the cultivation of similar crop varieties (GM, conventional or organic) in a particular area, as well as subparagraph 3.3.3 concerning voluntary agreements among farmers on zones of a single production type.
Prav tako sta bila upoštevana odstavka 2 in 3.3.2 (usklajeni upravljavski ukrepi), ki vključuje prostovoljno povezovanje polj različnih kmetij za gojenje podobnih sort pridelkov (gensko spremenjenih, konvencionalnih ali organskih) na določenem območju, ter pododstavek 3.3.3 o prostovoljnih dogovorih med kmeti glede območij, namenjenih enemu tipu proizvodnje.
According to the draft act, cultivation of genetically modified plants should be limited to areas which do not contain elements of value from a nature conservation standpoint and whose agrarian structure enables safe cultivation of transgenic plants, without damaging the operations of other farmers.
V skladu z osnutkom akta je treba gojenje gensko spremenjenih rastlin omejiti na območja, ki niso pomembna z vidika ohranjanja narave ter imajo kmetijsko strukturo, ki omogoča varno gojenje transgenih rastlin, brez oviranja dejavnosti drugih kmetov.