natgillin/translations-raw huggingface dataset:
Done at Brussels, 8 March 2018.
Direktiva (EU) 2015/412 Evropskega parlamenta in Sveta z dne 11. marca 2015 o spremembi Direktive 2001/18/ES glede možnosti držav članic, da omejijo ali prepovejo gojenje gensko spremenjenih organizmov (GSO) na svojem ozemlju (UL L 68, 13.3.2015, str. 1).
The President
Uredba (ES) št. 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi (UL L 268, 18.10.2003, str. 1).
OJ L 106, 17.4.2001, p. 1.
Izvedbena uredba Komisije (EU) št. 503/2013 z dne 3. aprila 2013 o vlogah za odobritev gensko spremenjenih živil in krme v skladu z Uredbo (ES) št. 1829/2003 Evropskega parlamenta in Sveta in o spremembi uredb Komisije (ES) št. 641/2004 in (ES) št. 1981/2006 (UL L 157, 8.6.2013, str. 1).
EFSA Journal 2010;8(11):1879.
PRILOGA
Directive (EU) 2015/412 of the European Parliament and of the Council of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory (OJ L 68, 13.3.2015, p. 1).
Direktiva 2001/18/ES se spremeni:
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
Priloga II se spremeni:
Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (OJ L 268, 18.10.2003, p. 1).
oddelek C se nadomesti z naslednjim:
Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1).
Metodologija
ANNEX
Za izvajanje tega oddelka za prijave po delu C so na voljo smernice, ki jih je izdala Evropska agencija za varnost hrane.
Directive 2001/18/EC is amended as follows:
Splošni in posebni vidiki v zvezi z OTO
Annex II is amended as follows:
Namerne in nenamerne spremembe
Section C is replaced by the following:
Pri določitvi in oceni možnih škodljivih učinkov iz oddelka A se v OTO opredelijo namerne in nenamerne spremembe, ki izhajajo iz genske spremembe, poleg tega se oceni, ali lahko povzročijo škodljive učinke na zdravje ljudi in na okolje.
Methodology
Namerne spremembe, ki izhajajo iz genske spremembe, so spremembe, ki so namenske in izpolnjujejo prvotne namene genske spremembe.
Guidance issued by the European Food Safety Authority is available for the implementation of this section for Part C notifications.
Nenamerne spremembe, ki izhajajo iz genske spremembe, so konstantne spremembe, ki presegajo namerne spremembe, ki izhajajo iz genske spremembe.
General and specific considerations for the e.r.a.
Namerne in nenamerne spremembe imajo lahko neposreden ali posreden ter takojšnji ali zakasneli učinek na zdravje ljudi in na okolje.
Intended and unintended changes
Dolgoročni škodljivi učinki in kumulativni dolgoročni škodljivi učinki v OTO za prijave po delu C
As part of the identification and evaluation of the potential adverse effects referred to in Section A, the e.r.a shall identify the intended and unintended changes resulting from the genetic modification and shall evaluate their potential to cause adverse effects on human health and on the environment.
Dolgoročni učinki GSO izhajajo bodisi iz zakasnelega odziva organizmov ali njihovih potomcev na dolgoročno ali kronično izpostavljenost GSO bodisi iz široke uporabe GSO v času in prostoru.
Intended changes resulting from the genetic modification are changes that are designed to occur and which fulfil the original objectives of the genetic modification.
Pri določitvi in oceni možnih dolgoročnih škodljivih učinkov GSO na zdravje ljudi in na okolje se upošteva naslednje:
Unintended changes resulting from the genetic modification are consistent changes which go beyond the intended change(s) resulting from the genetic modification.
dolgoročno medsebojno učinkovanje GSO in prejemnega okolja;
Intended and unintended changes can have either direct or indirect, and either immediate or delayed effects on human health and on the environment.
značilnosti GSO, ki dolgoročno postanejo pomembne;
Long-term adverse effects and cumulative long-term adverse effects in the e.r.a. of Part C notifications
podatki, ki se pridobijo pri ponavljajočem namernem sproščanju ali dajanju v promet GSO v daljšem časovnem obdobju.
Long-term effects of a GMO are effects resulting either from a delayed response by organisms or their progeny to long-term or chronic exposure to a GMO or from an extensive use of a GMO in time and space.
Pri določitvi in oceni možnih kumulativnih dolgoročnih škodljivih učinkov iz uvodnega dela Priloge II se upoštevajo tudi GSO, ki so se namerno sproščali ali dajali v promet v preteklosti.
The identification and evaluation of the potential long-term adverse effects of a GMO on human health and on the environment shall take into account the following:
Kakovost podatkov
the long-term interactions of the GMO and the receiving environment;
Za izvedbo OTO za prijavo po delu C te direktive prijavitelj pregleda že razpoložljive podatke iz znanstvene literature ali iz drugih virov, vključno s poročili o spremljanju, in pridobi ustrezne podatke tako, da opravi ustrezne študije, kadar je to mogoče.
the characteristics of the GMO which become important on a long-term basis;
Kadar je ustrezno, prijavitelj v OTO utemelji, zakaj podatkov s študijami ni bilo mogoče pridobiti.
data obtained from repeated deliberate releases or placings on the market of the GMO over a long period.
OTO za prijave po delu B Direktive temelji vsaj na že razpoložljivih podatkih iz znanstvene literature ali iz drugih virov ter se lahko dopolni z dodatnimi podatki, ki jih pridobi prijavitelj.
The identification and evaluation of the potential cumulative long-term adverse effects referred to in the introductory part of Annex II shall also take into account the GMOs deliberately released or placed on the market in the past.
Kadar se v OTO navedejo podatki, pridobljeni zunaj Evrope, se utemelji njihova relevantnost za prejemna okolja v Uniji.
Quality of the data
Podatki v OTO za prijave po delu C te direktive izpolnjujejo naslednje zahteve:
In order to carry out an e.r.a. for a notification under Part C of this Directive, the notifier shall collate already available data from scientific literature or from other sources, including monitoring reports, and shall generate the necessary data by performing, where possible, appropriate studies.
kadar so v OTO navedene toksikološke študije, ki so bile opravljene za ocenitev tveganja za zdravje ljudi ali živali, prijavitelj zagotovi dokaze, da so bile izvedene v prostorih, ki izpolnjujejo:
Where applicable, the notifier shall justify in the e.r.a. why generating data by studies is not possible.
zahteve iz Direktive 2004/10/ES ali
The e.r.a. for notifications under Part B of the Directive shall be based at least on already available data from scientific literature or from other sources and may be supplemented by additional data generated by the notifier.
„načela OECD o dobri laboratorijski praksi (DLP)“, če se opravijo zunaj Unije;
Where data generated outside Europe is provided in the e.r.a., its relevance to receiving environment(s) in the Union shall be justified.
kadar se v OTO zagotovijo študije, ki niso toksikološke študije:
Data provided in the e.r.a for notifications under part C of this Directive shall comply with the following requirements:
izpolnjujejo načela dobre laboratorijske prakse (DLP) iz Direktive 2004/10/ES, kadar je ustrezno, ali
where toxicological studies carried out to assess risk to human or animal health are provided in the e.ra., the notifier shall provide evidence to demonstrate that they were conducted in facilities which comply with:
jih izvedejo organizacije, akreditirane v okviru ustreznega standarda ISO, ali
the requirements of Directive 2004/10/EC; or
se izvedejo v skladu z mednarodno priznanimi standardi, če ni ustreznega standarda ISO;
the “OECD Principles on Good Laboratory Practice” (GLP), if carried out outside the Union;
informacije o rezultatih študij, navedenih v točkah (a) in (b), in uporabljenih študijskih protokolih so zanesljive in celovite ter vključujejo surove podatke v elektronski obliki, primerne za opravljanje statističnih ali drugih analiz;
where studies other than toxicological studies are provided in the e.r.a., they shall:
prijavitelj opredeli velikost učinka, ki naj bi ga zaznala vsaka študija, in ga utemelji, kadar je to mogoče;
comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC, where relevant; or
izbor mest za študije na prostem temelji na ustreznih prejemnih okoljih glede na potencialno izpostavljenost in vpliv, ki bi ga imelo sproščanje GSO.
be conducted by organisations accredited under the relevant ISO standard; or
Izbor se utemelji v OTO;
in the absence of a relevant ISO standard, be conducted in accordance with internationally recognised standards;
gensko nespremenjene primerjalne vrste ustrezajo prejemnemu okolju in imajo primerljivo gensko podlago kot GSO.
information on the results obtained from the studies referred to in points (a) and (b) and on the study protocols used shall be reliable and comprehensive and shall include the raw data in an electronic format suitable for carrying out statistical or other analysis;
Izbira primerjalne vrste se utemelji v OTO.
the notifier shall specify, where possible, the size of effect that each study performed intends to detect and justify it;
Zložbe transformacijskih dogodkov v prijavah po delu C
the selection of sites for field studies shall be based on relevant receiving environments in view of the potential exposure and impact that would be observed where the GMO may be released.
Za OTO za GSO, ki vsebuje zložbe transformacijskih dogodkov, v prijavah po delu C velja naslednje:
The selection shall be justified in the e.r.a.;
prijavitelj zagotovi OTO za vsak posamezni transformacijski dogodek v GSO ali se sklicuje na že predložene prijave za navedene posamezne transformacijske dogodke;
the non-genetically modified comparator shall be appropriate for the relevant receiving environment(s) and shall have a genetic background comparable to the GMO.
prijavitelj zagotovi oceno naslednjih vidikov:
The choice of the comparator shall be justified in the e.r.a.
stabilnost transformacijskih dogodkov;
Stacked transformation events in Part C notifications
izražanje transformacijskih dogodkov;
The following shall apply to the e.r.a. of a GMO containing stacked transformation events in Part C notifications:
možni aditivni, sinergijski ali nasprotni učinki, ki izhajajo iz kombinacije transformacijskih dogodkov;
the notifier shall provide an e.r.a. for each single transformation event in the GMO or refer to already submitted notifications for those single transformation events;
kadar lahko potomci GSO vsebujejo različne podkombinacije zložb transformacijskih dogodkov, prijavitelj predloži znanstveno utemeljitev, ki dokazuje, da za zadevne podkombinacije ni treba zagotoviti rezultatov poskusa ne glede na njihov izvor, če pa take znanstvene utemeljitve ni, zagotovi ustrezne rezultate poskusa.
the notifier shall provide an assessment of the following aspects:
Značilnosti GSO in sproščanj
the stability of the transformation events;
OTO upošteva ustrezne tehnične in znanstvene podrobnosti glede:
the expression of the transformation events;
prejemnih ali starševskih organizmov,
the potential additive, synergistic or antagonistic effects resulting from the combination of the transformation events;
genskih sprememb, in sicer vnosa ali odstranitve genskega materiala, ter ustreznih informacij o vektorju in dajalcu,
where the progeny of the GMO can contain various subcombinations of the stacked transformation events, the notifier shall provide a scientific rationale justifying that there is no need to provide experimental data for the concerned subcombinations, independently of their origin, or, in the absence of such scientific rationale, shall provide the relevant experimental data.
GSO,
Characteristics of the GMO and of the releases
namernega sproščanja ali uporabe, vključno z obsegom,
The e.r.a. shall take into account the relevant technical and scientific details regarding characteristics of:
možnega prejemnega okolja, v katerega se bo sproščal GSO in v katerega se lahko razširi transgen, ter
the recipient or parental organism(s),
medsebojnega učinkovanja med temi značilnostmi.
the genetic modification(s), be it insertion or deletion of genetic material, and relevant information on the vector and the donor,
Ustrezne informacije iz prejšnjih sproščanj istih ali podobnih GSO in organizmov s podobnimi lastnostmi ter njihovo biotsko in abiotsko medsebojno učinkovanje s podobnimi prejemnimi okolji, vključno z informacijami, ki izhajajo iz spremljanja takih organizmov, se upoštevajo v OTO v skladu s členom 6(3) ali 13(4).
the GMO,
Koraki v OTO
the intended release or use including its scale,
OTO iz členov 4, 6, 7 in 13 se izvede za vsako ustrezno področje tveganja iz oddelka D1 ali D2 v skladu z naslednjimi šestimi koraki:
the potential receiving environment(s) into which the GMO will be released and into which the transgene may spread, and
Opis problematike, vključno z identifikacijo nevarnosti
the interaction(s) between these characteristics.
V opisu problematike se:
Relevant information from previous releases of the same or similar GMOs and organisms with similar traits and their biotic and abiotic interaction with similar receiving environments, including information resulting from the monitoring of such organisms, shall be considered in the e.r.a., subject to Article 6(3) or Article 13(4).
opredelijo vse spremembe značilnosti GSO, povezane z gensko spremembo, in sicer s primerjavo značilnosti GSO z značilnostmi izbranih gensko nespremenjenih primerjalnih vrst pod ustreznimi pogoji sproščanja ali uporabe;
Steps in the e.r.a.
določijo možni škodljivi učinki na zdravje ljudi ali na okolje, ki so povezani s spremembami, opredeljenimi v točki (a) zgoraj;
The e.r.a. referred to in Articles 4, 6, 7 and 13 shall be conducted for each relevant area of risk referred to in Section D1 or in Section D2 in accordance with the following six steps:
možni škodljivi učinki se ne smejo zanemariti samo zato, ker ni verjetno, da bi se pojavili.
Problem formulation including hazard identification
Možni škodljivi učinki bodo drugačni za vsak posamezen primer in lahko vključujejo:
The problem formulation shall:
učinke na populacijsko dinamiko vrst v prejemnem okolju in gensko raznovrstnost vsake od teh populacij, kar bi lahko privedlo do manjše biotske raznovrstnosti,
identify any changes in the characteristics of the organism, linked to the genetic modification, by comparing the characteristics of the GMO with those of the chosen non-genetically modified comparator under corresponding conditions of release or use;
spremenjeno dovzetnost za patogene, ki pospešuje širjenje infekcijskih bolezni ali oblikovanje novih rezervoarjev ali vektorjev,
identify potential adverse effects on human health or the environment which are linked to the changes that have been identified under point (a) above;
ogrožanje profilaktičnih ali terapevtskih medicinskih, veterinarskih ali fitofarmacevtskih uporab, na primer s prenosom genov, ki omogočajo odpornost proti antibiotikom, ki se uporabljajo v medicini ali veterini,
Potential adverse effects shall not be discounted on the basis that they are unlikely to occur.
učinke na biogeokemijo (biogeokemični cikli), vključno s kroženjem ogljika in dušika prek sprememb v razgradnji organskega materiala v tleh,
Potential adverse effects will vary from case to case, and may include:
bolezni ljudi, vključno z alergenimi ali toksičnimi reakcijami,
effects on the dynamics of populations of species in the receiving environment and the genetic diversity of each of these populations leading to a potential decline in biodiversity,
bolezni živali in rastlin, vključno s toksičnimi in v primeru živali alergenimi reakcijami, kadar je ustrezno.
altered susceptibility to pathogens facilitating the dissemination of infectious diseases or creating new reservoirs or vectors,
Kadar se ugotovijo možni dolgoročni škodljivi učinki GSO, se ocenijo v obliki teoretičnih študij, kadar je to mogoče, z uporabo:
compromising prophylactic or therapeutic medical, veterinary, or plant protection treatments, for example by transfer of genes conferring resistance to antibiotics used in human or veterinary medicine,
dokazov iz prejšnjih izkušenj in/ali
effects on biogeochemistry (biogeochemical cycles), including carbon and nitrogen recycling through changes in soil decomposition of organic material,
razpoložljivih zbirk podatkov ali literature in/ali
disease affecting humans, including allergenic or toxic reactions,
matematičnega modeliranja;
disease affecting animals and plants, including toxic, and, in the case of animals, allergenic reactions, where appropriate.
določijo ustrezne končne točke ocene.
Where potential long-term adverse effects of a GMO are identified, they shall be assessed in the form of desk based studies using, where possible, one or more of the following:
Navedeni možni škodljivi učinki, ki bi lahko vplivali na določene končne točke ocene, se upoštevajo pri naslednjih korakih ocene tveganja.
evidence from previous experiences;
določijo in opišejo poti izpostavljenosti ali drugi mehanizmi, prek katerih se lahko pojavijo škodljivi učinki.
available data sets or literature;
Škodljivi učinki se lahko pojavijo neposredno ali posredno prek poti izpostavljenosti ali drugih mehanizmov, ki lahko vključujejo:
mathematical modelling;
širjenje GSO v okolje,
identify relevant assessment endpoints.
prenos vnesenega genskega materiala na isti organizem ali druge organizme, gensko spremenjene ali ne,
Those potential adverse effects that could impact the identified assessment endpoints shall be considered in the next steps of the risk assessment;
fenotipsko in gensko nestabilnost,
identify and describe the exposure pathways or other mechanisms through which adverse effects may occur.
medsebojno učinkovanje z drugimi organizmi,
Adverse effects may occur directly or indirectly through exposure pathways or other mechanisms which may include:
spremembe v upravljanju, vključno s kmetijskimi praksami, kadar je to ustrezno;
the spread of the GMO(s) in the environment,
oblikujejo preverljive hipoteze in opredelijo ustrezne končne točke meritev, da se, kadar je mogoče, omogoči kvantitativna ocena možnih škodljivih učinkov;
the transfer of the inserted genetic material to the same organism or other organisms, whether genetically modified or not,
upoštevajo možne negotovosti, vključno z vrzelmi v znanju in metodološkimi omejitvami.
phenotypic and genetic instability,
Opredelitev nevarnosti
interactions with other organisms,
Oceni se razsežnost vsakega možnega škodljivega učinka.
changes in management, including, where applicable, in agricultural practices;
Pri tej oceni se predpostavi, da se bo pojavil tak škodljivi učinek.
formulate testable hypotheses, and define relevant measurement endpoints, to allow, where possible, a quantitative evaluation of the potential adverse effect(s);
OTO upošteva, da bo na razsežnost verjetno vplivalo prejemno okolje, v katerega se namerava sproščati GSO, ter obseg in pogoji sproščanja.
consider possible uncertainties, including knowledge gaps and methodological limitations.
Kadar je mogoče, je ocena kvantitativna.
Hazard characterisation
Kadar je ocena kvalitativna, se uporabi kategorični opis („velika“, „zmerna“, „majhna“ ali „zanemarljiva“) in razloži obseg učinka za vsako kategorijo.
The magnitude of each potential adverse effect shall be evaluated.
Opredelitev izpostavljenosti
This evaluation shall assume that such an adverse effect will occur.
Oceni se verjetnost pojava vsakega določenega možnega škodljivega učinka, da se zagotovi kvantitativna ocena izpostavljenosti kot relativno merilo verjetnosti, kadar je to mogoče, drugače pa kvalitativna ocena izpostavljenosti.
The e.r.a shall consider that the magnitude is likely to be influenced by the receiving environment(s) into which the GMO is intended to be released and by the scale and conditions of the release.
Upoštevajo se značilnosti prejemnih okolij in področje uporabe iz prijave.
Where possible, the evaluation shall be expressed in quantitative terms.
Kadar je ocena kvalitativna, se uporabi kategorični opis izpostavljenosti („velika“, „zmerna“, „majhna“ ali „zanemarljiva“) in razloži obseg učinka za vsako kategorijo.
Where the evaluation is expressed in qualitative terms, a categorical description (“high”, “moderate”, “low” or “negligible”) shall be used and an explanation of the scale of effect represented by each category shall be provided.
Opredelitev tveganja
Exposure characterisation
Tveganje se za vsak možni škodljivi učinek opredeli kot kombinacija razsežnosti in verjetnosti pojava navedenega škodljivega učinka, da se zagotovi kvantitativna ali semikvantitativna ocena tveganja.
The likelihood or probability of each identified potential adverse effect occurring shall be evaluated to provide, where possible, a quantitative assessment of the exposure as a relative measure of probability, or otherwise a qualitative assessment of the exposure.
Kadar kvantitativna ali semikvantitativna ocena ni mogoča, se zagotovi kvalitativna ocena tveganja.
The characteristics of the receiving environment(s) and the scope of the notification shall be taken into consideration.
V tem primeru se uporabi kategorični opis tveganja („visoko“, „zmerno“, „nizko“ ali „zanemarljivo“) in razloži obseg učinka za vsako kategorijo.
Where the evaluation is expressed in qualitative terms, a categorical description (“high”, “moderate”, “low” or “negligible”) of the exposure shall be used and an explanation of the scale of effect represented by each category shall be provided.
Kadar je ustrezno, se opiše negotovost za vsako ugotovljeno tveganje in, kadar je mogoče, oceni kvantitativno.
Risk characterisation
Strategije obvladovanja tveganja
The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi quantitative estimation of the risk.
Kadar se ugotovijo tveganja, ki na podlagi njihove opredelitve zahtevajo ukrepe za njihovo obvladovanje, se predlaga strategija obvladovanja tveganja.
Where a quantitative or semi quantitative estimation is not possible, a qualitative estimation of the risk shall be provided.
Strategije obvladovanja tveganja se opišejo v smislu zmanjševanja nevarnosti ali izpostavljenosti ali obeh in so sorazmerne s predvidenim zmanjšanjem tveganja, obsegom in pogoji sproščanja ter ravnmi negotovosti iz OTO.
In that case, a categorical description (“high”, “moderate”, “low” or “negligible”) of the risk shall be used and an explanation of the scale of effect represented by each category shall be provided.
Posledično zmanjšanje tveganja se količinsko opredeli, kadar je to mogoče.
Where relevant, the uncertainty for each identified risk shall be described and, where possible, expressed in quantitative terms.
Ocena tveganja in zaključki
Risk management strategies
Pri kvalitativni in, če je možno, kvantitativni oceni tveganja GSO se upoštevajo rezultati opredelitve tveganja, predlagane strategije obvladovanja tveganja in zadevne ravni negotovosti.
Where risks are identified that require, on the basis of their characterisation, measures to manage them, a risk management strategy shall be proposed.
Ocena tveganja vključuje, kadar je ustrezno, predlagane strategije obvladovanja tveganja za vsako ugotovljeno tveganje.