natgillin/translations-raw huggingface dataset:
In cases where the compound has been safely consumed in food, the intake levels of consumers from a conventional diet shall be considered as safe.
Ko je poraba snovi v živilih varna, se ravni vnosa pri porabnikih s konvencionalno prehrano štejejo za varne.
The applicant shall evaluate the information on the effects of processing on the new compounds.
Vlagatelj oceni informacije o učinkih predelave na nove snovi.
Potential accumulation/depletion in food and feed products entering the human or animal diet shall be considered.
Upošteva se morebitno kopičenje/osiromašenje v živilskih in krmnih proizvodih, ki vstopajo v prehrano ljudi in živali.
The applicant shall also evaluate the relevance of differences resulting from chemical reactions known to occur under processing conditions.
Vlagatelj oceni tudi pomembnost razlik, ki so rezultat kemijskih reakcij, za katere je znano, da se pojavljajo v pogojih predelave.
In cases where more complex genetic modifications are produced, for example, via transfer of multiple genes in a single construct, retransformation of pre-existing genetically modified lines, and stacking of transformation events through conventional breeding of genetically modified parents, the applicant shall discuss strategies for the assessment of any risk(s) associated with possible interactions between the newly expressed proteins, new metabolites and original plant constituents.
Ko nastane več sestavljenih genskih sprememb, na primer s prenosom več genov v enotni gradnik, s ponovno transformacijo obstoječih gensko spremenjenih linij in z nalaganjem transformacijskih dogodkov pri konvencionalni pridelavi gensko spremenjenih staršev, vlagatelj razpravlja o strategijah za oceno vsakega tveganja, povezanega z morebitnim medsebojnim učinkovanjem med novoizraženimi beljakovinami, novimi metaboliti in sestavinami izvirne rastline.
The assessment shall take into account all available information including the mode of action of the newly expressed proteins, the molecular and compositional/agronomical characteristics of the genetically modified plant, and the outcome of animal toxicity studies and feeding trials.
Pri oceni se upoštevajo vse razpoložljive informacije, vključno z obliko dejavnosti novoizraženih beljakovin, molekularnih in agronomskih značilnosti ali značilnosti sestave spremenjene rastline ter rezultata študij o toksičnosti na živalih ter poskusov krmljenja.
The applicant shall evaluate data obtained to assess the allergenic potential of newly expressed proteins in genetically modified plants with respect to introduction of new allergenic proteins into the food and feed plants, a possible provocation of allergic reactions of susceptible individuals, as well as information to demonstrate that the genetic modification does not cause unintended changes in the characteristics and/or levels of expression of endogenous allergenic proteins in the genetically modified food.
Vlagatelj oceni pridobljene podatke za presojo potenciala alergenosti novoizraženih beljakovin v gensko spremenjenih rastlinah, možnosti, da se z uvedbo novih alergenih beljakovin v živilske in krmne rastline sprožijo alergične reakcije pri občutljivih posameznikih, pa tudi informacij za dokazovanje, da genska sprememba ne povzroča nenamernih sprememb značilnosti in/ali ravni izražanja endogenih alergenih beljakovin v gensko spremenjenem živilu.
In particular, the choice of the test models shall be justified with respect to specificity, predictability and validation status.
Utemelji se zlasti izbira modelov testiranja glede na specifičnost, predvidljivost in status validacije.
With respect to intake estimations of genetically modified foods, the applicant shall evaluate the applied methodologies with respect to uncertainties associated with the prediction of long-term intake.
Ob upoštevanju ocenjenega vnosa gensko spremenjenih živil vlagatelj oceni uporabljene metodologije glede na negotovosti, povezane z napovedjo dolgoročnega vnosa.
Specific attention shall be paid to those genetically modified plants which are aimed at modifying nutritional characteristics of the food and feed.
Posebna pozornost se posveti tistim gensko spremenjenim rastlinam, ki so usmerjene v spremembo hranilne sestave živil in krme.
For those genetically modified products, the requirement for post-market monitoring shall be discussed as a mechanism for determining actual changes to overall dietary intake patterns of the genetically modified food, to what extent this has occurred and whether or not the product induces known (side) effects or unexpected side effects.
Pri navedenih gensko spremenjenih proizvodih se razpravlja o spremljanju po dajanju na trg, o zahtevi po mehanizmu za določanje dejanskih sprememb na celotni prehranski vzorec uživanja gensko spremenjenih živil, o obsegu, v katerem se to pojavlja, ter ali proizvod povzroča znane (stranske) učinke ali nepričakovane stranske učinke.
If the performance of post-market monitoring is deemed necessary, the reliability, sensitivity and specificity of the proposed methods shall be provided.
Če je izvedba spremljanja po dajanju na trg potrebna, se zagotovi zanesljivost, občutljivost in specifičnost predlaganih metod.
The result of risk characterisation
3.3 Rezultat opredelitve tveganja
In accordance with the requirements of Articles 4 and 16 of Regulation (EC) No 1829/2003, the applicant shall ensure that the final risk characterisation clearly demonstrates that:
V skladu z zahtevami iz členov 4 in 16 Uredbe (ES) št. 1829/2003 vlagatelj zagotovi, da opredelitev tveganja jasno dokaže, da:
the genetically modified food and feed has no adverse effects on human and animal health;
gensko spremenjeno živilo in krma nimata škodljivih učinkov na zdravje ljudi in živali;
the genetically modified food does not differ from the food which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer;
gensko spremenjeno živilo ni tako različno od živila, ki naj bi ga nadomestilo, da bi bila njegova običajna poraba glede hranilne vrednosti neugodna za potrošnika;
the genetically modified food does not mislead the consumer;
gensko spremenjeno živilo ne zavaja potrošnika;
the genetically modified feed does not harm or mislead the consumer by impairing the distinctive features of the animal products;
gensko spremenjena krma ne povzroča škode rejcu in ga ne zavaja s poslabšanjem posebnih značilnosti živalskih proizvodov;
the genetically modified feed does not differ from the feed which it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for animals or humans.
gensko spremenjena krma ni tako različna od krme, ki naj bi jo nadomestila, da bi bilo njeno normalno zaužitje glede hranilne vrednosti neugodno za živali ali ljudi.
The applicant shall clearly indicate what assumptions have been made during the risk assessment in order to predict the probability of occurrence and severity of adverse effect(s) in a given population, and the nature and magnitude of uncertainties associated with establishing these risks.
Vlagatelj jasno navede, katere predpostavke so bile uporabljene pri ocenjevanju tveganja, da bi napovedali verjetnost pojava in resnost škodljivih učinkov v dani populaciji ter naravo in razsežnost negotovosti, povezanih z ugotavljanjem teh tveganj.
The applicant shall also include detailed information justifying the inclusion or not of a proposal for labelling in the application, in accordance with Article 13(2)(a), Article 13(3), Article 25(2)(c) and Article 25(3) of Regulation (EC) No 1829/2003.
Vlagatelj vključi tudi podrobne informacije, ki utemeljujejo predlog, da se označevanje vključi v vlogo v skladu s členom 13(2)(a) in (3) in členom 25(2)(c) in (3) Uredbe (ES) št. 1829/2003.
VALIDATION OF METHODS FOR THE DETECTION, IDENTIFICATION AND QUANTIFICATION OF THE TRANSFORMATION EVENT, AND REQUIREMENTS FOR CONTROL SAMPLES AND THE CERTIFIED REFERENCE MATERIAL
VALIDACIJA METOD ZA ODKRIVANJE, IDENTIFIKACIJO IN KVantifiKAciJo TRANSFORMACIJSKEGA DOGODKA ter ZAHTEVE ZA KONTROLNE VZORCE IN CERTIFICIRANI REFERENČNI MATERIAL
For the purposes of implementing Article 5(3)(i) and (j) and Article 17(3)(i) and (j) of Regulation (EC) No 1829/2003, this Annex sets out requirements on:
Za izvajanje člena 5(3)(i) in (j) ter člena 17(3)(i) in (j) Uredbe (ES) št. 1829/2003 so v tej prilogi določene zahteve za:
the performance characteristics of the submitted method(s);
značilnosti zmogljivosti predloženih metod;
technical requirements regarding the type of information that the applicant must submit so as to verify that those requirements are met;
tehnične zahteve glede vrste informacij, ki jih mora vlagatelj predložiti, da se preveri, ali so izpolnjene te zahteve;
samples of the food and feed and their control samples;
vzorce živil in krme ter njihove kontrolne vzorce;
certified reference material.
certificirani referenčni material.
The applicant must include information on the method as such and on the method testing carried out by the applicant.
Vlagatelj mora vključiti informacije o metodi kot taki in o testiranju metode, ki ga je opravil vlagatelj.
The applicant shall also consider further guidance and information about the operational procedures of the validation process that is made available by the EU Reference Laboratory (EURL) as referred to in Article 32 of Regulation (EC) No 1829/2003, assisted by the European Network of GMO Laboratories [1].
Vlagatelj upošteva tudi nadaljnja navodila in informacije o operativnih postopkih validacijskega procesa, ki ga je dal na voljo referenčni laboratorij EU (EURL) iz člena 32 Uredbe (ES) št. 1829/2003 ob pomoči Evropske mreže laboratorijev za določanje GSO [1].
‘certified reference material’ means reference material as referred to in Articles 5(3)(j) and 17(3)(j) of Regulation (EC) No 1829/2003 and corresponds to any material or substance, one or more of whose property values are certified for calibration or quality control of methods.
„certificirani referenčni material“ pomeni referenčni material iz člena 5(3)(j) in člena 17(3)(j) Uredbe (ES) št. 1829/2003 in ustreza vsakemu materialu ali snovi, pri katerem je ena ali več vrednosti lastnosti potrjena za kalibracijo ali nadzor kakovosti metod.
It is accompanied by a certificate that provides value of the specified property, its associated uncertainty and a statement of metrological traceability;
Priloženo je potrdilo, ki določa vrednost navedene lastnosti, povezano negotovost in izjavo o meroslovni sledljivosti;
‘method performance requirements’ means the minimum performance criteria that the method shall demonstrate upon completion of the validation study carried out by the EURL, according to internationally accepted technical provisions.
„zahteve za izvajanje metode“ pomenijo minimalna izvedbena merila, ki naj bi jih metoda dokazala po končani validacijski študiji, izvedeni pri EURL v skladu z mednarodno sprejetimi tehničnimi predpisi.
METHOD VALIDATION
VALIDACIJA METODE
Information about the method
3.1 Informacije o metodi
A. The method(s) shall refer to all the methodological steps needed to analyse the relevant food and feed material in accordance with Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003.
A. Metoda zajema vse metodološke faze, ki so potrebne za analizo ustreznega živilskega in krmnega materiala v skladu s členom 5(3)(i) in členom 17(3)(i) Uredbe (ES) št. 1829/2003.
For a particular food or feed material, the methodological steps shall include the methods for DNA extraction and the subsequent quantification in a real-time Polymerase Chain Reaction (PCR) System.
Metodološke faze za posamezen živilski ali krmni material vključujejo metode za ekstrakcijo DNK in poznejšo količinsko opredelitev v dejanskem času v sistemu verižne reakcije s polimerazo (PCR).
In such a case, the whole process from extraction up to the PCR-technique shall constitute a method.
V tem primeru predstavlja metodo celotni postopek od ekstrakcije do tehnike PCR.
The applicant shall provide information about the whole method.
Vlagatelj predloži informacije o celotni metodi.
B. The applicant shall be allowed to refer to validated protocols, if available and appropriate, for method modules used in the analytical procedure such as a DNA extraction protocol from a certain matrix.
B. Vlagatelj se lahko sklicuje na validirane protokole, če so na voljo in primerni za module metod, uporabljene v analitičnem postopku, kot je protokol ekstrakcije DNK iz določene matrice.
In that case, the applicant shall provide experimental data from an in-house validation in which the method module has been successfully applied in the context of the application for authorisation.
V tem primeru vlagatelj posreduje podatke o poskusu iz interne validacije, pri kateri je bil modul metode uspešno uporabljen v vlogi za odobritev.
C. The applicant shall demonstrate that the method(s) fulfils the following requirements:
C. Vlagatelj dokaže, da metoda izpolnjuje naslednje zahteve:
The method(s) shall be specific to the transformation event (hereafter referred to as ‘event-specific’) and thus shall only be functional with the genetically modified organism or genetically modified based product considered and shall not be functional if applied to other transformation events already authorised; otherwise the method cannot be applied for unequivocal detection/identification/quantification.
1. metode so specifične za transformacijski dogodek (v nadaljnjem besedilu: za dogodek specifične), zato delujejo samo s tistim gensko spremenjenim organizmom ali proizvodom, ki temelji na gensko spremenjenem organizmu, ki se dokazuje, ne deluje pa, če se uporablja pri drugih, že odobrenih transformacijskih dogodkih; drugače se metoda ne bi mogla uporabljati za nedvoumno odkrivanje/identifikacijo/kvantifikacijo.
This shall be demonstrated with a selection of non-target transgenic authorised transformation events and conventional counterparts.
To se dokaže z izbiro neciljnih transgenih odobrenih transformacijskih dogodkov in podobnih konvencionalnih vrst.
This testing shall include closely related transformation events.
To testiranje vključuje tesno povezane transformacijske dogodke;
The method(s) shall be applicable to samples of the food or feed, to the control samples and to the certified reference material.
2. metode se uporabljajo za vzorce živil ali krme, za kontrolne vzorce in za certificirani referenčni material;
The applicant shall take into consideration the following documents for the development of the detection method:
3. pri razvoju metode odkrivanja vlagatelj upošteva naslednje dokumente:
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — General requirements and definitions: ISO 24276;
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Splošne zahteve in definicije: ISO 24276;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction: ISO 21571;
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Izolacija nukleinskih kislin: ISO 21571;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Quantitative nucleic acid based methods: ISO 21570;
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Kvantitativne metode na osnovi nukleinske kisline: ISO 21570;
Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Qualitative nucleic acid based methods: draft European standard ISO 21569.
Živila – Analitske metode za odkrivanje gensko spremenjenih organizmov in njihovih produktov – Kvalitativne metode na osnovi nukleinske kisline: osnutek evropskega standarda ISO 21569;
D. For the purpose of implementing Articles 5(3)(i) and 17(3)(i) of Regulation (EC) No 1829/2003, the applicant shall provide the event-specific quantitative detection method(s) of the genetically modified material.
D. Za izvajanje člena 5(3)(i) in člena 17(3)(i) Uredbe (ES) št. 1829/2003 vlagatelj zagotovi za dogodek specifične kvantitativne metode odkrivanja gensko spremenjenega materiala.
The applicant shall discuss the validity and limitations of the detection methods in the various types of foods and feeds (the various matrixes) that are expected to be placed on the market.
Vlagatelj razpravlja o veljavnosti in omejitvah metod odkrivanja v različnih vrstah živil in krme (v različnih matricah), za katere se pričakuje, da bodo dani na trg.
E. The applicant shall provide a complete and detailed description of the method.
E. Vlagatelj predloži popoln in podroben opis metode.
The following points shall be clearly addressed by the applicant:
Vlagatelj podrobno obravnava naslednje točke:
Scientific basis: the applicant shall provide an overview of the principles of how the method works.
1. znanstvena osnova: vlagatelj predloži pregled načel, po katerih metoda deluje.
This overview shall include references to relevant scientific publications.
Ta pregled vključuje sklicevanja na ustrezne znanstvene publikacije;
Scope of the method: the applicant shall indicate the matrix(es) (for example, processed food, raw materials), the type of samples and the percentage range to which the method may be applied.
2. področje uporabe metode: vlagatelj navede matrice (npr. predelana živila, surovine), vrsto vzorcev in območje odstotkov, v katerem se metoda lahko uporablja;
Operational characteristics of the method: the required equipment for the application of the method shall be specified, with regard to the analysis as such and the sample preparation.
3. operativne značilnosti metode: navede se zahtevana oprema za uporabo metode za analizo kot tako in za pripravo vzorca.
Further information of any specific aspects crucial for the application of the method shall also be included.
Navedejo se tudi dodatne informacije o kakršnem koli posebnem vidiku, ki je bistven za uporabo metode;
Protocol: the applicant shall provide a complete optimised protocol of the method.
4. protokol: vlagatelj predloži popoln, optimiziran protokol metode.
The protocol shall present all the details as required to transfer and apply the method independently in other laboratories.
V protokolu se prikažejo vse zahtevane podrobnosti za prenos in samostojno uporabo metode v drugih laboratorijih;
A prediction model (or a similar tool) needed to interpret results and to make inferences shall be described in full details.
5. podrobno se opiše napovedni model (ali podobno orodje), ki je potreben za razlago rezultatov in medsebojna sklicevanja.
Instructions for the correct application of the model shall be provided by the applicant.
Predložijo se navodila za pravilno uporabo modela;
Breeding schemes that are to be applied for the production of genetically modified food and feed and their impact on the interpretation of results shall be provided by the applicant.
6. vlagatelj predloži sheme pridelave, ki se bodo uporabljale za proizvodnjo gensko spremenjenih živil in krme, in njihov vpliv na razlago rezultatov.
Information about the method testing carried out by the applicant
3.2 Informacije o testiranju metode, ki ga je opravil vlagatelj
A. The applicant shall provide all the available and relevant data of the method optimisation and testing carried out.
A. Vlagatelj predloži vse razpoložljive in relevantne podatke, ki so na voljo v zvezi z optimizacijo metode in opravljenim testiranjem.
These data and results shall be presented, where possible and appropriate, by using the performance parameters as referred to under point 3.1.C.4.
Ti podatki in rezultati se prikažejo, kadar je mogoče in primerno, s pomočjo parametrov izvajanja, ki so navedeni v točki 3.1.C.4.
The applicant shall also provide a summary of the testing carried out and the main results as well as all the data including the outliers.
Vlagatelj predloži povzetek opravljenega testiranja in glavne rezultate ter podatke, vključno z vrednostmi zunaj območja.
B. The applicant shall ensure that the provided information demonstrates the robustness of the method for inter-laboratory transferability.
B. Vlagatelj zagotovi, da posredovane informacije dokazujejo robustnost metode za medlaboratorijsko prenosljivost.
For this purpose, the applicant shall provide the results of the testing of the method by at least one laboratory that is different from the laboratory which has developed the method.
V ta namen predloži rezultate testiranja metode najmanj enega laboratorija poleg tistega, ki je razvil metodo.
C. The applicant shall provide the following information about the method development and the method optimisation:
C. Vlagatelj predloži naslednje informacije o razvoju in optimizaciji metode:
primer pairs tested and probe, if appropriate, including a justification as to how and why the proposed primer pair has been selected;
1. testirani pari primerjev in, če je primerno, sonde, vključno z utemeljitvijo, kako so bili predlagani pari primerjev izbrani in zakaj;
stability testing, which shall be established through the submission of experimental results from testing the method with different plant varieties;
2. testiranje stabilnosti, ki se dokaže s predložitvijo rezultatov poskusa iz testiranja metode z različnimi rastlinskimi sortami;
specificity, which shall be established through the submission of the full sequence of the insert(s) in a standardised electronic format, together with the base pairs of the host flanking sequences so as to enable the EURL to assess the specificity of the proposed method by running homology searches in a molecular database;
3. specifičnost, ki se dokaže s predložitvijo popolnega zaporedja vključkov v standardizirani elektronski obliki, skupaj z osnovnimi pari gostiteljevih sosednjih zaporedij, ki omogoča EURL, da oceni specifičnost predlagane metode z izvedbo iskanja homologije v molekularni podatkovni zbirki;
precision, the relative repeatability standard deviation shall be less than or equal to 25 % related to mass fraction over the whole dynamic range of the method.
4. natančnost, relativni standardni odklon ponovljivosti naj bo manjši ali enak 25 mas. % v celotnem dinamičnem obsegu metode.
D. The applicant shall, in addition to the information required under Sections A, B and C provide the following information regarding the testing:
D. Vlagatelj poleg informacij, ki se zahtevajo v oddelkih A, B in C, predloži še naslednje informacije o testiranju:
participating laboratories, time of the analysis and outline of the experimental design, including the details about the number of runs, samples, replicates, etc.;
1. sodelujoči laboratoriji, čas analize in pregled načrta poskusa, vključno s podrobnostmi o številu nizov, vzorcev, ponovitev itd.;
description of the laboratory samples (such as size, quality, date of sampling), positive and negative controls as well as certified reference material, plasmids and alike used;
2. opis laboratorijskih vzorcev (npr. velikost, kakovost, datum vzorčenja), kontrol s pozitivnimi in negativnimi rezultati ter uporabljenega certificiranega referenčnega materiala, plazmidov in podobnega;
description of the approaches that have been used to analyse the test results and outliers;
3. opis pristopov, ki so se uporabljali za analizo rezultatov testa in vrednosti zunaj območja;
any particular points observed during the testing;
4. vse posebne točke, opažene med testiranjem;
references to relevant literature or technical provisions used in the testing.
5. sklicevanja na ustrezno literaturo ali tehnične predpise, uporabljene pri testiranju.
Samples of the food and feed and their control samples
3.3 Vzorci živil in krme ter kontrolni vzorci živil in krme