natgillin/translations-raw huggingface dataset:
Regulation (EC) No 1830/2003 of the European Parliament and of the Council, of 22 September 2003, concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [1] sets up a system for the transmission and retention of information between operators at each stage of the placing on the market of products containing or consisting of genetically modified organisms, hereinafter ‘GMOs’, or food and feed products produced from GMOs, but does not require operators to sample and test products at each stage of the placing of the market for presence of GMOs or material produced from GMOs.
Uredba Evropskega parlamenta in Sveta (ES) št. 1830/2003 z dne 22. septembra 2003 o sledljivosti in označevanju gensko spremenjenih organizmov ter sledljivosti živil in krme, proizvedenih iz gensko spremenjenih organizmov, ter o spremembi Direktive 2001/18/ES [1] vzpostavlja sistem za posredovanje in shranjevanje informacij med nosilci dejavnosti v vsaki fazi dajanja v promet proizvodov, ki vsebujejo ali so sestavljeni iz gensko spremenjenih organizmov, v nadaljnjem besedilu „GSO“, ali o živilih in krmi, proizvedenih iz GSO, pri čemer se od nosilcev dejavnosti ne zahteva, da v vsaki fazi dajanja v promet vzorčijo in preskusijo proizvode ali materiale, proizvedene iz GSO, zaradi ugotavljanja prisotnosti GSO.
According to Article 9(1) of Regulation (EC) No 1830/2003, Member States are, however, required to ensure that inspections and other control measures including sample checks and testing (qualitative and quantitative), as appropriate, are carried out to ensure compliance with that Regulation.
V skladu s členom 9(1) Uredbe (ES) št. 1830/2003 pa se od držav članic zahteva, da zagotovijo izvedbo inšpekcij in drugih kontrolnih ukrepov, vključno s preverjanjem in analizo vzorcev (kvalitativno in kvantitativno), kakor je primerno, da se zagotovi skladnost z navedeno uredbo.
In order to facilitate a coordinated approach for those inspections and control measures, Article 9(2) of Regulation (EC) No 1830/2003 requires that technical guidance on sampling and testing for GMOs and food and feed material produced from GMOs in products should be established.
Z namenom olajšati usklajen pristop k izvajanju teh inšpekcij in kontrolnih ukrepov, člen 9(2) Uredbe (ES) št. 1830/2003 zahteva uvedbo tehničnih navodil za vzorčenje in preskušanje GSO ter živil in krme, proizvedenih iz GSO, v obliki proizvodov.
This guidance should cover products that have received authorisations for their placing on the market but is without prejudice to Article 4(5) of Directive 2001/18/EC of the European Parliament and of the Council [2] with regard to GMOs which are not authorised in the European Union.
Ta navodila naj zajamejo proizvode, ki so pridobili dovoljenje za dajanje v promet, pri čemer naj navodila ne posegajo v člen 4(5) Direktive Evropskega parlamenta in Sveta 2001/18/ES [2] v zvezi z GSO, ki niso dovoljeni v Evropski uniji.
The sampling and detection should be carried out using sound scientific and statistical protocols in order to achieve an appropriate level of confidence for detection of GMOs or material produced from GMOs.
Vzorčenje in odkrivanje naj se izvajata z uporabo ustreznih znanstvenih in statističnih protokolov zaradi doseganja ustrezne stopnje zanesljivosti pri odkrivanju GSO ali materiala, proizvedenega iz GSO.
In developing the guidance, the Committee set up by Article 30 of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC has been consulted, and account has been taken of the work of the national competent authorities, the Standing Committee on the Food Chain and Animal Health and the Community Reference Laboratory.
Med pripravo navodil je bilo izvedeno posvetovanje z Odborom, ustanovljenim s členom 30 Direktive 2001/18/ES, upoštevano pa je bilo tudi delo pristojnih nacionalnih organov, Stalnega odbora za prehransko verigo in zdravstveno varstvo živali in Referenčnega laboratorija Skupnosti.
Where lots of non-GM seed or other plant propagating material are required to comply with standards on adventitious or technically unavoidable presence of genetically modified seeds or other plant propagating material, a legally-binding protocol on sampling and testing for the presence of genetically modified seeds or other plant propagating material should be developed in the context of the specific legislation on seeds and other plant propagating material; whereby the elements provided in that protocol should also serve as a basis for sampling and testing of other GM crop species not covered by the abovementioned legislation, where appropriate,
Če obstaja zahteva, da serije gensko nespremenjenega semena ali drugega rastlinskega sadilnega materiala izpolnjujejo standarde o naključni ali tehnično neizogibni prisotnosti gensko spremenjenih semen ali drugega rastlinskega sadilnega materiala, se naj pripravi pravno zavezujoč protokol o vzorčenju in preskušanju za ugotavljanje prisotnosti gensko spremenjenih semen ali drugega rastlinskega sadilnega materiala v okviru področne zakonodaje o semenih in o drugem rastlinskem sadilnem materialu; ob upoštevanju, da naj elementi, določeni v tem protokolu, po potrebi služijo kot podlaga za vzorčenje in preskušanje drugih gensko spremenjenih vrst pridelkov, ki niso zajeti v zgoraj navedeni zakonodaji –
For the purpose of fulfilling the requirements set out in Article 9(1) of Regulation (EC) No 1830/2003, Member States should take account of:
Za namene izpolnjevanja zahtev iz člena 9(1) Uredbe (ES) št. 1830/2003 naj države članice upoštevajo:
the past record of operators with respect to compliance with relevant legislation;
preteklo evidenco nosilcev dejavnosti glede izvajanja zadevnih zakonskih predpisov;
the reliability of any controls that operators have already carried out;
zanesljivost nadzorov, ki so jih nosilci dejavnosti že izvedli;
situations where non-compliance is suspected;
okoliščine, v katerih obstaja sum o kršitvah;
using means proportionate to the desired specific objectives and particularly in the light of experience gained;
uporabo sredstev, sorazmernih z želenimi konkretnimi cilji, zlasti glede na pridobljene izkušnje;
the degree of heterogeneity and the point in the supply chain at which testing is being undertaken.
stopnjo heterogenosti in točko v prehranski verigi, na kateri je bilo izvedeno preskušanje.
Official controls should be carried out without prior warning, except in cases where prior notification of an operator is necessary.
Uradni nadzori naj se izvajajo brez predhodnega opozorila, razen v primerih, kjer je nujno predhodno obvestiti nosilca dejavnosti.
Official controls should be carried out at any stage of the production, processing, and storage, distribution of products that contain or may contain GMOs or food and feed produced from GMOs, including at the point of import [3].
Uradni nadzori naj se izvajajo v vseh fazah proizvodnje, predelave in shranjevanja ter razdeljevanja proizvodov, ki vsebujejo ali bi lahko vsebovali GSO, ali živil in krme, proizvedenih iz GSO, vključno z nadzori ob uvozu [3].
Official controls should not differentiate between products intended for export outside the Community and products intended for placing on the market within the Community.
Uradni nadzor naj se ne razlikuje za proizvode, ki so namenjeni za izvoz izven Skupnosti, in za proizvode, ki so namenjeni za dajanje v promet v Skupnosti.
Operators whose products are subject to sampling and analysis should be entitled to appeal for a second opinion.
Nosilci dejavnosti, katerih proizvodi morajo iti skozi vzorčenje in analizo, naj bodo upravičeni do pritožbe za pridobitev drugega mnenja.
Official bodies should collect a sufficient number of counter samples for enforcement and referee purposes in order to guarantee operators appeal right and have a second opinion, as required by national legislation.
Uradni organi naj zberejo zadostno število nasprotnih vzorcev za namene preverjanja in presoje, da nosilcem dejavnosti zagotovijo pravico do pritožbe in drugega mnenja, v skladu z nacionalno zakonodajo.
Alternative sampling strategies to those recommended in this guidance may be applied.
Lahko se uporabijo tudi strategije vzorčenja, drugačne od tistih, ki so priporočene v teh navodilih.
Alternative testing strategies to those recommended in this guidance may be applied provided such methods are approved by the Community Reference Laboratory established under Regulation (EC) 1829/2003.
Lahko se uporabijo tudi strategije preskušanja, drugačne od tistih, ki so priporočene v teh navodilih pod pogojem, da jih odobri Referenčni laboratorij Skupnosti, ustanovljen z Uredbo (ES) št. 1829/2003.
Without prejudice to specific requirements laid down in EU legislation concerning food, feed and other controls, and in particular Directive 95/53/EC fixing the principles governing the organisation of official inspections in the field of animal nutrition, Directive 70/373/EEC on the introduction of Community methods of sampling and analysis for the official control of feeding stuffs, Directive 89/397/EEC on the official controls of foodstuffs and Directive 93/99/EEC on the subject of additional measures concerning the official control on foodstuffs, Member States should ensure that official controls are carried out, so as to achieve the objectives of Regulation (EC) No 1830/2003.
Ne glede na posebne zahteve, določene v zakonodaji EU o nadzoru živil, krme in o drugih nadzorih, zlasti v Direktivi 95/53/ES o določitvi načel izvajanja uradnega nadzora na področju prehrane živali, Direktivi 70/373/EGS o uvedbi metod vzorčenja in analiz Skupnosti za uradni nadzor krme, Direktivi 89/397/EGS o uradnem nadzoru živil in Direktivi 93/99/EGS o dodatnih ukrepih v zvezi z uradnim nadzorom živil, bi morale države članice zagotoviti izvajanje uradnih nadzorov za doseganje ciljev iz Uredbe (ES) št. 1830/2003.
DEFINITIONS
OPREDELITVE
Lot is defined as a distinct and specified quantity of material.
Serija je opredeljena kot razločljiva in določena količina materiala.
The following definitions take account of the type of material forming a lot and are in line with ISTA, ISO standards 6644 and 13690 and FAO (International Standards for Phytosanitary Measures):
Spodnje opredelitve upoštevajo vrsto materiala, ki sestavlja serijo, in so v skladu z ISTA, standardoma ISO 6644 in 13690 in FAO (Mednarodni standardi za fitosanitarne ukrepe):
seed lot: a specified quantity of seed, physically identifiable and uniform, not exceeding the maximum lot size as defined in the seeds Directives and forming the total or a part of a consignment;
Serija semen določena količina semen, fizično prepoznavna in enovita, ki ne presega največje velikosti serije, opredeljene v direktivah o semenih, in tvori celotno pošiljko ali del pošiljke.
other plant propagating material lot: a number of units of a single commodity identifiable by its homogeneity of composition, origin etc., not exceeding the maximum lot size as defined in the legislation on other plant propagating material, and forming the total or a part of a consignment;
Serija drugega rastlinskega sadilnega materiala število enot enega samega proizvoda, prepoznavnega po homogenosti sestave, poreklu itn., ki ne presega največje velikosti serije, opredeljene v zakonodaji o drugem rastlinskem sadilnem materialu, in tvori celotno pošiljko ali del pošiljke.
food and feed products lot: quantity of product dispatched or received at one time and covered by a particular contract or shipping document.
Serija živil in krme količina poslanih ali prejetih proizvodov, zajetih v posebni pogodbi ali odpremni listini.
Increment sample: small equal quantity of product taken from each individual sampling point in the lot through the full depth of the lot (static sampling), or taken from the product stream during a stated portion of time (flowing commodities sampling).
Posamični vzorec: majhna količina proizvoda, odvzeta iz vsake posamezne točke vzorčenja v seriji skozi celotno sestavo serije (statično vzorčenje), ali iz pretoka proizvoda v določenem časovnem obdobju (pretočno vzorčenje proizvoda).
File increment sample: an increment sample that is retained for a specific period of time for further analysis.
Posamični vzorec za shrambo: posamični vzorec, ki se shrani za določeno časovno obdobje za nadaljnjo analizo.
Bulk sample: quantity of product obtained by combining and mixing the increments taken from a specific lot.
Zbirni vzorec: količina proizvoda, pridobljena z združevanjem in mešanjem posamičnih vzorcev iz določene serije.
Laboratory sample: quantity of product taken from the bulk sample intended for laboratory inspection and testing.
Laboratorijski vzorec: količina proizvoda, odvzeta iz zbirnega vzorca, namenjena laboratorijskemu pregledu in preskušanju.
Analytical sample: homogenised laboratory sample, consisting either of the whole laboratory sample or a representative portion thereof.
Analitski vzorec: homogenizirani laboratorijski vzorec, sestavljen bodisi iz celotnega laboratorijskega vzorca ali iz reprezentativnega deleža homogeniziranega laboratorijskega vzorca.
Counter sample: a sample retained for a specific period of time for enforcement or referee purposes.
Nasprotni vzorec: vzorec, ki se shrani za določeno časovno obdobje za namene preverjanja in presoje.
Percentage of GM DNA: the percentage of GM-DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes.
Odstotek gensko spremenjene DNK: odstotek števila kopij gensko spremenjene DNK glede na ciljno taksonomsko specifično število kopij DNK, izračunano v obliki haploidnih genomov.
PRINCIPLES FOR SAMPLING PROTOCOLS
NAČELA ZA PROTOKOLE VZORČENJA
Member States should take account of the guidance on sampling protocols for products consisting of, containing or produced from GMOs when inspecting and controlling whether operators are complying with Articles 4 and 5 of Regulation (EC) No 1830/2003.
Države članice naj upoštevajo navodila za protokole vzorčenja za proizvode, ki so sestavljeni iz GSO, vsebujejo GSO ali so proizvedeni iz GSO, ko preverjajo ali kontrolirajo, ali nosilci dejavnosti ravnajo v skladu s členoma 4 in 5 Uredbe (ES) št. 1830/2003.
The Community Reference Laboratory established under Regulation (EC) No 1829/2003, and the nationally designated laboratories to the European Network of GMO Laboratories, hereinafter ‘ENGL’, will provide further guidance and assistance on the methods of sampling falling within the scope of this Recommendation.
Referenčni laboratorij Skupnosti, ustanovljen z Uredbo (ES) št. 1829/2003, in nacionalni pooblaščeni laboratoriji v okviru Evropskega omrežja laboratorijev za GSO, v nadaljnjem besedilu „ENGL“, bodo zagotovili nadaljnja navodila in pomoč v zvezi z metodami vzorčenja, ki spadajo v področje uporabe tega priporočila.
Harmonised sampling procedures should be utilised for the purpose of estimating the presence of GMOs.
Za namene ocenjevanja prisotnosti GSO se naj uporabljajo usklajeni postopki vzorčenja.
These procedures should apply to seed and other plant propagating material, food, feed and agricultural commodity lots.
Ti postopki se naj uporabljajo za semena in drugi rastlinski sadilni material, živila, krmo in serije kmetijskih proizvodov.
The following sampling procedures are defined in order to ensure that the samples collected and analysed are representative of the different types of commodities under investigation.
Opredeljeni so naslednji postopki vzorčenja zaradi zagotavljanja, da so zbrani in analizirani vzorci reprezentativni za različne vrste zadevnih proizvodov.
Whereas sampling protocols for the presence of GM seeds and other plant propagating material in seed lots should be developed according to the specific legislation on seeds or other propagating material, sampling strategies for bulk commodities and food and feed products are addressed in separate sections that take into account commodity-specific properties.
Glede na to, da je treba razviti protokole vzorčenja za ugotavljanje prisotnosti gensko spremenjenega semena in drugega rastlinskega sadilnega materiala v serijah semen v skladu s področno zakonodajo o semenih in drugem sadilnem materialu, so strategije vzorčenja za razsute proizvode ter živila in krmo obravnavane v ločenih poglavjih, ki upoštevajo posebne značilnosti posameznih proizvodov.
SAMPLING PROTOCOLS
PROTOKOLI VZORČENJA
Sampling seed and other plant propagating material lots
Vzorčenje semena in serij drugega rastlinskega sadilnega materiala
This section deals with the detection of genetically modified seeds or other plant propagating material in lots of seed or other plant propagating material of non-GM varieties or clones and the detection of GM seeds or other plant propagating material arising from a transformation event other than that designated for a lot of seed or other plant propagating material of a GM variety or clone.
To poglavje obravnava odkrivanje gensko spremenjenega semena ali drugega rastlinskega materiala v serijah semena ali drugega rastlinskega sadilnega materiala gensko nespremenjenih sort ali klonov ter odkrivanje gensko spremenjenega semena ali drugega rastlinskega sadilnega materiala, ki izhaja iz preobrazbenega dogodka, ki ni določen za serijo semen ali serijo drugega rastlinskega sadilnega materiala gensko spremenjene sorte ali klona.
Samples should be drawn in accordance with current international methods and where appropriate from lot sizes as defined in Council Directives 66/401/EEC, 66/402/EEC, 68/193/EEC, 92/34/EEC, 98/56/EEC, 1999/105/EC, 2002/54/EC, 2002/55/EC, 2002/56/EC and 2002/57/EC.
Odvzem vzorcev naj poteka v skladu z veljavnimi mednarodnimi metodami, kjer je primerno pa naj se odvzemajo tudi iz velikosti serij, opredeljenih v direktivah Sveta 66/401/EGS, 66/402/EGS, 68/193/EGS, 92/34/EGS, 98/56/EGS, 1999/105/ES, 2002/54/ES, 2002/55/ES, 2002/56/ES in 2002/57/ES.
The general principles and methods of sampling of seeds and other plant propagating material should be in accordance with the International Seed Testing Association (ISTA) rules and the associated ISTA Handbook on Seed Sampling.
Splošna načela in metode vzorčenja semen in drugega rastlinskega sadilnega materiala naj bodo skladna s pravili Mednarodne organizacije za testiranje semena (ISTA) in zadevnim Priročnikom ISTA o vzorčenju semena.
The sampling and testing schemes to be used for seeds or other plant propagating material should meet the requirements indicated in the specific legislation on seeds and other propagating material as regards statistical risks.
Programi vzorčenja in preskušanja, ki se uporabljajo za semena in drugi rastlinski sadilni material, naj izpolnjujejo zahteve, navedene v področni zakonodaji, ki ureja semena in drug sadilni material, v zvezi s statističnimi tveganji.
Seed or other plant propagating material lot quality level and its associated statistical uncertainty are defined in relation to thresholds for GMOs and relate to the percentage of GM-DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes.
Stopnja kakovosti serij semen in drugega rastlinskega sadilnega materiala in povezana statistična negotovost sta opredeljeni glede na prage za GSO in sta povezani z odstotkom števila kopij gensko spremenjene DNK v zvezi s ciljnim taksonomskim specifičnim številom kopij DNK, izračunanim v obliki haploidnih genomov.
Sampling bulk agricultural commodities
Vzorčenje kmetijskih proizvodov v razsutem stanju
The sampling protocol is based on a two-step procedure that allows, if necessary, to obtain estimates of GMO presence levels, together with their associated uncertainty expressed as Standard Deviation (SD), without imposing any assumption on the possible heterogeneity of the GMOs.
Protokol vzorčenja temelji na dvostopenjskem postopku, ki po potrebi omogoča oceno ravni prisotnosti GSO, skupaj s povezano statistično negotovostjo, izraženo kot standardno odstopanje (SO), brez vsiljevanja vsakršnih predpostavk o morebitni heterogenosti GSO.
In order to allow the estimation of SD, in the first instance, a bulk sample should be produced and the derived analytical sample analysed for the presence of GM materials.
Za omogočanje ocene standardnega odstopanja je treba najprej pripraviti zbirni vzorec, pridobljeni analitski vzorec, pa se analizira, da se preveri prisotnost gensko spremenjenih materialov.
Where the obtained analytical result is close to the established threshold (± 50 % of its value), the analysis of the individual file increment samples is recommended to provide a measure of the associated uncertainty.
Če je rezultat analize blizu določenega praga (± 50 % vrednosti), je priporočeno, da se opravi analiza posamičnih vzorcev za shrambo, da se vzpostavi merilo povezane statistične negotovosti.
The following documents should be taken into account:
Upoštevajo naj se naslednje listine:
ISO standard 6644 (2002);
Standard ISO 6644 (2002);
ISO standard 13690 (1999);
Standard ISO 13690 (1999);
ISO standard 5725 (1994);
Standard ISO 5725 (1994);
ISO standard 2859 (1985);
Standard ISO 2859 (1985);
ISO standard 542 (1990).
Standard ISO 542 (1990).
Protocol for sampling lots of bulk agricultural commodities
Protokol vzorčenja serij kmetijskih proizvodov v razsutem stanju
It is recommended that sampling of bulk commodities (grains, oilseeds) takes place in accordance with the general principles and methods of sampling described in ISO standards 6644 and 13690.
Priporočeno je, da vzorčenje razsutih proizvodov (zrnje, semena oljnic) poteka v skladu s splošnimi načeli in metodami vzorčenja, ki so opisane v standardih ISO 6644 in 13690.
In case of flowing commodities, the sampling period should be defined, according to ISO standard 6644, as: total off-loading time/total number of increments.
V primeru naslednjih proizvodov je treba opredeliti obdobje vzorčenja v skladu s standardom ISO 6644 kot: skupni čas raztovarjanja/skupno število posamičnih vzorcev.
In case of static sampling, increments should be collected at specific sampling points.
V primeru statičnega vzorčenja naj se posamični vzorci odvzamejo na posebnih točkah vzorčenja.
Such sampling points should be uniformly distributed throughout the lot volume, according to the principles described in ISO 13690.
Take točke vzorčenja naj bodo enakomerno razporejene skozi celotno količino serije v skladu z načeli, opisanimi v standardu ISO 13690.
The number of increments or sampling points (where the increment samples for creating the bulk sample and the file increment samples are taken) is defined according to lot size, as follows:
Število posamičnih vzorcev ali točk vzorčenja (na katerih se odvzamejo posamični vzorci za pripravo zbirnega vzorca in posamičnih vzorcev za shrambo) se opredeli glede na velikost serije na naslednji način:
Lot size in tonnes
Velikost serije v tonah
Size of the bulk sample in kg
Velikost zbirnega vzorca v kg
Number of incremental samples
Število posamičnih vzorcev
In case of lots from 50 to 500 tonnes, the size of the bulk sample should be 0,01 % of the total lot size.
V primeru serij po 50 do 500 ton naj bo velikost zbirnega vzorca 0,01 % velikosti celotne serije.
In case of lots smaller than 50 tonnes, the size of the bulk sample should be 5 kg.
V primeru serij, ki so manjše od 50 ton naj bo velikost zbirnega vzorca 5 kg.
In case of lots larger than 500 tonnes, the size of the bulk sample should be 50 kg.
V primeru serij, večjih od 500 ton, naj bo velikost zbirnega vzorca 50 kg.
At each sampling interval (systematic sampling) or sampling point (static sampling) an increment of 1kg should be collected and split into two portions of 0,5 kg: one to be used as an increment for the production of the bulk sample, the other to be stored as a file increment sample.
Ob vsakem vzorčenju (sistematično vzorčenje) ali na vsaki točki vzorčenja (statično vzorčenje) se odvzame posamičen vzorec, velik 1 kg, in razdeli na dva dela po 0,5 kg; en se uporabi kot posamični vzorec za pripravo zbirnega vzorca, drugi pa se shrani kot posamični vzorec za shrambo.