natgillin/translations-raw huggingface dataset:
These methods should be based on recognised scientific and statistical protocols and, when available, on international standards and should cover the different steps of sampling, including the rules applicable to the sampling of the material, the precautions to be taken in the course of sampling and preparation of samples, the conditions to be applied for taking incremental samples and replicate laboratory samples, the handling of laboratory samples and the sealing and labelling of samples.
Te metode morajo temeljiti na priznanih znanstvenih in statističnih protokolih ter mednarodnih standardih, ko so na voljo, ter morajo zajemati različne faze vzorčenja, vključno s pravili, ki se uporabljajo za vzorčenje snovi, varnostne ukrepe, sprejete v času vzorčenja in priprave vzorcev, pogoje, ki se uporabljajo za jemanje posamičnih vzorcev in referenčnih laboratorijskih vzorcev, ravnanje z laboratorijskimi vzorci ter pečatenje in označevanje vzorcev.
To ensure adequate representativeness of the samples taken for official control purposes, specific conditions adapted to the fact that the lot of feed is presented in bulk agricultural commodities, pre-packaging or retail should also be adopted.
Za zagotovitev zadostne reprezentativnosti vzorcev, ki so bili odvzeti za namene uradnega nadzora, je treba sprejeti tudi posebne pogoje, ki so prilagojeni dejstvu, da se veliko krme pojavlja v kmetijskih proizvodih v razsutem stanju, predpakiranih proizvodih ali prodaji na drobno.
It is also appropriate to harmonise the rules for the interpretation of the results of the analysis, to ensure that throughout the European Union the same conclusion is drawn from the same analytical results.
Prav tako je primerno uskladiti pravila za razlago rezultatov analize, da se v celotni Evropski uniji na podlagi enakih analitskih rezultatov sprejmejo enake odločitve.
In this context, it is also necessary to take into account the technical constraints associated with any method of analysis, in particular at trace levels since analytical uncertainty increases with decreasing levels of GM material.
Skladno s tem je tudi treba upoštevati tehnične omejitve vsake analitske metode, zlasti v sledeh, saj analitska negotovost narašča z zmanjšanjem ravni GS snovi.
To take these constraints into account, as well as the need to ensure that controls are both feasible, robust and proportionate, as set out in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [11], it is appropriate to set as a Minimum Required Performance Limit (MRPL) the lowest level of GM material which is considered by the EU-RL for the validation of quantitative methods.
Ob upoštevanju teh omejitev ter potrebe po zagotovitvi, da so nadzori izvedljivi, temeljiti in sorazmerni, kot je določeno z Uredbo (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane [11], je primerno kot mejo najmanjše zahtevane učinkovitosti (MRPL) določiti najnižjo raven GS snovi, ki jo RL-EU uporabi za validacijo kvantitativnih metod.
This level corresponds to 0,1 % related to mass fraction of GM material in feed and is the lowest level where results are satisfactorily reproducible between official laboratories when appropriate sampling protocols and methods of analysis for measuring feed samples are applied.
Ta raven je enaka 0,1 mas. % GS snovi v krmi in je najnižja raven, pri kateri je zagotovljena zadovoljiva ponovljivost rezultatov med uradnimi laboratoriji, ko se uporabljajo ustrezni protokoli vzorčenja in analitske metode za merjenje vzorcev krme.
The methods validated by the EU-RL are specific to each transformation event irrespective of the fact that the transformation event is present in one or several GMOs containing one or several transformation events.
Metode, ki jih je validiral RL-EU, so specifične za vsako transformacijo, ne glede na dejstvo, da je transformacija prisotna v enem ali več GSO, ki vsebujejo eno ali več transformacij.
The MRPL should thus apply to the whole GM material containing the measured transformation event.
MRPL se mora zato začeti uporabljati za vse GS snovi, ki vsebujejo izmerjeno transformacijo.
Measurement uncertainty should be determined by each official laboratory and confirmed as described in the guidance document on Measurement Uncertainty for GMO testing laboratories [12] developed by the Joint Research Centre of the Commission (JRC).
Negotovost merjenja morajo določiti vsi uradni laboratoriji in jo potrditi, kot je opisano v smernicah o negotovosti merjenja v preskuševalnih laboratorijih za GSO [12], ki jih je oblikovalo Skupno raziskovalno središče Komisije (JRC).
A decision of non-compliance of the feed should therefore only be taken when GM material falling under the scope of this Regulation is present at levels equal or above the MRPL, measurement uncertainty being taken into account.
Odločitev o neskladnosti krme je zato treba sprejeti le, če je GS snov s področja uporabe te uredbe prisotna pri ravneh enakih ali višjih od MRPL, ob upoštevanju negotovosti merjenja.
The rules established by this Regulation should not affect the possibility for the Commission, or where applicable for a Member State, to adopt emergency measures in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002.
Pravila, določena s to uredbo, ne smejo vplivati na možnost Komisije ali, kjer je primerno, države članice, da sprejme nujne ukrepe v skladu s členi 53 in 54 Uredbe (ES) št. 178/2002.
These implementing rules should be adapted if this becomes necessary to take account of new developments in particular as regards their impact on the internal market and on food and feed operators.
Ta izvedbena pravila je treba prilagoditi, če je to potrebno zaradi upoštevanja novih dosežkov, zlasti glede njihovega vpliva na notranji trg ter na proizvajalce živil in krme.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee for the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
Ukrepi, predvideni s to uredbo, so v skladu z mnenjem Stalnega odbora za prehranjevalno verigo in zdravje živali, Evropski parlament in Svet pa jim nista nasprotovala –
‘Precision — Relative Repeatability Standard Deviation (RSDr)’
„natančnost – relativen standardni odmik ponovljivosti (RSDr)“
The relative standard deviation of test results obtained under repeatability conditions.
relativen standardni odmik testnih rezultatov, pridobljenih pri pogojih ponovljivosti.
Repeatability conditions are conditions where test results are obtained with the same method, on identical test items, in the same laboratory, by the same operator, using the same equipment within short intervals of time;
Pogoji ponovljivosti so pogoji, ko isti izvajalec dobi testne rezultate v kratkih časovnih razmakih z isto opremo in metodo na enakem poskusnem materialu in v istem laboratoriju;
‘Minimum Required Performance Limit (MRPL)’
„meja najmanjše zahtevane učinkovitosti (MRPL)“
the lowest amount or concentration of analyte in a sample that has to be reliably detected and confirmed by official laboratories;
najmanjša vrednost ali koncentracija analita v vzorcu, ki ga je treba zanesljivo zaznati in ga morajo potrditi uradni laboratoriji;
‘GM material’
„GS snov“
material which contains, consists of or is produced from GMOs.
snov, ki vsebuje, sestoji iz ali je proizvedena iz GSO.
The definitions set out in Article 2 of Regulation (EC) No 1829/2003 and in Annex I to Regulation (EC) No 152/2009 apply.
Uporabljajo se opredelitve iz člena 2 Uredbe (ES) št. 1829/2003 in Priloge I Uredbe (ES) št. 152/2009.
This Regulation shall apply to the official control of feed with respect to the presence of the following material:
Ta uredba se uporablja za uradni nadzor krme glede prisotnosti naslednjih snovi:
GM material authorised for commercialisation in a third country and for which a valid application has been submitted under Article 17 of Regulation (EC) No 1829/2003 and for which the authorisation procedure has been pending for more than 3 months provided that:
GS snovi, ki je odobrena za komercializacijo v tretji državi in za katero je bila predložena veljavna vloga v skladu s členom 17 Uredbe (ES) št. 1829/2003 ter za katero se je postopek odobritve začel pred več kot 3 meseci pod pogojem, da:
it has not been identified by EFSA as susceptible to have adverse effects on health or the environment when present under the MRPL;
EFSA zanjo ni ugotovila, da škodljivo vpliva na zdravje in okolje, ko je prisotna pod MRPL;
the quantitative method requested under that Article has been validated and published by the European Union Reference Laboratory; and
je zahtevano kvantitativno metodo iz navedenega člena validiral in objavil referenčni laboratorij Evropske unije ter
that the certified reference material fulfils the conditions set out in Article 3;
certificiran referenčni material izpolnjuje pogoje iz člena 3;
after 25 April 2012, GM material notified under Article 20 of Regulation (EC) No 1829/2003 of which the authorisation has expired and for which a quantitative method has been validated and published by the European Union Reference Laboratory provided that certified reference material fulfils the conditions set out in Article 3; and
po 25. aprilu 2012 GS snovi, ki je bila prijavljena v skladu s členom 20 Uredbe (ES) št. 1829/2003, za katero je odobritev potekla in za katero je referenčni laboratorij Evropske unije validiral in objavil kvantitativno metodo, pod pogojem, da certificiran referenčni material izpolnjuje pogoje iz člena 3 ter
GM material for which the authorisation has expired due to the fact that no application for renewal in accordance with Article 23 of Regulation (EC) No 1829/2003 has been submitted provided that certified reference material fulfils the conditions set out in Article 3.
GS snovi, za katero je odobritev potekla, saj zanjo v skladu s členom 23 Uredbe (ES) št. 1829/2003 ni bila predložena vloga za obnovitev, pod pogojem, da certificiran referenčni material izpolnjuje pogoje iz člena 3.
Certified reference material
Certificiran referenčni material
Certified reference material must be available to Member States and any third party.
Certificiran referenčni material mora biti na voljo državam članicam in kateri koli tretji strani.
Certified reference material shall be produced and certified in accordance with ISO guides 30 to 35.
Certificiran referenčni material se proizvaja in certificira v skladu s smernicami ISO 30 do 35.
The information accompanying the certified reference material shall include information on the breeding of the plant which has been used for the production of the certified reference material and on the zygosity of the insert(s).
Informacije, priložene certificiranemu referenčnemu materialu, vključujejo informacije o gojenju rastline, ki se uporablja za proizvodnjo certificiranega referenčnega materiala, in o zigotnosti vključkov.
The certified value of the GMO content shall be given in mass fraction and, where available, in copy number per haploid genome equivalent.
Certificirana vrednost vsebnosti GSO se izrazi v masnem deležu in, kadar je na voljo, v številu kopij na haploidni ekvivalent genoma.
Methods of sampling
Metode vzorčenja
Samples for the official control of feed as regards the presence of the GM material referred to in Article 2, shall comply with the methods of sampling, as set out in Annex I.
Vzorci za uradni nadzor krme glede prisotnosti GS snovi iz člena 2 so v skladu z metodami vzorčenja iz Priloge I.
Sample preparation, methods of analysis and interpretation of results
Priprava vzorca, analitske metode in razlaga rezultatov
The preparation of laboratory samples, the methods of analysis and the interpretation of results shall comply with the requirements set out in Annex II.
Priprava laboratorijskih vzorcev, analitske metode in razlaga rezultatov so v skladu z zahtevami iz Priloge II.
Measures in case of detection of GM material referred to in Article 2
Ukrepi v primeru odkritja GS snovi iz člena 2
Where results of analytical tests indicate the presence of GM material referred to in Article 2 are at or above the MRPL as defined in accordance with the rules of interpretation set out in Annex II Part B, the feed shall be considered as non-compliant with Regulation (EC) No 1829/2003.
Kadar rezultati analitskih preskusov kažejo na prisotnost GS snovi iz člena 2 na ravni MRPL ali nad njo, kot je opredeljeno v skladu s pravili razlage iz dela B Priloge II, se krma šteje za neskladno z Uredbo (ES) št. 1829/2003.
Member States shall immediately notify this information through the RASFF in accordance with Article 50 of Regulation (EC) No 178/2002.
Države članice nemudoma sporočijo te informacije prek sistema hitrega obveščanja za živila in krmo (RASFF) v skladu s členom 50 Uredbe (ES) št. 178/2002.
Where results of analytical tests indicate the presence of GM material referred to in Article 2 is below the MRPL as defined in accordance with the rules of interpretation set out in Annex II Part B, Member States shall record this information and notify the Commission and the other Member States by 30 June of each year.
Kadar rezultati analitskih preskusov kažejo na prisotnost GS snovi iz člena 2 pod MRPL, kot je opredeljeno v skladu s pravili razlage iz dela B Priloge II, države članice zabeležijo te informacije in obvestijo Komisijo in druge države članice vsako leto do 30. junija.
Recurrent findings over a period of time of 3 months shall be notified without delay.
Ugotovitve, ki se ponavljajo v obdobju treh mesecev, je treba takoj sporočiti.
The Commission shall or a Member State may, where appropriate, adopt emergency measures in accordance with Articles 53 and 54 of Regulation (EC) No 178/2002.
Komisija po potrebi sprejme nujne ukrepe v skladu s členoma 53 in 54 Uredbe (ES) št. 178/2002; to lahko storijo tudi države članice.
List of GM material referred to in Article 2
Seznam GS snovi iz člena 2
The Commission shall publish the list of GM material complying with the conditions set out in Article 2 on its website.
Komisija na svoji spletni objavi seznam GS snovi, ki so skladne s pogoji iz člena 2.
The list shall include information as to the place where the certified reference material can be accessed as required by Article 17(3)(j) of Regulation (EC) No 1829/2003 and, if applicable, information on the measures adopted in accordance with paragraph 3 of Article 6 of this Regulation.
Seznam vključuje informacije o tem, kje se lahko dostopa do certificiranega referenčnega materiala, kot določa člen 17(3)(j) Uredbe (ES) št. 1829/2003, in, če je ustrezno, informacije o ukrepih, sprejetih v skladu z odstavkom 3 člena 6 te uredbe.
The Commission shall monitor the application of this Regulation and its impact on the internal market as well as on feed, livestock and other operators, and, if necessary, bring forward proposals to review this Regulation.
Komisija spremlja uporabo te uredbe in njen vpliv na notranji trg ter proizvajalce krme, živinorejce in druge subjekte ter po potrebi predloži predloge za pregled te uredbe.
OJ L 117, 5.5.2007, p. 14.
UL L 117, 5.5.2007, str. 14.
OJ L 117, 5.5.2007, p. 17.
UL L 117, 5.5.2007, str. 17.
OJ L 117, 5.5.2007, p. 20.
UL L 117, 5.5.2007, str. 20.
OJ L 117, 5.5.2007, p. 23.
UL L 117, 5.5.2007, str. 23.
OJ L 117, 5.5.2007, p. 25.
UL L 117, 5.5.2007, str. 25.
For the purpose of applying Annex I to Regulation (EC) No 152/2009, GM material shall be considered as a substance likely to be distributed non-uniformly throughout the feed.
Za namene uporabe Priloge I k Uredbi (ES) št. 152/2009 se GS snov šteje za snov, za katero obstaja verjetnost, da bo neenakomerno porazdeljena po krmi.
By derogation from points 5.B.3., 5.B.4 and 6.4 of Annex I to Regulation (EC) No 152/2009, the size of the aggregate samples for feed materials shall be not less than the weight corresponding to 35000 grains/seeds and the final sample shall be not less than the weight corresponding to 10000 grains/seeds.
Z odstopanjem od točk 5.B.3., 5.B.4 in 6.4 Priloge I k Uredbi (ES) št. 152/2009 velikost skupnih vzorcev za posamična krmila ne sme biti manjša od teže, ki ustreza 35000 zrnja/semena, končni vzorec pa ne sme biti manjši od teže, ki ustreza 10000 zrnja/semena.
The mass equivalent of 10000 grains/seeds is provided in Table 1 below.
Ekvivalent mase 10000 zrnja/semena je naveden v spodnji preglednici 1.
Mass equivalent of 10000 grains/seeds for different plants
Ekvivalent mase 10000 zrnja/semena za različne rastline
Mass, in grams, corresponding to 10000 grain/seed
Masa v gramih, ki ustreza 10000 zrnja/semena
Barley, Millet, Oat, Rice, Rye, Wheat
Ječmen, proso, oves, riž, rž, pšenica
CRITERIA FOR SAMPLE PREPARATION AND METHODS OF ANALYSIS
MERILA ZA PRIPRAVO VZORCA IN ANALITSKE METODE
In order to detect the presence in feed of the GM material referred to in Article 2, the official laboratories shall use the methods of analysis and control requirements described in this Annex.
Za odkrivanje prisotnosti GS snovi iz člena 2 v krmi uradni laboratoriji uporabljajo analitske metode in zahteve nadzora, opisane v tej prilogi.
In addition to the requirements of Annex II Part A to Regulation (EC) No 152/2009, the following provisions shall apply.
Poleg zahtev iz dela A Priloge II k Uredbi (ES) št. 152/2009 se uporabljajo naslednje določbe.
Treatment of the final samples
Obdelava končnih vzorcev
Official laboratories shall use the standard EN ISO 24276, ISO 21570, ISO 21569 and ISO 21571 that indicate strategies for the homogenisation of the final sample (also designated as the ‘laboratory sample’ in the ISO standards), the reduction of the final sample to the sample for analysis, the preparation of the test sample and the extraction and the analysis of target analyte.
Uradni laboratoriji uporabljajo standarde EN ISO 24276, ISO 21570, ISO 21569 in ISO 21571, ki navajajo strategije za homogenizacijo končnega vzorca (prav tako poimenovan „laboratorijski vzorec“ v standardih ISO), zmanjšanje končnega vzorca na vzorec za analizo, pripravo preskusnega vzorca ter ekstrakcijo in analizo ciljnega analita.
Size of the sample for analysis
Velikost vzorca za analizo
The sample for analysis shall be of a size which ensures the quantification of GM material at a presence corresponding to the MRPL with a statistical degree of confidence of 95 %.
Velikost vzorca za analizo mora biti taka, da zagotavlja količinsko opredelitev GS snovi v prisotnosti, ki ustreza MRPL s statistično stopnjo zaupanja 95 %.
By derogation from Part C of Annex II to Regulation (EC) No 152/2009, the following rules for the application of methods of analysis and expression of results shall apply.
Z odstopanjem od dela C Priloge II k Uredbi (ES) št. 152/2009 se za uporabo analitskih metod in prikaz rezultatov uporabljajo naslednja pravila.
Official laboratories shall comply with the requirements of ISO 17025 and use quantitative methods of analysis that have been validated by the European Union Reference Laboratory in collaboration with the European Network of GMO Laboratories.
Uradni laboratoriji izpolnjujejo zahteve standarda ISO 17025 in uporabljajo kvantitativne analitske metode, ki jih je validiral referenčni laboratorij Evropske unije skupaj z Evropskim omrežjem laboratorijev GSO.
They shall ensure that, considering the whole analytical method starting with the treatment of the laboratory sample of feed, they are in position to carry out the analysis at the level of 0,1 % related to mass fraction of GM material in feed with an adequate precision (relative repeatability standard deviation less than or equal to 25 %).
Zagotavljajo, da lahko ob upoštevanju celotne analitske metode, ki se začne z obdelavo laboratorijskega vzorca krme, izvedejo analize na ravni 0,1 mas. % GS snovi v krmi z zadostno natančnostjo (relativen standardni odmik ponovljivosti, ki je manjši ali enak 25 %).
Rules for interpretation of results
Pravila za razlago rezultatov
To ensure a level of confidence of approximately 95 %, the outcome of the analysis shall be reported as x +/– U whereby x is the analytical result for one measured transformation event and U is the appropriate expanded measurement uncertainty.
Za zagotavljanje stopnje zaupanja v višini približno 95 % se rezultat analize sporoči kot x +/– U, pri čemer je x analitski rezultat za eno merjeno transformacijo, U pa je ustrezna razširjena negotovost merjenja.
U shall be specified by the official laboratory for the whole analytical method and confirmed as described in the guidance document on Measurement Uncertainty for GMO testing laboratories [1] developed by JRC.
U določi uradni laboratorij za celotno analitsko metodo ter se potrdi, kot je opisano v smernicah o negotovosti merjenja v preskuševalnih laboratorijih za GSO [1], ki jih je oblikoval JRC.
A feed material, feed additive or, in the case of compound feed each of the feed material and feed additive of which it is composed shall be considered as non-compliant with Regulation (EC) No 1829/2003 when the analytical result (x) for one measured transformation event minus the expanded measurement uncertainty (U) equals or exceeds the level of 0,1 % related to mass fraction of GM material.
Posamična krmila, krmni dodatki ali, v primerih krmnih mešanic, vsako posamično krmilo ali krmni dodatek, iz katerega je sestavljena, se štejejo za neskladne z Uredbo (ES) št. 1829/2003, ko je rezultat analize (x) za eno izmerjeno transformacijo minus razširjena negotovost merjenja (U) enak ali večji od 0,1 mas. % GS snovi.
When results are primarily expressed as GM-DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes, they shall be translated into mass fraction in accordance with the information provided in each validation report of the EU-RL.
Ko so rezultati izraženi predvsem kot število kopij gensko spremenjene DNK glede na ciljno taksonomsko specifično število kopij DNK, izračunano v obliki haploidnih genomov, se prevedejo v masne deleže v skladu z informacijami iz vseh poročil o validaciji RL-EU.
Commission Implementing Regulation (EU) No 620/2011
Izvedbena uredba Komisije (EU) št. 620/2011
Having regard to Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff [1], and in particular Article 9(1)(d) thereof,
ob upoštevanju Uredbe Sveta (EGS) št. 2658/87 z dne 23. julija 1987 o tarifni in statistični nomenklaturi ter o skupni carinski tarifi [1] in zlasti člena 9(1)(d) Uredbe,
Further to a complaint brought in the World Trade Organisation (WTO) by certain countries, a WTO panel report adopted by the WTO Dispute Settlement Body on 21 September 2010 [2] concluded that the European Union had acted, inter alia, inconsistently with the General Agreement on Tariffs and Trade 1994 (GATT 1994) by according tariff treatment less favourable than that provided in the tariff bindings with regard to certain information technology products made by the European Union pursuant to the Information Technology Agreement (ITA).
Po pritožbi, ki so jo vložile nekatere države v Svetovni trgovinski organizaciji (STO), je bilo v poročilu Odbora STO, ki ga je 21. septembra 2010 sprejel organ za reševanje sporov STO [2], zaključeno, da Evropska unija med drugim ni ukrepala v skladu s Splošnim sporazumom o tarifah in trgovini 1994 (GATT 1994), ko je za določene proizvode informacijske tehnologije, izdelane v Evropski uniji, določila manj ugodne tarife od zavezujočih tarif v skladu s sporazumom o informacijski tehnologiji.
Annex I to Regulation (EEC) No 2658/87 should be amended in order to bring it into conformity with the international obligations of the European Union under the GATT 1994.
Prilogo I k Uredbi (EGS) št. 2658/87 je treba spremeniti, da bi bila skladna z mednarodnimi obveznostmi Evropske unije v okviru GATT 1994.