natgillin/translations-raw huggingface dataset:
The aggregate sample uniting all incremental samples shall be at least 1 kg (see point II.5).
Sestavljeni vzorec, ki združuje vse posamezne vzorce, tehta najmanj 1 kg (glej točko II.5).
In case the lot to be sampled contains small fishes (individual fishes weighing < about 1 kg), the whole fish is taken as incremental sample to form the aggregate sample.
Če lot za vzorčenje vsebuje majhne ribe (posamezne ribe, teže < približno 1 kg), se iz posameznega vzorca vzame cela riba, da se oblikuje sestavljeni vzorec.
In case the lot to be sampled contains larger fishes (individual fishes weighing more than about 1 kg), the incremental sample consists of the middle part of the fish.
Če lot, ki ga je treba vzorčiti, vsebuje večje ribe (posamezne ribe, ki so težje od približno 1 kg), posamezni vzorec sestoji iz srednjega dela ribe.
For fishes of intermediate size (about 1-6 kg) the incremental sample is taken as a slice of the fish from backbone to belly in the middle part of the fish.
Pri ribah srednje velikosti (približno 1 do 6 kg) se posamezni vzorec odvzame kot rezina od hrbtenice do trebuha iz srednjega dela ribe.
For very large fishes (e.g. > about 6 kg), the incremental part is taken from the right side (frontal view) dorso-lateral muscle meat in the middle part of the fish In case the taking of such a piece of the middle part of the fish would result in a significant economic damage, taking of three incremental samples of at least 350 grams each may be considered as being sufficient, independently of the size of the lot or alternatively an equal part of the muscled meat close to the tail part and the muscle meat close to the head part of one fish may be taken to form the incremental sample being representative for the level of dioxins in the whole fish.
Pri zelo velikih ribah (npr. > približno 6 kg) se posamezni vzorec mesa mišic odvzame iz srednjega dela ribe, in sicer iz desnega hrbtno-bočnega dela (pogled od spredaj). Če bi odvzem takšnega kosa iz srednjega dela ribe povzročil bistveno gospodarsko škodo, zadošča odvzem treh posameznih vzorcev po najmanj 350 g, ne glede na velikost lota; lahko pa se posamezni vzorec, ki je reprezentativen glede vsebnosti dioksina v celi ribi, dobi tako, da se odvzame ustrezni del mesa mišic ene ribe iz predela ob repu in glavi.
The provisions of point III.3 as regards sample constitution shall apply.
Za sestavljanje vzorca se uporabljajo določbe točke III.3.
In case a size or weight class/category is predominant (about 80 % or more of the lot), the sample is taken from fishes with the predominant size or weight.
Če prevladuje kategorija/razred velikosti ali teže (približno 80 % lota ali več), se odvzame vzorec rib s prevladujočo težo ali velikostjo.
This sample is to be considered as being representative for the whole lot.
Ta vzorec se šteje kot reprezentativen za celoten lot.
In case no particular size or weight class/category predominates, then it must be ensured that the fishes selected for the sample are representative for the lot.
Če ne prevladuje nobena posebna kategorija/razred velikosti ali teže, potem je treba zagotoviti, da so ribe, izbrane za vzorec, reprezentativne za lot.
Specific guidance for such cases is provided in ‘Guidance on sampling of whole fishes of different size and/or weight’ [2].
Posebna navodila za takšne primere so v „Navodilih za vzorčenje celih rib različnih velikosti in/ali teže“ [2].
Sampling of foodstuffs at retail stage shall be done where possible in accordance with the sampling provisions set out in point III.2 of this Annex.
Vzorčenje živil na stopnji prodaje na drobno se po možnosti izvede v skladu z določbami za vzorčenje iz točke III.2 te priloge.
As regards non-dioxin-like PCBs
Glede dioksinom nepodobnih PCB
The lot is accepted, if the analytical result does not exceed the maximum level of non-dioxin-like PCBs as laid down in Regulation (EC) No 1881/2006 taking into account the measurement uncertainty.
Lot se sprejme, če rezultat analiznega preskušanja ne presega mejne vrednosti dioksinom nepodobnih PCB iz Uredbe (ES) št. 1881/2006 ob upoštevanju merilne negotovosti.
The lot is non-compliant with the maximum level as laid down in Regulation (EC) No 1881/2006, if the upperbound analytical result confirmed by duplicate analysis [3], exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty.
Lot ni v skladu z mejno vrednostjo iz Uredbe (ES) št. 1881/2006, če rezultat analiznega preskušanja na zgornji meji, potrjen z dvakratno analizo [3], ob upoštevanju merilne negotovosti nedvomno presega mejno vrednost.
The measurement uncertainty may be taken into account according to one of the following approaches:
Merilna negotovost se lahko upošteva po enem od naslednjih pristopov:
by calculating the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.
z izračunom razširjene negotovosti, ob uporabi faktorja zajetja 2, ki omogoča približno 95-odstotno stopnjo zaupanja.
A lot or sublot is non-compliant if the measured value minus U is above the established permitted level,
Lot ali sublot je neskladen, če je izmerjena vrednost minus U nad določeno dovoljeno vrednostjo,
by establishing the decision limit (CCα) according to the provisions of Decision 2002/657/EC (point 3.1.2.5 of Annex I to that Decision — the case of substances with an established permitted level).
z uvedbo odločitvene meje (CCα) v skladu z določbami Odločbe 2002/657/ES (točka 3.1.2.5 Priloge I k navedeni odločbi – primer snovi z določeno dovoljeno vrednostjo).
A lot or sublot is non-compliant if the measured value is equal to or above the CCα.
Lot ali sublot je neskladen, če je izmerjena vrednost enaka odločitveni meji CCα ali večja od nje.
The abovementioned rules shall apply for the analytical result obtained on the sample for official control.
Navedena pravila se uporabljajo za rezultat analiznega preskušanja, dobljen na vzorcu za uradni nadzor.
In case of analysis for defence or reference purposes, the national rules apply.
Pri analizi za dopolnilno izvedensko mnenje in referenčne namene se uporabljajo nacionalni predpisi.
As regards dioxins (PCDD/PCDF) and dioxin-like PCBs
Glede dioksinov (PCDD/PCDF) in dioksinom podobnih PCB
The lot is accepted, if the result of a single analysis
Lot se sprejme, če rezultat posamezne analize,
performed by a screening method with a false-compliant rate below 5 % indicates that the level does not exceed the respective maximum level of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs as laid down in Regulation (EC) No 1881/2006,
opravljene s presejalno metodo, pri kateri je delež lažno skladnih rezultatov manjši kot 5 %, pokaže, da vsebnost ne presega zadevne mejne vrednosti PCDD/F ter vsote PCDD/F in dioksinom podobnih PCB iz Uredbe (ES) št. 1881/2006,
performed by a confirmatory method does not exceed the respective maximum level of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs as laid down in Regulation (EC) No 1881/2006 taking into account the measurement uncertainty.
opravljene s potrditveno metodo, ne presega zadevne mejne vrednosti PCDD/F ter vsote PCDD/F in dioksinom podobnih PCB iz Uredbe (ES) št. 1881/2006 ob upoštevanju merilne negotovosti.
For screening assays a cut-off value shall be established for the decision on the compliance with the respective levels of interest set for either PCDD/Fs, or for the sum of PCDD/Fs and dioxin-like PCBs.
Za presejalne teste se določi izločitvena vrednost za odločitev o skladnosti z zadevnimi predpisanimi vrednostmi, določenimi za PCDD/F ali za vsoto PCDD/F in dioksinom podobnih PCB.
The lot is non-compliant with the maximum level as laid down in Regulation (EC) No 1881/2006, if the upperbound analytical result obtained with a confirmatory method and confirmed by duplicate analysis [3] The duplicate analysis is necessary to exclude the possibility of internal cross-contamination or an accidental mix-up of samples.
Lot ni v skladu z mejno vrednostjo iz Uredbe (ES) št. 1881/2006, če rezultat analiznega preskušanja na zgornji meji, pridobljen s potrditveno metodo in potrjen z dvakratno analizo [3] Dvakratna analiza je potrebna za izključitev možnosti notranje navzkrižne kontaminacije ali naključne zamenjave vzorcev.
The first analysis, taking into account the measurement uncertainty is used for verification of compliance.
Prva analiza se ob upoštevanju merilne negotovosti uporablja za preverjanje skladnosti.
In case the analysis is performed in the frame of a contamination incident, confirmation by duplicate analysis might be omitted in case the samples selected for analysis are through traceability linked to the contamination incident.
Če se analiza izvaja pri kontaminaciji z dioksini, se lahko izpusti potrjevanje z dvakratno analizo, če so vzorci, izbrani za analizo, sledljivo povezani s kontaminacijo z dioksini.
, exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty.
, ob upoštevanju merilne negotovosti nedvomno presega mejno vrednost.
In case of a separate determination of PCDD/Fs and dioxin-like-PCBs the sum of the estimated expanded uncertainty of the separate analytical results of PCDD/Fs and dioxin-like PCBs has to be used for the estimated expanded uncertainty of the sum of PCDD/Fs and dioxin-like PCBs,
Pri ločenem preskušanju za določitev PCDD/F in dioksinom podobnih PCB je treba vsoto ocenjene razširjene negotovosti ločenih rezultatov analize vsebnosti PCDD/F in dioksinu podobnih PCB uporabiti za ocenjeno razširjeno negotovost vsote PCDD/F in dioksinom podobnih PCB,
by establishing the decision limit (CCα) according to the provisions of Decision 2002/657/EC (point 3.1.2.5 of Annex I to that Decision — the case of substances with established permitted level) a lot or sublot is non-compliant if the measured value is equal to or above the CCα.
z uvedbo odločitvene meje (CCα) v skladu z določbami Odločbe 2002/657/ES (točka 3.1.2.5 Priloge I k navedeni odločbi – primer snovi z določeno dovoljeno vrednostjo) je lot ali sublot neskladen, če je izmerjena vrednost enaka odločitveni meji CCα ali večja od nje.
V. EXCEEDANCE OF ACTION LEVELS
V. PRESEGANJE PRAGOV UKREPANJA
Action levels serve as tool for selection of samples in those cases where it is appropriate to identify a source of contamination and to take measures for its reduction or elimination.
Pragovi ukrepanja so orodje za izbiro vzorcev v tistih primerih, ko je treba določiti vir kontaminacije in sprejeti ukrepe za njeno zmanjšanje ali odpravo.
Screening methods shall establish appropriate cut-off values for selection of these samples.
S presejalnimi metodami se določijo ustrezne izločitvene vrednosti za izbiro teh vzorcev.
The efforts necessary to identify a source and to reduce or eliminate the contamination shall be deployed only if exceedance of the action level is confirmed by duplicate analysis using a confirmatory method and taking into account the measurement uncertainty [4].
Ukrepi za določitev vira in zmanjšanje ali odpravo kontaminacije se izvedejo le, če je preseganje praga ukrepanja potrjeno z dvakratno analizo s potrditveno metodo ob upoštevanju merilne negotovosti [4].
Identical explanation and requirements for duplicate analysis for control of action levels as in footnote 3 for maximum levels.
Enaka razlaga in zahteve za dvakratno analizo za nadzor pragov ukrepanja kot v opombi 3 za mejne vrednosti.
Sample preparation and requirements for methods of analysis used in offical control of the levels of dioxins (PCDD/PCDF) and dioxin-like PCBS in certain foodstuffs
Priprava vzorca in zahteve za analitske metode za uradni nadzor vsebnosti dioksinov (PCDD/PCDF) in dioksinom podobnih PCB v nekaterih živilih
The requirements set out in this Annex shall be applied where foodstuffs are analysed for the official control of the levels of 2,3,7,8-substituted polychlorinated dibenzo-p-dioxins and polychlorinated dibenzofurans (PCDD/Fs) and dioxin-like polychlorinated biphenyls (dioxin-like PCBs) and for other regulatory purposes.
Zahteve iz te priloge se uporabijo, kadar se živila analizirajo za uradni nadzor vsebnosti 2,3,7,8-substituiranih polikloriranih dibenzo-p-dioksinov in polikloriranih dibenzofuranov (PCDD/F) ter dioksinom podobnih polikloriranih bifenilov (dioksinom podobnih PCB) in za druge regulativne namene.
Monitoring for the presence of PCDD/Fs and dioxin-like PCBs in foodstuffs may be performed with two different goals:
Prisotnost PCDD/F in dioksinom podobnih PCB v živilih se lahko spremlja z dvema namenoma:
selection of those samples with levels of PCDD/Fs and dioxin-like PCBs that exceed the maximum levels, or the action levels.
za izbiro tistih vzorcev, katerih vsebnosti PCDD/F in dioksinom podobnih PCB presegajo mejne vrednosti ali pragove ukrepanja.
This approach may involve a screening method allowing cost-effective high sample-throughput, thus increasing the chance to discover new incidents with high exposure and health risks of consumers.
Ta pristop se lahko izvaja s presejalno metodo, ki omogoča stroškovno učinkovito veliko prepustnost vzorcev in tako povečuje možnosti za odkrivanje novih incidentov z veliko izpostavljenostjo in nevarnostjo za zdravje potrošnikov.
Screening methods may comprise bioanalytical methods and GC/MS methods.
Presejalne metode lahko vključujejo bioanalitske metode in metode GC/MS.
Their application should aim at avoiding false-compliant results.
Oblikovane so tako, da se z njimi izognemo lažno skladnim rezultatom.
The concentration of PCDD/Fs and the sum of PCDD/Fs and dioxin-like PCBs in those samples with significant levels needs to be determined/confirmed by a confirmatory method;
Koncentracijo PCDD/F ter vsoto PCDD/F in dioksinom podobnih PCB v navedenih vzorcih z znatnimi vsebnostmi je treba določiti/potrditi s potrditveno metodo;
determination of the levels of PCDD/Fs and dioxin-like PCBs in food samples in the range of low background levels.
za določitev vsebnosti PCDD/F in dioksinom podobnih PCB v vzorcih živil v območju z nizko ravnjo prisotnosti.
This is important in order to follow time trends, exposure assessment of the population and to build a database for possible re-evaluation of action and maximum levels.
To je pomembno za spremljanje časovnih gibanj, oceno izpostavljenosti prebivalstva in ustvarjanje zbirke podatkov za morebitno ponovno oceno pragov ukrepanja in mejnih vrednosti.
This goal is achieved by confirmatory methods enabling the PCDD/Fs and dioxin-like PCBs to be identified and quantified unequivocally at the level of interest.
Za dosego tega cilja se uporabljajo potrditvene metode, ki omogočajo ugotavljanje PCDD/F in dioksinom podobnih PCB in nedvoumno količinsko določanje pri predpisani vrednosti.
These methods can be used for confirmation of results obtained by screening methods and for determination of low background levels in food monitoring.
Te metode se lahko uporabijo za potrditev rezultatov, pridobljenih s presejalnimi metodami, in za določitev nizkih ravni prisotnosti pri nadzoru živil.
They are also important for establishing congener patterns in order to identify the source of a possible contamination.
Pomembne so tudi za določitev vzorcev kongenerov za ugotovitev vira mogoče kontaminacije.
At present such methods utilise high-resolution gas chromatography/high resolution mass spectrometry (HRGC/HRMS).
Trenutno se pri takih metodah uporablja visoko ločljiva plinska kromatografija / visoko ločljiva masna spektrometrija (HRGC/HRMS).
CLASSIFICATION OF METHODS BY THEIR DEGREE OF QUANTIFICATION [1]
RAZVRSTITEV METOD PO STOPNJI KOLIČINSKEGA DOLOČANJA [1]
‘Qualitative methods’ give a yes/no response on the presence of analytes of interest, with no quantified indication of the concentration of the putative analyte.
„Kakovostne metode“ dajejo odgovor da/ne na prisotnost predpisanih analitov, pri čemer koncentracija domnevnega analita ni količinsko navedena.
These methods may have the potential for providing semi-quantitative results but are used solely for report of a yes/no decision as indication of levels above or below certain ranges, e.g. limit of detection, limit of quantification or cut-off values.
Te metode lahko dajo delno količinske rezultate, vendar se uporabljajo izključno za poročanje o odločitvah da/ne kot navedba vrednosti nad nekaterimi ravnmi ali pod njimi, kot so meja zaznavanja, meja določanja ali izločitvene vrednosti.
For control of maximum and action levels for PCDD/Fs and dioxin-like compounds in food, screening methods may be applied which are based on comparison of the analytical result with a cut-off value and give a yes/no-decision for indication for the possible exceedance of the level of interest.
Za nadzor mejnih vrednosti in pragov ukrepanja za PCDD/F in dioksinom podobne spojine v živilih se lahko uporabijo presejalne metode, ki temeljijo na primerjavi rezultata analiznega preskušanja z izločitveno vrednostjo in omogočajo odločitev da/ne za navedbo mogočega preseganja predpisane vrednosti.
For this purpose, bioanalytical methods were introduced.
V ta namen so bile uvedene bioanalitske metode.
Generally, also physico-chemical methods could be developed; however, with regard to the TEQ-based maximum and action levels and the complex analysis with required determination of the relevant individual congeners, there are no practical examples.
Na splošno bi bilo mogoče razviti tudi fizikalno-kemijske metode, vendar glede na mejne vrednosti in pragove ukrepanja, ki temeljijo na TEQ, ter zapleteno analizo, ki zahteva določitev ustreznih posameznih kongenerov, ni praktičnih primerov njihove uporabe.
‘Semi-quantitative methods’ give an approximate indication of the concentration which may be useful as information on the range of the analyte concentration and helpful for the analyst in deciding the calibration range for the confirmatory test subsequently to be performed and for quality control purposes.
„Semikvantitativne metode“ pokažejo približno koncentracijo, ki je lahko koristna kot informacija o stopnji koncentracije analita in lahko analitiku pomaga določiti območje umerjanja za potrditveni preskus, ki se izvede pozneje, ter za zagotavljanje kakovosti.
Examples include:
Primeri vključujejo:
bioanalytical methods which are able to detect the analytes of interest, include a calibration curve, give a yes/no-decision for indication for the possible exceedance of the level of interest and allow to report the result as Bioanalytical Equivalents (BEQ), being an indication of the TEQ value in the sample,
bioanalitske metode, s katerimi je mogoče odkriti predpisane analite in ki vključujejo umeritveno krivuljo, omogočajo odločitev da/ne za navedbo mogočega preseganja predpisane vrednosti in poročanje o rezultatih, izraženih v bioanalitskih ekvivalentih (BEQ), ki pokažejo vrednost TEQ v vzorcu,
physico-chemical test (e.g. GC-MS/MS or GC/LRMS) where the measured method precision characteristics do not meet the requirements for quantitative tests.
fizikalno-kemijski preskus (na primer GC-MS/MS ali GC/LRMS), kadar značilnosti izmerjene natančnosti metode ne izpolnjujejo zahtev za količinske preskuse.
‘Quantitative methods’ meet the same requirements for accuracy, dynamic range, and precision as confirmatory tests.
„Kvantitativne metode“ izpolnjujejo iste zahteve glede točnosti, dinamičnega območja in natančnosti kot potrditveni preskusi.
When the quantification is required, these methods shall be validated as confirmatory methods, as detailed in this document for PCDD/Fs and dioxin-like PCBs.
Kadar se zahteva količinska določitev, se te metode validirajo kot potrditvene metode, kakor je v tem dokumentu podrobno določeno za PCDD/F in dioksinom podobne PCB.
For calculation of Toxic Equivalents (TEQ) concentrations, the concentrations of the individual substances in a given sample shall be multiplied by their respective Toxic Equivalency Factor (TEF), as established by the World Health Organisation and listed in the Appendix to this Annex, and subsequently summed to give the total concentration of dioxin-like compounds expressed as TEQs.
Za izračun koncentracij toksičnih ekvivalentov (TEQ) se koncentracije posameznih snovi v danem vzorcu pomnožijo z njihovim ustreznim faktorjem toksične ekvivalentosti (TEF), ki ga je uvedla Svetovna zdravstvena organizacija in je naveden v Dodatku k tej prilogi, in se nato seštejejo, da se dobi skupna koncentracija dioksinom podobnih spojin, izraženih kot toksični ekvivalenti (TEQ).
Screening and confirmatory methods may only be applied for control of a certain matrix if the methods are sensitive enough to detect levels reliably at the level of interest (action or maximum level).
Presejalne in potrditvene metode se lahko uporabijo za nadzor določene matrice le, če so metode dovolj občutljive, da zanesljivo odkrijejo vsebnosti pri predpisani vrednosti (prag ukrepanja ali mejna vrednost).
QUALITY ASSURANCE REQUIREMENTS
ZAHTEVE ZA ZAGOTAVLJANJE KAKOVOSTI
The samples must be stored and transported in glass, aluminium, polypropylene or polyethylene containers suitable for storage without any influence on the levels of PCDD/Fs and dioxin-like PCBs in the samples.
Vzorce je treba hraniti in prevažati v steklenih, aluminijastih, polipropilenskih ali polietilenskih posodah, ki so primerne za shranjevanje in ne vplivajo na vsebnost PCDD/F in dioksinom podobnih PCB v vzorcih.
The sample storage and transportation has to be performed in a way that maintains the integrity of the foodstuff sample.
Vzorce je treba hraniti in prevažati tako, da se ohrani neoporečnost vzorca živila.
In so far as relevant, finely grind and mix thoroughly each laboratory sample using a process that has been demonstrated to achieve complete homogenisation (e.g. ground to pass a 1 mm sieve); samples have to be dried before grinding if moisture content is too high.
Če je ustrezno, se vsak laboratorijski vzorec drobno zmelje in temeljito premeša po postopku, s katerim se dokazano doseže popolna homogenizacija (npr. zmleto tako, da se preseje z 1-milimetrskim sitom); če je vsebnost vlage previsoka, je treba vzorce pred mletjem posušiti.
Control of reagents, glassware and equipment for possible influence of TEQ- or BEQ-based results is of general importance.
Splošnega pomena je nadzor reagentov, steklovine in opreme zaradi mogočega vpliva na rezultate, izražene v TEQ ali BEQ.
A blank analysis shall be performed by carrying out the entire analytical procedure omitting only the sample.
Slepa analiza se opravi z izvedbo celotnega analitskega postopka, iz katerega se izpusti le vzorec.
For bioanalytical methods, it is of great importance that all glassware and solvents used in analysis shall be tested to be free of compounds that interfere with the detection of target compounds in the working range.
Pri bioanalitskih metodah je zelo pomembno testirati, da steklovina in topilo, ki se uporabljata za analizo, ne vsebujeta spojin, ki vplivajo na ugotavljanje ciljnih spojin v delovnem območju.
Glassware shall be rinsed with solvents or/and heated at temperatures suitable to remove traces of PCDD/Fs, dioxin-like compounds and interfering compounds from its surface.
Steklovina se spere s topili in/ali segreje do temperatur, primernih za odstranitev sledi PCDD/F, dioksinom podobnih spojin in motečih spojin s površine.
Sample quantity used for the extraction must be sufficient to fulfil the requirements with respect to a sufficiently low working range including the concentrations of interest.
Količina vzorca, uporabljenega za ekstrakcijo, mora biti zadostna, da so izpolnjene zahteve glede dovolj nizkega delovnega območja, vključno s predpisanimi koncentracijami.
The specific sample preparation procedures used for the products under consideration shall follow internationally accepted guidelines.
Posebni postopki za pripravo vzorca, ki se uporabljajo za obravnavane izdelke, so skladni z mednarodno sprejetimi smernicami.
In the case of fish, the skin has to be removed as the maximum level applies to muscle meat without skin.
Pri ribah je treba odstraniti kožo, saj mejna vrednost velja za meso mišic brez kože.