natgillin/translations-raw huggingface dataset:
The samples intended for the official control of the levels of dioxins (polychlorinated dibenzo-p-dioxins (PCDD) and polychlorinated dibenzofurans (PCDF)) and dioxin-like polychlorinated biphenyls (PCBs) in feed, shall be taken in accordance with the provisions of Annex I. The quantitative requirements in relation to the control of substances or products uniformly distributed throughout the feed as provided for in point 5.A. of the Annex I have to be applied. Aggregate samples thus obtained shall be considered as representative for the lots or sublots from which they are taken.
Vzorci za uradni nadzor ravni dioksinov (polikloriranih dibenzo-p-dioksinov (PCDD)) in polikloriranih dibenzofuranov (PCDF) ter dioksinom podobnih polikloriranih bifenilov (PCB) v krmi se odvzamejo v skladu z določbami iz Priloge I. Upoštevati je treba količinske zahteve za nadzor snovi ali proizvodov, enakomerno razporejenih po krmi, kakor so določene v točki 5.A Priloge I. Tako dobljeni sestavljeni vzorci se obravnavajo kot reprezentativni za serije in podserije, iz katerih so odvzeti.
Compliance with maximum levels laid down in Directive 2002/32/EC of the European Parliament and of the Council shall be established on the basis of the levels determined in the laboratory samples.2.
Skladnost z mejnimi vrednostmi iz Direktive 2002/32/ES Evropskega parlamenta in Sveta se ugotavlja na podlagi ravni, določenih v laboratorijskih vzorcih.2.
Compliance of the lot or sublot with the specification
Skladnost serije ali podserije s specifikacijo
The lot is accepted if the analytical result of a single analysis does not exceed the respective maximum level as laid down in Directive 2002/32/EC taking into account the measurement uncertainty.
Serija je sprejeta, če rezultat posamezne analize ne presega zadevne mejne vrednosti iz Direktive 2002/32/ES ob upoštevanju nezanesljivosti meritve.
The lot is non-compliant with the maximum level as laid down in Directive 2002/32/EC, if the upperbound analytical result, confirmed by duplicate analysis , exceeds the maximum level beyond reasonable doubt taking into account the measurement uncertainty.
Serija ni v skladu z mejno vrednostjo iz Direktive 2002/32/ES, če navzgor zaokroženi rezultat analize, potrjen z dvakratno analizo , ob upoštevanju nezanesljivosti meritve nedvomno presega mejno vrednost.
Measurement uncertainty may be taken into account according to one of the following approaches:
Nezanesljivost meritve se lahko upošteva v skladu z enim 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 nezanesljivosti ob uporabi faktorja za zajetje 2, ki zagotavlja 95 % stopnjo zaupanja.
by establishing the decision limit (CCα) in accordance with Commission Decision 2002/657/EC (point 3.1.2.5 of the Annex — the case of substances with established permitted level).
z določitvijo odločitvene meje (CCα) v skladu z Odločbo Komisije 2002/657/ES (točka 3.1.2.5 Priloge – v primeru snovi z določeno dovoljeno mejo).
A lot is non-compliant if the measured value is equal to or above the CCα.The present interpretation rules apply for the analytical result obtained on the sample for official control.
Serija ni skladna, če je izmerjena vrednost enaka ali večja od CCα.Sedanja pravila razlage se uporabljajo za rezultat analize vzorca za uradni nadzor.
It does not affect the right of Member States to apply national rules to analyses for defence or referee purposes.
Ne vplivajo na pravico držav članic, da uporabljajo nacionalna pravila za analize za varovalne ali referenčne namene.
SAMPLE PREPARATION AND REQUIREMENTS FOR METHODS OF ANALYSIS USED IN OFFICAL CONTROL OF THE LEVELS OF DIOXINS (PCDD/PCDF) AND DIOXIN-LIKE PCBs
PRIPRAVA VZORCA IN ZAHTEVE ZA ANALITSKE METODE PRI URADNEM NADZORU RAVNI DIOKSINOV (PCDD/PCDF) IN DIOKSINOM PODOBNIH PCB
Objective and field of application
Cilj in področje uporabe
These requirements shall be applied where feed materials and feed are analysed for the determination of the dioxins (polychlorinated dibenzo-p-dioxins (PCDD) and polychlorinated dibenzofurans (PCDF)) and dioxin-like polychlorinated biphenyls (PCBs).
Te zahteve se uporabljajo, kadar se posamična krmila in krma analizirajo za določanje dioksinov (polikloriranih dibenzo-p-dioksinov (PCDD) in polikloriranih dibenzofuranov (PCDF)) ter dioksinom podobnih polikloriranih bifenilov (PCB).
Monitoring for the presence of dioxins in feed can be performed by a strategy involving a screening method in order to select those samples with levels of dioxins and dioxin-like PCBs that are less than 25 % below or exceed the level of interest.
Spremljanje prisotnosti dioksinov v krmi se lahko izvaja s presejalno metodo, da se izberejo tisti vzorci, katerih ravni dioksinov ali dioksinom podobnih PBC so nižje od 25 % ali so nad predpisano ravnjo.
The concentration of dioxins in those samples with significant levels needs to be determined/confirmed by a confirmatory method.
Kadar je koncentracija dioksinov v navedenih vzorcih povišana, jo je treba določiti/potrditi s potrditveno metodo.
Screening methods are methods that are used to detect the presence of dioxins and dioxin-like PCBs at the level of interest.
Presejalne metode so metode, ki se uporabljajo za ugotavljanje prisotnosti dioksinov in dioksinom podobnih PCB pri predpisani ravni.
These methods have a capacity for a high sample throughput and are used to sift large numbers of samples for potential positives.
Pri teh metodah je prepustnost vzorcev visoka in uporabljajo se za ločevanje številnih vzorcev na morebitne vzorce s pozitivnim rezultatom.
They are specifically designed to avoid false negatives.
So posebej oblikovane, da se preprečijo lažno negativni rezultati.
Confirmatory methods are methods that provide full or complementary information enabling the dioxins and dioxin-like PCBs to be identified and quantified unequivocally at the level of interest.
Potrditvene metode so metode, ki zagotavljajo celovite ali dopolnilne informacije ter natančno količinsko določitev dioksinov in dioksinom podobnih PCB pri predpisani ravni.
Because environmental and biological samples (including samples of feed materials/feed) in general contain complex mixtures of different dioxin congeners, the concept of Toxic Equivalency Factors (TEFs) has been developed to facilitate risk assessment.
Ker okoljski in biološki vzorci (vključno z vzorci posamičnih krmil/krme) na splošno vsebujejo kompleksne mešanice različnih dioksinov iste vrste, se je razvila zasnova dejavnikov ekvivalence toksičnosti (TEF), da se olajša ocena tveganja.
These TEFs have been established to express concentrations of mixtures of 2,3,7,8-substituted PCDDs and PCDFs and some non-ortho and mono-ortho chlorine substituted PCBs which possess dioxin-like activity in toxic equivalents (TEQs) of 2,3,7,8-TCDD.
Ti TEF-i so bili oblikovani za izražanje koncentracij mešanic 2,3,7,8-substituiranih PCDD in PCDF ter nekaterih ne-orto in mono-orto s klorom substituiranih PCB, ki imajo dioksinom podobne aktivnosti v ekvivalentih toksičnosti (TEQ) 2,3,7,8-TCDD.
The concentrations of the individual substances in a given sample are multiplied by their respective TEF and subsequently summed to give the total concentration of dioxin-like compounds expressed in TEQs.
Koncentracije posameznih snovi v danem vzorcu se pomnožijo z ustreznim TEF in nato seštejejo, da se izračuna celotna koncentracija dioksinom podobnih spojin, izraženih v ekvivalentih toksičnosti.
For the purposes of this Regulation only, the accepted specific limit of quantification of an individual congener is the concentration of an analyte in the extract of a sample which produces an instrumental response at two different ions to be monitored with an S/N (signal/noise) ratio of 3:1 for the less sensitive signal and fulfilment of the basic requirements such as e.g. retention time and isotope ratio according to the determination procedure as described in EPA method 1613 revision B.
Samo v tej uredbi je sprejemljiva specifična meja določljivosti posameznega pripadnika iste vrste tista koncentracija analita v ekstraktu vzorca, ki sproži instrumentalni odziv na dva različna iona, ki se spremljata z razmerjem S/Š (signal/šum) 3:1 za manj občutljiv signal, in izpolnjuje osnovne zahteve, npr. retencijski čas in razmerje izotopov v skladu s postopkom določanja, kakor je opisan v metodi EPA 1613, revizija B.
Quality assurance requirements to be complied with for sample preparation
Zahteve za zagotavljanje kakovosti, ki jih treba izpolnjevati pri pripravi vzorca
The general provisions on the preparation of samples for analysis as laid down in the Annex II are applicable.
Uporabljajo se splošne določbe za pripravo vzorcev za analizo iz Priloge II.
In addition following requirements have to be complied with:
Poleg tega je treba izpolnjevati naslednje pogoje:
The samples must be stored and transported in glass, aluminium, polypropylene or polyethylene containers.
vzorce je treba hraniti in prevažati v steklenih, aluminijastih, polipropilenskih ali polietilenskih posodah.
Traces of paper dust must be removed from the sample container.
Iz posode za vzorce je treba odstraniti sledi papirnega prahu.
Glassware shall be rinsed with solvents previously controlled for the presence of dioxins.
Steklena posoda se spere s topili, ki se predhodno preverijo zaradi prisotnosti dioksinov;
Perform a blank analysis by carrying out the entire analytical procedure omitting only the sample.
slepi preskus se izvede tako, da se izvede celotni analitski postopek brez vzorca;
Sample weight used for the extraction must be sufficient to fulfil the requirements with respect to sensitivity.
masa vzorca, ki se uporablja za ekstrakcijo, mora zadoščati za izpolnitev zahtev glede občutljivosti.
Requirements for laboratories
Zahteve za laboratorije
Laboratories shall demonstrate the performance of a method in the range of the level of interest, e.g. 0,5x, 1x and 2x the level of interest with an acceptable coefficient of variation for repeated analysis.
Laboratoriji dokažejo zmogljivost metode v območju predpisane vrednosti, tj. 0,5-kratna, 1-kratna in 2-kratna predpisana vrednost s sprejemljivim koeficientom variacije za ponovljene analize.
For details of acceptance criteria, see point 5.
Za podrobnosti o merilih sprejemljivosti glej točko 5.
Limit of quantification for a confirmatory method shall be in the range of about one fifth of the level of interest, to make sure that acceptable coefficients of variations are met in the range of the level of interest.
Meja kvantifikacije za potrditveno metodo je v območju približno ene petine predpisane vrednosti, s čimer se zagotovi, da so v območju predpisanih vrednosti sprejemljivi koeficienti variacije.
Regular blank controls and spiking experiments or analysis of control samples (preferably, if available, certified reference material) shall be performed as internal quality control measures.
Redne slepe kontrole in preskusi z dodatkom ali analize kontrolnih vzorcev (zaželen je certificiran referenčni material, če je na voljo) se izvajajo kot ukrepi za notranji nadzor kakovosti.
Successful participation in interlaboratory studies that assess laboratory proficiency is the best way to prove the competence in specific analyses.
Uspešno sodelovanje v medlaboratorijskih študijah, ki ocenjujejo uspešnost laboratorijev, je najboljši način za dokazovanje usposobljenosti za posebne analize.
However successful participation in interlaboratory studies for e.g. soil or sewage samples does not necessarily prove the competence also in the field of food or feed samples, which present lower contamination levels.
Vendar pa uspešno sodelovanje v medlaboratorijskih študijah, npr. za vzorce tal ali odplak, ne dokazuje nujno tudi usposobljenosti na področju vzorcev živil ali krme, ki predstavljajo nižje ravni onesnaženja.
Therefore, the continuous participation in interlaboratory studies for the determination of dioxins and dioxin-like PCBs in the relevant feed/food matrices is mandatory.
Zato je stalno sodelovanje v medlaboratorijskih študijah za določanje dioksinov in dioksinom podobnih PCB v ustreznih krmnih/živilskih matricah obvezna.
Laboratories shall be accredited by a recognised body operating in accordance with ISO Guide 58 to ensure that they are applying analytical quality assurance.
Laboratorije akreditirajo priznani organi, ki delujejo v skladu z ISO Guide 58, kar zagotovlja, da uporabljajo analitsko zagotavljanje kakovosti.
Laboratories shall be accredited following the ISO/IEC/17025 standard.
Laboratoriji se akreditirajo v skladu s standardom ISO/IEC/17025.
Requirements for the analytical procedures for dioxins and dioxin-like PCBS
Zahteve za analitske postopke za dioksine in dioksinom podobne PCB
For PCDDs and PCDFs, detectable quantities have to be in the picogram TEQ (10-12 g) range because of extreme toxicity of some of these compounds.
Za PCDD in PCDF morajo biti zaznavne količine v območju pikograma TEQ (10-12 g) zaradi visoke toksičnosti nekaterih od teh spojin.
PCBs are known to occur at higher levels than the PCDDs and PCDFs.
Za PCB je znano, da so njihove ravni višje od ravni PCDD in PCDF.
For most PCB congeners sensitivity in nanogram (10-9 g) range is already sufficient.
Za večino PCB pripadnikov iste vrste je občutljivost v območju nanograma (10-9 g) že zadostna.
However, for the measurement of the more toxic dioxin-like PCB congeners (in particular non-ortho substituted congeners), the same sensitivity must be reached as for the PCDDs and PCDFs.
Pri merjenju bolj toksičnih dioksinom podobnih PCB pripadnikov iste vrste (zlasti ne-orto substituiranih pripadnikov iste vrste) je treba doseči enako občutljivost kot za PCDD in PCDF;
High selectivity (specificity).
visoka selektivnost (specifičnost).
A distinction is required for PCDDs, PCDFs and dioxin-like PCBs from a multitude of other, coextracted and possibly interfering compounds present at concentrations up to several orders of magnitude higher than those of the analytes of interest.
Razlikovati je treba med PCDD, PCDF in dioksinom podobnimi PCB ter med številnimi drugimi, sočasno ekstrahiranimi spojinami ter po možnosti spojinami, ki motijo analizo in so prisotne v koncentracijah, ki so do več velikostnih razredov večje od koncentracij zadevnih analitov.
For gas chromatography/mass spectrometry (GC/MS) methods, a differentiation among various congeners is necessary, such as between toxic (e.g. the 17 2,3,7,8-substituted PCDDs and PCDFs and dioxin-like PCBs) and other congeners.
Pri metodi plinske kromatografije/masne spektrometrije (GC/MS) je treba razlikovati med različnimi pripadniki iste vrste, na primer med toksičnimi (npr. sedemnajstimi 2,3,7,8-substituiranimi PCDD in PCDF ter dioksinom podobnimi PCB) in pripadniki iste vrste.
Bioassays must be able to determine TEQ values selectively as the sum of PCDDs, PCDFs and dioxin-like PCBs.
Biološki preskusi morajo biti sposobni selektivno določiti vrednosti TEQ kot vsoto PCDD, PCDF in dioksinom podobnih PCB;
High accuracy (trueness and precision).
visoka točnost (pravilnost in natančnost).
The determination shall provide a valid and reliable estimate of the true concentration in a sample.
Določanje zagotovlja veljavne in zanesljive ocene pravih koncentracij v vzorcu.
High accuracy (accuracy of the measurement: the closeness of agreement between the result of a measurement with the true or assigned value of the measurand) is necessary to avoid the rejection of a sample analysis result on the basis of poor reliability of the estimate of TEQ.
Visoka točnost (točnost meritve: ujemanje merilnega rezultata s pravo ali dogovorjeno vrednostjo merilne veličine) je potrebna, da se prepreči zavrnitev rezultata analize vzorca na podlagi slabe zanesljivosti ocene TEQ.
Accuracy is expressed as trueness (difference between the mean value measured for an analyte in a certified material and its certified value, expressed as percentage of this value) and precision (RSDR, relative standard deviation calculated from results generated under reproducibility conditions).
Točnost se izrazi kot pravilnost (razlika med srednjo vrednostjo izmerjenega analita v certificiranem materialu, in njegovo certificirano vrednostjo, izraženo kot odstotek te vrednosti) in natančnost (RSDR, relativni standardni odmik od rezultatov, pridobljenih pri pogojih, ki jih je možno obnoviti).
Screening methods can comprise bioassays and GC/MS methods; confirmatory methods are high-resolution gas-chromatography/high-resolution mass-spectrometry (HRGC/HRMS) methods.
Presejalne metode lahko obsegajo biološke preskuse in metode GC/MS; potrditvene metode so visoko ločljive plinske kromatografske/visoko ločljive masne spektrometrične (HRGC/HRMS) metode.
Following criteria have to be complied with on total TEQ value:
Pri skupni vrednosti TEQ morajo biti izpolnjena naslednja merila:
False negative rate
Delež lažno negativnih rezultatov
Specific requirements for gc/ms methods to be complied with for screening or confirmatory purposes.
Posebne zahteve, ki jih morajo za presejanje ali potrditev izpolnjevati metode GC/MS
Addition of 13C-labelled 2,3,7,8-chlorine substituted internal PCDD/F standards and of 13C-labelled internal dioxin-like PCB standards must be carried out at the very beginning or start of the analytical method, e.g. prior to extraction in order to validate the analytical procedure.
Dodajanje s 13C-označenih 2,3,7,8-klor substituiranih notranjih PCDD/F standardov in s 13C-označenih notranjih standardov za dioksinom podobne PCB je treba izvesti na samem začetku analitske metode, npr. pred ekstrakcijo, da se potrdi analitski postopek.
At least one congener for each of the tetra to octa-chlorinated homologous groups for PCDD/F and at least one congener for each of the homologous groups for dioxin-like PCBs must be added (alternatively, at least one congener for each mass spectrometric selected ion recording function used for monitoring PCDD/F and dioxin-like PCBs).
Dodati je treba vsaj enega pripadnika iste vrste za vsako od tetra- do okta-kloriranih homolognih skupin za PCDD/F in vsaj enega pripadnika iste vrste za vsako od homolognih skupin za dioksinom podobne PCB (lahko pa se doda vsaj en pripadnik iste vrste za vsak spektrometrično izbran ion s funkcijo evidentiranja, ki se uporablja za spremljanje PCDD/F in dioksinom podobnih PCB).
There shall be a clear preference, certainly in case of confirmatory methods, of using all 17 13C-labelled 2,3,7,8-substituted internal PCDD/F standards and all 12 13C-labelled internal dioxin-like PCB standards.
Prednost ima, še zlasti v primeru potrditvenih metod, uporaba vseh 17 s 13C-označenih 2,3,7,8-klor substituiranih notranjih PCDD/F standardov in vseh 12 s 13C-označenih notranjih standardov za dioksinom podobne PCB.
Relative response factors shall also be determined for those congeners for which no 13C-labelled analogue is added by using appropriate calibration solutions.
Prav tako se z uporabo ustreznih raztopin za umerjanje določijo relativni faktorji odzivnosti za tiste pripadnike iste vrste, katerim ni dodan s 13C označen analog.
For feed of plant origin and feed of animal origin containing less than 10 % fat, the addition of the internal standards is mandatory prior to extraction.
Za krmo rastlinskega in živalskega izvora, ki vsebuje manj kot 10 % maščob, je obvezen dodatek notranjih standardov pred ekstrakcijo.
For feed of animal origin containing more than 10 % fat, the internal standards can be added either before extraction or after fat extraction.
Za krmo živalskega izvora, ki vsebuje več kot 10 % maščob, se notranji standardi lahko dodajo pred ekstrakcijo ali po ekstrakciji maščobe.
An appropriate validation of the extraction efficiency shall be carried out, depending on the stage at which internal standards are introduced and on whether results are reported on a product or fat basis.
Izvede se ustrezna potrditev učinkovitosti ekstrakcije, ki je odvisna od stopnje, na kateri se dodajo notranji standardi, in od tega, ali se o rezultatih poroča na podlagi proizvoda ali maščob.
Prior to GC/MS analysis, 1 or 2 recovery (surrogate) standard(s) must be added.
Pred analizo GC/MS je treba dodati 1 ali 2 (nadomestna) standarda za izračun izkoristka.
For confirmatory methods, the recoveries of the individual internal standards must be in the range of 60 % to 120 %.
Za potrditvene metode morajo biti izkoristki posameznih notranjih standardov 60–120-odstotni.
Lower or higher recoveries for individual congeners, in particular for some hepta- and octa- chlorinated dibenzodioxins and dibenzofurans, are acceptable on the condition that their contribution to the TEQ value does not exceed 10 % of the total TEQ value (based on sum of PCDD/F and dioxin-like PCBs).
Nižji ali višji izkoristki za posamezne pripadnike iste vrste, zlasti za nekatere hepta- in okta-klorirane dibenzodioksine in dibenzofurane, so sprejemljivi, če njihov prispevek k vrednosti TEQ ne presega 10 % celotne vrednosti TEQ (temelji na vsoti PCDD/F in dioksinom podobnih PCB).
For screening methods, the recoveries must be in the range of 30 % to 140 %.
Pri presejalnih metodah morajo biti izkoristki 30–140 %.
Separation of dioxins from interfering chlorinated compounds such as non-dioxin-like PCBs and chlorinated diphenyl ethers shall be carried out by suitable chromatographic techniques (preferably with a florisil, alumina and/or carbon column).
Ločevanje dioksinov od motečih kloriranih spojin, kot so dioksinom nepodobni PCB-ji in klorirani difenil etri, se izvede z ustreznimi kromatografskimi tehnikami (prednost imajo kolona s florizilom, kolona z aluminijevim oksidom in/ali kolona z ogljikom).
Gaschromatographic separation of isomers shall be sufficient (< 25 % peak to peak between 1,2,3,4,7,8-HxCDF and 1,2,3,6,7,8-HxCDF).
Plinsko kromatografsko ločevanje izomerov je zadostno (< 25 % vrh do vrha med 1,2,3,4,7,8-HxCDF in 1,2,3,6,7,8-HxCDF).
Determination shall be performed according to EPA Method 1613 revision B: Tetra- through octa-chlorinated dioxins and furans by isotope dilution HRGC/HRMS or another with equivalent performance criteria.
Določanje se izvede v skladu z metodo EPA, revizija 1613 B: tetra- do okta-klorirani dioksini in furani z redčenjem izotopov HRGC/HRMS ali drugi z enakovrednimi merili zmogljivosti.
The difference between upperbound level and lower bound level must not exceed 20 % for feed with a dioxin contamination in the range or above the maximum level.
Razlika med vrednostjo, zaokroženo navzgor, in vrednostjo, zaokroženo navzdol, ne sme presegati 20 % pri krmi, onesnaženi z dioksini v območju najvišje vrednosti ali nad njo.
For feed with contamination levels well below the maximum level, the difference may be in the range of 25 %-40 %.
Pri krmi z ravnjo onesnaženosti bistveno pod najvišjo vrednostjo je lahko razlika 25–40-odstotna.
Screening methods of analysis
Presejalne analitske metode
Different analytical approaches can be performed using a screening method: a pure screening approach and a quantitative approach.
Pri presejalni metodi se lahko uporabita različna analitska pristopa: čisti presejalni pristop in kvantitativni pristop.
Samples with a response less than the reference are declared negative, those with a higher response are suspected positives.
Vzorci z odzivom, ki je manjši od odziva referenčnega vzorca, so negativni, vzorci z višjim odzivom pa so verjetno pozitivni.
A blank and a reference sample(s) have to be included in each test series, which is extracted and tested at the same time under identical conditions.
v vsako serijo preskusov je treba vključiti slepe in referenčne vzorce, ki se ekstrahirajo in preskušajo sočasno in pod enakimi pogoji.
The reference sample must show a clearly elevated response in comparison to a blank.
Pri referenčnem vzorcu mora biti odziv jasno povišan glede na slepega;
Additional reference samples at 0,5x and 2x the level of interest shall be included to demonstrate the proper performance of the test in the range of interest for the control of the level of interest.
vključijo se dodatni referenčni vzorci z 0,5-kratno in 2-kratno predpisano vrednostjo, da se dokaže primerna zmogljivost preskusa v območju predpisane vrednosti;