FrancophonIA/DGT-Translation_Memory huggingface dataset:
English: For foodstuffs of animal origin containing more than 10 % fat, the internal standards may be added either before or after fat extraction. 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 product or fat basis.
French: Pour les denrées alimentaires d’origine végétale et les denrées alimentaires d’origine animale contenant moins de 10 % de graisses, il est obligatoire d’ajouter les étalons internes avant la phase d’extraction.
Italian: Deve essere aggiunto almeno un congenere per ciascuno dei gruppi omologhi da tetra a octaclorati di PCDD/F e almeno un congenere per ciascuno dei gruppi omologhi di PCB diossina-simile (in alternativa, almeno un congenere per ciascuna funzione di registrazione di ioni selezionati tramite spettrometria di massa utilizzata per il monitoraggio di PCDD/F e PCB diossina-simili).
Swedish: För livsmedel som innehåller mindre än 10 % fett och är av vegetabiliskt eller animaliskt ursprung ska interna standarder tillsättas innan extraktionen görs.
Lithuanian: Jeigu augalinių ir gyvūninių maisto produktų sudėtyje yra mažiau kaip 10 proc. riebalų, vidinius etalonus būtina įdėti prieš ekstrahavimą.
English: SPECIFIC REQUIREMENTS FOR BIOANALYTICAL METHODS Bioanalytical methods are methods based on the use of biological principles like cell-based assays, receptor-assays or immunoassays.
French: PRESCRIPTIONS SPÉCIFIQUES APPLICABLES AUX MÉTHODES DE BIOANALYSE
Slovenian: POSEBNE ZAHTEVE ZA BIOANALITSKE METODE
English: This point 8 establishes requirements for bioanalytical methods in general. A screening method in principle classifies a sample as compliant or suspected to be non-compliant.
French: Les méthodes de bioanalyse sont des méthodes fondées sur le recours aux principes biologiques tels que les bioessais cellulaires, les tests d’interaction récepteurs ou les immuno-essais.
Swedish: I denna punkt (punkt 8) fastställs krav på bioanalytiska metoder i allmänhet.
Slovenian: Bioanalitske metode so metode, ki temeljijo na uporabi bioloških načel, kot so testi na celični osnovi, testi na osnovi receptorjev ali imunološki testi.
English: BEQ DL BEQ corresponding to the GC/HRMS decision limit, being the ML including measurement uncertainty
French: BEQ correspondant à la limite de décision de la CG/SMHR, soit la TM compte tenu de l’incertitude de mesure
English: SD R standard deviation of bioassay results at BEQDL, measured under within-laboratory reproducibility conditions
French: Écart type des résultats de bioanalyse à la BEQDL, mesuré dans des conditions de reproductibilité intralaboratoire
English: ‘Action level’ means the level of a given substance, as laid down in Annex to Recommendation 2011/516/EU, which triggers investigations to identify the source of that substance in cases where increased levels of the substance are detected. 1.2. ‘Bioanalytical methods’ means methods based on the use of biological principles like cell-based assays, receptor-assays or immunoassays.
Italian: Livello di azione livello di una data sostanza, definito nell'allegato della raccomandazione 2011/516/UE, che, nel caso in cui ne sia rilevato il superamento, determina l'avvio di indagini per individuare la fonte di tale sostanza.
English: ‘Sublot’ means designated part of a large lot in order to apply the sampling method on that designated part. Each sublot must be physically separated and identifiable.
Italian: Sottopartita porzione di una partita di grandi dimensioni cui è applicato il metodo di campionamento; ogni sottopartita deve essere fisicamente separata e identificabile.
English: selection of those samples with levels of PCDD/Fs and dioxin-like PCBs that exceed the maximum levels, or the action levels. 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.
Italian: la selezione di campioni con livelli di PCDD/F e di PCB diossina-simili superiori ai livelli massimi o ai livelli di azione, eventualmente ricorrendo a un metodo di screening che permetta un alto throughput di campioni a costi commisurati all'efficacia, in modo da accrescere la possibilità di scoprire nuovi incidenti con alta esposizione e rischi per la salute dei consumatori.
English: These methods can be used for confirmation of results obtained by screening methods and for determination of low background levels in food monitoring. They are also important for establishing congener patterns in order to identify the source of a possible contamination.
Italian: Questi metodi possono essere utilizzati per la conferma dei risultati ottenuti con i metodi di screening e per la determinazione dei livelli di background bassi nel monitoraggio dei prodotti alimentari; sono importanti anche per stabilire pattern di congeneri per identificare la fonte di una possibile contaminazione.
English: If this measured concentration is more than 25 % lower than the calculated (sum) concentration, this is an indication of a potential signal suppression and the respective sample must be submitted to GC/HRMS confirmatory analysis. Results shall be monitored in quality control charts. Quality control on compliant samples Approximately 2 to 10 % of the compliant samples, depending on sample matrix and laboratory experience, shall be confirmed by GC/HRMS.
Italian: Se la concentrazione misurata è inferiore di più del 25 % alla concentrazione (somma) calcolata, si ha un'indicazione di una potenziale soppressione del segnale e il rispettivo campione deve essere sottoposto ad analisi di conferma GC/HRMS.
Lithuanian: Bioanalitiniams ląstelių metodams taikomi šio priedo 8 punkte nustatyti specialieji reikalavimai.
English: In case of confirmatory methods, all 17 13C-labelled 2,3,7,8-substituted internal PCDD/F standards and all 12 13C-labelled internal dioxin-like PCB standards shall be used. Relative response factors shall also be determined for those congeners for which no 13C-labelled analogue is added by using appropriate calibration solutions. For foodstuffs of plant origin and foodstuffs of animal origin containing less than 10 % fat, the addition of the internal standards is mandatory prior to extraction.
Italian: All'inizio del metodo d'analisi, ad esempio prima dell'estrazione, devono essere aggiunti standard interni di PCDD/F 2,3,7,8-clorosostituiti e marcati con 13C e standard interni di PCB diossina-simile marcati con 13C per convalidare la procedura d'analisi.
English: tα,f=m-2 1/n + 1/m + xi – x– 2 /Qxx with: BEQ DL
Italian: tα,f=m-2
English: BEQ corresponding to the GC/HRMS decision limit, being the ML including measurement uncertainty s y,x
Italian: 1/n + 1/m + xi
English: xi GC/HRMS sample concentration (in TEQ) of calibration point i
Italian: BEQ corrispondente al limite di decisione GC/HRMS, ossia al livello massimo compresa l'incertezza di misura
English: mean of the concentrations (in TEQ) of all calibration samples Qxx = Σj=1 m xi – x–
Italian: deviazione standard residua
English: Calculation of cut-off values based on a 95 % level of confidence implying a false-compliant rate < 5 %, and a RSDR < 25 %: 1. from the lower band of the 95 % prediction interval at the HRGC/HRMS decision limit, 2. from multiple analysis of samples (n ≥ 6) contaminated at the HRGC/HRMS decision limit as the lower endpoint of the data distribution (represented in the figure by a bell-shaped curve) at the corresponding mean BEQ value. 8.3.4. Restrictions to cut-off values: BEQ-based cut-off values calculated from the RSDR achieved during validation using a limited number of samples with different matrix/congener patterns may be higher than the TEQ-based levels of interest due to a better precision than attainable in routine when an unknown spectrum of possible congener patterns has to be controlled.
Italian: Calcolo dei valori di cut-off in base a un livello di fiducia del 95 % implicante un tasso di falsi conformi < 5 %, e un RSDR < 25 %: 1. a partire dalla banda inferiore dell'intervallo di predizione del 95 % al limite di decisione HRGC/HRMS, 2. a partire dall'analisi multipla di campioni (n ≥ 6) contaminati al limite di decisione HRGC/HRMS come endpoint inferiore della distribuzione dei dati (rappresentata nella figura da una curva a campana) al corrispondente valore BEQ medio.
English: Performance characteristics Since no internal standards can be used in bioanalytical methods, tests on repeatability shall be carried out to obtain information on the standard deviation within and between test series.
Italian: In tali casi, i valori di cut-off sono calcolati a partire da una RSDR = 25 %, o sono preferiti i due terzi del livello di interesse.
English: As part of the validation process, the test must be shown to discriminate between a blank sample and a level at the cut-off value, allowing the identification of samples above the corresponding cut-off value (see 8.1.2). Target compounds, possible interferences and maximum tolerable blank levels shall be defined.
Italian: La ripetibilità è inferiore al 20 %, la riproducibilità in laboratorio inferiore al 25 % in base ai livelli calcolati in BEQ dopo correzione del bianco e del recupero.
English: The percent standard deviation in the response or concentration calculated from the response (only possible in working range) of a triplicate determination of a sample extract shall not be above 15 %. The uncorrected results of the reference sample(s) expressed in BEQs (blank and level of interest) shall be used for evaluation of the performance of the bioanalytical method over a constant time period. Quality control (QC) charts for procedure blanks and each type of reference sample shall be recorded and checked to make sure the analytical performance is in accordance with the requirements, in particular for the procedure blanks with regard to the requested minimum difference to the lower end of the working range and for the reference samples with regard to within-laboratory reproducibility.
Italian: Nel processo di validazione il test deve permettere di distinguere tra un campione in bianco e un livello al valore di cut-off, consentendo l'identificazione dei campioni al di sopra del corrispondente valore di cut-off (cfr. 8.1.2).
English: Number of packages or units in the lot/sublot Number of packages or units to be taken
Lithuanian: Pakuočių arba vienetų skaičius partijoje arba jos dalyje
English: 1 to 25 at least 1 package or unit
Lithuanian: Imtinų pakuočių arba vienetų skaičius
English: 20 % to + 20 % Repeatability (RSDr)
Lithuanian: Patvirtinamieji metodai
English: < 20 % Within-laboratory reproducibility (RSDR) < 25 % < 15 %
Lithuanian: Klaidingų atitikimo nustatymo rezultatų dalis [2]
English: There must be a continuous programme for control of compliant results. Check on possible suppression of the cell response and cytotoxicity
Lithuanian: Atkuriamumas vienoje laboratorijoje (SSNR)
English: Actual false-compliant rates shall be below 5 %. After a minimum of 20 confirmed results per matrix/matrix group is available from the quality control of compliant samples, conclusions on the false-compliant rate shall be drawn from this database. The results from samples analysed in ring trials or during contamination incidents, covering a concentration range up to, e.g. 2 × the maximum level (ML), may also be included in the minimum of 20 results for evaluation of the false-compliant rate. The samples shall cover most frequent congener patterns, representing various sources. Although screening assays shall preferentially aim at detecting samples exceeding the action level, the criterion for determining false-compliant rates is the maximum level, taking into account the measurement uncertainty of the confirmatory method.
Lithuanian: Atliekant įprastinę analizę, būtina patikrinti atrankinio metodo tinkamumą; tai daroma taikant analizės kokybės kontrolę ir nuolat tikrinant metodo pagrįstumą.
English: Potential non-compliant results from screening shall always be verified by a confirmatory method of analysis (GC/HRMS). These samples may also be used to evaluate the rate of false-non-compliant results. For screening methods, the rate of ‘false-non-compliant results’ is the fraction of results confirmed to be compliant from GC/HRMS confirmatory analysis, while in previous screening the sample had been declared to be suspected to be non-compliant.
Lithuanian: Turi būti vykdoma tęstinė reikalavimus atitinkančių rezultatų kontrolės programa.
English: However, evaluation of the advantageousness of the screening method shall be based on comparison of false-non-compliant samples with the total number of samples checked. This rate shall be low enough to make the use of a screening tool advantageous. At least under validation conditions, bioanalytical methods shall provide a valid indication of the TEQ level, calculated and expressed as BEQ. Also for bioanalytical methods carried out under repeatability conditions, the intra-laboratory RSDr would typically be smaller than the reproducibility RSDR.
Lithuanian: Galimo ląstelių atsako slopinimo ir citoksiškumo tikrinimas
English: SPECIFIC REQUIREMENTS FOR GC/HRMS METHODS TO BE COMPLIED WITH FOR SCREENING OR CONFIRMATORY PURPOSES 7.1. General requirements
Lithuanian: 20 proc. mėginio ekstraktų matuojama atliekant įprastinę atranką pridėjus dominančio lygmens koncentracijos 2, 3, 7, 8 eilės TCDD arba be jų, siekiant patikrinti, ar atsaką gali slopinti mėginio ekstrakte esančios jam galinčios trukdyti medžiagos.
English: The difference between upper-bound level and lower bound level shall not exceed 20 % for foodstuffs with a contamination of about 1 pg WHO-TEQ/g fat (based on the sum of PCDD/Fs and dioxin-like PCBs). For foodstuffs with a low fat content, the same requirements for contamination levels of about 1 pg WHO-TEQ/g product have to be applied.
Lithuanian: Išmatuota įdėtosios analitės koncentracija palyginama su nežymėto ekstrakto koncentracijos ir žymėtų etalonų koncentracijos suma.
English: SD R
Latvian: SDR
Lithuanian: SN R
English: /Qxx
Latvian: /Qxx.
English: The provisions laid down in this Regulation relate only to the sampling and analysis of dioxins, dioxin-like PCBs and non-dioxin-like PCBs for the implementation of Regulation (EC) No 1881/2006. They do not affect the sampling strategy, sampling levels and frequency as specified in Annexes III and IV to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC [5].
Slovenian: Določbe iz te uredbe obravnavajo le vzorčenje in analizo dioksinov, dioksinom podobnih PCB in dioksinom nepodobnih PBC za izvajanje Uredbe (ES) št. 1881/2006 Ne vplivajo pa na strategijo, količine in pogostnost vzorčenja iz prilog III in IV k Direktivi Sveta 96/23/ES z dne 29. aprila 1996 o ukrepih za spremljanje nekaterih snovi in njihovih ostankov v živih živalih in v živalskih proizvodih ter razveljavitvi direktiv 85/358/EGS in 86/469/EGS in odločb 89/187/EGS in 91/664/EGS [5].
Maltese: Id-dispożizzjonijiet stabbiliti f’dan ir-Regolament jikkonċernaw biss it-teħid ta’ kampjuni u l-analiżi ta’ diossini, PCB simili għad-diossini u PCB mhux simili għad-diossini għall-implimentazzjoni tar-Regolament (KE) Nru 1883/2006 Dawn ma jaffettwawx l-istrateġija tat-teħid ta’ kampjuni, il-livelli u l-frekwenza tat-teħid ta’ kampjuni kif speċifikat fl-Annessi III u IV tad-Direttiva tal-Kunsill 96/23/KE tad-29 ta’ April 1996 dwar miżuri għall-monitoraġġ ta’ ċerti sustanzi u residwi tagħhom f’annimali ħajjin u prodotti tal-annimali u li tħassar id-Direttivi 83/358/KEE u 86/469/KEE u d-Deċiżjonijiet 89/187/KEE u 91/664/KEE [5].
English: This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.20on (EC) No 1881/2006 shall be carried out in accordance with the requirements for analytical procedures set out in Annex IV to this Regulation.
Maltese: Dan ir-Regolament għandu jidħol fis-seħħ fl-20 jum wara l-pubblikazzjoni tiegħu f’Il-Ġurnal Uffiċjali tal-Unjoni Ewropea.
English: In case of confirmatory methods, all 17 13C-labelled 2,3,7,8-substituted internal PCDD/F standards and all 12 13C-labelled internal dioxin-like PCB standards shall be used. Relative response factors shall also be determined for those congeners for which no 13C-labelled analogue is added by using appropriate calibration solutions.
Maltese: Fil-każ ta’ metodi konfermatorji, għandhom jintużaw is-17-il standard intern kollha ta’ PCDD/F sostitwiti għal 2,3,7,8 ttikkettati bi 13C u t-12-il standard intern kollha ta’ PCB simili għad-diossini ttikkettati bi 13C.
English: Reference samples used for recovery correction must comply with requirements as given in point 8.2. 8.1.2.2. Calibration with reference samples
Slovenian: Za popravek izkoristka mora biti navidezni izkoristek vedno v zahtevanem območju (glej točko 8.1.4).
English: Number of incremental samples The aggregate sample uniting all incremental samples shall be at least 1 kg (see point II.5 of this Annex). The minimum number of incremental samples to be taken from the lot or sublot shall be as given in Tables 3 and 4. In the case of bulk liquid products the lot or sublot shall be thoroughly mixed in so far as possible and in so far as it does not affect the quality of the product, by either manual or mechanical means immediately prior to sampling. In this case, a homogeneous distribution of contaminants is assumed within a given lot or sublot. It is therefore sufficient to take three incremental samples from a lot or sublot to form the aggregate sample. The incremental samples shall be of similar weight. The weight of an incremental sample shall be at least 100 grams. Departure from this procedure must be recorded in the record provided for under point II.8 of this Annex. In accordance with the provisions of Commission Decision 97/747/EC of 27 October 1997 fixing the levels and frequencies of sampling provided for by Council Directive 96/23/EC for the monitoring of certain substances and residues thereof in certain animal products [1], the aggregate sample size for hen eggs is at least 12 eggs (for bulk lots as well for lots consisting of individual packages, Tables 3 and 4 shall apply).Table 3 Minimum number of incremental samples to be taken from the lot or sublot Weight or volume of lot/sublot (in kg or litre) Minimum number of incremental samples to be taken < 50 3 50 to 500
Swedish: Antal delprov
English: If the lot or sublot consists of individual packages or units, then the number of packages or units which shall be taken to form the aggregate sample is given in Table 4. Table 4
Swedish: I enlighet med kommissionens beslut 97/747/EG av den 27 oktober 1997 om fastställande av omfattning och frekvens av provtagningar som föreskrivs i rådets direktiv 96/23/EG för kontroll av vissa ämnen och restsubstanser av dessa i vissa animaliska produkter [1] ska storleken på samlingsprov för hönsägg vara minst 12 ägg (både för bulkpartier och partier som består av enskilda förpackningar ska tabellerna 3 och 4 tillämpas).Tabell 3
English: Control of recoveries for clean-up The loss of compounds during the clean-up shall be checked during validation.
Swedish: Hur stor förlusten av föreningar är under uppreningen ska kontrolleras under valideringen.