Commission Regulation (EU) 2017/644Show full title

ANNEX I U.K. DEFINITIONS AND ABBREVIATIONS

I. DEFINITIONS U.K.

For the purposes of this Regulation the definitions laid down in Annex I to Decision 2002/657/EC shall apply.

Further to those definitions, the following definitions shall apply for the purposes of this Regulation:

1.1.

‘Action level’ means the level of a given substance, as laid down in [F1 Annex 5], which triggers investigations to identify the source of that substance in cases where increased levels of the substance are detected.

1.2.

‘Screening methods’ means methods used for the selection of those samples with levels of PCDD/Fs and dioxin-like PCBs that exceed the maximum levels or the action levels. They shall allow for a cost-effective high sample-throughput, thus increasing the chance of discovering new cases where high exposure may lead to health risks for consumers. Screening methods shall be based on bioanalytical or GC-MS methods. Results from samples exceeding the cut-off value established to check compliance with the maximum level shall be verified by a full re-analysis from the original sample using a confirmatory method.

1.3.

‘Confirmatory methods’ means methods that provide full or complementary information enabling the PCDD/Fs and dioxin-like PCBs to be identified and quantified unequivocally at the maximum or, in case of need, at the action level. Such methods utilise gas chromatography/high resolution mass spectrometry (GC-HRMS) or gas chromatography/tandem mass spectrometry (GC-MS/MS).

1.4.

‘Bioanalytical methods’ means methods based on the use of biological principles such as cell-based assays, receptor-assays or immunoassays. They do not give results at the congener level but merely an indication(1) of the TEQ level, expressed in Bioanalytical Equivalents (BEQ) to acknowledge the fact that not all compounds present in a sample extract that produce a response in the test may meet all requirements of the TEQ-principle.

1.5.

‘Bioassay apparent recovery’ means the BEQ level calculated from the TCDD or PCB 126 calibration curve corrected for the blank and then divided by the TEQ level determined by the confirmatory method. It attempts to correct factors like the loss of PCDD/Fs and dioxin-like compounds during the extraction and clean-up steps, co-extracted compounds increasing or decreasing the response (agonistic and antagonistic effects), the quality of the curve fit, or differences between the TEF and the REP values. The bioassay apparent recovery is calculated from suitable reference samples with representative congener patterns around the maximum or action level.

1.6.

‘Duplicate analysis’ means separate analysis of the analytes of interest using a second aliquot of the same homogenised sample.

1.7.

‘Accepted specific limit of quantification(2) of an individual congener in a sample’ means the lowest content of the analyte that can be measured with reasonable statistical certainty, fulfilling the identification criteria as described in internationally recognised standards, for example, in standard EN 16215:2012 ('Animal feed — Determination of dioxins and dioxin-like PCBs by GC/HRMS and of indicator PCBs by GC/HRMS') and/or in EPA methods 1613 and 1668 as revised.

The limit of quantification of an individual congener may be identified as

(a)

the concentration of an analyte in the extract of a sample which produces an instrumental response at two different ions to be monitored with a S/N (signal/noise) ratio of 3:1 for the less intensive raw data signal;

or, if for technical reasons the signal-to-noise calculation does not provide reliable results,

(b)

the lowest concentration point on a calibration curve that gives an acceptable (≤ 30 %) and consistent (measured at least at the start and at the end of an analytical series of samples) deviation to the average relative response factor calculated for all points on the calibration curve in each series of samples(3).

1.8.

‘Upper-bound’ means the concept which requires using the limit of quantification for the contribution of each non-quantified congener.

1.9.

‘Lower-bound’ means the concept which requires using zero for the contribution of each non-quantified congener.

1.10.

‘Medium-bound’ means the concept which requires using half of the limit of quantification calculating the contribution of each non-quantified congener.

1.11.

‘Lot’ means an identifiable quantity of food delivered at one time and determined by the official to have common characteristics, such as origin, variety, type of packing, packer, consignor or markings. In the case of fish and fishery products, also the size of fish shall be comparable. In case the size and/or weight of the fish is not comparable within a consignment, the consignment may still be considered as a lot but a specific sampling procedure has to be applied.

1.12.

‘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.

1.13.

‘Incremental sample’ means a quantity of material taken from a single place in the lot or sublot.

1.14.

‘Aggregate sample’ means the combined total of all the incremental samples taken from the lot or sublot.

1.15.

‘Laboratory sample’ means a representative part/quantity of the aggregate sample intended for the laboratory.

Textual Amendments

F1 Words in Annex 1 para. 1.1 substituted (31.12.2020) by The Contaminants in Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/639), regs. 1, 38; 2020 c. 1, Sch. 5 para. 1(1)

II. ABBREVIATIONS USED U.K.

BEQ

Bioanalytical Equivalents

GC

Gas chromatography

HRMS

High resolution mass spectrometry

LRMS

Low resolution mass spectrometry

MS/MS

Tandem mass spectrometry

PCB

Polychlorinated biphenyl

Non-dioxin-like PCBs

PCB 28, PCB 52, PCB 101, PCB 138, PCB 153 and PCB 180

PCDD

Polychlorinated dibenzo-p-dioxins

PCDF

Polychlorinated dibenzofurans

QC

Quality control

REP

Relative potency

TEF

Toxic Equivalency Factor

TEQ

Toxic Equivalents

TCDD

2,3,7,8-Tetrachlorodibenzo-p-dioxin

U

Expanded measurement uncertainty

(1)

Bioanalytical methods are not specific to those congeners included in the TEF-scheme. Other structurally related AhR-active compounds may be present in the sample extract which contribute to the overall response. Therefore, bioanalytical results cannot be an estimate but rather an indication of the TEQ level in the sample.

(2)

The principles as described in the 'Guidance Document on the Estimation of LOD and LOQ for Measurements in the Field of Contaminants in Feed and Food' [link to website] shall be followed when applicable.

(3)

The LOQ is calculated from the lowest concentration point taking into account the recovery of internal standards and sample intake.