Division 2.2 As regards PCDD/Fs and dioxin-like PCBsF1

United Kingdom

The lot or sublot complies with the maximum level if the result of a single analysis

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 laid down by F2the CMU Regulations,
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 laid down by the CMU Regulations, taking into account the expanded measurement uncertainty.

For screening assays a cut-off value shall be established for decisions on sample compliance with the respective maximum levels set for either PCDD/Fs, or for the sum of PCDD/Fs and dioxin-like PCBs.

The lot or sublot does not comply with the maximum level as laid down by the CMU Regulations if the mean of two upper-bound^f1 analytical results obtained from duplicate analysis^f2 using a confirmatory method, taking into account the expanded measurement uncertainty, exceeds the maximum level beyond reasonable doubt, i.e. the analysed concentration after deduction of the expanded measurement uncertainty is used to assess compliance.

The expanded measurement uncertainty is calculated using a coverage factor of 2 which gives a level of confidence of approximately 95 %. A lot or sublot is non-compliant if the mean of the measured values minus the expanded uncertainty of the mean is above the maximum level.

The sum of the estimated expanded uncertainties of the separate analytical results of PCDD/Fs and dioxin-like PCBs shall be used for the sum of PCDD/Fs and dioxin-like PCBs.

The rules, mentioned in the paragraphs above under this point, shall apply for the analytical result obtained on the sample for official control. In case of analysis for defence or reference purposes, F3enactments other than EU-derived domestic legislation apply.

Annotations

Textual amendments

F1: Substituted by Commission Regulation (EU) 2017/771 of 3 May 2017 amending Regulation (EC) No 152/2009 as regards the methods for the determination of the levels of dioxins and polychlorinated biphenyls (Text with EEA relevance).
F2: Words in Annex 5 Pt. B Ch. 1 point 2.2 substituted (31.12.2022) by The Food and Feed (Miscellaneous Amendments) Regulations 2022 (S.I. 2022/1351), regs. 1(1), 16(6)(a)(iii)
F3: Words in Annex 5 Pt. B Ch. 1 point 2.2 substituted (31.12.2020) by The Animal Feed (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/654), regs. 1, 89(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

Footnotes

f1: The concept of ‘ upper-bound ’ requires using the limit of quantification for the contribution of each non-quantified congener to the Toxic Equivalent (TEQ). The concept of ‘ lower-bound ’ requires using zero for the contribution of each non-quantified congener to the TEQ. The concept of ‘ medium-bound ’ requires using half of the limit of quantification calculating the contribution of each non-quantified congener to the TEQ.
f2: In general, the requirements for duplicate analysis as provided for in Annex II, Chapter C, point 2 apply. However, for confirmatory methods with the use of ¹³ C-labelled internal standard for the relevant analytes, the duplicate analysis is only necessary if the result of the first determination is not compliant. The duplicate analysis is necessary to exclude the possibility of internal cross-contamination or an accidental mix-up of samples. In case the analysis is performed in the course of a contamination incident, confirmation by duplicate analysis may be omitted in case the samples selected for analysis are through traceability linked to the contamination incident and the level found is significantly above the maximum level.