{
  "url": "https://openlegislation.uk/eu-regulation-2017-644/annex-III/division-7/division-7.4",
  "json_url": "https://openlegislation.uk/eu-regulation-2017-644/annex-III/division-7/division-7.4.json",
  "legislation": "eur/2017/644",
  "legislation_title": "Commission Regulation (EU) 2017/644 of 5 April 2017 laying down methods of sampling and analysis for the control of levels of dioxins, dioxin-like PCBs and non-dioxin-like PCBs in certain foodstuffs and repealing Regulation (EU) No 589/2014 (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2017-644",
  "path": "annex/III/division/7/division/7.4",
  "kind": "division",
  "number": "7.4",
  "heading": "Performance characteristics",
  "text": "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. Repeatability shall be below 20 % and intra-laboratory reproducibility shall be below 25 %. This shall be based on the calculated levels in BEQs after blank and recovery correction.\nAs 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 point 7.1.2).\nTarget compounds, possible interferences and maximum tolerable blank levels shall be defined.\nThe per cent 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 %.\nThe uncorrected results of the reference sample(s) expressed in BEQs (blank and at the maximum or action level) shall be used for evaluation of the performance of the bioanalytical method over a constant time period.\nQCcharts 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. Procedure blanks must be well controlled in order to avoid false-compliant results when subtracted.\nThe results from the confirmatory methods of suspected samples and 2 to 10 % of the compliant samples (minimum of 20 samples per matrix) shall be collected and used to evaluate the performance of the screening method and the relationship between BEQs and TEQs. This database might be used for re-evaluation of cut-off values applicable to routine samples for the validated matrices.\nSuccessful method performance may also be demonstrated by participation in ring trials. The results from samples analysed in ring trials, covering a concentration range up to, e.g. 2× ML, may also be included in the evaluation of the false-compliant rate, if a laboratory is able to demonstrate its successful performance. The samples shall cover most frequent congener patterns, representing various sources.\nDuring incidents, the cut-off values may be re-evaluated, reflecting the specific matrix and congener patterns of this single incident.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2017/644/annex/III/division/7/division/7.4",
    "retrieved_at": "2026-11-01T14:45:03.439389+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}