{
  "url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.2/division-4.3.2.4",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.2/division-4.3.2.4.json",
  "legislation": "eur/2006/401",
  "legislation_title": "Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2006-401",
  "path": "annex/II/division/4/division/4.3/division/4.3.2/division/4.3.2.4",
  "kind": "division",
  "number": "4.3.2.4",
  "heading": "Determination of cut-off level and rate of false suspected results of blank samples",
  "text": "The (relative) responses for the negative control and positive control samples are taken as basis for the calculation of the required parameters.\nScreening methods with a response proportional with the mycotoxin concentration\nFor screening methods with a response proportional with the mycotoxin concentration the following applies:\nCut-off = R STC – t-value 0,05 * SD STC\nR STC = mean response of the positive control samples (at STC)\nt-value: one tailed t-value for a rate of false negative results of 5 % (see table B)\nSD STC = standard deviation\nScreening methods with a response inversely proportional with the mycotoxin concentration\nSimilarly, for screening methods with a response inversely proportional with the mycotoxin concentration, the cut-off is determined as:\nCut-off = R STC + t-value 0,05 * SD STC\nBy using this specific t-value for establishing the cut-off value, the rate of false negative results is by default set at 5 %.\nFitness for purpose assessment\nResults from the negative control samples are used to estimate the corresponding rate of false suspect results. The t-value is calculated corresponding to the event that a result of a negative control sample is above the cut off value, thus erroneously classified as suspect.\nt-value (cut off – mean blank )/SD blank\nfor screening methods with a response proportional with the mycotoxin concentration\nor\nt-value ( mean blank – cut off)/SD blank\nfor screening methods with a response inversely proportional with the mycotoxin concentration\nFrom the obtained t-value, based on the degrees of freedom calculated from the number of experiments, the probability of false suspect samples for a one tailed distribution can either be calculated (e.g.. spread sheet function ‘ TDIST ’ ) or taken from a table for t-distribution.\nThe corresponding value of the one tailed t-distribution specifies the rate of false suspect results.\nThis concept is described in detail with an example in Analytical and Bioanalytical Chemistry DOI 10.1007/s00216 -013-6922-1.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) No 519/2014 of 16 May 2014 amending Regulation (EC) No 401/2006 as regards methods of sampling of large lots, spices and food supplements, performance criteria for T-2, HT-2 toxin and citrinin and screening methods of analysis (Text with EEA relevance)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2006/401/annex/II/division/4/division/4.3/division/4.3.2/division/4.3.2.4",
    "retrieved_at": "2026-11-01T14:53:51.511015+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."
}