{
  "url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.2/division-4.3.2.3/division-4.3.2.3.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.2/division-4.3.2.3/division-4.3.2.3.1.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/4.3.2.3/division/4.3.2.3.1",
  "kind": "division",
  "number": "4.3.2.3.1",
  "heading": "Initial validation by single laboratory validation",
  "text": "Mycotoxins:\nThe validation shall be performed for every individual mycotoxin in the scope. In case of bio-analytical methods that give a combined response for a certain mycotoxin group (e.g. aflatoxins B 1 , B 2 , G 1 & G 2 ; fumonisins B 1 & B 2 ), applicability must be demonstrated and limitations of the test mentioned in the scope of the method. Undesired cross-reactivity (e.g. DON-3-glycoside, 3- or 15-acetyl-DON for immuno-based methods for DON) is not considered to increase the false negative rate of the target mycotoxins, but may increase the false suspect rate. This unwanted increasing will be diminished by confirmatory analysis for unambiguous identification and quantification of the mycotoxins.\nMatrices:\nAn initial validation should be performed for each commodity, or, when the method is known to be applicable to multiple commodities, for each commodity group. In the latter case, one representative and relevant commodity is selected from that group (see table A).\nSample set:\nThe minimum number of different samples required for validation is 20 homogeneous negative control samples and 20 homogeneous positive control samples that contain the mycotoxin at the STC, analysed under intermediate precision (RSD Ri ) conditions spread over 5 different days. Optionally, additional sets of 20 samples containing the mycotoxin at other levels can be added to the validation set to gain insight to what extent the method can distinguish between different mycotoxin concentrations.\nConcentration:\nFor each STC to be used in routine application, a validation has to be performed.",
  "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/4.3.2.3/division/4.3.2.3.1",
    "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."
}