{
  "url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.1/division-4.3.1.1",
  "json_url": "https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.1/division-4.3.1.1.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/4.3.1/division/4.3.1.1",
  "kind": "division",
  "number": "4.3.1.1",
  "heading": "Performance criteria",
  "text": "It is recommended that fully validated confirmatory methods (i.e. methods validated by collaborative trials for relevant matrices) are used where appropriate and available. Other suitable validated confirmatory methods (e.g. methods validated in-house on relevant matrices belonging to the commodity group of interest) may also be used provided they fulfil the performance criteria set out in the following tables.\nWhere possible, the validation of in-house validated methods shall include a certified reference material.\n(a) Performance criteria for aflatoxins\nNote:\nValues to apply to both B 1 and sum of B 1 + B 2 + G 1 + G 2\nIf sum of individual aflatoxins B 1 + B 2 + G 1 + G 2 are to be reported, then response of each to the analytical system must be either known or equivalent.\nCriterion\nConcentration Range\nRecommended Value\nMaximum permitted Value\nBlanks\nAll\nNegligible\n—\nRecovery — Aflatoxin M 1\n0,01-0,05 μg/kg\n60 to 120 %\n> 0,05 μg/kg\n70 to 110 %\nRecovery — Aflatoxins B 1 , B 2 , G 1 , G 2\n< 1,0 μg/kg\n50 to 120 %\n1-10 μg/kg\n70 to 110 %\n> 10 μg/kg\n80 to 110 %\nReproducibility RSD R\nAll\nAs derived from Horwitz Equation (*)(**)\n2 × value derived from Horwitz Equation (*)(**)\nRepeatability RSD r may be calculated as 0,66 times Reproducibility RSD R at the concentration of interest.\n(b) Performance criteria for ochratoxin A\nLevel μg/kg\nOchratoxin A\nRSD r %\nRSD R %\nRecovery %\n< 1\n≤ 40\n≤ 60\n50 to 120\n≥ 1\n≤ 20\n≤ 30\n70 to 110\n(c) Performance criteria for patulin\nLevel μg/kg\nPatulin\nRSD r %\nRSD R %\nRecovery %\n< 20\n≤ 30\n≤ 40\n50 to 120\n20-50\n≤ 20\n≤ 30\n70 to 105\n> 50\n≤ 15\n≤ 25\n75 to 105\n(d) Performance criteria for deoxynivalenol\nLevel μg/kg\nDeoxynivalenol\nRSD r %\nRSD R %\nRecovery %\n> 100-≤ 500\n≤ 20\n≤ 40\n60 to 110\n> 500\n≤ 20\n≤ 40\n70 to 120\n(e) Performance criteria for zearalenone\nLevel μg/kg\nZearalenone\nRSD r %\nRSD R %\nRecovery %\n≤ 50\n≤ 40\n≤ 50\n60 to 120\n> 50\n≤ 25\n≤ 40\n70 to 120\n(f) Performance criteria for Fumonisin B 1 and B 2 individually\nLevel μg/kg\nFumonisin B 1 and B 2 individually\nRSD r %\nRSD R %\nRecovery %\n≤ 500\n≤ 30\n≤ 60\n60 to 120\n> 500\n≤ 20\n≤ 30\n70 to 110\n(g) Performance criteria for T-2 and HT-2 toxin individually\nLevel μg/kg\nT-2 and HT-2 toxin individually\nRSD r %\nRSD R %\nRecovery %\n15-250\n≤ 30\n≤ 50\n60 to 130\n> 250\n≤ 25\n≤ 40\n60 to 130\n(h) Performance criteria for citrinin\nLevel μg/kg\nCitrinin\nRSD r %\nRecommended RSD R %\nMaximum allowed RSD R %\nRecovery %\nAll\n0,66 × RSD R\nAs derived from Horwitz Equation (*) (**)\n2 × value derived from Horwitz Equation (*) (**)\n70 to 120\n(i) Notes to the performance criteria for the mycotoxins:\nThe detection limits of the methods used are not stated as the precision values given at the concentrations of interest.\nThe precision values are calculated from the Horwitz equation, in particular the original Horwitz equation (for concentrations 1,2 × 10 –7 ≤ C ≤ 0,138) (*) and the modified Horwitz equation (for concentrations C < 1,2 × 10 –7 ) (**).\n(*) Horwitz equation for concentrations 1,2 × 10 –7 ≤ C ≤ 0,138:\nRSD R = 2 (1-0.5logC)\n(ref: W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,1980, 63, 1344)\n(**) Modified Horwitz equation (*) for concentrations C < 1,2 × 10 –7 :\nRSD R = 22 %\n(ref: M. Thompson, Analyst, 2000, 125, p. 385-386)\nWhere:\nRSD R is the relative standard deviation calculated from results generated under reproducibility conditions [(sR/) × 100]\nC is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1 000 mg/kg)\nThis is a generalised precision equation which has been found to be independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.",
  "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)."
    },
    {
      "type": "X",
      "label": "X1",
      "text": "Substituted by Corrigendum to 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 (Official Journal of the European Union L 147 of 17 May 2014)."
    }
  ],
  "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/4.3.1/division/4.3.1.1",
    "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."
}