{
  "url": "https://openlegislation.uk/eu-regulation-2007-333/annex/part-C/division-C.3/division-C.3.3/division-C.3.3.2",
  "json_url": "https://openlegislation.uk/eu-regulation-2007-333/annex/part-C/division-C.3/division-C.3.3/division-C.3.3.2.json",
  "legislation": "eur/2007/333",
  "legislation_title": "Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2007-333",
  "path": "annex/part/C/division/C.3/division/C.3.3/division/C.3.3.2",
  "kind": "division",
  "number": "C.3.3.2",
  "heading": "‘Fitness-for-purpose’ approach",
  "text": "For in-house validated methods, as an alternative a ‘fitness-for-purpose’ approach may be used to assess their suitability for official control. Methods suitable for official control must produce results with a combined standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:\nUf=LOD∕22+αC2\nwhere:\nUf is the maximum standard measurement uncertainty (μg/kg).\nLOD is the limit of detection of the method (μg/kg). The LOD must meet the performance criteria set in point C.3.3.1 for the concentration of interest.\nC is the concentration of interest (μg/kg);\nα is a numeric factor to be used depending on the value of C. The values to be used are given in Table 10.\nTable 10\nNumeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest\nC (μg/kg)\nα\n≤ 50\n0,2\n51-500\n0,18\n501- 1 000\n0,15\n1 001 - 10 000\n0,12\n> 10 000\n0,1\nThe analyst shall note the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation’.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Substituted by Commission Regulation (EU) No 836/2011 of 19 August 2011 amending Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs (Text with EEA relevance)."
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Substituted by Commission Implementing Regulation (EU) 2019/2093 of 29 November 2019 amending Regulation (EC) No 333/2007 as regards the analysis of 3-monochloropropane-1,2-diol (3-MCPD) fatty acid esters, glycidyl fatty acid esters, perchlorate and acrylamide (Text with EEA relevance)."
    },
    {
      "type": "footnote",
      "label": "f1",
      "text": "M. Thompson and R. Wood, Accred. Qual. Assur., 2006, p. 10 and 471-478."
    },
    {
      "type": "footnote",
      "label": "f2",
      "text": "http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2007/333/annex/part/C/division/C.3/division/C.3.3/division/C.3.3.2",
    "retrieved_at": "2026-11-01T14:53:01.572573+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."
}