{
  "url": "https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1/division-3.1.2.5",
  "json_url": "https://openlegislation.uk/eu-decision-2002-657/annex/chapter-3.1/division-3.1.2.5.json",
  "legislation": "eudn/2002/657",
  "legislation_title": "Commission Decision of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results (notified under document number C(2002) 3044) (Text with EEA relevance) (2002/657/EC)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2002-657",
  "path": "annex/chapter/3.1/division/3.1.2.5",
  "kind": "division",
  "number": "3.1.2.5",
  "heading": "Decision Limit (CCɑ)",
  "text": "The decision limit has to be established according to the requirements for identification or identification plus quantification as defined under ‘Performance criteria and other requirements for analytical methods’ (part 2).\nIn the case of substances for which no permitted limit has been established, CCɑ can be established:\neither by the calibration curve procedure according to ISO 11843 (17) (here referred to as critical value of the net state variable). In this case blank material shall be used, which is fortified at and above the minimum required performance level in equidistant steps. Analyse the samples. After identification, plot the signal against the added concentration. The corresponding concentration at the y-intercept plus 2,33 times the standard deviation of the within-laboratory reproducibility of the intercept equals the decision limit. This is applicable to quantitative assays only (ɑ = 1 %),\nor by analysing at least 20 blank materials per matrix to be able to calculate the signal to noise ratio at the time window in which the analyte is expected. Three times the signal to noise ratio can be used as decision limit. This is applicable to quantitative and qualitative assays.\nIn the case of substances an with established permitted limit, CCɑ can be established:\neither by the calibration curve procedure according to ISO 11843 (17) (here referred to as critical value of the net state variable). In this case blank material shall be used, which is fortified around the permitted limit in equidistant steps. Analyse the samples. After identification, plot the signal against the added concentration. The corresponding concentration at the permitted limit plus 1,64 times the standard deviation of the within-laboratory reproducibility equals the decision limit (ɑ = 5 %),\nor by analysing at least 20 blank materials per matrix fortified with the analyte(s) at the permitted limit. The concentration at the permitted limit plus 1,64 times the corresponding standard deviation equal the decision limit (ɑ = 5 %).\nSee also Article 5 and point 3.2.",
  "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/eudn/2002/657/annex/chapter/3.1/division/3.1.2.5",
    "retrieved_at": "2026-11-01T15:18:31.211349+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."
}