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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) in England

EU Decision 2002/657 · Adopted 12 August 2002 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC f1, and in particular the second subparagraph of Article 15(1) thereof,

Whereas:

(1)

The presence of residues in products of animal origin is a matter of concern for public health.

(2)

Commission Decision 98/179/EC of 23 February 1998 laying down detailed rules on official sampling for the monitoring of certain substances and residues thereof in live animals and animal products f2 provides that the analysis of samples is to be carried out exclusively by laboratories approved for official residue control by the competent national authority.

(3)

It is necessary to ensure the quality and comparability of the analytical results generated by laboratories approved for official residue control. This should be achieved by using quality assurance systems and specifically by applying of methods validated according to common procedures and performance criteria and by ensuring traceability to common standards or standards commonly agreed upon.

(4)

Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs and Decision 98/179/EC f3 require official control laboratories to be accredited according to ISO 17025 (1) from January 2002 onwards. Pursuant to Decision 98/179/EC, participation in an internationally recognised external quality control assessment and accreditation scheme is required for approved laboratories. Moreover, approved laboratories must prove their competence by regular and successful participation in adequate proficiency testing schemes recognised or organised by the national or Community reference laboratories.

(5)

A network of Community reference laboratories, national reference laboratories and national control laboratories operates under Directive 96/23/EC to enhance coordination.

(6)

As a result of advances in analytical chemistry since the adoption of Directive 96/23/EC the concept of routine methods and reference methods has been superseded by criteria approach, in which performance criteria and procedures for the validation of screening and confirmatory methods are established.

(7)

It is necessary to determine common criteria for the interpretation of test results of official control laboratories in order to ensure a harmonised implementation of Directive 96/23/EC.

(8)

It is necessary to provide for the progressive establishment of minimum required performance limits (MRPL) of analytical method for substances for which no permitted limit has been established and in particular for those substances whose use is not authorised, or is specifically prohibited in the Community, in order to ensure harmonised implementation of Directive 96/23/EC.

(9)

Commission Decision 90/515/EEC of 26 September 1990 laying down the reference methods for detecting residues of heavy metals and arsenic f4, Commission Decision 93/256/EEC of 14 May 1993 laying down the methods to be used for detecting residues of substances having a hormonal or a thyrostatic action f5, and of Commission Decision 93/257/EEC of 15 April 1993 laying down the reference methods and the list of the national reference laboratories for detecting residues f6, as last amended by Decision 98/536/EC f7 have been re-examined before in order to take account of developments in scientific and technical knowledge, have been found outdated in their scope and provisions and should accordingly be repealed with this Decision.

(10)

In order to allow methods for the analysis of official samples to be adapted to the provisions of this Decision, a transitional period should be laid down.

(11)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:

Annotations to the whole text

Footnotes

f1

OJ L 125, 23.5.1996, p. 10.

f2

OJ L 65, 5.3.1998, p. 31.

f3

OJ L 290, 24.11.1993, p. 14.

f4

OJ L 286, 18.10.1990, p. 33.

f5

OJ L 118, 14.5.1993, p. 64.

f6

OJ L 118, 14.5.1993, p. 75.

f7

OJ L 251, 11.9.1998, p. 39.

Contents

  1. 1Subject matter and scope
  2. 2Definitions
  3. 3Analytical methods
  4. 4Minimum required performance limits
  5. 5Quality control
  6. 6Interpretation of results
  7. 7Repeal Repealed
  8. 8Transitional provisions
  9. 9Date of application
  10. 10Addressees Repealed
  11. Signature
  12. Annex I: PERFORMANCE CRITERIA, OTHER REQUIREMENTS AND PROCEDURES FOR ANALYTICAL METHODS
  13. Part 1.: DEFINITIONS
  14. 1.1Division 1.1
  15. 1.2Division 1.2
  16. 1.3Division 1.3
  17. 1.4Division 1.4
  18. 1.5Division 1.5
  19. 1.6Division 1.6
  20. 1.7Division 1.7
  21. 1.8Division 1.8
  22. 1.9Division 1.9
  23. 1.10Division 1.10
  24. 1.11Division 1.11
  25. 1.12Division 1.12
  26. 1.13Division 1.13
  27. 1.14Division 1.14
  28. 1.15Division 1.15
  29. 1.16Division 1.16
  30. 1.17Division 1.17
  31. 1.18Division 1.18
  32. 1.19Division 1.19
  33. 1.20Division 1.20
  34. 1.21Division 1.21
  35. 1.22Division 1.22
  36. 1.23Division 1.23
  37. 1.24Division 1.24
  38. 1.25Division 1.25
  39. 1.26Division 1.26
  40. 1.27Division 1.27
  41. 1.28Division 1.28
  42. 1.29Division 1.29
  43. 1.30Division 1.30
  44. 1.31Division 1.31
  45. 1.32Division 1.32
  46. 1.33Division 1.33
  47. 1.34Division 1.34
  48. 1.35Division 1.35
  49. 1.36Division 1.36
  50. 1.37Division 1.37
  51. 1.38Division 1.38
  52. 1.39Division 1.39
  53. 1.40Division 1.40
  54. 1.41Division 1.41
  55. 1.42Division 1.42
  56. 1.43Division 1.43
  57. 1.44Division 1.44
  58. 1.45Division 1.45
  59. 1.46Division 1.46
  60. 2.PERFORMANCE CRITERIA AND OTHER REQUIREMENTS FOR ANALYTICAL METHODS
  61. Chapter 2.1.: GENERAL REQUIREMENTS
  62. 2.1.1Handling of samples
  63. 2.1.2Performance of tests
  64. 2.1.2.1Recovery
  65. 2.1.2.2Specificity
  66. 2.2.SCREENING METHODS
  67. 2.3.CONFIRMATORY METHODS FOR ORGANIC RESIDUES AND CONTAMINANTS
  68. 2.3.1Common performance criteria and requirements
  69. 2.3.2Additional performance criteria and other requirements for quantitative methods of analysis
  70. 2.3.2.1Trueness of quantitative methods
  71. 2.3.2.2Precision of quantitative methods
  72. 2.3.3Performance criteria and other requirements for mass spectrometric detection
  73. 2.3.3.1Chromatographic separation
  74. 2.3.3.2Mass spectrometric detection
  75. 2.3.4Performance criteria and other requirements for chromatography coupled to infrared detection
  76. 2.3.4.1Infra-red detection
  77. 2.3.4.2Interpretation of infra-red spectral data
  78. 2.3.5Performance criteria and other requirements for the determination of an analyte using LC with other detection techniques
  79. 2.3.5.1Chromatographic separation
  80. 2.3.5.2Full-scan UV/VIS detection
  81. 2.3.5.3Performance criteria for fluorimetric detection
  82. 2.3.5.4Performance criteria for the determination of an analyte by an LC-immunogram
  83. 2.3.5.5Determination of an analyte using LC with UV/VIS detection (single wavelength)
  84. 2.3.6Performance criteria and other requirements for the determination of an analyte by 2-D TLC coupled to full-scan UV/VIS spectrometric detection
  85. 2.3.7Performance criteria and requirements for the determination of an analyte by GC in combination with electron capture detection (ECD)
  86. 2.4.CONFIRMATORY METHODS FOR ELEMENTS
  87. 2.4.1Common performance criteria and other requirements for confirmatory methods
  88. 2.4.2Additional performance criteria and other requirements for quantitative methods of analysis
  89. 2.4.2.1Trueness of quantitative methods
  90. 2.4.2.2Precision of quantitative methods
  91. 2.4.3Specific requirements for differential pulse anodic stripping voltametry (DPASV)
  92. 2.4.4Specific requirements for atomic absorption spectrometry (AAS)
  93. 2.4.4.1Specific requirements for flame AAS
  94. 2.4.4.2Specific requirements for graphite furnace AAS
  95. 2.4.5Specific requirements for hydride generation atomic absorption spectrometry
  96. 2.4.6Specific requirements for cold vapour atomic absorption spectrometry
  97. 2.4.7Specific requirements for inductively coupled plasma atomic emission spectrometry (ICP-AES)
  98. 2.4.8Specific requirements for inductively coupled mass spectrometry (ICP-MS)(11))
  99. 3.VALIDATION
  100. 3.1.VALIDATION PROCEDURES
  101. 3.1.1Model-independent performance characteristics
  102. 3.1.1.1Specificity
  103. 3.1.1.2Trueness
  104. 3.1.1.3Applicability/ruggedness (minor changes)
  105. 3.1.1.4Stability
  106. 3.1.1.5Calibration curves
  107. 3.1.2Conventional validation procedures
  108. 3.1.2.1Recovery
  109. 3.1.2.2Repeatability
  110. 3.1.2.3Within-laboratory reproducibility
  111. 3.1.2.4Reproducibility
  112. 3.1.2.5Decision Limit (CCɑ)
  113. 3.1.2.6Detection capability (CCβ)
  114. 3.1.2.7Ruggedness (major changes)
  115. 3.1.3Validation according to alternative models
  116. 3.1.3.1Experimental plan
  117. 3.1.3.2Power curve
  118. 3.1.3.3Reproducibility
  119. 3.2.GRAPHICAL REPRESENTATION OF THE DIFFERENT ANALYTICAL LIMITS
  120. 3.3.CALCULATION EXAMPLE FOR RUGGEDNESS TESTING OF MINOR CHANGES ACCORDING TO THE YOUDEN APPROACH (16)
  121. Standard deviation of the differences Di (SDi):
  122. 3.4.CALCULATION EXAMPLES FOR THE IN-HOUSE VALIDATION PROCEDURE
  123. 3.5.EXAMPLES FOR THE STANDARD ADDITION METHOD
  124. 4.ABBREVIATIONS USED
  125. 5.REFERENCES
  126. Annex IIMinimum required performance limits