OpenLegislation

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)

EU Regulation No 401/2006 · Adopted 23 February 2006 · 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 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)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rulesf1, in particular Article 11(4),

Whereas:

(1)

Commission Regulation (EC) No 466/2001 of 8 March 2001 setting maximum levels for certain contaminants in foodstuffsf2 provides for maximum limits for certain mycotoxins in certain foodstuffs.

(2)

Sampling plays a crucial part in the precision of the determination of the levels of mycotoxins, which are very heterogeneously distributed in a lot. It is therefore necessary to fix general criteria which the sampling method should comply with.

(3)

It is also necessary to fix general criteria which the method of analysis should comply with in order to ensure that control laboratories use methods of analysis with comparable levels of performance.

(4)

Commission Directive 98/53/EC of 16 July 1998 laying down the sampling methods and the methods of analysis for the official control of the levels for certain contaminants in foodstuffsf3 establishes sampling methods and performance criteria for the methods of analysis to be used for the official control of levels of aflatoxins in foodstuffs.

(5)

Commission Directive 2002/26/EC of 13 March 2002 laying down the sampling methods and the methods of analysis for the official control of the levels of ochratoxin A in foodstuffsf4, Commission Directive 2003/78/EC of 11 August 2003 laying down the sampling methods and the methods of analysis for the official control of the levels of patulin in foodstuffsf5 and Commission Directive 2005/38/EC of 6 June 2005 laying down the sampling methods and the methods of analysis for the official control of the levels of Fusarium-toxins in foodstuffsf6 similarly establish sampling methods and performance criteria for ochratoxin A, patulin and Fusarium-toxins respectively.

(6)

It is appropriate to apply whenever possible the same sampling method to the same product for the control of mycotoxins. Therefore, the sampling methods and performance criteria for the methods of analysis to be used for the official control of all mycotoxins should be brought together in a single legal act in order to make them easier to apply.

(7)

Aflatoxins are very heterogeneously distributed in a lot, in particular in a lot of food products with a large particle size such as dried figs or groundnuts. In order to obtain the same representativeness, for batches with food products with large particle size, the weight of the aggregate sample should be larger than in case of batches with food products with a smaller particle size. Since the distribution of mycotoxins in processed products is generally less heterogeneous than in the unprocessed cereal products, it is appropriate to provide for simpler sampling provisions for processed products.

(8)

Directives 98/53/EC, 2002/26/EC, 2003/78/EC and 2005/38/EC should therefore be repealed.

(9)

It is appropriate that the date of application of this Regulation coincides with the date of application of Commission Regulation (EC) No 856/2005 of 6 June 2005 amending Regulation (EC) No 466/2001 as regards Fusarium toxinsf7.

(10)

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

HAS ADOPTED THIS REGULATION:

Annotations to the whole text

Footnotes

f1

OJ L 165, 30.4.2004, p. 1, corrected by OJ L 191, 28.5.2004, p. 1.

f2

OJ L 77, 16.3.2001, p. 1. Regulation as last amended by Regulation (EC) No 199/2006 (OJ L 32, 4.2.2006, p. 34).

f3

OJ L 201, 17.7.1998, p. 93. Directive as last amended by Directive 2004/43/EC (OJ L 113, 20.4.2004, p. 14).

f4

OJ L 75, 16.3.2002, p. 38. Directive as last amended by Directive 2005/5/EC (OJ L 27, 29.1.2005, p. 38).

f5

OJ L 203, 12.8.2003, p. 40.

f6

OJ L 143, 7.6.2005, p. 18.

f7

OJ L 143, 7.6.2005, p. 3.

Contents

  1. 1Article 1
  2. 2Article 2
  3. 3Article 3
  4. 4Article 4
  5. Signature
  6. Annex I: METHODS OF SAMPLING FOR OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS
  7. AGENERAL PROVISIONS
  8. A.1Purpose and scope
  9. A.2Definitions
  10. General provisions
  11. A.3.1Personnel
  12. A.3.2Material to be sampled
  13. A.3.3Precautions to be taken
  14. A.3.4Incremental samples
  15. A.3.5Preparation of the aggregate sample
  16. A.3.6Replicate samples
  17. A.3.7Packaging and transmission of samples
  18. A.3.8Sealing and labelling of samples
  19. A.4Different types of lots
  20. BMETHOD OF SAMPLING FOR CEREALS AND CEREAL PRODUCTS
  21. B.1Weight of the incremental sample
  22. B.2General survey of the method of sampling for cereals and cereal products
  23. B.3Method of sampling for cereals and cereal products for lots ≥ 50 tonnes
  24. B.4Method of sampling for cereals and cereal products for lots < 50 tonnes
  25. B.5Sampling at retail stage
  26. B.6Acceptance of a lot or sublot
  27. CMETHOD OF SAMPLING FOR DRIED FRUIT, INCLUDING DRIED VINE FRUIT AND DERIVED PRODUCTS BUT WITH THE EXCEPTION OF DRIED FIGS
  28. C.1Weight of the incremental sample
  29. C.2General survey of the method of sampling dried fruit, with the exception of figs
  30. C.3Method of sampling for dried fruit (lots ≥ 15 tonnes), with the exception of figs
  31. C.4Method of sampling for dried fruit (lots < 15 tonnes), with the exception of figs
  32. C.5Sampling at retail stage
  33. C.6Specific sampling provisions for dried fruit with the exception of dried figs traded in vacuum packs
  34. C.7Acceptance of a lot or sublot
  35. DMETHOD OF SAMPLING FOR DRIED FIGS, GROUNDNUTS AND NUTS
  36. D.1Method of sampling for dried figs
  37. D.1.1Weight of the incremental sample
  38. D.1.2General survey of the method of sampling for dried figs
  39. D.1.3Method of sampling for dried figs (lots ≥ 15 tonnes)
  40. D.1.4Method of sampling for dried figs (lots < 15 tonnes)
  41. Method of sampling for derived products and compound foods
  42. D.1.5.1Derived products with very small particle weight (homogeneous distribution of aflatoxin contamination)
  43. D.1.5.2Other derived products with a relatively large particle size (heterogeneous distribution of aflatoxin contamination)
  44. D.1.6Sampling at retail stage
  45. Specific method of sampling of dried figs and derived products traded in vacuum packs
  46. D.1.7.1Dried figs
  47. D.1.7.2Products derived from dried figs with small particle size
  48. D.1.8Acceptance of a lot or sublot
  49. D.2Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts
  50. D.2.1Weight of the incremental sample
  51. D.2.2General survey of the method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts
  52. D.2.3Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts (lots ≥ 15 tonnes)
  53. D.2.4Method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels and tree nuts (lots < 15 tonnes)
  54. Method of sampling for derived products, with the exception of vegetable oil, and compound foods
  55. D.2.5.1Derived products (other than vegetable oil) with small particle size, i.e. flour, peanut butter (homogeneous distribution of aflatoxin contamination)
  56. D.2.5.2Derived products with a relatively large particle size (heterogeneous distribution of aflatoxin contamination)
  57. D.2.6Sampling at retail stage
  58. Specific method of sampling for groundnuts (peanuts), other oilseeds, apricot kernels, tree nuts and derived products traded in vacuum packs
  59. D.2.7.1Pistachios, groundnuts (peanuts), Brazil nuts
  60. D.2.7.2Apricot kernels, tree nuts other than pistachios and Brazil nuts, other oilseeds
  61. D.2.7.3Products derived from tree nuts, apricot kernels and groundnuts (peanuts) with small particle size
  62. D.2.8Acceptance of a lot or sublot
  63. EMETHOD OF SAMPLING FOR SPICES
  64. E.1Weight of the incremental sample
  65. E.2General survey of the method of sampling for spices
  66. E.3Method of sampling for spices (lots ≥ 15 tonnes)
  67. E.4Method of sampling for spices (lots < 15 tonnes)
  68. E.5Sampling at retail stage
  69. E.6Specific method of sampling for spices traded in vacuum packs
  70. E.7Acceptance of a lot or sublot
  71. FMETHOD OF SAMPLING FOR MILK AND MILK PRODUCTS; INFANT FORMULAE AND FOLLOW-ON FORMULAE, INCLUDING INFANT MILK AND FOLLOW-ON MILK
  72. F.1Method of sampling for milk, milk products, infant formulae and follow-on formulae, including infant milk and follow-on milk.
  73. F.2Sampling at retail stage
  74. F.3Acceptance of a lot or sublot
  75. GMETHOD OF SAMPLING FOR COFFEE, COFFEE PRODUCTS, LIQUORICE ROOT AND LIQUORICE EXTRACT
  76. G.1Weight of the incremental sample
  77. G.2General survey of the method of sampling for roasted coffee, ground roasted coffee, soluble coffee, liquorice root and liquorice extract
  78. G.3Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee liquorice root and liquorice extract (lots ≥ 15 tonnes)
  79. G.4Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee liquorice root and liquorice extract (lots < 15 tonnes)
  80. G.5Method of sampling for roasted coffee beans, ground roasted coffee, soluble coffee, liquorice root and liquorice extract traded in vacuum packs
  81. G.6Sampling at retail stage
  82. G.7Acceptance of a lot or sublot
  83. HMETHOD OF SAMPLING FOR FRUIT JUICES INCLUDING GRAPE JUICE, GRAPE MUST, CIDER AND WINE
  84. H.1Method of sampling
  85. H.2Sampling at retail stage
  86. H.3Acceptance of a lot or sublot
  87. IMETHOD OF SAMPLING FOR SOLID APPLE PRODUCTS
  88. I.1Method of sampling
  89. I.2Sampling at retail stage
  90. I.3Acceptance of a lot or sublot
  91. JMETHOD OF SAMPLING FOR BABY FOODS AND PROCESSED CEREAL BASED FOODS FOR INFANTS AND YOUNG CHILDREN
  92. J.1Method of sampling
  93. J.2Sampling at retail stage
  94. J.3Acceptance of a lot or sublot
  95. KMETHOD OF SAMPLING FOR VEGETABLE OILS
  96. K.1Method of sampling for vegetable oils
  97. K.2Method of sampling for vegetable oils at retail stage
  98. K.3Acceptance of a lot or sublot
  99. METHOD OF SAMPLING FOR VERY LARGE LOTS OR LOTS STORED OR TRANSPORTED IN A WAY WHEREBY SAMPLING THROUGHOUT THE LOT IS NOT FEASIBLE
  100. L.1General principles
  101. L.2Number of incremental samples to be taken in the case of very large lots
  102. Large lots transported by ship
  103. L.3.1Dynamic sampling of large lots transported by ship
  104. L.3.2Sampling of lots transported by ship by static sampling
  105. L.4Sampling of large lots stored in warehouses
  106. Sampling of storage facilities (silos)
  107. L.5.1Sampling of silos (easily) accessible from above
  108. Sampling of silos not accessible from above (closed silos)
  109. L.5.2.1Silos not accessible from above (closed silos) with individual sizes > 100 tonnes
  110. L.5.2.2Silos not accessible from above (closed silos) with individual sizes < 100 tonnes
  111. L.6Sampling of loose food in large closed containers
  112. MMETHOD OF SAMPLING OF FOOD SUPPLEMENTS BASED ON RICE FERMENTED WITH RED YEAST MONASCUS PURPUREUS
  113. Sampling procedure and sample size
  114. Annex II: CRITERIA FOR SAMPLE PREPARATION AND FOR METHODS OF ANALYSIS USED FOR THE OFFICIAL CONTROL OF THE LEVELS OF MYCOTOXINS IN FOODSTUFFS
  115. INTRODUCTION
  116. 1.1Precautions
  117. 1.2Calculation of proportion of shell/kernel of whole nuts
  118. 2TREATMENT OF THE SAMPLE AS RECEIVED IN THE LABORATORY
  119. 3REPLICATE SAMPLES
  120. METHOD OF ANALYSIS TO BE USED BY THE LABORATORY AND LABORATORY CONTROL REQUIREMENTS
  121. 4.1Definitions
  122. 4.2General requirements
  123. Specific requirements
  124. Specific requirements for confirmatory methods
  125. 4.3.1.1Performance criteria
  126. 4.3.1.2‘ Fitness-for-purpose ’ approach
  127. Specific requirements for semi-quantitative screening methods
  128. 4.3.2.1Scope
  129. 4.3.2.2Terminology
  130. 4.3.2.3Validation procedure
  131. 4.3.2.3.1Initial validation by single laboratory validation
  132. 4.3.2.3.2Initial validation through collaborative trials
  133. 4.3.2.4Determination of cut-off level and rate of false suspected results of blank samples
  134. Extension of the scope of the method
  135. 4.3.2.5.1Extension of scope to other mycotoxins:
  136. 4.3.2.5.2Extension to other commodities:
  137. 4.3.2.6Verification of methods already validated through collaborative trials
  138. 4.3.2.7Continuous method verification/on-going method validation
  139. 4.3.2.8Validation report
  140. Division
  141. Division
  142. 4.3.3Requirements for qualitative screening methods (methods that do not give numerical values)
  143. Estimation of measurement uncertainty, recovery calculation and reporting of results
  144. 4.4.1Confirmatory methods
  145. 4.4.2Screening methods
  146. 4.5Laboratory quality standards