# 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), Division 4.3.1.1: Performance criteria

Extent: E+W+S+N.I.

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.
Where possible, the validation of in-house validated methods shall include a certified reference material.
(a) Performance criteria for aflatoxins
Note:
Values to apply to both B 1 and sum of B 1 + B 2 + G 1 + G 2
If 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.
Criterion
Concentration Range
Recommended Value
Maximum permitted Value
Blanks
All
Negligible
—
Recovery — Aflatoxin M 1
0,01-0,05 μg/kg
60 to 120 %
> 0,05 μg/kg
70 to 110 %
Recovery — Aflatoxins B 1 , B 2 , G 1 , G 2
< 1,0 μg/kg
50 to 120 %
1-10 μg/kg
70 to 110 %
> 10 μg/kg
80 to 110 %
Reproducibility RSD R
All
As derived from Horwitz Equation (*)(**)
2 × value derived from Horwitz Equation (*)(**)
Repeatability RSD r may be calculated as 0,66 times Reproducibility RSD R at the concentration of interest.
(b) Performance criteria for ochratoxin A
Level μg/kg
Ochratoxin A
RSD r %
RSD R %
Recovery %
< 1
≤ 40
≤ 60
50 to 120
≥ 1
≤ 20
≤ 30
70 to 110
(c) Performance criteria for patulin
Level μg/kg
Patulin
RSD r %
RSD R %
Recovery %
< 20
≤ 30
≤ 40
50 to 120
20-50
≤ 20
≤ 30
70 to 105
> 50
≤ 15
≤ 25
75 to 105
(d) Performance criteria for deoxynivalenol
Level μg/kg
Deoxynivalenol
RSD r %
RSD R %
Recovery %
> 100-≤ 500
≤ 20
≤ 40
60 to 110
> 500
≤ 20
≤ 40
70 to 120
(e) Performance criteria for zearalenone
Level μg/kg
Zearalenone
RSD r %
RSD R %
Recovery %
≤ 50
≤ 40
≤ 50
60 to 120
> 50
≤ 25
≤ 40
70 to 120
(f) Performance criteria for Fumonisin B 1 and B 2 individually
Level μg/kg
Fumonisin B 1 and B 2 individually
RSD r %
RSD R %
Recovery %
≤ 500
≤ 30
≤ 60
60 to 120
> 500
≤ 20
≤ 30
70 to 110
(g) Performance criteria for T-2 and HT-2 toxin individually
Level μg/kg
T-2 and HT-2 toxin individually
RSD r %
RSD R %
Recovery %
15-250
≤ 30
≤ 50
60 to 130
> 250
≤ 25
≤ 40
60 to 130
(h) Performance criteria for citrinin
Level μg/kg
Citrinin
RSD r %
Recommended RSD R %
Maximum allowed RSD R %
Recovery %
All
0,66 × RSD R
As derived from Horwitz Equation (*) (**)
2 × value derived from Horwitz Equation (*) (**)
70 to 120
(i) Notes to the performance criteria for the mycotoxins:
The detection limits of the methods used are not stated as the precision values given at the concentrations of interest.
The 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 ) (**).
(*) Horwitz equation for concentrations 1,2 × 10 –7 ≤ C ≤ 0,138:
RSD R = 2 (1-0.5logC)
(ref: W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,1980, 63, 1344)
(**) Modified Horwitz equation (*) for concentrations C < 1,2 × 10 –7 :
RSD R = 22 %
(ref: M. Thompson, Analyst, 2000, 125, p. 385-386)
Where:
RSD R is the relative standard deviation calculated from results generated under reproducibility conditions [(sR/) × 100]
C is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1 000 mg/kg)
This 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.

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Source: https://www.legislation.gov.uk/eur/2006/401/annex/II/division/4/division/4.3/division/4.3.1/division/4.3.1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2006-401/annex-II/division-4/division-4.3/division-4.3.1/division-4.3.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.