Division 4.3.1.1 Performance criteriaF1

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.

1. (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.
   X1Criterion	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.

2. (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

3. (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

4. (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

5. (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

6. (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

7. (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

8. (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

9. (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 ) (**).

     1. (*)

        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)

     2. (**)

        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.