ANNEX

The Annex to Regulation (EC) No 333/2007 is amended as follows:

  1. (1)

    in point C.3.1, Definitions, the definitions of ‘LOD’ and ‘LOQ’ are replaced by the following:

    “LOD”

    Limit of detection, smallest measured content, from which it is possible to deduce the presence of the analyte with reasonable statistical certainty.

    “LOQ”

    Limit of quantification, lowest content of the analyte which can be measured with reasonable statistical certainty.

  2. (2)

    in point C.3.3.1, Performance criteria, point (b) is replaced by the following:

    1. (b)

      Performance criteria for methods of analysis for 3-monochloropropane-1,2-diol (3-MCPD), 3-MCPD fatty acid esters and glycidyl fatty acid esters:

      • Performance criteria for methods of analysis for 3-MCPD in foods specified in point 4.1 of the Annex to Regulation (EC) No 1881/2006

        Table 6a

        Parameter

        Criterion

        Applicability

        Foods specified in point 4.1 of the Annex to Regulation (EC) No 1881/2006

        Specificity

        Free from matrix or spectral interferences

        Field blanks

        Less than LOD

        Repeatability (RSDr)

        0,66 times RSDR as derived from (modified) Horwitz equation

        Reproducibility (RSDR)

        as derived from (modified) Horwitz equation

        Recovery

        75-110 %

        Limit of Detection (LOD)

        ≤ 5 μg/kg (on dry matter basis)

        Limit of Quantification (LOQ)

        ≤ 10 μg/kg (on dry matter basis)

      • Performance criteria for methods of analysis for 3-MCPD in foods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006

        Table 6b

        Parameter

        Criterion

        Applicability

        Foods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006

        Specificity

        Free from matrix or spectral interferences

        Field blanks

        Less than LOD

        Repeatability (RSDr)

        0,66 times RSDR as derived from (modified) Horwitz equation

        Reproducibility (RSDR)

        as derived from (modified) Horwitz equation

        Recovery

        75-110 %

        Limit of Detection (LOD)

        ≤ 7 μg/kg

        Limit of Quantification (LOQ)

        ≤ 14 μg/kg

      • Performance criteria for methods of analysis for 3-MCPD fatty acid esters, expressed as 3-MCPD, in foods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006

        Table 6c

        Parameter

        Criterion

        Applicability

        Foods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006

        Specificity

        Free from matrix or spectral interferences

        Repeatability (RSDr)

        0,66 times RSDR as derived from (modified) Horwitz equation

        Reproducibility (RSDR)

        as derived from (modified) Horwitz equation

        Recovery

        70-125 %

        Limit of Detection (LOD)

        Three tenths of LOQ

        Limit of Quantification (LOQ)

        for foods specified in 4.3.1 and 4.3.2

        ≤ 100 μg/kg in oils and fats

        Limit of Quantification (LOQ)

        for foods specified in 4.3.3 and in 4.3.4 with a fat content < 40 %

        ≤ two fifths of the ML

        Limit of Quantification (LOQ)

        for foods specified in 4.3.4 with a fat content ≥ 40 %

        ≤ 15 μg/kg fat

      • Performance criteria for methods of analysis for glycidyl fatty acid esters, expressed as glycidol, in foods specified in point 4.2 of the Annex to Regulation (EC) No 1881/2006

        Table 6d

        Parameter

        Criterion

        Applicability

        Foods specified in point 4.2 of the Annex to Regulation (EC) No 1881/2006

        Specificity

        Free from matrix or spectral interferences

        Repeatability (RSDr)

        0,66 times RSDR as derived from (modified) Horwitz equation

        Reproducibility (RSDR)

        as derived from (modified) Horwitz equation

        Recovery

        70-125 %

        Limit of Detection (LOD)

        Three tenths of LOQ

        Limit of Quantification (LOQ)

        for foods specified in 4.2.1 and 4.2.2

        ≤ 100 μg/kg in oils and fats

        Limit of Quantification (LOQ)

        for foods specified in 4.2.3 with a fat content < 65 % and in 4.2.4 with a fat content < 8 %

        ≤ two fifths of the ML

        Limit of Quantification (LOQ)

        for foods specified in 4.2.3 with a fat content ≥ 65 % and in 4.2.4 with a fat content ≥ 8 %

        ≤ 31 μg/kg fat

  3. (3)

    in point C.3.3.1, Performance criteria, point (d), ‘Notes to the performance criteria’ is replaced by the following:

    1. (d)

      Performance criteria for methods of analysis for acrylamide:

      Table 8

      Parameter

      Criterion

      Applicability

      All foods

      Specificity

      Free from matrix or spectral interferences

      Field blanks

      Less than Limit of Detection (LOD)

      Repeatability (RSDr)

      0,66 times RSDR as derived from (modified) Horwitz equation

      Reproducibility (RSDR)

      as derived from (modified) Horwitz equation

      Recovery

      75-110 %

      Limit of Detection (LOD)

      Three tenths of LOQ

      Limit of Quantification (LOQ)

      For foods with benchmark levels < 125 µg/kg: ≤ two fifths of the benchmark level, however not required to be lower than 20 µg/kg

      For foods with benchmark level ≥ 125 µg/kg: ≤ 50 µg/kg

  4. (4)

    in point C.3.3.1, Performance criteria, the following points (e) and (f) are added:

    1. (e)

      Performance criteria for methods of analysis for perchlorate:

      Table 9

      Parameter

      Criterion

      Applicability

      All foods

      Specificity

      Free from matrix or spectral interferences

      Repeatability (RSDr)

      0,66 times RSDR as derived from (modified) Horwitz equation

      Reproducibility (RSDR)

      as derived from (modified) Horwitz equation

      Recovery

      70-110 %

      Limit of Detection (LOD)

      Three tenths of LOQ

      Limit of Quantification (LOQ)

      ≤ two fifths of the ML

    2. (f)

      Notes to the performance criteria:

      The Horwitz equation7 (for concentrations 1,2 x 10-7 ≤ C ≤ 0,138) and the modified Horwitz equation8 (for concentrations C < 1,2 × 10-7) are generalised precision equations which are independent of analyte and matrix but solely dependent on concentration for most routine methods of analysis.

      Modified Horwitz equation for concentrations C < 1,2 × 10-7:

      RSDR = 22 %

      where:

      • RSDR is the relative standard deviation calculated from results generated under reproducibility conditions Image_r00001

      • C is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1 000 mg/kg). The modified Horwitz equation applies to concentrations C < 1,2 × 10-7.

      Horwitz equation for concentrations 1,2 x 10-7 ≤ C ≤ 0,138:

      RSDR = 2C(-0,15)

      where:

      • RSDR is the relative standard deviation calculated from results generated under reproducibility conditions Image_r00002

      • C is the concentration ratio (i.e. 1 = 100g/100g, 0,001 = 1 000 mg/kg). The Horwitz equation applies to concentrations 1,2 x 10-7 ≤ C ≤ 0,138.

  5. (5)

    in point C.3.3.2., ‘Fitness-for-purpose’ approach, the words ‘Table 8’ are replaced by the words ‘Table 10’.