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Annex

United Kingdom

Original text. Later amendments are not shown.

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

  3. “LOQ”
  4. Limit of quantification, lowest content of the analyte which can be measured with reasonable statistical certainty.’;

  5. (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

        ParameterCriterion
        ApplicabilityFoods specified in point 4.1 of the Annex to Regulation (EC) No 1881/2006
        SpecificityFree from matrix or spectral interferences
        Field blanksLess than LOD
        Repeatability (RSDr)0,66 times RSDR as derived from (modified) Horwitz equation
        Reproducibility (RSDR)as derived from (modified) Horwitz equation
        Recovery75-110 %
        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

        ParameterCriterion
        ApplicabilityFoods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006
        SpecificityFree from matrix or spectral interferences
        Field blanksLess than LOD
        Repeatability (RSDr)0,66 times RSDR as derived from (modified) Horwitz equation
        Reproducibility (RSDR)as derived from (modified) Horwitz equation
        Recovery75-110 %
        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

        ParameterCriterion
        ApplicabilityFoods specified in point 4.3 of the Annex to Regulation (EC) No 1881/2006
        SpecificityFree 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
        Recovery70-125 %
        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

        ParameterCriterion
        ApplicabilityFoods specified in point 4.2 of the Annex to Regulation (EC) No 1881/2006
        SpecificityFree 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
        Recovery70-125 %
        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

    ’

  6. (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

      ParameterCriterion
      ApplicabilityAll foods
      SpecificityFree from matrix or spectral interferences
      Field blanksLess 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
      Recovery75-110 %
      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

    ’

  7. (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

      ParameterCriterion
      ApplicabilityAll foods
      SpecificityFree 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
      Recovery70-110 %
      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 equationf1 (for concentrations 1,2 x 10-7 ≤ C ≤ 0,138) and the modified Horwitz equationf2 (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

      • 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

      • 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.’

  8. (5)

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

Annotations

Footnotes

f1

W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,63, 1980, 1344-1354.

f2

M. Thompson, Analyst, 125, 2000, 385-386.’