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Commission Implementing Regulation (EU) 2019/2093Dangos y teitl llawn
Commission Implementing Regulation (EU) 2019/2093 of 29 November 2019 amending Regulation (EC) No 333/2007 as regards the analysis of 3-monochloropropane-1,2-diol (3-MCPD) fatty acid esters, glycidyl fatty acid esters, perchlorate and acrylamide (Text with EEA relevance)
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- 2019 No. 2093
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ANNEXU.K.
The Annex to Regulation (EC) No 333/2007 is amended as follows:
(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)
in point C.3.3.1, Performance criteria, point (b) is replaced by the following:
‘(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)
in point C.3.3.1, Performance criteria, point (d), ‘Notes to the performance criteria’ is replaced by the following:
‘(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)
in point C.3.3.1, Performance criteria, the following points (e) and (f) are added:
‘(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 |
(f)
Notes to the performance criteria:
The Horwitz equation(1) (for concentrations 1,2 x 10-7 ≤ C ≤ 0,138) and the modified Horwitz equation(2) (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.’
(5)
in point C.3.3.2., ‘Fitness-for-purpose’ approach, the words ‘Table 8’ are replaced by the words ‘Table 10’.
(1)
W. Horwitz, L.R. Kamps, K.W. Boyer, J.Assoc.Off.Analy.Chem.,63, 1980, 1344-1354.
(2)
M. Thompson, Analyst, 125, 2000, 385-386.’
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