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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)

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)

Implementing Regulation (EU) 2019/2093 · Regulation · 3 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

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Regulation (EC) No 333/2007 is amended as follows: (1) in Article 1, paragraph 1 is replaced by the following: ‘1.   Sampling and analysis for the control of the levels of lead, cadmium, mercury, inorganic tin, inorganic arsenic, 3-monochloropropane-1,2-diol (3-MCPD), 3-MCPD fatty acid esters, glycidyl fatty acid esters, polycyclic aromatic hydrocarbons (PAH) and perchlorate listed in Sections 3, 4, 6 and 9 of the Annex to Regulation (EC) No 1881/2006 and for the control of the levels of acrylamide in accordance with Commission Regulation (EU) 2017/2158  ( *1 ) shall be carried out in accordance with the Annex to this Regulation. ( *1 )   Commission Regulation (EU) 2017/2158 of 20 November 2017 establishing mitigation measures and benchmark levels for the reduction of the presence of acrylamide in food ( OJ L 304, 21.11.2017, p. 24 ).’;" (2) the Annex is amended in accordance with the Annex to this Regulation.

Article 2

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This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from 14 December 2019.

Supplementary provisions

ANNEXSupplementary provisions

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ANNEX 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 (RSD r ) 0,66 times RSD R as derived from (modified) Horwitz equation Reproducibility (RSD R ) 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 : RSD R = 22 % where: — RSD R 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: RSD R = 2C (-0,15) where: — RSD R 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. ( *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.’ " (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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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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