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.
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.
ANNEXSupplementary provisions
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.’
’
