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Commission Regulation (EC) No 333/2007Show full title
Commission Regulation (EC) No 333/2007 of 28 March 2007 laying down the methods of sampling and analysis for the control of the levels of trace elements and processing contaminants in foodstuffs (Text with EEA relevance)
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Changes over time for: Division C.3.3.
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- Signature words omitted by S.I. 2019/639 reg. 29
- Annex para. B.1.1 words omitted by S.I. 2019/639 reg. 30(a) (This amendment not applied to legislation.gov.uk. Reg. 30 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 8(10))
- Annex para. C.3.3.1 words omitted by S.I. 2019/639 reg. 30(e) (This amendment not applied to legislation.gov.uk. Reg. 30 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 8(10))
- Annex para. B words omitted by virtue of S.I. 2019/639, reg. 30(a) (as substituted) by S.I. 2020/1504 reg. 8(10)
- Annex para. C words omitted by virtue of S.I. 2019/639, reg. 30(e) (as substituted) by S.I. 2020/1504 reg. 8(10)
- Annex para. B.1.6 words substituted by S.I. 2019/639 reg. 30(b) (This amendment not applied to legislation.gov.uk. Reg. 30 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 8(10))
- Annex para. B.1.8 words substituted by S.I. 2019/639 reg. 30(c) (This amendment not applied to legislation.gov.uk. Reg. 30 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 8(10))
- Annex para. C.2.4 words substituted by S.I. 2019/639 reg. 30(d) (This amendment not applied to legislation.gov.uk. Reg. 30 substituted immediately before IP completion day by S.I. 2020/1504, regs. 1(2), 8(10))
- Annex para. B words substituted by S.I. 2019/639, reg. 30(b) (as substituted) by S.I. 2020/1504 reg. 8(10)
- Annex para. B words substituted by S.I. 2019/639, reg. 30(c) (as substituted) by S.I. 2020/1504 reg. 8(10)
- Annex para. C words substituted by S.I. 2019/639, reg. 30(d) (as substituted) by S.I. 2020/1504 reg. 8(10)
C.3.3.Specific requirementsU.K.
[F1C.3.3.1. Performance criteria U.K.
Where no specific methods for the determination of contaminants in foodstuffs are prescribed at European Union level, laboratories may select any validated method of analysis for the respective matrix provided that the selected method meets the specific performance criteria set out in Tables 5, 6 and 7.
It is recommended that fully validated methods (i.e. methods validated by collaborative trial for the respective matrix) are used where appropriate and available. Other suitable validated methods (e.g. in-house validated methods for the respective matrix) may also be used provided that they fulfil the performance criteria set out in Tables 5, 6 and 7.
Where possible, the validation of in-house validated methods shall include a certified reference material.
(a)
[F2Performance criteria for methods of analysis for lead, cadmium, mercury, inorganic tin and inorganic arsenic
Table 5
| Parameter | Criterion | ||||
|---|---|---|---|---|---|
| Applicability | Foods specified in Regulation (EC) No 1881/2006 | ||||
| Specificity | Free from matrix or spectral interferences | ||||
| Repeatability (RSD r ) | HORRAT r less than 2 | ||||
| Reproducibility (RSD R ) | HORRAT R less than 2 | ||||
| Recovery | The provisions of point D.1.2 apply | ||||
| LOD | = three tenths of LOQ | ||||
| LOQ | Inorganic tin | ≤ 10 mg/kg | |||
| Lead | ML ≤ 0,01 mg/kg | 0,01 < ML ≤ 0,02 mg/kg | 0,02 < ML < 0,1 mg/kg | ML ≥ 0,1 mg/kg | |
| ≤ ML | ≤ two thirds of the ML | ≤ two fifths of the ML | ≤ one fifth of the ML | ||
| Cadmium, mercury, inorganic arsenic | ML is < 0,100 mg/kg | ML is ≥ 0,100 mg/kg | |||
| ≤ two fifths of the ML | ≤ one fifth of the ML] | ||||
(b)
[F3Performance 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]
(c)
Performance criteria for methods of analysis for polycyclic aromatic hydrocarbons:
The four polycyclic aromatic hydrocarbons to which these criteria apply are benzo(a)pyrene, benz(a)anthracene, benzo(b)fluoranthene and chrysene.
Table 7
| Parameter | Criterion |
|---|---|
| Applicability | Foods specified in Regulation (EC) No 1881/2006 |
| Specificity | Free from matrix or spectral interferences, verification of positive detection |
| Repeatability (RSD r ) | HORRAT r less than 2 |
| Reproducibility (RSD R ) | HORRAT R less than 2 |
| Recovery | 50-120 % |
| LOD | ≤ 0,30 μg/kg for each of the four substances |
| LOQ | ≤ 0,90 μg/kg for each of the four substances |
(d)
[F3Performance 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] |
(e)
[F4Performance 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:
Textual Amendments
F2 Substituted by Commission Regulation (EU) 2016/582 of 15 April 2016 amending Regulation (EC) No 333/2007 as regards the analysis of inorganic arsenic, lead and polycyclic aromatic hydrocarbons and certain performance criteria for analysis (Text with EEA relevance).
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 836/2011 of 19 August 2011 amending Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs (Text with EEA relevance).
[F1C.3.3.2. ‘Fitness-for-purpose’ approach U.K.
For in-house validated methods, as an alternative a ‘fitness-for-purpose’ approach (3) may be used to assess their suitability for official control. Methods suitable for official control must produce results with a combined standard measurement uncertainty (u) less than the maximum standard measurement uncertainty calculated using the formula below:
where:
Uf is the maximum standard measurement uncertainty (μg/kg).
LOD is the limit of detection of the method (μg/kg). The LOD must meet the performance criteria set in point C.3.3.1 for the concentration of interest.
C is the concentration of interest (μg/kg);
α is a numeric factor to be used depending on the value of C. The values to be used are given in [F3Table 10] .
[F3Table 10]
Numeric values to be used for α as constant in formula set out in this point, depending on the concentration of interest
| C (μg/kg) | α |
|---|---|
| ≤ 50 | 0,2 |
| 51-500 | 0,18 |
| 501- 1 000 | 0,15 |
| 1 001 - 10 000 | 0,12 |
| > 10 000 | 0,1 |
The analyst shall note the ‘Report on the relationship between analytical results, measurement uncertainty, recovery factors and the provisions of EU food and feed legislation’(4) .]
(3)
[F1M. Thompson and R. Wood, Accred. Qual. Assur., 2006, p. 10 and 471-478.]
(4)
[F1http://ec.europa.eu/food/food/chemicalsafety/contaminants/report-sampling_analysis_2004_en.pdf]
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 836/2011 of 19 August 2011 amending Regulation (EC) No 333/2007 laying down the methods of sampling and analysis for the official control of the levels of lead, cadmium, mercury, inorganic tin, 3-MCPD and benzo(a)pyrene in foodstuffs (Text with EEA relevance).
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