Commission Directive 2001/22/EC (repealed)Dangos y teitl llawn

3.3. Specific requirements U.K.

3.3.1. Lead, cadmium and mercury analyses U.K.

Specific methods for the determination of lead, cadmium and mercury contents are not prescribed. Laboratories shall use a validated method that fulfils the performance criteria indicated in Table 3. Where possible, the validation shall include a certified reference material in the collaborative trial test materials.

Table 3:

Performance criteria of methods for lead, cadmium and mercury analyses

Parameter	Value/comment
Applicability	Foods specified in Regulation (EC) No 466/2001
Detection limit	No more than one tenth of the value of the specification in Regulation (EC) No 466/2001, except if the value of the specification for lead is less than 0,1 mg/kg. For the latter, no more than one fifth of the value of the specification
Limit of quantification	No more than one fifth of the value of the specification in Regulation (EC) No 466/2001, except if the value of the specification for lead is less than 0,1 mg/kg. For the latter, no more than two fifths of the value of the specification
Precision	HORRATr or HORRATR values of less than 1,5 in the validation collaborative trial
Recovery	80-120 % (as indicated in the collaborative trial)
Specificity	Free from matrix or spectral interferences

3.3.2. 3-MCPD analysis U.K.

Specific methods for the determination of 3-MCPD contents are not prescribed. Laboratories shall use a validated method that fulfils the performance criteria indicated in Table 4. Where possible, the validation shall include a certified reference material in the collaborative trial test materials. A specific method has been validated by collaborative trial and has been shown to meet the requirements of Table 4 (^c).

Table 4:

Performance criteria of methods for 3-MCPD analysis

Criterion	Recommended value	Concentration
Field blanks	Less than the detection limit	—
Recovery	75-110 %	All
Limit of quantification	10 (or less) μg/kg on a dry matter basis	—
Standard deviation of the field blank signal	Less than 4 μg/kg	—
In-house precision estimates — standard deviation of replicate measurements at different concentrations	< 4 μg/kg	20 µg/kg
	< 6 μg/kg	30 µg/kg
	< 7 μg/kg	40 µg/kg
	< 8 μg/kg	50 µg/kg
	< 15 μg/kg	100 µg/kg

[F1 3.3.3. Performance Criteria — Uncertainty Function Approach U.K.

However, an uncertainty approach may also be used to assess the suitability of the method of analysis to be used by the laboratory. The laboratory may use a method which will produce results within a maximum standard uncertainty. The maximum standard uncertainty can be calculated using the following formula:

where:

Uf is the maximum standard uncertainty

LOD is the limit of detection of the method

C is the concentration of interest

α is a numeric factor to be used depending on the value of C. The values to be used are given in the table below:

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

and U is the expanded uncertainty, using a coverage factor of 2 which gives a level of confidence of approximately 95 %.

If an analytical method provides results with uncertainty measurements less than the maximum standard uncertainty the method will be equally suitable to one which meets the performance characteristics given above.]

Textual Amendments

F1 Inserted by Commission Directive 2005/4/EC of 19 January 2005 amending Directive 2001/22/EC laying down the sampling methods and the methods of analysis for the official control of the levels of lead, cadmium, mercury and 3-MCPD in foodstuffs (Text with EEA relevance).