ANNEX II
Annex III to Directive 98/83/EC is amended as follows:
- (1)
the introductory paragraph is replaced by the following:
Member States shall ensure that the methods of analysis used for the purposes of monitoring and demonstrating compliance with this Directive are validated and documented in accordance with EN ISO/IEC 17025 or other equivalent standards accepted at international level. Member States shall ensure that laboratories or parties contracted by laboratories apply quality management system practices in accordance with EN ISO/IEC 17025 or other equivalent standards accepted at international level.
In the absence of an analytical method meeting the minimum performance criteria set out in Part B, Member States shall ensure that monitoring is carried out using best available techniques not entailing excessive costs.
- (2)
point 1 is amended as follows:
- (a)
the heading of point 1 is replaced by the following:
PART AMicrobiological parameters for which methods of analysis are specified
- (b)
the third to the ninth paragraphs, including Note 1, are replaced by the following:
The methods for microbiological parameters are:
- (a)
Escherichia coli (E. coli) and coliform bacteria (EN ISO 9308-1 or EN ISO 9308-2)
- (b)
Enterococci (EN ISO 7899-2)
- (c)
Pseudomonas aeruginosa (EN ISO 16266)
- (d)
enumeration of culturable microorganisms — colony count 22 °C (EN ISO 6222)
- (e)
enumeration of culturable microorganisms — colony count 36 °C (EN ISO 6222)
- (f)
Clostridium perfringens including spores (EN ISO 14189)
- (a)
- (a)
- (3)
point 2 is amended as follows:
- (a)
the heading of point 2 is replaced by the following:
PART BChemical and indicator parameters for which performance characteristics are specified
- (b)
point 2.1 is replaced by the following:
1.Chemical and indicator parameters
For the parameters set out in Table 1, the specified performance characteristics are that the method of analysis used must, as a minimum, be capable of measuring concentrations equal to the parametric value with a limit of quantification, as defined in Article 2(2) of Commission Directive 2009/90/EC17, of 30 % or less of the relevant parametric value and an uncertainty of measurement as specified in Table 1. The result shall be expressed using at least the same number of significant figures as for the parametric value considered in Parts B and C of Annex I.
Until 31 December 2019 Member States may allow for the use of “trueness”, “precision” and “limit of detection” as specified in Table 2, as an alternative set of performance characteristics to “limit of quantification” and “uncertainty of measurement” as specified respectively in the first paragraph and Table 1.
The uncertainty of measurement laid down in Table 1 shall not be used as an additional tolerance to the parametric values set out in Annex I.
Table 1Minimum performance characteristic “Uncertainty of measurement”Parameters
Uncertainty of measurement(See Note 1)% of the parametric value (except for pH)
Notes
Aluminium
25
Ammonium
40
Antimony
40
Arsenic
30
Benzo(a)pyrene
50
See Note 5
Benzene
40
Boron
25
Bromate
40
Cadmium
25
Chloride
15
Chromium
30
Conductivity
20
Copper
25
Cyanide
30
See Note 6
1,2-dichloroethane
40
Fluoride
20
Hydrogen ion concentration pH (expressed in pH units)
0,2
See Note 7
Iron
30
Lead
25
Manganese
30
Mercury
30
Nickel
25
Nitrate
15
Nitrite
20
Oxidisability
50
See Note 8
Pesticides
30
See Note 9
Polycyclic aromatic hydrocarbons
50
See Note 10
Selenium
40
Sodium
15
Sulphate
15
Tetrachloroethene
30
See Note 11
Trichloroethene
40
See Note 11
Trihalomethanes — total
40
See Note 10
Total organic carbon (TOC)
30
See Note 12
Turbidity
30
See Note 13
Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.
Table 2Minimum performance characteristics “Trueness”, “precision” and “limit of detection” — may be used until 31 December 2019Parameters
Trueness(See Note 2)% of the parametric value (except for pH)
Precision(See Note 3)% of the parametric value (except for pH)
Limit of detection(See Note 4)% of the parametric value (except for pH)
Notes
Aluminium
10
10
10
Ammonium
10
10
10
Antimony
25
25
25
Arsenic
10
10
10
Benzo(a)pyrene
25
25
25
Benzene
25
25
25
Boron
10
10
10
Bromate
25
25
25
Cadmium
10
10
10
Chloride
10
10
10
Chromium
10
10
10
Conductivity
10
10
10
Copper
10
10
10
Cyanide
10
10
10
See Note 6
1,2-dichloroethane
25
25
10
Fluoride
10
10
10
Hydrogen ion concentration pH (expressed in pH units)
0,2
0,2
See Note 7
Iron
10
10
10
Lead
10
10
10
Manganese
10
10
10
Mercury
20
10
20
Nickel
10
10
10
Nitrate
10
10
10
Nitrite
10
10
10
Oxidisability
25
25
10
See Note 8
Pesticides
25
25
25
See Note 9
Polycyclic aromatic hydrocarbons
25
25
25
See Note 10
Selenium
10
10
10
Sodium
10
10
10
Sulphate
10
10
10
Tetrachloroethene
25
25
10
See Note 11
Trichloroethene
25
25
10
See Note 11
Trihalomethanes — total
25
25
10
See Note 10
Turbidity
25
25
25
Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.
- (c)
point 2.2 is replaced by the following:
2.Notes to Tables 1 and 2
Note 1
Uncertainty of measurement is a non-negative parameter characterising the dispersion of the quantity values being attributed to a measurand, based on the information used. The performance criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in the table or better. Measurement uncertainty shall be estimated at the level of the parametric value, unless otherwise specified.
Note 2
Trueness is a measure of systematic error, i.e. the difference between the mean value of the large number of repeated measurements and the true value. Further specifications are those set out in ISO 5725.
Note 3
Precision is a measure of random error and is usually expressed as the standard deviation (within and between batches) of the spread of results from the mean. Acceptable precision is twice the relative standard deviation. This term is further specified in ISO 5725.
Note 4
Limit of detection is either:
three times the standard deviation within a batch of a natural sample containing a low concentration of the parameter, or
five times the standard deviation of a blank sample (within a batch).
Note 5
If the value of uncertainty of measurement cannot be met, the best available technique should be selected (up to 60 %).
Note 6
The method determines total cyanide in all forms.
Note 7
Values for trueness, precision and uncertainty of measurement are expressed in pH units.
Note 8
Reference method: EN ISO 8467
Note 9
The performance characteristics for individual pesticides are given as an indication. Values for the uncertainty of measurement as low as 30 % can be achieved for several pesticides, higher values up to 80 % may be allowed for a number of pesticides.
Note 10
The performance characteristics apply to individual substances, specified at 25 % of the parametric value in Part B of Annex I.
Note 11
The performance characteristics apply to individual substances, specified at 50 % of the parametric value in Part B of Annex I.
Note 12
The uncertainty of measurement should be estimated at the level of 3 mg/l of the total organic carbon (TOC). CEN 1484 Guidelines for the determination of TOC and dissolved organic carbon (DOC) shall be used.
Note 13
The uncertainty of measurement should be estimated at the level of 1,0 NTU (nephelometric turbidity units) in accordance with EN ISO 7027.
- (a)
- (4)
point 3 is deleted.