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ANNEX IIU.K.

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 A Microbiological 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);

(3)

point 2 is amended as follows:

(a)

the heading of point 2 is replaced by the following:

PART B Chemical 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/EC(1), 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 1

Minimum performance characteristic “Uncertainty of measurement”

Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.

ParametersUncertainty of measurement(See Note 1)% of the parametric value (except for pH)Notes
Aluminium25
Ammonium40
Antimony40
Arsenic30
Benzo(a)pyrene50See Note 5
Benzene40
Boron25
Bromate40
Cadmium25
Chloride15
Chromium30
Conductivity20
Copper25
Cyanide30See Note 6
1,2-dichloroethane40
Fluoride20
Hydrogen ion concentration pH (expressed in pH units)0,2See Note 7
Iron30
Lead25
Manganese30
Mercury30
Nickel25
Nitrate15
Nitrite20
Oxidisability50See Note 8
Pesticides30See Note 9
Polycyclic aromatic hydrocarbons50See Note 10
Selenium40
Sodium15
Sulphate15
Tetrachloroethene30See Note 11
Trichloroethene40See Note 11
Trihalomethanes — total40See Note 10
Total organic carbon (TOC)30See Note 12
Turbidity30See Note 13

Table 2

Minimum performance characteristics “Trueness”, “precision” and “limit of detection” — may be used until 31 December 2019

Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.

ParametersTrueness(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
Aluminium101010
Ammonium101010
Antimony252525
Arsenic101010
Benzo(a)pyrene252525
Benzene252525
Boron101010
Bromate252525
Cadmium101010
Chloride101010
Chromium101010
Conductivity101010
Copper101010
Cyanide101010See Note 6
1,2-dichloroethane252510
Fluoride101010
Hydrogen ion concentration pH (expressed in pH units)0,20,2See Note 7
Iron101010
Lead101010
Manganese101010
Mercury201020
Nickel101010
Nitrate101010
Nitrite101010
Oxidisability252510See Note 8
Pesticides252525See Note 9
Polycyclic aromatic hydrocarbons252525See Note 10
Selenium101010
Sodium101010
Sulphate101010
Tetrachloroethene252510See Note 11
Trichloroethene252510See Note 11
Trihalomethanes — total252510See Note 10
Turbidity252525
(c)

point 2.2 is replaced by the following:

2. Notes to Tables 1 and 2

Note 1Uncertainty 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 2Trueness 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 3Precision 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 5If the value of uncertainty of measurement cannot be met, the best available technique should be selected (up to 60 %).
Note 6The method determines total cyanide in all forms.
Note 7Values for trueness, precision and uncertainty of measurement are expressed in pH units.
Note 8Reference method: EN ISO 8467
Note 9The 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 10The performance characteristics apply to individual substances, specified at 25 % of the parametric value in Part B of Annex I.
Note 11The performance characteristics apply to individual substances, specified at 50 % of the parametric value in Part B of Annex I.
Note 12The 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 13The uncertainty of measurement should be estimated at the level of 1,0 NTU (nephelometric turbidity units) in accordance with EN ISO 7027.
(4)

point 3 is deleted.

(1)

Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status (OJ L 201, 1.8.2009, p. 36).’