Water Policy Framework (Amendment) Regulations, 2011

L.N. 16 of 2011

ENVIRONMENT PROTECTION ACT

(CAP. 435)

Water Policy Framework (Amendment) Regulations, 2011

IN exercise of the powers conferred by article 28(1) of the

Malta Resources Authority Act, and by articles 6, 9, 11 and 23

of the Environment Protection Act, the Prime Minister and the

Minister for Resources and Rural Affairs, after consultation with

the Malta Resources Authority and the Malta Environment and

Planning Authority, have made the following regulations:-

The title of these regulations is the Water Policy

Framework (Amendment) Regulations, 2011 and they shall

be read and construed as one with the Water Policy Framework

Regulations, 2004 hereinafter referred to as “the principal

regulations”.

(1) These regulations provide for the implementation

in Malta and Gozo of Environmental Quality Standards (EQS)

for priority substances and certain other pollutants, with the aim

of achieving good surface water chemical status, by transposing

Directive 2008/105/EC of the European Parliament and of the

Council of 16th December, 2008 on environmental quality

standards in the field of water policy, amending and subsequently

repealing Council Directives 82/176/EEC, 83/513/EEC, 84/156/

EEC, 84/491/EEC, 86/280/EEC and amending Directive 2000/60/

EC of the European Parliament and of the Council.

(2) These regulations also establish minimum

performance criteria for methods of analysis to be applied by the

competent authority when monitoring water status, sediment and

biota, as well as rules for demonstrating the quality of analytical

results, by transposing 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.

For the word “Annex” in the principal regulations,

wherever it occurs, shall be substituted the word “Schedule”.

Immediately after sub-regulation (8) of regulation 4 of

the principal regulations, there shall be added the following new

sub-regulation

“(9) The competent authority shall not be in breach

of its obligations under these regulations as a result of any

excess of an EQS in coastal waters, if it can demonstrate that

(a) the excess was due to a source of pollution

outside its national jurisdiction;

(b) it was unable as a result of such transboundary

pollution to take effective measures to comply with the

relevant EQS;

(c) it had applied the coordination mechanisms

set out in relevant international agreements and, as

appropriate, taken advantage of the provisions of sub-

regulations (4), (5) and (6) of this regulation, for those

water bodies affected by transboundary pollution; and

(d) in the circumstances set out in point (a) above,

the competent authority shall communicate a summary

of the measures taken in relation to transboundary

pollution in the relevant water catchment management

plans as laid down in sub-regulation (3) of regulation 12

of these regulations.”

For sub-regulation (3) of regulation 8 of the principal

regulations, there shall be substituted the following

“(3) The competent authority shall adhere to technical

specifications and standardised methods for analysis

and monitoring of water status in accordance with the

requirements of Schedules V and XI.”.

Immediately after the heading “1.4 Identification of

Pressures” in Schedule II to the principal regulations, there shall be

added the following new item

“Inventory of Emissions, Discharges and Losses

1. The competent authority shall establish an

inventory, including maps, if available, of emissions,

discharges and losses of all priority substances and

pollutants listed in Part A, Table 1 of Schedule IX on

the basis of the information collected in accordance

with regulation 5 and regulation 8 of these regulations,

the European Pollutant Release and Transfer Register

Reporting Obligations Regulations, 2007 (L.N. 152

of 2007), environmental permits and/or operational

permits as issued by the relevant competent authority

and other available data, for the water catchment district

lying within the Maltese territory, including their

concentrations in sediment and biota, as appropriate.

In fulfilling the requirement to establish and maintain

the inventory of emissions, discharges and losses, the

competent authority may request any further information

it deems necessary from any relevant installation.

2. The reference period for the estimation of

pollutant values to be entered in the inventories referred

to in point (1) above shall be one year between 2008

and 2010. However, for priority substances or pollutants

covered by the Plant Protection Products Regulations,

2004 (L.N. 115 of 2004), the entries may be calculated

as the average of the years 2008, 2009 and 2010.

3. The inventories shall be updated as part of the

reviews of the analyses specified in sub-regulation (2) of

regulation 5 of these regulations. The reference period

for the establishment of values in the updated inventories

shall be the year before that analysis is to be completed.

For priority substances or pollutants covered by Plant

Protection Products Regulations, 2004, the entries may

be calculated as the average of the three years before

the completion of that analysis. The updated inventories

shall be published in the updated water catchment

management plans as laid down in sub-regulation (5) of

regulation 12 of these regulations.”.

Immediately after item 4 in Part B of Schedule VII to the

principal regulations, there shall be added the following new item

“5. a description of the designation of any mixing

zones, a communication of the measures in relation to

transboundary pollution and the updated inventory of

emissions, discharges and losses.”.

Schedule IX to the principal regulations shall be

amended as follows

(a) for the first paragraph thereof, there shall be

substituted the following

“The ‘limit values’ established under the

regulations following the Pollution Caused by Certain

Dangerous Substances Discharged into the Aquatic

Environment Regulations, 2001 (L.N. 213 of 2001) shall

be considered emission limit values for the purposes of

these regulations. They are established in the following

regulations:”; and

(b) immediately at the end of the said Schedule there

shall be added the following new provisions

“Amendments to L.N. 220 of 2001, L.N. 221 of

2001, L.N. 219 of 2001, L.N. 218 of 2001 and L.N. 227

of 2001

1. Annex II of L.N. 220 of 2001, L.N. 221

of 2001, L.N. 219 of 2001 and L.N. 218 of 2001,

respectively shall be deleted.

2. Heading B in Sections I to XI of Annex II

to L.N. 227 of 2001 shall be deleted.

Environmental Quality Standards

1. The competent authority shall apply the

EQS laid down in Part A of Table 1 below to bodies

of surface waters in Malta and Gozo, in accordance

with the requirements laid down in Part B of Table

1 below.

2. The following EQS for biota shall apply

instead of those laid down in Part A of Table 1 in

certain categories of surface water

(a) mercury and its compounds an

EQS of 20 μg/kg applies;

(b) hexachlorobenzene an EQS of 10

μg/kg applies;

(c) hexachlorobutadiene an EQS of 55

μg/kg applies.

These EQS are applicable for prey tissue

(wet weight), choosing the most appropriate

indicator among fish, molluscs, crustaceans

and other biota.

3. EQS other than those mentioned in

point (2) above may be applied by the competent

authority for sediment and/or biota for specified

substances. These EQS shall offer at least the same

level of protection as the EQS for water set out in

Part A of Table 1.

4. For substances mentioned in points

(2) and (3) above, the competent authority shall

determine the frequency of monitoring in biota

and/or sediment. However the competent authority

shall undertake monitoring at least once every year,

unless technical knowledge and expert judgment

justify another interval. The competent authority

shall apply its technical knowledge and expert

judgment to justify the reasons and basis for using

the methodologies in points (2) and (3).

Long-term Analysis for Priority

Substances

1. The competent authority shall arrange

for the long-term trend analysis of concentrations

of those priority substances listed in Part A of

Table 1 that tend to accumulate in sediment and/or

biota, giving particular consideration to substances

numbers 2, 5, 6, 7, 12, 15, 16, 17, 18, 20, 21, 26,

28 and 30 on the basis of the monitoring of water

status carried out in accordance with regulation 8

of these regulations.

2. Measures shall be taken by the competent

authority aimed at ensuring, subject to regulation 4

of these regulations that such concentrations do not

significantly increase in sediment and/or relevant biota.

3. The competent authority shall determine

the frequency of monitoring in sediments and/or

biota so as to provide sufficient data for a reliable

long-term trend analysis. Monitoring should take

place every three years, unless technical knowledge

and expert judgment justify another interval.

Mixing Zones

1. Adjacent to the points of discharge, the

competent authority may designate mixing zones

where the concentrations of one or more substances

listed in Part A of Table 1 may exceed the relevant

EQS within such mixing zones and provided they

do not affect the compliance of the rest of the body

of surface water with those standards.

2. If mixing zones are designated, the

water catchment management plans as required by

regulation 12 of these regulations, shall include a

description of

(a) the approaches and methodologies

applied to define such zones; and

(b) measures taken with a view to

reducing the extent of the mixing zones in the

future, such as those pursuant to sub-regulation

(3k) of regulation 11 of these regulations or by

reviewing permits referred to in the Integrated

Pollution Prevention and Control Regulations,

2002 (L.N. 234 of 2002) or prior regulations

referred to in sub-regulation (3g) of regulation

11 of these regulations.

3. The competent authority shall ensure that

the extent of any designated mixing zone is

(a) restricted to the proximity of the

point of discharge;

(b) proportionate, having regard to the

concentrations of pollutants at the point of

discharge and to the conditions on emissions

of pollutants contained in the prior regulations,

such as authorizations and/or permits, referred

to in sub-regulation (3g) of regulation 11

of these regulations and any other relevant

national law, in accordance with the application

of best available techniques and regulation 10

of these regulations, in particular after those

prior regulations are reviewed.

Table 1

Environmental Quality Standards for Priority Substances and Certain Other

Pollutants

PART A: ENVIRONMENTAL QUALITY STANDARDS (EQS)

AA: annual average

MAC: maximum allowable concentration

Unit: [g/l]

(1)

(2)

(3)

(4)

(5)

(6)

(7)

AA-EQS

AA-EQS

MAC-

MAC-

( 2 )

( 2 )

EQS ( 5 )

EQS ( 5 )

CAS

Name of

Other

No

Inland

Inland

Other

number

substance

surface

( 1 )

surface

surface

surface

waters ( 4 )

waters ( 3 )

waters ( 3 )

waters ( 4 )

15972-

(1)

Alachlor

0,3

0,3

0,7

0,7

60-8

(2)

Anthracene

120-12-7

0,1

0,1

0,4

0,4

1912-24-

(3)

Atrazine

0,6

0,6

2,0

2,0

(4)

Benzene

71-43-2

Brominated

32534-

not

not

(5)

0,0005

0,0002

diphenylether ( 6 )

81-9

applicable

applicable

 0,08

 0,45

 0,45

(Class 1),

(Class 1),

(Class 1),

0,08

0,45

0,45

Cadmium and its

(Class 2),

(Class 2),

(Class 2),

compounds

7440-43-

0,09

0,6

0,6

(6)

(depending on

0,2

(Class 3),

(Class 3),

(Class 3),

water hardness

0,15

0,9

0,9

classes) ( 7 )

(Class 4),

(Class 4),

(Class 4),

0,25

1,5

1,5

(Class 5)

(Class 5)

(Class 5)

Carbon-

not

not

(6a)

56-23-5

tetrachloride ( 8 )

applicable

applicable

C10-13

85535-

(7)

0,4

0,4

1,4

1,4

Chloroalkanes

84-8

(8)

Chlorfenvinphos

470-90-6

0,1

0,1

0,3

0,3

Chlorpyrifos

2921-88-

(9)

(Chlorpyrifos-

0,03

0,03

0,1

0,1

ethyl)

(9a)

Cyclodiene

309-00-2

 = 0,01

 = 0,005

not

not

pesticides

60-57-1

applicable

applicable

Aldrin ( 8 )

72-20-8

Dieldrin ( 8 )

465-73-6

Endrin ( 8 )

Isodrin ( 8 )

not

not

not

DDT total ( 8 ) ( 9 )

0,025

0,025

applicable

applicable

applicable

(9b)

para-para-DDT

not

not

50-29-3

0,01

0,01

( 8 )

applicable

applicable

1,2-

not

not

(10)

107-06-2

Dichloroethane

applicable

applicable

not

not

(11)

Dichloromethane

75-09-2

applicable

applicable

Di(2-ethylhexyl)-

not

not

(12)

117-81-7

1,3

1,3

phthalate (DEHP)

applicable

applicable

(13)

Diuron

330-54-1

0,2

0,2

1,8

1,8

(14)

Endosulfan

115-29-7

0,005

0,0005

0,01

0,004

(15)

Fluoranthene

206-44-0

0,1

0,1

Hexachloro-

0,01 ( 10 )

0,01 ( 10 )

(16)

118-74-1

0,05

0,05

benzene

Hexachloro-

0,1 ( 10 )

0,1 ( 10 )

(17)

87-68-3

0,6

0,6

butadiene

Hexachloro-

(18)

608-73-1

0,02

0,04

0,02

cyclohexane

0,002

34123-

(19)

Isoproturon

0,3

0,3

1,0

1,0

59-6

Lead and its

7439-92-

not

not

(20)

7,2

7,2

compounds

applicable

applicable

Mercury and its

7439-97-

0,05 ( 10 )

0,05 ( 10 )

(21)

0,07

0,07

compounds

not

not

(22)

Naphthalene

91-20-3

2,4

1,2

applicable

applicable

Nickel and its

7440-02-

not

not

(23)

compounds

applicable

applicable

Nonylphenol (4-

(24)

104-40-5

0,3

0,3

2,0

2,0

Nonylphenol)

Octylphenol ((4-

not

not

(1,1’,3,3’-

(25)

140-66-9

0,1

0,01

applicable

applicable

tetramethylbutyl)-

phenol))

Pentachloro-

not

not

(26)

608-93-5

0,007

0,0007

benzene

applicable

applicable

Pentachloro-

(27)

87-86-5

0,4

0,4

phenol

Polyaromatic

not

not

not

not

not

(28)

hydrocarbons

applicable

applicable

applicable

applicable

applicable

(PAH) ( 11 )

Benzo(a)pyrene

50-32-8

0,05

0,05

0,1

0,1

Benzo(b)fluor-

205-99-2

not

not

anthene

 = 0,03

 = 0,03

applicable

applicable

Benzo(k)fluor-

207-08-9

anthene

Benzo(g,h,i)-

191-24-2

not

not

perylene

 = 0,002

 = 0,002

applicable

applicable

Indeno(1,2,3-cd)-

193-39-5

pyrene

(29)

Simazine

122-34-9

Tetrachloro-

not

not

(29a)

127-18-4

ethylene ( 8 )

applicable

applicable

Trichloro-

not

not

(29b)

79-01-6

ethylene ( 8 )

applicable

applicable

Tributyltin

36643-

compounds

(30)

0,0002

0,0002

0,0015

0,0015

28-4

(Tributhyltin-

cation)

Trichloro-

12002-

not

not

(31)

0,4

0,4

benzenes

48-1

applicable

applicable

Trichloro-

not

not

(32)

67-66-3

2,5

2,5

methane

applicable

applicable

1582-09-

not

not

(33)

Trifluralin

0,03

0,03

applicable

applicable

(1) CAS: Chemical Abstracts Service.

(2) This parameter is the EQS expressed as an annual average value (AA-EQS). Unless otherwise

specified, it applies to the total concentration of all isomers.

(3) Inland surface waters refer to all standing or flowing waters on the surface of the land and related

artificial or heavily modified water bodies.

(4) Other surface waters refer to transitional waters, coastal waters, territorial waters and related

artificial or heavily modified water bodies.

(5) This parameter is the EQS expressed as a maximum allowable concentration (MAC-EQS).

Where the MAC-EQS are marked as "not applicable", the AA-EQS values are considered protective

against short-term pollution peaks in continuous discharges since they are significantly lower than

the values derived on the basis of acute toxicity.

(6) For the group of priority substances covered by brominated diphenylethers (No 5) listed in

Decision No 2455/2001/EC, an EQS is established only for congener numbers 28, 47, 99, 100, 153

and 154.

(7) For cadmium and its compounds (No 6) the EQS values vary depending on the hardness of the

water as specified in five class categories (Class 1: < 40 mg CaCO 3 /l, Class 2: 40 to < 50 mg

CaCO 3 /l, Class 3: 50 to < 100 mg CaCO 3 /l, Class 4: 100 to < 200 mg CaCO 3 /l and Class 5:  200 mg

CaCO 3 /l).

(8) This substance is not a priority substance but one of the other pollutants for which the EQS are

identical to those laid down in the legislation that applied prior to 13 January 2009.

(9) DDT total comprises the sum of the isomers 1,1,1-trichloro-2,2 bis (p-chlorophenyl) ethane

(CAS number 50-29-3; EU number 200-024-3); 1,1,1-trichloro-2 (o-chlorophenyl)-2-(p-

chlorophenyl) ethane (CAS number 789-02-6; EU number 212-332-5); 1,1-dichloro-2,2 bis (p-

chlorophenyl) ethylene (CAS number 72-55-9; EU number 200-784-6); and 1,1-dichloro-2,2 bis (p-

chlorophenyl) ethane (CAS number 72-54-8; EU number 200-783-0).

(10) For certain categories of surface water, if the competent authority does not apply EQS for biota,

stricter EQS for water shall be introduced in these categories of surface water; in order to achieve the

same level of protection as the EQS for biota set out in the section above ‘Environmental Quality

Standards’, point (2). The competent authority shall notify the Commission and the Member States,

through the Committee referred to in Article 21 of Directive 2000/60/EC, of the reasons and basis

for using this approach, the alternative EQS for water established, including the data and the

methodology by which the alternative EQS were derived, and the categories of surface water to

which they would apply.

(11) For the group of priority substances of polyaromatic hydrocarbons (PAH) (No 28), each

individual EQS is applicable, i.e. the EQS for Benzo(a)pyrene, the EQS for the sum of

Benzo(b)fluoranthene and Benzo(k)fluoranthene and the EQS for the sum of Benzo(g,h,i)perylene

and Indeno(1,2,3-cd)pyrene must be met.

PART B: APPLICATION OF THE EQS SET OUT IN PART A

1. Columns 4 and 5 of the table: For any given surface water body, applying the AA-

EQS means that, for each representative monitoring point within the water body, the

arithmetic mean of the concentrations measured at different times during the year does

not exceed the standard.

and Indeno(1,2,3-cd)pyrene must be met.

PART B: APPLICATION OF THE EQS SET OUT IN PART A

1. Columns 4 and 5 of the table: For any given surface water body, applying the AA-

EQS means that, for each representative monitoring point within the water body, the

arithmetic mean of the concentrations measured at different times during the year does

not exceed the standard.

The calculation of the arithmetic mean, the analytical method used and, where there is

no appropriate analytical method meeting the minimum performance criteria, the

method of applying an EQS must be in accordance with implementing acts adopting

technical specifications for chemical monitoring and quality of analytical results, in

accordance with these regulations.

2. Columns 6 and 7 of the table: For any given surface water body, applying the MAC-

EQS means that the measured concentration at any representative monitoring point

within the water body does not exceed the standard.

However, in accordance with section 1.3.4 of Schedule V to these regulations, the

competent authority may introduce statistical methods, such as a percentile calculation,

to ensure an acceptable level of confidence and precision for determining compliance

with the MAC-EQS. If it does so, such statistical methods shall comply with detailed

rules laid down in accordance with the regulatory procedure referred to in Article 9(2)

of Directive 2008/105/EC.

3. With the exception of cadmium, lead, mercury and nickel (hereinafter "metals") the

EQS set up in this Schedule are expressed as total concentrations in the whole water

sample. In the case of metals the EQS refers to the dissolved concentration, i.e. the

dissolved phase of a water sample obtained by filtration through a 0,45 m filter or any

equivalent pre-treatment.

The competent authority may, when assessing the monitoring results against the EQS,

take into account

(a) natural background concentrations for metals and their compounds, if they prevent

compliance with the EQS value; and

(b) hardness, pH or other water quality parameters that affect the bioavailability of

metals.”.

For Schedule X to the principal regulations there shall be substituted

the following

“Schedule X

LIST OF PRIORITY SUBSTANCES IN THE FIELD OF WATER POLICY

Identified as

CAS number

EU number

Name of priority

priority

Number

( 1 )

( 2 )

substance ( 3 )

hazardous

substance

(1)

15972-60-8

240-110-8

Alachlor

(2)

120-12-7

204-371-1

Anthracene

X

(3)

1912-24-9

217-617-8

Atrazine

(4)

71-43-2

200-753-7

Benzene

not

not

Brominated

X ( 5 )

diphenylether ( 4 )

applicable

applicable

(5)

Pentabromodiphenylether

not

(congener numbers 28,

32534-81-9

applicable

47, 99, 100, 153 and 154)

Cadmium and its

(6)

7440-43-9

231-152-8

X

compounds

Chloralkanes, C 10-13 ( 4 )

(7)

85535-84-8

287-476-5

X

(8)

470-90-6

207-432-0

Chlorfenvinphos

Chlorpyrifos

(9)

2921-88-2

220-864-4

(Chlorpyrifos-ethyl)

(10)

107-06-2

203-458-1

1,2-dichloroethane

(11)

75-09-2

200-838-9

Dichloromethane

Di(2-

(12)

117-81-7

204-211-0

ethylhexyl)phthalate

(DEHP)

(13)

330-54-1

206-354-4

Diuron

(14)

115-29-7

204-079-4

Endosulfan

X

Fluoranthene ( 6 )

(15)

206-44-0

205-912-4

(16)

118-74-1

204-273-9

Hexachlorobenzene

X

(17)

87-68-3

201-765-5

Hexachlorobutadiene

X

(18)

608-73-1

210-158-9

Hexachlorocyclohexane

X

(19)

34123-59-6

251-835-4

Isoproturon

(20)

7439-92-1

231-100-4

Lead and its compounds

Mercury and its

(21)

7439-97-6

231-106-7

X

compounds

(22)

91-20-3

202-049-5

Naphthalene

Nickel and its

(23)

7440-02-0

231-111-14

compounds

25154-52-3

246-672-0

Nonylphenol

X

(24)

104-40-5

203-199-4

(4-nonylphenol)

X

1806-26-4

217-302-5

Octylphenol

(25)

not

(4-(1,1’,3,3’-

140-66-9

applicable

tetramethylbutyl)-phenol)

(26)

608-93-5

210-172-5

Pentachlorobenzene

X

(27)

87-86-5

231-152-8

Pentachlorophenol

not

not

Polyaromatic

X

(28)

applicable

applicable

hydrocarbons

50-32-8

200-028-5

(Benzo(a)pyrene)

X

205-99-2

205-911-9

(Benzo(b)fluoranthene)

X

191-24-2

205-883-8

(Benzo(g,h,i)perylene)

X

207-08-9

205-916-6

(Benzo(k)fluoranthene)

X

193-39-5

205-893-2

(Indeno(1,2,3-cd)pyrene)

X

(29)

122-34-9

204-535-2

Simazine

not

not

X

Tributyltin compounds

applicable

applicable

(30)

not

X

36643-28-4

(Tributyltin-cation)

applicable

(31)

12002-48-1

234-413-4

Trichlorobenzenes

Trichloromethane

(32)

67-66-3

200-663-8

(chloroform)

(33)

1582-09-8

216-428-8

Trifluralin

(1) CAS: Chemical Abstracts Service.

(2) EU number: European Inventory of Existing Commercial Substances (Einecs) or European List

of Notified Chemical Substances (Elincs).

(3) Where groups of substances have been selected, typical individual representatives are listed as

indicative parameters (in brackets and without number). For these groups of substances, the

indicative parameter must be defined through the analytical method.

(4) These groups of substances normally include a considerable number of individual compounds.

At present, appropriate indicative parameters cannot be given.

(5) Only Pentabromobiphenylether (CAS-number 32534-81-9).

(6) Fluoranthene is on the list as an indicator of other, more dangerous polyaromatic

hydrocarbons. ”.

Immediately after Schedule X to the principal regulations, there shall

be added the following new Schedule

“Schedule XI

TECHNICAL SPECIFICATIONS FOR CHEMICAL ANALYSIS AND

MONITORING OF WATER STATUS

A: Definitions

For the purpose of these regulations, the following definitions shall apply

1. ‘limit of detection’ means the output signal or concentration value above

which it can be affirmed, with a stated level of confidence that a sample is

different from a blank sample containing no determinand of interest;

2. ‘limit of quantification’ means a stated multiple of the limit of detection at

a concentration of the determinand that can reasonably be determined with an

acceptable level of accuracy and precision. The limit of quantification can be

calculated using an appropriate standard or sample, and may be obtained from

the lowest calibration point on the calibration curve, excluding the blank;

3. ‘uncertainty of measurement’ means a non-negative parameter

characterizing the dispersion of the quantity values being attributed to a

measurand, based on the information used.

B: Methods of analysis

The competent authority shall ensure that all methods of analysis, including

laboratory, field and on-line methods, used for the purposes of chemical

monitoring programmes carried out under these regulations are validated and

documented in accordance with MSA EN ISO/IEC-17025: 2005 standard or

other equivalent standards accepted at international level.

C: Minimum performance criteria for methods of analysis

1. The competent authority shall ensure that the minimum performance

criteria for all methods of analysis applied are based on an uncertainty of

measurement of 50 % or below (k = 2) estimated at the level of relevant

environmental quality standards and a limit of quantification equal or below a

value of 30 % of the relevant environmental quality standards.

2. In the absence of relevant environmental quality standard for a given

parameter, or in the absence of method of analysis meeting the minimum

performance criteria set out in point C(1) above, the competent authority shall

ensure that monitoring is carried out using best available techniques not

entailing excessive costs.

D: Calculation of mean values

1. Where the amounts of physico-chemical or chemical measurands in a given

sample are below the limit of quantification, the measurement results shall be

set to half of the value of the limit of quantification concerned for the

calculation of mean values.

2. Where a calculated mean value of the measurement results referred to in

D(1) above, is below the limits of quantification, the value shall be referred to

as "less than limit of quantification".

3. Point D(1) shall not apply to measurands that are total sums of a given

group of physico-chemical parameters or chemical measurands, including

their relevant metabolites, degradation and reaction products. In those cases,

results below the limit of quantification of the individual substances shall be

set to zero.

E: Quality assurance and control

1. The competent authority shall ensure that laboratories or parties contracted

by laboratories apply quality management system practices in accordance

with MSA EN ISO/IEC-17025:2005 or other equivalent standards accepted at

international level.

2. The competent authority shall ensure that laboratories or parties contracted

by laboratories demonstrate their competences in analysing relevant physico-

chemical or chemical measurands by

(a) participation in proficiency testing programmes covering the methods of

analysis referred to in ‘B: Methods of analysis’ of this Schedule of

measurands at levels of concentrations that are representative of chemical

monitoring programmes carried out under these regulations; and

(b) analysis of available reference materials that are representative of

collected samples which contain appropriate levels of concentrations in

relation to relevant environmental quality standards referred to in point C(1)

of ‘C: Minimum performance criteria for methods of analysis’ as included in

this Schedule.

3. The proficiency testing programmes referred to in point E(2a) above shall

be organised by accredited organisations or internationally or nationally

recognised organisations which meet the requirements of ISO/IEC guide 43-1

or of other equivalent standards accepted at international level.

The results of participation in those programmes shall be evaluated on the

basis of the scoring systems set out in ISO/IEC guide 43-1 or in the ISO-

13528 standard or in other equivalent standards accepted at international

level.

F: Coming into effect of this schedule

The competent authority shall adhere to the technical specifications and

standardised methods for analysis and monitoring of water status, as per

requirements in this Schedule XI, at the latest 7 years from the publication of

these regulations.”.

€1.49