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WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

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Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

SUBSIDIARY LEGISLATION 449.57

WATER INTENDED FOR HUMAN CONSUMPTION

REGULATIONS *

16th January, 2009

LEGAL NOTICE 17 of 2009, as amended by Legal Notice 242 of 2009;

and Act XXV of 2015, and by Legal Notice 299 of 2017.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

The title of these regulations is the Water Intended for

Human Consumption Regulations.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) These regulations transpose the provisions of

(a) Council Directive 98/83/EC of 3 November, 1998, on

the quality of water intended for human consumption;

(b) Council Directive 2015/1787 of 6 October 2015

amending Annexes II and III to Council Directive 98/

83/EC on the quality of water intended for human

consumption.

(2) These regulations concern the quality of water intended for

human consumption, with the objective to protect human health from

the adverse effects of any contamination of water intended for human

consumption by ensuring that it is wholesome and clean, and to set in

place a regime that provides protection to persons consuming the

water and shall apply to any water supplied by a water supplier.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

For the purposes of these regulations and unless the

context otherwise requires

"the Act" means the Food Safety Act;

"competent authority" means the Superintendent of Public

Health or a person authorized to act on his behalf;

"the Directive" means Council Directive 98/83/EC of 3

November, 1998 on the quality of water intended for human

consumption and any amendments thereto;

"distribution network" includes any method by which water

intended for human consumption is transported to a domestic

distribution system;

"domestic distribution system" means the pipe work, fittings and

appliances which are installed between the taps intended to convey

water for human consumption, and the distribution network, except

those which fall under the responsibility of the water supplier in its

capacity as a water supplier;

"Licensing Authority" means such authority as may be

established by the Regulator for Energy and Water Services;

"private water supply" means any potable water which is not

distributed through a distribution network;

"source" with respect to water shall include the outlet of water

treatment works, a borehole, a pumping station, a blending point or

*These regulations have been repealed by Legal Notice 297 of 2023.

a service reservoir, whether permanent or not;

"water intended for human consumption" means

(a) all water either in its original state or after treatment,

intended for drinking, cooking, food preparation or

other domestic purposes, regardless of its origin and

whether it is supplied from a distribution network,

from a tanker, or in bottles or containers;

(b) all water used in any food-production undertaking for

the manufacture, processing, preservation or

marketing of products or substances intended for

human consumption unless the competent authority is

satisfied that the quality of the water cannot affect the

wholesomeness of the foodstuff in its finished form;

"water supplier" means any person who supplies water intended

for human consumption and includes a private water supplier.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1)

The provisions of these regulations shall not apply to

(a) natural mineral waters recognised as such by the

competent authority, in accordance with Council

Directive 80/777/EEC of 15 July 1980 on the

approximation of the laws of the Member States

relating to the exploitation and marketing of natural

mineral waters;

(b) waters which are medicinal products within the

meaning of Council Directive 65/65/EEC of 26

January 1965 on the approximation of provisions laid

down by law, regulation or administrative action

relating to medicinal products.

(2) The competent authority may exempt from the provisions

of these regulations

(a) water intended exclusively for those purposes for

which the competent authority is satisfied that the

quality of the water has no influence, either directly or

indirectly, on the health of the consumers concerned;

(b) water intended for human consumption from an

individual supply providing less than 10 m³ a day as an

average or serving fewer than fifty persons, unless the

water is supplied as part of a commercial or public

activity.

(3) In those cases where the competent authority grants the

exemptions provided for in the preceding sub-regulation it shall

ensure that the population concerned is informed thereof and of any

action that can be taken to protect human health from the adverse

effects resulting from any contamination of water intended for

human consumption. In addition, when a potential danger to human

health arising out of the quality of such water is apparent, the

population concerned shall promptly be given appropriate advice.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) Without prejudice to other obligations under the

provisions of other laws, the competent authority shall take the

measures necessary to ensure that water intended for human

consumption is wholesome and clean. For the purposes of the

minimum requirements of these regulations, water intended for

human consumption shall be wholesome and clean if

(a) it is free from any micro-organisms and parasites and

from any substances which, in numbers or

concentrations, constitute a potential danger to human

health, and

(b) it meets the minimum requirements set out in Schedule

I, Parts A and B; and

(c) if in accordance with the relevant provisions of these

regulations and in accordance with the Treaty, the

competent authority takes all other measures necessary

to ensure that water intended for human consumption

complies with the requirements of these regulations.

(2) The competent authority shall ensure that the measures

taken to implement the provisions of these regulations in no

circumstances have the effect of allowing, directly or indirectly,

either any deterioration of the present quality of water intended for

human consumption so far as that is relevant for the protection of

human health or any increase in the pollution of waters used for the

production of drinking water.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) The competent authority shall set values applicable to

water intended for human consumption for the parameters set out in

Schedule I.

(2) The values set in accordance with the preceding sub-

regulation shall not be less stringent than those set out in Schedule

I. As regards the parameters set out in Schedule I, Part C, the

values need be fixed only for monitoring purposes and for the

fulfillment of the obligations imposed in regulation 9.

(3) The competent authority shall set values for additional

parameters not included in Schedule I where the protection of

human health in Malta or any part within it so requires. The values

set should, as a minimum, satisfy the requirements of regulation

5(1)(a).

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) The parametric values set in accordance with the

preceding regulation shall be complied with

(a) in the case of water supplied from a distribution

network, at the point, within premises or an

establishment, at which it emerges from the taps that

are normally used for human consumption;

(b) in the case of water supplied from a tanker, at the point

at which it emerges from the tanker;

(c) in the case of water put into bottles or containers

intended for sale, at the point at which the water is put

into the bottles or containers;

(d) in the case of water used in a food-production

undertaking, at the point where the water is used in the

undertaking.

(2) In the case of water covered by sub-regulation (1)(a), the

competent authority shall be deemed to have fulfilled its obligation

under this regulation and under regulations 5 and 9(2) where it can

be established that non-compliance with the parametric values set

in accordance with regulation 6 is due to the domestic distribution

s y s t e m o r t h e m a i n t e n a n c e t h e r eo f e x c e p t i n p r e m i se s a n d

establishments where water is supplied to the public, such as

schools, hospitals and restaurants.

(3) Where the provision of sub-regulation (2) applies and there

is a risk that water covered by sub-regulation (1)(a) would not

comply with the parametric values established in accordance with

regulation 5, the competent authority shall nevertheless ensure that

(a) appropriate measures are taken to reduce or eliminate

the risk of non-compliance with the parametric values,

such as advising property owners of any possible

remedial action they could take, and, or other

measures, such as appropriate treatment techniques,

are taken to change the nature or properties of the

water before it is supplied so as to reduce or eliminate

the risk of the water not complying with the parametric

values after supply; and

(b) the consumers concerned are duly informed and

advised of any possible additional remedial action that

they should take.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) The competent authority shall take all measures

necessary to ensure that regular monitoring of the quality of water

intended for human consumption is carried out, in order to check

that the water available to consumers meets the requirements of

these regulations and in particular the parametric values set in

accordance with regulation 6. Samples should be taken so that they

are representative of the quality of the water consumed throughout

the year. In addition, the competent authority shall take all

measures necessary to ensure that, where disinfection forms part of

the preparation or distribution of water intended for human

consumption, the efficiency of the disinfection treatment applied is

verified, and that any contamination from disinfection by-products

is kept as low as possible without compromising the disinfection.

(2) To meet the obligations imposed in sub-regulation (1),

appropriate monitoring programmes shall be established by the

competent authority for all water intended for human consumption.

Those monitoring programmes shall meet the minimum

requirements set out in Schedule II.

(3) The sampling points shall be determined by the competent

authority and shall meet the relevant requirements set out in

Schedule II.

(4)

(a) The competent authority shall comply with the

specifications for the analyses of parameters set out in

Schedule III.

(b) Methods other than those specified in Schedule III,

Part 1, may be used, providing it can be demonstrated

that the results obtained are at least as reliable as those

produced by the methods specified. Should the

competent authority have recourse to alternative

methods, it shall provide the European Commission

with all relevant information concerning such methods

and their equivalence.

(c) For those parameters listed in Schedule III, Parts 2 and

3, any method of analysis may be used provided that it

meets the requirements set out therein.

(5) The competent authority shall ensure that additional

monitoring is carried out on a case-by-case basis of substances and

micro-organisms for which no parametric value has been set in

accordance with regulation 6, if there is reason to suspect that they

may be present in amounts or numbers which constitute a potential

danger to human health.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) The competent authority shall ensure that any failure to

meet the parametric values set in accordance with regulation 6 is

immediately investigated in order to identify the cause.

(2) If, despite the measures taken to meet the obligations

imposed in regulation 5(1), water intended for human consumption

does not meet the parametric values set in accordance with

regulation 6, and subject to regulation 7(2), the competent authority

shall ensure that the necessary remedial action is taken by the water

supplier as soon as possible to restore its quality and shall give

priority to their enforcement action, having regard inter alia to the

extent to which the relevant parametric value has been exceeded

and to the potential danger to human health.

(3) Whether or not any failure to meet the parametric values

has occurred, where any supply of water intended for human

consumption constitutes a potential danger to human health, the

competent authority shall inform the Licensing Authority which

shall prohibit the distribution, or restrict the use, of such water by

the water supplier concerned as the case may be, or shall ensure

that any other action which may be necessary to protect human

health is taken by the water supplier. In addition the water supplier,

following consultation with the competent authority, shall promptly

inform consumers and give the necessary advice.

(4) The competent authority shall decide what action under the

preceding sub-regulation should be taken, bearing in mind the risks

to human health which would be caused by an interruption of the

supply or a restriction in the use of water intended for human

consumption.

(5) The competent authority may establish guidelines to assist

the water suppliers to fulfill their obligations under sub-regulation

(3).

(6) In the event of non-compliance with the parametric values

or with the specifications set out in Schedule I, Part C, the

competent authority shall consider whether that non-compliance

poses any risk to human health. It shall ensure that water suppliers

take remedial action to restore the quality of the water where that is

necessary to protect human health.

(7) The competent authority shall ensure that, where remedial

action is taken, water suppliers shall immediately notify consumers

except in those cases where the competent authority considers the

non-compliance with the parametric value to be trivial.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) The competent authority may provide for derogations

from the parametric values set out in Schedule I, Part B, or set in

accordance with regulation 6(3), up to a maximum value to be

determined by it, provided no derogation constitutes a potential

danger to human health and provided that the supply of water

intended for human consumption in the area concerned cannot

otherwise be maintained by any other reasonable means.

Derogations shall be limited to as short a time as possible and shall

not exceed three years, towards the end of which a review shall be

conducted to determine whether sufficient progress has been made.

Where the competent authority intends to grant a second

derogation, it shall communicate the review along with the grounds

f o r i t s d e c isi o n o n t he se c o nd de ro g a t io n , t o t h e E ur o pe a n

Commission. No such second derogation shall exceed three years.

(2) In exceptional circumstances, the competent authority may

ask the European Commission for a third derogation for a period

not exceeding three years.

(3) Any derogation granted in accordance with this regulation

shall specify the following

(a) the grounds for the derogation;

(b) the parameter concerned, previous relevant monitoring

results, and the maximum permissible value under the

derogation;

(c) the geographical area, the quantity of water supplied

each day, the population concerned and whether or not

any relevant food-production undertaking would be

affected;

(d) an appropriate monitoring scheme, with an increased

monitoring frequency where necessary;

(e) a summary of the plan for the necessary remedial

action, including a timetable for the work and an

estimate of the cost and provisions for reviewing;

(f)

the required duration of the derogation.

(4) If the competent authority consider the non-compliance

with the parametric value to be trivial, and if action taken in

accordance with regulation 9(2) is sufficient to remedy the problem

within thirty days, the requirements of sub-regulation (3) need not

be applied. In that case, only the maximum permissible value for

the parameter concerned and the time allowed to remedy the

problem shall be set by the competent authority.

(5) Recourse may no longer be had to sub-regulation (4) if

failure to comply with any one parametric value for a given water

supply has occurred on more than thirty days on aggregate during

the previous twelve months.

(6) In the case where the competent authority has recourse to

the derogations provided for in this regulation, it shall ensure that

the population affected by any such derogation is immediately

informed of the derogation and of the conditions governing it by

notice published in the Gazette and through any other appropriate

media. In addition the competent authority shall, where necessary,

ensure that advice is given to particular population groups for

which the derogation could present a special risk

Provided that these obligations shall not apply in the

circumstances described in regulation 4 unless the competent

authorities decide otherwise.

(7) With the exception of derogations granted in accordance

with the preceding sub-regulation (4), the competent authority shall

inform the European Commission within two months of any

derogation concerning an individual supply of water exceeding

1,000 m³ a day as an average or serving more than five thousand

persons, including the information specified in sub-regulation (3).

(8) This regulation shall not apply to water intended for human

consumption offered for sale in bottles or containers.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

The competent authority shall take all measures necessary

to ensure that no substances or materials for new installations used

in the preparation or distribution of water intended for human

consumption or impurities associated with such substances or

materials for new installations remain in water intended for human

consumption in concentrations higher than is necessary for the

purpose of their use and do not, either directly or indirectly, reduce

the protection of human health provided for in these regulations;

the interpretative document and technical specifications pursuant to

Article 3 and Article 4(1) of Council Directive 89/106/EEC of 21

December 1988 on the approximation of laws, regulations and

ad ministrati ve provisions of the Member States relating to

construction products shall respect the requirements of these

regulations.

Laws of Malta — Subsidiary Legislation 449.57 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS *

(1) Water suppliers shall quarterly publish up to date

information on the quality of water for human consumption on a

publicly available internet web page set up for this purpose and,

where so practicable, they shall also make such information

available to consumers through any other suitable electronic media.

(2) Without prejudice to the Freedom of Access to Information

on the Environment Regulations, the competent authority shall

publish a report every three years on the quality of water intended

for human consumption with the objective of informing consumers.

The first report shall cover the years 2002, 2003 and 2004. Each

report shall include, as a minimum, all individual supplies of water

exceeding 1 000 m³ a day as an average or serving more than five

thousand persons and it shall cover three calendar years and be

published within one calendar year of the end of the reporting

period.

(3) The competent authority shall send its reports to the

European Commission within two months of their publication.

(4) The formats and the minimum information for the reports

provided for in sub-regulation (2) shall be determined having

special regard to the measures referred to in these regulations and

shall, if necessary, be amended in accordance with the procedure

laid down in Article 12 of the Directive.

(5) Together with the first report the competent authority shall

also produce a report to be forwarded to the European Commission

on the measures it has taken or plans to take to fulfill its obligations

pursuant to regulation 7(3) and Schedule I, Part B, note 10.

Schedule I

Amended by

L.N. 242 of 2009.

(Regulation 5)

PARAMETERS AND PARAMETRIC VALUES

PART A

Microbiological parameters

Parameter

Parametric value

(number/100 ml)

Escherichia coli (E. coli)

Enterococci

The following applies to water offered for sale in bottles or containers

Parameter

Parametric value

0/250 ml

Escherichia coli (E. coli)

0/250 ml

Enterococci

0/250 ml

Pseudomonas aeruginosa

Colony count 22ºC

100/ml

Colony count 37ºC

20/ml

PART B

Chemical parameters

Parameter

Parametric

Unit

Notes

value

Acrylamide

0.10

μg/l

Note 1

Antimony

5.0

μg/l

Arsenic

μg/l

Benzene

1.0

μg/l

Benzo(a)pyrene

0.010

μg/l

Boron

1.0

mg/l

Bromate

μg/l

Note 2

Cadmium

5.0

μg/l

Chromium

μg/l

Copper

2.0

mg/l

Note 3

Cyanide

μg/l

1,2-dichloroethane

3.0

μg/l

Epichlorohydrin

0.10

μg/l

Note 1

Fluoride

1.5

mg/l

Shall not apply until

31st December 2005

Lead

μg/l

Notes 3 and 4

Mercury

1.0

μg/l

Nickel

μg/l

Note 3

Nitrate

mg/l

Note 5

Shall not apply until

31st December 2005

0.50

mg/l

Note 5

Pesticides

0.10

μg/l

Notes 6 and 7

Pesticides - Total

0.50

μg/l

Notes 6 and 8

Polycyclic aromatic hydrocarbons

0.10

μg/l

Sum of concentrations

of specified compounds;

Note 9

μg/l

Tetrachloroethene and

μg/l

Sum of concentrations

of specified parameters

Trichloroethene

Trihalomethanes - Total

μg/l

Sum of concentrations

of specified compounds;

Note 10

Vinyl chloride

0.50

μg/l

Note 1

The parametric value refers to the residual monomer concentration in

the water as calculated according to specifications of the maximum

release from the corresponding polymer in contact with the water.

Where possible, lower values should be aimed without compromising

disinfection. For the water referred to in regulation 7(1)(a), (b) and (d),

the value must be met, at the latest, ten calendar years after the entry

into force of Council Directive 98/83/EC. The parametric value for

bromate from five years after the entry into force of Council Directive

98/83/EC until ten years after its entry into force is 25ug/l.

The value applies to a sample of water intended for human consumption

obtained by an adequate sampling method at the tap and taken so as to

be representative of a weekly average value ingested by consumers.

For the water referred to in regulation 7(1)(a), (b) and (d), the value

must be met, at the latest, fifteen calendar years after the entry into force

of the Directive. The parametric value for lead from five years after the

entry into force of the Directive until fifteen years after its entry into

force is 25ug/l. Water suppliers must ensure that all appropriate

measures are taken to reduce the concentration of lead in water intended

for human consumption as much as possible during the period needed to

achieve compliance with the parametric value. When implementing the

measures to achieve compliance with that value water suppliers must

progressively give priority where lead concentrations in water intended

for human consumption are highest.

Water suppliers must ensure that the condition that [nitrate]/50 +

[nitrite]/3 < 1, the square brackets signifying the concentrations in mg/l

for nitrate (NO 3 ) and nitrite (NO 2 ), is complied with and that the value

of 0,10 mg/l for nitrites is complied with ex water treatment works.

‘Pesticides’ means

-

organic insecticides,

-

organic herbicides,

-

organic fungicides,

-

organic nematocides,

-

organic acaricides,

-

organic algicides,

-

organic rodenticides,

-

organic slimicides,

-

related products (inter alia, growth regulators)

and their relevant metabolites, degradation and reaction products.

Only those pesticides which are likely to be present in a given supply need be

monitored.

Note 7

The parametric value applies to each individual pesticide. In the case of

aldrin, dieldrin, heptachlor and heptachlor epoxide the parametric value

is 0.030 μg/l.

Note 8

‘Pesticides – Total’ means the sum of all individual pesticides detected

and quantified in the monitoring procedure.

Note 9

The specified compounds are

-

benzo(b)fluoranthene,

-

benzo(k) fluoranthene,

-

benzo(ghi)perylene,

-

indeno(1,2,3-cd)pyrene.

Note 10: Where possible, lower values should be aimed without compromising

disinfection.

The specified compounds are: chloroform, bromoform, dibromochloromethane,

bromodichloromethene.

For the water referred to in regulation 7(1)(a), (b) and (d) the value must be met at

the latest, ten calendar years after the entry into force of the Directive . The

parametric value for total THMs from five years after the entry into force of the

Directive until ten years after its entry into force is 150ug/l.

Water suppliers must ensure that all appropriate measures are taken to reduce the

concentration of THMs in water intended for human consumption as much as

possible during the period needed to achive compliance with the parametric value.

When implementing the measures to achieve this value, water suppliers must give

priority to those areas where THM concentrations in water intended for human

consumption are highest.

PART C

Indicator parameters

Parameter

Parametric

Unit

Notes

value

Aluminium

μg/l

Ammonium

0.50

mg/l

Chloride

mg/l

Note 1

N u m b e r / Note 2

Clostridium perfringens

(including spores)

100 ml

Colour

Acceptable to

consumers

and no

abnormal

change

μS cm -1 at Note 1

Conductivity

20ºC

Hydrogen ion concentration

> 6.5 and < PH units

Notes 1 and 3

9.5

μg/l

Manganese

μg/l

Acceptable to

consumers

and no

abnormal

change

Oxidisability

5.0

mg/l O 2

Note 4

mg/l

Note 1

mg/l

Acceptable to

consumers

and no

abnormal

change

Colony count 22ºC

No abnormal N u m b e r / Note 5

change

100 ml

Coliform bacteria

Total organic carbon (TOC)

Note 6

No abnormal

change

Note 7

Acceptable to

consumers

and no

abnormal

change

RADIOACTIVITY

Parameter

Parametric

Unit

Notes

value

Bq/l

Notes 8 and 10

Total indicative dose

0.10

MSv/year Notes 9 and 10

The water should not be aggressive.

This parameter need not be measured unless the water originates from or

is influenced by surface water. In the event of non-compliance with this

parametric value, the water supplier concerned must investigate the

supply to ensure that there is no potential danger to human health arising

from the presence of pathogenic micro-organisms, e.g. cryptosporidium.

The competent authority shall include the results of all such

investigations in the reports it is bound to submit under regulation 12(2).

For still water put into bottles or containers, the minimum value may be

reduced to 4.5 pH units. For water put into bottles or containers which is

naturally rich in or artificially enriched with carbon dioxide, the

minimum value may be lower.

This parameter need not be measured if the parameter TOC is analysed.

For water put into bottles or containers the unit is number/250 ml.

This parameter need not be measured for supplies of less that 10,000 m 3

a day.

In the case of surface water treatment, water suppliers should aim for a

parametric value not exceeding 1.0 NTU (nephelometric turbidity units)

in the water ex treatment works.

Monitoring frequencies to be set later in Schedule II.

Excluding tritium, potassium –40, radon and radon decay products;

monitoring frequencies, monitoring methods and the most relevant

locations for monitoring points to be set later in Schedule II.

Note 10: 1. The proposals required by note 8 on monitoring frequencies, and note

9 on monitoring frequencies, monitoring methods and the most relevant

locations for monitoring points in Schedule II shall be adopted in

accordance with the procedure laid down in Article 12 of the Directive.

When elaborating these proposals, the European Commission shall take

into account inter alia the relevant provisions under existing legislation

or appropriate monitoring programmes including monitoring results as

derived from them. The European Commission shall submit these

proposals at the latest within eighteen months following the date

referred to in Article 18 of the Directive.

2. A Member State is not required to monitor drinking water for tritium

or radioactivity to establish total indicative dose where it is satisfied

that, on the basis of other monitoring carried out, the levels of tritium of

the calculated total indicative dose are well below the parametric value.

In that case, the competent authority shall communicate the grounds for

its decision to the European Commission, including the results of this

other monitoring carried out.

Schedule II

Amended by

L.N. 242 of 2009.

(Regulation 8)

Substituted by

L.N.299 of 2017.

Monitoring

PART A

General objectives and monitoring programmes for water intended for human

consumption

1. Monitoring programmes for water intended for human consumption must

(a) verify that the measures in place to control risks to human health

throughout the water supply chain from the catchment area through

abstraction, treatment and storage to distribution are working

effectively and that water at the point of compliance is wholesome and

clean;

(b) provide information on the quality of the water supplied for human

consumption to demonstrate that the obligations set out in regulations 5

and 6 in the principal regulations, and the parametric values laid down

in Schedule I, are being met;

(c) identify the most appropriate means of mitigating the risk to human

health.

2. Pursuant to regulation 8(2), the competent authority shall establish

monitoring programmes complying with the parameters and frequencies set out in

Part B of this schedule which consist of

(a) collection and analysis of discrete water samples; or

(b) measurements recorded by a continuous monitoring process.

In addition, monitoring programmes may consist of

(a) inspections of records of the functionality and maintenance status of

equipment; and/or

(b) inspections of the catchment area, water abstraction, treatment, storage

and distribution infrastructure.

3. Monitoring programmes may be based on a risk assessment as set out in Part

C of this schedule.

4. The competent authority shall ensure that monitoring programmes are

reviewed on a continuous basis and updated or reconfirmed at least every 5 years.

PART B

Parameters and frequencies

1. General framework

A monitoring programme must take into account the parameters referred to

in regulation 6, including those that are important for assessing the impact of

domestic distribution systems on the quality of water at the point of compliance, as

set out in regulation 7(1). When choosing appropriate parameters for monitoring,

local conditions for each water supply must be taken into consideration.

The competent authority shall ensure that the parameters listed in point 2 are

monitored at the relevant sampling frequencies as set out in point 3.

2. List of parameters

Group A parameters

The following parameters (Group A) shall be monitored in accordance with the

monitoring frequencies set out in Table 1 of point 3

(a) Escheichia coli (E. coli), coliform bacteria, colony count 22 o C, colour,

turbidity, taste, odour, pH, conductivity;

(b) other parameters identified as relevant in the monitoring programme, in

accordance with regulation 6(3) and, where relevant, through a risk

assessment as set out in Part C.

Under specific circumstances, the following parameters shall be added to the

Group A Parameters

(a) ammonium and nitrite, if chlorination is used;

(b) aluminium and iron, if used as water treatment chemicals.

Group B parameters

In order to determine compliance with all parametric values set in these

regulations, all other parameters not analysed under Group A and set in accordance

with regulation 6 shall be monitored at least at the frequencies set out in Table 1 of

point 3.

3. Sampling frequencies

Table 1

Minimum frequency of sampling and analysis for compliance monitoring

Volume of water distributed

Group A parameters

or produced each day within

Group B parameters

number of samples per

a supply zone

number of samples per

year

(See Notes 1 and 2)

year

(See Note 3)

m 3

> 0

> 0

≤ 100

(See Note 4)

(See Note 4)

> 100

≤ 1,000

+ 1

For each 4,500 m 3 /d and

> 1,000

≤ 10,000

part thereof of the total

volume

+ 3

+ 1

For each 1,000 m 3 /d and

For each 10,000 m 3 /d and

> 10,000

≤ 100,000

part thereof of the total

part thereof of the total

volume

volume

+ 1

For each 25,000 m 3 /d and

> 100,000

part thereof of the total

volume

Note 1: A supply zone is a geographically defined area within which water

intended for human consumption comes from one or more sources and water quality

may be considered as being approximately uniform.

Note 2: The volumes are calculated as averages taken over a calendar year. The

number of inhabitants in a supply zone may be used instead of the volume of water

to determine the minimum frequency, assuming water consumption of 200 l/

(day*capita).

Note 3: The frequency indicated is calculated as follows: e.g. 4,300 m 3 /d = 16

samples (four for the first 1,000 m 3 /d + 12 for additional 3,300 m 3 /d).

Note 4: The competent authorities that have decided to exempt individual supplies

under regulation 4(2)(b) shall apply these frequencies only for supply zones that

distribute between 10 and 100 m 3 per day. For these supply zones the frequency for

Group A parameters shall be 4 samples per year and for Group B parameters shall be

1 sample every 2 years.

PART C

Risk assessment

1. The competent authority may provide for the possibility to derogate from

the parameters and sampling frequencies in Part B, provided that a risk assessment is

performed in accordance with this Part.

2. The risk assessment referred to in point 1 shall be based on the general

principles of risk assessment set out in relation to international standards such as EN

15975-2 concerning "security of drinking water supply, guidelines for risk and crisis

3. The risk assessment shall take into account the results from the monitoring

programmes established by the second sub-paragraph of Article 7(1), and Article 8

of Directive 2000/60/EC of the European Parliament and of the Council as

transposed in regulation 7(1) and regulation 8 of the Water Policy Framework

Regulations, for bodies of water intended under regulation 7(1) that provide more

than 100 m 3 a day on average, in accordance with Annex V to those regulations.

4. Based on the results of the risk assessment, the list of parameters in point 2

of Part B shall be extended and/or the sampling frequencies in point 3 of Part B

increased, where any of the following conditions is fulfilled

(a) the list of parameters or frequencies set in this Schedule is not sufficient

to fulfil the obligations imposed under regulation 8(1);

(b) additional monitoring is required for the purpose of regulation 8(6);

(c) it is necessary to provide the necessary assurance set out in point (1)(a)

of Part A.

5. Based on the results of the risk assessment, the list of parameters set out in

point 2 of Part B and the sampling frequencies set out in point 3 of Part B may be

reduced provided the following conditions are met

(a) the frequency of sampling for E. coli must not be reduced below the one

laid down in point 3 of Part B under any circumstances;

(b) for all other parameters

(i) the location and frequency of sampling shall be determined in

relation to the parameter’s origin, as well as the variability and

long-term trend of its concentration, taking into account regulation

7;

(ii) to reduce the minimum sampling frequency of a parameter, as set

out in point 3 of Part B, the results obtained from samples collected

at regular intervals over a period of at least 3 years from sampling

points representative of the whole supply zone must all be less than

60% of the parametric value;

(iii) to remove a parameter from the list of parameters to be monitored,

as set out in point 2 of Part B, the results obtained from samples

collected at regular intervals over a period of at least 3 years from

points representative of the whole supply zone must all be less than

30% of the parametric value;

(iv) the removal of a particular parameter set out in point 2 of Part B

from the list of parameters to be monitored shall be based on the

result of the risk assessment, informed by the results of monitoring

of sources of water intended for human consumption and

confirming that human health is protected from the adverse effects

of any contamination of water intended for human consumption, as

laid down in regulation 2;

(v) the sampling frequency may be reduced or a parameter removed

from the list of parameters to be monitored as set out in points (ii)

and (iii) only if the risk assessment confirms that no factor that can

be reasonably anticipated is likely to cause deterioration of the

quality of water intended for human consumption.

6. The competent authority shall ensure

(a) risk assessments are approved by it and/or by any other competent

authority; and

(b) information is available showing that a risk assessment has been carried

out, together with a summary of its results.

PART D

Sampling methods and sampling points

1. Sampling points shall be determined so as to ensure compliance with the

points of compliance as defined in regulation 7(1). In the case of a distribution

network, the competent authority may take samples within the supply zone or at the

treatment works for particular parameters if it can demonstrated that there would be

no adverse change to the measured value of the parameter concerned. As far as

possible, the number of samples shall be distributed equally in time and location.

2. Sampling at the point of compliance shall meet the following requirements

(a) compliance samples for certain chemical parameters (in particular

copper, lead and nickel) shall be taken at the consumer’s tap without

prior flushing. A random daytime sample of one litre volume is to be

taken. As an alternative, the competent authority may use fixed

stagnation time methods that better reflect its national situation,

provided that, at the supply zone level, this does not result in fewer

cases of non-compliance than using the random daytime method;

(b) compliance samples for microbiological parameters at the point of

compliance shall be taken and handled according to EN ISO 19458,

sampling purpose B.

3. Sampling in the distribution network, with the exception of sampling at the

consumers’ tap, shall be in accordance with ISO 5667-5. For microbiological

parameters, sampling in the distribution network shall be taken and handled according to

EN ISO 19458, sampling purpose A.

Schedule III

Amended by

L.N. 299 of 2017.

(Regulation 8)

SPECIFICATIONS FOR THE ANALYSIS OF PARAMETERS

The competent authority shall ensure that the methods of analysis used for the

purposes of monitoring and demonstrating compliance with these regulations are

validated and documented in accordance with EN ISO/IEC 17025 or other equivalent

standards accepted at international level. The competent authority shall ensure that

laboratories or parties contracted by laboratories apply quality management system

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, the competent authority shall ensure that monitoring is carried out

using best available techniques not entailing excessive costs.

PART A

MICROBIOLOGICAL PARAMETERS FOR WHICH METHODS OF ANALYSIS

ARE SPECIFIED;

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 o C (EN

ISO 6222)

(e) enumeration of culturable microorganisms – colony count 36 o C (EN

ISO 6222)

(f)

Clostridium perfringens including spores (EN ISO 14189).

PART B

Chemical and indicator parameters for which performance characteristics are

specified

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 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, 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

Schedule I.

Until 31 December 2019 the competent authority 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 Schedule I.

Table 1

Minimum performance characteristic "Uncertainty of measurement"

Uncertainty of measurement

(See Note 1)

Parameters

Notes

% of the parametric value (except for

pH)

Aluminium

Ammonium

Antimony

Arsenic

Benzo(a)pyrene

See Note 5

Benzene

Boron

Bromate

Cadmium

Chloride

Chromium

Conductivity

Copper

Cyanide

See Note 6

1,2-dichloroethane

Fluoride

Hydrogen ion concentration pH

0,2

See Note 7

(expressed in pH units)

Iron

Lead

Manganese

Mercury

Nickel

Nitrate

Nitrite

Oxidisability

See Note 8

Pesticides

See Note 9

Polycyclic aromatic hydrocarbons

See Note 10

Selenium

Sodium

Sulphate

Tetrachloroethene

See Note 11

Trichloroethene

See Note 11

Trihalomethanes – total

See Note 10

Total organic carbon (TOC)

See Note 12

Turbidity

See Note 13

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

Table 2

Minimum performance characteristics "Trueness", "precision" and "limit of detection"

may be used until 31 December 2019

Limit of

Trueness

Precision

detection

(See Note 2)

(See Note 3)

(See Note 4)

Parameters

% of the

% of the

Notes

% of the

parametric value

parametric value

parametric value

(except for pH)

(except for pH)

(except for pH)

Aluminium

Ammonium

Antimony

Arsenic

Benzo(a)pyrene

Benzene

Boron

Bromate

Cadmium

Chloride

Chromium

Conductivity

Copper

Cyanide

See Note 6

1,2-dichloroethane

Fluoride

Hydrogen ion

concentration pH

0,2

0,2

See Note 7

(expressed in pH units)

Iron

Lead

Manganese

Oxidisability

See Note 8

See Note 9

Polycyclic aromatic

See Note

hydrocarbons

See Note

Tetrachloroethene

See Note

Trichloroethene

See Note

Trihalomethanes – total

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

2. Notes to Table 1 and 2

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.

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.

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.

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).

If the value of uncertainty of measurement cannot be met, the best available

technique should be selected (up to 60%).

The method determines total cyanide in all forms.

Values for trueness, precision and uncertainty of measurement are expressed in pH

units.

Reference method: EN ISO 8467

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.

The performance characteristics apply to individual substances, specified at 25% of

the parametric value in Part B of Schedule I.

The performance characteristics apply to individual substances, specified at 50% of

the parametric value in Part B of Schedule I.

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.

The uncertainty of measurement should be estimated at the level of 1,0 NTU

(nephelo-metric turbidity units) in accordance with EN ISO 7027.

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