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Water Intended for Human Consumption Regulations, 2023

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Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

L.N. 297 of 2023

FOOD SAFETY ACT

(CAP. 449)

Water Intended for Human Consumption Regulations, 2023

IN EXERCISE of the powers conferred by article 10 of the Food

Safety Act, the Minister responsible for public health, has made the

following regulations:-

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

The title of these regulations is the Water Intended for Citation.

Human Consumption Regulations, 2023.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulations 5, 6, 7, 8, 9, 10, 12, 13, 14, 15, 18, 19)

LIST OF SUPPORTING ENTITIES

Regulation Number

Supporting Entity

5(1)(c)

All entities mentioned in regulations 6

to 15

6 (3)

The corporation established by the

Water Services Corporation Act (Cap.

355)

7 (2)

The corporation established by the

Water Services Corporation Act (Cap.

355)

7 (3)

The corporation established by the

Water Services Corporation Act (Cap.

355)

8 (1) (a)

The entity responsible for the

implementation of the Water Policy

Framework Regulations (S.L. 549. 100)

9 (2)

The corporation established by the

Water Services Corporation Act (Cap.

355), the entity responsible for issuing

of permits of water extraction points,

the entity responsible for land use, the

entity responsible for agriculture, the

entity responsible for storm water

management, and the entity responsible

for the location of registered industries,

as well as other entities that the

competent authority may indicate from

time to time

9 (4)

The corporation established by the

Water Services Corporation Act (Cap.

355), the entity responsible for issuing

of permits of water extraction points,

the entity responsible for land use, the

entity responsible for agriculture, the

entity responsible for storm water

management, and the entity responsible

for the location of registered industries,

as well as other entities that the

competent authority may indicate from

time to time

9 (5)

The entity responsible for the

implementation of the Water Policy

Framework Regulations (S.L. 549. 100)

9 (7)

The entity responsible for the

implementation of the Water Policy

Framework Regulations (S.L. 549. 100)

10 (1)

The Regulator for Energy and Water

Services

10 (2)

The Regulator for Energy and Water

Services

12 (1)

The entity responsible for building and

construction

12 (3)

The entity responsible for responsible

for building and construction and the

entity

responsible

for

the

implementation of Regulation (EU) No

305/2011 of the European Parliament

and of the Council of 9 March 2011

laying down harmonised conditions for

the marketing of construction products

and repealing Council Directive 89/

106/EEC

The entity responsible for the

implementation of Regulation (EU) No

305/2011 of the European Parliament

and of the Council of 9 March 2011

laying down harmonised conditions for

the marketing of construction products

and repealing Council Directive 89/

106/EEC

14 (3)

The corporation established by the

Water Service Corporation Act (Cap.

355)

15 (4)

The corporation established by the

Water Service Corporation Act (Cap.

355)

18 (1)

The Regulator for Energy and Water

Services

19 (1) (a)

The Ministry responsible for social

policy

19 (1) (b)

The entity responsible for the

implementation of the Water Policy

Framework Regulations (S.L. 549. 100)

19 (1) (e)

The corporation established by the

Water Service Corporation Act (Cap.

355) and the Regulator for Energy and

Water Services

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) These regulations transpose the provisions of Scope.

Directive (EU) 2020/2184 of the European Parliament and of the

Council of 16 December 2020 on the quality of water intended for

human consumption (recast).

(2) The purpose of these regulations is 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

improve access to water intended for human consumption.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulations 4, 5, 6, 7, 9, 10, 11, 14, 15, 16, 19, 21)

MINIMUM REQUIREMENTS FOR PARAMETRIC VALUES

USED TO ASSESS THE QUALITY OF WATER INTENDED FOR

HUMAN CONSUMPTION

Part A

Microbiological parameters

Parametric

Unit

Notes

Parameter

value

number/100 ml

For water put into

bottles or

Intestinal enterococci

containers, the unit

is number/250 ml.

number/100 ml

For water put into

Escherichia coli (E.

bottles or

coli)

containers, the unit

is number/250 ml.

Part B

Chemical parameters

Parameter

Parametric

Unit

Notes

value

Acrylamide

0,10

μg/l

The parametric value of 0,10

μg/l 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.

Antimony

μg/l

Arsenic

μg/l

Benzene

1,0

μg/l

Benzo(a)pyrene

0,010

μg/l

Bisphenol A

2,5

μg/l

Boron

1,5

mg/l

A parametric value of 2,4 mg/l

shall be applied when

desalinated water is the

predominant water source of

the supply system concerned

or in regions where geological

conditions may lead to high

levels of boron in

groundwater.

Bromate

μg/l

Cadmium

5,0

μg/l

Chlorate

0,25

mg/l

A parametric value of 0,70 mg/

l shall be applied where a

disinfection method that

generates chlorate, in

particular chlorine dioxide, is

used for disinfection of water

intended for human

consumption. Where possible,

without compromising

disinfection, Member States

shall strive for a lower value.

This parameter shall be

measured only if such

disinfection methods are used.

Chlorite

0,25

mg/l

A parametric value of 0,70 mg/

l shall be applied where a

disinfection method that

generates chlorite, in particular

chlorine dioxide, is used for

disinfection of water intended

for human consumption.

Where possible, without

compromising disinfection,

Member States shall strive for

a lower value. This parameter

shall be measured only if such

disinfection methods are used.

Chromium

μg/l

The parametric value of 25 μg/

l shall be met, at the latest, by

12th January 2036. The

parametric value for chromium

until that date shall be 50 μg/l.

Copper

2,0

mg/l

Cyanide

μg/l

1,2-dichloroethane

3,0

μg/l

Epichlorohydrin

0,10

μg/l

The parametric value of 0,10

μg/l 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.

Fluoride

1,5

mg/l

Haloacetic acids

μg/l

This parameter shall be

(HAAs)

measured only when

disinfection methods that may

generate HAAs are used for

the disinfection of water

intended for human

consumption. It is the sum of

the following five

representative substances

monochloro-, dichloro-, and

trichloro-acetic acid, and

mono- and dibromo-acetic

acid.

Lead

μg/l

The parametric value of 5 μg/l

shall be met, at the latest, by

12th January 2036. The

parametric value for lead until

that date shall be 10 μg/l.

After that date, the parametric

value of 5 μg/l shall be met at

least at the point of supply to

the domestic distribution

system.

For the purposes of regulation

12(2)(b), the parametric value

of 5 μg/l at the tap shall apply.

Mercury

1,0

μg/

Microcystin-LR

1,0

μg/l

This parameter shall be

measured only in the event of

potential blooms in source

water (increasing

cyanobacterial cell density or

bloom forming potential).

Nickel

μg/l

Nitrate

mg/l

Member States shall ensure

that the condition [nitrate]/50 +

[nitrite]/3 ≤ 1, where the

square brackets signify the

concentrations in mg/l for

nitrate (NO3) and nitrite

(NO2), is complied with and

that the parametric value of

0,10 mg/l for nitrites is

complied with ex water

treatment works.

Nitrite

0,50

mg/l

Member States shall ensure

that the condition [nitrate]/50 +

[nitrite]/3 ≤ 1, where the

square brackets signify the

concentrations in mg/l for

nitrate (NO3) and nitrite

(NO2), is complied with and

that the parametric value of

0,10 mg/l for nitrites is

complied with ex water

treatment works.

Pesticides

0,10

μg/l

"Pesticides" means

(a) organic insecticides,

(b) organic herbicides,

(c) organic fungicides,

(d) organic nematocides,

(e) organic acaricides,

(f) organic algicides,

(g) organic rodenticides,

(h) organic slimicides,

(i) related products (inter alia,

growth regulators),

and their metabolites as

defined in Article 3(32) of

Regulation (EC) No 1107/

2009 of the European

Parliament and of the Council

of 21 October 2009 concerning

the placing of plant protection

products on the market and

repealing Council Directives

79/117/EEC and 91/414/EEC,

that are considered relevant for

water intended for human

consumption.

A pesticide metabolite shall be

deemed relevant for water

intended for human

consumption if there is reason

to consider that it has intrinsic

properties that may be

comparable to those of the

parent substance in terms of its

pesticide target activity or that

either itself or its

transformation products

generate a health risk for

consumers.

The parametric value of 10 μg/

l shall apply to each individual

pesticide. In the case of aldrin,

dieldrin, heptachlor and

heptachlor epoxide, the

parametric value shall be 0,030

μg/l.

Member States shall define a

guidance value to manage the

presence of non-relevant

metabolites of pesticides in

water intended for human

consumption. Only pesticides

which are likely to be present

in a given supply shall be

monitored.

Based on the data reported by

Member States, the

Commission may establish a

database of pesticides and their

relevant metabolites, taking

into account their possible

presence in water intended for

human consumption.

Pesticides Total

0,50

μg/l

"Pesticides Total" means the

sum of all individual

pesticides, as defined in the

previous row, detected and

quantified in the monitoring

procedure.

PFAS

0,50

μg/l

"PFAS Total" means the

totality of per- and

polyfluoroalkyl substances.

This parametric value shall

only apply once technical

guidelines for monitoring this

parameter are developed in

accordance with Article 13(7)

of the Directive. Member

States may then decide to use

either one or both of the

parameters "PFAS Total" or

"Sum of PFAS".

Sum of PFAS

0,10

μg/l

"Sum of PFAS" means the sum

of per- and polyfluoroalkyl

substances considered a

concern as regards water

intended for human

consumption listed in item 3 of

Part B of the Fifth Schedule.

This is a subset of "PFAS

Total" substances that contain

a perfluoroalkyl moiety with

three or more carbons

(meaning –CnF2n–, n ≥ 3) or a

perfluoroalkylether moiety

with two or more carbons

(meaning –CnF2nOCmF2m–,

n and m ≥ 1).

Polycyclic aromatic

0,10

μg/l

Sum of concentrations of the

hydrocarbons

following specified

compounds

benzo(b)fluoranthene,

benzo(k)fluoranthene, benzo

(ghi)perylene, and

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

Selenium

μg/l

A parametric value of 30 μg/l

shall be applied for regions

where geological conditions

may lead to high levels of

selenium in groundwater.

Tetrachloroethene and

μg/l

The sum of concentrations of

Trichloroethene

these two parameters.

Trihalomethanes Total

μg/l

Where possible, without

compromising disinfection,

Member States shall strive for

a lower parametric value. It is

the sum of concentrations of

the following specified

compounds: chloroform,

bromoform,

dibromochloromethane and

bromodichloromethane.

Uranium

μg/l

Vinyl chloride

0,50

μg/l

The parametric value of 0,50

μg/l 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.

Part C

Indicator parameters

Parameter

Parametric

Unit

Notes

value

Aluminium

μg/l

Ammonium

0,50

mg/l

Chloride

mg/l

The water should not be

corrosive.

Clostridium

number This parameter shall be

perfringens including

/100 ml measured if the risk

spores

assessment indicates that this

is appropriate to do so.

Colour

Acceptable to

consumers and

no abnormal

change

Conductivity

2 500

μS cm-

The water shall not be

1 at 20

aggressive.

°C

Hydrogen ion

≥ 6,5 and ≤ 9,5

pH

The water should not be

concentration

units

aggressive. 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.

Iron

μg/l

Manganese

μg/l

Odour

Acceptable to

consumers and

no abnormal

change

Oxidisability

5,0

mg/l

This parameter shall not be

measured if the parameter

TOC is analysed.

Sulphate

mg/l

The water shall not be

corrosive.

Sodium

mg/l

Taste

Acceptable to

consumers and

no abnormal

change

Colony count at a

No abnormal

change

temperature of 22 o C

Coliform bacteria

number For water put into bottles or

/100 ml containers, the unit is

number/250 ml.

Total organic carbon

No abnormal

This parameter shall not be

(TOC)

change

measured for supplies of less

than 10 000 m 3 a day.

Turbidity

Acceptable to

consumers and

no abnormal

change

Water shall not be aggressive or corrosive. This applies particularly to water

undergoing treatment (demineralization, softening, membrane treatment, reverse

osmosis, etc.).

Where water intended for human consumption is derived from treatment that

significantly demineralizes or softens water, calcium and magnesium salts may be

added to condition the water in order to reduce any possible negative health impact,

as well as to reduce the corrosiveness or aggressivity of water and to improve taste.

Minimum concentrations of calcium and magnesium or total dissolved solids in

softened or demineralized water may be established taking into account the

characteristics of water that enters those processes.

Part D

Parameters relevant for the risk assessment of domestic distribution

systems

Parameter

Parametric

Unit

Notes

value

Legionella

< 1 000

CFU/l

This parametric value is set

for the purposes of

regulations 11 and 15.

Actions provided for in

those regulations may be

considered even when the

value is below the

parametric value, example

in cases of infections and

outbreaks. In such cases, the

source of infection should

be confirmed and the

species of Legionella

should be identified. The

provisions of the Control of

Legionella Regulations

(S.L. 465. 03.) and the

Registration of Cooling

Towers and Evaporative

Condensers Regulations

(S.L. 465. 04.) shall remain

applicable.

Lead

μg/l

This parametric value is set

for the purposes of

regulations 11 and 15. The

competent authority should

use its best endeavours to

achieve the lower value of 5

μg/l by 12th January 2036.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

For the purposes of these regulations and unless the Interpretation.

context otherwise requires

"the Act" means the Food Safety Act;

"competent authority" means the Superintendent of Public Cap. 465.

Health or a person authorized to act on his behalf, as established

by the Public Health Act;

"composition" means the chemical composition of a metal,

enamel, ceramic or other inorganic material;

"the Directive" means Directive (EU) 2020/2184 of the

European Parliament and of the Council of 16 December 2020

on the quality of water intended for human consumption (recast),

and any amendments thereto;

"distribution network" means any method by which water

intended for human consumption is transported to a domestic

distribution system;

"domestic distribution system" means the pipework,

fittings and appliances which are installed between the taps that

are normally used for water intended for human consumption in

both public and private premises and the distribution network,

but only if they are not the responsibility of the water supplier, in

its capacity as a water supplier;

"food business" means a food business as defined in article

2(1) of the Act and Article 3(2) of Regulation (EC) No 178/2002

of the European Parliament and of the Council of 28 January

2002 laying down the general principles and requirements of

food law, establishing the European Food Safety Authority and

laying down procedures in matters of food safety;

"food business operator" means a food business operator as

defined in Article 3(3) of Regulation (EC) No 178/2002 of the

European Parliament and of the Council of 28 January 2002

laying down the general principles and requirements of food law,

establishing the European Food Safety Authority and laying

down procedures in matters of food safety, who is the natural or

legal persons responsible for ensuring that the requirements of

laws relating to food are met within the food business under their

control;

"hazard" means a biological, chemical, physical or

radiological agent in water, or another aspect of the condition of

water, with the potential to cause harm to human health;

"hazardous event" means an event that introduces hazards

into, or fails to remove them from, the supply system of water

intended for human consumption;

"other premises" means all non-domestic premises that are

not listed as priority premises;

"premises" means all non-domestic premises used for or in

connection with the carrying on of a trade or business (whether

for profit or not);

"Minister" means the Minister responsible for public

health;

"priority premises" means large non-domestic premises

with many users who may potentially be exposed to water-

related risks, in particular large premises for public use,

including hospitals, health care centres, retirement homes, non-

domestic accommodations, wellness centres and pools, and any

other premises so defined by the competent authority;

"risk" means a combination of the likelihood of a hazardous

event and the severity of the consequences if the hazard and

hazardous event occur in the supply system of water intended for

human consumption;

"starting substance" means a substance that has been

intentionally added in the production of organic materials or of

admixtures for cementitious materials;

"supporting entities" means entities required to provide

support, information, data and any other necessary aid to the

competent authority in relation to the objectives and scope of

these regulations;

"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 in both public and private premises,

regardless of its origin and whether it is supplied from a

distribution network, supplied from a tanker or put into bottles or

containers, including spring waters;

(b) all water used in any food business for the

manufacture, processing, preservation or marketing of products

or substances intended for human consumption;

"water supplier" means the entity responsible for supplying

water intended for human consumption.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulations 9, 10, 14)

MONITORING

Part A

General objectives and monitoring programmes for water intended

for human consumption

(1) The monitoring programmes established pursuant to

regulation 14(2) for water intended for human consumption shall

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

human health throughout the water supply chain from the

abstraction area through treatment and storage to distribution are

working effectively and that water intended for human

consumption at the point of compliance is wholesome and clean;

(b) provide information on the quality of water supplied

for human consumption to demonstrate that the obligations set

out in regulation 5 and the parametric values set in accordance

with regulation 6 are being met;

(c) identify the most appropriate means of mitigating the

risk to human health.

(2) (a) The monitoring programmes established pursuant to

regulation 14(2) shall include one or a combination of the following

(i)

collection and analysis of discrete water samples;

(ii)

measurements recorded by a continuous monitoring

process.

(b)

In addition, monitoring programmes may consist of

(i) inspections of records of the functionality and

maintenance status of equipment;

(ii) inspections of the abstraction area, and of the

treatment, storage and distribution infrastructure, without

prejudice to monitoring requirements provided for under

regulation 9(2)(c) and regulation 11(1)(b).

(3) The monitoring programmes shall also include an

operational monitoring programme that provides rapid insight into

operational performance and water quality problems and that allows

rapid pre-planned remedial action. Such operational monitoring

programmes shall be supply-specific, taking into account the outcomes

of the identification of hazards and hazardous events and the risk

assessment of the supply system, and shall be intended to confirm the

effectiveness of all control measures in abstraction, treatment,

distribution and storage.

The operational monitoring programme shall include the

monitoring of the parameter turbidity at the water supply plant in order

to regularly control the efficacy of physical removal by filtration

processes, in accordance with the reference values and frequencies

indicated in the following table (not applicable for groundwater

sources where turbidity is caused by iron and manganese)

Operational parameter

Reference value

Turbidity at the water supply plant

0,3 NTU in 95 % of samples and none to

exceed 1 NTU

Volume (m 3 ) of water distributed or

Minimum frequency of sampling and

produced each day within a supply analysis

Weekly

> 1 000 to ≤ 10 000

Daily

Continuous

The operational monitoring programme shall also include the

monitoring of the following parameters in raw water to control the

efficacy of the treatment processes against microbiological risks

Operational

Reference

Unit

Notes

parameter

value

Somatic

50 (for

raw Plaque

This

parameter

coliphages

water)

Forming

measured

if

the

Units

assessment indicates that it is

(PFU)/100

appropriate to do so. If it is

ml

found

in

raw

concentrations > 50 PFU/100

ml, it should be analysed

after steps of the treatment

train in order to determine

log removal by the barriers in

place and to assess whether

the risk of a breakthrough of

pathogenic

viruses

sufficiently under control.

(4) The competent authority shall ensure that the monitoring

programmes are reviewed on a continuous basis and updated or

confirmed at least every six years.

Part B

Parameters and sampling frequencies

(1)

List of parameters

Group A

The following parameters shall be monitored in accordance with

the monitoring frequencies set out in Table 1 of item 2

(a) Escherichia coli (E. coli), intestinal enterococci,

coliform bacteria, colony count 22 °C, colour, turbidity, taste,

odour, pH and conductivity;

(b)

other parameters identified as relevant in the

monitoring programme, in accordance with regulation 6(3) and,

where relevant, through a risk assessment of the supply system

as set out in regulation 10 and Part C.

Under specific circumstances, the following parameters shall be

added to the Group A parameters

(a)

ammonium and nitrite, if chloramination is used;

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

chemicals.

Escherichia coli (E. coli) and intestinal enterococci are

considered core parameters and their monitoring frequencies shall not

be the subject of a reduction due to a risk assessment of the supply

system in accordance with regulation 10 and Part C. They shall always

be monitored at least at the frequencies set out in Table 1 of item 2.

Group B

In order to determine compliance with all parametric values set

out in these regulations, all other parameters not analysed under Group

A and set in accordance with regulation 6, except for parameters in

Part D of the Second Schedule, shall be monitored at least at the

frequencies set out in Table 1 of item 2, unless a different sampling

frequency is determined on the basis of a risk assessment of the supply

system carried out in accordance with regulation 10 and Part C.

(2)

Sampling frequencies

Table 1. Minimum frequency of sampling and analysis for

compliance monitoring

Volume of water distributed

Group A parameter

Group B parameter number

or produced each day within

number of samples

of samples per year

a supply zone (See Notes 1

per year

and 2) m 3

< 10

> 0 (See Note 4)

> 0 (See Note 4)

≤ 100

1 (See Note 5)

≤ 1 000

1 for the first 1 000 m 3 /d + 1

> 1 000

≤ 10 000

4 for the first 1 000

m 3 /d + 3 for each

for each additional 4 500

additional 1 000 m 3 /

m 3 /d and part thereof of the

d and part thereof of

total volume (See Note 3)

> 10 000

≤ 100 000

3 for first 10 000 m 3 /d + 1

the total volume

for each additional 10 000

(See Note 3)

m 3 /d and part thereof of the

total volume (See Note 3)

> 100 000

12 for first 100 000 m 3 /d + 1

for each additional 25 000

m 3 /d and part thereof of the

total volume (See Note 3)

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

which water intended for human consumption comes from one or more

sources and within which the 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 for Group A parameters (4 for the first 1 000

m 3 /d + 12 for additional 3 300 m 3 /d).

Note 4: For water suppliers, when an exemption has not been

granted under regulation 4(3)(b), the competent authority shall lay

down the minimum sampling frequency for parameters of Groups A

and B, provided that core parameters are monitored at least once per

year.

Note 5: The competent authority may reduce the sampling

frequency provided that all parameters set in accordance with

regulation 6 are monitored at least once every six years and are

monitored in cases where a new water source is integrated into the

water supply system or changes to that system, as a result of which a

potentially adverse effect on the quality of water is to be expected, are

made.

Part C

Risk assessment and risk management of the supply system

(1) Based on the outcome of the risk assessment of the supply

system as referred to in regulation 10, the list of parameters considered

in the monitoring shall be extended and the sampling frequencies set

out in Part B shall be increased, where any of the following conditions

is fulfilled

(a) the list of parameters or frequencies set out in this

Schedule is not sufficient to fulfil the obligations imposed under

regulation 14(1);

(b) additional monitoring is required for the purposes of

regulation 14(5);

(c) it is necessary to provide the assurances set out in

item 1(a) of Part A;

(d) increasing the sampling frequencies is necessary

pursuant to regulation 9(4)(a).

(2) As a result of a risk assessment of the supply system, the

list of parameters considered in the monitoring and the sampling

frequencies set out in Part B may be reduced provided that all of the

following conditions are met

(a) the location and frequency of sampling is determined

in relation to the parameter’s origin, as well as the variability of,

and long-term trend regarding its concentration, taking into

account regulation 7;

(b) as regards reducing the minimum sampling frequency

of a parameter, the results obtained from samples collected at

regular intervals over a period of at least three years, from

sampling points representative of the whole supply zone, are all

less than 60% of the parametric value;

(c) as regards removing a parameter from the list of

parameters to be monitored, the results obtained from samples

collected at regular intervals over a period of at least three years,

from sampling points representative of the whole supply zone,

are all less than 30% of the parametric value;

(d) as regards removing a parameter from the list of

parameters which shall be monitored, the decision is based on

the outcome of the risk assessment that takes into account the

results of monitoring of sources of water intended for human

consumption and confirms that human health is protected from

the adverse effects of any contamination of water intended for

human consumption, as laid down in regulation 2(2);

(e) as regards reducing the sampling frequency of a

parameter or removing a parameter from the list of parameters to

be monitored, the risk assessment confirms that no factor that

may be reasonably anticipated is likely to cause deterioration of

the quality of the water intended for human consumption.

When monitoring results, demonstrating that the conditions set

out in items (2)(b) to (2)(e) are met, are already available by 12th

January 2021, those monitoring results may, from that date, be used to

adapt the monitoring following the risk assessment of the supply

system.

Where adjustments of monitoring have already been

implemented following risk assessment of the supply system in

accordance, inter alia, with Part C of Annex II of Directive 98/83/EC

of 3 November 1998 on the quality of water intended for human

consumption, the competent authority may provide for the possibility

to confirm their validity without requiring monitoring in accordance

with items 2(b) and 2(c) over a further period of at least three years

from points representative of the whole supply zone.

Part D

Sampling methods and points

(1) Sampling points shall be determined so as to ensure

compliance with regulation 7(1). In the case of a distribution network,

the competent authority assisted by the corporation established by the

Water Services Corporation Act (Cap. 355) may take samples within

the supply zone or at the treatment works for particular parameters if it

can be demonstrated that there would be no adverse change to the

measured value of the parameters 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) the compliance samples for certain chemical

parameters, in particular copper, lead, and nickel, shall be taken

at the consumers’ tap without prior flushing. A random daytime

sample of one litre volume shall be taken. As an alternative, the

competent authority may use fixed stagnation time methods that

better reflect the national situation, such as the average weekly

intake by consumers, provided that, at the supply zone level, this

does not result in fewer cases of non-compliance than using the

random daytime method;

(b) the compliance samples for microbiological

parameters at the point of compliance shall be taken and handled

in accordance with EN ISO 19458, sampling purpose B.

(3) The samples for Legionella in domestic distribution

systems shall be taken at risk points for proliferation of Legionella,

points representative for systemic exposure to Legionella, or both. The

competent authority shall establish guidelines for sampling methods

for Legionella.

(4) 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, samples in the distribution network

shall be taken and handled in accordance with EN ISO 19458,

sampling purpose A.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

The provisions of these regulations shall not apply to: Exemptions.

(a) natural mineral waters recognised as such by the

entity responsible for the recognition of natural mineral waters,

in accordance with the Natural Mineral Waters Regulations and S.L. 449.44

Directive 2009/54/EC of the European Parliament and of the

Council of 18 June 2009 on the exploitation and marketing of

natural mineral waters (recast); or

(b) waters which are medicinal products within the

meaning of Directive 2001/83/EC of the European Parliament

and of the Council of 6 November 2001 on the Community code

relating to medicinal products for human use.

(2) Maritime vessels that desalinate water, carry passengers

and act as water suppliers shall only be subject to regulations 3 to 7

and regulations 10, 11, 14 and 15 and the relevant Schedules

Provided that priority shall be given to existing

international regulations or internationally acknowledged standards for

Union flag maritime vessels that comply with the international

regulatory framework when sailing in international waters, such as the

vessel sanitation programme developed by the United States Public

Health Service, or the ship sanitation certificate issued in accordance

with EU SHIPSAN ACT Joint Action (2012 2103) – European Manual

for Hygiene Standards and Communicable Disease Surveillance on

Passenger Ships.

(3)

The following shall be exempt from 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 ten cubic meters (10 m 3 ) a

day as an average or serving fewer than fifty (50) persons, unless

the water is supplied as part of a commercial or public activity.

(4) When the competent authority grants the exemption in

accordance with sub-regulation (3), it shall ensure that the population

concerned is informed thereof and of any action that may 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 immediately be

informed about this.

(5) Food business operators shall be exempt from these

regulations with regards to the water used for the specific purposes of

the food business, if the competent authority is satisfied that the

quality of such water cannot affect the safety of the foodstuff in its

finished form

Provided that the water supply of the food business shall

comply with relevant obligations, in particular under the procedures on

hazard analysis and critical control point principles and remedial

actions under the relevant legislation on food, be it on a national level

or at Union level

Provided further that it shall be ensured that producers of

water intended for human consumption that is put into bottles or

containers comply with regulations 2 to 6, and Parts A and B of the

Second Schedule

Provided further that the minimum requirements set out in

Part A of the Second Schedule shall not apply to spring water as

referred to in Directive 2009/54/EC of the European Parliament and of

the Council of 18 June 2009 on exploitation and marketing of natural

mineral waters (recast).

(6) Without prejudice to regulation 10, the water suppliers

supplying less than ten cubic meters (10m 3 ) a day as an average or

serving fewer than fifty (50) persons as part of a commercial or public

activity, shall only be subject to regulations 2 to 7 and regulations 14,

15 and 16 and the relevant Schedules.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulation 12)

PRINCIPLES FOR SETTING METHODOLOGIES

Groups of materials

1. Organic materials

The organic materials shall only be made of

(a) the starting substances listed in the European positive

list of starting substances to be established by the Commission in

accordance with Article 11(2)(b) of the Directive; and

(b) substances in relation to which there may be no

possibility that the substance and its reaction products are

present at levels exceeding 0.1 μg/l in water intended for human

consumption, unless for specific substances a more stringent

value is needed taking into account their toxicity.

Organic materials shall be tested in accordance with Table 1 in

conformity with methods for testing specified in relevant European

standards or, in the absence thereof, an internationally or nationally

recognised method and shall satisfy the requirements stipulated

therein. For this purpose, the results of the tests in terms of substance

migration shall be converted into estimated levels at the tap.

2. Metallic materials

Only the metallic materials included in the European positive list

of compositions to be established by the Commission in accordance

with Article 11(2)(b) of the Directive shall be used. The limitations

stipulated in the European positive list in respect of the composition of

these materials, their use for certain products and the use of these

products shall be complied with.

The metallic materials shall be tested in accordance with Table 1

in conformity with methods for testing specified in relevant European

standards or, in the absence thereof, an internationally or nationally

recognised method and shall satisfy the requirements stipulated

therein.

3. Cementitious materials

The cementitious materials shall only be made of one or more of

the following

(a) organic constituents listed in the European positive

list of constituents to be established by the Commission in

accordance with Article 11(2)(b) of the Directive;

(b) organic constituents in relation to which there is no

possibility that the constituents and their reaction products are

present at levels exceeding 0.1 μg/l in water intended for human

consumption; or

(c)

inorganic constituents.

Cement-bound materials shall be tested in accordance with Table

1 in conformity with methods for testing specified in relevant

European standards or, in the absence thereof, an internationally or

nationally recognised method and shall satisfy the requirements

stipulated therein. For this purpose, the results of the tests in terms of

substance migration shall be converted into estimated levels at the tap.

4. Enamels and ceramic materials

Enamels and ceramic materials shall only be made of starting

substances from the European positive list of compositions to be

established by the Commission in accordance with Article 11(2)(b) of

the Directive, after carrying out an assessment of the elements used in

the composition of these materials.

Enamels and ceramic materials shall be tested in accordance with

Table 1 in conformity with methods for testing specified in relevant

European standards or, in the absence thereof, an internationally or

nationally recognised method and shall satisfy the requirements

stipulated therein. For this purpose, the results of the tests in terms of

substance migration shall be converted into estimated levels at the tap.

5. Exceptions for assessment of materials used in minor and

assembled components

For assembled products: minor components, parts and materials

shall be described in detail and testing shall be reduced accordingly.

For this purpose, "minor" refers to a level of influence on the quality of

water intended for human consumption that does not require full

testing.

Table 1. Testing related to material types

Criteria

Organic

Metallic

Cementitious

Enamels

(See

(See Note

and

Note 1)

2)

ceramic

material

s

European positive lists

European positive list of

X

N.N.

X

N.N.

starting substances for

organic materials

European positive list of

N.N.

X

N.N.

N.N.

accepted metallic

compositions

European positive list of

N.N.

N.N.

X

N.N.

constituents for

cementitious materials

European positive list of

N.N.

N.N.

N.N.

X

compositions for enamels

and ceramic materials

Organoleptic tests

Odour and flavour

X

N.N.

X

N.N.

Colour and turbidity

X

N.N.

X

N.N.

General hygiene

assessments

Leaching of total organic X

N.N.

X

N.N.

carbon

Surface residues (metals) N.N.

X

N.N.

N.N.

Migration testing

Relevant parameters of this X

X

X

X

Directive

MTC tap of PL substances X

N.N.

X (See Note 3) N.N.

Unexpected substances

X

N.N.

X (See Note 3) N.N.

(GCMS)

Compliance with

N.N.

X

N.N.

X

compositions lists

Enhancement of microbial X

N.N.

X (See Note 3) N.N

N.N.: Not necessary;

MTCtap: Maximum tolerable concentration at the tap (either

derived from the opinion of ECHA for the purposes of inclusion of the

substance in the European positive list, or based on a specific

migration limit set in Commission Regulation (EU) No 10/2011 of 14

January 2011 on plastic materials and articles intended to come into

contact with food and considering a 10 % allocation factor and water

consumption of 2 litres per day);

GCMS: Gas Chromatography – Mass Spectrometry (screening

method).

Note 1: Specific exceptions shall be determined in line with item

5. Note 2: The metals shall not be subject to organoleptic testing

because it is generally accepted that if the parametric values set out in

the Second Schedule are met, organoleptic problems are unlikely to

arise.

Note 3: Depending on the existence of organic substances in the

composition.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) Without prejudice to other obligations under the General

provisions of other laws, the competent authority shall take the obligations.

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 all the following

requirements are met

(a)

that water is free from any micro-organisms,

parasites and substances which, in numbers or concentrations,

may constitute a potential danger to human health;

(b) that water meets the minimum requirements set out in

Parts A, B and D of the Second Schedule; and

(c) that the competent authority and relevant supporting

entity as established in the First Schedule have taken all other

measures necessary in compliance with regulations 6 to 15.

(2) The competent authority shall ensure that the measures

taken to implement the provisions of these regulations are based on the

precautionary principle and in no circumstances allow, directly or

indirectly, any deterioration of the present quality of water intended for

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

the production of water intended for human consumption.

(3) In accordance with Directive 2000/60/EC of the European

Parliament and of the Council of 23rd October 2000 on establishing a

framework for Community action in the field of water policy and the

Water Policy Framework Regulations, the entity responsible for the S.L. 549.100.

implementation and enforcement of the Directive 2000/60/EC of the

European Parliament and of the Council of 23rd October 2000 on

establishing a framework for community action in the field of water

policy and the Water Policy Framework Regulations shall ensure that S.L. 549.100.

an assessment of water leakage levels and of the potential for

improvements in water leakage reduction is performed using the

infrastructural leakage index (ILI) rating method or another

appropriate method. That assessment shall take into account relevant

public health, environmental, technical and economic aspects and

cover at least water suppliers supplying at least ten thousand cubic

meters (10,000 m 3 ) per day or serving at least fifty thousand (50,000)

persons.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulation 14)

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, with the exception of turbidity, 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 practices in accordance

with EN ISO/IEC 17025 or other equivalent standards accepted at

international level.

For the purposes of assessing the equivalence of alternative

methods with the methods laid down in this Schedule, the competent

authority may use standard EN ISO 17994, established as the standard

on the equivalence of microbiological methods, or standard EN ISO

16140 or any other similar internationally accepted protocols, to

establish the equivalence of methods based on principles other than

culturing, which are beyond the scope of EN ISO 17994.

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 the best available

techniques not entailing excessive costs.

Part A

Microbiological parameters for which methods of analysis are

specified

The methods of analysis for microbiological parameters are

(a) Escherichia coli (E. coli) and coliform bacteria (EN

ISO 9308-1 or EN ISO 9308-2);

(b)

intestinal enterococci (EN ISO 7899-2);

(c) colony count or heterotrophic plate counts at 22°C

(EN ISO 6222);

(d)

Clostridium perfringens including spores (EN ISO

14189);

(e) Legionella (EN ISO 11731 for compliance with the

value in Part D of the Second Schedule); for risk-based

verification monitoring and to complement culture methods, in

addition methods, such as ISO/TS 12869, rapid culture methods,

non-culture-based methods, and molecular-based methods, in

particular qPCR, may be used;

(f) somatic coliphages; for operational monitoring, Part

A of the Third Schedule, EN ISO 10705-2, and EN ISO 10705-3

can be used.

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 method of analysis used

shall, 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 referred to in Parts B

and C of the Second Schedule.

The uncertainty of measurement laid down in Table 1 shall not be

used as an additional tolerance to the parametric values set out in the

Second Schedule.

Table 1. Minimum performance characteristic ‘Uncertainty of

measurement’

Parameters

Uncertainty

of Notes

measurement

(See

Note 1) % of the

parametric

value

(except for pH)

Aluminium

Ammonium

Acrylamide

Benzo(a)pyrene

See Note 2

Benzene

Bisphenol A

Boron

Bromate

Cadmium

Chloride

Chlorate

Chlorite

Chromium

Copper

Cyanide

See Note 3

1,2-dichloroethane

Epichlorohydrin

Fluoride

HAAs

Hydrogen ion concentration

0,2

See Note 4

pH

Iron

Lead

Manganese

Mercury

Microcystin-LR

Nickel

Nitrate

Nitrite

Oxidisability

See Note 5

Pesticides

See Note 6

PFAS

Polycyclic aromatic

See Note 7

hydrocarbons

Selenium

Sodium

Sulphate

Tetrachloroethene

See Note 8

Trichloroethene

See Note 8

Trihalomethanes – total

See Note 7

Total organic carbon (TOC)

See Note 9

See Note 10

Vinyl chloride

(2)

Notes to Table 1

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 any stricter value. The

uncertainty of measurement shall be estimated at the level of the

parametric value unless otherwise specified.

Note 2: If the value of uncertainty of measurement cannot be

met, the best available technique shall be selected (up to 60%).

Note 3: The method shall determine total cyanide in all forms.

Note 4: The value for the uncertainty of measurement is

expressed in pH units.

Note 5: Reference method: EN ISO 8467.

Note 6: The performance characteristics for individual pesticides

are given as an indication. Values for the uncertainty of measurement

as low as 30% may be achieved for several pesticides, while higher

values up to 80% may be allowed for a number of pesticides.

Note 7: The performance characteristics apply to individual

substances, specified at 25% of the parametric value in Part B of the

Second Schedule.

Note 8: The performance characteristics apply to individual

substances, specified at 50% of the parametric value in Part B of the

Second Schedule.

Note 9: The uncertainty of measurement should be estimated at

the level of 3 mg/l of the total organic carbon (TOC). EN 1484

Guidelines for the determination of TOC and dissolved organic carbon

(DOC) shall be used for the specification of the uncertainty of the test

method.

Note 10: The uncertainty of measurement should be estimated at

the level of 1.0 NTU (nephelometric turbidity units), in accordance

with EN ISO 7027 or another equivalent standard method.

(3)

Sum of PFAS

The following substances shall be analysed based on the

technical guidelines developed in accordance with Article 13(7) of the

Directive

(a)

Perfluorobutanoic acid (PFBA);

(b)

Perfluoropentanoic acid (PFPA);

(c)

Perfluorohexanoic acid (PFHxA);

(d)

Perfluoroheptanoic acid (PFHpA);

(e)

Perfluorooctanoic acid (PFOA);

(f)

Perfluorononanoic acid (PFNA);

(g)

Perfluorodecanoic acid (PFDA);

(h)

Perfluoroundecanoic acid (PFUnDA);

(i)

Perfluorododecanoic acid (PFDoDA);

(j)

Perfluorotridecanoic acid (PFTrDA);

(k)

Perfluorobutane sulfonic acid (PFBS);

(l)

Perfluoropentane sulfonic acid (PFPS);

(m) Perfluorohexane sulfonic acid (PFHxS);

(n)

Perfluoroheptane sulfonic acid (PFHpS);

(o)

Perfluorooctane sulfonic acid (PFOS);

(p)

Perfluorononane sulfonic acid (PFNS);

(q)

Perfluorodecane sulfonic acid (PFDS);

(r)

Perfluoroundecane sulfonic acid;

(s)

Perfluorododecane sulfonic acid;

(t)

Perfluorotridecane sulfonic acid.

Those substances shall be monitored when the risk assessment

and risk management of the catchment areas for abstraction points

carried out in accordance with regulation 9 conclude that those

substances are likely to be present in a given water supply.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) The competent authority shall set values applicable to

water intended for human consumption for the parameters set out in

the Second Schedule.

(2) The parametric values set pursuant to sub-regulation (1)

shall not be less stringent than those set out in Parts A, B, C and D of

the Second Schedule. As regards the parameters set out in Part C of the

Second Schedule, the values shall be set only for monitoring purposes

and for the purpose of ensuring that the requirements set out in

regulation 15 are met.

(3) The competent authority and the supporting entity as

established in the First Schedule shall set values for additional

parameters not included in the Second Schedule where the protection

of human health within Malta or part thereof so requires. The values

set shall, as a minimum, satisfy the requirements of regulation 5(1)(a).

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(Regulation 18)

INFORMATION TO THE PUBLIC

The information in the following points shall be accessible to

consumers on-line, in a user-friendly and customised way, and

consumers may obtain access to that information by other means upon

justified request

(1) identification of the relevant water supplier, the area

and number of people supplied, and the method of water

production, including general information on types of water

treatment and disinfection applied; the competent authority may

derogate from this requirement in accordance with Article 13(1)

of Directive 2007/2/EC of the European Parliament and of the

Council of 14 March 2007 establishing an Infrastructure for

Spatial Information in the European Community (INSPIRE);

(2) the most recent monitoring results for parameters

listed in Parts A, B and C of the Second Schedule, including

monitoring frequency together with the parametric value set in

accordance with regulation 6; the monitoring results shall not be

more than one year old, except where the monitoring frequency

set by these regulations allow otherwise;

(3) information on the following parameters not listed in

Part C of the Second Schedule and the associated values

(a)

hardness;

(b)

minerals, anions or cations dissolved in water

(i)

calcium Ca;

(ii)

magnesium Mg;

(iii) potassium K;

(4) in the event of a potential danger to human health as

determined by competent authorities or other relevant bodies

following an exceedance of the parametric values set in

accordance with regulation 6, information on the potential

danger to human health and the associated health and

consumption-related advice or a hyperlink providing access to

such information;

(5)

relevant information on the risk assessment of the

supply system;

(6) advice to consumers, including on how water

consumption may be reduced when appropriate, how to use

water responsibly according to local conditions and how to avoid

health risks due to stagnant water;

(7) for water suppliers supplying at least 10 000 m 3 per

day or serving at least 50 000 people, annual information on

(a) the overall performance of the water system in

terms of efficiency and leakage rates, once that information

is available and at the latest on the date set out in regulation

5(3);

(b) the ownership structure of the water supply by

the water supplier;

(c) when costs are recovered through a tariff

system, information on the structure of the tariff per cubic

metre of water, including fixed and variable costs and costs

related to measures for the purposes of regulation 17, where

such measures have been taken by water suppliers;

(d) where available, a summary and statistics

regarding consumer complaints received by the water

suppliers on matters within the scope of these regulations;

(8) upon justified request, consumers shall be given

access to historical data for information under sub-items (2) and

(3), dating back up to 10 years, if available, and not earlier than

13th January 2023.

€5.85

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) The parametric values set in accordance with

regulation 6 for the parameters listed in Parts A and B of the Second

Schedule shall be complied with

(a) in the case of water intended for human consumption

supplied from a distribution network, at the point, within

premises or an establishment, at which the water emerges from

the taps that are normally used for water intended for human

consumption;

(b) in the case of water intended for human consumption

supplied from a tanker, at the point at which the water emerges

from the tanker;

(c) in the case of water intended for human consumption

put into bottles or containers, at the point at which the water is

put into the bottles or containers;

(d) in the case of water intended for human consumption

used in a food business, at the point at which the water is used in

that business.

(2)

In the case of water intended for human consumption

covered by sub-regulation (1)(a), the competent authority assisted by

the supporting entity as established in the First Schedule shall be

deemed to have fulfilled their obligations under this regulation and

under regulation 6 and regulation 15(2) where it may be established

that non-compliance with the parametric values set in accordance with

regulation 6 is due to the domestic distribution system or the

maintenance thereof, without prejudice to regulation 11 as regards

priority premises.

(3) Where sub-regulation (2) applies and there is a risk that the

water intended for a human consumption covered by sub-regulation

(1)(a) would not comply with the parametric values set in accordance

with regulation 6, the competent authority assisted by the supporting

entity as established in the First Schedule 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

may take, and if necessary that 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 they should

take.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

It shall be ensured that the supply, treatment and Risk-based

distribution of water intended for human consumption is subject to a approach

water safety.

risk-based approach that covers the whole supply chain from the

catchment area, abstraction, treatment, storage and distribution of

water to the point of compliance specified in regulation 7

Provided that the risk-based approach shall entail the

following elements

(a)

risk assessment and risk management of the

catchment areas for abstraction points of water intended for

human consumption in accordance with regulation 9, ensured by

the competent authority assisted by the supporting entity as

established in the First Schedule;

(b) risk assessment and risk management for each supply

system that includes the abstraction, treatment, storage and

distribution of water intended for human consumption to the

point of supply carried out by the water suppliers in accordance

with regulation 10, ensured by the competent authority; and

(c) risk assessment of the domestic distribution systems

in accordance with regulation 11.

(2) The competent authority may adapt the implementation of

the risk-based approach, without compromising the objective of these

regulations concerning the quality of water intended for human

consumption and the health of consumers, when there are particular

constraints due to geographical circumstances such as remoteness or

limited accessibility of the water supply zone.

(3) The competent authority shall ensure that there is a clear

and appropriate distribution of responsibilities between stakeholders,

for the implementation of the risk-based approach. Such distribution of

responsibilities shall be tailored to their institutional and legal

framework.

(4) The risk assessment and risk management of the catchment

areas for abstraction points of water intended for human consumption

shall be carried out for the first time by 12th July 2027 and shall be

reviewed at regular intervals of no longer than six (6) years by the

entity responsible for the implementation of the Water Policy

Framework Regulations, taking account of the requirements provided

for in Article 7 of Directive 2000/60/EC of the European Parliament

and of the Council of 23 October 2000 establishing a framework for

Community action in the field of water policy, and the relevant

provisions of Water Policy Framework Regulations. This information

resulting from the risk assessments and risk management shall be

shared by entity responsible for the implementation of the Water

Policy Framework Regulations with the competent authority.

(5) The risk assessment and risk management of the supply

system shall be carried out for the first time by 12th January 2029 by

the water supplier. That risk assessment and risk management shall be

reviewed at regular intervals of no longer than six (6) years, and

updated as necessary. This information resulting from the risk

assessments and risk management shall be shared by water supplier

with the competent authority, in the form and at the time as may be

established by the competent authority.

(6) The risk assessment of the domestic distribution systems

shall be carried out for the first time by 12th January 2029. That risk

assessment shall be reviewed every six (6) years, and updated as

necessary

Provided that the risk assessment of priority premises shall

be carried out by the responsible person of the priority premises.

(7) Owners of private premises shall be encouraged to carry

out risk assessment of their domestic distribution system.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) Without prejudice to Articles 4 to 8 of Directive Risk assessment

2000/60/EC of the European Parliament and of the Council of 23 and

management of

October 2000 establishing a framework for Community action in the the

areas for

field of water policy, and the Water Policy Framework Regulations, abstraction

the entity responsible for the implementation of the Water Policy points

intended for

Framework Regulations shall ensure that risk assessment and risk human

consumption.

management of the catchment areas for abstraction points of water S.L. 549.100.

intended for human consumption are carried out. This information

resulting from the risk assessments and risk management shall be

shared with the competent authority, in the form and at the time as may

be established by the competent authority.

(2) The entity responsible for the implementation of the Water S.L. 549.100.

Policy Framework Regulations duly assisted by the supporting entities

as established by the First Schedule shall ensure that the risk

assessment includes the following elements

(a) a characterisation of the catchment areas for

abstraction points including

(i) the identification and mapping of the catchment

areas for abstraction points;

(ii) the mapping of the safeguard zones where those

zones have been established in accordance with Article

7(3) of Directive 2000/60/EC of the European Parliament

and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water

policy, and the relevant provisions of the Water Policy

Framework Regulations;

(iii) the geo-references for all abstraction points in

the catchment areas, given that that data may be potentially

sensitive, in particular in the context of public health and

public security, the competent authority shall ensure that

such data is protected and communicated only to the

relevant authorities and water suppliers; and

(iv) the description of land-use, runoff, and recharge

processes in the catchment areas for abstraction points;

(b) an identification of hazards and hazardous events in

the catchment areas for abstraction points and an assessment of

the risk they may pose to the quality of water intended for human

consumption; that assessment shall assess potential risks that

might cause deterioration of the water quality to the extent that it

may constitute a risk to human health;

(c) an appropriate monitoring in surface water or

groundwater, or both, in the catchment areas for abstraction

points or in raw water, of relevant parameters, substances or

pollutants selected from the following

(i) the parameters in Parts A and B of the Second

Schedule or set in accordance with regulation 6(3);

(ii) the groundwater pollutants in Annex I to

Directive 2006/118/EC of the European Parliament and of

the Council of 12 December 2006 on the protection of

groundwater against pollution and deterioration; and

pollutants and indicators of pollution for which threshold

values have been established in accordance with Annex II

to that Directive, and the relative provisions of the

Protection of Groundwater Against Pollution and

Deterioration Regulations, by the entity responsible for

their implementation;

(iii) the priority substances and certain other

pollutants in Annex I to Directive 2008/105/EC of the

European Parliament and of the Council of 16 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, and the

relative provisions of the Water Policy Framework

Regulations;

(iv) the river basin specific pollutants established by

the entity responsible for the implementation of the Water

Policy Framework Regulations in accordance with

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

the Council of 23 October 2000 establishing a framework

for Community action in the field of water policy, and the

relevant provisions of Water the Policy Framework

Regulations;

(v) other pollutants relevant for water intended for

human consumption established the competent authority on

the basis of the information collected in accordance with

paragraph (b);

(vi)

naturally occurring substances that may

constitute a potential danger for human health through use

of water intended for human consumption;

(vii) substances and compounds included in the

watch list as established in accordance with regulation

14(6)

Provided that for the purposes of sub-regulation (2)(a), the

competent authority may use information collected in accordance with

Articles 5 and 7 of Directive 2000/60/EC of the European Parliament

and of the Council of 23 October 2000 establishing a framework for

Community action in the field of water policy, and the relevant

provisions of Water Policy Framework Regulations

S. L. 549. 100.

Provided further that for the purposes of sub-regulation

(2)(b), the competent authority may use the review of the impact of

human activity undertaken in accordance with Article 5 of Directive

2000/60/EC and the information on significant pressures collected in

accordance with points 1.4, 1.5 and 2.3 to 2.5 of Annex II to that

Directive.

The competent authority and the entity responsible for the

implementation of the Water Policy Framework Regulations shall S.L. 549.100.

choose from sub-regulation (2)(c)(i) to (c)(vii), the parameters,

substances or pollutants that are considered relevant for monitoring in

light of the hazards and hazardous events identified under sub-

regulation (2)(b) or in light of the information provided by the water

suppliers in accordance with sub-regulation (3).

For the purpose of appropriate monitoring as referred to sub-

regulation (2)(c), including to detect new substances that are harmful

to human health through use of water intended for human

consumption, the competent authority assisted by the supporting entity

as established by the First Schedule may use the monitoring performed

in accordance with Articles 7 and 8 of Directive 2000/60/EC of the

European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of water

policy or other Union legislation and relevant to the catchment areas

for abstraction points.

(3) Water suppliers that perform monitoring in the catchment

areas for abstraction points or in raw water shall be required to inform

the competent authority of trends in, and of unusual numbers or

concentrations of, monitored parameters, substances or pollutants.

(4) On the basis of the outcome of the risk assessment carried

out in accordance with sub-regulation (2), the competent authority and

the entity responsible for the implementation of the Water Policy

Framework Regulations, duly assisted by the other supporting entities

as established by the First Schedule shall ensure that the following risk

management measures to prevent or control the risks identified are

taken as relevant, starting with the preventive measures

(a)

the definition and implementation of preventive

measures in the catchment areas for abstraction points in

addition to the measures foreseen or taken in accordance of

Article 11(3)(d) of Directive 2000/60/EC of the European

Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy,

and the relevant provisions of the Water Policy Framework

Regulations, where required to safeguard the quality of the water

intended for human consumption

Provided that, where appropriate, those preventive

measures shall be included in the programmes of measures

referred to in Article 11 of Directive 2000/60/EC of the

European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of

water policy and the relevant provisions of Water Policy

Framework Regulations

Provided further that, where appropriate, the entity

responsible for the Water Policy Framework Regulations shall

ensure that polluters, in cooperation with water suppliers and

other relevant stakeholders, take such preventive measures in

accordance with Directive 2000/60/EC of the European

Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy;

(b) the definition and implementation of mitigation

measures in the catchment areas for abstraction points in

addition to the measures foreseen or taken in accordance with

Article 11(3)(d) of Directive 2000/60/EC of the European

Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy and

the relevant provisions of the Water Policy Framework S.L. 549.100.

Regulations, where required to safeguard the quality of the water

intended for human consumption. Where appropriate, those

mitigation measures shall be included in the programmes of

measures referred to in Article 11 of Directive 2000/60/EC of the

European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of

water policy and the relevant provisions of the Water Policy S.L. 549.100.

Framework Regulations. Where appropriate, the competent

authority shall ensure that polluters, in cooperation with water

suppliers and other relevant stakeholders, take such mitigation

measures in accordance with Directive 2000/60/EC of the

European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of

water policy and the relevant provisions of Water Policy S.L. 549.100.

Framework Regulations;

(c) ensuring appropriate monitoring of parameters,

substances or pollutants in surface water or groundwater, or both,

in the catchment areas for abstraction points, or in raw water,

that may constitute a risk to human health through water

consumption or lead to unacceptable deterioration of the quality

of water intended for human consumption and that have not been

taken into consideration in the monitoring performed in

accordance with Articles 7 and 8 of Directive 2000/60/EC of the

European Parliament and of the Council of 23 October 2000

establishing a framework for Community action in the field of

water policy and the relevant provisions of Water Policy S.L. 549.100.

Framework Regulations. Where appropriate, this monitoring

shall be included in the monitoring programs referred to in

Article 8 of Directive 2000/60/EC of the European Parliament

and of the Council of 23 October 2000 establishing a framework

for Community action in the field of water policy and the

relevant provisions of Water Policy Framework Regulations;

(d) the evaluation of the need to establish or adapt

safeguard zones for groundwater and surface water, as referred to

in Article 7(3) of Directive 2000/60/EC of the European

Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy and

the relevant provisions of Water Policy Framework Regulations, S.L. 549.100.

and any other relevant zones

Provided that the competent authority shall ensure that the

effectiveness of any measures referred to in this sub-regulation is

reviewed at appropriate intervals.

(5) The competent authority shall ensure that water suppliers

and relative competent entities have access to the information referred

to in sub-regulations (2) and (3). In particular, relevant water suppliers

shall have access to the monitoring results obtained under sub-

regulation (2)(c). On the basis of the information referred to in sub-

regulations (2) and (3), the competent authority assisted by the

supporting entity as provided for in the First Schedule may

(a) require water suppliers to perform additional

monitoring or treatment of certain parameters;

(b) allow water suppliers to decrease the monitoring

frequency of a parameter, or to remove a parameter from the list

of parameters which shall be monitored by the water supplier in

accordance with regulation 14(2)(a), without being required to

carry out a risk assessment of the supply system

Provided that

(i) the parameter is not a core parameter within the

meaning of item 1 of Part B of the Third Schedule; and

(ii) no factor that may be reasonably anticipated is

likely to cause deterioration of the quality of water intended

for human consumption.

(6) When a water supplier is allowed to decrease the

monitoring frequency of a parameter or remove a parameter from the

list of parameters which shall be monitored, as referred to in sub-

regulation (5)(b), the entity responsible for the Water Policy

Framework Regulations shall ensure that appropriate monitoring of

those parameters is performed when reviewing the risk assessment and

risk management of the catchment areas for abstraction points, in

accordance with regulation 8(4).

(7) All information resulting from assessments carried out by

the entities indicated under this regulation, shall be shared with the

competent authority.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) The water supplier shall carry out a risk assessment

and risk management of the supply system. The competent authority

assisted by the supporting entities as provided for in the First Schedule

shall ensure that this obligation is carried out.

(2) The competent authority assisted by the supporting entities

as provided for in the First Schedule shall ensure that the risk

assessment of the supply system

(a) takes into account the results of the risk assessment

and risk management of the catchment areas for abstraction

points carried out in accordance with regulation 9;

(b) includes a description of the supply system from the

abstraction point, treatment, storage and distribution of water to

the point of supply; and

(c) identifies the hazards and hazardous events in the

supply system and includes an assessment of the risks they may

pose to human health through use of water intended for human

consumption, taking into consideration risks stemming from

climate change, leakages and leaking pipes.

(3) On the basis of the outcome of the risk assessment carried

out in accordance with sub-regulation (2), it shall be ensured that the

following risk management measures are taken

(a) defining and implementing control measures for the

prevention and mitigation of the risks identified in the supply

system that may compromise the quality of water intended for

human consumption, by the competent authority;

(b) defining and implementing control measures in the

supply system by the competent authority in addition to the

measures foreseen or taken in accordance with regulation 9(4) or

Article 11(3) of Directive 2000/60/EC of the European

Parliament and of the Council of 23 October 2000 establishing a

framework for Community action in the field of water policy for

the mitigation of risks coming from the catchment areas for

abstraction points that may compromise the quality of water

intended for human consumption, by the entity responsible for S.L. 549.100.

the Water Policy Frame Work Regulations;

(c)

implementing a supply-specific operational

monitoring programme in accordance with regulation 14, by the

competent authority;

(d) ensuring that, where disinfection forms part of the

preparation or distribution of water intended for human

consumption, the efficiency of the disinfection treatment applied

is validated, that any contamination from disinfection by-

products is kept as low as possible without compromising the

disinfection, that any contamination from treatment chemicals is

kept as low as possible and that any substances remaining in the

water do not compromise the fulfilment of the general

obligations set out in regulation 5, by the competent authority;

(e) verifying that the materials, treatment chemicals and

filter media that come into contact with water intended for

human consumption used in the supply system comply with

regulations 12 and 13.

(4) On the basis of the outcome of the risk assessment of the

supply system carried out in accordance with sub-regulation (2), the

competent authority shall

(a) allow the possibility of decreasing the monitoring

frequency of a parameter or of removing a parameter from the

list of parameters which shall be monitored, except for the core

parameters referred to in item 1 of Part B of the Third Schedule,

if the competent authority is satisfied that to do so would not

compromise the quality of water intended for human

consumption

(i) on the basis of the occurrence of a parameter in

raw water, in accordance with the risk assessment of the

catchment areas for abstraction points as set out in

regulations 9(1) and (2);

(ii) when a parameter may only occur as a result of

the use of a certain treatment technique or disinfection

method, and that technique or method is not used by the

water supplier; or

(iii) on the basis of the specifications set out in Part

C of the Third Schedule;

(b) ensure that the list of parameters which shall be

monitored in water intended for human consumption in

accordance with regulation 14 is extended or that the monitoring

frequency is increased

(i) on the basis of the occurrence of a parameter in

raw water, in accordance with the risk assessment of the

catchment areas for abstraction points as set out in

regulations 9(1) and (2); or

(ii)

on the basis of the specifications set out in Part

C of the Third Schedule.

(5) The risk assessment of the supply system shall concern the

parameters listed in Parts A, B and C of the Second Schedule, the

parameters set in accordance with regulation 6(3) and the substances

or compounds included in the watch list established in accordance with

regulation 14(6).

(6) The competent authority may exempt water suppliers

supplying between ten cubic meters (10m 3 ) and one hundred cubic

meters (100m 3 ) per day as an average or serving between fifty (50) and

five hundred (500) persons from the requirement to carry out risk

assessment and risk management of the supply system

Provided that the competent authority shall be satisfied that

such an exemption would not compromise the quality of water

intended for human consumption. In the event of such an exemption,

the exempted water suppliers shall carry out regular monitoring in

accordance with regulation 14.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

Risk assessment of domestic distribution systems Risk assessment

of domestic

shall comprise of the following elements

distribution

systems.

(a)

a general analysis of the potential risks associated

with domestic distribution systems, and with related products

and materials, and whether those potential risks affect the quality

of water at the point where it emerges from the taps that are

normally used for water intended for human consumption. This

general analysis shall not entail an analysis of individual

properties; and

(b) monitoring of the parameters listed in Part D of the

Second Schedule in premises where specific risks to water

quality and human health have been identified during the general

analysis performed under paragraph (a)

Provided that in relation to Legionella or lead, the

competent authority may decide to focus the monitoring referred

to in paragraph (b) on priority premises.

(2)

When the competent authority identifies, on the basis of

the general analysis carried out under sub-regulation (1)(a), that there

is a risk to human health stemming from domestic distribution systems

or from the related products and materials, or when the monitoring

performed in accordance with sub-regulation (1)(b) demonstrates that

the parametric values set out in Part D of the Second Schedule are not

met, the competent authority shall ensure that appropriate measures

are taken to eliminate or reduce the risk of non-compliance with the

parametric values set out in Part D of the Second Schedule

Provided that in relation to Legionella, those measures

shall target at least priority premises.

(3) Sub-regulation (2) shall be without prejudice to the

provisions of the Control of Legionella Regulations and the

Registration of Cooling Towers and Evaporative Condensers

Regulations.

(4) In order to reduce the risks connected with domestic

distribution across all domestic distribution systems, the competent

authority assisted by supporting entities shall ensure that all of the

following measures are considered and that those measures considered

relevant are taken to

(a) encourage owners of public and private premises to

carry out a risk assessment of the domestic distribution system;

(b) inform the consumers and owners of public and

private premises about the measures which aim to eliminate or

reduce the risk of non-compliance with the quality standards for

water intended for human consumption due to the domestic

distribution system;

(c) advise consumers about the conditions of

consumption and the use of water intended for human

consumption, and about possible action to avoid the

reoccurrence of those risks;

(d) promote training for plumbers and other professionals

dealing with domestic distribution systems and the installation of

construction products and materials that come into contact with

water intended for human consumption;

(e) in relation to Legionella, ensure that effective control

and management measures which are proportionate to the risk

are in place to prevent and address possible outbreaks of the

disease; and

(f)

in relation to lead, if economically and technically

feasible, implement measures for substitution of components

made of lead in existing domestic distribution systems.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) For the purposes of regulation 5, the competent Minimum

authority assisted by the supporting entity as established by the First hygiene

requirements for

Schedule shall ensure that materials that are intended to be used in new material

come into

installations or, in the case of repair works or reconstruction, in contact with

existing installations for the abstraction, treatment, storage or water

for human

distribution of water intended for human consumption and that come consumption.

into contact with such water

(a) do not directly or indirectly compromise the

protection of human health as provided for by these regulations;

(b) do not adversely affect the colour, odour or taste of

the water;

(c)

do not enhance microbial growth; and

(d) do not leach contaminants into the water at levels that

are higher than necessary in view of the intended purpose of the

material.

(2) The products approved in accordance with specific

minimum hygiene requirements provided for in the Fourth Schedule

shall satisfy the requirements provided for in regulation 12(1).

(3)

The competent authority assisted by the supporting entity

as established in the First Schedule pursuant to the Coordination of Cap. 568.

Government Inspections Act shall ensure that only such products in

contact with water intended for human consumption that use final

materials approved in accordance with the Directive and these

regulations may be placed on the market for the purposes of the

Directive and these regulations

Provided that Regulation (EU) 2019/1020 of the European

Parliament and of the Council of 20 June 2019 on market surveillance

and compliance of products and amending Directive 2004/42/EC and

Regulations (EC) No 765/2008 and (EU) No 305/2011 shall apply to

products covered by these regulations.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

For the purposes of regulation 5, the competent Minimum

authority assisted by the supporting entity as established by the First requirements

treatment

Schedule shall ensure that treatment chemicals and filter media that chemical

substances and

come into contact with water intended for human consumption

filter media that

come into

contact with

(a) do not directly or indirectly compromise the

water intended

for human

protection of human health as provided for by these regulations;

consumption.

(b) do not adversely affect the colour, odour or taste of

the water;

(c)

do not unintentionally enhance microbial growth; and

(d) do not contaminate the water at levels that are higher

than necessary in view of the intended purpose.

(2) For the national implementation of the requirements of this

regulation, regulation 5(2) shall apply accordingly.

(3) Pursuant to regulation 13(1), and without prejudice to

Regulation (EU) No 528/2012 of the European Parliament and of the

Council of 22 May 2012 concerning the making available on the

market and use of biocidal products and the provisions of Biocidal

Products (Implementation of Regulation (EU) No 528/2012)

Regulations, and by using relevant national and European standards

for specific treatment chemicals or filter media, the competent

authority assisted by the supporting entity as established in the First

Schedule shall ensure that the purity of treatment chemicals and filter

media is assessed and the quality of such chemicals and filter media is

guaranteed.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(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 accordance with this

regulation and Parts A and B of the Third Schedule, 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 of water intended for human consumption

shall be taken so that they are representative of its quality throughout

the year.

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

appropriate monitoring programmes shall be established in accordance

with Part A of the Third Schedule for all water intended for human

consumption. Those monitoring programmes shall be supply-specific,

taking into account the outcomes of the risk assessment of the

catchment areas for abstraction points and of the supply systems, and

shall consist of the following elements

(a) the monitoring of the parameters listed in Parts A, B

and C of the Second Schedule, and of the parameters set in

accordance with regulation 6(3), in accordance with the Third

Schedule, and, when a risk assessment of the supply system is

carried out in accordance with regulation 10 and Part C of the

Third Schedule, unless the competent authority decides that one

(1) of those parameters may be removed, in accordance with

regulation 9(5)(b) or regulation 10(4)(a), from the list of

parameters to be monitored;

(b) the monitoring of the parameters listed in Part D of

the Second Schedule, for the purposes of the risk assessment of

domestic distribution systems, as provided for in regulation

11(1)(b);

(c) the monitoring of the substances and compounds

included in the watch list;

(d) the monitoring, for the purposes of the identification

of hazards and hazardous events, as provided for in regulation

9(2)(c);

(e) the operational monitoring conducted in accordance

with item 3 of Part A of the Third Schedule.

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

authority assisted by the supporting entity as established in the First

Schedule and shall meet the relevant requirements set out in Part D of

the Third Schedule.

(4) The competent authority shall comply with the

specifications for the analysis of parameters set out in the Fifth

Schedule, in accordance with the following principles

(a) methods of analysis other than those specified in Part

A of the Fifth Schedule may be used

Provided that it may be demonstrated that the results

obtained are at least as reliable as those produced by the methods

specified in Part A of the Fifth Schedule, by providing the

Commission with all relevant information concerning such

methods and their equivalence;

(b)

for the parameters listed in Part B of the Fifth

Schedule, 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

microorganisms 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 numbers or concentrations which constitute a

potential danger to human health.

(6) The competent authority shall put in place monitoring

requirements with regard to the potential presence of the substances or

compounds which are included in the watch list, at relevant points of

the supply chain for water intended for human consumption

Provided that the monitoring results shall be included in the

data sets, set up in accordance regulation 19(1)(b), together with the

results of the monitoring performed under regulation 9(2)(c)

Provided further that where a substance or compound

included in the watch list in accordance with regulation 9(2) or sub-

regulation (5) is detected, in concentrations exceeding the guidance

values set out in the watch list, the entity responsible for the Water

Policy Framework Regulations supported by the competent authority

shall ensure that the following measures are considered and that those

measures considered relevant are taken

(a) preventive measures, mitigation measures or

appropriate monitoring in the catchment areas for abstraction

points or in raw water as set out in regulations 9(4)(a), (b) and

(c);

(b) obligation on the water suppliers to carry out

monitoring of those substances or compounds, in accordance

with regulation 9(5)(a);

(c) obligation on the water suppliers to check whether

treatment is adequate to reach the guidance value and, where

necessary, to optimise the treatment; and

(d) remedial actions in accordance with regulation 15(6)

where the competent authority consider it necessary to protect

human health.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(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 without prejudice to regulation 7(2), the competent authority

shall ensure that the necessary remedial action is taken as soon as

possible to restore the quality of that water and shall give priority to its

enforcement, having regard to, inter alia, the extent to which the

relevant parametric value has been exceeded and the associated

potential danger to human health

Provided that in the event of non-compliance with the

parametric values set out in Part D of the Second Schedule, remedial

action shall include the measures set out in regulation 11(4).

(3)

Regardless of whether any failure to comply with the

parametric values has occurred, the competent authority shall ensure

that any supply of water intended for human consumption which may

constitute a potential danger to human health is prohibited or the use of

such water restricted and that any other remedial action that is

necessary to protect human health is taken

Provided that the competent authority shall consider a

failure to meet the minimum requirements for parametric values set

out in Parts A and B of the Second Schedule as a potential danger to

human health, except when the competent authority considers the non-

compliance with the parametric value to be trivial.

(4) In the cases described in sub-regulations (2) and (3), when

the non-compliance with the parametric values is considered to be a

potential danger to human health, the competent authority assisted,

where applicable, by the supporting entity as established in the First

Schedule shall, as soon as possible, take all of the following measures

(a) notify all affected consumers of the potential danger

to human health and its cause, of the exceedance of a parametric

value and of the remedial actions taken, including prohibition or

restriction of use or other action;

(b) give, and regularly update, the necessary advice to

consumers on conditions of consumption and use of the water,

while taking particular account of population groups with

increased water-related health risks; and

(c) inform consumers once it has been established that

there is no longer a potential danger to human health and inform

them that the service has returned to normal.

(5) The competent authority and where applicable with the

assistance of supporting entities shall decide what action under sub-

regulation (3) is to 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.

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

or with the specifications set out in Part C of the Second Schedule, the

competent authority shall consider whether that non-compliance poses

any risk to human health. It shall take remedial actions to restore the

quality of water intended for human consumption when that is

necessary to protect human health.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

In duly justified circumstances, the competent Derogations.

authority may provide for derogations from the parametric values set

out in Part B of the Second Schedule, or in accordance with regulation

6(3), up to a maximum value to be determined by it

Provided that such derogations shall not constitute a

potential danger to human health

Provided further that the supply of water intended for

human consumption in the area concerned may not be maintained by

any other reasonable means. Such derogations shall be limited to the

following

(a) a new catchment area for the abstraction of water

intended for human consumption;

(b) a new source of pollution detected at the catchment

area for the abstraction of water intended for human

consumption or parameters newly searched for or detected; or

(c) an unforeseen and exceptional situation in an existing

catchment area for the abstraction of water intended for human

consumption that may lead to temporary limited exceedances of

the parametric values

Provided that the derogations referred to in this sub-

regulation shall be limited to as short a period as possible and shall not

exceed three (3) years in duration. Towards the end of the period of the

derogation, the competent authority shall conduct a review to

determine whether sufficient progress has been made.

(2) Any derogation granted in accordance with sub-regulation

(1) shall specify the following

(a)

the grounds for the derogation;

(b) the parameter concerned, previous relevant

monitoring results, and the maximum permissible parametric

value under the derogation;

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

each day, the population concerned and whether any relevant

food business operator 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; and

(f)

the duration of the derogation.

(3) If the competent authority considers the non-compliance

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

accordance with regulation 15(2) is sufficient to remedy the problem

within thirty (30) days, it shall not be required to specify the

information provided for in this sub-regulation in the derogation

Provided that, in that event, only the maximum permissible

value for the parameter concerned and the time allowed to remedy the

problem shall be set by the competent authorities or other relevant

bodies in the derogation.

(4) If there is a failure to comply with any parametric value for

a given water supply on more than thirty (30) days on aggregate during

the previous twelve (12) months, recourse may no longer be had to

sub-regulation (3).

(5) The competent authority which has granted a derogation as

provided for in this regulation shall ensure that the population affected

by any such derogation is promptly informed in an appropriate manner

of that derogation and of the conditions governing it. Moreover, the

competent authority assisted by the supporting entity as established in

the First Schedule shall, where necessary, ensure that advice is given to

particular population groups for which the derogation may present a

special risk

Provided that the obligations referred to in sub-regulation

(1) shall not apply in the circumstances described in sub-regulation

(3), unless the competent authorities decide otherwise.

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

consumption put into bottles or containers.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) Without prejudice to the relevant provisions of the Access to water

Water Policy Framework Regulations and Article 9 of Directive 2000/ intended

human

60/EC of the European Parliament and of the Council of 23 October consumption.

2000 establishing a framework for Community action in the field of

water policy and to the principles of subsidiarity and proportionality,

whilst taking into account the local, regional and cultural perspectives

and circumstances for water distribution, the corporation established

by the Water Services Corporation Act shall take the necessary Cap. 355.

measures to improve or maintain access to water intended for human

consumption for all, in particular for vulnerable and marginalised

groups. For that purpose, the entity responsible for social policy shall

(a) identify people without access, or with limited access,

to water intended for human consumption, including vulnerable

and marginalised groups, and reasons for such lack of access;

(b)

assess possibilities for improving access for such

people;

(c) inform such people about possibilities for connecting

to the distribution network or about alternative means of having

access to water intended for human consumption; and

(d)

take measures that it considers necessary and

appropriate to ensure that there is access to water intended for

human consumption for vulnerable and marginalised groups.

(2)

In order to promote the use of tap water intended for

human consumption, the entity responsible shall ensure that outdoor

and indoor equipment is set up in public spaces, where technically

feasible, in a manner that is proportionate to the need for such

measures and taking into account specific local conditions, such as

climate and geography. The competent authority may also take the

following measures to promote the use of tap water intended for

human consumption

(a) raising awareness of the nearest outdoor or indoor

equipment;

(b) launching campaigns to inform citizens about the

quality of such water;

(c) encouraging the provision of such water in public

administrations and public buildings.

(3) It shall be ensured that the necessary assistance is

facilitated in order to implement the measures referred to in this

regulation.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1)

The competent authority assisted by the supporting

entity as established in the First Schedule shall ensure that adequate

and up-to-date information on water intended for human consumption

is available in accordance with the Sixth Schedule, while complying

with applicable data protection rules.

(2) All water suppliers and the corporation established by the

Water Services Corporation Act shall ensure that all persons supplied

with water intended for human consumption receive the following

information regularly and at least once a year, without having to

request it, and in the most appropriate and easily accessible form, such

as on invoices or by digital means such as smart applications

(a) information on the quality of water intended for

human consumption, including the indicator parameters;

(b) the price of water intended for human consumption

supplied, per litre and cubic metre;

(c) the volume consumed by the household, at least per

year or per billing period, together with yearly trends of the

household consumption, if technically feasible and if this

information is available to the water supplier;

(d) comparisons of the yearly water consumption of the

household with an average household consumption, when

applicable in accordance with paragraph (c); and

(e) a link to the website containing the information set

out in the Sixth Schedule.

(3) This regulation is without prejudice to Directive 2003/4/EC

of the European Parliament and of the Council of 28 January 2003 on

public access to environmental information and repealing Council

Directive 90/313/EEC and Directive 2007/2/EC of the European

Parliament and of the Council of 14 March 2007 establishing an

Infrastructure for Spatial Information in the European Community

(INSPIRE).

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) Without prejudice to Directive 2003/4/EC of the Information on

European Parliament and of the Council of 28 January 2003 on public monitoring

implementation.

access to environmental information and repealing Council Directive

90/313/EEC and Directive 2007/2/EC of the European Parliament and

of the Council of 14 March 2007 establishing an Infrastructure for

Spatial Information in the European Community (INSPIRE), the

competent authority

(a) assisted by the supporting entity as established in the

First Schedule, shall set up, by 12th January 2029, and update

every six (6) years thereafter, a data set containing information

on measures taken to improve access to and promote the use of

water intended for human consumption in accordance with

regulation 17, and on the share of their population that has access

to water intended for human consumption. This shall not include

water put into bottles or containers;

(b) assisted by the supporting entity as established in the

First Schedule, shall set up, by 12th July 2027, and update every

six (6) years thereafter, a data set containing information related

to the risk assessment and risk management of the catchment

areas for abstraction points carried out in accordance with

regulation 9, including the following elements

(i) the information on catchment

areas

for

abstraction points under regulation 9(2)(a);

(ii) the results of the monitoring performed under

regulation 9(2)(c); and

(iii) the concise information on the measures taken

pursuant to regulation 9(4), including information on the

type of measures taken;

(c) shall set up, by 12th January 2029, and update every

six (6) years thereafter, a data set containing information related

to the risk assessment of domestic distribution systems carried

out in accordance with regulation 11, including the following

elements

(i) the results of the monitoring performed under

regulation 11(1)(b); and

(ii) the concise information on the measures taken

pursuant to regulation 11(2) and (3), including information

on the type of measures taken, and the progress made, in

accordance with regulation 11(3)(f);

(d) shall set up and update annually thereafter, a data set

containing the monitoring results, in cases of exceedances of the

parametric values set out in Parts A and B of the Second

Schedule, collected in accordance with regulations 10 and 14 and

information about the remedial actions taken in accordance with

regulation 15;

(e) assisted by the supporting entity as established by the

First Schedule, shall set up, and update annually thereafter, a

data set containing information on incidents relating to water

intended for human consumption that have caused a potential

risk to human health, regardless of whether any failure to meet

the parametric values occurred, that lasted for more than ten (10)

consecutive days and that affected at least one thousand (1000)

persons, including the causes of those incidents and remedial

actions taken in accordance with regulation 15; and

(f) shall set up, and update annually thereafter, a data set

containing information on all derogations granted in accordance

with regulation 16(1), including the information provided for in

regulation 16(2). Where possible, spatial data services as defined

in Article 3(4) of Directive 2007/2/EC of the European

Parliament and of the Council of 14 March 2007 establishing an

Infrastructure for Spatial Information in the European

Community (INSPIRE) shall be used to present the data sets

referred to in sub-regulation (1).

(2) The competent authority shall ensure that the Commission,

the EEA and the European Centre for Disease Prevention and Control

have access to the data sets referred to in sub-regulation (1).(2) The

competent authority shall ensure that the Commission, the EEA and

the European Centre for Disease Prevention and Control have access

to the data sets referred to in sub-regulation (1).

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) The Superintendent shall appoint a Committee, which Committee

shall be made up of all the entities mentioned in these regulations and Procedure.

any other relevant stakeholders so identified by the Superintendent.

(2) This Committee shall be chaired by the Superintendent or

his appointed representative.

(3) The main functions of this Committee shall be to foresee

the requirements and implementation of the Directive and these

regulations.

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

(1) By 12th January 2026, the competent authority shall Transitional

take the measures necessary to ensure that water intended for human period.

consumption complies with the parametric values set out in Part B of

the Second Schedule for Bisphenol A, Chlorate, Chlorite, Haloacetic

Acids, Microcystin-LR, PFAS Total, Sum of PFAS and Uranium.

(2) Until 12 January 2026, water suppliers shall not be obliged

to monitor water intended for human consumption in accordance with

regulation 14 for the parameters listed in sub-regulation (1).

Malta Government Gazette — Legal Notice 2023 297 · Gazzetta tal-Gvern ta’ Malta Nru. 21,166– 15.12.2023 — Water Intended for Human Consumption Regulations, 2023

The Water Intended for Human Consumption Regulations Repeal.

S. L. 449. 57

are hereby repealed.

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