WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS (sl_449.63) | MT

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Preamble — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

SUBSIDIARY LEGISLATION 449.63

WATER INTENDED FOR HUMAN CONSUMPTION

REGULATIONS

15th December, 2023

LEGAL NOTICE 297 of 2023.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 1 Citation. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

The title of these regulations is the Water Intended for

Human Consumption Regulations.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

First Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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

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)

WATER INTENDED FOR HUMAN CONSUMPTION

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

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 2 Scope. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

These regulations transpose the provisions of

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Second Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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

value

number/100 ml

For water put into

bottles or containers,

Intestinal enterococci

the unit is number/

250 ml.

number/100 ml

For water put into

bottles or containers,

Escherichia coli (E. coli)

the unit is number/

250 ml.

Part B

Chemical parameters

Parametric

Unit

Notes

value

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.

μg/l

1,0

μg/l

Benzo(a)pyrene

0,010

μg/l

2,5

μg/l

WATER INTENDED FOR HUMAN CONSUMPTION

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

WATER INTENDED FOR HUMAN CONSUMPTION

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).

WATER INTENDED FOR HUMAN CONSUMPTION

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.

WATER INTENDED FOR HUMAN CONSUMPTION

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.

WATER INTENDED FOR HUMAN CONSUMPTION

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".

WATER INTENDED FOR HUMAN CONSUMPTION

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

WATER INTENDED FOR HUMAN CONSUMPTION

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 value

Unit

Notes

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

WATER INTENDED FOR HUMAN CONSUMPTION

Oxidisability

5,0

mg/l O 2

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

temperature of 22 o C

change

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.

WATER INTENDED FOR HUMAN CONSUMPTION

Part D

Parameters relevant for the risk assessment of domestic distribution

systems

Parameter

Parametric value

Unit

Notes

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.

WATER INTENDED FOR HUMAN CONSUMPTION

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 3 Interpretation. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

For the purposes of these regulations and unless the

context otherwise requires

"the Act" means the Food Safety Act;

"competent authority" means the Superintendent of

Public Health or a person authorized to act on his behalf, 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

WATER INTENDED FOR HUMAN CONSUMPTION

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Third Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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

Minimum

frequency

of

sampling

Volume (m 3 ) of water distributed or

analysis

produced each day within a supply zone

≤ 1 000

Weekly

> 1 000 to ≤ 10 000

Daily

> 10 000

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 shall be

coliphages

water)

Forming

measured

if

the

Units

assessment indicates that it

(PFU)/100

is appropriate to do so. If it

ml

is found in raw water at

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

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 or

Group A parameter

Group B parameter number

produced each day within a

number of samples

of samples per year

supply zone (See Notes 1 and

per year

2) m 3

< 10

> 0 (See Note 4)

≥ 10

≤ 100

1 (See Note 5)

> 100

≤ 1 000

> 1 000

≤ 10 000

4 for the first 1 000

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

m 3 /d + 3 for each

for each additional 4 500 m 3 /

additional 1 000 m 3 /d

d and part thereof of the total

and part thereof of

volume (See Note 3)

3 for first 10 000 m 3 /d + 1 for

> 10 000

≤ 100 000

the total volume (See

Note 3)

each additional 10 000 m 3 /d

and part thereof of the total

volume (See Note 3)

12 for first 100 000 m 3 /d + 1

> 100 000

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 4 Exemptions. to: — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

The provisions of these regulations shall not apply

(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

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Fourth Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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.

WATER INTENDED FOR HUMAN CONSUMPTION

Table 1. Testing related to material types

Criteria

Organic

Metallic

Cementitious

Enamels

(See Note

and

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.

accepted metallic

compositions

European positive list of

N.N.

X

N.N.

constituents for cementitious

materials

European positive list of

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.

Migration testing

Relevant parameters of this

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

growth

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 5 General obligations. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

Without prejudice to other obligations under the

provisions of other laws, the competent authority shall take the

measures necessary to ensure that water intended for human

consumption is wholesome and clean. For the purposes of the

minimum requirements of these regulations, water intended for human

consumption shall be wholesome and clean if 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 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 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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Fifth Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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

Antimony

Arsenic

Benzo(a)pyrene

See Note 2

Benzene

Bisphenol A

Boron

Bromate

Cadmium

Chloride

See Note 3

1,2-dichloroethane

Epichlorohydrin

Hydrogen ion concentration pH

0,2

See Note 4

Microcystin-LR

See Note 5

See Note 6

Polycyclic aromatic hydrocarbons

See Note 7

Tetrachloroethene

See Note 8

Trichloroethene

See Note 8

Trihalomethanes – total

See Note 7

Total organic carbon (TOC)

See Note 9

See Note 10

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 6 Quality standards. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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).

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Sixth Schedule — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 7 Points of compliance. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 8 Risk-based approach to water safety. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

It shall be ensured that the supply, treatment and

distribution of water intended for human consumption is subject to a

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 9 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

Without prejudice to Articles 4 to 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 Water Policy Framework Regulations,

the entity responsible for the implementation of the Water Policy

Framework Regulations shall ensure that risk assessment and risk

management of the catchment areas for abstraction points of water

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 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

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

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

WATER INTENDED FOR HUMAN CONSUMPTION

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

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 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

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

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, 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.

WATER INTENDED FOR HUMAN CONSUMPTION

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 10 Risk assessment and risk management of the supply system. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 11 Risk assessment of domestic distribution systems. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

Risk assessment of domestic distribution systems

shall comprise of the following elements

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 12 Minimum hygiene requirements for material that come into contact with water intended for human consumption. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

For the purposes of regulation 5, the competent

authority assisted by the supporting entity as established by the First

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

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

existing installations for the abstraction, treatment, storage or

distribution of water intended for human consumption and that come

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 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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 13 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

For the purposes of regulation 5, the competent

authority assisted by the supporting entity as established by the First

Schedule shall ensure that treatment chemicals and filter media that

come into contact with water intended for human consumption

(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 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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 14 Monitoring. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 15 Remedial action and restrictions of use. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 16 Derogations. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

In duly justified circumstances, the competent

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 17 Access to water intended for human consumption.  — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

Without prejudice to the relevant provisions of the

Water Policy Framework Regulations and Article 9 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 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

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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 18 Information to the public. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(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).

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 19 Information on monitoring of implementation. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

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), 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

WATER INTENDED FOR HUMAN CONSUMPTION

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).

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 20 Committee Procedure. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

The Superintendent shall appoint a Committee,

which shall be made up of all the entities mentioned in these

regulations and 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.

Laws of Malta — Subsidiary Legislation 449.63 — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Reg. 21 Transitional period. — WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS Open official source

(1)

By 12th January 2026, the competent authority

shall take the measures necessary to ensure that water intended for

human 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).

WATER INTENDED FOR HUMAN CONSUMPTION

WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS

Table of Provisions (28)

Statutory Text (28 Articles)

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