Regulations, 2017

L.N. 299 of 2017

FOOD SAFETY ACT

(CAP. 449)

Water Intended for Human Consumption (Amendment)

Regulations, 2017

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

Safety Act, the Minister responsible for Health has made the following

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

Human Consumption (Amendment) Regulations, 2017 and they shall

be read and construed as one with the Water Intended for Human S.L. 449.57.

Consumption Regulations, hereinafter referred to as "the principal

Regulation 2 of the principal regulations shall be Substitutes

regulation 2 of

substituted by the following

the principal

regulations.

2. (1) These regulations transpose the

provisions of

(a) Council Directive 98/83/EC of 3

November, 1998, on the quality of water intended

for human consumption;

(b) Council Directive 2015/1787 of 6

October 2015 amending Annexes II and III to

Council Directive 98/83/EC on the quality of

water intended for human consumption.

(2) These regulations concern the quality of

water intended for human consumption, with the

objective to protect human health from the adverse

effects of any contamination of water intended for

human consumption by ensuring that it is wholesome

and clean, and to set in place a regime that provides

protection to persons consuming the water and shall

apply to any water supplied by a water supplier.".

Schedule II of the principal regulations shall be substituted Substitutes

Schedule II of

by the following

the principal

regulations.

"SCHEDULE II

(Regulation 8)

Monitoring

PART A

General objectives and monitoring programmes for water

intended for human consumption

1. Monitoring programmes for water intended for human

consumption must

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

human health throughout the water supply chain from the

catchment area through abstraction, treatment and storage to

distribution are working effectively and that water at the point of

compliance is wholesome and clean;

(b) provide information on the quality of the water

supplied for human consumption to demonstrate that the

obligations set out in regulations 5 and 6 in the principal

regulations, and the parametric values laid down in Schedule I,

are being met;

(c) identify the most appropriate means of mitigating the

risk to human health.

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

establish monitoring programmes complying with the parameters and

frequencies set out in Part B of this schedule which consist of

(a)

collection and analysis of discrete water samples; or

(b)

measurements recorded by a continuous monitoring

process.

In addition, monitoring programmes may consist of

(a) inspections of records of the functionality and

maintenance status of equipment; and/or

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

treatment, storage and distribution infrastructure.

3. Monitoring programmes may be based on a risk assessment

as set out in Part C of this schedule.

The competent authority shall ensure that monitoring

programmes are reviewed on a continuous basis and updated or

reconfirmed at least every 5 years.

PART B

Parameters and frequencies

1. General framework

A monitoring programme must take into account the

parameters referred to in regulation 6, including those that are

important for assessing the impact of domestic distribution systems on

the quality of water at the point of compliance, as set out in regulation

7(1). When choosing appropriate parameters for monitoring, local

conditions for each water supply must be taken into consideration.

The competent authority shall ensure that the parameters

listed in point 2 are monitored at the relevant sampling frequencies as

set out in point 3.

2. List of parameters

Group A parameters

The following parameters (Group A) shall be monitored in

accordance with the monitoring frequencies set out in Table 1 of point

3

(a) Escheichia coli (E. coli), coliform bacteria, colony

count 22 o C, colour, turbidity, taste, odour, pH, conductivity;

(b) other parameters identified as relevant in the

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

where relevant, through a risk assessment as set out in Part C.

Under specific circumstances, the following parameters

shall be added to the Group A Parameters

(a)

ammonium and nitrite, if chlorination is used;

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

chemicals.

Group B parameters

In order to determine compliance with all parametric values

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

A and set in accordance with regulation 6 shall be monitored at least at

the frequencies set out in Table 1 of point 3.

3. Sampling frequencies

Table 1

Minimum frequency of sampling and analysis for compliance

monitoring

Volume of water distributed or

produced each day within a

Group A parameters

Group B parameters

supply zone

number of samples per year

number of samples per year

(See Notes 1 and 2)

(See Note 3)

m 3

> 0

> 0

≤ 100

(See Note 4)

(See Note 4)

≤ 1,000

+ 1

≤ 10,000

For each 4,500 m 3 /d and part

thereof of the total volume

+ 1

+ 3

≤ 100,000

For each 10,000 m 3 /d and part

For each 1,000 m 3 /d and part

thereof of the total volume

thereof of the total volume

+ 1

> 100,000

For each 25,000 m 3 /d and part

thereof of the total volume

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

which water intended for human consumption comes from one or more

sources and water quality may be considered as being approximately

uniform.

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

calendar year. The number of inhabitants in a supply zone may be used

instead of the volume of water to determine the minimum frequency,

assuming water consumption of 200 l/(day*capita).

Note 3: The frequency indicated is calculated as follows: e.g.

4,300 m 3 /d = 16 samples (four for the first 1,000 m 3 /d + 12 for

additional 3,300 m 3 /d).

Note 4: The competent authorities that have decided to exempt

individual supplies under regulation 4(2)(b) shall apply these

frequencies only for supply zones that distribute between 10 and 100

m 3 per day. For these supply zones the frequency for Group A

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

shall be 1 sample every 2 years.

PART C

Risk assessment

1. The competent authority may provide for the possibility to

derogate from the parameters and sampling frequencies in Part B,

provided that a risk assessment is performed in accordance with this

Part.

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

the general principles of risk assessment set out in relation to

international standards such as EN 15975-2 concerning "security of

drinking water supply, guidelines for risk and crisis management".

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

the monitoring programmes established by the second sub-paragraph

of Article 7(1), and Article 8 of Directive 2000/60/EC of the European

Parliament and of the Council as transposed in regulation 7(1) and

regulation 8 of the Water Policy Framework Regulations, for bodies of

water intended under regulation 7(1) that provide more than 100 m 3 a

day on average, in accordance with Annex V to those regulations.

4. Based on the results of the risk assessment, the list of

parameters in point 2 of Part B shall be extended and/or the sampling

frequencies in point 3 of Part B increased, where any of the following

conditions is fulfilled

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

Schedule is not sufficient to fulfil the obligations imposed under

regulation 8(1);

(b) additional monitoring is required for the purpose of

regulation 8(6);

(c) it is necessary to provide the necessary assurance set

out in point (1)(a) of Part A.

Based on the results of the risk assessment, the list of

parameters set out in point 2 of Part B and the sampling frequencies set

out in point 3 of Part B may be reduced provided the following

conditions are met

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

reduced below the one laid down in point 3 of Part B under any

circumstances;

(b) for all other parameters

(i)

the location and frequency of sampling shall be

determined in relation to the parameter’s origin, as well as

the variability and long-term trend of its concentration,

taking into account regulation 7;

(ii) to reduce the minimum sampling frequency of a

parameter, as set out in point 3 of Part B, the results

obtained from samples collected at regular intervals over a

period of at least 3 years from sampling points

representative of the whole supply zone must all be less

than 60% of the parametric value;

(iii)

to remove a parameter from the list of

parameters to be monitored, as set out in point 2 of Part B,

the results obtained from samples collected at regular

intervals over a period of at least 3 years from points

representative of the whole supply zone must all be less

than 30% of the parametric value;

(iv) the removal of a particular parameter set out in

point 2 of Part B from the list of parameters to be

monitored shall be based on the result of the risk

assessment, informed by the results of monitoring of

sources of water intended for human consumption and

confirming that human health is protected from the adverse

effects of any contamination of water intended for human

consumption, as laid down in regulation 2;

(v) the sampling frequency may be reduced or a

parameter removed from the list of parameters to be

monitored as set out in points (ii) and (iii) only if the risk

assessment confirms that no factor that can be reasonably

anticipated is likely to cause deterioration of the quality of

water intended for human consumption.

The competent authority shall ensure

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

other competent authority; and

(b) information is available showing that a risk

assessment has been carried out, together with a summary of its

results.

PART D

Sampling methods and sampling points

1. Sampling points shall be determined so as to ensure

compliance with the points of compliance as defined in regulation

7(1). In the case of a distribution network, the competent authority

may take samples within the supply zone or at the treatment works for

particular parameters if it can demonstrated that there would be no

adverse change to the measured value of the parameter concerned. As

far as possible, the number of samples shall be distributed equally in

time and location.

2. Sampling at the point of compliance shall meet the

following requirements

(a) compliance samples for certain chemical parameters

(in particular copper, lead and nickel) shall be taken at the

consumer’s tap without prior flushing. A random daytime sample

of one litre volume is to be taken. As an alternative, the

competent authority may use fixed stagnation time methods that

better reflect its national situation, provided that, at the supply

zone level, this does not result in fewer cases of non-compliance

than using the random daytime method;

(b) compliance samples for microbiological parameters

at the point of compliance shall be taken and handled according

to EN ISO 19458, sampling purpose B.

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

sampling at the consumers’ tap, shall be in accordance with ISO 5667-

5. For microbiological parameters, sampling in the distribution

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

sampling purpose A.".

4. Schedule III of the principal regulations shall be amended Amends

Schedule III of

as follows

the principal

regulations.

(a) the introductory

paragraph

thereof

shall

be

substituted by the following

"The competent authority shall ensure that the

methods of analysis used for the purposes of monitoring

and demonstrating compliance with these regulations are

validated and documented in accordance with EN ISO/IEC

17025 or other equivalent standards accepted at

international level. The competent authority shall ensure

that laboratories or parties contracted by laboratories apply

quality management system in accordance with EN ISO/

IEC 17025 or other equivalent standards accepted at

international level.

In the absence of an analytical method meeting the

minimum performance criteria set out in Part B, the

competent authority shall ensure that monitoring is carried

out using best available techniques not entailing excessive

costs.";

(b) the heading of item 1 thereof up to including "Note 1"

shall be substituted by the following

"PART A

MICROBIOLOGICAL PARAMETERS FOR WHICH

METHODS OF ANALYSIS ARE SPECIFIED;

The methods for microbiological parameters are

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

bacteria (EN ISO 9308-1 or EN ISO 9308-2)

(b)

Enterococci (EN ISO 7899-2)

(c)

(EN

ISO

Pseudomonas

aeruginosa

16266)

(d) enumeration

of

culturable

microorganisms – colony count 22 o C (EN ISO 6222)

(e) enumeration

of

culturable

microorganisms – colony count 36 o C (EN ISO 6222)

(f) Clostridium perfringens including spores

(EN ISO 14189).";

(c) items 2, 2.1and 2.2 thereof shall be substituted by the

following

"PART B

Chemical and indicator parameters for which performance

characteristics are specified

1. Chemical and indicator parameters

For the parameters set out in Table 1, the

specified performance characteristics are that the method of

analysis used must, as a minimum, be capable of measuring

concentrations equal to the parametric value with a limit of

quantification, as defined in Article 2(2) of Commission

Directive 2009/90/EC of 31 July 2009 laying down,

pursuant to Directive 2000/60/EC of the European

Parliament and of the Council, technical specifications for

chemical analysis and monitoring of water status, of 30%

or less of the relevant parametric value and an uncertainty

of measurement as specified in Table 1. The result shall be

expressed using at least the same number of significant

figures as for the parametric value considered in Parts B

and C of Schedule I.

Until 31 December 2019 the competent

authority may allow for the use of "trueness", "precision"

and "limit of detection" as specified in Table 2, as an

alternative set of performance characteristics to "limit of

quantification" and "uncertainty of measurement" as

specified respectively in the first paragraph and Table 1.

The uncertainty of measurement laid down in

Table 1 shall not be used as an additional tolerance to the

parametric values set out in Schedule I.

Table 1

Minimum performance characteristic "Uncertainty of

measurement"

Uncertainty of measurement

Parameters

(See Note 1)

Notes

% of the parametric value (except for pH)

Aluminium

Ammonium

Antimony

Arsenic

Benzo(a)pyrene

See Note 5

Benzene

Boron

Bromate

Cadmium

Chloride

Chromium

Conductivity

Copper

Cyanide

See Note 6

1,2-dichloroethane

Fluoride

Hydrogen ion concentration pH

0,2

See Note 7

(expressed in pH units)

Iron

Lead

Manganese

Mercury

Nickel

Nitrate

Nitrite

Oxidisability

See Note 8

Pesticides

See Note 9

Polycyclic aromatic hydrocarbons

See Note 10

Selenium

Sodium

Sulphate

Tetrachloroethene

See Note 11

Trichloroethene

See Note 11

Trihalomethanes – total

See Note 10

Total organic carbon (TOC)

See Note 12

Turbidity

See Note 13

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

Table 2

Minimum performance characteristics "Trueness", "precision" and

"limit of detection" may be used until 31 December 2019

Limit of

Trueness

Precision

detection

(See Note 2)

(See Note 3)

(See Note 4)

Parameters

% of the

% of the

% of the

parametric value

parametric value

parametric value

(except for pH)

(except for pH)

(except for pH)

Aluminium

Ammonium

Antimony

Arsenic

Benzo(a)pyrene

Benzene

Boron

Bromate

Cadmium

Chloride

Chromium

Conductivity

Copper

Cyanide

See Note 6

1,2-dichloroethane

Fluoride

Hydrogen ion concentration

0,2

0,2

See Note 7

pH (expressed in pH units)

Iron

Lead

Manganese

Mercury

Nickel

Nitrate

Nitrite

Oxidisability

See Note 8

Pesticides

See Note 9

Polycyclic aromatic

See Note 10

hydrocarbons

Selenium

Sodium

Sulphate

Tetrachloroethene

See Note 11

Trichloroethene

See Note 11

Trihalomethanes – total

See Note 10

Turbidity

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

2. Notes to Table 1 and 2

Uncertainty of measurement is a non-negative parameter characterising the dispersion of the

quantity values being attributed to a measurand, based on the information used. The performance

criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in

the table or better. Measurement uncertainty shall be estimated at the level of the parametric

value, unless otherwise specified.

Trueness is a measure of systematic error, i.e. the difference between the mean value of the large

number of repeated measurements and the true value. Further specifications are those set out in

ISO 5725.

Precision is a measure of random error and is usually expressed as the standard deviation (within

and between batches) of the spread of results from the mean. Acceptable precision is twice the

relative standard deviation. This term is further specified in ISO 5725.

Limit of detection is either

-

three times the standard deviation within a batch of a natural sample containing a low

concentration of the parameter, or

-

five times the standard deviation of a blank sample (within a batch).

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

selected (up to 60%).

The method determines total cyanide in all forms.

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

Reference method: EN ISO 8467

The performance characteristics for individual pesticides are given as an indication. Values for

the uncertainty of measurement as low as 30% can be achieved for several pesticides, higher

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

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

parametric value in Part B of Schedule I.

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

parametric value in Part B of Schedule I.

The uncertainty of measurement should be estimated at the level of 3 mg/l of the total organic

carbon (TOC). CEN 1484 Guidelines for the determination of TOC and dissolved organic

carbon (DOC) shall be used.

The uncertainty of measurement should be estimated at the level of 1,0 NTU (nephelo-metric

turbidity units) in accordance with EN ISO 7027.’

"; and

(d)

item 3 thereof shall be deleted.

€1.08