PROTECTION OF PUBLIC HEALTH (RADIOACTIVE SUBSTANCES IN WATER INTENDED FOR HUMAN CONSUMPTION)

CONSUMPTION)

SUBSIDIARY LEGISLATION 449.61

PROTECTION OF PUBLIC HEALTH

(RADIOACTIVE SUBSTANCES IN WATER

INTENDED FOR HUMAN CONSUMPTION)

REGULATIONS

1st January, 2016 *

LEGAL NOTICE 8 of 2016, as amended by Legal Notice 151 of 2022.

(1) The title of these regulations is the Protection of Public

Health (Radioactive Substances in Water intended for Human

Consumption) Regulations.

(2) These regulations implement the provisions of Council

Directive 2013/51/EURATOM of 22 October 2013 laying down

requirements for the protection of the health of the general public

with regard to radioactive substances in water intended for human

consumption.

(3) The purpose of these regulations is to lay down

requirements for the protection of the health of the general public

with regard to radioactive substances in water intended for human

cons um ption as well as l aying down paramet ric values and

frequencies and methods for monitoring radioactive substances.

PARAMETRIC VALUES FOR RADON, TRITIUM AND ID OF

WATER INTENDED FOR HUMAN CONSUMPTION

Parameter

Parametric value

Unit

Notes

Radon

Bq/l

(note 1)

Tritium

Bq/l

(note 2)

ID

0,10

mSv

Note 1

(a)

The competent authority may set a level for radon which is judged

inappropriate to be exceeded and below which optimisation of protection

should be continued, without compromising water supply on a national or

regional scale. The level set by the competent authority may be higher than

100 Bq/l but lowe r tha n 1 000 Bq/l. In order to sim pli fy natio na l

legislation, the competent authority may choose to adjust the parametric

value to this level.

(b)

Remedial action is deemed to be justified on radiological

p r o t e c t i o n g r o un d s , wi t ho u t f u r t h er c on s i d e r a t i on , w h e r e r ad o n

concentrations exceed 1 000 Bq/l.

Note 2

Elevated levels of tritium may indicate the presence of other artificial

radionuclides. If the tritium concentration exceeds its parametric value, an

analysis of the presence of other artificial radionuclides shall be required.

For the purposes of these regulations, unless the context

otherwise requires

"competent authority" means the Superintendent of Public

Health or a person authorised to act on his behalf;

"indicative dose" or "ID" means the committed effective dose for

one year of ingestion resulting from all the radionuclides whose

presence has been detected in a supply of water intended for human

consumption, of natural and artificial origin, but excluding tritium,

potassium-40, radon and short-lived radon decay products;

"parametric value" means the value of radioactive substances in

water intended for human consumption above which the competent

authority shall assess whether the presence of radioactive substances

in water intended for human consumption poses a risk to human health

which requires action and, where necessary, shall take remedial action

to improve the quality of water to a level which complies with the

requirements for the protection of human health from a radiation

protection point of view;

"radioactive substance" means any substance that contains one or

more radionuclides the activity or concentration of which cannot be

disregarded as far as radiation protection is concerned;

"water intended for human consumption" means

* see regulation 1(4) of these Regulations, as originally promulgated.

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

intended for drinking, cooking, food preparation or

other domestic purposes, regardless of its origin and

whether it is supplied from a distribution network, a

tanker, or in bottles or containers; and

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

the manufacture, processing, preservation or

marketing of products or substances intended for

human consumption unless the competent national

authorities are satisfied that the quality of the water

cannot affect the wholesomeness of the foodstuff in its

finished form.

Amended by

L.N. 151 of 2022.

MONITORING OF RADIOACTIVE

SUBSTANCES

=1.

General principles and monitoring frequencies

All parameters for which parametric values must be set pursuant

with regulation 5(1) shall be subject to monitoring. However, no

monitoring of a specific parameter shall be required where a

competent authority can establish that, for a period of time to be

determined by it, that parameter is not likely to be present in a

gi ven s u pply o f wa te r i nt ende d f or hum a n c ons um pt ion i n

concentrations which could exceed the corresponding parametric

value.

In case of naturally occurring radionuclides, where previous

results have shown that the concentration of radionuclides is stable,

t h e f r e q ue nc y, i n d e ro g a t i o n f r o m t he mi ni m u m s a m p l i n g

requirements set out in paragraph 6, is t o be decided by the

competent authority, taking into consideration the risk to human

health. The competent authority is not required to request water

utilities and, or private water suppliers to monitor water intended

for human consumption for radon or tritium or to establish the ID

where it is sat isfied, on the basi s of repres entative s urveys,

monitoring data or other reliable information, that, for a period of

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time to be determined by it, the levels of radon, tritium or of the

calculated ID will remain below the respective parametric values

listed in Schedule I. In that case, it shall communicate the grounds

for its decision to the Commission and provide the Commission

with the nec essary doc ument ation supporti ng that decisi on,

including the findings of any surveys, monitoring or investigations

carried out. In this context, the provisions with regard to the

minimum sampling and analysis requirements set out in paragraph

6 of this Schedule do not apply.

2. Radon

The competent authority shall ensure that representative surveys

a r e u nde r tak e n to det erm i ne t he s c a le an d na tur e of l ik el y

exposures to radon in water intended for human consumption

originating from different types of ground water sources and wells

in different geological areas. The surveys shall be designed in such

a way that underlying parameters, and especially the geology and

hydrology of the area, radioactivity of rock or soil, and well type,

can be identified and used to direct further action to areas of likely

high exposure. Monitoring of radon concentrations s hall be

undertaken where there is reason to believe, on the basis of the

results of the representative surveys or other reliable information,

that the parametric value laid down pursuant to regulation 5(1)

might be exceeded.

3. Tritium

The competent authority shall ensure that monitoring of tritium

in water intended for human consumption is carried out where an

anthropogenic source of tritium or other artificial radionuclides is

present within the catchment area and it cannot be shown on the

basis of other surveillance programmes or investigations that the

level of tritium is below the parametric value listed in Schedule I.

Where monitoring for tritium is required, it shall be carried out at

the frequencies indicated in the table appearing in paragraph 6 of

this Schedule. If the concentration of tritium exceeds its parametric

v a l u e , a n i nv e s t i g a t i o n o f t h e p r e s e n c e o f o t he r a rt i f i c i a l

radionuclides shall be required.

4. Indicative dose

Monitoring of water intended for human consumption for the ID

shall be carried out where a source of artificial or elevated natural

radioactivity is present and it cannot be shown on the basis of other

representative monitoring programmes or other investigations that

the level of ID is below the parametric value listed in Schedule I.

Where monitoring for artificial radionuclide levels is required, it

shall be carried out at the frequency indicated in the table appearing

in paragraph 6 of this Schedule. Where monitoring for natural

radionuclide levels is required, the competent authority shall define

the frequency of the monitoring of either gross alpha activity, gross

beta activity or individual natural radionuclides depending on the

screening strategy adopted by it (according to Schedule III). The

monitoring frequency may vary from a single check measurement

to the frequencies indicated in the table appearing in paragraph 6 of

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this Schedule. Where only a single check for natural radioactivity is

required, a re-check shall be required at least where any change

occurs in relation to the supply likely to influence the

concentrations of radionuclides in water intended for human

consumption.

5. Water treatment

Where treatment to reduce the level of radionuclides in water

intended for human consumption has been taken by the water utility

and, or private water supplier, monitoring shall be carried out at the

frequencies indicated in the table appearing in paragraph 6 to

ensure the continued efficacy of that treatment.

6. Minimum sampling and analysis frequencies

The minimum sampling and analysis frequency for the monitoring of

water intended for human consumption supplied from a distribution

network shall be as set out in the following Table. The frequencies in the

following table shall also apply to private water supplies intended for

human consumption and shall include all water, either in its original

state or after treatment, intended for drinking, cooking, food preparation,

put in bottles and containers or other domestic purposes, which is not

distributed through a distribution network.

Table

Minimum sampling and analysis frequencies for monitoring of

water intended for human consumption supplied from a distribution

network or from a tanker or used in a food production undertaking

Volume of water distributed or

Number of samples per year

produced each day within a

(Notes 3 and 4)

supply zone

(Notes 1 and 2) m3

volume ≤ 100

(Note 5)

100 < volume ≤ 1 000

1 000 < volume ≤ 10 000

+ 1 for each 3 300 m3 /d and part

thereof of the total volume

10 000 < volume ≤ 100 000

+ 1 for each 10 000 m3 /d and

part thereof of the total volume

volume > 100 000

+ 1 for each 25 000 m3 /d and

part thereof of the total volume

Note 1: A supply zone is a geographically defined area and, or a private

water

supply

within

which

water

intended

for

human consumption comes from one or more sources and within which

water quality may be considered as being approximately uniform.

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

year. The competent authority may use the number of inhabitants in a

supply zone instead of the volume of water to determine the minimum

frequency, assuming a water consumption of 200 l/day/capita.

Note 3: As far as possible, the number of samples should be distributed

equally in time and location.

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Note 4: In the event of intermittent short-term supply the monitoring

frequency of water distributed by tankers is to be decided by the competent

authority concerned.

Note 5: The competent authority shall stipulate the minimum sampling and

analysis frequency in the registration certificate issued in terms of the

Registration of Private Water Supplies Intended for Human Consumption

Regulations .

7. Averaging

Where a parametric value is exceeded in a particular sample, the

com p eten t a uthor it y sh all def ine th e ex tent of re -sam p ling

necessary to ensure that the measured values are representative of

an average activity concentration for a full year.

(1) These regulations apply to water intended for human

consumption.

(2)

These regulations do not apply to

(a) natural mineral waters recognised as such by the

competent national authorities, in accordance with

Directive 2009/54/EC; and

(b) waters which are medicinal products within the

meaning of Directive 2001/83/EC.

(3) The competent

authority

may

exempt

from

these

regulations

(a) water intended exclusively for those purposes for

which the competent authorities are satisfied that the

quality of the water has no influence, either directly or

indirectly, on the health of the general public

concerned;

(b) water intended for human consumption from an

individual supply providing on average less than 10 m 3

a day, or serving fewer than fifty persons, unless the

water is supplied as part of a commercial or public

activity.

(4) The competent authority that has recourse to the

exemptions provided for in sub-regulation (3)(b) shall ensure that

(a) the general public concerned is informed thereof and

of any action that can be taken to protect human health

from the adverse effects resulting from any

contamination of water intended for human

consumption; and

(b) when a potential danger to human health arising from

the quality of such water is apparent, the general

public concerned is promptly given appropriate

advice.

Amended by

L.N. 151 of 2022.

MONITORING FOR INDICATIVE DOSE AND

ANALYTICAL PERFORMANCE

CHARACTERISTICS

1. Monitoring for compliance with the ID

the competent authority shall require the water utilities and, or

private water suppliers to use various reliable screening strategies

to indicate the presence of radioactivity in water intended for

human consumption. These strategies may include screening for

certain radionuclides, or screening for an individual radionuclide,

or gross alpha activity or gross beta activity screening.

(a) screening for certain radionuclides, or screening for an

individual radionuclide

if one of the activity concentrations exceeds 20% of

the corresponding derived value or the tritium

concentration exceeds its parametric value listed in

Schedule I, an analysis of additional radionuclides

shall be required. The radionuclides to be measured

shall be defined by the competent authority taking into

account all relevant information about likely sources

of radioactivity;

(b) screening strategies for gross alpha activity and gross

beta activity

the competent authority may require the water utility

and, or private water supplier to use screening

strategies for gross alpha activity and gross beta

activity * to monitor for the parametric indicator value

for ID

*

Where appropriate gross beta activity may be replaced by residual beta activity

after subtraction of the K-40 activity concentration.

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Provided that the screening levels for gross alpha

activity or gross beta activity should be as follows

The screening level for gross alpha activity should not

exceed 0,1 Bq/1.

The screening level for gross beta activity should not exceed

1,0 Bq/1.

For this purpose gross alpha activity or gross beta activity

screening levels shall be set. The recommended screening level for

gross alpha activity is 0,1 Bq/l. The recommended screening level

for gross beta activity is 1,0 Bq/l.

If the gross alpha activity and gross beta activity are less than 0,1

Bq/l and 1,0 Bq/l respectively, the competent authority may assume

that the ID is less than the parametric value of 0,1 mSv and

radiological investigation is not needed unless it is known from

other sources of information that specific radionuclides are present

in the water that are liable to cause an ID in excess of 0,1 mSv.

If the gross alpha activity exceeds 0,1 Bq/l or the gross beta

activity exceeds 1,0 Bq/l, analysis for specific radionuclides shall

be required.

The competent authority may set alternative screening levels for

gros s al pha a ctivi ty a nd gros s bet a ac tivi ty wher e the y can

demonstrate that the alternative levels are in compliance with an ID

of 0,1 mSv.

The ra di onuclides to be me asured sha ll be defined by the

competent authority taking into account all relevant information

about likely sources of radioactivity. Since elevated levels of

tritium may indicate the presence of other artificial radionuclides,

tritium, gross alpha activity and gross beta activity should be

measured in the same sample.

2. Calculation of the ID

The ID shall be calculated from the measured radionuclide

concentrations and the dose coefficients laid down in Annex III,

Table A of Directive 96/29/Euratom or more recent information

recognised by the competent authority in the Member State, on the

basis of the annual intake of water (730 l for adults). Where the

following formula is satisfied, the competent authority may assume

that the ID is less than the parametric value of 0,1 mSv and no

further investigation shall be required

n

Σ

Ci (obs)

<1

Ci (der)

[-]

where

Ci (obs) = observed concentration of radionuclide i

Ci (der) = derived concentration of radionuclide i

n = number of radionuclides detected.

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Derived concentrations for radioactivity in water

intended for human consumption (2)

Origin

Nuclide

Derived Concentration

U-238 (3)

Natural

3,0 Bq/l

U-234 (3)

2,8 Bq/l

Ra-226

0,5 Bq/l

Ra-228

0,2 Bq/l

Pb-210

0,2 Bq/l

Po-210

0,1 Bq/l

Artificial

C-14

240 Bq/l

Sr-90

4,9 Bq/l

Pu-239/Pu-240

0,6 Bq/l

Am-241

0,7 Bq/l

Co-60

40 Bq/l

Cs-134

7,2 Bq/l

Cs-137

11 Bq/l

I-131

6,2 Bq/l

(2)

This table includes values for the most common natural and

artificial radionuclides; these are precise values, calculated for a dose of

0,1 mSv, an annual intake of 730 litre and using the dose coefficients laid

down in Anne x III, Ta bl e A of Di rec ti ve 96/29 / Eu rat o m ; de ri v ed

concentrations for other radionuclides can be calculated on the same basis,

and values can be updated on the basis of more recent informat ion

recognised by the competent authority in the Member State.

(3)

This table allows only for the radiological properties of uranium,

not for its chemical toxicity

3. Performance characteristics and methods of analysis

For the following parameters and radionuclides, the method of

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

concentrations with a limit of detection specified below

Parameters and

Limit of detection

Notes

radionuclides

(Notes 1, 2)

Tritium

10 Bq/l

Note 3

Radon

10 Bq/l

Note 3

gross alpha activity

0,04 Bq/l

Note 4

gross beta activity

0,4 Bq/l

Note 4

U-238

0,02 Bq/l

U-234

0,02 Bq/l

Ra-226

0,04 Bq/l

Ra-228

0,02 Bq/l

Note 5

Pb-210

0,02 Bq/l

Po-210

0,01 Bq/l

C-14

20 Bq/l

Sr-90

0,4 Bq/l

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Pu-239/Pu-240

0,04 Bq/l

Am-241

0,06 Bq/l

Co-60

0,5 Bq/l

Cs-134

0,5 Bq/l

Cs-137

0,5 Bq/l

I-131

0,5 Bq/l

Note 1: The limit of detection shall be calculated according to the ISO

standard 11929: Determination of the characteristic limits (decision

threshold, detection limit and limits of the confidence interval) for

measurements of ionising radiation - Fundamentals and application, with

probabilities of errors of 1st and 2nd kind of 0,05 each.

Note 2: Measurement uncertainties shall be calculated and reported as

complete standard uncertainties, or as expanded standard uncertainties

with an expansion factor of 1,96, according to the ISO Guide for the

Expression of Uncertainty in Measurement.

Note 3: The limit of detection for tritium and for radon is 10% of its

parametric value of 100 Bq/l.

Note 4: The limit of detection for gross alpha activity and gross beta

activities are 40% of the screening values of 0,1 and 1,0 Bq/l respectively.

Note 5: This limit of detection applies only to initial screening for ID for

a new water source; if initial checking indicates that it is not plausible that

Ra-228 exceeds 20% of the derived concentration, the limit of detection

may be increased to 0,08 Bq/l for routine Ra-228 nuclide specific

measurements, until a subsequent re-check is required.

The competent authority shall take all measures necessary

to establish an appropriate monitoring programme for water

intended for human consumption, to ensure that, in the event of

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non-compliance with the parametric values laid down pursuant to

these regulations -

(a) it shall be assessed whether that non-compliance poses

a risk to human health which requires action; and

(b) remedial action shall be taken, where necessary, to

improve the quality of water to a level which complies

with requirements for the protection of human health

from a radiation protection point of view.

(1) The competent authority shall set parametric values

applicable for the monitoring of radioactive substances in water

intended for human consumption in accordance with Schedule I.

(2) Where monitoring of water intended for human

consumption is undertaken in accordance with the requirements of

Schedule II, the point of compliance shall be

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

network, the point at which it emerges from the taps

where the water is normally taken;

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

which it emerges from the tanker;

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

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

into the bottles or containers;

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

undertaking, the point where the water is used in the

undertaking.

(3) The definition of points of compliance in sub-regulation

(2)(a) is without prejudice to the choice of a sampling point, which

may be any point within the supply zone or at the treatment works,

provided there is no adverse change in the concentration value

between the sampling point and the point of compliance.

(1)(a) The competent authority shall take all measures

necessary to ensure that monitoring for radioactive

substances in water intended for human consumption

is undertaken by the water utilities and, or private

water suppliers in accordance with the monitoring

strategies and frequencies set out in Schedule II, in

order to check whether t he values of radioactive

substances comply with the parametric values laid

down pursuant to regulation 5(1).

(b) The competent authority shall ensure that monitoring

is undertaken by the water utilities and, or private

water suppliers so as to ensure that the measured

values obtained are representative of the quality of the

water consumed throughout the year. For water

intended for human consumption that is put into

bottles or containers intended for sale, this shall be

without prejudice to the principles of HACCP as

required by Regulation (EC) No 852/2004 and to the

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principles of official controls as laid down in

Regulation (EC) No 882/2004.

(2) Monitoring for the ID shall be carried out, and analytical

performance characteristi cs shall be in accordance with the

requirements set out in Schedule III.

(3) The competent authority shall ensure that any laboratory at

which samples are analysed has a system of analytical quality

control that is subject to checking by an external organisation

approved by the competent authority for that purpose.

(1) It is the duty of the water utilities and, or private water

suppliers to immediately inform the competent authority with any

non-compliance and, or failures to the parametric values laid down

pursuant to regulation 5(1) and Schedule I.

(2) The water utilities and, or private water suppliers are to

carry out the necessary monitoring in accordance to the frequencies

laid down in Schedule II.

(3) Upon failure to comply with the provisions of sub-

regulations (1) and (2), the water utilities and, or private water

suppliers shall be in breach of these regulations.

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

comply with a parametric value laid down pursuant to regulation

5(1) is immediately investigated in order to identify the cause.

(2) Where a failure to comply with a parametric value occurs,

the competent authority shall assess whether the failure poses a risk

to human health which requires action.

(3) In the event that such a risk referred to in sub-regulation (2)

exists, the competent authority shall

(a) order the water utilities and, or private water suppliers

to take remedial action in order to comply with

requirements for the protection of human health from a

radiation protection point of view; and

(b) ensure that the general public concerned is

(i)

notified of the risk and the remedial action

taken; and

(ii) advised on any additional precautionary

measures that may be needed for the protection

of human health in respect of radioactive

substances.

(4) The notifications referred to in sub-regulation (3)(b) are to

be issu ed by the com pete nt au thori ty ba sed o n the det ailed

information which is to be provided to it by the water utility and, or

private water supplier.

(5) The competent authority shall always have the right to issue

such notifications to the public immediately once such a non-

compliance becomes known.

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