intended for Human Consumption) Regulations, 2016

L.N. 8 of 2016

FOOD SAFETY ACT

(CAP. 449)

Protection of Public Health (Radioactive Substances in Water

intended for Human Consumption) Regulations, 2016

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

Safety Act, the Parliamentary Secretary for Health has made the

following regulations:-

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

Public Health (Radioactive Substances in Water intended for Human

Consumption) Regulations, 2016.

(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

consumption as well as laying down parametric values and

frequencies and methods for monitoring radioactive substances.

(4) These regulations shall come into force on 1 January 2016.

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 lower than 1

000 Bq/l. In order to simplify national legislation, the competent authority may

choose to adjust the parametric value to this level.

(b) Remedial action is deemed to be justified on radiological protection

grounds, without further consideration, where radon 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 Member States

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

(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.

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 given

supply of water intended for human consumption in 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,

the frequency, in derogation from the minimum sampling

requirements set out in paragraph 6, is to 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

satisfied, on the basis of representative surveys, monitoring data or

other reliable information, that, for a period of 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 necessary

documentation supporting that decision, 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

are undertaken to determine the scale and nature of likely 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 shall 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 value,

an investigation of the presence of other artificial 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 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 or from a tanker or by private water suppliers or

used in a food production undertaking shall be as set out in the

following table

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

produced each day within a

Number of samples per year

supply zone

(Notes 3 and 4)

(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.

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 frequency is to be decided by the competent authority. The

competent authority shall define sampling frequencies for water intended for human

consumption put into bottles or containers intended for sale. In so doing the

competent authority may take into consideration the volume of water produced.

7. Averaging

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

competent authority shall define the extent of re-sampling 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 Scope and

exemptions.

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.

MONITORING FOR INDICATIVE DOSE AND ANALYTICAL

PERFORMANCE CHARACTERISTICS

1. Monitoring for compliance with the ID

The competent authority may 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.

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

gross alpha activity and gross beta activity where they can

demonstrate that the alternative levels are in compliance with an ID

of 0,1 mSv.

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

after subtraction of the K-40 activity concentration.

The radionuclides to be measured shall 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 Ci (obs)

<1

(der)

[-]

where

Ci (obs) = observed concentration of radionuclide i

Ci (der) = derived concentration of radionuclide i

n = number of radionuclides detected.

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 Annex III, Table A

of Directive 96/29/Euratom; derived concentrations for other radionuclides can be

calculated on the same basis, and values can be updated on the basis of more recent

information 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

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.

B

€1.26

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 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 Monitoring for

necessary to ensure that monitoring for radioactive substances in radioactive

substances in

water intended for human consumption is undertaken by the water 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 the 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 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 characteristics 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 Duty to inform

water suppliers to immediately inform the competent authority with the

authority.

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 issued by the competent authority based on the detailed

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.