
Article 1 
This Directive lays down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption. It lays down parametric values and frequencies and methods for monitoring radioactive substances.
Article 2 
For the purposes of this Directive the following definitions apply:

((1)) ‘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;
((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;
((2)) ‘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;
((3)) ‘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;
((4)) ‘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.
Article 3 

1. This Directive applies to water intended for human consumption.
2. This Directive does not apply to:
(a) natural mineral waters recognised as such by the competent national authorities, in accordance with Directive 2009/54/EC;
(b) waters which are medicinal products within the meaning of Directive 2001/83/EC.
3. Member States may exempt from this Directive:
(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 m3 a day, or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity.
4. Member States that have recourse to the exemptions provided for in paragraph 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;
(b) when a potential danger to human health arising from the quality of such water is apparent, the general public concerned promptly be given appropriate advice.
Article 4 
Without prejudice to the provisions laid down in point a of Article 6(3) of Directive 96/29/Euratom, Member States 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 this Directive:

((a)) it shall be assessed whether that 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.
Article 5 

1. Member States shall set parametric values applicable for the monitoring of radioactive substances in water intended for human consumption in accordance with Annex I.
2. Where monitoring of water intended for human consumption is undertaken in accordance with the requirements of Annex II of this Directive 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 paragraph (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.
Article 6 

1. Member States shall take all measures necessary to ensure that monitoring for radioactive substances in water intended for human consumption is undertaken in accordance with the monitoring strategies and frequencies set out in Annex II, in order to check whether the values of radioactive substances comply with the parametric values laid down pursuant to Article 5(1).Member States shall ensure that monitoring is undertaken 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 Annex III.
3. Member States 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.
Article 7 

1. Member States shall ensure that any failure to comply with a parametric value laid down pursuant to Article 5(1) is immediately investigated in order to identify the cause.
2. Where a failure to comply with a parametric value occurs, the Member State shall assess whether the failure poses a risk to human health which requires action.
3. In the event that such a risk referred to under paragraph 2 exists, the Member State shall:
(a) 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.
Article 8 

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 28 November 2015 at the latest. They shall forthwith communicate to the Commission the text of those provisions.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. The Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.
Article 9 
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 10 
This Directive is addressed to the Member States.
Done at Luxembourg, 22 October 2013.
For the Council
The President
L. LINKEVIČIUS
ANNEX I
Parameter Parametric value Unit Notes
Radon 100 Bq/l (Note 1)
Tritium 100 Bq/l (Note 2)
ID 0,1 mSv 
Note 1:
(a) Member States 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 a Member State may be higher than 100 Bq/l but lower than 1 000 Bq/l. In order to simplify national legislation, Member States 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.
ANNEX II
1. 
All parameters for which parametric values must be set pursuant with Article 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 them, 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 point 6, is to be decided by the Member State, taking into consideration the risk to human health. A Member State is not required 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 them, the levels of radon, tritium or of the calculated ID will remain below the respective parametric values listed in Annex 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 point 6 of this Annex do not apply.

2. 
Member States 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 Article 5(1) might be exceeded.

3. 
Member States 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 Annex I. Where monitoring for tritium is required, it shall be carried out at the frequencies indicated in the table appearing in point 6 of this Annex. If the concentration of tritium exceeds its parametric value, an investigation of the presence of other artificial radionuclides shall be required.

4. 
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 Annex I. Where monitoring for artificial radionuclide levels is required, it shall be carried out at the frequency indicated in the table appearing in point 6 of this Annex. Where monitoring for natural radionuclide levels is required, each Member State 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 Annex III). The monitoring frequency may vary from a single check measurement to the frequencies indicated in the table appearing in point 6 of this Annex. Where only a single check for natural radioactivity is required, a recheck 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. 
Where treatment to reduce the level of radionuclides in water intended for human consumption has been taken, monitoring shall be carried out at the frequencies indicated in the table appearing in point 6 to ensure the continued efficacy of that treatment.

6. 
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 used in a food production undertaking shall be as set out in the following table:


Volume of water distributed or produced each day within a supply zone(Notes 1 and 2)m3 Number of samples per year(Notes 3 and 4)
volume ≤ 100 (Note 5)
100 < volume ≤ 1 000 1
1 000 < volume ≤ 10 000 1+ 1 for each 3 300 m3/d and part thereof of the total volume
10 000 < volume ≤ 100 000 3+ 1 for each 10 000 m3/d and part thereof of the total volume
volume > 100 000 10+ 1 for each 25 000 m3/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 within which water quality may be considered as being approximately uniform.
Note 2: The volumes are calculated as averages taken over a calendar year. A Member State 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 Member State concerned.
Note 5: The frequency is to be decided by the Member State concerned.
Member States shall define sampling frequencies for water intended for human consumption put into bottles or containers intended for sale. In so doing Member States may take into consideration the volume of water produced.

7. 
Where a parametric value is exceeded in a particular sample, Member States shall define the extent of resampling necessary to ensure that the measured values are representative of an average activity concentration for a full year.

ANNEX III
1. 
Member States may 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) 
If one of the activity concentrations exceeds 20 % of the corresponding derived value or the tritium concentration exceeds its parametric value listed in Annex I, an analysis of additional radionuclides shall be required. The radionuclides to be measured shall be defined by Member States taking into account all relevant information about likely sources of radioactivity.
 (b) 
Member States may 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 Member State 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.

Member States 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.

The radionuclides to be measured shall be defined by Member States 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. 
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 authorities in the Member State, on the basis of the annual intake of water (730 l for adults). Where the following formula is satisfied, Member States may assume that the ID is less than the parametric value of 0,1 mSv and no further investigation shall be required:

∑i=1nCiobsCider≤1

where

Ci(obs)observed concentration of radionuclide iCi(der)derived concentration of radionuclide innumber of radionuclides detected.


Origin Nuclide Derived concentration
Natural U-238 3,0 Bq/l
U-234 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



3. 
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 radionuclides Limit of detection (Notes 1, 2) Notes
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.
