# EUR-Lex - 52012PC0147 - EN

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# 52012PC0147

**Proposal for a COUNCIL DIRECTIVE laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption /* COM/2012/0147 final - 2012/0074 (NLE) */**

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EXPLANATORY MEMORANDUM

1.           Justification of the
proposal

Water is one
of the most comprehensively regulated areas of Community environmental
legislation. Early European water policy began in the 1970s with the adoption
of political programmes as well as legally binding legislation.

On 3 November
1998 the Council adopted Directive 98/83/EC on the quality of water intended
for human consumption. This new Directive had to be transposed into national
legislation by the end of the year 2000, and had to be complied with by the end
of 2003.

Drinking water
contamination by radioactive substances may occur through accidental releases
of radioactivity or through improper disposal practices. Water systems that are
vulnerable to this type of contamination undergo extensive monitoring for
radioactive contamination to ensure that the water is safe for drinking. There
are many regions in Europe where the geological and hydrological features are
such that the presence of naturally occurring radioactive substances is of concern.

So far the
requirements for monitoring tritium and total indicative dose under Council
Directive 98/83/EC have not been implemented, pending the adoption of
amendments to Annexes II (monitoring) and III (specifications for the analysis
of parameters). Technical requirements for the protection of the health of the
general public with regard to radioactive substances in water intended for
human consumption have been finalised for about six years now, after a
consultation process involving the Group of Experts provided for under Article
31 Euratom, the Committee established under the Drinking Water Directive and
the consultation of the Committee of Member State representatives established
under Articles 35‑36 of the Euratom Treaty.

Indicator
parameters set out in Annex I Part C relating to radioactivity and tritium and
the related monitoring provisions in Annex II to Directive 98/83/EC actually fall
within the scope of the basic standards as set out in Article 30 of the Euratom
Treaty. As a result, it is justified to incorporate the requirements for
monitoring levels of radioactivity into specific legislation under the Euratom
Treaty in order to maintain the uniformity, coherence and completeness of
radiation protection legislation at Community level.

Therefore the Commission adopted on 27 June
2011 a draft proposal laying down requirements for the protection of the health
of the general public with regard to radioactive substances in water intended
for human consumption based on Article 31 of the Euratom Treaty.

On 27 October
2011 the EESC adopted an opinion on this draft Commission proposal, calling
amongst others for the inclusion of radon gas within the scope of the
Directive. The EESC referred to a Commission Recommendation (2001/928/Euratom) for
the protection against radon gas in drinking water. In 1998 radon gas had been
excluded from the scope of the Directive in view of the fact that it constitutes
a risk of inhalation rather than of ingestion as drinking water. The draft
proposal for a Euratom Directive focussed on the change of the legal basis,
without technical amendments, but the Commission agrees with the EESC recommendation
and has now made provision for the inclusion of radon gas in the Directive. In
order to address the specific feature of radon gas, it is included as a
separate indicator parameter, while the long-lived decay products of radon are
included in the evaluation of total indicative dose as defined in Directive
98/83/EC.

The EESC also
advocated mirroring to the largest possible extent the general provisions of
Directive 98/83/EC, so as to offer one coherent policy. This would require,
amongst other, the inclusion of bottled waters. The Commission agrees with this
recommendation but also needs to allow for the fact that after adoption of the
1998 EC Directive, specific legislation was adopted for the monitoring of
bottled waters, in the overall context of food safety. Hence the new Commission
proposal includes on the one hand bottled water within the scope of the
Directive, on the other hand refers to the monitoring criteria laid down in Regulation (EC) No 852/2004.

Taking into
account the implementation of the general principle in legal theory and
practice that establishes that a law governing a specific subject matter
overrides a law which only governs general matters ("lex specialis derogat
legi generali"), the provisions of the Directive under the Euratom Treaty
supersede those of the Directive 98/83/EC as regards radioactive substances in
drinking water. In a second step, the Commission will propose the deletion of
Tritium and Total Indicative Dose from the list of indicator parameters in part
C of Annex I to Directive 98/83/EC and the repeal of all references to these
parametric values.

2.           Subsidiarity and
proportionality

• Legal basis

The provisions
of this Directive are related to the basic standards for the protection of the
health of workers and the general public. Consequently, the legal base chosen
is the Treaty establishing the European Atomic Energy Community, and in
particular Articles 31 and 32 thereof.

• Subsidiarity
principle

The
subsidiarity principle applies insofar as the proposal does not fall under the
exclusive competence of the Community. As the Community's legislative powers
under Title II Chapter III of the Euratom Treaty are exclusive in nature, they
are not subject to the principle of subsidiarity.

•
Proportionality principle

The proposal
complies with the proportionality principle for the following reason(s):

The proposal
sets out minimum harmonised standards for monitoring radon, tritium and total
indicative dose and adapts the requirements of Directive 98/83/EC related to
radioactivity to the latest scientific and technical progress.

• Choice of
instruments

While the
Community is responsible for establishing uniform rules in the radiation
protection field in order to achieve a high level of health protection of
workers and the general public, it falls on the Member States to transpose into
their national legislation such rules and to implement them.

A directive is
therefore best suited to create a common approach on defining requirements for
radioactivity parameters for monitoring the quality of water intended for human
consumption in the light of scientific and technical progress.

As a
consequence, harmonised requirements for the protection of the health of the
general public with regard to radioactive substances in water intended for
human consumption are defined.

3.           Budgetary implication

The proposal
has no implication for the Community budget.

2012/0074 (NLE)

Proposal for a

COUNCIL DIRECTIVE

laying down requirements for the
protection of the health of the general public with regard to radioactive
substances in water intended for human consumption

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing
the European Atomic Energy Community, and in particular Articles 31 and 32
thereof,

Having regard to the proposal from the
Commission[1]
drawn up after obtaining the opinion of a group of persons appointed by the
Scientific and Technical Committee from among scientific experts in the Member
States, in accordance with Article 31 of the Treaty,

Having regard to the opinion of the
European Economic and Social Committee[2],

After consulting the European Parliament[3],

Whereas:

(1)       The ingestion of water is
one of the pathways of incorporation of radioactive substances into the human
body. In accordance with Council Directive 96/29/Euratom of 13 May 1996 laying
down basic safety standards for the protection of the health of workers and the
general public against the dangers arising from ionizing radiation[4], the contribution to the
exposure of the population as a whole from practices which involve a risk from
ionizing radiation must be kept as low as reasonably achievable.

(2)       In view of the importance
for human health of the quality of water intended for human consumption, it is
necessary to lay down at Community level quality standards which have an
indicator function and provide for the monitoring of the compliance with those
standards.

(3)       Indicator parameters have
already been set out in Annex I, Part C relating to radioactive substances, as
well as the related monitoring provisions in Annex II to Council Directive
98/83/EC of 3 November 1998 on the quality of water intended for human
consumption[5].
However, those parameters fall within the scope of the basic standards defined
in Article 30 of the Euratom Treaty.

(4)       The requirements for
monitoring levels of radioactivity in water intended for human consumption
should therefore be adopted in specific legislation that ensures the
uniformity, coherence and completeness of radiation protection legislation under
the Euratom Treaty.

(5)       The provisions of this Directive
adopted under the Euratom Treaty should supersede those of the Directive
98/83/EC as regards the contamination of drinking water by radioactive
substances.

(6)       In the event of
non-compliance with a parameter that has an indicator function, the Member
State concerned should assess whether that non-compliance poses any risk to
human health and, where necessary, take remedial action to restore the quality
of the water.

(7)       Consumers should be
adequately and appropriately informed of the quality of water intended for
human consumption.

(8)       It is necessary to exclude
from the scope of this Directive natural mineral waters and waters which are
medicinal products, since special rules for those types of water have been
established in 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[6]
and 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[7]. The monitoring of waters put into bottles or containers intended
for sale, other than natural mineral waters, for the purpose of checking
that the levels of radioactive substances comply with
the parametric values laid down in this Directive should be done
in accordance with the principles of hazard analysis and critical control
points (HACCP) as required by Regulation (EC) No 852/2004[8].

(9)       Each Member State should
establish monitoring programmes to check that water intended for human
consumption meets the requirements of this Directive.

(10)     The methods used to analyse
the quality of water intended for human consumption should be such as to ensure
that the results obtained are reliable and comparable.

(11)     Commission Recommendation 2001/928/Euratom
of 20 December 2001 on the protection of the public against exposure to radon
in drinking water supplies[9]
deals with the radiological quality of drinking water supplies regarding radon
and long-lived radon decay products, and it is appropriate to include these
radionuclides in the scope of this Directive.

HAS ADOPTED THIS DIRECTIVE:

Article1
Subject matter

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 sets out parametric
values, frequencies and methods for monitoring radioactive substances.

Article 2
Definitions

For the purposes of this Directive,
definitions laid down in Article 2 of Council Directive 98/83/EC shall apply.

Article 3
Scope

This Directive shall apply to water
intended for human consumption with the exemptions set out in Article 3(1) of
Directive 98/83/EC and laid down in accordance with Article 3(2) of that
Directive.

Article 4
General obligations

Without prejudice to the provisions laid
down in Article 6(3)a of Directive 96/29/Euratom, Member States shall take all
measures necessary to establish an appropriate monitoring programme to ensure
that water intended for human consumption complies with the parametric values
established in accordance with this Directive.

Article 5
Parametric values

Member States shall set parametric values
applicable for the monitoring of radioactive substances in water intended for
human consumption in accordance with Annex I; for water put into bottles or
containers intended for sale this shall be
without prejudice to the principles of hazard analysis and critical control
points (HACCP) as required by Regulation (EC) No 852/2004.

Article 6
Monitoring

Member States shall ensure regular
monitoring of water intended for human consumption in accordance with Annex II
in order to check that the concentrations of radioactive substances do not
exceed the parametric values laid down in accordance with Article 5.

Article 7
Sampling locations

Member States may take samples:

(a)
in the case of water supplied from a
distribution network, at the point within the supply zone or at the treatment
works if it can be demonstrated that such sampling gives the same or higher measured
value of the parameters concerned;

(b)
in the case of water supplied from a tanker, at
the point at which it emerges from the tanker;

(c)
in the case of water put into bottles or
containers intended for sale, at the point at which the waer is put into the
bottles or containers;

(d)
in the case of water used in a food-production
undertaking, at the point where the water is used in the undertaking.

Article 8
Sampling and analysis

1. Samples representative of the quality of
the water consumed throughout the year shall be taken and analysed in
accordance with the methods set out in Annex III.

2. Member States shall ensure that all laboratories
analysing samples of water intended for human consumption have a system of
analytical quality control. They shall ensure that that system is subject to occasional
checks by an independent controller approved by the competent authority for
that purpose.

Article 9
Remedial action and notification of consumers

1. Member States shall ensure that any
failure to comply with the parametric values laid down in accordance with
Article 5 is immediately investigated in order to identify its cause.

2. Where a failure to comply with the
parametric values laid down in accordance with Article 5 occurs, the Member
State shall assess whether the failure poses a risk to human health. In the
event that there is such a risk, the Member State shall take remedial action to
restore the quality of the water.

3. Where the risk to human health cannot be
regarded as trivial, the Member State shall ensure that consumers are notified.

Article 10
Transposition

1. Member States shall bring into force the
laws, regulations and administrative provisions necessary to comply with this
Directive by [one year after the date referred to in Article 11- specific
date to be inserted by the Publications Office] 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. 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 11
Entry into force

This Directive shall enter into force on
the twentieth day following that of its publication in the Official Journal
of the European Union.

Article 12
Addressees

This Directive is
addressed to the Member States.

Done at Brussels,

For
the Council

The
President

ANNEX I
Parametric values for radon and tritium and parametric values for Total
Indicative Dose, for other radioactive substances, in water intended for human
consumption

Radioactivity

Parameter || Parametric value || Unit || Notes

Radon || 100 || Bq/l ||

Tritium || 100 || Bq/l ||

Total indicative dose || 0,10 || mSv/year || (Note 1)

Note 1:
Excluding tritium, potassium -40, radon and short-lived radon decay products

ANNEX II
Monitoring of radioactive substances

1. General
principles and monitoring frequencies

A Member State
is not required to monitor drinking water for tritium or radioactivity to
establish total indicative dose where it is satisfied on the basis of other
monitoring that the levels of both tritium and of the calculated total
indicative dose are well below the parametric value. Monitoring drinking water
for radon is not required where a Member State is satisfied on the basis of
other monitoring that the levels of radon are well below the parametric value. In
these cases, it shall communicate the grounds for its decision to the
Commission, including the results of the other monitoring carried out.

2. Radon and Tritium

Monitoring of drinking water for radon or tritium
shall be carried out where a source of radon or tritium is present within the
catchment and it cannot be shown on the basis of other surveillance programmes
or investigations that the level of radon or tritium is well below its
parametric indicator value 100 Bq/l. Where monitoring for radon or tritium is
required, it shall be carried out at the audit frequency.

3. Total Indicative Dose

Monitoring of drinking water for Total
Indicative Dose (TID) shall be carried out where a source of artificial or
enhanced natural radioactivity is present within the catchment and it cannot be
shown on basis of other surveillance programmes or investigations that the
level of TID is well below its parametric indicator value 0.1 mSv/year. Where
monitoring for artificial radionuclide levels is required, it shall be carried
out at the audit frequency indicated in the table. Where monitoring for natural
radionuclide levels is required, Member States shall define the frequency of
the monitoring having regard to all relevant information available on temporal
variations of natural radionuclide levels in different types of waters. Depending
on the expected variations, monitoring frequency may vary from a single check
measurement to the audit frequency. 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 the drinking water.

Where methods for removing radionuclides
from drinking water have been applied in order to ensure that a parametric
value is not exceeded, monitoring shall be carried out at the audit frequency.

Where results of other surveillance
programmes or investigations than those required as provided in the first
paragraph of this point are used to ensure compliance with this Directive, the
Member State shall communicate the grounds for its decision to the Commission,
including the relevant results of these monitoring programmes or
investigations.

4. The audit frequency of monitoring shall
be as set out in the following table:

TABLE
Audit frequency of monitoring for water intended for
human consumption supplied from a distribution network

Volume of water distributed or produced each day within a supply zone (Notes 1 and 2) m3 || Number of samples per year (Notes 3 )

≤ 100 || (Note 4)

> 100 ≤ 1 000 || 1

> 1 000 ≤ 10 000 || 1 + 1 for each 3 300 m3/d and part thereof of the total volume

> 10 000 ≤ 100 000 || 3 + 1 for each 10 000 m3/d and part thereof of the total 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:
The frequency is to be decided by the Member State concerned.

ANNEX III
Sampling and analysis methods

1. Screening for compliance with total
indicative dose (TID)

Member States may use screening methods for
gross alpha activity and gross beta activity to monitor for the parametric indicator
value for TID, excluding tritium, potassium–40, radon
and short-lived radon decay products.

If the gross alpha and the gross beta
activity are less than 0.1 Bq/l and 1.0 Bq/l respectively, the Member State may
assume that the TID is less than the parametric indicator value of 0.1 mSv/year
and no radiological investigation is needed unless it is known from other
sources of information that specific radionuclides are present in the water
supply and are liable to cause a TID in excess of 0.1 mSv/year.

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 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.

In replacement of gross alpha and gross
beta activity screening discussed above, Member States may decide to use other
reliable screening methods for radionuclides to indicate the presence of
radioactivity in drinking water. If one of the activity concentrations exceeds
20% of its reference concentration or the tritium concentration exceeds its
parametric value of 100 Bq/l, 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.

2. Calculation of the Total Indicative Dose
(TID)

The TID is the committed effective dose for
one year of intake resulting from all the radionuclides whose presence in a
water supply has been detected, both of natural and artificial origin, excluding tritium, potassium–40, radon and short-lived radon
decay products. The TID shall be calculated from the radionuclide
concentrations and the dose coefficients for adults 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. Where the following formula is
satisfied, Member States may assume that the TID is less than the parametric
indicator value of 0.1 mSv/year and no further investigation shall be required:

(1)

where

Ci(obs) = observed concentration of radionuclide i

Ci(ref)  = reference concentration of radionuclide i

n          = number of
radionuclides detected.

Where the formula is not satisfied, the
parametric value shall only be regarded as having been exceeded if the radionuclides
are persistently present at similar activity concentrations for a full year.
Member States shall define the extent of resampling necessary to ensure that
the measured values are representative for an average activity concentration
for a full year.

Reference concentrations for
radioactivity in drinking water1

Origin || Nuclide || Reference concentration

Natural || U-2382 || 3.0 Bq/l

U-2342 || 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

1 This table includes the most
common natural and artificial radionuclides. Reference concentrations for other radionuclides can
be calculated using the dose coefficients for adults 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, and by assuming an intake of 730
litres per year.

2 One milligram (mg) of natural
uranium contains 12.3 Bq of U-238 and 12.3 Bq of U-234. 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 radioactivity parameters,
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 detection specified.

Parameters || Limit of detection (Note 1) || Notes

Radon || 10 Bq/l || Note 2, 3

Tritium || 10 Bq/l || Note 2, 3

Gross alpha Gross beta || 0.04 Bq/l 0.4 Bq/l || Note 2, 4 Note 2, 4

U-238 || 0.02 Bq/l || Note 2, 6

U-234 || 0.02 Bq/l || Note 2, 6

Ra-226 || 0.04 Bq/l || Note 2

Ra-228 || 0.08 Bq/l || Note 2, 5

Pb-210 || 0.02 Bq/l || Note 2

Po-210 || 0.01 Bq/l || Note 2

C-14 || 20 Bq/l || Note 2

Sr-90 || 0.4 Bq/l || Note 2

Pu-239/Pu-240 || 0.04 Bq/l || Note 2

Am-241 || 0.06 Bq/l || Note 2

Co-60 || 0.5 Bq/l || Note 2

Cs-134 || 0.5 Bq/l || Note 2

Cs-137 || 0.5 Bq/l || Note 2

I-131 || 0.5 Bq/l || Note 2

Note 1:
the limit of detection shall be calculated according to ISO 11929-7, Determination of the
detection limit and decision thresholds for ionizing radiation
measurements-Part 7: Fundamentals and general applications, 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 (ISO, Geneva 1993, corrected reprint Geneva, 1995)

Note 3:
the limit of detection for radon and
for tritium is 10% of its parametric value of
100 Bq/l

Note 4:
the limit of detection for gross alpha 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 routine screening; for a new water
source for which it is plausible that Ra-228 exceeds 20% of the reference
concentration, the limit of detection for the first check shall be 0.02 Bq/l
for Ra-228 nuclide specific measurements. This shall also apply where a
subsequent re-check is required.

Note 6:
The low value of the specified detection limit for U is due to taking into
account the chemotoxicity of uranium.

[1]               OJ C , , p.

[2]               OJ C , , p.

[3]               OJ C , , p.

[4]               OJ L 159, 29.6.1996, p. 1

[5]               OJ L 330, 5.12.1998, p. 32

[6]               OJ L 164, 26.6.2009, p. 45

[7]               OJ L 311, 28.11.2001, p. 67

[8]               OJ L 226,
25.6.2004, p. 3

[9]               OJ L 344, 28.12.2001, p.85