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
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 European Commission 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 establishing the European Atomic Energy Community,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the European Parliament,
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 (2), the contribution to the exposure of the general public as a whole from practices which involve a risk from ionising 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 to provide for the monitoring of compliance with those standards.
(3)
Council Directive 98/83/EC (3) sets out indicator parameters relating to radioactive substances in Annex I, Part C and related monitoring provisions in Annex II thereto. 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 radioactive substances 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)
Since the Community is competent to adopt the basic safety standards for the protection of the health of workers and general public against the dangers arising from ionising radiations, the provisions of this Directive supersede those of Directive 98/83/EC as regards the requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption.
(6)
As recognised by the Court of Justice in its case-law, the tasks imposed on the Community by Article 2(b) of the Euratom Treaty to establish uniform safety standards to protect the health of workers and of the general public do not preclude, unless explicitly stated in those standards, a Member State from providing for more stringent measures of protection. Since this Directive provides for minimum rules, Member States should be free to adopt or maintain more stringent measures in the field covered by this Directive, without prejudice to the free movement of goods in the internal market as defined by the case-law of the Court of Justice.
(7)
Parametric values should not be regarded as limit values. In the event that monitoring of water intended for human consumption indicates non-compliance with a parametric value, the Member State concerned should consider whether that poses a risk to human health which requires action and, where necessary, take remedial action to improve the quality of the water to a level which complies with the requirements for the protection of human health from a radiation protection point of view.
(8)
Monitoring of waters intended for human consumption put into bottles or containers intended for sale, other than natural mineral waters, for the purpose of checking whether the levels of radioactive substances comply with the parametric values laid down pursuant to this Directive, should be carried out in accordance with the principles of hazard analysis and critical control points (HACCP) as required by Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) and without prejudice to the principles of official controls laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (5).
(9)
The general public should be adequately and appropriately informed of the quality of water intended for human consumption.
(10)
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 (6) and Directive 2001/83/EC of the European Parliament and of the Council (7).
(11)
Each Member State should establish monitoring programmes to check that water intended for human consumption meets the requirements of this Directive.
(12)
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.
(13)
Taking into consideration the large geographical variability in the natural occurrence of radon, the Commission adopted Recommendation 2001/928/Euratom (8), which deals with the quality of water intended for human consumption regarding radon and long-lived radon decay products. It is appropriate to include these radionuclides in the scope of this Directive.
(14)
In order to maintain the high quality of water intended for human consumption in view of its importance for human health, it is necessary for Annexes II and III to be regularly updated in the light of scientific and technical progress.
(15)
While it is for Member States to define the sampling and analysis frequencies for water intended for human consumption put into bottles or containers intended for sale, it is advisable for those Member States required to monitor water intended for human consumption for radon or tritium or to establish the Indicative Dose (ID), to carry out sampling and analysis at least once per year,
HAS ADOPTED THIS DIRECTIVE:
Article 1
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 lays down parametric values and frequencies and methods for monitoring radioactive substances.
Article 2
Definitions
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
Scope and exemptions
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
General obligations
Without prejudice to the provisions laid down in point a of Article 6(3) of Directive 96/29/Euratom (9), 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
Parametric values and points of compliance
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
Monitoring and analysis
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
Remedial action and notification of the general public
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
Transposition into national law
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
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 10
Addressees
This Directive is addressed to the Member States.
Done at Luxembourg, 22 October 2013.