COMMON POSITION (EC) No 13/98 adopted by the Council on 19 December 1997 with a view to the adoption of Council Directive 98/. . ./EC of . . . on the quality of water intended for human consumption (98/C 91/01)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community and, in particular, Article 103s(1) thereof,

Having regard to the proposal from the Commission (1),

Having regard to the opinion of the Economic and Social Committee (2),

Having regard to the opinion of the Committee of the Regions (3),

Acting in accordance with the procedure laid down in Article 189c (4),

(1) Whereas it is necessary to adapt Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption (5) to scientific and technological progress; whereas experience gained from implementing that Directive shows that it is necessary to create an appropriately flexible and transparent legal framework for Member States to address failures to meet the standards; whereas, furthermore, that Directive should be re-examined in the light of the Treaty on European Union and in particular the principle of subsidiarity;

(2) Whereas in keeping with Article 3b of the Treaty, which provides that no Community action should go beyond what is necessary to achieve the objectives of the Treaty, it is necessary to revise Directive 80/778/EEC so as to focus on compliance with essential quality and health parameters, leaving Member States free to add other parameters if they see fit;

(3) Whereas, in accordance with the principle of subsidiarity, Community action must support and supplement action by the competent authorities in the Member States;

(4) Whereas, in accordance with the principle of subsidiarity, the natural and socio-economic differences between the regions of the Union require that most decisions on monitoring, analysis, and the measures to be taken to redress failures be taken at a local, regional or national level insofar as those differences do not detract from the establishment of the framework of laws, regulations and administrative provisions laid down in this Directive;

(5) Whereas Community standards for essential and preventive health-related quality parameters in water intended for human consumption are necessary if minimum environmental-quality goals to be achieved in connection with other Community measures are to be defined so that the sustainable use of water intended for human consumption may be safeguarded and promoted;

(6) Whereas, in view of the importance of the quality of water intended for human consumption for human health, it is necessary to lay down at Community level the essential quality standards with which water intended for that purpose must comply;

(7) Whereas it is necessary to include water used in the food industry unless it can be established that the use of such water does not affect the wholesomeness of the finished product;

(8) Whereas to enable water-supply undertakings to meet the quality standards for drinking water, appropriate water-protection measures should be applied to ensure that surface and groundwater is kept clean; whereas the same goal can be achieved by appropriate water-treatment measures to be applied before supply;

(9) Whereas the coherence of European water policy presupposes that a suitable water framework Directive will be adopted in due course;

(10) Whereas 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;

(11) Whereas measures are required for all parameters directly relevant to health and for other parameters if a deterioration in quality has occurred; whereas, furthermore, such measures should be carefully coordinated with the implementation of Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (6) and Directive 98/. . ./EC of the European Parliament and of the Council of . . . . concerning the placing of biocidal products on the market (7);

(12) Whereas it is necessary to set individual parametric values for substances which are important throughout the Community at a level strict enough to ensure that this Directive's purpose can be achieved;

(13) Whereas the parametric values are based on the scientific knowledge available and the precautionary principle has also been taken into account; whereas those values have been selected to ensure that water intended for human consumption can be consumed safely on a life-long basis, and thus represent a high level of health protection;

(14) Whereas a balance should be struck to prevent both microbiological and chemical risks; whereas, to that end, and in the light of a future review of the parametric values, the establishment of parametric values applicable to water intended for human consumption should be based on public-health considerations and on a method of assessing risk;

(15) Whereas there is at present insufficient evidence on which to base parametric values for endocrine-disrupting chemicals at Community level, yet there is increasing concern regarding the potential impact on humans and wildlife of the effects of substances harmful to health;

(16) Whereas in particular the standards in Annex I are generally based on the World Health Organisation's 'Guidelines for drinking water quality`, and the opinion of the Commission's Scientific Advisory Committee to examine the toxicity and ecotoxicity of chemical compounds;

(17) Whereas Member States must set values for other additional parameters not included in Annex I where that is necessary to protect human health within their territories;

(18) Whereas Member States may set values for other additional parameters not included in Annex I where that is deemed necessary for the purpose of ensuring the quality of the production, distribution and inspection of water intended for human consumption;

(19) Whereas, when Member States deem it necessary to adopt standards more stringent than those set out in Annex I, Parts A and B, or standards for additional parameters not included in Annex I but necessary to protect human health, they must notify the Commission of those standards;

(20) Whereas Member States are bound, when introducing or maintaining more stringent protection measures, to respect the principles and rules of the Treaty, as they are interpreted by the Court of Justice;

(21) Whereas the parametric values are to be complied with at the point where water intended for human consumption is made available to the appropriate user;

(22) Whereas the quality of water intended for human consumption can be influenced by the domestic distribution system; whereas, furthermore, it is recognised that neither the domestic distribution system nor its maintenance may be the responsibility of the Member States;

(23) Whereas each Member State should establish monitoring programmes to check that water intended for human consumption meets the requirements of this Directive; whereas such monitoring programmes should be appropriate to local needs and should meet the minimum monitoring requirements laid down in this Directive;

(24) Whereas 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;

(25) Whereas, in the event of non-compliance with the standards imposed by this Directive the Member State concerned should investigate the cause and ensure that the necessary remedial action is taken as soon as possible to restore the quality of the water;

(26) Whereas it is important to prevent contaminated water causing a potential danger to human health; whereas the supply of such water should be prohibited or its use restricted;

(27) Whereas, in the event of non-compliance with a parameter that has an indicator function, the Member State concerned must consider whether that non-compliance poses any risk to human health; whereas it should take remedial action to restore the quality of the water where that is necessary to protect human health;

(28) Whereas, should such remedial action be necessary to restore the quality of water intended for human consumption, in accordance with Article 130r(2) of the Treaty, priority should be given to action which rectifies the problem at source;

(29) Whereas Member States should be authorised, under certain conditions, to grant derogations from this Directive; whereas, furthermore, it is necessary to establish a proper framework for such derogations, provided that they do not constitute a potential danger to human health and provided that the supply of water intended for human consumption in the area concerned cannot otherwise be maintained by any other reasonable means;

(30) Whereas, since the preparation or distribution of water intended for human consumption may involve the use of certain substances or materials, rules are required to govern the use thereof in order to avoid possible harmful effects on human health;

(31) Whereas scientific and technical progress may necessitate rapid adaptation of the technical requirements laid down in Annexes II and III; whereas, furthermore, in order to facilitate application of the measures required for that purpose, provision should be made for a procedure under which the Commission can adopt such adaptations with the assistance of a committee composed of representatives of the Member States;

(32) Whereas consumers should be adequately and appropriately informed of the quality of water intended for human consumption, of any derogations granted by the Member States and of any remedial action taken by the competent authorities; whereas, furthermore, consideration should be given both to the technical and statistical needs of the Commission, and to the rights of the individual to obtain adequate information concerning the quality of water intended for human consumption;

(33) Whereas, in exceptional circumstances and for geographically defined areas, it may be necessary to allow Member States a more extensive timescale for compliance with certain provisions of this Directive;

(34) Whereas this Directive should not affect the obligations of the Member States as to the time limit for transposition into national law, or as to application, as shown in Annex IV,

HAS ADOPTED THIS DIRECTIVE:

Article 1 Objective

1. This Directive concerns the quality of water intended for human consumption.

2. The objective of this Directive shall be to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean.

Article 2 Definitions

For the purposes of this Directive:

1. 'water intended for human consumption` shall mean:

(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, from 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. 'domestic distribution system` shall mean the pipework, fittings and appliances which are installed between the taps that are normally used for human consumption and the distribution network but only if they are not the responsibility of the water supplier, in its capacity as a water supplier, according to the relevant national law, except in premises and establishments where water is supplied to the public, such as schools, hospitals and restaurants.

Article 3 Exemptions

1. This Directive shall not apply to:

(a) natural mineral waters recognised as such by the competent national authorities, in accordance with Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (8);

(b) waters which are medicinal products within the meaning of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (9).

2. Member States may exempt from the provisions of 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 consumers concerned;

(b) water intended for human consumption from an individual supply providing less than 10 m³ a day as an average or serving fewer than 50 persons, unless the water is supplied as part of a commercial or public activity.

3. Member States that have recourse to the exemptions provided for in paragraph 2(b) shall ensure that the population 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. In addition, when a potential danger to human health arising out of the quality of such water is apparent, the population concerned shall promptly be given appropriate advice.

Article 4 General obligations

1. Without prejudice to their obligations under other Community provisions, Member States shall take the measures necessary to ensure that water intended for human consumption is wholesome and clean. For the purposes of the minimum requirements of this Directive, water intended for human consumption shall be wholesome and clean if it:

(a) is free from any micro-organisms and parasites and from any substances which, in numbers or concentrations, constitute a potential danger to human health, and

(b) meets the minimum requirements set out in Annex I, Parts A and B;

and if, in accordance with the relevant provisions of Articles 5 to 8 and 10 and in accordance with the Treaty, Member States take all other measures necessary to ensure that water intended for human consumption complies with the requirements of this Directive.

2. Member States shall ensure that the measures taken to implement this Directive in no circumstances have the effect of allowing, directly or indirectly, either any deterioration of the present quality of water intended for human consumption so far as that is relevant for the protection of human health or any increase in the pollution of waters used for the production of drinking water.

Article 5 Quality standards

1. Member States shall set values applicable to water intended for human consumption for the parameters set out in Annex I.

2. The values set in accordance with paragraph 1 shall not be less stringent than those set out in Annex I. As regards the parameters set out in Annex I, Part C, the values need be fixed only for monitoring purposes and for the fulfilment of the obligations imposed in Article 8.

3. A Member State shall set values for additional parameters not included in Annex I where the protection of human health within its national territory or part of it so requires. The values set should, as a minimum, satisfy the requirements of Article 4(1)(a).

Article 6 Point of compliance

1. The parametric values set in accordance with Article 5 shall be complied with:

(a) in the case of water supplied from a distribution network, at the point, within premises or an establishment, at which it emerges from the taps that are normally used for human consumption;

(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 water 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.

2. In the case of water covered by paragraph 1(a), Member States shall be deemed to have fulfilled their obligations under this Article and under Articles 4 and 8(2) where it can be established that non-compliance with the parametric values set in accordance with Article 5 is due to the domestic distribution system or the maintenance thereof.

3. Where paragraph 2 applies and there is a risk that water covered by paragraph 1(a) would not comply with the parametric values established in accordance with Article 5, Member States shall nevertheless ensure that:

(a) appropriate measures are taken to reduce or eliminate the risk of non-compliance with the parametric values, such as advising property owners of any possible remedial action they could take, and/or

other measures, such as appropriate treatment techniques, are taken to change the nature or properties of the water before it is supplied so as to reduce or eliminate the risk of the water not complying with the parametric values after supply;

and

(b) the consumers concerned are duly informed and advised of any possible additional remedial action that they should take.

Article 7 Monitoring

1. Member States shall take all measures necessary to ensure that regular monitoring of the quality of water intended for human consumption is carried out, in order to check that the water available to consumers meets the requirements of this Directive and in particular the parametric values set in accordance with Article 5. Samples should be taken so that they are representative of the quality of the water consumed throughout the year. In addition, Member States shall take all measures necessary to ensure that, where disinfection forms part of the preparation or distribution of water intended for human consumption, the efficiency of the disinfection treatment applied is verified.

2. To meet the obligations imposed in paragraph 1, appropriate monitoring programmes shall be established by the competent authorities for all water intended for human consumption. Those monitoring programmes shall meet the minimum requirements set out in Annex II.

3. The sampling points shall be determined by the competent authorities and shall meet the relevant requirements set out in Annex II.

4. Community guidelines for the monitoring prescribed in this Article may be drawn up in accordance with the procedure laid down in Article 12.

5 (a) Member States shall comply with the specifications for the analyses of parameters set out in Annex III.

(b) Methods other than those specified in Annex III, Part 1, may be used, providing it can be demonstrated that the results obtained are at least as reliable as those produced by the methods specified. Member States which have recourse to alternative methods shall provide the Commission with all relevant information concerning such methods and their equivalence.

(c) For those parameters listed in Annex III, Parts 2 and 3, any method of analysis may be used provided that it meets the requirements set out therein.

6. Member States shall ensure that additional monitoring is carried out on a case-by-case basis of substances and micro-organisms for which no parametric value has been set in accordance with Article 5, if there is reason to suspect that they may be present in amounts or numbers which constitute a potential danger to human health.

Article 8 Remedial action and restrictions in use

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

2. If, despite the measures taken to meet the obligations imposed in Article 4(1), water intended for human consumption does not meet the parametric values set in accordance with Article 5, and subject to Article 6(2), the Member State concerned shall ensure that the necessary remedial action is taken as soon as possible to restore its quality, having regard inter alia to the extent to which the relevant parametric value has been exceeded and to the potential danger to human health.

3. Whether or not any failure to meet the parametric values has occurred, Member States shall ensure that any supply of water intended for human consumption which constitutes a potential danger to human health is prohibited or its use restricted or such other action is taken as is necessary to protect human health. In such cases consumers shall be informed promptly thereof and given the necessary advice.

4. The competent authorities or other relevant bodies shall decide what action under paragraph 3 should be taken, bearing in mind the risks to human health which would be caused by an interruption of the supply or a restriction in the use of water intended for human consumption.

5. Member States may establish guidelines to assist the competent authorities to fulfil their obligations under paragraph 4.

6. In the event of non-compliance with the parametric values or with the specifications set out in Annex I, Part C, Member States shall consider whether that non-compliance poses any risk to human health. They shall take remedial action to restore the quality of the water where that is necessary to protect human health.

7. Member States shall ensure that, where remedial action is taken, consumers are notified except where the competent authorities consider the non-compliance with the parametric value to be trivial.

Article 9 Derogations

1. Member States may provide for derogations from the parametric values set out in Annex I, Part B, or set in accordance with Article 5(3), up to a maximum value to be determined by them, provided no derogation constitutes a potential danger to human health and provided that the supply of water intended for human consumption in the area concerned cannot otherwise be maintained by any other reasonable means. Derogations shall be limited to as short a time as possible and shall not exceed three years, towards the end of which a review shall be conducted to determine whether sufficient progress has been made. Where a Member State intends to grant a second derogation, it shall communicate the review, along with the grounds for its decision on the second derogation, to the Commission. No such second derogation shall exceed three years.

2. In exceptional circumstances, a Member State may ask the Commission for a third derogation for a period not exceeding three years. The Commission shall take a decision on any such request within three months.

3. Any derogation granted in accordance with paragraphs 1 or 2 shall specify the following:

(a) the grounds for the derogation;

(b) the parameter concerned, previous relevant monitoring results, and the maximum permissible value under the derogation;

(c) the geographical area, quantity of water supplied each day, the population concerned and whether or not any relevant food-production undertaking would be affected;

(d) an appropriate monitoring scheme, with an increased monitoring frequency where necessary;

(e) a summary of the plan for the necessary remedial action, including a timetable for the work and an estimate of the cost and provisions for reviewing;

(f) the required duration of the derogation.

4. If the competent authorities consider the non-compliance with the parametric value to be trivial, and if action taken in accordance with Article 8(2) is sufficient to remedy the problem within 30 days, the requirements of paragraph 3 need not be applied.

In that event, only the maximum permissible value for the parameter concerned and the time allowed to remedy the problem shall be set by the competent authorities or other relevant bodies.

5. Recourse may no longer be had to paragraph 4 if failure to comply with any one parametric value for a given water supply has occurred on more than 30 days on aggregate during the previous 12 months.

6. Any Member State which has recourse to the derogations provided for in this Article shall ensure that the population affected by any such derogation is promptly informed in an appropriate manner of the derogation and of the conditions governing it. In addition the Member State shall, where necessary, ensure that advice is given to particular population groups for which the derogation could present a special risk.

These obligations shall not apply in the circumstances described in paragraph 4 unless the competent authorities decide otherwise.

7. With the exception of derogations granted in accordance with paragraph 4 a Member State shall inform the Commission within two months of any derogation concerning an individual supply of water exceeding 1 000 m³ a day as an average or serving more than 5 000 persons, including the information specified in paragraph 3.

8. This Article shall not apply to water intended for human consumption offered for sale in bottles or containers.

Article 10 Quality assurance of treatment, equipment and materials

Member States shall take all measures necessary to ensure that no substances or materials for new installations used in the preparation or distribution of water intended for human consumption or impurities associated with such substances or materials for new installations remain in water intended for human consumption in concentrations higher than is necessary for the purpose of their use and do not, either directly or indirectly, reduce the protection of human health provided for in this Directive, without prejudice to Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and administrative provisions of the Member States relating to construction products (10).

Article 11 Review of annexes

1. At least every five years, the Commission shall review Annex I in the light of scientific and technical progress and shall make proposals for amendments, where necessary, under the procedure laid down in Article 189c of the Treaty.

2. At least every five years, the Commission shall adapt Annexes II and III to scientific and technical progress. Such changes as are necessary shall be adopted in accordance with the procedure laid down in Article 12.

Article 12 Committee procedure

1. The Commission shall be assisted by a committee composed of representatives of the Member States and chaired by a Commission representative.

2. The Commission representative shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote.

3. The Commission shall adopt measures which shall apply immediately. However, if those measures are not in accordance with the committee's opinion, the Commission shall communicate them to the Council forthwith. In that event:

(a) the Commission shall defer application of the measures which it has adopted for a period of three months from the date of communication;

(b) the Council, acting by a qualified majority, may take a different decision within the time limit referred to in point (a).

Article 13 Information and reporting

1. Member States shall take the measures necessary to ensure that adequate and up-to-date information on the quality of water intended for human consumption is available to consumers.

2. Without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment (11), each Member State shall publish a report every three years on the quality of water intended for human consumption with the objective of informing consumers. That report shall include, as a minimum, all individual supplies of water exceeding 1 000 m³ a day as an average or serving more than 5 000 persons and it shall cover three calendar years and be published within one calendar year of the end of the reporting period.

3. Member States shall send their reports to the Commission within two months of their publication.

4. The formats and the minimum information for the reports provided for in paragraph 2 shall be determined having special regard to the measures referred to in Articles 3(2), 5(2) and (3), 7(2), 8, 9(6) and (7) and 15(1), and shall if necessary be amended in accordance with the procedure laid down in Article 12.

5. The Commission shall examine the Member States' reports and, every three years, publish a synthesis report on the quality of water intended for human consumption in the Community. That report shall be published within nine months of the receipt of the Member States' reports.

Article 14 Timescale for compliance

Member States shall take the measures necessary to ensure that the quality of water intended for human consumption complies with this Directive within five years of its entry into force, without prejudice to Notes 2, 4 and 10 in Annex I, Part B.

Article 15 Exceptional circumstances

1. A Member State may, in exceptional circumstances and for geographically defined areas, submit a special request to the Commission for a period longer than that laid down in Article 14. The additional period shall not exceed three years, towards the end of which a review shall be carried out and forwarded to the Commission which may, on the basis of that review, permit a second additional period of up to three years. This provision shall not apply to water intended for human consumption offered for sale in bottles or containers.

2. Any such request, grounds for which shall be given, shall set out the difficulties experienced and include, as a minimum, all the information specified in Article 9(3).

3. The Commission shall examine that request in accordance with the procedure laid down in Article 12.

4. Any Member States which has recourse to this Article shall ensure that the population affected by its request is promptly informed in an appropriate manner of the outcome of that request. In addition, the Member State shall, where necessary, ensure that advice is given to particular population groups for which the request could present a special risk.

Article 16 Repeal

1. Directive 80/778/EEC is hereby repealed with effect from five years after the entry into force of this Directive. Subject to paragraph 2, this repeal shall be without prejudice to Member States' obligations regarding deadlines for transposition into national law and for application as shown in Annex IV.

Any reference to the Directive repealed shall be construed as a reference to this Directive and shall be read in accordance with the correlation table set out in Annex V.

2. As soon as a Member State has brought into force the laws, regulations and administrative provisions necessary to comply with this Directive and has taken the measures provided for in Article 14, this Directive, not Directive 80/778/EEC, shall apply to the quality of water intended for human consumption in that Member State.

Article 17 Transposition into national law

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive within two years of its entry into force. They shall forthwith inform the Commission thereof.

When the Member States adopt those measures, these shall contain references to this Directive or shall be accompanied by such references on the occasion of their official publication. The methods of making such references shall be laid down by the Member States.

2. The Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.

Article 18 Entry into force

This Directive shall enter into force on the 20th day after that of its publication in the Official Journal of the European Communities.

Article 19 Addresses

This Directive is addressed to the Member States.

Done at . . .

For the Council

The President

(1) OJ C 213, 15.7.1997, p. 8.

(2) OJ C 82, 19.3.1996, . p. 64.

(3) OJ C 100, 2.4.1996, p. 134.

(4) Opinion of the European Parliament of 12 December 1996 (OJ C 20, 20.1.1997, p. 121), Council common position of 19 December 1997 and Decision of the European Parliament of . . . (not yet published in the Official Journal).

(5) OJ L 229, 30.8.1980, p. 11. Directive as last amended by the 1994 Act of Accession.

(6) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 96/68/EC (OJ L 277, 30.10.1996, p. 25).

(7) Not yet published in the Official Journal.

(8) OJ L 229, 30.8.1980, p. 1. Directive as last amended by Directive 96/70/EC (OJ L 299, 23.11.1996, p. 26).

(9) OJ 22 9.2.1965, p. 369. Directive as last amended by Directive 93/39/EEC (OJ L 214, 24.8.1993, p. 22).

(10) OJ L 40, 11.2.1989, p. 12. Directive as last amended by Directive 93/68/EEC (OJ L 220, 30.8.1993, p. 1).

(11) OJ L 158, 23.6.1990, p. 56.

ANNEX I

PARAMETERS AND PARAMETRIC VALUES

PART A Microbiological parameters

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TABLE POSITION>

The following applies to water offered for sale in bottles or containers:

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PART B Chemical parameters

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PART C Indicator parameters

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ANNEX II

MONITORING

TABLE A Parameters to be analysed

1. Check monitoring

The purpose of check monitoring is regularly to provide information on the organoleptic and microbiological quality of the water supplied for human consumption as well as information on the effectiveness of drinking-water treatment (particularly of disinfection) where it is used, in order to determine whether or not water intended for human consumption complies with the relevant parametric values laid down in this Directive.

The following parameters must be subject to check monitoring. Member States may add other parameters to this list if they deem it appropriate.

Aluminium (Note 1)

Ammonium

Colour

Conductivity

Clostridium perfringens (including spores) (Note 2)

Escherichia coli (E. coli)

Hydrogen ion concentration

Iron (Note 1)

Nitrite (Note 3)

Odour

Pseudomonas aeruginosa (Note 4)

Taste

Colony count 22 °C and 37 °C (Note 4)

Coliform bacteria

Turbidity

Note 1: Necessary only when used as flocculant (1*).

Note 2: Necessary only if the water originates from or is influenced by surface water (2*).

Note 3: Necessary only when chloramination is used as a disinfectant (3*).

Note 4: Necessary only in the case of water offered for sale in bottles or containers.

2. Audit monitoring

The purpose of audit monitoring is to provide the information necessary to determine whether or not of all of the Directive's parametric values are being complied with. All parameters set in accordance with Article 5(2) and (3) must be subject to audit monitoring unless it can be established by the competent authorities, for a period of time to be determined by them, that a parameter is not likely to be present in a given supply in concentrations which could lead to the risk of a breach of the relevant parametric value.

TABLE B1 Minimum frequency of sampling and analyses for water intedend for human consumption supplied from a distribution network or from a tanker or used in a food-production undertaking

Member States must take samples at the points of compliance as defined in Article 6(1) to ensure that water intended for human consumption meets the requirements of the Directive. However, in the case of a distribution network, a Member State may take samples within the supply zone or at the treatment works for particular parameters if it can be demonstrated that there would be no adverse change to the measured value of the parameters concerned.

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TABLE B2 Minimum frequency of sampling and analysis for water put into bottles or containers intended for sale

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(1*) In all other cases, the parameters are in the list for audit monitoring.

ANNEX III

SPECIFICATIONS FOR THE ANALYSIS OF PARAMETERS

Each Member State must ensure that any laboratory at which samples are analysed has a system of analytical quality control that is subject from time to time to checking by a person who is not under the control of the laboratory and who is approved by the competent authority for that purpose.

1. PARAMETERS FOR WHICH METHODS OF ANALYSIS ARE SPECIFIED

The following principles for methods of microbiological parameters are given either for reference whenever a CEN/ISO method is given or for guidance, pending the possible future adoption, in accordance with the procedure laid down in Article 12, of further CEN/ISO international methods for these parameters. Member States may use alternative methods, providing the provisions of Article 7 (5) are met.

Coliform bacteria and Escherichia coli (E. coli) (ISO 9308-1)

Enterococci (ISO 7899-2)

Pseudomonas aeruginosa (prEN ISO 12780)

Enumeration of culturable microorganisms - Colony count 22 °C (prEN ISO 6222)

Enumeration of culturable microorganisms - Colony count 37 °C (prEN ISO 6222)

Clostridium perfringens (including spores)

Membrane filtration followed by anaerobic incubation of the membrane on m-CP agar (Note 1) at 44 ± 1 °C for 21 ± 3 hours. Count opaque yellow colonies that turn pink or red after exposure to ammonium hydroxide vapours for 20 to 30 seconds.

Note 1: The composition of m-CP agar is:

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Dissolve the ingredients of the basal medium, adjust pH to 7,6 and autoclave at 121 °C for 15 minutes. Allow the medium to cool and add:

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2. PARAMETERS FOR WHICH PERFORMANCE CHARACTERISTICS ARE SPECIFIED

2.1. For the following 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 trueness, precision and limit of detection specified. Whatever the sensitivity of the method of analysis used, the result must be expressed using at least the same number of decimals as for the parametric value considered in Annex I, Parts B and C.

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2.2. For hydrogen ion concentration the specified performance characterisatics are that the method of analysis used must be capable of measuring concentrations equal to the parametric value with a trueness of 0,2 pH unit and a precision of 0,2 pH unit.

Note 1 (1*): Trueness is the systematic error and is the difference between the mean value of the large number of repeated measurements and the true value.

Note 2 (2*): Precision is the random error and is usually expressed as the standard deviation (within and between batch) of the spead of results about the mean. Acceptable precision is twice the relative standard deviation.

Note 3: Limit of detection is either:

- three times the relative within batch standard deviation of a natural sample containing a low concentration of the parameter,

or

- five times the relative within batch standard deviation of a blank sample.

Note 4: The method should determine total cyanide in all forms.

Note 5: Oxidation should be carried out for 10 minutes at 100 °C under acid conditions using permanganate.

Note 6: The performance characteristics apply to each individual pesticide and will depend on the pesticide concerned. The limit of detection may not be achievable for all pesticides at present, but Member States should strive to achieve this standard.

Note 7: The performance characteristics apply to the individual substances specified at 25 % of the parametric value in Annex I.

Note 8 8: The performance characteristics apply to the individual substances specified at 50 % of the parametric value in Annex I.

3. PARAMETERS FOR WHICH NO METHOD OF ANALYSIS IS SPECIFIED

Colour

Odour

Taste

Total organic carbon

Turbidity (Note 1)

Note 1: For turbidity monitoring in treated surface water 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 trueness of 25 %, precision of 25 % and a 25 % limit of detection.

(1*) These terms are further defined in ISO 5725:

ANNEX IV

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ANNEX V

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STATEMENT OF THE COUNCIL'S REASONS

I. INTRODUCTION

1. On 28 April 1995, the Commission sent the Council its initial proposal, based on Article 130s(1) of the EC Treaty, on the quality of water intended for human consumption (1).

2. The European Parliament, the Economic and Social Committee and the Committee of the Regions delivered their opinions on 12 December 1996 (2), 21 December 1995 (3) and 19 September 1995 (4) respectively.

3. On 4 June 1997, the Commission forwarded an amended proposal to Council (5).

4. On 19 December 1997, the Council adopted its common position in accordance with Article 189c of the Treaty.

II. OBJECTIVE

The aim of the draft Directive is to protect human health from the adverse effects of any contamination of water intended for human consumption by ensuring that it is wholesome and clean.

To this end, the draft Directive revises Directive 80/778/EEC in such a way that it provides Member States with a more flexible and adequate legal framework which redresses some of the difficulties previously encountered in the production and distribution of drinking water. It also takes account of the new scientific knowledge and technical progress achieved so far, which is based on the WHO drinking water quality guidelines and advice given by the Commission Advisory Scientific Committee on Toxicity and Ecotoxicity. It includes only those parameters considered essential at Community level to ensure a high level of health protection at practicable values.

III. ANALYSIS OF THE COMMON POSITION

A. Amended Commission proposal

The Council adopted either in full or in part, and occasionally in spirit, 39 amendments proposed by the European Parliament of which 5 were originally rejected by the Commission.

The latter amendments regard Article 4(1)(a) (Amendment 43), Article 5 (Amendments 23 and 24), Article 10 (Amendment 34) and Annex II, Table A (Amendment 91) (6).

B. Amendments accepted by the Commission but not included in the common position

1. Amendment 20

As this amendment covers a more horizontal issue, the Council considered that catchment protection measures taking full account of the precautionary principle and the polluter-pays principle are more appropriately catered for in the Directive establishing a framework for Community action in the field of water policy.

2. Amendment 77

The Council considered that the addition proposed by the European Parliament concerning possible new contamination from disinfection degradation products was already covered in the notion of the verification of the 'efficiency of the disinfection treatment applied` (Article 7(1)). However, the Council added that regular monitoring shall be ensured in particular to check whether all of the parametric values set in accordance with Article 5 are met and specified that samples should be taken so that they are representative of the quality of the water consumed throughout the year.

C. Changes or innovations introduced by the Council

1. Notion of 'wholesome and clean` (Articles 1(2) and 4(1))

Because of the broadening in Article 1 of the qualification for water intended for human consumption to 'wholesome and clean`, as was proposed by the European Parliament and accepted by the Council, and, for the sake of legal certainty, the Council defined that concept in Article 4(1) by adding:

- in (a) that it shall also be free from any substances in concentrations which constitute a potential danger to human health, and

- that, in accordance with the relevant provisions of Articles 5 to 8 and 10, and in accordance with the Treaty, Member States also take all other measures necessary to ensure its compliance with the Directive.

2. Definition of 'domestic distribution system` (Article 2(2) and 6(2) and (3))

With a view to establishing an appropriate balance in terms of responsibility between the different actors concerned, the Council has redrafted the definition of the 'domestic distribution system`.

Relevant only to Article 6(2), the Council reduced the scope of the 'domestic distribution system` so as to exclude from any possible non-compliance with the parametric values those premises and establishments where water is supplied to the public such as schools, hospitals and restaurants. Food-production undertakings are also excluded from the cases covered by Article 6(2).

Moreover, the Council provided in Article 6(3) that Member States shall ensure that appropriate measures be taken to reduce or eliminate the risk of non-compliance with parametric values and that consumers be informed of or advised on any possible additional remedial action that they should take.

3. The lead parameter, its point of compliance for and way of sampling and its transitional provisions (Article 6(1) and (2), Article 2(2) and Annex I, Part B, Notes 3 and 4)

Having been one of the most controversial issues throughout negotiations, the Council reached an agreement on the following elements:

(a) parametric value and timetable are accepted as in the Commission proposal;

(b) the point of compliance of the parametric value needs to be read in conjunction with the explanation given in paragraph 2 above;

(c) an adequate sampling method at the tap which is representative of a weekly average value ingested by consumers need to be elaborated and added to the Directive, and Member States must take account of the occurrence of peak levels that may cause averse effects on human health (Annex I, Part B, Note 2).

4. Derogations and exceptional circumstances (Articles 9(1) and (2) and 15(1))

The Council agreed to limit in time both possible derogations envisaged under the general scheme (Article 9) and the prolongation of the timescale for compliance in exceptional circumstances (Article 15), as was put forward by the European Parliament. However, in light of the difficulties Member States, in some cases, shall have to face in terms of costs or time needed to take measures (e.g. adjust the water treatment or develop an alternative resource), and provided certain criteria and conditions are met, the Council considered that a longer period than the one proposed by the Parliament would be more appropriate.

5. Transparency (Articles 3(3), 6(3), 8(7) and 15(4))

To those articles referring to situations where Member states may either exempt or derogate from the provisions of the Directive, and where such measures had not yet been included, the Council systematically added a clause to inform and properly advise the consumer or population concerned.

6. Quality standards and the provisions relating to the internal market

Bearing in mind that this Directive is based on Article 130s(1) of the Treaty and that, according to Article 130t of that same Treaty, Member States are allowed to maintain or introduce more stringent measures if, subject to certain provisions, protective measures under Article 130s are adopted, the Council:

- deleted former Article 13 and former recital 22,

- transferred former Article 6(4) to the preamble (recital 19),

- added extra recitals to indicate that Member States may set values for parameters not included in Annex I (recital 18), and also to underline that in doing so, Member States are bound to respect the principles and rules of the Treaty (recital 20).

7. Parameters and parametric values

The Council considered that parametric values should be set at a level considered appropriate to protect public health.

Therefore, the Council, inter alia:

- changed some of the names of the parameters to render them more precise (eg. 'Enterococci` instead of 'faecal streptococci`, 'clostridium perfringens` instead of 'sulphite reducing clostridia`, 'colony count at 22 °C` instead of 'total bacteria count`),

- added some parameters (eg. colony counts at 22 °C and 37 °C to Annex I, Part A concerning water in bottles and containers, chloride and sodium to Annex I, Part C),

- set tighter values, eg. for acrylamide, epichlorohydrin, four individual pesticides and tri- and tetrachloroethene,

- changed the standard for antimony, boron, nitrite at the tap and PAH,

- added the WHO guideline value as an interim value for bromate,

- replaced bromodichloromethane and chloroform by sum of 4 THMs,

- moved clostridium perfringens from Annex I, Part A, to Annex I, Part C, and also added it to check monitoring in Annex II;

- deleted dissolved oxygen and the parametric value for TOC from Annex I, Part C, (Commission proposal).

Moreover, to ensure that monitoring results were reliable and accurate, the Council made the minimum sampling frequencies more proportional to the volume of water supplied (Annex II, Tables B1 and B2) and entered a provision in Annex III on quality control for laboratories.

As far as analytical methods are concerned and where at all possible, the Council introduced internationally-accepted ISO/CEN standards which resulted in major changes to Annex III.

The Commission has agreed to the amendments made by the Council.

(1) OJ C 131, 30.5.1995, p. 5 and OJ C 243, 20.9.1995, p. 10.

(2) OJ C 20, 20.1.1997, p. 121.

(3) OJ C 82, 19.3.1996, p. 64.

(4) OJ C 100, 2.4.1996, p. 134.

(5) OJ C 213, 15.7.1997, p. 8.

(6) The numbering of the articles follows those retained in the common position.