7.10.2015 |
EN |
Official Journal of the European Union |
L 260/6 |
COMMISSION DIRECTIVE (EU) 2015/1787
of 6 October 2015
amending Annexes II and III to Council Directive 98/83/EC on the quality of water intended for human consumption
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (1), and in particular Article 11(2) thereof,
Whereas:
(1) |
Annexes II and III to Directive 98/83/EC lay down the minimum requirements of the monitoring programmes for all water intended for human consumption and the specifications for the method of analysis of different parameters. |
(2) |
The specifications in those Annexes II and III should be updated in the light of scientific and technical progress and so as to ensure coherence with Union legislation. |
(3) |
Annex II to Directive 98/83/EC grants a certain degree of flexibility in performing the audit monitoring and check monitoring, allowing for less frequent sampling under certain circumstances. The specific conditions to perform the monitoring of parameters at appropriate frequencies and the range of monitoring techniques need to be clarified in the light of scientific progress. |
(4) |
Since 2004, the World Health Organisation has developed the water safety plan approach which is based on risk assessment and risk management principles, laid down in its Guidelines for Drinking Water Quality (2). Those Guidelines, together with standard EN 15975-2 concerning security of drinking water supply, are internationally recognised principles on which the production, distribution, monitoring and analysis of parameters in drinking water is based. Annex II to Directive 98/83/EC should therefore be aligned to the latest updates of those principles. |
(5) |
To control risks to human health, the monitoring programmes should ensure that there are measures in place throughout the water supply chain and consider information from water bodies used for drinking water abstraction. The general obligations for monitoring programmes should bridge the gap between water abstraction and supply. Pursuant to Article 6 of Directive 2000/60/EC of the European Parliament and of the Council (3), Member States must ensure the establishment of register(s) of protected areas. Such protected areas include all bodies of water used for the abstraction of drinking water, or intended for such use, under Article 7(1) of that Directive. Results from the monitoring of those bodies of water under the second subparagraph of Article 7(1) and Article 8 of that Directive should be used to determine the potential risk for drinking water before and after treatment for the purposes of Directive 98/83/EC. |
(6) |
Experience has shown that, for many (particularly physico-chemical) parameters, the concentrations present would rarely result in any breach of limit values. Monitoring and reporting such parameters without practical relevance imply significant costs, especially where a large number of parameters need to be considered. Introducing flexible monitoring frequencies under such circumstances presents potential cost-saving opportunities that would not damage public health or other benefits. Flexible monitoring also reduces the collection of data that provide little or no information on the quality of the drinking water. |
(7) |
Member States should therefore be allowed to derogate from the monitoring programmes they have established, provided credible risk assessments are performed, which may be based on the WHO Guidelines for Drinking Water Quality and should take into account the monitoring carried out under Article 8 of Directive 2000/60/EC. |
(8) |
Table B2 in Annex II to Directive 98/83/EC, which concerns water put into bottles or containers intended for sale, has become obsolete, as those products are covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Those products are also covered by the principle of ‘hazard analysis and critical control point’ (HACCP) laid down in Regulation (EC) No 852/2004 of the European Parliament and of the Council (5) and the principles of official controls as laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (6). As a consequence of the adoption of those Regulations, Annex II to Directive 98/83/EC de facto no longer applies to water put into bottles or containers intended for sale. |
(9) |
Council Directive 2013/51/Euratom (7) introduced specific arrangements for monitoring for radioactive substances. Monitoring programmes for radioactive substances should therefore exclusively be established under that Directive. |
(10) |
Laboratories applying the specifications for the analysis of the parameters laid down in Annex III to Directive 98/83/EC should work in accordance with internationally approved procedures or criteria-based performance standards and use methods of analysis that have, as far as possible, been validated. |
(11) |
Commission Directive 2009/90/EC (8) provides for standard EN ISO/IEC 17025, or other equivalent standards accepted at international level, to be used to validate the methods of analysis. EN ISO/IEC 17025 is also one of the standards used under Regulation (EC) No 882/2004 for the accreditation of laboratories designated by the competent authorities in the Member States. It is therefore necessary to provide for that standard, or other equivalent standards accepted at international level, for the validation of the methods of analysis in the context of Directive 98/83/EC. In order to align Annex III to Directive 98/83/EC with Directive 2009/90/EC, the limit of quantification and uncertainty of measurement should be introduced as performance characteristics. However, Member States should be able to continue to allow the use of trueness, precision and limit of detection as performance characteristics under Annex III to Directive 98/83/EC for a limited period, thus providing laboratories with sufficient time to adapt to this technical advance. |
(12) |
A number of ISO standards have been established for analysing microbiological parameters. Thus, EN ISO 9308-1 and EN ISO 9308-2 (for the enumeration of E. coli and coliform bacteria) and standard EN ISO 14189 (for the analysis of Clostridium perfringens) provide all necessary specifications for performing the analysis. Those new standards and technical developments should be reflected in Annex III to Directive 98/83/EC. |
(13) |
For the purposes of assessing the equivalence of alternative methods with the method laid down in Annex III to Directive 98/83/EC, Member States should be permitted to use standard EN ISO 17994, which has already been established as the standard on the equivalence of microbiological methods in the context of Directive 2006/7/EC of the European Parliament and of the Council (9) and by Commission Decision 2009/64/EC (10). Alternatively, they should be permitted to use standard EN ISO 16140 or any other similar internationally accepted protocols, as referred to in Article 5(5) of Commission Regulation (EC) No 2073/2005 (11), to establish the equivalence of methods based on principles other than culturing, which are beyond the scope of EN ISO 17994. |
(14) |
Annexes II and III to Directive 98/83/EC should therefore be amended accordingly. |
(15) |
The measures provided for in this Directive are in accordance with the opinion of the Drinking Water Committee established under Article 12(1) of Directive 98/83/EC, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 98/83/EC is amended as follows:
(1) |
Annex II is replaced by the text set out in Annex I to this Directive; |
(2) |
Annex III is amended in accordance with Annex II to this Directive. |
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 27 October 2017 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 text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 6 October 2015.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 330, 5.12.1998, p. 32.
(2) http://www.who.int/water_sanitation_health/publications/2011/dwq_guidelines/en/index.html
(3) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
(4) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(5) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
(6) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
(7) 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 (OJ L 296, 7.11.2013, p. 12).
(8) Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC, technical specifications for chemical analysis and monitoring of water status (OJ L 201, 1.8.2009, p. 36).
(9) Directive 2006/7/EC of the European Parliament and of the Council of 15 February 2006 concerning the management of bathing water quality (OJ L 64, 4.3.2006, p. 37).
(10) Commission Decision 2009/64/EC of 21 January 2009 specifying, pursuant to Directive 2006/7/EC of the European Parliament and of the Council, ISO 17994:2004(E) as the standard on the equivalence of microbiological methods (OJ L 23, 27.1.2009, p. 32).
(11) Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, p. 1).
ANNEX I
‘ANNEX II
MONITORING
PART A
General objectives and monitoring programmes for water intended for human consumption
1. |
Monitoring programmes for water intended for human consumption must:
|
2. |
Pursuant to Article 7(2), competent authorities shall establish monitoring programmes complying with the parameters and frequencies set out in Part B of this Annex which consist of:
In addition, monitoring programmes may consist of:
|
3. |
Monitoring programmes may be based on a risk assessment as set out in Part C. |
4. |
Member States shall ensure that monitoring programmes are reviewed on a continuous basis and updated or reconfirmed at least every 5 years. |
PART B
Parameters and frequencies
1. General framework
A monitoring programme must take into account the parameters referred to in Article 5, including those that are important for assessing the impact of domestic distribution systems on the quality of water at the point of compliance, as set out in Article 6(1). When choosing appropriate parameters for monitoring, local conditions for each water supply system must be taken into consideration.
Member States shall ensure that the parameters listed in point 2 are monitored at the relevant sampling frequencies as set out in point 3.
2. List of parameters
Group A parameters
The following parameters (Group A) shall be monitored in accordance with the monitoring frequencies set out in Table 1 of point 3:
(a) |
Escherichia coli (E. coli), coliform bacteria, colony count 22 °C, colour, turbidity, taste, odour, pH, conductivity; |
(b) |
other parameters identified as relevant in the monitoring programme, in accordance with Article 5(3) and, where relevant, through a risk assessment as set out in Part C. |
Under specific circumstances, the following parameters shall be added to the Group A Parameters:
(a) |
ammonium and nitrite, if chloramination is used; |
(b) |
aluminium and iron, if used as water treatment chemicals. |
Group B parameters
In order to determine compliance with all parametric values set out in this Directive, all other parameters not analysed under Group A and set in accordance with Article 5 shall be monitored at least at the frequencies set out in Table 1 of point 3.
3. Sampling frequencies
Table 1
Minimum frequency of sampling and analysis for compliance monitoring
Volume of water distributed or produced each day within a supply zone (See Notes 1 and 2) m3 |
Group A parameter number of samples per year (See Note 3) |
Group B parameter number of samples per year |
|
|
≤ 100 |
> 0 (See Note 4) |
> 0 (See Note 4) |
> 100 |
≤ 1 000 |
4 |
1 |
> 1 000 |
≤ 10 000 |
4 + 3 for each 1 000 m3/d and part thereof of the total volume |
1 + 1 for each 4 500 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 |
|
12 + 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 water quality may be considered as being approximately uniform. |
Note 2: |
The volumes are calculated as averages taken over a calendar year. The number of inhabitants in a supply zone may be used instead of the volume of water to determine the minimum frequency, assuming water consumption of 200 l/(day*capita). |
Note 3: |
The frequency indicated is calculated as follows: e.g. 4 300 m3/d = 16 samples (four for the first 1 000 m3/d + 12 for additional 3 300 m3/d). |
Note 4: |
Member States that have decided to exempt individual supplies under Article 3(2)(b) of this Directive shall apply these frequencies only for supply zones that distribute between 10 and 100 m3 per day. |
PART C
Risk assessment
1. |
Member States may provide for the possibility to derogate from the parameters and sampling frequencies in Part B, provided that a risk assessment is performed in accordance with this Part. |
2. |
The risk assessment referred to in point 1 shall be based on the general principles of risk assessment set out in relation to international standards such as standard EN 15975-2 concerning “security of drinking water supply, guidelines for risk and crisis management”. |
3. |
The risk assessment shall take into account the results from the monitoring programmes established by the second subparagraph of Article 7(1), and Article 8 of Directive 2000/60/EC of the European Parliament and of the Council (1) for bodies of water identified under Article 7(1) that provide more than 100 m3 a day on average, in accordance with Annex V to that Directive. |
4. |
Based on the results of the risk assessment, the list of parameters in point 2 of Part B shall be extended and/or the sampling frequencies in point 3 of Part B increased, where any of the following conditions is fulfilled:
|
5. |
Based on the results of the risk assessment, the list of parameters set out in point 2 of Part B and the sampling frequencies set out in point 3 of Part B may be reduced provided the following conditions are met:
|
6. |
Member States shall ensure that:
|
PART D
Sampling methods and sampling points
1. |
Sampling points shall be determined so as to ensure compliance with the points of compliance as defined in Article 6(1). 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. As far as possible, the number of samples shall be distributed equally in time and location. |
2. |
Sampling at the point of compliance shall meet the following requirements:
|
3. |
Sampling in the distribution network, with the exception of sampling at the consumers' tap, shall be in accordance with ISO 5667-5. For microbiological parameters, sampling in the distribution network shall be taken and handled according to EN ISO 19458, sampling purpose A. |
(1) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).’
ANNEX II
Annex III to Directive 98/83/EC is amended as follows:
(1) |
the introductory paragraph is replaced by the following: ‘Member States shall ensure that the methods of analysis used for the purposes of monitoring and demonstrating compliance with this Directive are validated and documented in accordance with EN ISO/IEC 17025 or other equivalent standards accepted at international level. Member States shall ensure that laboratories or parties contracted by laboratories apply quality management system practices in accordance with EN ISO/IEC 17025 or other equivalent standards accepted at international level. In the absence of an analytical method meeting the minimum performance criteria set out in Part B, Member States shall ensure that monitoring is carried out using best available techniques not entailing excessive costs.’; |
(2) |
point 1 is amended as follows:
|
(3) |
point 2 is amended as follows:
|
(4) |
point 3 is deleted. |