WATER INTENDED FOR HUMAN CONSUMPTION [ S.L. 449.63 SUBSIDIARY LEGISLATION 449.63 WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS 15th December, 2023 LEGAL NOTICE 297 of 2023. 1. The title of these re
Article 11
(2)(
- b)of the Directive; and (
- b)substances in relation to which there may be no possibility that the substance and its reaction products are present at levels exceeding 0.1 μg/l in water intended for human consumption, unless for specific substances a more stringent value is needed taking into account their toxicity. Organic materials shall be tested in accordance with Table 1 in conformity with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the results of the tests in terms of substance migration shall be converted into estimated levels at the tap. 2. Metallic materials Only the metallic materials included in the European positive list of compositions to be established by
Article 11(2)(b) of the Directive shall be used.
The limitations stipulated in the European positive list in respect of the composition of these materials, their use for certain products and the use of these products shall be complied with. The metallic materials shall be tested in accordance with Table 1 in conformity with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. 3. Cementitious materials The cementitious materials shall only be made of one or more of the following: (a) organic constituents listed in the European positive list of constituents to be established by
Article 11(2)(b) of the WATER INTENDED FOR HUMAN CONSUMPTION [ S.L.
449.63 Directive; (
- b)organic constituents in relation to which there is no possibility that the constituents and their reaction products are present at levels exceeding 0.1 μg/l in water intended for human consumption; or (
- c)inorganic constituents. Cement-bound materials shall be tested in accordance with Table 1 in conformity with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the results of the tests in terms of substance migration shall be converted into estimated levels at the tap. 4. Enamels and ceramic materials Enamels and ceramic materials shall only be made of starting substances from the European positive list of compositions to be established by
Article 11
(2)(
- b)of the Directive, after carrying out an assessment of the elements used in the composition of these materials. Enamels and ceramic materials shall be tested in accordance with Table 1 in conformity with methods for testing specified in relevant European standards or, in the absence thereof, an internationally or nationally recognised method and shall satisfy the requirements stipulated therein. For this purpose, the results of the tests in terms of substance migration shall be converted into estimated levels at the tap. 5. Exceptions for assessment of materials used in minor and assembled components For assembled products: minor components, parts and materials shall be described in detail and testing shall be reduced accordingly. For this purpose, "minor" refers to a level of influence on the quality of water intended for human consumption that does not require full testing. 49 50 [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION Table 1. Testing related to material types Criteria Organic Metallic (See Note (See Note Cementitious Enamels and 1) 2) ceramic material s European positive lists European positive list of X N.N. X N.N. N.N. X N.N. N.N. N.N. N.N. X N.N. N.N. N.N. N.N. X Odour and flavour X N.N. X N.N. Colour and turbidity X N.N. X N.N. X N.N. X N.N. N.N. X N.N. N.N. X X X X MTCtap of PL substances X N.N. X (See Note 3) N.N. Unexpected substances X N.N. X (See Note 3) N.N. N.N. X N.N. X X N.N. X (See Note 3) N.N starting substances for organic materials European positive list of accepted metallic compositions European positive list of constituents for cementitious materials European positive list of compositions for enamels and ceramic materials Organoleptic tests General hygiene assessments Leaching of total organic carbon Surface residues (metals) Migration testing Relevant parameters of this Directive (GCMS) Compliance with compositions lists Enhancement of microbial growth N.N.: Not necessary; WATER INTENDED FOR HUMAN CONSUMPTION [ S.L. 449.63 MTCtap: Maximum tolerable concentration at the tap (either derived from the opinion of ECHA for the purposes of inclusion of the substance in the European positive list, or based on a specific migration limit set in Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food and considering a 10 % allocation factor and water consumption of 2 litres per day); GCMS: Gas Chromatography – Mass Spectrometry (screening method). Note 1: Specific exceptions shall be determined in line with item 5. Note 2: The metals shall not be subject to organoleptic testing because it is generally accepted that if the parametric values set out in the Second Schedule are met, organoleptic problems are unlikely to arise. Note 3: Depending on the existence of organic substances in the composition. 51 52 [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION FIFTH SCHEDULE (Regulation 14) SPECIFICATIONS FOR THE ANALYSIS OF PARAMETERS The competent authority shall ensure that the methods of analysis used for the purposes of monitoring and demonstrating compliance with these regulations, with the exception of turbidity, are validated and documented in accordance with EN ISO/IEC 17025 or other equivalent standards accepted at international level. The competent authority 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. For the purposes of assessing the equivalence of alternative methods with the methods laid down in this Schedule, the competent authority may use standard EN ISO 17994, established as the standard on the equivalence of microbiological methods, or standard EN ISO 16140 or any other similar internationally accepted protocols, to establish the equivalence of methods based on principles other than culturing, which are beyond the scope of EN ISO 17994. In the absence of an analytical method meeting the minimum performance criteria set out in Part B, the competent authority shall ensure that monitoring is carried out using the best available techniques not entailing excessive costs. Part A Microbiological parameters for which methods of analysis are specified The methods of analysis for microbiological parameters are: (
- a)Escherichia coli (E. coli) and coliform bacteria (EN ISO 9308-1 or EN ISO 9308-2); (
- b)intestinal enterococci (EN ISO 7899-2); (
- c)colony count or heterotrophic plate counts at 22°C (EN ISO 6222); (
- d)14189); Clostridium perfringens including spores (EN ISO (
- e)Legionella (EN ISO 11731 for compliance with the value in Part D of the Second Schedule); for risk-based verification monitoring and to complement culture methods, in addition methods, such as ISO/TS 12869, rapid culture methods, non-culture-based methods, and molecular-based methods, in particular qPCR, may be used; [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION (
- f)somatic coliphages; for operational monitoring, Part A of the Third Schedule, EN ISO 10705-2, and EN ISO 10705-3 can be used. Part B Chemical and indicator parameters for which performance characteristics are specified
(1)Chemical and indicator parameters For the parameters set out in Table 1, the method of analysis used shall, as a minimum, be capable of measuring concentrations equal to the parametric value with a limit of quantification, as defined in Article 2
(2)of Commission Directive 2009/90/EC of 31 July 2009 laying down, pursuant to Directive 2000/60/EC of the European Parliament and of the Council, technical specifications for chemical analysis and monitoring of water status, of 30% or less of the relevant parametric value and an uncertainty of measurement as specified in Table
- The result shall be expressed using at least the same number of significant figures as for the parametric value referred to in Parts B and C of the Second Schedule. The uncertainty of measurement laid down in Table 1 shall not be used as an additional tolerance to the parametric values set out in the Second Schedule. Table
- Minimum performance characteristic ‘Uncertainty of measurement’ Parameters Uncertainty of measurement (See Note 1) % of the parametric value (except for pH) Aluminium 25 Ammonium 40 Acrylamide 30 Antimony 40 Arsenic 30 Benzo(a)pyrene 50 Benzene 40 Bisphenol A 50 Boron 25 Bromate 40 Cadmium 25 Chloride 15 Notes See Note 2 53 54 [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION Chlorate 40 Chlorite 40 Chromium 30 Copper 25 Cyanide 30 1,2-dichloroethane 40 Epichlorohydrin 30 Fluoride 20 HAAs 50 Hydrogen ion concentration pH 0,2 Iron 30 Lead 30 Manganese 30 Mercury 30 Microcystin-LR 30 Nickel 25 Nitrate 15 Nitrite 20 Oxidisability 50 See Note 5 Pesticides 30 See Note 6 PFAS 50 Polycyclic aromatic hydrocarbons 40 Selenium 40 Sodium 15 Sulphate 15 Tetrachloroethene 40 See Note 8 Trichloroethene 40 See Note 8 Trihalomethanes – total 40 See Note 7 Total organic carbon (TOC) 30 See Note 9 Turbidity 30 See Note 10 Uranium 30 Vinyl chloride 50
(2)See Note 3 See Note 4 See Note 7 Notes to Table 1 Note 1: Uncertainty of measurement is a non-negative parameter characterising the dispersion of the quantity values being attributed to a measurand, based on the information used. The performance criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in the table or any stricter WATER INTENDED FOR HUMAN CONSUMPTION [ S.L. 449.63 value. The uncertainty of measurement shall be estimated at the level of the parametric value unless otherwise specified. Note 2: If the value of uncertainty of measurement cannot be met, the best available technique shall be selected (up to 60%). Note 3: The method shall determine total cyanide in all forms. Note 4: The value for the uncertainty of measurement is expressed in pH units. Note 5: Reference method: EN ISO 8467. Note 6: The performance characteristics for individual pesticides are given as an indication. Values for the uncertainty of measurement as low as 30% may be achieved for several pesticides, while higher values up to 80% may be allowed for a number of pesticides. Note 7: The performance characteristics apply to individual substances, specified at 25% of the parametric value in Part B of the Second Schedule. Note 8: The performance characteristics apply to individual substances, specified at 50% of the parametric value in Part B of the Second Schedule. Note 9: The uncertainty of measurement should be estimated at the level of 3 mg/l of the total organic carbon (TOC). EN 1484 Guidelines for the determination of TOC and dissolved organic carbon (DOC) shall be used for the specification of the uncertainty of the test method. Note 10: The uncertainty of measurement should be estimated at the level of 1.0 NTU (nephelometric turbidity units), in accordance with EN ISO 7027 or another equivalent standard method.
(3)Sum of PFAS The following substances shall be analysed based on the technical guidelines developed in accordance with Article 13
(7)of the Directive: (
- a)Perfluorobutanoic acid (PFBA); (
- b)Perfluoropentanoic acid (PFPA); (
- c)Perfluorohexanoic acid (PFHxA); (
- d)Perfluoroheptanoic acid (PFHpA); (
- e)Perfluorooctanoic acid (PFOA); 55 56 [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION (
- f)Perfluorononanoic acid (PFNA); (
- g)Perfluorodecanoic acid (PFDA); (
- h)Perfluoroundecanoic acid (PFUnDA); (
- i)Perfluorododecanoic acid (PFDoDA); (
- j)Perfluorotridecanoic acid (PFTrDA); (
- k)Perfluorobutane sulfonic acid (PFBS); (
- l)Perfluoropentane sulfonic acid (PFPS); (
- m)Perfluorohexane sulfonic acid (PFHxS); (
- n)Perfluoroheptane sulfonic acid (PFHpS); (
- o)Perfluorooctane sulfonic acid (PFOS); (
- p)Perfluorononane sulfonic acid (PFNS); (
- q)Perfluorodecane sulfonic acid (PFDS); (
- r)Perfluoroundecane sulfonic acid; (
- s)Perfluorododecane sulfonic acid; (
- t)Perfluorotridecane sulfonic acid. Those substances shall be monitored when the risk assessment and risk management of the catchment areas for abstraction points carried out in accordance with regulation 9 conclude that those substances are likely to be present in a given water supply. WATER INTENDED FOR HUMAN CONSUMPTION [ S.L. 449.63 SIXTH SCHEDULE (Regulation 18) INFORMATION TO THE PUBLIC The information in the following points shall be accessible to consumers on-line, in a user-friendly and customised way, and consumers may obtain access to that information by other means upon justified request:
(1)identification of the relevant water supplier, the area and number of people supplied, and the method of water production, including general information on types of water treatment and disinfection applied; the competent authority may derogate from this requirement in accordance with Article 13
(1)of Directive 2007/2/EC of the European Parliament and of the Council of 14 March 2007 establishing an Infrastructure for Spatial Information in the European Community (INSPIRE);
(2)the most recent monitoring results for parameters listed in Parts A, B and C of the Second Schedule, including monitoring frequency together with the parametric value set in accordance with regulation 6; the monitoring results shall not be more than one year old, except where the monitoring frequency set by these regulations allow otherwise;
(3)information on the following parameters not listed in Part C of the Second Schedule and the associated values: (
- a)hardness; (
- b)minerals, anions or cations dissolved in water: (
- i)calcium Ca; (
- ii)magnesium Mg; (iii) potassium K;
(4)in the event of a potential danger to human health as determined by competent authorities or other relevant bodies following an exceedance of the parametric values set in accordance with regulation 6, information on the potential danger to human health and the associated health and consumption-related advice or a hyperlink providing access to such information;
(5)relevant information on the risk assessment of the supply system;
(6)advice to consumers, including on how water consumption may be reduced when appropriate, how to use water responsibly according to local conditions and how to avoid health risks due to stagnant water;
(7)for water suppliers supplying at least 10 000 m3 per day or serving at least 50 000 people, annual information on: 57 58 [ S.L. 449.63 WATER INTENDED FOR HUMAN CONSUMPTION (a) the overall performance of the water system in terms of efficiency and leakage rates, once that information is available and at the latest on the date set out in regulation 5
(3); (
- b)the ownership structure of the water supply by the water supplier; (
- c)when costs are recovered through a tariff system, information on the structure of the tariff per cubic metre of water, including fixed and variable costs and costs related to measures for the purposes of regulation 17, where such measures have been taken by water suppliers; (
- d)where available, a summary and statistics regarding consumer complaints received by the water suppliers on matters within the scope of these regulations;
(8)upon justified request, consumers shall be given access to historical data for information under sub-items
(2)and
(3), dating back up to 10 years, if available, and not earlier than 13th January 2023.