Water Intended for Human Consumption (Amendment) Regulations, 2017 (L.N. 299 of 2017)

L.N. 299 of 2017 VERZJONI ELETTRONIKA FOOD SAFETY ACT (CAP. 449) Water Intended for Human Consumption (Amendment) Regulations, 2017 IN EXERCISE of the powers conferred by article 10 of the Food Safety Act, the Minister responsible for Health has made the following regulations: B 2129 1. The title of these regulations is the Water Intended for citation. Human Consumption (Amendment) Regulations, 2017 and they shall be read and construed as one with the Water Intended for Human SL. 449.57. Consumption Regulations, hereinafter referred to as "the principal regulations". 2. Regulation 2 of the principal regulations shall be Substitutes substituted by the following: regulationZof "Scope and applicability. ~ the principal 2. ( 1) These regulations transpose the provisions of: (a) Council Directive 98/83/EC of 3 November, 1998, on the quality of water intended for human consumption; (b) Council Directive 2015/ 1787 of 6 October 20 15 amending Annexes II and III to Council Directive 98/83/EC on the quality of water intended for human consumption. (2) These regulations concern the quality of water intended for human consumption, with the objective 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, and to set in place a regime that provides protection to persons consuming the water and shall apply to any water supplied by a water supplier.". regulations. 3. Schedule II of the principal regulations shall be substituted Substitutes c- • Schedule II of by the 1ollowmg: the principal "SCHEDULE II (Regulation 8) Monitoring PART A regulations. B 2130 VERZJONI ELETTRONIKA General objectives and monitoring programmes for water intended for human consumption 1. Monitoring programmes for water intended for human consumption must: (a) verify that the measures in place to control risks to human health throughout the water supply chain from the catchment area through abstraction, treatment and storage to distribution are working effectively and that water at the point of compliance is wholesome and clean; (b) provide infom1ation on the quality of the water supplied for human consumption to demonstrate that the obligations set out in regulations 5 and 6 in the principal regulations, and the parametric values laid down in Schedule I, are being met; (c) identify the most appropriate means of mitigating the risk to human health. 2. Pursuant to regulation 8(2), the competent authority shall establish monitoring programmes complying with the parameters and frequencies set out in Part B of this schedule which consist of: (a) collection and analysis of discrete water samples; or (b) measurements recorded by a continuous monitoring process. In addition, monitoring programmes may consist of: (a) inspections of records of the functionality and maintenance status of equipment; and/or (b) inspections of the catchment area, water abstraction, treatment, storage and distribution infrastructure. 3. Monitoring programmes may be based on a risk assessment as set out in Part C of this schedule. 4. The competent authority shall ensure that monitoring programmes are reviewed on a continuous basis and updated or reconfirmed at least every 5 years. PARTB Parameters and frequencies VERZJONI ELETTRONIKA 1. General framework A monitoring programme must take into account the parameters referred to in regulation 6, 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 regulation 7(1). When choosing appropriate parameters for monitoring, local conditions for each water supply must be taken into consideration. The competent authority 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) Escheichia coli (E. cob) , 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 regulation 6(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 chlorination 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 in these regulations, all other parameters not analysed under Group A and set in accordance with regulation 6 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 B 213 1 VERZJONI ELETTRONIKA B 2132 monitoring Volume of water distributed or produced each day within a Group A parameters Group B parameters supply zone number of samples per year number of samples per year (See Notes 1 and 2) (See Note 3) > 100 > 1,000 > 10,000 > 100,000 m3 >0 >0 :S 100 (See Note 4) (See Note 4) :S 1,000 4 1 1 + 1 :S 10,000 For each 4,500 m3/d and part thereof of the total volume 4 3 +3 + 1 :S 100,000 For each 1,000 m3/d and part For each 10,000 m3/d and part thereof of the total volume thereof of the total volume 12 + 1 For each 25,000 m3/d and part thereof of the total volume Note I: 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 detennine the minimum frequency, assuming water consumption of 200 1/ ( 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: The competent authorities that have decided to exempt individual supplies under regulation 4(2)(b) shall apply these frequencies only for supply zones that distribute between 10 and 100 m3 per day. For these supply zones the frequency for Group A parameters shall be 4 samples per year and for Group B parameters shall be 1 sample every 2 years. VERZJONI ELETTRONIKA PARTC Risk assessment 1. The competent authority 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 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 sub-paragraph of Article 7(1), and Article 8 of Directive 2000/60/EC of the European Parliament and of the Council as transposed in regulation 7(1) and regulation 8 of the Water Policy Framework Regulations, for bodies of water intended under regulation 7(1) that provide more than 100 m3 a day on average, in accordance with Annex V to those regulations. 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: (a) the list of parameters or frequencies set in this Schedule is not sufficient to fulfil the obligations imposed under regulation 8( 1 ); (b) additional monitoring is required for the purpose of regulation 8(6); ( c) it is necessary to provide the necessary assurance set out in point ( 1 )(a) of Part A. 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: (a) the frequency of sampling for E. coli must not be reduced below the one laid down in point 3 of Part B under any circumstances; (b) for all other parameters: (i) the location and frequency of sampling shall be B 2133 B 2134 VERZJONI ELETTRONIKA determined in relation to the parameter 's origin, as well as the variability and long-tenn trend of its concentration, taking into account regulation 7; (ii) to reduce the minimum sampling frequency of a parameter, as set out in point 3 of Part B, the results obtained from samples collected at regular intervals over a period of at least 3 years from sampling points representative of the whole supply zone must all be less than 60% of the parametric value; (iii) to remove a parameter from the list of parameters to be monitored, as set out in point 2 of Part B, the results obtained from samples collected at regular intervals over a period of at least 3 years from points representative of the whole supply zone must all be less than 30% of the parametric value; (iv) the removal of a particular parameter set out in point 2 of Part B from the list of parameters to be monitored shall be based on the result of the risk assessment, informed by the results of monitoring of sources of water intended for human consumption and confinning that human health is protected from the adverse effects of any contamination of water intended for human consumption, as laid down in regulation 2; (v) the sampling frequency may be reduced or a parameter removed from the list of parameters to be monitored as set out in points (ii) and (iii) only if the risk assessment confirms that no factor that can be reasonably anticipated is likely to cause deterioration of the quality of water intended for human consumption. 6. The competent authority shall ensure: (a) risk assessments are approved by it and/or by any other competent authority; and (b) infonnation is available showing that a risk assessment has been carried out, together with a summary of its results . PARTD Sampling methods and sampling points 1. Sampling points shall be determined so as to ensure VERZJONI ELETTRONIKA compliance with the points of compliance as defined in regulation 7(1). In the case of a distribution network, the competent authority may take samples within the supply zone or at the treatment works for particular parameters if it can demonstrated that there would be no adverse change to the measured value of the parameter 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: (a) compliance samples for certain chemical parameters (in particular copper, lead and nickel) shall be taken at the consumer 's tap without prior flushing. A random daytime sample of one litre volume is to be taken. As an alternative, the competent authority may use fixed stagnation time methods that better reflect its national situation, provided that, at the supply zone level, this does not result in fewer cases of non-compliance than using the random daytime method; (b) compliance samples for microbiological parameters at the point of compliance shall be taken and handled according to EN ISO 19458, sampling purpose B. 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.". B 2135 4. Schedule III of the principal regulations shall be amended Amends c- Schedule III of as 1ollows: the principal (a) the introductory paragraph thereof shall be substituted by the following: "The competent authority shall ensure that the methods of analysis used for the purposes of monitoring and demonstrating compliance with these regulations 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 in accordance with EN ISO/ IEC 17025 or other equivalent standards accepted at international level. In the absence of an analytical method meeting the regulations. B 2136 VERZJONI ELETTRONIKA mmunum perfonnance criteria set out in Part B, the competent authority shall ensure that monitoring is carried out using best available techniques not entailing excessive costs."; (b) the heading of item 1 thereof up to including "Note l " shall be substituted by the following: "PART A MICROBIOLOGICAL PARAMETERS FOR WHICH METHODS OF ANALYSIS ARE SPECIFIED; The methods for microbiological parameters are: (a) Escherichia coh (E. coli) and colifonn bacteria (EN ISO 9308-1 or EN ISO 9308-2) (b) Enterococci (EN ISO 7899-2) ( c) Pseudomonas aeruginosa (EN ISO 16266) ( d) enumeration of culturable microorganisms - colony count 22°C (EN ISO 6222) (e) enumeration of culturable microorganisms - colony count 36°C (EN ISO 6222) (f) Clostridium pe1fringens including spores (EN ISO 14189)."; ( c) items 2, 2. 1 and 2.2 thereof shall be substituted by the following: "PARTB Chemical and indicator parameters for which performance characteristics are specified 1. Chemical and indicator parameters For the parameters set out in Table 1, the specified perfonnance characteristics are that the method of analysis used must, as a minimum, be capable of measuring concentrations equal to the parametric value with a limit of 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 VERZJONI ELETTRONIKA 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 1. The result shall be expressed using at least the same number of significant figures as for the parametric value considered in Parts B and C of Schedule I. Until 31 December 2019 the competent authority may allow for the use of "trueness", "precision" and "limit of detection" as specified in Table 2, as an alternative set of performance characteristics to "limit of quantification" and "uncertainty of measurement" as specified respectively in the first paragraph and Table 1. The uncertainty of measurement laid down in Table 1 shall not be used as an additional tolerance to the parametric values set out in Schedule I. B 2137 B 2138 Parameters Aluminium Ammonium Antimony Arsenic Benzo( a )pyrene Benzene Boron Bromate Cadmium Chloride Chromium Conductivity Copper Cyanide 1,2-dichloroethane Fluoride Hydrogen ion concentration pH (expressed in pH units) Iron Lead Manganese Mercwy Nickel Nitrate Nitrite Oxidisability Pesticides Polycyclic aromatic hydrocarbons Selenium Sodium Sulphate T etrachloroethene T richloroethene Trihalomethanes - total Total organic carbon (TOC) Turbidity VERZJONI ELETTRONIKA Table 1 Minimum performance characteristic "Uncertainty of measurement" Uncertainty of measurement (See Note 1) Notes % of the parametric value ( except for pH) 25 40 40 30 50 See Note 5 40 25 40 25 15 30 20 25 30 See Note 6 40 20 0,2 See Note 7 30 25 30 30 25 15 20 50 See Note 8 30 See Note 9 50 See Note JO 40 15 15 30 See Note 11 40 See Note 11 40 See Note JO 30 See Note 12 30 See Note 13 Aery/amide, epichlorohydrin and vinyl chloride to be controlled by product specification. VERZJONI ELETTRONIKA Table 2 Minimum performance characteristics "Trueness", "precision" and "limit of detection" may be used until 31 December 2019 Trueness Precision Limit of (See Note 2) (See Note 3) detection Parameters % of the %of the (See Note 4) Notes parametric value parametric value % of the parametric value ( except for pH) ( except for pH) ( except for pH) Aluminium 10 10 10 Ammonium 10 10 10 Antimony 25 25 25 Arsenic 10 10 10 Benzo( a )pyrene 25 25 25 Benzene 25 25 25 Boron 10 10 10 Bromate 25 25 25 Cadmium 10 10 10 Chloride 10 10 10 Chromium 10 10 10 Conductivity 10 10 10 Copper 10 10 10 Cyanide 10 10 10 See Note 6 1,2-dichloroethane 25 25 10 Fluoride 10 10 10 Hydrogen ion concentration 0,2 0,2 See Note 7 pH ( expressed in pH units) Iron 10 10 10 Lead 10 10 10 Manganese 10 10 10 Mercury 20 10 20 Nickel 10 10 10 Nitrate 10 10 10 Nitrite 10 10 10 Oxidisabil ity 25 25 10 See Note 8 Pesticides 25 25 25 See Note 9 Polycyclic aromatic 25 25 25 See Note JO hydrocarbons Selenium 10 10 10 Sodium 10 10 10 Sulphate 10 10 10 Tetrachloroethene 25 25 10 See Note 11 T richloroethene 25 25 10 See Note 11 Trihalomethanes - total 25 25 10 See Note JO Turbidity 25 25 25 Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification. B 2139 VERZJONI ELETTRONIKA B 2140 2. Notes to Table 1 and 2 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 info1mation used. The performance criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in the table or better. Measurement unce1tainty shall be estimated at the level of the parametric value, unless otherwise specified. Note2 Trueness is a measure of systematic error, i.e. the difference between the mean value of the large number of repeated measurements and the true value. Further specifications are those set out in ISO 5725. Note3 Precision is a measure of random error and is usually expressed as the standard deviation (within and betwe-en batches) of the spread of results from the mean. Acceptable precision is twice the relative standard deviation. This term is fu1ther specified in ISO 5725. Note4 Limit of detection is either: . three times the standard deviation within a batch of a natural sample containing a low concentration of the parameter, or . five times the standard deviation of a blank sample (within a batch) . Note5 If the value of uncertainty of measurement cannot be met, the best available technique should be selected (up to 60%). Note6 The method dete1mines total cyanide in all fo1ms. Note 7 Values for trueness, precision and uncertainty of measurement are expressed in pH units. Note8 Reference method: EN ISO 8467 Note9 The performance characteristics for individual pesticides are given as an indication. Values for the uncertainty of measurement as low as 30% can be achieved for several pesticides, higher values up to 80% may be allowed for a number of pesticides. Note JO The performance characteristics apply to individual substances, specified at 25% of the parametric value in Part B of Schedule I. Note 11 The performance characteristics apply to individual substances, specified at 50% of the parametric value in Part B of Schedule I. Note 12 The uncertainty of measurement should be estimated at the level of 3 mg/I of the total organic carbon (TOC). CEN 1484 Guidelines for the dete1mination of TOC and dissolved organic carbon (DOC) shall be used. Note 13 The uncertainty of measurement should be estimated at the level of 1,0 NTU (nephelo-metric turbidity units) in accordance with EN ISO 7027.' "; and ( d) item 3 thereof shall be deleted. l ppubblikat mid-Diparti.ment tal-Informazzjoni (doi.govnrt) - Valletta - Published by the Department of bifon11ati.on(doi.gov.mt) - Valletta Mitbu,,ah 11-Istamperija tal-Gvern fuq karta FSC - Prillted at the Government PrintiJlg Press on FSC certified paper J;;s FSC PreziJPrice €1.08