WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 1 SUBSIDIARY LEGISLATION 449.57 WATER INTENDED FOR HUMAN CONSUMPTION REGULATIONS * 16th January, 2009 LEGAL NOTICE 17 of 2009, as amended by Legal Notice 242 of 2009; and Act XXV of 2015, and by Legal Notice 299 of 2017. 1. The title of these regulations is the Water Intended for Human Consumption Regulations. 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; Citation. Scope and applicability. Substituted by: L.N.299 of 2017. (
- b)Council Directive 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.
(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.
- For the purposes of these regulations and unless the context otherwise requires: "the Act" means the Food Safety Act; "competent authority" means the Superintendent of Public Health or a person authorized to act on his behalf; "the Directive" means Council Directive 98/83/EC of 3 November, 1998 on the quality of water intended for human consumption and any amendments thereto; "distribution network" includes any method by which water intended for human consumption is transported to a domestic distribution system; "domestic distribution system" means the pipe work, fittings and appliances which are installed between the taps intended to convey water for human consumption, and the distribution network, except those which fall under the responsibility of the water supplier in its capacity as a water supplier; "Licensing Authority" means such authority as may be established by the Regulator for Energy and Water Services; "private water supply" means any potable water which is not distributed through a distribution network; "source" with respect to water shall include the outlet of water treatment works, a borehole, a pumping station, a blending point or *These regulations have been repealed by Legal Notice 297 of
- Definitions. Amended by: L.N. 242 of 2009; XXV. 2015.
- Cap.
- 2 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION a service reservoir, whether permanent or not; "water intended for human consumption" means: (a) all water either in its original state or after treatment, intended for drinking, cooking, food preparation or other domestic purposes, regardless of its origin and whether it is supplied from a distribution network, 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 authority is satisfied that the quality of the water cannot affect the wholesomeness of the foodstuff in its finished form; "water supplier" means any person who supplies water intended for human consumption and includes a private water supplier. Exemptions. 4.
(1)The provisions of these regulations shall not apply to: (
- a)natural mineral waters recognised as such by the competent authority, 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; (
- 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.
(2)The competent authority may exempt from the provisions of these regulations: (
- a)water intended exclusively for those purposes for which the competent authority is 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 fifty persons, unless the water is supplied as part of a commercial or public activity.
(3)In those cases where the competent authority grants the exemptions provided for in the preceding sub-regulation it 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. General obligations. 5.
(1)Without prejudice to other obligations under the provisions of other laws, the competent authority shall take the measures necessary to ensure that water intended for human WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 3 consumption is wholesome and clean. For the purposes of the minimum requirements of these regulations, water intended for human consumption shall be wholesome and clean if: (
- a)it 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)it meets the minimum requirements set out in Schedule I, Parts A and B; and (
- c)if in accordance with the relevant provisions of these regulations and in accordance with the Treaty, the competent authority takes all other measures necessary to ensure that water intended for human consumption complies with the requirements of these regulations.
(2)The competent authority shall ensure that the measures taken to implement the provisions of these regulations 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. 6.
(1)The competent authority shall set values applicable to water intended for human consumption for the parameters set out in Schedule I. Quality standards.
(2)The values set in accordance with the preceding subregulation shall not be less stringent than those set out in Schedule I. As regards the parameters set out in Schedule I, Part C, the values need be fixed only for monitoring purposes and for the fulfillment of the obligations imposed in regulation 9.
(3)The competent authority shall set values for additional parameters not included in Schedule I where the protection of human health in Malta or any part within it so requires. The values set should, as a minimum, satisfy the requirements of regulation 5
(1)(a). 7.
(1)The parametric values set in accordance with the preceding regulation 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. Point of compliance. Amended by: L.N. 242 of 2009. 4 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION
(2)In the case of water covered by sub-regulation
(1)(a), the competent authority shall be deemed to have fulfilled its obligation under this regulation and under regulations 5 and 9
(2)where it can be established that non-compliance with the parametric values set in accordance with regulation 6 is due to the domestic distribution s y s t e m o r t h e m a i n t e n a n c e t h e r eo f e x c e p t i n p r e m i se s a n d establishments where water is supplied to the public, such as schools, hospitals and restaurants.
(3)Where the provision of sub-regulation
(2)applies and there is a risk that water covered by sub-regulation
(1)(
- a)would not comply with the parametric values established in accordance with regulation 5, the competent authority 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. Monitoring. 8.
(1)The competent authority 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 these regulations and in particular the parametric values set in accordance with regulation 6. Samples should be taken so that they are representative of the quality of the water consumed throughout the year. In addition, the competent authority 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, and that any contamination from disinfection by-products is kept as low as possible without compromising the disinfection.
(2)To meet the obligations imposed in sub-regulation
(1), appropriate monitoring programmes shall be established by the competent authority for all water intended for human consumption. Those monitoring programmes shall meet the minimum requirements set out in Schedule II.
(3)The sampling points shall be determined by the competent authority and shall meet the relevant requirements set out in Schedule II.
(4)(
- a)The competent authority shall comply with the specifications for the analyses of parameters set out in Schedule III. (
- b)Methods other than those specified in Schedule III, Part 1, may be used, providing it can be demonstrated WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 5 that the results obtained are at least as reliable as those produced by the methods specified. Should the competent authority have recourse to alternative methods, it shall provide the European Commission with all relevant information concerning such methods and their equivalence. (
- c)For those parameters listed in Schedule III, Parts 2 and 3, any method of analysis may be used provided that it meets the requirements set out therein.
(5)The competent authority 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 regulation 6, if there is reason to suspect that they may be present in amounts or numbers which constitute a potential danger to human health. 9.
(1)The competent authority shall ensure that any failure to meet the parametric values set in accordance with regulation 6 is immediately investigated in order to identify the cause.
(2)If, despite the measures taken to meet the obligations imposed in regulation 5
(1), water intended for human consumption does not meet the parametric values set in accordance with regulation 6, and subject to regulation 7
(2), the competent authority shall ensure that the necessary remedial action is taken by the water supplier as soon as possible to restore its quality and shall give priority to their enforcement action, 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, where any supply of water intended for human consumption constitutes a potential danger to human health, the competent authority shall inform the Licensing Authority which shall prohibit the distribution, or restrict the use, of such water by the water supplier concerned as the case may be, or shall ensure that any other action which may be necessary to protect human health is taken by the water supplier. In addition the water supplier, following consultation with the competent authority, shall promptly inform consumers and give the necessary advice.
(4)The competent authority shall decide what action under the preceding sub-regulation 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)The competent authority may establish guidelines to assist the water suppliers to fulfill their obligations under sub-regulation
(3).
(6)In the event of non-compliance with the parametric values or with the specifications set out in Schedule I, Part C, the competent authority shall consider whether that non-compliance poses any risk to human health. It shall ensure that water suppliers take remedial action to restore the quality of the water where that is Remedial action and restrictions in use. Amended by: L.N. 242 of 2009. 6 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION necessary to protect human health.
(7)The competent authority shall ensure that, where remedial action is taken, water suppliers shall immediately notify consumers except in those cases where the competent authority considers the non-compliance with the parametric value to be trivial. Derogations. Amended by: L.N. 242 of 2009. 10.
(1)The competent authority may provide for derogations from the parametric values set out in Schedule I, Part B, or set in accordance with regulation 6
(3), up to a maximum value to be determined by it, 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 the competent authority intends to grant a second derogation, it shall communicate the review along with the grounds f o r i t s d e c isi o n o n t he se c o nd de ro g a t io n , t o t h e E ur o pe a n Commission. No such second derogation shall exceed three years.
(2)In exceptional circumstances, the competent authority may ask the European Commission for a third derogation for a period not exceeding three years.
(3)Any derogation granted in accordance with this regulation 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, the 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 authority consider the non-compliance with the parametric value to be trivial, and if action taken in accordance with regulation 9
(2)is sufficient to remedy the problem within thirty days, the requirements of sub-regulation
(3)need not be applied. In that case, only the maximum permissible value for the parameter concerned and the time allowed to remedy the problem shall be set by the competent authority.
(5)Recourse may no longer be had to sub-regulation
(4)if failure to comply with any one parametric value for a given water supply has occurred on more than thirty days on aggregate during the previous twelve months. WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 7
(6)In the case where the competent authority has recourse to the derogations provided for in this regulation, it shall ensure that the population affected by any such derogation is immediately informed of the derogation and of the conditions governing it by notice published in the Gazette and through any other appropriate media. In addition the competent authority shall, where necessary, ensure that advice is given to particular population groups for which the derogation could present a special risk: Provided that these obligations shall not apply in the circumstances described in regulation 4 unless the competent authorities decide otherwise.
(7)With the exception of derogations granted in accordance with the preceding sub-regulation
(4), the competent authority shall inform the European 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 five thousand persons, including the information specified in sub-regulation
(3).
(8)This regulation shall not apply to water intended for human consumption offered for sale in bottles or containers. 11. The competent authority 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 these regulations; the interpretative document and technical specifications pursuant to Article 3 and Article 4
(1)of Council Directive 89/106/EEC of 21 December 1988 on the approximation of laws, regulations and ad ministrati ve provisions of the Member States relating to construction products shall respect the requirements of these regulations. Quality assurance of treatment, equipment and materials. 12.
(1)Water suppliers shall quarterly publish up to date information on the quality of water for human consumption on a publicly available internet web page set up for this purpose and, where so practicable, they shall also make such information available to consumers through any other suitable electronic media. Information and reporting. Amended by: L.N. 242 of 2009.
(2)Without prejudice to the Freedom of Access to Information on the Environment Regulations, the competent authority shall publish a report every three years on the quality of water intended for human consumption with the objective of informing consumers. The first report shall cover the years 2002, 2003 and 2004. Each report shall include, as a minimum, all individual supplies of water exceeding 1 000 m³ a day as an average or serving more than five thousand persons and it shall cover three calendar years and be published within one calendar year of the end of the reporting period. S.L. 435.61
(3)The competent authority shall send its reports to the European Commission within two months of their publication. 8 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION
(4)The formats and the minimum information for the reports provided for in sub-regulation
(2)shall be determined having special regard to the measures referred to in these regulations and shall, if necessary, be amended in accordance with the procedure laid down in Article 12 of the Directive.
(5)Together with the first report the competent authority shall also produce a report to be forwarded to the European Commission on the measures it has taken or plans to take to fulfill its obligations pursuant to regulation 7
(3)and Schedule I, Part B, note
- WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 Schedule I (Regulation 5) Amended by: L.N. 242 of
- PARAMETERS AND PARAMETRIC VALUES PART A Microbiological parameters Parameter Parametric value (number/100 ml) Escherichia coli (E. coli) 0 Enterococci 0 The following applies to water offered for sale in bottles or containers: Parameter Parametric value Escherichia coli (E. coli) 0/250 ml Enterococci 0/250 ml Pseudomonas aeruginosa 0/250 ml Colony count 22ºC 100/ml Colony count 37ºC 20/ml PART B Chemical parameters Parameter Acrylamide Antimony Arsenic Benzene Benzo(a)pyrene Boron Bromate Cadmium Chromium Copper Cyanide 1,2-dichloroethane Epichlorohydrin Fluoride Parametric value 0.10 5.0 10 1.0 0.010 1.0 10 5.0 50 2.0 50 3.0 0.10 1.5 Unit μg/l μg/l μg/l μg/l μg/l mg/l μg/l μg/l μg/l mg/l μg/l μg/l μg/l mg/l Lead Mercury Nickel Nitrate 10 1.0 20 50 μg/l μg/l μg/l mg/l Notes Note 1 Note 2 Note 3 Note 1 Shall not apply until 31st December 2005 Notes 3 and 4 Note 3 Note 5 Shall not apply until 31st December 2005 9 10 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION Nitrite Pesticides Pesticides - Total Polycyclic aromatic hydrocarbons 0.50 0.10 0.50 0.10 mg/l μg/l μg/l μg/l Note 5 Notes 6 and 7 Notes 6 and 8 Sum of concentrations of specified compounds; Note 9 Selenium Tetrachloroethene and Trichloroethene Trihalomethanes - Total 10 10 μg/l μg/l 100 μg/l Vinyl chloride 0.50 μg/l Sum of concentrations of specified parameters Sum of concentrations of specified compounds; Note 10 Note 1 Note 1: The parametric value refers to the residual monomer concentration in the water as calculated according to specifications of the maximum release from the corresponding polymer in contact with the water. Note 2: Where possible, lower values should be aimed without compromising disinfection. For the water referred to in regulation 7
(1)(a), (b) and (d), the value must be met, at the latest, ten calendar years after the entry into force of Council Directive 98/83/EC. The parametric value for bromate from five years after the entry into force of Council Directive 98/83/EC until ten years after its entry into force is 25ug/l. Note 3: The value applies to a sample of water intended for human consumption obtained by an adequate sampling method at the tap and taken so as to be representative of a weekly average value ingested by consumers. Note 4: For the water referred to in regulation 7
(1)(a), (
- b)and (d), the value must be met, at the latest, fifteen calendar years after the entry into force of the Directive. The parametric value for lead from five years after the entry into force of the Directive until fifteen years after its entry into force is 25ug/l. Water suppliers must ensure that all appropriate measures are taken to reduce the concentration of lead in water intended for human consumption as much as possible during the period needed to achieve compliance with the parametric value. When implementing the measures to achieve compliance with that value water suppliers must progressively give priority where lead concentrations in water intended for human consumption are highest. Note 5: Water suppliers must ensure that the condition that [nitrate]/50 + [nitrite]/3 < 1, the square brackets signifying the concentrations in mg/l for nitrate (NO 3) and nitrite (NO 2), is complied with and that the value of 0,10 mg/l for nitrites is complied with ex water treatment works. Note 6: ‘Pesticides’ means: - organic insecticides, - organic herbicides, - organic fungicides, - organic nematocides, - organic acaricides, - organic algicides, - organic rodenticides, WATER INTENDED FOR HUMAN CONSUNPTION - organic slimicides, - related products (inter alia, growth regulators) [ S.L.449.57 11 and their relevant metabolites, degradation and reaction products. Only those pesticides which are likely to be present in a given supply need be monitored. Note 7: The parametric value applies to each individual pesticide. In the case of aldrin, dieldrin, heptachlor and heptachlor epoxide the parametric value is 0.030 μg/l. Note 8: ‘Pesticides – Total’ means the sum of all individual pesticides detected and quantified in the monitoring procedure. Note 9: The specified compounds are: - benzo(b)fluoranthene, - benzo(
- k)fluoranthene, - benzo(ghi)perylene, - indeno(1,2,3-cd)pyrene. Note 10: Where possible, lower values should be aimed without compromising disinfection. The specified compounds are: chloroform, bromoform, dibromochloromethane, bromodichloromethene. For the water referred to in regulation 7
(1)(a), (
- b)and (
- d)the value must be met at the latest, ten calendar years after the entry into force of the Directive . The parametric value for total THMs from five years after the entry into force of the Directive until ten years after its entry into force is 150ug/l. Water suppliers must ensure that all appropriate measures are taken to reduce the concentration of THMs in water intended for human consumption as much as possible during the period needed to achive compliance with the parametric value. When implementing the measures to achieve this value, water suppliers must give priority to those areas where THM concentrations in water intended for human consumption are highest. PART C Indicator parameters Parameter Aluminium Ammonium Chloride Clostridium perfringens (including spores) Colour Conductivity Parametric value 200 0.50 250 0 Unit μg/l mg/l mg/l Note 1 N u m b e r / Note 2 100 ml Acceptable to consumers and no abnormal change 2500 μS cm -1 at Note 1 20ºC Notes 12 [ S.L.449.57 Hydrogen ion concentration Iron Manganese Odour WATER INTENDED FOR HUMAN CONSUNPTION > 6.5 and < PH units 9.5 200 μg/l 50 μg/l Notes 1 and 3 Acceptable to consumers and no abnormal change Oxidisability Sulphate Sodium Taste Colony count 22ºC Coliform bacteria Total organic carbon (TOC) Turbidity 5.0 250 200 mg/l O 2 mg/l mg/l Note 4 Note 1 Acceptable to consumers and no abnormal change No abnormal N u m b e r / Note 5 change 100 ml 0 No abnormal change Acceptable to consumers and no abnormal change Note 6 Note 7 RADIOACTIVITY Parameter Tritium Total indicative dose Parametric Unit Notes value 100 Bq/l Notes 8 and 10 0.10 MSv/year Notes 9 and 10 Note 1: The water should not be aggressive. Note 2: This parameter need not be measured unless the water originates from or is influenced by surface water. In the event of non-compliance with this parametric value, the water supplier concerned must investigate the supply to ensure that there is no potential danger to human health arising from the presence of pathogenic micro-organisms, e.g. cryptosporidium. The competent authority shall include the results of all such investigations in the reports it is bound to submit under regulation 12
(2). Note 3: For still water put into bottles or containers, the minimum value may be reduced to 4.5 pH units. For water put into bottles or containers which is naturally rich in or artificially enriched with carbon dioxide, the minimum value may be lower. Note 4: This parameter need not be measured if the parameter TOC is analysed. Note 5: For water put into bottles or containers the unit is number/250 ml. Note 6: This parameter need not be measured for supplies of less that 10,000 m 3 a day. Note 7: In the case of surface water treatment, water suppliers should aim for a WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 13 parametric value not exceeding 1.0 NTU (nephelometric turbidity units) in the water ex treatment works. Note 8: Monitoring frequencies to be set later in Schedule II. Note 9: Excluding tritium, potassium –40, radon and radon decay products; monitoring frequencies, monitoring methods and the most relevant locations for monitoring points to be set later in Schedule II. Note 10:
- The proposals required by note 8 on monitoring frequencies, and note 9 on monitoring frequencies, monitoring methods and the most relevant locations for monitoring points in Schedule II shall be adopted in accordance with the procedure laid down in Article 12 of the Directive. When elaborating these proposals, the European Commission shall take into account inter alia the relevant provisions under existing legislation or appropriate monitoring programmes including monitoring results as derived from them. The European Commission shall submit these proposals at the latest within eighteen months following the date referred to in Article 18 of the Directive.
- A Member State is not required to monitor drinking water for tritium or radioactivity to establish total indicative dose where it is satisfied that, on the basis of other monitoring carried out, the levels of tritium of the calculated total indicative dose are well below the parametric value. In that case, the competent authority shall communicate the grounds for its decision to the European Commission, including the results of this other monitoring carried out. Schedule II (Regulation 8) Amended by: L.N. 242 of
- Substituted by: L.N.299 of
- Monitoring PART A General objectives and monitoring programmes for water intended for human consumption
- 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 information 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.
- Pursuant to regulation 8
(2), the competent authority shall establish 14 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION 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. PART B Parameters and frequencies 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
- 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. coli), coliform bacteria, colony count 22 oC, 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. WATER INTENDED FOR HUMAN CONSUNPTION 3. [ S.L.449.57 15 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) Group A parameters number of samples per year (See Note 3) Group B parameters number of samples per year ≤ 100 >0 (See Note 4) >0 (See Note 4) ≤ 1,000 4 1 m3 > 100 1 +1 > 1,000 > 10,000 For each 4,500 m3/d and part thereof of the total volume ≤ 10,000 ≤ 100,000 4 +3 3 +1 For each 1,000 m3/d and part thereof of the total volume For each 10,000 m3/d and part thereof of the total volume 12 +1 > 100,000 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 m 3/d + 12 for additional 3,300 m 3/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 m 3 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. 16 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION PART C Risk assessment
- 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.
- 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".
- 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 m 3 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 determined in relation to the parameter’s origin, as well as the variability and long-term 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 confirming that human health is protected from the adverse effects WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 17 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)information is available showing that a risk assessment has been carried out, together with a summary of its results. 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 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. 18 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION Schedule III (Regulation 8) Amended by: L.N. 299 of 2017. 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 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 minimum performance criteria set out in Part B, the competent authority shall ensure that monitoring is carried out using best available techniques not entailing excessive costs. PART A MICROBIOLOGICAL PARAMETERS FOR WHICH METHODS OF ANALYSIS ARE SPECIFIED; The methods for microbiological parameters are: (
- a)Escherichia coli (E. coli) and coliform 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 oC (EN ISO 6222) (
- e)enumeration of culturable microorganisms – colony count 36 oC (EN ISO 6222) (
- f)Clostridium perfringens including spores (EN ISO 14189). 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 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 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 WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 19 specified in Table
- 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
- 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. Table 1 Minimum performance characteristic "Uncertainty of measurement" Parameters Uncertainty of measurement (See Note 1) % of the parametric value (except for pH) Aluminium 25 Ammonium 40 Antimony 40 Arsenic 30 Benzo(a)pyrene 50 Benzene 40 Boron 25 Bromate 40 Cadmium 25 Chloride 15 Chromium 30 Conductivity 20 Copper 25 Cyanide 30 1,2-dichloroethane 40 Fluoride 20 Hydrogen ion concentration pH (expressed in pH units) 0,2 Iron 30 Lead 25 Manganese 30 Mercury 30 Nickel 25 Nitrate 15 Nitrite 20 Notes See Note 5 See Note 6 See Note 7 [ S.L.449.57 20 WATER INTENDED FOR HUMAN CONSUNPTION Oxidisability 50 See Note 8 Pesticides 30 See Note 9 Polycyclic aromatic hydrocarbons 50 See Note 10 Selenium 40 Sodium 15 Sulphate 15 Tetrachloroethene 30 See Note 11 Trichloroethene 40 See Note 11 Trihalomethanes – total 40 See Note 10 Total organic carbon (TOC) 30 See Note 12 Turbidity 30 See Note 13 Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification. Table 2 Minimum performance characteristics "Trueness", "precision" and "limit of detection" may be used until 31 December 2019 Parameters Trueness (See Note 2) % of the parametric value (except for pH) Precision (See Note 3) % of the parametric value (except for pH) Limit of detection (See Note 4) % of the parametric value (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 1,2-dichloroethane 25 25 10 Fluoride 10 10 10 Hydrogen ion concentration pH (expressed in pH units) 0,2 0,2 Iron 10 10 10 Lead 10 10 10 Manganese 10 10 10 Notes See Note 6 See Note 7 WATER INTENDED FOR HUMAN CONSUNPTION [ S.L.449.57 Mercury 20 10 20 Nickel 10 10 10 21 Nitrate 10 10 10 Nitrite 10 10 10 Oxidisability 25 25 10 See Note 8 Pesticides 25 25 25 See Note 9 Polycyclic aromatic hydrocarbons 25 25 25 See Note 10 Selenium 10 10 10 Sodium 10 10 10 Sulphate 10 10 10 Tetrachloroethene 25 25 10 See Note 11 Trichloroethene 25 25 10 See Note 11 Trihalomethanes – total 25 25 10 See Note 10 Turbidity 25 25 25 Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.
- 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 information used. The performance criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in the table or better. Measurement uncertainty shall be estimated at the level of the parametric value, unless otherwise specified. Note 2 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
- Note 3 Precision is a measure of random error and is usually expressed as the standard deviation (within and between batches) of the spread of results from the mean. Acceptable precision is twice the relative standard deviation. This term is further specified in ISO
- Note 4 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). Note 5 If the value of uncertainty of measurement cannot be met, the best available technique should be selected (up to 60%). Note 6 The method determines total cyanide in all forms. Note 7 Values for trueness, precision and uncertainty of measurement are expressed in pH units. 22 [ S.L.449.57 WATER INTENDED FOR HUMAN CONSUNPTION Note 8 Reference method: EN ISO 8467 Note 9 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 10 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/l of the total organic carbon (TOC). CEN 1484 Guidelines for the determination 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.