Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 2009 (No. 405/09)

Statutory Document No. 405109 FOOD ACT 1996 NATURAL MINERAT WATE& SPRING WATER AND BOTTLED DRINKING WATER REGULATIONS 2OO9 INDEX PART 1 Lrtroductory Title Commencement hrterpretation Exemptions PART 2 Natural mineral water Recognition as natural mineral water Exploitation of natural mineral water springs Treatrnents and additions for natural mineral water Bottling of natural mineral water Marking, labell-ing and advertising of natural mineral water Sale of natural mineral water PART 3 Spring water Bottling of spring water and exploitation of spring water springs Marking, labelling and advertising of spring water Sale of spring water 1. 2 3 4 5 6 7 8 9 10 11 12 13 1.4 15 16 PART 4 Bottled drinking water Bottling of drinking water Marking, labelling and advertising of bottled drinking water SaIe of bottled drinking water PART 5 Miscellaneous and supplemental Enforcement Arrangements for samples taken for analysis Secondary analysis by the LIK Government Chemist Methods of analysis Offences and penalties Defences Application of other provisions Schedule 1 - Conditions for treatment of natural mineral waters and spring waters with ozone-enriched air Schedule 2 - Requirements for spring water and drinking water including prescribed concentrations or values of parameters Part L - Requirements for spring water and drinking water Part2 - Prescribed concentrations or values Schedule 3 - Recognition of natural mineral waters Part 1 - Natural mineral waters extracted from the ground in the Island Part2 - Natural mineral waters extracted from the ground in a country other than an EEA State Part 3 - Requirements and criteria for recognition as a nafural mineral water Schedule 4 - Exploitation and bottling requirements for natural mineral water and spring water Schedule 5 - Particulars of anions, cations, non-ionised compounds and trace elements Schedule 6 - Maximum limits for constituents of natural mineral waters Schedule 7 - Performance characteristics for analysing the constituents in Sdredule 6 Schedule 8 - Labelling indications for natural mineral water and criteria for use. 17 18 19 20 2't 22 23 2 Statutory Document No. 405109 FOOD ACT 1996 NATURAL MINERAL WATE& SPRING WATER AND BOTTLED DRINKING WATER REGULATIONS 2OO9 þproaedby Tynzaøld 16lune 2009 Coming into operøtion L luIY 2009 The Department of Local Government and the Environment makes these Regulations under sections 4, 17(1), 2'l'(a), 25, 4I(T),(2),(3) and (6), of and paragraphs L and aþ) of Schedule L to the Food Actl9961having consulted as required by section 41(8) of that Act. PART 1 INTRODUCTORY Title These Regulations may be cited as the Natural Mineral Water, Spti.g Water and Bottled Drinking Water Regulations 2009. Commencement If approved by Tynwald2, these Regulations come into operation on 1 JuIy 2009. Interpretation (1) In these Regulations "the Act" means the Food Act1996; "advertisement" and "advertise" shall have the same meanings as those given to them in regulation 2(1) of the Food Labelling Regulations 20043; t1996 c.8 2 As required by section a1.Q) ofthe Act '5.D.453104 Price Band o f3.40 I 2 3 3 "authorised ozone-enriched air oxidation technique" mearì.s (a) a treatment with ozone-enriched air authorised and carried out in accordance with Schedule 1; or (b) in the case of water brought into the Island from other parts of the United Kingdom or from another EEA Státe a treatment which complies with Article 5 of Directive 2003140 as implemented in that part of the United Kingdom or that EEA State; "bottle", the noun, means a closed container of any kind in which water is sold for drinking by humans or from which water sold for drinking by humans is derived, and "bottle", the verb, and cognate expressions, shall be construed accordingly; "Department" means the Department of Local Government and the Environmen! "Directive 801777" means Council Directive 801777lEECa on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters; "Directive 98183' means Council Directive 98l83lBcs relating to the quality of water intended for human consumption; "Directive 2003 I 40' means Commis sion Directi v e 2003 I 40 lEC6 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters; "drinking wateÍ" means water which is intended for sale for drinking by humans other than (a) natural mineral water; or a 01 No. L229,90.8.80, p.I, as last amended by Regulation (EC) No. 1882/2003 of the European Parliament and of the Council adapting to Council Decision 199914681E.C the provisions relating to Committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 25'1. of the EC Treaty (Of No. L284,3'J..10.2003, p.1). s o¡ No. Lz:;o,s.L2.9B,p.B2. 6 o¡ No. Lrz6, 22.s.2003, p.34. 4 (b) water bottted in a bottle marked or labelled "spring water" in accordance with regulation 12; "effervescent nafural mineral w ate{' means natural mineral water whiclu at source or after bottling, gives off carbon dioxide spontaneously and in a clearly visible manner under normal conditions of temperature and pressure; "nahttalmineral wateÍ" means water which (a) ismicrobiologicallywholesome; (b) originates in an underground water table or deposit and emerges from a spring tapped at one or more nafural or bore exits; (c) can be clearly distinguished from ordinary drinking water on account of the following characteristics having been preserved intact because of the underground origin of the water, which origin shall have been protected from all risk of pollution its nature, which is characterised by its mineral content, trace elements or other constituents and, where appropriate, by certain effects, (iÐ its original state; and (d) is for the time being recognised pursuant to and in accordance with regulation S; "parameter" means a property, elemenf organism or substance listed in the second column of any Table in part 2 of schedule2; "prescribed concentration oï va\ue", in relation to any parameter, means the concentration or value specified in relation to that parameter i. *y Table in part 2 of schedule 2 as measured by reference to the unit of measurement so specified; and "serr" includes possess for sale and offer, expose or advertise for sale, and "sale" shall be construed accordingly. other expressions used both in these Regulations and in Directive 801777 or DirectivegSlB3 have the same meaning in these Regulations as they bear in the Directive concerned. (Ð (2) 5 "water subjected to an authorised ozone-enriched air oxidation technique", which must appear in proximity to the analytical composition of characteristic constituents; and (e) it any case where its fluoride concentration exceeds 1.5 mg/I (Ð the words "contains more than 1.5 mg/l of fluoride: not suitable for regular consumption by infants and drildren under 7 yearc of age", which shall aPPear in proximity to the trade narne and in clearly visible draracters, and (ii) the actual fluoride content in relation to the physico-chemical compositioru which shall be included within the statement referred to in paragraph (Z)(a). (3) Where in accordance with paragraph (1Xb) a bottle containing a natural mineral water is required to be marked or labelled with the place of exploitation or the name of the spring (a) the same requirement shall also apply to any written advertisement for that natural mineral water; and (b) i^ any other advertisemenf at least equivalent prominence shall be given to the place of exploitation or the narne of the spring as is given to the trade description. (4) A person must not advertise any natural mineral water under any designation, proprietary name, trade mark, brand name, illustration or other sign, whether emblematic or nof the use of which suggests a characteristic which the water does not possess, in particular as regards its origi:r, the date of authorisation to exploit it, the results of analyses or any similar references to guarantees of authenticity. (5) A person must not advertise any natural mineral water in contravention of paragraph (3). t2 10 Sale of natural mineral water (1) A person must not sell any water bottled in a bottle the marking or labelling of which uses the name "natural mineral water" ir:r or as the name of the water unless that water is natural mineral water. (2) A person must not sell any bottled natural mineral water (a) which contains (i) Parasites or pathogenic micro-organisms, (ä) Escherichia coli or other coliforms and faecal streptococci in any 250 ml sample examined, (iii) Sporulated sulphite-reducing anaerobes in any 50 ml sample examined or (iv) Pseudomonøs øeruginosø in any 250 ml sample examined; (b) where the total colony count of the water at the source from which that water was taken does not comply with paragraph 7 of Schedule 4; (c) where the revivable total colony count of that water is in excess of that which would result from the normal increase in the bacteria content which it had at source; or (d) where that water contains any organoleptic defect. (3) A person must not sell any bottled natural mineral water (a) which has been extracted from a spring which is exploited in contravention of regulation 6; @) which has been subjected to any treatment or addition in contravention of regulation7; or (c) which is marked or labelled in contravention of regulation 9. (4) A person must not sell any natural mineral water from one and the same spring under more than one trade description. PART 3 SPRING WATER Bottling of spring water and exploitation of spring water springs tl 13 72 (1) A person must not cause any water to be bottled in a bottle marked or labelled with the description "spring water" u¡less that water (a) has been extracted from a spring; and (b) meets the requirements of Schedules 2 and 4. (2) A person must not cause any water which has been treated with ozone-enriched air to be bottled in a bottle marked or labelled spring watet u¡less that treatment is an authorised ozone enriched air oxidation technique. (3) If it is found during exploitation that spring water is polluted and that bottling of the water would contravene paragraph 6,7 or 8 of Schedule 4, a person must not exploit the spring from which the water is extracted until the cause of the pollution is eradicated and the bottling of the water would comply with those paragraphs. Marking, labelling and advertising of spring water (1) A person must not cause any bottle to be marked or labelled with the description "spring water" unless the water contained in it (a) is bottled as specified in regulation 11; and (b) is intended for consumption in its natural state. (2) A person must not cause any bottle containing water and marked or labelled with the description "spring water" to be marked or labelled with (a) a trade description including the name of a locality, hamlet or other place, un-less that trade description refers to water the spring of which is exploited at the place indicated by that description and is not misleading as regards the place of exploitation of the spring; or (b) a trade description that is different from the name of the spring or the place of its exploitation unless the place of exploitation or the name of the spring is also marked or labelled on the bottle, using letters at least one and a half times the height and width of the largest of the letters used for that trade description. L4 13 (3) A person must not cause any water to be bottled in a bottle marked or labelled with the description "spring water" unless the bottle is also marked or labelled with (a) the name of the place where the spring in question is exploited; and (b) the name of the spring; and (c) it aoy case where the water has undergone an authorised ozone-effiched air oxidation technique, the words "water subjected to an authorised ozonæffiched air oxidation technique", which words shall appear in proxi^ity to the particulars referred to in sub-paragraphs (a) and þ). (4) If in accordance with paragraph (2Xb) a bottle containing spring water is required to be marked or labelled with the place of exploitation or the name of the spring (u) the same requirement applies also to any written advertisement for that spring water; and (b) i^ aoy other advertisement, at least equivalent importance must be given to the place of exploitation or the name of the spring as is given to the trade description. (5) A person must not advertise any spring water in contravention of paragraph (4). Sale of spring water (1) A person must not sell any water bottled in a bottle marked or labelled with the description "spring water" (a) which has not been bottled in accordance with regulation 11,; or þ) which is not marked or labelled in accordance with regulattonL2. (2) A person must not sell water from one and the same spring, bottled in a bottle marked or labelled with the description "spring wateÍ", under more than one trade description. PART 4 BOTTLED DRINKING WATER 15 15 1.4 L6 Bottling of drinking water A person must not cause any drinking water to be bottled unless that water meets the requirements of Schedule 2. Marking, labelling and advertising of bottled drinking water A person must not (a) cause any drinking water which does not satisfy the provisions of Section I of Annex I to be bottled in a bottle marked or labelled with (Ð any designatiorL proprietary name/ trade marþ brand narne, illustration or other sign, whether emblematic or not the use of which is liable to cause confusion of the water with a natural mineral water, or (iÐ the description "mineral water"; or (b) cause any bottled drinking water which does not satisfy the provisions of Section I of A¡nex I to be advertised under (i) any designatiorç proprietary n¿une/ trade marþ brand name, illustration or other sign, whether emblematic or not the use of which is liable to cause confusion of the water with a natural mineral water, or (iÐ the description "mineral water". Sale of bottled drinking water A person must not sell any bottled drinking water which (a) has not been bottled in accordance with regulation 14; or (b) has not been marked or labelled in accordance with regulation 1"5. PART 5 MISCELLANEOUS AND SUPPLEMENTAL Enforcement (1) The Department must carry out periodic checks on any water which has been recognised as a natural mineral water to ensure that L7 16 19 ïegulation) having his or her name and an address in the Island displayed on the bottle or any other container, the officer must, r.urless he or she decides not to have an analysis made, within 3 days of procuring the sample send to that Person a notice informing them (a) that the sample has been procured by the officer; and þ) where the sample was taken or, as the case may be, from whom it was purchased. (10) Where a sample taken or purchased by an authorised officer has been analysed by a public analyst, any Person to whom a part of the sample was given under this regulation is entitled, upon request to the Departrnent, to be supplied with a coPy of the certificate of analysis by the Departnnent. Secondary analysis by the UK Government Chemist (1) This regulation applies where a part of a sample has been retained under regulation 18(7) and (a) proceedings are intended to be or have been cofiunenced against a person for an offence under these Regulations; and (b) the prosecution intends to adduce as evidence the result of the anaþsis mentioned in regulation 18, (2) The authorised officer may, and, if so ordered by the court or so requested by the prosecutor (if a person other than the authorised officer) or (subject to paragraph (3)) by the defendant, must, send the retained part of the sample to the Government Chemist in the UK for analysis. (3) If the defendant makes a request under paragraph (2), the authorised officer may request payment of a fee to defray some or all of the Government Chemisls charges and in the absence of agreement by the defendant to play that fee, the authorised officer may refuse to comply with the request. (4) On receipt of the Government Chemist's certificate of analysis the authorised officer must forthwith send a coPy to the prosecutor (if a person other than the authorised officer) and the defendant. (5) In this regulation "defendant" includes a ProsPective defendant. 19 20 Methods of analysis Methods of analysis which accord with Article 7.5 of Directive 98/83 must be used for the purposes of determining whether or not water satisfies the provisions of Schedule 2. Offences and penalties A person who contravenes regulation 6,7(I),8(1), (3), or (4), 9,'1.0, 1'1., 12, 13, L4, 15, '16 or 23(3) is g"ilty of an offence and liable on sununary conviction to a fine not exceeding €5000 or imprisonment for a term not exceeding 6 months or to both. Def ences (1) Irt ary proceedings for an offence under these Regulations it is a defence for the accused to show that the water was bottled and marked or labelled before these Regulations came into operation; and (2) In any proceedings for an offence under these Regulations where it is alleged that water does not meet the requirements in paragraph 1(c) of Part L of Schedule 2, 7t is a defence for the person accused to show that (a) the water in question was bottled or sold in an EEA State other than the UK; and (b) the water complied with the law in that EEA State when it was bottled or sold. Application of other provisions (1) The following provisions of the Act shall apply for the purposes of these Regulations and, unless the context otherntise requires, any reference in those provisions to the Act or Part shall be construed for the purposes of these Regulations as a reference to these Regulations (a) section 2 (extended meaning of "sale" etc.); (b) section 3 (presumptions that food intended for human consumption); (c) section 24(n (which relates to documentary evidence); (d) section 27(1) (obstruction etc. of officers); (e) section 27(2), with the modification that the reference to "arry such requirement as is mentioned in subsection 1(b) above" shall be deemed to be a reference to any such requirement 27 22 23 20 as is mentioned in that subsection as applied by sub-paragraph (d) (Ð section 29(L) (punishment of offences) in so far as it relates to offences under section 27(1) as applied by sub-paragraph (d); (g) section 29(2) and (3) insofar as they relate to offences under section 27(2) as applied by sub paragraph (e) (h) section 30 (offences by bodies corporate); (i) section 3L (offences due to fault of another person); û) section 32 (defence of due diligence) as it applies for the purposes of section L5 or 1,6; and (k) section 33 (defence of publication in the course of business); (2) Regulation 39 (intelligibility) of the Food Labelling Regulations 2004 shall apply to any narne, description" indication, information or other wording with which water is required or permitted by these Regulations to be marked or labelled as it applies to particulars required to be labelled under the Food Labelling Regulation s 2004. (3) A person must not sell any water to which these Regulations apply if the bottle in which it is bottled is not marked or labelled in accordance with regulation 39 of the Food Labelling Regulations2004 as applied by paragraph (2). 24 Revocation The Drinking Water in Containers Regulations 200L11 are revoked MADE 20ù May 2009 I P Shimmín Minister for Local Government and the Environment 11 so tsglot 2T 't RegulationlT(2) SCHEDULE 1 CONDITIONS FOR TREATMENT OF NATURAL MINERAL WATERS AND SPRING WATERS WITH OZONE ENRICHED AIR Treatment of natural mineral waters and spring waters with ozone enriched air must only be carried out if (a) it is for the purpose of separating compourìds of irorç manganese, sulphur and arsenic from water in which they occur nafurally at source; (b) prior to treatment the requirements of paragraphs 3, 4 and 5 of Schedule 4 are satisfied; and (") the treatment does not have a disinfectant action. Treatment of natural mineral waters and spring waters with ozone enriched air must not (a) modify the physico--chemical composition of the water in terms of its characteristic constituents; or (b) leave residues in the water which could pose a risk to public health, or, in the case of the substances listed below, above the levels specified. Treøtment residue Møxímumlimit (¡tg/I) Dissolved ozone 50 Bromate 3 Bromoform 1 A person seeking to have a treatment with ozone-enriched air authorised must (a) make application in writing to the Departmen! (b) permit representatives of the Department to examine the proposed method of treatment, and place of treatment, and take samples for analysis in accordance with regulation 18; and (c) provide such information in support of the application as is requested by the Department. The Department must assess the application and any information in its possession and must authorise the treatment if it is satisfied that 2 3 4 22 5 (a) the treatment is justified by the composition of the water at source; (b) the person carrying out the treatment is taking all necessary measures to ensure that the treatment is effective and safe; and (c) the treatment otherwise complies with paragraphs 1 and 2. If the Department decides to authorise a treatment pursuant to paragraph 4 it must inform the operator of the treatment in writing and state the date from which the authorisation for commercial use of the treatment has effect. If the Department refuses to authorise a treatment pursuant to paragraph 4, it must inform the operator of the treatment in writing stating its reasons. If a treatment has been authorised pursuant to paragraph[, the person carrying out the treatrnent must, for the PurPose of enabling the Departrnent to assess whether the conditions in paragraph a(a) and (b) continue to be satisfied (a) permit representatives of the Department to examine the method of treatrnent and place of treatment and take samples for analysis in accordance with regulation L8; and (b) provide such information related to the treatment as is requested by the DePartment. If the Department is satisfied that the conditions specified in paragraph 4 are no longer fulfilled, it may withdraw authorisation of a treatment by giving the person operating that treatment a written notice stating the grounds for withdrawal. Where the Department has informed an operator under paragraph 6 of its refusal to authorise a treatment under paragraph 4 or withdraws authorisation of a treatment under paragraph 8, the person who wishes to carry out the treatrnent may apply to the Department for a review of that decision. Upon receiving the application for review, the Department must make such inquiry into the matter as seems to it to be appropriate and, having considered the results of that enquiry and any relevant facts elicited by rt, must either confirm the decision to grant or restore, as appropriate, authorisation of the treatment Process in operation. 6 7 8 9 10 23 1. Regulations 3(1), 11(1)(b),14,20 and 22(2) SCHEDULE 2 REQUIREMENTS FOR SPRING WATER AND DRINKING WATER INCLUDING PRESCRIBED CONCENTRATIONS OR VALUES OF PARAMETERS PART 1 REQUIREMENTS FOR SPRING WATER AND DRINKING WATER Water satisfies the requirements of this Schedule if (a) the water does not contain (i) any micro-organism (other than a parameter) or parasite, or (ii) any properly, element or substance (other than a parameter), at a concentration or value which would constifute a potential danger to human health; (b) the water does not contain any substance (whether or not a parameter) at a concentration or value whicþ in conjunction with any other property, elemenÇ substance or organism it contains (whether or not a parameter), would constitute a potential danger to human health; (c) the water does not contain concentrations or values of any of the parameters listed in Tables A to D in Part 2 of this Schedule in excess of the prescribed concentrations or values; and (d) in the case of water prepared from water which has been softened or desalinated, its hardness is not below a minimum concentration of 60 mg Ca/l. The concentrations or values of the parameters listed in Tables A to D in Part 2 of this Schedule must be read in conjunction with the notes below the tables. 2 24 PART 2 PRESCRIBED CONCENTRATIONS OR VALUES Table A Notes: 1. The concentration (mg/l) of nitrate divided by 50 added to the concentration (mg/l) of nitrite divided by 3 must not exceed L. 2. Excluding tritium, potassium-4O, radon and radon decay products. Columnl Item Column 2 Pørameters ColumnS Units of Measurement Column4 Concentration or VøIue (møximum unless othennise støted) 1 Colour mgl1PtlCo scale 20 2. Turbidity NTU 4 J. Odour Dilution number 3 at 25'C 4. Taste Dilution number 3 at 25'C 5 Sulphate mg SOa/l 250 6 Sodium mg Na/l 200 7 Nitrate mg NOs/l 50 (note 1) 8. Nitrite mg NOz/l 0.5 (note 1) 9 Aluminium FgAUI 200 10. Copper mg Cu[ 2 11.. Fluoride mg F/l 1.5 12. Hydrogen ion concentration pHunits 4.5 (minimum) 9.5 (maximum) 13. Tritium (for radioactivity) Bqll 100 1,4. Total indicative dose mSv/year 0.1,0 (note 2) 15. Manganese ¡rg lvf¡ú 50 25 Table B Notes: 'I.. 'Pesticides" means organic insecticides, organic herbicides, organic fungicides, organic nematocides, organic acaricides, organic algicides, organic rodenticides, organic slimicides, and related products (inter alia, growth regulators) attd their relevant metabolites, degradation and reaction products. OoIy those pesticides which are likely to be present in a given water need to be monitored. 2 The maximum concentration applies to each individual pesticide. In the case of aldrin, dieldri+ heptaclor and heptachlor epoxide the maximum concentration is 0.030 ¡rg/1. 3 The maximum concenlration for "total substances" refers to the sum of the concentrations of all individual pesticides detected and quantified in the monitoring procedure. 4 The specified compounds are benzoþ)fluoranthene, benzo (k)fl uoranthene, benzo ( ghi) perylene, indeno (1..2,3- cd) pyrene. Column 1 Item Column 2 Pørameters Column 3 Units of Meøsuremant Column4 Max,imum Concentr øtion 1. Arsenic Pg Asfl 1.0 2. Cadmium pg Cd/l 5 3. Cyanide ¡-tg CNÄ 50 4. Ch¡omium ¡ryCrll 50 5 Mercury þLgF{El L 6. Nickel ¡rgNi/l 20 7 Selenium ¡rg Se/l 10 8. Antimony v'gsb/I 5 9 Lead ygPblI 10 10. Pesticides and related products: individual substances v9n 0.10 (notes 1 and 2) total substances þLgll 0.50 (notes L and 3) LL Polyryclic aromatic Hydrocarbons FEII 0.1 sum of concentrations of specified compounds (note 4) 12 Bromate ¡rg BrOs/l 10 26 Column 4 Møximum Concentration Column3 Units of Meøsurement Column 2 Pørømeters Column 1 Item 01250 rnlnumber25O ml1 Es cherichia coli (E. coli) 0/250 mlnumber/25O ml2. Enterococci 100/ml (notes 1 and 2)number/ml3. Colony count 22oC 20lml (notes 1 and 3)number/ml4. Colony count 37oC 0/250 mlnumber/250/ml5. P s eudomonøs aeru gino s ø Table C Notes: 1. 2 3 The total viable colony count should be measured within L2 hours of bottling, with the samPle water being kept at a constant temperature during that 12 hour period. Any increase in the total viable colony count of the water between 12 hours after bottling and the time of sale should not be greater than that normally expected. InZ2hours on agar-agar or an agar-gelatine mixture. In z4hours on agar-agar. Table D Column 3 Units of Meøsuretnent Column4 Møxilnum Concentrøtion Column2 Pørømeters Column 1 Item 1.0mgllBoron1. 0.010vsllBenzo (a) pyrene2 10 (note 1)v9lrTetrachloroethene and TrichloroetheneJ J*sll4 Tetrachloromethane 1.0vslr5 Benzene 3,0VEIL6 1,2-dichloroethane vslr 100 (note 1)Trichloromethane, Dichlororbromomethane, Dibromochloromethane and Tribromomethane 7 0.10 (note 2)vsllEpichlorohydrin8 0.50 (note 2)vsll9 Vinyl chloride 0.10 (note 2)vslr10. Acrylamide 27 1. 2 J 4 Regulations 5 and 1.7 SCHEDULE 3 RECOGNITION OF NATURAL MINERAL WATERS PART 1 NATURAL MINERAL WATERS EXTRACTED FROM THE GROUND IN THE ISLAND A person seeking to have water which is extracted from the ground in the Island recognised as a natural mineral water for the purposes of Article 1- must make application in writing to the Department giving the particulars set out in paragraphZ. The particulars are (a) those specified in paragraph 1 of Parl2; (b) any other information showing that the matters specified in paragraphs 2 and 3 of Part 2 are established; and (c) suc-h evidence as is satisfactory to show that the water contains no substance listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule. In so far as particulars of any of the anions, cations, non-ionised compounds or trace elements specified in column 1 of Schedule 5 are required to be given pursuant to paragraphzþ), the concentration of each such aniorç cation" non-ionised compound or trace element shall be expressed in those particulars in the unit of measurement specified opposite to it in column 2 of that Schedule. Where such particulars have been so giverç the Department must assess them and must recognise the water to which those particulars relate as nafural mineral water if it is satisfied that (a) the water is natural mineral water which complies with paragraph 3 of Section I of Annex I; and þ) the characteristics of the water have been assessed. in accordance with (Ð the points numbered l to 4 set out in paragraph 2(a) of Section I of Annex I, (iÐ the requirements and criteria listed in Part 2 of this Schedule, and 29 5 (iiÐ recognisedscientificmethods. The Department musf on recognising a natural mineral water in accordance with paragraph 4 publish an announcement of such recognition and the grounds on which it has been granted in two papers in the Island. PART 2 REQUIREMENTS AND CRITERIA FOR RECOGNITION AS A NATURAL MINERAL WATER Geological and hydrological surveys must include the following particulars (a) the exact site of the catchment with an indication of its altifude, on a map with a scale of not more than L:1,000; (b) a detailed geological report on the origin and nature of the terrain; (c) the stratigraphy of the hydrogeological layer; (d) a description of the catchment operations; and (e) the demarcation of the area or details of other measures protecting the spring against pollution. Physicaf chemical and physico-chemical surveys must establish (a) the rate of flow of the spring; (b) the temperafure of the water at source and the ambient temperature; (c) the relationship between the nature of the terrain and the nafure and type of minerals in the water; (d) the dry residues at 180"C and260"C; (e) the electrical conductivity or resistivity, with the measurement temperature being specified; (f) the hydrogen ion concentration (pH); (g) the anions and cations; (h) the non-ionised elements; (Ð the trace elements; 0) the radio-actinological properties at source; 1. 2 30 õ J (k) where appropriate, the relative isotope levels of the constituent elements of water, oxygen (tuo 18O) and hydrogen (protium, deuterium, tritium); and (1) the toxicity of certain constituent elements of the water, taking account of the limits laid down for each of them. Microbiological analysis at source must show (a) the absence of parasites and pathogenic micro-organisms; (b) quantitative determination of the revivable colony count indicative of faecal contamination, demonstrating (Ð absence of Escherichiø coli and other coli[orms in 250 ml at37"C artd M.S"C, (iÐ absence of faecal streptococci in 250 ml, (üÐ absence of sporulated sulphite-reducing anaerobes in 50m1, and (i") absence of Pseudomonns aeruginosøin25O ml; and (c) the revivable total colony count per ml of water (Ð at 20 to 22"Cin72}:rours on agar-agar or an agar gelatine mixture, and (ü) atS7"Cln24hours on agar-agar. (1) Subject to sub-paragraph (2), clinical and pharmacological analyses must be carried out in accordance with scientifically recognised methods and should be suited to the particular draracteristics of the nafural mineral water and its effects on the human organism, such as diuresis, gastric and intestinal functions, compensation for mineral deficiencies. (2) Clinical analyses Ítãlr in appropriate cases, take the place of analyses referred to in sub-paragraph (1), provided that the consistenry and concordance of a substantial number of observations enable the same results to be obtained. 4 31 Regulations 5, 6,8,'J.0,l-L and L7 and Schedule 1 SCHEDULE 4 1. EXPLOITATION AND BOTTLING REQUIREMENTS FOR NATURAL MINERAL WATER AND SPRING WATER Equipment for exploiting the water must be so installed as to avoid *y possibility of contamination and to preserve the properties corresponding to those ascribed to it which the water possesses at source. The spring or outlet must be protected against the risks of pollution. The catchmenf pipes and reservoirs must be of materials suitable for water and so built as to prevent any chemical, physico-d:remical or microbiological alteration of the water. The conditions of exploitation, particularly at the washing and bottling plant, must meet hygiene requirements. In particular, the containers must be so treated or manufactured as to avoid adverse effects on the microbiological and c-hemical characteristics of the nafural water. (1) Subject to sub-paragraphs (2) and (3), water must not be transported in containers other than those authorised for distribution to the ultimate consurner. (2) Natural mineral water may be transported from the spring to the bottling plant in a container which is not for distribution to the ultimate consumer if on or before the coming into operation of these Regulations, water from that spring was so transported. (3) Water distributed to the ultimate consumer in a bottle marked or labelled with the description "spring wate{' may be transported from the spring to the bottling plant in a container which is not for distribution to the ultimate consumer if on or before the coming into operation of these Regulations, water from that spring was so transported. (1) The revivable total colony count of the water at source, determined according to sub-parcgrapl":. (2), must conform to the normal viable colony count of that water and must not show that the source of that water is contaminated. (2) The colony count is that determined per ml of water (a) at 20 to 22oCn72hours on agar-agar or an agar-gelatine mixture; and 2 3 4 5 6 32 7 Regulation 5(7) and paragraph 3 of Part 1 of Schedule 3 SCHEDULE 5 PARTICULARS OF ANIONS, CATIONS, NON-IONISED COMPOUNDS AND TRACE ELEMENTS Anions Unit of measurement Borate BOr mglT Carbonate COa2- rngll Chlo¡ide Cl- mE/L Fluoride F- mg/l Hydrogen Ca¡bonate HCOr mgll Nitrate NOr rr.gll Nitrite NO¡ rnglL Phosphate POe! mg/1 Silicate SiOz mg/L Sulphate SOaz- rng/7 Sulphide SL mgll Cøtions Unit of measurement AluminiumAL mglL Ammonium NH¿* lr.E/L Calcium Ca mgll MagnesiumMg mglL Potassium K mg/t Sodium Na rr.g/t Non-ionised compounds Unit of measure¡nent Total organic carbon C mgl1. Free carbon dioxide COz mglL Silica SiOz mglt Trøce elements Unit of measuranent Barium Ba FLgll Bromine (total) Br FL9II Cobalt Co 34 vEll $8ll 35 Regulation 8 and Schedule 3 and Schedule 7 SCHEDUTE 6 MAXIMUM LIMITS FOR CONSTITUENTS OF NATURAL MINERAL WATERS Note: The constituents described above refer to constituents naturally present in the water at source and not to substances present as the result of contamination. Constituntts Antimony Møimumlimits (mgll) 0.0050 Arsenic 0.010 (as total) Barium 1.0 Cadmium 0.003 0.050Chromium Copper 1.0 Cyanide 0.070 Fluoride 5.0 Lead 0.010 Manganese 0.50 Mercury 0.0010 Nickel 0.020 Nitrate 50 Nit¡ite 0.1 0.010Selenium 36 Regulation 8(2) SCHEDULE 7 PERFORMANCE CHARACTERISTICS FOR ANALYSING THE CONSTITUENTS IN SCHEDULE 6 The method of analysis used to measure the concentration of the constituents in Schedule 6 must be capable of measuring concentrations equal to the parametric value with the specified acfllracy, precision and detection limits. Regardless of the sensitivity of the method of analysis, the result must be expressed to at least the same number of decimal places as the maximum limit set out in Schedule 6 for the particular constituent being analysed. Accurary is the systematic error and represents the difference between the average value of a large number of repeated measurements and the exact value. Precision represents the random error and is expressed in general as the standard deviation (within a batch and between batches) of a sample of results from the average. Notes: 1 2 3 4 Constituent Accurøcy of parømetríc oalue in o/o P recision of p ør ømetríc aalue Detection limit of pørameh'ic aalue ín "/o Antimony 25 25 25 Arsenic 10 10 L0 Barium 25 25 25 Cadmium 10 10 10 Chromium 10 10 10 Copper 10 10 10 Cyanides 10 10 10 Fluoride L0 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 Selenium 1.0 10 10 37 Acceptable precision is equal to twice the relative standard deviation. The detection limit is (a) three times the relative standard deviation within a batch of a natural sample containing a low concentration of the constituenÇ or (b) five times the relative standard deviation within a batdr of a virgin sample. The method should make it possible to determine cyanide in all its forms. 7 Regulation 9(1)(e) SCHEDULE 8 LABELLING INDICATIONS FOR NATURAL MINERAL WATER AND CRITERIA FOR USE Indication Criteria Low mineral content Very low mineral content Rich in mineral salts Contains bicarbonate Contains sulphate Contains chloride Contains calcium Contains magnesium Contains fluoride Contains iron Acidic Contains sodium Suitable for a low-sodium diet Mineral salt contenf calculated as a fixed residue, not greater than 500 mg/l Mineral salt content, calculated as a fixed residue, not greater than 50 mgl Mineral salt content. Calculated as a fixed residue, greater than 1500 mgil Bicarbonate content great$ than 600 mg[ Sulphate content greater than 200 mg Chloride content greater than 200 mgl Calcium content greater than 150 mg Magnesium content greater than 50 mgfl Fluoride content greater than L mgÄ Bivalent iron content greater than 1 mgl Free carbon dioxide content greater than 250 mg/l Sodium content greater than 200 mg Sodium content less than 20 rr.gll 39 1. 2 EXPLANATORY NOTE (This note is notpørt of the Reguløtions) These Regulations implement in relation to the Island and to the extent specified in paragraph 2 below the Community insfruments specified in that paragraph. The Community instruments are (a) Council Directive 80l777lEEC on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (OJ No. L229, 30.8.80, p.1.) as last amended by Regulation (EC) No. 188212003 of the European Parliament and of the Council (OI L284, 31..10.2003, p.1); (b) ComrnissionDirective200S|40/ECestablishingthelist, concentration limits and labelling requirements for the constifuents of natural mineral waters and the conditions for using ozone-enriched air for the treahnent of natural mineral waters and spring waters (O] No. L126,22.5.2003, p34); and (c) in relation to spring water and bottled drinking water, Council Directive 98l83lEC relating to the quality of water intended for human consumption (O] No. L330, 3.1'1..98, p.32) . The Regulations (a) provide for exemptions from the Regulations in relation to specified types of water and ice for cooling food (reguløtion 4); (b) prescribe the conditions for recognition of natural mineral water and the procedures for withdrawal of such recognition and provide for review of decisions not to grant or to withdraw recognition where that is requested by the person affected by the decision (regulation 5\; (c) set out the conditions which must be satisfied for springs to be exploited with a view to marketing water from them as natural mineral water and prohibit exploitation of polluted springs until the cause of the pollution is eradicated (regulation 6 ) ; (d) prohibit subjection of natural mineral water to treatments and additions other than specified ones, subject to an 3. 40 (s) (h) (e) (Ð (Ð (') (k) exception in the case of such water when used in the manufacture of soft drinks (reguløtion 7); prohibit bottling of natural mineral water containing specified substances above specified limits and prescribe the methods to be used for detection of such substances (reguløtion 8(1) ønd (2)); prohibit bottling of natural mineral water where specified requirements relating to exploitation of the spring from which the water comes and to bottling of the water are not complied with (reguløtion 8(3)); prohibit bottling of natural mineral water in containers not satisSring specified requirements (regulntion 8@)); restrict the marking and labelling that may be applied to bottled natural mineral water (including effervescent natural mineral water), require such water to be marked or labelled with specified information and in two respects regulate advertising of such water in addition to its marking and labelltng (regulation g); prohibit sale of water in a bottle whose marking or labelling uses the name "natural mineral water" unless it is such water; impose other prohibitions in relation to the sale of bottled natural mineral water; and prohibit the sale of natural mineral water from a single spring under more tlran one trade descrþtion (reguløtion 10); prohibit bottling of water in a bottle marked or labelled "spring water" unless the water satisfies specified requirements, prohibit such bottling where the water has been treated with ozone enriched air unless the treatment is an authorised one and prohibit exploitation of polluted springs until the cause of the pollution is eradicated (reguløtion 11); restrict the marking and labelling that may be applied to spring water, require such water to be marked or labelled with specified information and in one respect regulate advertising of such water in addition to its marking and labelling (r eguløtíon L2) ; prohibit sale of water bottled in a bottle marked or labelled "spring wate{' if the water does not comply with the requirements as regards bottling, labelling and advertisement in regulations 11 and 12 respectively, and (1) 4t (*) (n) (o) (p) (q) (') (s) (r) (u) prohibit sale of such water from one spring under more than one trade description (regulation 1-3); prohibitbottling of drinking water unless it satisfies the requirements of Schedule 2 (regulatíon L4); impose restrictions on the marking, labelling and advertising of bottled drinking water (reguløtion 1,5); prohibit sale of bottled drinking water not bottled in accordance with regulation 14 or not marked or labelled in accordance with regulation 75 (regutøtion 16); allocate responsibility for the enforcement and execution of the Regulations, including the carrying out of specified checks for the purpose of ensuring that specified requirements relating to natural mineral water and the requirements as regards ozone-enriched air oxidation techniques applicable to natural mineral water and spring water are satisfied (regulation 1-7); prescribe the arrangements for handling samples of water taken for analysis for the purposes of the Regulations, provide for submission of a part of the sample to the Government Chemist in specified circumstances and require that, for the purpose of determining whether water complies with Schedule2, methods of analysis according with Article 7.5 of Directive 98l83lEC must be used (regulations 1,8 to 20 respectiaelfl; provide that contravention of specified provisions of the Regulations is an offence and prescribe the penalty applicable in the event of conviction (reguløtion 21); provide defences for any such offence in relation to water bottled, marked and labelled before the Regulations come into force and water bottled or sold in an EEA State other than the LIK and compliant with the law in that EEA State when it was bottled or sold (reguløtion 22); apply for the purposes of the Regulations certain provisions of the Food ActL996 and the Food Labelling Regulations 2004 (453104) (regulatíon 23(1) ønd (2)); prohibit sale of water not marked or labelled in accordance with regulation 39 (intetligibility) of those Regulation s (reguløtion 23 (3 ) ) ; md 42