wsi/2015/1867 — <div xmlns="http://www.w3.org/1999/xhtml"> <span xml:lang="en">The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015</span> / <span xml:lang="cy">Rheoliadau Dŵr Mwynol Naturiol, Dŵr Ffynnon a Dŵr Yfed wedi’i Botelu (Cymru) 2015</span> </div>

2015 No. 1867 (W. 274) Food, Wales The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 Made 4 November 2015 Laid before the National Assembly for Wales 6 November 2015 Coming into force 28 November 2015 The Welsh Ministers make the following Regulations in exercise of the powers conferred by sections 6(4) , 16(1) , 17(1) , 26(1) and (3) , 31 and 48(1) of the Food Safety Act 1990 and paragraph 1A of Schedule 2 to the European Communities Act 1972 . The Welsh Ministers have had regard to the relevant advice given by the Food Standards Agency in accordance with section 48(4A) of the Food Safety Act 1990 . There has been consultation during the preparation and evaluation of the following Regulations, as required by Article 9 of Regulation ( EC ) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety . These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Welsh Ministers that it is expedient for the references in these Regulations to the Annexes to the EU Instruments listed in regulation 2(3) to be construed as references to those Annexes as amended from time to time. PART 1 Introductory Title, commencement and application 1 1 The title of these Regulations is the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015. 2 These Regulations come into force on 28 November 2015 and apply in relation to Wales. Interpretation 2 1 In these Regulations— “ the Act ” (“ y Ddeddf ”) means the Food Safety Act 1990; “ advertisement ” (“ hysbyseb ”) means a representation in any form in connection with a trade or business in order to promote the supply of goods, and “ advertise ” (“ hysbysebu ”) is to be construed accordingly; “ the Agency ” (“ yr Asiantaeth ”) means the Food Standards Agency; “ bottle ” (“ potel ”) where used as a 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 ” (“ potelu ”), where used as a verb, and cognate expressions, are to be construed accordingly; “ Directive 98/83 ” (“ Cyfarwyddeb 98/83 ”) means Council Directive 98/83/EC on the quality of water intended for human consumption ; ... “ Directive 2009/54 ” (“ Cyfarwyddeb 2009/54 ”) means Directive 2009/54/EC of the European Parliament and of the Council on the exploitation and marketing of natural mineral waters ; “ Directive 2013/51 ” (“ Cyfarwyddeb 2013/51 ”) means Council Directive 2013/51/EURATOM laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption ; “ drinking water ” (“ dŵr yfed ”) means water which is intended for sale for drinking by humans other than— natural mineral water, or water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language; “ effervescent natural mineral water ” (“ dŵr mwynol naturiol eferw ”) means natural mineral water which, at source or after bottling, gives off carbon dioxide spontaneously and in a clearly visible manner under normal conditions of temperature and pressure; “fluoride removal treatment” (“ triniaeth tynnu fflworid ”) has the meaning given in regulation 27A; “ label ” (“ label ”) means any tag, brand, mark, pictorial or other descriptive matter, which is written, printed, stencilled, marked, embossed or impressed on, or attached to the bottle of water, and “ labelled ” (“ wedi'i labelu ”) and “ labelling ” (“ labelu ”) are to be construed accordingly; “ natural mineral water ” (“ dŵr mwynol naturiol ”) means water which— is microbiologically wholesome within the meaning of Article 5 of Directive 2009/54, originates in an underground water table or deposit and emerges from a spring tapped at one or more natural or bore exits, can be clearly distinguished from drinking water on account of the following characteristics having been preserved intact because of the underground origin of the water, which has 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, and its original purity, and is for the time being recognised pursuant to and in accordance with regulation 4; “ozone-enriched air treatment” (“ triniaeth aer a gyfoethogir ag osôn ”) has the meaning given in regulation 27B; “ parameter ” (“ paramedr ”) means a property, element, organism or substance listed in the second column of any table in Part 2, Part 3 or Part 4 of Schedule 7; “ Regulation 115/2010 ” (“ Rheoliad 115/2010 ”) means Commission Regulation (EU) No 115/2010 laying down the conditions for use of activated alumina for the removal of fluoride from natural mineral waters and spring waters; and “ relevant bottled water legislation ” (“ deddfwriaeth berthnasol ynghylch dŵr wedi'i botelu ”) means— in relation to England, the Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007; in relation to Northern Ireland, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Northern Ireland) Regulations 2015; in relation to Scotland, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) (No. 2) Regulations 2007; “ sell ” (“ gwerthu ”) includes possess for sale and offer, expose or advertise for sale, and “ sale ” (“ gwerthiant ”) is to be construed accordingly. “ third country ” (“ trydedd wlad ”) means any country other than the United Kingdom, and includes— the Bailiwick of Guernsey; the Bailiwick of Jersey; the Isle of Man. 2 Expressions used in these Regulations that are also used in Directive 98/83, Directive 2009/54, Regulation 115/2010 or Directive 2013/51 have the same meaning in these Regulations as they have in those Directives or that Regulation. 3 References to the Annexes to Directive 98/83, ... Directive 2009/54, Regulation 115/2010 and Directive 2013/51 are references to those Annexes as amended from time to time. 4 Any reference in these Regulations to the labelling of a bottle includes labelling done before any water is bottled and labelling after bottling. Exemptions 3 1 These Regulations do not apply to any water which— a is a medicinal product within the meaning of regulation 2(1) of the Human Medicines Regulations 2012 ; b is a natural mineral water which is used at source for curative purposes in thermal or hydromineral establishments; c is not intended for sale for drinking by humans; or d is a natural mineral water intended for— i movement into Northern Ireland; or ii export to a third country. 2 These Regulations do not apply to packaged ice portions intended for use in cooling food. PART 2 Natural mineral water Recognition as natural mineral water 4 1 Natural mineral water may only be sold as natural mineral water if it is recognised in accordance with paragraph (2). 2 Water is recognised as natural mineral water where— a in the case of water extracted from the ground in Wales, a food authority grants recognition in accordance with Part 1 of Schedule 1; b in the case of water extracted from the ground in another part of the United Kingdom, the responsible authority of that part of the United Kingdom recognises it under the relevant bottled water legislation ; c . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . d in the case of water extracted from the ground in a third country— i the Agency grants recognition in accordance with Part 2 of Schedule 1; ii it has equivalent recognition in England granted by the Secretary of State in accordance with regulation 4(1)(d)(i) of, and Part 2 of Schedule 3 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (England) Regulations 2007; iii it has equivalent recognition in Scotland granted by Food Standards Scotland in accordance with regulation 4(1)(d)(i) of, and Part 2 of Schedule 3 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Scotland) (No. 2) Regulations 2007; iv it has equivalent recognition in Northern Ireland granted by the Agency in accordance with regulation 4(2)(d)(i) of, and Part 2 of Schedule 1 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations (Northern Ireland) 2015. 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Transitional provision: withdrawal from the EEA and the EU 4A 1 The following waters are accredited, that is to say treated for the purposes of these Regulations as if they were natural mineral waters recognised by the Agency under regulation 4(2)(d)(i)— a established EU recognised natural mineral waters; b established Icelandic recognised natural mineral waters; c established Norwegian recognised natural mineral waters. 2 The accreditation in paragraph (1) continues to have effect in relation to a natural mineral water to which sub-paragraph (a), (b) or (c) of that paragraph applies until the relevant accreditation cessation date. 3 In the case of an established EU recognised natural mineral water, if the Welsh Ministers are of the opinion that there is at least one established recognised UK mineral water that is not treated by the responsible authority in at least one member State as a recognised mineral water for the purposes of Directive 2009/54/EC , the Welsh Ministers may notify the Commission that the accreditation provided for in paragraph (1)(a) in relation to established EU recognised natural mineral waters is to cease. 4 In the case of an established Icelandic recognised natural mineral water, if the Welsh Ministers are of the opinion that there is at least one established recognised UK mineral water that is not treated as a recognised mineral water in Iceland for the purposes of Directive 2009/54/EC , the Welsh Ministers may notify the Icelandic Food and Veterinary Authority that the accreditation provided for in paragraph (1)(b) in relation to established Icelandic recognised natural mineral waters is to cease. 5 In the case of an established Norwegian recognised natural mineral water, if the Welsh Ministers are of the opinion that there is at least one established recognised UK mineral water that is not treated in Norway as a recognised mineral water for the purposes of Directive 2009/54/EC , the Welsh Ministers may notify the Norwegian Food Safety Authority that the accreditation provided for in paragraph (1)(c) in relation to established Norwegian recognised natural mineral waters is to cease. 6 No notification may be given under paragraph (3), (4) or (5) before the end of the period of 6 months beginning on the day on which IP completion day falls. 7 The accreditation cessation date specified in a notification given under paragraph (3), (4) or (5) must be a date that is at least 6 months after the date on which the notification is given, beginning with the day after the day on which that notification is given. 8 The Welsh Ministers must publish a copy of any notification given under paragraph (3), (4) or (5) in such manner as appears appropriate to the Welsh Ministers in order to bring its effect to the notice of those that the Welsh Ministers consider likely to be, or representative of those likely to be, affected in Wales as soon as is reasonably practicable. 9 The Welsh Ministers must from time to time publish, in such manner as appears appropriate to the Welsh Ministers, a list of the names of the established EU, Icelandic and Norwegian recognised natural mineral waters that are treated as accredited natural mineral waters under paragraph (1) (“the paragraph 9 list”). 10 Where a notification is given under paragraph (3), (4) or (5), the Welsh Ministers must update the paragraph 9 list as soon as reasonably practicable after the accreditation cessation date specified in the notification. 11 The paragraph 9 list is to be treated as conclusive evidence that the waters are accredited natural mineral waters for the purposes of these Regulations. 12 In this regulation— “ accreditation cessation date ” (“ dyddiad y daw'r achrediad i ben ”) means the cessation date as notified by the Welsh Ministers under paragraph (3), (4) or (5); “ Directive 2009/54/EC ” (“ Cyfarwyddeb 2009/54/EC ”) means Directive 2009/54/EC as incorporated into the EEA agreement, and as it had effect, immediately before IP completion day; “ established EU recognised natural mineral water ” (“ dŵr mwynol naturiol sefydledig a gydnabyddir yn yr UE ”) means— a natural mineral water extracted from the ground in any member State— that immediately before IP completion day had the status of a recognised natural mineral water for the purposes of Directive 2009/54/EC , and for which that recognition remains in force; a natural mineral water extracted from the ground in a third country— that immediately before IP completion day had the status of a recognised natural mineral water for the purposes of Directive 2009/54/EC having been recognised by any member State as a natural mineral water for the purposes of Directive 2009/54/EC based on a certificate (“Article 1(2) certificate”) of the type referred to in the second subparagraph of Article 1(2) of Directive 2009/54/EC issued by the responsible authority in the country of extraction, for which that recognition remains in force, and for which the Article 1(2) certificate remains valid; “ established Icelandic recognised natural mineral water ” (“ dŵr mwynol naturiol sefydledig a gydnabyddir yng Ngwlad yr Iâ ”) means a natural mineral water extracted from the ground in Iceland— that immediately before IP completion day had the status of a recognised natural mineral water for the purposes of Directive 2009/54/EC , and for which that recognition remains in force; “ established Norwegian recognised natural mineral water ” (“ dŵr mwynol naturiol sefydledig a gydnabyddir yn Norwy ”) means a natural mineral water extracted from the ground in Norway— that immediately before IP completion day had the status of a recognised natural mineral water for the purposes of Directive 2009/54/EC , and for which that recognition remains in force; “ established recognised UK natural mineral water ” (“ dŵr mwynol naturiol sefydledig a gydnabyddir yn y DU ”) means a natural mineral water extracted from the ground in the United Kingdom— that immediately before IP completion day had the status of a recognised natural mineral water for the purposes of Directive 2009/54/EC , and for which that recognition remains in force; “ member State ” (“ Aelod-wladwriaeth ”) means a member State of the EU as constituted immediately after IP completion day ; “ third country ” (“ trydedd wlad ”) has the same meaning as in Directive 2009/54/EC . Declining to grant or withdrawing recognition 5 1 Where, in relation to any water that has been recognised under regulation 4(2)(a) or 4(2)(d)(i), it is found that— a by analysis in accordance with Part 3 of Schedule 1, the requirements of paragraph 10(c) of that Part are not met; b the requirements of Schedule 4 are not met; or c the content of the water is not in accordance with paragraph 1(c) of Part 1 or, as the case may be, paragraph 5(c) of Part 2 of Schedule 1, the food authority or, as the case may be, the Agency may withdraw that recognition until such time as the requirements concerned are met. 2 Where the food authority or, as the case may be, the Agency declines to grant or withdraws recognition of a water, the person who exploits or wishes to exploit the spring from which that water emerges or, if different, the person who owns the land on which that spring is situated, may within 6 months of being notified of the decision, appeal against it to a person appointed for the purpose by the Agency. 3 The appointed person must consider the appeal and any representations made by the food authority or the Agency, as appropriate, and within 3 months report in writing with a recommended course of action to the Agency. 4 The Agency must either— a confirm the decision together with the reasons; or b direct the food authority to grant or restore, or itself restore, as appropriate, recognition of the water in question. 5 Where a food authority is directed by the Agency under paragraph (4)(b) to grant or restore recognition, it must immediately comply with that direction. Application to withdraw recognition 6 A person who exploits a spring from which water is extracted which is recognised as natural mineral water in accordance with regulation 4(2)(a) or 4(2)(d)(i), may apply to the food authority or the Agency, as appropriate, to have that recognition withdrawn. Notification of changes 7 A food authority must immediately notify the Agency if— a it grants, restores or withdraws recognition of a natural mineral water; or b it is notified of any change to the trade description of a natural mineral water or to the name of a spring from which natural mineral water has been extracted. Exploitation of natural mineral water springs 8 1 No person may exploit a spring for the purpose of marketing the water from it as natural mineral water unless— a the water extracted from that spring is natural mineral water; b the food authority of the area in which the spring is located has given permission for that spring to be exploited; and c the requirements of Schedule 4 are met. 2 Where it is found during exploitation that natural mineral water is polluted and that bottling of the water would contravene paragraphs 6, 7 or 8 of Schedule 4, no person may 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. Treatments and additions for natural mineral water 9 1 No person may subject natural mineral water in its state at source to— a any treatment other than— i the separation of its unstable elements, such as iron and sulphur compounds, by filtration or decanting, whether or not preceded by oxygenation, in so far as the treatment does not alter the composition of the water as regards the essential constituents which give it its properties; ii the total or partial elimination of free carbon dioxide by exclusively physical methods; iii a fluoride removal treatment which is authorised in accordance with Schedule 2; or iv an ozone-enriched air oxidation treatment which is authorised in accordance with Schedule 3; b any addition other than the introduction or the re-introduction of carbon dioxide to produce effervescent natural mineral water; or c any disinfection treatment by whatever means, or, subject to paragraph (1)(b), the addition of bacteriostatic elements or any other treatment likely to change the viable colony count of the natural mineral water. 2 Paragraph (1) does not prevent the use of natural mineral water in the manufacture of soft drinks. Bottling of natural mineral water 10 1 No person may bottle natural mineral water— a unless the requirements of Schedule 4 are met; b in a container other than a container which is fitted with closures designed to avoid any possibility of adulteration or contamination; and c which, at the time of bottling, contains any substance listed in Part 1 of Schedule 5 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule. 2 The methods used for detection of the substances listed in Part 1 of Schedule 5 must conform to the performance characteristics for analysis specified in Part 2 of Schedule 5. Labelling of natural mineral water 11 1 No person may bottle natural mineral water and label it with— a a trade description which includes the name of a locality, hamlet or other place, unless that trade description refers to a natural mineral water, the spring of which is exploited at the place indicated by that name, and is not misleading as regards the place of exploitation of the spring; b a trade description which is different from the name of the spring or the place of its exploitation, unless the name of the spring or the place of exploitation is also 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; c any indication, designation, trade mark, brand name, picture or other sign, whether figurative or not, the use of which suggests a characteristic which the water does not possess, in particular as regards its origin, the date of authorisation to exploit the spring, the results of analyses or any similar references to guarantees of authenticity; d any indication other than those specified in sub-paragraphs (f) and (g), attributing to the natural mineral water properties relating to the prevention, treatment or cure of a human illness; e any indication listed in the first column of the Table in Schedule 6, except where the natural mineral water meets the criterion so listed and corresponds to the indication; f the indication “may be diuretic”, “gall fod yn ddiwretig”, or “may be laxative”, “gall fod yn garthydd”, or the equivalent in any other language, unless the natural mineral water has been assessed as possessing the property attributed by the indication in accordance with physico-chemical analysis and pharmacological, physiological or clinical examination as appropriate; or g the indication “stimulates digestion”, “mae'n ysgogi treuliad”, or “may facilitate the hepato-biliary functions”, “gall hyrwyddo'r swyddogaethau hepato-bustlog”, or the equivalent in any other language, unless the natural mineral water has been assessed as possessing the property attributed by the indication in accordance with the physico-chemical analysis and pharmacological, physiological and clinical examination. 2 No person may bottle natural mineral water and label it with a sales description other than— a “natural mineral water”; or b in the case of an effervescent natural mineral water, one of the following, as appropriate— i “naturally carbonated natural mineral water” to describe water whose content of carbon dioxide from the spring after decanting, if any, and bottling is the same as at source, taking into account where appropriate, the reintroduction of a quantity of carbon dioxide from the same water table or deposit equivalent to that released in the course of those operations and subject to the usual technical tolerances; ii “natural mineral water fortified with gas from the spring” to describe water whose content of carbon dioxide from the same water table or the same deposit after decanting, if any, and bottling is greater than that established at source; or iii “carbonated natural mineral water” to describe water to which has been added carbon dioxide of an origin other than the water table or deposit from which the water comes; c nothing in sub-paragraph (a) prevents a person from using the words “dŵr mwynol naturiol” in addition to the words “natural mineral water”; d nothing in sub-paragraph (b) prevents the use of the words “dŵr mwynol naturiol wedi'i garboneiddio'n naturiol” in addition to “naturally carbonated natural mineral water”, “dŵr mwynol naturiol wedi'i gryfhau â nwy o'r ffynnon” in addition to “natural mineral water fortified with gas from the spring”, “dŵr mwynol naturiol wedi'i garboneiddio” in addition to “carbonated natural mineral water”; and e nothing in sub-paragraphs (a), (b), (c) or (d) prevents the use of equivalent words in any other language in addition to Welsh and English. 3 No person may bottle natural mineral water unless the bottle is labelled with— a a statement of analytical composition indicating the characteristic constituents of the water; b the name of the place where the spring is exploited and the name of the spring; c where the water has undergone the treatment of total or partial elimination of free carbon dioxide by exclusively physical methods, the indication “fully de-carbonated” or “partially de-carbonated”, as appropriate; d where the water has undergone an ozone-enriched air treatment, the words “water subjected to an authorised ozone-enriched air oxidation technique”, which must appear in proximity to the analytical composition of characteristic constituents; e where its fluoride concentration exceeds 1.5 mg/l— i the words “contains more than 1.5 mg/l of fluoride; not suitable for regular consumption by infants and children under 7 years of age”, which must appear in immediate proximity to the trade name and in clearly visible characters; and ii the actual fluoride content in relation to the physico-chemical composition, which must be included within the statement referred to in paragraph (3)(a); f nothing in sub-paragraph (c) prevents the use of the indication “cwbl ddad-garbonedig” in addition to “fully de-carbonated”, or “rhannol ddad-garbonedig” in addition to “partially de-carbonated”; g nothing in sub-paragraph (d) prevents the use of the words “dŵr wedi ei drin â thechneg awdurdodedig i'w ocsideiddio ag aer a gyfoethogir ag osôn” in addition to “water subjected to an authorised ozone-enriched air oxidation technique”; h nothing in sub-paragraph (e)(i) prevents the use of the words “yn cynnwys mwy na 1.5 mg/l o fflworid; nid yw'n addas i'w yfed yn rheolaidd gan blant bach a phlant o dan 7 oed” in addition to “contains more than 1.5 mg/l of fluoride; not suitable for regular consumption by infants and children under 7 years of age”; and i nothing in sub-paragraphs (c), (d), (e)(i), (f), (g) and (h) prevents the use of equivalent words in any other language in addition to Welsh and English. Advertising of natural mineral water 12 1 Where, in accordance with regulation 11(1)(b) a bottle containing natural mineral water is required to be labelled with the name of the spring or the place of its exploitation— a the same requirement also applies to any written advertisement for that natural mineral water; and b in any other advertisement, at least equivalent prominence must be given to the place of exploitation or the name of the spring as is given to the trade description. 2 No person may advertise natural mineral water in contravention of paragraph (1). 3 No person may advertise natural mineral water under any indication, designation, trade mark, brand name, picture or other sign, whether figurative or not, the use of which suggests a characteristic which the water does not possess, in particular as regards its origin, the date of authorisation to exploit it, the results of analyses or any similar references to guarantees of authenticity. Sale of natural mineral water 13 1 No person may sell water which is bottled and labelled “natural mineral water”, “dŵr mwynol naturiol”, or its equivalent in any other language, unless that water is natural mineral water recognised in accordance with regulation 4(2). 2 No person may sell bottled natural mineral water if it— a has been extracted from a spring— i in Wales, which has been exploited in contravention of regulation 8; or ii otherwise than in Wales, which has been exploited otherwise than in compliance with the requirements as described at regulation 8(1)(a) and (c) and regulation 8(2), or if the responsible authority of the area in which the spring is exploited has not given permission for the spring to be so exploited; b has been subjected— i in Wales, to any treatment or addition in contravention of regulation 9; or ii otherwise than in Wales, to— aa a treatment which is not described at regulation 9(1)(a)(i), 9(1)(a)(ii), a fluoride removal treatment, or an ozone-enriched air oxidation treatment; bb any addition other than an addition described in regulation 9(1)(b); or cc any disinfection treatment, the addition of bacteriostatic elements, or any other treatment likely to change the viable colony count of the natural mineral water; c is bottled— i in Wales, in contravention of regulation 10; or ii otherwise than in Wales, in contravention of the requirements as described in regulation 10; d is labelled— i in Wales, in contravention of regulation 11; or ii otherwise than in Wales, in contravention of the requirements as described in regulation 11; or e is advertised in contravention of regulation 12. 3 No person may sell bottled natural mineral water— a which contains— i parasites or pathogenic micro-organisms; ii Escherichia coli or other coliforms and faecal streptococci in any 250ml sample examined; iii sporulated sulphite-reducing anaerobes in any 50ml sample examined; or iv Pseudomonas aeruginosa in any 250ml 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 bacterial count which it had at source; or d where that water contains any organoleptic defect. 4 No person may sell natural mineral water from the same spring under more than one trade description. PART 3 Water intended to be sold as “spring water” or “dŵr ffynnon” Exploitation of springs and bottling of water intended to be labelled and sold as “spring water” or “dŵr ffynnon” 14 1 No person may bottle water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, unless— a the water has been extracted from a spring and is bottled at source; b the water is intended for human consumption in its natural state; c the requirements of Schedule 4 are met; and d the water meets the requirements of Schedule 7. 2 Where it is found during exploitation that water from a spring is polluted and that bottling of the water would contravene paragraphs 6, 7 or 8 of Schedule 4, no person may 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. Treatments and additions for water intended to be labelled and sold as “spring water” or “dŵr ffynnon” 15 1 No person may subject water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, in its state at source to— a any treatment, other than— i the separation of its unstable elements, such as iron and sulphur compounds, by filtration or decanting, whether or not preceded by oxygenation, in so far as the treatment does not alter the composition of the water as regards the essential constituents which give it its properties; ii the total or partial elimination of free carbon dioxide by exclusively physical methods; iii a fluoride removal treatment which is authorised in accordance with Schedule 2; or iv an ozone-enriched air treatment which is authorised in accordance with Schedule 3; or b any addition other than the introduction or the re-introduction of carbon dioxide; or c any disinfection treatment by whatever means, or, subject to sub-paragraph (b), the addition of bacteriostatic elements, or any other treatment likely to change the viable colony count of the water. 2 Paragraph (1) does not prevent the use of water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language in the manufacture of soft drinks. Labelling of water as “spring water” or “dŵr ffynnon” 16 1 No person may label a bottle of water as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, unless the water contained in it— a meets the requirements of regulation 14(1); and b if treated, has undergone a treatment or addition permitted under regulation 15. 2 If a bottle of water is labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, no person may label that bottle with a trade description which— a includes the name of a locality, hamlet or other place, unless that trade description refers to water, the spring of which is exploited at the place indicated by that name, and is not misleading as regards the place of exploitation of the spring; or b is different from the name of the spring or the place of its exploitation unless the name of the spring or the place of exploitation is also 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. 3 No person may label a bottle of water as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, unless the bottle is also labelled with— a the name of the place where the spring is exploited; b the name of the spring; c where the water has undergone an ozone-enriched air treatment, the words “water subjected to an authorised ozone-enriched air oxidation technique”, which must appear in proximity to the particulars referred to in sub-paragraphs (a) and (b); d nothing in sub-paragraph (c) prevents the use of the words “dŵr wedi ei drin â thechneg awdurdodedig i'w ocsideiddio ag aer a gyfoethogir ag osôn” in addition to “water subjected to an authorised ozone-enriched air oxidation technique”; and e nothing in sub-paragraphs (c) or (d) prevents the use of equivalent words in any other language in addition to Welsh and English. Advertising of water as “spring water” or “dŵr ffynnon” 17 1 Where, in accordance with regulation 16(2)(b), a bottle of water is required to be labelled with the name of the spring or its place of exploitation in addition to a trade description— a the same requirement also applies to any written advertisement for that water; and b in any other advertisement, at least equivalent prominence must be given to the place of exploitation or the name of the spring as is given to the trade description. 2 No person may advertise a bottle of water as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, in contravention of paragraph (1). 3 No person may advertise water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language under— a a designation, proprietary name, trade mark, 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 b the description “mineral water”, “dŵr mwynol”, or its equivalent in any other language. Sale of water as “spring water” or “dŵr ffynnon” 18 1 No person may sell water which is bottled or labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, if it— a is bottled— i in Wales, in contravention of regulation 14(1); or ii otherwise than in Wales, in contravention of the requirements as described in regulation 14(1); b has been subjected— i in Wales, to any treatment or addition in contravention of regulation 15; or ii otherwise than in Wales, to— aa treatment which is not described at regulation 15(1)(a)(i), 15(1)(a)(ii), a fluoride removal treatment, or an ozone-enriched air oxidation treatment; bb any addition other than an addition described in regulation 15(1)(b); or cc any disinfection treatment, the addition of bacteriostatic elements, or any other treatment likely to change the viable colony count of the natural mineral water; c is labelled— i in Wales, in contravention of regulation 16; or ii otherwise than in Wales, in contravention of the requirements as described in regulation 16; or d is advertised in contravention of regulation 17. 2 No person may sell water from the same spring as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, under more than one trade description. PART 4 Bottled drinking water Bottling of drinking water 19 No person may bottle drinking water unless that water meets the requirements of Schedule 7. Labelling of bottled drinking water 20 No person may bottle drinking water and label it with— a a designation, proprietary name, trade mark, brand name, illustration or other sign, whether emblematic or not, the use of which is liable to cause confusion of the drinking water with a natural mineral water, or b the description “mineral water”, “dŵr mwynol”, or its equivalent in any other language. Advertising of bottled drinking water 21 No person may advertise bottled drinking water under— a a designation, proprietary name, trade mark, 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 b the description “mineral water”, “dŵr mwynol”, or its equivalent in any other language. Sale of bottled drinking water 22 No person may sell bottled drinking water which is— a bottled in contravention of regulation 19; b labelled in contravention of regulation 20; or c advertised in contravention of regulation 21. PART 5 Monitoring and sampling CHAPTER 1 Natural mineral water Monitoring of natural mineral water 23 In the case of natural mineral water, each food authority must carry out periodic checks to ensure that— a the composition, temperature and other essential characteristics of the water remain stable within the limits of natural fluctuation; b without prejudice to paragraph (a), the composition, temperature and other essential characteristics of the water are unaffected by any variations in the rate of flow; c the viable colony count at source (before the water is subjected to any treatment) is reasonably constant, taking into account the qualitative and quantitative composition of the water considered in the recognition of the water and whether it continues to satisfy the requirements of Part 1 of Schedule 1; and d the requirements of Schedule 4 are met in relation to the water. CHAPTER 2 Water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water Monitoring of water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water 24 1 In the case of water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, and bottled drinking water, each food authority must carry out regular monitoring of the quality of the water to check that— a it ... complies with the parametric values set in accordance with Schedule 7; and b where disinfection forms part of the preparation or distribution of bottled drinking water, the disinfection treatment applied is efficient and any contamination from disinfection by-products is kept as low as possible without compromising the disinfection. 2 In order to comply with paragraph (1), each food authority must carry out— a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . b monitoring in accordance with Schedule 9 to check whether the water complies with the relevant parametric values specified in Part 4 of Schedule 7. 3 Each food authority must carry out additional monitoring, on a case-by-case basis, in relation to any property, element, substance or organism other than a parameter specified in Schedule 7, if the food authority has reason to suspect that it may be present in the water concerned in an amount or number which constitutes a potential danger to human health. Samples and analysis 25 1 For the purpose of monitoring water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, and bottled drinking water, each food authority must carry out— a sampling and analysis in accordance with Schedule 10 to check compliance with the parametric values specified in Parts 2 and 3 of Schedule 7; and b sampling and analysis in accordance with Schedule 11 to check compliance with the parametric value for indicative dose specified in Part 4 of Schedule 7. 2 Each food authority must take samples at the point at which the water is bottled. Remedial action 26 1 If a food authority determines that water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, or bottled drinking water, does not comply with the parametric concentrations or values specified in Schedule 7, the food authority must— a immediately investigate the non-compliance in order to identify the cause; b assess whether the non-compliance poses a risk to human health which requires action; c require the business operator to take remedial action as soon as possible to restore the quality of the water where that is necessary to protect human health; d in respect of any parameter specified in Parts 2 and 3 of Schedule 7, notify the general public of the remedial action taken, unless the food authority considers that non-compliance with the parametric value is trivial; and e in respect of any parameter specified in Part 4 of Schedule 7, notify the general public of the risks and remedial action taken and advise the general public on any additional precautionary measures that may be needed for the protection of human health in respect of radioactive substances. 2 If water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, or bottled drinking water, constitutes a potential danger to human health, irrespective of whether it meets the relevant parametric values in Schedule 7, the food authority must— a prohibit or restrict the supply of that water in its area or take such other action as is necessary to protect human health; and b inform the general public promptly of that fact and provide advice where necessary. 3 A food authority is not required to prohibit or restrict the supply of water under paragraph (2)(a) if it considers that such action will give rise to an unacceptable risk to human health. CHAPTER 3 Treatments Monitoring of certain treatments 27 1 Each food authority must carry out periodic checks on any fluoride removal treatment which it has authorised to ensure that the requirements of paragraph 3 of Schedule 2 continue to be satisfied. 2 Each food authority must carry out periodic checks on any ozone-enriched air treatment which it has authorised to ensure that the requirements of paragraph 4 of Schedule 3 continue to be satisfied. Fluoride removal treatment 27A For the purposes of these Regulations, a fluoride removal treatment means— a a treatment of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, with activated alumina in order to remove fluoride which is authorised in accordance with regulations 9(1)(a)(iii) or 15(a)(iii) and Schedule 2; b in the case of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, brought into Wales from another part of the United Kingdom ... , a treatment which has been authorised by the responsible authority in the area in which the water is extracted as complying with the requirements of the relevant bottled water legislation that applies in that part of the United Kingdom and which does not have a disinfectant action; or c in the case of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, brought into Wales from a third country , a treatment that complies with Articles 1 and 2 of Regulation 115/2010 and which does not have a disinfectant action. Ozone-enriched air treatment 27B For the purposes of these Regulations, an ozone-enriched air treatment means— a a treatment of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, with ozone-enriched air which is authorised in accordance with regulations 9(1)(a)(iv) or 15(a)(iv) and Schedule 3; b in the case of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, brought into Wales from another part of the United Kingdom ... , a treatment which has been authorised by the responsible authority in the area in which the water is extracted under the relevant bottled water legislation applying in that part of the United Kingdom ... and which does not have a disinfectant action; or c in the case of natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, brought into Wales from a third country , a treatment that has been authorised by the responsible authority in that country in accordance with procedures for authorising ozone-enriched air treatment in that country which have been determined by the Agency to be equivalent to the requirements of these Regulations, or by the responsible authority in another part of the United Kingdom ... to be equivalent to the requirements of the relevant bottled water legislation that applies in that part of the United Kingdom , and which does not have a disinfectant action. CHAPTER 4 Samples General 28 The food authority must ensure that each sample is representative of the quality of the water concerned consumed throughout the year in which the sample is taken. Delivery 29 1 An authorised officer of a food authority who has procured a sample under section 29 of the Act and is required to give part of that sample to the owner in accordance with regulation 7(3)(c) of the Food Safety (Sampling and Qualifications) (Wales) Regulations 2013 may deliver that sample—— a directly to the owner or the owner's agent; or b by registered post or recorded delivery service. 2 If, after reasonable enquiry, the authorised officer is unable to ascertain the name and address of the owner, the authorised officer may retain the sample. 3 In this regulation, “ owner ” has the same meaning as in the Food Safety (Sampling and Qualifications) (Wales) Regulations 2013. Notification 30 1 An authorised officer of a food authority who has procured a sample of water under section 29 of the Act for the purpose of analysis by a public analyst must serve notice in accordance with paragraph (2) if it appears that the water was exploited or bottled by a person (other than the owner) having a name and an address in the United Kingdom displayed on the bottle. 2 The authorised officer must, 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 b where the sample was taken or, as the case may be, from who it was purchased. 3 Paragraph (1) does not apply if the authorised officer decides not to have the sample analysed. Analysis by the Government Chemist 31 1 Paragraphs (2) to (6) apply where a part of a sample procured under section 29 of the Act has been submitted for analysis and another part of the sample has been retained in accordance with regulation 7(3)(e) of the Food Safety (Sampling and Qualifications) (Wales) Regulations 2013 and— a an improvement notice has been served on a person under section 10(1) of the Act, as applied and modified by regulation 33, as read with Schedule 12, for a contravention of a provision of these Regulations in connection with that sample; b an appeal against that improvement notice has been made by that person to the magistrates' court; and c the authorised officer intends to adduce as evidence the result of the analysis mentioned above. 2 An authorised officer may send the retained part of the sample to the Government Chemist for analysis but must send it— a if requested by the magistrates' court; or b subject to paragraph (6), if requested by the recipient of the improvement notice. 3 The Government Chemist must analyse, or direct a food analyst to analyse, the part of the sample sent under paragraph (2) and send to the authorised officer a Government Chemist's certificate of analysis. 4 Any certificate sent by the Government Chemist must be signed by or on behalf of the Government Chemist, but the analysis may be carried out by a person under the direction of the person who signs the certificate. 5 On receipt of the certificate the authorised officer must, as soon as is reasonably practicable, supply a copy of it to the magistrates' court and to the recipient of the improvement notice. 6 Where a request is made under paragraph (2)(b), the authorised officer may request payment of a fee specified in writing from the recipient of the improvement notice to defray some or all of the Government Chemist's charges for performing the functions under paragraph (3). 7 Where a notice is served under paragraph (6) and the recipient of the improvement notice refuses to pay the fee specified in the notice, the authorised officer may refuse to comply with the request made under paragraph (2)(b). PART 6 Enforcement and miscellaneous provisions Enforcement 32 Each food authority must execute and enforce these Regulations in its area. Application of the Act: improvement notices 33 1 The provisions of section 10 of the Act specified in column 1 of Table 1 of Schedule 12 apply for the purpose of these Regulations, with the modifications specified in column 2 of that table to enable an authorised officer of a food authority to serve an improvement notice on any person who is failing to comply with regulations 8 to 22 of these Regulations or a provision of Regulation 115/2010 mentioned in column 2 of Table 1 of Schedule 12. 2 Paragraph (1) is without prejudice to the application of section 10 of the Act for purposes other than those specified in paragraph (1). 3 An authorised officer of a food authority must not serve an improvement notice under section 10(1) of the Act, as applied and modified in accordance with paragraph (1), if— a the improvement notice would relate to water bottled and labelled before 28 November 2015; and b the matters constituting the alleged contravention would not have constituted an offence under the Regulations listed in regulation 37. 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Application of the Act: powers of entry 34 1 The provisions of section 32 of the Act specified in column 1 of Table 2 of Schedule 12 apply for the purposes of enabling these Regulations, with the modifications specified in column 2 of that table, to enable an authorised officer of a food authority— a to exercise a power of entry to ascertain whether there is, or has been, any contravention of a provision of Regulation 115/2010 mentioned in column 2 of that table; b to exercise a power of entry to ascertain whether there is any evidence of any contravention of such provisions; and c where exercising a power of entry under the applied section 32 provisions, to exercise the associated powers in subsections (5) and (6) relating to records. 2 Paragraph (1) is without prejudice to the application of section 32 of the Act for purposes other than those specified in paragraph (1). Application of other provisions of the Act 35 The provisions of the Act specified in column 1 of Table 3 of Schedule 12 apply for the purposes of these Regulations, with the modifications specified in column 2 of that table. Savings and transitional provisions 36 1 Any recognition of water as natural mineral water granted under the Natural Mineral Waters Regulations 1985, the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999, or the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2007 and subsisting on the date that these Regulations come into force shall— a in the case of water extracted from the ground in Wales, be treated as if it were recognition granted by the food authority under regulation 4(2)(a); and b in the case of water extracted from the ground in a third country , be treated as if it were recognition granted by the Agency under regulation 4(2)(d)(i). 2 The revocation of the Regulations listed in regulation 37 does not affect the validity of any authorisation, recognition or notification made or given by the Agency or the food authority as the relevant authority under those Regulations, and any such authorisation, recognition or notification continues in effect. 3 Where an application has been made under the Regulations listed in regulation 37 to a food authority for recognition of water as natural mineral water, the application is to be treated as if it had been made under Parts 1 or 2 of Schedule 1 to these Regulations. Revocations 37 The following Regulations are revoked— a the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2007 ; b the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) (Amendment) Regulations 2009 ; c the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) (Amendment) Regulations 2010 ; d the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) (Amendment) Regulations 2011 . Amendments to other legislation 38 Schedule 13 (amendments to other legislation) has effect. Vaughan Gething Deputy Minister for Health, one of the Welsh Ministers SCHEDULE 1 Recognition of natural mineral water Regulation 4(2)(a) and 4(2)(d)(i) PART 1 Natural mineral water extracted from the ground in Wales 1 A person seeking to have water which is extracted from the ground in Wales recognised as natural mineral water ... must apply in writing to the food authority within whose area the water is extracted, giving the following information— a the particulars specified in paragraph 10(a) of Part 3; b the information obtained as a result of the surveys and analyses required under paragraph 10(b) and (c), as read with paragraph 11, of Part 3; and c evidence to show that the water contains no substance listed in Part 1 of Schedule 5 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule. 2 Where information on the anions, cations, non-ionised compounds and trace elements is required to be given pursuant to paragraph 1(b), the concentration of each anion, cation, non-ionised compound and trace element specified in the first column of the tables in Part 4 of this Schedule must be expressed in the unit of measurement specified in the second column of the tables in Part 4. 3 Where information required by paragraph 1 has been given, the food authority must assess it and must recognise the water to which the information relates as natural mineral water if it is satisfied that— a the water is natural mineral water which complies with paragraph 3 of Section I of Annex 1 to Directive 2009/54; b the characteristics of the water have been assessed in accordance with— i the points numbered 1 to 4 in paragraph 2(a) of Section I of Annex 1 to Directive 2009/54; ii the particulars and criteria listed in Part 3 of this Schedule, and iii recognised scientific methods. 4 The food authority must, on recognising a natural mineral water in accordance with paragraph 3, publish an announcement of such recognition and the grounds on which it has been granted in the London Gazette. PART 2 Natural mineral water extracted from the ground in a third country 5 A person seeking to have a water which is extracted from the ground in a third country recognised as a natural mineral water ... must apply in writing to the Agency, giving the following information— a the particulars specified in paragraph 10(a) of Part 3; b the information obtained as a result of the surveys and analyses required under paragraph 10(b) and (c), as read with paragraph 11, of Part 3; and c evidence to show that the water contains no substance listed in Part 1 of Schedule 5 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule. 6 Where information on the anions, cations, non-ionised compounds and trace elements is required to be given pursuant to paragraph 5(b), the concentration of each anion, cation, non-ionised compound and trace element specified in the first column of the tables in Part 4 of this Schedule must be expressed in the unit of measurement specified in the second column of the tables in Part 4. 7 The Agency must recognise such a water if the responsible authority of the country in which the water is extracted has certified that— a it is satisfied— i that the requirements in paragraph 10(b) and (c) of Part 3 are established; ii with the evidence given pursuant to paragraph 5(c); and b periodic checks are made to ascertain that— i the water is natural mineral water which complies with paragraph 3 of Section I of Annex I to Directive 2009/54; ii the characteristics of the water are assessed in accordance with— aa points numbered 1 to 4 in paragraph 2(a) of Section I of Annex I to Directive 2009/54; bb the particulars and criteria listed in Part 3 of this Schedule; and cc recognised scientific methods; and iii the provisions of Schedule 4 are being applied by the person exploiting the spring. 8 Recognition of such water lapses after a period of five years unless the responsible authority of the country in which the water is extracted has renewed the certification required by paragraph 7. 9 The Agency must, on recognising water in accordance with this Part, publish an announcement of such recognition in the London Gazette, the Edinburgh Gazette and the Belfast Gazette. PART 3 Requirements and criteria for recognition as a natural mineral water 10 A person seeking to have water recognised as natural mineral water in accordance with paragraph 1 of Part 1 or paragraph 5 of Part 2 of this Schedule, must carry out— a geological and hydrological surveys which include the following particulars— i the exact site of the catchment with an indication of its altitude, on a map with a scale of not more than 1:1,000; ii a detailed geological report on the origin and nature of the terrain; iii the stratigraphy of the hydrogeological layer; iv a description of the catchment operations; and v the demarcation of the area or details of other measures protecting the spring against pollution; b physical, chemical and physico-chemical surveys which must establish— i the rate of flow of the spring; ii the temperature of the water at source and the ambient temperature; iii the relationship between the nature of the terrain and the nature and type of minerals in the water; iv the dry residues at 180ºC and 260ºC; v the electrical conductivity or resistivity, with the measurement temperature being specified; vi the hydrogen ion concentration (pH); vii the anions and cations; viii the non-ionised elements; ix the trace elements; x the radio-actinological properties at source; xi where appropriate, the relative isotope levels of the constituent elements of water, oxygen ( 16 O– 18 O) and hydrogen (protium, deuterium, tritium); and xii the toxicity of certain constituent elements of the water, taking account of the limits laid down for each of them; c a microbiological analysis at source which must show— i the absence of parasites and pathogenic micro-organisms; ii quantitative determination of the revivable colony count indicative of faecal contamination, demonstrating an absence of— aa Escherichia coli and other coliforms in 250ml at 37ºC and 44.5ºC, bb faecal streptococci in 250ml, cc sporulated sulphite-reducing anaerobes in 50ml, and dd Pseudomonas aeruginosa in 250ml; and iii the revivable total colony count per ml of water— aa at 20 to 22ºC in 72 hours on agar-agar or an agar-gelatine mixture, and bb at 37ºC in 24 hours on agar-agar. 11 1 Subject to sub-paragraph (2), a person seeking to have water recognised as natural mineral water in accordance with paragraph 1 of Part 1 or paragraph 5 of Part 2 o