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The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015

Changes over time for: The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 (Schedules only)

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Regulation 4(2)(a) and 4(2)(d)(i)

SCHEDULE 1E+WRecognition of natural mineral water

PART 1 E+WNatural 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 F1... must apply in writing to the food authority within whose area the water is extracted, giving the following information—E+W

(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.E+W

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—E+W

(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.E+W

PART 2E+WNatural mineral water extracted from the ground in a [F2third country]

5.  A person seeking to have a water which is extracted from the ground in a [F3third country] recognised as a natural mineral water F4... must apply in writing to the Agency, giving the following information—E+W

(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.E+W

7.  The Agency must recognise such a water if the responsible authority of the country in which the water is extracted has certified that—E+W

(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.E+W

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.E+W

PART 3 E+WRequirements 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—E+W

(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 (16O–18O) 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 of this Schedule, must carry out clinical and pharmacological analyses in accordance with scientifically recognised methods which should be suited to the particular characteristics of the natural mineral water and its effect on the human body, such as diuresis, gastric and intestinal functions, and compensation for mineral deficiencies.E+W

(2) Clinical analyses may, in appropriate cases, take the place of the pharmacological analyses referred to in sub-paragraph (1), provided that the consistency and concordance of a substantial number of clinical observations enable the same results to be obtained.

PART 4 E+WParticulars of anions, cations, non-ionised compounds and trace elements

Table A

AnionsUnit of measurement
Borate BO3 -mg/l
Carbonate CO32-mg/l
Chloride Cl-mg/l
Fluoride F -mg/l
Hydrogen Carbonate HCO3-mg/l
Nitrate NO3 -mg/l
Nitrite NO2 -mg/l
Phosphate PO BO4 3-mg/l
Silicate SiO2 2-mg/l
Sulphate SO4 2-mg/l
Sulphide S2-mg/l

Table B

CationsUnit of measurement
Aluminium Almg/l
Ammonium NH4 +mg/l
Calcium Camg/l
Magnesium Mgmg/l
Potassium Kmg/l
Sodium Namg/l

Table C

Non-ionised compoundsUnit of measurement
Total organic carbon Cmg/l
Free carbon dioxide CO2mg/l
Silica SiO2mg/l

Table D

Trace elementsUnit of measurement
Barium Bamg/l
Bromine (total) Brmg/l
Cobalt Comg/l
Copper Cumg/l
Iodine (total) Img/l
Iron Femg/l
Lithium Limg/l
Manganese Mnmg/l
Molybdenum Momg/l
Strontium Srmg/l
Zinc Znmg/l

Regulations 9(1)(a)(iii) and 15(a)(iii)

SCHEDULE 2E+WFluoride removal treatment

1.  No person may carry out fluoride removal treatment on natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, unless that treatment is authorised by the food authority within whose area the water is extracted.E+W

2.  A person seeking authorisation to carry out fluoride removal treatment must—E+W

(a)apply in writing to the food authority within whose area the water is extracted;

(b)permit representatives of that authority to examine the proposed method of treatment and place of treatment and take samples for analysis; and

(c)provide such information in support of the application as is requested by the food authority.

3.  The food authority must assess the application and any supporting information and must authorise the fluoride removal treatment if it is satisfied that—E+W

(a)Articles 1 to 3 of Regulation 115/2010 are complied with in relation to the treatment; and

(b)the treatment does not have a disinfectant action.

4.  Where the food authority decides to authorise a fluoride removal treatment pursuant to paragraph 3, it must inform the applicant in writing and state the date from which the authorisation for use of the treatment has effect.E+W

5.  Where the food authority decides to refuse to authorise a fluoride removal treatment pursuant to paragraph 3, it must inform the applicant in writing, stating its reasons.E+W

6.  Where a fluoride removal treatment has been authorised pursuant to paragraph 3, the person carrying out the treatment must, for the purpose of enabling the food authority to assess whether the conditions in paragraph 3 continue to be satisfied—E+W

(a)permit representatives of the authority to examine the method of treatment and place of treatment and take samples for analysis; and

(b)provide such information related to the treatment as is requested by the food authority.

7.  The food authority may withdraw authorisation of a fluoride removal treatment if it is satisfied that the conditions specified in paragraph 3 are no longer fulfilled, by giving the person operating the treatment a written notice stating the grounds for withdrawal.E+W

8.  Where the food authority notifies a person seeking authorisation of a fluoride removal treatment of the authority's refusal to authorise a treatment under paragraph 3, or notifies the person operating a treatment of its decision to withdraw authorisation under paragraph 7, that person may, within 6 months of being notified of the decision, apply to the Agency for a review.E+W

9.  The Agency, upon receiving an application under paragraph 8, must within 3 months from the date of that application—E+W

(a)make such inquiries into the matter as the Agency considers appropriate;

(b)consider the results of those inquiries and any other relevant facts; and

(c)either—

(i)confirm the decision; or

(ii)direct the food authority to grant or restore authorisation of a fluoride removal treatment as appropriate.

10.  The food authority must immediately comply with a direction of the Agency under paragraph 9(c)(ii).E+W

Regulations 9(1)(a)(iv) and 15(a)(iv)

SCHEDULE 3E+WOzone-enriched air treatment

1.  No person may carry out an ozone-enriched air treatment on natural mineral water or water intended to be bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, unless—E+W

(a)it is for the purpose of separating compounds of iron, manganese, sulphur and arsenic from water in which they occur naturally at source;

(b)prior to treatment the requirements of paragraphs [F56, 7 and 8] of Schedule 4 are satisfied; and

(c)the treatment does not have a disinfectant action.

2.  An ozone-enriched air treatment must not—E+W

(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.

Treatment residueMaximum limit ug/l
Dissolved ozone50
Bromate3
Bromoform1

3.  A person seeking authorisation to carry out an ozone-enriched air treatment must—E+W

(a)make an application in writing to the food authority in whose area the water is extracted;

(b)permit representatives of that authority to examine the proposed method of treatment and place of treatment and take samples for analysis; and

(c)provide such information in support of the application as is requested by the food authority.

4.  The food authority must assess the application and any supporting information and must authorise the ozone-enriched air treatment if it is satisfied that—E+W

(a)the treatment process is justified by the composition of the water at source in terms of compounds of iron, manganese, sulphur and arsenic;

(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.

5.  Where the food authority decides to authorise an ozone-enriched air treatment pursuant to paragraph 4, it must inform the applicant in writing and state the date from which the authorisation for use of the treatment has effect.E+W

6.  Where the food authority refuses to authorise an ozone-enriched air treatment pursuant to paragraph 4, it must inform the applicant in writing, stating its reasons.E+W

7.  Where an ozone-enriched air treatment has been authorised pursuant to paragraph 4, the person carrying out the treatment must, for the purpose of enabling the food authority to assess whether the conditions in paragraph 4(a) and (b) continue to be satisfied—E+W

(a)permit representatives of the authority to examine the method of treatment and place of treatment and take samples for analysis; and

(b)provide such information related to the treatment as is requested by the food authority.

8.  The food authority may withdraw authorisation of an ozone-enriched air treatment if it is satisfied that the conditions specified in paragraph 4 are no longer fulfilled, by giving the person operating the treatment a written notice stating the grounds for withdrawal.E+W

9.  Where the food authority notifies a person seeking authorisation of an ozone-enriched air treatment of the authority's refusal to authorise a treatment under paragraph 4, or notifies the person operating a treatment of its decision to withdraw authorisation under paragraph 8, that person may, within 6 months of being notified of the decision, apply to the Agency for a review.E+W

10.  The Agency, upon receiving an application under paragraph 9, must within 3 months from the date of that application—E+W

(a)make such inquiries into the matter as the Agency considers appropriate;

(b)consider the results of those inquiries and any other relevant facts; and

(c)either—

(i)confirm the decision; or

(ii)direct the food authority to grant or restore authorisation of the ozone-enriched air treatment as appropriate.

11.  The food authority must immediately comply with a direction of the Agency under paragraph 10(c)(ii).E+W

Regulations 8, 10, 13 and 14

SCHEDULE 4E+WExploitation and bottling requirements for natural mineral water and water intended to be labelled and sold as “spring water” or “dŵr ffynnon”

1.  Equipment for exploiting the water must be so installed as to avoid any possibility of contamination and to preserve the properties corresponding to those ascribed to it which the water possesses at source.E+W

2.  The spring or outlet must be protected against the risks of pollution.E+W

3.  The catchment, pipes and reservoirs must be of materials suitable for water and so built as to prevent any chemical, physico-chemical or microbiological alteration of the water.E+W

4.  The conditions of exploitation, particularly the washing and bottling equipment, must meet hygiene requirements including, in particular, that containers must be so treated or manufactured as to avoid adverse effects on the microbiological and chemical characteristics of the water.E+W

5.—(1) Subject to sub-paragraphs (2) and (3), water must not be transported in containers other than those authorised for distribution to the ultimate consumer.E+W

(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 17 July 1980 water from that spring was so transported.

(3) Water intended to be labelled and sold as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, 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 13 December 1996, water from that spring was so transported.

6.—(1) The revivable total colony count of the water at source, determined according to sub-paragraph (2), must conform to the normal viable colony count of that water and must not show that the source of that water is contaminated.E+W

(2) The colony count is that determined per ml of water—

(a)at 20 to 22ºC in 72 hours on agar-agar or an agar-gelatine mixture; and

(b)at 37ºC in 24 hours on agar-agar.

7.—(1) After bottling, the total colony count of the water at source may not exceed—E+W

(a)100 per ml at 20 to 22ºC in 72 hours on agar-agar or on agar-gelatine mixture; and

(b)20 per ml at 37ºC in 24 hours on agar-agar.

(2) The total colony count of the water must be measured within a period of 12 hours following bottling, the water being maintained at 4ºC +/- 1ºC during that period.

8.  Water must be free from—E+W

(a)parasites and pathogenic micro-organisms;

(b)Escherichia coli and other coliforms and faecal streptococci in any 250ml sample examined;

(c)sporulated sulphite-reducing anaerobes in any 50ml sample examined; and

(d)Pseudomonas aeruginosa in any 250ml sample examined.

Regulation 10

SCHEDULE 5E+WConstituents of natural mineral water

PART 1 E+WMaximum limits for constituents of natural mineral water

1 The constituents described above refer to constituents naturally present in the water at source and not to substances present as the result of contamination.

Constituents1Maximum limits (mg/l)
Antimony0.0050
Arsenic0.010 (as total)
Barium1.0
Cadmium0.003
Chromium0.050
Copper1.0
Cyanide0.070
Fluoride5.0
Lead0.010
Manganese0.50
Mercury0.0010
Nickel0.020
Nitrate50
Nitrite0.1
Selenium0.010

PART 2 E+WPerformance characteristics for analysing the constituents in Part 1

1 The method of analysis used to measure the concentration of the constituents in Part 1 must be capable of measuring concentrations equal to the parametric value with the specified accuracy, 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 Part 1 for the particular constituent being analysed.

2 Accuracy is the systematic error and represents the difference between the average value of a large number of repeated measurements and the exact value.

3 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. Acceptable precision is equal to twice the relative standard deviation.

4 The detection limit is—

(a) three times the relative standard deviation within a batch of a natural sample containing a low concentration of the constituent; or

(b) five times the relative standard deviation within a batch of a virgin sample.

5 The method should make it possible to determine cyanide in all its forms.

Constituents1Accuracy of parametric value in %2Precision of parametric value3Detection limit of parametric value in % 4
Antimony252525
Arsenic101010
Barium252525
Cadmium101010
Chromium101010
Copper101010
Cyanide5101010
Fluoride101010
Lead101010
Manganese101010
Mercury201020
Nickel101010
Nitrate101010
Nitrite101010
Selenium101010

Regulation 11(1)(e)

SCHEDULE 6E+WLabelling indications for natural mineral water

IndicationCriteria
Low mineral contentMineral salt content, calculated as a fixed residue, not greater than 500 mg/l
Very low mineral contentMineral salt content, calculated as a fixed residue, not greater than 50 mg/l
Rich in mineral saltsMineral salt content, calculated as a fixed residue, greater than 1500 mg/l
Contains bicarbonateBicarbonate content greater than 600 mg/l
Contains sulphateSulphate content greater than 200 mg/l
Contains chlorideChloride content greater than 200 mg/l
Contains calciumCalcium content greater than 150 mg/l
Contains magnesiumMagnesium content greater than 50 mg/l
Contains fluorideFluoride content greater than 1 mg/l
Contains ironBivalent iron content greater than 1 mg/l
AcidicFree carbon dioxide content greater than 250 mg/l
Contains sodiumSodium content greater than 200 mg/l
Suitable for a low-sodium dietSodium content less than 20 mg/l

Regulations 14(1)(d) and 19

SCHEDULE 7E+WRequirements for water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water including prescribed concentrations or values of parameters

PART 1 E+WRequirements for water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

1.  Water satisfies the requirements of this Schedule if—E+W

(a)the water does not contain any micro-organism (other than a parameter) or parasite, or any property, element or substance (other than a parameter) at a concentration or value which would constitute a potential danger to human health;

(b)the water does not contain any substance (whether or not a parameter) at a concentration or value which, in conjunction with any other property, element, substance or organism it contains (whether or not a parameter), would constitute a potential danger to human health; and

(c)the water does not contain concentrations or values of any of the parameters listed in the tables in Part 2, Part 3 and Part 4 of this Schedule in excess of the prescribed concentrations or values.

2.  The concentrations or values of the parameters listed in the tables in Part 2, Part 3 and Part 4 of this Schedule must be read in conjunction with the notes to those tables.E+W

PART 2 E+WParametric values for microbiological and chemical parameters

Table A: Microbiological Parameters

1 The total viable colony count should be measured within 12 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.

2 In 72 hours on agar-agar or an agar-gelatine mixture.

3 In 24 hours on agar-agar.

ItemParameterUnits of MeasurementMaximum Concentration or Value
1.

Escherichia coli

(E coli)

number/250 ml0/250 ml
2.Enterococcinumber/250 ml0/250 ml
3.Pseudomonas aeruginosanumber/250ml0/250 ml
4.Colony count 22ºCnumber/ml100/ml 12
5.Colony count 37ºCnumber/ml20/ml13

Table B: Chemical Parameters

1 The parametric value refers to the residual monomer concentration in the water as calculated according to specifications of the maximum release from the corresponding polymer in contact with the water.

2 The concentration (mg/l) of nitrate divided by 50 added to the concentration (mg/l) of nitrite divided by 3 must not exceed 1.

3Pesticides” means:

– organic insecticides,

– organic herbicides,

– organic fungicides,

– organic nematocides,

– organic acaricides,

– organic algicides,

– organic rodenticides,

– organic slimicides, and

– related products (inter alia, growth regulators) and their relevant metabolites, degradation and reaction products.

Only those pesticides which are likely to be present in a given water need to be monitored.

4 The maximum concentration applies to each individual pesticide. In the case of aldrin, dieldrin, heptachlor and heptachlor epoxide the maximum concentration is 0.030 µg/l.

5 The maximum concentration for “total substances” refers to the sum of the concentrations of all individual pesticides detected and quantified in the monitoring procedure.

6 The specified compounds are benzo(b)fluoranthene, benzo(k)fluoranthene, benzo(ghi)perylene, indeno(1,2,3-cd)pyrene.

7 The maximum concentration specified applies to the sum of the concentrations of the specified parameters.

ItemParameterUnits of MeasurementMaximum Concentration or Value
1.Acrylamideµg/l0.10 1
2.Antimonyµg Sb/l5
3.Arsenicµg As/l10
4.Benzeneµg/l1.0
5.Benzo (a) pyreneµg/l0.010
6.Boronmg/l1.0
7.Bromateµg/l BrO3/l10
8.Cadmiumµg Cd/l5
9.Chromiumµg Cr/l50
10.Coppermg Cu/l2
11.Cyanideµg CN/l50
12.1,2-dichloroethaneµg/l3.0
13.Epicholorohydrinµg/l0.10 1
14.Fluoridemg F/l1.5
15.Leadµg Pb/l10
16.Mercuryµg Hg/l1
17.Nickelµg Ni/l20
18.Nitratemg NO3/l50 2
19.Nitritemg NO2/l0.5 2
20.Pesticides and related products:
- individual substancesµg/l0.10 34
- total substancesµg/l0.50 35
21.Polycyclic aromatic hydrocarbonsµg/l0.1 sum of concentrations of specified compounds 6
22.Seleniumµg Se/l10
23.Tetrachloroethene and Trichloroetheneµg/l10 7
24.

Trichloromethane,

Dicholrorbromomethane, Dibromocholromethane and Tribromomethane

µg/l100 7
25.Vinyl chlorideµg/l0.50 1

PART 3E+WParametric values for indicator parameters

Table C: Indicator Parameters

1 The water must not be aggressive.

2 Necessary only if the water originates from or is influenced by surface water.

3 This parameter need not be measured if the parameter Total Organic Carbon is analysed.

4 This parameter need not be measured for supplies of less than 10,000m3 a day.

ItemParameterUnits of MeasurementMaximum Concentration or Value
1.Aluminiumµg/l200
2.Ammoniummg/l0.50
3.Chloridemg/l250 1
4.Clostridium perfringens (including spores)number/100ml0 2
5.Colour [F6Acceptable to consumers and no abnormal change]F7. . .
6.ConductivityµS cm-1 at 20°C2500 1
7.Hydrogen ion concentrationpH units

4.5 (minimum)

9.5 (maximum) 1

8.Ironµg/l200
9.Manganeseµg/l50
10.Odour [F8Acceptable to consumers and no abnormal change]F9. . .
11.Oxidisabilitymg/l O25 3
12.Sulphatemg/l250 1
13.Sodiummg/l200
14.Taste [F10Acceptable to consumers and no abnormal change]F11. . .
15.Colony Count 22°CNo abnormal change
16.Coliform bacterianumber/250ml0
17.Total Organic CarbonNo abnormal change4
18.TurbidityAcceptable to consumers and no abnormal change

PART 4 E+WParametric values for radon, tritium and indicative dose (ID)

Table D:

1 Remedial action is deemed to be justified on radiological protection grounds, without further consideration, where radon concentrations exceed 1000 Bq/l.

2 Elevated levels of tritium may indicate the presence of other artificial radionuclides. If the tritium concentration exceeds its parametric value, an analysis of the presence of other artificial radionuclides is required.

ItemParameterUnit of MeasurementMaximum Concentration or Value
1.RadonBq/l100 1
2.TritiumBq/l100 2
3.Indicative DosemSv0.10

Regulation 24(2)(a)

F12SCHEDULE 8E+WMonitoring for parameters other than radioactive substances in water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Regulation 24(2)(b)

SCHEDULE 9E+WMonitoring for radioactive substances in water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

PART 1 E+WGeneral

1.  Each food authority must monitor water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, and bottled drinking water, for radon, tritium and indicative dose in accordance with this Part.E+W

RadonE+W

2.  Each food authority must undertake representative surveys to determine the scale and nature of likely exposure to radon originating from different types of ground water sources and wells in different geological areas.

3.  The representative surveys must be designed in such a way that underlying parameters, including the geology and hydrology of the area, radioactivity of rock or soil and well type, can be identified and used to direct further action to areas of likely high exposure.E+W

4.  Each food authority must monitor for radon if there is reason to believe, on the basis of the results of the representative surveys or other reliable information, that the parametric value for radon specified in Part 4 of Schedule 7 might be exceeded.E+W

TritiumE+W

5.  Each food authority must monitor for tritium if an anthropogenic source of tritium or other artificial radionuclide is present within the catchment area and it cannot be shown on the basis of other surveillance programmes or investigations that the level of tritium is below the parametric value specified in Part 4 of Schedule 7.

6.  Sampling must be carried out at the frequencies specified in the Table in Part 2 of this Schedule.E+W

7.  If the concentration of tritium exceeds the parametric value specified in Part 4 of Schedule 7, the food authority must investigate the presence of other artificial radionuclides.E+W

Indicative doseE+W

8.  Each food authority must monitor for indicative dose if a source of artificial or elevated natural radioactivity is present and it cannot be shown on the basis of representative monitoring programmes or other investigations that the level of indicative dose is below the parametric value specified in Part 4 of Schedule 7.

9.  Sampling must be carried out at the frequencies specified in the Table in Part 2 of this Schedule.E+W

10.  The food authority may use various reliable screening strategies to monitor for the parametric indicator value for indicative dose.E+W

11.  If the food authority screens for an individual radionuclide or certain radionuclides and—E+W

(a)one of the activity concentrations exceeds 20% of the corresponding derived value specified in Table 1 in Part 2 of Schedule 11; or

(b)where applicable, the concentration of tritium exceeds the parametric value specified in Part 4 of Schedule 7, the food authority must investigate the presence of other radionuclides, as determined by the food authority, taking into account all relevant information about likely sources of radioactivity.

12.—(1) If the food authority screens for gross alpha activity and gross beta activity and—E+W

(a)the screening level for gross alpha activity exceeds 0.1 Bq/l; or

(b)the screening level for gross beta activity exceeds 1.0 Bq/l, the food authority must investigate the presence of other radionuclides as determined by the food authority, taking into account all relevant information about likely sources of radioactivity.

(2) The food authority may set alternative screening levels for gross alpha activity and gross beta activity if it can demonstrate that the alternative levels are in compliance with an indicative dose of 0.1mSv.

(3) If elevated levels of tritium are detected which indicate the presence of other artificial radionuclides, tritium, gross alpha activity and gross beta activity must be measured in the same sample.

(4) If the gross alpha activity and gross beta activity are less than 0.1 Bq/l and 1.0 Bq/l respectively, the food authority may assume that the indicative dose is less than the parametric value of 0.1 mSv in which case further radiological investigation is not required unless it is known from other sources of information that specific radionuclides are present in the water that are liable to cause an indicative dose in excess of 0.1 mSv.

Exemption from monitoringE+W

13.[F13(1)]  A food authority is not required to monitor water bottled and labelled as “spring water”, “dŵr ffynnon”, or its equivalent in any other language, or bottled drinking water, for radon, tritium or indicative dose if—

(a)it is satisfied on the basis of representative surveys, monitoring data or other reliable information that, for a minimum period of 5 years, the parameter in question will remain below the respective parametric value specified in Part 4 of Schedule 7; and

(b)it notifies the Agency of that decision and provides the Agency with a copy of the representative surveys, monitoring data or other reliable information referred to in sub-paragraph (a).

[F14(2) Subject to sub-paragraph (3), the exemption from monitoring under sub-paragraph (1) lapses after a period of 5 years, beginning on the date the food authority notifies its decision to the Agency in accordance with sub-paragraph (1)(b).

(3) The exemption from monitoring under sub-paragraph (1) lapses immediately if the level of radon, tritium or indicative dose exceeds the relevant parametric value specified in Part 4 of Schedule 7.]

Treatment of bottled drinking waterE+W

14.  Where bottled drinking water has been treated to reduce the level of radionuclides, the food authority must carry out monitoring at the frequencies indicated in the Table in Part 2 to ensure the continued efficacy of that treatment.

AveragingE+W

15.  If a parametric value specified in Part 4 of Schedule 7 is exceeded in a sample of water, the food authority must take further samples as appropriate, having regard to guidance issued by the Agency, to ensure that the measured values are representative of an average activity concentration for a full year.

PART 2 E+WMinimum sampling and analysis frequencies

1 A supply zone is a geographically defined area within which water intended for human consumption comes from one or more sources and within which water quality may be considered as being approximately uniform.

2 The volumes are calculated as averages taken over a calendar year.

3 As far as possible, the number of samples should be distributed equally in time and location.

Volume of water produced each day within a supply zone 12 m3Number of samples per year 3
volume ≤ 1001
100 < volume ≤ 1001
1,000 < volume ≤ 10,0001+1 for each 3,300m3/d and part thereof of the total volume
10, 000 < volume ≤ 100,0003+1 for each 10,000 m3/d and part thereof of the total volume
volume > 100,00010+1 for each 25,000 m3/d and part thereof of the total volume

Regulation 25(1)(a)

SCHEDULE 10E+WSampling and analysis for parameters other than radioactive substances in water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

PART 1 E+WGeneral

Analysis of samplesE+W

1.—(1) The food authority must ensure that each sample is analysed in accordance F15... this Schedule.

(2) For each parameter specified in the first column of Table 1 in Part 2 of this Schedule the method of analysis is specified in the second column of that table.

(3) For each parameter specified in the first column of Table 2 in Part 2 of this Schedule the method of analysis is one that is capable of—

(a)measuring concentrations and values with the trueness and precision specified in the second and third columns of that table; and

(b)detecting the parameter at the limit of detection specified in the fourth column of that table.

(4) For hydrogen ion, the method of analysis must be capable of measuring a value with a trueness of 0.2pH unit and a precision of 0.2pH unit.

(5) The method of analysis used for odour and taste parameters must be capable of measuring values equal to the parametric value with a precision of 1 dilution number at 25ºC.

(6) For the purposes of this paragraph—

limit of detection” (“terfyn canfod”) is—

(a)

three times the relative within-batch standard deviation of a natural sample containing a low concentration of the parameter; or

(b)

five times the relative within-batch standard deviation of a blank sample;

precision” (“trachywiredd”) (the random error) is twice the standard deviation (within a batch and between batches) of the spread of results about the mean;

trueness” (“cywirdeb”) (the systematic error) is the difference between the mean value of the large number of repeated measurements and the true value.

Authorisation of alternative methods of analysisE+W

2.—(1) The Agency may authorise a method different from that set out in Part 2 of this Schedule if satisfied that it is at least as reliable.

(2) An authorisation may be time-limited and may be revoked at any time.

Sampling and analysis by persons other than food authoritiesE+W

3.—(1) A food authority may enter into an arrangement for any person to take and analyse samples on its behalf.

(2) A food authority must not enter into an arrangement under sub-paragraph (1) unless—

(a)it is satisfied that the task will be carried out promptly by a person competent to perform it; and

(b)it has made arrangements that ensure that any breach of these Regulations is communicated to it immediately, and any other result is communicated to it within 28 days.

PART 2 E+WMethods of analysis and performance characteristics

Table 1

Prescribed methods of analysis

1 Use the following method to make m-CP agar:

ParameterMethod
Clostridium perfringens (including spores)Membrane filtration followed by anaerobic incubation of the membrane on m-CP agar1 at 44 ±1ºC for 21± 3 hours. Count opaque yellow colonies that turn pink or red after exposure to ammonium hydroxide vapours for 20 to 30 seconds.
Coliform bacteriaBS-EN ISO 9308-1
Colony count 22ºC – enumeration of culturable microorganismsBS-EN ISO 6222
Colony count 37ºC – enumeration of culturable microorganismsBS-EN ISO 6222
EnterococciBS-EN ISO 7899-2
Escherichia coli (E. Coli)BS-EN ISO 9308-1
Pseudomonas aeruginosaBS-EN ISO 12780
Make a basal medium consisting of—
Tryptose30.0g
Yeast extract20.0g
Sucrose5.0g
L-cysteine hydrochloride1.0g
MgSO4.7H2O0.1g
Bromocresol purple40.0mg
Agar15.0g
Water1,000.0ml
Dissolve the ingredients of basal medium, adjust pH to 7.6 and autoclave at 121ºC for 15 minutes. Allow the medium to cool.
Dissolve—
D-cycloserine400.0mg
Polymyxine-B sulphate25.0mg
Indoxl-β-D-glucoside60.0mg
into 8ml sterile water and add it to the medium.Add to the medium—
Filter-sterilised 0.5% phenolphthalein diphosphate solution20.0ml
Filter-sterilised 4.5% FeCl3.6H2O2.0ml

Table 2

Prescribed performance characteristics for methods of analysis

1 The method of analysis should determine total cyanide in all forms.

2 Oxidation should be carried out for 10 minutes at 100°C under acid conditions using permanganate.

3 The performance characteristics apply to each individual pesticide and will depend on the pesticide concerned.

4 The performance characteristics apply to the individual substances specified at 25% of the parametric value in Table B in Part 2, Schedule 7.

5 The performance characteristics apply to the individual substance specified at 50% of the parametric value in Table B in Part 2, Schedule 7.

ParametersTrueness % of prescribed concentration or value or specificationPrecision % of prescribed concentration or value or specificationLimit of detection % of prescribed concentration or value or specification
Aluminium101010
Ammonium101010
Antimony252525
Arsenic101010
Benzene252525
Benzo(a)pyrene252525
Boron101010
Bromate252525
Cadmium101010
Chloride101010
Chromium101010
Conductivity101010
Copper101010
Cyanide1101010
1,2-dichloroethane252510
Fluoride101010
Iron101010
Lead101010
Manganese101010
Mercury201020
Nickel101010
Nitrate101010
Nititre101010
Oxidisability2252510
Pesticides and related products3252525
Polycyclic aromatic hydrocarbons4252525
Selenium101010
Sodium101010
Sulphate101010
Tetrachloroethene5252510
Trichloroethene5252510
Trihalomethanes4252510

Regulation 25(1)(b)

SCHEDULE 11E+WSampling and analysis for indicative dose in water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

PART 1 E+WGeneral

Analysis of samplesE+W

1.  The food authority must ensure that each sample is analysed for indicative dose in accordance with F16... this Part.

2.  For each parameter and radionuclide specified in the first column of Table 1 in Part 2 of this Schedule, the derived concentration and dose coefficient for calculating the indicative dose is specified in the second column of that table.E+W

3.  For each parameter specified in the first column of Table 2 in Part 2 of this Schedule, the method of analysis must be one that is capable of detecting the parameter at the limit of detection specified in the second column of that table.E+W

4.  If the following formula is satisfied, the indicative dose is considered to be less than the parametric value of 0.1 mSv and no further investigation is required—E+W

  • where

  • Ci(obs) = observed concentration radionuclide i

  • Ci(der) = derived concentration of radionuclide i

  • n = number of radionuclides detected

PART 2 E+WMethods of analysis and performance characteristics

Table 1

Derived concentrations for radioactivity

1 This table allows only for the radiological properties of uranium, not for its chemical toxicity.

OriginNuclideDerived concentration
NaturalU-23813.0 Bq/l
U-23412.8 Bq/l
Ra-2260.5 Bq/l
Ra-2280.2 Bq/l
Pb-2100.2 Bq/l
Po-2100.1 Bq/l
ArtificialC-14240 Bq/l
Sr-904.9 Bq/l
Pu-239/Pu-2400.6 Bq/l
Am-2410.7 Bq/l
Co-6040 Bq/l
Cs-1347.2 Bq/l
Cs-13711 Bq/l
I-1316.2 Bq/l

Table 2

Performance characteristics and methods of analysis

1 The limit of detection is calculated according to the ISO standard 11929: Determination of the characteristic limits (decision threshold, detection limit and limits of the confidence interval) for measurements of ionising radiation – Fundamentals and application, with probabilities of errors of 1st and 2nd kind of 0.05 each.

2 Measurement uncertainties are calculated and reported as complete standard uncertainties, or as expanded standard uncertainties with an expansion factor of 1.96, according to the ISO Guide for the Expression of Uncertainty in Measurement.

3 The limit of detection for tritium and for radon is 10% of its parametric value of 100 Bq/l.

4 The limit of detection for gross alpha activity and gross beta activities are 40% of the screening values of 0.1 and 1.0 Bq/l respectively.

5 This limit of detection applies only to initial screening for indicative dose for a new water source. If initial checking indicates that it is not plausible that Ra-228 exceeds 20% of the derived concentration, the limit of detection may be increased to 0.08 Bq/l for routine Ra-228 nuclide specific measurements, until a subsequent re-check is required.

Parameters and radionuclidesLimit of detection 12
Tritium10 Bq/l 3
Radon10 Bq/l 3

gross alpha activity

gross beta activity

0.04 Bq/l 4

0.4 Bq/l 4

U-2380.02 Bq/l
U-2340.02 Bq/l
Ra-2260.04 Bq/l
Ra-2280.02 Bq/l 5
Pb-2100.02 Bq/l
Po-2100.01 Bq/l
C-1420 Bq/l
Sr-900.4 Bq/l
Pu-239/Pu-2400.04 Bq/l
Am-2410.06 Bq/l
Co-600.5 Bq/l
Cs-1340.5 Bq/l
Cs-1370.5 Bq/l
I-1310.5 Bq/l

Regulations 33, 34 and 35

SCHEDULE 12E+WApplication and modification of provisions of the Act

Table 1

Improvement notices

Provision of the ActModifications
Section 10(1) and (2) (improvement notices)

(1) For subsection (1) substitute—

(2) If an authorised officer of an enforcement authority has reasonable grounds for believing that a person is failing to comply with any provision specified in subsection (1A) or is carrying out either a fluoride removal treatment or an ozone-enriched air treatment that has a disinfectant action, the authorised officer may, by a notice served on that person (in this Act referred to as an “improvement notice”)—

(a)state the authorised officer's grounds for believing that the person is failing to comply with the relevant provision;

(b)specify the matters which constitute the person's failure so to comply;

(c)specify the measures which, in the officer's opinion, the person must take in order to secure compliance; and

(d)require the person to take those measures or measures that are at least equivalent to them, within such period as may be specified in the notice.

(1A) The provisions referred to in subsection (1) are—

(a)any of regulations 8 to 22 of the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015; and

(a)any of the following provisions of 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 M1

(i)Article 1.2 (requirement that any fluoride removal treatment be performed in accordance with the technical requirements set out in the Annex);

(ii)the first sentence of Article 2 (requirement that the release of residues into natural mineral water or spring water as a result of any fluoride removal treatment be as low as technically feasible according to the best practices and not pose a risk to public health);

(iii)the second sentence of Article 2 (requirement to ensure compliance with the first sentence of Article 2, operators implement and monitor the critical processing steps set out in the Annex);

(iv)Article 3.1 (requirement that the application of any fluoride removal treatment be notified to the competent authorities at least three months prior to use); and

(v)Article 4 (requirement that the label on natural mineral water or spring water subjected to any fluoride removal treatment include specified information in proximity to the statement of the analytical composition).

Marginal Citations

M1OJ No L 37, 10.2.2010, p 13.

Table 2

Powers of entry

Provision of the ActModifications
Section 32(1) to (7) (powers of entry)

In subsection (1), for paragraphs (a) to (c) substitute—

(a)to enter any premises within the authority's area for the purpose of ascertaining whether there is or has been on the premises a contravention of any of the following provisions of 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—

(i)Article 1.2 (requirement that any fluoride removal treatment be performed in accordance with the technical requirements set out in the Annex);

(ii)the first sentence of Article 2 (requirement that the release of residues into natural mineral water or spring water as a result of any fluoride removal treatment be as low as technically feasible according to the best practices and not pose a risk to public health);

(iii)the second sentence of Article 2 (requirement to ensure compliance with the first sentence of Article 2, operators implement and monitor the critical processing steps set out in the Annex);

(iv)Article 3.1 (requirement that the application of any fluoride removal treatment be notified to the competent authorities at least three months prior to use); and

(v)Article 4 (requirement that the label on natural mineral water or spring water subjected to any fluoride removal treatment include specified information in proximity to the statement of the analytical composition); and

(b)to enter any business premises, whether within or outside the authority's area, for the purpose of ascertaining whether there is on the premises any evidence of any contravention within that area of the provisions set out in paragraph (a);.

Table 3

Other provisions of the Act

Provision of the ActModifications
Section 2 M2 (extended meaning of “sale” etc.)

In subsection (1), for “this Act” substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”. In subsection (2), for “This Act” substitute “ The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 3 (presumptions that food intended for human consumption)

In subsection (1), for “this Act” substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 20 (offences due to fault of another person)

For “any of the preceding provisions of this part” substitute “ section 10(2) as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, ”.

Section 21(1) and (5) M3 (defence of due diligence)

In subsection (1), for “any of the preceding provisions of this Part” substitute “ section 10(2) as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, ”.

Section 22 (defence of publication in the course of business)

For “any of the preceding provisions of this Part” substitute “ section 10(2) as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 29 (procurement of samples)

In paragraph (b)(ii), after “under section 32 below”, insert “ as applied by regulation 34 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 30(6) and (8) (which relates to evidence of certificates given by a food analyst or examiner)

In subsection (8), for “this Act” substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 33 (obstruction etc. of officers)

In subsection (1), for “this Act” (in each place where it occurs) substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 35(1) M4 and (2) (punishment of offences)

In subsection (1), after “section 33(1) above” insert “ , as applied and modified by regulation 35 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, ”.

After subsection (1), insert—

(1A) A person guilty of an offence under section 10(2), as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 shall be liable, on summary conviction, to a fine not exceeding level 4 on the standard scale.

In subsection (2), in the opening words, for “any other offence under this Act” substitute “ an offence under section 33(2), as applied by regulation 35 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, ”.

Section 36 (offences by bodies corporate)

In subsection (1), for “this Act” substitute “ section 10(2) as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 36A M5 (offences by Scottish partnerships)

For “this Act” substitute “ section 10(2) as applied by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Section 37(1) and (6) (appeals)

For subsection (1) substitute—

Any person who is aggrieved by a decision of an authorised officer of an enforcement authority to serve an improvement notice under section 10(1), as applied and modified by regulation 33 of, and Schedule 12 to, the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, may appeal to a magistrates' court.

In subsection (6)—

for “(3) and (4)” substitute “ (1) ”; and

in paragraph (a), omit “or to the sheriff”.

Section 39 (appeals against improvement notices)

For subsection (1) substitute—

(1) On an appeal against an improvement notice served under section 10(1), as applied and modified by regulation 33 of, and Schedule 12 to the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015, the magistrates' court may either cancel or affirm the notice and, if it affirms it, may do so either in its original form or with such modifications as the magistrates' court may in the circumstances think fit.

In subsection (3), omit “for want of prosecution”.

Section 44 (protection of officers acting in good faith)

For “this Act” (in each place where it occurs) substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.

Marginal Citations

M2Section 2(1) was amended by the section 40(1) of, and paragraph 8 of Schedule 5 to, the Food Standards Act 1999 (c. 28).

M4Section 35(1) is to be amended by section 280(2) of, and paragraph 42 of Schedule 26 to, the Criminal Justice Act 2003 (c. 44) from a date to be appointed.

M5Section 36A was inserted by section 40(1) of, and paragraph 16 of Schedule 5 to, the Food Standards Act 1999.

Regulation 38

SCHEDULE 13E+WAmendments to other legislation

The Private Water Supplies (Wales) Regulations 2010E+W

1.  The Private Water Supplies (Wales) Regulations 2010 M6 are amended as follows.

Marginal Citations

2.  In regulation 3(a), for “the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2007” substitute “ the Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2015 ”.E+W

The Food Safety (Sampling and Qualifications) (Wales) Regulations 2013E+W

3.  The Food Safety (Sampling and Qualifications) (Wales) Regulations 2013 M7 are amended as follows.

Marginal Citations

M7S.I. 2013/479 (W.55), amended by S.I. 2013/2493 (W.242).

4.  In Schedule 1, omit the reference to “The Natural Mineral Water, Spring Water and Bottled Drinking Water (Wales) Regulations 2007”.E+W

The Food Information (Wales) Regulations 2014E+W

5.  The Food Information (Wales) Regulations 2014 M8 are amended as follows.

Marginal Citations

6.  In Schedule 7, omit paragraphs 49 and 50.E+W

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