SCHEDULE 1Recognition of natural mineral water

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

PART 1Natural 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 F12... 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 2Natural mineral water extracted from the ground in a F11third country

Annotations:
Amendments (Textual)

5

A person seeking to have a water which is extracted from the ground in a F13third country recognised as a natural mineral water F14... 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 3Requirements 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 (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.

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 4Particulars of anions, cations, non-ionised compounds and trace elements

Table A

Anions

Unit 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

Cations

Unit of measurement

Aluminium Al

mg/l

Ammonium NH4 +

mg/l

Calcium Ca

mg/l

Magnesium Mg

mg/l

Potassium K

mg/l

Sodium Na

mg/l

Table C

Non-ionised compounds

Unit of measurement

Total organic carbon C

mg/l

Free carbon dioxide CO2

mg/l

Silica SiO2

mg/l

Table D

Trace elements

Unit of measurement

Barium Ba

mg/l

Bromine (total) Br

mg/l

Cobalt Co

mg/l

Copper Cu

mg/l

Iodine (total) I

mg/l

Iron Fe

mg/l

Lithium Li

mg/l

Manganese Mn

mg/l

Molybdenum Mo

mg/l

Strontium Sr

mg/l

Zinc Zn

mg/l

SCHEDULE 2Fluoride removal treatment

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

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.

2

A person seeking authorisation to carry out fluoride removal treatment must—

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—

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.

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.

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—

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.

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.

9

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

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).

SCHEDULE 3Ozone-enriched air treatment

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

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—

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 F86, 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—

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 residue

Maximum limit ug/l

Dissolved ozone

50

Bromate

3

Bromoform

1

3

A person seeking authorisation to carry out an ozone-enriched air treatment must—

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—

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.

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.

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—

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.

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.

10

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

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).

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

Regulations 8, 10, 13 and 14

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.

2

The spring or outlet must be protected against the risks of pollution.

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.

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.

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.

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.

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—

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—

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.

SCHEDULE 5Constituents of natural mineral water

Regulation 10

PART 1Maximum limits for constituents of natural mineral water

Constituents1

Maximum limits (mg/l)

Antimony

0.0050

Arsenic

0.010 (as total)

Barium

1.0

Cadmium

0.003

Chromium

0.050

Copper

1.0

Cyanide

0.070

Fluoride

5.0

Lead

0.010

Manganese

0.50

Mercury

0.0010

Nickel

0.020

Nitrate

50

Nitrite

0.1

Selenium

0.010

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.

PART 2Performance characteristics for analysing the constituents in Part 1

Constituents1

Accuracy of parametric value in %2

Precision of parametric value3

Detection limit of parametric value in % 4

Antimony

25

25

25

Arsenic

10

10

10

Barium

25

25

25

Cadmium

10

10

10

Chromium

10

10

10

Copper

10

10

10

Cyanide5

10

10

10

Fluoride

10

10

10

Lead

10

10

10

Manganese

10

10

10

Mercury

20

10

20

Nickel

10

10

10

Nitrate

10

10

10

Nitrite

10

10

10

Selenium

10

10

10

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.

SCHEDULE 6Labelling indications for natural mineral water

Regulation 11(1)(e)

Indication

Criteria

Low mineral content

Mineral salt content, calculated as a fixed residue, not greater than 500 mg/l

Very low mineral content

Mineral salt content, calculated as a fixed residue, not greater than 50 mg/l

Rich in mineral salts

Mineral salt content, calculated as a fixed residue, greater than 1500 mg/l

Contains bicarbonate

Bicarbonate content greater than 600 mg/l

Contains sulphate

Sulphate content greater than 200 mg/l

Contains chloride

Chloride content greater than 200 mg/l

Contains calcium

Calcium content greater than 150 mg/l

Contains magnesium

Magnesium content greater than 50 mg/l

Contains fluoride

Fluoride content greater than 1 mg/l

Contains iron

Bivalent iron content greater than 1 mg/l

Acidic

Free carbon dioxide content greater than 250 mg/l

Contains sodium

Sodium content greater than 200 mg/l

Suitable for a low-sodium diet

Sodium content less than 20 mg/l

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

Regulations 14(1)(d) and 19

PART 1Requirements for water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

1

Water satisfies the requirements of this Schedule if—

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.

PART 2Parametric values for microbiological and chemical parameters

Table A: Microbiological Parameters

Item

Parameter

Units of Measurement

Maximum Concentration or Value

1.

Escherichia coli

(E coli)

number/250 ml

0/250 ml

2.

Enterococci

number/250 ml

0/250 ml

3.

Pseudomonas aeruginosa

number/250ml

0/250 ml

4.

Colony count 22ºC

number/ml

100/ml 12

5.

Colony count 37ºC

number/ml

20/ml13

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.

Table B: Chemical Parameters

Item

Parameter

Units of Measurement

Maximum Concentration or Value

1.

Acrylamide

µg/l

0.10 1

2.

Antimony

µg Sb/l

5

3.

Arsenic

µg As/l

10

4.

Benzene

µg/l

1.0

5.

Benzo (a) pyrene

µg/l

0.010

6.

Boron

mg/l

1.0

7.

Bromate

µg/l BrO3/l

10

8.

Cadmium

µg Cd/l

5

9.

Chromium

µg Cr/l

50

10.

Copper

mg Cu/l

2

11.

Cyanide

µg CN/l

50

12.

1,2-dichloroethane

µg/l

3.0

13.

Epicholorohydrin

µg/l

0.10 1

14.

Fluoride

mg F/l

1.5

15.

Lead

µg Pb/l

10

16.

Mercury

µg Hg/l

1

17.

Nickel

µg Ni/l

20

18.

Nitrate

mg NO3/l

50 2

19.

Nitrite

mg NO2/l

0.5 2

20.

Pesticides and related products:

- individual substances

µg/l

0.10 34

- total substances

µg/l

0.50 35

21.

Polycyclic aromatic hydrocarbons

µg/l

0.1 sum of concentrations of specified compounds 6

22.

Selenium

µg Se/l

10

23.

Tetrachloroethene and Trichloroethene

µg/l

10 7

24.

Trichloromethane,

Dicholrorbromomethane, Dibromocholromethane and Tribromomethane

µg/l

100 7

25.

Vinyl chloride

µg/l

0.50 1

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.

3 “Pesticides” means:

– organic insecticides,

– organic herbicides,

– organic fungicides,

– organic nematocides,

– organic acaricides,

– organic algicides,

– organic rodenticides,

– organic slimicides, and

– related products (inter alia, growth regulators) 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.

PART 3Parametric values for indicator parameters

Annotations:
Amendments (Textual)
Table C: Indicator Parameters

Item

Parameter

Units of Measurement

Maximum Concentration or Value

1.

Aluminium

µg/l

200

2.

Ammonium

mg/l

0.50

3.

Chloride

mg/l

250 1

4.

Clostridium perfringens (including spores)

number/100ml

0 2

5.

Colour

F1Acceptable to consumers and no abnormal change

F2. . .

6.

Conductivity

µS cm-1 at 20°C

2500 1

7.

Hydrogen ion concentration

pH units

4.5 (minimum)

9.5 (maximum) 1

8.

Iron

µg/l

200

9.

Manganese

µg/l

50

10.

Odour

F3Acceptable to consumers and no abnormal change

F4. . .

11.

Oxidisability

mg/l O2

5 3

12.

Sulphate

mg/l

250 1

13.

Sodium

mg/l

200

14.

Taste

F5Acceptable to consumers and no abnormal change

F6. . .

15.

Colony Count 22°C

No abnormal change

16.

Coliform bacteria

number/250ml

0

17.

Total Organic Carbon

No abnormal change

4

18.

Turbidity

Acceptable to consumers and no abnormal change

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.

PART 4Parametric values for radon, tritium and indicative dose (ID)

Table D:

Item

Parameter

Unit of Measurement

Maximum Concentration or Value

1.

Radon

Bq/l

100 1

2.

Tritium

Bq/l

100 2

3.

Indicative Dose

mSv

0.10

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.

F7SCHEDULE 8Monitoring for parameters other than radioactive substances in water bottled and labelled as “spring water” or “dŵr ffynnon” and bottled drinking water

Regulation 24(2)(a)

Annotations:
Amendments (Textual)

F7PART 1Check monitoring

SamplingF71

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

F72

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

Frequency of samplingF73

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

F7PART 2Audit monitoring

SamplingF74

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

F75

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

Frequency of samplingF76

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

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

Regulation 24(2)(b)

PART 1General

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.

Radon2

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.

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.

Tritium5

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.

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.

Indicative dose8

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.

10

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

11

If the food authority screens for an individual radionuclide or certain radionuclides and—

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—

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 monitoring13

F91

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).

F102

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 water14

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.

Averaging15

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 2Minimum sampling and analysis frequencies

Volume of water produced each day within a supply zone 12m3

Number of samples per year 3

volume ≤ 100

1

100 < volume ≤ 100

1

1,000 < volume ≤ 10,000

1+1 for each 3,300m3/d and part thereof of the total volume

10, 000 < volume ≤ 100,000

3+1 for each 10,000 m3/d and part thereof of the total volume

volume > 100,000

10+1 for each 25,000 m3/d and part thereof of the total volume

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.

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

Regulation 25(1)(a)

PART 1General

Analysis of samples1

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—

    1. a

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

    2. 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 analysis2

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 authorities3

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 2Methods of analysis and performance characteristics

Table 1

Prescribed methods of analysis

Parameter

Method

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 bacteria

BS-EN ISO 9308-1

Colony count 22ºC – enumeration of culturable microorganisms

BS-EN ISO 6222

Colony count 37ºC – enumeration of culturable microorganisms

BS-EN ISO 6222

Enterococci

BS-EN ISO 7899-2

Escherichia coli (E. Coli)

BS-EN ISO 9308-1

Pseudomonas aeruginosa

BS-EN ISO 12780

Make a basal medium consisting of—

Tryptose

30.0g

Yeast extract

20.0g

Sucrose

5.0g

L-cysteine hydrochloride

1.0g

MgSO4.7H2O

0.1g

Bromocresol purple

40.0mg

Agar

15.0g

Water

1,000.0ml

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-cycloserine

400.0mg

Polymyxine-B sulphate

25.0mg

Indoxl-β-D-glucoside

60.0mg

into 8ml sterile water and add it to the medium.

Add to the medium—

Filter-sterilised 0.5% phenolphthalein diphosphate solution

20.0ml

Filter-sterilised 4.5% FeCl3.6H2O

2.0ml

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

Table 2

Prescribed performance characteristics for methods of analysis

Parameters

Trueness % of prescribed concentration or value or specification

Precision % of prescribed concentration or value or specification

Limit of detection % of prescribed concentration or value or specification

Aluminium

10

10

10

Ammonium

10

10

10

Antimony

25

25

25

Arsenic

10

10

10

Benzene

25

25

25

Benzo(a)pyrene

25

25

25

Boron

10

10

10

Bromate

25

25

25

Cadmium

10

10

10

Chloride

10

10

10

Chromium

10

10

10

Conductivity

10

10

10

Copper

10

10

10

Cyanide1

10

10

10

1,2-dichloroethane

25

25

10

Fluoride

10

10

10

Iron

10

10

10

Lead

10

10

10

Manganese

10

10

10

Mercury

20

10

20

Nickel

10

10

10

Nitrate

10

10

10

Nititre

10

10

10

Oxidisability2

25

25

10

Pesticides and related products3

25

25

25

Polycyclic aromatic hydrocarbons4

25

25

25

Selenium

10

10

10

Sodium

10

10

10

Sulphate

10

10

10

Tetrachloroethene5

25

25

10

Trichloroethene5

25

25

10

Trihalomethanes4

25

25

10

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.

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

Regulation 25(1)(b)

PART 1General

Analysis of samples1

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.

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.

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—

∑ i = 1 n C i ( o b s ) C i ( d e r ) ≤ 1math

  • where

  • Ci(obs) = observed concentration radionuclide i

  • Ci(der) = derived concentration of radionuclide i

  • n = number of radionuclides detected

PART 2Methods of analysis and performance characteristics

Table 1Derived concentrations for radioactivity

Origin

Nuclide

Derived concentration

Natural

U-2381

3.0 Bq/l

U-2341

2.8 Bq/l

Ra-226

0.5 Bq/l

Ra-228

0.2 Bq/l

Pb-210

0.2 Bq/l

Po-210

0.1 Bq/l

Artificial

C-14

240 Bq/l

Sr-90

4.9 Bq/l

Pu-239/Pu-240

0.6 Bq/l

Am-241

0.7 Bq/l

Co-60

40 Bq/l

Cs-134

7.2 Bq/l

Cs-137

11 Bq/l

I-131

6.2 Bq/l

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

Table 2Performance characteristics and methods of analysis

Parameters and radionuclides

Limit of detection 12

Tritium

10 Bq/l 3

Radon

10 Bq/l 3

gross alpha activity

gross beta activity

0.04 Bq/l 4

0.4 Bq/l 4

U-238

0.02 Bq/l

U-234

0.02 Bq/l

Ra-226

0.04 Bq/l

Ra-228

0.02 Bq/l 5

Pb-210

0.02 Bq/l

Po-210

0.01 Bq/l

C-14

20 Bq/l

Sr-90

0.4 Bq/l

Pu-239/Pu-240

0.04 Bq/l

Am-241

0.06 Bq/l

Co-60

0.5 Bq/l

Cs-134

0.5 Bq/l

Cs-137

0.5 Bq/l

I-131

0.5 Bq/l

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.

SCHEDULE 12Application and modification of provisions of the Act

Regulations 33, 34 and 35

Annotations:
Marginal Citations
M1

OJ No L 37, 10.2.2010, p 13.

M2

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

M3

Section 21(2) was amended by S.I. 2004/3279.

M4

Section 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.

M5

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

Table 1Improvement notices

Provision of the Act

Modifications

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).

Table 2Powers of entry

Provision of the Act

Modifications

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 3Other provisions of the Act

Provision of the Act

Modifications

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 ”.

SCHEDULE 13Amendments to other legislation

Regulation 38

The Private Water Supplies (Wales) Regulations 20101

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

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 ”.

The Food Safety (Sampling and Qualifications) (Wales) Regulations 20133

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

4

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

The Food Information (Wales) Regulations 20145

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

6

In Schedule 7, omit paragraphs 49 and 50.