SCHEDULE 1PRESCRIBED CONCENTRATIONS AND VALUES

Regulation 5

Wholesomeness

TABLE AMICROBIOLOGICAL PARAMETERS

(1) Item

(2) Parameters

(3) Concentration or Value (maximum)

(4) Unit of measurement

(5) Point of Compliance1

Part I: Directive requirements

1.

Enterococci

0

number/100ml

Consumers' taps

2.

Escherichia coli (E. coli)

0

number/100ml

Consumers' taps

Part II: National requirements

1.

Coliform bacteria

0

number/100ml

Service reservoirs2 and water treatment works

2.

Escherichia coli (E. coli)

0

number/100ml

Service reservoirs and water treatment works

1 Where water is supplied from a tanker see regulation 5(3)(a)

2 Compliance required as to 95% of samples taken for coliform bacteria from each service reservoir (regulation 5(6)).

TABLE BCHEMICAL PARAMETERS

(1) Item

(2) Parameters

(3) Concentration or Value (maximum)

(5) Units of Measurement

(6) Point of compliance

Part I: Directive requirements

1.

Acrylamide1

0.10

µg/l

2.

Antimony

5.0

µg/l

Consumers' taps

3.

Arsenic

10

µg/l

Consumers' taps

4

Benzene

1.0

µg/l

Consumers' taps

5

Benzo(a)pyrene

0.010

µg/l

Consumers' taps

6

Boron

1.0

mg/l

Consumers' taps

7

Bromate2

10

µg/l

Consumers' taps

8

Cadmium

5.0

µg/l

Consumers' taps

9

Chromium

50

µg/l

Consumers' taps

10

Copper3

2.0

mg/l

Consumers' taps

11

Cyanide

50

µg/l

Consumers' taps

12

1, 2 dichloroethane

3.0

µg/l

Consumers' taps

13

Epichlorohydrin1

0.10

µg/l

14

Fluoride

1.5

mg/l

Consumers' taps

15

Lead3

10

µg/l

Consumers' taps

16

Mercury

1.0

µg/l

Consumers' taps

17

Nickel3

20

µg/l

Consumers' taps

18

Nitrate4

50

mg/l

Consumers' taps

19

Nitrite4

0.50

mg/l

Consumers' taps

0.10

Treatment works

20

Pesticides56

Aldrin

Dieldrin

Heptachlor

Heptachlor epoxide

0.030

µg/l

Consumers' taps

other pesticides56

0.10

µg/l

Consumers' taps

21

Pesticides: Total7

0.50

µg/l

Consumers' taps

22

Polycyclic aromatic hydrocarbons8

0.10

µg/l

Consumers' taps

23

Selenium

10

µg/l

Consumers' taps

24

Tetrachloroethene and Trichloroethene9

10

µg/l

Consumers' taps

25

Trihalomethanes: Total10

100

µg/l

Consumers' taps

26

Vinyl chloride1

0.50

µg/l

Part II: National requirements

1.

Aluminium

200

µg/l

Consumers' taps

2.

Colour

20

mg/l Pt/Co

Consumers' taps

3.

Iron

200

µg/l

Consumers' taps

4.

Manganese

50

µg/l

Consumers' taps

5.

Odour

Acceptable to consumers and no abnormal change

Consumers' taps

6.

Sodium

200

mg/l

Consumers' taps

7.

Taste

Acceptable to consumers and no abnormal change

Consumers' taps

8.

Tetrachloromethane

3

µg/l

Consumers' taps

9.

Turbidity

4

NTU

Consumers' taps

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. This is controlled by product specification.

2 Where possible, without compromising disinfection, a water undertaker (in relation to a supply of water for human consumption purposes) must strive for a lower value.

3 See also regulation 8(5).

4 See also regulation 5(3)(d).

5 See the definition of “pesticides and related products” in regulation 2.

6 The parametric value applies to each individual. “other pesticide” means a pesticide other than aldrin, dieldrin, heptachlor and heptachlor epoxide.

7Pesticides: Total” means the sum of the concentrations of the individual pesticides detected and quantified in the monitoring process.

8 The specified compounds are benzo(b)fluoranthene, benzo(k)fluoranthene, benzo(ghi)perylene, indeno(1,2,3-cd)pyrene and the parametric value applies to the sum of the concentrations of the individual compounds detected and quantified in the monitoring process.

9 The parametric value applies to the sum of the concentrations of the individual compounds detected and quantified in the monitoring process.

10 The specified compounds are chloroform, bromoform, dibromochloromethane, bromodichloromethane and the parametric value applies to the sum of the concentrations of the individual compounds detected and quantified in the monitoring process.

SCHEDULE 2INDICATOR PARAMETERS

Regulation 2 and 5

(1) Item

(2) Parameters

(3) Specification Concentration or Value (maximum unless otherwise stated) or State

(4) Units of Measurement

(5) Point of monitoring

1

Ammonium

0.50

mg/l

Consumers' taps

2

Chloride12

250

mg/l

Supply point

3

Clostridium perfringens (including spores)1

0

Number/100ml

Supply point

4

Coliform bacteria

0

Number/100ml

Consumers' taps

5

Colony counts

No abnormal change

Number/1ml at 22°C Number/1ml at 37°C

Consumers' taps, service reservoirs and treatment works

6

Conductivity12

2500

µS/cm at 20°C

Supply point

7

Hydrogen ion2

9.5

pH units

Consumers' taps

6.5 (minimum)

8

Radon (for radioactivity)136

100

Bq/l

Supply point

9

Sulphate12

250

mg/l

Supply point

10

Indicative dose (for radioactivity)1467

0.10

mSv

Supply point

11

Total organic carbon (TOC)1

No abnormal change

mg/l

Supply point

12

Tritium (for radioactivity)156

100

Bq/l

Supply point

13

Turbidity

1

NTU

Treatment works

1 May be monitored from samples of water leaving treatment works or other supply point, as no significant change during distribution.

2 The water should not be aggressive.

3 Where radon concentrations exceed 1000Bq/l, remedial action must be carried out on radiological protection grounds without further consideration.

4 Excluding tritium, potassium-40, radon and radon decay products.

5 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 radionuclides is required.

6 Where treatment to reduce the level of radionuclides in water intended for human consumption has been taken, monitoring must be carried out to ensure the continued efficacy of the treatment.

7 If the gross alpha activity exceeds 0.1Bq/l or gross beta activity exceeds 1.0Bq/l, analysis for specific radionuclides is required.

SCHEDULE 3MONITORING PROGRAMMES

Regulation 6

1

1

A monitoring programme established under Part 4 of these Regulations must—

a

verify that—

i

the measures in place to control risks to human health throughout the water supply chain (from the catchment area through abstraction, treatment and storage to distribution) are working effectively; and

ii

water at the point of compliance is wholesome;

b

provide information on the quality of water supplied to—

i

demonstrate whether or not the water complies with prescribed concentrations and values for parameters in Schedule 1;

ii

determine the organoleptic and microbiological quality of the water; and

iii

establish the effectiveness of the treatment of the water, particularly of disinfection where it is used.

c

identify the most appropriate means of mitigating any risk to human health; and

d

have regard to Part 5.

2

A monitoring programme must consist of either—

a

the collection and analysis of discrete water samples; or

b

measurement recorded by a continuous monitoring process; or

c

a combination of both of the methods described in sub-paragraphs (a) and (b).

3

In addition, monitoring programmes may consist of—

a

inspections of records of the functionality and maintenance status of equipment; and/or

b

inspections of the catchment area, water abstraction, treatment, storage and distribution infrastructure.

4

The monitoring programme may be based on a risk assessment as set out in regulation 30.

5

When choosing appropriate parameters and other micro-organisms, parasites or substances for monitoring programmes, local conditions for each water supply system must be taken into consideration.

TABLE 1PARAMETERS AND CIRCUMSTANCES FOR GROUP A MONITORING

(1) Item

(2) Parameter

(3) Circumstances

1

Aluminium

If used as water treatment chemicals or where the water originates from, or is influenced by, surface waters

2

Ammonium

Where chloramination is practised

3

Coliform bacteria

In all supplies

4

Colony Counts

In all supplies

5

Colour

In all supplies

6

Conductivity

In all supplies

7

Disinfectant residual

When disinfection treatment is practised

8

Escherichia coli (E. coli)

In all supplies

9

Indicative Dose

Where there is treatment in place to reduce the level of radionuclides in water intended for human consumption.

10

Iron1

If used as water treatment chemicals or where the water originates from, or is influenced by, surface waters

11

Manganese1

Where the water originates from, or is influenced by, surface waters

12

Nitrate

Where chloramination is practised

13

Nitrite

Where chloramination is practised

14

Odour

In all supplies

15

pH (Hydrogen ion)

In all supplies

16

Radon

Where there is treatment in place to reduce the level of radionuclides in water intended for human consumption.

17

Taste

In all supplies

18

Tritium

Where there is treatment in place to reduce the level of radionuclides in water intended for human consumption.

19

Turbidity

In all supplies

1 A supply which consists of both groundwater and surface water is deemed to be a supply which consists only of surface water.

TABLE 2Annual Sampling Frequencies: Water Supply Zones

This table sets out the annual sampling frequencies for all the substances and parameters in column 1. These are determined for each water supply zone according to its estimated population (column 2).

(1) Substances and parameters subject to monitoring

(2) Estimated population of water supply zone1

(3) Number of samples per year

Group A monitoring

Escherichia coli (E. coli)

< 100

≥ 100

4

12 per 5,000 population1

Coliform bacteria

Residual disinfectant

Aluminium

<100

100–4,999

5,000–9,999

10,000–29,999

30,000–49,999

50,000–79,999

80,000–100,000

2

4

12

24

36

52

76

Ammonium

Colony counts

Colour

Conductivity2

Hydrogen ion

Iron

Manganese

Nitrate3

Nitrite3

Odour

Taste

Turbidity

Group B monitoring

Aluminium

<100

100–4,999

5,000–100,000

1

4

8

Antimony

Arsenic

Benzene2

Benzo(a)pyrene

Boron2

Bromate4

Cadmium

Chromium

Clostridium perfringens (including spores)

Copper

Cyanide2

1,2 dichloroethane2

Enterococci

Fluoride2

Gross alpha25

Gross beta25

Iron

Lead

Manganese

Mercury2

Nickel

Nitrate3

Nitrite3

Pesticides and related

products2

Polycyclic aromatic hydrocarbons

Radon26

Selenium

Sodium

Trichloroethene/

Tetrachloroethene2

Tetrachloromethane2

Trihalomethanes

Chloride2

Sulphate2

Total organic carbon2

Tritium2

1 Where the population is not an exact multiple of 5,000, the population figure should be rounded up to the nearest multiple of 5,000.

2 Sampling for these parameters may be within water supply zones or at supply points as specified in Table 3, subject to notes (5) and (6) below.

3 Group A monitoring in water supply zones is required only where chloramination is practised. In other circumstances Group B monitoring is required.

4 Group B monitoring in water supply zones is required only where sodium hypochlorite is added after water has left the treatment works. In other circumstances, Group B monitoring is required at supply points.

5 To monitor for indicative dose (for radioactivity).

6 In the event that a single sample is taken in a year, a further sample should be taken if there is any change in relation to that supply that could affect the concentration of radionuclides in the water supply.

TABLE 3Annual Sampling Frequencies: Treatment Works or Supply Points

Sampling is at treatment works for the substances and parameters shown in column (1) of the Table as items (1) to (6) and at supply points for the other substances and parameters, except nitrite subject to notes 2 and 3 to the Table below. This table sets out the annual sampling frequencies for all the substances and parameters in column 2 at treatment works or supply points. The frequencies are determined according to the volume of water supplied at each treatment works or supply point (column 3).

(1) Item

(2) Substances and parameters

(3) Volume of water supplied m3/d1

(4) Number of samples per year2

1

Escherichia coli (E. coli)

<20

20-1,999

2,000-5,999

6,000-11,999

≥ 12,000

4

52

104

208

365

2

Coliform bacteria

3

Colony counts

4

Nitrite3

5

Residual disinfectant

6

Turbidity

Group A monitoring

7

Conductivity

<20

20-999

1,000-1,999

2,000-5,999

6,000-9,999

10,000-15,999

16,000-32,999

33,000-49,999

50,000-67,999

68,000-84,999

85,000-101,999

102,000-119,999

120,000-241,999

242,000-484,999

485,000-728,999

2

4

12

24

36

52

104

156

208

260

312

365

730

1,460

2,190

Group A monitoring

8

Gross alpha6

<20

20-999

1,000-49,999

50,000-89,999

90,000-299,999

300,000-649,999

≥ 650,000

1

4

8

12

24

36

48

9

Gross beta6

10

Radon

11

Tritium

Group B monitoring

12

Benzene

<20

20-999

1,000-49,999

50,000-89,999

90,000-299,999

300,000-649,999

≥650,000

1

4

8

12

24

36

48

13

Boron

14

Bromate5

15

Clostridium perfringens (including spores)

16

Cyanide

17

1,2,dichloroethane

18

Fluoride

19

Mercury

20

Nitrite4

21

Pesticides and related products

22

Trichloroethene/

Tetrachloroethene

23

Tetrachloromethane

24

Chloride

25

Sulphate

26

Total Organic Carbon

27

Radon

28

Tritium

29

Gross alpha6

30

Gross beta6

1 The water undertaker may use the number of inhabitants in a supply zone instead of the volume of water to determine the minimum frequency, assuming a water consumption of 200 l/day/capita.

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

3 Sampling at treatment works when chloramination is practised.

4 Sampling at treatment works when chloramination is not practised.

5 Group B monitoring at supply points is required only where sodium hypochlorite is not added after water has left the treatment works. In other circumstances, Group B monitoring is required in water supply zones

6 To monitor for indicative dose (for radioactivity).

SCHEDULE 4ANALYTICAL METHODOLOGY

Regulation 18

TABLE AParameters for which, subject to regulation 18(12), methods of analysis are prescribed

(1) Parameter

(2) Method

Clostridium perfringens (including spores)

EN ISO 14189

Coliform bacteria

EN ISO 9308-1 or EN ISO 9308-2

Colony count 22°C-enumeration of culturable microorganisms

ENISO 6222

Colony count 36°C-enumeration of culturable microoganisms

EN ISO 6222

Enterococci

EN ISO 7899-2

Escherichia coli (E. coli)

EN ISO 9308-1 or EN ISO 9308-2

Pseudomonas aeruginosa

EN ISO 16266

TABLE BMinimum performance characteristic: “uncertainty of measurement”

(1) Parameter1

(2) Uncertainty of measurement (% of parametric value, except pH)2

Aluminium

25

Ammonium

40

Antimony

40

Arsenic

30

Benzo(a)pyrene3

50

Benzene

40

Boron

25

Bromate

40

Cadmium

25

Chloride

15

Chromium

30

Conductivity

20

Copper

25

Cyanide4

30

1,2-dichloroethane

40

Fluoride

20

Hydrogen ion concentration pH (expressed in pH units)5

0.2

Iron

30

Lead

25

Manganese

30

Mercury

30

Nickel

25

Nitrate

15

Nitrite

20

Oxidisability6

50

Pesticides7

30

Polycyclic aromatic hydrocarbons8

50

Selenium

40

Sodium

15

Sulphate

15

Tetrachloroethene9

30

Tetrachloromethane

30

Trichloroethene9

40

Trihalomethanes: total8

40

Total organic carbon10

30

Turbidity11

30

1 Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.

2 Uncertainty of measurement is a non-negative parameter characterising the dispersion of the quantity values being attributed to a measurand, based on the information used. The performance criterion for measurement uncertainty (k = 2) is the percentage of the parametric value stated in the table or better. Measurement uncertainty must be estimated at the level of the parametric value, unless otherwise specified.

3 If the value of uncertainty of measurement cannot be met, the best available technique should be selected (up to 60%).

4 The method determines total cyanide in all forms.

5 Values for trueness, precision and uncertainty of measurement are expressed in pH units.

6 Reference method EN ISO 8467.

7 The performance characteristics for individual pesticides are given as an indication. Values for the uncertainty of measurement as low as 30 % can be achieved for several pesticides, higher values up to 80 % may be allowed for a number of pesticides

8 The performance characteristics apply to individual substances, specified at 25% of the parametric value in Table B in Schedule 1.

9 The performance characteristics apply to individual substances, specified at 50% of the parametric value in Table B in Schedule 1.

10 The uncertainty of measurement should be estimated at the level of 3 mg/l of the total organic carbon. CEN 1484 Guidelines for the determination of total organic carbon and dissolved organic carbon must be used.

11 The uncertainty of measurement must be estimated at the level of 1.0 NTU (nephelometric turbidity units) in accordance with EN ISO 7027.

TABLE CMinimum performance characteristics: trueness, precision and limit of detection- may be used until 31 December 2019

(1) Parameter1

(2) Trueness2

(3) Precision3

(4) Limit of detection4

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

Colour

10

10

10

Conductivity

10

10

10

Copper

10

10

10

Cyanide5

10

10

10

1,2-dichloroethane

25

25

10

Fluoride

10

10

10

Hydrogen ion concentration pH (expressed in pH units)6

0.2

0.2

Iron

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

Oxidisability7

25

25

25

Pesticides8

25

25

25

Polycyclic aromatic hydrocarbons9

25

25

25

Selenium

10

10

10

Sodium

10

10

10

Sulphate

10

10

10

Tetrachloroethene10

25

25

10

Tetrachloromethane

20

20

20

Trichloroethene10

25

25

10

Trihalomethanes: total9

25

25

10

Turbidity11

10

10

10

Turbidity12

25

25

25

1 Acrylamide, epichlorohydrin and vinyl chloride to be controlled by product specification.

2 Trueness is a measure of systematic error, i.e. the difference between the mean value of the large number of repeated measurements and the true value. Further specifications are those set out in ISO 5725.

3 Precision is a measure of random error and is usually expressed as the standard deviation (within and between batches) of the spread of results from the mean. Acceptable precision is twice the relative standard deviation. This term is further specified in ISO 5725.

4 Limit of detection is either three times the standard deviation within a batch of a natural sample containing a low concentration of the parameter; or five times the standard deviation of a blank sample (within a batch).

5 The method determines total cyanide in all forms.

6 Values for trueness, precision and uncertainty of measurement are expressed in pH units.

7 Reference method EN ISO 8467 1995.

8 The performance characteristics for individual pesticides are given as an indication. Values for the uncertainty of measurement as low as 30% can be achieved for several pesticides, higher values up to 80% may be allowed for a number of pesticides

9 The performance characteristics apply to individual substances, specified at 25% of the parametric value in Table B in Schedule 1.

10 The performance characteristics apply to individual substances, specified at 50% of the parametric value in Table B in Schedule 1.

11 The performance characteristics apply to prescribed value 4 NTU.

12 The performance characteristics apply to prescribed value 1 NTU for water leaving surface water treatment works.

SCHEDULE 5MONITORING FOR INDIVIDUAL RADIONUCLIDES

Regulation 8

1

A water undertaker may use a screening strategy for gross alpha and gross beta to monitor for the parametric indicator value for indicative dose M1. The recommended screening value for gross alpha is 0.1Bq/l and for gross beta is 1.0Bq/l.

If the gross alpha activity exceeds 0.1Bq/l or the gross beta activity exceeds 1.0Bq/l, analysis for specific radionuclides is required.

The radionuclides to be measured must be based on all relevant information about likely sources of radioactivity.

Annotations:
Marginal Citations
M1

Where appropriate gross beta activity may be replaced by residual beta activity after subtraction of the K-40 activity concentration.

2

Calculation of the ID

The ID must be calculated from the measured radionuclide concentrations and the dose coefficients F1referred to as “standard values and relationships” in Article 13, and recommended for the estimation of doses from internal exposure in the definition of “standard values and relationships” in Article 4(96), of the Council Directive 2013/59/Euratom laying down basic safety standards for the protection against the dangers arising from exposure to ionising radiation or more recent information recognised by the Department, on the basis of the annual intake of water (730l for adults). Where the following formula is satisfied, it can be assumed that the ID is less than the parametric value if 0.1mSv and no further investigation is required.

i=1nC(obs)iC(der)i1math

where

Ci(obs) = observed concentration of radionuclide i

Ci(der) = derived concentration of radionuclide i (see Table 1)

n – number of radionuclides detected.

TABLE 1

Derived concentration for radioactivity in water intended for human consumption1

Origin

Radionuclide

Derived concentration2

Natural

U-2383

3.0 Bq/l

U-2343

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 includes value for the most common natural and artificial radionuclides; these are precise values, calculated for a dose of 0.1mSV, an annual intake of 730 litres and using the dose coefficients F2referred to as “standard values and relationships” in Article 13, and recommended for the estimation of doses from internal exposure in the definition of “standard values and relationships” in Article 4(96), of the Council Directive 2013/59/Euratom laying down basic safety standards for the protection against the dangers arising from exposure to ionising radiation ; derived concentration for other radionuclides can be calculated on the same basis, and values can be updated on the basis of more recent information recognised by the competent authorities.

2 Where appropriate gross beta activity may be replaced by residual beta activity after subtraction of the K-40 concentration.

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

3

Performance characteristics and method of analysis.

For the following parameters and radionuclides, the method of analysis used must, as a minimum be capable of measuring activity concentrations with a limit of detection specified in Table 2 below:

TABLE 2

Parameters and radionuclides

Limit of detection12

Tritium3

10 Bq/l

Radon3

10 Bq/l

gross alpha activity4

0.04 Bq/l

gross beta activity4

0.4 Bq/l

U-238

0.02 Bq/l

U-234

0.02 Bq/l

Ra-226

0.04 Bq/l

Ra-2285

0.02 Bq/l

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

2 Measurement uncertainties must be calculated and reported as complete standard uncertainties or as expanded uncertainties with an expansion factor of 1.96 according 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 ID for a new water source, if initial checking indicates that is not plausible that Ra-228 exceeds 20% of the derived concentration, the limit of detection may be increased to 0.8 Bq/l for routine Ra-228 nuclide specific measurements until a subsequent re-check is required.

SCHEDULE 6REVOCATIONS

Regulation 39

Revocations coming into operation on the 27th October 2017

No.

Regulations revoked

Extent of revocation

1.

The Water Supply (Water Quality) Regulations (Northern Ireland) 2007

The whole Regulations

2.

The Water Supply (Water Quality) (Amendment) Regulations (NI) 2009

The whole Regulations

3.

The Water Supply (Water Quality) (Amendment) Regulations (NI) 2010

The whole Regulations

4.

The Water Supply (Water Quality) (Amendment) Regulations (NI) 2015

The whole Regulations