[F1SCHEDULE 12E+W+SMonitoring of water bottled and labelled as “spring water” and bottled drinking water

PART 8E+W+SMonitoring obligations relating to indicative dose

SECTION 1E+W+SGeneral

Monitoring obligationE+W+S

35.  If a source of artificial or elevated natural radioactivity is present in a food authority’s area, it must monitor the indicative dose for any water in its area to which this Schedule applies unless an exemption from monitoring under paragraph 36 is in force.

ExemptionE+W+S

36.—(1) A food authority is not required to monitor the indicative dose for any water in its area to which this Schedule applies if—

(a)on the basis of representative surveys, monitoring data and such other information that it considers to be reliable, it is satisfied that the indicative dose for the water does not exceed 0.10 mSv and has decided that it is unlikely to do so for at least five years beginning with the day after the day on which it comes to that decision (“assessment decision”),

(b)it notifies the Secretary of State of its assessment decision and provides the Secretary of State with a copy of the representative surveys, monitoring data and any other information that the authority took into account in coming to that decision,

(c)it notifies the Secretary of State that, on the basis of its assessment decision, the authority has decided not to monitor the indicative dose for the water for a period of five years beginning with the day after the day on which the notification is submitted to the Secretary of State, and

(d)in a case where sub-paragraph (2) applies, the food authority is satisfied that the indicative dose for the water is unlikely to exceed 0.10 mSv for a period of five years beginning with the day after the day on which the food authority submits the notification under paragraph (c) to the Secretary of State.

(2) This sub-paragraph applies where a notification under sub-paragraph (1)(c) is submitted more than three months after the day after the day on which a food authority makes an assessment decision under sub-paragraph (1)(a).

(3) A notification submitted by a food authority under sub-paragraph (1) may relate to all or some of the water in its area to which this Schedule applies.

(4) The exemption from monitoring provided for in sub-paragraph (1) lapses after a period of five years beginning with the day after the day on which the food authority submits the notification referred to in sub-paragraph (1)(c).

(5) But the exemption lapses immediately if the food authority becomes aware (by whatever means) at any time during the five year exemption period that the indicative dose for the water exceeds 0.10 mSv or it has reason to suspect that the indicative dose for the water may exceed 0.10 mSv.

ScreeningE+W+S

37.—(1) For the purpose of monitoring the indicative dose for any water in its area to which this Schedule applies, the food authority may use such screening strategy as it considers to be reliable to determine whether it is necessary for it to carry out a paragraph 45 determination for the water, including—

(a)screening by determining the gross alpha activity in a sample,

(b)screening by determining the gross beta activity in a sample,

(c)screening by determining the activity concentration of a single radionuclide in a sample, or

(d)screening by determining the activity concentration of two or more radionuclides in a sample.

(2) A food authority, in deciding which radionuclide to analyse for the purpose of screening under sub-paragraph (1)(c), and which radionuclides to analyse for the purpose of screening under sub-paragraph (1)(d), must take into account all information available to the authority that it considers relevant relating to likely sources of radioactivity that may affect the water.

Screening by determining gross alpha activityE+W+S

38.—(1) This paragraph applies where a food authority decides to screen any water under paragraph 37(1)(a) (screening of gross alpha activity) to determine whether it is necessary for the authority carry out a paragraph 45 determination for the water.

(2) The food authority must analyse a sample of water to determine whether the gross alpha activity in a sample is less than 0.1 Bq/l.

(3) Where the gross alpha activity detected in a sample does not exceed 0.1 Bq/l, the food authority may assume that the indicative dose for the water does not exceed 0.10 mSv.

(4) Where sub-paragraph (3) applies, the food authority does not need to carry out any further analysis for the purpose of carrying out a paragraph 45 determination for the water, unless it knows from other sources of information that specific radionuclides are present in the water that mean that the indicative dose for the water is likely to exceed 0.10 mSv.

(5) Where the gross alpha activity detected in a sample exceeds 0.1 Bq/l, the food authority must determine, by analysis, the activity concentration of such other radionuclides in the water (using water from the same sample or another sample of the water) as the food authority believes or suspects may be present in the water, taking into account such information about likely sources of radioactivity affecting the water as the food authority considers relevant.

(6) For the purpose of this paragraph, the food authority may set an alternative screening level for gross alpha activity in relation to any water that it is monitoring—

(a)if it is satisfied that, if set at the alternative level that it proposes, the indicative dose for the water will not exceed 0.10 mSv, and

(b)if called upon to do so by the Secretary of State, it can demonstrate to the Secretary of State that, at that alternative screening level, the indicative dose for the water will not exceed 0.10 mSv.

(7) When determining the gross alpha activity in a sample of water for the purpose of this paragraph, the food authority must analyse the sample using a method of analysis that is capable of detecting gross alpha activity in the sample at a level of detection not exceeding 0.04 Bq/l.

(8) The provisions in paragraph 25(3) and (4) (relating to the calculation and reporting of the limit of detection) apply in the same way to the calculation of the limit of detection for a method of analysis used to measure gross alpha activity as they apply to the calculation and reporting of the limit of detection for a method of analysis used to measure the activity concentration of radon.

Screening by determining gross beta activityE+W+S

39.—(1) This paragraph applies where a food authority decides to screen any water under paragraph 37(1)(b) (screening of gross beta activity) to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water.

(2) The food authority must analyse a sample of the water to determine whether the gross beta activity in the sample is less than 1.0 Bq/l.

(3) Where the gross beta activity detected in a sample does not exceed 1.0 Bq/l, the food authority may assume that the indicative dose for the water does not exceed 0.10 mSv.

(4) Where sub-paragraph (3) applies, the food authority does not need to carry out any further analysis for the purpose of carrying out a paragraph 45 determination for the water, unless it knows from other sources of information that specific radionuclides are present in the water that mean that the indicative dose for the water is likely to exceed 0.10 mSv.

(5) Where the gross beta activity of a sample exceeds 1.0 Bq/l, the food authority must determine, by analysis, the activity concentration of such other radionuclides in the water (using water from the same sample or from another sample of the water) as the food authority believes or suspects may be present in the water, taking into account such information about likely sources of radioactivity affecting the water as the food authority considers relevant.

(6) For the purpose of this paragraph, the food authority may set an alternative screening level for gross beta activity in relation to any water that it is monitoring—

(a)if it is satisfied that, if set at the alternative level that it proposes, the indicative dose for the water will not exceed 0.10 mSv, and

(b)if called upon to do so by the Secretary of State, it can demonstrate to the Secretary of State that, at that alternative screening level, the indicative dose for the water will not exceed 0.10 mSv.

(7) When determining the gross beta activity in a sample of water for the purpose of this paragraph, the food authority must analyse the sample using a method of analysis that is capable of detecting gross beta activity in the sample at a level of detection not exceeding 0.4 Bq/l.

(8) The provisions in paragraph 25(3) and (4) (relating to the calculation and reporting of the limit of detection) apply in the same way to the calculation of the limit of detection for a method of analysis used to measure gross beta activity as they apply to the calculation and reporting of the limit of detection for a method of analysis used to measure the activity concentration of radon.

Screening based on analysis relating to one radionuclideE+W+S

40.—(1) This paragraph applies where a food authority decides to screen any water under paragraph 37(1)(c) by determining the activity concentration of one radionuclide in the water to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water.

(2) The food authority must analyse a sample of the water to determine whether the activity concentration of the relevant radionuclide in the sample exceeds 20% of its derived concentration.

(3) Where the activity concentration of the radionuclide in the sample does not exceed 20% of its derived concentration, the food authority may assume that the indicative dose for the water does not exceed 0.10 mSv.

(4) Where sub-paragraph (3) applies, the food authority does not need to carry out any further analysis for the purpose of carrying out a paragraph 45 determination for the water.

(5) Where the activity concentration of the relevant radionuclide in the sample exceeds 20% of its derived concentration, the food authority must determine, by analyses, the activity concentration of such other radionuclides in the water (using water from the same sample or from another sample of the water) as the food authority believes or suspects may be present in the water, taking into account such information about likely sources of radioactivity affecting the water as the food authority considers relevant and the result of any analysis carried out by it under paragraph 32(2)(d).

Screening based on analysis relating to more than one radionuclideE+W+S

41.—(1) This paragraph applies where a food authority decides to screen any water under paragraph 37(1)(d) by determining the activity concentration of more than one radionuclide in the water (“the relevant radionuclides”) to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water.

(2) The food authority must analyse a sample of the water to determine whether, in relation to each of the relevant radionuclides, the activity concentration of any of the relevant radionuclides in the sample exceeds 20% of its derived concentration.

(3) Where the activity concentration of each of the relevant radionuclides in a sample is analysed and none of them are found to be present in the sample at an activity concentration that exceeds 20% of the derived concentration that applies to them, the food authority may assume that the indicative dose for the water does not exceed 0.10 mSv.

(4) Where sub-paragraph (3) applies, the food authority does not need to carry out any further analysis for the purpose of carrying out a paragraph 45 determination for the water.

(5) Where the food authority screens a sample of water for more than one radionuclide and the activity concentration of any one or more of those radionuclides in the sample exceeds 20% of the derived concentration that applies to it or them, the food authority must determine, by analyses, the activity concentration of such other radionuclides in the water (using water from the same sample or from another sample of the water) as the food authority believes or suspects may be present in the water, taking into account such information about likely sources of radioactivity affecting the water as the food authority considers relevant and the result of any analysis carried out by it under paragraph 32(2)(d).

Stopping or reducing the frequency of sampling: screening for indicative doseE+W+S

42.—(1) In relation to screening for indicative dose, a food authority may, from time to time, decide to stop taking samples for screening purposes, or to take such samples at a reduced frequency, where—

(a)it is satisfied that only naturally occurring radionuclides are present in the water,

(b)the result of the analysis of the last sample of the water carried out by the food authority for screening purposes shows that—

(i)where screening has been carried out under paragraph 38, the gross alpha activity in the water did not exceed 0.1 Bq/l,

(ii)where screening has been carried out under paragraph 39, the gross beta activity in the water did not exceed 1.0 Bq/l, or

(iii)where screening has been carried out under paragraph 40 or 41, the activity concentration of any radionuclide in the water analysed for the purpose of that screening did not exceed 20% of its derived concentration,

(c)in a case where the results of the analyses of previous samples taken by the food authority for screening purposes are available and the food authority considers them to be relevant to its decision, the results of the analyses of those samples, taken together with the result of the analysis of the last sample, show that—

(i)where screening has been carried out under paragraph 38, the gross alpha activity in the water is stable,

(ii)where screening has been carried out under paragraph 39, the gross beta activity in the water is stable, or

(iii)where screening has been carried out under paragraph 40 or 41, the activity concentration of any radionuclide analysed for the purpose of that screening is stable, and

(d)the authority is satisfied that the change in the monitoring arrangements will not increase any risk to human health.

(2) Where a food authority has made a decision under sub-paragraph (1) to stop taking samples of water for the purpose of screening under paragraph 38, 39, 40 or 41 but a change occurs in relation to the supply of the water that the food authority believes is likely to influence the activity concentration of radionuclides in the water, the food authority must—

(a)take and analyse a sample of the water using one of the screening methods specified in paragraph 37(1), or

(b)take and analyse a sample of the water and use the results of that analysis to make a paragraph 45 determination for the water.

(3) A food authority which has made a decision under sub-paragraph (1) to stop taking samples of any water, or to reduce the frequency at which it takes samples of the water, may at any time decide to start taking samples of the water again at the frequency provided for in the table in Part 3 or, in accordance with sub-paragraph (1), at some other reduced frequency.

Analysis of sampleE+W+S

43.—(1) Where sub-paragraph (2) applies, a food authority must, taking into account such information about likely sources of radioactivity affecting the water as the authority considers relevant, analyse a sample of the water to determine—

(a)which radionuclides are present in the water, and

(b)in relation to each radionuclide found to be present in the water (including radionuclides found to be present in the water as the result of an analysis carried out by it under paragraph 32(2)(d)), the activity concentration at which the radionuclide is present in the water.

(2) This sub-paragraph applies where a food authority is obliged under paragraph 35 to monitor any water in its area to which this Schedule applies and—

(a)the food authority has not carried out any screening during the relevant period under paragraph 38, 39, 40 or 41, and

(b)the water is not water to which a decision to stop taking samples for screening purposes is in force under paragraph 42.

(3) When analysing a sample of water for the purpose of this Part to determine the presence and activity concentration of a radionuclide specified in the first column of the table in Section 2 (minimum levels of detection), the food authority must analyse the sample using a method of analysis that is capable of detecting the activity concentration of the relevant radionuclide at a level of detection not exceeding that specified in the second column of the table, as read, in the case of Ra-228, with the additional provisions specified in the third column of the table.

(4) The provisions in paragraph 25(3) and (4) (relating to the calculation and reporting of the limit of detection) apply in the same way to the calculation of the limit of detection for a method of analysis used to measure the activity concentration of a radionuclide specified in the first column of the table in Section 2 as they apply to the calculation and reporting of the limit of detection for a method of analysis used to measure the activity concentration of radon.

Obligation to make an indicative dose determinationE+W+S

44.—(1) A food authority must make a paragraph 45 determination for any water in its area to which this Schedule applies if—

(a)it has not carried out any screening of the water under paragraph 38, 39, 40 or 41 and the obligation does not arise during a period in which a decision made under paragraph 42 to stop taking samples for screening purposes applies,

(b)it has carried out such screening and a determination made under paragraph 38(5), 39(5), 40(5) or 41(5) detected the presence of a radionuclide in the water at an activity concentration that exceeds 20% of its derived concentration, or

(c)a food authority decides to comply with paragraph 42(2) by taking and analysing a sample of the water and using the results of that analysis to make a paragraph 45 determination for the water.

(2) Sub-paragraph (1) does not apply if the obligation arises during a period in which a decision made under paragraph 47 to stop taking samples for the purpose of carrying out a paragraph 45 determination applies.

Determination relating to indicative doseE+W+S

45.—(1) This paragraph applies where it is necessary under paragraph 44 for a food authority to make a determination relating to whether the indicative dose for any water in its area to which this Schedule applies exceeds 0.10 mSv.

(2) The food authority must use the formula in sub-paragraph (3) to make a determination relating to the indicative dose for the water by—

(a)carrying out the calculation in sub-paragraph (4) for each radionuclide that the food authority has found, by analysis, to be present in the water, and

(b)adding together the results of all the calculations done under paragraph (a).

(3) For the purposes of sub-paragraph (2), the formula is—

(4) For the purpose of sub-paragraph (2)(a), the calculation is Ci(obs) ÷ Ci(der).

(5) For the purpose of the formula in sub-paragraph (3) and the calculation in sub-paragraph (4)—

(a)Ci(obs) is the activity concentration (observed concentration) at which a radionuclide has been found, by analysis, to be present in the water expressed in becquerels per litre, and

(b)Ci(der) is the derived concentration for that radionuclide expressed in becquerels per litre.

(6) For the purpose of the formula in sub-paragraph (3), n is the number of radionuclides the food authority has found, by analysis, to be present in the water.

(7) Any non-integer numbers resulting from the calculation carried out under sub-paragraph (2), as read with sub-paragraphs (3) and (4), must be taken into account in calculating and making a determination under this paragraph.

Action following the result of a paragraph 45 determinationE+W+S

46.—(1) If a paragraph 45 determination for any water produces a result that does not exceed 1, the indicative dose for the water is to be considered as not exceeding 0.10 mSv and no further investigation by the food authority is required.

(2) If a paragraph 45 determination for any water produces a result that exceeds 1 (“Indicative Dose Determination X”), sub-paragraphs (3) to (7) apply to such water.

(3) The food authority must—

(a)take and analyse an extra sample of the water as soon as reasonably practicable after the result of Indicative Dose Determination X is known and use the result of the analysis of that sample to carry out another paragraph 45 determination for the water;

(b)if the food authority considers it appropriate to do so taking into account the determination made under paragraph (a), continue taking and analysing extra samples of the water, and use the results of those analyses to carry out further paragraph 45 determinations for the water, at such intervals and for such period as the food authority (taking into account the provisions of sub-paragraphs (4) to (6)) considers appropriate.

(4) The food authority must, disregarding the determination of Indicative Dose Determination X, determine the average of the indicative dose determinations for the water for such 12 month period as the authority considers appropriate (whether the 12 month period used by the food authority for the purpose of its monitoring programme or some other 12 month period) on the basis of—

(a)the results of paragraph 45 determinations relating to the water carried out before the determination of Indicative Dose Determination X,

(b)the result of the extra paragraph 45 determination for the water carried out under sub-paragraph (3)(a), and

(c)where any extra paragraph 45 determinations for the water are carried out under sub-paragraph (3)(b), the results of those extra determinations.

(5) No further action by the food authority is required if the outcome of the determination under sub-paragraph (4) is that the average of the indicative dose determinations for the water for the relevant 12 month period does not exceed 1.

(6) The food authority must take action under paragraph 57(1) (remedial action) if the outcome of the determination under sub-paragraph (4) is that the average of the indicative dose determinations for the water for the relevant 12 month period exceeds 1.

(7) Sub-paragraphs (2) to (6) do not apply if the food authority is of the opinion that—

(a)even if it took extra samples under sub-paragraph (3) to enable it to make extra paragraph 45 determinations under that sub-paragraph, it would have insufficient results from previous paragraph 45 determinations for the water to enable it to make the determination required by sub-paragraph (4) within such period as the food authority considers to be reasonable, or

(b)for some other reason, the result of such a determination under sub-paragraph (4), based on the results of those extra samples and the previous paragraph 45 determinations, may give a distorted result.

(8) Where the paragraph 45 determination for a sample of water exceeds 1 and, by virtue of sub-paragraph (7), sub-paragraphs (2) to (6) do not apply, the food authority must take action under paragraph 57(1).

(9) For the purposes of the determination required under sub-paragraph (4), any non-integer numbers resulting from the calculation carried out by a food authority under paragraph 45(2), as read with sub-paragraphs (3) and (4) of that paragraph, must be taken into account in determining whether the result of the determination of the average of the indicative dose for the water for the relevant 12 month period exceeds 1.

Stopping or reducing the frequency of sampling: indicative doseE+W+S

47.—(1) A food authority may, from time to time, decide to stop taking samples for the purpose of carrying out a paragraph 45 determination for any water, or to take such samples at a reduced frequency, where—

(a)it is satisfied that only naturally occurring radionuclides are present in the water,

(b)the result of the last paragraph 45 determination for the water carried out by the food authority produces a result that does not exceed 1,

(c)in a case where the results of previous paragraph 45 determinations for the water are available and the food authority considers them to be relevant to its decision, the average of the results of those determinations produce a result that does not exceed 1, and

(d)the authority is satisfied that the change in the monitoring arrangements will not increase any risk to human health.

(2) Where a food authority has made a decision under sub-paragraph (1) to stop taking samples of water for the purpose of carrying out a paragraph 45 determination for the water but a change occurs in relation to the supply of the water that the food authority believes is likely to influence the concentration of radionuclides in the water, a food authority must—

(a)take and analyse a sample of the water using one of the screening methods specified in paragraph 37, or

(b)take and analyse a sample of the water and use the results of that analysis to make a paragraph 45 determination for the water.

(3) A food authority which has made a decision under sub-paragraph (1) to stop taking samples of any water, or to reduce the frequency at which it takes samples of the water, for the purpose of making paragraph 45 determinations for any water in its area may at any time decide to start taking samples of the water again at the frequency provided for in the table in Part 3 or, in accordance with sub-paragraph (1), at some other reduced frequency.

Treated bottled drinking waterE+W+S

48.  The provisions of this Part, except for paragraph 47, apply to bottled drinking water that has been treated to reduce the level of radionuclides in the water in the same way as it applies to water that has not been treated in that way.]