Textual Amendments
F1Sch. 12 inserted (6.4.2018) by The Natural Mineral Water, Spring Water and Bottled Drinking Water (England) (Amendment) Regulations 2018 (S.I. 2018/352), reg. 1(1), Sch. 2
3. This Schedule applies to the monitoring of—
(a)water that is bottled and labelled as “spring water” by a food business in the course of its business as a bottler of water, whether the bottling of water is its main business or part of its business, and
(b)drinking water that is bottled by a food business in the course of its business as a bottler of water, whether the bottling of water is its main business or part of its business.
4.—(1) For the purpose of carrying out its obligations under the provisions specified in sub-paragraph (2), each food authority must take and analyse samples of any water bottled in its area to which this Schedule applies.
(2) The provisions are—
(a)paragraph 7(1) (microbiological parameters);
(b)paragraph 8(1) (chemical parameters);
(c)paragraph 9, as read with paragraphs 23 and 25(1) (radon);
(d)paragraph 10, as read with paragraphs 29 and 31(1) (tritium);
(e)paragraph 11 (indicative dose), as read with—
(i)paragraph 38(2), where a decision is taken by the food authority under paragraph 38(1) to screen water by determining its gross alpha activity to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water;
(ii)paragraph 39(2), where a decision is taken by the food authority under paragraph 39(1) to screen water by determining its gross beta activity to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water;
(iii)paragraph 40(2), where a decision is taken by the food authority under paragraph 40(1) to screen water by analysing one radionuclide to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water;
(iv)paragraph 41(2), where a decision is taken by the food authority under paragraph 41(1) to screen water by analysing more than one radionuclide to determine whether it is necessary for the authority to carry out a paragraph 45 determination for the water;
(v)paragraph 43(1) (determination relating to the presence and concentration of radionuclides);
(f)paragraph 12, as read with paragraph 50(1) (indicator parameters);
(g)paragraph 13 (other parameters not mentioned in this sub-paragraph).
(3) For the purpose of its sampling obligations under this Schedule, a food authority must take samples of water at the point at which the water is put into a bottle.
5.—(1) In the case of samples of water that a food authority must take and analyse to enable it to discharge its obligations under the provisions specified in [F2paragraph 4(2)(a),] (b), (f) and (g), each food authority must take and analyse such samples regularly, having regard to the provisions contained in—
(a)Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (monitoring responsibilities), and
[F3(b)Article 9 of Regulation (EU) 2017/625.]
(2) Where, under sub-paragraph (1), a food authority only takes one sample in a year of any water in its area to which this Schedule applies, the authority must take the samples from year to year at intervals that are spread out in such a way—
(a)to avoid the results, when considered together, giving a potentially distorted picture of the state of the water because the samples have been taken too closely together in time, and
(b)so that the results, when considered together, provide information about the water that is representative of the quality of the water during the relevant years.
(3) Where, under sub-paragraph (1), a food authority takes more than one sample in a year of any water in its area to which this Schedule applies, the authority must take the samples at intervals that are spread out throughout the year in such a way—
(a)to avoid the results, when considered together, giving a potentially distorted picture of the state of the water because the samples have been taken too closely together in time, and
(b)so that the results, when considered together, provide information about the water that is representative of the quality of the water during the course of that year.
Textual Amendments
F2Words in Sch. 12 para. 5(1) substituted (29.3.2019) by The Environment, Food and Rural Affairs (Miscellaneous Amendments etc.) Regulations 2019 (S.I. 2019/526), regs. 1(2), 27(2)(a)
6. In the case of samples that a food authority must take and analyse to discharge its obligations under the provisions specified in paragraph 4(2)(c) to (e), the samples must—
(a)be taken and analysed by the food authority no less frequently than provided for in the table in Part 3, unless—
(i)a decision is taken by the authority under paragraph 27, 33, 42 or 47 to reduce the minimum frequency at which it must take and analyse samples, in which case the authority must take and analyse samples at the reduced minimum frequency decided by it under the relevant paragraph until such time as it takes a different decision relating to the minimum frequency at which relevant samples must be taken and analysed;
(ii)a decision is taken by the authority under paragraph 42 or 47 to stop taking and analysing samples, in which case the authority, in accordance with that decision, is not obliged to take and analyse samples until such time as it takes a different decision relating to the minimum frequency at which relevant samples must be taken and analysed;
(b)be taken, in so far as possible, so that the number of samples are distributed equally in time and (where appropriate) location.
7.—(1) A food authority must monitor the value for each of the parameters specified in the first column of the table in Part 2 of Schedule 2 (microbiological parameters) in any water in its area to which this Schedule applies by analysing a sample of the water to determine whether the value for the parameter in the sample exceeds the value specified for the parameter in the second column of the table, as measured by reference to the unit of measurement specified in the third column of the table.
(2) For the purpose of the determination required by sub-paragraph (1), the food authority must analyse the sample using the method of analysis for the relevant parameter specified in Part 4.
8.—(1) A food authority must monitor the concentration of each of the parameters specified in the first column of the table in Part 3 of Schedule 2 (chemical parameters) in any water in its area to which this Schedule applies by analysing a sample of the water to determine whether the concentration of the parameter in the sample exceeds the concentration specified for the relevant parameter in the second column of the table—
(a)as measured by reference to the unit of measurement specified in the third column of the table, and
(b)as read, in the case of a parameter for which there is an entry in the fourth column of the table, with the further provision relating to the parameter or parametric concentration specified in that entry.
(2) For the purpose of the determination required by sub-paragraph (1), the food authority must analyse the sample using a method of analysis that complies with Part 5.
(3) But sub-paragraph (2) does not apply, and it is not necessary for a food authority to analyse a sample of water under sub-paragraph (1) to determine whether the concentration of acrylamide, epichlorohydrin or vinyl chloride exceeds the concentration specified for that parameter in the second column of the table in Part 3 of Schedule 2, where—
(a)the food authority is satisfied that the water, before it is bottled, does not come into contact with a pipe or other construction product that has been constructed using that parameter as a component in its construction, or
(b)in other cases, the food authority is satisfied, on the basis of a certificate of conformity, declaration of conformity or declaration of performance relating to a pipe or other construction product that the water comes into contact with, or may come into contact with, before being bottled, and any other related information that it considers to be relevant, that any residual monomer concentration of that parameter in the water does not exceed the concentration for that parameter specified in the second column of the table in Part 3 of Schedule 2.
(4) A food authority must not use the uncertainty of measurement percentage specified in the second column of the table in Section 2 of Part 5 (which is concerned with whether a method of analysis complies with minimum performance characteristics) as an additional tolerance when determining whether a parameter specified in the first column of the table in Part 3 of Schedule 2 exceeds the concentration for that parameter specified in the second column of the table in Part 3 of Schedule 2.
(5) In sub-paragraph (3)(b)—
“certificate of conformity” means a certificate of conformity issued on or before 30th June 2013—
“construction product” has the meaning given in point (1) of Article 2 of Regulation (EU) No 305/2011 of the European Parliament and of the Council laying down harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC;
“declaration of conformity” means a declaration of conformity issued on or before 30th June 2013—
“declaration of performance” means a declaration of performance drawn up in accordance with Article 4 of Regulation (EU) No 305/2011 of the European Parliament and of the Council.
Textual Amendments
F4Words in Sch. 12 para. 8(5) omitted (31.12.2020) by virtue of The Food (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/150), regs. 1, 3(7)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5Words in Sch. 12 para. 8(5) omitted (31.12.2020) by virtue of The Food (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/150), regs. 1, 3(7)(b); 2020 c. 1, Sch. 5 para. 1(1)
9. A food authority must monitor the level of radon in any water in its area to which this Schedule applies in accordance with Part 6.
10. A food authority must monitor the level of tritium in any water in its area to which this Schedule applies in accordance with Part 7.
11. A food authority must monitor the level of the indicative dose for any water in its area to which this Schedule applies in accordance with Part 8.
12. A food authority must monitor the concentration or value (as the case may be) of each of the parameters specified in the first column of the table in Section 1 of Part 9 (indicator parameters) in any water in its area to which this Schedule applies in accordance with Part 9.
13. Where a food authority believes, or has reason to suspect, that a property, element, substance or organism that is not specified in any of the tables in Schedule 2 or the table in Section 1 of Part 9, may be present in any water in its area to which this Schedule applies at any concentration, or in any number, that may constitute a potential danger to human health, it must take and analyse samples of the water, on a case by case basis, to determine whether that property, element, substance or organism is present in the water and whether it is present in the water at any concentration, or in any number, that may constitute a potential danger to human health.
14. To enable a food authority to discharge its functions under this Schedule, a food authority may from time to time enter into an arrangement with another person under which the food authority delegates specified tasks to the delegate to carry out on behalf of the food authority on condition that—
(a)such arrangement is in accordance with—
(i)Part 10, and
[F6(ii)Article 29 of Regulation (EU) 2017/625, and]
[F7(b)the food authority notifies the Secretary of State, in advance of the proposed delegation, of the tasks that are being delegated to a delegated body.]
Textual Amendments
F6Sch. 12 para. 14(a)(ii) substituted (14.12.2019) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) Regulations 2019 (S.I. 2019/1488), regs. 1(1), 24(b)(ii)(aa)
F7Sch. 12 para. 14(b) substituted (14.12.2019) by The Official Controls (Animals, Feed and Food, Plant Health Fees etc.) Regulations 2019 (S.I. 2019/1488), regs. 1(1), 24(b)(ii)(bb)
15.—(1) A food authority must not analyse a sample taken for the purpose of carrying out its monitoring obligations under regulation 16A, as read with this Schedule, unless quality management practices that comply with BS EN ISO/IEC 17025:2017 entitled “General requirements for the competence of testing and calibration laboratories” (ISBN 978 0 580 88466 5) published by the BSI on 31st December 2017, or another equivalent standard accepted at international level, are being complied with at the laboratory in which the sample is analysed.
(2) But, in the case of the analysis of a sample for the purposes of the monitoring obligations under the provisions specified in sub-paragraph (3), it is sufficient if the laboratory at which the sample is analysed has a system of analytical quality control in place that is checked by the United Kingdom Accreditation Service from time to time.
(3) The provisions are those in—
(a)paragraph 9, as read with Part 6 (radon),
(b)paragraph 10, as read with Part 7 (tritium), and
(c)paragraph 11, as read with Part 8 (indicative dose).
16.—(1) A food authority must ensure that any analysis that it carries out for the purpose its monitoring obligations under regulation 16A, as read with this Schedule, is validated and documented in accordance with BS EN ISO/IEC 17025:2017 entitled “General requirements for the competence of testing and calibration laboratories” (ISBN 978 0 580 88466 5) published by the BSI on 31st December 2017 or another equivalent standard accepted at international level.
(2) But, in the case of the analysis of a sample for the purpose of the monitoring obligations under the provisions specified in sub-paragraph (3), it is sufficient if the laboratory at which the sample is analysed has a system of analytical quality control in place that is checked by the United Kingdom Accreditation Service from time to time.
(3) The provisions are those in—
(a)paragraph 9, as read with Part 6 (radon),
(b)paragraph 10, as read with Part 7 (tritium), and
(c)paragraph 11, as read with Part 8 (indicative dose).]