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The National Assembly for Wales, in exercise of the powers conferred by sections 16(1), 17(1), 26(1)(a) and (3), 31 and 48(1) of, and paragraph 1 of Schedule 1 to, the Food Safety Act 1990[1] and now vested in it[2] and having had regard in accordance with section 48(4A) of that Act to relevant advice given by the Food Standards Agency and after consultation as required by Article 9 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[3] and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations: Title, commencement and application 1. - (1) These Regulations may be cited as the Natural Mineral Water, Spring Water and Bottled Drinking Water (Amendment) (Wales) Regulations 2004 and shall apply in relation to Wales only. (2) Subject to paragraph (3) below these Regulations shall come into force on 19 June 2004. (3) Regulations 5, 8(2), 11(a) and 12(2) shall come into force on 1 July 2004. Amendments to the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999 2. The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999[4] shall be amended insofar as they apply to Wales in accordance with regulations 3 to 14. 3. - (1) In regulation 2 paragraph (1) after the definition of "the Agency" there shall be inserted the following definition -
(b) in the case of water brought into Wales from other parts of the United Kingdom or from another EEA State a treatment which complies with Article 5 of Directive 2003/40 as implemented in that part of the United Kingdom or that EEA State.".
(2) In regulation 2 paragraph (1) after the definition of "Directive 98/83" there shall be inserted -
4.
In regulation 7 subsection (1) for paragraph (a) there shall be substituted -
(ii) a treatment referred to in sub-paragraph (a) or (d) of Article 4.1; or".
5.
After regulation 7 there shall be inserted -
(2) No person shall sell any natural mineral water bottled in contravention of paragraph (1). (3) The methods used for detection of the substances listed in Schedule 6 shall conform to the performance characteristics for analysis in Schedule 7. (4) For the purposes of paragraphs (1) and (2) above, where -
(ii) the water concerned was bottled in another EEA State, (iii) the EEA State concerned had not, at the time of bottling, implemented Article 2(1) of Directive 2003/40, (iv) the water was bottled prior to 1st January 2006 and at the date of bottling otherwise complied with Directives 80/777, 98/83 and the provisions of Directive 2003/40 which were in force in that EEA State; or
(b)
(ii) the water concerned was bottled in another EEA State, (iii) the EEA State concerned had not, at the time of bottling, implemented Article 2(1) of Directive 2003/40 insofar as it relates to limits for nickel and fluoride, (iv) the water was bottled prior to 1st January 2008 and at the date of bottling otherwise complied with Directives 80/777, 98/83 and the provisions of Directive 2003/40 which were in force in that EEA State,
that water shall be deemed to comply with the limits in Schedule 6.".
6.
After regulation 9 there shall be inserted -
7.
For regulation 10 paragraph (3) there shall be substituted -
(b) where it has undergone an authorised ozone-enriched air oxidation technique, the words "water subjected to an authorised ozone-enriched air oxidation technique", which shall appear in proximity to the analytical composition of characteristic constituents; (c) where its fluoride concentration exceeds 1.5 mg/l -
(ii) the actual fluoride content in relation to the physio-chemical composition, which shall be included within the mandatory information referred to in paragraph (4) below; and
(d) the mandatory information referred to in paragraph (4) below.".
8.
- (1) In regulation 10(5)(b), after "has undergone any of the treatments referred to in paragraph (3)(a)" there shall be inserted the words "or (b)".
(e) does not bear the labelling indication set out in sub-paragraph (c) of paragraph (3) above where required by that sub-paragraph.".
9.
In regulation 11(1) at the end of sub-paragraph (d) the word "and" shall be omitted and at the end of sub-paragraph (e) the following shall be inserted -
(f) where the water has undergone an authorised ozone-enriched air oxidation technique, the water is marked or labelled with the words "water subjected to an authorised ozone-enriched air oxidation technique" which shall appear in close proximity to the particulars in paragraph (3) of this regulation.".
10.
After regulation 11 there shall be inserted -
11.
In regulation 17 -
(b) after the number "9," there shall be inserted "9A,"; (c) after "11(1), (2), (3) or (5)," there shall be inserted "11A,".
12.
- (1) In regulation 18, after sub-paragraph (3) there shall be added the following -
(b) the matters constituting the alleged offence would not have constituted an offence under these Regulations as they stood immediately before the coming into force of the Natural Mineral Water, Spring Water and Bottled Drinking Water (Amendment) (Wales) Regulations 2004.".
(2) In regulation 18, after sub-paragraph (4) there shall be added the following -
(b) the matters constituting the alleged offence would not have constituted an offence under these Regulations as they stood immediately before the coming into force of the Natural Mineral Water, Spring Water and Bottled Drinking Water (Amendment) (Wales) Regulations 2004.".
13.
- (1) In Schedule 1 Part I paragraph 2, sub-paragraph (c), after the words "contains no substance" the remainder of that sub-paragraph shall be omitted and the following words inserted -
(2) In Schedule 1 Part II paragraph 2, sub-paragraph (c), after the words "contains no substance" the remainder of that sub-paragraph shall be omitted and the following words inserted -
14.
After Schedule 4 there shall be added Schedules 5, 6 and 7 contained in the Schedule to these Regulations. 1. Treatment of natural mineral waters and spring waters with ozone-enriched air shall only be carried out if -
(b) prior to treatment the water satisfies regulation 8 of these regulations; (c) the treatment does not have a disinfectant action.
2.
Treatment of natural mineral waters and spring waters with ozone-enriched air shall not -
(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:
3.
A person seeking to have a process of treatment with ozone-enriched air authorised shall -
(b) permit representatives of that authority to examine the proposed method of treatment, and place of treatment, and take samples for analysis in accordance with regulation 14; (c) provide such information in support of the application as is requested by the relevant authority.
4.
The relevant authority shall assess the application and any information in its possession and shall authorise the treatment process, if it is satisfied that -
(b) the person carrying out the treatment is taking all necessary measures to ensure that the treatment is effective and safe; (c) the treatment process otherwise complies with paragraphs 1 and 2 of this Schedule.
5.
(b) Where the relevant authority refuses to authorise a treatment process pursuant to paragraph 4 above, it shall inform the operator of the treatment process in writing, stating its reasons.
6.
Where a treatment process has been authorised pursuant to paragraph 4 above, the person carrying out the treatment process must continue to allow periodic examination of the treatment process by the relevant authority by the methods in paragraph 3(b) and (c), for the purpose of assessing whether the conditions in paragraph 4(a) and (b) continue to be satisfied.
(b) Upon receiving the application for review the Agency shall make such inquiry into the matter as may seem to the Agency to be appropriate, and having considered the results of that enquiry and any relevant facts elicited by it, shall either confirm the decision or direct the relevant authority to grant or restore, as appropriate, authorisation of the treatment process in operation. In the case of such a direction the relevant authority shall thereupon comply with the said direction.
Notes: 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.
Notes: 1. The method of analysis used to measure the concentration of the constituents in Schedule 6 shall be able to measure at least concentrations equal to the parametric value with the specified accuracy, precision and detection limits. 2. Regardless of the sensitivity of the method of analysis, the result must be expressed to the same number of decimal places as the maximum limit set out in Schedule 6 for the particular constituent being analysed. 3. Accuracy is the systematic error and represents the difference between the average value of a large number of repeated measurements and the exact value. 4. 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. 5. Acceptable precision is equal to twice the relative standard deviation. 6. The detection limit is either -
(b) five times the relative standard deviation within a batch of a virgin sample.
7.
The method used to detect cyanide must be such that it is possible to determine total cyanide in all its forms."
(This note is not part of the Regulations) 1. These Regulations, which apply to Wales only, implement Commission Directive 2003/40 establishing the list, concentration limits and labelling requirements for the constituents of natural mineral waters and the conditions for using ozone-enriched air for the treatment of natural mineral waters and spring waters. They amend the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999. 2. The Regulations -
(b) allow, for the first time, treatment of natural mineral waters with an authorised ozone-enriched air oxidation technique (regulation 4); (c) set maximum limits for certain naturally-occurring substances in natural mineral water and standards for methods used to detect these substances (regulation 5 and the Schedule); (d) provide for a defence for products produced by other EEA States which do not yet conform to the limits, where the EEA State concerned has not yet implemented those limits and the deadline for implementation has not yet passed (regulation 5); (e) prohibit the treatment of natural mineral water with unauthorised ozone-enriched air oxidation techniques (regulation 6); (f) provide for an appropriate form of labelling indication on natural mineral water where it has undergone an authorised treatment with ozone-enriched air or where it contains a high level of fluoride (regulation 7); (g) prohibit the sale of natural mineral water without the applicable labelling indications (which will become an offence by virtue of the operation of regulation 17 of the principal Regulations) (regulation 8); (h) provide for an appropriate labelling indication where a spring water has undergone an authorised ozone-enriched air oxidation technique and prohibit its sale without that labelling indication (which will become an offence by virtue of the operation of regulation 11(5) of the principal Regulations, the penalty for which is specified by regulation 17 of the principal Regulations as being a fine not exceeding level 5 on the standard scale) (regulation 9); (i) prohibit bottling or sale of water described as spring water if treated with an unauthorised ozone-enriched air oxidation treatment (regulation 10); (j) create offences of bottling or selling natural mineral water containing a specified substance in excess of the maximum limit; bottling or selling natural mineral water or spring water treated with ozone-enriched air unless an authorised technique was used (subject to penalties provided for in the principal Regulations) (regulation 11); (k) introduce a transitional defence to allow the use of stock products bottled and labelled before 1st July 2004, where the product would otherwise be legal under existing law (regulation 12); (l) provide that the maximum limits in the new Schedule 6 to be added to the principal Regulations shall be the relevant limits for recognition of a natural mineral water, replacing the limits in Schedule 3 to the principal Regulations for this purpose (regulation 13); (m) insert a new Schedule 5 into the principal Regulations, which sets down -
(ii) a process for obtaining a written authorisation for a treatment from a county council or county borough council; (iii) a requirement to allow officers of the relevant authority to conduct periodic examinations of the process in order to check that the treatment continues to be necessary and is effective and safe; (iv) the ability of an authority to withdraw authorisation by means of a written notice if conditions are not observed; (v) a mechanism for applying to the Food Standards Agency for review of an authority's decision not to grant or to withdraw authorisation (regulation 14, Schedule);
(n) insert a new Schedule 6 into the principal Regulations, setting down maximum limits for certain naturally-occurring substances in natural mineral water (regulation 14, Schedule);
3.
A full Regulatory Appraisal has been prepared and placed in the Library of the National Assembly for Wales, together with a Transposition Note setting out how the main elements of the European legislation referred to above are transposed in these Regulations. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Cardiff, CF10 1EW. Notes: [1] 1990 c. 16.back [2] Functions of the Secretary of State under the Food Safety Act 1990, so far as exercisable in relation to Wales, were transferred to the National Assembly for Wales by the National Assembly for Wales (Transfer of Functions) Order 1999 (S.I. 1999/672) as read with section 40(3) of the Food Standards Act.back [3] OJ No. L31, 1.2.2002, p.1.back [4] S.I. 1999/1540, as amended by S.I. 2000/656 and S.I. 2003/3042 (W.287).back [5] S.I. 1990/2463; to which there are amendments not relevant to these Regulations.back [6] S.I. 1995/1763; to which there are amendments not relevant to these Regulations.back
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