Scottish Statutory Instruments
2004 No. 132
FOOD
The Natural Mineral Water, Spring Water and Bottled Drinking Water Amendment (Scotland) Regulations 2004
Made
17th March 2004
Laid before the Scottish Parliament
18th March 2004
Coming into force
Regulations 1–4, 6–7, 8(1), 9–10, 11(b) and (c), 12(1) and 13–15
24th April 2004
Regulations 5, 8(2), 11(a) and 12(2)
1st July 2004
The Scottish Ministers, 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 of all other powers enabling them in that behalf, after having had regard, in accordance with section 48(4A)(2) of that Act to relevant advice given by the Food Standards Agency, and after consultation in accordance with section 48(4) and (4B)(3) of that Act, hereby make the following Regulations:
Citation, commencement and extent
1.—(1) These Regulations may be cited as the Natural Mineral Water, Spring Water and Bottled Drinking Water Amendment (Scotland) Regulations 2004.
(2) Subject to paragraph (3) below these Regulations shall come into force on 24th April 2004.
(3) Regulations 5, 8(2), 11(a) and 12(2) shall come into force on 1st July 2004.
(4) These Regulations extend to Scotland only.
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 in accordance with regulations 3 to 15.
3. In regulation 2(1)–
(a)after the definition of “the Agency” there shall be inserted–
““authorised ozone-enriched air oxidation technique” means–
a treatment with ozone enriched air authorised and carried out in accordance with Schedule 5; or
in the case of water brought into Scotland 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.”; and
(b)after the definition of “Directive 98/83” there shall be inserted–
““Directive 2003/40” means Commission Directive 2003/40/EC 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(5).”.
4. In regulation 7(1) for sub-paragraph (a) there shall be substituted–
“(a)any treatment other than–
(i)an authorised ozone-enriched air oxidation technique;
(ii)a treatment referred to in sub-paragraph (a) or (d) of Article 4.1; or”.
5. After regulation 7 there shall be inserted–
“7A.—(1) No person shall bottle any natural mineral water which, at the time of bottling, contains any substance listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule.
(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–
(a)(i)the water concerned exceeds the maximum limits specified in Schedule 6;
(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; and
(iv)the water was bottled prior to 1st January 2006 and at the date of bottling otherwise complied with Directives 80/777 and 98/83 and the provisions of Directive 2003/40 which were in force in that EEA State; or
(b)(i)the water concerned exceeds the maximum limits specified in Schedule 6 relating to nickel and fluoride;
(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 maximum limits for nickel and fluoride; and
(iv)the water was bottled prior to 1st January 2008 and at the date of bottling otherwise complied with Directives 80/777 and 98/83 and the provisions of Directive 2003/40 which were in force in that EEA State
that water shall be deemed not to exceed the maximum limits specified in Schedule 6.”.
6. After regulation 9 there shall be inserted–
“9A. No person shall bottle any natural mineral water, or sell natural mineral water which is bottled if it has been treated with ozone-enriched air unless that treatment is an authorised ozone-enriched air oxidation technique.”.
7. For regulation 10(3) there shall be substituted–
“(3) Natural mineral water shall be bottled in a bottle marked or labelled with–
(a)where it has undergone the treatment of total or partial elimination of free carbon dioxide by exclusively physical methods, the indication “fully de carbonated” or “partially de-carbonated” as appropriate;
(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/1–
(i)the words “contains more than 1.5 mg/1 of fluoride not suitable for regular consumption by infants and children under 7 years of age”, which shall appear in immediate proximity to the trade name and in clearly visible characters; and
(ii)the actual fluoride content in relation to the physico 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 “or (b)”.
(2) In regulation 10(5)(c) “or” shall be omitted, and at the end of sub paragraph (d) there shall be inserted–
“or
(e)does not bear the labelling indications 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) “and” shall be omitted, and at the end of sub-paragraph (e) there shall be inserted–
“; and
(f)where the water has undergone an authorised ozone-enriched air oxidation technique, the bottle is marked or labelled with the words “water subjected to an authorised ozone-enriched air oxidation technique” which shall appear in proximity to the particulars in paragraph (3) of this regulation”.
10. After regulation 11 there shall be inserted–
“11A. No person shall cause any water to be bottled in a bottle marked or labelled with the description spring water, or sell any bottled water which is described as spring water, if it has been treated with ozone-enriched air unless that treatment is an authorised ozone enriched air oxidation technique.”.
11. In regulation 17–
(a)after “7,” there shall be inserted “7A(1) or (2),”;
(b)after “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 paragraph (3) there shall be inserted–
“(4) In any proceedings for an offence for contravening regulations 9A, 10(3)(b), 11(1)(f) or 11A it shall be a defence for the person charged to prove that the water in respect of which the offence is alleged to have been committed was bottled and marked or labelled before 1st July 2004.”.
(2) In regulation 18, after the paragraph (4) inserted by paragraph (1) above there shall be inserted–
“(5) In any proceedings for an offence for contravening regulations 7A(1) or (2) or 10(5)(e) it shall be a defence for the person charged to prove that the water in respect of which the offence is alleged to have been committed was bottled and marked or labelled before 1st July 2004.”.
13.—(1) In paragraph 2(c) of Part I of Schedule I, for the words following “contains no substance” there shall be substituted–
“listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule.”.
(2) In paragraph 2(c) of Part II of Schedule I, for the words following “contains no substance” there shall be substituted–
“listed in Schedule 6 at a level which exceeds the maximum limit specified in relation to that substance in that Schedule.”.
14. In the second sub paragraph (c) of paragraph 1 of Part I of Schedule 3, for “(c)” there shall be substituted “(d)”.
15. After Schedule 4 there shall be inserted as Schedules 5, 6 and 7 the contents of the Schedule to these Regulations.
TOM McCABE
Authorised to sign by the Scottish Ministers
St Andrew’s House, Edinburgh
17th March 2004
Regulation 15
SCHEDULESCHEDULES 5, 6 AND 7 TO BE INSERTED IN THE NATURAL MINERAL WATER, SPRING WATER AND BOTTLED DRINKING WATER REGULATIONS 1999
Regulation 2
“SCHEDULE 5CONDITIONS FOR TREATMENT OF NATURAL MINERAL WATERS AND SPRING WATERS WITH OZONE-ENRICHED AIR
1. Treatment of natural mineral waters and spring waters with ozone-enriched air shall only be carried out if–
(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 water satisfies regulation 8 of these Regulations; and
(c)the treatment does not have a disinfectant action.
2. Treatment of natural mineral waters and spring waters with ozone-enriched air shall 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 (μg/l) |
|---|---|
| Dissolved ozone | 50 |
| Bromates | 3 |
| Bromoforms | 1 |
3. A person seeking to have a process of treatment with ozone-enriched air authorised shall–
(a)make application in writing to the relevant 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 in accordance with regulation 14; and
(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–
(a)the treatment process is justified by the composition of the water at source;
(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 process otherwise complies with paragraphs 1 and 2 of this Schedule.
5.—(a) Where the relevant authority decides to authorise a treatment process pursuant to paragraph 4 above, it shall inform the operator of the treatment process in writing, and state the date on which the authorisation for commercial use of the process beings.
(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.
7. If the relevant authority is satisfied that the conditions in paragraph 4 above are no longer fulfilled, it may withdraw its authorisation of a treatment process by giving the person operating that process a written notice stating the grounds for withdrawal.
8.—(a) Where the relevant authority decides either not to grant or to withdraw authorisation of a treatment process under paragraph 5(b) or paragraph 7 above, the person who wishes to carry out the treatment process may apply to the Agency for a review of that decision.
(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.
Regulation 7A
SCHEDULE 6MAXIMUM LIMITS FOR CONSTITUENTS OF NATURAL MINERAL WATERS
| Constituents | Maximum limits (mg/l) |
|---|---|
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. | |
| 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 |
Regulation 7A
SCHEDULE 7PERFORMANCE CHARACTERISTICS FOR ANALYSING THE CONSTITUENTS IN SCHEDULE 6
| Constituent | Accuracy of parametric value in % | Precision of parametric value | Detection limit of parametric value in % |
|---|---|---|---|
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– (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. 7. The method used to detect cyanide must be such that it is possible to determine total cyanide in all its forms.” | |||
| Antimony | 25 | 25 | 25 |
| Arsenic | 10 | 10 | 10 |
| Barium | 25 | 25 | 25 |
| Cadmium | 10 | 10 | 10 |
| Chromium | 10 | 10 | 10 |
| Copper | 10 | 10 | 10 |
| Cyanide | 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 |
Explanatory Note
(This note is not part of the Regulations)
These Regulations, which extend to Scotland only, amend the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999 (S.I. 1999/1540, as already amended by S.S.I. 2000/62 and 2003/139) (“the 1999 Regulations”). Regulations 1 to 4, 6 to 7, 8(1), 9 to 10, 11(b) and (c), 12(1) and 13 to 15 come into force on 24th April 2004 and regulations 5, 8(2), 11(a) and 12(2) come into force on 1st July 2004.
The Regulations implement Commission Directive 2003/40/EC 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 (O.J. No. L 126, 22.5.03, p.34).
The Regulations —
(a)prescribe a definition of authorised ozone-enriched air oxidation technique (regulation 3 and the Schedule);
(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 an exception for products produced in 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 1999 Regulations which also specifies a penalty of a fine not exceeding level 5 on the standard scale) (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 1999 Regulations, the penalty for which is specified by regulation 17 of the 1999 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 in relation to the prohibitions mentioned in paragraphs (c),(e) and (i) above (subject to penalties provided for in the 1999 Regulations as being a fine not exceeding level 5 on the standard scale) (regulation 11);
(k)introduce a transitional defence to allow the use of stock products bottled and labelled before 1st July 2004.
(l)provide that the maximum limits in the new Schedule 6 to be added to the 1999 Regulations shall be the relevant limits for recognition of a natural mineral water, replacing the limits in Schedule 3 to the 1999 Regulations for this purpose (regulation 13);
(m)correct a minor error in the 1999 Regulations (regulation 14);
(n)insert a new Schedule 5 into the 1999 Regulations, which sets down —
(i)conditions to be satisfied before an ozone-enriched air oxidation technique can be authorised;
(ii)a process for obtaining a written authorisation for a treatment from a food authority;
(iii)a requirement to allow officers of the food 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 a food 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 a food authority’s decision not to grant or to withdraw authorisation (regulation 15 and the Schedule);
(o)insert a new Schedule 6 into the 1999 Regulations, setting down maximum limits for certain naturally-occurring substances in natural mineral water (regulation 15 and the Schedule);
(p)insert a new Schedule 7 containing standards for scientific methods used to detect the substances specified in Schedule 6 (regulation 15 and the Schedule).
A Regulatory Impact Assessment, which includes a compliance cost assessment of the effect which these Regulations have on business costs, has been prepared and has been placed in the Scottish Parliament Information Centre. Copies may be obtained from the Food Standards Agency, 6th Floor, St. Magnus House, 25 Guild Street, Aberdeen AB11 6NJ.
1990 c. 16; Sections 16(1) and 48(1) were amended by the Food Standards Act 1999 (c. 28) (“the 1999 Act”), Schedule 5, paragraph 8; section 17(1) was amended by the 1999 Act, Schedule 5, paragraphs 8 and 12; amendments made by the 1999 Act shall be taken as pre-commencement enactments for the purposes of the Scotland Act 1998 (c. 46) by virtue of section 40(2) of the 1999 Act. The functions of the Secretary of State were transferred to the Scottish Ministers by virtue of section 53 of the Scotland Act 1998.
Section 48(4A) was inserted by the 1999 Act, Schedule 5, paragraph 21.
Section 48(4B) was inserted by the 1999 Act, Schedule 5, paragraph 21.
S.I. 1999/1540, as amended by S.S.I. 2000/62 and 2003/139.
O.J. No. L 126, 22.5.03, p.34.