2004 No. 1509 (W.158)
The Natural Mineral Water, Spring Water and Bottled Drinking Water (Amendment) (Wales) Regulations 2004
Made
Coming into force
Except for regulations 5, 8(2), 11(a) and 12(2)
Regulations 5, 8(2), 11(a) and 12(2)
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 F1 and now vested in it F2 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 F3 and in accordance with section 48(4) and (4B) of that Act, makes the following Regulations:
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.
OJ No. L31, 1.2.2002, p.1.
Title, commencement and application1
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 19992
The Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999 F4 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 —
“authorised ozone-enriched air oxidation technique” means —
a
a treatment with ozone-enriched air authorised and carried out in accordance with Schedule 5; or
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 —
“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.
4
In regulation 7 subsection (1) for 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 does not comply with the 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 does not comply with the limits 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,
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
i
the water concerned does not comply with the limits 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 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 —
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 paragraph (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/l —
i
the words “contains more than 1.5 mg/l 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,
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)
”
.
2
In regulation 10(5)(c) the word “or” shall be omitted, and at the end of sub-paragraph (d) there shall be added —
or
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 —
and
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 —
11A
No person shall bottle any water described as spring water, or sell water described as spring water which is bottled, 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 the number “7,” there shall be inserted “
7A(1) or (2),
”
;
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 —
4
In any proceedings for an offence for contravening regulations 9A, 10(5)(b) to the extent that it relates to regualtion 10(3)(b)), 11(1)(f) or 11A it shall be a defence for the accused to prove that —
a
the water in respect of which the offence is alleged to have been committed was bottled and marked or labelled as the case may be, before 1st July 2004; and
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 —
5
In any proceedings for an offence for contravening regulations 7A or 10(5)(e) it shall be a defence for the accused to prove that —
a
the water in respect of which the offence is alleged to have been committed was bottled and marked or labelled as the case may be, before 1st July 2004; and
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 — “
listed in Schedule 6 at a level which does not comply with the limit specified in relation to that substance in that Schedule.
”
.
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 — “
listed in Schedule 6 at a level which does not comply with the limit specified in relation to that substance in that Schedule.
”
.
14
After Schedule 4 there shall be added Schedules 5, 6 and 7 contained in the Schedule to these Regulations.
Consequential amendments15
1
In Schedule 1 to the Food Safety (Sampling and Qualifications) Regulations 1990 F5
(provisions to which those Regulations do not apply) the reference in the second column, opposite to the reference in
the first column to the Natural Mineral Water, Spring Water and Bottled Drinking Water Regulations 1999 shall be amended insofar
as it applies to Wales so as to read “
S.I. 1999/1540 as amended by S.I. 2000/656, S.I. 2003/3042 (W.287) and S.I. 2004/1509 (W.158)
”
.
2
In the Food Safety (General Food Hygiene) Regulations 1995 F6 in paragraph (1) of regulation 2 (interpretation), in the definition of “water”, after the words “as amended by the Natural
Mineral Water, Spring Water and Bottled Drinking Water (Amendment)
(Wales) Regulations 2003” there shall be inserted the words “
and the Natural Mineral Water, Spring Water and Bottled Drinking Water (Amendment)
(Wales) Regulations 2004
”
.
Signed on behalf of the National Assembly for Wales under section 66(1) of the Government of Wales Act 1998 F7.
SCHEDULESCHEDULES 5, 6 AND 7 TO BE ADDED TO THE NATURAL MINERAL WATER, SPRING WATER AND BOTTLED DRINKING WATER REGULATIONS 1999
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;
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 physio-chemical composition of the water in terms of its characteristic constituents;
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
Bromate
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;
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;
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 begins.
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.
SCHEDULE 6MAXIMUM LIMITS FOR CONSTITUENTS OF NATURAL MINERAL WATERS
Constituents
Maximum limits (mg/l)
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
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.
SCHEDULE 7PERFORMANCE CHARACTERISTICS FOR ANALYSING THE CONSTITUENTS IN SCHEDULE 6
Constituent
Accuracy of parametric
Precision of parametric value value in %
Detection limit of parametric value in %
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
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.
1990 c. 16.