DEPARTMENT OF HEALTH
No. R 502
30 April 2004
FOODSTUFFS, COSMETICS AND DISINFECTANTS ACT, 1972 (ACT 54 OF 1972)
REGULATIONS GOVERNING BOTTLED WATERS INCLUDING NATURAL
MINERAL WATER: DRAFT REGULATION
The Minister of Health intends, in terms of section 15 (1) of the Foodstuffs, Cosmetics and
Disinfectants Act, 1972 (Act 54 of 1972), to make regulations in the Schedule.
Interested persons are invited to submit any substantiated comments or representations on the
proposed regulations to the Director-General of Health, Private Bag X 828, Pretoria, 0001 (for
the attention of the Directorate: Food Control), within three months of the date of publication of
this notice.
SCHEDULE
Definitions
1. In these regulations any expression to which a meaning has been assigned in the Act shall bear that
meaning and, unless context otherwise indicates“bottled water” refers to all bottled waters offered for sale as a foodstuff for human consumption;
“bulk ” means non bottled water in direct contact with the surface of the transportation vessel and
the atmosphere;
“carbonated natural mineral water” is a natural mineral water which, after possible treatment
and packaging, has been made effervescent by the addition of carbon dioxide from an origin other
than that of the natural mineral water;
“decarbonated natural mineral water” is a natural mineral water which, after possible treatment
and packaging, has a lower carbon dioxide content than that at emergence and does not visibly and
spontaneously give off carbon dioxide under normal conditions of temperature and pressure;
“free carbon dioxide” means carbon dioxide that is not chemically bound to other elements and/or
compounds
“naturally-carbonated natural mineral water” is a natural mineral water which, after possible
treatment and re-incorporation of gas from the same source and packaged, taking into
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consideration normal technical tolerance, has the same content of carbon dioxide as it would if
carbon dioxide were spontaneously and visibly given off under normal conditions of temperature
and pressure;
“natural mineral water” means bottled water which contains mineral salts in various proportions
and which is characterized by the presence of trace elements and other substances such as calcium,
magnesium, sodium, and potassium;
“natural mineral water fortified with carbon dioxide from the source” is a natural mineral
water which, after possible treatment and packaging, has more carbon dioxide content than such
natural mineral water had at its source;
“non-carbonated natural mineral water” is a natural mineral which, by nature and after
possible treatment and packaging taking in consideration usual technical tolerance, does not
contain free carbon dioxide in amounts larger than are necessary to keep the hydrogen carbonate
salts present in the water dissolved;
“normal technical tolerance” means natural variation in carbon dioxide content of natural
mineral water;
“perimeter” means the outer boundary of the source of natural water;
“prepared water” means bottled water that do not comply with any of the provisions set for
waters defined by origin and may originate from any type of water supply;
“spring water” means bottled water sourced from an underground formation from which water
flows naturally to the surface of the earth. Spring water shall be collected from the spring or a
borehole tapping the underground formation;
“the Act” refers to the Foodstuffs, Cosmetics and Disinfectants Act, 1972 (Act No. 54 of 1972);
“waters defined by origin” refers to bottled water originating from underground or surface water
system, e.g. glacial water, artesian water, spring water etc.
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SECTION I
Natural mineral waters
General requirements
2. Natural mineral water shall (a)
be obtained directly from natural or drilled sources from the underground water-bearing
strata in respect of which all precautions shall be taken within the protected perimeters to
avoid any pollution of or any external effect on, the chemical and physical qualities of
the natural mineral water;
(b)
be constant in its composition and have a stable discharge rate and temperature taking
into account cycles of minor natural fluctuations, while it is still at the source;
(c)
be collected under conditions which guarantee the original bacteriological purity and
chemical composition of essential components;
(d)
be packaged at or in close proximity to the point of emergence of the source with
particular hygienic precautions;
(e)
be subject to treatment only as prescribed in regulation 3 below provided that the mineral
content of the natural mineral water in its essential constituent is not modified;
(f)
comply with all conditions stipulated for bottled waters (Annexure to these regulations).
Treatment
3. Natural mineral water shall be subjected only to the following treatments:
(a) separation from unstable constituents by decantation and/or filtration, which can be
accelerated by previous aeration;
(b) removal of carbon dioxide from the natural mineral water;
(c) addition of carbon dioxide to the natural mineral water, either direct or after initially
removing carbon dioxide as referred to in clause (b).
Transportation
4. Natural mineral water shall not be transported in bulk from the source to another facility for
treatment, packaging or any other process.
Labelling
5. For natural mineral water, the following particulars shall appear on the label:
(a)
the name of the product shall be “natural mineral water”;
(b)
the physical address and the name of the source;
(c)
the analytical composition of the natural mineral water which gives its characteristics should
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be declared in milligrams per litre (mg/l) on the label together with the date of analysis
(d)
the specification of the natural mineral water by the use of the expressions “naturallycarbonated natural mineral water”, “non-carbonated natural mineral water”, “decarbonated
natural mineral water", “natural mineral water fortified with carbon dioxide from source” or
“carbonated natural mineral water”, which may be accompanied by a further descriptive
expressions such as “still” and “sparkling”.
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SECTION II
Waters defined by origin
General requirements
6. Waters defined by origin shall(a) originate from any specific environmental water resource without passing through a
community water system;
(b) be extracted with precaution within the vulnerability perimeters to avoid any
contamination, pollution or external influence on the chemical, microbiological and
physical quality of water at the origin;
(c) be collected under conditions which guarantee the original microbiological purity and
essential elements of its chemical make-up at the origin;
(d) be subjected only to treatments stipulated in regulation 7 below, provided that such
treatments do not change the essential physicochemical characteristics nor compromise the
chemical, radiological and microbiological safety of these waters;
(e) comply to all the general requirements stipulated for bottled waters (Annexure to these
regulations).
Treatment
7. Waters defined by origin may be subjected only to the following treatmentsa. reduction and/or elimination of dissolved gases and unstable constituents such as iron,
manganese, sulphur, excess carbonates under normal pressure and temperature conditions;
b. addition of carbon dioxide or re-incorporation of original carbon dioxide present at the
emergence;
c. addition of air, oxygen or ozone on condition that the by-products due to ozone treatment do not
affect the tolerance levels established under regulation 12;
d. decrease and/or increase in temperature;
e. reduction and/or separation of elements originally present in excess of maximum limits as
stipulated in the general requirements for bottled waters;
f.
antimicrobial treatments may be used in order to conserve the original microbiological fitness
for human consumption, original purity and safety of these waters.
Labelling
8. For waters defined by origin, the following particulars shall appear on the label:
(a)
the name of the product shall be “spring water” or any specific name indicating its
environmental resource;
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(b)
the product name should be accompanied by further descriptive expressions such as
“naturally carbonated” or “naturally sparkling” or “fortified with carbon dioxide” or “non
carbonated” or “non sparkling” or “still”;
(c)
the physical address and the name of the source;
(d)
the chemical composition of the water should be declared in milligrams per litre (mg/l) on the
label together with the date of analysis
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SECTION III
Prepared waters
General requirements
9. Prepared waters can be collected from any source of water supply and can be subjected to any
treatment that modifies the physical and chemical characteristics of the original water provided that
such treatments result in prepared waters that comply with all provisions under general
requirements for bottled waters hereto (Annexure).
Labelling
10. Prepared waters shall be labelled as follows:
(a)
any appropriate name to designate prepared water should appear on the label;
(b)
descriptive expression such as “carbonated” or “sparkling” should accompany the name;
(c)
the chemical composition of the prepared water may be declared on the label together with
the date of analysis;
(d)
the phrase “from a public or private distribution system” if the prepared water was supplied
by a public or private tap water distribution system and prior to bottling had not undergone
any treatment that would modify its original composition.
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ANNEXURE
GENERAL REQUIREMENTS FOR BOTTLED WATERS
11. No bottled water shall contain substances or emit radioactivity in quantities that may be injurious
to the health of the consumer. Minerals added to prepared water before packaging must comply
with the provisions outlined in these regulations.
12. Bottled water in its packaged state shall not contain the elements listed in column I of the
following table in quantities greater than those indicated in column II when tested in accordance
with the methods prescribed in column III.
TABLE
I
II
III
IV
Substance
Maximum limit
Test method
Principle which is used
(mg/l)
for isolation and/or
measurement
Antimony
0.005
ISO 11885
Emission spectroscopy
Arsenic
0.01 (as total
ISO 6595:1982
-Spectrophotometry
Arsenic)
AOAC 986.15
-Atomic absorption
spectrophotometry
Barium
0.7
Examination of Water Pollution
Control. WHO Pergamom Press
(1982) Vol. 2, pp. 67-68
Borate
0.5 (as total
ISO 9390:1990
Spectrophotometry
ISO 9390: 1986
-Flame atomic absorption
Boron)
Cadmium
0.003
spectrophotometry
AOAC 986.15
-Atomic absorption
spectrophotometry
AOAC 974.27
-Atomic absorption
spectrophotometry
Chromium
0.05
Examination of Water Pollution
Control. WHO Pergamom Press
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I
II
III
IV
Substance
Maximum limit
Test method
Principle which is used
(mg/l)
for isolation and/or
measurement
(1982) Vol. 2, pp.86-87
Copper
1
AOAC 960.40
-Colorimetry
ISO 8288:1986
-Spectrophotometry
Cyanide
0.07
SABS method 204
Colorimetry
Fluoride
1.5 (and see
AOAC 939.11
Colorimetry
regulation 17)
Examination of Water Pollution
Iron selective electrode
Control. WHO Pergamom Press
(1982) Vol. 2, pp.245-247&247-250
Lead
0.01
ISO 8288: 1986
-Flameless atomic
absorption
AOAC 974.27
spectrophotometry
-Atomic absorption
spectrophotometry.
Manganese
0.5
AOAC 974.27
Atomic absorption
Examination of Water Pollution
pectrophotometry
Control WHO Pergamon Press
(1982) Vol. 2, pp. 121 –122 ISO
6333: 1986
Mercury
0.001
ISO 5666-3: 1984
-Flameless atomic
absorption
AOAC 977.22
spectrophotometry
-Flameless atomic
absorption
spectrophotometry
Molybdenum
0.07
Nickel
0.02
SABS ISO 11885
Atomic absorption
spectrophotometry
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I
II
III
IV
Substance
Maximum limit
Test method
Principle which is used
(mg/l)
for isolation and/or
measurement
Nitrate
50, calculated as
ISO 7890-2:1986
nitrate
Handbuch Lebensmitel Chemie
Spectrophotometry
(1969). Examination of Water
Pollution Control. WHO Pergamon
Press (1982), Vol. 2, pp.280-283
Nitrite
0.2, calculated as
SABS ISO 6777
nitrite
SABS ISO 10304-1
Organophosph
Below limit of
AOAC 990.06
ate pesticides
quantification
AOAC Method 991.07
Organochlorine
Below limit of
APHA Method 6630(b)
pesticides and
quantification
Spectrophotometry
Gas chromatography
polychlorinated
biphenyls
Selenium
0.01
AOAC 986.15
-Atomic absorption
spectrophotometry
SABS Method 1058
-Atomic absorption
Examination of Water Pollution
spectrophotometry
Control. WHO Pergamon Press
(1982) Vol. 2, pp. 320-322
Surface active
Below limit of
agents
quantification
Uranium
0.002
ISO 7875 1:1984
Spectrophotometry/Meth
ylene Blue
AOAC: Association of Official Analytical Chemists
APHA: American Public Health Association
ISO: International Standards Organisation
SABS: South African Bureau of Standards
13. At the source right through to marketing, drinking water shall conform to the microbiological
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requirements for bottled water as set out in the Regulations Governing Microbiological Standards
for Foodstuffs and Related Matters (No. R. 692 of May 1997) of the Act.
14. Prior to use bottled water shall be packed in hermetically sealed, sterilised containers suitable for
preventing any adulteration or contamination of such water.
15. Notwithstanding regulations 5, 8 and 10, bottled water shall be labelled in accordance with the
provisions of the Regulations Governing the Labelling and Advertising of Foodstuffs (No. R. 908
of May 1997) of the Act.
16. The total dissolved solutes for all bottled waters should be declared on the label.
17. Notwithstanding the provisions of regulation 12 and 15, if the bottled water contains more than 1
mg/l fluoride, the expression “contains fluoride” shall be affixed in close proximity to the name of
the water or in a prominent place on the label. If the product contains more than 2 mg/l fluoride,
the expression ‘this product is not suitable for infants and children under the age of seven years’
shall be affixed in close proximity to the name of the water or in a prominent place on the label.
18. No claims concerning medicinal effects (e.g. preventative, alleviate or curative) shall be made in
respect to the properties of the bottled waters covered in these regulations.
19. Notwithstanding regulation 15, these regulations prohibit the use of any statement or any pictorial
device, which may create confusion in the minds of the public about the nature, origin,
composition and properties of bottled waters, put on sale in South Africa.