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 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.

SECTION I Natural mineral waters

General requirements

2. Natural mineral water shall -

1. 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;
2. 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;
3. be collected under conditions which guarantee the original bacteriological purity and chemical composition of essential components;
4. be packaged at or in close proximity to the point of emergence of the source with particular hygienic precautions;
5. 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;
6. 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:

1. separation from unstable constituents by decantation and/or filtration, which can be accelerated by previous aeration;
2. removal of carbon dioxide from the natural mineral water;
3. 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:

1. the name of the product shall be "natural mineral water";

2. the physical address and the name of the source;

3. the analytical composition of the natural mineral water which gives its characteristics should be declared in milligrams per litre (mg/l) on the label together with the date of analysis

4. the specification of the natural mineral water by the use of the expressions "naturally-carbonated 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".

6. Waters defined by origin shall-

1. originate from any specific environmental water resource without passing through a community water system;
2. 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;
3. be collected under conditions which guarantee the original microbiological purity and essential elements of its chemical make-up at the origin;
4. 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;
5. 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 treatments-

1. reduction and/or elimination of dissolved gases and unstable constituents such as iron, manganese, sulphur, excess carbonates under normal pressure and temperature conditions;
2. addition of carbon dioxide or re-incorporation of original carbon dioxide present at the emergence;
3. 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;
4. decrease and/or increase in temperature;
5. reduction and/or separation of elements originally present in excess of maximum limits as stipulated in the general requirements for bottled waters;
6. antimicrobial treatments may be used in order to conserve the original microbiological fitness for human consumption, original purity and safety of these waters.

8. For waters defined by origin, the following particulars shall appear on the label:

1. the name of the product shall be "spring water" or any specific name indicating its environmental resource;

2. 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";

3. the physical address and the name of the source;

4. the chemical composition of the water should be declared in milligrams per litre (mg/l) on the label together with the date of analysis

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:

1. any appropriate name to designate prepared water should appear on the label;

2. descriptive expression such as "carbonated" or "sparkling" should accompany the name;

3. the chemical composition of the prepared water may be declared on the label together with the date of analysis;

4. 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.

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 Substance	II Maximum limit (mg/l)	III Test method	IV Principle which is used for isolation and/or measurement
Antimony	0.005	ISO 11885	Emission spectroscopy
Arsenic	0.01 (as total Arsenic)	ISO 6595:1982 AOAC 986.15	-Spectrophotometry -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 Boron)	ISO 9390:1990	Spectrophotometry
Cadmium	0.003	ISO 9390: 1986 AOAC 986.15 AOAC 974.27	-Flame atomic absorption spectrophotometry -Atomic absorption spectrophotometry -Atomic absorption spectrophotometry
Chromium	0.05	Examination of Water Pollution Control. WHO Pergamom Press (1982) Vol. 2, pp.86-87
Copper	1	AOAC 960.40 ISO 8288:1986	-Colorimetry -Spectrophotometry
Cyanide	0.07	SABS method 204	Colorimetry
Fluoride	1.5 (and see regulation 17)	AOAC 939.11 Examination of Water Pollution Control. WHO Pergamom Press (1982) Vol. 2, pp.245-247&247-250	Colorimetry Iron selective electrode
Lead	0.01	ISO 8288: 1986 AOAC 974.27	-Flameless atomic absorption spectrophotometry -Atomic absorption spectrophotometry.
Manganese	0.5	AOAC 974.27 Examination of Water Pollution Control WHO Pergamon Press (1982) Vol. 2, pp. 121 –122 ISO 6333: 1986	Atomic absorption pectrophotometry
Mercury	0.001	ISO 5666-3: 1984 AOAC 977.22	-Flameless atomic absorption spectrophotometry -Flameless atomic absorption spectrophotometry
Molybdenum	0.07
Nickel	0.02	SABS ISO 11885	Atomic absorption spectrophotometry
Nitrate	50, calculated as nitrate	ISO 7890-2:1986 Handbuch Lebensmitel Chemie (1969). Examination of Water Pollution Control. WHO Pergamon Press (1982), Vol. 2, pp.280-283	Spectrophotometry
Nitrite	0.2, calculated as nitrite	SABS ISO 6777 SABS ISO 10304-1	Spectrophotometry
Organophosphate pesticides	Below limit of quantification	AOAC 990.06 AOAC Method 991.07	Gas chromatography
Organochlorine pesticides and polychlorinated biphenyls	Below limit of quantification	APHA Method 6630(b)
Selenium	0.01	AOAC 986.15 SABS Method 1058 Examination of Water Pollution Control. WHO Pergamon Press (1982) Vol. 2, pp. 320-322	-Atomic absorption spectrophotometry -Atomic absorption spectrophotometry
Surface active agents	Below limit of quantification	ISO 7875 1:1984	Spectrophotometry/Methylene Blue
Uranium	0.002

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 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.