1. Introduction
2. Scope and use of the document
3. Primary production
4. Establishment: design and facilities
5. Establishment: Control of operation
6. Establishment: Maintenance and sanitation
7. Establishment: Personal hygiene
8. Transportation of bottled water
9. Product information and consumer awareness
10. Training
Appendix 1: Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application - Considerations for Bottled Waters (Other than Natural Mineral Water)
Appendix 2: Microbiological, Chemical, and Physical Criteria - Source Water and Critical Control Points - End-Product Specifications
(At Step 5 of the Procedure)
International trade in bottled water has increased in recent years, both in quantity and diversity. Because of increased transport capacity, it is now possible to distribute bottled water not just as ship, rail, and road cargo but also as air freight, the latter being used mainly in crisis situations due to the higher cost. By all these means of transport, a water shortage remedy has become available when local water supply systems fail due to natural causes (such as droughts and earthquakes) or societal disasters (such as sieges or sabotage) and bottled water other than natural mineral water has been used to meet some of these needs.
Aside from water shortages, real and perceived needs to improve health also have contributed to an escalating trade in bottled water. Increasingly it has been recognized that traditional suppliers of drinking water such as public and private waterworks may not be able in many instances or under all circumstances to guarantee the microbiological, chemical and physical safety of their product to the extent previously thought possible.
2.1 Scope
2.2 Use of the document
2.3 Definitions
This Code recommends general techniques for collecting, processing, [labelling], packaging, storing, transporting, distributing, and offering for sale a variety of drinking waters (other than natural mineral water) for direct consumption. Recommendations concerning natural mineral water are provided in a separate Code (Recommended International Code of Hygienic Practice for the Collecting, Processing and Marketing of Natural Mineral Waters, CAC/RCP 33-1985). Included in this Code are the Application of the Hazard Analysis Critical Control Point (HACCP) System and Guidelines principles to ensure the production of safe and suitable bottled water.
The Codex HACCP System and Guidelines for its Application is annexed to the General Principles of Food Hygiene (CAC/RCP I-1969, Rev. 3-1997). Appended to this Code are Hazard Analysis and Critical Control Point Considerations for Bottled Water (Other than Natural Mineral Water). Also appended to this Code are Microbiological, Chemical, and Physical Criteria Considerations for Bottled Waters (Other than Natural Mineral Water). The Revised Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/CL 21-1997) are detailed in Supplement to the Codex Alimentarius Volume 1B.
It is emphasized that this document must be used in combination with the Recommended International Code of Practice - General Principles of Food Hygiene, (CAC/RCP 1-1969, Rev. 3-1997) whose paragraph numbers and section headings it maintains, supplementing or specifically applying them to packaged (bottled) drinking waters (other than natural mineral water).
These definitions are supplemental to the definitions in section 2.3 of the Draft Revised Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997).
- Disinfection - The reduction, by means of chemical agents and/or physical methods, of the number of microorganisms to a level that does not compromise food safety or suitability.- Drinking water systems - Public or private systems providing the consumer with tap water suitable for direct consumption.
- Establishment - Any building(s), area(s) or surroundings in which water intended for bottling is collected, processed and bottled.
- Food - For the purposes of this Code, the term includes bottled drinking water.
- Food handling - Any operation pertaining to collecting, processing, bottling, packing of bottles, storing, transporting, distributing and marketing of bottled drinking water.
- Food hygiene - All conditions and measures necessary to ensure the safety and suitability of bottled drinking water at all stages of its production.
- Ground water - Waters such as spring water, artesian water, and well water originating from subsurface aquifers. Ground waters may be classified broadly as protected or unprotected water. Protected ground waters are not directly influenced by surface water or the surface environment and thus, they are suitable from a microbiological point of view.
- Ingredient - Any substance, including food additives used to manufacture or prepare foods, intentionally added to a finished product, sometimes in a modified form (it may or may not be suitable for human consumption without further treatment).
- Packaged (bottled) drinking water - Water filled into hermetically sealed containers of various compositions, forms, and capacities that is suitable for direct consumption without necessary further treatment. Bottled drinking water is considered a food.
- Pests - Any animals capable of directly or indirectly contaminating bottled drinking waters.
- Surface water - Waters open to the atmosphere such as streams, rivers, lakes, ponds and reservoirs.
3.1 Environmental hygiene
3.2 Hygienic production of water supplies
3.3 Handling, storage and transport of water intended for bottling
These guidelines are supplemental to those set forth in Section 3 of the Recommended International Code of Practice - General Principles of Food Hygiene, (CAC/RCP 1-1969, Rev. 3-1997).
Prior to utilizing a water for bottling purposes, the chemical composition and microbiological quality of the water should be established.
3.1.1 Protection of watershed and perimeter
A hydrogeologist should determine the watershed and the perimeter (area surrounding the water's point of origin) that can be sources of contamination. These critical areas should be protected as much as possible.
3.1.2 Protective measures
All possible precautions should be taken within the protected perimeter to avoid any pollution of, or external influence on, the quality of the ground or surface water. Preventive measures should be taken for disposal of liquid, solid or gaseous waste that could pollute the ground or surface water. Disposal of pollutants such as microorganisms, fertilizers, hydrocarbons, detergents, pesticides, phenolic compounds, toxic metals, radioactive substances and other soluble organic and inorganic substances should be controlled. Drinking water resources should not be in the path of potential sources of underground contamination, such as sewers, septic tanks, industrial waste ponds, gas or chemical tanks, pipelines and solid waste disposal sites.
3.2.1 Protection of ground water supplies
3.2.1.1 Criteria for ground water supplies
It is not easy to distinguish between protected and unprotected ground water. Ground water supplies should be tested regularly for constancy of biological (including microbial), chemical, physical and radiological characteristics. The frequency of testing is determined by the hydrogeological evaluation and historical constancy pattern of a particular water supply. If abnormal contamination is detected, and the chosen corrective action is ineffective, production should cease temporarily until the water quality has returned to normal. The underground supply, from which the water is collected, should be approved by an official authority having jurisdiction or by a third party with expertise for approving such underground supplies.
3.2.2 Protection of surface water supplies
[To be developed.]
3.2.2.1 Criteria for surface water supplies
[To be developed.]
3.3.1 Hygienic extraction or collection of water
3.3.1.1 At point of origin
The extraction or collection of water intended for bottling should be conducted in such a manner as to prevent other than the intended water from entering the extraction or collection device. The extraction or collection of water intended for bottling should also be conducted in a hygienic manner to prevent any contamination. If necessary there should be appropriate sampling mechanisms.
3.3.1.2 Protection of the area of origin
The immediate surroundings of the extraction or collection area should be protected by limiting access to authorized persons only. Wellheads and spring outflows should be protected by a suitable structure to prevent entry by unauthorized individuals, pests and other sources of extraneous matter.
3.3.1.3 Maintenance of extraction or collection facilities
Methods and procedures for maintaining the extraction facilities should be hygienic. They should not be a potential hazard to humans or a source of contamination for the water. Wells should be disinfected following construction and development of new wells nearby, pump repair or replacement, any well maintenance, detection of indicator organisms, pathogens, or abnormal plate counts in the water, and whenever biological growth inhibits proper operation. Water collection chambers should be disinfected before use. Extraction devices such as those used for bore holes should be constructed and maintained in a manner that avoids contamination and minimizes hazards to human health.
3.3.2 Storage and transport of water intended for bottling
When storage and transport of the water intended for bottling from the point of origin to the processing plant is necessary, these operations must be conducted in a hygienic manner to prevent any contamination. Relevant provisions of the Codex Alimentarius Code of Hygienic Practice for Bulk Transport of Food and Food Ingredients, which is being developed parallel to this Code, apply. In addition, see 3.3.2.1 and 3.3.2.2 below.
Guidelines that are supplemental to those set forth in Section 3 of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) are found in the Codex Code of Hygienic Practice for Bulk Transport of Food and Food Ingredients, which is being developed parallel to this Code. Supply of water through the piping directly connected to the point of origin, wherever possible, is one of the means of avoiding contamination from bulk transport.
3.3.2.1 Requirements
Where or when they are necessary, bulk containers and conveyances such as tanks, pipings and tanker trucks should be designed and constructed so that they:
do not contaminate the water intended for bottling;3.3.2.2 Use and maintenance
can be effectively cleaned and disinfected;
provide effective protection from contamination, including dust and fumes; and
allow any situation that arises to be checked easily.
Conveyances and bulk containers for transporting water intended for bottling should be kept in an appropriate state of cleanliness, repair and condition. Containers and conveyances, particularly in bulk transport, should preferably be used only for transporting water intended for bottling and, in any case, should be used exclusively for food transportation.
4.2 Premises and rooms
4.3 Facilities
These guidelines are supplemental to those set forth in Section 4 of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997).
In those areas of the processing establishment where containers are exposed to the external environment (i.e., on the loading dock), especially prior to filling and sealing, some specific preventive measures should be incorporated into the facility's design to avoid contamination of the containers used for production of bottled water.
4.3.1 Water supply
This section pertains to water used for cleaning and disinfection purposes; not for bottled water.
For cleaning and disinfection purposes an ample supply of potable water not intended for bottling in compliance with Section 4.4.1 of the Codex Alimentarius International Code of Practice -General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) under adequate pressure and of suitable temperature should be available with adequate facilities for its storage, where necessary, and distribution, and with adequate protection against contamination. The standards of potability should not be less than those contained in the latest edition of Guidelines for Drinking Water Quality (WHO).
Water not intended for bottling should be carried in completely separate lines from water intended for bottling. These lines should be identified, preferably by different colours. There must be no cross connections. Water not intended for bottling may be potable or not potable (used for steam production or refrigeration).
5.1 Control of food hazards
5.4 Packaging
These guidelines are supplemental to those set forth in Section 5 of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997).
Water is an excellent vehicle for carrying substances in soluble, dispersed, or emulsified form. Steps must be taken at all stages of processing to ensure that contamination of water intended for bottling does not occur, including the formation of treatment by-products (particularly bromides) in accordance with relevant WHO guidelines.
5.1.1 Preventative measures for waters intended for bottling
Waters, from drinking water systems, intended for bottling should meet all public drinking water standards (i.e., chemical, microbiological, physical, radiological) established by the official authority having jurisdiction. For documentation of an approved source, firms using waters from drinking water systems may use public drinking water system testing results showing full compliance with drinking water standards established by the official authority having jurisdiction in accordance with the Guidelines for Drinking Water Quality (WHO).
No waters intended for bottling or other ingredients should be accepted by an establishment if it is known to contain parasites, undesirable microorganisms, pesticides, or toxic substances that are decomposed or extraneous which would not be eliminated or reduced to an acceptable level by normal treatment and/or processing. Where appropriate, specifications for ingredients should be identified and applied. Ingredients should, where appropriate, be inspected and sorted before processing. Where necessary, laboratory testing should be done to establish fitness for use. Only ingredients which meet the above parameters should be used.
Where necessary, surface waters should be tested and treated. Water intended for bottling should be of a quality (i.e., microbiological, chemical, physical, radiological), such that treatment (including multiple barrier treatments such as combination of filtration, chemical disinfection, etc.) of that water during processing results in finished bottled drinking water products that are safe and of suitable quality for consumption. Generally, the higher the quality of the water intended for bottling, the less treatment is required to produce safe and wholesome bottled drinking water products.
A hazard analysis of the water supply for pathogenic microorganisms or harmful substances should be the basis for treating waters intended for bottling during processing to reduce, remove or prevent growth of microorganisms or to reduce or remove chemical or radiological hazards. A hazard analysis which will be based on a HACCP methodology or alternative methodology will be used to determine whether treatment is necessary and, if it is necessary, the type and degree of treatment. Waters originating from protected underground supplies are less likely to require treatment than waters originating from surface supplies or unprotected underground supplies.
Treatment of waters intended for bottling, if necessary, to reduce, remove or prevent growth of microorganisms may include the application of chemical processes (such as chlorination, ozonation, carbonation) and physical agents or processes (such as high heat, ultraviolet radiation, filtration). These treatments can be used singly or in combination as multiple barriers. Treatments vary in their effectiveness against specific organisms. Bottled waters produced with the use of an adequate multiple barrier treatment technique will be less likely to contain microorganisms of public health concern. See also Section 9.3.
Treatments to remove or reduce chemical substances, if necessary, may include particulate (mechanical) filtration such as achieved with surface filters (e.g., pleated membrane filters) or depth filters (e.g., sand or compressed fiber (cartridge) filters), activated carbon filtration, demineralization (deionization, water softening, reverse osmosis, nano-filtration), and aeration. These treatments for chemicals may not adequately reduce or remove microorganisms and, likewise, treatments for microorganisms may not adequately reduce or remove chemicals and must be conducted or carried out in a way to avoid any type of contamination.
5.4.1 Washing and sanitizing containers
5.4.1.1 Washing and sanitizing of reusable containers
[The washing and sanitizing of reusable and disposable containers for bottled drinking water should be conducted when necessary in an enclosed system and positioned within the processing plant so as to minimize post-sanitizing contamination of containers before the filling and sealing of containers.
5.4.1.2 Filling and sealing of containers
Bottling operations (i.e., filling and sealing of containers) should be conducted in an enclosed area under positive air pressure. Another method of conducting bottling operations is to contain them in an enclosed system separate from other operations of the processing plant to protect against contamination. Dust, dirt, microorganisms and excessive moisture in the air should be controlled and monitored.
5.4.1.3 Product containers and closures
The containers intended for bottling drinking waters should be non-toxic and used exclusively for that purpose. Reusable containers should not have been used for any purpose that may lead to contamination of the product and should be individually inspected for suitability. New product containers should be inspected if and as appropriate.]
No specific requirements beyond those made in the Recommended International Code of Practice - General Principles of Food Hygiene(CAC/RCP 1-1969, Rev. 3-1997) are needed.
No specific requirements beyond those made in the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) are needed.
Guidelines that are supplemental to those set forth in Section 8 of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) are found in the Codex Code of Hygienic Practice for the Transport of Foodstuffs in Bulk and Semi-Packed Foodstuffs, which is being developed parallel to this Code.
9.3 Labeling
These guidelines are supplemental to those set forth in Section 9 of the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997).
[NOTE: The Labelling Section of this Code will be deleted in future drafts. However, the issues contained in it will be taken care of, as appropriate, in other sections of this Code or in the Product Standard that is to be developed.9.3.1 BOTTLED DRINKING WATERS INTENDED FOR INFANTS
Producers of bottled drinking water products and individual governments having jurisdiction may wish to provide information to consumers concerning bottled drinking water products intended for infants. Such information can address the concern with ingestion of water by infants, particularly 0 to 4-6 months of age, that may cause hyponatremia. The information can also address the potential confusion by parents regarding bottled drinking waters intended for infants and electrolyte solutions intended for the maintenance of an electrolyte level depleted by diarrhoea or vomiting; parents of infants mistakenly use bottled drinking water products with unsubstantiated label statements or claims of nutritional benefit in lieu of infant formula. Further, because bottled drinking water products intended for infants may not be sterile, they should have information concerning their use as directed by a physician or have labelling directions for preparation of infant formula.
9.3.2 BOTTLED DRINKING WATERS INTENDED FOR IMMUNOCOMPROMISED INDIVIDUALS
Immunocompromised consumers include persons with HIV/AIDS, patients receiving treatment for cancer, recipients of organ or tissue transplants, and persons who have congenital immunodeficiencies.
Since tests for parasitic protozoa are unreliable, it may be helpful to immunocompromised consumers to supply information regarding treatments the water has received. Boiling, pasteurization, distillation, reverse osmosis filtration, absolute one micron or submicron filtration are treatments used to inactivate or remove surface water contaminants such as the oocysts of Cryptosporidium parvum, Cyclospora cayetanensis, Toxoplasma gondii and the cysts of other waterborne parasitic protozoa such as Giardia lamblia and Entamoeba histolytica. All treatments which can change the composition, whether chemical, physical, or microbiological, of the water after extraction should be mentioned on the label.]
No specific requirements beyond those made in the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) are needed.
[NOTE: Details for this Section to be filled in at a later date. The Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, (annex to CAC/RCP 1-1969, Rev. 3-1997) will also apply.]
[NOTE: Details for this Section to be filled in at a later date. The Codex Alimentarius Draft Revised Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21 - 1997) will also apply.]
