CAC/RCP 48-2001

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CODE OF HYGIENIC PRACTICE FOR BOTTLED/PACKAGED DRINKINGWATERS (OTHER THAN NATURAL MINERAL WATERS)CAC/RCP 48-2001
SECTION 1.
1.1
1.2
1.3

SCOPE, USE AND DEFINITIONS ......................................................................................... 2

SCOPE ........................................................................................................................................................ 2
USE OF THE DOCUMENT ............................................................................................................................. 2
DEFINITIONS .............................................................................................................................................. 3

SECTION 2.

PRIMARY PRODUCTION ...................................................................................................... 3

2.1 ENVIRONMENTAL HYGIENE ........................................................................................................................ 3
2.1.1 Precautions in selecting a resource site ........................................................................................... 3
2.2 HYGIENIC PRODUCTION OF WATER SUPPLIES ............................................................................................. 4
2.2.1 Protection of ground water supplies ................................................................................................ 4
2.2.1.1.

2.2.2

Considerations for ground water supplies ............................................................................................... 4

Protection of surface water supplies ................................................................................................ 4

2.2.2.1.

Considerations for surface water supplies ............................................................................................... 4

2.3 HANDLING, STORAGE AND TRANSPORT OF WATER INTENDED FOR BOTTLING ............................................ 4
2.3.1 Hygienic extraction or collection of water ....................................................................................... 4
2.3.1.1.
2.3.1.2.
2.3.1.3.

2.3.2

Storage and transport of water intended for bottling ....................................................................... 5

2.3.2.1.
2.3.2.2.

SECTION 3.

At point of origin .................................................................................................................................... 4
Protection of the area of origin................................................................................................................ 4
Maintenance of extraction or collection facilities ................................................................................... 4
Requirements .......................................................................................................................................... 5
Use and maintenance .............................................................................................................................. 5

ESTABLISHMENT: DESIGN AND FACILITIES................................................................ 5

3.1 PREMISES AND ROOMS ............................................................................................................................... 5
3.2 FACILITIES ................................................................................................................................................. 5
3.2.1 Water supply not intended for bottling ............................................................................................. 5
SECTION 4.

ESTABLISHMENT: CONTROL OF OPERATION ............................................................. 6

4.1 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS........................................................................................... 6
4.2 PACKAGING................................................................................................................................................ 7
4.2.1 Washing and disinfecting of containers ........................................................................................... 7
4.3 FILLING AND SEALING OF CONTAINERS ...................................................................................................... 7
4.3.1 Product containers and closures ...................................................................................................... 7
4.3.2 Use of closures ................................................................................................................................. 7
SECTION 5.

ESTABLISHMENT: MAINTENANCE AND SANITATION .............................................. 7

SECTION 6.

ESTABLISHMENT: PERSONAL HYGIENE ....................................................................... 7

SECTION 7.

TRANSPORTATION AND STORAGE OF BOTTLED WATER ....................................... 8

SECTION 8.

PRODUCT INFORMATION AND CONSUMER AWARENESS ....................................... 8

SECTION 9.

TRAINING ................................................................................................................................. 8

APPENDIX 1-MICROBIOLOGICAL AND OTHER SPECIFICATIONS .................................................... 9

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INTRODUCTION
International trade in bottled water has increased in recent years, both in quantity and diversity.
Because of greater transport capacity, it is now possible to distribute bottled water not just as ship,
rail, and road cargo but also as airfreight, the latter being used mainly in crisis situations due tothe higher cost. By all these means of transport, a remedy for water shortages has become
available when local water supply systems fail due to natural causes (such as droughts andearthquakes) or societal disasters (such as sieges or sabotage) and bottled water, both naturalmineral water and diverse other sorts, has been brought in to meet such emergencies.
Aside from water shortages, real and perceived needs to improve health also have contributed toan escalating trade in bottled water. Increasingly it has been recognized that traditional suppliersof drinking water such as public and private waterworks may not always be able to guarantee themicrobiological, chemical and physical safety of their product to the extent previously thoughtpossible.
The contamination of water with viruses and parasitic protozoa is a serious concern to all
consumers, particularly the immunocompromised. These pathogens are difficult to detect andbacterial indicators of their potential presence are not always reliable. Therefore it may be helpful
to consumers to supply information regarding control measures the water has received. Protectionof natural resources and such treatments as boiling, pasteurization, distillation, reverse osmosis
filtration, absolute one micron or submicron filtration are some of the control measures used toguard against, inactivate or remove possible water contaminants such as oocysts of
Cryptosporidium parvum, Cyclospora cayentanensis, and Toxoplasma gondii and cysts of otherwaterborne parasitic protozoa such as Giardia (lamblia) intestinalis, and Entamoeba histolytica.
It may be necessary that bottled drinking water products of particular chemical composition
provide information concerning their proper consumption and/or have directions regardingwhether or not they are suitable for infants and for the rehydration of infant formula.

SECTION 1. SCOPE, USE AND DEFINITIONS
1.1 SCOPE
This Code recommends general techniques for collecting, processing, packaging, storing,transporting, distributing, and offering for sale a variety of drinking waters (other than naturalmineral water) for direct consumption. Recommendations concerning natural mineral water areprovided in a separate Code (Recommended International Code of Hygienic Practice for theCollecting, Processing and Marketing of Natural Mineral Waters (CAC/RCP 33-1985)). All
bottled/packaged drinking waters other than natural mineral water are covered by this Code.

1.2 USE OF THE DOCUMENT
It is emphasized that this document must be used in combination with the Recommended
International
CodeofPractice
GeneralPrinciplesof
Food
Hygiene,(CAC/RCP 1-1969, Rev. 3-1997), including the HACCP Annex, whose paragraph numbers andsection headings it maintains, supplementing or specifically applying them to bottled drinking
waters (other than natural mineral waters). This Code should also be used in combination with
the Principles for the Establishment of and Application of Microbiological Criteria for Foods(CAC/GL 21-1997).

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1.3 DEFINITIONS
These definitions are supplemental to the definitions in section 2.3 of the Recommended
International
CodeofPractice
GeneralPrinciplesof
Food
Hygiene(CAC/RCP 1-1969, Rev. 3-1997). The Food, and Food handling definitions apply only to thisCode.
Bottled/packaged drinking water - Water filled into hermetically sealed containers of various
compositions, forms, and capacities that is safe and suitable for direct consumption without
necessary further treatment. Bottled drinking water is considered a food. The terms “drinking”
and “potable” are used interchangeably in relation to water.
Drinking water systems - Public or private systems providing the consumer with tap water safe
and suitable for direct consumption.
Establishment - Any suitable building(s), area(s) or surroundings in which water intended forbottling is collected, processed and bottled.
Food - For the purposes of this Code, the term includes bottled/packaged drinking water.
Food handling - Any operation pertaining to collecting, processing, bottling, packing of bottles,
storing, transporting, distributing and marketing of bottled drinking water.
Ground water - Waters such as spring water, artesian water, and well water originating fromsubsurface 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.
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 besafe and suitable for human consumption without further treatment).
Surface water - Waters open to the atmosphere such as streams, rivers, lakes, ponds andreservoirs.

SECTION 2. PRIMARY PRODUCTION
These guidelines are supplemental to those set forth in Section III of the Recommended
International Code of Practice - General Principles of Food Hygiene, (CAC/RCP 1-1969,
Rev. 3-1997).
Prior to using a water resource for bottling purposes, its chemical composition andmicrobiological safety should be established over an appropriate period to allow for variations.

2.1 ENVIRONMENTAL HYGIENE
2.1.1

Precautions in selecting a resource site

Hydrogeological data should determine the watershed and the perimeter (area surrounding the
body of water from which supplies are drawn or the water’s point of origin in the ground) that canbe sources of contamination. These critical areas should be protected as much as possible.
All possible precautions should be taken within the protected perimeter (zone of protection) to
avoid any pollution of, or external influence on, the quality of the ground or surface water.
Disposal of liquid, solid or gaseous waste that could pollute the ground or surface water should becontrolled. Disposal of pollutants such as microorganisms, fertilizers, hydrocarbons, detergents,
pesticides, phenolic compounds, toxic metals, radioactive substances and other soluble organicand inorganic substances in the watershed should be avoided. Nor should drinking waterCAC/RCP 48-2001

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resources 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.

2.2 HYGIENIC PRODUCTION OF WATER SUPPLIES
2.2.1

Protection of ground water supplies

2.2.1.1.

Considerations for ground water supplies

It is not easy to distinguish between protected and unprotected ground water. Ground watersupplies should be tested regularly for constancy of biological (including microbial), chemical,
physical and, where necessary, radiological characteristics. The frequency of testing isdetermined by the hydrogeological evaluation, the amount of water collected, and the historicalconstancy pattern of a particular water supply. If contamination is detected, production of bottled
water should cease until the water characteristics have returned to established parameters. Any
underground supply from which water is collected, should be approved by an official authority
having jurisdiction or by a third party with expertise for approving such underground supplies.

2.2.2

Protection of surface water supplies

Surface waters intended for bottling should be protected from contamination to the fullest extent
possible even when treatments follow. Surface waters may be highly variable, so supplies shouldbe tested frequently.
2.2.2.1.

Considerations for surface water supplies

Stringency in determining which surface waters are suitable for bottling should be the rule, evenwhen treatment(s) is foreseen.

2.3 HANDLING, STORAGE AND TRANSPORT OF WATER INTENDED FOR BOTTLING
2.3.1

Hygienic extraction or collection of water

2.3.1.1.

At point of origin

The extraction or collection of water intended for bottling should be conducted in such a manneras 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. Where sampling points are necessary, they should bedesigned and operated to prevent any contamination of the water.
2.3.1.2.

Protection of the area of origin

The immediate surroundings of the extraction or collection area should be protected by limiting
access to only authorized persons. Wellheads and spring outflows should be protected by asuitable structure to prevent entry by unauthorized individuals, pests, dust and other sources ofcontamination such as extraneous matter, drainage, floodwaters, and infiltration water.
2.3.1.3.

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 beproperly disinfected following construction and development of new wells nearby, after pumprepair or replacement, or any well maintenance activity such as testing for and finding indicatororganisms, pathogens, or abnormal plate counts in the water, and whenever biological growth
inhibits proper operation. Water collection chambers should be disinfected within a reasonable
time before use. Extraction devices such as those used for bore holes should be constructed andmaintained in a manner that avoids contamination of the water and minimizes hazards to humanhealth.

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2.3.2

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Storage and transport of water intended for bottling

When storage and transport of the water intended for bottling from the point of origin to theprocessing plant is necessary, these operations must be conducted in a hygienic manner to prevent
any contamination.
In addition, see 2.3.2.1 and 2.3.2.2 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 Code of Hygienic Practice for Bulk
Transport of Food and Semi-Packaged Foodstuffs (CAC/RCP 47-2001). Directing the supply ofwater through piping from the point of origin wherever possible is one of the means of avoiding
risks of contamination from bulk transport.
2.3.2.1.

Requirements

Where or when they are necessary, bulk containers and conveyances such as tanks, pipings andtanker trucks should be designed and constructed so that they:

do not contaminate the water intended for bottling;

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.
2.3.2.2.

Use and maintenance

Means of transport of water intended for bottling should be kept in an appropriate state ofcleanliness, repair and condition. Containers and conveyances, particularly in bulk transport,
should preferably be used only for transporting water intended for bottling. When this cannot be
achieved, conveyances and bulk containers should be used exclusively for food transportation andmust be cleaned and disinfected as necessary to prevent contamination. See also Code ofHygienic Practice for the Transport of Bulk and Semi-Packed Food (CAC/RCP 47-2001).

SECTION 3. ESTABLISHMENT: DESIGN AND 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).

3.1 PREMISES AND ROOMSIn 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, specific preventive
measures should be incorporated into the facility's design to avoid contamination of the containers
used for bottled water.

3.2 FACILITIES
3.2.1

Water supply not intended for bottlingThis section pertains to water for cleaning and disinfection purposes; not to water for bottling.
Water intended for bottling should be carried in completely separate lines from water not intended
for bottling. These lines should be identified, preferably by different colours. There must be nocross-connections. Water used for cleaning and disinfection, should be potable (the standards of
potability should not be less than those contained in the latest edition of the WHO Guidelines for
Drinking Water Quality) if there is a chance that it comes into direct or indirect contact with waterthat is intended for bottling; otherwise it may be non-potable (if used where there is no direct or

CAC/RCP 48-2001

Page 6 of 9indirect contact with water for bottling). For storage, the provision in the Recommended
International Code of Practice: General Principles of Food Hygiene (CAC/RCP 1-1969,
Rev. 3-1997) apply.

SECTION 4. ESTABLISHMENT: CONTROL OF OPERATION
These guidelines are supplemental to those set forth in Section V 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.
Control measures must be taken at all steps of processing to ensure that food safety and suitability
are not compromised by hazards or other contaminants during operations.

4.1 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS
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 fromdrinking water systems may use drinking water system testing results showing full compliancewith drinking water standards established by the official authority having jurisdiction inaccordance with the Guidelines for Drinking Water Quality (WHO).
No waters intended for bottling should be accepted by an establishment if it is known to containpathogens or excessive residues of pesticides or other toxic substances.
Water intended for bottling should be such (i.e. microbiologically, chemically, physically, andradiologically), that treatment if necessary (including multiple barrier treatments such as
combination of filtration, chemical disinfection, etc.) of that water during processing results infinished bottled drinking water products that are safe and suitable for consumption. Generally, thehigher the quality of the water intended for bottling, the less treatment is required to produce safe
bottled drinking water products. Surface waters should be tested for safety frequently and treatedas necessary.
A hazard analysis which takes into consideration pathogens and toxic substances should beundertaken in the overall context of the application of principles such as HACCP to the
production of bottled water. This should provide the basis for determining the appropriate
combination of control measures to reduce, eliminate or prevent, as necessary, hazards(microbiological, chemical and radiological) for the production of safe bottled water. Waters
originating from protected underground supplies are less likely to require treatment than waters
originating from surface supplies or unprotected underground supplies.
When necessary, treatment of waters intended for bottling, to reduce, remove or prevent growth ofpathogens, 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 intheir effectiveness against specific organisms. Bottled waters produced with the use of anadequate multiple barrier treatment technique will be less likely to contain pathogens of publichealth concern.
When necessary, treatments to remove or reduce chemical substances may include chemical andparticulate (mechanical) filtration such as achieved with surface filters (e.g., pleated membranefilters) or depth filters (e.g., sand or compressed fibre (cartridge) filters), activated carbon
filtration, demineralization (deionization, water softening, reverse osmosis, nano-filtration), andaeration. These treatments for chemicals may not adequately reduce or remove microorganisms

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All treatments of water intended for bottling should be carried out under controlled conditions to
avoid any type of contamination, including the formation of toxic by-products (particularly
bromates) and the presence of residues of water treatment chemicals in amounts that raise healthconcerns in accordance with relevant WHO guidelines.

4.2 PACKAGING
The requirements in the Recommended International Code of Practice – General Principles ofFood Hygiene (CAC/RCP 1-1969, Rev. 3-1997) cover these topics.

4.2.1

Washing and disinfecting of containers

Reused containers and where necessary other containers should be washed and disinfected in an
appropriate system and positioned within the processing plant so as to minimize post-sanitizing
contamination prior to filling and sealing. Disposable containers may be ready for use without
prior washing and disinfecting. Determine if this is the case; if not, treat as carefully as reusable
containers.

4.3 FILLING AND SEALING OF CONTAINERS
Bottling operations (i.e. filling and sealing of containers) should be conducted in a manner that
protects against contamination. Control measures include the use of an enclosed area and acontainment enclosed system separate from other operations of the processing plant to protect
against contamination. Dust, dirt, microorganisms in the air, and condensation should becontrolled and monitored.

4.3.1

Product containers and closures

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 containers should be
inspected and, if necessary, cleaned and disinfected.

4.3.2

Use of closures

Closures are generally supplied in a ready to use state and should be tamper resistant; they are notreusable.

SECTION 5. ESTABLISHMENT: MAINTENANCE AND SANITATIONThe requirements in the Recommended International Code of Practice - General Principles ofFood Hygiene (CAC/RCP 1-1969, Rev. 3-1997) cover these topics.

SECTION 6. ESTABLISHMENT: PERSONAL HYGIENE
The requirements in the Recommended International Code of Practice - General Principles ofFood Hygiene (CAC/RCP 1-1969, Rev. 3-1997) cover this topic.

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SECTION 7. TRANSPORTATION AND STORAGE OF BOTTLED WATER
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) arefound in the Code of Hygienic Practice for the Transport of Foodstuffs in Bulk and Semi-Packed
Food (CAC/RCP 47-2001). For storage, the provisions in the Recommended International Codeof Practice - General Principles of Food Hygiene (CAC/RCP 1-1969, Rev. 3-1997) apply.

SECTION 8. PRODUCT INFORMATION AND CONSUMER AWARENESS
These requirements are covered in the Recommended International Code of Practice - General
Principles of Food Hygiene, (CAC/RCP 1-1969, Rev. 3-1997). See also the text in the
Introduction of this document.

SECTION 9. TRAINING
The requirements made in the International Recommended Code of Practice - General Principlesof Food Hygiene, (CAC/RCP 1-1969, Rev. 3-1997) cover this topic.

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APPENDIX 1-MICROBIOLOGICAL AND OTHER SPECIFICATIONS
Section 5.2.3 Microbiological and Other Specifications of the International Recommended Codeof Practice - General Principles of Food Hygiene, (CAC/RCP 1-1969, Rev. 3-1997) applies.
The provisions of the Principles for the Establishment and Application of Microbiological
Criteria for Foods (CAC/GL 21-1997) apply.
Microbiological and additional specifications for bottled drinking waters (other than naturalmineral waters) are those of the World Health Organization Guidelines for Drinking Water
Quality.