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Voluntary addition of fluoride to bottled water

The Australian Beverages Council Ltd has applied for approval of the voluntary addition of fluoride, at a level of 0.6 – 1.0 milligrams per litre (total of naturally occurring and added fluoride), to packaged (bottled) water.   This level aligns with fluoride levels in fluoridated tap water.  The Applicant believes approval would enable bottlers to offer fluoridated bottled water to consumers as an alternative to fluoridated tap water, or as a source of fluoride for those who do not have access to fluoridated tap water.  

Food Standards Australia New Zealand (FSANZ) has concluded that there are no public health and safety concerns. FSANZ proposes to approve the application, with the condition that the presence of added fluoride must be stated on the package label.  

Why does FSANZ have to approve the voluntary addition of fluoride to bottled water?

Certain substances like fluoride must undergo a safety assessment by FSANZ before they can be added to food and sold in Australia and New Zealand. FSANZ will only give approval if the added substance does not present any public health and safety concerns.  FSANZ can also require a statement on the food label identifying the presence of the substance.

What is the process of reaching a regulatory decision for the addition of fluoride to bottled water?

FSANZ has conducted a thorough risk assessment to determine if there is any health risk for people drinking bottled water with added fluoride.  FSANZ’s risk assessment has concluded that there is a history of safe use of fluoride in water supplies at the same level as that being sought for addition to bottled water.  In addition, bottled water with added fluoride (to approved levels) is nutritionally equivalent to fluoridated tap water and is safe for all population groups.  

Therefore, FSANZ is recommending permission for the voluntary addition of fluoride in the range of 0.6 – 1.0 milligrams per litre and mandatory labelling to indicate that the product contains added fluoride. This requirement will assist consumers to make an informed choice.  

A Draft Assessment Report was released for public comment in late 2008.  FSANZ is currently assessing the submitter comments and will respond to any issues raised in the Final Assessment Report. This report will go to the FSANZ Board for approval in mid 2009. If approved, the proposed food standard (regulation) will be included in the Australia New Zealand Food Standards Code.

The Ministerial Council for food regulation will be notified of the Board’s decision and has 60 days in which to request a review of the decision.  If no review request is made, the new or amended food standard is gazetted (published) and becomes law.

Why is ‘voluntary’ approval being sought?

The Applicant believes that bottled water with added fluoride will be a niche product, comprising less than 10% of the market for bottled water.  

It is being introduced to provide choice as an alternative to fluoridated tap water or for consumers who do not have access to fluoridated tap water.  If approved, the new standard will allow manufacturers to add fluoride to certain levels, with mandatory labelling requirements.

What would be the nutritional difference between fluoridated tap water and bottled water with added fluoride?

Our assessment has determined that fluoridated bottled water (at approved levels) is nutritionally equivalent to fluoridated tap water.  The amount of fluoride added ( 0.6 – 1.0 milligrams per litre) would align with the recommended target range in fluoridated tap water in Australia and New Zealand.  

How will consumers know bottled water has added fluoride?

Bottled water with added fluoride will be clearly labelled with words to indicate the product contains added fluoride to enable consumers to make an informed choice.

Can fluoridated water be used to make up infant formula?

Bottled water with added fluoride is nutritionally equivalent to fluoridated tap water and can be safely used by all population groups.  

However, it is important that infant formulas are prepared safely.  Plain bottled water (but not natural or sparkling mineral water or soda water) may be used to prepare infant formulas.   Any water used to prepare infant formulas should be boiled and cooled before use according to instructions. Further information on the preparation of infant formula is available from the National Health and Medical Research Council’s publication Dietary Guidelines for Children and Adolescentsin Australia incorporating the Infant Feeding Guidelines for Health Workers(2003) (see www.nhmrc.gov.au/PUBLICATIONS/synopses/dietsyn.htm#large ) or the Ministry of Health’s publicationFood and Nutrition Guidelines for Healthy Infants and Toddlers (aged 0-2. A Background Paper. 4^th Edition.(2008) (see http://www.moh.govt.nz/moh.nsf/pagesmh/7756/$File/0-2-food-and-nutrition-guidelines-may08.pdf )

 

February 2009