3 Au g
[18-1 2
 
Call f
 
World
 
FSANZ 
for cert a
establis h
Pursua n
now callconsoli
d
 For info
r
 
Under t h
publish e
be publi s
docume 
Under s
e
More in f
FSANZ  Submis
s
correct p
more c o
link on d
submis s
 There i
s
FSANZ 
busines s
 
DEA
 
Submis s
before t h
submis s
submitt e
 
Questio n
standar d
followin g
 
Food St a
PO Box 
Canber r
AUSTR A
Tel +61 
gust 201 2
2] 
for sub m
d Healt h
has assess e
ain chemical 
hed by the W
nt to section 3
s for submi s
dated list of q
rmation abo u
he Informati o
ed on our we
shed as soo
nts are invol
ection 114 o
formation ab
website at in
sions should 
project num b
onvenient an d
documents f o
sions@foods
s no need to 
website. FS A
s days. 
ADLINE F
sions receiv e
he closing d a
sion period. A
ers. 
ns about ma
ds.manage m
g addresses :
andards Au s
7186 
ra BC  ACT  
ALIA 
2 6271 222 2
2 
missio n
h Organ i
ed an Applic a
substances 
World Health 
31 of the Foo
ssions to ass
questions ha s
ut making a s
on Publicatio
bsite. We wi
n as possibl e
ved, FSAN Z
f the FSAN Z
out the discl o
nformation f o
be made in 
ber and nam e
d quicker to r
or public co m
tandards.go v
send a hard 
ANZ endea v
OR SUB M
ed after this d
ate. Extensi o
Any agreed e
king submis s
ment@foodst a
: 
stralia New Z
2610 
2   
ns – Ap
ization L
ation made b
in packaged 
Organizatio n
od Standard s
ist its consid
s been provi d
submission, 
n Scheme a
ll not publis h
e after the e n
Z will make t h
Z Act, some i
osure of con
or submitters
writing; be m
e. While FS A
receive sub m
mment . You c
v.au.  
copy of you r
vours to form
MISSIONS :
date will not 
ons will only 
extension wil
sions or the 
andards.go v
Zealand
 
i 
 plicati o
Limits f o
by the Austr a
water to ref l
n and has p r
s Australia N
eration of th e
ded to assis t
visit the FS A
ll submissio n
h any materi a
nd of the pu b
hese availab l
nformation p
fidential co m
.  
marked clear
ANZ accepts
missions ele c
can also em a
r submissio n
ally acknowl
:  6pm (C a
be consider e
be granted d
l be notified 
application p
v.au. Hard c o
Food 
PO BWEL
L
NEW Tel +
6
 
on A10 4
or Pack a
alasian Bottl e
lect current l
repared a dr a
New Zealan d
e draft food r
t submitters 
ANZ website 
ns on applic a
al provided i n
blic commen t
le on CD, ra t
provided to F
mmercial info
ly with the w
 submission s
ctronically th
ail your sub m
n if you have 
edge receip t
anberra ti m
ed unless a n
due to extra o
on the FSA N
process can 
opy submissi
Standards A
ox 10559 
LINGTON 6 1
ZEALAND
64 4 978 56 3
43 
aged W a
ed Water Ins t
imits in inter n
aft food regu
d Act 1991 (F
regulatory m
(Attachment 
at informati o
ations and p r
n-confidenc e
t period. Wh
ther than on 
FSANZ cann o
rmation is a v
word ‘Submis s
s in hard co p
rough the F S
mission direc t
submitted it 
t of submissi
me) 13 Se p
n extension h
ordinary circ u
NZ website a
be sent to 
ons may be 
Australia Ne w
143 
30 ater 
titute to ado p
national sta n
latory meas u
FSANZ Act), 
measure. A 
C).  
on for submi t
roposals, wil l
e. Submissio
ere large nu
the website.
ot be disclos
vailable on t h
sion’ and qu o
py to our offi c
SANZ websi t
tly to 
by email or v
ons within 3 
ptember 2
had been giv e
umstances d u
and will appl y
sent to one o
w Zealand pt limits 
ndards 
ure. 
FSANZ 
tters. 
l be 
ns will mbers of 
 
ed. 
he 
ote the 
ces, it is 
te via the 
via the 
2012 
en 
uring the 
y to all 
of the  
1 
 Table of Contents 
 
1. EXECUTIVE SUMMARY  ...................................................................................................................  2 
2. INTRODUCTION  ...............................................................................................................................  4 
2.1 THE APPLICANT  ............................................................................................................................... .. 4 
2.2 THE APPLICATION  ..............................................................................................................................  4 
2.2.1 Previous consideration of the Application  ................................................................................  4 
2.3 THE CURRENT STANDARD  .................................................................................................................  4 
2.3.1 The relationship between packaged water and other forms of water for human 
consumption  ............................................................................................................................... .............. 5 
2.4 REASONS FOR ACCEPTING APPLICATION  ...........................................................................................  5 
2.5 PROCEDURE FOR ASSESSMENT  .........................................................................................................  5 
2.6  APPROACH TO THE ASSESSMENT  ......................................................................................................  5 
3. SUMMARY OF THE ASSESSMENT  ...............................................................................................  6 
3.1 EVIDENCE BASE  ............................................................................................................................... .. 6 
3.2 RISK MANAGEMENT  ............................................................................................................................  6 
3.3 REGULATORY OPTIONS AND IMPACTS  ................................................................................................  7 
3.3.1  Impact analysis  .......................................................................................................................  8 
3.3.2  Other measures  ....................................................................................................................  11 
3.3.3  New Zealand standards  .......................................................................................................  11 
3.3.4  Other relevant matters  .........................................................................................................  11 
3.3.5 Proposed approach  ..................................................................................................................  11 
3.3.6 Addressing FSANZ’s objectives for standards setting  ..........................................................  12 
3.4 RISK COMMUNICATION  .....................................................................................................................  13 
3.4.1 Consultation  ...............................................................................................................................  13 
3.4.2 World Trade Organization (WTO)  ..............................................................................................  13 
4. DRAFT VARIATION  ........................................................................................................................  14 
4.1 TRANSITIONAL ARRANGEMENTS  ......................................................................................................  14 
5.  ATTACHMENTS ..............................................................................................................................  15 
ATTACHMENT A – DRAFT VARIATIONS TO THE AUSTRALIA NEW ZEALAND FOOD STANDARDS CODE.......... 16 
ATTACHMENT B – DRAFT EXPLANATORY STATEMENT  .................................................................................  18 
ATTACHMENT C – CONSOLIDATED LIST OF QUESTIONS FOR SUBMITTERS  ...................................................  20 
 
 Supporting documents  
SD1 Consideration of various regulatory and non-regulatory measures for the control of 
chemicals in packaged water. 
SD2  Comparative table of chemical guidelines/standards for drinking water. 
SD3  Fluoride in packaged water. 
 
Material relating to Application A588 – Voluntary Addition of Fluoride to Packaged Water , 
has also been used in the preparation of the current report with respects to the limit for 
fluoride in packaged water. This material is available from the FSANZ website at:  
 
http://www.foodstandards.gov.au/foodstandards/applications/applicationa588volun3872.cfm  
   
2 
 1. Executive summary 
Food Standards Australia New Zealand (FSANZ) received an Application from the 
Australasian Bottled Water Institute (ABWI), a Division of the Australian Beverages Council 
(ABC) on 25 January 2010. The Applicant has requested a variation to Standard 2.6.2 – 
Non-alcoholic Beverages and Brewed Soft Drinks, in the Australia New Zealand Food 
Standards Code  (the Code), to adopt limits for certain chemical substances in packaged 
water to reflect limits in the internatio nal standard established by the World Health 
Organization (WHO). The limits are set out in WHO Guidelines for Drinking-water Quality, 
Fourth Edition (2011), Table A3.3, Guideline values for chemicals that are of health 
significance in drinking-water .1 The Table to subclause 2(2) of Standard 2.6.2 has not been 
comprehensively amended since the Code was published on 20 December 2000. Thus, the 
currency of the Table to subclause 2(2) in terms of safety for water for human consumption 
is questionable and updating it to take account of current scientific evidence relating to the 
safety of chemicals found in bottled wate r requires an application to amend the Code. 
 The primary objectives of FSANZ in developing or varying a food regulatory measure, as 
stated in section 18 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act), 
are the protection of public health and safety ; the provision of adequate information relating 
to food to enable consumers to make informed choices; and the prevention of misleading or 
deceptive conduct . While there was no information to demonstrate regulatory failure for packaged water in terms of these primary objectives, regulatory intervention was supported on the grounds that: (1) The current selection of chemicals and their respective limits listed 
in the Table to subclause 2(2) of Standard 2.6.2, are not in keeping with contemporary 
national and international standards/guidelines for drinking water safety and are not based 
on the best currently available evidence; (2) The need to ensure a level playing field for 
locally produced (Australia and New Zealand) and imported packaged water. The latter would also purportedly assist industry to access export markets.  
As the safety assessment for the WHO guidelines has been undertaken by experts, FSANZ 
has not conducted its own assessment of each listed chemical substance. In this 
assessment, FSANZ has considered the me rits of adopting the WHO guidelines or, 
alternatively, another set of relevant drinking water guidelines or standards, to replace the 
current Table to subclause 2(2) of Standard 2.6.2 in the Code. A key consideration from a risk assessment perspective was whether the WHO guidelines represented maximum limits 
from a safety rather than a quality perspective. FSANZ was satisfied that the guidelines were 
established on safety grounds and are an appropriate set of chemical limits for adoption into 
the Code.   FSANZ also took into account the relevance of other guidelines or standards associated with 
water for human consumption and concluded that the WHO guidelines represented the most 
contemporary international set of limits that could be used for such purposes. 
 
  
                                                 
1 In this document, Annex 3 Chemical summary tables, Table A3.3 Guideline values for chemicals 
that are of health significance in drinking-water in the Guidelines for drinking-water quality, 4th edition, 
World Health Organization, Geneva 20 11, will be referred to as ‘WHO GDWQ’.  
3 
 Two exceptions to adopting the chemical limits  of the WHO guidelines as a whole into the 
Code have been recommended. Firstly, a maximum limit for fluoride of 1.0 mg/L is proposed 
not 1.5 mg/L as indicated in the WHO guidelines. This value is based on FSANZ’s dietary 
intake assessment of fluoride in packaged water (Application A588), which recommended a maximum level of 1.0 mg/L, and is specified in Clause 2A of Standard 2.6.2 of the Code. 
Secondly, a maximum limit for styrene of 0.03 mg/L is proposed and not 0.02 mg/L as 
indicated in the WHO guidelines. This value would be consistent with its maximum permitted 
level when used as a processing aid in packaged water (Table to clause 11, Standard 1.3.3). 
 Overall, a comprehensive impact analysis was undertaken of this Application, including a cost estimate of the associated testing regimen under the WHO guidelines. The impact 
analysis included consideration of consumer, industry and government perspectives. While 
recognising the attributes of the current, voluntary industry Code of Practice with regards to 
chemical limits and safety, which are being fo llowed by up to 80% of Australian producers, 
FSANZ has considered a regulatory approach to be the most appropriate means to ensure 
the continued protection of all consumers in Australia and New Zealand of domestically 
produced and imported bottled waters.   
 
Therefore, FSANZ has prepared a draft variation to the Code to remove the existing Table to subclause 2(2) in Standard 2.6.2 and to include a reference to the WHO guidelines, with exceptions for fluoride and styrene.    
 
 
  
4 
 2. Introduction 
2.1 The Applicant 
The Applicant is the Australasian Bottled Water Institute (ABWI), a Division of the Australian 
Beverages Council. The ABWI is an industry organisation with membership in Australia, New 
Zealand and Fiji. 
2.2 The Application 
Application A1043 – World Health Organization limits for packaged water, has sought approval for a variation to Standard 2.6.2 – Non- Alcoholic Beverages and Brewed Soft Drink.   
 The specific request for variation included the removal of: 
(1) subclause 2(2) in Standard 2.6.2, and 
(2) Table to subclause 2(2) in Standard 2.6.2. 
 
and for it to be replaced with the following sentence: 
 
Water presented in packaged form must not contain substances in greater corresponding proportion than those limits specified in Anne x 4 of Chemical Summary Tables of WHO 
Guidelines for Drinking Water Quality (2
nd Addendum to 3rd Edition, Volume 1) 2008. 
Table A4.3 Guideline values for chemicals that are of health significance in drinking 
water. 
 
In response to a request for further information from FSANZ under Section 108(1) of the 
FSANZ Act, dated 9 October 2011, the Applicant i ndicated that it wished the assessment of 
A1043 to proceed on the basis of the 4th edition of the WHO Guidelines Drinking-water 
Guidelines (2011). In the 2011 edition of the WHO guidelines, the relevant chemical 
summary table is Table A3.3 Guideline values for chemicals that are of health significance in 
drinking-water (Annex 3 (Chemical Summary Tables)). 
 
Under section 108(1) of the FSANZ Act, FSANZ requested further information from the 
Applicant on two occasions. Responses from the Applicant were received on 19 October 
2011 and 6 February 2012. The information provided in these responses has been 
incorporated into the assessment where appropriate. 
2.2.1 Previous consideration of the Application 
This Application was considered under Code Maintenance Proposal IX (P1013) during 2010-
2011. However, comments from three jurisdiction s (New Zealand Ministry of Agriculture and 
Forestry; South Australia Health; and the Victor ian Department of Health) indicated that this 
Application should not proceed under that Proposal. As a result, FSANZ withdrew 
consideration of this Application under the Code Maintenance Proposal, and re-initiated its 
consideration (27 June 2011) to allow for further analysis and consultation.  
2.3 The current Standard 
The current Clause 2 to Standard 2.6.2 stipulates the composition of packaged water. 
Subclause 2(1) notes that water presented in packaged form may or may not contain added 
carbon dioxide. Subclause 2(2) and the Table to subclause 2(2) lists 17 chemical substances (including ‘organic matter’) and their respective limits that are permitted in 
packaged water. 
  
5 
 Clauses 2A and 2B of Standard 2.6.2, stipulate chemical limits and labelling requirements for 
the addition of fluoride to packaged water. 
 
The Table to clause 11, Standard 1.3.3, stipulates chemical limits for various processing aids used in packaged water and in water used as an ingredient in other foods. 
 
An application to FSANZ was required because any change to the list of chemicals and their 
respective limits needs to be assessed on its merits for the protection of public health and 
safety, and other matters relevant to s 18 of the FSANZ Act.  
2.3.1 The relationship between packaged water and other forms of water 
for human consumption 
The term ‘packaged water’ is not explicitly defined in the Code. Standard 2.6.2 does define 
‘mineral water or spring water’ to mean ground water obtained from subterranean water-
bearing strata that, in its natural state, contains soluble matter. A definition for ‘package’ is 
provided in Standard 1.1.1 of the Code. For the purpose of this Application, packaged water 
is considered to include various sources of water that are suitable for human consumption, 
including but not limited to: spring water, mineral water, artesian water, demineralised water, 
sterile water, purified water, distilled water, deionized water and glacial water. Water 
prepared for human consumption and generally s upplied via a reticulated plumbing system 
such as potable or municipal tap water is not subjected to controls under the Code. However, if potable water is packaged (e.g. in bottles or plastic containers), then it is subject 
to the requirements of the Code. Water used as an ingredient in food or beverages or in the 
processing of food is not captured under Standar d 2.6.2 and will not be considered under 
this Application. 
2.4 Reasons for acce pting Application 
The Application was accepted for assessment because: 
 
 it complied with the procedural requirements under subsection 22(2) 
 it related to a matter that warranted the variation of a food regulatory measure. 
2.5 Procedure fo r assessment 
The Application is being assessed under the General Procedure. 
2.6  Approach to the assessment 
FSANZ considered a number of factors during assessment including whether the chemical 
limits in the WHO guidelines were about quality or safety. FSANZ also considered whether:  
 
 the pesticides, industrial chemicals and disinfection products/by-products which are 
listed in the WHO guidelines were relevant to the production of packaged water 
produced in Australia and New Zealand 
 
 other drinking water guidelines or standards , such as from Codex Alimentarius, the 
National Health and Medical Research Council or the New Zealand Ministry of Health were more applicable to packaged water or production in Australia and New Zealand  
 
 there is a justifiable reason to make an exception to the WHO guidelines or other 
guideline/standard.  
6 
  
These considerations are discussed in more detail in SD1 and SD3.  
 
 
3. Summary of the assessment 
3.1 Evidence base  
A comprehensive safety assessment of the chemicals and their respective limits/guideline values, as listed in Table A3.3 of the WHO guidelines was not undertaken by FSANZ. FSANZ considers the WHO guidelines hav e been established by experts using 
contemporary data and methods of analysis.  
 
The approach taken by the WHO experts was verified by FSANZ. Briefly, a tolerable daily 
intake (TDI) was calculated for chemicals which may have an adverse effect via a threshold 
mechanism, based on an appropriate BMDL, NOAEL or LOAEL
2. Standard uncertainty 
factors were used to control for interspecies and intraspecies effects; the adequacy of the 
database and the nature and severity of the toxicological effect. Subsequently, the guideline 
value was determined by considering the total in take of the chemical in question from all 
sources, and allocating a proportion of the TDI or Acceptable Daily Intake (ADI)  to drinking 
water. For chemicals where exposure from food was very low, such as some of the water 
disinfection by-products, the allocation to drinki ng water may be as high as 80%. In the case 
of some pesticides, for which exposure from food was considered high, the allocation to 
drinking water may be as low as 1%. For carcinogens for which there was no threshold, the 
guideline value was calculated based on a reference risk set to a lifetime excess cancer risk of 10
-5. 
 
FSANZ has previously performed a risk analysis for fluoride in packaged water and 
concluded the maximum level for Australian and New Zealand consumers should be set at 
1.0 mg/L and not 1.5 mg/L as indicated in the WHO guidelines.   FSANZ also considered the consistency between the limits permitted for certain chemicals 
as processing aids in Standard 1.3.3 and noted a higher level was permitted for styrene as a 
processing aid than that in the WHO guidelines . Current values in the Code are considered 
to be protective of human health and safety and commensurate with technical need. The 
impacts of lowering the values to ensure consistency with the WHO guidelines were not available to FSANZ.  
3.2 Risk management  
Various regulatory and non-regulatory options we re considered during assessment of this 
Application. The benefits and costs of these measures have been considered in more detail 
in SD1. 
 
The key non-regulatory option available for t he control of chemical contaminants in 
packaged water is the current industry Code of Practice.  The ABWI currently maintains a voluntary Code of Practice (Model Code) for the maximum limits of 49 chemical substances 
in packaged water. This ‘Model Code’ currently utilises the 3
rd edition (2008) of the WHO 
guidelines as the basis for its chemical limits . These limits include those stipulated in the 
Table to subclause 2(2) of Standard 2.6.2, but with lower maximum limits for cadmium, 
fluoride, lead, manganese and nitrate. FSAN Z considered whether a regulatory approach 
                                                 
2 BMDL: Benchmark Dose Level; NOAEL: No Observed Adverse Effect Level; LOAEL: Lowest 
Observed Adverse Effect Level.  
7 
 was warranted but considered that reliance on a voluntary approach would not be sufficiently 
protective of human health and safety and did not promote fair trading in packaged water. 
 
Regulatory options relevant to this application included: (i) varying the chemicals and limits to those chemicals in the Table to subclause 2(2), based on an appropriate set of limits 
established through a rigorous risk assessment e.g. WHO guidelines and (ii) labelling of 
specific chemical constituents that pose a health  and safety concern, e.g. fluoride. The use 
of labelling statements is considered further in SD3. They were not considered appropriate 
given that the risk assessment and risk management associated with the previous consideration of fluoride in packaged water (Application A588) supported the setting of a 
maximum limit for fluoride. FSANZ therefore proposes to set a maximum limit for fluoride of 
1.0 mg/L on the basis of protection of health and safety. This exception to the WHO 
guidelines would be consistent with the notes accompanying the limits in the WHO 
guidelines whereby local water consumption information should be considered when setting 
national standards. 
 
A number of chemical substances listed in the WHO guidelines are currently listed in 
Standard 1.3.3 (Table to clause 11) for the purposes of permitting processing aids to be 
used in packaged water and water used as an ingredient in other foods. Of these chemical substances, the maximum permitted level in the Table to clause 11 for styrene (0.03 mg/kg) will be marginally greater than the maximum level for styrene in the WHO guidelines, i.e. 
0.02 mg/L (assuming 1 kg of water is equivalent to 1 L of water). Furthermore, some of the 
chemical substances when used as processing aids do not have a numerical limit and can 
be used at a level commensurate with good manufacturing practice. FSANZ considers compliance with the levels and use indicated in the Table to clause 11 of Standard 1.3.3 to 
be an acceptable risk management measure and not  in conflict with the levels in the 
proposed changes to Standard 2.6.2. Therefore it is proposed that the maximum level for 
styrene would be raised from the WHO guidelines value of 0.02 mg/L to 0.03 mg/L, to be 
consistent with the maximum permitted level of styrene as a processing aid in packaged 
water that has already been stipulated in the Table to clause 11, Standard 1.3.3 of the Code.  Further discussion of this matter is provided in SD1.  
 
3.3 Regulatory opt ions and impacts 
When assessing this Application and the subsequent development of a food regulatory 
measure, FSANZ has had regard to the followin g matters in section 29 of the FSANZ Act: 
 
 whether costs that would arise from a f ood regulatory measure developed or varied as 
a result of the application outweigh the direct and indirect benefits to the community, 
Government or industry that would arise from the development or variation of the food 
regulatory measure  
 there are no other measures that would be more cost-effective than a variation to 
Standard that could achieve the same end 
 any relevant New Zealand standards 
 any other relevant matters. 
 
   
8 
 3.3.1  Impact analysis 
The Office of Best Practice Regulation (O BPR) was consulted to determine if a Regulation 
Impact Statement (RIS) was required for this Application. Based on the information provided, the OBPR considered the proposal was likely to have a minor regulatory impact. Therefore a 
RIS was not required (OBPR Reference: 12956). 
 
Three regulatory options have been considered in detail as part of the assessment of this 
Application: 
 
1.  Reject the Application and maintain the status quo.  
 
2.  Prepare a draft variation to Standard 2.6.2 to adopt limits for specific chemical 
substances in packaged water to reflect the current limits in place established by the 
World Health Organization (WHO) for drinking water, to limit the use of fluoride to 1.0 
mg/L and to permit the use of styrene at a higher maximum level of 0.03 mg/L.  3.  Prepare a draft variation to Standard 2.6.2 to adopt limits for specific chemical 
substances in packaged water to reflect the current limits in place established by 
another authority, to limit the use of fluoride to 1.0 mg/L and to permit the use of 
styrene at a higher maximum level of 0.03 mg/L. 
 
3.3.1.1  Option 1  
There was no information to demonstrate regulatory failure for the current control of 
chemical limits in packaged water in terms of  the three primary objectives of the FSANZ Act 
(see section 2 of SD1). However, the selecti on of chemicals and their respective limits 
currently listed in the Table to subclause 2(2) is not in keeping with current national and international standards/guidelines for drinking water safety. If this option was adopted, no 
amendment to the Code would be required. The benefits and costs of option 1 have been 
summarised below. 
 
 
Affected 
party Benefits 
Consumers No new benefits were identified. 
Industry No new benefits were identified.  
Government No new benefits were identified. 
 
 
Affected 
party Costs 
Consumers No costs were identified. 
Industry No financial costs were identified. Industry, however, fails to gain a more 
comprehensive and internationally recognised set of safety standards for chemical 
limits in packaged water, and the ability to use claims relating to adherence to 
international standards for access to international markets. 
Government There would be no new financial costs associated with the assessment of 
compliance against the Code. From a public health perspective, chemical limits for 
packaged water would remain less conservative than for potable water 
 
   
9 
 3.3.1.2  Option 2 
The adoption of this option would fulfil the pr imary objective of protecting public health and 
safety along with a number of secondary obj ectives of the FSANZ Act. The WHO guidelines 
reflect a credible risk analysis by experts that has been based on contemporary scientific data to ensure the safety of drinking water. The WHO guidelines are the basis for chemical 
limits in the Codex Standard for Bottled/Packaged Water , the Australian Drinking Water 
Guidelines and the Drinking Water Standards for New Zealand. It is also the basis for the 
current ABWI Model Code.  
 This option also includes two exceptions to t he WHO guidelines. Firstly, the total fluoride 
content of packaged water would be limited to 1.0 mg/L, based on FSANZ’s risk 
assessment. FSANZ has previous ly considered limits for fluoride in packaged water when it 
assessed Application A588 (Voluntary Addition of Fluoride to Packaged Water) in 2009 – 
see SD3 and link to additional supporting material for further information. Modelling of water 
consumption in both Australia and New Zealand indicated that fluoride may be added to 
packaged water, provided that the total amount of the naturally occurring and any added fluoride be no less than 0.6 mg/L (0.6 ppm) and no more than 1 mg/L (1 ppm). Secondly, the 
maximum level for styrene in packaged water would be raised from the value given by the 
WHO guidelines of 0.02 mg/L to 0.03 mg/L. This would ensure a consistent maximum level 
for styrene in packaged water under Standard 2.6.2 and that already in place for its use as a 
processing aid in packaged water under Standard 1.3.3. 
 
The adoption of the WHO guidelines has industry  support, with claims that it would also 
support access to export markets. Cost estimates have been provided against a proposed 
testing regimen. The adoption of this opt ion would provide regulatory certainty and 
consistency for Australian and New Zealand producers/bottlers and importers of packaged 
water. The benefits and costs of option 2 have been identified as follows. 
 
Affected 
party Benefits 
Consumers Consumers would benefit from a standard that would now capture a range of 
organic contaminants. Packaged water would meet an international recognised set of guideline values; and would meet similar standards as potable water. All 
packaged water would also have the same maximum permissible level for total 
fluoride, irrespective of whether it was naturally occurring or added to the water. Overall, this option offers an enhanced level of protection for consumers.  
Industry The current, voluntary compliance to the ABWI Model Code would be replaced by a 
regulatory standard which sets the same limits. The majority of packaged water suppliers/bottlers in Australia and New Zealand are already using the proposed 
chemical limits and they would no longer need to comply with two separate sets of 
chemical limits, the Code and the voluntary Model Code. The Applicant claims this option would assist with international market access. There would also be no 
inconsistency in the different fluoride levels currently in Standard 2.6.2. This option 
would ensure a consistent approach to domestic and imported packaged water with respects to fluoride. 
Government Packaged water would be subjected to the same level of chemical scrutiny as 
potable water.  
 
   
10 
 Affected 
party Costs 
Consumers Possible small cost from testing would be passed on to consumers. Possible loss 
from the market of some imported waters with fluoride levels in excess of 1.0 mg/L; 
and other inorganic constituents found naturally in some imported spring/mineral waters. 
Industry Increase in testing costs – small for those already testing, but considerably more for 
those that are not testing as per the ABWI Model Code or per comprehensive 
product specifications for domestic or export markets e.g. local supermarkets. See Table 1 in SD1 for sampling plan and cost estimates. 
There is the potential for negative effects if domestic or imported water contained 
fluoride levels in excess of 1.0 mg/L. This is considered negligible for domestically produced packaged water and a small proportion of mineral waters available in the world. 
Government There may be additional costs associated with testing compliance against the new 
Standard. Regulatory agencies may need to establish a compliance testing plan for 
packaged waters, if warranted on the basis of risk, similar to current potable water guidelines/standards. 
 
3.3.1.3  Option 3 
Alternative sets of chemical limits have been developed for drinking water e.g. the Codex 
Standard for Natural Mineral Waters , the Codex Standard for Bottled/Packaged Water , the 
Australian Drinking Water Guidelines and the Drinking Water Standards New Zealand. The 
WHO guidelines have been used in the development of the Australian (Australian Drinking 
Water Guidelines) and New Zealand (Drinking Water Standards New Zealand) 
guideline/standard for potable drinking water but t here are some differences in the chemicals 
specified and the limits in the two countries. The adoption of regionally specific 
guidelines/standards for packaged water that parallel those used for potable water such as 
the Australian Drinking Water Guidelines and the Drinking Water Standards New Zealand 
would appear to have merit from the perspecti ve of reducing the current discordance for 
chemical limits in packaged and potable water. If this option was adopted, FSANZ would also recommend adopting a limit of 1.0 mg/L for fluoride and raising the limit for styrene to 
0.03 mg/L in packaged water.  
 
Notwithstanding the merits of adopting one of the abovementioned sets of regional 
guidelines/standards, the adoption of the Australian Drinking Water Guidelines and the 
Drinking Water Standards New Zealand into Standard 2.6.2 would be problematic from a 
regulatory perspective and would be inconsistent with the intent of the FSANZ Act and the 
Trans-Tasman treaty. See SD1 for further discussion.   Similar costs and benefits associated with limiting the total level of fluoride in packaged 
water to 1.0 mg/L that have been outlined in Option 2, would also apply under Option 3. The 
benefits and costs  of option 3 have been identified as follows: 
 
Affected 
party Benefits 
Consumers Consistent safet y standards for drinkin g water irrespective of source. 
Industry Use of locally relevant safety standards for water. This option provides for a level 
playing field as all water suppliers (potable and packaged) would be subjected to 
the same testing regimen.  
Government Testing facilities and test method s have already been established for the potable 
water industry.  
 
   
11 
 Affected 
party Costs 
Consumers Consistent with the costs associated  with Option 2. There could be a loss of 
imported bottled waters from domestic markets due to failure to comply with 
Australian & New Zealand guidelines/standards or compliance costs exceeding economic viability in the Australian/New Zealand domestic market.  
Industry Increased financial costs associated with  compliance testing, due to the number of 
new chemical analytes. Questionable improved domestic and international market 
access. Could make some businesses economically unviable. Potential for loss of imported packaged waters. 
Government Inconsistency with the Trans-Tasman  treaty. Regulatory difficulty with ensuring 
compliance against two guidelines/standards.  
 
3.3.2  Other measures 
There were no other regulatory measures relevant to the consideration of this Application. 
FSANZ considered and rejected the use of labell ing as an alternative to setting a maximum 
limit for fluoride (see SD3). The continued use of the industry Code of Practice (Model Code) 
as a non-regulatory measure was not supported by  FSANZ. For further information, see the 
discussion under Option 1 of the SD1. 
 
3.3.3  New Zealand standards 
There were no relevant New Zealand only standards related to packaged water. The potable 
Drinking Water Standards for New Zealand (Drinking Water Standards New Zealand) were 
considered under Option 3. See SD1 for the consideration of adopting the Drinking Water 
Standards New Zealand into Standard 2.6.2 of the Code.   
3.3.4  Other relevant matters 
There were no other relevant matters that could be identified.  
3.3.5 Proposed approach 
FSANZ has considered the merits of a number of  options in light of subsections 18(1) and 
18(2) of the FSANZ Act, during the assessment of this Application.   FSANZ recommends adoption of Option 2, i.e. 
 
1. Replacing subclause 2(2) and the table to subclause (2) with a reference to the 
‘guideline values for chemicals that are of health significance in drinking-water’ as 
listed in the Chemical Summary Tables, from the WHO guidelines.  
2. That an exception is made for fluoride, to specify a maximum limit of 1.0 mg/L for 
total fluoride, irrespective of whether it is added or naturally occurring fluoride. 
3. That an exception is made for styrene, to specify a maximum limit of 0.03 mg/L for 
styrene, consistent with its maximum permitted use as a processing aid in packaged 
water (Table to clause 11, Standard 2.6.2). 
 
 
  
12 
 3.3.6 Addressing FSANZ’s objectives for standards setting 
FSANZ has also considered the three objective s in subsection 18(1) of the FSANZ Act 
during the assessment. 
3.3.6.1  Protection of public health and safety 
FSANZ has concluded that the adoption of Opti on 2 supports the primary objective of 
protecting public health and safety. The key attributes of this option that support this 
objective include:  
 
 The WHO guidelines have been developed by experts to produce a contemporary and 
extensive list of chemical substances and t heir respective limits for use with drinking 
water. 
 The guidelines are based on a scientifically justifiable risk assessment. 
 The guidelines provide the basis for the Australian Drinking Water Guidelines,  
Drinking Water Standards New Zealand and the CODEX Standard for 
Bottled/Packaged Drinking Waters (other than natural mineral waters ) (CODEX STAN 
227-2001). 
 The limit for fluoride as an exception to t he WHO guidelines is justified from a regional 
(Australian and New Zealand) perspective. 
 Adopting this option would enhance the safety of packaged water compared to the 
current chemical specifications in Standard 2.6.2 of the Code. 
 
Further detail of the consideration of the pr eferred option from the perspective of this 
objective has been discussed in detail in SD1 and SD3.  
 
FSANZ considered introducing new labelling requirements for packaged water containing 
levels of fluoride greater than 1.0 mg/L, as an alternative regulatory measure for fluoride. 
However, this measure was rejected because previous consideration by FSANZ under 
Application A588 ( Voluntary Addition of Fluoride to Packaged Water ) supported establishing 
a maximum limit (ML) for fluoride as the most appropriate regulatory measure. A single ML 
for all packaged water ensures that all consumers are protected against excessive fluoride 
intake. The labelling aspects for high fluori de content in packaged water are discussed in 
more detail in SD3. 
3.3.6.2 The provision of adequate informat ion relating to food to enable consumers 
to make informed choices 
The current requirements for provision of cert ain information to enable consumers to make 
informed choices in regard to packaged wate r are unchanged by this Application. There 
were no other relevant issues identified under this objective with respect to the preferred 
option. 
3.3.6.3 The prevention of misleading or deceptive conduct 
There were no relevant issues identified under this objective with respect to the preferred 
option. 
   
13 
 3.3.6.4 Subsection 18(2) considerations 
FSANZ has also had regard to the matters listed in subsection 18(2): 
 
 the need for standards to be based on risk analysis using the best available scientific 
evidence 
 the promotion of consistency between domestic and international food standards 
 the desirability of an efficient and internationally competitive food industry 
 the promotion of fair trading in food 
 any written policy guidelines formulated by the Ministerial Council3. 
 
These subsection 18(2) considerations have been noted as part of the impact analysis 
(SD1). 
3.4 Risk communication  
3.4.1 Consultation 
All calls for submissions are notified to the community through the FSANZ Notification Circular, a media release and through FSANZ’s social media tools and the Food Standards 
News .  
 
The process by which FSANZ considers standard matters is open, accountable, consultative 
and transparent. Public submissions are called to  obtain the views of interested parties on 
issues raised by the application and the impacts of regulatory options. 
 Individuals and organisations that make submissions on this Proposal will be notified at each 
stage of the assessment.   
 
If a draft variation to the Code is approved by the FSANZ Board, that decision will be notified 
to the COAG Legislative and Governance Forum on Food Regulation. If the decision is not subject to a request from the Forum for a review, stakeholders, including the public, will be notified of the gazettal of the variation to the Code in the national press and on the FSANZ 
website.  
 
3.4.2 World Trade Organization (WTO) 
As members of the World Trade Organization (WTO), Australia and New Zealand are 
obliged to notify WTO member nations wher e proposed mandatory regulatory measures are 
inconsistent with any existing or imminent international standards and the proposed measure 
may have a significant effect on trade. 
 
Amending the Code to adopt the chemical limits  in Table A3.3 of the WHO guidelines and 
setting a total maximum level of fluoride (added and naturally occurring) at 1.0 mg/L and 
styrene at 0.03 mg/L, may have a significant effect on international trade as some 
mineral/spring waters may contain various natur ally occurring chemicals at levels greater 
than that stipulated in the guidelines. Therefor e, a notification to the WTO under Australia’s 
and New Zealand’s obligations under the WTO Sanitary and Phytosanitary Measures 
Agreement has been made to enable other WTO member countries to comment on the proposed amendments.  
                                                 
3 Now known as the COAG Legislative and Governance Forum on Food Regulation  
14 
 4. Draft variation 
The draft Standard to Standard 2.6.2 is given at Attachment A.  
 
The draft Explanatory Statement is given at Attachment B.  
4.1 Transitional arrangements 
The Applicant has indicated that a 36 month transition period from gazettal would be 
preferred. FSANZ supports this transition period so  as to allow sufficient time for the industry 
to clear their existing stock and to establish their testing regimen.  
   
15 
 5.  Attachments 
A. Draft variation/s to the Australia New Zealand Food Standards Code   
B. Draft Explanatory Statement 
C Consolidated list of questions for submitters 
 
  Attac
Stan d
 
Food S t
Variati o
 
The Bo a
under s e
on the d 
Dated 
X
 
 
   
Standar
d
Delegat e
 
 
hment A
dards C o
tandards ( A
on 
ard of Food S
ection 92 of t
ate specifie d
XXXX 
ds Manage m
e of the Boa r
A – Draft 
ode 
Application A
Standards A u
the Food St a
d in clause 3 
ment Officer 
rd of Food S
variatio n
A1043 – Wo r
ustralia New 
andards Aus t
of this varia
tandards Au
 
 
16 
 ns to th e
 
 
rld Health O
Zealand gi v
tralia New Z e
tion. 
stralia New Z
e Austral i
Organizatio n
ves notice of 
ealand Act 1
Zealand ia New Z
n Limits for P
the making o
991.  The S tZealand F
Packaged W
of this variat i
tandard comFood 
Water) 
ion 
mences  
17 
 1 Name 
 
This instrument is the Food Standards (Application A1043 – World Health Organization Limits for 
Packaged Water) Variation. 
 2 Variation to Standards in the Australia New Zealand Food Standards Code  
 
The Schedule varies the Standards in the Australia New Zealand Food Standards Code . 
 3 Commencement 
 
These variations commence 3 years after the date of gazettal . 
 
SCHEDULE 
 
[1] Standard 2.6.2 is varied by omitting subclause 2(2) including the Table to the subclause, 
and substituting –  
 
“(2) Water presented in packaged form must not contain a chemical listed in Table A3.3 
Guideline values for chemicals that are of health significance in drinking-water of Annex 3 Chemical 
summary tables in the Guidelines for drinking-water quality, 4th edition, 2011, World Health 
Organization, Geneva 2008, unless the level of the chemical is equal to or less than the guideline 
value for the chemical specified in that Table. 
 (3) Subclause (2) does not apply to fluoride and styrene.  
 
(4) Water presented in packaged form must not contain fluoride that is naturally occurring in that water unless the level of that chemic al is equal to or less than 1.0 mg/L. 
 
(5) Water presented in packaged form must not contain styrene unless the level of that chemical is equal to or less than 0.03 mg/L. 
 
Editorial note: 
 
Clause 11 of Standard 1.3.3 sets a similar maximum permitted limit for styrene when it is present in 
packaged water as a result of use of a polymer containing styrene as a processing aid. 
” 
 
[2] Standard 1.4.2 is varied by inserting after clause 1 
 
“1A Application 
 
This Standard does not apply to water presented in packaged form.”  
 
   
18 
 Attachment B – Draft Explanatory Statement 
1. Authority 
 
Section 13 of the Food Standards Australia New Zealand Act 1991  (the FSANZ Act) 
provides that the functions of Food Standards Australia New Zealand (the Authority) include 
the development of standards and variations of standards for inclusion in the Australia New 
Zealand Food Standards Code  (the Code). 
 
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for 
the development or variation of food regulator y measures, including standards. This Division 
also stipulates the procedure for considering an application for the development or variation 
of food regulatory measures.   
FSANZ accepted Application A1043 which seeks to institute to adopt limits for certain 
chemical substances in packaged water to reflect the current limits in place in international 
Standards established by the World Health Organization
. The Authority considered the 
Application in accordance with Division 1 of Part 3 and has approved a draft Standard.    
2. Purpose and operation 
 
Currently, the Code specifies chemical limits for packaged water (Table to subclause 2(2) of 
Standard 2.6.2). The purpose of this variation to the Standard is to provide a more 
contemporary and comprehensive list of chemicals and their respective limits, for producers, 
bottlers, importers and marketers of packaged water. This variation will enhance the safety 
of packaged water for consumers. The variation will result in the adoption by reference to the 
chemical limits listed in Table A3.3 Guideline values for chemicals that are of health 
significance in drinking-water (Annex 3 (Chemical Summary Tables)) of the WHO guidelines.  
 
This variation will come into force 36 months a fter gazettal to permit industry to clear current 
stock and to implement a testing regimen for the chemicals so listed in the WHO guidelines. 
 3. Documents incorporated by reference 
 
The variations to the current food regulatory m easure will be undertaken by reference to the 
appropriate section of the WHO guidelines. 
 
4. Consultation  In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s 
consideration of Application A1043 will include one round of public consultation following an 
assessment and the preparation of a draft Standard and associated report. A Call for 
Submissions (which includes the draft variation)  will be released for a six-week consultation 
period.   A Regulation Impact Statement (RIS) was not required because the proposed variations to 
Standard 2.6.2 are likely to have a minor impact on business and individuals (OBPR 
Reference 12956). 
 
5. Statement of compatib ility with human rights 
 
This instrument is exempt from the requirem ents for a statement of compatibility with human 
rights as it is a non-disallowable instru ment under section 97 of the FSANZ Act.  
19 
  
6. Variations  
 
6.1 Item [1]  
 
Item 1 of the variation amends Standard 2.6.2 by amending subclause 2(2) and inserting 
new subclauses 2(3) to 2(5). 
 
Subclause 2(2) of that Standard is amended to prescribe maximum limits for certain chemical substances in packaged water by reference to the relevant chemical limits listed in Table A3.3 - Guideline values for chemicals that  are of health significance in drinking-water 
of Annex 3 Chemical summary tables in the 4
th edition of the World Health Organization’s  
Guidelines for drinking-water quality, published in 2011. 
 
New subclause 2(3) provides that subclause 2(2) does not prescribe maximum limits for 
fluoride and styrene in packaged water. As such, the limits listed in the World Health 
Organization’s  Guidelines for those two chemicals are not applied to packaged water by 
subclause 2(2).  
 New subclause 2(4) prescribes a maximum limit for packaged water of 1.0 mg/L for fluoride that naturally occurs in water. 
 
New subclause 2(5) prescribes a maximum limit of 0.03 mg/L for styrene in water presented 
in a packaged form. (Clause 11 of Standard 1.3.3 sets a similar limit for styrene present in packaged water as a result of the use of a polymer containing styrene as a processing aid.) 
 
6.2  Item [2] 
 
Item 2 of the variation amends Standard 1.4.2 to make it clear that that Standard does not 
apply to packaged water.   
  
20 
  
Attachment C – Consolidated list of questions for submitters 
Submitters may wish to consider some or all of the following questions in response to this 
call for submissions document. 
 
1.  Is access to international markets important to your business’ success or survival? If so, what are the compositional requirements or chemical specifications 
for entering and maintaining access to those markets? 
 
2.  For consumers of packaged water, what are the expectations or perceptions of 
packaged water safety or quality?   3.  How will packaged water businesses benefit domestically and/or internationally 
from the adoption of the WHO guidelines?  
 
4.  How will bottled/packaged water imported into either Australia or New Zealand 
be affected by the adoption of the WHO guidelines?  5.  What is your current testing regimen for packaged water? 
 
6.  The Australian Drinking Water Guidelines and the Drinking Water Standards for 
New Zealand incorporate a comprehens ive risk management strategy to ensure 
water safety. Would industry and government utilise a similar strategy for packaged 
water? 
 
7.   Will imported packaged/bottled water be adversely affected by a limit of 1.0 mg/L for fluoride?