Bills Digest no. 145 2006–07
Food Standards Australia
New Zealand Amendment Bill
2007
WARNING:
This Digest was prepared for debate. It reflects the legislation as
introduced and does not canvass subsequent amendments. This Digest
does not have any official legal status. Other sources should be
consulted to determine the subsequent official status of the
Bill.
CONTENTS
Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details
Passage History
Food Standards
Australia New Zealand
Amendment Bill 2007
Date introduced:
28 March 2007
House: Senate
Portfolio: Health and Ageing
Commencement:
A range of
dates.
This Bill
changes the arrangements for the development of food standards
developed by Food Standards Australia New Zealand. It also puts in
place a regime for the variation of the Nutrition, Health and
Related Claims Standard. The Bill also makes some other small
amendments to the operation of the Food Standards
Australia New Zealand Act 1991.
Food Standards
Australia New Zealand (FSANZ) is an independent statutory body
established by the Food Standards Australia
New Zealand Act 1991. FSANZ is responsible for
developing food standards and codes of practise covering the
content and labelling of food, which are applied in Australia and
New Zealand. FSANZ also develops food safety standards that are
applied in Australia.
Since its creation in 1991, the nature of
FSANZ and its standard setting processes have changed considerably.
Further background regarding FSANZ and its standard setting
arrangements can be found in Bills Digest No 120. 2000-2001
Australia New Zealand Food Authority
Amendment Bill 2007.(1)
The proposals contained within this Bill have
been subject to public comment. The explanatory memorandum to the
Bill provides information relating to the consultation processes
that the proposed amendments have gone through.(2)
The development of food regulatory measures
was altered considerably in 2001 following the commencement of the
Australia New Zealand Food FSANZ Amendment
Act 2001. This Bill looks to further change that regulatory
development process. The application/proposal method of developing
or changing food regulatory measures will remain. The changes are
however a move away from the one size fits all assessment process
and are designed to increase the efficiency of the current standard
setting arrangements. In effect, the Bill suggests three different
options for developing and changing food regulatory measures:
-
a truncated process for minor variations of a
food regulatory measure
-
a more extended process for a new food
regulatory measure or a major variation to a food regulatory
measure, and
-
a general procedure for all other
changes.
Where a body or a person other than FSANZ
wishes to have a food regulatory measure changed, they must submit
an application to FSANZ for the change.(3)
Proposed new sections 26-35
sets out the general procedures to be followed in processing an
application. FSANZ must determine whether to accept or reject the
application, notify the applicant if the application is accepted
(proposed section 27) and also release a public
notice of the application (proposed section 28).
FSANZ must then assess the application (proposed section
29), which includes performing a cost/benefit analysis
(proposed paragraph 29(2)(a)) and either reject it
or decide to proceed and prepare a draft of the proposed amendment
(proposed section 30). If FSANZ prepares a
proposed amendment, it must seek public comment on the draft
(proposed section 31). After receiving and
considering the public submissions, FSANZ must then decide whether
to approve, amend or reject the draft and prepare a report which
reflects this decision (proposed section 33). If
FSANZ does not reject the draft, it must give the Ministerial
Council notification of the approval. Note that changes to codes of
practise do not need Ministerial Council approval (proposed
section 35).
As noted above, the Bill proposes that
applications to FSANZ for minor variations of a food regulatory
measure should be subject to a shortened assessment process. The
Bill proposes that a cost/benefit analysis will not need to be
performed for minor variations and FSANZ will not be required to
seek public comment on the proposed changes (proposed
section 40). FSANZ is however required to provide the
applicant and appropriate government agencies with a draft of the
standard, and give them an opportunity to provide written
submissions. FSANZ is not expressly required to consider
submissions received when making a decision whether to approve,
vary or reject the draft variation. After the submission period,
FSANZ must decide whether to approve, amend or reject the draft
standard and prepare a report which reflects its decision
(proposed section 41). If FSANZ does not reject
the draft standard, it must give the Ministerial Council
notification of the approval (proposed section
41).
An application for the development of a new
food regulatory measure or major variations to a food regulatory
measure will require a more extended assessment process. In
relation to a major variation the Bill states that it is one
which
-
Involves such scientific or technical complexity
that it is necessary to adopt this procedure in considering it;
or
-
Involves such a significant change to the scope
of the food regulatory measure that it is necessary to adopt this
procedure in considering it (proposed section
42)
In essence, the extended processes involve an
additional round of consultation (proposed section
44) which takes place before the draft variation or new
standard is prepared.
Where FSANZ wishes to develop or change a food
regulatory measure, they must generate a proposal. The Bill
proposes to change the processes to be followed where FSANZ
generates a proposal.
As with the application process, the proposal
processes have been divided into three separate forms depending on
whether there is a:
-
minor variation of the food regulatory
measure
-
a proposal for the development of a new food
regulatory measure or a major variation of a food regulatory
measure, or
-
a proposal which doesn t fall into one of the
above categories.
If FSANZ generates a proposal, it must issue a
public notice which gives notification of this (proposed
section 58). FSANZ is required to assess the proposal (and
this includes developing a cost/benefit analysis) and after
assessing the proposal it must prepare a draft regulatory measure
or abandon the proposal (proposed section 60).
FSANZ must then call for public submissions on the proposal
(proposed section 61). After receiving and
considering the public submissions, FSANZ must then decide whether
to approve, amend or reject the draft and prepare a report which
reflects this decision (proposed section 63). If
FSANZ does not reject the draft, it must give the Ministerial
Council notification of the approval (proposed section
64).
Where FSANZ generates a proposal for minor
variations of a food regulatory measure, the proposal is subject to
a shortened assessment process. FSANZ is not required to submit the
proposal to a round of public comment, although it is required to
seek comments from appropriate government agencies
(proposed section 68). Unlike the general
procedure, there is no express requirement in the legislation for
FSANZ to consider the submissions when making a decision regarding
the draft standard. After the submission period, FSANZ must decide
whether to approve, amend or reject the draft and prepare a report
which reflects its decision (proposed subsection
69(1)). If FSANZ does not reject the draft, it must give
the Ministerial Council notification of the approval
(proposed subsection 69(4)).
A proposal for the development of a new food
regulatory measure or major variations to a food regulatory measure
will require a more extended assessment process. Proposed
section 70 sets out the criteria for what is regarded as a
major food regulatory measure, namely one which;
-
involves such scientific or technical complexity
that it is necessary to adopt this procedure in considering it;
or
-
involves such a significant change to the scope
of the food regulatory measure that it is necessary to adopt this
procedure in considering it.
The extended processes involve an additional
round of consultation (proposed section 72) which
takes place before the draft variation or new food regulatory
measure is prepared.
Proposed sections 80-83 set
out the procedures to be followed for variations to the maximum
residue limits standard.
There appears to be a minor drafting error in
the table set out at proposed section 54. Step 8
states that if the proposal is for a minor variation, FSANZ calls
for submissions from the applicant and appropriate government
agencies . This sentence is inconsistent with the legislation which
states that FSANZ must only give notice to and call for submissions
from appropriate government agencies (proposed paragraph
68(2)(c)). Proposals are variations to the Code generated
within FSANZ and therefore there will be no applicant to seek
submissions from in relation to the proposal.
The Bill amends the procedures to be followed
by the Ministerial Council in relation to approving the standard.
Proposed new section 84 states that the Council
can request FSANZ review the draft. FSANZ must then review the
draft and decide to re-affirm, re-affirm with amendments or
withdraw the draft and notify the Council accordingly. The Council
can request FSANZ to review the draft again (proposed
section 85).
Following the second review, the Council can
accept, amend or reject the draft (proposed section
86). Once the Council has accepted or modified the draft
FSANZ must notify that the food regulatory measures will come into
effect on a date specified in the notice through:
-
the Australia and New Zealand Gazette and
-
generally circulating newspapers in each State
and Territory and in New Zealand
-
and publishing a copy of the notice on FSANZ s
website.
Currently the Food Standards Australia New
Zealand Act 1991 contains provisions that deal with progressing
urgent applications and proposals. Proposed sections
95-106 is to an extent a re-write of the current
provisions however there are some key changes being:
-
In addition to FSANZ being able to amend or
vary a standard if there is a public health and safety concern,
under proposed section 95 FSANZ will also be able
to vary a standard if the standard has had or will have a negative
impact on trade that was not envisaged when the standard was made
(see paragraph 95(2)(b)).
The Bill also changes the processes to be
followed by the Ministerial Council when assessing urgent
application and proposals. These changes are needed to ensure
consistency with the new processes that are to be followed by the
Ministerial Council for all other applications and proposals.
The amendments contained within this schedule
will not take effect unless amendments reflecting these changed
processes are made to the Australia New Zealand Joint Food
Standards Agreement.
In essence, schedule 3 repeals the provisions
(as amended by schedule 1 of the Bill) dealing with the operation
of the Ministerial Council and inserts new provisions setting out
the Ministerial Council s role in the food standard setting
processes.
The key change made to the Ministerial Council
s role by these provisions is that it removes the second round of
review by FSANZ.
Food Standards Australia New Zealand is
currently finalising a new health claims food standard.
The following draws on documents on FSANZ s
web-site and sets out some background on the current status of the
health claims food standard(4):
In December 2003, the Australia and New Zealand
Food Regulation Ministerial Council asked FSANZ to develop a
standard and an appropriate management system for the regulation of
nutrition, health and related claims. This recognised the
increasing complexity of the food supply, especially with the
increasing presence of functional foods, and the benefits of
regulating nutrition and health claims under a unified and
mandatory system.
The Ministerial Council provided FSANZ with
policy guidelines to consider in developing the standard. These
policy guidelines recommend that manufacturers may make claims if
the food is safe, and the claim is socially responsible, does not
promote irresponsible consumption patterns, and is scientifically
substantiated. They suggest that there must be enough of the
specified component in the food to contribute to the claimed
benefit. Certain foods are disqualified from health claims,
including alcohol and infant formula, and claims must not promote
unhealthy food consumption patterns.
We released an initial consultation document in August 2004 seeking
views on how these policy guidelines should be translated into food
regulations, and options for the way forward. Having considered the
comments received, we released a second consultation document in
November 2005 describing our preferred regulatory option and
containing a draft food standard for inclusion in the Code.
From our second round of consultation we received numerous and
detailed comments from 131 submitters.
We have now carefully considered these, and in addition have
carried out some targeted research to assist our decision making.
As a result, we are recommending a number of revisions to our
previous recommendations and are now introducing this additional
round of consultation.
Currently, FSANZ is proposing the following as
the key aspects of the Nutrition, Health and Related Claims Food
Standard: (5)
Claims classification
framework
Nutrition, health and related claims will be
classified into three categories:
-
Nutrition content claims are statements
regarding the amount of a nutrient, energy or a biologically active
substance in the food;
-
General level health claims are claims that
describe a relationship between the consumption of a food or
constituent and particular benefits of the food in relation to
health.
-
High level health claims also describe a
relationship between the consumption of a food or constituent and
particular benefits of the food in relation to health, but these
claims reference to a serious disease or condition, or a biomarker
of a serious disease or condition.
The category of a claim determines how that claim
is regulated, including the evidence required for
substantiation.
Nutrition, Health and Related Claims
Standard
The proposed standard will appear as Standard
1.2.7 Nutrition, Health and Related Claims in the Australia New
Zealand Food Standards Code. Important provisions include:
-
a requirement that all claims be
substantiated
-
criteria for foods allowed to make claims
-
specific qualifying criteria for nutrition
content claims (e.g. food described as low salt must contain no
more than 120mg sodium per 100g for solid food)
-
additional labelling for some nutrition content
claims (e.g. the level of potassium in the food must be declared if
a claim about salt is made)
-
specific conditions for some claims (e.g. a
weight loss or weight maintenance claim must be made in the context
of the importance of regular exercise)
-
substantiated and approved claims about
diet-disease relationships (e.g. low sodium diet assists in
reducing blood pressure)
-
recommendations for cause-related marketing and
dietary information.
Substantiation
All nutrition and health claims on food will have
to be scientifically substantiated. FSANZ has developed a
Substantiation Framework, which should be used by manufacturers
before making a claim on a food product. For nutrition content
claims, we require manufacturers to have proof that the nutrient,
substance or property that is the subject of the claim is present
at levels referred to in the claim.
For general level health claims, manufacturers can
make claims based on a list of nutrient function statements
considered by FSANZ to have been substantiated, or based on
authoritative, generally accepted information sources.
Substantiation of high level health claims will
involve a case-by-case assessment by FSANZ. Once a high level
health claim is approved and listed in the standard, all
manufacturers will be able to use it. We will approve a limited
number of high level health claims to go into the standard before
the standard becomes law.
Schedule 2 of the Bill amends
the Food Standards Australian New Zealand Act 1991 to put
in place the necessary legislation framework for variations to the
Nutrition, Health and Related Claims Standard which relate to high
level health claims. In particular, the Bill requires that FSANZ
consult with both the High Level Health Claims Committee and the
Food Regulation Standing Committee where there is an application or
a proposal to make a high level health claim variation
(proposed section 49). The Bill does not contain
any requirement that FSANZ seek public comment where an application
has been lodged to vary that part of the standard dealing with high
level health claims. FSANZ will only be required to seek public
comment in the applicant requests that FSANZ does this (see
proposed section 51).
Variations to the standard that do not relate
to high level health claims are to be made following the processes
set out in schedule 1.
Health claims are a particularly contentious
area of standard development, generating strident comment from both
proponents and opponents of the health claims scheme.
Choice have stated the
following(6):
CHOICE does not support the use of health claims
on food labels. In our opinion health claims will assist
manufacturers to market their products on the basis of nutrient
content or a potential health benefit. In particular health claims
are most likely to be used on processed foods rather that the fresh
foods we should all be eating more of.
Despite our concerns, governments have decided to allow
manufacturers to make health claims. Enforceable regulation will be
required to ensure they do not mislead consumers.
In countries like the United States, where health claims have been
used for a number of years, there is little evidence that health
claims have been successful in encouraging healthy eating habits.
Instead the incidence of obesity has markedly increased.
In its submission to the recent Senate
Community and Public Affairs Committee inquiry into the Bill,
Choice made particular criticism of the health claims aspects of
the Bill and in particular were critical of the fact that FSANZ
will not be required to seek public comment on an application to
vary a high level health claim, unless the applicant elects to have
public comment. In its submission Choice stated that:
One of the major strengths of the current FSANZ
process is its openness and transparency and the consistency of
consultation processes for all applications and proposals. The
proposed changes to the health claims process remove public
consultation altogether. In CHOICE s opinion this threatens the
integrity of the FSANZ process and undermines its primary
objectives.
CHOICE does not support the proposed changes to the FSANZ
assessment and approval processes for health claims. On numerous
occasions throughout the consultation process, we have argued that
this proposal is not in the best interest of consumers and public
health, instead placing industry interests ahead of the three
primary objectives of FSANZ. It appears that the views expressed by
public health and consumer groups have largely been ignored.
Sacrificing openness and transparency and the inhibiting the
capacity of public health and consumer organisations to engage in
consultation undermines these primary objectives of FSANZ.
CHOICE appreciates that data protection may be of concern to the
food industry, because disclosure may prevent any market advantage
that may be gained from product innovation. However, the current
processes are designed to protect public health and safety and
consumer interests, and to do this there must be openness and
transparency. CHOICE is also concerned that if information is kept
confidential then it will not be subject to peer-review an
important part of the process for establishing the strength of any
scientific evidence.
The establishment of an expert panel to advise FSANZ on
applications to amend the health claims standard does not go far
enough to address CHOICE s concerns. In order to provide adequate
protection of consumer and public health interests, applications to
amend the health claims standard must be subject to public
consultation to enable all public health and consumer stakeholders
to comment on the implications of and strength of evidence
supporting the proposed changes. This also places unreasonable onus
on State and Territory health departments and food authorities to
ensure that public health and consumer issues are adequately
addressed. Many departments already struggle to address all the
food regulatory issues that they are asked to comment on.
The Food and Grocery Council argue however
that the public comment provisions do not go far enough and in its
submission to the Community and Public Affairs Committee argued
that(7):
While the new provisions do not compel FSANZ to
undertake public consultations, they do not prohibit FSANZ from
undertaking such consultations if it sees fit. This is not
understood to be the intention of the new procedures, which is that
no public consultation occur in relation to such
applications.
A specific prohibition against public notification and consultation
(except at the request or with the consent of the applicant) needs
to be added.
Further information regarding the Health
Claims scheme may be found on FSANZ s web-site and views of
interest groups may be found in submissions to the Senate Community
and Public Affairs Committee inquiry into health claims.
Item 13 of Schedule 1 amends the definition of
standard in the Act. The amendment states that :
Neither of the following is taken to be part of
a standard
-
boxed text identified as an editorial
note;
-
boxed text identified as an example.
The explanatory memorandum explains
that(8)
This item amends the definition of standard in
subsection 3(1) of the Act to clarify that boxed text identified as
an editorial note or an example is not part of a standard.
This aims to remove previous confusion regarding the legal effect
of editorial notes. Such notes are not legally binding but can
assist in providing an explanation of relevant parts of the
Australia New Zealand Food Standard Code (the Standards
Code).
The Regulation Impact Statement also states
that(9):
Amendment to the definition of a Standard to
expressly provide that editorial notes and examples that are
identified in a Standard do not form a part of a Standard. As these
notes and examples, will not form part of the Standard, the FSANZ
may amend these non-legally binding parts of the Code without the
need to follow statutory processes in the Act.
The Food Standards Code makes heavy use of
examples and editorial notes. Subsection 13(3) of the Commonwealth
Acts Interpretation Act 1901 state that no marginal
note, footnote or endnote to an Act, and no heading to a section of
an Act, shall be taken to be part of the Act. All state and
territory Interpretation Acts also have words that have the same
effect.(10) The proposed amendment set out in
item 13 of schedule 1 is for the main part,
consistent with the provisions in each jurisdiction s Acts
Interpretation Act, however one glaring point of difference is the
reference in the Bill to the notes and examples being contained
within a box .(11)
Some witnesses at the recent Senate Community
and Public Affairs Committee Hearing were concerned that the
proposed amendment focused only on editorial notes and examples
that were inside a text box. The concern being that if an editorial
note appeared in the Food Standards Code and not inside a box, that
it may be regarded as being part of the standard. It was therefore
suggested that the reference to box in the Bill, should be removed.
Reference to a box may also limit FSANZ s drafting style. If in the
future, FSANZ decides that it does not wish to place editorial
notes and examples inside a box, it would find that it could not
change its drafting style and remove the boxes because the Act
makes express reference to the phrase box .
Editorial notes are used extensively in the
Food Standards Code. This has been the subject of some criticism,
especially where it appears that the editorial note may be
modifying the law, as set out in the actual food standard.
Witnesses at the recent Community and Public Affairs Committee
hearing made the following comments in regard to editorial
notes.
Mr Chris Preston, Consultant to the Australian
Food and Grocery Council gave the following oral evidence at the
public hearings that were held by the Community and Public Affairs
Committee:
Editorial notes can be a useful thing, in our
view. Food regulation is inherently technical; it can get very
complicated ..
So I suppose that where we are coming from in that the editorial
note is not a bad concept is this sort of regulation where you are
dealing with technical concepts. It has a legitimate and good and
beneficial use when used appropriately but there has been a
tendency-forgive the pun-to editorialise the editorial note and to
try and go further than giving examples or explaining terms or
cross-referencing terms to actually try and introduce concepts that
are not reflected in the law .
One recent example is the editorial note on the country of origin
standard, which editorialises and maybe goes beyond what the
standard actually says.
Whilst this evidence does not relate directly
to amendments contained within the Bill, it is an important issue
that FSANZ needs to be mindful of when drafting standards.
Concluding comments
The Bill makes a series of amendments to the
Food Standards Australia New Zealand
Act 1991. Key elements of the Bill are as follows:
-
inserts a provision regarding the use of
editorial notes in the Food Standards Code
-
seeks to change the processes that FSANZ must
go through to develop food standards, and
-
puts in arrangements for changes to the food
standard dealing with health claims.
The amendments do make considerable changes to
Food Standards Australia New Zealand s current assessment
processes. It would appear that they are designed to streamline
FSANZ s assessment processes, however some of the changes, such as
those relating to high level health claims, may be criticised for
leaving out the vital public consultation element of the assessment
processes.
-
Bills Digest, Food Standards Australia New Zealand Amendment
Bill 2007, No 145 2006-07, http://www.aph.gov.au/library/pubs/bd/2000-01/01BD120.PDF,
[accessed 8 May 2007].
-
Food Standards Australia New Zealand Amendment Bill 2007
Explanatory Memorandum, p. 4 and 10.
-
Section 12 Food Standards Australia New
Zealand Act 1991.
-
Food Standards Australia New Zealand, Nutrition, Health and
Related Claims : A guide to the development of a food standard
for Australia and New Zealand,
March 2007, p. 5.
-
Food Standards Australia New Zealand, Nutrition, Health and
Related Claims : A guide to the development of a food standard
for Australia and New Zealand,
March 2007, p. 6.
-
Australian Consumers Association, Health claims on food,
http://www.choice.com.au/viewArticle.aspx?id=104915&catId=100384&tid=100008&p=
1&title=Health+claims+on+food, [accessed 7 May 2007].
-
Australian Food and Grocery Council, Submission to the
Community Affairs Committee in response to Food Standards
Australia New Zealand Amendment Bill
2007, 13 April 2007, p. 11.
http://www.aph.gov.au/senate/committee/clac_ctte/food_standards/submissions/sub07.pdf,
[accessed 7 May 2007].
-
Food Standards Australia New Zealand Amendment Bill 2007
Explanatory Memorandum, p. 18.
-
Food Standards Australia New Zealand Amendment Bill 2007
Explanatory Memorandum, p. 14.
-
ACT section 127(1), NSW section 35(2), NT section 55(3), Qld,
section 14(6), SA section 19(3), Tas section 6(4), Vic section
36(6), WA section 32(2).
-
D C Pearce and R S Geddes, Statutory Interpretation in
Australia, 6th edition, LexisNexis Butterworths,
2006, p. 22 and p. 196.
Susan Dudley
9 May 2007
Bills Digest Service
Parliamentary Library
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