FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Table 1: General comments
Issue
Section of document and page number
Number
1.
General comment on structure of document
Comments
To the reader the general structure of the document is confusing.
The purpose of this document states “to support optimum infant nutrition by
providing a review of the evidence, and clear evidence-based recommendations on
infant feeding for health workers”
Then throughout the document there is a mixture of general text and two types of
recommendations - those based on a grade of evidence and those just referenced
to one study or paper. The mixture is confusing as it there is no clear delineation.
2.
3.
4.
Summary and Recommendations p. 2
There is no mention that both ‘infant
formula’ and ‘follow-on formula’ are
prescribed names in the Australia New
Zealand Food Standards Code (the Code).
There is no reference to the mandatory
warning statement for infant formula
products ‘Important Notice [or similar] –
breast milk is best for babies. Before you
decide to use this product, consult your
doctor or health worker for advice’ Clause
14(4) of Standard 2.9.1
Agree that it is important to give as much information as possible of the range of
topics however it would be good to separate what are the evidence-based
guidelines and why they are evidence based. Suggest that there is better
information provided up front to explain the structure of the document and the
difference between the two types of evidence, why there are differences, how each
should be interpreted.
Recommendations table
Suggest separation of evidence-graded statements and other recommendations into
two tables.
Mention this information in Section 8?
Suggest this information be included and noting that this mandatory warning
statement is a requirement under the Code and supports public health initiatives that
promote breast-feeding to all new mothers. It could be included in Section 8.2
‘Health workers and infant formula.’
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
5.
6.
7.
Section of document and page number
Comments
Headings
Suggest reformatting headings as there is little or no differentiation between chapter
and section headings
Suggest this requirement is noted.
There is no mention of the requirements for:
 date marking (clause 17(1) of Standard
2.9.1), or
 storage instructions covering the period
after the infant formula product or
commercially prepared infant food is
opened (clause 17(2) of Standard 2.9.1;
clause 11 of Standard 2.9.2
respectively).
Literature review document : general
comment
Currently the document does not clearly outline the process undertaken to review
the evidence base and where the reviews underpin recommendations.
It is not clear which topics were targeted for systematic review process and which
were not, or the rationale for this decision.
Actual search terms and processes for inclusion/exclusion are not clear at all.
8.
Literature review document Notes on Methodology Used in this Review
This section seems abrupt and doesn’t provide a very clear summary of the
processes and use of the evidence.
2
FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Table 2: Section specific comments
Issue
Section of document and page number
Number
9.
Section 1.1.1.3 Health
p. 34
10.
Physiology of breast milk and breastfeeding
p. 33
11.
Recommendations table
p. 20
Recommendation:
“Soy (except soy formula where specifically
indicated), rice and other cereal beverages
are inappropriate alternatives to breastmilk,
formula or pasteurised whole cow’s milk in
the first two years of life”
12.
Definitions p. 28
13.
Section 2.2. p. 53
14.
Section 2.5 Breast milk composition p. 56
Table II.1 Composition of mature human
milk and cow’s milk and composition of
infant formula
15.
Section 2.5 Breast milk composition p. 56
Table II.1 Composition of mature human
milk and cow’s milk and composition of
infant formula
Comments
Suggest this information would be more clearly explained in a table form. The
current list with a mixture of references, evidence grades etc is very difficult to read
No corresponding grade of evidence is given in relation to “convincing evidence of
the protective effects of breastfeeding as detailed below”
Include note that clause 2(2) of Standard 1.2.3 stipulates a mandatory advisory
statement on these products (containing no more than 2.5% m/m fat) to the effect
that they are not suitable as a complete milk food for children under the age of two
years.
‘Spoon foods’ definition – second sentence says “to include all foods other than
liquids given to infants the term ‘spoon foods’ have been used in this document”
Suggest this should say ‘has been’ or ‘is’ used.
Spelling error for heading of Section 2.2 ‘breastfeeding’
Table II.1 Make the cross reference ‘letters’ in column headings more distinct
e.g. Mature human milk (a) or Mature human milk a
Data for Mature Human milk - is referenced to two text books Brodribb (2006),
Mahan and Escott-Stump (2008). As the data actually comes from the USDA
National Nutrient Database for Standard Reference, Release 24 (2011) it would be
preferable to reference this as the primary source and because it gives a summary
of whether the value is analytically derived or not.
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
16.
17.
Section of document and page number
Comments
Section 2.5 Breast milk composition p. 56
B Reference for Cow’s milk is AUSNUT 2007. NUTTAB 2010 has more recent
Table II.1 Composition of mature human
milk and cow’s milk and composition of
infant formula
analytical data and should be referenced rather than AUSNUT 2007 which is a
survey database and was developed to support the 2007 National Children’s
Nutrition and Physical Activity survey. There are some differences in calcium,
sodium, fat, carbohydrate etc between the 2007 data and more recent analytical
data in NUTTAB 2010.
Section 2.5 Breast milk composition p. 56
C “Ranges for infant formula products (from birth, cow’s milk-based). Adapted
from: Australia New Zealand Food Standards Code 2.9.1 (2011)”
Table II.1 Composition of mature human
milk and cow’s milk and composition of
infant formula
18.
Section 5.3 Storage of breast milk
p. 99
19.
Section 5 Storage of breast milk
p. 94-100
Section 7 ‘Informed use of supplementary
feeds in hospital’
p. 113
Section 8 ‘Infant formula’
20.
21.
22.
Section 8 ‘Infant formula’
p.114
It should be clearly spelt out that these figures are based on the regulatory
minimum and where given, maximum range permitted in the Code - they are not
analytical composition data like the others.
Table V.1 This section is difficult to read. There seems to be some alignment
problems in the first and second column.
Section 5.3.2 makes no reference to cross-contamination issues in storage of
breast milk. i.e. containers should be clean
Make the heading ‘Prelacteal feeds’ after the first paragraph more distinct
Paragraph 3 narrowly refers to composition and labelling requirements in Standard
2.9.1.
Add a sentence to the paragraph to note that there are other general labelling
requirements contained in Chapter 1.2 that would also apply to infant formula
products.
Section 8 refers to label statement ‘suitable from birth’ for infants from birth to 12
months. These words are not prescribed. Clause 14(5)(a) requires the statement
to indicate that the infant formula product may be used from birth.
Include ‘or similar words’?
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
23.
Section of document and page number
Comments
Section 8.1 Protein levels in infant formula
p. 115
Protein levels in infant formula references WHO European Region 2007 for the
following statement
“Formula fed infants grow at different rates to breastfed infants and are heavier at
12 months and have a slightly increased risk of obesity”
This implies that the reference is reporting on infant growth studies. The document
referenced actually states “Large-scale studies have shown elevated levels of
overweight among children at school entry age (5 or 6 years old) who had been
formula-fed as infants compared with the breastfed (56)”
Suggest this is re-worded to describe the evidence.
24.
Section 8.1 Protein levels in infant formula
p. 115
25.
Section 8
p. 114
If the statement refers to the following “Still another study of infant feeding and
later growth followed repeated surveys, from 16 weeks gestation to
8 years in a recent longitudinal birth cohort of 2087 subjects in Australia.” Suggest
referencing the direct source.
Protein levels in infant formula discusses compositional requirements. It omits the
requirement for a statement of the specific source(s) of protein in conjunction with
the name of the infant formula product (clause 18, Std 2.9.1). Although a slightly
different issue, the statement declaration is required for consumer information and
is also a Codex requirement. Additionally, the requirement applies across all infant
formula products, not just those infant formula products based upon protein
substitutes.
Suggest that this requirement be added in the last paragraph of Section 8.1.
Refers to label statement ‘suitable only for babies over six months’ for follow-on
formulas. These words are not prescribed. Clause 14(5)(b) requires the
statement to indicate that the infant formula product should not be used for infants
aged under 6 months in the case of follow-on formula.
Include ‘or similar words’?
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
26.
Section of document and page number
Comments
Safe use of infant formula
Section 8.3.1 p. 116-120
Page 118, section 8.3.2 point 10. “…to cool bottle to safe temperature after
preparation allow to sit for at least 30 minutes” – appears contradictory to the
advice to make up formula from pre-boiled lukewarm water.
Formula prepared with 70oC water will be cooled to ‘safe temperature’ after 30
minutes (last line 2nd last para page 117) – with the added benefit of killing
E. sakazakii.
27.
Section 8.3.2 Point 13
28.
Section 8 ‘Infant formula’
p. 114
29.
Section 8.6 ‘Fluoride in infant feeding’
30.
Section 9.1, p. 127
‘Correct preparation of infant formula’ does not refer to preparation, handling or
storage instructions.
Suggest point 13 becomes a footnote
Paragraph 3 refers incorrectly to Standard 2.9.1 – Infant Formula Products. We
suggest that you add a sentence to the paragraph to note that there are other
general labelling requirements contained in Chapter 1.2 that would also apply to
infant formula products.
Use correct name; as per the reference listed on page 198.
States that if the fluoride levels exceed amounts stipulated by FSANZ, a statement
about this is required on the label. However, it does not describe the information
the statements must include as per clause 19(2) of Standard 2.9.1, i.e. statements
must
 indicate that consumption of the formula has the potential to cause dental
fluorosis
 Recommend that the risk of dental fluorosis should be discussed with a
medical practitioner or other health professional.
Note what the statements must indicate or a reference to the clause.
Last paragraph: Introducing solid foods too late can also cause problems:
Needs a dot point on the association with increased risk of developing allergic
syndromes, as stated earlier in the document (see dot point 3 in Box 1.2 – p. 42).
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
31.
32.
33.
Section of document and page number
Comments
Section 9.2 Food allergy and the
introduction of spoon foods
General comment: This section is cursory and does not reflect the extensive
scientific debate on this issue. To do this complex area justice, expert input should
be sought to provide in-depth analysis of the literature and insightful commentary
on the emerging evidence.
Section 9.2 ‘Food allergy and the
introduction of spoon foods’
p. 18-129
Refers to the exposure of new foods (and common allergens) in the period after
the introduction of spoon foods. No mention is given that commercially prepared
packaged infant formula products and infant foods must comply with mandatory
allergen declaration requirements in clause 4 of Standard 1.2.3.
Section 9.2, p. 129
Mention mandatory allergen declaration requirements for commercially prepared
packaged infant formula products and infant foods in the last paragraph of Section
9.2.
Second paragraph: Although exclusive breastfeeding to around six months of age
is recommended, more experience is needed….
This paragraph is unclear and needs to be expanded. It should openly
acknowledge the limitations of the current state of knowledge in this area, and the
fact that the jury is still out on the optimal timing of introducing complementary food
in developed countries. It should highlight the fact that our understanding of its role
in food allergy risk, within specific subgroups as well as the general population,
continues to evolve.
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
34.
35.
Section of document and page number
Comments
Section 9.2, p. 129
Second paragraph: Fewtrell article have challenged the scientific basis of the
article (Renfrew, McGuire et al. 2011; UNICEF UK 2011; Forsyth, 2011; Williams
and Anne Prentice 2011).
Section 9.4.1 ‘What foods should be
introduced’
p. 130-133
36.
Section 10.1 ‘Honey’
p. 134
37.
Section 11.1.2 ‘The MAIF Agreement’
p. 142
The UNICEF UK 2011 is no longer accessible on the link provided in the reference
list. As it is an anonymous paper with no indication of expertise or professional
affiliation, We suggest deleting it. A more appropriate reference would be this:
Forsyth, J.S. (2011). “Policy and pragmatism in breast feeding.” Arch Dis
Child 96: 909-910 originally published online June 2, 2011 (PDF attached).
The paper is attached with FSANZ’s submission.
Omits reference to commercially prepared infant foods, and therefore any
information about mandatory labelling requirements that Health Workers may find
useful to assist parents.
For example, clause 5(3)(a) of Standard 2.9.2 requires a statement indicating the
consistency of the food. The Draft Guideline refers to texture, but in the context of
home prepared foods e.g. ‘mashed with a fork or minced’ (page 133).
Include a paragraph in Section 9.4.1 alerting Health Workers to the mandatory
labelling requirements of commercially prepared infant foods – Standard 2.9.2.
States that honey should not be given to children aged less than two years.
Clause 2(4)(b) of Standard 2.9.2 permits honey in food for infants if it has been
treated to inactivate Clostridium botulinum spores. Clause 5(3)(e) states that the
label on a package of food for infants must include the word ‘sterilised’ in
association with the word ‘honey’ when used as an ingredient.
Include in Section 10.1.
Clause 3 definition for ‘infant formula’ refers to the Australian Food Standard R7 –
Infant Formula (from Volume 1 of the Food Standards Code).
Insert a footnote to indicate the Standard has since been updated and is now
called Std 2.9.1.
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FSANZ COMMENTS ON DRAFT INFANT FEEDING GUIDELINES FOR HEALTH WORKERS
Issue
Number
38.
Section of document and page number
Comments
Section 11.1.2 ‘The MAIF Agreement’
p. 145
Clause 9(b) states that manufacturers and importers of infant formulas must
ensure that labels provide the information required to be provided by the Australian
Food Standard A1 – Labelling and Advertising and Standard R7 – Infant Formula
(from Volume 1 of the Food Standards Code).
39.
Appendix A p. 151
40.
Appendix C: infant feeding evidence
statements
p. 155-163
41.
Section 11.1.6
Insert a footnote to indicate these Standards have since been updated.
Title ‘Interpreting breastfeeding rates in Australia’ could be re-worded to provide a
better description of the appendix e.g. limitations in interpretation of breastfeeding
data OR Considerations in interpretation of the breastfeeding evidence base
Suggest that the one table is split into two tables – one of evidence statements
from NHMRC infant feeding literature review and one from the NHMRC dietary
guidelines literature review. The text in brackets in each question box that states
‘(from NHMRC infant feeding literature review) or ‘(from NHMRC dietary guideline
literature review) is not easily seen.
“Who is a health worker”
Agree that staff of retail pharmacies perform duties consistent with being a health
worker and therefore should be included in the definitions for the Code and
Agreement.
9