Download draft revised general principles for the addition of essential

Annex 1
DRAFT REVISED GENERAL PRINCIPLES FOR THE ADDITION OF
ESSENTIAL NUTRIENTS TO FOODS (CAC/GL 9-1987)
Response Form
Please use this form to respond to the questions in the consultation
document for the CCNFSDU Electronic Working Group, May, 2013.
Codex member country or organization, or observer organization:
INTERNATIONAL COUNCIL OF GROCERY MANUFACTURERS’ ASSOCIATIONS
Q.1
Do you agree to revising the title of the document to “Principles for the Addition of
Essential Nutrients to Foods”? If not, please provide a rationale.
ICGMA agrees with simplification of the title to Principles for the Addition of Essential
Nutrients to Foods. Nothing in meaning is lost by removing General from the title.
Q.2
Would you support including the purposes of addition in section 3? If not, please provide
a rationale for why it should be in the introduction.
ICGMA agrees with including the purposes of addition in Section 3. Specifically, the
purposes for the addition of essential nutrients is best stated in 3.1.1
Q.3
Do you consider that the text “and that prevent the indiscriminate addition of essential
nutrients to foods” should be deleted? Please provide a rationale.
ICGMA supports the version that was reviewed in 2012 plenary:
the establishment of a set of principles that serve as a basis for the rational and safe
addition of essential nutrients to foods.
ICGMA does not see a need to add back “to prevent the indiscriminate addition of
essential nutrients to foods
A simple review of definition for the terms rationale and indiscriminate confirm that it is
not necessary to add the additional statement:
Definition of indiscriminate: done at random or without careful judgment
Definition of rational: reasonable, sensible, based on sound judgment
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Q.4
Do you have any objections to using the term, “Official Authorities”? If so please
provide a rationale. (Please note that throughout this document, we will continue to use
the term “National Authorities”, which had been used previously, until the decision is
made as to the preferred term, so it is not necessary to comment on the choice of the
term in other principles.)
ICGMA suggests that the committee co-chairs seek the Codex Secretariat’s advice in
advance of the physical WG to be held prior to plenary sessions in November. In
particular, it would be valuable to have advice on:
1.0 What is the Codex definitions (and therefore limits) for national and official?
2.0 How are these terms used in other Codex standards?
3.0 What is their recommendation on appropriate use of the two terms?
This is an issue that has been debated more than once in plenary sessions. Having the
Secretariat’s perspective would help.
Q.5
Do you think this third paragraph is necessary? Please explain. If not, skip to Section iv.
ICGMA supports inclusion of this 3rd paragraph – clearly articulates what is captured in
these Principles: both mandatory and voluntary addition of essential nutrients.
Q.6
Do you prefer this text in i. the introduction, ii. the scope, or iii. an introduction to
Section 3? Please provide a rationale for your choice and indicate how important your
preference is.
ICGMA supports inclusion of this sentence in the Scope – augments the current Scope
statement as it appropriately places a framework for the type of fortification covered:
mandatory and voluntary
Q.7
Are either or both of “as appropriate” and “unless otherwise indicated” necessary?
Please explain
ICGMA believes these additional qualifiers are not needed. The use of these terms adds a
degree of ambiguity when, in the future, member countries refer to these principles in
making decisions on the addition of essential nutrients to foods. t
Q.8
Do you agree that “both mandatory and voluntary” could be replaced by “all types of“?
ICGMA believes that “both mandatory and voluntary” should be retained. Use of these
terms provides clarity; use of the term “all types of” does not.
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Q.9
Can you accept retaining the text as proposed in 2012 “(new) National authorities should
may also consult the FAO/WHO publications Guidelines on food fortification with
micronutrients (WHO, 2006) for further guidance on nutrient addition. information.” if
not, please provide a rationale.
ICGMA does not support inclusion of a generic reference to “publications”,
regardless of source. The Principles developed through this process should provide the
users with the framework required to make decisions on appropriate addition of essential
nutrients to foods.
Q.10 Do you agree with the addition of the second sentence suggesting that the principles may
be considered by Official National Authorities alongside provisions for Foods for
Special Dietary Use? Please provide a rationale.
ICGMA can support the addition of this sentence specific to foods for special dietary
uses. Inclusion removes ambiguity .
Note, as stated in Question 4, the committee chairs are asked to get the Codex
Secretariat’s advice on appropriate use of the terms “Official” and “National”
Q.11 If these changes are made to the Scope, do you consider that the definition of “Special
Purpose Foods” and Section 4.4 could be deleted?
ICGMA does not support. A section specific to Special Purpose Foods should be
retained.
While review of the Definitions Section is yet to be completed, the current set of
definitions (see CAC/GL9) includes a definition for Special Purpose Foods. It states that
special purpose foods are broader than foods for special dietary uses. Spelling out special
purpose foods in section 4 ensures that there is no confusion in future when these
principles are put to use.
Q.12
Do you agree with adding the sentence “Official National authorities may request
evidence demonstrating that the purposes listed above are fulfilled? Please provide
rationale
The conditions to be met for either the mandatory or voluntary addition of essential
nutrients to foods are stated in 3.1.1. The proposed additional statement “National
Authorities may request evidence…..” would appear to be related only to the voluntary
addition of essential nutrients to foods.
ICGMA does not understand the need to add this sentence. As already stated in the
Introduction Section, the principles are designed to provide a basis for the rational and
safe addition of essential nutrients to foods – which as will be defined in the scope
includes both mandatory and voluntary.
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Q.13 Do you agree that it is not necessary to add “preventing or” in the 1st bullet? Please
provide rationale
ICGMA agrees, “preventing or” is not required. The concept is captured under bullet 2:
“meeting [requirements][recommended intakes] of one or more essential nutrients” and 3:
“the maintenance or improvement of health”
Q.14 Do you agree with using the term “requirement” in bullet 2? Please provide rationale
ICGMA agrees with the Chair that the concept of nutrient addition for purposes beyond strictly
meeting nutritional requirements, such as for preventing disease, is covered in bullet 3
(maintenance or improvement of health), however, ICGMA suggests that the Chair bring back to
the physical working group a clear definition of the terms “requirement” and “recommended
intakes” so the differences can be understood before a decision is made on which is most
appropriate. It is not clear.
For example, from the WHO/FAO publication Vitamin and Mineral Requirements in human
nutrtion (2004), Chapter 1 (Introduction) it says
“The choice of criteria used to define requirements is of critical importance since the
recommended nutrient intake to meet the defined requirement will clearly vary, depending,
among other factors, on the criteria used to define nutrient adequacy.”
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Q.15 Can you accept the other revisions proposed in 3.1.1? Please provide a rationale.
The only other proposed revision appears to be in line 1:
Correcting a demonstrated….. or [inadequate intakes or [inadequate nutritional status]
of one or more essential nutrients in the population.
In context of comments provided for Questions 12 – 14, ICGMA can support this
proposed revision.
Q.16 Do you agree with deleting the 3rd sentence? If not, please provide a rationale.
ICGMA agrees that sentence 3 should be deleted from 3.1.3. The point should be kept
however. Depending on how the balance of discussions and changes unfold, Section 3.2
- Selection of Nutrients and Determination of Amounts may be the best place to capture
this point.
Q.17 Do you agree with retaining the 2nd sentence? If not, please provide a rationale.
ICGMA supports retention of sentence 2
Q.18 Can you agree with deleting the 1st sentence? If not, please provide a rationale.
ICGMA supports deletion of 1st sentence
Q.19 Do you agree with using the term may rather than should in this instance? If not, please
provide a rationale.
ICGMA supports using the term MAY
Q.20
Do you agree with the re-introducing the 2nd part of the sentence in principle 3.1.5, i.e.
“including by presentation or labelling practices, as to the nutritional merit [or the health
benefit]/[and possible additional health benefit] of the food”? If not, please provide a
rationale.
ICGMA supports removal of the 2nd sentence and supports the succinct wording proposed
in EWG 2012:
“Addition of essential nutrients to foods should not be used to mislead or deceive the
consumer”
It very clearly states the point in a manner that cannot be misunderstood.
Q.21 Do you agree with the use of [amount of an added]? If not, please provide a rationale.
ICGMA supports term “amount of an added…”:
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Q.22
Do you agree with stating that the addition should be risk-based rather than
[scientifically and nutritionally justified]. Please provide rationale, whether you agree or
disagree.
ICGMA supports use of the term “risk-based” rather than [scientifically and nutritionally
justified]. Using a “risk-based” approach to determine the amount of an essential nutrient
that should be added would encompass assessing the scientific and nutritional merit of
the determination.
ICGMA suggest the following wording for added clarity:
A risk-based approach should be used to determine the amount of an essential nutrient to
be added, in line with one or more….
Q.23
Do you agree with retaining [in line with one or more of the purposes stated in 3.1.1] If
not, please provide a rationale.
ICGMA agrees that is should be retained.
Q.24 Do you agree with deleting the last sentence in 3.2.1 ““[Upper levels of intake based on
scientific risk assessment may be used to identify the need for any restrictions on the
types of foods to be fortified.] If not, please provide a rationale for retaining it.
ICGMA supports deletion of this sentence.
Q.25 Do you agree that these guidelines should not elaborate on dietary modeling. If not,
please provide a rationale as to why it should.
Q.26 Do you agree with using the text above adapted from the Codex Guidelines on Vitamin
and Mineral Food Supplements to replace 3.2.2 and 3.2.3. If not, please provide a
rationale or any additional changes you may have.
For 3.2.3 suggest the following:
Maximum amounts of vitamins and minerals in foods may be set taking the following criteria into
account:
a. upper safe levels of vitamins and minerals established by scientific risk assessment based on generally
accepted scientific data, taking into consideration as appropriate the varying degrees of sensitivity of
different consumer groups
b. the daily intake of vitamins and minerals from all sources.
When the maximum levels are set due account should be taken of the reference intake values of vitamins
and minerals for the population including an assessment of potential exposure to evaluate safety and
adequacy of intake.
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Q.27 Do you believe that it is critical to retain this principle in the document? Please provide a
rationale.
ICGMA supports retention of this principle as modified – it provides additional,
supportive guidance
Q.28 Do you believe that it is critical to retain this principle in the document? Please provide a
rationale. If yes, do you agree with incorporating it in 3.2.1?
ICGMA supports retention of this principle. It provides additional important guidance.
It is best included with 3.2.1
Q.29 Do you agree that potential adverse effects on the metabolism of other nutrient is linked
to the amount of the nutrient being added and that therefore “the amount” should be
used? If not, please provide a rationale.
ICGMA believes that the amount as well as the form of the nutrient (e.g. type of iron salt
– which would impact on absorption) should be considered.
Q.30 Do you agree with the proposed revised text? If not, please provide a rationale.
ICGMA agrees with the proposed text
Q.31 Do you agree with the proposed revised text? If not, please provide a rationale.
ICGMA continues to support the following wording for 3.3.1:
“The selection of food(s) to which to add an essential nutrient(s) should be primarily
based on achieving appropriate purposes of nutrient addition as identified in 3.1.1.
Q.32 Do you agree with the proposed revised text? If not, please provide a rationale
ICGMA continues to support the following wording for 3.3.2
“The selection of foods to which essential nutrients may be added is best determined by
National Authorities”
Q.33 Do you agree that it is not necessary to retain this principle? If not, please provide a
rationale as to why it is important to retain it.
ICGMA agrees that it is not necessary to retain principle 3.3.4
Q.34 Do you consider it necessary to retain this principle? If so, please provide a rationale as to
why it is important to retain it.
ICGMA does not support retaining this principle. Alcoholic beverages are not captured
under Codex Alimentarius
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Q.35 Do you agree with deleting the text in the square brackets “in the following order”? If
not, please provide a rationale and an indication of how important it is to retain it.
ICGMA supports deletion of “in the following order” as depending on individual member
country circumstances, use of one set of standards over the over will be different. What
is important is that the principle be included with links to credible sources.
Q.36
Do you consider it necessary to retain this principle? If so, please provide a rationale and
an indication of how important it is to retain it.
ICGMA supports inclusion of 3.4.2 as it spells out an important technological aspect
essential to successful addition of essential nutrients to foods
______________________________________________________________________________
FOR 37 and 38: ICGMA welcomes further discussion as under 3.4 Technological Aspects to sort
out what is important as a principle compared to what should be covered under Good
Manufacturing Practices. What is necessary to keep as a principle?
Q.37 Do you consider it necessary to retain this principle? If so, please provide a rationale and
an indication of how important it is to retain it.
Q.38 Do you consider it necessary to retain this principle? If so, please provide a rationale and
an indication of how important it is to retain it.
Q.39 Do you agree with using “[It is important that] National authorities”…? If not, please
provide a rationale.
ICGMA does not see the need to include this phrase. The principle is clear without
benefit of additional wording
Q.40 Can you accept using” the purposes identified in 3.1.1”…? If not, please provide a
rationale.
ICGMA can accept
Q.41 Do you agree with deleting this principle? If not, please provide a rationale for retaining
it?
ICGMA agrees with deleting this principle
Q.42. Recognizing these different points of view and taking into account the nature of the
principles in it, what recommendation would you have for the title of this sub-section?
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ICGMA supports the title “Addition of Essential Nutrients to Address a Demonstrated
Public Health Need” in line with our position that such a need can be addressed via a
mandatory or voluntary process.
Q.43 Is it necessary to retain this principle? If yes, do you consider it necessary to retain the
text “A demonstrated public health need, however, may also be addressed through
voluntary addition” given that the purposes for addition are listed previously? Please
explain your answer.
ICGMA supports retaining this principle and ICGMA supports stating that this need can
be met by either mandatory or voluntary addition. Clearly stated confirmation that either
method can be appropriate will remove potential ambiguity in interpretation by those who
will be using the Principles down the road.
Q.44 Should the list include just evidence types or should it convey the degree of inadequacy
that is consistent with a demonstrated public health need? Alternatively, would it be
sufficient to simply state that the need should be determined by national authorities?.
ICGMA supports retaining information on the means for identifying a public health need
but suggest the following wording to clearly indicate that there should be conclusive
evidence of a public health need.
“The public health need may be identified through clinical or subclinical evidence of
deficiency; assessments confirming inadequate intake of nutrient(s) or deficiencies
resulting from changes in food habits”
Clearly stated means of identifying a public health need will remove potential ambiguity
in interpretation by those using the Principles once adopted.
Q.45 Could the term “target population” be used instead of “population at risk [of inadequate
intake]”? Please provide a rationale for your answer.
ICGMA supports use of the term “target population” as it does link “the intended
population to the specific intervention”
Q. 46 How important is it that this principle make reference to when the food is consumed in
habitual amounts by the population at risk (or target population)?
ICGMA believes that consideration of amount required and the vehicle(s) (food(s)) used
to provide the essential nutrient should be covered under Section 3.2 Selection of
Nutrients and Determination of Amounts
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Q. 47 Do you agree that the terms, “reduce inadequate intakes” and “correct or prevent the
deficiency” should be retained? Please provide a rationale along with an indication of
how important it is.
ICGMA proposes the following more succinct means to convey the same message:
The sentence should read simply and clearly “The amount of the essential nutrient added
to the food should aim to be sufficient to address the identified public health need”
Q.48 Do you agree that the reference to “lowest and highest percentiles” is appropriate in this
principle? Would you consider “distribution of intakes” to be an acceptable alternative?
ICGMA supports “distribution of intakes” as an acceptable alternative.
Q.49
Is this text needed in this sub-section given the new sub-section 3.2?
ICGMA supports removal of this sub-section as it should be covered under Section 3.2
Selection of Nutrients and Determination of Amounts
Q.50 Do you agree with retaining this principle as written? If not, please provide alternative
text with rationale.
In answering this question it must be noted that the original wording in 3.9 “The
additional cost should be reasonable for the intended consumer” was directed at
mandatory fortification situations.
The Principles being shaped now encompass both voluntary and mandatory fortification.
Under voluntary fortification processes in particular, there is a role for the food
manufacturer to make decisions on the best food vehicles to use that include cost but do
not limit the decision to cost only.
ICGMA suggests that this principle be re-visited to include dealing with these two points.
Q.51 Can you accept the wording provided? If not, please provide a rationale.
ICGMA can support proposed wording
“Where the food has been identified as a significant contributor to intake of essential
nutrients in the population and particularly where there is a public health need for one or
more of those nutrients, addition of essential nutrients to restore those nutrients of
concern lost during processing, storage or handling, should be considered.”
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Q.52 Is it necessary to have guidance on when a food is a significant contributor or source of a
nutrient for the purposes of restoration in the Principles?
Q.53 If yes, is it sufficient for the purposes of this restoration for a food to meet certain content
criteria or should frequency of consumption by the population also be taken into account?
Q.54 Is there a reason for the content criterion to be different from that for nutritional
equivalence
Q.55 Would it be acceptable to provide the criteria only as examples of how a food could be
determined to be a significant contributor to intake
Q.56 Do you consider this sentence to be applicable to restoration or not? Please explain
[Where there is a clear public health reason to moderate the intake of a specific nutrient, the level
of this nutrient need not be restored]
Q.57
Can you accept the wording provided? If not, please provide a rationale.
ICGMA supports:
“Where a substitute food is intended to replace a food which has been identified as a
significant contributor to intake of essential nutrients in the population, and particularly
where there is a public health need, addition of essential nutrients of concern should be
recommended.
Q.58 Is it necessary to have guidance on when a food is a significant contributor or source for
the purposes of nutritional equivalence of substitute foods in the Principles?
Q.59
If yes to Q 58, is it sufficient for the purposes of substitute foods for a food to meet
certain content criteria or should frequency of consumption by the population also be
taken into account?
Q.60 Is there a reason for the content criterion to be different from that for restoration?
Q.61
Would it be acceptable to provide the criteria only as examples of how a food could be
determined to be a significant contributor to intake?
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Q.62 Would you consider that the changes proposed to the Scope mean that this sub-section
could be deleted? If not, please provide a rationale indicating how important it would be
to retain it.
Section 4.4 Nutrient Addition to Special Purpose Foods should be retained.
Food for special dietary uses are not synonymous with special purpose foods.
The proposed Scope under discussion now states “ With regard to foods for special
dietary uses, National Authorities may consider these principles, as appropriate, in
conjunction with the provisions in Codex standards and guidelines for such foods”
However, by definition (2.7, CAC/GL9) Special Purpose Foods are foods that have been
designed to perform a specific function, such as to replace a meal which necessitates a
content of essential nutrients which cannot be achieved except by addition of one or more
of these nutrients. These foods include but are not limited to foods for special dietary
uses.
END OF QUESTIONNAIRE
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