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REP18/NFSDU
Forty-first Session
Rome, Italy
2 – 7 July 2018
Berlin, Germany
4 – 8 December 2017
REP18/NFSDU i
TABLE OF CONTENTS
Paragraphs
Introduction ........................................................................................................................................................ 1
Opening of the Session ............................................................................................................................... 2 - 3
Adoption of the Agenda (Agenda item 1) .......................................................................................................... 4
Matters referred to the Committee by the Codex Alimentarius Commission
and/or Other Subsidiary Bodies (Agenda item 2) ........................................................................................ 5 - 7
Matters of interest arising from FAO and WHO (Agenda item 3) ...........................................................8 - 15
Review of the Standard for Follow-up Formula (Agenda item 4) ............................................................. 16 - 71
Proposed draft definition for biofortification (Agenda item 5) ...................................................................72 – 93
Proposed draft NRV-NCD for EPA and DHA (Agenda item 6)...............................................................94 – 104
Proposed draft guideline for ready-to-use therapeutic foods (Agenda item 7).....................................105 – 129
NRV-R for older infants and young children (Agenda item 8) ..............................................................130 – 132
Food additives – mechanism / framework for considering technological justification
and other matters (Agenda item 9) .......................................................................................................133 – 144
Discussion paper on claim for “free” of trans fatty acids (Agenda item 10) .......................................... 145 - 150
Other business and future work (Agenda item 11) ............................................................................. 151 - 161
Date and place of next session (Agenda item 12) ......................................................................................... 162
Appendices page
Appendix I - List of Participants ....................................................................................................................... 19
Appendix II – Proposed draft revised Standard for Follow-up Formula (CXS 156-1987)
(essential composition) ..................................................................................................................................... 49
Appendix III – Proposed draft revised Standard for Follow-up Formula (CXS 156-1987)
(other sections) ................................................................................................................................................. 57
Appendix IV – Proposed draft definition for biofortification .............................................................................. 63
Appendix V – Proposed draft guidelines for ready-to-use therapeutic foods (RUTF) ......................................64
Appendix VI – Proposed draft conditions for a “free” of trans fatty acids (TFA) claim .....................................66
Appendix VII – Methods of analysis for provisions in the Standard for Infant Formula and Formulas
for Special Medical Purposes Intended for Infants (CXS 72-1981) .................................................................. 67
REP18/NFSDU ii
LIST OF ABBREVIATIONS
INTRODUCTION
1. The thirty-ninth Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU)
was held in Berlin, Germany, from 4 to 8 December 2017 at the kind invitation of the Federal Government of
Germany. Dr Pia Noble and Ms Marie-Luise Trebes, Former Head and Head of Division of Special Foods,
Food Supplements, Food Additives, Federal Ministry of Food and Agriculture of Germany, served as Chair
and vice-Chair of the Session, respectively. The Committee was attended by 66 member countries, one
member organisation and 39 observer organisations. A list of participants is given in Appendix I.
OPENING OF THE SESSION
2. Dr Maria Flachsbarth, Parliamentary State Secretary, Federal Ministry of Food and Agriculture, speaking on
behalf of Mr Christian Schmidt, Federal Minister of Food and Agriculture, opened the Session and welcomed
delegates. She indicated that the large number of participants to the meeting demonstrated both the interest
in the work in contributing towards realisation of the UN Decade of Action on Nutrition (2016-2025) and further
stressed the importance of science-based Codex standards in consumer protection and food trade. Ms Mariam
Eid, Vice-Chairperson of the Codex Alimentarius Commission, also addressed the meeting and emphasised
the importance of consensus in decision making for several crucial agenda items at this meeting.
Division of competence 1
3. The Committee noted the division of competence between the European Union (EU) and its Member States,
according to paragraph 5, Rule II of the Rules of Procedure of the Codex Alimentarius Commission as
presented in CRD1.
ADOPTION OF THE AGENDA (Agenda item 1) 2
4. The Committee adopted the Agenda with the following additions under agenda item 11 - Other business:
i. General guidelines to establish nutritional profiles (Costa Rica and Paraguay);
ii. Methods of analysis in the Standard for Infant Formula and Formulas for Special Medical Purposes
Intended for Infants (CXS 72-1981) (the United States of America); and
iii. Harmonised probiotic guidelines for use in foods and dietary supplements (International Probiotics
Association).
Matters Referred to the Committee by the Codex Alimentarius Commission and/or Other Subsidiary
Bodies (Agenda item 2) 3
5. The Committee noted that some matters were for information only, and that several matters would be
considered under other relevant agenda items, and took the following decisions:
Method for Chromium, molybdenum and selenium: Infant formula
6. The Committee; noted the request of the Committee on Methods of Analysis and Sampling (CCMAS)
concerning the possible retyping of the method for chromium, molybdenum and selenium provided validation
data is submitted; and encouraged members to submit such validation data to CCMAS.
Criteria for endorsement of biological methods used to detect chemicals of concern
7. The Committee agreed to defer the discussion on this matter to its next session.
MATTERS OF INTEREST ARISING FROM FAO AND WHO (Agenda item 3) 4
8. The Representative of FAO called the attention of the Committee to various activities of FAO of interest to
CCNFSDU: (1) FAO Expert Working Group on protein quality assessment in follow-up formula for young
children and Ready to Use Therapeutic Foods, that was held in Rome from 6 to 9 November 2017; (2)
FAO/WHO Global Individual Food Consumption Data Tool (GIFT), which provides simple and accurate food-
based indicators, derived from sex and age disaggregated data on individual food consumption; (3) UN
Decade of Action on Nutrition 2016 – 2025, under which the Milan Global Nutrition Summit has taken place
on 4 November 2017; and (4) the International Symposium on Sustainable Food Systems for Healthy Diets
and Improved Nutrition organised jointly by FAO and WHO in December 2016 and the Regional Symposia on
the same theme organised in 2017 to further anchor the discussion around the actual challenges of each
region.
1 CRD1 (Annotated Agenda – Division of competence between the European Union and its Member States)
2 CX/NFSDU 17/39/1; CRD3 (Comments of IPA); CRD4 (Costa Rica, Paraguay); CRD14 (the United States of America);
CRD21 (ISDI)
3 CX/NFSDU 17/39/2, CRD4 (Costa Rica, Paraguay)
4 CX/NFSDU 17/39/3
REP18/NFSDU 2
9. The Representative of WHO highlighted some of the activities of relevance to the ongoing work of the
Committee. With reference to the UN Decade of Action on Nutrition, the Representative provided additional
information which included: launching of Member States’ SMART commitment repository linked to WHO Global
Database on the Implementation of Nutrition Action (GINA), establishment of Action Networks such as Global
Action Network on Sustainable Food from the Ocean for Food Security and Nutrition led by Norway, Global
Action Network on Nutrition Labelling led by France, Regional Action Network on enabling food environment led
by Chile, Regional Action Network on childhood obesity led by the Pacific countries and Regional Action Network
on school food procurement led by Thailand. She also called the attention of the Committee to the new World
Health Assembly (WHA) resolution and decision – one being WHA70.11 5 on updated Appendix 3 (which lists
“best buys” and other recommended interventions to address Non-communicable diseases (NCDs)) of the NCD
Action Plan 2013 – 2020 and the WHA70 (19) 6 on the implementation plan of the report of the Commission on
Ending Childhood Obesity.
10. The Representative also provided updates: (i) on the work of the NUGAG Subgroup on Diet and Health,
including planned launching of draft guidelines on saturated fatty acids and trans-fatty acids for public
consultation; preparation of draft guidelines on non-sugar sweeteners, polyunsaturated fatty acids (including
n-3, n-6 and total PUFA) and carbohydrates (starch and fibre); and ongoing evidence reviews on dietary
patterns, as well as starting of the work of the NUGAG Subgroup on Policy Actions, including nutrition labelling
policies, fiscal policies, trade and investment policies which affect diet and nutrition; and (ii) on WHO’s work
on nutrient profiling, including the adaptations of nutrient profile models for different applications such as
regulating food and beverages in schools and nutrition labelling, and the planned development of a regional
nutrient profile model for the African Region.
11. The Representative of WHO further informed the Committee of three additional activities which were not
included in the document CX/NFSDU 17/39/3. They were: (i) preparation of the 13th General Programme of
Work which contains 5 nutrition-related targets (reduction in stunting, reduction in wasting, no increase of
overweight/obesity in children and adolescents, elimination of industrially produced trans fatty acids (TFA) and
reduction in salt/sodium intake) and will guide WHO’s work in 2019 – 2023; (ii) taking part in the implementation
of the RESOLVE initiative which is a new global health initiative, aiming to save millions of lives by reducing
preventable deaths from cardiovascular diseases (CVDs) through accelerating progress in improving
treatments of high blood pressure, sodium reduction and elimination of industrially produced TFA; and (iii)
updating of nutrient requirements for infants and young children (0 – 24 months) jointly with FAO.
12. The Delegation of France, supported by the United States of America and the EU, stated that the WHA
“welcomed with appreciation”, but did not approve or endorse the WHA resolution on the WHO Guidance on
Ending the Inappropriate Promotion of Foods for Infants and Young Children (WHA69.9) and therefore it was
an error to state in CX/NFSDU 17/39/3 that WHA69.9 was approved by WHA. The Delegation of the United
States of America further informed the Committee that it had dissociated from WHA Resolution 70.11 because
the evidence underlying certain recommendations was not sufficient to support them.
13. In response, the Representative of WHO stated that there was no error as WHA69.9 was in fact approved by
WHA. The Representative stated that resolutions and decisions of the WHO Governing Bodies (i.e. Executive
Board, WHA) use various operative phrases to express their views regarding the substantive content contained
in or annexed to the resolutions or decisions. After reviewing resolutions and decisions approved by WHA
during the last 10 years, it was clearly noted that they do use various operative phrases and commonly used
phrases are: adopts, approves, endorses, welcomes, noted with appreciation and notes. The Representative
of the WHO reported that according to the WHO Department of Governing Bodies and External Relations, and
Office of the Legal Counsel, it is possible to see these various phrases as lying on a spectrum expressing
approval – with greater or somewhat less strength – on one side, and general recognition on the other and the
terms “welcomes”, “welcomes with appreciation” (which was the term used in WHA69.9) and “notes with
appreciation” express approval as well, although somewhat less strongly. She highlighted that regardless of
different operative phrases used by various resolutions and decisions, there is one thing which is common to
all these resolutions and decisions and that is they are the resolutions and decisions of the WHA which is the
highest Governing Body of WHO. The Representative noted that at WHA in May 2017, there were 2 Member
States which had disassociated themselves from WHA70.11 on Appendix 3 of the NCD Action Plan (2013 –
2020) which lists “best buys” and other recommended interventions to address NCDs, but no Member State
had disassociated from WHA69.9.
14. One Observer commented that conflict of interest safeguards are embedded in all WHO policies and
recommendations, and are highly relevant for the standard-setting procedures of Codex.
5 http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70_R11-en.pdf
6 http://apps.who.int/gb/ebwha/pdf_files/WHA70/A70(19)-en.pdf
REP18/NFSDU 3
15. Delegations noted that the document had been distributed late and requested that, in future, FAO and WHO
should make available the document well in advance of the meeting to allow sufficient time to undertake
thorough review and carry out consultations with their experts. A delegation, while noting the usefulness of the
information, requested that the document should focus on joint work of FAO and WHO that can benefit the
work of the Committee.
REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA (CXS 156-1987) (Agenda item 4) 7
16. The Chair of the electronic working group (EWG) New Zealand, introduced the item and briefly outlined the
work undertaken.
17. The Committee agreed to focus discussion first on the essential composition of follow-up formula for older
infants and for the “product” for young children before discussing the labelling, the name of the product, product
definition, scope and preamble, noting the proposal of one observer that the preamble should be considered
before other sections due to its importance.
General
18. An observer expressed the view that since the market growth of these products is strongest in developing
countries, it is essential for these countries to assess the risks, safety and appropriateness of these products
as a whole, in the local context, before allowing imports.
Essential Composition of Follow-up Formula for older infants (6-12 months)
19. The Chair of the EWG recalled that for follow-up formula for older infants aged 6-12 months the essential
compositional requirements for protein and Docosahexaenoic acid (DHA) needed to be finalised.
20. The Committee considered the recommendations of the EWG, and made the following decisions and
comments.
Protein
21. The chair of the EWG recalled that CCNFSDU38 had agreed to postpone decision on a minimum protein level
in order to take into account the European Food Safety Authority (EFSA) opinion. She noted that while EFSA
proposed a minimum protein level of 1.6 g / 100kcal, it was recognised that this was not a global value.
Discussion
22. Delegations, in particular those from developing countries, expressed a preference for a higher value (of
protein level) of 1.8 g / 100 kcal, noting that the high incidence of protein and energy malnutrition occurred
during the weaning period and that intake of high quality protein was necessary; and other complementary
foods in their region were often from sources with low protein content or quality and would therefore not provide
sufficient levels of protein. These delegations were also of the view this would avoid countries having to carry
out or to assess clinical trials in order to establish a higher protein level as stated in the associated footnote 6;
this would be of particular difficulty for many countries. It was noted that 1.6 g/100 kcal was not a global
recommendation as it had been evaluated for the European infant population only.
23. Those in favour of the protein level of 1.6 g / 100 kcal noted that the associated footnote would state that below
protein level of 1.8 g / 100 kcal, the follow-up formula needed to be evaluated. It was further noted that
competent authorities were not responsible for clinical trials, but the assessment or evaluation thereof.
24. Many delegations further noted that:
a) all follow-up formula based on hydrolysed protein should be evaluated, and not only those containing
less than 2.25 g of protein / 100 kcal; and
b) those products with protein levels falling between 1.6 g / 100 kcal and 1.8 g / 100 kcal should be
evaluated for their safety and suitability and assessed based on clinical evidence.
Conclusion
25. The Committee agreed with a minimum protein value (level) of 1.8 g/ 100 kcal and an amended associated
footnote 6.
7 CX/NFSDU 17/39/4 Rev1; CX/NFSDU 17/39/4-Add.1 (Comments of Argentina, Brazil, Colombia, Ecuador, India, Japan,
Nepal, New Zealand, Russia, Senegal, Switzerland, USA, EU speciality food ingredients, GOED, HKI, IACFO, IBFAN,
IDF, IFT, ISDI, UNICEF); CX/FH 17/39/5-Add.2 (Australia, Canada, Kenya, Malaysia, Norway, Philippines, Tanzania,
Thailand, EFLA, ICGMA, ISDI); CRD5 (Discussion paper by USA and Canada); CRD7 (Costa Rica, El Salvador, EU,
Kyrgyzstan, Morocco, Nigeria, Sierra Leone, Sri Lanka, African Union, EU Specialty Food Ingredients); CRD17
(Indonesia); CRD19 (Republic of Korea); CRD24 (EUVEPRO); CRD25 (Mali); CRD26 (Mexico); CRD28 (El Salvador)
REP18/NFSDU 4
The essential composition of [name of the product] for young children (12-36 months)
34. The Chair of the EWG recalled that outstanding requirements for the essential composition of product for
young children (12-36 months) included: i) minimum total fat level; ii) maximum available carbohydrates and
associated sugar specifications in footnote 4; iii) whether a calcium-to-phosphorous ratio should be
established; and iv) vitamin D minimum and maximum levels.
35. The Committee agreed that no calcium to phosphorous ratio was needed, and took the following decisions on
minimum total fat, maximum available carbohydrates and vitamin D minimum and maximum levels.
Minimum total fat
36. Those in favour of a higher minimum total fat level of 4 g / 100 kcal expressed the opinion that this level would
contribute to about 30% of energy from fat; and fat was an important contributor to child growth and
development in the first three years of age.
37. Those in favour of a minimum total fat of 3.5 g / 100 kcal were of the opinion that:
• this level was in line with public health advice to lower fat intake by young children
• the level was consistent with low fat milk recommended as part of a diet for this age group; and
• there was a problem with overweight, therefore the need for the lowest minimum level of fat.
38. An observer pointed out that a minimum total fat of 4 g / 100 kcal would result in a 36% of energy intake from
fat. Another observer clarified that 28 – 29% of energy should come from fat and the product was part of a
diversified diet.
39. It was also pointed out that all macronutrient options should be considered together and add up to 100% of
needed kcal, i.e. the ranges of total fat, protein and maximum carbohydrates.
Maximum level for available carbohydrates
40. Those in favour of 12.5 g / 100 kcal (of available carbohydrates) expressed the following views:
• that this level was closer to that of breastmilk and cow’s milk;
• that the level was within the recommended range for available carbohydrates and would contribute to
about 50% of energy which was aligned with the recommendations on energy; and
• there was a need to limit the addition of sugars in order to avoid that young children consume products
with too high sugar levels.
41. Those in favour of a higher maximum level of 14 g / 100 kcal (of available carbohydrates) expressed the
following views:
• that this was based on nutrient modelling;
• was in line with international recommendations for nutrient range for young children; and
• if taken with the agreed protein level, the proposed minimum total fat level, 14 g / 100 kcal, was
appropriate to achieve 100kcal.
42. A delegation clarified that a product with 14 g / 100 kcal of available carbohydrate could result in a product
with little protein and fat. Breastmilk had a high carbohydrate content, and this was the sole food for infants,
whereas the product in question was part of a diversified diet with carbohydrates from other sources in the
diet. Several observers noted that the carbohydrate content in breastmilk was different from that in these
products.
43. In view of the discussion on the total available carbohydrate and fats, it was agreed to convene an in-session
working group led by New Zealand to prepare further proposals for consideration.
44. The in-session working group proposed a minimum level of fat of 3.5 g / 100 kcal of fat (equivalent to 31.5%
of energy), but could not conclude on the maximum level of available carbohydrate. It was noted that the
product was considered a substitute for cow’s milk, the level of 14 g /100 kcal of available carbohydrate was
too high, but would provide greater flexibility.
45. In view of this, consideration was given to the lower level available carbohydrates of 12.5 g / 100 kcal with the
addition of a footnote to clarify that a maximum level of available carbohydrate up to 14 g / 100 kcal may be
permitted by competent national and/or regional authorities for a product with a protein level below 3 g / 100
kcal.
REP18/NFSDU 6
Footnote 4
46. The Committee; agreed that lactose should be the preferred carbohydrate in the product and the need to limit
the amount of mono- and disaccharides to reduce sweet taste; but could not agree on a proposal that for
products not based on milk protein, carbohydrate sources that have no contribution to the sweet taste should
be preferred. The Committee also noted that no non-carbohydrate sweeteners were permitted in this products.
47. There was agreement that the percentage limit for sugars is converted to an absolute amount based on energy
density.
48. Further proposals considered were to include: (i) a text to clarify that the content of mono- and disaccharides,
other than lactose, should not exceed 2.5 g /100 kcal amounting to 20% of available carbohydrate; and (ii) that
competent authorities may limit this level to 1.25 g / 100 kcal. The major discussion was on ensuring that when
carbohydrates were added they were not added for the purpose of sweetening the product; and that the text
should avoid making comparisons on sweetness as this would be difficult to implement and control due to a
lack of internationally validated methods and it would be difficult to objectively measure sweetness. A
delegation stated that the sensory profile could be measured in an objective way by ISO methods 3972 and
13299 and that in this context the sweetness level could be compared. Several observers expressed concern
about the impact that sweet products have on the development of a child’s taste palate.
Conclusion
49. The Committee agreed with a minimum level for fat of 3.5 g / 100 kcal and for a maximum level for available
carbohydrates of 12.5 g / 100 kcal with the addition of a new footnote to indicate that for a product with a
protein level below 3 g/ 100 kcal, a maximum level of available carbohydrate up to 14 g / 100 kcal may be
permitted by national and/or regional competent authorities; and agreed to retain the amended footnote 4 in
square brackets for further consideration.
Vitamin D
50. Some delegations supported the view for vitamin D to be an optional ingredient as increased levels of vitamin
D could have toxic effects, especially in countries with high sunlight. However, some other delegations were
of the opinion that vitamin D should be a mandatory ingredient.
51. Other delegations expressed support for the levels recommended by the EWG and noted that even in countries
with high sunlight, vitamin D deficiency remained a problem. It was further noted that it was necessary to clarify
which form of Vitamin D was referred to, either vitamin D2 or vitamin D3. While other delegations reiterated
their position for lower levels of vitamin D, i.e. minimum of 1 µg / 100 kcal and maximum of 3 µg /100 kcal,
noting that levels up to 4.5 µg /100kcal could result in unsafe levels of vitamin D being consumed; that the
lower levels would safeguard breast feeding. A delegation pointed out that there was a wide margin of safety
between the maximum level and the upper level of 62.5 µg per day of vitamin D for this age group set by the
US Institute of Medicine.
52. Noting the different requirements for vitamin D in different parts of the world, a proposal was made to allow
competent authorities to deviate from the conditions appropriate for the nutritional needs of their local
population.
Conclusion
53. The Committee noted the diverse views on the appropriate levels for vitamin D and the need to clarify in the
text that the form of vitamin D was vitamin D3, the Committee agreed to retain the proposal in square brackets
for further consideration at CCNFSDU40.
Labelling section: older infants
54. The Committee agreed with the sections: list of ingredients which was amended by deletion of reference to
“optional ingredients”, declaration of nutritive value; and date marking and storage instructions which was
aligned with the work on date marking finalised by Codex Committee on Food Labelling (CCFL); and made
the following additional decisions or comments.
55. The Committee noted the diverse views on whether to include in the introductory text, explaining that the
requirements included a prohibition on the use of nutrition and health claims, from the Guidelines for use of
nutrition and health claims (CXG 23-1997). Those in favour of retaining the text noted that the proposed
wording was consistent with the infant formula standard; and that it was necessary to reiterate and clarify that
nutrition and health claims were not appropriate for older infants.
Conclusion
56. The Committee agreed to retain the last sentence of the introductory paragraph in square brackets for further
consideration.
REP18/NFSDU 7
• the product for young children should not be considered breastmilk substitutes as it was not intended
to replace breastmilk and was not nutritionally adequate;
• the preference for other terms such as “formula for older infants” which would help to better define the
product for older infants; and that consideration should be given to combining the standard for infant
formula with that for older infants, and to have a separate standard for the product for young children;
• the term “follow-up” implied that one does follow up, which was not the case and consideration should
therefore be given to naming the product “drink for older infants”; and
• the product for young children was meant to be used as part of a diversified diet, but the product for
older infants could be part of the overall foods to meet nutritional requirements for this age group.
65. The Committee noted that consideration could be given to the structure of the standard as discussed at
CCNFSDU38.
66. The Committee noted that it was premature to discuss the name of the product for young children and the
scope, and agreed to hold a general exchange of views on the preamble to inform the ongoing work.
67. The Committee confirmed its decision to have a preamble to the standard. However, the chair noted that
several fundamental questions needed to be answered first on whether to have specific references to WHA
resolutions and WHO guidelines or whether to have a more general reference; that some of the WHA
resolutions went beyond the mandate of Codex and therefore was inappropriate to reference them; and
whether guidance from the CCEXEC or CAC might be needed before the wording of the preamble could be
refined.
68. The Committee noted the following views made by delegations but did not take any decisions:
• That relevant WHA resolutions, such as WHA69.9, 55.25 and 39.28, and the International Code of
Marketing of Breastmilk Substitutes, the Global Strategy for Infant and Young Child Feeding and the
Guidance on Ending the Inappropriate Promotion of Foods for Infants and Young Children should be
explicitly mentioned either in the preamble or the scope and such references would give credibility to
Codex standards;
• That inclusion of references to WHA resolutions could have implications under the World Trade
Organization (WTO) and that decision on the preamble was premature in view of ongoing discussions
in CAC on WHO and FAO policies in relation to Codex work;
• It was not the role of Codex to include references to WHO policies and some WHA resolutions that
may go beyond the scope of the standard and the mandate of Codex, and such inclusion could set a
risky precedent and could undermine the credibility of Codex standards;
• There was precedent in Codex to include WHA resolutions and WHO guidelines and it should be borne
in mind that the preamble was an introductory part to the standard to set the context for the standard;
• Governments that had adopted the 1981 Code of Marketing of Breastmilk Substitutes were under
obligation to promote breast feeding beyond 6 months and beyond, and reference to relevant WHO
policies in this regard could serve as reminder to governments;
• Resolutions of WHA state that Codex should give full consideration to WHA resolutions; and
• It was premature to discuss the preamble and that such a discussion would be informed once there
was more clarity on the structure of the standard.
69. The Secretariat clarified that CCEXEC73 had concluded its discussion on relations between FAO and WHO
policies, strategies and guidelines and Codex work 8 and that the discussion at CAC was not on policy
coherence, but was on matters arising from FAO and WHO: policy and related matters 9. The aim was to inform
members of the WHO and FAO policies and other related matters so that the work of FAO and WHO could be
taken into account at national and other levels, including Codex.
70. The Committee further noted that it was premature to request advice from CCEXEC and that work should
continue on the preamble, scope, product name and definitions in order to assess whether any further
guidance was needed. The Committee also recalled that CCNFSDU38 10 had agreed that the reference to
relevant WHO guidelines and WHA resolutions could either be included in a preamble to the standard or in
the scope.
Conclusion
71. The Committee agreed to:
• forward the essential composition requirements for older infants and young children agreed at this
and previous sessions to Step 5 for adoption by CAC41 (Appendix II);
• to keep in bracket the preamble for further discussion at the next session of the CCNFSDU; and
• re-establish the EWG chaired by New Zealand, and co-chaired by France and Indonesia and working
in English with the following terms of reference:
i. finalise the labelling requirements for follow up formula for older infants (see Appendix III);
ii. finalise the labelling requirements for [name of product] for young children (see Appendix
III);
iii. consider options for the structure of the standard/standards (e. g. whether one standard or
two separate standards for the products for the two age groups);
iv. develop a proposal for the scope sections for both follow-up formula for older infants and
[name of product] for young children consistent with discussions at CCNFSDU39; and
v. finalise the product definitions contained within section 2.1 for both follow-up formula for
older infants and [name of product] for young children and finalise the name of the product
for young children.
PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION (Agenda item 5) 11
72. Zimbabwe, as the co-chair of the EWG, introduced the item and noted that the EWG had focused on further
development of the five criteria to assist in guiding the drafting of the definition. Accordingly the EWG had
made six recommendations (five related to the draft criteria and one on the draft definition) for consideration
by the Committee.
73. The Chair of the Committee reminded the Committee of the other outstanding issues from CCNFSDU38, i.e.
how the definition would be used and where it would be placed, and that these would also need consideration.
She proposed that the Committee first consider the draft definition (recommendation 6) since the criteria had
been discussed several times and that these were tools developed to assist the EWG in coming up with the
draft definition. She further noted that not all the specific wording in the five criteria would necessarily form part
of the definition.
74. The Committee agreed with the proposal of the Chair to first consider the definition (recommendation 6) and
noted the following general and specific comments made by delegations:
General Comments
75. The EU and its Member States, supported by two delegations, observed that before embarking on the
elaboration of the definition, it would be important to first clarify how the definition would be used; the purpose
of the work and where the definition would be best placed as requested by CAC38 following the CCEXEC
recommendations. Answers to these questions were a pre-requisite to enable substantial progress on the
definition. These delegations further observed that in the EU there were legally binding regulations on the use
of the term “bio” where it is reserved for organic production. Therefore, a claim for biofortification on a food
label of any foods not produced through organic farming could not be supported. It was not necessary for
Committee resources to be spent on developing a definition for biofortification as a definition already existed
in the WHO website under the glossary of terms.
76. Some observers, expressed support for the views of the EU. In addition, it was noted that there was no Codex
definition for the term “conventional fortification”. Some observers and one delegation noted that such a
definition would open avenues for use of technologies including genetic modification (GM), that they consider
harmful. These observers proposed that the work be discontinued and further expressed the view that the
definition would also promote a single nutrient approach rather than a biodiverse diet.
77. The observer from NHF objected to the inclusion with definition of the words “any potential sources,” and “any
method of production”, and the associated footnote 5 – “the methods of production may be determined by
national authorities” -, in their view, this would allow use of techniques used in genetic modification to be
employed for biofortification thereby misleading consumers who could view “biofortification” as a natural
processes for enhancing the nutrient content of food. NHF further objected to the term itself as “bio” is already
a term of art meaning “organic” and consumers would be confused by the two terms’ similarity.
11 CX/NFSDU 17/39/5; CX/NFSDU 17/39/5 Add.1 (Comments of Albania, Australia, Brazil, Canada, Colombia, Costa Rica,
Egypt, India, New Zealand, Paraguay, Philippines, Switzerland, Thailand, USA, IBFAN, ICBA, ICGMA, IFU, FAO);
CX/NFSDU 17/39/5 Add.2 (Kenya, Malaysia, Tanzania and IACFO); CRD8 (EU, Nicaragua, Nigeria, African Union);
CRD16 (Sierra Leone); CRD22 (NHF); CRD 25 (Mali); CRD26 (Mexico).
REP18/NFSDU 10
78. The observer from IFPRI reiterated their view expressed at previous committee sessions that the focus of
biofortification was the breeding of conventional crops as one of the strategies to combat micronutrient
deficiencies in the population. She explained that alternative, but equivalent terminologies to biofortification
existed, e.g. agro-fortification, agri-fortification, nutri-fortification, and these could be used in different countries.
To bring clarity around the definition, the observer proposed that the Committee could consider inserting a
footnote: “Some member governments may prefer to use the equivalent terms agri-fortification, agro-
fortification, nutri-fortification” to this effect.
79. A delegation expressed the view that the definition of biofortification was important for countries in developing
their legislation and policies, particularly since biofortification is currently used to increase the vitamin A content
of cassava, for example.
80. Noting the potential limitation to the use of the term biofortification in some regions/countries where it was
associated with organic agriculture, the Committee therefore agreed that the use of alternative term(s) to
“biofortification” be explored.
81. In response to the question about the definition of biofortification noted in the WHO e-Library of Evidence for
Nutrition Actions (eLENA), the Representative of WHO clarified that there is in fact a title page on
biofortification of staple foods where some information on biofortification can be found in eLENA. But it states
clearly that currently there is no WHO guideline on biofortification and although the 2016 WHO/FAO technical
consultation reviewed the definition of biofortification of staple crops among various other issues, it was not a
guideline-development expert meeting and therefore did not develop any definitive recommendations.
82. The Chair of the Committee explained that the request for undertaking new work originated from CCFL, that
CCFL was the right committee to make a recommendation on how the definition would be used and where it
would be best placed, but that CCNFSDU could make proposals to CCFL. It was further clarified that the
definition would exclude feed.
Specific comments
83. The Committee considered the proposed draft definition and exchanged views on the following elements:
- “Potential Source organisms”
84. Agreed that the definition should be simple, clear and concise, and that examples of potential source
organisms, i.e. animal, plant, fungi, yeasts, bacteria should be included in a footnote.
- “Nutrient”
85. Noted that the term “nutrients” as defined in the Guidelines on Nutrition Labelling (CXG 2-1985) was more
appropriate for use in the definition. The Committee noted that the term “nutrient”, instead of essential nutrient
(as defined in the General Principles for the Addition of Essential Nutrients to Foods (CXG 9-1985)), should
be used both in the definition and the associated footnote 1.
- “Related substances”
86. It was explained that the inclusion of the term “related substances” was intended to accommodate other
substances such as phytochemicals and anti-nutritional factors that may not fall within the definition of
nutrients. However, a concern was raised that including “related substances” in the definition would make the
scope broader and thus complicate the situation, and that such substances needed to be clearly defined.
87. The Representative of FAO noted that there would be a need to clarify explicitly which substances fall within
the category of related substances; how the health outcomes associated with these would be evaluated and
proposed that this parameter be reconsidered.
88. It was thus proposed that these should be excluded from the definition.
- Increase of nutrient by measurable levels and nutrient bioavailability
89. It was mentioned that the intended positive health outcomes could be achieved either, through a quantitative
increase in the desired nutrients, or through reduction of target anti-nutrients (e.g. phytate) and thus make the
nutrients more bioavailable. However, from an enforcement point of view, it would be easier to measure the
nutrient increase rather than nutrient bioavailability. Therefore the definition should focus on the expected
outcome, i.e. measurable levels but also take into account nutrient bioavailability.
- Footnote 4 – Intended purpose
90. The Committee considered the suitability of the principles listed in section 3.1.1 of CXG 9-1987, and reaffirmed
that the purpose of biofortification is to improve nutritional quality and confirmed that the principles as listed
were applicable and suitable for use in the definition. To ensure clarity and precision of the definition, it was
proposed the principles should be listed in a footnote as follows:
REP18/NFSDU 11
a) preventing/reducing the risk of, or correcting, a demonstrated deficiency of one or more essential
nutrients in the population;
b) reducing the risk of, or correcting, inadequate nutritional status or intakes of one or more essential
nutrients in the population;
c) meeting requirements and/or recommended intakes of one or more essential nutrients;
d) maintaining or improving health; and/or
e) maintaining or improving the nutritional quality of foods.
- Method of production
91. Some delegations expressed the view that production methods should not be part of the definition and that
their inclusion would create potential trade barriers as competent authorities would seek verification of
production methods. Other delegations noted that the definition should apply only to conventional plant
breeding and should exclude GM techniques.
Other considerations
- Allergenicity
92. Concerns were also expressed on the potential increase in allergens in foods; and that there would be a need
to specify the target population the products obtained from biofortification are intended for. It was clarified the
allergenicity should be dealt with through labelling.
Conclusion
93. The Committee noted that a number of aspects in the definition needed further consideration, as well as the
questions on where the definition would be placed and how it should be used, and agreed to re-establish the
eWG, chaired by Zimbabwe and co-chaired by South Africa and working in English and French to:
a) refine the draft definition and its accompanying footnotes’ texts on the basis of the comments received
and CCNFSDU39 recommendations (Appendix IV);
b) explore other alternative terms to biofortification; and
c) consider the request from CAC38 on how the definition would be used and where it would be best
placed.
PROPOSED DRAFT NRV-NCD for EPA and DHA LONG CHAIN OMEGA-3 FATTY ACIDS (Agenda item
6) 12
94. The Russian Federation, as Co-Chair of the EWG, introduced the item and presented the results of the EWG.
95. The Co-Chair of the EWG reported that:
• the EWG proposal of 250 mg/day for EPA/DHA was based on two Joint FAO/WHO expert
consultations and one FAO expert consultation in accordance with the general principles, in a similar
way for establishing NRV-NCD for sodium and potassium;
• ten RASBs whose opinion was recommended to be taken into account when discussing NRV-NCD
for EPA and DHA had been identified; and
• there were conflicting views on the RASB selection, i.e. whether opinions of RASBs which did not find
convincing evidence for setting a daily intake reference value (DIRV) should also be considered or
not.
96. The Committee was further informed that the two NUGAG documents (abridged versions) were also
considered in the work of the EWG.
97. The Representative of WHO further clarified that with reference to NRV-NCD for sodium and potassium, the
Committee established initially the values based on the outcome of the 2002 Joint WHO/FAO Expert
Consultation on Diet, Nutrition and the Prevention of Chronic Diseases (TRS 916), but when the updated WHO
guideline on sodium intake for adults and children (2012) became available, the Committee updated it to follow
the 2012 WHO guideline as indicated in the reference to the NRV-NCD for sodium. In the same manner, NRV-
NCD for potassium was developed based on the WHO guideline on potassium intake for adults and children
(2012) as the 2002 Joint WHO/FAO expert consultation did not provide any specific value for potassium.
12 CX/NFSDU 17/39/6; CRD9 (Comments of European Union, Thailand, GOED); CRD23 (Canada); CRD29 (Peru)
REP18/NFSDU 12
98. The Committee welcomed the side-event on evidence reviews on n-3 polyunsaturated fatty acids (PUFA):
background reviews conducted for the work of NUGAG, considered the six recommendations of the EWG and
made the following decisions and comments.
Recommendations 1 - 3
99. Delegations were of the view that: i) the systematic reviews conducted for the PUFA guideline development
by the NUGAG Subgroup on Diet and Health (NUGAG documents) were: very comprehensive, but had been
presented late to the EWG and more time would be needed to consider them; ii) risk assessors should consider
the systematic NUGAG reviews rather than the Committee who were risk managers.
100. In response to the question on the publication process and status of the NUGAG documents, the
Representative of WHO stated that it is planned that the n-3, n-6 and total PUFA randomised clinical trial
(RCT) reviews on CVD related outcomes would be published as Cochrane reviews while RCT reviews on all
other health outcomes and the reviews on cohort studies would be published in peer-reviewed journals in
2018.
101. The Committee agreed with recommendations 1, 2 and 3.
Recommendation 4 - 6
102. The Committee noted the explanation from WHO that the term “convincing” was included in the text of section
3.2.2 on NRV-NCD under general principles after the discussion took place at CCNFSDU32 (2010) based on
the criteria used by the 2002 Joint WHO/FAO Expert Consultation on Diet, Nutrition and the Prevention of
Chronic Diseases (TRS 916). The criteria for evaluating the strength of evidence using “critical, probably,
possible and insufficient” was developed based on the criteria used by the World Cancer Research Fund, but
with some modifications made by the 2002 Expert Consultation in an effort to evaluate the quality of evidence
in a more systematic manner. But these criteria were used only at the 2002 Expert Consultation and again at
the 2008 Joint FAO/WHO Expert Consultation on Fats and Fatty Acids in Human Nutrition. But since the
implementation of the organisation-wide change in the guideline development process in WHO in 2010, WHO
no longer uses such criteria as the evaluation of the quality of evidence is now required to be done through
Grading of Recommendations Assessment, Development and Evaluation (GRADE). The Representative
therefore suggested that the Committee might wish to consider whether it was still necessary to keep the term
“convincing”.
103. The Committee agreed to recommendations 5 and 6 and that recommendation 4 should be further considered.
The Committee also agreed that the clarification of sections 3.1 and 3.2 of the Annex: General Principles for
Establishing Nutrient Reference Values for the General Population to the Guidelines on Nutrition Labelling
(CXG 2-1985) would first focus on resolving the work on establishing NRV-NCD for EPA and DHA noting the
interpretation of the principles might be applicable for other NRV-NCD in future.
Conclusion
104. The Committee agreed to establish an EWG, co-chaired by the Russian Federation and Chile, working in
English with the following terms of reference:
(i) to complete the assessment of the most current scientific evidence as presented in the NUGAG
systematic reviews taking into consideration further advice from FAO/WHO;
(ii) to clarify under Section 3.1 of the Annex: General Principles for Establishing Nutrient Reference
Values for the General Population to the Guidelines on Nutrition Labelling (CXG 2-1985) if opinions
from RASBs that did not set DIRVs could also be taken into account when establishing NRVs;
(iii) to discuss the first bullet of Section 3.2.2 of the Annex: General Principles for Establishing Nutrient
Reference Values for the General Population to the Guidelines on Nutrition Labelling (CXG 2-1985)
and clarify what level of evidence quality under the GRADE classification shall be considered as the
“relevant convincing/generally accepted scientific evidence”;
(iv) to discuss if the definition of convincing evidence given in “Diet, Nutrition and the Prevention of Chronic
Diseases: Report of a Joint FAO/WHO Expert Consultation, 2002” is applicable for the purpose of
establishing an NRV-NCD; and
(v) to make proposals to CCNFSDU40.
REP18/NFSDU 13
13 CX/NFSDU 17/39/7; CX/NFSDU 17/39/7 Add 1 (Albania, Brazil, Canada, Colombia, Costa Rica, Egypt, India, Paraguay,
Philippines, USA, EU Specialty Food Ingredients, HKI, IBFAN, ICAAS, IDF, IOFI, ISDI, MSF, UNICEF);CX/NFSDU
17/39/7 Add.2 (Kenya, Malaysia, Tanzania, Thailand and IACFO); CRD10 (European Union, Nigeria, African Union);
CRD15 (Proposal of EWG Chairs); CRD16 (Sierra Leone); CRD25 (Mali)
REP18/NFSDU 14
125. The Secretariat clarified that while a reference to the GSCTFF was the preferred option as outlined in the
Format for Codex Commodity Standards in the Procedural Manual, exceptions to this rule were allowed.
However, any MLs would still require endorsement by CCCF and clear justification should be provided on why
a general reference to the GSCTFF was not appropriate. She further explained that any MLs sent to CCCF
should also be accompanied by an explanation on the scientific basis of the ML.
126. A delegation proposed that consideration be given to a ML for aflatoxin of 5 ppb as prescribed in the Joint
Statement by the World Health Organization, the World Food Programme, the United Nations System Standing
Committee on Nutrition and the United Nations’ Children’s Fund: Community-based Management of Severe
Acute Malnutrition.
127. The Committee agreed with the proposed stepwise approach by the EWG, and that it would be the starting
point for further work in this area.
Other sections
128. Due to time constraints, other sections could not be considered.
Conclusion
129. The Committee agreed to establish:
a) an EWG, Chaired by South Africa and co-chaired by Senegal and Uganda and working in English and
French (with the support of France) to continue drafting the guidelines for RUTF taking into account
the decisions and comments made at the session (Appendix V) and written comments submitted to
CCNFSDU39, for comments and further discussion at the next session.
b) a PWG, to meet immediately prior to the next session, chaired by South Africa, and co-chaired by
Senegal and Uganda, working in English, French and Spanish, to further elaborate the proposed draft
guidelines for RUTF taking into account the conclusions and recommendations of the EWG and the
comments received prior to CCNFSDU40.
NRV-R FOR OLDER INFANTS AND YOUNG CHILDREN (Agenda item 8) 14
130. The Chair introduced the item and recalled that while there was interest to continue this work, the Committee
had been unable to find countries ready to lead the work in the previous two sessions. The Delegation of
Australia urged the Committee to continue the work and proposed how it could be taken forward through an
EWG as presented in CRD 2.
131. The Committee agreed to continue this work and considered the terms of reference of the EWG presented by
Australia. The Committee made amendments to the terms of reference for clarity and feasibility.
Conclusion
132. The Committee agreed to establish an EWG chaired by Ireland, and co-chaired by Mexico and the United
States of America, working in English and Spanish, with the following terms of reference:
A. Assess the need and value for the establishment of NRV-R for older infants and young children in
Codex texts in relation to:
i. the purpose of such NRVs-R in the Guidelines for Nutrition Labelling (CXG 2-1985) and Codex
texts for special dietary use for older infants and young children; and
ii. the specific age groups to which these NRV-R may apply.
Where a need is established under TOR A:
B. Analyse nutrition labelling provisions in Codex texts under TOR A (i) and, where appropriate,
develop a request to CCFL to provide advice on the potential for amendments to provide further
clarity.
FOOD ADDITIVES – MECHANISM / FRAMEWORK FOR CONSIDERING TECHNOLOGICAL
JUSTIFICATION AND OTHER MATTERS (Agenda item 9) 15
133. The EU as chair of the EWG, reviewed the process followed by the EWG, and presented their results.
134. The Committee considered the three recommendations of the EWG and made the following decisions and
comments.
14 REP17/NFSDU, para.40; CRD2 (Discussion paper by Australia); CRD11 (Comments of Tanzania, Thailand, African
Union, ISDI); CRD17 (Indonesia); CRD25 (Mali)
15 CX/NFSDU 17/39/8; CRD6 (ISDI); CRD12 (Canada, European Union, USA); CRD17 (Indonesia)
REP18/NFSDU 16
Recommendation 1 – Scope
135. One observer was of the view that the scope should be limited to standards with foods intended for infants and
young children.
136. The Committee agreed that all foods within its mandate should be covered by the framework.
Recommendation 2 – criteria (Annex A)
137. The Committee noted the views that: i) the questions included in Annex A were overly complex and difficult to
understand; ii) some questions went beyond technological justification, and should be considered by the
Committee on Food Additives (CCFA); and iii) the three sub-titles were unnecessary.
138. After explaining the rationale for the three sections in Annex A, i.e. section I was to check the eligibility and
intended use, Section II was to verify the compliance with the approach on the use of additives in foods
intended for infants and young children, and section III was to verify the compliance with section 3.2 of the
preamble to the General Standard for Food Additives (GSFA), the EU indicated that the order of sections II
and III could be changed in view of the decision on the scope.
139. The Committee agreed to use Annex A, comments received at the meeting, and comments reflected in the
CRDs as a basis for further consideration.
Recommendation 3 - continuation of the framework
140. In response to the concern on whether the framework could have an impact on special dietary foods such as
gluten-free foods, it was clarified that the purpose of the development of the framework was to appraise the
technological justification for food additives intended for JECFA evaluation rather than to prevent use of food
additives.
141. The Committee agreed to continue the work on the framework.
142. On the proposed list of food additives for testing the framework, the Committee noted the explanation and
views that:
• there had been concerns that several adopted food additive provisions for foods intended for infants
below 12 weeks of age had no appropriate safety assessment (see CRD15 of CCFA49), and that the
Committee was requested to consider this matter in its ongoing work on technological justification;
depending on the outcome of technological justification, these food additives could be either deleted
from the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
(CXS 72-1981) or included in the JECFA priority list;
• testing of the framework should be focused first on xanthum gum (INS 415), pectin (INS 440) and
gellan gum (INS 418); and that the food additives in CRD15 of CCFA49 should only be considered
after the framework had been tested on the aforementioned three food additives; and
• the framework should be applicable to new food additive requests and not delay decision on pectin
and xanthan gum for which JECFA has already undertaken safety assessments, and for which
sufficient technological justification had already been provided.
143. In the spirit of compromise, the Committee agreed to evaluate the relevant food additives in CRD15 of CCFA49
as a next step.
Conclusion
144. The Committee agreed to establish an EWG, chaired by the EU, and co-chaired by the Russian Federation
working in English with the following terms of reference:
(i) continue working on a mechanism or framework for considering the technological justification on the
basis of CX/NFSDU 17/39/8 and taking into account the comments in the CRDs and the discussion at
CCNFSDU39; and
(ii) test the agreed framework with the proposed use of xanthan gum (INS 415), pectin (INS 440) and
gellan gum (INS 418).
REP18/NFSDU 17
DISCUSSION PAPER ON CLAIM FOR “FREE” OF TRANS FATTY ACIDS (Agenda item 10) 16
145. Canada introduced the item and recalled that CCNFSDU38 had been presented with a value for a free of TFAs
claim of 1 g per 100 g of fat, and that three analytical methods for determining TFAs, had been referred to
CCMAS for consideration. Canada further informed the Committee that CCMAS38 had replied that the three
analytical methods could detect the levels of the proposed claim.
146. Based on the discussions of CCNFSDU38 and feedback from CCMAS38, the discussion paper had been
revised. The Committee considered an updated proposal of Canada that in order to carry a claim for “free of
trans-fat” the food should contain no more than 1 g per 100 g of fat and must meet the conditions set for “low”
in saturated fats.
Discussion
147. There was a general agreement on the value of 1 g per 100 g of fat. Several delegations and an observer,
while in support of the level of 1 g per 100 g of fat, did not support the accompanying conditions for “low” in
saturated fats based on a number of recent studies including a prospective cohort study in 18 countries (PURE
study) in five continents that saturated fat consumption showed no association with CVD and mortality, hence
the approach to limit the choice of TFA-free products to only those low in saturated fats would deprive
consumers of the right choice of food.
148. The Representative of WHO supported the proposal made by Canada to include the conditions for low
saturated fats in order to avoid increasing replacement of TFA with saturated fats. She also stated that the
PURE study cited by some member countries as new scientific evidence had in fact been criticised by many
experts and that WHO had also reviewed it carefully. It could be considered that an important strength of the
PURE study might be the large sample size and inclusion of populations from various countries and regions
throughout the world. But the pooling together of such diverse populations with diverse dietary patterns and
other factors would pose challenges and concerns with respect to interpretation of the results presented in the
study. WHO further found various concerns about their conclusion indicating that a higher intake of fats
(including saturated fats) was associated with lower NCD events and mortality. Among others, a key limitation
of the study was a lack of a clear definition of carbohydrates, whose consumption was compared with that of
fats in the paper. It was not clear which carbohydrates were included in the analyses and they did not seem to
distinguish carbohydrates with detrimental health effects (e.g. free sugars, refined grains) and those with health
benefits (e.g. fibre rich wholegrains, legumes, vegetables and fruits). She stated, therefore, it should not be
used as the evidence to promote the consumption of saturated fats.
149. The Committee further noted the following additional views expressed by delegations and observers:
• the condition for nutrient content claims for saturated fats requires that TFA should be taken into
account, and therefore the same should be applied to the claim free of TFA for consistency;
• the two large-scale prospective cohort studies, the Nurses’ Health Study and the Health Professional
Follow-up Study, found that increase in TFA by 1% was associated with 10% increase in total mortality
whereas increase in saturated fats by 5% was associated with the same outcome: therefore, the ratio
between TFA (1 g) and saturated fats (1.5 g) seemed to be an underestimation;
• the ingredient of concern was industrial trans fats; and that the methods should be sent back to
CCMAS to obtain validation data per 100 g of fat; and
• the issue of trans fats was better addressed through warnings, rather than through health claims.
Conclusion
150. The Committee agreed to send the proposal for comments at Step 3 and further consideration at its next
session (Appendix VI).
OTHER BUSINESS AND FUTURE WORK (Agenda item 11) 17
Methods of analysis for provisions in the Standard for infant formula and formulas for special medical
purposes intended for infants (CXS 72-1981)
151. The United States of America introduced this item.
16 CX/NFSDU 17/39/9; CRD13 (Comments of Philippines, Tanzania, Thailand, USA, African Union); CRD17 (Indonesia);
CRD18 (Malaysia); CRD19 (Republic of Korea); CRD20 (IFMA); CRD25 (Mali)
17 CRD3 (Comments of IPA); CRD4 (Costa Rica, Paraguay); CRD14 (USA); CRD21 (ISDI); CRD27 (Argentina).
REP18/NFSDU 18
Appendix I
LIST OF PARTICIPANTS
LISTE DES PARTICIPANTS
LISTA DE PARTICIPANTES
Dr Pia Noble
Federal Ministry of Food and Agriculture
Rochusstraße 1
53123 Bonn
Germany
Email: [email protected]
Ms Marie-Luise Trebes
Federal Ministry of Food and Agriculture
Rochusstraße 1
Bonn
Germany
Tel: +49 (0)228 99 529 3394
Email: [email protected]
Ms Melissa Toh
Mr Alexandre Novachi
Nestle Australia Ltd
ABIA’s Technical Consultant
Level 2, Building D 1 Homebush Bay Drive
ABIA – Brazilian Association of Food Industries
Rhodes, NSW
Av. Brigadeiro Faria Lima, 1478 – 11ª andar
Australia
São Paulo
Tel: +61 411 162 459
Brazil
Email: [email protected]
Email: [email protected]
AUSTRIA - AUTRICHE
Dr Marina Ferreira Rea
Coordinator for IBFAN/Brasil
Mrs Lisa-Maria Urban IBFAN/Brasil
Deputy Head of Department Rua Mourato Coelho, 208.
Federal Ministry of Health and Women´s Affairs Sao Paulo - SP
Radetzkystraße 2 Brazil
Vienna Tel: + 55 11 999033801
Austria Email: [email protected]
Tel: +43171100644793
Email: [email protected]
REP18/NFSDU Appendix I 21
Mr Theng Dim
Deputy Director General Mr Héctor Cori Traverso
General Directorate of CAMCONTROL Nutrition Science Director LatAm, DSM Nutritional
Ministry of Commerce Products
New building, National Road-1/ Str. No 18; Nutrition Science and Advocacy
Sangkat Viel Sbov, Khan Meanchey, Phnom Penh DSM Nutritional Products Chile S.A.
Phnom Penh Nueva Sucre 2544, Ñuñoa
Cambodia Santiago
Tel: +855-12526660 Chile
Email: [email protected] Tel: 56 222375 4179
Email: [email protected]
REP18/NFSDU Appendix I 22
Dr Éva Barna
Dr Susanne Veith
Expert Registration Referent
EU Government Affairs Manager
National Institute of Pharmacy and Nutrition
DuPont Deutschland Holding GmbH & Co. KG
Albert Flórián út 3/a
Unter den Linden 21
Budapest
Berlin
Hungary
Germany
Tel: +36 1 476 6450
Tel: +49 (0) 30-2092-4130
Email: [email protected]
Email: [email protected]
INDIA - INDE
Dr Anke Weissenborn
Unit Nutritional Risks, Allergies and Novel Foods
Department of Food Safety Mr Kms Khalsa
German Federal Institute for Risk Assessment Deputy Secretary
Max-Dohrn-Strasse 8-10 Food and Public Distribution
Berlin Ministry of Consumer Affairs, Food & PD
Germany Department of Food & Public Distribution Krishi
Tel: +49 30 18412-3812 Bhawan.
Email: [email protected] New Delhi
India
Tel: +91 11 23383046
Mrs Petra Wendorf-Ams
Email: [email protected]
Nutricia Research Early Nutrition Team
Milupa Nutricia GmbH
Germany Mr Ganesh Vishweshwar Bhat
Tel: 0049 6172 99 1186 Technical Officer
Email: [email protected] Ministry of Health and Family Welfare
Food Standards and Safety Authority of India
FDA Bhawan, Kotla Road, Near BAL Bhawan
GHANA
New Delhi
India
Ms Maria Aba Lovelace-Johnson Tel: +91 7834988648
Chief Regulatory Officer Email: [email protected]
Head Food Enforcement Department
Food and Drugs Authority
Ms Sukhmani Singh
P. O. BOX CT 2783 Cantonments
Technical Officer -Codex
Accra
Ministry of Health and Family Welfare
Ghana
Food Standards and Safety Authority of India
Tel: +233 208115619
FDA Bhawan, Kotla Road, 110002
Email: [email protected]
New Delhi
India
Mrs Gloria Aba Aryee Tel: +91 9560517397
Principal Regulatory Officer Email: [email protected]
Food and Drugs Authority
P. O. BOX CT 2783 Cantonments
Accra
Ghana
Tel: +233 243 089522
Email: [email protected]
REP18/NFSDU Appendix I 28
KENYA
LITHUANIA - LITUANIE - LITUANIA
Mr Peter Mutua
MALAYSIA - MALAISIE - MALASIA
Principle standard officer
Standard development
KENYA BUREAU OF STANDARDS Ms Zalma Abdul Razak
P.O.BOX 54974 POPO ROAD OFF MOMBASA Director
ROAD Nutrition Division
Nairobi Ministry of Health Malaysia
Kenya Level 1, Block E3, Parcel E, Federal Government
Tel: +254-20 6948000 Administration Centre
Email: [email protected] Putrajaya
Malaysia
Mr James Ojiambo Olumbe Tel: +603-8892 4556
Regulatory and scientific affairs Manager Email: [email protected]
Regulatory Affairs
Nestle Kenya Limited Ms Norrani Eksan
P.O.Box 30265 Nairobi Deputy Director
Nairobi Food Safety and Quality Division
Kenya Ministry of Health Malaysia
Tel: +254 20 3990000 Level 4, Menara Prisma No 26, Jalan Persiaran
Email: [email protected] Perdana, Precint 3
Putrajaya
Malaysia
REP18/NFSDU Appendix I 30
Tel: +603 88850794 Oklahoma No. 14, Colonia Nápoles, Del. Benito
Email: [email protected] Juárez , Ciudad de México, México
Ciudad de México
Ms Rohaya Mamat Mexico
Director Email: [email protected]
Regulatory Affairs
Federation of Malaysian Manufacturers Mr Javier Luna
Wisma FMM, No. 3, Persiaran Dagang PJU 9, Chairman of ANIPRON
Bandar Sri Damansara Mexican Trade Association for Natural Products
Kuala Lumpur CDMX
Malaysia Mexico
Tel: +6012-4880110 Email: [email protected]
Email: [email protected]
Mr Carlos Almanza
Dr Kanga Rani Selvaduray Coordinador del Comité de Industria para la
Head of Nutrition Unit Atención de Codex Alimentarius
Product Development and Advisory Services Confederación de Cámaras Industriales (CIACA-
Division CONCAMIN)
Malaysia Palm Oil Board Manuel Ma. Contreras 133
No 6, Persiaran Institusi Bandar Baru Bangi CDMX
Kajang, Selangor Mexico
Malaysia Email: [email protected]
Tel: +603-87694216
Email: [email protected] Ms Ana Laura Castro Becerra
Representante
MALI - MALÍ Cámara Nacional de Industriales de la Leche,
CANILEC
Dr Diakite Oumou Soumana Maiga Benjamín Franklin 134, Colonia Escandón ,
Directrice Générale Delegación Miguel Hidalgo.
Ministère de la Santé et de l'Hygiène Publique CDMX
Agence Nationale de la Sécurité Sanitaire des Mexico
Aliments Email: [email protected]
Centre Commercial, Quartier du Fleuve BPE: 2362
Bamako Ms Magda Cristina García Domínguez
Mali Sr. Manager Regulatory Science, México
Tel: +223 66741504 /+223 20220747 Mead Johnson Nutrition
Email: [email protected] Lago Zurich No. 245, Edificio Presa Falcón, Piso
11, Col. Ampliación Granada, Del. Miguel Hidalgo
Mr Mahmoud Abdoul Camara CDMX
Chargé du Service Central de Liaison du Codex Mexico
pour le Mali Email: [email protected]
Ministère de la Santé et de l'Hygiène Publique
Agence Nationale de la Sécurité Sanitaire des Ms Angélica Carmina Martinez Méndez
Aliments Gerente de Asuntos Regulatorios North Latam
Centre Commercial, Rue 305 Quartier du Fleuve Cámara Nacional de Industriales de la Leche,
BPE: 2362 Bamako CANILEC
Mali Benjamín Franklin 134, Colonia Escandón ,
Tel: +223 20 22 07 54 , +223 663245 Delegación Miguel Hidalgo.
Email: [email protected] CDMX
Mexico
MEXICO - MEXIQUE - MÉXICO Email: [email protected]
Wellington Abuja
New Zealand Nigeria
Email: [email protected] Tel: +2348034591774
Email: [email protected]
Ms Jane Broughton
Manager NORWAY - NORVÈGE - NORUEGA
Fonterra Co-operative Group Ltd
Private Bag 11029, Fitzherbert Dairy Farm Rd Mrs Svanhild Vaskinn
Palmerston North Senior Adviser
New Zealand Head Office
Email: [email protected] Norwegian Food Safety Authority
Brumunddal
Ms Charlotte Channer Norway
Senior Adviser Tel: 0047 22 40 00 00
Ministry for Primary Industries Email: [email protected]
25 The Terrace
Wellington Mrs Gry Hay
New Zealand Senior Adviser, Dr.Philos
Email: [email protected] Norwegian Directorate of Health
Oslo
Ms Dianne Lowry Norway
Regulatory and Technical Liaison Manager Tel: 0047 24 16 30 00
Dairy Goat Co-operative (NZ) Ltd Email: [email protected]
18 Gallagher Drive
Hamilton PHILIPPINES - FILIPINAS
New Zealand
Email: [email protected]
Ms Helena Alcaraz
Food and Drug Regulation Officer V
NIGERIA - NIGÉRIA Food and Drug Administration
Department of Health
Mrs Adeyinka Elizabeth Akinbinu Civic Drive Filinvest Corporate City, Alabang
Principal Agric. Superintendent Muntinlupa City
Federal Department of Agriculture Philippines
Federal Ministry of Agriculture and Rural Tel: 0063 9209499432
Development Email: [email protected]
FCDA Secretariat, Area 11, Garki Abuja FCT
Abuja Ms Catherine Sarmiento
Nigeria Official Representative
Tel: +2348059607576 Infant Nutrition Association of the Philippines
Email: [email protected] Infant and Pediatric Nutrition Association of the
Philippines
Mrs Margaret Efiong Eshiett 6A, 6/F DAO 1 Condominium, 189 Salcedo Street
Head, Codex Contact Point (Nigeria) Legaspi Village
Standards Organisation of Nigeria Makati City
Plot 13/14 Victoria Arobieke Street, Off Admiralty Philippines
Way, Lekki Pennisula- Lekki Phase 1 Tel: 639175312771
Lagos Email: [email protected]
Nigeria
Tel: +2348023179774 POLAND - POLOGNE - POLONIA
Email: [email protected]
Dr Katarzyna Stos
Mrs Olanrewaju Olaotan Olaobaju Deputy Director
Assistant Chief Regulatory Officer Food Safety and Food Supplements
Food Safety and Applied Nutrition Directorate National Food and Nutrition Institute
National Agency for Food and Drug Administration Powsińska Street 61/63
and Control (NAFDAC) Warsaw
NAFDAC, Wuse Zone 7
REP18/NFSDU Appendix I 33
PALESTINE – PALESTINA
Ms Luisa Candido
Ms Joanna Skinner
Nutrition and Technical Manager
Manager, Regulatory Labeling & Nutrition
Dairy UK
Global Scientific & Regulatory Affairs
United Kingdom
The Coca-Cola Company
Email: [email protected]
One Coca-Cola Plaza
Atlanta
REP18/NFSDU Appendix I 44
Mr Scott Tips
Ms Mareike Preller
President
Specialised Nutrition Europe
National Health Federation
Avenue des Nerviens 9-31
PO Box 688
Brussels
Monrovia
Belgium
United States of America
Tel: +32 2 508 10 74
Tel: 6263572181
Email: [email protected]
Email: [email protected]
Ms Aurélie Perrichet
Specialised Nutrition Europe (SNE)
Brussels
Belgium
Tel: +32 2 508 10 74
Email: [email protected]
REP18/NFSDU Appendix I 47
Ms Alison Fleet
Technical Specialist Dr Chizuru Nishida
Nutrition Coordinator, Nutrition Policy and Scientific Advice
UNICEF (NPU)
Oceanvej 10-12 Department of Nutrition for Health and
Copenhagen Development (NHD)
Denmark World Health Organization
Tel: +45 45335642 Email: [email protected]
Email: [email protected]
Dr Lee Hooper
FAO PERSONNEL Reader in Research Synthesis, Nutrition and
PERSONNEL DE LA FAO Hydration
PERSONAL DE LA FAO Norwich Medical School
University of East Anglia NR4 7TJ Norwich United
Dr Warren Lee Kingdom of Great Britain and Northern Ireland
Senior Nutrition Officer & Group Leader United Kingdom
Nutrition and Food Systems Division (ESN) Tel: +44 1603 591 268
FAO Email: [email protected]
Viale delle Terme di Caracalla
Rome Dr Cintia Lombardi
Italy Specialist, Prevention of Childhood and Adolescent
Tel: +39 06 570 54077 Obesity
Email: [email protected] Department of Noncommunicable Diseases and
Mental Health
Mr Markus Lipp 525 23rd Street NW Washington DC 20037 USA
Senior Food Safety Officer Tel: +1 202 974-3280
Agriculture and Consumer Protection Department Email: [email protected]
Food and Agriculture Organization of the U.N.
Viale delle Terme di Caracalla Dr Jason Montez
Rome Technical Officer
Italy Department of Nutrition for Health and
Email: [email protected] Development (NHD)
WORLD HEALTH ORGANIZATION
Ms Maria Xipsiti AVENUE APPIA, 20
Nutrition Officer GENEVA 27
Nutrition and Food Systems Division Switzerland
Food and Agriculture Organization of the UN Email: [email protected]
Viale delle Terme di Caracalla
Rome Mr Kim Petersen
Italy Scientist
Tel: 0657056060 Food Safety and Zoonoses Department (FOS)
Email: [email protected] World Health Organization
20 Avenue Appia
Geneva
Switzerland
Tel: +41227911439
Email: [email protected]
Mr Marcus Stahlhofer
Technical Officer
Department of Maternal, Newborn, Child and
Adolescent Health &
WORLD HEALTH ORGANIZATION
20, AVENUE APPIA
GENEVA 27
REP18/NFSDU Appendix I 48
Dr Rain Yamamoto
Food Standards Officer
FAO/WHO Codex Alimentarius Commission
Viale delle Terme di Caracalla
Rome
Italy
Tel: (+39) 06 5705 5868
Email: [email protected]
Ms Lingping Zhang
Food Standards Officer
Joint FAO/WHO Food Standards Programme Food
and Agriculture Organization of the UN
REP18/NFSDU Appendix II 49
Appendix II
PROPOSED DRAFT REVISED STANDARD FOR FOLLOW-UP FORMULA (CXS 156-1987)
- ESSENTIAL COMPOSITION -
(for adoption at Step 5)
2) For the purpose of this standard the calculation of the protein content of the final product ready for consumption should be based on
N x 6.25, unless a scientific justification is provided for the use of a different conversion factor for a particular product. The protein levels
set in this standard are based on a nitrogen conversion factor of 6.25. For information the value of 6.38 is used as a specific factor
appropriate for conversion of nitrogen to protein in other Codex standards for milk products.
3) For an equal energy value the formula must contain an available quantity of each essential and semi essential amino acid at least
equal to that contained in the reference protein (breast-milk as defined in Annex I of the Standard for Infant Formula and Formulas for
Special Medical Purposes Intended for Infants (CXS 72-1981)); nevertheless for calculation purposes the concentrations of tyrosine and
phenylalanine may be added together and the concentrations of methionine and cysteine may be added together.
4) Isolated amino acids may be added to follow-up formula only to improve its nutritional value for infants. Essential and semi-essential
amino acids may be added to improve protein quality, only in amounts necessary for that purpose. Only L-forms of amino acids shall be
used.
5) The minimum value applies to cows’ and goats’ milk protein. For follow-up formula based on non-cows’ or non-goats’ milk protein
other minimum values may need to be applied. For follow-up formula based on soy protein isolate, a minimum value of 2.25 g/100 kcal
(0.54 g/100 kJ) applies.
6)
A lower minimum protein level between 1.6 and 1.8 g/100 kcal (0.38 and 0.43 g/100 kJ) in follow-up formula based on non-hydrolysed
milk protein can be accepted. Such follow-up formula and follow-up formula based on hydrolysed protein should be evaluated for their
safety and suitability and assessed by a competent national and/or regional authority based on clinical evidence.
b) Lipids
Total Fat 7), 8)
Unit Minimum Maximum GUL
g/100 kcal 4.4 6.0 -
g/100 kJ 1.1 1.4 -
7)
Partially hydrogenated oils and fats shall not be used in follow-up formula for older infants.
8)
Lauric acid and myristic acids are constituents of fats, but combined shall not exceed 20% of total fatty acids. The content
of trans fatty acids shall not exceed 3% of total fatty acids. Trans fatty acids are endogenous components of milk fat. The
acceptance of up to 3% of trans fatty acids is intended to allow for the use of milk fat in infant formulae. The erucic acid content
shall not exceed 1% of total fatty acids. The total content of phospholipids should not exceed 300 mg/100 kcal (72 mg/100 kJ).
Linoleic acid
Unit Minimum Maximum GUL
mg/100 kcal 300 - 1400
mg/100 kJ 72 - 335
REP18/NFSDU Appendix II 50
α-Linolenic acid
Unit Minimum Maximum GUL
mg/100 kcal 50 N.S.* -
mg/100 kJ 12 N.S. -
*N.S. = not specified
c) Carbohydrates
Available carbohydrates 9)
Unit Minimum Maximum GUL
g/100 kcal 9.0 14.0 -
g/100 kJ 2.2 3.3 -
9)
Lactose and glucose polymers should be the preferred carbohydrates in formula based on cow’s milk protein and hydrolysed protein.
Only precooked and/or gelatinised starches gluten-free by nature may be added. Sucrose and/or fructose should not be added, unless
needed as a carbohydrate source, and provided the sum of these does not exceed 20% of available carbohydrate.
d) Vitamins
Vitamin A
Unit Minimum Maximum GUL
µg RE10)/100 kcal 75 180 -
µg RE10)/100 kJ 18 43 -
10)
expressed as retinol equivalents (RE)
1 µg RE = 3.33 IU Vitamin A = 1 µg trans retinol. Retinol contents shall be provided by preformed retinol, while any contents of carotenoids
should not be included in the calculation and declaration of vitamin A activity.
Vitamin D
Unit Minimum Maximum GUL
µg11) /100 kcal 1.0 3.0 -
µg11) /100 kJ 0.24 0.72 -
11)
Calciferol. 1 µg calciferol = 40 IU vitamin D.
Vitamin E
Unit Minimum Maximum GUL
mg α-TE12) /100 kcal 0.5 13) - 5
mg α-TE12) /100 kJ 0.12 13) - 1.2
12)
1 mg α-TE (alpha-tocopherol equivalents) = 1 mg d-α-tocopherol
13)
Vitamin E shall be at least 0.5 mg α-TE per g PUFA, using the following factors of equivalence to adapt the minimal vitamin E content
to the number of fatty acid double bonds in the formula: 0.5 mg αTE /g linoleic acid (18:2 n-6); 0.75 α-TE/g α-linolenic acid (18:3 n-3); 1.0
mg α-TE/g arachidonic acid (20:4 n-6); 1.25 mg α-TE/g eicosapentanoic acid (20:5 n-3); 1.5 mg α-TE/g docosahexaenoic acid (22:6 n-3).
Vitamin K
Unit Minimum Maximum GUL
µg /100 kcal 4 - 27
µg /100 kJ 1.0 - 6.5
Thiamin
Unit Minimum Maximum GUL
µg /100 kcal 60 - 300
µg /100 kJ 14 - 72
Riboflavin
Unit Minimum Maximum GUL
µg /100 kcal 80 - 500
µg /100 kJ 19 - 119
REP18/NFSDU Appendix II 51
Niacin 14)
Unit Minimum Maximum GUL
µg /100 kcal 300 - 1500
µg /100 kJ 72 - 360
14)
Niacin refers to preformed niacin
Vitamin B 6
Unit Minimum Maximum GUL
µg /100 kcal 35 - 175
µg /100 kJ 8.4 - 41.8
Vitamin B12
Unit Minimum Maximum GUL
µg /100 kcal 0.1 - 1.5
µg /100 kJ 0.024 - 0.36
Pantothenic acid
Unit Minimum Maximum GUL
µg /100 kcal 400 - 2000
µg /100 kJ 96 - 478
Folic acid
Unit Minimum Maximum GUL
µg /100 kcal 10 - 50
µg /100 kJ 2.4 - 12
Vitamin C 15)
Unit Minimum Maximum GUL
mg /100 kcal 10 - 70 16)
mg /100 kJ 2.4 - 17 16)
15)
expressed as L-ascorbic acid
16)
This GUL has been set to account for possible high losses over shelf-life in liquid formulas; for powdered products lower upper levels
should be aimed for.
Biotin
Unit Minimum Maximum GUL
µg /100 kcal 1.5 - 10
µg /100 kJ 0.4 - 2.4
Calcium
Unit Minimum Maximum GUL
mg /100 kcal 50 - 180
mg /100 kJ 12 - 43
Phosphorus
Unit Minimum Maximum GUL
mg /100 kcal 25 - 100 18)
mg /100 kJ 6 - 24 18)
18)
This GUL should accommodate higher needs with Follow-up formula based on soy protein isolate.
REP18/NFSDU Appendix II 52
Ratio calcium/phosphorus
Min Max
1:1 2:1
Magnesium
Unit Minimum Maximum GUL
mg /100 kcal 5 - 15
mg /100 kJ 1.2 - 3.6
Sodium
Unit Minimum Maximum GUL
mg /100 kcal 20 60 -
mg /100 kJ 5 14 -
Chloride
Unit Minimum Maximum GUL
mg /100 kcal 50 160 -
mg /100 kJ 12 38 -
Potassium
Unit Minimum Maximum GUL
mg /100 kcal 60 180 -
mg /100 kJ 14 43 -
Manganese
Unit Minimum Maximum GUL
µg /100 kcal 1.0 - 100
µg /100 kJ 0.24 - 24
Iodine
Unit Minimum Maximum GUL
µg /100 kcal 10 - 60
µg /100 kJ 2.4 - 14.3
Selenium
Unit Minimum Maximum GUL
µg /100 kcal 2 - 9
µg /100 kJ 0.48 - 2.2
Copper 19)
Unit Minimum Maximum GUL
µg /100 kcal 35 - 120
µg /100 kJ 8.4 - 29
19) Adjustment may be needed in these levels for Follow-up formula made in regions with a high content of copper in the water supply.
Zinc 20)
Unit Minimum Maximum GUL
mg /100 kcal 0.5 - 1.5
mg /100 kJ 0.12 - 0.36
20) For Follow-up formula based on soy protein isolate a minimum value of 0.75 mg/100 kcal (0.18 mg/100 kJ).
3.2.3 The following substances may be added in conformity with national legislation, in which case their
content per 100 kcal (100kJ) in the Follow-up Formula ready for consumption shall not exceed the
levels listed below. This is not intended to be an exhaustive list, but provides a guide for competent
national and/or regional authorities as to appropriate levels when these substances are added.
Taurine
Unit Minimum Maximum GUL
mg /100 kcal - 12 -
mg /100 kJ - 3 -
Total nucleotides
Levels may need to be determined by national authorities.
mg /100 kcal - - 30
mg /100 kJ - - 7.2
21)
If docosahexaenoic acid (22:6 n-3) is added to follow-up formula, a minimum level of 20 mg/100 kcal (4.8 mg/100 kJ) should be
reached, and arachidonic acid (20:4 n-6) contents should reach at least the same concentration as DHA. The content of
eicosapentaenoic acid (20:5 n-3), which can occur in sources of LC-PUFA, should not exceed the content of docosahexaenoic
acid. Competent national and/or regional authorities may deviate from the above conditions, as appropriate for the nutritional
needs.
Choline
Unit Minimum Maximum GUL
mg /100 kcal - - 50
mg /100 kJ - - 12
Myo-inositol
Unit Minimum Maximum GUL
mg /100 kcal - - 40
mg /100 kJ - - 9.6
L-carnitine
Levels may need to be determined by national authorities.
L (+) lactic producing cultures
Only L (+) lactic producing cultures may be used for the purpose of producing acidified follow-up formula for
older infants. The acidified final formula product should not contain significant amounts of viable L (+) lactic
acid-producing cultures, and residual amounts should not represent any health risk.
The safety and suitability of the addition of specific strains of L(+) lactic acid producing cultures for particular
beneficial physiological effects, at the level of use, must be demonstrated by clinical evaluation and generally
accepted scientific evidence. When added for this purpose, the final product ready for consumption shall
contain sufficient amounts of viable cultures to achieve the intended effect.
REP18/NFSDU Appendix II 54
b) Lipids 3)
Total fat
Unit Minimum Maximum GUL
g /100 kcal 3.5 - -
g /100 kJ 0.84 - -
α-linolenic acid
Unit Minimum Maximum GUL
mg /100 kcal 50 - -
mg /100 kJ 12 - -
Linoleic acid
Unit Minimum Maximum GUL
mg /100 kcal 300 - -
mg /100 kJ 72 - -
3)
Partially hydrogenated oils and fats shall not be used in [name of product] for young children.
c) Carbohydrates
Available carbohydrates 4)
Unit Minimum Maximum5) GUL
g /100 kcal - 12.5 -
g /100 kJ - 3.0 -
∗
Guidance upper levels are for nutrients without sufficient information for a science-based risk assessment. These levels are values
derived on the basis of meeting nutritional requirements of young children and an established history of apparent safe use. They may be
adjusted based on relevant scientific or technological progress. The purpose of the GULs is to provide guidance to manufacturers and
they should not be interpreted as goal values. Nutrient contents in [name of product] for young children should usually not exceed the
GULs unless higher nutrient levels cannot be avoided due to high or variable contents in constituents of [name of product] for young
children or due to technological reasons. When a product type or form has ordinarily contained lower levels than the GULs, manufacturers
should not increase levels of nutrients to approach the GULs.
REP18/NFSDU Appendix II 55
4) [Lactose should be the preferred carbohydrates in [name of product] based on milk protein. For products not based on milk protein,
carbohydrate sources (like starch) that have no contribution to the sweet taste should be preferred.
Mono- and disaccharides, other than lactose, either added as ingredients, or constituents of ingredients and/or increased above the
amount contributed by the ingredients by some other means, should not exceed 2.5 g/100kcal (0.60 g/100kJ) of available carbohydrate.
National and/or regional authorities may limit this level to 1.25 g/100 kcal (0.30 g/100 kJ). Sucrose and/or fructose or other carbohydrates
contributing to the sweet taste of [name of product] should not be added, unless needed as a carbohydrate source. Other non-carbohydrate
ingredients should not be added with the purpose of imparting or enhancing a sweet taste. ]
5
) For [Name of the product] for young children with a protein level below 3.0 g/100 kcal a maximum level of available carbohydrates
up to 14 g/100 kcal (3.3 g/100 kJ) may be permitted by competent national and/or regional authorities.
Vitamin C 7)
Unit Minimum Maximum GUL
mg /100 kcal 10 - 70
mg /100 kJ 2.4 - 17
7) expressed as L-ascorbic acid
Calcium
Unit Minimum Maximum GUL
mg /100 kcal 90 - 280
mg /100 kJ 22 - 67
Riboflavin
Unit Minimum Maximum GUL
µg /100 kcal 80 - 650
µg /100 kJ 19 - 155
Vitamin B12
Unit Minimum Maximum GUL
µg /100 kcal 0.1 - 2.0
µg /100 kJ 0.024 - 0.48
Zinc
Unit Minimum Maximum GUL
mg /100 kcal 0.5 - 1.5
mg /100 kJ 0.12 - 0.36
Vitamin A
Unit Minimum Maximum GUL
µg RE8) /100 kcal 60 180 -
µg RE8) /100 kJ 14 43 -
8)
expressed as retinol equivalents (RE)
1 µg RE = 3.33 IU Vitamin A = 1 µg all-trans retinol. Retinol contents shall be provided by preformed retinol, while any contents of
carotenoids should not be included in the calculation and declaration of vitamin A activity.
REP18/NFSDU Appendix II 56
[Vitamin D39)]
Unit Minimum Maximum GUL
µg10) /100 kcal [1.5] [4.5] -
µg10) /100 kJ [0.36] [1.08] -
[9) Competent national and/or regional authorities may deviate from the conditions as appropriate for the nutritional needs of their
population.]
10)
Calciferol. 1 µg calciferol = 40 IU vitamin D.
Sodium chloride should not be added to [name of the product] for young children.
3.1.4 National and/or regional authorities may add mandatory requirements for essential nutrients listed
under 3.1.3, Section B. Any additional mandatory nutrients should be chosen from the essential
composition of follow-up formula for older infants under 3.1.3 Section A. If additional mandatory
nutrients are added, the nutrient levels must be based on the nutrient composition of follow-up formula
for older infants (3.1.3 Section A) which is informed by the composition of breast milk, and take into
account the inherent levels of nutrients in cows’ milk.
All nutrient levels may be amended if the nutritional needs of the local population and scientific
justification warrants such deviation.
3.2 Optional Ingredients
3.2.1 In addition to the essential compositional requirements listed under 3.1.3 Section B, other ingredients,
substances or nutrients may be added to [name of the product] for young children where the safety
and suitability of the optional ingredient for particular nutritional purposes, at the level of use, is
evaluated by national and/or regional authorities and demonstrated by generally accepted scientific
evidence. Optional ingredients listed in 3.2.3 Section A are also permitted.
3.2.2 When any of these ingredients, substances or nutrients is added the formula shall contain sufficient
amounts to achieve the intended effect.
3.2.3 Additional nutrients may also be added to [name of the product] for young children provided these
nutrients are chosen from the essential composition of follow-up formula for older infants and levels
are as per the minimum, maximum, GULs stipulated for follow-up formula for older infants (3.1.3
Section A) and take into account the inherent levels of nutrients in cows’ milk; or amended by national
and/or regional authorities if the nutritional needs of the local population and scientific justification
warrants such deviation.
REP18/NFSDU Appendix III 57
Appendix III
PROPOSED DRAFT REVISED STANDARD FOR FOLLOW-UP FORMULA (CXS 156-1987)
- OTHER SECTIONS -
(for further consideration by EWG)
PREAMBLE
[The Codex Alimentarius Commission acknowledges the need to [protect and support / recognize] breast-
feeding as an unequalled way of providing ideal food for the healthy growth and development of infants. At the
same time Codex acknowledges that numerous formulae have been produced, intended for use, where
[necessary / appropriate], as a substitute for human milk in meeting the normal nutritional requirements of
infants provided they are prepared under hygienic conditions and given in adequate amounts. In addition,
various products have also been produced intended specifically for young children as they progress to a more
diversified diet of family foods and these products should not discourage breastfeeding.
The production, distribution, sale and use of follow-up formula for older infants and [name of product] for young
children should be consistent with national health and nutrition policies and relevant national/regional
legislation, and take into account, [as appropriate,] the recommendations made in the International Code of
Marketing of Breast-milk Substitute (1981) and the Global Strategy for Infant and Young Child Feeding.
Relevant WHO guidelines and policies as well as relevant World Health Assembly (WHA) resolutions that have
been [endorsed / supported] by member states [may also] provide guidance to countries in this context.
This Standard is divided into two sections. Section A refers to Follow-up Formula for Older Infants (6 to 12
months of age), and Section B deals with [Name of Product] for Young Children (12 to 36 months of age). It
does not apply to products covered by the Codex Standard for Infant Formula and Formulas for Special
Medical Purposes Intended for Infants (CODEX STAN 72 – 1981 CXS 72-1981).]
SECTION A: FOLLOW-UP FORMULA FOR OLDER INFANTS
1 [SCOPE
1.1 This section of the Standard applies to Follow-up Formula for Older Infants, as defined in Section 2.1,
in liquid or powdered form.
1.2 This section of the Standard contains compositional, quality, safety, [labelling and analytical]
requirements for Follow-up Formula for Older Infants.
1.3 Only products that comply with the criteria laid down in the provisions of this section of this
Standard [should / shall] be presented as Follow-up Formula for Older Infants.]
2 DESCRIPTION
2.1 Product Definition
2.1.1 [Follow-up formula for older infants means a product, specially manufactured for use as a
substitute for breastmilk, as a liquid part of a progressively diversified diet for older infants when
complementary feeding is introduced.]
2.1.2 Follow-up formula [for older infants] is so processed by physical means only and so packaged as to
prevent spoilage and contamination under all normal conditions of handling, storage and distribution
in the country where the product is sold.
2.2 Other Definitions
2.2.1 The term infant means a person of not more than 12 months of age.
2.2.2 The term older infant means a person from the age of 6 months and not more than 12 months of age.
9. [LABELLING]
The requirements of the Codex General Standard for the Labelling of Pre-packaged Foods (CXS 1-1985), the
Guidelines on Nutrition Labelling (CXG 2-1985) and the Guidelines for Use of Nutrition and Health Claims
(CXG 23-1997) apply to follow-up formula for older infants. [These requirements include a prohibition on the
use of nutrition and health claims for foods for infants and young children except where specifically provided
for in relevant Codex Standards or national legislation.]
9.1 The Name of the Product
9.1.1 The text of the label and all other information accompanying the product shall be written in the
appropriate language(s).
REP18/NFSDU Appendix III 58
9.1.2 The name of the product shall be Follow-up Formula for Older Infants as defined in Section 2.1, or any
appropriate designation indicating the true nature of the product, in accordance with national [or
regional] usage.
9.1.3 The sources of protein in the product shall be clearly shown on the label.
a) If [name of animal] milk is the only source of protein[*], the product may be labelled ‘Follow-up
Formula for Older Infants Based on [name of animal] milk [protein].
b) If [name of plant] is the only source of protein[*], the product may be labelled ‘Follow-up Formula
for Older Infants Based on [name of plant] [protein].
c) if [name of animal] milk and [name of plant] are the sources of proteins*, the product may be
labelled ‘Follow-up Formula for Older Infants Based on [name of animal] milk protein and
[name of plant] protein or ‘Follow-up Formula for Older Infants Based on [name of plant]
protein and [name of animal] milk protein’.
[* For clarity, addition of individual amino acids where needed to improve protein quality does not
preclude use of the above labelling options.]
9.1.5 A product which contains neither milk nor any milk derivative [shall] [may] be labelled "contains no
milk or milk products" or an equivalent phrase.
9.2 List of Ingredients
9.2.1 A complete list of ingredients [including optional ingredients] shall be declared on the label in
descending order of proportion except that in the case of added vitamins and minerals, these
ingredients may be arranged as separate groups for vitamins and minerals. Within these groups the
vitamins and minerals need not be listed in descending order of proportion.
9.2.2 The specific name shall be declared for ingredients of animal or plant origin and for food additives. In
addition, appropriate functional classes for these ingredients and additives may be included
on the label. [The food additives INS number may also be optionally declared the INS number].
9.3 Declaration of Nutritive Value
The declaration of nutrition information [for follow-up formula for older infants] shall contain the following
information which should be in the following order:
a) the amount of energy, expressed in kilocalories (kcal) and/or kilojoules (kJ), and the number of grams
of protein, carbohydrate and fat per 100 grams or per 100 millilitres of the food as sold [as well as] [or]
per 100 millilitres of the food ready for use, when prepared according to the instructions on the label.
b) the total quantity of each vitamin, and mineral as listed in paragraph 3.1.3 of Section A and any other
ingredient as listed in paragraph 3.2 of Section A per 100 grams or per 100 millilitres of the food as
sold [as well as] [or] per 100 millilitres of the food ready for use, when prepared according to the
instructions on the label.
c) In addition, the declaration of nutrients in a) and b) per 100 kilocalories (or per 100 kilojoules) is
permitted.
9.4 Date Marking and Storage Instructions
9.4.1 (i) The “Best Before Date” or “Best Quality Before Date” shall be declared by the day, month and
year except that for products with a shelf-life of more than three months, [at least] the month and year
[shall be declared]. [The day and year shall be declared by uncoded numbers with the year to be
denoted by 2 or 4 digits, and the month shall be declared by letters or characters or numbers. Where
only numbers are used to declare the date or where the year is expressed as only two digits, the
competent authority should determine whether to require the sequence of the day, month, year, be
given by appropriate abbreviations accompanying the date mark (e.g. DD/MM/YYYY or
YYYY/DD/MM).]
(ii) In the case of products requiring a declaration of month and year only, the [date shall be introduced
by the words “Best before end <insert date>; or “Best Quality Before end <insert date>].
9.4.2 In addition to the date, any special conditions for the storage of the food shall be indicated if [where
they are required to support the integrity of the food and, where] the validity of the date depends
thereon.
Where practicable, storage instructions shall be in close proximity to the date marking.
REP18/NFSDU Appendix III 59
9.2.2 The specific name shall be declared for ingredients of animal or plant origin and for food
additives. [Food additives may also optionally declare the INS number].
9.3 Declaration of Nutritive Value
The declaration of nutrition information [for [name of product] for young children] shall contain the following
information which should be in the following order:
a) the amount of energy, expressed in kilocalories (kcal) and/or kilojoules (kJ), and the number of grams
of protein, carbohydrate and fat per 100 grams or per 100 millilitres of the food as sold [as well as] [or]
per 100 millilitres of the food ready for use, when prepared according to the instructions on the label.
b) the total quantity of each vitamin, and mineral as listed in paragraph 3.1.3 of Section B and any other
ingredient as listed in paragraph 3.2 of Section B per 100 grams or per 100 millilitres of the food as
sold [as well as] [or] per 100 millilitres of the food ready for use, when prepared according to the
instructions on the label.
c) In addition, the declaration of nutrients in a) and b) per [serving size and/or per] 100 kilocalories (or
per 100 kilojoules) is permitted.
9.4 Date Marking and Storage Instructions
9.4.1 The “Best Before Date” or “Best Quality Before Date” date of minimum durability (preceded by the
words "best before") shall be declared by the day, month and year in uncoded numerical sequence
except that for products with a shelf-life of more than three months, [at least] the month and year [shall
be declared] will suffice. The month may be indicated by letters in those countries where such use will
not confuse the consumer. [The day and year shall be declared by uncoded numbers with the year to
be denoted by 2 or 4 digits, and the month shall be declared by letters or characters or
numbers. Where only numbers are used to declare the date or where the year is expressed as only
two digits, the competent authority should determine whether to require the sequence of the day,
month, year, be given by appropriate abbreviations accompanying the date mark (e.g. DD/MM/YYYY
or YYYY/DD/MM).]
In the case of products requiring a declaration of month and year only, and the shelf-life of the product
is valid to the end of a given year, the expression "end (stated year)" may be used as an alternative.
9.4.2 In addition to the date, any special conditions for the storage of the food shall be indicated if [where
they are required to support the integrity of the food and, where] the validity of the date depends
thereon.
Where practicable, storage instructions shall be in close proximity to the date marking.
9.5 Information for use
9.5.1 [Ready to use] products in liquid form may be used [either] directly or in the case of concentrated liquid
products [and powdered products], must be prepared with water that is safe or has been rendered
safe by previous boiling before feeding, according to directions for use. [Products in powder form
should be reconstituted with water that is safe or has been rendered safe by previous boiling for
preparation.] Adequate directions for the appropriate preparation and handling should be in
accordance with Good Hygienic Practice.
9.5.2 Adequate directions for the appropriate preparations and use of the product, including its storage and
disposal after preparation, i.e. that formula [product] remaining after feeding should be discarded, shall
appear on the label.
9.5.3 The label shall carry clear graphic instructions illustrating the method of preparation of the
product. [Pictures of feeding bottles are not permitted on labels of (name of product) for young
children.]
9.5.4 [The directions should be accompanied by a warning and about the health hazards of inappropriate
preparation, storage and use].
9.5.5 Adequate directions regarding the storage of the product after the container has been opened, shall
appear on the label.
[9.5.6 The label of [name of product] for young children shall include a statement that the product shall not
be introduced before 12 months of age and should be used as part of a [diversified] [balanced] diet.]
REP18/NFSDU Appendix III 62
Appendix IV
PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION
(for further consideration by EWG)
Definition:
[ Biofortification* is the process whereby any nutrients1) are increased [by a measurable level] or become
more bioavailable inof all potential source organisms2) [for] OR [of] OR [and] foods are increased by a
measurable levelfor the intended nutritional purposes3).The process applies to any method of production4)
[and excludes conventional addition of nutrients to food5)].
*)
Some Member governments may prefer to use the equivalent term of agro-fortification, agri-
fortification or nutri-fortification.
1) Nutrientis defined by Guidelines on Nutrition Labelling (CAC/GL 2-1985) to mean: any substance normally
consumed as a constituent of food: a) which provides energy; or b) which is needed for growth and
development and maintenance of life; c) or a deficit of which will cause characteristic biochemical or
physiological changes to occur.
2) e.g. animal, plant, fungi, yeasts, bacteria.
3) Intended purposes:
- preventing/reducing the risk of, or correcting, a demonstrated deficiency in the population;
- reducing the risk of, or correcting, inadequate nutritional status or intakes in the population;
- meeting requirements and/or recommended intakes of one or more nutrients;
- maintaining or improving health; and/or
- maintaining or improving the nutritional quality of food.
4) Method of production should be determined by the competent National/Regional authority.
5) Biofortification does not include conventional fortification covered by CAC/GL 9/1987.]
REP18/NFSDU Appendix V 64
Appendix V
PROPOSED DRAFT GUIDELINES FOR READY TO USE THERAPEUTIC FOODS (RUTF)
(for further consideration by EWG)
1. PREAMBLE
[The major objectives of the work of the Codex Alimentarius Commission are to protect the health of the
consumer and ensure fair practices in the trade in food through the elaboration and harmonization of definitions
and requirements for food. In order to realize this objective CAC developed a Code of Ethics for International
Trade in Food including Concessional and Food Aid Transactions (CAC/RCP 20-1979) embodying the
principles of sound consumer protection. The objective of this code is to establish standards of ethical conduct
for all those engaged in international trade in food or for those responsible for regulating food and thereby
protecting the health of the consumers and promoting fair trade practices. It is within this context that all those
engaging in the international trade in food with specific reference to Ready-to-Use Therapeutic Foods (RUTF)
commit themselves to the provisions of the code].
Children affected by severe acute malnutrition (SAM) need [adequate treatment and care] OR [safe,
palatable foods with a high energy content and adequate amounts of vitamins, minerals and other critical
nutrients. Children with SAM need timely treatment and RUTF is a critical part of the treatment]. [RUTF are
high energy, fortified, ready-to-eat foods for special medical purposes suitable for the dietary management of
children with SAM]. RUTF are primarily intended for children with uncomplicated SAM from 6-59 months.
Although RUTF are given to other age groups with various forms of malnutrition at the implementation level,
the primary focus for these guidelines is children with SAM from 6-59 months. Since RUTF are prescribed
according to weight, National Authorities may decide to include the provision of RUTF in their national protocols
for use by other age groups.
1JointStatement on Community-Based Management of Severe Acute Malnutrition by the World Health Organization, the
World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s
Fund, 2007
2WHO. Child growth standards and the identification of severe acute malnutrition in infants and children, 2006
A Joint Statement by the World Health Organization and the United Nations Children's Fund; Geneva: World Health
Organization; 2009
3WHO. Guideline: Updates on the management of severe acute malnutrition in infants and children.
Geneva: World Health Organization; 2013.
4WHO. Global Strategy for Infant and Young Child Feeding. Geneva: World Health Organization; 2003.
5WHO. International code of marketing of breast-milk substitutes. Geneva: World Health Organization;
1981.
4. DESCRIPTION
4.1 Ready-to-Use Therapeutic Foods (RUTF) are foods for special medical purposes that are high-
energy, fortified, ready-to-eat foods for special medical purposes and contain adequate protein and other
essential nutrients for the dietary management of children from 6 to 59 months with severe acute malnutrition
without medical complications and with appetite. These foods should be soft or crushable and should be easy
for children to eat without any prior preparation.
4.2 Severe Acute Malnutrition is defined by weight for height (or length) less than –3 Z-score of the median
WHO growth standards, or by mid upper arm circumference (MUAC)<11.5 cm, or by the presence of bilateral
oedema10.
5. RAW MATERIALS AND INGREDIENTS
RUTF are made of powdered or ground ingredients embedded in a lipid-rich matrix, [e.g. paste or and biscuit],
resulting in an energy and nutrient-dense food. The following raw materials, many of which can be sourced
locally, are suitable ingredients for the production of RUTF under the specified conditions given below. The
formulation of RUTF shall comply with Section 3 of the Standard for the Labelling of and Claims for Foods for
Special Medical Purposes (CXS 180-1991).
5.1 Basic Raw Materials and Ingredients
5.1.1 Milk and other Dairy Products OR “Animal source products”
Milk and other dairy products used in the manufacturing of RUTF must comply with the Standard for Milk
Powders and Cream Powder (Codex STAN 207-1999) and the Standard for Whey Powders (CXS 289-1995),
and other Codex milk and milk product standards as well as other guidelines and Codes of Practice
recommended by Codex Alimentarius Commission which are relevant to these products. Relevant codes of
practice include the Code of Hygienic Practice for Milk and Milk Products (CXC 57-2004) and the Code of
Hygienic Practices for Low-Moisture Foods (CXC 75-2015).
REP18/NFSDU Appendix V 65
by the World Health Organization and the United Nations Children’s Fund. Geneva: World Health Organization; 2009]
5.1.3 Fats and Oils
Fats and oils used in the manufacturing of RUTF must comply with the relevant Codex Alimentarius texts. Fats
and oils are incorporated as technologically feasible for the purpose of achieving the energy density and
providing essential fatty acids. [Care must be taken to avoid oxidized fat which will adversely affect nutrition,
flavour and shelf life]. [The composition of fats and oils should allow for a product that flows during processing
to have desirable consistency and ensures physical and chemical stability throughout the supply chain].
Partially Hydrogenated fats and oils [, the major dietary source of industrially-produced trans fat in processed
food,] should not be used in RUTF.
5.1.4 Cereals
All milled cereals suitable for human consumption may be used provided that [their processing reduces] they
are processed in such a way that the fibre content is reduced, when necessary. , and that The effects of aAnti-
nutritional factors such as phytates, tannins or other phenolic materials, lectins, trypsin, and chymotrypsin
inhibitors which can lower the protein quality and digestibility, amino acid bioavailability and mineral absorption
should be are removed or reduced, whilst retaining maximum nutrient value.
5.1.5 Vitamins and Minerals
All added vitamins and minerals must be in accordance with the [principles of] Advisory Lists of Nutrient
Compounds for use in Foods for Special Dietary Uses Intended for Infants and Young Children (CXG 10-
1979). Examples of minerals for RUTF can be found in WHO Management of severe Malnutrition: a
manual for physicians and other senior health workers (1999).
5.2 Other Ingredients
5.2.1 [Available] Carbohydrates1
The palatability of the RUTF can be increased by the addition of [appropriate] available carbohydrates.
[Available] carbohydrates must adhere to the relevant Codex Alimentarius texts.
Honey should not be used in RUTF due to the risk of infant botulism from Clostridium botulinum.
1[Sucrose, plant vegetable starch, [maltodextrin], glucose, glucose syrup] should be the preferred carbohydrates in RUTF.
[Fructose and corn syrup as ingredients should [not be used] OR [be avoided] in RUTF, because of potential adverse
effects in SAM children.] Only precooked and/or gelatinised starches [gluten-free] by nature may be added]. [Any
carbohydrate added for sweetness should be used sparingly.]
REP18/NFSDU Appendix VI 66
Appendix VI
PROPOSED DRAFT CONDITIONS FOR A “FREE” OF TRANS FATTY ACIDS (TFAs) CLAIM
IN THE GUIDELINES FOR USE OF NUTRITION AND HEALTH CLAIMS (CXG 23-1997) 1
(for comments at Step 3)
1 To be inserted between Saturated Fat and Cholesterol within the Table of conditions for nutrient content claims in the
Guidelines for Use of Nutrition and Health Claims (CXG 23-1997)
2 As per the Table conditions for nutrient content claims in the Guidelines for Use of Nutrition and Health Claims, the
conditions for “low” in saturated fats are as follows: 1.5 g saturated fat per 100 g (solids), 0.75 g saturated fat per 100 mL
(liquids) and 10% of energy of saturated fat.
REP18/NFSDU Appendix VII 67
Appendix VII
METHODS OF ANALYSIS FOR PROVISIONS IN THE STANDARD FOR INFANT FORMULA AND
FORMULAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS
(CXS 72-1981)
(for endorsement by CCMAS)