ALINORM 09/32/26

JOINT FAO/WHO FOOD STANDARDS PROGRAMME

CODEX ALIMENTARIUS COMMISSION

Thirty second Session
Rome, Italy, 29 June - 4 July 2009

REPORT OF THE 30th SESSION

OF THE CODEX COMMITTEE ON NUTRITION AND FOODS
FOR SPECIAL DIETARY USES

Cape Town, South Africa

3 - 7 November 2008

Note: This report includes Circular Letter CL 2008/35-NFSDU

 - iii -

CX 5/20.2 CL 2008/35-NFSDU
November 2008

TO: Codex Contact Points

Interested International Organizations

FROM: Secretary,
Codex Alimentarius Commission,
Joint FAO/WHO Food Standards Programme, FAO,
Viale delle Terme di Caracalla,
00153 Rome, Italy
Fax: +39 06 570 54593
Email: codex@fao.org

SUBJECT: Distribution of the Report of the 30th Session of the Codex Committee on Nutrition and
Foods for Special Dietary Uses (ALINORM 09/32/26)

A. MATTERS FOR ADOPTION BY THE 32ND SESSION OF THE COMMISSION:

1. Guidelines for Use of Nutrition and Health Claims: Table of Conditions for Nutrient Contents
(Part B Provisions on Dietary Fibre) (ALINORM 09/32/26 para. 54 and Appendix II)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email to the above address before 1 April 2009.
2. Draft Advisory List of Nutrient Compounds for Use in Foods for Special Dietary Uses
Intended for Infants and Young Children: Section D: Advisory List of Food Additives for Special
Nutrient Forms: Provisions on Gum Arabic (Gum acacia) (ALINORM 09/32/26, para. 62 and
Appendix III)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email to the above address before 1 April 2009.
3. Draft Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the
Committee on Nutrition and Foods for the Special Dietary Uses (ALINORM 09/32/26, para. 82 and
Appendix IV)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email to the above address before 1 April 2009.

4. Proposed Draft Annex on Recommendations on the Scientific Substantiation of Health Claims

to the Codex Guidelines for Use of Nutrition and Health at Step 4 (ALINORM 09/32/26, para. 102 and
Appendix V)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email to the above address before 1 April 2009.
 - iv -
B. REQUEST FOR COMMENTS AND INFORMATION AT STEP 6 OF THE PROCEDURE:

Methods of Analysis for Dietary Fibre

The Committee noted that the list of recommended methods presented in Appendix II of ALINORM
08/31/26 was elaborated a few years ago and that a number of provisions for dietary fibre were newly
introduced at this session, recommended that the list of methods presented in this Appendix needed to be
updated.
In view of this, Governments and international organizations are invited to submit any information that they
deem would be necessary to fulfill the mandate of the electronic working group on methods of analysis for
dietary fibre (see paras 51 – 53) and should do so in writing, preferably by email to Mr Pascal Audebert,
Point de Codex du Codex alimentarius en France, Premier Ministre Secrétariat général des Affaires
européenes, 2 boulevard Diderot, 75572 Paris Cedex 12, France, Fax: +33 (1) 44871604, e-mail:
pascal.audebert@sgae.gouv.fr with a copy to the Secretary, Codex Alimentarius Commission, Viale delle
Terme di Caracalla, 00153 Rome, Italy (fax: +39 06 5705 4593, e-mail: codex@fao.org) before 1 March
2009;
 -v-

SUMMARY AND CONCLUSIONS

The 30th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses
reached the following conclusions:
MATTERS FOR FINAL ADOPTION BY THE 32ND SESSION OF THE CODEX ALIMENTARIUS
COMMISSION:

The Committee:
- agreed to forward to the Commission the Draft Table of Conditions for Nutrient Content (Part B
Containing Provisions for Dietary Fibre) for adoption at Step 8 (ALINORM 09/32/26 para. 54 and
Appendix II);
- agreed to forward to the Commission the Draft Advisory List of Nutrient Compounds for Use in
Foods for Special Dietary Uses Intended for Infants and Young Children: Section D: Advisory List of
Food Additives for Special Nutrient Forms: Provisions on Gum Arabic (Gum acacia) for adoption at
Step 8 (ALINORM 09/32/26, para. 62 and Appendix III);
- agreed to forward to the Commission the Draft Nutritional Risk Analysis Principles and Guidelines
for Application to the Work of the Committee on Nutrition and Foods for the Special Dietary Uses
(ALINORM 09/32/26, para. 82 and Appendix IV);
- agreed to forward to the Commission the Proposed Draft Annex on Recommendations on the
Scientific Substantiation of Health Claims to the Codex Guidelines for Use of Nutrition and Health
for adoption at Step 5/8 with the recommendation to omit Steps 6 and 7 (ALINORM 09/32/26, para.
102 and Appendix V).

MATTERS OF INTEREST TO THE 32ND SESSION OF THE COMMISSION

The Committee:
- agreed to consider how to proceed with new work on the revision of General Principles for the
Addition of Essential Nutrients to Foods (CAC/GL 9-1987); development of the separate Standard for
Cereal Based-Foods for Underweight Children; revision of the Guidelines on Formulated
Supplementary Foods for Older Infants and Young Children (CAC/GL 8-1991); and the development
of Nutrient Reference Values (NRVs) associated with increased or decreased risk of non-
communicable diseases at the next session of the Committee (paras 123-154).

MATTERS REFERRED TO OTHER COMMITTEES

Codex Committee on Methods of Analysis and Sampling (CCMAS)

The CCNFSDU refers some responses to the questions on several methods in the standard for Infant
Formula and Formulas for Special Medical Purposes Intended for Infants and the List of methods for
which advice of the CCMAS is sought (paras 17-21 and Appendix VI).

Codex Committee on Food Additives (CCFA)

The Committee refers a level of 10 mg/kg of Gum Arabic (Gum acacia) to the CCFA for endorsement
as a coating agent for inclusion in Section D Advisory List of Food Additives for Special Nutrient
Forms in the Advisory List of Nutrient Compounds for Use in Foods for Special Dietary Use by
Infants and Young Children (CAC/GL 10-1979) (paras 55-62 and Appendix III).

Codex Committee on Food Labelling (CCFL)

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The Committee refers the Draft Table (Provisions on Dietary Fibre including the definition of dietary
fibre, Appendix II, para. 48) and the proposed draft Annex on Recommendations on the Scientific
Substantiation of Health Claims to the Guidelines for Nutrition and Health Claims, para. 102, Appendix
V) for information by the CCFL.

Codex Committee on General Principles (CCGP)

The Committee refers the draft Nutritional Risk Analysis Principles and Guidelines for
Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses to
the CCGP for their review and endorsement (paras 82, Appendix IV).
 - vii -

TABLE OF CONTENTS
Paragraphs
INTRODUCTION ..................................................................................................................................................1
OPENING OF THE SESSION .............................................................................................................................. 2-3
DIVISION OF COMPETENCE ....................................................................................................................4
ADOPTION OF THE AGENDA (AGENDA ITEM 1) .............................................................................................. 5-8
MATTERS REFERRED BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER
CODEX COMMITTEES (AGENDA ITEM 2): .................................................................................................... 8-26
REVIEW OF CODEX COMMITTEE STRUCTURE AND MANDATES OF THE CODEX
COMMITTEES AND TASK FORCES .................................................................................................. 10-13
AMENDMENTS TO CODEX STANDARDS AND RELATED TEXTS ...................................................... 14-16
METHODS OF ANALYSIS IN THE CODEX STANDARD FOR INFANT FORMULA
AND FORMULAS FOR SPECIAL MEDICAL PURPOSES FOR INFANTS ................................................ 17-22
APPLICABILITY OF ADIS TO INFANTS AND YOUNG CHILDREN ...........................................................23
CODEX COMMITTEE ON FOOD LABELLING..........................................................................................24
ACTIVITIES FROM FAO/WHO OF INTEREST TO THE CCNFSDU .................................................. 25-26
GUIDELINES FOR THE USE OF NUTRITION CLAIMS: DRAFT TABLE OF CONDITIONS FOR
NUTRIENT CONTENTS (PART B CONTAINING PROVISIONS ON DIETARY FIBRE) AT STEP 7
(AGENDA ITEM 3) ....................................................................................................................................... 27-54
DRAFT REVISION OF ADVISORY LIST OF NUTRIENT COMPOUNDS FOR USE IN FOODS
FOR SPECIAL DIETARY USES INTENDED FOR THE USE BY INFANTS AND YOUNG
CHILDREN: SECTION D ADVISORY LIST OF FOOD ADDITIVES FOR SPECIAL NUTRIENT
FORMS PROVISIONS ON GUM ARABIC (GUM ACCACIA) AT STEP 7 (AGENDA ITEM 4)............................... 55-62
DRAFT NUTRITIONAL RISK ANALYSIS PRINCIPLES AND GUIDELINES FOR APPLICATION
TO THE WORK OF THE COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETARY
USES AT STEP 7 (AGENDA ITEM 5) ............................................................................................................. 63-82
PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS OF HEALTH CLAIMS
AT STEP 4 (AGENDA ITEM 6) ..................................................................................................................... 83-102
PROPOSED DRAFT ADDITIONAL OR REVISED NUTRIENT REFERENCE VALUES FOR
LABELLING PURPOSES IN THE CODEX GUIDELINES ON NUTRITION LABELLING AT STEP 4
(AGENDA ITEM 7) ................................................................................................................................... 103-122
DISCUSSION PAPER ON THE PROPOSAL FOR NEW WORK TO AMEND THE CODEX
GENERAL PRINCIPLES FOR THE ADDITION OF ESSENTIAL NUTRIENTS TO FOODS
(CAC/GL 09-1987) (AGENDA ITEM 8) ................................................................................................... 123-134
DISCUSSION PAPER ON THE PROPOSAL FOR NEW WORK TO ESTABLISH A STANDARD
FOR PROCESSED CEREAL-BASED FOODS FOR UNDERWEIGHT INFANTS AND YOUNG
CHILDREN (AGENDA ITEM 9).................................................................................................................. 135-151
OTHER BUSINESS AND FUTURE WORK ................................................................................................... 135-151
SUMMARY OF THE PROPOSAL TO REVISE THE CODEX GUIDELINES ON
FORMULATED SUPPLEMENTARY FOODS FOR OLDER INFANTS AND YOUNG
CHILDREN (AGENDA ITEM 10 (A))............................................................................................. 135-151
MATTERS RELATED TO CONSIDERATION OF THE WHO GLOBAL STRATEGY ON
DIET, PHYSICAL ACTIVITY AND HEALTH (AGENDA ITEM 10 (B).............................................. 152-154
DATE AND PLACE OF THE NEXT SESSION .......................................................................................................155
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LIST OF APPENDICES
Page
APPENDIX I LIST OF PARTICIPANTS ................................................................................................... 21
APPENDIX II GUIDELINES FOR THE USE OF NUTRITION CLAIMS: DRAFT TABLE OF
CONDITIONS FOR NUTRIENT CONTENTS (PART B CONTAINING
PROVISIONS ON DIETARY FIBRE AT STEP 8 .................................................................... 46
APPENDIX III DRAFT REVISION OF THE ADVISORY LIST OF NUTRIENT
COMPOUNDS FOR USE IN FOODS FOR SPECIAL DIETARY USES
INTENDED FOR THE USE BY INFANTS AND YOUNG CHILDREN:
SECTION D ADVISORY LIST OF FOOD ADDITIVES FOR SPECIAL
NUTRIENT FORMS AT STEP 8 .......................................................................................... 47
APPENDIX IV DRAFT NUTRITIONAL RISK ANALYSIS PRINCIPLES AND GUIDELINES
FOR APPLICATION TO THE WORK OF THE COMMITTEE ON NUTRITION
AND FOODS FOR SPECIAL DIETARY USES AT STEP 8...................................................... 48
APPENDIX V PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS
FOR HEALTH CLAIMS AT STEP 5/8 .................................................................................. 54
APPENDIX VI METHODS OF ANALYSIS FOR INFANT FORMULA AND FORMULAS FOR
SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS.................................................. 57
ALINORM 09/32/26 1

INTRODUCTION
1. The Thirtieth Session of the Codex Committee on Nutrition and Foods for Special Dietary
Uses (CCNFSDU) was held in Cape Town, South Africa from 3 to 7 November 2008 at the kind
invitation of the Government of South Africa in cooperation with the Government of Germany. The
Session was chaired by Dr Rolf Grossklaus, Director and Professor, the Federal Institute for Risk
Assessment, Berlin and co-chaired by Mrs Lynn Moeng, Director Nutrition, the South African
National Department of Health. The Committee was attended by 240 delegates, observers and
advisors representing 52 member countries, one member organization and 27 international
organizations.
OPENING OF THE SESSION
2. Ms Barbara Hogan, Minister of Health of the Republic of South Africa welcomed the
participants to Cape Town and indicated that it was an honor for South Africa to have been selected as
co-hosting country especially since this had allowed more African delegations to participate. She said
food insecurity, high rates of malnutrition and high food prices were big threats to consumers in Africa
and that a lot of efforts had been made in South Africa to ensure equitable health services to all
citizens and drew the attention of the delegates to the fact that participation in Codex work had helped
South Africa to develop science based regulations that would help to reach this goal. She also
informed the Committee that South Africa had implemented a successful food fortification
programme. Ms Hogan acknowledged the challenges before the Committee to develop science based
guidance for both developing and developed countries to ensure safe, good food for everyone and
stressed the importance of the work on a scientific basis for health claims and also of new work on a
Standard for Processed Cereal-Based Foods for Underweight Infants and Young Children. and wished
the delegates all the best in their deliberations.
3. Mr Bernhard Kühnle, Director General for Food Safety and Veterinary Affairs – Federal
Ministry of Food, Agriculture and Consumer Protection, Germany addressed the Committee on behalf
of the German Federal Minister, Ms Ilse Aigner and expressed his gratitude to South Africa for
offering to co-host the session. He said that the CCNFSDU had the predominant task to protect
consumers and especially those most vulnerable or with special needs such as infants and small
children. He pointed out three areas in which it was particularly important to reach consensus in the
Committee: (1) the contribution of the Committee to the implementation of the WHO Global Strategy
on Diet Physical Activity and Health; (2) the adoption on Nutritional Risk Analysis Principles for the
CCNFSDU; and (3) the work on a scientific basis for health claims to avoid that consumers can be
misled; and also stressed the responsibility of the Committee to develop new standards which would
ensure adequate nutritional supplements for underweight infants and young children.
Division of competence
4. Following Rule II.5 of the Rules of Procedure of the Codex Alimentarius Commission the
Committee was informed about CRD 11 on the division of competence between the European
Community (EC) and its Member States and noted that 14 Member States of the EC were present at
the current session.1
ADOPTION OF THE AGENDA (Agenda Item 1)2
5. The Committee agreed to the proposal to considered items 9 and 10 together as they were
closely interlinked.
6. The Committee also agreed to consider the outcome of the Physical Working Group held prior
to the session on issues related to the implementation of the WHO Global Strategy on Diet, Physical
Activity and Health under Agenda Item 10 “Other Business and Future Work”.

1
CRD 11 (Annotated Provisional Agenda on the Division of Competence between the European community
and its Member States according to Rule II paragraph 5 of the Codex Alimentarius Commission.
2
CX/NFSDU 08/30/1.
ALINORM 09/32/26 2

7. The Committee noted the considerable amount of comments received on the Draft Nutritional
Risk Analysis Principles and Guidelines for Application to the Work of the Committee on Nutrition
and Foods for Special Dietary Uses and agreed to establish a physical in-session working group led by
Australia and working in English only with the mandate to consider the text in square brackets and to
provide a revised document for consideration by the Committee.
8. With these modifications the Committee adopted the Provisional Agenda as the Agenda for
the Session.
MATTERS REFERRED BY THE CODEX ALIMENTARIUS COMMISSION AND/OR
OTHER CODEX COMMITTEES (Agenda Item 2)3
9. The Committee noted the matters referred by the 31st session of the Commission for
information and in particular the adoption of standards and related texts submitted by the CCNFSDU
as well as the approval of new work on the revision of nutrient reference values of vitamins and
minerals in the Guidelines on Nutrition Labelling (CAC/GL 2-1985).
Review of Codex Committee Structure and Mandates of Codex Committees and Task Forces
10. The Committee noted that the 60th Session of the Executive Committee4 and the 31st Session
of the Commission5 had discussed the work on nutrition in Codex when reviewing the Codex
committee structure and mandates of Codex committees and task forces and had found that the current
structure allowed tasks related to nutrition to be adequately covered in the CCFL and the CCNFSDU.
11. The Committee noted further the information given by FAO and WHO to the Executive
Committee and the Commission on discussions on a mechanism to provide scientific advice to the
CCNFSDU.
12. Regarding the update on progress of developing mechanisms for providing scientific advice to
the CCNFSDU, the Representative of WHO indicated that FAO and WHO were not yet in a position
to inform on a definitive joint mechanism, given the need for high-level policy decision and legal and
administrative process clearance within each Organization to establish a joint expert body. Both
Organizations indicated that they were very much committed to strengthen their roles in providing
scientific advice on nutrition-related matters and efforts were being made in WHO to strengthen its
present structure and capacity to provide scientific advice to Member States and to the Codex.
13. The Representative of FAO informed the Committee that the establishment of a joint
FAO/WHO Expert body could be expedited if CCNFSDU would request such a committee to provide
scientific advice. ustralia indicated its strong support for the establishment of such a body.
Amendments to Codex standards and related texts
14. The Committee noted that when adopting the Proposed Draft Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children it had also revoked the Recommended
International Code of Hygienic Practice for Foods for Infants and Children (CAC/RCP 21-1979)
which had contained end-product microbiological specifications of advisory nature for a number of
products which are not contained in the new code.
15. This had created an inconsistency as the section on food hygiene in the Guidelines on
Formulated Supplementary Foods for Infants and Young Children (CAC/GL 08-1991) contains a
reference to the revoked CAC/RCP 21-1979.

3
CX/NFSDU 08/30/2-Rev; CX/NFSDU 08/30/2-Add.1 (Report of the electronic working group on methods of
analysis for infant formula and formulas for special medical purposes (CODEX STAN 72-1981), CX/NFSDU
08/30/2-Add.2 (Summary of activities from FAO/WHO of interest to the CCNFSDU), CRD 2 (Comments from
Malaysia and ISDI), CRD 12 (WHO/UNICEF/WFP/UNHCR Informal consultation on the management of
moderate malnutrition in under-5 children) and CRD 15 (Comments from the United States).
4
ALINORM 08/31/3, paras 27-38.
5
ALINORM 08/31/REP, paras 162-163.
ALINORM 09/32/26 3

16. The Committee noted that this matter was outside its mandate and decided to refer it to the
Committee on Food Hygiene for appropriate action.
Methods of Analysis in the Codex Standard for Infant Formula and Formulas for Special
Medical Purposes for Infants
17. The Committee recalled that the 29th Session of the Committee had agreed to establish an
electronic working group led by New Zealand to prepare a list of methods of analysis for infant
formulae for consideration by this session of the Committee.
18. The Delegation of New Zealand introduced the report of the electronic working group and
recalled that in preparing the list of methods of analysis it had been requested to review the methods of
analysis for provisions listed in Section 3.1 of the Standard for Infant Formula and Formulas for
Special Medical Purposes for Infants (CODEX STAN 72-1991) and to follow the Principles for the
Establishment of Codex Methods of Analysis in the Codex Procedural Manual, including the General
Criteria for the Selection of Methods of Analysis.
19. The electronic working group recommended that the Committee:
• Submit the methods contained in Table 1 of the report of the electronic working group to the
Committee on Method of Analysis and Sampling (CCMAS) for endorsement and inclusion in
the Recommended Methods of Analysis and Sampling (CODEX STAN 234) in the section
titled “Foods for Special Dietary Uses” with the description “Infant Formula” in the column
titled “Commodity Standard” with notes to explain that some methods are for specific forms
of the provisions in section 3.1 and that methods should include the units of expression when
it was part of the provision (see Appendix VI).
• Request advice from the CCMAS on the criteria for selecting Type II methods from a list of
Type III methods because the working group had not found an agreement on such selection
criteria. As an interim measure the working group had proposed some of the methods as Type
III for endorsement until clarification was received from the CCMAS how to select the
appropriate Type II methods; these methods are indicated as III* in the Appendix.
• Periodically review the methods in the proposed infant formula list in CODEX STAN 234 to
keep them updated.
• Consider whether to recommend methods for moisture content, total solids and ash which
were not in the original scope of the working group but which were needed to calculate
carbohydrates and calories.
20. In response to the questions raised by the 28th and 29th Session of the Committee on Methods
of Analysis and Sampling the working group proposed to reply that:
• Methods using microbioassay had been reviewed and more updated methods for total
carbohydrates (AOAC 986.25, determination by difference) and for fats (AOAC 989.05 and
ISO 8381│IDF 123:2008 or ISO 8262-1│IDF 124-1:2005) were being recommended;
• Vitamin C was expressed as ascorbic acid and the difference between the proposed methods
for Vitamins K, B12 and B6 was provided in the list of methods submitted for endorsement;
and
• A method for dietary fibre was not necessary to calculate the total energy as there was
insignificant indigestible carbohydrate in infant formula.
21. The Committee expressed its appreciation to the Delegation of New Zealand and the working
group for their work and after some discussion, agreed to follow the recommendations of the working
group and also to provide the responses to the questions posed by CCMAS as recommended by the
Working Group. It was noted that the method for total fats had been published as ISO 8381│IDF 123-
2008 and amended the list of methods accordingly. It was clarified that comments on the proposed
methods could be submitted to CCMAS for their consideration during the endorsement process.
ALINORM 09/32/26 4

22. The Committee considered the need to re-establish the electronic working group but decided
to first await a reply from the CCMAS.
Codex Committee on Food Additives
Applicability of ADIs to Infants and Young Children
23. The Committee noted the response by the Committee on Food Additives regarding questions
from the CCNFSDU on the applicability of an ADI for infants below 12 weeks of age. The
Committee also noted that WHO had no plan to update the scientific opinion on an ADI for infants
below 12 weeks at present. The Committee noted the report of the CCFA and also noted that it would
be desirable that WHO should update the Committee on this matter as new information became
available.
Codex Committee on Food Labelling (CCFL)
24. The Committee noted the work of the CCFL on the implementation of the WHO Global
Strategy on Diet, Physical Activity and Health and that this would be taken into account when
discussing the issue of nutrient reference values (Agenda Item 7) and the WHO Global Strategy
(Agenda Item 10b)
Activities from FAO/WHO of Interest to CCNFSDU
25. The Representative of the WHO referring to document CX/NFSDU 08/30/2-Add.2, informed
the Committee of the reports of scientific work undertaken and of several on-going and future work to
be completed in 2009 including the development of a FAO/WHO Procedural Manual for the
formulation and implementation of regional and country-specific food-based dietary guidelines
(FBDG) (scheduled for completion June 2009), and a joint WHO/UNICEF consultation to update the
guidelines for vitamin A supplementation with new scientific evidence (expected in 2009).
26. The Representative of the FAO added information on the FAO/WHO Expert consultation on
Fat and Fatty Acids in Human Nutrition which will be held in Geneva on 10 – 14 November 2008
where experts will develop recommendations on requirements for infants, children, adults and women
during pregnancy and lactation and review scientific evidence related to inadequate and excess intakes
of fats and fatty acids to health risks and benefits. The report of this consultation will be available in
early 2009. The Representative indicated that an expert consultation on Biodiversity and food
consumption and an expert consultation on risk-benefit-analysis is planned in 2009 and that the Food
Composition Study Guide to be published in 2009 is a distance learning tool and will allow learners to
acquire and evaluate their knowledge in food composition.
GUIDELINES FOR THE USE OF NUTRITION CLAIMS: DRAFT TABLE OF CONDITIONS
FOR NUTRIENT CONTENTS (PART B CONTAINING PROVISIONS ON DIETARY FIBRE)
AT STEP 7 (Agenda Item 3)6
27. The Committee recalled that its last session had agreed to return the Draft Table of Conditions
for Claims (dietary fibre) to Step 6 asking for comments and additional input on the definition,
conditions for claims and methods of analysis for dietary fibre in the light of the results of the
FAO/WHO scientific update of carbohydrates in human nutrition.
28. The Representative of WHO drew the attention of the Committee to the fact that following the
request for scientific advice, FAO/WHO had provided a recommendation on the definition of dietary
fibre derived from the Joint FAO/WHO expert consultation and the Joint FAO/WHO scientific update
on carbohydrates in human nutrition. However, in order to facilitate progress of the discussion the
Representative of WHO informed the Committee that Professor J. Cummings, as scientist participating
in the FAO/WHO carbohydrate consultation and scientific update, would suggest alternative wording
6
CL 2007/43-NFSDU; ALINORM 08/31/26, Appendix II, CX/NFSDU 08/30/3 (comments from Australia,
Costa Rica, Guatemala, New Zealand, AAF, AIDGUM, IDF, ILSI, ISDI); CX/NFSDU 08/30/3- Add.1
(comments of Brazil, South Africa); CX/NFSDU 08/30/3-Add. 2 (comments from Mali, Thailand, IFAC); CRD
3 (comments from Canada, European Community, India, Indonesia, Kenya, Philippines, United States of
America, CIAA).
ALINORM 09/32/26 5

for the definition, taking into account the new work and reports published by some Member States
since the 29th Session of the Committee.
29. Prof Cummings indicated that when considering the definition of dietary fibre, the expert
groups had reviewed existing definitions, including the currently proposed definition by this
Committee and that of the US National Academy of Sciences (Institute of Medicine 2005).
30. Recognising the need to move to an agreed definition of fibre by the Committee, Professor
Cummings noted three main areas where the proposed Codex definition and that of the Scientific
Update differed. The Codex definition includes the phrase “neither digested nor absorbed in the small
intestine”, a concept also incorporated into two other existing definitions of fibre, that of the US
National Academy of Sciences and of the European Community. Having pointed out that digestibility
is poorly defined and very difficult to measure, especially in the human small intestine, professor
Cummings stated that intrinsic plant cell wall polysaccharides were essentially not digested in the
human small intestine, and that this historical concept could remain as part of the definition.
31. However, included in the category of non-digestibility are the non α-glucan oligosaccharides
(DP 3-9) (non digestible oligosaccharides, NDO). The Scientific Update had felt strongly that NDO
should not be included in the definition of dietary fibre. This was because the Codex definition
includes the assertion that “Dietary fibre generally has properties such as: decrease intestinal transit
time and increase stools bulk; fermentable by colonic microflora; reduce blood total and/or LDL
cholesterol levels; reduce post-prandial blood glucose and /or insulin levels”. It was felt that there was
no convincing evidence that NDO had a significant effect on gut transit time or stool weight, on blood
lipids in healthy people, since they are not glycaemic carbohydrates, nor on the control of blood
glucose and insulin. Whilst they are fermented this was felt to be part of normal digestive physiology
and not something that conferred a specific health benefit. Therefore, inclusion of these water-soluble
low molecular weight carbohydrates was potentially misleading for the consumer. Nevertheless the
Joint FAO/WHO Scientific Update had acknowledged that NDO were important carbohydrates with
unique properties, likely to be shown of importance to other aspects of health after further research. In
such case, NDO should be recognized on its own right, but not as dietary fibre.
32. Professor Cummings indicated that the use of the terms “intrinsic”, “extrinsic”, “functional”
and “synthetic” in existing definitions, and the incorporation of this categorization of dietary fibre into
the Committee’s proposed definition as “carbohydrate polymers, which have been obtained from food
raw material by physical, enzymatic or chemical means” and “synthetic carbohydrate polymers”. The
Joint FAO/WHO Scientific Update had wanted the definition to be closely linked to health and felt
that the established epidemiological support for the health benefits of dietary fibre was based on diets
that contain fruits, vegetables and whole grain foods, which are rich in intrinsic plant cell wall
polysaccharides. Although isolated or extracted fibre preparations have been shown to have
physiological effects experimentally, these have not been translated into health benefits directly
because of a lack of epidemiological and longer term evidence. He therefore suggested that the
inclusion of categories of dietary fibre other than those intrinsic to the plant cell wall should be
required to show “a beneficial physiological effect demonstrated by generally accepted scientific
evidence” as specified in the definition of the European Community.
33. The Committee considered proposed changes and made the following comments and
conclusions.
34. The Delegation of South Africa indicated that in order to protect consumers from misleading
claims carbohydrate polymers obtained from raw materials by enzymatic or chemical means and
synthetic carbohydrate polymers could be allowed only if beneficial physiological effects were
demonstrated by scientific evidence to provide a ‘long-term’ benefit to health.
35. The Delegation of Canada supported to link the definition for dietary fibre to physiological
effects and explained that the fact that a substance was not digested or absorbed in the small intestine
did not necessarily mean that it had the properties of a dietary fibre. Therefore the inclusion of such
compounds needed to be justified by data on physiological efficacy. The delegation also proposed to
ALINORM 09/32/26 6

move the text on fermentability by colonic microflora from the section on properties to the definition
section as this was a defining characteristic of dietary fibre.
36. Some delegations from developing countries were of the view that their dietary
recommendations were designed to promote consumption of fruits, vegetables and whole grain cereal
foods which were naturally rich in dietary fibre and that inclusion of the concept of synthetic and
isolated fibres might mislead consumers regarding potential health benefits and supported the
approach proposed by the WHO.
37. Some observers were of the view that the concept of independent scientific evaluation or
review to obtain or validate scientific data for health benefits of fibre should be stressed.
38. The Delegation of the European Community proposed to simplify and clarify the draft Codex
definition as proposed in CRD 3 so that Dietary fibre means carbohydrate polymers with three or
more monomeric units, which are neither digested nor absorbed in the small intestine and belong to
the following categories as described in the Codex definition, to add “edible” to more precisely
characterize the nature of carbohydrate polymers and also to add ‘beneficial” before “physiological
effect” and to move the section on properties as preamble to the definition and that the criteria to
quantify physiological effects or evaluate demonstrated scientific evidence should be left to national
competent authorities to decide. Some delegations and observers supported this proposal as a
pragmatic way forward.
39. Several other proposals were put forward to amend the definition, however there was no
agreement to accept any of these proposals, therefore after a long discussion the Committee decided to
ask small drafting group to find an appropriate wording on how to amend the definition.
40. The Delegation of Thailand, on behalf of this drafting group, informed the Committee that a
revised version had been prepared in which the entire section on properties was deleted and that the
definition was much simplified to specify that dietary fibre meant carbohydrate polymers which were
not hydrolysed in the small intestine of humans with degree of polymerization not lower than three
and that the decision on whether to include carbohydrates with the degree of polymerization from 3 to
10 should be left to national authorities to decide. The definition took into account that three main
categories of carbohydrate polymers were distinguished: (a) naturally occurring carbohydrate
polymers; (b) carbohydrate polymers obtained from raw material by physical, enzymatic or chemical
means and (c) and synthetic polymers with the understanding that physiological effect and benefit to
health for categories (b) and (c) should be demonstrated by generally accepted scientific evidence to
competent authorities.
41. The Delegation of the United States was of the view that before finally agreeing on a dietary
fibre definition a number of questions presented in their comments (CRD 3) should be considered.
For example the scientific evidence to indicate that a revised Codex definition was needed to improve
public health; on whether international consensus on the terms and definitions used exists; or on the
presence of validated methods or validated procedures for combining methods to measure total fibre
content based on proposed definitions should be clarified.
42. The Committee noted that the major unresolved issue was the inclusion of oligosaccharides
with a degree of polymerization from 3 to 10 and had a long discussion on this matter.
43. Some delegations were of the view that these carbohydrates should not be included in the
definition as they did not have the properties traditionally attributed to dietary fibre and felt that their
inclusion might mislead consumers.
44. Other delegations and some observers believed that these carbohydrates were naturally
associated with dietary fibre and might have some health benefits and therefore should be included in
the definition
45. After some discussion, the Committee agreed to refer to monomeric units rather than to degree
of polymerization and that the decision on whether to include carbohydrates with monomeric units
from 3 to 9 should be left to national authorities to decide. As a consequence the sentence referring to
exclusion of mono and disaccharides was deleted from the definition.
ALINORM 09/32/26 7

Conditions for claims

46. The Committee agreed to express conditions both per 100g and 100 kcal as well as per serving
and that conditions for dietary fibre claims per serving should be expressed in terms of daily reference
value instead of “recommended intake” with 10 % or more for “source”, and 20 % or more for “high”.
After some discussion, it was also agreed that conditions for nutrient content claims in liquid foods are
to be determined at national level and should appear in a footnote.
47. To clarify that amounts for content claims for dietary fibre should be expressed on “ready-to-
use” basis, the Committee noted that there were no such requirement in the table of conditions for the
other nutrient contents in the Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997)
and asked that the Codex Committee on Food Labelling should address this matter for all claims in the
table of conditions.
48. The Committee agreed to forward the amended Draft Table (Provisions on Dietary Fibre)
including the definition on dietary fibre to the CCFL for information.
Methods of analysis
49. The Committee, in noting that the list of recommended methods presented in Appendix II of
ALINORM 08/31/26 was elaborated a few years ago and that a number of provisions for dietary fibre
were newly introduced at this session, recommended that the list of methods presented in this
Appendix needed to be updated.
50. The Committee noted that footnote 1 would also need to be further considered in relation to
methods of analysis.
51. The Committee therefore agreed to establish an Electronic Working Group in order to:
• review and update, as appropriate, the list of methods of analysis in Appendix II, taking into
account the new provisions in the draft definition of dietary fibre that would require the
selection of methods of analysis, and possible information of new available methods;
• consider how the results from different methods specific to different types of dietary fibre
could be combined together to arrive at the total dietary fibre content in a food;
• evaluate the performance of methods in measuring different types of dietary fibre;
• make recommendations for methods of analysis for dietary fibre in different food matrices;
• consider the footnote 1 and prepare a recommendation as to its revision with regard to the
methods of analysis, if necessary.
52. The Electronic Working Group will be led by the Delegation of France, be open to all Codex
members and observers and will work in English only.
53. The Delegation of the United States expressed concerns that the proposed definition contained
significant modifications to the previous text considered by the Committee and incorporated new text
that appeared to be subject to different interpretations as well as inclusion of text that was not
considered by the Committee (i.e. footnote 1). In this regard, the United States recommended that the
Committee have additional time to reflect on the proposed definition and its implications before the
definition is advanced for adoption.
Status of the Guidelines for the Use of Nutrition Claims: Draft Table of Conditions for Nutrient
Contents (Part B Containing Provisions on Dietary Fibre)
54. The Committee agreed to forward the Draft Table (Provisions on Dietary Fibre) including the
definition on dietary fibre to the 32nd Session of the Commission for adoption at Step 8 (see Appendix
II).
ALINORM 09/32/26 8

DRAFT REVISION OF THE ADVISORY LIST OF NUTRIENT COMPOUNDS FOR USE IN

FOODS FOR SPECIAL DIETARY USES INTENDED FOR THE USE BY INFANTS AND
YOUNG CHILDREN: SECTION D ADVISORY LIST OF FOOD ADDITIVES FOR SPECIAL
NUTRIENT FORMS AT STEP 7 (Agenda Item 4)7
55. The Committee recalled that at its last session it agreed to return the provisions for Gum
Arabic (Acacia gum) (INS 414) to Step 6 for comments as the Committee did not come to a
conclusion on levels of 10 or 100 mg to be recommended in the advisory list of food additives for
special nutrient forms.
56. The Observer from AIDGUM indicated that the use of Gum Arabic at 100 mg/kg as a coating
agent was necessary for adequate protection of vitamins and other minor ingredients from oxidation in
finished, packaged foods for infants and young children and that, if used for this purpose, the level in
the [finished product check all these with Food additives report] would be below 10 mg/kg.
57. The Delegation of the European Community was of the view that there was no technological
need for a level higher than 10 mg/kg of gum Arabic in finished products.
58. The Delegation of Australia informed the Committee that the CCFA was considering
inclusion of Gum Arabic in infant formulae, follow-up formulae, formulae for special medical
purposes for infants and complementary foods for infants and young children at the level of GMP
(ALINORM 08/31/12, Appendix VI) and that the Codex Standard for Processed Cereal-Based Foods
(CODEX STAN 74-1981, Rev.1-2006) allowed the use of Gum Arabic as a thickener in the final
product at a level which was significantly higher.
59. The Secretariat informed the Committee that the selection of food additives for inclusion in
commodity standards or other texts was the responsibility of Codex Committees which elaborated
those standards and that any request for endorsement and inclusion of proposed food additives in the
GSFA has to be technologically justified. The Secretariat indicated that there was no functional class
for coating agents in GSFA and therefore the CCNFSDU should ask the CCFA how to accommodate
it. A delegation indicated that such functional class could be indicated under “carriers”.
60. A delegation, supported by some observers, was of the view that this food additive should not
be allowed in products for use by infants below 12 weeks of age.
61. After some discussion, the Committee agreed to send the level of 10 mg/kg of Gum Arabic
(gum acacia) to the CCFA for endorsement as a coating agent for inclusion in Section D: Advisory list
of food additives for special nutrient forms of the Advisory List of Nutrient Compounds for Use in
Foods for Special Dietary Uses Intended for Use by Infants and Young Children (CAC/GL 10-1979)
Status of the revision of the advisory list of nutrient compounds for use in foods for special
dietary uses intended for the use by infants and young children: Section D Advisory list of food
additives for special nutrient forms
62. The Committee agreed to advance the provision on Gum Arabic at a level of 10 mg/kg in the
ready-to-use product to the 32nd Session of the Commission for adoption at Step 8 (see Appendix III).

7
ALINORM 08/31/26, Appendix V; CX/NFSDU 08/30/4 (comments from Australia, Guatemala, AIDGUM);
CX/NFSDU 08/31/4-Add.1 (comments from the European Community); CRD 4 (comments from Brazil, India,
Indonesia, Kenya, Mali, Philippines).
ALINORM 09/32/26 9

DRAFT NUTRITIONAL RISK ANALYSIS PRINCIPLES AND GUIDELINES FOR

APPLICATION TO THE WORK OF THE COMMITTEE ON NUTRITION AND FOODS
FOR SPECIAL DIETARY USES AT STEP 7 (Agenda Item 5)8
63. The Delegation of Australia introduced CRD 21 and indicated that following the decision of
the Committee (see para. 7) an in-session working group had made proposals for most of the issues
remaining in square brackets in the draft text with the exception of those in paragraphs 32 and 34
because of time constraints and that the working group additionally proposed a number of editorial
changes to the text. The Committee thanked the Delegation of Australia and the working group for
their excellent work.
64. The Committee then discussed the document section by section, agreed to most of the editorial
changes and made the following modifications and comments:
Section 1 - Background
65. Paragraph 6 from the section Scope and Application as amended by the working group was
moved to section 1 as it was considered to be more relevant to the background.
Section 2 – Introduction
66. Several delegations were of the view that the term “related substances” as defined in footnote
2 was not clear. A number of proposals were made on how to improve the definition. The Delegation
of Australia clarified that the term “related substances” was taken from a Model for Establishing
Upper Levels of Intake for Nutrients and Related Substances, Report of the Joint FAO/WHO Technical
Workshop, (WHO, 2006) publication to describe constituents of food other than nutrients which have
favourable physiological effects. After some discussion the Committee adopted the text as amended
by the working group.
67. In paragraph 3, the words “inherent constituents such as” and “inherent constituents that” were
deleted as they were found to be superfluous and the wording on microbiological pathogens and
contaminants were placed together as other examples of hazards.
68. In paragraph 5 several delegations felt that the last sentence related to the choice of “other
sources of scientific advice” did not clearly describe what other sources of scientific advice could be
used and how they were verified. The Secretariat recalled that the Draft Principles were intended for
use by the CCNFSDU and should be based on the Working Principles for Risk Analysis for
Application in the Framework of the Codex Alimentarius as contained in the Procedural Manual.
After some discussion the paragraph was amended to align it with the Working Principles,
acknowledging FAO/WHO as primary source of nutritional risk assessment advice and requesting that
the use of any other expert bodies should be approved by the Commission.
69. Subsequently it was decided to move the amended paragraph 5 to replace existing paragraph
32 in order to avoid duplication.
70. One observer expressed the view that conflict of interest in relation to the selection of
international expert groups was not addressed in the text. The Committee however noted that the
general reference to the Working Principles for Risk Analysis for Application in the Framework of the
Codex Alimentarius was sufficient to address this and similar concerns.
Section 3 – Scope and Application
71. The Committee agreed to the proposal of the working group regarding clarification of the last
sentence in paragraph 7.

8
ALINORM 08/31/26, Appendix VI; CX/NFSDU 08/30/5 (comments from Australia, Brazil, Costa Rica,
Ghana, Guatemala, Malaysia, New Zealand, the Philippines, South Africa, Thailand, the United States, CRN,
IDF and NHF); CX/NFSDU 08/30/5-Add.1 (comments from Argentina, the United States and IADSA); CRD 5
(comments from Canada, the European Community, India, Indonesia, Kenya, Malaysia and the Philippines);
CRD 21 (Text revised by the in-session working group)
ALINORM 09/32/26 10

72. There was a lengthy discussion on the wording of paragraph 8 on how to better describe the
food constituents of primary interest in nutritional risk analysis as well as the risk of increasing the
adverse effects of the food matrix. The Committee decided to leave the introductory phrase and the
first two bullets as originally drafted, to delete the third bullet and to insert a new paragraph to read:
“When favourable effects of the nutrient or related substance of primary interest are being assessed,
consideration should be given to whether the food matrix could increase the risk of an adverse health
effect.”
73. In paragraphs 9 and 10, the first occurrence of the term “risk analysis” was replaced with “risk
assessment” to clarify that “quantitative” only related to this part of risk analysis.
Section 4 – Definitions
74. Several proposals were made to amend definitions on intake (exposure) assessment, nutrient-
related hazard and homeostatic mechanism however after some discussion, the Committee decided to
leave them as originally drafted.
75. Concerning the proposal to delete the definition for dose response assessment because it was
not used in the text, the Committee felt that it was useful to retain it as it had been adapted from the
definition in the Codex Procedural Manual to show how it could be applied in nutritional risk analysis
and that this useful information should not be lost.
Section 5 – Principles for Nutritional Risk Analysis
76. In paragraph 17 the term “relevant route(s) of exposure” was replaced with “relevant source(s)
of intake”
77. The Committee discussed how to proceed with paragraph 29 as text related to the impact of
nutritional risk management decisions on consumers’ behaviour had been left in square brackets with
three different options proposed by the in-session working group to address the issue.
78. After some discussion, the Committee decided to insert a new paragraph after paragraph 29 to
read: “Nutritional risk management decisions should take into account their impact on dietary patterns
and consumer behaviour. Such information should be supported by relevant research.”
79. In paragraph 31 the word “Risk” was included before “Analysis”.
Section 6 – Selection of Risk Assessor by CCNFSDU
80. In paragraph 33 the words “relevant Codex subsidiary body” were replaced with
“CCNFSDU”.
Section 7 – Review Process
81. The Committee decided to delete this section as relevant guidance on this matter was included
in the Procedural Manual.
Status of the Proposed Draft Nutritional Risk Analysis Principles and Guidelines for Application
to the Work of the Committee on Nutrition and Foods for the Special Dietary Uses
82. The Committee agreed to forward the Proposed Draft Nutritional Risk Analysis Principles and
Guidelines for Application to the Work of the Committee on Nutrition and Foods for the Special
Dietary Uses as amended during the session to the Committee on General Principles (CCGP) for
endorsement and to the 32nd Session of the Codex Alimentarius Commission for adoption at Step 8
(see Appendix IV).
ALINORM 09/32/26 11

PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS OF HEALTH

CLAIMS AT STEP 4 (Agenda Item 6)9
83. The Committee recalled that the last session of the Committee had agreed to return the
Proposed Draft Recommendations to Step 2/3 for redrafting by an electronic working group led by
France.
84. The Delegation of France informed the Committee of the outcome of the physical working
group that had met prior to the session to prepare proposals to the plenary on the recommendations on
the scientific basis of health claims (see CRD 17).
85. The Delegation explained that the physical working group had focused discussions on sections
not discussed at the last session of the Committee, i.e. from section 3 onwards, but that it had not been
able to complete its discussions. Therefore it had only made proposals for sections 3.1 and 3.2 and
paragraph 5 (a) of section 3.1 had been retained in square brackets for further discussion in the
Committee.
86. The Committee agreed to consider the working document including the recommendations of
the working group section by section, and in addition to editorial corrections, made the following
comments and changes.
General amendment
87. The Committee agreed to replace throughout the text “governments” by “competent national
authorities” for consistency with the parent document. The Committee noted concerns by several
delegations that these terms were not consistently used throughout Codex texts and noted the
information given by the Codex Secretariat that a document on amendments to Codex standards
addressing such and other issues would be prepared for discussion by the 32nd Session of the
Commission.
2. Definitions
88. The Committee amended section 2.2 to clarify that the definition for food or food constituent
applied to food as well as a whole food or a category of foods and that a health effect can be more
correctly described as a health outcome as defined in sections 2.2.1 to 2.2.3 of the Codex Guidelines
for the Use of Nutrition and Health Claims.
3.1 Process for the substantiation of health claims
89. The Committee discussed whether to retain paragraph 5 (a) (new 3.1 (a)). Several delegations
proposed to delete this step as it did not add useful information. Other Delegations and Observers
supported to retain the text as it provided useful guidance and clarifications to governments on what
criteria and policies were needed to make judgments on health claims.
90. The Committee however took the view that the preamble to the Guidelines for Use of
Nutrition and Health Claims (CAC/GL 23-1997) already stated that health claims needed to be
consistent with various policies and as the Annex was an integral part of the Guidelines, the
Committee agreed to delete paragraph 5 (a).
91. The Committee did not agree to a proposal by some Observers to indicate in paragraph 5 (e)
(new 3.1 e) that assessment of conflict of interest was a necessary criterion. The Committee also did
not agree to the proposal by some observers to indicate explicitly that in particular for health claims

9
CX/NFSDU 08/30/6; CX/NFSDU 08/30/6-Add.1 (comments from Brazil, Guatemala, United States of
America, EHPM, IADSA, ISDI, WSRO); CRD 1 (Report of the ad hoc Physical Working Group on Health
Claims, Nutrient Reference Values and Matters Related to Consideration of the WHO Global Strategy on Diet,
Physical Activity and Health); CRD 6 (comments from European Community, India, Indonesia, Kenya,
Malaysia, Mexico, Philippines, EFLA); CRD 17 (Proposals from the ad hoc Physical Working Group on Health
Claims, Nutrient Reference Values and Matters Related to Consideration of the WHO Global Strategy on Diet,
Physical Activity and Health); CRD 19 (comments from IADSA).
ALINORM 09/32/26 12

for breastmilk substitutes, independently funded research was needed and that the reviews of the
health claims should be conducted by independent bodies.
92. The Committee was of the view that these aspects were sufficiently covered in the parent
document and by adding a reference to The Working Principles for Risk Analysis for Food Safety for
Application by Governments in a footnote to the title of the Annex.
93. The Committee agreed with other editorial amendments proposed in paragraphs 5 (b), (c), (d),
(e) and (f) (new 3.1 (a), (b), (c), (d) and (e).
3.2 Criteria for the substantiation of health claims
94. Paragraph 7(b) (new 3.2.2 (b)) was amended to ensure that epidemiological studies used as
evidence should provide a consistent body of evidence from well-designed studies, and to include
“authoritative statements” in addition to evidence-based dietary guidelines to enable all categories of
evidence generally available to be taken into account to substantiate some health claims.
95. One Observer highlighted the dilemma of scientific substantiation by human trials and the
ethical considerations relating to trials on infants under 12 weeks and possibly one year, and proposed
to include a recommendation in this paragraph that health claims should not be permitted for foods for
infants and young children because they cannot be substantiated according to the criterion.
96. The Committee however felt that these concerns were already taken into account by other
criteria in the text.
3.3 Consideration of the evidence
97. The Committee amended the second sentence of paragraph 10 (new 3.3.3) by inserting “or
mediates the effect” after “target site” for purposes of clarity and also inserted an example “forms of
the constituents” to clarify what was meant by factors that could affect absorption or utilization of a
constituent for which a health claim was made.
98. The Committee agreed to insert a new paragraph after paragraph 11 (new 3.3.5) to clarify
under what conditions studies should be excluded from further review and exclusion from relevant
scientific data.
99. One Observer proposed to include a reference also to a “special diet required for a specific
disease or condition” in addition to a balanced diet in paragraph 12 (new 3.3.6). The Committee
however was of the view that such a reference would not be appropriate as health claims were directed
to a generally healthy population and the Guidelines themselves were applicable to all foods. The
Committee agreed to amend this section to indicate that the evidence should provide information
relating to a balanced diet as it related to the target population for which the claim was intended.
5 Re-evaluation
100. The Committee agreed with the principle that health claims should be re-evaluated and agreed
to indicate that such re-evaluation should be undertaken by national competent authorities either
periodically or following emergence of significant new evidence.
Conclusion
101. In view of the considerable progress made on the document, the Chairperson proposed to
advance the document to Step 5/8 with the omission of Steps 6 and 7 for adoption by the next Session
of the Commission. The Delegation of Australia, supported by the Observer from NHF, however
expressed its concern with this proposal in view of the considerable changes made to the text and
proposed that the document be advanced for adoption at Step 5 to allow more time for its
consideration.
ALINORM 09/32/26 13

Status of the Proposed Draft Annex on Recommendations on the Scientific Substantiation of

Health Claims to the Codex Guidelines for Use of Nutrition and Health Claims
102. The Committee agreed to forward the proposed draft Annex to the Committee on Food
Labelling for their information and to the 32nd Session of the Commission for adoption at Step 5/8
with the recommendation to omit Steps 6 and 7 (see Appendix V).
PROPOSED DRAFT ADDITIONAL OR REVISED NUTRIENT REFERENCE VALUES FOR
LABELLING PURPOSES IN THE CODEX GUIDELINES ON NUTRITION LABELLING AT
STEP 4 (Agenda Item 7)10
103. The Committee recalled that the 31st Session of the Commission had approved new work on
additional or revised vitamin and mineral Nutrient Reference Values (NRVs) for labelling purposes
and that the document elaborated by the Republic of Korea with assistance from other interested
parties had been circulated before this session of the Committee. The Committee also recalled that the
physical working group was held prior to this session in order to review comments received and
prepare proposals on how to revise the document for consideration by the Plenary.
104. The Delegation of Republic of Korea informed the Committee that the physical working
group proposed to use the terms from the United Nations University/FAO/WHO/UNICEF workshop
on harmonization of approaches for developing nutrient-based dietary standards11 and that these terms
were included in footnotes. The Delegation drew the attention of the Committee to the fact that in
order to proceed with the work, the Committee should decide on the selection basis for NRVs for
which two options were proposed; decide on how to determine general population NRVs; take a
decision on upper levels of intake and on how to select data sources to establish NRVs.
105. The Committee expressed its appreciation to the Delegation of Republic of Korea and the
working group for their work and considered the options proposed by the working group.
106. The Committee agreed to use the terminology proposed by the above mentioned workshop on
international harmonization.
Preamble
107. The Committee agreed to editorial amendments proposed in the Preamble. The Delegation of
the United States noted the importance of the second paragraph to clarify that countries should be able
to select their own values based on scientific justification including consideration of country- and
region- specific factors.
Selection of the appropriate basis
108. The Committee noted the concern expressed by the Delegation of Japan and their request not
to delete Option 1 since their NRVs were based on Average Nutrient Requirements (ANR) because
the nutrition problem they are facing was excessive nutrient intake, however the Committee did not
agree to this request as many delegations preferred to use Option 2 - Individual Nutrient Level (INLx).
The Delegation of Japan accepted the decision of the Committee on condition that government in
establishing its own NRVs for labelling purposes may consider the suitability of the general principles
taking into account the characteristic of its own nutrition problems. The Committee made some

10
CX/NFSDU 08/30/7; CX/NFSDU 08/0/7-Add. 1 (comments from United States of America and South
Africa); CRD 1 (Report of the Physical Working Group); CRD 7 (comments from the European Community,
Indonesia, Kenya, Philippines); CRD 12 (WHO/UNICEF/WFP/UNHCR Information on Informal Consultation
on management of moderate malnutrition in under-5 children); CRD 13 (Summaries of the comments from
EWG members (Australia, Brazil, China, Costa Rica, European Community, Malaysia, New Zealand,
Switzerland, CRN, IADSA and NHF) and recommendations); CRD 18 (Results of the Physical Working Group
on NRVs).
11
International Harmonization of Approaches for Developing Nutrient-Based Dietary Standards, Janet King and
Cutberto Garza, Guest editors, Food and Nutrition Bulletin, vol 28, No1, 2007.
ALINORM 09/32/26 14

amendments to Option 2 to read: Individual Nutrient Level (INLX)12, the estimated nutrient intake
value that meets the requirements of most (98 percent) of an apparently healthy specific sub-group of
the population (e.g., considering the subgroup’s sex and lifestage such as age and
pregnancy/lactation). In cases where there is an absence of an established INLX for a nutrient for a
specific sub-group, it may be appropriate to consider the use of other reference values or ranges that
have been established by authoritative scientific bodies. It is necessary to review how these values
were derived on a case-by-case basis.
Consideration of different age-sex specific values
109. The Committee had a long discussion on how general population NRVs should be determined.
Some delegations indicated that they were using the Option 1 i.e. the highest values from different
age-sex groups while some other delegations were of the view that the most preferred should be
Option 2: which considers the specific sub-group population weighted means such as means of adult
males and females values.
110. Some delegations drew the attention of the Committee to their experience in arriving at NRVs
and indicated that in order to protect consumers an intermediate decision between options for some
nutrients might be required.
111. To the concerns expressed by the Delegation of China that for example different values for
vitamin A are needed, the Chairperson clarified that the calculated differences between the two
options were negligible. Generally NRVs should compare the nutrient content of the food items in the
standardised form to avoid misleading of consumer.
112. The Delegation of Australia proposed an approach to choose an average of male and female
nutrient values from FAO/WHO Vitamin and Mineral Requirements in Human Nutrition (2004) from
one population group which would reasonably represent all population groups over three years. The
following wording for Option 2 was proposed: Average mean value for chosen reference population
group that reasonably represents the general population above 3 years of age, such as means of adult
male and female values.
113. The Committee noted that practical implications of choosing one approach were not clear and
that it was difficult to decide on how this option could work in practice.
114. The Delegation of the United States requested that further consideration be given to both
options presented by the working group for age-sex specific once values were calculated to illustrate
the implications of each choice. Other delegations indicated that this information could be useful.
115. The Committee decided to put both options in square brackets for further consideration.
Consideration of upper levels of intake
116. The Committee noted the proposal to make consideration of the establishment of NRVs more
flexible, however after some discussion agreed to retain the text as proposed by the working group.
117. The Committee noted that the proposed new definitions including Upper Nutrient Level
(UNL) that appeared in this section were placed in a footnote and agreed that it would be more useful
to move the terminology from the footnote into a new section on definitions.
Selection of suitable data sources to establish NRVs
118. After some discussion the Committee agreed that recent and relevant FAO/WHO values
would be the basis for NRVs and if such FAO/WHO values are not available, relevant and recent
values from recognized authoritative scientific bodies other than FAO/WHO could be used.
119. In response to the question from the Delegation of Japan regarding the representativeness of
data used to develop the FAO/WHO Vitamin and Mineral Requirements in Human Nutrition (2nd

12
“Individual Nutrient Level (INLX)” is used as the generic term. Different countries may use other
terminologies for this concept: for example, Recommended Dietary Allowance (RDA), Recommended Daily
Allowance (RDA), Reference Nutrient Intake (RNI), Population Reference Intake (PRI), or Ingestion Diaria
Recomendada (IDR).
ALINORM 09/32/26 15

edition, 2004), the Representative of WHO informed the Committee that this document used data from
around the world which was available to the experts at that time.
120. The Committee considered whether the actual NRVs should be elaborated by FAO/WHO or
would be determined by the CCNFSDU. The Committee noted that an assessment part containing
actual human requirements for vitamins and minerals was available from FAO/WHO Vitamin and
Mineral Requirements in Human Nutrition (2004), therefore agreed that elaboration of actual NRVs
was the responsibility for the Committee.
121. The Committee noted that the General Principles for Establishing Vitamin and Mineral NRVs
especially to determine which options should be used for different age-sex groups needed more
elaboration, therefore agreed to re-establish the electronic working group lead by Republic of Korea to
prepare a revised version of the document based on decisions made at the current session with the
understanding that the Delegation of Australia would help in calculating actual values of NRVs based
on options 1 and 2 using date from FAO/WHO Vitamin and Mineral Requirements in Human
Nutrition (2004). Working group will be opened to all interested parties and work in English only.
Status of the General Principles for Establishing Nutrient Reference Values of Vitamins and
Minerals for General Population
122. The Committee agreed to return the General Principles for Establishing Nutrient Reference
Values of Vitamins and Minerals for General Population to Step 2/3 for redrafting by the above
electronic working group to prepare a revised version for circulation for comments and consideration
by the next session of the Committee.
DISCUSSION PAPER ON THE PROPOSAL FOR NEW WORK TO AMEND THE CODEX
GENERAL PRINCIPLES FOR THE ADDITION OF ESSENTIAL NUTRIENTS TO FOODS
(CAC/GL 09-1987) (Agenda Item 8)13
123. The Committee recalled the request of the last session of the committee that the Delegation of
Canada should prepare a revised discussion paper narrowing its scope in light of the comments made
at that session.
124. The Delegation of Canada introduced their revised discussion paper taking into account
comments made at the last session. The delegation indicated that since the adoption in 1987 of the
General Principles and their last amendment in 1991, changes in lifestyle and dietary habits have led
to an increased availability of foods with added vitamins and mineral nutrients that go beyond the
purposes set out in Section 3 – “Basic Principles” of the General Principles: restoration; nutritional
equivalence of substitute foods; fortification; and ensuring the appropriate nutrient composition of a
special purpose food.
125. The Delegation explained that there were concerns that the General Principles no longer
adequately addressed current practices, limited consumer choice and the development of new products
and could result in barriers to trade that are not justified based on safety considerations.
126. The Delegation proposed to revise the General Principles and in particular the Basic Principles
to expand their applicability to include the discretionary addition of vitamins and mineral nutrients to
foods for purposes beyond the prevention or correction of demonstrated deficiencies. The Delegation
stressed that it was not their intent to replace the Basic Principles which have a public health basis but
to extend them to also set out principles for the safe discretionary addition of vitamin and mineral
nutrients to acknowledge current practices and to ensure that they are safe.
127. The Delegation recommended using a risk-based approach including for example: restrictions
for which foods it would be prohibited to add vitamins and mineral nutrients at the discretion of the
manufacturer (e.g. beverages exceeding a certain alcoholic content, foods considered to have
negligible nutritional value; foods exceeding a certain level of risk increasing nutrients etc.); which
nutrients could be added; and maximum and minimum levels to which permitted nutrients could be
added.

13
CX/NFSDU 08/30/8; CRD 8 (Comments from the European Community).
ALINORM 09/32/26 16

128. The Delegation pointed out that in carrying out the revision, changes would be needed to the
“intent” of the General Principles and to the Basic Principles to make provision for discretionary
nutrient addition in addition to the four current purposes. Additionally a new Section to address the
prevention of the indiscriminate addition of vitamins and mineral nutrients would have to be
developed.
129. The Delegation also pointed out the need that the applicability of the General Principles to
non-traditional or indirect addition of essential nutrients should be affirmed within the General
Principles as these methods were of growing importance. Consideration should be given to the need
for any potential additional restrictions for this type of nutrient enhancement e.g., its prohibition for
certain types of foods.
130. The Delegation of the European Community warmly welcomed the suggestion to include the
concept of discretional fortification, however reiterated its position that it does not consider
appropriate at this stage to enlarge the scope of the General Principles beyond the direct addition of
nutrients to foods and that biofortification as well as other forms of indirect fortification should be
eventually addressed by a separate activity due to their complexity. The Delegation suggested a
number of changes to the draft project document in accordance with their comments in CRD 8 and
with these amendments could support initiation of new work.
131. The Delegation of New Zealand supported the revision of the General Principles as outlined
by Canada and amended by the European Community but felt that the issue of non-traditional addition
of nutrients was an area of work that needed to be addressed at some point.
132. The Delegation of the United States appreciated that Canada had made some revisions to their
proposal but noted that it had had very little time to review it. The Delegation was of the opinion that
the document as presented did not seem to be consistent with its stated purpose and still included areas
where it might not be possible to reach agreement. The Delegation did not support new work at this
moment but could support further efforts to narrow the focus so that the work was more clearly
defined and did not contradict the principles of fortification. The Delegation supported by Australia
suggested continuing to develop the proposal in an electronic working group in order to give more
time to study the issue and receive comments from more members.
133. The Delegation of Norway supported the revision of the General Principles but considered
that the primary reason for fortification should be a demonstrated need in the population and any
revision of the General Principles should take this aspect into account.
134. The Committee agreed to establish an electronic working group led by Canada and working in
English only to revise the document in line with the comments made at the Session and for
consideration by the 31st Session of the CCNFSDU.
DISCUSSION PAPER ON THE PROPOSAL FOR NEW WORK TO ESTABLISH A
STANDARD FOR PROCESSED CEREAL-BASED FOODS FOR UNDERWEIGHT INFANTS
AND YOUNG CHILDREN (Agenda Item 9)14
OTHER BUSINESS AND FUTURE WORK
SUMMARY OF THE PROPOSAL TO REVISE THE CODEX GUIDELINES ON
FORMULATED SUPPLEMENTARY FOODS FOR OLDER INFANTS AND YOUNG
CHILDREN (Agenda Item 10a)15
135. The Committee recalled its earlier decision to consider items 9 and 10 together since the two
items were interlinked (see para. 5).

14
CX/NFSDU 08/30/9; CRD 9 (comments from Mali); CRD 12 (prepared by WHO); CRD 20 (comments from
IBFAN).
15
CX/NFSDU 08/30/10; CRD 12 (prepared by WHO); CRD 14 (Technical support paper on separate Codex
Standard for Processed Cereal-based Foods for Underweight Infants and Young Children for Developing
Countries).
ALINORM 09/32/26 17

136. The Committee recalled that at its last session it had agreed that the Delegation of India with
assistance from other interested parties would revise the document presented at that session and
prepare a more structured project document for consideration by this session of the Committee.
137. The Delegation of India introduced their revised proposal (CX/NFSDU 08/30/9) and
explained that a separate standard for processed cereal-based foods for underweight infants and young
children was necessary to address the needs of the large numbers of underweight infants in developing
countries.
138. The Delegation emphasized that the problem of malnutrition was intergenerational in nature.
The problem of iron deficient anaemia was widely prevalent in both children under five years of age
and in women. In order to address this problem India is implementing a scheme of Integrated Child
Development Services (ICDS) under which around 84 million children, pregnant women and lactating
mothers are provided with supplementary nutrition, immunization and vaccination. However, 43% of
children in India are still malnourished.
139. The Delegation further explained that when complementary foods were introduced to infants
after 6 months of age, their energy requirements are not completely met by breast milk. Therefore,
adequate intake of energy, protein and other nutrients is required through complementary food of
adequate nutrient level for normal growth of children.
140. The Delegation explained that the intention of the proposed new standard was to address three
main components: 1) cereal content, 2) protein content and 3) energy density. The Delegation further
emphasized that they did not intend to reopen discussions on the already adopted Standard for
Processed Cereal-Based Foods for Infants and Young Children (CODEX STAN 74-1981).
141. The Delegation urged the Committee to consider this proposal separately from the proposal of
Ghana, which also dealt with a strategy to reduce malnutrition but with a different approach namely to
introduce a new category of fortified food supplements to the Guidelines on Formulated
Supplementary Foods for Older Infants and Young Children (CAC/GL 08-1991) as a strategy to
improve the quality of home made foods.
142. The Delegation of Ghana introduced their proposal (CX/NFSDU 08/30/10) and agreed that it
differed from the proposal from India, while also having the goal of reducing malnutrition in infants
and young children. The Delegation informed the Committee that in Ghana, infants were generally
exclusively breastfed until the age of 6 months and did generally well until that age. Problems
occurred after this period when they started receiving complementary foods which in most cases were
generally low in energy and nutrients including minerals and vitamins.
143. The Delegation explained that their proposal was to introduce a new category of foods to the
Guidelines for Formulated Supplementary Foods for Older Infants and Young Children (CAC/GL 08-
1991) to ensure the safety and efficacy of these foods and prevent their misuse. The Delegation stated
that their proposal was restricted to the revision of Section 6 of the Guidelines to reflect new
information and evidence of energy needs for breastfed children.
144. The Representative of the WHO informed the Committee of the Joint
WHO/UNICEF/WFP/UNHCR technical meeting on the management of moderate malnutrition in
children under 5 years of age held in Geneva (30 September – 3 October 2008) with the overall aim to
answer questions on the type of diets to be recommended to feed moderately malnourished children.
The Representative said further that the report of this meeting would be released in early 2009
containing recommendations on the formulation, effectiveness, and efficacy of diets and food
supplements to be given to moderately malnourished children. The Representative also informed the
Committee that WHO had been asked to form an expert advisory group in collaboration with other
agencies (UNICEF, WFP and Codex) within the next 6 months to develop specifications for food
supplements for moderately wasted children based on recommendations formulated during this
meeting which could possibly be of assistance to both Ghana and India in the development of their
proposals to the CCNFSDU.
ALINORM 09/32/26 18

145. The Representative was also of the opinion that the two proposals should be considered
separately as the Ghana proposal aimed at developing complementary food supplements that can be
made without cereals, while the India proposal was for cereal-based foods.
146. A number of delegations expressed their support for both proposals and for considering them
separately, while a number of other delegations supported considering them together.
147. The Delegation of Thailand proposed to consider developing an Annex to the Standard for
Processed Cereal-based Foods for Infants and Young Children, rather than a new separate standard to
address the proposal of India.
148. Some Observers cautioned against the development of a new standard as proposed by India,
since several standards already existed and agreed to the proposal made by Thailand. The Observers
indicated further that foods referred to in the two proposals were usually distributed by aid agencies
and were not commercially available. The Observers also expressed concern that such products if
introduced commercially could damage breastfeeding programmes and reduce the use of traditional
foods.
149. The Delegation of the European Community while acknowledging that the two proposals
intended to tackle very serious problems associated with malnutrition and under-nourishment, noted
that several questions remained on both proposals such as (a) who the intended population for the
products were, (b) that the proposal of Ghana targeted specifically breastfed infants and did not
address the situation of non-breastfed children, (c) that the true nature of these cereal-based foods or
supplements was unclear (d) that the composition requirements of these foods needed to be clarified as
well as the channels for distribution of these products (commercially available or not) and if
commercially available, how risk of confusion by potential users would be avoided and how the work
of WHO/UNICEF/WFP/UNHCR could contribute to the consideration of the proposed work. The
Delegation also asked that consideration should be given to the options available to the Committee to
take forward this work within the Codex process.
150. Some Delegations were of the view that before proceeding with the request for new work on
these two distinct proposals, implications of the above concerns should be clarified in more detail for
both proposals.
151. The Committee agreed to establish two electronic working groups, led by Ghana and India
respectively to prepare revised proposals taking into account the comments and concerns above for
consideration by the next session of the Committee. The electronic working groups will be open to all
members and observers and work in English only.
MATTERS RELATED TO CONSIDERATION OF THE WHO GLOBAL STRATEGY ON
DIET, PHYSICAL ACTIVITY AND HEALTH (Agenda Item 10b)16
152. The Committee noted the report of the ad hoc Physical Working Group and agreed with the
recommendation that the Committee should not delay consideration of new work on the development
of NRVs associated with increased or decreased risk on non-communicable diseases (CRD 1) but did
not consider how to proceed in this respect due to time constraints.
153. The Committee therefore agreed to convene a physical working group to be led by the United
States of America and Thailand, open to all members and observers and working in English, French
and Spanish that would meet prior to the next session of the Committee and:
• would develop principles and criteria for the development of NRVs for nutrients associated
with risk of non-communicable disease; and
• based on the agreed upon principles and criteria, to select and prioritize nutrients for
development of NRVs.

16
CRD 1 (Report of the ad hoc Physical Working Group on Health Claims, Nutrient Reference Values and
Matters Related to Consideration of the WHO Global Strategy on Diet, Physical Activity, and Health).
ALINORM 09/32/26 19

154. The Committee agreed that the Delegations of the United States of America and Thailand will
prepare a background paper well in advance of the next session of the Committee for circulation to
members and observers for comments. The background paper and comments will be considered by
the above physical working group in developing their proposals.
DATE AND PLACE OF NEXT SESSION (Agenda Item 11)
155. The Committee was informed that its 31st Session would take place in Germany from 2 to 6
November 2009, subject to confirmation by the Host Government and the Codex Secretariat.
ALINORM 09/32/26 20

SUMMARY STATUS OF WORK

Subject Matter Step For Action by Reference in
ALINORM 09/32/26
Guidelines for Use of Nutrition and 8 Governments; CCFL; para. 54 and
Health Claims: Table of Conditions for 32nd CAC Appendix II
Nutrient Contents (Part B: Provisions on
Dietary Fibre)
Advisory Lists of Nutrient Compounds 8 Governments, 41st paras 61-62 and
for Use in Foods for Special Dietary CCFA; 32nd CAC Appendix III
Uses Intended for Infants and Young
Children: Section D Advisory List of
Food Additives for Special Nutrient
Forms: Provisions on Gum Arabic
(Gum acacia)
Draft Nutritional Risk Analysis 8 Governments; 25th - para. 82 and Appendix
Principles and Guidelines for CCGP; 32nd CAC IV
Application to the Work of the
Committee on Nutrition and Foods for
the Special Dietary Uses
Proposed Draft Recommendations on 5/8 Governments, 30th para. 102 and
the Scientific Basis of Health Claims CCNFSDU Appendix V
List of Methods for Dietary Fibre 6 EWG led by France; paras 49-53
Governments; 31st
CCNFSDU
Proposed Draft Additional or Revised 2/3 EWG led by Republic para. 122
Nutrient Reference Values (NRVs) of Korea;
Governments; 31th
CCNFSDU
Discussion papers
Proposal for New Work to Amend the - EWG led by Canada; para. 134
Codex General Principles for the 31th CCNFSDU
Addition of Essential Nutrients to Foods
(CAC/GL 09-1987)
Proposal for New Work to Establish a - India with assistance paras 135-151
Standard for Processed Cereal-Based of EWG; 31st
Foods for Underweight Infant and CCNFSDU
Young Children; and

Proposal to Revise the Codex

Guidelines on Formulated
EWG led by Ghana,
Supplementary Foods for Older Infants - paras 137-151
31st CCNFSDU
and Young Children
Nutrient Reference Values (NRVs) for - EWG led by the US, paras 152-154
Nutrients Associated with Risk of Non- Governments;
Communicable Disease Physical Working
Group Co-Chaired by
the US and Thailand
ALINORM 09/32/26 21

Appendix I
LIST OF PARTICIPANTS
LISTE DES PARTICIPANTS
LISTA DE PARTICIPANTES

CHAIRPERSON/PRÉSIDENT/PRESIDENTE
Dr Rolf Grossklaus
Director and Professor
Federal Institute for Risk Assessment (BfR)
P.O. Box 33 00 13
14191 Berlin,
Germany
Tel: +49 (30) 8412 – 3230
Fax: +49 (288) 99 529 – 4965
E-Mail: ccnfsdu@bmelv.bund.de

VICE CHAIRPERSON / VICE PRÉSIDENT / VICE PRESIDENTE

Mrs Lynn Moeng
National Department of Health
Private Bag X828,
0001 Pretoria
South Africa
Tel.: +27 (12) 312 0071
Fax: +27 (12) 312 3112
E-Mail: MoengL@health.gov.za

ASSISTANTS TO THE CHAIRPERSON/ASSISTANT AU PRESIDENT/

ASISTENTE AL PRESIDENTE
Ms Katharina Adler
Federal Ministry of Food, Agriculture
and Consumer Protection
Rochusstraße 1
53123 Bonn
Germany
Tel: +49 (228) 99 529 4647
Fax: +49 (228) 99 529 4965
E-Mail: ccnfsdu@bmelv.bund.de

MEMBER COUNTRIES/PAYS MEMBRES/ Ms Lidia Morais

PAYSES MIEMBROS Engenheira Quimica
Ministerio da Agricultura e do Deswenvolvimento Rural
ANGOLA 7°Andar, Rua Comandante Gika
DR Francisco Antonio da Silva Joao 00527 Luanda
Codex- Instituto National de Saúde Pública Angola
Bairro da Samba-Casa 79 A Tel.: +244 222 327424
00527 Luanda Fax: +244 222 327424
Angola E-Mail: lidiamorais43@hotmail.com
Tel.: +244 9177 39826
E-Mail: chico.silva06@hotmail.com
ALINORM 09/32/26 22

Dr Maria Pedro Gaspar Sobrinho Dr Dorothy Mackerras

Engenheira Quimica Chief Public Health Nutrition Advisor
Ministerio da Agricultura e do Deswenvolvimento Rural Food Standards Australia New Zealand
7°Andar, Rua Comandante Gika P. O. Box 7186
00527 Luanda 2610 Canberra
Angola Australia
Tel.: +244 222 327424 Tel.: +61 (2) 6271 2683
Fax: +244 222 327424 Fax: +61 (2) 6271 2278
E-Mail: teh_gaspar@hotmail.com E-Mail: dorothy.mackerras@foodstandards.gov.au
Ms Maria de Fatima C.Melo Ms Usha Sriram-Prasad
Agronomica Engieener Manager, Food Regulation and Safety
Ministerio da Agricultura e do Deswenvolvimento Rural Australian Government Department of Agriculture,
7°Andar, Rua Comandante Gika Fisheries and Forestry
00527 Luanda GPO Box 858
Angola 2601 Canberra
Tel.: +244 222 327424 Australia
Fax: +244 222 327424 Tel.: +61 (2) 6272 3547
Fax: +61 (2) 6272 4367
ARGENTINA / ARGENTINE
E-Mail: usha.sp@daff.gov.au
Prof Maria Luz Martinez
Farm./Lic. En Industrias AUSTRIA/AUTRICHE
Ministerio de Salud de la Nación Dr Fritz Wagner
ANMAT / INAL Federal Ministry for Health, Family and Youth
Estados Unidos 25, Radetzkystrasse 2
1101 Ciudad Autonoma de Buenos Aires 1100 Vienna
Argentina Austria
Tel.: +54 (11) 4340 0800 int 3514 Tel.: +43 (1) 7 11 00 44 26
Fax: +54 (11) 4340 0800 int. 3514 E-Mail: fritz.wagner@bmgf.gv.at
E-Mail: mmartin@anmat.gov.ar
BELGIUM / BELGIQUE / BÉLGICA
Dr Maria Cristina López Pascale De Gryse
Licenciada en Ciencias Qúimicas Expert
Instituto Nacional de Tecnología Service public fédéral de la Santé Publique, Sécurité de
Industrial-Cereales y Oleaginosas la Chaîne alimentaire et Environnement
Colectora Gral Paz 5445 Eurostation Bloc II Place Victor Horta 40 bte 10
1650 San Martín – Provincia de Buenos Aires 1060 Bruxelles
Argentina Belgium
Tel.: +54 (11) 4753 5743 Tel.: +32 (0) 2 524 7368
Fax: +54 (11) 4653 5743 Fax: +32 (0) 2 524 7399
E-Mail: kitty@inti.gob.ar E-Mail : pascale.degryse@health.fgov.be
AUSTRALIA / AUSTRALIE BOTSWANA
Ms Janine Lewis Miss Matsapa Phegelo
Principal Nutritionist Principal Health Officer I Nutrition and Food Control
Food Standards Australia New Zealand Public Health Department Ministry of Health
P.O. Box 7186 Plot No : 54609 Government Enclave
2610 Canberra BC ACT Ministry of Health Headquaters Building Room GB 17
Australia Private Bag 00269 Gabarone
Tel.: +61 (2) 6271 2245 Botswana
Fax: +61 (2) 6271 2278 Tel. : +267 363 204
E-Mail: janine.lewis@foodstandards.gov.au Fax : +267 390 2092
E-Mail : mphegelo@gov.bw
ALINORM 09/32/26 23

BRAZIL / BRÉSIL / BRASIL Ms Charmaine Kuran

Mr André Baker Méio National Manager
First Secretary Nutrition and Health Claims
Embassy of Brazil Canadian Food Inspection Agency
Hillcrest Office Park 159 Cleopatra Drive
Woodpecker Place 1st Floor K1A OY9 Ottawa, Ontario
177 Dyer Road Canada
0083 Pretoria Tel.: +1 (613) 221 7200
South Africa Fax: +1 (613) 221 7295
Tel.: +27 12 366 5200 Dr Stanley Zlotkin
Fax: +27 12 366 5299 Professor of Nutrition
E-Mail: abaker@brazilianembassy,org.za University of Toronto
Mrs Elisabete Gonçalves Dutra 555 University Ave
Technical Assistant M5G IX8 Toronto
National Health Suveillance Agency – Anvisa Canada
SEPN 511 – Bloco A - Edificio Bittar II Tel:: +1 416 417 1404
70750-541 Brasilia – DF Fax: +1 416 813 4972
Brazil E-Mail: stanley.zlotkin@sickkids.ca
Tel:: +55 (61) 3448 6285
CHILE/CHILI
Fax: +55 (61) 3448 6274
Dr Lorena Rodriguez-Osiac
E-Mail: elisabete.goncalves@anvisa.gov.br
Pediatrician Master in Nutrition
Ana Claudia Maraguim Firmo Araujo Ministry of Health
Specialist in Health Surveillance Mac Ivercharmaine.kuran@inspection.gc.ca 459 8° Piss.
National Health Surveillance Agency - Anvisa Dpto. Alimentos y Nutrición
Ministry of Health Santiago
SEPN 511 – Bloco A – Edificio Bittar II Chile
70750-502 Brasilia – DF Tel.: +56 (2) 5740 474
Brazil E-Mail: lrodriguez@minsal.cl
Tel:: +55 (61) 3448 6352
Fax: +55 (61) 3448 6274 CHINA/CHINE
E-Mail: ana.firmo@anvisa.gov.br Ms Tonggang Zhao
Public Servant
CANADA/CANADÁ Ministry of Health
Dr Mary L’Abbé 1 Nanlu Xizhimenwai
Director 100044 Beijing
Bureau of Nutriton Sciences P.R. China
Health Canada Tel.: +86 (10) 6879 2383
251 Sir Frederick Banting Driveway Fax: +86 (10) 6979 2408
K1A OK9 Ottawa, Ontario E-Mail: zhanglp@moh.gov.cn
Canada
Ms Lingping Zhang
Tel.: +1 (613) 948-8476 Public Servant
Fax: +1 (613) 948 8470 Ministry of Health
E-Mail: mary_labbe@hc-sc.gc.ca 1 Nanlu Xizhimenwai
Ms Christina Zehaluk 100044 Beijing
Head, Special Purpose Foods P.R. China
Bureau of Nutritional Sciences Tel.: +86 (10) 6879 2403
Health Canada Fax: +86 (10) 6979 2408
251 Sir Frederick Banting Driveway E-Mail: zhanglp@moh.gov.cn
K1A OK9 Ottawa, Ontario
Canada
Tel.: +1 (613) 957 1739
Fax: +1 (613) 941 6636
E-Mail: christina_zehaluk@hc-sc.gc.ca
ALINORM 09/32/26 24

Prof Shi An Yin Prof Jinbao Yong

National Institute for Nutrition and Food Safety National Dairy Testing Center
Chinese Center for Diseases Control and No 337 Xuefu Road
revention 150086 Harbin
29 Nan Wei Road, Xuanwu District China
Beijing 100050 Tel. : +86 451 8668 4267
P. R. China
Tel.: +86 (10) 8313 2932 Prof Yun Wang
Fax: +86 (10) 8313 2932 National Dairy Testing Center
E-Mail: shianyin@gmail.com No 337 Xuefu Road
150086 Harbin
Dr Xuejun Zhao
China
Scientific and Regulatory Affairs Director
Tel :: +86 451 8663 0308
International Nutrition Co. Ltd.
Building #12, Jln Qiao Office Park, Ms Ruimin Xu
27 Xin Jin Qiao Rd. Pudong Assistant Regulatory Affairs Manager
Shanghai, 201206 Meadjonson Nutritionals (China) Ltd.
P. R. China 34F Gonxin Place No 33 HuongPu West Road
Tel.: +86 (21) 3860 8840 510620 Guangzhon
Fax: +86 (21) 3860 8889 China
E-Mail: xuejun.zhao@dumex.com.cn Tel :: +86 8670 3811 1078
Fax : +86 8670 3811 1185
Mr Jianbo Zhang
amy.xu@bms.com
National Institutefor Nutrition and Food Safety
7 Panjiayuan Nan li, Chaoyang District, Ms Melissa Liu
100021 Beijing Centre for Food Safety, Food an Environmental Hygiene
P.R. China Department
Tel.: +86 (10) 8777 6914 HKSAR, China
Fax: +86 (10) 6771 1813 43/F Queensway Government Offices, 66 Queensway
E-Mail: zhjb318@163.com Admiralty Hong Kong
Tel. : +882 2867 5808
Mr Hongmin Xu
E-Mail : mpsliu@fehd.gov.hk
Director of Technical and Regulatory
Amway (China) Co.Ltd DENMARK / DANEMARK / DINAMARCA
41/F CITIC Plaza Ms Anne Scott
233 Tianhe N. Road Master of Food Science an Technology
510613 Guangzhou Danish Veterinary and Food Administration
P. R. China Mørkhøj Bygade 19
Tel. : +86 (20) 8519 8811 2860 Copenhagen
Fax : +86 (29) 3891 2807 Denmark
E-Mail : hongmin_xu@amway.com Tel : +45 3395 6142
Dr Xianfeng Zhao E-Mail : ansc@fvst.dk
National Institute for Nutrition and Food Safety Mr Søren Langkilde
Chinese Center for Disease Control and Prevention Master of Biology
29 Nanwei Rd., Xuanwu District Danisch Veterinary and Food Administration
100050 Beijing Division of Nutritioin
P. R. China Mørkhøj Bygade 19
Tel. : +86 (10) 8313 2932 2860 Copenhagen
Fax : +86 (10) 8313 2932 Denmark
E-Mail : zhao.xf.xianfeng@gmail.com Tel.: +45 3395 6143
E-Mail: srbl@fvst.dk
ALINORM 09/32/26 25

EGYPT / ÉGYPTE / EGIPTO Dr Eva Maria Zamora Escribano

Dr Salah Hussein Abo-Raya Administrator
Professor of Food Industries European Commission
Faculty of Agriculture, Cairo University Rue Froissart 101 – 2/60
Gamaa Street 1040 Brussels
Giza Belgium
Egypt Tel :: +32 (2) 299 8682
Tel.: +20 (2) 3337 5003 Fax : +32 (2) 299 8566
Fax: +20 (2) 3336 5799 E-Mail: eva-maria.zamora-escribano@ec.europa.eu
E-Mail: aborayaaoad@yahoo.com Ms Helen Lee
Dr Mohamed Kamal Abdel-Rahman European Commission
Head of Central Lab. Directorate-General SANCO
Nutrition National Institute Rue Froissart 101
16 Kaser al Eyne Street 1049 Brussels
Cairo Belgium
Egypt Tel.: +32 (2) 299 8668
Tel.: +20 (2) 2364 6413 E-Mail : helen.lee@ec.europa.eu
Fax: +20 (2) 2364 7476
E-Mail: mk_mansour_egypt@yahoo.com
FINLAND / FINLANDE / FINLANDIA
Dr Nagia Abd El-Mohsen Mohamed Attia Ms Anna Lemström
Senior Food Standard Specialist Senior Adviser
Egyptian Organization for Standardization and Quality Ministry of Agriculture and Forestry
(EOS) P.O.Box 30
16 Tadreeb El Modarrebeen Street, Ameriya 00023 Government, Helsinki
Cairo FinlandV
Egypt Tel.: +358 (9) 1605 2305
Tel.: +20 (2) 2284 5531 Fax: +358 (9) 1605 3338
Fax: +20 (2) 2284 5504 E-Mail: anna.lemstrom@mmm.fi
E-Mail: moi@idse.net.eg
Ms Sirpa Salio-Lähteenkorva
ETHIOPIA / ÉTHIOPIE / ETIOPÍA Ministerial Advisor
Mr Belete Argaw Ministry of Social Affairs and Health
General Manager P.O. Box 33
Health Care Food Manufacturers Plc 00023 Government, Helsinki
P.O.Box 80313 Finland
Akaki Kality Sub City Kebele 10/11 Tel.: +358 (9) 16 07 40 35
80313 Addis Abeba Fax: +358 (9) 16 07 41 44
Ethiopia E-Mail: sirpa.sarlio-lahteenkorva@mmm.fi
Tel.: +251 (11) 439 0854 FRANCE / FRANCIA
Fax: +251 (11) 439 3940 Mrs Marianne Dessen-Mugniot
E-Mail: hcfm@ethionet.et Direction générale de la concurrence, de la
EUROPEAN COMMUNITY / COMMUNAUTÉ EUROPÉENNE / consommation et de la répression des fraudes
COMUNIDAD EUROPEA Bureau D 3
Mr Basil Mathioudakis Secteur Nutrition et Diététique
Head of Unit 59 bd Vincent Auriol
European Commission 75703 Paris 13e
Directorate-General SANCO France
Rue Froissart 101 Tel. : +33 (1) 4497 2415
1049 Brussels Fax : +33 (1) 4497 3048
Belgium E-Mail :
Tel.: +32 (2) 2959 182 marianne.dessen-mugniot@dgccrf.finances.gouv.fr
’Fax: +32 (2) 2961 735
E-Mail: basil.mathioudakis@ec.europa.eu
ALINORM 09/32/26 26

Pascal Audebert GERMANY / ALLEMAGNE / ALEMANIA

Point de Contact du Codex alimentarius en France Dr Pia Noble
Premier Ministre Federal Ministry of Food,
Secrétariat général des Affaires européenes Agriculture and Consumer Protection
2, boulevard Diderot Rochusstrasse 1
75572 Paris Cedex 12 53123 Bonn
France Germany
Tel.: +33 (1) 44 87 16 03 Tel.: +49 (228) 99 529 4665
Fax: +33 (1) 44 87 16 04 Fax: +49 (228) 99 529 4965
E-Mail: pia.noble@bmelv.bund.de
E-Mail: pascal.audebert@sgae.gouv.fr
Mrs Murielle Clemente Dr Anke Niederhaus
Chargée de mission sur les questions liées Federal Ministry of Food,
à la réglementation relative à la Nutrition Agriculture and Consumer Protection
Ministère chargé de la Santé Rochusstrasse 1
DGS, Bureau alimentation et nutrition (EA3) 53123 Bonn
Germany
14, Avenue Duquesne
Tel.: +49 (228) 99 529 4172
75350 Paris SR 07
Fax: +49 (228) 99 529 4965
France
E-Mail : anke.niederhaus@bmelv.bund.de
Tel.: +33 (1) 4056 4332
Fax: +33 (1) 4056 5412 Mr Norbert Pahne
E-Mail: murielle.clemente@sante.gouv.fr Manager
Bundesverband der Hersteller für eine besondere
Mrs Annie Loch
Ernährung (Diätverband)
Corporate Food Law Director
Godesberger Allee 142-148
Groupe Danone
53175 Bon
15 Rue du Helder
Tel. : +49 (228) 308 5140
75009 Paris
Fax : +49 (228) 308 5150
France
E-Mail : info@diaetverband.de
Tel.: +33 (1) 061 4672 825
Fax: +33 (1) 014 4352 695 Ms Anke Weissenborn
E-Mail: annie.loch@danone.com Bundesinsitut für Risikobewertung
Federal Institute for Risk Assessment
Mr Kari Töllikkö
Thielallee 88-92
Principal Administrator
14195 Berlin
General Secretariat of the Council of the European Union
Germany
The French Presidency
Tel.: +49 (30) 8412 3812
Rue de la Loi 175
Fax: +49 (30) 8412 3715
1048 Bruxelles
E-Mail: anke.weissenborn@bfr.bund.de
Belgium
Tel.: +32 (2) 281 7841 GHANA
Fax: +32 (2) 281 6198 Prof Anna Lartey
E-Mail : kari.tollikko@consilium.europa.eu Associate Professor
University of Ghana, Department of Nutrition
GAMBIA, THE / GAMBIE /GAMBIA
Legon, Accra
Mrs Isatou Jeng-Ngom
Ghana
Senior Programme Officer
Tel.: +233 (21) 513294
National Nutrition Agency
E-Mail: aalartey@hotmail.com
Bertil Harding Highway
PMB 162, Banjul Ms Maria Lovelace-Johnson
Gambia, The Head, Food Safety Management Unit
Tel:: (220) 9817062 Food and Drugs Board, P.O.Box CT 2783
Fax: (220) 8900022 Cantonments, Accra
E-Mail: ijngom@hotmail.com Ghana
Tel.: +233 (21) 233200
Fax +233 (21) 22 9794
E-Mail: maljohnson@fdbghana.gov.gh
ALINORM 09/32/26 27

GREECE / GRÈCE /GRECIA

Dr Georgios Marakis Mr Yogesh Kumar Verma
Officer – Nutritionist (PhD) Food Regulatory Affairs Manager
Hellenic Food Authority (EFET)
Confederation of Indian Industries
Kifisias Av. 124 & Iatridou 2
23, Institutional Area, Lodhi Road
11526 Athens
New Delhi - 110003
Greece
Tel.: +30 2106 971552 India
Fax: +30 2106 971650 Tel.: +91 (11) 2462 9994
E-Mail: gmarakis@efet.gr Fax: +91 (11) 2462 1649
E-Mail: vermayk@indiatimes.com
Dr Vasileios Kontolaimos
Legal Advisor Mr Deepak Gunvante
Ministry or rural Development and Food Head – R & D Innovations & Regulatory Affairs
29 Acharnon GlaxoSmithKline Consumer Healthcare Ltd
10439 Athens DLF Plaza Towers, DLF Phase 1
Greece Gurgaon - 122002
Tel.: +30 2108 250307 India
Fax: +30 2108 254621 Tel:: +91 (124) 2540720
E-Mail: cohalka@otenet.gr Fax: +91 (124) 2540721
E-Mail: deepak.g.gunvante@gsk.com
GUINEA, REPUBLIC OF / GUINÉE, REPUBLIQUI DE /
GUINEA, REPUBLICA DE Dr Rajesh Kapur
Dr Ibrahima Seffan Camara Adviser Food & Nutrition
Coordonateur Adjoint Department of Biotechnology
Comité National de Nutrition Ministry of Science & Technology
Ministère de l’Elevage et de la Protection Animale Block 2 CGO Compex
559 Conakry Lodhi Road
Guinea New Delhi – 110 003
Tel.: +224 6239 6921 India
E-Mail: ibseffancamara@yahoo.fr Tel.: +91 24360745
E-Mail: kapur.dbt@nic.in
HUNGARY / HONGRIE / HUNGRÌA
Dr Éva Barna
Head of Department INDONESIA / INDONÉSIE
National Institute for Nutrition and Food Science Mrs Tetty Helfery Sihombing
Gyáli út 3/a Head of Sub Directorate for Certain Food
1097 Budapest National Agency of Drug and Food Control
Hungary Jl. Percetakan Negara No 23
Tel.: +36 (1) 476 6443 10560 Jakarta
Fax: +36 (1) 215 5369 Indonesia
E.Mail: barna.eva@oeti.antsz.hu Tel:: +62 (21) 4287 5584
Fax: +62 (21) 4287 5780
INDIA / INDE
E-Mail: tettyhelfery@yahoo.com
Mr Mahesh Arora
Director Mr Dharmaginta Thanos
Ministry of Women & Child Development Consulate General of the Republic of Indonesia
Room No 613, A Wing 129 Rosmead Avenue, Kendworth
Shastri Bhawan Cape Town
New Delhi – 11000 South Africa
India Tel.: +27 82 734916
Tel.: +91 (11) 2338 9434 E-Mail: bidekon@indonesia-capetown.org.za
Fax: +91 (11) 2338 1600
E-Mail: mcarora2@yahoo.co.in
ALINORM 09/32/26 28

Dr Damayanti Rusli Sjarif, PhD JAPAN / JAPON / JAPÓN

Indonesian Pediatric Society Dr Chieko Ikeda
Jl. Empang Tiga Dalam No 13 Director
12510 Jakarta Office of International Food Safety, Policy, Planning and
Indonesia Communication Division, Department of Food Safety,
Tel.: +62 (21) 3910 096 Pharmaceutical and Food Safety Bureau
E-Mail: nutrika@cbn.net.id Ministry of Health, Labour and Welfare
Dr Sri Soedarjati Nasar 1-2-2 Kasumigaseki Chiyoda-ku
Indonesian Pediatric Society 100-8916 Tokyo
Jl. Salamba 6 Japan
11040 Jakarta Tel.: +81 (3) 3595 2326
Indonesia Fax: +81 (3) 3503 7965
Tel.: +62 (21) 3910 096 E-Mail: codexj@mhlw.go.jp
E-Mail: nutrika@cbn.net.id Dr Katsuhiro Chosho
Deputy Director
Office of Health Policy on newly developed Foods
IRAN (ISLAMIC REPUBLIC OF)- IRAN (REPUBLIQUE
Standards and Evaluation Division, Department of Food
ISLAMIQUE DE) – IRÁN (REPÚBLICA ISLÁMICA DE
Safety,
Mrs Atefeh Fooladi Moghaddam
Pharmaceutical and Food Safety Bureau, Ministry of
Special Foods & Dietary Supplements Office,
Health, Labour and Walfare
Food and Cosmetic Dept. Food and Drug Division
1-2-2 Kasumigaseki, Chiyoda-ku
Ministry of Health & Medical Education
100-8916 Tokyo
Building #3
Japan
Enghelab Ave, Fakhre Razi Ave
Tel.: +81 (3) 3595 2327
1314715311 Teheran
Fax: +81 (3) 3501 4867
Iran
E-Mail: codexj@mhlw.go.jp
Tel: +98 2166 954441
Fax: +98 2166 954441 Mr Yasuki Matsui
E-Mail: fooladi_50@yahoo.com Section Chief
Office of Health Policy on newly developed Foods
Standards and Evaluation Division, Department of Food
IRELAND / IRELANDE / IRLANDA Safety,
Dr Mary Flynn Pharmaceutical and Food Safety Bureau, Ministry of
Chief Specialist Public Health Nutrition Health, Labour and Walfare
Food Safety Authority of Ireland 1-2-2 Kasumigaseki, Chiyoda-ku
Abbey Court, Lr. Abbey Street 100-8916 Tokyo
Dublin 1 Japan
Irelan Tel.: +81 (3) 3595 2327
Tel.: +353 (1) 817 1315 Fax: +81 (3) 3501 4867
Fax: +353 (1) 817 1215 E-Mail: codexj@mhlw.go.jp
E-Mail: mflynn@fsai.ie
Dr Kazuhiko Yamada
ITALY/ITALIE/ITALIA Director
Dr Lucia Guidarelli Division of Applied Food Research,
Food Safety and Nutrition Directorate National Institute of Health and Nutrition
Head of Nutriton Unit 1-23-1, Toyama, Shinjuku-ku
Welfare, Health and Social Affiars Ministry 162-8636 Tokyo
Vira Giorgio Ribotta 5 Japan
00144 Roma Tel:: +81 (3) 3203-5721
Italy Fax: +81 (3) 3202-3278
Tel.: +39 (6) 5994 6828 E-Mail: codexj@mhlw.go.jp
Fax: +39 (6) 5994 3598
E-Mail: l.guidarelli@sanita.it
ALINORM 09/32/26 29

Mr Hiroaki Hamano KOREA, REPUBLIC OF / CORÉE, RÉPUBLIQUE DE / COREA,

Technical Advisor REPUBLICA DE
Japan Health Food and Nutrition Food Association Prof Oran Kwon
2-7-27, Sadohara-cho, Ichigaya, Shinjuku-ku Ph. D.
162-0842 Tokyo Ewha Womans University
Japan Department of Nuitritional Science and Food
Tel:: +81 (3) 3268 3134 Management, College of Health Sciences
Fax: +81 (3) 3268 3136 11-1 Daehyung-dong, Seodaemun-ku
E-Mail: hiroaki.hamamo@danisco.com 120-750 Seoul
Dr Hiroshi Tsuchita Republic of Korea
Technical Advisor Tel. : +82 (2) 3277 6860
Japan Food Hygiene Assiciation E-Mail : orank@ewha.ac.kr
2.6.1 Jingu-mae, Shibuya-ku Ms Eun Ju Lee
150-0001 Tokyo Deputy Team Leader
Japan Korea Food and Drug Administration
Tel.: +81 (3) 3403 2112 #194 Tongil-Ro, Eunpyeong-Gu
Fax: +81 (3) 3403 2384 122-704 Seoul
E-Mail: idfjapan@rapid.ocn.ne.jp Republic of Korea
Tel.: +82 (2) 380 1678
KENYA
Fax: +82 (2) 359 0867
Mrs Joyce Wairimu Njoya
E-Mail: Eunju89@kfda.go.kr
Government Laboratory Analyst
Government Chemist Department Miss Soh Yoon Yun
P.O.Box 20753 Senior Researcher
00202 Nairobi Korea Food and Drug Administration
Kenya #194 Tongil-ro, Eunpyeong-gu
Tel.: +254 (20) 2725806 122-704 Seoul
Fax: +254 (20) 2717 567 Republic of Korea
E-Mail: gchemist@wananchi.com Tel.: +82 (2) 380 1317
Fax: +82 (2) 359 0025
Miss Jemimah Mambala
E-Mail: ysy0614@kfda.go.kr
Coca-Cola East&Central Africa
P.O.Box 30134 Mr Jae Woo Park
00100 Nairobi DVM
Kenya Ministry for Food, Agriculture, Forestry and Fisheries
Tel:: +254 3253518 National Veterinary Research and Quarantine Service
Fax: +254 3253362 430-824 Chungang-ro 335, Manan-gu
E-Mail: jmambala@afr.ko.com 430.824 Anyang-si
Republic of Korea
Mr Peter Mutua
Tel:: +82 (31) 467 1986
Standards Officer
Fax: +82 (31) 467 1989
Kenya Bureau Standards
E-Mail: jwpark@nvrqs.go.kr
P.O.Box 54974
00200 Nairobi Dr Cho-Il Kim
Kenya Director
Tel.: +254 2069 48000 Center for Nutrition Policy & Promotion
Fax: +254 20609 660 Korea Health Industry Development Institute
E-Mail: mutuap@kebs.org 57-1 Norgangjin-Dong, Dongjak-Ku
156-800 Seoul
Republic of Korea
Tel:: +82 (2) 881 1611
Fax: +82 (2) 822 8338
E-Mail: kimci@khidi.or.kr
ALINORM 09/32/26 30

MALAYSIA / MALASIE / MALASIA Dr Pedro Gutiérrez

Ms Rokiah Don Director de Investigación
Deputy Director (Nutrition) Instituto Nacional de Pediatría
Nutrition Division Av. Insurgentes sur No 3700 Letra C
Ministry of Health Malaysia 1er Piso Torre de Investigacion, Col Insurgentes
Level 7, Block E 10, Parcel E, Precint 1 Cuicuilco
Federal Governement Administrative Complex Delegación Coyoacán
62590 Putrajaya 04530 Ciudad de México
Malaysia México
Tel.: +60 (3) 8883 4083 Tel.: +52 (55) 1084 0906
Fax: +60 (3) 8883 4647 Fax: +52 (55) 1084 3883
E-Mail: rokiah@moh.gov.my E-Mal: pedrogtzca@prodigy.net.mx
Ms Kanga Rani Selvaduray
Senior Research Officer MONGOLIA / MONGOLIE
Malaysian Palm Oil Board Ms Jamin Batjargal
6, Persiaran Institusi, Bandar Baru Bangi Director of the Nutrition Research Centre and
43000 Kajang Member of National Codex Team
Malaysia Public Health Institute
Tel.: +60 (3) 8769 4606 Peace Avenur – 17
Fax: +60 (3) 8922 1742 Bayanzurkh district
E-Mail: krani@mpob.gov.my Ulaanbaatar – 21149
Mr Uthaya Kumar Muthu Mongolia
Malaysian Palm Oil Council Tel.: +976 (11) 455600
5 Nollsworth Crescent, Nollsworth park Fax: +976 (11) 458645
La Lucia Ridge Office Estate E-Mail: batjar_j@hotmail.com
La Lucia, 4051 KZN
NETHERLANDS / PAYS BAS / PAÍSES BAJOS
South Africa
Ms Letteke Boot
Tel. +27 (31) 5666 171
Policy Advisor
Fax: +27 (31) 5666 170
Ministry of Health, Welfare and Sport
E-Mail: kumar@mpoc.org.za
P.O.Box 20350
MEXICO / MEXIQUE / MÈXICO 2500 EJ The Hague
Q.A. Guadalupe Arizmendi The Netherlands
Enlace en Inocuidad Alimentaria Tel.: +31 (70) 3405447
Dirección de Operación Internacional Fax: +31 (70) 3405554
Comisión Federal para la Protección E-Mail: ca.boot@minvws.nl
contra Riesgos Sanitarios Dr Jaap Schrijver
Secretaría de Salud Manager Regulatory Affairs Baby Foods
Monterray #33 1° Piso, Danone Baby Nutrition
Colonia Roma, Delegación Cuautémac P.O.Box 75538
06700 Ciudad de México, D.F. 1118 ZN Schipol Airport
México The Netherlands
Tel.: +52 (55) 5080 5296 Tel.: +31 (20) 456 9466
Fax: +52 (55) 5208 2974 Fax: +31 (20) 456 8466
E-Mail: garizmendir@salud.gob.mx E-Mail: jaap.schrijver@danone.com
ALINORM 09/32/26 31

NEW ZEALAND / NOUVELLE-ZÉLANDE / NUEVA ZELANDA Mr Dennis Onyeagocha

Ms Jenny Reid Deputy Director
Assitant Director Federal Ministry of Health
Joint Food Standards Food an Drug Services Department
New Zealand Food Safety Authority Federal Secretariat, Phase III
PO Box 2835 Abuja
Wellington Nigeria
New Zealand Tel.: +234 080 3314 7808
Tel.: +64 (4) 894 2582 E-Mail: dennyo_2003@yahoo.com
Fax: +64 (4) 894 2583 Dr Yaya Olaniran
E-Mail: jenny.reid@nzfsa.govt.nz Nigerean Perm. Rep. to FAO
Nigeria Government
Mr David Roberts
Via Cassio Doro 2/c
Programme Manager (Nutrition) 00193 Rome
New Zealand Food Safety Authority Italy
PO Box 2835 E-Mail: nigeriapermrep@email.com
Wellington
Fred Chiazor
New Zealand
Assiciation of Food Beverage & Tobacco EMPLOYEE
Tel:: +64 (4) 894 4236
(AFBTE)
Fax: +64 (4) 894 2583 16 Gerrard Road, Iko 41
E-Mail: david.roberts@nzfsa.govt.nz Lagos
Ms Ann Hayman Nigeria
Senior Programme Manager (Food Standards) Tel:: +234 803 5352226
New Zealand Food Safety Authority E-Mail: fchiazor@afr.ko.com
PO Box 2835 Patricia Chizoba Monwuba
Wellington Deputy Director (Foods)
New Zealand National Agency for Food and Drug
Tel.: +64 (4) 894 2674 Administration and Control
Fax: +64 (4) 894 2675 (NAFDAC)
E-Mail: ann.hayman@nzfsa.govt.nz Plot 2032 Olusegun
Obasanjo Way, Zone 7, Wuse
NIGER Abuja
Mr Moussa Boureima Nigeria
Tel:: +234 7037 884145
Point Focal Codex Niger
E-Mail: patmonwuba@yahoo.com
Ministère de la Santé Publique
BP 623 Niamey
Niger NORWAY / NORVÈGE / NORUEGA
Tel. +227 9687 1982 Ms Svanhild Vaskinn
Fax: +227 2073 3570 Adviser
E-Mail: boureima_moussa@yahoo.fr Norwegian Food Safety Authority
P.O. Box 383
NIGERIA N-2381 Brumunddal
Mr Stephen Tunde Laiye Norway
Director Tel.: +47 (23) 21 6800
Federal Ministry of Health Fax: +47 (23) 21 6801
Food and Drug Services, Federal Secretariat E-Mail: svvas@mattilsynet.no
Abuja
Nigeria
Tel:: +234 080 5512 1318
E-Mail: tundelaiye@yahoo.com
ALINORM 09/32/26 32

Mrs Turid Ose SOUTH AFRICA / AFRIQUE DE SUD / SUDÁFRICA

Senior Adviser Ms Ann Behr
Norwegian Food Safety Authority Department of Health
P.O.Box 383 Directorate: Nutrition
2381 Brumunddal Private Bag X 828
Norway 0001 PRETORIA
Tel.: +47 2321 67 42 South Africa
Fax: +47 2321 68 01 Tel.: +27 (12) 312 0043
E-Mail: tuose@mattilsynet.no Fax: +27 (12) 312 3112
Email: Behra@health.gov.za
Dr Linda Granlund
Ms Andiswa Ngqaka
NHO mat og drikke/Mills
Department of Health
Sofienberggata 19, POB 4644 Sofienberg
Directorate: Nutrition
0506 Oslo Private Bag X 828
Norway 0001 PRETORIA
Tel.: + 47 9901 9418 South Africa
Fax: +47 2238 2380 Tel.: +27 (12) 312 0873
E-Mail: linda.granland@mills.no Fax: +27 (12) 312 3112
PHILIPPINES / FILIPINAS Email: NgqakA@health.gov.za
Mr Israel Dela Cruz Mrs Yolande Van Der Riet
Senior Science Research Specialist Department of Health
Bureau of Agriculture and Fisheries Product Standards Directorate: Food Control
Department of Agriculture Private Bag X 828
BPI Compound, Visayas Avenue, Diliman 0001 PRETORIA
1101 Quezon City South Africa
Philippines Tel.: +27 (12) 312 0202
Tel:: +63 (2) 920 6131 Fax: +27 (12) 312 3180
Fax: +63 (2) 455 2858 Email: debruy@health.gov.za
E-Mail: iqdelacruz@gmail.com Mr Robert Makuba
SINGAPORE / SINGAPOUR / SINGAPUR Principal Medicine Registration Officer
Ms Huay Leng Seah National Department of Health
Deputy Director (Food Control) Private Bag X 828
Agri-Food & Veterinary Authority 0001 PRETORIA
5 Maxwell Road, Tower Block #18-00 South Africa
Singapore 069110 Tel.: +27 (12) 312 0390
Tel.. +65 325 5480 Fax: +27 (12) 312 0134
Fax: +65 632 44563 Email: MakubM@health.gov.za
E-Mail: seah_huay_leng@ava.gov.sg Prof Hester Hendrina(Este) Vorster
Ms Lee San Lim Director: Center of Excellence for Nutrition
Head Pre-market Approval Branch & Faculty of Health Sciences
Deputy Branch Head (Food Legislation) Private Bag X 6001
2520 Potchfstroom
Agri-Food and Veterinary Authority
South Africa
5 Maxwell Road, Tower Block MND Complex #18-00
Tel.: +27 (18) 299 4237
Singapore 069110
Fax: +27 (18) 299 2464
Tel.. +65 6325 8553 Email: este.vorster@nwu.ac.za
Fax: +65 6324 4563
E-Mail: lim_lee_san@ava.gov.sg Prof Xikombiso Mbhenyane
Dean : School of Health Sciences
University of Venda
Private Bag X 5050
0950 Thohoynadou
South Africa
Tel.: +27 (15) 962 8114
Fax: +27 (15) 962 8647
Email: xikombiso.mbhenyane@univen.ac.za
ALINORM 09/32/26 33

Ms Jane Badham Mr Benny Sikhakhane

Association for Dietetics in South Africa Deputy Director: Community Nutriton Programme
P.O.Box 67396 National Department of Health
Bryanston Pirvate Bag X 828
2021 Johannesburg 0001 Pretoria
South Africa South Africa
Tel.: +27 (11) 463 0679 Tel: + 27(12) 312 0044
Fax: +27 (11) 463 0679 Fax: + 27(12) 312 3112
Email: jane@jbconsultancy.co.za Email: Sikhab@health.gov.za
Prof Johann Jerling Mr Gilbert Tshitaudzi
Nutrition Society of South Africa National Department of Health
2520 Potchefstroom 231 Preos Street
South Africa Hallmark Building
Tel.: +27 (18) 299 2481 0001 Pretoria
Fax: +27 (18) 299 2464 South Africa
Email: johann.jerling@nwu.ac.za Tel: + 27 (12) 312 0418
Mrs Rosemary Maguire Fax: +27 (12) 312 3112
President Email: Tshitg@health.gov.za
South African Association for Food Science and Mrs Penny Campbell
Technology National Department of Health
Suite 215 Food Control
Private Bag X 16 Private Bag X 828
7848 Constantia 0001 Pretoria
South Africa South Africa
Tel.: +27 (21) 790 5097 Tel: + 27 (12) 312 0159
Fax: +27 (21) 790 5097 Fax: + 27 (12) 312 3180
Email: rosie@inessence.co.za Email: campbp@health.gov.za
Mrs Anne Pringle Mr Chris Thabethe
Health Products Association of South Africa National Department of Health
P.O.Box 55544 Directorate:Food Control
Northlands Private Bag X 828
2116 Johannesburg 0001 Pretoria
South Africa South Africa
Tel.: +27 (11) 317 8300 Tel: + 27(12) 312 0162
Fax: +27 (11) 317 8547 Fax: + 27(12) 312 3180
Email: anne@sportron.co.za Email: thabec@health.gov.za
Ms Shirley Du Plessis
SOUTH AFRICAN OBSERVERS National Department of Health
Directorate: Food Control
Ms Moira Byers Private Bag X 828
Consumer Goods Council of South Africa 0001 Pretoria
P.O.Box 41417 South Africa
Craighall Tel: + 27 (12) 312 0132
2024 Johannesburg Fax: + 27 (12) 312 3180
South Africa Email: dupless@health.gov.za
Tel.: +27 82 804 9115
Fax: +27 (11) 919 0069 Ms Lenore Spies
Email: mby@cgcsa.co.za Director:Nutrition
Kwa-Zulu Natal Department of Health
Mrs Kathryn Sinclair Private Bag X9051
Senior Researcher and Development Manager 3200 Pietermaritzburg
Irvin and Johnson LTD South Africa
P.O.Box 1628 Tel: + 27 (83) 468 1251
8000 Cape Town Fax: + 27 (33) 395 3053
South Africa Email: lenore.spies@kzn.ac.za
Tel.: +27 (21) 440 7902
Fax: +27 (21) 440 7953
Email: Kathryn@ij.co.za
ALINORM 09/32/26 34

Mrs Hilary Goeiman Mr Moses Alphons Kaunyana Kau

Deputy Director :Nutrition Deputy Director – General
Western Cape Department of Health National Department of Health
P.O.Box 2060 Private Bag X 828
8000 Cape Town 0001 Pretoria
South Africa South Africa
Tel: +27 (21) 483 5663 Tel: + 27 (12) 312 3237
Fax: + 27(21) 483 2682 Fax: + 27 (12) 312 3135
Email: hgoeiman@rswc.gov.za Email: kaum@health.gov.za
Mrs Maria van der Merwe Dr Maricel Keyser
Acting Deputy Director SAAFoST + Cape Peninsula University of Technology
Mpumalanga Department of Health Cape Peninsula University of Technology
P.O.Box 1882 Department of Food Technology
White River PO Box 1906
1240 Nelspruit 7535 Bellville
South Africa South Africa
Tel: + 27 (82) 307 5345 Tel.: +27 (21) 959 6776
Fax: + 27 (86) 529 7987 Fax: +27 (21) 959 6095
Email: lynnV@social.mpu.gov.za E-Mail: keyserm@cput.ac.za
Mrs Christine Broadhurst Ms Ronel Keevè
Consumer and Regulatory Affairs Manager Department of Health
Unilever SA (Pty) Ltd Forensic Chemistry Laboratory
P.O.Box 4923 P.O.Box 668
4000 Durban 8000 Cape Town
South Africa South Africa
Tel: + 27 (31) 570 2098 Tel.: +27 (21) 442 8950
Fax: + 27 (31) 570 2657 Fax: +27 (21) 447 3478
Email: christine.broadhurst@unilever.com E-Mail: food@fclcape.com
Ms Karin Carstensen Dr Michelle Cameron
Woolworths South Africa Department of Food Science, University of Stellenbosch
93 Longmarket Street Private Bag X1
P.O.Box 680 Matieland
8000 Cape Town 7602 Stellenbosch
South Africa South Africa
Tel: + 27 (21) 407 2792 Tel.: +27 (21) 808 3579
Fax: + 27 (21) 407 3939 Fax: +27 (21) 808 3510
Email: Karincastensen@woolworths.co.za E-Mail: mcam@sun.ac.za
Ms Karen Vokes Mrs Karen Horseburgh
Regulatory Dietitian
Consumer Goods Council of South Africa ADSA
1st Floor Block, hurlingham Park, Woodlands Avenue, 18 Uplands Road
Hurlingham Manor Milnerton
2024 Sandton, Johannesburg 7435 Cape Town
South Africa South Africa
Tel: + 27 (11) 644 0881 Tel.: +27 (21) 551 2993
Fax: + 27 (11) 644 0673 Fax: +27 (21) 551 2801
Email: kvokes@afr.ko.com
E-Mail: Karen@factssa.com
Mr Joan Matji
Mr Russell Coote
Senior Nutirtion Specialist
Department of Health
UNICEF
P.O.Box 4884 96 Haig Road
0001 PRETORIA 4051 Durban
South Africa South Africa
Tel: + 27 (12) 354 8255 Tel.: +27 (31) 302 2111
Fax: + 27 (12) 354 8293/4 Fax: +27 (31) 307 6099
E-Mail: dohdurban@telkomsa.net
ALINORM 09/32/26 35

SPAIN / ESPAGNE / ESPAÑA Mrs Kristina Sjölin

Ms Almudena Rollán Principal Administrative Officer
Spanish Food Safety and Nutrition Agency National Food Administration
Alcalá, no 56 Box 622
28071 Madrid SE - 75126 Uppsala
Spain Sweden
Tel.: +34 (91) 3380 710 Tel.: +46 (18) 175500
Fax: +34 (91) 3380 169 Fax: +46 (18) 105848
E-Mail: jccalco@msc.es E-Mail: codex@slv.se
Dr Carmen Arias Mr Paul Tenning
Technical Assistant Regulatory Affairs
Spanish Food Safety and Nutrition Agency Langeboog 1
Alcalá, no 56 1001 Copenhagen
28071 Madrid Denmark
Spain Tel.: +45 3266 2028
Tel.: +34 (91) 3380 918 E-Mail: paul.tenning@danisco.com
Fax: +34 (91) 3380 169
SWAZILAND / SWAZILANDIA
E-Mail: jccalvo@msc.es Mrs Thankful M. Dlamini
SUDAN / SOUDAN / SUDÁN Senior Nutrition Officer
Dr Nadia Elshiekh Ministry of Agriculture
Head-Department of Dairy Sector Box 162 Mbabane-SWD
Ministry of Animal Resources & Fisheries Mbabane
P.O.Box 293 Khartoum Swaziland
Sudan Tel:: 09268 608 5802
Tel.: +249 9222 12862 E-Mail: dlaminithankful@yahoo.com
Fax: +249 1834 75996 Ms Dudu Emmah Dube
E-Mail: nadiavet5@yahoo.com Senior Environmental Health Officer
Dr Omer Abdalla Ibrahim Ministry of Health & Solcial Welfare
Laboratories Director P.O.Box 5
Sudanese Staandards and Metrology Organization H100 Mbabane
P.O.Box 13573 Swaziland
13573 Khartoum Tel.: +268 6629280
Sudan Fax: +268 404 7420
Tel.: +249 9230019007 E-Mail: duduzdube@yahoo.co.uk
Fax: +249 183771486
E-Mail: shonam2003@hotmail.com
SWITZERLAND / SUISSE / SUIZA
Dr Babiker Elmubarak Mohmed Elamin Ms Elisabeth Nellen-Regli
Sudanese Standards and Metrology Organization Pharmacist
Tel.: +249 8377 5247 Federal Office of Public Health
E-Mail: wadelmubarak@hotmail.com Consumer Protection Directorate
Schwarzenburgstr. 165
SWEDEN / SUÈDE / SUECIA
3003 Bern
Mrs Kerstin Jansson
Switzerland
Deputy Director
Tel.: +41 (31) 322 9560
Ministry of Agriculture
Fax: +41 (31) 322 9574
10333 Stockholm
E-Mail: elisabeth.nellen@bag.admin.ch
Sweden
E-Mail: kerstin.jansson@agriculture.ministry.se
ALINORM 09/32/26 36

Dr Hervé Nordmann Ms Patchanee Intaraluk

Scientific & Regulatory Affairs Food Specialist
Ajinomoto Inc Co Food Control Division
En Crochet 1 Food and Drug Administration
1143 Apples Ministry of Public Health
Switzerland Tiwanond Road
Tel.: +41 (21) 800 3763 11000 Nonthaburi
Fax: +41 (21) 800 4087 Thailand
E-Mail: herve.nordmann@asg.ajinomoto.com Tel:: +66 (2) 590 7030
Dr Philippe Pittet Fax: +66 (2) 591 8460
Deputy Head Regulatory & Scientific Affairs E-Mail: meefood@health.moph.go.th
Nestec Ltd. Ms Churairat Arpanantikul
Avenue Nestlé 55 The Federation of Thai Industries
1800 Vevey Food Processing Industry Club
Switzerland Queen Sirikit National Conventions Center, Zone C,
Tel.: +41 (21) 924 4264 4th Floor
Fax: +41 (21) 924 4547 60 New Rachadapisek Road, Klontoey
E-Mail: philippe.pittet@nestle.com 10110 Bangkok
Dr Dirk Cremer Thailand
Global Regulatory Affairs Manager Tel.: +66 (2) 345 1167
DSM NutritionalProducts Fax: +66 (2) 345 1281-3
P.O.Box 2676, Bldg. 241/421 E-Mail: churairat.arpanantikul@intl.pepsico.com
4002 Basel Mr Manat Larpphon
Switzerland Standards Officer,
Tel:: +41 (61) 815 8107 Office of Commodity and System Standards
Fax: +41 (61) 815 8770 National Bureau of Agricultural Commodity and Food
E-Mail: dirk.cremer@dsm.com Standards
50 Kaset. Klang Bang Khen, Lat Yao, Jatujak
10900 Bangkok
TANZANIA / TANZANIE
Ms Candida Shirima Thailand
Food Evaluation Officer Tel.: +66 (2) 561 2277 ext. 1443
Tanzania Food and Drugs Authority (TFDA) Fax: +66 (2) 561 3373
P.O.Box 77150 E-Mail: mlarpphon@yahoo.com
Dar es Salaam
Tanzania UGANDA / OUGANDA
Tel.: +255 754 379827 Mr David Eboku
Fax: +255 22 2450 793 Ag. Head, Food and Agriculture Standards Division
E-Mail: candidap@yahoo.co.uk Uganda National Bureau of Standards
THAILAND / THAÏLANDE / TAILANDIA Plot M217 Nakawa Industrial Area
Prof Kraisid Tontisirin 6329 Kampala
Senior Advisor Uganda
Institute of Nutrition Tel.: +256 (41) 428 6123
Mahidol University, Salaya E-Mail: david.eboku@unbs.go.ug
73170 Nakorm Pathom
Thailand
Tel. : +66 (2) 441 9740
Fax : +66 (2) 938 3604
E-Mail : raktt@mahidol.ac.th
ALINORM 09/32/26 37

UNITED KINGDOM / ROYAUME-UNI / REINO UNIDO Ms Nancy T. Crane

Ms Claire Boville Regulatory Review Scientist
Food Standards Agency Office of Nutrition, Labeling and Dietary Supplements
Aviation House, Roome 125 Center for Food Safety & Applied Nutrition
125, Kingsway Food and Drug Administration (HFS-830)
London, WC2B 6NH 5100 Paint Branch Parkway
United Kingdom College Park, MD 20740
Tel.: +44 (20) 7276 8168 USA
Fax: +44 (20) 7276 8193 Tel.: +1 (301) 436 1450
E-Mail: claire.boville@foodstandards.gsi.gov.uk
Fax: +1(301) 436 2636
E-Mail: nancy.crane@fda.hhs.gov
UNITED STATES OF AMERICA / ÉTATS-UNIS D'AMÉRIQUE Non-Government Advisors
/ ESTADOS UNIDOS DE AMÉRICA Dr Sukh D. Bassi
Dr Barbara O. Schneeman Vice President, Scientific Affairs
Director, Office of Nutrition, Chief Science Officer
Labeling and Dietary Supplements MGP Ingredients, Inc.
Center for Food Safety & Applied Nutrition P.O.Box 130
U.S. Food and Drug Administration (HFS-800) Atchison, Kansas 66002
5100 Paint Branch Parkway USA
College Park, MD 20740 Tel:: +1 (913) 360-5246
USA Fax: +1 (913) 360-5746
Tel.: +1 (301) 436 2373 E-Mail: sukh.bassi@mgpingredients.com
Fax: +1 (301) 436 2636
Dr Lisa Craig
E-Mail: barbara.schneeman@fda.hhs.gov
Director, Regulatory Affairs
Dr Allison A. Yates Abbott Nutrition
Director Dept. NL06NG/RP3-2
Beltsville Human Nutrition Research Center 625 Cleveland Avenue
Agricultural Research Service Columbus, Ohio 43215
U.S. Department of Agriculture USA
10300 Baltimore Avenue Tel.: +1 (614) 624 3696
Bldg 307C, Rm. 117 Fax: +1 (614) 727 3696
Beltsville, MD 20705 E-Mail: lisa.craig@abbott.com
USA
Dr Craig W. Hadley
Tel.: +1 (301) 504-8157
Associate Director
Fax: +1 (301) 504-9381
North America Regulatory Science
E-Mail: allison.yates@ars.usda.gov
Mead Johnson Nutritionals
Dr Sue A. Anderson 2400 W. Lloyd Expressway
Team Leader Evansville, Indiana 47721
Regulations and Review Team USA
Office of Nutrition, Labeling and Dietary Supplements Tel.: +1 (812) 429 5052
Center for Food Safety & Applied Nutrition Fax: +1 (812) 429 5904
Food and Drug Administration (HFS-850) E-Mail: craig.hadley@bms.com
5100 Paint Branch Parkway
Dr Mary H. Hager
College Park, MD 20740
Director Regulatory Affairs
USA
The American Dietetic Association
Tel.: +1 (301) 436 1450
1120 Connecticut Ave NW, Suite 480
Fax: +1 (301) 436 2636
Washington DC 20036
E-Mail: sue.anderson@fda.hhs.gov
USA
Tel.: +1 (202) 775 8277
Fax: +1 (202) 775 8284
E-Mail: mhager@eatright.org
ALINORM 09/32/26 38

Ms Mardi K. Mountford INTERNATIONAL NON-GOVERNMENTAL

Executive Vice President ORGANIZATIONS
International Formula Council
1100 Johnson Ferry Road, AEDA / EFLA - ASSOCIATION EUROPÉENNE POUR LE
Suite 300 DROIT DA L'ALIMENTATION / EUROPEAN FOOD LAW
Atlanta, Georgia 30342 ASSOCIATION/INGO
USA
Tel.: +1 (404) 252 3663 Ms Daniela Muchna
Fax: +1 (404) 252 0774 European Food Law Association (EFLA)
E-Mail: mmountford@kellencompany.com Association Europeenne pour le droit de l’Alimentation
(AEDA)
Dr Lisa A. Sutherland Rue de l’Association 50
Assistant Professor 1000 Brussels
Department of Pediatrics Belgium
Senior Nutrition Scientist Tel. : +32 (2) 218 1470
Hood Center for Children and Families Fax : +32 (2) 219 7342
Dartmouth Medical School
HB 7465, One Medical Center Drive Mr Matias Cortes
Lebanon, New Hampshire 03756 Member
USA European Food Law Association (EFLA)
Tel:: +1 (603) 653 0754 Association Europeenne pour le droit de l’Alimentation
E-Mail: lisa.a.sutherland@dartmouth.edu (AEDA)
Rue de l’Association 50
VENEZUELA 1000 Brussels
Miss Mattdign Medina Belgium
Directoria Investigation Nutrition Tel. : +32 (2) 218 1470
Institute Nacational Nutrition Venezuela Fax : +32 (2) 219 7342
1010 Caracas E-Mail : efla_aeda@hotmail.com
Venezuela
Tel.: +58 212 862 4524 AIDGUM – INTERNATIONAL ASSOCIATION FOR THE
Fax: +58 212 4818 254 DEVELOPMENT OF NATURAL GUM
E-Mail: mattdignmedina@gmail.com Dr John Lupien
Aquino Moreno Vice President, Scientific Adviser
Institute Nacational Nutrition Venezuela International Association for the Development of Natural
1010 Caracas Gum (AIDGUM)
Venezuela 129 Chemin de Croisset
Tel.: +58 212 483 3733 76723 Rouen
Fax: +58 212 4833 733 France
E-Mail: Tel.: +33 (2) 3283 2214
Fax: +32 (2) 3283 1919
ZIMBABWE / ZIMBABUE E-Mail: john@jrlupien.net
Dr Fredy Chinyavanhu
Deputy Director – Food Control CEFS – COMITÉ EUROPÉEN DES FABRICANTS DE SUCRE
Helath/GVT Analyst Laboratory Mrs Camille Perrin
P.O.Box CY 231 Scientific & Regulatory Affairs -Manager
Causeway CEFS- Comité Européen des Fabricants de Sucre
Harare Avenue de Tervuren 182
Zimbabwe 1150 Brussels
Tel.: +263 912 426 084 Belgium
E-Mail: fchinyavanhu@healthnet.org.zw Tel. : +32 (2) 762 0760
Fax : +32 (2) 771 0026
E-Mail : camille.perrin@cefs.org
ALINORM 09/32/26 39

CIAA - CONFÉDÉRATION DES INDUSTRIES AGRO- ESPGHAN - EUROPEAN SOCIETY FOR PAEDIATRIC
ALIMENTAIRES DE L'UE GASTROENTEROLOGY, HEPATOLOGY AND NUTRITION
Miss Elena Cogalniceanu Prof Dominique Turck
Manager Consumer Information, Diet and Health Professor of Pediatrics
CIAA University of Lille
43 Avenue des Arts European Society of Gastroenterology, Hepatology and
1040 Brussels Nutrition
Belgium 2. Avenue Oscar Lambret
Tel.: +32 (2) 514 1111 59037 Lille
E-Mail: e.cogalniceanu@ciaa.eu France
Tel.: +33 320446885
COUNCIL FOR RESPONSIBLE NUTRITION – CRN
fax: +33 320446134
Dr John Hathcock
E-Mail: dturck@chru-lille.fr
Senior Vice President
CRN IACFO – INTERNATIONAL ASSICIATION OF CONSUMER
1828 L St, NW Suite 510 FOOD ORGANIZATIONS
20036 Washington, DC Mrs Patti Rundall
USA Policy Director
Tel.: +1 202 204 7662 Baby Milk Action / IBFAN
Fax: +1 202 204 7701 34 Trumpington St.
E-Mail: jhathcock@crnusa.org Cambridge CB2 1QY
Mr Mark Mansour United Kingdom
Partner Tel.: +44 01223 464420
Bryan Cave, LLC Fax. +44 01223 464417
Washington, DC E-Mail: prundall@babymilkacion.org
USA IADSA - INTERNATIONAL ALLIANCE OF DIETARY / FOOD
Tel.: +1 202 508 6019 SUPPLEMENT ASSOCIATIONS
E-Mail: mark.mansour@bryancave.com Prof David Richardson
Mr John Venardos Scientific Advisor
Herbalife International International Alliance of Dietary/Food Supplement
USA Associations (IADSA)
Tel.: +1 310 203 7146 50, Rue de l'Association
E-Mail: johnv@herbalife.com 1000 Brussels, Belgium
Mr Byran Johnson Tel.: +32 (2) 2 09 11 55
Tel.: +1 616 787 7577 Fax: +32 (2) 2 23 30 64
E-Mail: byron.johnson@amway.com E-Mail: secretariat@iadsa.be
Mr David Pineda Ereño
EHPM – EUROPEAN FEDERATION OF ASSOCIATIONS OF
Manager Regulatory Affairs
HEALTH PRODUCT MANUFACTURERS
International Alliance of Dietary/Food Supplement
Mr Xavier Lavigne
Associations (IADSA)
EHPM
Rue de l’Association 50
Rue de l’Assiciation 50
1000 Brussels
1000 Bruxelles
Belgium
Belgium
Tel.: +32 (2) 209 1155
E-Mail: pieterdhondt@ehpm.be
Fax: +32 (2) 223 3064
ENCA – EUROEAN NETWORK OF CHILDBIRTH E-Mail: secretariat@iadsa.be
Mr Joseph Voss Mr Ric Hobby
European Network of Childbirth (ENCA) Secretariat
9, Hubert Clement International Alliance of Dietary/Food Supplement
L 3444 Dudelange Associations (IADSA)
Luxembourg Rue de l’Association 50
Tel:: +352 6913 77167 1000 Brussels
Fax: +352 525291 Belgium
E-Mail: vossjos@pt.lu Tel.: +32 (2) 209 1155
ALINORM 09/32/26 40

Fax: +32 (2) 223 3064

E-Mail: secretariat@iadsa.be ICBA - INTERNATIONAL COUNCIL OF BEVERAGES
Mr Daniel Tsi ASSOCIATIONS
Technical Expert Mrs Helen Falco
International Alliance of Dietary/Food Supplement Technical Advisor
Associations (IADSA) International Council of Beverages Associations
Rue de l’Association 50 3-3-3 Nihonbashi-Muromachi, CM Building 3F,
1000 Brussels Chuo-ku
Belgium 103-0022 Tokyo
Tel.: +32 (2) 209 1155 Japan
Fax: +32 (2) 223 3064 Tel.: +81 (3) 3270 7300
E-Mail: secretariat@iadsa.be Fax: +81 (3) 3270 7306
Mr Jesús Muñiz E-Mail: hefalco@na.ko.com
Secretariat Mr Hiromi Ohta
International Alliance of Dietary/Food Supplement Technical Advisor
Associations (IADSA) Japan Soft Drinks Association
Rue de l’Association 50 3-3-3 Nihonbashi-Muromachi Chuo Ku
1000 Brussels Tokyo
Belgium Japan
Tel.: +32 (2) 209 1155 Tel.: +81 (3) 3270 7300
Fax: +32 (2) 223 3064 Fax: +81 (3) 3270 7306
E-Mail: secretariat@iadsa.be E-Mail: hiromi_ohta@suntory.co.jp
Mr. Soichi Yamamoto
IBFAN - INTERNATIONAL BABY FOOD ACTION Technical Adviser
NETWORK Japan Soft Drinks Association
Ms Elisabeth Sterken 3-3-3 Nihonbashi-Muromachi Chuo Ku
Director 103-0022 Tokyo
INFACT Canada/IBFAN North America Japan
6 Trinity Square Tel.: +81 (3) 3270 7300
M5G 1B1 Toronto, Ontario Fax: +81 (3) 3270 7306
Canada E-Mail: soichi_yamamoto@suntory.co.jp
Tel.: +1 (416) 595 9819 Mrs Sibongile Chiumya
Fax: +1 (416) 591 9355 Advisor
E-Mail: esterken@infactcanada.ca South African Federation of Soft Drink Manufacturers
Mrs Joyce Chanetsa P.O.Box 1108
IBFAN Africa 2452 Johannesburg
Dhlanubeka House South Africa
P.O.Box 781 Tel.: +27 (11) 644 0544
Mbabane Fax: +27 (11) 644 0673
Swaziland E-Mail: schiumya@afr.ko.com
Tel.: +268 4045006
Fax: +268 404 0546
E-Mail: ibfan.jchanetsa@realnet.co.sz ICGA – INTERNATIONAL CHEWING GUM ASSOCIATION
Dr Mosadeq Sahebdin Mr Christophe Leprêtre
IBFAN Africa Manager
C8O Mapbin International Chewing Gum Association (ICGA)
1, Pont St Louis St c/o Keller and Heckman LLP
Pailles Avenue Louise 523
Mauritius B-1050 Brussels
Tel.: +230 292 7761 Belgium
E-Mail: mosadeq53@intnet.mu Tel.: +32 (2) 6455060
Fax: +32 (2) 6455050
E-Mail: icga@gumassociation.org
ALINORM 09/32/26 41

ICGMA – INTERNATIONAL COUNCIL OF GROCERY Ms Jolanta Leone

MANUFACTURERS ASSOCIATIONS Scientific and Regulatory Affairs
Mr Robert Earl Association des Industries des Aliments Diététiques de
Vice President for Science Policy, Nutrition and Health l’Union Européenne (IDACE)
ICGMA 194 Rue de Rivoli
1350 I Street, NW, Suite 300 75001 Paris, France
2005 Washington, DC Tel.: +33 (1) 5345 8787
USA Fax: +33 (1) 5345 8780
Tel:: +1 (202) 639 5970 E-Mail: andree.bronner@idace.org
Fax : +1 (202) 639 5991
E-Mail : rearl@gmaonline.org
IDF - INTERNATIONAL DAIRY FEDERATION
Mrs Leonie Louw Ms Isabelle Neiderer
Foods Regulatory Manager Director of Nutrition
Tiger Brands Dairy Farmers of Canada
PO Box 527 1801 McGill College Avenue, Suite 700
7260 Paarl H3E 2N4 Montreal
South Africa Canada
Tel.: +27 (21) 870 5023 Tel.: +1 (514) 284 1092
Fax: +27 (21) 863 1717 Fax: +1 (514) 284 0449
E-Mail: leonie.louw@tigerbrands.com E-Mail: isabelle.neiderer@dfc-placa
Mr Nigel Sunley Dr Marieke Lugt
Consumer Goods Council of South Africa Food Legislation Officer
P.O.Box 952 Friesland Foods
Lonehill 2062 P.O.Box 124
2062 Johannesburg 7940 AC Meppel
South Africa The Netherlands
Tel: +27 (11) 4673 108 Tel.: +31 (522) 276 354
Fax: +27 (11) 4673 108 Fax: +31 (522) 276 475
E-Mail: nigel@sunleyconsulting.co.za E-Mail: marieke.lugt@frieslandfoods.com
Mrs Queen Zuma Ms Sandra Tuijtelaars
Regulatory Affairs Manager Nutrition Officer
Nestlé International Dairy Federation
192 Broom Fischer Dr Diamant Building
Randburg 80, Boulevard Auguste Reyers
South Africa 1030 Brussels
Tel.: +27 (11) 889 6000 Belgium
E-Mail: quenn.zuma@za.nestle.com Tel.: +32 (2) 706 8650
IDACE - ASSOCIATION DES INDUSTRIES DES ALIMENTS Fax: +32 (2) 733 0413
DIÉTÉTIQUES DE L'UNION EUROPÉENNE E-Mail: stuijtelaars@fil-idf.org
Ms Marie-Odile Gailing IFAC
Scientific and Regulatory Affairs Mrs Victoria Betteridge
Association des Industries des Aliments Diététiques de Regulatory Affairs Director
l’Union Européenne (IDACE) Tate & Lyle PLC
194 Rue de Rivoli Sugar Quay
75001 Paris, France Lower Thames Street
Tel.: +33 (1) 5345 8787 London EC 3 R 6 DQ
Fax: +33 (1) 5345 8780 United Kingdom
E-Mail: andree.bronner@isdifederation.org Tel.: +44 (207) 626 6525
E-Mail: kate.wrona@tateandlyle.com
ALINORM 09/32/26 42

Mr Ashley Betteridge ILCA - INTERNATIONAL LACTATION CONSULTANT

Tate & Lyle PLC ASSOCIATION
Sugar Quay Maryse Arendt
Lower Thames Street IBCLC
London EC 3 R 6 DQ International Lactation Consultant Association - ILCA
United Kingdom Initiativ Liewensufank
Tel.: +44 (207) 626 6595 20 rue de Contern
E-Mail: ash@hisbam.demon.co.uk 5955 Itzig
Luxemburg
IFT - INSTITUTE OF FOOD TECHNOLOGISTS Tel. : +352 3605 97
Prof Rosemary Walzem Fax : +352 3661 34
Associate Professor E-Mail: info@liewensufank.lu
Texas A&M University ‘
Department of Poultry Science and Department of ILSI – INTERNATIONAL LIFE SCIENCES INSTITUTE
Nutrition and Food Science Dr Loek Pijls
College Station, TX 77845 Senior Scientist
USA ILSI Europe
Tel.: +1 (979) 845 7537 Av. e. Mournier 83, box 6
B-1200 Brussels
Fax: +1 (979) 845 1921
Belgium
E-Mail: rwalzem@poultry.tamu.edu
Tel:: +32 (2) 771 0014
Dr Rodney J.H. Gray Fax: +32 (2) 762 0044
Vice President Regulatory Affairs E-Mail: lpijls@ilsieurope.be
Martek Biosciences
6480 Dobbin Road Dr Joanne Lupton
21045 Columbia Distinguished Professor, Nutrition
USA Texas A&M University,
Tel.: +1 (410) 740 0081 213 Kleberg Center, 2253 TAMU
Fax: +1 (410) 470 2985 77840 College Station, Texas
E-Mail: rgray@martek.com USA
Ms Gloria Brooks-Ray Tel:: +1 (979) 845 0850
Exponent E-Mail: jlupton@tamu.edu
P.O.Box 97 Ms Lucyna Kurtyka
Mountain Lakes NJ 07046 Global Lead,
USA Monsanto Company
Tel.: +1 (973) 334 4652 1300 I Street, NW, Suite 450 East
E-Mail: gbrooksray@exponent.com 20005 Washingtong DC
Dr Betty Bugusu USA
Research Scientist E-Mail: lucyna.k.kurtyka@monsanto.com
Institute of Food Technologists Mr Andrew MacKenzie
1025 Connecticut Ave. NW Suite 503 Branch Coordinator
Washington, DC 20036 ILSI South Africa
USA 9 Quarry Road
Tel.: +1 (202) 330 4980 Fish Hoek 7975
Fax: +1 (202) 315 5174 South Africa
E-Mail: bbugusu@ift.org
Tel.: +27 (21) 785 7231
IGTC - INTERNATIONAL GLUTAMATE TECHNICAL Fax: +27 (21) 785 7231
COMMITTEE - E-Mail: amackenzie69@iafrica.com
Mrs Yoko Ogiwara Dr Barry V. McCleary
Scientific Advisor CEO, Technical Director
International Glutamate Technical Committee
Megazyme International Ireland Limited
1-15-1, Kyobashi, Chuo-ku
Bray Business Park
104-8315 Tokyo
Bray, County Wicklow
Japan
Tel.: +81 (3) 5250 8184 Ireland
Fax: +81 (3) 5250 8403 Tel.: +353 (1) 286 1220
E-Mail: yoko_ogiwara@ajinomoto.com Fax: +353 (1) 286 1264
E-Mail: barry@megazyme.com
ALINORM 09/32/26 43

Dr Susan Potter IWGA – INTERNATIONAL WHEAT GLUTEN ASSOCIATION

Vice President, Health and Nutrition Sciences Dr Marcel Feys
Tate & Lyle Regulatory Affairs Manager
2200 East Eldorado Street SYRAL Belgium N.V.
Decatur, IL 62525 Burchstraat 10
USA 9300 Aalst
Tel.: +1 (127) 421 2565 Belgium
Fax: +1 (127) 421 2936 Tel.: +32 (53) 733315
E-Mail: susan.potter@tateandlyle.com Fax: +32 (53) 733028
Mr Kazuo Sueki E-Mail: marcel.feys@syral.com
Director Scientific Information NHF – NATIONAL HEALTH FEDERATION
ILSI Japan
Dr Scott C. Tips
Kojimachi R, K Bldg. 2-6-7
General Legal Counsel
Kojimachi, Chiyoda-ku
National Health Federation
102-0083 Tokyo
PO Box 688
Japan
Monrovia, California 91017
Tel.: +81 (3) 5215 3535
USA
Fax: +81 (3) 5215 3537
Tel.: +1 (626) 357 2182
E-Mail: ksueki@ilsijapan.org
Fax: +1 (626) 303 0642
ISDI - INTERNATIONAL SPECIAL DIETARY FOODS E-Mail: scott@rivieramail.com
INDUSTRIES
WORLD SUGAR RESEARCH ORGANIZATION
Dr Duresa Cetaku-Fritz
Dr Richard Cottrell
Scient International Special Dietary Foods Industries
WSRO
(ISDI)
70 Collingwood House
194 Rue de Rivoli
Dolphin Square
75001 Paris, France
SWIV 3LX London
Tel.: +33 (1) 5345 8787
United Kingdom
Fax: +33 (1) 5345 8780
Tel:: +44 2078 2168000
E-Mail: andree.bronner@isdifederation.org
E-Mail: rcottrell@wsro.org
Ms Margaret J. Creedon
Ms Duzile Mthuli
Director
WSRO
International Special Dietary Foods Industries (ISDI)
70 Collingwood House
194 Rue de Rivoli
Dolphin Square
75001 Paris, France
SWIV 3LX London
Tel.: +33 (1) 5345 8787
United Kingdom
Fax: +33 (1) 5345 8780
Tel: +44 207 821 6800
E-Mail: andree.bronner@isdifederation.org
Mr Peter Van Dael
Scientific and Regulatory Affairs INTERNATIONAL GOVERNMENTAL ORGANIZATION
International Special Dietary Foods Industries (ISDI)
194 Rue de Rivoli WFP – WORLD FOOD PROGRAMME
75001 Paris, France Dr Saskia de Pee
Tel.: +33 (1) 5345 8787 Senior Adviser Nutrition & HIVAIDS
Fax: +33 (1) 5345 8780 World Food Programme
E-Mail: andree.bronner@isdifederation.org 8 Dyke End, Mt Edgecombe
Sapret POBox 3179
4000 Durban
South Africa
Tel.: +27 (71) 6721690
E-Mail: saskia.depee@wfp.org
ALINORM 09/32/26 44

WHO - WORLD HEALTH ORGANIZATION SOUTH AFRICAN SECRETARIAT

Dr Chizuru Nishida Mr Andries Pretorius
Scientist Director: Food Control
Department of Nutrition for Health and Development National Department of Health
NHD) Private Bag X828,
WHO 0001 Pretoria
20. Avenue Appia South Africa
1211 Geneva 27 Tel.: +27 (12) 312 0186
Switzerland Fax: +27 (12) 312 3180
Tel.: +41 (22) 791 3317/3455 E-Mail: petroa@health.gov.za
Fax: +41 (22) 791 4156 Mr Malose Daniel Matlala
E-Mail: nishidac@who.int National Codex Contact Point: South Africa
Dr Lisa Rogers National Department of Health
Technical Officer, Micronutrient Unit Private Bag X828,
Department of Nutrition for Health and Development 0001 Pretoria
(NHD) South Africa
WHO Tel.: +27 (12) 312 0158
20, Avenue Appia Fax: +27 (12) 312 3180
1211 Geneva E-Mail: CACPSA@health.gov.za
Switzerland Ms. Pontsho Malibe
Tel:: +41 (22) 791 1957 National Department of Health
Fax: +41 (22) 791 4156 Private Bag X828,
E-Mail: rogersl@who.int 0001 Pretoria
South Africa
Prof John Cummings Tel.: +27 (12) 312 0778
WHO Temporary Adviser Fax: +27 (12) 312 3112
c/o Dr Chizuru Nishida, Nutrition for Health and E-Mail: MalibP@health.gov.za
Development
Ms. Mabel Sinclair
WHO
National Department of Health
20. Avenue Appia Private Bag X828,
1211 Geneva 27 0001 Pretoria
Switzerland South Africa
Tel.: +41 (22) 791 3317/3455 Tel.: +27 (12) 312 0160
Fax: +41 (22) 791 4156 Fax: +27 (12) 312 3180
E-Mail: j.h.cummings@dundee.ac.uk E-Mail: sinclm@health.gov.za
Ms. Elize Pienaar
FAO – FOOD AND AGRICULTURE ORGANIZATION OF THE National Department of Health
UNITED NATIONS Private Bag X828,
Mrs Ruth Charrondiere 0001 Pretoria
NutritionOfficer South Africa
FAO Tel.: +27 (12) 312 0160
Viale delle Terme di Caracalla Fax: +27 (12) 312 3180
00153 Rome E-Mail: sinclm@health.gov.za
Italy Ms Rentia Maree
Tel.: +39 (6) 570 56134 National Department of Health
Fax: +39 (6) 570 54593 Private Bag X828,
E-Mail: ruth.charrondiere@fao.org 0001 Pretoria
South Africa
Tel.: +27 (12) 312 0062
Fax: +27 (12) 312 3112
E-Mail: MareeR@health.gov.za
ALINORM 09/32/26 45

Ms Maude de Hoop CODEX SECRETARIAT

National Department of Health Dr Jeronimas Maskeliunas
Directorate:Nutrition Food Standards Officer
Private Bag X 828 Joint FAO/WHO Food Standards Programme
0001 Pretoria Viale delle Terme di Caracalla
South Africa 00153 Rome
Tel: + 27 (12) 312 0042 Italy
Fax: + 27 (12) 312 3112 Tel.: +39 (6) 57 05 39 67
Email: DehooM@health.gov.za Fax: +39 (6) 57 05 45 93
Ms. Sophy Ndou E-Mail: jeronimas.maskeliunas@fao.org
National Department of Health
Mrs Verna Carolissen-Mackay
Private Bag X828,
Food Standards Officer
0001 Pretoria
South Africa Joint FAO/WHO Food Standards Programm
Tel.: +27 (12) 312 0041 Viale delle Terme di Caracalla
Fax: +27 (12) 312 3112 00153 Rome
E-Mail: MareeR@health.gov.za Italy
Tel.: +39 (6) 5705 5629
Ms Luzette van Niekerk
Fax: +39 (6) 5705 4593
Western Cape Department of Health
P O Box 2060, E-Mail: verna.carolissen@fao.org
Cape Town, 8001 Mr Tom Heilandt
South Africa Senior Food Standards Officer
Tel.: +27 (21) 483 5663 Joint FAO/WHO Food Standards Programm
Fax: +27 (21) 483 4345 Viale delle Terme di Caracalla
E-Mail: MareeR@health.gov.za 00153 Rome
Italy
Tel.: +39 (6) 5705 5629
GERMAN SECRETARIAT
Fax: +39 (6) 5705 4593
Mr Georg Müller
E-Mail: tom.heilandt@fao.org
Federal Ministry of Food,
Agriculture and Consumer Protection
Rochusstraße 1
53123 Bonn, Germany
Tel.: +49 (228) 99 529 33 87
Fax: +49 (228) 99 529 49 65
E-Mail: ccnfsdu@bmelv.bund.de
Mrs Ursula Siebert
Federal Ministry of Food,
Agriculture and Consumer Protection
Rochusstraße 1
53123 Bonn, Germany
Tel.: +49 (228) 99 529 33 87
Fax: +49 (228) 99 529 49 65
E-Mail: ccnfsdu@bmelv.bund.de
ALINORM 09/32/26, Appendix II 46

APPENDIX II

GUIDELINES FOR THE USE OF NUTRITION CLAIMS: TABLE OF CONDITIONS FOR

NUTRIENT CONTENTS (PART B) DIETARY FIBRE
(At Step 8 of the Procedure)

COMPONENT CLAIM CONDITIONS

B. NOT LESS THAN

Dietary Fibre Source 3 g per 100 g* or 1.5 g per 100 kcal
or 10 % of daily reference value per
serving**

High 6 g per 100 g* or 3 g per 100 kcal

or 20 % of daily reference value per
serving**

*
Conditions for nutrient content claims for dietary fibre in liquid foods to be determined at national
level.
**
Serving size and daily reference value to be determined at national level.
Definition:
Dietary fibre means carbohydrate polymers1 with ten or more monomeric units2 , which are not hydrolysed
by the endogenous enzymes in the small intestine of humans and belong to the following categories:
• Edible carbohydrate polymers naturally occurring in the food as consumed,
• carbohydrate polymers, which have been obtained from food raw material by physical, en-
zymatic or chemical means and which have been shown to have a physiological effect of
benefit to health as demonstrated by generally accepted scientific evidence to competent
authorities,
• synthetic carbohydrate polymers which have been shown to have a physiological effect of
benefit to health as demonstrated by generally accepted scientific evidence to competent
authorities
Methods of Analysis for Dietary Fibre
→ To be agreed.

1
When derived from a plant origin, dietary fibre may include fractions of lignin and/or other compounds when
associated with polysaccharides in the plant cell walls and if these compounds are quantified by the AOAC gra-
vimetric analytical method for dietary fibre analysis : Fractions of lignin and the other compounds (proteic frac-
tions, phenolic compounds, waxes, saponins, phytates, cutin, phytosterols, etc.) intimately "associated" with plant
polysaccharides are often extracted with the polysaccharides in the AOAC 991.43 method. These substances are
included in the definition of fibre insofar as they are actually associated with the poly- or oligo-saccharidic frac-
tion of fibre. However, when extracted or even re-introduced into a food containing non digestible polysaccha-
rides, they cannot be defined as dietary fibre. When combined with polysacchrides, these associated substances
may provide additional beneficial effects (pending adoption of Section on Methods of Analysis and Sampling).
2
Decision on whether to include carbohydrates from 3 to 9 monomeric units should be left to national authorities.
ALINORM 09/32/26, Appendix III 47

APPENDIX III

DRAFT ADVISORY LIST OF NUTRIENT COMPOUNDS FOR USE IN FOODS FOR SPECIAL
DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDERN

(At Step 8 of the Procedure)

Section D: ADVISORY LIST OF FOOD ADDITIVES FOR SPECIAL NUTRIENT FORMS

Maximum Level in
INS no. Additive/ Carrier Ready-to-use Food for
infants and young children
(mg/kg)

(a) 414 Gum arabic (gum acacia) 10

ALINORM 09/32/26, Appendix IV 48

APPENDIX IV

DRAFT NUTRITIONAL RISK ANALYSIS PRINCIPLES AND GUIDELINES FOR APPLICATION

TO THE WORK OF THE COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL
DIETARY USES

(At Step 8 of the Procedure)

SECTION 1 – BACKGROUND

1. The Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius
(hereafter cited as “Working Principles”) has established general guidance on risk analysis to Codex
Alimentarius. These Working Principles were adopted in 2003 and published in this Procedural
Manual.

2. The objective of the Working Principles is “to provide guidance to the Codex Alimentarius Commission
and the joint FAO/WHO expert bodies and consultations so that food safety and health aspects of Codex
standards and related texts are based on risk analysis”. By its reference to health aspects in addition to
food safety, the objective provides clearer direction for risk analysis to apply to nutritional matters that
are within the mandate of the Codex Alimentarius Commission and its subsidiary bodies.

3. The Nutritional Risk Analysis Principles are established to guide the Codex Alimentarius Commission
and its subsidiary bodies - primarily but not exclusively the Codex Committee on Nutrition and Foods
for Special Dietary Uses (CCNFSDU) - in applying nutritional risk analysis to their work. This guidance
may be used for the work of other Committees since CCNFSDU is also mandated, in accordance with its
4th term of reference, “to consider, amend if necessary, and endorse provisions on nutritional aspects” of
foods including those resulting from application of nutritional risk analysis that are developed by other
Codex subsidiary bodies.

SECTION 2 – INTRODUCTION

4. Codex nutritional risk analysis addresses nutrients1 and related substances2 and the risk to health from
their inadequate and/or excessive intake. Nutritional risk analysis applies the same general approach as
traditional food safety risk analysis to consideration of excessive intakes of nutrients and related
substances. However, unlike many constituents of food that are the subject of traditional food safety
risk analysis (such as food additives, chemical (pesticide and veterinary drug) residues, microbiological
pathogens, contaminants and allergens) nutrients and related substances are biologically essential (in the
case of essential nutrients) or in other ways potentially favourable to health. Nutritional risk analysis
therefore adds a new dimension to traditional risk analysis by also considering risks directly posed by
inadequate intakes.

5. The Nutritional Risk Analysis Principles and Guidelines for Application to the Work of the Committee
on Nutrition and Foods for Special Dietary Uses presented in this document (hereafter cited as
“Nutritional Risk Analysis Principles”) are subsidiary to and should be read in conjunction with the
Working Principles.

1
Nutrient is defined by Codex General Principles for the Addition of Essential Nutrients to Foods (CAC/GL 09-1987)
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 healthy life; or
(c) a deficit of which will cause characteristic biochemical or physiological changes to occur.
Essential nutrient means any substance normally consumed as a constituent of food which is needed for growth and
development and the maintenance of healthy life and which cannot be synthesized in adequate amounts by the body.
2
A related substance is a constituent of food (other than a nutrient) that has a favourable physiological effect.
ALINORM 09/32/26, Appendix IV 49

6. These Nutritional Risk Analysis Principles are framed within the three-component structure of the
Working Principles, but with an added initial step to formally recognize Problem Formulation as an
important preliminary risk management activity.

SECTION 3 – SCOPE AND APPLICATION

7. Nutritional risk analysis considers the risk of adverse health effects from inadequate and/or excessive
intakes of nutrients and related substances, and the predicted reduction in risk from proposed
management strategies. In situations that address inadequate intakes, such a reduction in risk through
addressing the inadequacy might be referred to as a nutritional benefit.

8. The food constituents of primary interest in nutritional risk analysis are inherent components of food
and/or intentionally added to food and are identified as:

• nutrients that may reduce the risk of inadequacy and those that may increase the risk of adverse
health effects; and/or

• related substances2 that may increase the risk of adverse health effects at excessive intake and may
also reduce the risk of other adverse health effects at lower intake.

9. When favourable effects of the nutrient or related substance of primary interest are being assessed,
consideration should be given to whether the food matrix could increase the risk of an adverse health
effect.

10. Where appropriate, the application of quantitative nutritional risk assessment may guide decision
making on quantitative content provisions for nutrients and related substances in certain Codex texts.

11. Nutritional risk assessment should be as quantitative as possible, although a qualitative risk-based
approach drawing on the principles of nutritional risk analysis could assist the development of Codex
texts in such situations as:

• formulating general principles related to nutritional composition (e.g. principles for the addition of
nutrients to foods);

• formulating general principles for assessing or managing risks related to foods for which a nutrition
or health claim has been requested;

• managing risks by labelling advice in relation to consumption of foods of certain nutrient-related3

composition, including foods for special dietary use; and

• advising on risk-risk analysis (e.g. risk associated with a significantly reduced or entirely avoided
consumption of a nutritious, staple food in response to a dietary hazard such as a contaminant
present in that food.

SECTION 4 – DEFINITIONS

12. The Definitions of Risk Analysis Terms Related to Food Safety in this Procedural Manual provide
suitable generic definitions of risk analysis, risk assessment, risk management, risk communication and
risk assessment policy. When applied in a nutritional risk analysis context, these high-level risk analysis
terms should be prefaced by ‘nutritional’ and their existing definitions appropriately adapted by
replacement of relevant existing terms and definitions with those listed below.

3
For the purpose of these Nutritional Risk Analysis Principles, the descriptive term ‘nutrient-related’ refers to one or
more nutrients and/or related substances, as the case may be.
ALINORM 09/32/26, Appendix IV 50

13. However, other Definitions of Risk Analysis Terms Related to Food Safety have been modified to
reference inadequate intake as a nutritional risk factor. Some new terms also have been defined to
provide further clarity. The modified or newly developed subsidiary definitions are as follows:

Nutritional risk – A function of the probability of an adverse health effect associated with inadequate
or excessive intake of a nutrient or related substance and the severity of that effect, consequential to a
nutrient-related hazard(s) in food.

Adverse health effect4 – A change in the morphology, physiology, growth, development, reproduction
or life span of an organism, system, or (sub)population that results in an impairment of functional
capacity, an impairment of the capacity to compensate for additional stress, or an increase in
susceptibility to other influences.

Nutrient-related3 hazard – A nutrient or related substance in food that has the potential to cause an
adverse health effect depending on inadequate or excessive level of intake.

Nutrient-related hazard identification – The identification of a nutrient-related hazard in a particular

food or group of foods.

Nutrient-related hazard characterization – The qualitative and/or quantitative evaluation of the

nature of the adverse health effects associated with a nutrient-related hazard.

Dose response assessment – The determination of the relationship between the magnitude of intake of
(or exposure to) (i.e. dose) a nutrient or related substance and the severity and/or frequency of
associated adverse health effects (i.e. response).

Upper level of intake4 – the maximum level of habitual intake from all sources of a nutrient or related
substance judged to be unlikely to lead to adverse health effects in humans.

Highest observed intake4 – the highest level of intake observed or administered as reported within a
stud(ies) of acceptable quality. It is derived only when no adverse health effects have been identified.

Intake (Exposure) assessment – The qualitative and/or quantitative evaluation of the likely intake of a
nutrient or related substance from food as well as intake from other relevant sources such as food
supplements.

Nutrient-related risk characterization – The qualitative and/or quantitative estimation, including

attendant uncertainties, of the probability of occurrence and severity of known or potential adverse
health effects in a given population based on nutrient-related hazard identification, nutrient-related
hazard characterization and intake assessment.

Bioavailability5 – The proportion of the ingested nutrient or related substance that is absorbed and
utilised through normal metabolic pathways. Bioavailability is influenced by dietary factors such as
chemical form, interactions with other nutrients and food components, and food processing/preparation;
and host–related intestinal and systemic factors.

Homeostatic mechanism4 – A mechanism effected through a system of controls activated by negative

feedback that allow the maintenance of normal body functions in the presence of a variable nutrition
environment.

4
A Model for Establishing Upper Levels of Intake for Nutrients and Related Substances. Report of a joint FAO/WHO
technical workshop 2005, WHO, 2006.
5
Gibson R.S. The role of diet- and host-related factors in nutrient bioavailability and thus in nutrient-based dietary
requirement estimates. Food and Nutrition Bulletin 2007;28 (suppl): S77-100.
ALINORM 09/32/26, Appendix IV 51

SECTION 5 – PRINCIPLES FOR NUTRITIONAL RISK ANALYSIS

14. Nutritional risk analysis comprises three components: risk assessment, risk management and risk
communication. Particular emphasis is given to an initial step of Problem Formulation as a key
preliminary risk management activity.

PRELIMINARY NUTRITIONAL RISK MANAGEMENT ACTIVITIES

15. Preliminary nutritional risk management activities should have regard to the particular sections in the
Working Principles titled General Aspects of Risk Analysis, and Risk Assessment Policy.

Nutritional Problem Formulation4

16. Nutritional Problem Formulation is necessary to identify the purpose of a nutritional risk assessment and
is a key component of preliminary nutritional risk management activity because it fosters interactions
between risk managers and risk assessors to help ensure common understanding of the problem and the
purpose of the risk assessment.

17. Such considerations should include whether a nutritional risk assessment is needed and if so:

• the priority it should be accorded;

• who should conduct and be involved in the nutritional risk assessment, nutritional risk management
and nutritional risk communication processes;

• the need for development of nutritional risk assessment policy;

• how the nutritional risk assessment will provide the information necessary to support the nutritional
risk management decision;

• whether data are available to embark on an evaluation of nutritional risks;

• what level of resources are available; and

• the timeline for completing the assessment.

18. Specific information to be gathered for nutritional problem formulation may include:

• a detailed inventory of prior knowledge;

• identification of the (sub)populations to be the focus for the risk assessment, geographical areas or
consumer settings to be covered;

• relevant source(s) of intake ; and

• the health endpoints to be considered.

NUTRITIONAL RISK ASSESSMENT

19. The risk assessment section of the Codex Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarius is generally applicable to nutritional risk assessment. Additional
nutritional risk assessment principles to consider within the Codex framework are identified below.
ALINORM 09/32/26, Appendix IV 52

Nutrient-Related Hazard Identification and Hazard Characterization

20. These two steps are often globally relevant because they are based on available scientific and medical
literature that contribute data from diverse population groups. This global relevance for characterization
of hazard does not, however, preclude the possibility of a (sub)population-specific hazard.

21. Nutritional risk assessment should take into consideration the nutrient-related hazard(s) posed by both
inadequate and excessive intakes. This may include consideration of hazard(s) posed by excessive
intakes of accompanying risk-increasing nutrients in the food vehicle(s) under consideration.

22. Nutrient-related hazard identification and characterization should recognize current methodological
differences in assessment of nutritional risk of inadequate and excessive intakes, and scientific advances
in these methodologies.

23. Nutrient-related hazard characterization should take into account homeostatic mechanisms for essential
nutrients, and limitations in the capacity for homeostatic adaptations. It may also take into account
bioavailability including factors affecting the bioavailability of nutrients and related substances such as
different chemical forms.

24. Nutrient reference standards that may be used to characterize nutrient-related hazard(s) related to
adequacy include measures of average requirement. Some globally applicable nutrient reference
standards for average requirement have been published by FAO/WHO. Official regional and national
nutrient reference standards are also available and have been periodically updated to reflect scientific
advances. These are more likely to relate to nutrients than to related substances.

25. Nutrient reference standards that may be used to characterize nutrient-related hazard(s) related to
excessive intakes include upper levels of intake. Some globally applicable reference standards of upper
level of intake have been published by FAO/WHO. In addition, the establishment of international upper
levels of intake and highest observed intake that build on recommendations4 may be considered in the
future. Some periodically-updated nutrient reference standards are available from regional and national
authorities. For some related substances, such standards developed from a systematic review of the
evidence are available only in the peer-reviewed scientific literature.

26. The assessment of inadequate and excessive levels of intake of particular nutrients and related
substances should take into account the availability of all such scientifically determined reference
sources, as appropriate. When using such reference standards for nutrient and related substances in
nutritional risk assessment, the basis for their derivation should be explicitly described.

Nutrient-Related Intake Assessment and Risk Characterization

27. These two steps are generally specific to the (sub)population(s) under consideration for risk assessment.
The populations relevant to Codex consideration are populations at large in Codex member countries or
particular subpopulation groups in these countries defined according to physiological parameters such as
age or state of health.

28. Nutrient-related intake assessment and risk characterization should be applied within a total diet context.
Where feasible, it would typically involve the evaluation of the distribution of habitual total daily
intakes for the target population(s). This approach recognizes that nutrient-related risks are often
associated with total intakes from multiple dietary sources, including fortified foods, food supplements6,
and in the case of certain minerals, water. It may also take into account the bioavailability and stability
of nutrients and related substances in the foods consumed.

6
Codex Guidelines for Vitamin and Mineral Food Supplements (CAC/GL 55 – 2005) define food supplements as
sources in concentrated forms of those nutrients or related substances alone or in combinations, marketed in forms such
as capsules, tablets, powders solution, etc., that are designed to be taken in measured small unit quantities but are not in
a conventional food form and whose purpose is to supplement the intake of nutrients or related substances from the diet.
ALINORM 09/32/26, Appendix IV 53

NUTRITIONAL RISK MANAGEMENT

29. The risk management section of the Codex Working Principles for Risk Analysis for Application in the
Framework of the Codex Alimentarius is generally applicable to nutritional risk management.
Additional nutritional risk management principles to consider within the Codex framework are
identified below.

30. Nutritional risk management can be effected through quantitative measures or qualitative guidance
elaborated in Codex texts. Such risk management could involve decisions about nutrient composition,
consideration of the suitability of foods containing risk-increasing nutrients for certain purposes or (sub)
populations, labelling advice intended to mitigate nutritional risks to public health, and formulation of
relevant general principles.

Nutritional risk management decisions should take into account their impact on dietary patterns and
consumer behaviour. Such information should be supported by relevant research.

31. Nutritional risk assessment policy should be articulated as appropriate for the selected risk assessor
prior to the conduct of the nutritional risk assessment.

NUTRITIONAL RISK COMMUNICATION

32. The risk communication section of the Codex Working Principles for Risk Analysis for Application in
the Framework of the Codex Alimentarius is generally applicable to nutritional risk communication.

SECTION 6 – SELECTION OF RISK ASSESSOR BY CCNFSDU

33. Consistent with their important role in providing scientific advice to the Codex Alimentarius
Commission and its subsidiary bodies, FAO and WHO are acknowledged as the primary source of
nutritional risk assessment advice to Codex Alimentarius. This acknowledgement however, does not
preclude the possible consideration of recommendations arising from other internationally recognised
expert bodies, as approved by the Commission.

34. All requests for risk assessment advice should be accompanied by terms of reference and where
appropriate risk assessment policy to provide guidance to the risk assessor. These parameters should be
established by CCNFSDU.
ALINORM 09/32/26, Appendix V 54

APPENDIX V

DRAFT ANNEX TO THE CODEX GUIDELINES FOR USE OF NUTRITION AND HEALTH
CLAIMS: RECOMMENDATIONS ON THE SCIENTIFIC SUBSTANTIATION OF HEALTH
CLAIMS1

(at Step 5/8 of the Procedure)

1. SCOPE

1.1 These Recommendations are intended to assist competent national authorities in their evaluation of
health claims in order to determine their acceptability for use by the industry. The recommendations focus
on the criteria for substantiating a health claim and the general principles for the systematic review of the
scientific evidence. The criteria and principles apply to the three types of health claims as defined in Section
2.2 of the Guidelines for use of nutrition and health claims.

1.2 These recommendations include consideration of safety in the evaluation of proposed health claims, but
are not intended for the complete evaluation of the safety and the quality of a food, for which relevant
provisions are laid out by other Codex Standards and Guidelines or general rules of existing national
legislations.

2. DEFINITIONS

For the purposes of this Annex:

2.1 Food or food constituent refers to energy, nutrients, related substances, ingredients, and any other
feature of a food, a whole food, or a category of foods on which the health claim is based. The category of
food is included in the definition because the category itself may be assigned a common property of some of
the individual foods making it up.

2.2 Health effect refers to a health outcome as defined in sections 2.2.1 to 2.2.3 of the Guidelines.

3. SCIENTIFIC SUBSTANTIATION OF HEALTH CLAIMS

3.1. Process for the substantiation of health claims

The systematic review of the scientific evidence for health claims by competent national authorities takes
into account the general principles for substantiation. Such a process typically includes the following steps:

(a) Identify the proposed relationship between the food or food constituent and the health effect;

(b) Identify appropriate valid measurements for the food or food constituent and for the health
effect;

(c) Identify and categorise all the relevant scientific data;

(d) Assess the quality of and interpret each relevant scientific study;

(e) Evaluate the totality of the available relevant scientific data, weigh the evidence across studies
and determine if, and under what circumstances, a claimed relationship is substantiated.

1
Note: This document is intended as an annex to the Codex Guidelines for the Use of Nutrition and Health
Claims (CAC/GL 23-1997, Rev. 1-2004) and should be read in conjunction with the Working Principles for
Risk Analysis for Food Safety for Application by Governments (CAC/GL 62-2007)
ALINORM 09/32/26, Appendix V 55

3.2. Criteria for the substantiation of health claims

3.2.1 The following criteria are applicable to the three types of health claims as defined in section 2.2 of
the Guidelines for use of nutrition and health claims:

(a) Health claims should primarily be based on evidence provided by well-designed human intervention
studies. Human observational studies are not generally sufficient per se to substantiate a health
claim but where relevant they may contribute to the totality of evidence. Animal model studies, ex
vivo or in vitro data may be provided as supporting knowledge base for the relationship between the
food or food constituent and the health effect but cannot be considered as sufficient per se to
substantiate any type of health claim.

(b) The totality of the evidence, including unpublished data where appropriate, should be identified and
reviewed, including: evidence to support the claimed effect; evidence that contradicts the claimed
effect; and evidence that is ambiguous or unclear.

(c) Evidence based on human studies should demonstrate a consistent association between the food or
food constituent and the health effect, with little or no evidence to the contrary.

3.2.2 Although a high quality of scientific evidence should always be maintained, substantiation may take
into account specific situations and alternate processes, such as:

(a) ‘Nutrient function’ claims may be substantiated based on generally accepted authoritative statements
by recognised expert scientific bodies that have been verified and validated over time.

(b) Some Health claims, such as those involving a relationship between a food category and a health
effect, may be substantiated based on observational evidence such as epidemiological studies. Such
studies should provide a consistent body of evidence from a number of well-designed studies.
Evidence-based dietary guidelines and authoritative statements prepared or endorsed by a competent
authoritative body and meeting the same high scientific standards may also be used.

3.3. Consideration of the evidence

3.3.1 The scientific studies considered relevant for the substantiation of health claim are those addressing the
relationship between the food or food constituent and the health effect. In case of a claimed health effect that
cannot be measured directly, relevant validated biomarkers may be used (e.g. plasma cholesterol
concentrations for cardiovascular disease risk).

3.3.2 The scientific data should provide adequate characterization of the food or food constituent considered
as responsible for the health effect. Where applicable, the characterization includes a summary of the studies
undertaken on production conditions, batch-to-batch variability, analytical procedures, results and conclusions
of the stability studies, and the conclusions with respect to storage conditions and shelf-life.

3.3.3 The relevant data and rationale that the constituent for which the health claim is made is in a form that
is available to be used by the human body should be provided where applicable. If absorption is not
necessary to produce the claimed effect (e.g. plant sterols, fibres, lactic acid bacteria), the relevant data and
rationale that the constituent reaches the target site or mediates the effect are provided. All available data on
factors ( e.g. forms of the constituents) that could affect the absorption or utilisation in the body of the
constituent for which the health claim is made should also be provided.

3.3.4 The methodological quality of each type of study should be assessed, including study design and
statistical analysis.

(a) The design of human intervention studies should notably include an appropriate control group,
characterize the study groups’ background diet and other relevant aspects of lifestyle, be of an
adequate duration, take account of the level of consumption of the food or food constituent that
ALINORM 09/32/26, Appendix V 56

can be reasonably achieved in a balanced diet, and assess the influence of the food matrix and
total dietary context on the health effect.

(b) (b) Statistical analysis of the data should be conducted with methods recognized as appropriate
for such studies by the scientific community and with proper interpretation of statistical
significance.

3.3.5 Studies should be excluded from further review and not included in the relevant scientific data if they
do not use appropriate measurements for the food or food constituent and health effect, have major design
flaws, or are not applicable to the targeted population for a health claim.

3.3.6 By taking into account the totality of the available relevant scientific data and by weighing the
evidence, the systematic review should demonstrate the extent to which:

(c) the claimed effect of the food or food constituent is beneficial for human health;

(d) a cause and effect relationship is established between consumption of the food or food
constituent and the claimed effect in humans such as the strength, consistency, specificity, dose-
response ,where appropriate, and biological plausibility of the relationship;

(e) the quantity of the food or food constituent and pattern of consumption required to obtain the
claimed effect could reasonably be achieved as part of a balanced diet as relevant for the target
population for which the claim is intended;

(f) the specific study group(s) in which the evidence was obtained is representative of the target
population for which the claim is intended.

3.3.7 Based on this evaluation and the substantiation criteria, competent national authorities can determine
if, and under what circumstances, a claimed relationship is substantiated.

4. SPECIFIC SAFETY CONCERNS

4.1 When the claim is about a food or food constituent, the amount should not expose the consumer to
health risks and the known interactions among constituents should be considered.

4.2 The expected level of consumption should not exceed relevant upper levels of intake for food
constituents.

4.3 The exposure assessment should be based on an evaluation of the distribution of usual total daily intakes
for the general population2,3 and, where relevant, those for vulnerable population groups. It should account
for the possibility of cumulative intake from all dietary sources, and of nutritional imbalance due to changes
in dietary patterns in response to information to consumers that lays emphasis on the food or food
constituent.

5. RE-EVALUATION

Health claims should be re-evaluated. Competent national authorities should re-evaluate health claims
either periodically or following the emergence of significant new evidence that has the potential to alter
previous conclusions about the relationship between the food or food constituent and the health effect.

2
Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary Reference Intakes: A Risk
Assessment Model for Establishing Upper Intake Levels for Nutrients. Washington, D.C. National Academy Press,
1998, p. 8.
3
European Commission, Scientific Committee on Food. Guidelines of the Scientific Committee on Food for the
Development of Tolerable Upper Intake Levels for Vitamins and Minerals. SCF/CS/NUT/UPPLEV/11 Final. 28
November 2000. p.4.
 ALINORM 09/32/26, Appendix VI 57

APPENDIX VI

METHODS OF ANALYSIS FOR INFANT FORMULA AND FORMULAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS,
CODEX STAN 72-1981
Table.1 Methods of analysis recommended for endorsement

Type III* method recommendations which are suitable for consideration as the Type II Reference Method using the guidance on selection criteria requested from
CCMAS.
Provision Requirement Method Principle Type
Calories (by Minimum 60kcal Method described in Calculation Type III
calculation) (250kJ), maximum CAC/Vol IX-Ed.1, Part method Notes
70kcal (295kJ), per III
1. Currently adopted as a Type III method for Special foods in CODEX
100ml prepared ready
STAN 234-1999, amended 2007.
for consumption.
2. The references in this method (methods of analysis and conversion
Compositional factors for specific food ingredients) need to be updated.
provisions are generally
specified per 100 kcal
or 100 kJ.
Total fat Minimum 4.4g/100kcal AOAC 989.05 Gravimetry Type I. This method should apply to milk-based infant formula containing
(1.05g/100kJ); (Röse-Gottlieb) ≤ 5% starch or dextrin,
maximum 6.0g/100kcal Notes
ISO 8381|IDF 123:2008
(1.4g/100kJ).
1. Validated for milk-based infant formulae, except formulae containing
starch or dextrin. Reference: Bulletin of the IDF (1988), N°235, J
Eisses, Methods for the determination of the fat content, part 3, Infant
foods, edibles ices, milk and milk products (special cases),
Determination of the fat content according to Röse-Gottlieb or Weibull-
Berntrop
2. Normally regarded as a defining method (Type I).
 ALINORM 09/32/26, Appendix VI 58

Total fat Minimum 4.4g/100kcal ISO 8262-1 |IDF 124-1: Gravimetry Type I, this method should apply to milk-based infant formula
(1.05g/100kJ); 2005 (Weibull- Notes
maximum 6.0g/100kcal Berntrop)
1. Validated. References:
(1.4g/100kJ).
Schuller, P.L. Report of the collaborative study of CX/MAS on
fat determination in infant foods. Codex Committee on Methods
of Analysis and Sampling, CX/MAS 75/10,1975
Bulletin of the IDF (1988), N°235, J Eisses, Methods for the
determination of the fat content, part 3, Infant foods, edibles
ices, milk and milk products (special cases), Determination of
the fat content according to Röse-Gottlieb or Weibull-Berntrop
2. Normally regarded as a defining method (Type I).
Fatty acids Lauric and myristic AOAC 996.06 Gas Type III*
fatty acids combined chromatography Notes
<20% total fatty acids.
1.
Erucic acid <1% total 2. Validated (but not for infant formulas). References: J.AOAC Int. 80:
fatty acids. 555 - 563 (1997). J.AOAC Int. 82: 1146 - 1155 (1999).
LA1 minimum 3. Adopted as Type II for determination of saturated fat for nutrition
300mg/100kcal labelling purposes.
(70mg/100kJ); no 4. Information should be adequate for listing as a reference method (Type
maximum; GUL II), or if not, a tentative method (Type IV).
1400mg/100kcal
(330mg/100kJ).
ALA23 minimum
50mg/100kcal
(12mg/100kJ); no
maximum limit nor
GUL specified.
PUFA4 is needed for
calculation of α-TE
content (see vitamin E).

1
Linoleic acid
2
Guidance Upper Level
3
Alpha-linoleic acid
4
Polyunsaturated fatty acids
 ALINORM 09/32/26, Appendix VI 59

Trans fatty acids ≤ 4% of total fatty acids AOCS Ce 1h-05 Gas liquid Type III*, for infant formulae not containing milkfat
chromatography Notes
1. Method for Determination of cis, trans, Saturated, Monounsaturated
and Polyunsaturated Fatty Acids in Vegetable or Non-Ruminant Animal
Oils and Fats.
2. Validated (but not for infant formula). Performance statistics were
extracted from the collaborative study report and are included with the
method.
3. Adopted as Type II for the purposes of the Guidelines for Nutrition
Labelling
4. The method states “The method is not suitable for the analysis of dairy,
ruminant, marine, long chain polyunsaturated (PUFA) fats and oils, or
products supplemented with conjugated linoleic acid (CLA).” The
method should therefore be endorsed for infant formulae not containing
milkfat.

Trans fatty acids ≤ 3% of total fatty acids AOAC 996.06 Gas Type IV, with optimisation for the determination of TFAs
chromatography Notes
1. Method for quantitation of individual fatty acids, including trans
2. A publication describing an improved procedure for the determination
of trans fatty acids is available under "Proposed Modifications to
AOAC 996.06, Optimizing the Determination of Trans Fatty Acids:
Presentation of Data; Rozemat at.: J. AOAC Int'l, VOL. 91, NO. 1,
2008"
3. Validated (but not for infant formulas). References: J.AOAC Int. 80:
555 - 563 (1997). J.AOAC Int. 82: 1146 - 1155 (1999).
Total ≤ 300mg/100kcal AOCS Ja7b-91 Gas liquid Type IV with suitable extraction and preparation procedures
phospholipids (72mg/100kJ) chromatography Notes
1. The method is applicable to oil-containing lecithins, deoiled lecithins,
lecithin fractions; not applicable to lyso-PC and lyso-PE.
2. Validated. Reference Pure Appl. Chem. 64: 447 - 454 (1992). A
summary of statistics from the IUPAC phospholipid collaborative study
is included with the method.
3. Suitable extraction and preparation procedures applicable to infant
formulae are needed in conjunction with this method. The Walstra &
de Graaf procedure for the extraction of the fat is suitable. Reference:
 ALINORM 09/32/26, Appendix VI 60

Walstra, P. & de Graaf, J. J. (1962) Note on the determination of the

phospholipid content of milk products. Netherlands Milk & Dairy J., 16,
283-287.
4. Recommended as a tentative method (Type IV) since the method is not
validated for infant formula.
Total Minimum 9.0g/100kcal AOAC 986.25 Determination Type II.
carbohydrates (2.2g/100kJ); maximum by difference, Notes
14.0g/100kcal i.e. the
1. Validated. Reference: JAOAC 69: 777 - 785 (1986).
(3.3g/100kJ). remainder after
deducting fat,
ash and crude
protein from
total solids.
Moisture/Total AOAC 934.01 Type I
Solids AOAC 925.23 Notes
No provision for moisture/total solids, however estimation of moisture content
or Gravimetry (total solids) is needed for calculation of carbohydrates and calories.
IDF 12B:1987
ISO 6731:1989

Ash AOAC 942.05 Gravimetry Type I

Notes
No provision for ash, however estimation of ash content is needed for
calculation of carbohydrates and calories

Vitamin A Note on the form of Vitamin A in Codex Standard 72

Footnote from Codex Stan 72, 3.1 Essential Composition, Vitamin A
Vitamin A: 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.
Comment: Carotenoids are unequivocally excluded from declaration of vitamin A content.
The requirement that vitamin A content shall be provided by “preformed retinol” implies only naturally present retinol, and excludes the common
vitamin A acetate and palmitate supplements. These forms are physiologically active and may be quantified either specifically as intact esters and
aggregated with natural retinol, or converted to retinol during analysis. It would seem that the standard should provide for all forms of retinol present in
 ALINORM 09/32/26, Appendix VI 61

infant formula, whether preformed or derived from supplemental acetate and/or palmitate forms. It does not make sense to exclude vitamin A added for
nutrient purposes from this provision and it seems at the least, that “preformed’ should be removed from the standard
Minimum AOAC 992.04 (retinol High performance Type III*
Vitamin A 60µg/100kcal isomers) liquid Notes
(14µg/100kJ); Vitamin A (both natural + chromatography
1. Currently adopted as Type II method for follow-up formula in CODEX
maximum supplemental ester forms) STAN 234-1999 rev 2007 and previously listed for infant formula in
180µg/100kcal aggregated and quantified rev 2006.
(43µg/100kJ). as individual retinol 2. Validated: Study matrices included powdered infant formula,
isomers (13, cis and all- powdered milk, and liquid infant formula
trans) 3. Reference: J.AOAC Int. 76.
Vitamin A Minimum AOAC 992.06 (retinol) High performance Type III*
60µg/100kcal Vitamin A (both natural + liquid Notes
(14µg/100kJ); supplemental ester forms) chromatography
1. Currently adopted as Type II method for follow-up formula in CODEX
maximum aggregated and quantified STAN 234-1999, amended 2007.
180µg/100kcal as individual retinol 2. Reference: J. AOAC Int. 76: 300-414 (1993).
(43µg/100kJ). isomers (13, cis and all-
trans)
12823-1:2000
Vitamin A Minimum EN 12823-1:2000 (all- High performance Type III
60µg/100kcal trans-retinol and 13-cis- liquid Notes
(14µg/100kJ); retinol) chromatography
1. Validated. Precision data for various foods is in CCNFSDU 29th session
maximum Vitamin A (both natural + CRD 15.
180µg/100kcal supplemental ester forms) 2. Collaboratively tested according to ISO 5725, among others an
(43µg/100kJ). aggregated and quantified enriched milk powder was included in the validation. In accordance
as individual retinol with the EU MAT Certification Study Guidelines, the parameters for
isomers (13, cis and all- margarine (CRM 122) and milk powder (CRM 421) have been defined
trans) in an interlaboratory test. The study was organised by the Institute of
Food Research, Norwich, United Kingdom.
3. Reference: Finglas, P.M., van den Berg, H. & de Froidmont-Gortz, I.,
1997. The certification of the mass fractions of vitamins in three
reference materials: margarine (CRM 122), milk powder (CRM 421),
and lyophilized Brussels sprouts (CRM 431). EUR-Report 18039,
Commission of the European Union, Luxembourg.
Vitamin D Note on the form of Vitamin D in Codex Standard 72
Footnote from Codex Stan 72, 3.1 Essential Composition, Vitamin D
 ALINORM 09/32/26, Appendix VI 62

Calciferol. 1 µg calciferol = 40 IU vitamin D

Comment: Calciferol is not specific and conceivably includes all forms of vitamin D. This currently generic descriptor could therefore include the parent
forms of vitamin D2 and D3 and the physiologically antirachitic hydroxylated metabolites. For food nutritional labelling requirements it is however
implicit that the parent cholecalciferol (vitamin D3) is the target nutrient, given that this is the form commonly added to infant formulas. The current
definition does not discriminate ergocalciferol (vitamin D2) which is rarely added to foods.
Vitamin D Minimum AOAC 992.26 High performance Type III, with limitations on applicability to infant formula containing
1µg/100kcal (D2 and/or D3 measured liquid 488-533 IU/L The minimum requirement for vitamin D in Codex STAN
(0.25µg/100kJ); as single components. chromatography 72 is 280 IU/L
maximum Hydroxylated forms not Notes
2.5µg/100kcal measured.) 1. Validated. The method is applicable to ready-to-feed milk-based infant
(0.6µg/100kJ).
formulas containing 488 to 533 IU/L vitamin D3.
2. References: J. AOAC 68: 177- 182 (1985) J. AOAC Int. 76: 1042 -
1056 (1993).
3. The method was listed for use with milk based infant formula in
CODEX STAN 234-1999, rev. 2006.
4. The minimum requirement for vitamin D3 (1 µg /100 kcal = 40 IU/100
kcal) means 280 IU/L vitamin D3, calculating the maximal energy
density (70 kcal/100 ml prepared ready for consumption infant
formula) laid down by CODEX STAN 72. This concentration is outside
of the applicable concentration range of method AOAC 992.26 (488-
533 IU/L).
5. D2 and/or D3 measured as single component. Method cannot
discriminate if both present. Hydroxylated forms not measured.

Vitamin D Minimum EN 12821:2000 High performance Type III*.

1µg/100kcal (D2 and/or D3 measured liquid Notes
(0.25µg/100kJ); as single components. chromatography
1. Precision data for various foods is in CCNFSDU 29th session CRD 15
maximum Hydroxylated forms not 2. Validated. Collaboratively tested according to ISO 5725, among others
2.5µg/100kcal measured.) an enriched milk powder was included in the validation.
(0.6µg/100kJ).
3. Reference: EN 12821:2000. Foodstuffs - Determination of vitamin D
by high performance liquid chromatography - Measurement of
cholecalciferol (D3) and ergocalciferol (D2)
4. The parameters on margarine (CRM 122) and milk powder (CRM 421)
have been defined in an interlaboratory test, in accordance with the EU
MAT Certification Study Guidelines. The study was organized by the
Laboratory of the Government Chemist, UK. Reference: Finglas, P.M.,
 ALINORM 09/32/26, Appendix VI 63

van den Berg, H. and de Froidmont-Görtz, I., 1997. The certification of

the mass fractions of vitamins in three reference materials: margarine
(CRM 122), milk powder (CRM 421), and lyophilized Brussels sprouts
(CRM 431). EUR-Report 18039, Commission of the European Union,
Luxembourg.
5. The parameters on milk, liquid infant, formula, cooking oil, margarine,
infant formula and fish oil have been defined in an interlaboratory test
according to AOAC Guidelines for collaborative study procedures to
validate characteristics of a method of analysis. The study was
organized by NMKL (Nordic Committee on Food Analysis).
Reference: Staffas A, Nyman A. JAOAC Int., 2003, 86:400-406
6. D2 and D3 measured as single component. Method cannot measure the
content of vitamin D if both forms are present. Hydroxylated forms not
measured. The method is capable to quantitate D2 and D3 in the same
sample, it is just not described.

Vitamin D Minimum AOAC 995.05 High performance Type III*

1µg/100kcal (D2 or D3. Method can liquid Notes
(0.25µg/100kJ); discriminate if both chromatography
1. Official Methods of AOAC Int. (18th ed., 2005): 50.1.23.
maximum present. Hydroxylated 2. References: J. AOAC Int. 75: 566 - 571 (1992). J. AOAC Int. 79: 73 -
2.5µg/100kcal forms not measured). 80 (1996).
(0.6µg/100kJ).
3. Validated. The method is applicable to the determination of 8 to 2600
IU (International Unit; 1 microgram vitamin D = 40 IU) vitamin
D/quart (1 quart = 0.946 L) in infant formulas and enteral products.
The results of the interlaboratory study supporting acceptance of the
method are included in the method.
4. Method can discriminate between D2 or D3, if both present.
Hydroxylated forms not measured.
Vitamin E Note on the form of Vitamin E in Codex Standard 72
Footnote from Codex Stan 72, 3.1 Essential Composition, Vitamin E
1 mg α-TE (alpha-tocopherol equivalent) = 1 mg d-α-tocopherol
Vitamin E content 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 -TE/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 eicosapentaenoic acid (20:5 n-3); 1.5 mg α-TE/g docosahexaenoic acid (22:6 n-3).
Comment: The standard does not provide conversion factors to determine tocopherol equivalents derived from the multiple vitamin E congeners
potentially present in an infant formula. Neither the congeners (α, β, γ, δ), their tocotrienol equivalents or the supplemental α -tocopheryl acetate form
 ALINORM 09/32/26, Appendix VI 64

are specified.

Vitamin E Minimum AOAC 992.03 High performance Type III*

0.5mg/100kcal (Measures all-rac-vitamin liquid Notes
(0.12mg/100kJ); E (both natural + chromatography
1.
no maximum supplemental ester forms) 2. Reference: J. AOAC Int. 76: 399 - 413 (1993).
limit. GUL aggregated and quantified 3. Validated. The results of the interlaboratory study supporting
5mg/100kcal as individual α -congeners) acceptance of the method (milk-based liquid, ready-to-feed) are stated
(1.2mg/100kJ).
in the method.
Minimum 0.5mg
4. The method was listed for use with infant formula in CODEX STAN
α-TE per g
234-1999, rev. 2006.
PUFA6 using
5. Measures all-rac-vitamin E (both natural + supplemental ester forms)
specified factors
aggregated and quantified as individual α -congeners.
of equivalence.
Vitamin E Minimum EN 12822: 2000 High performance Type III*
0.5mg/100kcal (Measures Vitamin E (both liquid Notes
(0.12mg/100kJ); natural + supplemental chromatography
1. Validated. Precision data for various foods incl. milk powder is in
no maximum ester forms) aggregated CCNFSDU 29th session CRD 15. Collaboratively tested according to
limit. GUL and quantified as ISO 5725, among others, an enriched milk powder was included in the
5mg/100kcal individual tocopherol validation.
(1.2mg/100kJ). congeners (α, β, γ, δ). 2. The parameters on margarine (CRM 122) and milk powder (CRM 421)
Minimum 0.5mg
of different methods for the determination of Vitamin E (α-tocopherol)
α-TE per g
have been defined in an international comparison study organised by
PUFA6 using
the European Commissions Standard, Measurement and Testing
specified factors
program. Reference: Finglas, P.M., van den Berg, H. and de
of equivalence.
Froidmont-Gortz, I., 1997. The certification of the mass fractions of
vitamins in three reference materials: margarine (CRM 122), milk
powder (CRM 421), and lyophilized Brussels sprouts (CRM 431).
EUR-Report 18039, Commission of the European Union, Luxembourg.
3. In accordance with ISO 5725 : 1986 [19], the validation data on milk
powder and oat powder have been defined in an inter-laboratory test.
The test was conducted by the Max von Pettenkofer-Institute of the
Federal Health Office, Food Chemistry Department, Berlin, Germany.
Reference: Untersuchung von Lebensmitteln - Bestimmung von
Tocopherolen und Tocotrienolen in dietätischen Lebensmitteln L
49.00-5 September 1998 (Food Analysis - Determination of
tocopherols and tocotrienols in dietetic foodstuffs L 49.00-5 September
 ALINORM 09/32/26, Appendix VI 65

1998) in: Amtliche Sammlung von Untersuchungsverfahren nach § 35

LMBG: Verfahren zur Probenahme und Untersuchung von
Lebensmitteln, Tabakerzeugnissen, kosmetischen Mitteln und
Bedargsgegenständen/Bundesgesundheitsamt (In: Collection of official
methods under article 35 of the German Federal Foods Act, Methods of
sampling and analysis of foods, tobacco products, cosmetics and
commodity goods/Federal Health Office), Loseblattausgabe September
1998, Bd. 1 (Loose leaf edition as of 1998-09, Vol.1) Berlin, Köln:
Beuth Verlag GmbH
4. Measures Vitamin E (both natural + supplemental ester forms)
aggregated and quantified as individual tocopherol congeners (α, β, γ,
δ).
Vitamin K Note on the form of Vitamin K in Codex Standard 72.
The standard provides no qualification on the definition of forms of vitamin K.
Comment: Vitamin K present in infant formulas can include cis and/or trans K1, dihydro-K1, and the menaquinone series, and a more rigorous
definition may be required.
Vitamin K Minimum AOAC 992.27 High performance Type III with limitations on applicability to ready-to-feed milk-based
4µg/100kcal (trans-K1). liquid infant formulas containing 75 to 130 micrograms/L trans-vitamin K1,the
(1µg/100kJ); no chromatography. minimum requirement for vitamin K in CODEX STAN 72 is 28 µg/L
maximum limit; Notes
GUL
1. The method was listed for use with infant formula in CODEX STAN
27µg/100kcal
234-1999, rev. 2006.
(6.5µg/100kJ)
2. Validated. The method is applicable to ready-to-feed milk-based infant
formulas containing 75 to 130 micrograms/L trans-vitamin K1.
3. The minimum requirement for vitamin K (4 µg /100 kcal) means 28
µg /L vitamin K, calculating the maximal energy density (70 kcal/100
ml prepared ready for consumption infant formula) laid down by the
Codex Standard. This concentration is outside of the applicable
concentration range of method AOAC 992.27 (75-130 µg /L).
4. References: J. AOAC 68: 684 - 689 (1985)
J. AOAC Int. 76: 1042 - 1056 (1993) AOAC 992.27
5. Measures trans-K1.
Vitamin K Minimum AOAC 999.15 High performance Type III*
4µg/100kcal (Measures either liquid Notes
(1µg/100kJ); no aggregated cis + trans K1 chromatography
1. Validated. The method is applicable to the determination of total
maximum limit; or can measure individual with vitamin K1 (phylloquinone) in infant formula and milk (fluid, ready-to-
 ALINORM 09/32/26, Appendix VI 66

GUL cis and trans forms C30 column to feed, and powdered) containing > 1 microgram vitamin K1/100 g
27µg/100kcal depending on LC column. separate the cis- and solids).
(6.5µg/100kJ) Can also discriminate and the trans- 2. Reference: J. AOAC Int. 83: 121- 130 (2000).
measure dihydro-K1 and K vitamins 3. Measures either aggregated cis + trans K1 or can measure individual cis
menaquinones). and trans forms depending on LC column. Can also discriminate and
measure dihydro-K1 and menaquinones.
Proposed by CCNFSDU 28. CCMAS 28 asked for clarification of the
differences from AOAC 992.27.
Consideration needs to be given to i) ability to discriminate the cis and trans-
forms of K1 which can be accomplished with a C30 column, ii) whether the
menaquinones (K2) be included.
AOAC 999.15 is a more specific fluorescence method than AOAC 999.27 and
has a better sample preparation with enzyme instead of a labor-intensive
multistep procedure.
AOAC 995.15 & EN 14148 are based on a joint AOAC/EN collaborative
study. The main weakness with this procedure is that both cis- and trans- K1
(total K1) are determined. The cis-form is inactive. To overcome this problem,
the C18 HPLC column must be replaced by a C30 HPLC column which
separates the two vitamers.
Vitamin K Minimum EN 14148:2003 (vitamin High performance Type III*
4µg/100kcal K1) liquid 1. Precision data for various foods including a range of infant formulae is
(1µg/100kJ); no (Measures either chromatography in CCNFSDU 29th session CRD 15.
maximum limit; aggregated cis + trans K1 2. Validated. The precision data have been defined in an international
GUL or can measure individual collaborative study:
27µg/100kcal cis and trans forms 3. Reference: Indyk, H. E. and Woollard, D. C.: Vitamin K in Milk and
(6.5µg/100kJ) depending on LC column.) Infant Formulas by Liquid Chromatography: Collaborative study. J.
AOAC intern. 83, 2000, 121-130.
4. Measures either aggregated cis + trans K1 or can measure individual
cis and trans forms depending on LC column.

Thiamin Note on the form of Thiamin in Codex Standard 72.

The standard provides no qualification on the definition of forms of thiamine.
Comment: Several endogenous phosphorylated forms exist in infant formulas, although vitamin B1 is usually dominated by the supplement thiamine
hydrochloride. In this case, units of expression (free base vs hydrochloride salt) need to be defined.
Thiamin Minimum AOAC 942.23 Fluorimetry Type III or IV
60µg/100kcal
 ALINORM 09/32/26, Appendix VI 67

(14µg/100kJ); no ( Measures all vitamin B1 1. Currently adopted as Type II method for Special foods in CODEX
maximum limit; forms and aggregates as STAN 234-1999, rev 2007.
GUL thiamine) 2. Validated on many food matrixes, but not infant formula or similar
300µg/100kcal food matrixes.
(72µg/100kJ) 3. The method has been used traditionally
4. The method is not applicable in presence of materials that adsorb
thiamin or which contain extraneous materials which affect thiochrome.
5. References: JAOAC 25: 456- 458 (1942);
JAOAC 27: 534 - 537 (1944) ; JAOAC 28: 554 - 559 (1945); JAOAC 31:
455 - 459 (1948); JAOAC 43: 45 - 46 (1960); JAOAC 43: 55 - 57 (1960);
AND
JAOAC 64: 1336 - 1338 (1981).
6. Measures all vitamin B1 forms and aggregates as thiamine. Subject to
significant spectral interference.
Minimum AOAC 986.27 Fluorimetry Type III*
Thiamin 60µg/100kcal (Measures all vitamin B1 1. Validated
(14µg/100kJ); no forms as thiamine) 2. Reference: JAOAC 69: 777 - 785 (1986).
maximum limit; 3. Measures all vitamin B1 forms as thiamine. Subject to significant
GUL spectral interference.
300µg/100kcal
(72µg/100kJ)
Thiamin Minimum EN 14122:2003 High performance Type III*
60µg/100kcal (Measures all vitamin B1 liquid 1. Validated. Precision data for various foods is in CCNFSDU 29th
(14µg/100kJ); no forms (natural and added chromatography session CRD 15
maximum limit; free, bound and with pre-or post 2. Collaboratively tested according to ISO 5725, among others, an
GUL phosphorylated) following column enriched milk powder was included in the validation.
300µg/100kcal extraction and conversion derivatization to In accordance with the EU SMT Certification Study guidelines, the
(72µg/100kJ) to thiamine) thiochrom data given for CRM 121 (wholemeal flour), CRM 421 (milk
powder), CRM 485 (mixed vegetables) and CRM 487 (pig’s liver)
have been defined in an interlaboratory test. The Institute of Food
Research, Norwich, UK on behalf of the EU Community Bureau of
Reference, conducted the study.
Reference: Finglas, P. M., Scott, K. J., Witthoft, C. M., van den
Berg, H. and de Froidmont-Gortz, I.: The certification of the mass
fractions of vitamins in four reference materials: Wholemeal flour
 ALINORM 09/32/26, Appendix VI 68

(CRM 121), milk powder (CRM 421), lyophilised mixed vegetables

(CRM 485) and lyophilised pig’s liver (CRM 487). EUR-report
18320, Office for Official Publications of the European
Communities, Luxembourg, 1999.
3. The data given for tube feeding solution, baby food, powdered milk,
meal with fruits, yeast and cereal, chocolate powder and food
supplement have been defined in a French interlaboratory test..
Reference: Arella, F., Lahély, S., Bourguignon, J. B. and Hasselmann,
C.: Liquid chromatographic determination of vitamin B1 and B2 in
foods. A collaborative study. Food Chem. 56, 1996, 81-86.
4. Measures all vitamin B1 forms (natural and added free, bound and
phosphorylated) following extraction and conversion to thiamine.

Riboflavin Note on the form of Riboflavin in Codex Standard 72.

The standard provides no qualification on the form of riboflavin.
Comment: Several endogenous phosphorylated forms exist in infant formulas, eg free and/or bound riboflavin, FMN, FAD etc. Vitamin B2 is generally
enhanced through supplementation with either free riboflavin or FMN.
Minimum AOAC 985.31 Fluorimetry Type III*
Riboflavin 80µg/100kcal (Measures free and bound 1. Validated
(19µg/100kJ); no forms. Uncertain whether 2. AOAC 985.31 Riboflavin in Ready-to-Feed Milk-Based Infant
maximum limit; phosphorylated forms Formula, Fluorometric Method. First Action 1985; Final Action 1988.
GUL captured) Official Methods of AOAC Int. (18th ed., 2005): 50.1.07.
500µg/100kcal 3. Reference: JAOAC 68: 514 - 522 (1985). Official Methods of AOAC
(119µg/100kJ) Int. (18th ed., 2005) cross-references AOAC 985.31 to AOAC 970.65
[45.1.08; Riboflavin (Vitamin B2) in Foods and Vitamin Preparations,
Fluorometric method, First Action 1970; Final Action 1971]. AOAC
970.65 dates from the 1970s.
4. Literature references for AOAC 970.65 date to 1940 and are not
included here.
5. Measures free and bound forms. Uncertain whether phosphorylated
forms captured. Subject to significant spectral interference.
Riboflavin Minimum EN 14152:2003 High performance Type III*
80µg/100kcal (Measures natural and liquid 1. Validated. Precision data for various foods is in CCNFSDU 29th session
(19µg/100kJ); no supplemental forms, free, chromatography CRD 15.
maximum limit; bound and phosphorylated 2. Collaboratively tested according to ISO 5725, an enriched milk powder
GUL (FMN and FAD) was included in the validation.
 ALINORM 09/32/26, Appendix VI 69

500µg/100kcal aggregated and measured The parameters on CRM 421 (milk powder) and CRM 487 (pig
(119µg/100kJ) as riboflavin.) liver) of different methods for the determination of riboflavin
(Vitamin B2) have been defined in an international comparison
study organised by the European Commissions Standard,
Measurement and Testing programme. Reference: Finglas, P. M.,
Scott, K. J., Witthoft, C. M., van den Berg, H. & de Froidmont-
Gortz, I.: The certification of the mass fractions of vitamins in four
reference materials: Wholemeal flour (CRM 121), milk powder
(CRM 421), lyophilised mixed vegetables (CRM 485) and
lyophilised pig’s liver (CRM 487). EU Report 18320, Office for
Official Publications of the European Communities, Luxembourg,
1999.
3. Both natural and supplemental forms, free, bound and phosphorylated
(FMN and FAD) aggregated and measured as riboflavin.
Niacin Note on the form of Niacin in Codex Standard 72.
Niacin refers to preformed niacin.
Comment; Niacin is the generic descriptor for two vitamers, nicotinic acid and nicotinamide. However terminology differs between the USA and Europe
for this vitamin and this standard needs to be unambiguous. Other forms also exist, eg NAD, NADH etc. It is therefore unclear what is meant by
“preformed niacin”.
Niacin Minimum AOAC 985.34 (niacin Microbioassay and Type III
300µg/100kcal (preformed) and turbidimetry 1. CCMAS recommended review and replacement with a more modern
(70µg/100kJ); no nicotinamide) method.
maximum limit;
GUL 2. Validated
1500µg/100kcal 3. AOAC 985.34 Niacin and Niacinamide (Nicotinic Acid and
(360µg/100kJ) Nicotinamide) in Ready-to-Feed Milk-Based Infant Formula;
Microbiological-turbidimetric method. First Action 1985; Final Action
1988. Official Methods of AOAC Int. (18th ed., 2005): 50.1.19.
4. Reference: JAOAC 68: 514 - 522 (1985).
5. The method is applicable to baby foods (meat based), beverages, juices,
cereal products, cheese, dairy products, fruits and potato products.
6. Free and bound forms aggregated and measured as nicotinic acid.
Niacin Minimum prEN 15652:2007 High performance Type III* when published as EN method
300µg/100kcal (Free and bound and liquid 1. Validated. Precision data for various foods is in CCNFSDU 29th session
(70µg/100kJ); no phosphorylated forms chromatography CRD 15
maximum limit; measured either as 2. Collaboratively tested according to ISO 5725, among others, an
 ALINORM 09/32/26, Appendix VI 70

GUL aggregate of nicotinic acid enriched milk powder was included in the validation.The precision data
1500µg/100kcal + nicotinamide, or as for the determination of niacin were established according to ISO 5725-
(360µg/100kJ) individual forms) 2 in 2002 by an international collaborative study organised by AéRIAL
(CRT: Centre de Ressources technologiques) and the CGd’UMA
(Commission Générale d’Unification des Méthodes d’Analyses)
according to ISO 5725-2 in 1999 by a French collaborative study
organized by CGd’UMA,
3. Reference:
• To be published: Bergantzlé M., Validation study on the
determination of niacin by HPLC in several matrices;
• Lahély S., Bergantzlé M., Hasselmann, C.: Fluorimetric
determination of niacin in foods by highperformance liquid
chromatography with post-column derivatization Food chem., 65,
129-133 (1999)
4. Free and bound and phosphorylated forms measured either as aggregate
of nicotinic acid + nicotinamide, or as individual forms
Vitamin B6 Note on the form of Vitamin B6 in Codex Standard 72.
The standard provides no qualification on the form of vitamin B6.
Comment: This means all forms are potentially included, i.e. pyridoxine, pyridoxal, pyridoxamine and the related phosphorylated forms. Vitamin B6 is
generally enhanced through supplementation with pyridoxine, and could be expressed as either the free base or hydrochloride salt. Methods for vitamin
B6 can therefore measure and report single or aggregate forms.
Minimum AOAC 985.32 Microbioassay Type III
Vitamin B6 35µg/100kcal (Aggregates free and 1.
(8.5µg/100kJ); no bound pyridoxal, 2. CCMAS 28 states in general, methods using microbioassay as a
maximum limit. pyridoxine and principle should be reviewed in order to replace them with more
GUL pyridoxamine and modern methods, and asked for clarification of the differences from
175µg/100kcal measures as pyridoxine.) AOAC 961.15.
(45µg/100kJ). 3. Validated
AOAC Method 985.32. (Pyridoxine, Pyridoxal, Pyridoxamine) in Ready-to
Feed Milk-Based Infant Formula Microbiological Method. First Action 1985;
Final Action 1988.

Official Methods of AOAC Int. (18th ed., 2005): 50.1.18.

Reference: JAOAC 68: 514 - 522 (1985).
4. Aggregates free and bound pyridoxal, pyridoxine and pyridoxamine
and measures as pyridoxine.
 ALINORM 09/32/26, Appendix VI 71

Vitamin B6 Minimum AOAC 2004.07 High performance Type III*

35µg/100kcal (Free and bound liquid 1. Validated. The method is applicable to the determination of vitamin B6
(8.5µg/100kJ); no phosphorylated forms chromatography in milk- and soy based liquid infant formula at 0 -1mg/100g.
maximum limit. (pyridoxal, pyridoxine and Reference: JAOAC Int. 88: 30 - 37 (2005)
GUL pyridoxamine) converted
175µg/100kcal Results of the interlaboratory study for vitamin B6 in reconstituted infant
and measured as
(45µg/100kJ). formula (milk- and soy-based) are included with the method.
pyridoxine.)
Measures free and bound phosphorylated forms (pyridoxal, pyridoxine and
pyridoxamine) converted and measured as pyridoxine.

Vitamin B6 Minimum EN 14166:2008 Microbioassay Type III

35µg/100kcal (Aggregates free and 1. CCMAS 28 states in general, methods using microbioassay as a
(8.5µg/100kJ); no bound pyridoxal, principle should be reviewed in order to replace them with more
maximum limit. pyridoxine and modern methods.
GUL pyridoxamine (including 2. Validated. Precision data for various foods is in CCNFSDU 29th session
175µg/100kcal phosphorylated forms) and CRD 15
(45µg/100kJ). measures as pyridoxine.) Foodstuffs - Determination of vitamin B6 by microbiological assay
The following data were obtained in an interlaboratory trial held in 1996
between participating European laboratories.
Reference:
The certification of the mass fractions of vitamins in four reference materials:
wholemeal flour (CRM 121), milk powder (CRM 421), lyophilised mixed
vegetables (CRM 485) and lyophilised pigs liver (CRM 487). Finglas, P.M.,
Scott, K.J., Witthoft, C., van den Berg, H. & Froidmont-Görtz, I. (1999);
EUR-report 18320, Office for Official Publications of the European
Communities, Luxembourg.
3. Aggregates free and bound pyridoxal, pyridoxine and pyridoxamine
(including phosphorylated forms) and measures as pyridoxine.
Vitamin B6 Minimum EN 14663:2005 (includes High performance Type III
35µg/100kcal glycosylated forms) liquid 1. Validated. Precision data for various foods (semolina with milk,
(8.5µg/100kJ); no (Free and bound chromatography powder; potato puree, powder; vegetables with ham (baby food); multi
maximum limit. phosphorylated and vitamin drink) is in CCNFSDU 29th session CRD 15
GUL glycosylated forms The precision data for the determination of vitamin B6 were
175µg/100kcal measured as the individual established in an interlaboratory test according to ISO 5725 carried
(45µg/100kJ). forms pyridoxal, out by the former BgVV (Bundesinstitut für gesundheitlichen
pyridoxine and Verbraucherschutz und Veterinärmedizin, German Federal Institute
 ALINORM 09/32/26, Appendix VI 72

pyridoxamine.) for Consumer protection and veterinary medicine).

Reference:
Bognár, A.: Bestimmung von Vitamin B6 in Lebensmitteln mit
Hilfe der Hochdruckflüssig-
Chromatographie (HPLC). Z Lebensm Unters Forsch A, 1985, 181:
200 – 205
2. Free and bound phosphorylated and glycosylated forms measured as
the individual forms pyridoxal, pyridoxine and pyridoxamine.
Vitamin B6 Minimum EN 14164:2008 High performance Type III*
35µg/100kcal (Free and bound liquid 1. Precision data for the determination of vitamin B6 in baby food,
(8.5µg/100kJ); no phosphorylated forms chromatography biscuit, cereal, yeast, tube-feeding solution, chocolate powder and
maximum limit. (pyridoxal, pyridoxine and powdered milk were established in an interlaboratory test according to
GUL pyridoxamine) converted ISO 5725 carried out by DGCCRF (Direction Génerale de la
175µg/100kcal and measured as Concurrence, de la Consommation et de le Repression des Fraudes).
(45µg/100kJ). pyridoxine.) Reference:
Bergaentzlé M., Arella F., Bourguignon J.B., Hasselmann C.,
Determination of vitamin B6 in foods by HPLC: a collaborative
study. Food Chem (1995), 52, 81-86
2. The precision data for the determination of vitamin B6 in reconstituted
infant formula were established in an interlaboratory test according to
AOAC Guidelines for collaborative study procedures to validate
characteristics of a method of analysis.
Reference:
Mann D.L., Ware G.W., Bonnin E. Liquid Chromatographic
analysis of vitamin B6 in reconstituted infant formula: Collaborative
Study. JAOAC (2005), 88,1:30-37
3. Free and bound phosphorylated forms (pyridoxal, pyridoxine and
pyridoxamine) converted and measured as pyridoxine.
Vitamin B12 Note on the form of Vitamin B12 in Codex Standard 72.
The standard provides no qualification on the form of vitamin B12.
Comment: This means all forms are potentially included. However cyanocobalamin is the form used in food supplementation and most extraction
conditions employed will convert multiple endogenous forms to a single cyano form.
Minimum AOAC 986.23 Turbidimetric Type III*
Vitamin B12 0.1µg/100kcal (Measures total vitamin Method 1. CCMAS asked for clarification of the differences from AOAC 952.20.
(0.025µg/100kJ); B12 as cyanocobalamin A great difference between AOAC 952.20 and AOAC 986.23
no maximum methods is the sample matrix; the first is applicable in vitamin
 ALINORM 09/32/26, Appendix VI 73

limit; GUL preparations, but not in infant formulae.

1.5µg/100kcal 2. Validated
(0.36µg/100kJ) AOAC Method 986.23 Cobalamin (Vitamin B12 Activity) in Milk-
Based Infant Formula. Turbidimetric method (microbiological).
First Action 1986; Final Action 1988.
Official Methods of AOAC Int. (18th ed., 2005): 50.1.20.
Reference: JAOAC 69: 777 - 785 (1986).
3. Measures total vitamin B12 as cyanocobalamin.
Pantothenic acid Note on the form of Pantothenic acid in Codex Standard 72.
The standard provides no qualification on the form of pantothenic acid.
Comment: This means all forms are potentially included eg the free calcium pantothenate supplement and that derived from Coenzyme A. It is important
to define units of expression either as pantothenic acid or the calcium salt.
Pantothenic acid Minimum AOAC 992.07 Microbioassay Type III. In line with the CCMAS 28 request to review methods using
400µg/100kcal (Measures total microbioassay as a principle, the suggestion is this method which has been
(96µg/100kJ); no pantothenate (free used traditionally should currently be endorsed as Type III and recommended
maximum limit; pantothenic acid + CoA- + as Type IV when another method can be recommended as Type II or III
GUL ACP-bound) and measured 1. The method was listed for use with infant formula in CODEX STAN
2000µg/100kcal as D-pantothenic acid (or 234-1999, rev. 2006.
(478µg/100kJ) calcium D-pantothenate).) 2. CCMAS 28 states in general, methods using microbioassay as a
principle should be reviewed in order to replace them with more
modern methods.
3. Validated. Results of the interlaboratory study supporting acceptance of
the method (milk-based liquid, ready-to-feed) are presented in the
method.
Reference: J. AOAC Int. 76: 399 - 413 (1993).
4. Measures total pantothenate (free pantothenic acid + CoA- + ACP-
bound) and measured as D-pantothenic acid (or calcium D-
pantothenate).
Folic acid Note on the form of Folic acid in Codex Standard 72.
The standard is specific for folic acid.
Comment: Currently the provision is specific for folic acid which implies that only the free supplemental form should be quantified during analysis, and
expressed as ug (despite DFE gaining common usage). However, such a test method would exclude all natural forms present in milk, and therefore
invalidate currently recommended microbiological assay methods.
Minimum AOAC 992.05 Microbioassay Type III In line with the CCMAS 28 request to review methods using
Folic acid 10µg/100kcal (Measures free folic acid + microbioassay as a principle, the suggestion is this method which has been
(2.5µg/100kJ); no used traditionally should currently be endorsed as Type III and recommended
 ALINORM 09/32/26, Appendix VI 74

maximum limit; free, unbound natural as Type IV when another method can be recommended as Type II or III.
GUL folates, aggregated and 1.
50µg/100kcal measured as folic acid.) 2. CCMAS 28 states in general, methods using microbioassay as a
(12µg/100kJ) principle should be reviewed in order to replace them with more
modern methods.
3. Validated. Results of the interlaboratory study supporting acceptance of
the method (milk-based, ready-to-feed) are listed in the method.
Reference: J. AOAC Int. 76: 399 - 413 (1993).
4. Measures free folic acid + free, unbound natural folates, aggregated and
measured as folic acid.
Folic acid Minimum EN 14131:2003 Microbioassay Type III In line with the CCMAS 28 request to review methods using
10µg/100kcal (Total folate (free + microbioassay as a principle, this method which has been used traditionally
(2.5µg/100kJ); no bound), aggregated and should currently be endorsed as Type III and recommended as Type IV when
maximum limit; measured as folic acid.) another method can be recommended as type II or III
GUL 1.
50µg/100kcal 2. Validated. Precision data for various foods is in CCNFSDU 29th session
(12µg/100kJ) CRD 15
The precision of the method was established by interlaboratory tests
conducted within the European Union’s Standards, Measurement
and Testing (EU SMT) programme, and carried out in accordance
with ISO 5725.
Reference:
Finglas, P.M., et al., The certification of the mass fractions of
vitamins in four reference materials: wholemeal flour (CRM 121),
milk powder (CRM 421), lyophilized mixed vegetables (CRM 485)
& lyophilized pig's liver (CRM 487). B1, B6 & folate in CRM 121;
B1, B2, B6, B12 & folate in CRMs 421 & 487, and B1, B6, folate &
carotenoids in CRM 485. 1999, Luxembourg: Office for Official
Publications of the European Communities.
3. Equivalent to AOAC 992.05. Note that these methods quantify total
folate, including folates of natural source and not folic acid alone,
which is used as source for fortification.
4. Measures total folate (free + bound), aggregated and measured as folic
acid.
Folic acid Minimum J AOAC Int. 2000:83; Optical Biosensor Not recommended as Type III as it is not established as official
10µg/100kcal 1141-1148 Immunoassay methodology. In line with the CCMAS 28 request to review methods using
(2.5µg/100kJ); no (Measures free folic acid + microbioassay as a principle,this method which is recently introduced and
 ALINORM 09/32/26, Appendix VI 75

maximum limit; proportion of free, natural currently under AOAC collaborative study should be endorsed as Type IV
GUL folate) 1. Reference: Indyk HE, Evans EA, et al. J AOAC Intl. 2000:83:1141-
50µg/100kcal 1148, Determination of Biotin and Folate in Infant Formula and Milk
(12µg/100kJ) by Optical Biosensor-Based Immunoassay.
http://www.atyponlink.com/AOAC/doi/abs/10.5555/jaoi.2000.83.5.114
1
2. Measures free folic acid + proportion of free, natural folate.
Folic acid Minimum J Chromatogr. A., 928, 77- High performance Not recommended as Type III as it is not established as official
10µg/100kcal 90, 2001 liquid methodology. In line with the CCMAS 28 request to review methods using
(2.5µg/100kJ); no (Measures total folates chromatography, microbioassay as a principle, this method which is recently introduced and
maximum limit; after conversion to, and incorporating currently under AOAC collaborative study should be endorsed as Type IV
GUL measurement as 5-Me- immunoaffinity 1. Under evaluation by CEN TC275/WG9
50µg/100kcal H4PteGlu) clean-up and 2. Measures total folates after conversion to, and measurement as 5-Me-
(12µg/100kJ) conversion to 5- H4PteGlu.
methyltetrahydrofol
ate
Vitamin C Note on the form of Vitamin C in Codex Standard 72.
“expressed as ascorbic acid”
Comment: Further clarification of form(s) of vitamin C is required, eg ascorbic acid (AA), oxidised dehydroascorbic acid (DHA), or total ascorbate (AA
+ DHA), since both forms are physiologically active. However, the enantiomeric D-forms are not antiscorbutic and need to be discriminated.
Vitamin C Minimum AOAC 985.33 2,6- Type III*
10µg/100kcal (measures ascorbic acid dichloroindophenol 1. .
(2.5µg/100kJ); no (AA)) titrimetry 2. CCMAS asked for clarification on how vitamin C was expressed.
maximum limit; Determines only L(+) ascorbic acid and not the total amount for
GUL which the amount of dehydroascorbic acid has to be included. This
70µg/100kcal method is specific for reduced ascorbic acid only
(17µg/100kJ) 3. Validated
References: J. AOAC 68: 514 - 522 (1985).
Vitamin C Minimum EN 14130:2003 High performance Type III*
10µg/100kcal (Measures ascorbic acid + liquid 1. .
(2.5µg/100kJ); no dehydroascorbic acid). chromatography 2. Validated. Precision data for various foods is in CCNFSDU 29th session
maximum limit; CRD 15. Validated
GUL Collaboratively tested according to ISO 5725, an enriched milk
70µg/100kcal powder was included in the validation.
(17µg/100kJ) The precision parameters for orange juice, liquid soup, powder milk,
 ALINORM 09/32/26, Appendix VI 76

freeze-dried soup, breakfast cereals and fruits baby food have been
defined in a collaborative study
3. Reference:
Arella F., Deborde J.L., Bourguignon J.B., Hasselmann C., (1997),
Ann. Fals. Exp. Chim., 90, N°940:217-233.
4. Measures total L-ascorbate (Ascorbic acid + dehydroascorbic acid).
Biotin Note on the form of Biotin in Codex Standard 72
The standard provides no qualification on the form of biotin.
Comment: Free d-biotin is generally used as a supplement. However, endogenous biotin is mostly present as a protein-bound form, which may be
liberated as bioactive d-biocytin. Attention needs to be given to which forms are to be quantified.
Biotin Minimum EN 15607:2008 (d-biotin) High performance Type III*
1.5µg/100kcal (Measures total D-biotin liquid 1.
(0.4µg/100kJ); no (free + D-biocytin) chromatography 2. Validated. Precision data for various foods including infant milk
maximum limit. powder is in CCNFSDU 29th session CRD 15. Collaboratively tested
GUL according to ISO 5725, among others, an enriched infant milk powder
10µg/100kcal was included in the validation.
(2.4µg/100kJ) The data were obtained in an interlaboratory study organized by
CGd’UMA (Commission Générale d’Unification des Méthodes
d’Analyses) in 2000. It was organized in accordance with ISO 5725-
2.
Reference:
Arella, F., Deborde, J.L., Bourguignon, J.B., Bergaentlze, M.,
Ndaw, S., Hasselmann, C.: Liquid chromatographic determination
of biotin in foods. A collaborative study. Ann. Fals. Exp. Chim., 93,
951,193-200 (2000)
3. Measures total D-biotin (free + D-biocytin)
Iron Minimum AOAC 985.35 Atomic absorption Type II
0.45mg/100kcal spectrophotometry The method is applicable to the determination of Ca, Mg, Fe, Zn, Cu, Mn, Na,
(0.1mg/100kJ); no and K.
maximum limit.
Validated. Interlaboratory study matrices include enteral product, ready-to-
GUL footnote:
feed soy formula, soy powder and whey powder (same matrices as AOAC
"levels may need
986.24 Phosphorus). The results of the interlaboratory study supporting
to be determined
acceptance of the method are presented in the method.
by national
authorities". References: JAOAC 68: 514 - 522 (1985), J. AOAC Int. 80: 834 - 844
(1997).
 ALINORM 09/32/26, Appendix VI 77

Iron Minimum AOAC 984.27 ICP emission Type III

0.45mg/100kcal spectroscopy Validated
(0.1mg/100kJ); no
Reference: JAOAC 67: 985 - 992 (1984).
maximum limit.
GUL footnote:
"levels may need
to be determined
by national
authorities".
Calcium Minimum ISO 8070 │ IDF 119: Flame atomic Type II
50mg/100kcal 2007 absorption Current Codex method for special foods, and adopted by CAC 31 for infant
(12mg/100kJ); no spectrophotometry formula, Type II, for determination of Na and K.
maximum limit;
Reference of the collaborative study: International Dairy Journal, Volume 18,
GUL
Issue 9, September 2008, Pages 899-904, Determination of sodium, potassium,
140mg/100kcal
calcium and magnesium content in milk products by flame atomic absorption
(35mg/100kJ).
spectrometry (FAAS): A joint ISO/IDF collaborative study, Laurent Noël,
Calcium to
Michael Carl, Christelle Vastel and Thierry Guérin
phosphorus ratio:
minimum 1:1 and
maximum 2:1
Calcium Minimum AOAC 985.35 Atomic absorption Type III
50mg/100kcal spectroscopy
(12mg/100kJ); no
Validated. Interlaboratory study matrices include enteral product, ready-to-
maximum limit;
feed soy formula, soy powder and whey powder (same matrices as AOAC
GUL
986.24 Phosphorus). The results of the interlaboratory study supporting
140mg/100kcal
acceptance of the method are presented in the method.
(35mg/100kJ).
Calcium to References: JAOAC 68: 514 - 522 (1985), J. AOAC Int. 80: 834 - 844
phosphorus ratio: (1997).
minimum 1:1 and
maximum 2:1
Calcium Minimum AOAC 984.27 ICP emission Type III
50mg/100kcal spectroscopy Current Codex method (Type III) for Special foods.
(12mg/100kJ); no
Validated
maximum limit;
GUL Reference: JAOAC 67: 985 - 992 (1984).
140mg/100kcal
 ALINORM 09/32/26, Appendix VI 78

(35mg/100kJ).
Calcium to
phosphorus ratio:
minimum 1:1 and
maximum 2:1
Phosphorus Minimum AOAC 986.24 Spectrophotometry Type II
25mg/100kcal (molybdovanadate) Current Codex method for special foods. .
(6mg/100kJ); no
Validated. The collaborative study was performed with soy powder infant
maximum limit;
formula, whey powder infant formula, soy ready-to-feed formula and enteral
GUL
formula. The results of the interlaboratory study supporting acceptance of the
100mg/100kcal
method are included in the method.
(24mg/100kJ)
References: JAOAC 69: 777-785 (1986)
J. AOAC Int. 80: 834-844 (1997)
Phosphorus Minimum AOAC 984.27 ICP emission Type III
25mg/100kcal spectroscopy Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus, Potassium,
(6mg/100kJ); no Sodium, and Zinc in Infant Formula.
maximum limit;
In this method, a test portion is digested in HNO3 / HClO4 and elements are
GUL
determined by ICP emission spectroscopy.
100mg/100kcal
(24mg/100kJ) Official Methods of AOAC Int. (18th ed., 2005): 50.1.15.
Reference: JAOAC 67: 985 - 992 (1984).
Magnesium Minimum ISO 8070 │ IDF 119: Flame atomic Type II
5mg/100kcal 2007 absorption Current Codex method for special foods and infant formula, Type II, for
(1.2mg/100kJ); no spectrophotometry determination of Na and K.
maximum limit.
Reference of the collaborative study: International Dairy Journal, Volume 18,
GUL
Issue 9, September 2008, Pages 899-904, Determination of sodium, potassium,
15mg/100kcal
calcium and magnesium content in milk products by flame atomic absorption
(3.6mg/100kJ)
spectrometry (FAAS): A joint ISO/IDF collaborative study, Laurent Noël,
Michael Carl, Christelle Vastel and Thierry Guérin
Magnesium Minimum AOAC 985.35 Atomic absorption Type III
5mg/100kcal spectroscopy
(1.2mg/100kJ); no
Validated for infant formula. Interlaboratory study matrices include enteral
maximum limit.
product, ready-to-feed soy formula, soy powder and whey powder (same
GUL
matrices as AOAC 986.24 Phosphorus). The results of the interlaboratory
15mg/100kcal
 ALINORM 09/32/26, Appendix VI 79

(3.6mg/100kJ) study supporting acceptance of the method are presented in the method.
References: JAOAC 68: 514 - 522 (1985), J. AOAC Int. 80: 834 - 844
(1997).
Magnesium Minimum AOAC 984.27 ICP emission Type III
5mg/100kcal spectroscopy
(1.2mg/100kJ); no
Validated
maximum limit.
GUL Reference: JAOAC 67: 985 - 992 (1984).
15mg/100kcal
(3.6mg/100kJ)
Chloride Minimum AOAC 986.26 Potentiometry Type II
50mg/100kcal Validated
(12mg/100kJ);
Reference: JAOAC 69: 777 - 785 (1986).
maximum
160mg/100kcal
(38mg/100kJ); no
GUL
Manganese Minimum AOAC 985.35 Atomic absorption Type II
1µg/100kcal spectrophotometry Validated. Interlaboratory study matrices include enteral product, ready-to-
(0.25µg/100kJ); feed soy formula, soy powder and whey powder (same matrices as 986.24
no maximum phosphorus).
limit. GUL
References: JAOAC 68: 514 - 522 (1985)
100µg/100kcal
(24µg/100kJ) J. AOAC Int. 80: 834 - 844 (1997).
Manganese Minimum AOAC 984.27 ICP emission Type III
1µg/100kcal spectroscopy Validated
(0.25µg/100kJ);
Reference: JAOAC 67: 985 - 992 (1984).
no maximum
limit. GUL
100µg/100kcal
(24µg/100kJ)
Iodine Minimum AOAC 992.24 Ion-selective Type II, for milk-based formula
10µg/100kcal potentiometry Current Codex method for milk-based follow-up formula, and was listed in
(2.5µg/100kJ); no CODEX STAN 234 (2006 revision) for milk-based infant formula (Type II
maximum limit; method).
GUL 60
 ALINORM 09/32/26, Appendix VI 80

µg/100kcal Validated. The method is applicable to ready-to-feed milk-based infant

(14µg/100kJ) formula containing 75-150 microgram/L iodide. The results of the
interlaboratory study supporting acceptance of the method (ready-to-feed milk-
based infant formula) are stated in the method.
Reference: J AOAC Int. 76: 1042 - 1056 (1993).
Selenium Minimum AOAC 996.17 Continuous hydride Type IV
1µg/100kcal generation atomic Validated (not with infant formula). Interlaboratory study included samples
(0.24µg/100kJ); absorption with selenium levels from 0.25 to 5,450 micrograms/g. Accuracy of method
no maximum spectrometry was substantiated by in-house analyses of NIST SRMs (1657 Wheat Flour;
limit; GUL (HGAAS) 1577a Bovine Liver; 1643c Trace Elements in Water). The results of the
9µg/100kcal interlaboratory study supporting acceptance of the method are listed in the
(2.2µg/100kJ) method.
Reference: J. AOAC Int. 80: 469 - 480 (1997).
Selenium Minimum EN 14627 Hydride generation Type IV
1µg/100kcal atomic absorption Foodstuffs. Determination of trace elements. Determination of total arsenic
(0.24µg/100kJ); spectrometry and selenium by hydride generation atomic absorption spectrometry (HGAAS)
no maximum (HGAAS) after pressure digestion
limit; GUL
Not validated for infant formulas
9µg/100kcal
(2.2µg/100kJ)
Selenium Minimum AOAC 2006.03 ICP emission Type IV
1µg/100kcal spectroscopy Validated (not with infant formula). Interlaboratory study included samples
(0.24µg/100kJ); with selenium levels from 0.25 to 257 micrograms/g. The results of the
no maximum interlaboratory study supporting acceptance of the method are included in the
limit; GUL method.
9µg/100kcal
Reference: J. AOAC Int. 89: 1447 - 1466 (2006).
(2.2µg/100kJ)
Copper Minimum AOAC 985.35 Atomic absorption Type II
35µg/100kcal spectroscopy Validated. Interlaboratory study matrices include enteral product, ready-to-
(8.5µg/100kJ); no feed soy formula, soy powder and whey powder (same matrices as 986.24
maximum limit. Phosphorus). The results of the interlaboratory study supporting acceptance of
GUL the method are presented in the method.
120µg/100kcal
References: JAOAC 68: 514 - 522 (1985)
(29µg/100kJ).
Footnote: J. AOAC Int. 80: 834 - 844 (1997).
“adjustment may
 ALINORM 09/32/26, Appendix VI 81

be needed in these
levels for IF made
in regions with a
high content of
copper in the
water supply".
Copper Minimum AOAC 984.27 ICP emission Type III
35µg/100kcal spectroscopy Validated for infant formula
(8.5µg/100kJ); no
Reference: JAOAC 67: 985 - 992 (1984).
maximum limit.
GUL
120µg/100kcal
(29µg/100kJ).
Footnote:
“adjustment may
be needed in these
levels for IF made
in regions with a
high content of
copper in the
water supply".
Zinc Minimum AOAC 985.35 Atomic absorption Type II
0.5mg/100kcal spectroscopy Applicable to Ca, Mg, Fe, Zn, Cu, Mn, Na, and K.
(0.12mg/100kJ);
Validated. Interlaboratory study matrices include enteral product, ready-to-
no maximum
feed soy formula, soy powder and whey powder (same matrices as 986.24
limit. GUL
Phosphorus). The results of the interlaboratory study supporting acceptance of
1.5mg/100kcal
the method are presented in the method
(0.36mg/100kJ)
References: JAOAC 68: 514 - 522 (1985)
J. AOAC Int. 80: 834 - 844 (1997).
Zinc Minimum AOAC 984.27 ICP emission Type III
0.5mg/100kcal spectroscopy Validated for infant formula.
(0.12mg/100kJ);
Reference: JAOAC 67: 985 - 992 (1984).
no maximum
limit. GUL
1.5mg/100kcal
 ALINORM 09/32/26, Appendix VI 82

(0.36mg/100kJ)
Choline Note on the form of Choline in CODEX STAN 72.
The standard provides no qualification on the form of choline.
Comment: Free choline is one of a number of salts used as supplement. However a number of bound forms are also present in infant formulas including
added lecithin and endogenous components of milk phospholipid. Units of expression also require definition (eg as choline hydroxide).
Choline Minimum AOAC 999.14 Enzymatic Type II, with limitations on applicability due to choline and ascorbate
7mg/100kcal Colorimetric concentration.
(1.7mg/100kJ); no Method 4. Validated.
maximum limit; 5. The method is applicable to the determination of choline in milk and
GUL infant formula containing 45-175 mg solids/100 g. The method does
50mg/100kcal not apply to powdered infant formula/milk containing more than 100
(12mg/100kJ) mg vitamin C/100 g solids because of ascorbate suppression of color
development. The results of the interlaboratory study supporting
acceptance of the method are included in the method.
6. References: J.AOAC Int. 83: 131 - 138 (2000).
JAOAC 87: 1297-1304 (2004)
Chromium Minimum EN 14082 AAS after dry Type IV
(Section B of 1.5µg/100kcal ashing Foodstuffs. Determination of lead, cadmium, zinc, copper, iron, and
STAN 72 only) (0.4µg/100kJ); no chromium by AAS after dry ashing. Infant formula was not included in the
maximum limit. validation.
GUL
10µg/100kcal
(2.4µg/100kJ)
Chromium Minimum EN 14083 Graphite furnace Type IV.
(Section B of 1.5µg/100kcal AAS after pressure Foodstuffs. Determination of lead, cadmium, chromium and molybdenum by
STAN 72 only) (0.4µg/100kJ); no digestion GF-AAS after pressure digestion. Infant formula was not included in the
maximum limit. validation.
GUL
10µg/100kcal
(2.4µg/100kJ)
Chromium Minimum AOAC 2006.03 ICP emission Type IV
(Section B of 1.5µg/100kcal spectroscopy Arsenic, Cadmium, Cobalt, Chromium, Lead, Molybdenum, Nickel, and
STAN 72 only) (0.4µg/100kJ); no Selenium in Fertilizers (Microwave Digestion and Inductively Coupled
maximum limit. Plasma-Optimal Emission Spectrometry). Infant formula was not included in
GUL the validation.
 ALINORM 09/32/26, Appendix VI 83

10µg/100kcal Reference: J. AOAC Int. 89: 1447 - 1466 (2006).

(2.4µg/100kJ)
Molybdenum Minimum EN 14083 Graphite furnace Type IV
(Section B of 1.5µg/100kcal AAS after pressure Foodstuffs. Determination of lead, cadmium, chromium and molybdenum by
STAN 72 only) (0.4µg/100kJ); no digestion GF-AAS after pressure digestion. Infant formula was not included in the
maximum limit. validation.
GUL
10µg/100kcal
(2.4µg/100kJ)
Molybdenum Minimum AOAC 2006.03 ICP emission Type IV
(Section B of 1.5µg/100kcal spectroscopy Arsenic, Cadmium, Cobalt, Chromium, Lead, Molybdenum, Nickel, and
STAN 72 only) (0.4µg/100kJ); no Selenium in Fertilizers (Microwave Digestion and Inductively Coupled
maximum limit. Plasma-Optimal Emission Spectrometry).
GUL
Reference: J. AOAC Int. 89: 1447 - 1466 (2006).
10µg/100kcal
(2.4µg/100kJ)