OFFICIAL Codex Alimentarius Commission
OFFICIAL Codex Alimentarius Commission
OFFICIAL Codex Alimentarius Commission
CX 5/20.2 CL 2007/43-NFSDU
November 2007
FROM: Secretary,
Codex Alimentarius Commission,
Joint FAO/WHO Food Standards Programme, FAO,
Viale delle Terme di Caracalla,
00153 Rome, Italy
SUBJECT: Distribution of the Report of the 29th Session of the Codex Committee on Nutrition and
Foods for Special Dietary Uses (ALINORM 08/31/26)
1. Draft Revised Codex Standard for Foods for Special Dietary Use for Persons Intolerant to
Gluten (ALINORM 08/31/26 para. 64 and Appendix III)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email 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 April 2008.
2. Draft Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses
Intended for Infants and Young Children (ALINORM 08/31/26, para. 78 and Appendix IV)
Governments and international organizations wishing to comment on the above text should do so in writing,
preferably by email 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 April 2008.
Establishment and Application of Risk Analysis Principles by the Codex Committee on Nutrition and
Foods for Special Dietary Uses (ALINORM 08/31/26 para. 121 and Appendix VI)
Governments and international organizations are invited to comment on the above text and should do so in
writing, preferably by email to the Secretary, Codex Alimentarius Commission, Viale delle Terme di
Caracalla, 00153 Rome, Italy (fax: +39 06 5705 4593, e-mail: codex@fao.org), with a copy to: Dr Rolf
Grossklaus, Director and Professor, Federal Institute for Risk Assessment, P.O. Box 33 00 13, 14191 Berlin,
Germany, Fax: +49 1888 529 – 49 65, e-mail: ccnfsdu@bmelv.bund.de before 1 April 2007;
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1. Guidelines for Use of Nutrition Claims: Draft Table of Contents for Nutrient Contents (Part B
Containing Provisions on Dietary Fibre) (ALINORM 08/31/6, para. 41 and Appendix II)
While considering this matter, the Committee agreed that it was not possible to progress further on the
document at this stage, as it was preferable to allow more time for consultations at the national level, as the
scientific papers had only been available shortly before the meeting. The Committee also agreed to ask
comments as to how the FAO/WHO scientific update applied to the definition proposed for dietary fibre and
its applicability for conditions for claims (for details of consideration see paras 22-41).
Governments and international organizations are invited to comment on the above text and should do so in
writing, preferably by email to: Dr Rolf Grossklaus, Director and Professor, Federal Institute for Risk
Assessment, P.O. Box 33 00 13, 14191 Berlin, Germany, Fax: +49 1888 5 29 – 49 65, e-mail:
ccnfsdu@bmelv.bund.de 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 April 2008;
2. Draft Advisory List of Nutrient Compounds for Use in Foods for Special Dietary Uses Intende
for Infants and Young Children: Part D Advisory List of Food Additives for Special Nutrient Forms:
Provisions on gum arabic (gum acacia) (ALINORM 08/31/26, paras 75-78 and Appendix V)
While considering the level of gum arabic that should be included in the list as there had been no consensus
at the last session on the levels of 10 or 100 mg/kg, the Committee could not come to a conclusion and
agreed to retain the two levels of 10 and 100 mg/kg in square brackets (for details of consideration see paras
75-78).
Governments and international organizations are invited to comment on the above text and should do so in
writing, preferably by email to: Dr Rolf Grossklaus, Director and Professor, Federal Institute for Risk
Assessment, P.O. Box 33 00 13, 14191 Berlin, Germany, Fax: +49 1888 5 29 – 49 65, e-mail:
ccnfsdu@bmelv.bund.de 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 April 2008.
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The 29th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses
reached the following conclusions:
MATTERS FOR FINAL ADOPTION BY THE 31ST SESSION OF THE CODEX ALIMENTARIUS
COMMISSION:
The Committee:
- agreed to forward to the Commission the Draft Revised Codex Standard for Foods for Special
Dietary Use for Persons Intolerant to Gluten for final adoption at Step 8 (ALINORM 08/31/26 para.
64 and Appendix III);
- agreed to forward to the Commission the Draft Advisory List of Nutrient Compounds for Use in
Foods for Special Dietary Uses Intende for Infants and Young Children for final adoption at Step 8
(ALINORM 08/31/26, para. 78 and Appendix IV)
The Committee:
- agreed to forward to the Commission the Establishment and Application of Risk Analysis Principles
by the Codex Committee on Nutrition and Foods for Special Dietary Uses for adoption at Step 5
(ALINORM 08/31/26 para. 121 and Appendix VI).
NEW WORK
The Committee:
- Agreed to ask, through the 61st Session of the Executive Committee, the 31st Session of the
Commission to approve new work on the Revision of Nutrient Reference Values for Labelling
Purposes. The Project Document is attached as Appendix VII (paras 122-133).
The Committee:
- agreed to return the draft Table of Conditions for Nutrient Content (Part B containing provisions on
dietary fibre) to Step 6 and to ask comments in the Circular Letter as to how the FAO/WHO scientific
update applied to the definition proposed for dietary fibre and its applicability for conditions for
claims (paras 22-41);
- agreed to cease the consideration of the Discussion Paper on the Production and Processing
Standards Regarding the Nutritional Quality and Safety of Foods as these matters were already
covered by the General Principles for the Addition of Essential Nutrients to Foods and the Proposed
Draft Risk Analysis Principles Applied by the Committee on Nutrition and Foods for Special Dietary
Uses being elaborated by the Committee (paras 134-140).
- following the established Procedures between General Committees and Commodity Committees, the
Committee noted that the proposed Annex on Food safety assessment of foods derived from
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recombinant-DNA plants modified for nutritional or health benefits was considerably debated by the
Itergovernmental Task Force on Foods derived from Biotechnology and after some discussion agreed
to endorse the text as proposed by the Task Force (paras 16-21).
The Committee noted the clarification of the Secretariat of JECFA regarding the applicability of ADI
concept for infants below 12 weeks of age as presented in CRD 12 and agreed that there was no need
to consider the food additives provisions at the Committee before JECFA and CCFA conclude their
work on remaining food additive issues posed by the 28th Session of the Committee (para.15).
Following the established Procedures between Commodity Committees and General Committees, the
CCNFSDU refers some responses to the questions on several methods in the standard for Infant Formula
and Formulass for Special Medical Purposes Intended for Infants (paras 149-159).
Following the established Procedures between Commodity Committees and General Committees, the
CCNFSDU refers the Section of Food Labelling of the Draft Revised Codex Standard for Foods for
Special Dietary Use for Persons Intolerant to Gluten for endorsement by the CCFL (see paras 59-60
and Appendix III).
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TABLE OF CONTENTS
Paragraphs
INTRODUCTION ..................................................................................................................................................1
METHODS OF ANALYSIS IN THE CODEX STANDARD FOR INFANT FORMULA ................................ 12-13
GUIDELINES FOR THE USE OF NUTRITION CLAIMS: DRAFT TABLE OF CONDITIONS FOR
NUTRIENT CONTENTS (PART B CONTAINING PROVISIONS ON DIETARY FIBRE) AT STEP 7 ....................... 22-41
DRAFT ADVISORY LIST OF NUTRIENT COMPOUNDS FOR USE IN FOODS FOR SPECIAL
DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDREN AT STEP 7 ............................................. 65-78
THE WORK OF THE COMMITTEE ON NUTRITION AND FOODS FOR SPECIAL DIETYARY
DISCUSSION PAPER ON THE PROPOSAL FOR NEW WORK TO AMEND THE CODEX
CEREAL-BASED FOODS FOR UNDERWEIGHT INFANT AND YOUNG CHILDREN .......................... 160-169
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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 CONTAQINING
PROVISIONS ON DIETARY FIBRE ..................................................................................... 47
APPENDIX III DRAFT REVISED STANDARD FOR FOODS FOR SPECIAL DIETARY USE
FOR PERSONS INTOLERANT TO GLUTEN AT STEP 8......................................................... 50
APPENDIX IV ADVISORY LIST OF NUTRIENT COMPOUNDS FOR USE IN FOODS FOR
SPECIAL DIETARY USES INTENDED FOR THE USE OF INFANTS AND
YOUNG CHILDREN .......................................................................................................... 52
APPENDIX V PROPOSEDDRAFT ADVISORY LIST OF NUTRIENT COMPOUNDS FOR
USE IN FOODS FOR SPECIAL DIETARY USES INTENDED INTENDED
FOR INFANTS AND YOUNG CHILDREN ............................................................................ 72
APPENDIX VI PROPOSED DRAFT NUTRITIONAL RISK ANALYSIS PRINCIPLES AND
GUIDELINES FOR APPLICATION TO THE WORK OF THE COMMITTEE
ON NUTRITION AND FOODS FOR SPECIAL DIETARY USES .............................................. 73
APPENDIX VII PROJECT DOCUMENT OF A PROPOSAL FOR NEW WORK TO REVISE
NUTRIENT REFERENCE VALUES OF VITAMINS AND MINERALS
(CAC/GL 2-1985)........................................................................................................... 79
ALINORM 08/31/26 1
INTRODUCTION
1. The Twenty-ninth Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses
(CCNFSDU) was held in Bad-Neuenahr-Ahrweiler, Germany from 12 to 19 November 2007 at the kind
invitation of the Government of Germany. Dr Rolf Grossklaus, Director and Professor of the Federal
Institute for Risk Assessment, Berlin chaired the Session. The Committee was attended by 278 delegates,
observers and advisors representing 71 member countries, one member organization and 26 international
organizations.
OPENING OF THE SESSION
2. Mr Gert Lindemann, State Secretary of the Federal Ministry of Food, Agriculture and Consumer
Protection, Germany welcomed the participants and noted the importance of the work of the Committee in
ensuring the highest standards worldwide to protect the health of consumers, especially infants and children
while ensuring fair practices of food trade. Mr Lindemann pointed out the importance of the Committee’s
work in implementing the WHO Global Strategy on Diet Physical Activity and Health and in such diverse
areas as reducing malnutrition and obesity in countries around the world. While referring to the Provisional
Agenda for this session of the Committee, Mr Lindemann encouraged the delegates to finalize the Draft
Revised Standard for Gluten Free Foods and the Advisory List of Nutrient Compounds for the Use in Foods
for Special Dietary Uses Intended for Infants and Young Children in order to ensure the protection of such
vulnerable populations. Mr Lindemann indicated that it was very important to progress with the work on
Substantiation of Health Claims and on the Application of Risk Analysis Principles by the Committee on
Nutrition and Foods for Special Dietary Uses and decide on the work for Nutrient Reference Values for Food
Labelling Purposes as these items were very important for the protection of consumers from deceptive and
misleading claims and for choosing products on the basis of appropriate information. In conclusion, Mr
Lindemann pointed out the importance of arriving at consensus with the work and wished all success to the
delegates in their important work.
3. Following Rule II.5 of the Rules of Procedure of the Codex Alimentarius Commission the Committee
was informed about CRD 2 on the division of competence between the European Community (EC) and its
Member States and noted that 19 Member States of the EC were present at the current session.
ADOPTION OF THE AGENDA (Agenda Item 1)1
4. The Committee noted the proposal of the delegation of Canada that the delegates might benefit from the
presence of the Chairperson of the Codex Committee on Food Labelling and agreed to consider information
from the Committee on Food Labelling on the consideration of the WHO Global Strategy on Diet, Physical
Activity and Health under Agenda Item 11 “Other Business and Future Work”.
5. The Committee also noted that the Delegation of India had prepared a document (CRD 9) containing the
proposal for new work on the elaboration of a standard for “Processed Cereal Based Foods for Underweight
Infants and Young Children” and agreed to discuss this matter on Agenda Item 11 “Other Business and
Future Work”.
6. The Delegation of Republic of Korea drew the attention of the Committee to the fact that sufficient time
should be allocated to discuss Item 8 in order to have a clear guidance from the Committee regarding further
work on this issue.
7. With these modifications the Committee adopted the Provisional Agenda as the Agenda for the 29th
Session of the Committee.
1
CX/NFSDU 07/26/1; CRD 2 (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; CRD 15
(comments of India).
ALINORM 08/31/26 2
2
CX/NFSDU 07/26/2; CX/NFSDU 07/29/2-Add.1 (matters referred from the Intergovernmental Task Force on
Biotechnology); CRD 3 (information from WHO); CRD 15 (comments of India).
ALINORM 08/31/26 3
Review of Codex Committee structure and mandates of Codex Committees and Task Forces
14. The Delegation of Australia drew the attention of the delegates to the fact that the last session of the
Commission due to time constraints was not able to finalize discussions and provide conclusions on Proposal
No 10 regarding the work of the Committee and encouraged the Executive Committee and the Commission
to finalize this discussion which would provide clear direction for future work to be undertaken by the
CCNFSDU.
Food additives in infant formula
15. The Committee noted the clarification of the Secretariat of JECFA regarding the applicability of ADI
concept for infants below 12 weeks of age as presented in CRD 12 and agreed that there was no need to
consider the food additives provisions at the Committee before JECFA and CCFA conclude their work on
remaining food additive issues posed by the 28th Session of the Committee.
Food safety assessment of foods derived from recombinant-DNA plants modified for nutritional or
health benefits3
16. The Committee recalled that the 7th session of the Codex ad hoc Intergovernmental Task Force invited
the 29th Session of the Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to review
the annex on Food safety assessment of foods derived from recombinant DNA plants modified for nutritional
or health benefits and provide comments if necessary as an annex contained references to certain concepts
related to nutrition.
17. The Chairperson of the Task Force Dr H. Yoshikura briefly introduced this Annex and explained that
while developing it, the Task Force tried to ensure its consistency with other Codex texts developed by the
Committees on Nutrition and Food Labelling by making references to appropriate texts elaborated by the
above Committees and indicated that the wording contained in annex was reached after a careful
consideration.
18. The Delegation of Norway while agreeing in principle with the content of the document proposed to
amend last sentences of paragraphs 14 and 17 for clarification purposes.
19. The Delegation of Thailand drew the attention of the Committee to the fact that in document in the
definition section only the definition of “nutrient” was included, however in the text the “upper level of
intake” and “bioavailability” was used, therefore was of the view that these terms should be also defined. The
Delegation also indicated that “bioavailability” in humans was required for both nutrients and undesirable
substances in the document and was of the view that it would be inappropriate to allow an evaluation of
undesirable substances in humans therefore in vitro or animal studies for them should be allowed.
20. Some delegations pointed out that this annex contained relevant references to the texts elaborated by the
CCNFSDU, therefore proposed to endorse the document without additional changes.
21. The Committee noted that the proposed Annex was considerably debated by the Task Force and after
some discussion agreed to endorse the text as proposed by the Task Force.
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)4
22. The Committee recalled that its last session had agreed to return the Draft Table of Conditions for
Claims (dietary fibre) to Step 6 with a Circular Letter asking comments and additional input on the definition
and other provisions for dietary fibre in the light of the results of the FAO/WHO scientific update of
3
ALINORM 08/31/34, Appendix III.
4
CL 2007/3-NFSDU, CX/NFSDU 07/29/3 (comments of Argentina, Australia, Costa Rica, Dominican Republic,
Guatemala, Japan, Mexico, New Zealand, Philippines, United States of America, INFOODS, AAC, AIDGUM, EDA,
IACST, IADSA, ICBA, ICGMA, IDF, IFAC, IFT, ILSI, IUNS), CX/NFSDU 07/29/3- Add.1 (comments of Brazil),
CRD 1 (Report of the Working Group on the Revision of the Standard for Gluten Free Foods), CRD 3 (comments of
India, Indonesia, Philippines), CRD 13 (comments of CIAA)
ALINORM 08/31/26 4
carbohydrates in human nutrition, including the definition of dietary fibre, which had been presented at the
last session of the Committee.
23. The Representative of WHO informed the Committee that FAO and WHO had agreed to undertake a
scientific update on some of the key issues related to carbohydrates in human nutrition in 2005. This
Scientific Update of existing knowledge and evidence relating to the current recommendations was viewed
as essential in the process leading up to an eventual expert consultation on carbohydrates in human nutrition.
A meeting of the authors of the scientific background papers, together with several other expert peer-
reviewers, was held in July 2006. At this meeting, the experts also reviewed issues related to dietary fibre,
among various other issues, and proposed a definition of dietary fibre.
24. The Representative also informed the Committee about the availability of all the papers prepared for the
Joint FAO/WHO Scientific Update on Carbohydrates in Human Nutrition as a supplement of the European
Journal of Clinical Nutrition (Volume 61, Supplement 1, December 2007), which was also distributed to
Codex Contact Points.
25. The brief rationale used by the experts for defining dietary fibre as "intrinsic plant cell wall
polysaccharides" was provided by the Representative of WHO at the 28th Session of CCNFSDU. However,
the Committee requested additional information regarding the work of the expert group and the issues and
approaches employed by the expert group in reaching the conclusions. Therefore, WHO requested Professor
J. Cummings, as a member of the expert group which undertook the scientific update for FAO and WHO, to
participate and further inform the Committee. This information is presented in paragraphs 27 to 35.
26. Professor Cummings highlighted that the Joint FAO/WHO Scientific Update concerned the whole of
carbohydrates, not just fibre. New evidence of the importance to health regarding glycaemic index and
glycaemic load, sugars in relation to obesity, resistant starch, the concept of whole grains and of prebiotic
oligosaccharides was considered. Most of these encroach upon the traditional area of fibre, and therefore, it
is necessary in considering any definition of fibre to place it in the context of carbohydrates as a whole.
27. The expert group reviewed the classification of carbohydrates, based on their chemistry and dividing
them into sugars, oligosaccharides and polysaccharides. The classification of the 1997 Joint FAO/WHO
Expert Consultation was endorsed by the expert group. For all food components, it was agreed that they
should be defined first by their chemistry. This was felt to be essential for good methods of measurement,
labelling, health claims and enforcement.
28. In this context the definition of fibre was discussed. The importance of fibre to general health was
accepted, in that a high fibre diet based on whole grain foods, fruits and vegetables was well established as
being protective against various chronic diseases, such as diabetes, coronary heart disease and some cancers.
The question of how to characterise fibre continues to present some difficulty. Existing definitions were
considered, including that being proposed by the CCNFSDU. After considerable discussion, the expert group
decided to define fibre as “intrinsic plant cell wall polysaccharides”.
29. A physiological basis for the definition, such as “non digestibility”, was considered inappropriate.
Inclusion of “non digestibility” poses many problems as there is no agreement on the definition of
digestibility and no method to measure nor validate it, without extensive difficult studies in humans.
Digestion of food components in the gut is affected by many factors, such as gut transit time, the nature of
the microflora, history of antibiotic use, other components of the diet and the amount consumed. Food
processing, storage conditions, cooking and physical treatments such as grinding, also affect digestibility.
30. The expert group agreed that a food component should be defined in the first instance by its chemistry,
not its function. The expert group was also unconvinced that the definition should include “properties” of
fibre, such as effects on transit time, fermentation and lipid metabolism. These were not consistent effects of
fibre and were felt to be the province of health claims. Many factors contributed to their control other than
fibre.
31. The inclusion of carbohydrates, such as resistant starch and the prebiotic oligosaccharides in the
definition of fibre was considered to be potentially misleading for the consumer. These carbohydrates, while
having important properties in their own right, cannot be said to confer the benefits of fibre as originally
ALINORM 08/31/26 5
proposed. “There is no good evidence of protection against cardiovascular disease and diabetes when various
oligosaccharides or isolated components of whole-grains, fruits, vegetables and legumes are added to
functional and manufactured foods.”
32. Professor Cummings further provided responses to some of the written comments made on the new
proposed definition as the outcome of the Joint FAO/WHO Scientific Update. One was the issue related to
"intrinsic". There are two reasons for the inclusion of the term “intrinsic” in the proposed new definition.
Firstly the Institute of Medicine of the USA makes the distinction between intrinsic and other types of fibre,
which the expert group found to be a reasonable concept. Secondly, as stated already, there is no evidence
that diets high in resistant starch, isolated and purified cell wall material, plant gums and oligosaccharides
confer the health benefits traditionally ascribed to fibre.
33. To the question regarding the exclusion of lignin, Prof Cummings clarified that lignin was not included
in the proposed definition because true lignin is very difficult to measure. What is normally reported as lignin
in the fibre method is Klasson lignin, which is an impure mixture of often unidentified substances. If true
lignin is found to be important to health, it should be measured separately.
34. Finally, the Committee was urged to take a broader view of carbohydrates, into which a definition of
fibre can be fitted. The newly discovered properties of the carbohydrate components of the diet can only be
exploited by the food industry with benefit to the consumer if these are defined and measured separately.
Fibre represents a unique component that does not encroach on the other clearly defined classes of
carbohydrates.
35. The Chair invited the Committee to provide general comments or questions on the scientific update and
to consider whether the discussion on the Draft Table should be deferred until the next session in order to
allow delegates to consider carefully the provisions for dietary fibre in the light of the scientific update.
36. The Committee had an opportunity to ask questions regarding the scientific update and considered in
particular the following questions: the difference between intrinsic and other fibre; the substances which
were not included in the definition of fibre, such as resistant starch; and analytical issues.
37. As regards the non-inclusion of resistant starch in the definition of fibre, Prof Cummings noted that there
was always a possibility of declaring the presence of resistant starch as a health claim if adequate scientific
justification existed. Other added nutrients could also be declared in the list of ingredients or as part of
nutrition labelling.
38. The Delegation of the EC pointed out that the purpose of the Table of Conditions was to define
nutritional claims. Therefore, some clarification was needed as to how the scientific update could affect the
definition of fibre in this context.
39. The Observer from IUNS drew the attention of the Committee to the problems related to methodology
and indicated that IUNS was currently working with IUPAC on the analytical methodology for the
determination of fibre and that this work would be completed in 2008.
40. Several delegations expressed the view that they would need more time to consider the results of the
scientific update. The Committee agreed that it was not possible at this stage to progress further on the
document, as it was preferable to allow more time for consultations at the national level, as the scientific
papers had only been available shortly before the meeting. It was noted that if the document was retained at
Step 7 no comments would be requested and several delegations indicated that they would prefer to submit
comments. After some discussion, the Committee agreed to return the current document to Step 6 and to ask
comments in the Circular Letter as to how the FAO/WHO scientific update applied to the definition proposed
for dietary fibre and its applicability for conditions for claims.
Status of the Guidelines for the Use of Nutrition Claims: Draft Table of Conditions for Nutrient
Contents (Part B Containing Provisions on Dietary Fibre)
41. The Committee agreed to return the Draft Table (Provisions on Dietary Fibre) to Step 6 for further
comments and consideration at the next session (see Appendix II).
ALINORM 08/31/26 6
DRAFT REVISED STANDARD FOR GLUTEN-FREE FOODS AT STEP 7 (Agenda Item 4)5
42. The Committee recalled that at its 28th session it had agreed to return the Draft Revised Standard for
Gluten-Free Foods to Step 6 for further comments and that a physical working group chaired by Sweden and
co-chaired by Canada would meet before the current Session of the Committee to review the comments
received and to prepare proposals in order to assist the Plenary in finalizing the Standard.
43. The Co-chairs from Sweden and Canada introduced CRD 1 and explained all changes that were
proposed in the title and other sections of the Standard, which was presented in Appendix to the CRD 1.
44. The Committee expressed its appreciation to the Working Group for their excellent work and decided to
consider the Standard based on the document prepared by the Working Group and presented in the Appendix
to CRD 1. The Committee agreed to concentrate discussion only on those sections comments were received
and square brackets existed. In addition to editorial and formatting corrections the Committee made the
following changes and recommendations on the following sections.
Title
45. The Committee agreed to rename the title to Standard for Foods for Special Dietary Use for Persons
Intolerant to Gluten.
Scope
46. After some discussion, the Committee accepted the second option for the scope proposed by the Working
Group. It also clarified in the second paragraph that foods were for “general” rather than “normal”
consumption and that foods that by their nature were “gluten-free” could also be represented for use by
persons intolerant to gluten.
Section 2.1.1 Gluten-free foods and Section 2.1.2 Foods specially processed to reduce gluten content to
levels above 20 up to 100 mg/kg
47. The Committee had a lengthy discussion regarding the definition for gluten-free foods described in this
section and how to address labelling issues related to gluten-free foods and foods specially processed to
reduce gluten.
48. A number of delegations were of the view that the term “gluten-free” sho uld be reserved only for
products that contain not more than 20 mg gluten per kg as sold or distributed to consumers or products
gluten-free by nature containing no more than 20 mg gluten per kg and preferred to have only this group of
products in the standard and pointed out that the Committee should help celiac patients to reduce the amount
of gluten in their diet as low as possible.
49. A number of other delegations preferred to have two groups of foods: one for gluten free foods with a
level not exceeding 20 mg/kg and another for products such as specially processed wheat starch based
products with reduced gluten content above 20 to at a level of 100 mg/kg. They drew the attention of the
Committee to the fact that products containing those levels of gluten were on the market and had been used
as gluten free foods for a long time without any negative consequence and that the removal of these products
would limit consumers’ choice for their diets.
50. Some delegations indicated that there was significant variation in the sensitivity to gluten among celiac
patients and not all countries have those products on their markets. However, it was important to convey a
message to consumers about the true nature of the products.
51. The Committee noted that this matter was also discussed at length at the Working Group which, as a
compromise solution, inserted a footnote that starch at levels above 20mg gluten per kg could not be labelled
as “gluten free” but can be as ingredient in a gluten-free product provided that the final product contained
5
ALINORM 07/30/26, Appendix IV; CX/NFSDU 07/29/4 (comments from Argentina, Australia, Canada, Costa Rica,
Guatemala, Mexico, United States of America, AAC, ISDI, IWGA, WGPAT); CX/NFSDU 07/29/4-Add.1 (comments
from Brazil, AOECS); CX/NFSDU 07/29/4-Add.2 (comments from Cuba, Ghana); CRD 1 (Report of the Working
Group); CRD 4 (comments from India, Philippines); CRD 11 (comments from AAC); CRD 16 (comments from South
Africa).
ALINORM 08/31/26 7
lesson more than 20 mg gluten per kg. The Committee inserted Section 2.1.2 for foods with gluten content
above 20 mg/km to 100 mg/kg.
52. After some discussion, the Committee agreed that matters presented in the Description Section regarding
gluten free foods and other foods with reduced gluten content should be addressed in conjunction with
Section 4 on Labelling.
53. The Committee made some amendments to sections 2.1.1 a) and b) and 2.1.2 for clarification purposes
and clarified a footnote regarding the tolerance to oats. The Committee agreed to specify that the allowance
of oats that are not contaminated with wheat, rye or barley in foods covered by the standard may be
determined at national level.
54. The Committee noted that the terms “very low gluten foods” or “low gluten foods’ or ‘gluten-reduced
foods” presented in the title and text of Section 2.1.2 might create confusion among consumers in different
countries and after some discussion decided to rename this section to Foods Specially Processed to Reduce
Gluten Content to level above 20 up to 100 mg/kg with consequential amendments in the text to that effect.
The Committee also made some editorial amendments to the first paragraph of this section and deleted the
square brackets around the level of 100 mg/kg.
55. The Committee agreed to insert the provision that decisions on marketing of products described in this
section may be determined at national level.
56. The Delegation of Spain expressed their reservation on the decision to include Section 2.1.2 defining
products from 20 to 100 mg gluten per kg.
57. In view of these changes, the Committee agreed to delete a footnote 2 from section 2.1.1 b) containing
provisions for starch at levels above 20 to 100 mg gluten per kg as this was already covered by Section 2.1.2.
Section 3 Essential composition and quality factors
58. The Committee agreed to delete the square brackets around 100mg/kg in section 3.2 in view of its
decision on section 2.1.2.
Section 4 Labelling
59. In section 4.1, the Committee clarified that the use of term “gluten-free” was for products described in
Section 2.1.1.
60. Different proposals were put forward for section 4.2 in order to describe how foods processed to reduce
gluten content to a level above 20 up to 100 mg/kg should be labelled. After some discussion the Committee
agreed to use the second option of section 4.2 proposed by the working group with the addition of
clarification that labeling of products described in Section 2.1.2 may be determined at the national level and
that these products must not be called “gluten-free” and that labelling terms for such products should indicate
the true nature of the food.
Section 5 Methods of analysis and sampling
61. The Committee agreed to the proposal of the Observer from WGPAT to rearrange section 5.1 for clarity
and in order to provide more logic for the text and clarified that for qualitative analysis the presence of gluten
shall be based on relevant methods e.g. ELISA or DNA.
62. The Committee agreed to emphasize that methods should be validated against a certified reference
material and clarified that the detection limit should be at 10 mg gluten per kg or below. The Committee also
deleted the reference to “traceability” and “internationally accepted standards” in the second paragraph.
63. To the concern expressed by the Delegation of Canada that the ELISA R5 Mendez method does not meet
the definition of a Type I method and the request to ask the Committee on Methods of Analysis and
Sampling to reconsider the status of this method, the Secretariat clarified that this matter had been
substantively considered by the CCMAS at its 26th and 27th sessions and that the Committee came to a
conclusion that a Type I should be allocated to this method. The Secretariat also recalled that new methods
ALINORM 08/31/26 8
could be proposed as they are available and meet criteria presented in Codex Procedural Manual, considered
by the Committee and forwarded to the CCMAS for endorsement.
Status of the draft revised Standard for Gluten-Free Foods
64. The Committee agreed to forward the renamed draft revised Standard for Foods for Special Dietary Uses
for Persons Intolerant to Gluten to the 31st Session of the Commission for final adoption at Step 8 (see
Appendix III).
DRAFT ADVISORY LIST OF NUTRIENTS COMPOUNDS FOR USE IN FOODS FOR SPECIAL
DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDREN AT STEP 7 (Agenda Item
5)6
65. The Committee recalled that the Draft Advisory List had been adopted at Step 5 by the 29th Session of
the Commission and circulated for comments at Step 6. The Committee considered the text section by
section and made the following amendments and comments.
66. The Committee agreed with the proposal of the Delegation of the United States to add a new section on
optional ingredients, as Codex standards on foods for infants and young children do not identify all optional
ingredients. It was agreed that optional ingredients should met the criteria specified in section 2.1, and the
provisions in relevant Codex standards.
67. The Delegation of Mexico expressed the view that Hydrogen reduced iron had a low bioavailabilty and
therefore should not be included in the advisory list. The Committee however retained this substance, noting
that it was of an advisory nature and that countries could select the nutrient source that was most suitable at
the national level.
68. The Delegation of India, referring to its written comments, proposed to include Sodium Iron EDTA as a
source of iron. The Committee agreed that in order to consider the inclusion of additional substances,
relevant data should be provided in accordance with the criteria set out in section 2.1.
69. Some editorial corrections were made throughout the text, including the references to the use of some
substances in Codex standards and to the relevant Pharmacopoeia.
70. It was clarified in footnote 7 that the last column referred to foods for special medical purposes other
than infant formula, as infant formula for special medical purposes intended for infants were included in a
specific column.
71. In section 4. Sources of Sodium, the references to the use of sodium sulphate in Codex Standards were
corrected. The Committee agreed with the proposal of the Delegation of the EC to delete Sodium Tartrate
due to the possibility of exceeding the ADI and the contribution to sodium intake resulting from its use.
72. Following some discussion, the Committee clarified that in section 10. Folic Acid, Calcium-L-methyl
folate was suitable only in foods for special medical purposes and section B of the Standard for Infant
Formula.
73. In Part C, the Committee agreed to include Calcium-L-methyl pholate in Part B on the basis of available
purity requirements and to delete 4.6 Lecithin as it is an additive. In section 6. Nucleotides, the square
brackets were deleted and all substances listed were retained.
74. The Committee agreed to delete the entire section listing the substances that lack official purity
requirements as no additional information had been provided on these substances.
75. In Part D. Advisory List of the Committee recalled that the Committee on Food Additives had endorsed
the additives in Part B with some amendments. The Committee discussed the level of gum arabic that should
be included in the list as there had been no consensus at the last session on the levels of 10 or 100 mg/kg.
6
ALINORM 07/29/26, Appendix V, CL CX/NFSDU 07/29/05 (comments of Brazil, Costa Rica, Cuba, Dominican
Republic, Ghana. Guatemala, United States), CRD 5 (comments of European Community, India, Indonesia, Philippines)
ALINORM 08/31/26 9
76. The Delegation of the European Community expressed the view that the level of gum arabic should be
10 mg/kg as there was no justification for a higher level. The Delegation of the United States pointed out that
the level in the current Advisory List was 100 mg/kg and that it should be retained as no new information
had been provided to justify a lower level. The Observer from AIDGUM supported this position and
proposed to provide additional information on technological justification why higher levels should be used.
77. The Committee could not come to a conclusion and agreed to retain the two levels of 10 and 100 mg/kg
in square brackets for further consideration. However, it was agreed that this should not delay the progress of
the Draft Revised Advisory List as all other issues had been addressed, including the other additives in part
D.
Status of the Draft Advisory List of Nutrients Compounds for Use in Foods for Special Dietary Uses
Intended for Infants and Young Children
78. The Committee agreed to advance the Draft Advisory List to Step 8 for adoption by the 31st Session of
the Codex Alimentarius Commission (See Appendix IV), with the exception of the level of gum Arabic in
Part D, which was returned to Step 6 for further comments and consideration at the next session (see
Appendix V).
PROPOSED DRAFT RECOMMENDATIONS ON THE SCIENTIFIC BASIS OF HEALTH
CLAIMS AT STEP 4 (Agenda Item 6)7
79. The Committee recalled that its 28th session had not been able to consider this item in detail due to time
constraints and had agreed to retain the Proposed Draft Recommendations at Step 4 for consideration at its
next session.
80. The Delegation of France recalled the background of the development of the recommendations and noted
that the text had been redrafted for the last session in the light of the comments received and the guidance
provided by the Committee at previous sessions. The Delegation stressed the importance of the nature of
scientific evidence as addressed in section 4 and noted that special cases were addressed separately. Some
issues remained to be clarified, such as the scope, since the Committee had taken different views at different
sessions as to whether claims should refer to total diets. The question of reevaluation of health claims also
required further consideration as two approaches were possible: reevaluation on a regular basis or only when
new substantial scientific evidence became available.
81. The Committee expressed its thanks to the Delegation of France and the drafting group for their excellent
work on complex issues and had a general discussion on the main sections in the document.
Preamble
82. The Committee agreed that the Proposed Draft Recommendations, when finalized would be included as
an Annex in the Guidelines for Use of Nutrition and Health Claims. The Committee therefore agreed to
delete the Preamble as no additional reference to other Codex texts would be required as the
recommendations would be part of the Guidelines.
Scope
83. The Delegation of India, referring to its written comments, proposed to add new provisions concerning
the application of health claims under various circumstances. The Committee however agreed that the
purpose of the Recommendations was to define the scientific basis of health claims and that other issues
concerning health claims were addressed in the adopted Guidelines, which were not under consideration.
84. The Committee discussed the need to include additional food safety considerations. After some
discussion, it was agreed to retain the current paragraph on food safety with an editorial amendment for
clarification purposes.
7
CX/NFSDU 07/29/6 (previously CX/NFSDU 06/28/7) CX/NFSDU 27/29/6-Add.1 (comments of Argentina, Australia,
Bolivia, Brazil, Guatemala, Kenya, New Zealand, United States, CIAA, IASDA, ISDI, WSRO), CRD 6 (comments of
Australia, Cuba, European Community, India, Indonesia, Malaysia, Philippines, United States)
ALINORM 08/31/26 10
Definition
85. It was proposed to delete this section as the Guidelines for Use of Nutrition and Health Claims did not
refer to properties in the definition of health claims and this would ensure consistency of the Annex with the
Guidelines.
86. Some delegations pointed out that biologically active substances were not defined and should not be
included in the definition. The Committee agreed that this term should be replaced by “related substances or
components”.
87. It was also agreed to replace “whole diets” with “categories of foods” as claims on whole diets were
excluded.
88. The Delegation of France pointed out that this definition has been inserted in order to cope with the
inclusion of whole diet in the Scope of the Recommendations and this might no longer be required.
89. The Delegation of the United States suggested that the phrase “properties of food" be replaced by the
language of the Guidelines for Use of Nutrition and Health Claims “food or food constituent” throughout the
text.
Evaluation of Scientific Evidence
90. The Delegation of the United States expressed the view that there should be a more detailed description
of the clinical studies used as a basis for the substantiation of health claims, and proposed additional text to
this effect The Delegation therefore proposed to add new text in section 4.1 in order to describe the
requirements for these studies more precisely. The Delegation of Malaysia proposed to include a reference to
epidemiological studies in paragraph 4.1.
91. Some observers expressed the view that it was not always possible to substantiate health claims on the
basis of well designed clinical trials. They were concerned that it might not be feasible and practical to base
all health claims on evidence from human studies, especially as many original health claims were based on
observational studies and epidemiological research. Some observers also pointed out that some common
claims, for example for groups of foods such as vegetables, would be excluded by such provisions.
92. After some discussion, the Committee recognized that it was not possible to complete the review of the
text section by section in view of the issues raised in the discussion and considered how to proceed further.
93. The Delegation of the United States proposed to reorganize the document in order to follow the steps for
the substantiation of health claims, and to include the following in Section 4. Evaluation of Scientific
Evidence: 4.1 Nature, quality and scope of the evidence; 4.2 Evaluation of the total body of relevant
evidence; and 4.3 Special cases.
94. The Delegation of France recalled that the current structure was the outcome of responses to a circular
letter and that a specific section was necessary to define the level of scientific evidence, while expressing
some concern that this might be lost if the document was reorganized. The Delegation pointed out that while
further development of the Section “Step-by-Step Process” might provide more useful information, the main
issue to be addressed was the standard of evidence required to substantiate claims and sought the guidance of
the Committee in order to proceed with the document.
95. The Delegation of Australia expressed the view that the structure of the document should correspond to
the different types of health claims described in the Guidelines for Use of Nutrition and Health Claims and
that the presentation of scientific evidence for substantiation could be also significantly different according to
the type of claim concerned.
96. The Committee could not come to a conclusion on the provisions for scientific evidence or the
reorganization of the text at this stage and agreed that an electronic working group led by France with the
assistance of interested delegations working in English only would revise the document in the light of the
comments received.
ALINORM 08/31/26 11
Status of the Proposed Draft Recommendations on the Scientific Basis of Health Claims
97. The Committee agreed to return the Proposed Draft Recommendations to Step 2/3 for redrafting by the
electronic working group led by France, comments and consideration at the next session.
PROPOSED 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 4 (Agenda Item 7)8
98. The Committee recalled that a new work proposal on the Establishment and Application of Nutritional
Risk Analysis Principles was approved by the 30th Session of the Commission.
99. The Delegation of Australia introduced the document and explained the structure and the content of the
document. The Delegation indicated that the main definitions were taken from the Codex Procedural Manual
and that two options for the title were proposed. The Delegation pointed out that the purpose of the document
was intended for the application in the framework of the Codex rather than by governments.
100. The Committee expressed appreciation to the Delegation of Australia for the very high quality of
their document.
General Comments
101. The Delegation of Malaysia drew the attention of the Committee to the need for a use of consistent
language in various examples and pointed out that not all saturated fatty acids have the same physiological
effect.
102. The Representative of FAO indicated that WHO/FAO should be the primary if not only source of
scientific advice to CCNFSDU, and that international expert groups might not provide independent and
unbiased scientific advice. FAO and WHO are committed, if requested by CCNFSDU, to hold expert
meetings and consultations on the topics requested and to publish reports in a timely manner. For global risk
assessment only international nutritional reference standards, but not regional or national ones should be
used. For international nutritional risk assessment international databases on food consumption and food
composition will have to be developed. For food safety, e.g. JECFA, the GEMS/food 13 cluster diets are
used for exposure assessment, which might not be appropriate for nutritional risk assessment.
103. In response to the clarification requested by the Delegation of the United States of America
regarding the need for a FAO/WHO expert consultation, the Representative of WHO indicated that the
suggestion was made as the purpose of the draft principles was not clear, whether they were being developed
for internal Codex use or for governments. However, following the explanation by the Delegation of
Australia while introducing the document, it was clear that these principles are being developed for internal
Codex use, but not for the use of the governments. The Representative of WHO explained that for
developing guidance to governments, such as to develop recommendations for an approach to nutritional risk
assessment, it is a standard practice for WHO to have an expert consultation involving external international
experts. The Representative of WHO further noted that WHO is very much aware that Codex Member
States are increasingly expressing the need for strengthening the role of FAO and WHO in providing timely
scientific advice. WHO is ready to ensure timely provision of scientific advice with timely support from
governments. A good example of this was the 2005 Technical Workshop on Nutrient Risk Assessment.
With support from governments, FAO and WHO were able to deliver scientific advice in time. This issue
should also be seen in the light of the development of the Global Initiative for Food related Scientific Advice
(GIFSA) which will support the scientific work of FAO/WHO expert bodies, including various expert
consultations and meetings related to nutrition.
104. The Committee considered the document section by section and in addition to editorial corrections
made the following comments and changes.
8
CX/NFSDU 07/29/7; CX/NFSDU 07/29/7 - Add.1 (comments from the United States, WSRO); CX/NFSDU 07/29/7
Add.2 (comments from Mexico); CRD 7(comments from the European Community, Indonesia and Philippines)
ALINORM 08/31/26 12
Title
105. The Committee agreed to clarify the title to read “Nutritional Risk Analysis Principles and
Guidelines for Application to the Work of the Committee on Nutrition and Foods for Special Dietary Uses”
as it better addressed the content of the document, and it was consistent with titles of documents elaborated
by other Codex Committees on this matter.
Section 1. Background
106. The Representative of WHO requested a clarification or adding some wording in the second
paragraph of the text to ensure that the joint FAO/WHO expert consultations referred to in the document are
those requested by the CCNFSDU, but not all FAO/WHO expert consultations, as many of the joint
FAO/WHO expert consultations are not only for Codex, but for developing guidelines and recommendations
for the governments, including those on human nutrient requirements, fortification guidelines,
supplementation guidelines.
Section 2. Introduction
107. The Committee noted that it was not clear what the term “attendant” meant in relation to risk,
therefore agreed to delete “attendant” in paragraph 3.
108. The Committee agreed to change “nutritional principles” to “nutritional risk analysis principles” in
paragraph 4 and throughout the document.
109. The Committee agreed that the “favorable impact on health” should be changed to “nutritional or
physiological effect” and placed it in square brackets in footnote 2 to better describe the potential impact of a
related substance.
Section 3. Scope and Application
110. The Committed agreed to combine paragraphs 9 and 10 by deleting the reference to examples in the
first and second bullet of paragraph 9 and combined the first and second bullets of paragraph 10 and moved it
as the third bullet in paragraph 9, and put this bullet in square brackets for further comments and
consideration.
111. The second bullet of old paragraph 12 was amended by deleting “potentially eligible ” and clarifying
that formulating general principles for assessing and managing risk related to food not only to health claims
but also to nutrition claims.
112. Paragraph 13 was deleted as it covered issues that were not related to nutritional risk analysis.
Section IV Definitions
113. The Delegation of the European Community requested clarification regarding the status of the
definitions as presented, indicating that some of these may need to be revised by the Committee to reflect
more clearly nutritional risk assessment.
Section 5. Principles for Nutritional Risk Analysis
114. The Committee deleted the paragraph 16 because Section 1 already covered it.
115. The Committee agreed to combine paragraph 31 and 32 by deleting the first sentence of paragraph
31 and move the second sentence to the end of paragraph 32 and put this sentence into square brackets. The
Delegation of Mexico proposed to add “stability” after “availability” in paragraph 31.
116. The Committee agreed to delete paragraph 33 as nutritional risk analysis was not in the terms of
reference of JECFA.
117. The Committee agreed to consider a new paragraph as proposed by the Delegation of European
Community in CRD 7 clarifying that nutritional risk management decisions should take into account food
habits of different consumers and put this paragraph in square brackets for further comments and
consideration.
ALINORM 08/31/26 13
9
CX/NFSDU 07/29/8; CRD 8 (comments from European Community, Indonesia, Philippines, IADSA); CRD 14
(Project Document for New Work to Revise Nutrient Reference Values for Vitamins and Minerals prepared by
Republic of Korea); CRD 16 (comments from South Africa).
ALINORM 08/31/26 14
128. The Committee agreed that the scope of the document should be limited to vitamins and minerals
and that the use of NRVs should be limited to food labeling purposes.
129. The Committee noted that it would be very difficult to progress on the elaboration of two sets of
principles and NRVs for adult population and for infants young children at the same time and agreed that this
work would involve a process to develop the general principles for the establishment of NRVs for the general
population as a first step. The Committee agreed that the next step would be a process to review all available
reference values and their scientific basis by the principles agreed upon and, if appropriate, update and
extend the current list of vitamin and mineral NRVs in the Guidelines for Nutrition Labelling. Once the
above was completed, the Committee would establish vitamin and mineral NRVs for labeling for individuals
6 months to 36 months of age. The Committee then begin to work to establish principles that would apply to
NRVs for this age group, using as a basis the principles identified for NRVs for the general population and
modifying them as appropriate. Once those principles were developed, the NRVs for this age group would
be established. The Committee also agreed to amend the Section 3 on Main Aspects to be covered in the
Project Document presented in CRD 14 to that effect.
130. The Committee considered the need for scientific advice for the development of NRVs for infants
and children and after some discussion agreed to amend Section 7 dealing with the identification of scientific
advice in Project Document that the necessity for FAO/WHO scientific advice would be identified at a later
stage during the elaboration of the document.
131. The Observer of NHF proposed to establish an additional NRV for each nutrient, to represent the
population group with the greatest need for it, however the Committee did not support this proposal.
132. The Committee agreed to request the 31st Session of the Commission to approve new work on the
revision of Nutrient Reference Values of Vitamins and Minerals for Food Labeling Purposes. Project
Document for this work is attached to this report as Appendix
133. The Committee agreed that the Delegation of Republic of Korea with assistance of other interested
parties would prepare a revised document, taking into account decisions taken by this session of the
Committee, which would be sent for comments and subsequent consideration by the next session of the
Committee.
DISCUSSION PAPER ON THE PRODUCTION AND PROCESSING STANDARDS REGARDING
THE NUTRITIONAL QUALITY AND SAFETY OF FOODS (Agenda Item 9)10
134. The Committee recalled that at its last session it had agreed that the delegation of Canada would
prepare a document providing more explanations on the development of such guidelines, for consideration at
the current session.
135. The Delegation of Canada introduced the document and recalled that the WHO/FAO Draft Action
Plan for the Implementation of the Global Strategy on Diet, Physical Activity and Health in Action 5, para.
43 addressed to the CCNFSDU stated that the CCNFSDU was to “Review the need for guidelines intended
for governments on the use of sound nutrition principles in the production, processing and formulation of
foods based on population nutrient intake goals of the 2002 Expert Consultation, taking into account
advances in nutrition sciences during the past decade and the General principles for the Addition of Essential
Nutrients to Foods”. The Draft Action Plan stated that such guidelines could assist in the development of
foods suitable for inclusion in diets aimed at reducing risk of chronic diseases e.g. when reducing or
eliminating trans fats in foods, such guidelines could provide advice on more healthful alternatives.
136. The Delegation recalled that the Guidelines for Use by Codex Committees on the Inclusion of
provisions on Nutritional Quality in Food Standards and other Codex Texts developed by the Committee
were adopted by the Commission in 1987 and were included in the CAC Procedural Manual. The major
focus of the Guidelines was on addition of essential nutrients and restoration of nutrient losses in foods. The
Committee started a revision of these guidelines in 1992 in order to address concerns over excessive intakes
of fat, sugars and sodium and inadequate intakes of fibre. Canada had lead on the revision at that time,
10
CX/NFSDU 07/29/9.
ALINORM 08/31/26 15
however the work on the revision was discontinued and the guidelines were withdrawn from the Procedural
Manual in 1997 after the Committee on General Principles and the Executive Committee of the Codex
Alimentarius Commission recognized that many definitions and objectives of the Guidelines were already
covered by the General Principles for the Addition of Essential Nutrients to Foods and that advice on
nutrition policy was outside the mandate of the Committee.
137. The Delegation emphasized that food standards should promote and not impede the development of
foods that are consistent with the Global Strategy. Food standards can clearly address several of the
recommendations for diet in the Global Strategy such as limit energy intake from total fats and shift fat
consumption away from saturated fats to unsaturated fats and towards elimination of trans-fatty acids, limit
intake of free sugars and limit salt (sodium) consumption from all sources and ensure that salt is iodized. The
Delegation therefore was of the view that guidance in the production, processing and formulation of foods
that would address the above recommendations would be useful for consideration both by Codex
Committees and national authorities. Canada pointed out however, that the Committee in deciding how to
proceed on this item, should also consider current and proposed work such as the Draft Nutritional Risk
Analysis Principles and Guidelines for Application by the Committee on Nutrition and the proposed work on
to revise the General Principles for the Addition of Essential Nutrients to Foods and the work of the Codex
Committee on Food Labelling on Modified Standardized Common Names.
138. The Delegation of the European Community while complimenting Canada for their work on the
Discussion Paper indicated that advice on nutrition policy was outside the mandate of the Committee and
that many definitions and objectives of the guidelines were already covered by the General Principles for the
Addition of Essential Nutrients to Foods and that the revision of the general principles for the addition of
essential nutrients to foods is currently under consideration for new work. The Delegation was of the opinion
that the recently adopted guidelines on nutrition and health claims already took into account specific
recommendations on nutritional quality and safety developed in the context of the WHO Global Strategy on
Diet, Physical Activity and Health and that a draft on the establishment and application of principles for
nutritional risk analysis and a discussion paper on the proposals for additional revised nutrient reference
values for labelling purpose were currently under discussion by the Committee, therefore some of the
specific recommendations of the WHO strategy could be taken into account in the above documents that are
currently under discussion.
139. The Delegation of the United States was of the view that many issues in the Guidelines for Use by
Codex Committees on the Inclusion of provisions on Nutritional Quality in Food Standards were already
covered by the General Principles for Addition of Essential Nutrients to Food and that the Committee would
consider its revision on the following agenda item and that several key issues would be addressed during the
elaboration of the Proposed Draft Nutritional Risk Analysis Principles and Guidelines for Application to the
Work of the CNFSDU.
140. In view of these proposals, the Committee agreed to cease the consideration of the discussion paper
and concluded that the revision of the Guidelines for Use by Codex Committees on the Inclusion of
provisions on Nutritional Quality in Food Standards and other Codex Texts was not necessary.
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 10)11
141. The Delegation of Canada introduced the document and indicated that the General Principles were
adopted in 1987 and since then there were changed approaches or philosophies related to controlling the
addition of vitamin and minerals for foods, changes in technologies employed for achieving addition or
enhancement of vitamin and mineral levels in foods and an increased interest in the addition to foods of non-
nutrient bioactive substances. The Delegation proposed new work to revise the General Principles that
would address three separate issues within the Principles: addition or enhancement of the levels of essential
nutrients to foods by indirect methods, including biofortification; discretionary addition of vitamins and
minerals to food to provide consumers with a greater variety of foods with added vitamin and mineral
11
CX/NFSDU 07/29/10.
ALINORM 08/31/26 16
nutrients, including the need for setting maximum and minimum levels of addition and addition of bioactive
substances that are non essential constituents to foods. The Delegation indicated that the project document
for new work was prepared and presented in CX/NFSDU 07/29/10-Add.1 in line with the terms of reference
and Strategic Objectives of the Commission.
142. The Committee expressed its appreciation to the Delegation of Canada for their work and agreed to
concentrate on general comments.
143. The Delegation of the European Community was of the view that the evolving dietary habits of the
population and technological progress accomplished by industry would justify the update of the General
Principles. However it was of the opinion that at a first stage this update should continue to concentrate on
the issues that are obviously within the scope of the current General Principles, namely the direct addition of
nutrient to foods. The Delegation acknowledged the importance of taking into account issues arising from
biofortification in the overall vitamin intake, but was sceptical about the capability of the CCNFSDU to
tackle all the issues that would be relevant to biofortification in the framework of these general principles.
The Delegation was in favour of the suggestion to introduce the concept of discretional fortification,
allowing the addition of essential nutrients for reasons other than those listed in the current General
Principles.
144. Concerning the addition of bioactive substances, the Delegation considered that, at this stage, the
General Principles should continue to consider as a priority the addition of essential nutrients and that the
inclusion of bioactive substances would render difficult to elaborate common principles.
145. As regards discretional fortification, the Delegation considered that restrictions for discretional
fortification should only be justified on the basis of safety and on the possibility to mislead consumers and
that discretionary fortification should be allowed only with sources evaluated for their safety and
bioavailability. The risk of excessive intake of nutrients could be tackled with the establishments of
maximum amounts for nutrients that could be added to foods and these maximum amounts should be
established taking into consideration in particular the tolerable upper intake levels established by scientific
risk assessment and the intakes from the diet. Periodic nutritional surveys should be envisaged in order to
monitor shifts in dietary habits and/or industrial practices, which would need a revision of such levels.
146. Some other delegations noted the availability of new technologies and were in favour for further
development of the document and emphasize importance of these issues for public health.
147. The Delegation of the United States supporting the concerns expressed by the Delegation of the
European Community, indicated that the document described how principles could be applied to new
technologies and pointed out that the last session of Task Force on Foods Derived from Biotechnology had
noted that the General Principles for the Addition of Essential Nutrients to Foods (CAC/GL 9-1987)
elaborated by this Committee were applicable to foods elaborated by these new technologies. The Delegation
also pointed out that the revision of the General Principles might open many controversial areas on which it
would be very difficult to reach an agreement as there was no common understanding on these issues.
148. The Committee noted that the work on the revision might proceed in areas where it could be possible
to get an agreement and requested the Delegation of Canada to prepare a revised document, narrowing its
scope in the light of the comments provided at the current session. The revised document would then be
considered by the next session of the Committee.
OTHER BUSINESS AND FUTURE WORK (Agenda Item 11):
Methods of Analysis in the revised infant formula Standard12
149. The Committee recalled that the Committee on Methods of Analysis and Sampling had not endorsed
the methods proposed for inclusion in the Standard for Infant Formula and Formulas for Special Medical
Purposes Intended for Infants and had addressed some specific questions on several methods (see Agenda
Item 2).
12
CRD 10 (comment of the United States), CRD 15 (comments of the EC), CRD 17 (proposals from the Working
Group held during the session), CRD 18 (proposed mandate of the electronic working group)
ALINORM 08/31/26 17
150. The Delegation of the United States introduced the report of the working group that had met during
the session and included proposals for reply to the questions from the CCMAS. The Delegation indicated that
it had not been possible to come to a conclusion on all issues and to establish a list of methods as this
required careful review of existing methods and delegations would need to consult with their experts at the
national level. It was therefore proposed to establish an electronic working group to consider all remaining
issues.
151. The Delegation of the European Community, recalling the recommendation of CCMAS to replace
microbiological assays with more modern methods, proposed to forward several methods developed by CEN
for the determination of vitamins for endorsement to CCMAS. The Delegation of the United States indicated
that it had also proposed specific methods for nutrients listed in Section 3.1 in the revised Standard for Infant
Formula . However as there was no consensus on these proposals, the Committee agreed that no specific
methods could be sent for endorsement at this stage.
152. The Committee discussed the terms of reference of the working group proposed in CRD 18, and
especially the possibility of revising other methods for special foods and the need for additional information
in addition to the Principles for the Establishment of Codex Methods of Analysis. The Committee however
agreed that the working group should concentrate on the finalisation of the methods applicable to infant
formula, with the understanding that other methods could be considered at a later stage, and agreed on the
following terms of reference.
153. The electronic working group (EWG) should prepare a list of methods of analysis for infant formulae
to be considered at the 30th Session of the CCNFSDU in 2008. In preparing this list, the EWG should:
• Review methods of analysis for provisions listed in Section 3.1 of the Codex Revised Standard for
Infant Formula and Formulas for Special Medical Purposes Intended for Infants;
• 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;
• The electronic working group, chaired by New Zealand, would be open to all members and
observers, and would work in English.
154. The Committee agreed with the proposal of the Delegation of France to provide some responses to
the questions from CCMAS specified in paragraphs 82-88 of ALINORM 07/30/23, as general agreement
existed on some proposals from the working group listed in CRD 17. After some discussion, the Committee
agreed on the following position.
155. The Delegation of the United States indicated that other responses in CRD 17 contained information
relevant to the CCMAS inquiries and CRD 17 indicates issues have been referred to the electronic working
group.
Paragraphs 82 and 83 (methods for dietary fibre and PER)
156. As Dietary Fibre and PER were not listed in section 3.1 Essential Composition, the Committee did
not recommend including a method for any substance or provision that was not included in section 3.1.
Paragraph 85 (Method for sodium and potassium)
157. The Committee agreed that both the current AOAC method and the ISO 8070IDF 119.2007 method
should be listed.
Paragraph 86 (crude protein)
158. The Committee noted that the AOAC method 991.20 Nitrogen (total) in milk, identical to ISO 8968
1/2IDF 20-1/2: 2001, specifies a nitrogen conversion factor of 6.38. This method can also be used for
analysis of nitrogen in soy infant formulas with the use on an appropriate conversion factor. The Revised
Standard includes a footnote for use of nitrogen conversion factors for calculation of the protein content of
infant formulas. Consistent with that footnote, the Committee proposed the following wording for the use of
nitrogen conversion factor for insertion in the Description column or footnote to the method.
ALINORM 08/31/26 18
”The calculation of the protein content of infant formulas prepared ready for consumption may
be based on N x 6.25, unless a scientific justification is provided for the use of a different
conversion factor for a particular product. The value of 6.38 is generally established as a
specific factor appropriate for conversion of nitrogen to protein in other milk products, and the
value of 5.71 as a specific factor for conversion of nitrogen to protein in other soy products.
159. The Committee agreed that the other questions from the CCMAS would be considered further at the
next session on the basis of the recommendations of the electronic working group.
Proposal for new work to establish a standard for processed cereal-based foods for underweight infant
and young children13
160. The Delegation of India recalled that the 29th session of the Commission had adopted the Revised
Standard for Processed Cereal-Based Foods for Infants and Young Children. India’s comments related to
minimum cereal content, energy density and protein content in the revised Standard. The delegations of India
and Thailand had reserved their position on the decision of the Commission to adopt a revised Standard. The
Commission agreed to request the Committee on Nutrition and Foods for Special Dietary Uses to evaluate
the need for revising sections 3.2, 3.3 and 3.4 of the adopted standard.
161. The Delegation drew the attention of the Committee to the adverse effects of malnutrition especially
in developing countries of the world, causing a high infant, child and maternal mortality. Further
consequences of malnutrition could lead to high level of anemia, low weight gain during pregnancy, acute
infections and chronic diseases. It also significantly affects cognitive development and learning achievements
of children and this puts additional stress on health care expenditures.
162. A vicious intergenerational cycle of malnutrition commences when a child is born with low birth
weight. While malnutrition is caused by multiple problems including poverty, lack of health care and low
consumption of protective foods such as milk, cereals, fruits and vegetables, the delayed and inadequate
complementary feeding is found to be an important reason for the onset of malnutrition among children of 6
months to 2 years.
163. The Delegation indicated that in India about 46% of children in 0 to 3 years of age group are
underweight and about 30% of children born in the country whose birth weight was reported, had low birth
weight. Micronutrient deficiencies are also wide spread and 79% of children between 6 month to 3 years
suffer from anemia. The Delegation indicated that in developing countries 146 million children under 5 years
are underweight. Of these more than a half live in south Asia and 57 million live in India. The Delegation
also emphasized that about 30000 children die each day and most of these children live in developing
countries. Malnutrition contributes to these deaths.
164. The Delegation of India also pointed out that improving nutritional standards, particularly in the
early years, is crucial for achieving the “Millennium Development Goals”, and that priorities must be altered
for reducing child malnutrition by half by 2015. The delegation stated that while multiple strategies are
required for addressing the problems of under nutrition in children, issues of timely and adequate
complementary feeding with appropriate levels of nutritional density foods are very important.
165. The Delegation of India therefore urged the Committee to start working on a separate standard for
Processed Cereal-Based Foods for Underweight Infants and Young Children so that nutritionally and energy
dense composition in the proposed standard will help to reduce the burden of malnutrition in the developing
countries.
166. The Delegation of the EC, while acknowledging the importance of this problem in developing
countries, was of the view that the proposal for this work came in the beginning of the meeting and that it
was not enough time to study this question in detail. The Delegation indicated that a number of issues such
as nature of standard (regional or world-wide) and products concerned should be clarified. The delegation
indicated that more thorough analysis of the problem was needed and proposed to prepare a more structured
project document on this matter for consideration by the next session of the Committee.
13
CRD 9 (prepared by India).
ALINORM 08/31/26 19
167. The Delegation of Australia questioned whether the existing Codex Guidelines on Formulated
Supplementary Foods for Older Infants and Young Children could help to address this problem.
168. Several delegations and observers supported the spirit of the document and volunteered to join India
to develop the revised version of supporting document containing analysis and proposals on how the
Committee could address this issue.
169. The Committee agreed that the Delegation of India with assistance from other interested parties14
working electronically would revise the document in the light of comments at the current session and prepare
a more structured project document for consideration by the next session of the Committee.
Information from the Committee on Food Labelling
170. The Delegation of Canada, speaking as the Chair of the Committee on Food Labelling (CCFL),
informed the Committee of the decisions taken by the CCFL on eight recommendations contained in the
Draft Action Plan from WHO and FAO on the implementation of the WHO Global Strategy on Diet,
Physical Activity and Health as related to labeling. It was also recalled that a physical working group would
be held prior to the next CCFL session to discuss pending issues (ALINORM 07/30/22, paras. 20-64). The
Delegation expressed the view that there was a need to consider what mechanisms were available for inter-
committee communication and cooperation and seek guidance from WHO and FAO as to what were their
roles, responsibilities and obligations in assisting with the implementation of the Global Strategy in relation
to Codex activities.
171. The Chairperson thanked the Delegation of Canada for this information and recalled that the
Committee was also intensifying its work on nutrition issues identified by the Global Strategy, and
welcomed continued cooperation with the CCFL in order to ensure that Codex standards were consistent
with the Global Strategy.
172. The Delegation of the EC expressed the view that the Committee should consider the Action Plan
and for this purpose establish a physical working group prior to the next session in order to consider
additional issues that may arise from the discussions of the Committee on Food labelling, or any other
relevant nutritional issue relevant to the Global Strategy.
173. The Secretariat recalled that the Committee had complied with the request from the Commission
concerning the implementation of the Global Strategy, as it had replied specifically to the proposals from
WHO related to its mandate and was currently considering specific work of direct relevance to the Global
Strategy. There had been no request for consideration of other issues related to the Global Strategy by the
Commission, by other Committees or by any delegation for inclusion in the Agenda prior to the Committee
or as Other Business when adopting the Agenda, as only a presentation of CCFL work for information
purposes had been mentioned. The Secretariat noted that this Committee and the Committee on Food
Labelling regularly exchanged advice and cooperated quite efficiently, as had been the case regarding Global
Strategy issues of common relevance (NRVs). As regards procedures and mechanisms, any matter directed
by any Codex Committee to another was systematically brought to the attention of that Committee under
Matters Referred, while overall coordination regarding work on the Global Strategy was exercised by the
Commission. The Secretariat also recalled that if a working group was established, it should have a clear
mandate in application of the Guidelines for Physical Working Groups.
174. The Delegation of the United States suggested that in order to focus the discussion, a working group
could consider some issues related to current work which is related to the Global Strategy, such as the
extension of NRVs and substantiation of health claims. The Delegation of the European Community
supported this view and also suggested to consider the issues that may be coming from the discussions of the
CCFL or the Commission.
175. The Chairperson pointed out that in order to avoid confusion, it was important to give a clear
mandate if a working group was established, and recalled that important items of work related to the Global
14
Australia, Brazil, Ghana, Guatemala, Indonesia, Republic of Korea, Malaysia, Mexico, South Africa, Thailand, CI,
IBFAN, ISDI and NHF.
ALINORM 08/31/26 20
Strategy were currently under consideration: the scientific basis of health claims and NRVs for labelling
purposes. Discussion of these issues in a working group prior to the session might facilitate progress in the
Plenary Session, as it had been the case with other issues. Several delegations supported the consideration of
health claims and NRVs in a working group.
176. As regards other issues related to the Global Strategy, the Committee noted that it was not possible at
that stage to anticipate if any questions or requests would be referred to the CCNFSDU from either CCFL or
the Commission. The Committee therefore agreed with the proposal of the Delegation of France to insert a
general reference to other matters related to the WHO Global Strategy as this would allow the working group
to consider any relevant matters if required.
177. After some further discussion, the Committee agreed to convene a physical working group prior to
the next session, with the following mandate:
Within the context of the mandate of CCNFSDU, the Working Group is asked to consider:
• Issues of relevance to the implementation of the Global Strategy on Diet, Physical Activity and
Health which are under consideration by CCNFSDU
o NRVs; Health Claims; and
o any other matters related to the WHO Global Strategy
178. The Committee agreed that the physical Working Group, to be held immediately prior to the 30th
Session, would be co-chaired by France and the Republic of Korea and by the United States and that it would
work in English, French and Spanish.
Other Matters
Correction of report of the 28th session of the Committee
179. The Committee noted that the last sentence in paragraph 160 of ALINORM 07/30/26 should be
deleted as the Delegation of Norway had not supported the proposal on the revision of the Standard for
Processed Cereal-Based Foods for Infants and Young Children (Sections 3.2, 3.3 and 3.4) and that this was
not corrected at the adoption of of the report at the last session of the Committee.
DATE AND PLACE OF THE NEXT SESSION (Agenda Item 12)
180. The Committee was informed that its 30th Session would take place in South Africa from 3 to 7
November 2008, subject to confirmation by the host government and the Codex Secretariat. The Committee
thanked the Delegation of South Africa for its kind offer to host the next Session of the Committee.
ALINORM 08/31/26 21
LIST OF PARTICIPANTS
LISTE DES PARTICIPANTS
LISTA DE PARTICIPANTES
CHAIRPERSON/PRESIDENT/PRESIDENTE
Dr Rolf Grossklaus
Director and Professor
Federal Institute for Risk Assessment (BfR)
P.O. Box 33 00 13
14191 Berlin,
Germany
Tel: +49 (1888) 4 12 – 32 30
Fax: +49 (1888) 5 29 – 49 65
E-Mail: ccnfsdu@bmelv.bund.de
Ministério de Agricultura e Desenvolvimento Rural, Av. Paseo Colón 922 Piso 2 Of. 222
E-Mail: lidiamorais43@hotmail.com.br
ALINORM 08/31/26 23
Ms Katrin Woese
Norbert Pahne
Landesamt für Verbraucherschutz Sachsen-Anhalt
Diätverband e.V.
Fachbereich Lebensmittelsicherheit
Godesberger Allee 142-148
Filderhauptstraße 61
61381 Friedrichsdorf
70599 Stuttgart
Germany
Germany
Tel.: +49 6172 991423
E-Mail: srams@bll-online.de
Fax: +49 (228) 30851-50
53115 Bonn
Head, Food Safety Management Unit
Germany
Food and Drugs Board
E-Mail: g.granel@verbaende-jess.de
Ghana
Dr Gert Krabichler
Fax: +233 (21) 660389
Tel.:
Pharmacist
E-Mail: gert.krabichler@pfizer.com
124 Kifisias Av. & 2
Dr Michael Packert
Iatridou Str. Ampelokipi
Südzucker AG
11526 Athens
Gottlieb-Daimler-Str- 12
Greece
68165 Mannheim
Tel.: +30 210697 1554
E-Mail: michael.packert@suedzucker.de
ALINORM 08/31/26 29
Adj. Prof. Hae-Rang Chung MACEDONIA, THE FMR YUG RP / MACÉDONIA L’EX RÈP
Ewha Womans University YOUG / MACEDONIA LA EX REP YUG
Dept. of Nutritional Science Dr Arsim Agushi
11-1 Daehyun-dong, Seodaemun-ku Head of Unit for Quality Insurance
120-750 Seoul Ministry of Health
Korea Food Directorate
Tel.: +82 (2) 886 0243 Str. “50-ta Divizija” Nr 6
Fax: +82 (2) 6008 6878 1000 Skopje
E-Mail: chunghr@empal.com Macedonia
Dr Jung-Ah Byun Tel.: + 389 (2) 3296 430
Science Officer Fax: +389 (2) 3296 823
Daejeon Regional Food & Drug Administration E-Mail: arsimagusi@yahoo.com
120 Seonsa-ro, Seo-Gu
MALAYSIA / MALASIE / MALASIA
302-828 Daejeon
Ms Rokiah Don
Korea
Senior Principal Assitant Director (Nutrition)
Tel.: +82 (42) 480 8786
Family Health Development Division
Fax: +82 (42) 480 8790
Department of Public Health
E-Mail: junga68@kfda.go.kr
Ministry of Health Malaysia
Ms Eunju Lee Level 7, Block E 10, Parcel E
Deputy Director Federal Government Administrative Centre
Nutritional Evaluation Team 62590 Putrajaya
Korea Food and Drug Administration Malaysia
#194 Tongil-Ro, Eunpyeong-Gu Tel.: +60 (3) 8883 4083
122-704 Seoul Fax: +60 (3) 8883 6175
Korea E-Mail: rokiah@moh.gov.my
Tel.: +82 (2) 380 1678
Ms Norrani Eksan
Fax: +82 (2) 359 0867
Senior Principal Assistant Director
E-Mail: Eunju@korea.kr
Food Safety and Quality Division
Miss So Yoon Yun Department of Public Health
Senior Researcher Ministry of Health Malaysia
Korea Food and Drug Administration Level 3, Block E 7, Parcel E
#194 Tongil-Ro, Eunpyeong-Gu Federal Government Administrative Centre
122-704 Seoul 62590 Putrajaya
Korea Malaysia
Tel.: +82 (2) 380 1317 Tel.: +60 (3) 8883 3511
Fax: +82 (2) 359 0025 Fax: +60 (3) 8883 3815
E-Mail: ysy0614@kfda.go.kr E-Mail: norrani@moh.gov.my
LITHUANIA / LITUANIE / LITUANIA Dr Tangavelu Thiagarajan
Ms Indre Chmieliauskaite Regional Manager
Head of Department Malaysian Palm Oil Board
National Nutrition Centre of Ministry of Health 3516 International Court, N.W.
Kalvariju 153 20008 Washington D.C.
LT-08221 Vilnius USA
Lithuania Tel.: +1 (202) 572 9719
Tel:: +370 5277 8919 Fax: +1 (202) 572 9783
Fax: +370 5277 8713 E-Mail: mpobtas@aol.com
E-Mail: indre@rmc.lt
ALINORM 08/31/26 33
MOZAMBIQUE
NIGERIA / NIGÉRIA
Mrs Francisca Barrote Cabral Mr Dennis Onyeagocha
Chief od Information Unit in SETSAN Mozambique Deputy Director
Food Security and Nutrition Secretariat Foods and Drug Services Dept.
Ministerio da Agriculture Federal Ministry of Health
2396 Maputo Federal Secretariat Complex Phase III
Mozambique 900244 Abuja
Tel. : +258 82 3943820 Tel.: +234 (9) 8033 147808
E-Mail : fcabral@setsan.org.mz E-Mail: dennyo_2003@yahoo.com
NETHERLANDS / PAYS BAS / PAÍSES BAJOS Mr Chris Ojembe
Mr Bas Van der Heide Chief Dept. of Food and Drug Services
Senior Policy Officer Federal Ministry of Health
Ministry of Health, Welfare and Sports Federal Secretariat
Nutrition, Health Protection and Prevention Department 900244 Abuja
P.O.Box 20350 Nigeria
2500 EJ The Haque Tel.: +234 (9) 8033 004551
The Netherlands NORWAY / NORVÈGE / NORUEGA
Tel.: +31 (70) 340 5619 Mrs Turid Ose
Fax: +31 (70) 340 5554 Senior Adviser
E-Mail: b.vd.heide@minvws.nl Norwegian Food Safety Authority
Dr Jaap Schrijver P.O.Box 383
2381 Brumunddal
Manager Regulatory Affairs Baby Foods
Norway
Royal Numico N.V.
Tel.: +47 2321 67 42
Schipol Boulevard 105
Fax: +47 2321 68 01
P.O.Box 75538 E-Mail: tuose@mattilsynet.no
1118 ZN Schipol Airport
The Netherlands Dr Linda Granlund
Tel.: +31 (20) 456 9466 Nutrition Manager
Fax: +31 (20) 456 8466 NBL/Mills DA
E-Mail: jaap.schrijver@numico.com Sofienberggata 19, POB 4644 Sofienberg
0506 Oslo
NEW ZEALAND / NOUVELLE-ZÉLANDE / NUEVA ZELANDA
Norway
Ms Jenny Reid
Tel.: + 47 9901 9418
Assistant Dirctor
Fax: +47 2238 2380
New Zealand Food Safety Authority
E-Mail: linda.granlund@mills.no
PO Box 2835
Level 4, Televom Building South Tower Prof Helle Margrete Meltzer
86 Jervais Quay Norwegian Institute of Public Health
6001 Wellington P.Box 4404 Nydalen
New Zealand 0403 Oslo
Tel.: +64 (4) 463 2582 Norway
Fax: +64 (4) 463 2583 Tel.: +47 2204 2337
E-Mail: jenny.reid@nzfsa.govt.nz Fax: +47 2204 2243
E-Mail: heme@fhi.no
Mr David Roberts
Programme Manager (Nutrition) PHILIPPINES / FILIPINAS
New Zealand Food Safety Authority Ms Maria Victoria Pinion
P.O.Box 2835 Nutritionist-Dietitian
Wellington Bureau of Food and Drugs – Department of Health
New Zealand Civic Drive Filinvest Corporate City,
E-Mail: david.roberts@nzfsa.govt.nz Alabang, Muntinlupa City
1770 Muntinlupa
Philippines
Tel.: +63 (2) 8425606
Fax: +63 (2) 8425606
E-Mail: vdpinion@yahoo.com.ph
ALINORM 08/31/26 35
#3 Magdalost.
Advisor
Real Vill. 2
Ministry of Agriculture Rural Development and Fisheries
Project 8
Rua Padre António Vieira, 1
Quezon City
1099-073 Lisbon
Philippines
Portugal
E-Mail: lida.villamor@bms.com
E-Mail: lsalino@gpp-pt
Products
The Portuguese Presidency
Powsinska 61/63
1048 Bruxelles
02903 Warsaw
Belgium
Poland
Tel.: +32 (2) 281 7841
E-Mail: h.kunachowicz@izz.waw.pl
Mrs Pilar Velazquez
Dr Katarzyna Stos
Administrattor
61/63 Powsinska
1048 Bruxelles
02-903 Warsaw
Belgium
Poland
Tel.: +32 (2) 281 6628
E-Mail: k.stos@izz.waw.pl
SERBIA
Prof Janusz Ksiazyk
Prof Ivan Stankovic
Dzieci Polskich 20
Vojvode Stepe 450
04-730 Warsaw
11000 Belgrade
Poland
Serbia
E-Mail: j.ksiazyk@czd.pl
E-Mail : istank@eunet.yu
Senior Technician
Head, Pre-Market Approval Branch
Dr.Ricardo Jorge
5, Maxwell Road
1649-016 Lisbon
069110 Singapore
Portugal
Singapore
E-Mail: dirce.silveira@insa.min-saude.pt
E-Mail: lim_lee_san@ava.gov.sg
ALINORM 08/31/26 36
Center for Food Safety & Applied Nutrition Room 4861 – South Building
USA
Tel.: +1 (202) 205-7760
E-Mail: barbara.schneeman@fda.hhs.gov
Non-Government Advisors
Dr Allison A. Yates Mr Michael Auerbach
Beltsville, MD 20705
Tel.: +1 (800) 255 6837
USA
Fax: +1 (914) 592 1407
E-Mail: allison.yates@ars.usda.gov
Chief Science Officer
Dr Sue A. Anderson
Vice President
Supplements
Atchison, Kansas 66002
USA
Ms Melanie Fairchild-Dzanis
E-Mail: sue.anderson@fda.hhs.gov
800 No Brand Blvd
Ms Nancy T. Crane
Glendale, California 91203,
Supplements
Fax: +1 (818) 549 5704
USA
1120 Connecticut Av. NW, Suite 480
E-Mail: nancy.crane@fda.hhs.gov
Tel.: +1 (202) 775 8277
E-Mail: mhager@eatright.org
ALINORM 08/31/26 39
Dr William C. MacLean
INTERNATIONAL NON-GOVERNMENTAL
Consultant
ORGANIZATIONS
1800 Upper Chelsea Road AAC – ASSOCIATION DES AMIDONNERIES ET CEREALES
Columbus, Ohio 43212 Mr Marcel Feys
USA AAC
Tel.: +1 (614) 486 6170 Avenue des Arts 43
E-Mail: William.maclean@earthlink.net 1040 Brussels
Ms Mardi K. Mountford Belgium
Executive Vice President Tel. : +32 (2) 289 6760
International Formula Council Fax : +32 (2) 513 5592
1100 Johnson Ferry Road, E-Mail : aaf@aaf-eu.org
Suite 300 ASPPG– ASSOCIATION OF THE EUROPEAN SELF
30342 Atlanta, Georgia MEDICATION INDUSTRY
USA Dr Rose Schraitle
Tel.: +1 (404) 252 3663 Association of the European Self-Medication Industry
Fax: +1 (404) 252 0774 7, Avenue de Tervuren
E-Mail: mmountford@kellencompany.com B-1040 Brussels
Charlene J. Rainey Belgium
President Tel.: +32 2735 5130
Food Research, Inc. Fax: +32 2735 5222
575 Anton Boulevard, Suire 300 E-Mail: info@aesgp.be
Costa Mesa, California 92626
AIDGUM
USA
Prof John Lupien
Tel:: +1 (949) 497 6066
via Aventina 30
Fax: +1 (714) 523-2556
00153 Rome
E-Mail: charlierainey@sbcglobal.net
Italy
ZAMBIA / ZAMBIE Tel.: +39 (6) 5725 0042
Mrs Agnes Aongola E-Mail: john@@jrlupien.net
Nutrition Specialist
Mr Gontran Dondain
Ministry of Health HQ
President AIDGUM
Haile Selassie Rd, Ndeke House, Box 32588
129, Chemin de Croisset
10101 Lusaka
BP 4151
Zambia
76723 Rouen Codex 3
Tel.: +260 (1) 253179-82
France
Fax: +260 (1) 253173
Tel.: +33 232 831818
E-Mail: aaongola@yahoo.com
AOECS - ASSOCIATION OF EUROPEAN COELIAC
ZIMBABWE / ZIMBABUE
SOCIETIES
Mr Munyaradzi Livingstone Musiyambiri
Mrs Hertha Deutsch
Chief Government Analyst
Chair of AOECS-WG Codex, Labelling and Symbol
Government Analyst Laboratory
AOECS Association of European Coeliac Societies
Ministry of Health & Child Welfare
Anton Baumgartner Strasse 44/C5/2302
P.O.Box CY 231
1230 Vienna, Austria
Causeway
Tel.: +43 (1) 667 1887
Harare
Fax: +43 (1) 667 1887
Zimbabwe
E-Mail: hertha.deutsch@utanet.at
Tel.: +263 (4) 792026/7 / +263 11 874588
Fax: +263 (4) 708527 CEFS – COMITÉ EUROPÉEN DES FABRICANTS DE SUCRE
E-Mail: musiml@africaonline.co.zw Oscar Ruiz de Imaña
Head of Scientific and Regulatory Affairs
CEFS- Comité Européen des Fabricants de Sucre
Avenue de Tervuren 182
1150 Brussels
Belgium
Tel. : +32 (2) 762 0760
Fax : +32 (2) 771 0026
E-Mail : oscar.ruiz@cefs.org
ALINORM 08/31/26 40
NutritionOfficer
00153 Rome
FAO
Italy
00153 Rome
Fax: +39 (06) 57 05 45 93
Italy
E-Mail: jeronimas.maskeliunas@fao.org
E-Mail: ruth.charrondiere@fao.org
Joint FAO/WHO Food Standards Programme
GERMAN SECRETARIAT
00153 Rome
Mr Georg Müller
Italy
Rochusstraße 1
E-Mail: Selma.Doyran@fao.org
E-Mail: ccnfsdu@bmelv.bund.de
Codex Secretariat
00153 Rome
Italy
Rochusstraße 1
E-Mail: jinjing.zhang@fao.org
E-Mail: ccnfsdu@bmelv.bund.de
Rochusstraße 1
E-Mail: ccnfsdu@bmelv.bund.de
Rochusstraße 1
E-Mail: ccnfsdu@bmelv.bund.de
Mr Peter Braun
Rochusstraße 1
E-Mail: ccnfsdu@bmelv.bund.de
CODEX SECRETARIAT
Dr Jeronimas Maskeliunas
ALINORM 08/31/26, Appendix II page 47
APPENDIX II
*
Serving size [and recommended intake] to be determined at national level.
DEFINITION:
Dietary fibre means carbohydrate polymers1 with a degree of polymerisation (DP) not lower than 3, which
are neither digested nor absorbed in the small intestine. A degree of polymerisation not lower than 3 is
intended to exclude mono- and disaccharides. It is not intended to reflect the average DP of a mixture.
Dietary fibre consists of one or more of:
• Edible carbohydrate polymers naturally occurring in the food as consumed,
• carbohydrate polymers , which have been obtained from food raw material by physical,
enzymatic or chemical means,.
• synthetic carbohydrate polymers.
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 gravimetric
analytical method for dietary fibre analysis : Fractions of lignin and the other compounds (proteic fractions, 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 fraction of fibre. However, when
extracted or even re-introduced into a food containing non digestible polysaccharides, they cannot be defined as dietary
fibre. When combined with polysaccharides, these associated substances may provide additional beneficial effects.
ALINORM 08/31/26, Appendix II page 48
Properties:
Dietary fibre generally has properties such as:
1
As presented in CX/NFSDU 04/3-Add.1.
2
Official Methods of Analysis of AOAC International. 17th edition. Volume II. Horwitz, editor.
ALINORM 08/31/26, Appendix II page 49
All the above methods are approved AOAC techniques. These methods have the advantage of being used
world-wide as well as being easily used in routine analysis.
The AOAC 985.29 and 991.43 are the general methods for measuring ‘total dietary fibre’ in most foods. The
other methods can be used for complementary assessment of other fibre components/fractions not measured
by the general methods due to their solubility in aqueous alcohol or for analysis of certain foods or raw
materials for which the standard methods may be less suitable. The methods for total or soluble+insoluble
dietary fibre give satisfactory results for foods that contain neither added non-digestible oligosaccharides
(e.g. FOS) nor resistant starch3 fractions RS1 and RS2 which are not measured by these AOAC method.
The AOAC 991.43 includes part of the resistant starch fractions (retrograded starches, RS3). Therefore, in
order to include total RS, it is necessary to analyse RS independently and correct for the RS in the fibre
residue.
The Englyst method, which is not used world-wide, is complicated and may therefore be less suitable for
routine analysis. However, this or similar methods may be necessary in some foods difficult to analyse with
the routine methods, e.g. infant formula.
3
Resistant starch (RS) is defined as the fraction of starch not absorbed in the small intestine. It consists of physically
enclosed starch (RS1), certain types of raw starch granules (RS2) and retrograded amylose (RS3). Modified starches
used as food additives may also be partially resistant (RS4).
ALINORM 08/31/26, Appendix III page 50
APPENDIX III
DRAFT REVISED CODEX STANDARD FOR FOODS FOR SPECIAL DIETARY USE FOR
1. SCOPE
1.1 This standard applies to foods for special dietary uses that have been formulated, processed or
prepared to meet the special dietary needs of people intolerant to gluten.
1.2 Foods for general consumption which by their nature are suitable for use by people with gluten
intolerance may indicate such suitability in accordance with the provisions of section 4.3.
2. DESCRIPTION
2.1 Definitions
The products covered by this standard are described as follows:
2.1.1 Gluten-free foods
Gluten-free foods are dietary foods
a) consisting of or made only from one or more ingredients which do not contain wheat (i.e., all Triticum
species, such as durum wheat, spelt, and kamut), rye, barley, oats1 or their crossbred varieties, and the
gluten level does not exceed 20 mg/kg in total, based on the food as sold or distributed to the consumer,
and/or
b) consisting of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat,
spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed
to remove gluten, and the gluten level does not exceed 20 mg/kg in total, based on the food as sold or
2.1.2 Foods specially processed to reduce gluten content to a level above 20 up to 100 mg/kg
These foods consist of one or more ingredients from wheat (i.e., all Triticum species, such as durum wheat,
spelt, and kamut), rye, barley, oats1 or their crossbred varieties, which have been specially processed to
reduce the gluten content to a level above 20 up to 100 mg/kg in total, based on the food as sold or
distributed to the consumer.
Decisions on the marketing of products described in this section may be determined at the national level.
2.2 Subsidiary Definitions
2.2.1 Gluten
For the purpose of this standard, "gluten" is defined as a protein fraction from wheat, rye, barley, oats1 or
their crossbred varieties and derivatives thereof, to which some persons are intolerant and that is insoluble
in water and 0.5M NaCl.
2.2.2 Prolamins
Prolamins are defined as the fraction from gluten that can be extracted by 40 - 70% of ethanol. The
prolamin from wheat is gliadin, from rye is secalin, from barley hordein and from oats1 avenin.
It is however an established custom to speak of gluten sensitivity. The prolamin content of gluten is
generally taken as 50%.
3. ESSENTIAL COMPOSITION AND QUALITY FACTORS
3.1 For products referred to in 2.1.1 a) and b), the gluten content shall not exceed 20 mg/kg in the food as
sold or distributed to the consumer.
1
Oats can be tolerated by most but not all people who are intolerant to gluten. Therefore, the allowance of oats that are
not contaminated with wheat, rye or barley in foods covered by this standard may be determined at the national level.
ALINORM 08/31/26, Appendix III page 51
3.2 For products referred to in 2.1.2 the gluten content shall not exceed 100 mg/kg in the food as sold or
distributed to the consumer.
3.3. Products covered by this standard substituting important basic foods, should supply approximately the
same amount of vitamins and minerals as the original foods they replace.
3.4 The products covered by this standard shall be prepared with special care under Good Manufacturing
Practice (GMP) to avoid contamination with gluten.
4. LABELLING
In addition to the general labelling provisions contained in the General Standard for the Labelling of
Prepackaged Foods (CODEX STAN 1-1985) and the General Standard for the Labelling of and Claims for
Prepackaged Foods for Special Dietary Uses (CODEX STAN 146-1985), and any specific labelling
provisions set out in a Codex standard applying to the particular food concerned, the following provisions
for the labelling of “gluten-free foods” shall apply:
4.1 The term "gluten-free" shall be printed in the immediate proximity of the name of the product in the
case of products described in section 2.1.1.
4.2 The labelling of products described in section 2.1.2 should be determined at the national level.
However these products must not be called gluten-free. The labelling terms for such products should
indicate the true nature of the food, and shall be printed in the immediate proximity of the name of the
product.
4.3 A food which, by its nature, is suitable for use as part of a gluten-free diet, shall not be designated
“special dietary”, “special dietetic” or any other equivalent term. However, such a food may bear a
statement on the label that “this food is by its nature gluten-free” provided that it complies with the
essential composition provisions for gluten-free as set out in section 3.1 and provided that such a statement
does not mislead the consumer. More detailed rules in order to ensure that the consumer is not misled may
be determined at the national level.
5. METHODS OF ANALYSIS AND SAMPLING
5.1 General outline of the methods
• The quantitative determination of gluten in foods and ingredients shall be based on an
immunologic method or other method providing at least equal sensitivity and specificity.
• The antibody used should react with the cereal protein fractions that are toxic for persons
intolerant to gluten and should not cross-react with other cereal proteins or other constituents of
the foods or ingredients.
• Methods used for determination should be validated and calibrated against a certified reference
material,, if available.
• The detection limit has to be appropriate according to the state of the art and the technical
standard. It should be 10 mg gluten/kg or below.
• The qualitative analysis that indicates the presence of gluten shall be based on relevant methods
(e.g. ELISA-based methods, DNA methods).
5.2 Method for determination of gluten
Enzyme-linked Immunoassay (ELISA) R5 Mendez Method.
ALINORM 08/31/26, Appendix IV 52
APPENDIX IV
DRAFT ADVISORY LISTS OF NUTRIENT COMPOUNDS FOR USE IN FOODS FOR SPECIAL
1. PREAMBLE
These lists include nutrient compounds, which may be used for nutritional purposes in foods for special
dietary uses intended for infants and young children in accordance with 1) the criteria and conditions of use
identified below and 2) other criteria for their use stipulated in the respective standards. In addition, the
sources from which the nutrient compound is produced may exclude the use of specific substances where
religious or other specific dietary restrictions apply. As noted in the respective standards, their use may either
be essential or optional.
2.1 Nutrient compounds that are to be added for nutritional purposes to foods for infants and young children
may be included in the Lists only if:
(a) they are shown to be safe and appropriate for the intended use as nutrient sources for infants and
young children
(b) it is demonstrated by appropriate studies in animals and/or humans that the nutrients are biologically
available
(c) the purity requirements of the nutrient compounds conform with the applicable Specifications of
Identity and Purity recommended by the Codex Alimentarius Commission, or in the absence of such
specifications, with another internationally recognised specification. If there is no internationally
recognised specification, national purity requirements that have been evaluated according to or
similar to a FAO/WHO process may be considered
(d) the stability of nutrient compound(s) in the food(s) in which it is (they are) to be used can be
demonstrated
(e) the fulfilment of the above criteria shall be demonstrated by generally accepted scientific criteria.
2.2 Nutrient compounds may be added to the Lists based on the criteria above. Nutrient compounds shall be
deleted from the Lists if they are found no longer to meet the above criteria. If a country proposes to add or
delete a nutrient compound to/from a list, the country should provide information that addresses how the
nutrient compound satisfies/does not satisfy the criteria in Section 2.1.
3. Optional ingredients
The Optional Ingredients sections in Codex standards for foods for infants and young children do not
identify all optional ingredients that may be considered for use in foods for special dietary uses intended for
infants and young children. Optional ingredients added for nutritional purposes to foods for special dietary
uses intended for infants and young children should meet the criteria specified in Section 2.1. They should
also meet the provisions for optional ingredients in the respective Codex standard for foods for infants and
young children.
ALINORM 08/31/26, Appendix IV 53
A: ADVISORY LIST OF MINERAL SALTS AND TRACE ELEMENTS FOR USE IN FOODS FOR
SPECIAL DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDREN
1
CAC = Codex Alimentarius Commission
2
IF Sect. A = Section A of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
3
IF Sect. B = Section B of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
4
FUF = Follow-up Formula
5
PCBF = Processed Cereal Based Food for Infants and Young Children
6
CBF = Canned Baby Food
7
FSMP = Food for Special Medical Purposes other than Infant Formula
ALINORM 08/31/26, Appendix IV 54
1
CAC = Codex Alimentarius Commission
2
IF Sect. A = Section A of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
3
IF Sect. B = Section B of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
4
FUF = Follow-up Formula
5
PCBF = Processed Cereal Based Foods for Infants and Young Children
6
CBF = Canned Baby Food
7
FSMP = Food for Special Medical Purposes other than Infant Formula
ALINORM 08/31/26, Appendix IV 63
3. Vitamin D
6.1 Ph Int, √ √ √ √ √ √
Thiaminchlori FCC, USP,
de Ph Eur, Jap
hydrochloride Food Stan,
DAB
6.2 Thiamin Ph Int, √ √ √ √ √ √
mononitrate FCC, USP,
Ph Eur, Jap
Food Stan,
DAB
7. Vitamin B2
8. Niacin
C: ADVISORY LIST OF AMINO ACIDS AND OTHER NUTRIENTS FOR USE IN FOODS FOR
SPECIAL DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDREN
only for improving the nutritional quality of the protein (when the protein is
e
protein (when the
1.7 L- Histidine
FCC, USP,
√ √
Ph Eur,
DAB
DAB
1
CAC = Codex Alimentarius Commission
2
IF Sect. A = Section A of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
3
IF Sect. B = Section B of the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants
4
FUF = Follow-up Formula
5
PCBF = Processed Cereal Based Foods for Infants and Young Children
6
CBF = Canned Baby Food
7
FSMP = Food for Special Medical Purposes other than Infant Formula
8
As far as applicable, also the free, hydrated and anhydrous forms of amino acids, and the hydrochloride, sodium, and potassium
salts of amino acids may be used for FSMP.
ALINORM 08/31/26, Appendix IV 68
only for improving the nutritional quality of the protein (when the
1.14 L-Lysine FCC, USP, √ √
monohydrochl Ph Eur,
oride DAB
1.15 L-Methionine Ph Int, √ √
4. Choline
For reasons of stability and safe handling, some vitamins and other nutrients have to be converted
into suitable preparations, e.g. gum arabic coated products, dry rubbed preparations. For this
purpose, the food additives included in the respective specific Codex standard may be used. In
addition, the following food additives may be used as nutrient carriers:
Maximum Level in
INS no. Additive/ Carrier Ready-to-use Food for
infants and young
children
(mg/kg)
(a) 551 Silicon dioxide 10
Abbreviations:
BP = British Pharmacopoeia
BPC = British Pharmaceutical Codex
DAB = Deutsches Arzneibuch
DAC = Deutscher Arzneimittel-Codex
DVFA = Danish Veterinary and Food Administration
FCC = Food Chemicals Codex
FSANZ = Food Standards Australia New Zealand
FU = Farmacopoea Ufficiale della Republica Italiana
JP = The Pharmacopeia of Japan
Jap Food Stan = Japanese Food Standard
MI = Merck Index
MP = Martindale Pharmacopoeia
ÖAB = Österreichisches Arzneibuch
Ph Eur = Pharmacopoeia Europaea
Ph Franç = Pharmacopée Française
Ph Helv = Pharmacopoeia Helvetica
Ph Int = International Pharmacopoeia
USP = The United States Pharmacopoeia
ALINORM 08/31/26, Appendix V 72
APPENDIX V
FOR SPECIAL DIETARY USES INTENDED FOR INFANTS AND YOUNG CHILDERN
Maximum Level in
INS no. Additive/ Carrier Ready-to-use Food for
infants and young children
[mg/kg]
APPENDIX VI
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.
SECTION 2 – INTRODUCTION
3. 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 inherent
constituents such as allergens, nutrients and related substances are inherent constituents that 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., microbiological pathogens, contaminants and
4. 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.
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.
5. Consistent with their important role in providing scientific advice to the Codex Alimentarius
Commission and its subsidiary bodies, FAO and WHO and their joint expert consultations [and expert
bodies] are acknowledged as the primary source of nutritional risk assessment advice to Codex
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 an inherent constituent of food (other than a nutrient) that has a [potential] nutritional or
physiological effect. ]
ALINORM 08/31/26, Appendix VI 74
Alimentarius. This role however, does not preclude the choice of other sources of scientific advice such
as appropriate international expert groups or organizations if and when justified.
6. [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 potentially extends beyond CCNFSDU since the Committee 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. ]
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 might be
referred to as [one form of] 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; 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;
• [nutrients that increase the risk of adverse health effects that exist in a food matrix with a nutrient(s)
or related substance(s) associated with reduction of the risk of inadequacy or adverse health effects
at lower intake];].
9. Where appropriate, the application of quantitative nutritional risk analysis may guide decision making
on quantitative content provisions for nutrients and related substances in certain Codex texts.
10. Nutritional risk analysis 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;
• 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.
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 08/31/26, Appendix VI 75
SECTION 4 – DEFINITIONS
11. 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.
12. 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.
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.
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
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 08/31/26, Appendix VI 76
chemical form, interactions with other nutrients and food components, and food processing/preparation;
and host–related intestinal and systemic factors.
13. 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.
14. 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.
15. 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.
16. Such considerations should include whether a nutritional risk assessment is needed and if so:
• who should conduct and be involved in the nutritional risk assessment, nutritional risk management
and nutritional risk communication processes;
• how the nutritional risk assessment will provide the information necessary to support the nutritional
risk management decision;
17. Specific information to be gathered for nutritional problem formulation may include:
• identification of the (sub)populations to be the focus for the risk assessment, geographical areas or
consumer settings to be covered;
18. 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.
19. 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.
20. 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.
21. 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.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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
ALINORM 08/31/26, Appendix VI 78
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.]
28. 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.
29. 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 the actual, or likely, impact on
consumers’ behaviour, such as dietary patterns and preparation practices, which are cultural habits, in
order to anticipate possible product substitutions and to ensure an overall risk reduction.]
30. Nutritional risk assessment policy should be articulated as appropriate for the selected risk assessor
prior to the conduct of the nutritional risk assessment.
31. The risk communication section of the Codex Working Principles for Analysis for Application in the
Framework of the Codex Alimentarius is generally applicable to nutritional risk communication.
32. Consistent with their important role in providing scientific advice to Codex Alimentarius and its
subsidiary bodies, FAO and WHO are acknowledged as the primary source of nutritional risk
assessment advice to Codex Alimentarius. However, this role does not preclude the choice of other
sources of advice such as appropriate international expert groups or organizations [as well as national
relevant expertise,] if and when justified.
33. 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 the relevant Codex subsidiary body.
34. These Nutritional Risk Analysis Principles should be reviewed by CCNFSDU at appropriate intervals
after implementation to ensure currency and consistency with [good regulatory practice] and subsequent
to any future amendments to the Codex Working Principles.
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 08/31/26, Appendix VII 79
APPENDIX VII
Section 3.4.4 of the Codex Guidelines for Nutrition Labelling (CAC/CL 2-1985, Rev. 1-1993) provides that
numerical information on vitamins, minerals and protein should be expressed as a percentage of the
reference labeling value referred to as “Nutrient Reference Value” (NRV). Since the first introduction of
this guideline in 1985, Section 3.4.4 was amended once in 1993 following the Report of a Joint FAO/WHO
Consultation on Recommended Allowances of Nutrients for Food Labelling Purposes (Helsinki, Finland, 12
16 September 1988). At that time, it was indicated that the definition and review of these values was on
ongoing process, subject to revision according to new scientific data by the Committee of Food Labelling
(CCFL). The CCFL also recognized a need for general principles to guide the choice and amendment of
NRVs, and had requested the advice of the Committee on Nutrition and Foods for Special Dietary Uses in
this respect (ALINORM 93/40)
Currently the list of NRVs in Codex Guidelines for Nutrition Labelling covers 9 vitamins (A, D, C, thiamin,
riboflavin, niacin, B6, folic acid and B12), 5 minerals (Calcium, Magnesium, Iron, Zinc, Iodine) and protein,
which were in general based on the Reference RDAs for adult men. These values are indicated as a basis
for expressing nutrient content in nutrition labeling of food supplements in the Codex Guidelines for Vitamin
and Mineral Food Supplements (CAC/GL 55-2005). Also the Codex Guidelines for Use of Nutrition and
Health Claims (CAC/GL 23-1997, Rev. 1-2004) indicates NRVs as a basis for criteria for nutrition and
health claims.
At the 25th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSUD)
agreed that the current list of NRVs in the Codex Guidelines for Nurition Labelling was incomplete and
required additions and updates. It was also pointed out that a set of principles should be developed for the
establishment of NRVs taking into account the experience of member countries in the establishment of
reference values for the purpose of labelling.
The purpose of the proposed new work is to develop the science-based general principles for establishing
NRVs and to revise the list of NRVs in the Codex Guidelines for Nutrition Labelling, taking full account of
the prior work related to nutrient reference values.
WHA Resolution 57.17 endorsing the Global Strategy requested the Codex Alimentarius Commission to
continue to give full consideration within the framework of its operational mandate, to measures which it
might take to contribute towards the improvement of health standards of foods consistent with the aims and
objectives of the Global Strategy.
Accordingly, the 28th Session of the Commission agreed to ask WHO and FAO to prepare a document
ALINORM 08/31/26, Appendix VII 80
focused on actions that could be taken by Codex including specific proposals for new work for consideration
by the CCNFSDU and the CCFL. At its 29th Session of the Commission, it was agreed to complete a
document containing concrete proposals for possible actions by Codex and to circulate for comments and
consideration by the CCNFSDU and CCFL.
The CCNFSDU and CCFL had discussed extensively the proposals for actions and both Committees agreed
for CCNFSDU to revise the NRVs of vitamins and minerals in the Guidelines for Nutrition Labelling
(ALINORM 07/30/26). Therefore the proposal of this new work is timely as well as relevant.
This work would involve a process to develop the general principles for establishment of vitamin and
The next step would be a process to review all available reference values and their scientific basis by the
principles agreed upon and, if appropriate, update and extend the current list of vitamin and mineral NRVs in
the Guidelines for the Nutrition Labelling.
Once the above is completed, the Committee would establish vitamin and mineral NRVs for labelling for
individuals 6 months to 36 months of age. The Committee could then beginn to work to establish principles
that would apply to NRVs for this age group, using as a basis the principles identified for NRVs for the
general population and modifying them as appropriate. Once those principles are developed, the NRVs for
this age group would be established.
WORK PRIORITIES
Consumer protection from the point of view of health, food safety, ensuring fair practices in the food trade
and taking into account the identified needs of developing countries: This proposed new work would
provide Codex and national/regional authorities principles to be used in establishing NRVs, thus assisting
in establishing appropriate level of protection for consumers. The project could particularly assist countries
that have limited experience with NRVs, particularly for selecting NRVs for labelling purposes.
Scope of work and establishment of priorities between the various sections of the work: The scope of the
work relates to work previously undertaken by Codex on a high priority basis.
• Work already undertaken by other organizations in this field: This proposed new work is consistent with,
complements, and builds upon work already undertaken by CCFL.
This proposal is consistent with the following strategic goals presented in the Codex Strategic Plan 2008
2013:
Promoting Widest and Consistent Application of Scientific Principles and Risk Analysis (Activities 2.3).
The Codex Guidelines on Nutrition Labelling (CAC/GL 2-1985, Rev. 1-1993) and Codex Guidelines for
Vitamin and Mineral Food Supplements (CAC/GL 55-2005) indicate the NRVs as a basis for expressing
nutrient content in nutrition labelling of all foods including conventional foods and food supplements. The
Codex Guidelines for Use of Nutrition and Health Claims (CAC/GL 23-1997, Rev. 1-2004) also indicates
NRVs as a basis for criteria for nutrition and health claims.
None foreseen.
9. THE PROPOSED TIME-LINE FOR COMPLETION OF THE NEW WORK, INCLUDING THE
START DATE, THE PROPOSED DATE FOR STEP 5 AND THE PROPOSED DATE FOR
ADOPTION BY THE COMMISSION: THE TIME FRAME FOR DEVELOPING GUIDELINE
SHOULD NOT NORMALLY EXCEED FIVE YEARS
Activity Step/date
Step 5 2009/2010