The United States was pleased that substantive progress was made on a number of important work items at the 26th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU). The Committee advanced the Draft Guidelines for Vitamin and Mineral Food Supplements to Step 8 with a recommendation for their adoption by the next (28th) Session of the Codex Alimentarius Commission. The CCNFSDU also progressed work on the Draft Revised Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants, and the Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children. CCNFSDU agreed on a definition for "Trans Fatty Acids" and progressed work on provisions relating to dietary fiber. Importantly, the CCNFSDU reached general agreement to further pursue a Discussion Paper on the Application of Risk Analysis to the Work of the CCNFSDU. Unfortunately, the Committee did not have sufficient time to consider a paper on Proposed Draft Recommendations on the Scientific Basis of Health Claims and work on this subject will have to await the next Session of the CCNFSDU.

The 26th Session of the CCNFSDU was attended by 280 delegates representing 62 Member countries and 25 Observer organizations. The United States was represented by: the U.S. Delegate, Dr. Barbara Schneeman, FDA Center for Food Safety and Applied Nutrition: the Alternate U.S. Delegate, Ms. Patricia McKinney, USDA Food and Nutrition Service; 6 government advisors; and, 8 non-government advisors.

The full report of the 26th Session of the CCNFSDU can be found in ALINORM 05/28/26 on the Codex Web site, www.codexalimentarius.net.

The following summarizes the results of the 26th Session of CCNFSDU.

Guidelines for the Use of Nutrition Claims: Draft Table of Conditions for Nutrient Contents–Part B Containing Provisions on Dietary Fiber (Agenda Item 3)

Based upon a request from the Codex Committee on Food Labelling, the CCNFSDU has been undertaking work to develop a definition for dietary fiber for use with the conditions for dietary fiber content claims being established for the Codex Guidelines for the Use of Nutrition and Health Claims, and for use with other applicable Codex texts such as the Codex Guidelines for Nutrition Labelling.

The work on dietary fiber involves: 1) amendments to the "table of conditions for nutrient contents" to include dietary fiber content claims; 2) a definition for dietary fiber; and 3) recommendations to Codex Committees using the definition.

Definition of Dietary Fiber
Different views were expressed with the listing of physiological properties within the definition of dietary fiber. The United States expressed concern that such a listing might be interpreted as a justification for health claims related to the properties. It also expressed concern that the proposed definition implied that justification should be provided even for foods that naturally contain fiber, whereas such justification should normally apply only to foods containing added fiber. Other Delegations indicated that a listing of physiological properties should be mentioned in order to provide a clear definition of fiber. The Committee generally agreed that the definition of dietary fiber should include the physiological properties of substances in addition to its chemical characteristics.

The Committee discussed the degree of polymerization that should characterize dietary fiber. The degree of polymerization (DP) proposed was not lower than 3. The United States expressed the view that a DP of 10 was more appropriate since substances with a lower DP had a sweetening effect and their physiological effects were not those associated with fiber. Other Delegations preferred the DP of 3. The Committee included both values (3 and 10) for future consideration, with the 10 in square brackets.

The Committee agreed to delete the reference to "laxative properties" as this could be understood to be a medical claim, and replace it with "decreased transit time". The Committee also retained the understanding that dietary fiber was from raw food and not substances derived from non-food material such as tree bark.

Table of Conditions for Nutrient Contents
The Committee agreed that the Table should refer to "dietary fiber", and the square brackets on that term were deleted. The Committee decided not to discuss the fiber content values in the Table (relating to claims that a food is a "source" of dietary fiber or is "high" in dietary fiber) as the issues relating to the definition had not been resolved.

Recommendations to Other Codex Committees
The Committee agreed to add a sentence to the recommendations stating that, with the exception of non-digestible edible carbohydrate polymers naturally occurring in foods as consumed, where a declaration or claim is made with respect to dietary fiber, the physiological effect must be scientifically demonstrated. Another sentence was added to the recommendations that states that the establishment of criteria to quantify physiological effects is left to national authorities. The remainder of the recommendations were retained for further consideration, but the Committee did not come to a conclusion on where they should be placed in the Guidelines.

The Committee agreed to return the provisions on dietary fiber, as amended, to Step 6, for further comment and subsequent consideration at the next Session of the CCNFSDU.

Draft Guidelines for Vitamin and Mineral Food Supplements (Agenda Item 4)

The Codex Alimentarius Commission adopted the Guidelines at Step 5 at its last (27th) Session.

CCNFSDU made several technical amendments to the text, including the following.

• After discussing whether to and if so how to address wording to reference small unit quantities, amended the definition of "vitamin and mineral food supplements" to indicate that these supplements are "designed to be taken in measured small-unit quantities". A footnote was added, however, to clarify that the small-unit quantities referred to the physical forms and not the potency of supplements. This change was made to clarify the difference between these products and ordinary foods.
• Agreed that sources of vitamins and minerals may be natural or synthetic and that their selection should be based on considerations of safety and bioavailability.
• Noted that, in the absence of international purity criteria, national legislation may be used.
• After lengthy discussion on aspects of the provisions for maximum amounts of vitamins and minerals, agreed that "when the maximum levels are set, due account may be taken of the reference intake values of vitamins and minerals for the population". Further, that "this provision should not lead to the setting of maximum levels that are solely based on recommended nutrient intakes (e.g., Population Reference Intake or Recommended Dietary Allowance values)."
• Agreed to additional wording in the labeling section to clarify that, in addition to the amounts of vitamins and minerals declared per portion of the product as recommended for daily consumption, the amount per unit for single use may also be given.

With these and certain other technical changes, the Committee recommended that the Guidelines be forwarded for adoption by the Commission at Step 8 of the Codex Step Procedure.

Report on the Proposals for Additional or Revised Nutrient Reference Values (NRVs) (Included under Agenda Item 4)

The Committee agreed that the purpose of the revision of the NRVs was to establish reference values for the purpose of labeling that would apply to all foods.

The Committee discussed the need to receive expert scientific advice from FAO/WHO. Based on comments from FAO and WHO, the Committee noted that, due to priorities and resources, it did not seem feasible to convene a specific expert consultation in the near future but accepted the offer of FAO and WHO to address the revision of the NRVs in the context of Joint Expert Consultations that are planned, including those for carbohydrates and fats and oils.

The Committee discussed the substances that should be included in the list of NRVs. Some delegations suggested the list should focus on vitamins and minerals and not include other substances (e.g., long chain fatty acids, lutein, choline, lycopene) while other delegations noted that NRVs were also needed for macronutrients (noting that the current list included a NRV for protein). The United States recommended that a set of principles should be developed for the establishment of NRVs taking into account the experience of countries in the establishment of reference values for labeling purposes.

The Committee also discussed whether sets of NRVs should be established for different population groups. No conclusion was reached on this issue and the matter was left to further consideration.

The CCNFSDU agreed to continue work on the revision of NRVs using an electronic working group. The Committee agreed that the working group should address the following questions: the development of principles for the establishment of NRVs, taking into account the guidelines developed by member countries in this area; the need to establish NRVs for different population groups; and the revision of the current list of nutrients.

Draft Revised Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Agenda Item 5)

This standard had been advanced to Step 5 by the 27th Session of the Codex Alimentarius Commission. Following a pre-session meeting of the working group charged with the development of the essential composition portion of the revised standard, the Committee had a lengthy discussion on the document including both Section A dealing with regular infant formula and Section B dealing with formulas for special medical purposes intended for infants.

It should be noted that there is a significant amount of the provisions in this standard that are still in square brackets-especially in Section 3.1 on essential composition. Germany, as the lead for the working group responsible for preparing Section 3.1 indicated that the work group did not finish its work in the pre-session meeting due to time constraints and other factors, and requested the Committee to provide guidance on how it might do its work more effectively. The Committee agreed that an electronic working group chaired by Germany would prepare proposals by the end of 2004, and that these would be forwarded to the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN), who is a member of the Working Group. ESPGHAN, would then prepare a paper containing a scientific analysis of these proposals by June 2004 for the Committee's further consideration that takes into account existing scientific reports on the subject, in consultation with the international scientific community.

Section A (regular infant formula)
A large number of technical changes were made to, or proposed for, the text to Section A (regular infant formula), both by the working group and by the Committee as a whole. These included:

• Deletion of the reference to the World Health Assembly Resolution 55.25 (2002) on infant and young child nutrition as the basic provisions were already covered by the WHO Global Strategy for Infant and Young Child Feeding.
• Agreement on wording that nutritional safety and adequacy of infant formula shall be scientifically demonstrated to support growth and development of infants.
• A suggestion to establish levels for trace elements such as chromium and molybdenum in the "essential composition" portion of the standard.
• A proposal by the United States to rearrange the format of Section 3.1 to separate essential composition from optional constituents, and a recommendation by the delegation of the EC that the mandate to the Working Group should be extended to include this rearrangement.
• A discussion on the handling of "specific prohibitions" in the essential composition section, specifically the need to separate ionizing radiation from a listing of partially hydrogenated oils and fats. The United States expressed concern that the development of a "prohibited" list might be understood as an all inclusive list and thus could lead to confusion. No consensus was reached on this matter and it was decided to leave the section unchanged for the present.
• Agreement by the Committee to a proposal from the United States that the selection of food additives should follow the principles put forth in the Codex General Principles for the Use of Food Additives and the Preamble of the General Standard of Food Additives.
• Agreement that Switzerland would coordinate an electronic working group to prepare a revised list of additives taking into account the written comments and comments raised at the Session.
• Amended the Labelling section to include references to other pertinent Codex labeling texts. including a consequential amendment to delete section 9.1.5 concerning prohibition of health claims since it was covered by the Codex Guidelines for the Use of Nutrition and Health Claims.
• Agreed that, with respect to labeling, the arrangement of vitamins and minerals as separate groups should remain optional and amended the text to indicate that mandatory nutrition information "should be" in a specific order consistent with the language of the Codex Guidelines on Nutritional Labeling.
• Considered the issue of non-sterility of products and how this issue should be handled; the Committee agreed that this issue would be discussed at the next Session.
• Considered whether instructions for use should always be on the label or could be just in accompanying information. The Committee agreed to keep a reference to accompanying leaflets in the text but in square brackets and will further consider the subject.
• Initiated a discussion on insertion of a paragraph to allow the use of nutrition claims but did not discuss the matter in depth due to time constraints.

The Committee noted that, despite progress made in the revision of the Standard, the section on composition requirements required fundamental reconsideration and therefore Section A was held at held at Step 6 for further comment and consideration at the next Session of the CCNFSDU. Two working groups, one on essential composition and one on food additives will carry out work between Sessions.

Section B (Formulas for Special Medical Purposes Intended for Infants)
The committee noted many technical comments and considerations including the need for several consequential changes arising from changes made to Section A. The working groups established for Section A will also undertake work, as appropriate, on Section B.

The Committee returned Section B to Step 3 for continued work and development.

Draft Revised Standard for Processed Cereal-Based Foods for Infants and Young Children (Agenda Item 6)

As with the Infant Formula Standard, this Standard was advanced to Step 5 by the 27th Session of the Codex Alimentarius Commission. The Committee undertook a section-by-section discussion of the Standard, including the following items. The Committee:

• Agreed to remove references to WHO 55.25 for the same reasons given for the Infant Formula Standard (see above).
• Deleted special provisions for sodium content for children over one year of age.
• Discussed the appropriate value for thiamin, with some delegations noting that the proposed value of 60 µg/100 kcal could not be reached in foods that were not fortified, and reaching consensus on a value of 50 µg/100 kcal.
• Agreed that food additives should be expressed on the basis of 100 g of the product ready for consumption.
• Discussed the issue of flavors and their inclusion in the Standard. After an exchange of views, the Committee deleted provisions for vanilla extract, vanillin, and ethyl vanillin.
• Agreed to section on the "carry over of food additives" indicating that no food additives shall be present as a result of carry over from raw materials and other ingredients with certain exceptions including carry over of food additives authorized by the standard.
• Agreed, as with the Infant Formula Standard, to include references to pertinent Codex food labeling texts with consequential deletion of certain provisions.
• Agreed to a proposal to allow the use of nutrition claims with the new provision reading: "nutrition claims shall be permitted for foods for infants and young children where they have been demonstrated in rigorous studies with adequate scientific standards.
• Agreed to delete a labeling provision that "the presence or absence of gluten should be indicated on the label", but added a provision in square brackets for consideration at the next session stating that "when the product is composed of gluten-free ingredients and food additives, the label should show the statement "gluten-free".

Noting that significant progress had been made but that some sections required further work, the Committee returned the draft Standard, as amended, to Step 6 for further comments and consideration at the next Session of the Committee.

Proposed Draft Advisory List(s) of Mineral Salts and Vitamin Compounds for the Use in Foods for Infants and Children (Agenda Item 7)

The Delegation of Germany, as the lead for the document, noted that it was necessary to obtain guidance from the Committee on three areas:

1. Whether, in absence of purity criteria elaborated by JECFA, other references for purity criteria should be accepted;
2. Whether the use of nutrient compounds should also be indicated for the category of "foods for special medical purposes"; and,
3. Whether food additives for nutrient carriers again be included in the list.

With respect to purity criteria, the Committee agreed that in the absence of JECFA criteria and/or criteria from other recognized international organizations, national requirements could be used. The United States also suggested that the identity and purity specifications for food additives accepted by the Commission should be considered.

Regarding nutrient carriers, the Committee recognized that it could not take a final decision on this issue until it had received guidance from CCFAC on how to address carriers. The United States proposed to support establishment by CCFAC of an additive functional class for nutrient carriers. The Committee agreed to reintroduce the table containing additives used for special vitamin form carriers and keep it only for the purpose of nutrient carriers.

Proposed Draft Recommendations on the Scientific Basis of Health Claims (Agenda Item 8)

Due to time constraints, the Committee did not have time to discuss this Paper and returned it to Steps 2/3 for redrafting based on comments received and to consider it again at the next Session of the Committee.

Discussion Paper on the Application of Risk Analysis to the Work of the CCNFSDU (Agenda Item 9)

This Paper had been developed by Australia and an electronic working group of which the United States was a member. The Paper, initially, has been patterned after the Codex Working Principles for Risk Analysis for Application in the Framework of the Codex Alimentarius. The Committee agreed, after a brief discussion due to limited time, to request the working group to further develop the Paper, to include the following aspects:

• A description of the scope of nutritional risk analysis and interpretation of Codex risk analysis terminology in relation to nutrition;
• A description of the role of risk assessor and risk manager and place of risk communication as they apply to the Committee and in relation to the FAO/WHO; and,
• An examination of risk analysis models that are developed or being developed by other Codex Committees or Ad Hoc Task Forces to assist consideration of the most appropriate format and level of detail for principles and guidelines that will best serve the Committee's purposes.

Discussion Paper on the Definition of Trans Fatty Acids (Agenda Item 10)

The Committee agreed to the following definition of trans fatty acids:

For the purpose of the Codex Guidelines on Nutritional Labelling and other related Codex Standards and Guidelines, trans fatty acids are defined as all the geometrical isomers of monounsaturated and polyunsaturated fatty acids having non-conjugated ( interrupted by at least one methylene group (-CH2-CH2-)) carbon-carbon double bonds in the trans configuration.

Other Business and Future Work (Agenda Item 11)

Gluten Free Foods
As an item discussed under "Matters Referred" (Agenda Item 2), the Committee considered a matter referred to the Codex Committee on Methods of Analysis and Sampling(CCMAS), specifically whether the Enzyme-Linked Immunoassay R5 method measured gluten or gliadins. The Committee was informed by the CCMAS that the method measured gliadins and that a conversation factor of 2.0 must be applied to convert the gliadins to gluten. The Committee agreed to amend Section 6.2. of the Codex Draft Standard for Gluten-Free Foods and insert "gluten" after "ppm". The Committee also agreed to consider the Codex Draft Standard for Gluten-Free Foods at its next Session. Additionally, the Committee was informed that the R5 method was independently validated and that additional information regarding particulars of the method would be submitted to the CCMAS.

Date and Place of the Next Session

The 27th Session of the CCNFSDU will be held 21-25 November, 2005, in Bonn, Germany.