U.S. Draft Positions for the 41st Session of the Codex ...U.S. DRAFT POSITIONS . 41st SESSION of the . CODEX COMMITTEE ON . NUTRITION AND . FOODS FOR SPECIAL DIETARY USES (CCNFSDU)

U.S. DRAFT POSITIONS

41st SESSION of the CODEX COMMITTEE ON

NUTRITION AND FOODS FOR SPECIAL DIETARY USES

(CCNFSDU)

Public Meeting November 1, 2019

These positions may be revised or updated prior to the Committee

meeting.

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Table of Contents AGENDA ITEM 1 - ADOPTION OF THE AGENDA......................................................... 3

AGENDA ITEM 2 – MATTERS REFERRED ................................................................... 4

AGENDA ITEM 3 – MATTERS OF INTEREST ARISING FROM FAO AND WHO ......... 6

AGENDA ITEM 4 – REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA ...... 7

4A: Draft Scope, Description and labelling for older infants ........................................... 7

4B: Essential Composition requirements ...................................................................... 12

4C: Proposed draft product definition and labelling for [product] for young children (at Step 4) ........................................................................................................................... 13

4D: Proposed draft follow up formula for older infants and [product] for young children (at Step 4) ..................................................................................................................... 17

AGENDA ITEM 5 – READY-TO-USE THERAPEUTIC FOODS (RUTF) AT STEP 4 .... 22

5A: Proposed Draft Guideline for RUTF ....................................................................... 22

5B: Section 5.2.2 (Food Additives) and Section 6.2 (Proteins) ..................................... 25

AGENDA ITEM 6 – TRANS-FATTY ACIDS (TFAs) ...................................................... 29

6A: Proposed Draft Claim for ‘free’ of Trans Fatty Acids (held step 4) ......................... 29

6B: Risk Management possibilities for the reduction of TFAs Discussion Paper .......... 31

AGENDA ITEM 7 - PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION ...... 32

AGENDA ITEM 9 – FOOD ADDITIVES ........................................................................ 37

9A: Mechanism/framework for considering technological justification of Food Additives ...................................................................................................................................... 37

9B: Alignment of food additive provisions in CCFNSDU standards with the GSFA Discussion Paper .......................................................................................................... 40

AGENDA ITEM 10 – PRIORITIZATION MECHANISM TO BETTER MANAGE THE WORK OF CCNFSDU ................................................................................................... 41

AGENDA ITEM 11 – HARMONIZED PROBIOTIC GUIDELINES ................................. 42

AGENDA ITEM 12 – GENERAL GUIDELINES TO ESTABLISH NUTRITIONAL PROFILES .................................................................................................................... 43

AGENDA ITEM 13 – OTHER BUSINESS AND FUTURE WORK ................................. 44

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AGENDA ITEM 1 – ADOPTION OF THE AGENDA

Document: CX/NFSDU 19/41/1 Background: Member countries may offer new items to be considered at this time or may request a change in the order in which the agenda items are considered. The United States anticipates submitting proposals via a Conference Room Document (CRD) to discuss under Agenda Item 13, Other Business, Methods of Analysis in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72-1981). U.S. Position: We support agenda changes to accommodate discussion of Methods of Analysis under Other Business.

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AGENDA ITEM 2 – MATTERS REFERRED BY THE CODEX ALIMENTARIUS COMMISSION AND/OR OTHER CODEX COMMITTEES

Documents: CX/NFSDU 19/41/2 Background: Matters Referred by the Codex Alimentarius Commission (CAC) normally relate to decisions taken by the Commission on CCNFSDU matters (e.g., texts that were adopted), or to policy or procedural matters that have an impact on CCNFSDU. Matters referred by other Codex Committees/Task Forces usually relate to requests for guidance relating to Nutrition and Foods for Special Dietary Uses or inform CCNFSDU of work undertaken by other Codex committees/task forces that may impact the work of CCNFSDU. The matters in this Agenda Item are usually for information only but action items may occur. A. MATTERS for INFORMATION From the 77th Session of the Executive Committee of the Codex Alimentarius Commission (CCEXEC77) CCEXEC77 (July 2019) recommended to CAC42 (July 2019) to adopt the draft scope, description and labelling for follow-up formula for older infants (Section A) of the proposed revised Standard for Follow-up Formula (CX 156-1987) at Step 5 (allowing for another round of consideration in the Committee) as endorsed and amended by the Codex Committee on Food Labeling (CCFL) specifically noting that the part on restriction of cross-promotion had not been endorsed by CCFL and required further discussion in CCNFSDU. CCEXEC77 further noted that the work on follow-up formula had a target date of 2019 encouraged CCNFSDU to complete this work in 2019 or to establish a more realistic target date. CCEXEC77 and CAC42, while noting that the work on biofortification had been on the agenda for several years and that CCFL saw no need for a definition for biofortification related to food labeling, requested CCNFSDU to clarify how a definition would be useful in the context of Codex work and to consider discontinuation of this work if no use was identified. CCEXEC77 recalled and reaffirmed the advice given by CCEXEC75 (June 2018) regarding use of references to World Health Organization (WHO and World Health Assembly (WHA) documents. U.S. Position: The United States notes and supports applying the CCEXEC77 advice and concur with the expectation to complete other elements of the Follow-Up Formula (FUF) Standard, including scope, definitions and labeling, irrespective of any additional CCNFSDU requests for advice from CCEXEC.

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B. MATTERS for ACTION (REFERRED BY OTHER COMMITTEES) Endorsement of Methods of Analysis Methods of analysis for provisions in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72-1981) The 40th Session of the Codex Committee on Methods of Analysis and Sampling (CCMAS40, May 2019) agreed to:

• endorse the AOAC 2011.14 / ISO 15151 | IDF 229 as a Type III method for calcium, copper, iron, magnesium, manganese, phosphorous, potassium, sodium and zinc, but that the methods should be referred to CCNFSDU for their concurrence before submission to CAC for adoption;

• recommend that CCNFSDU consider establishing numerical method performance criteria for calcium, copper, iron, magnesium, manganese, phosphorous, potassium, sodium and zinc, and identify appropriate methods that meet the criteria;

• consider whether the methods for Vitamin K in follow-up formula currently in CXS 234 (AOAC 999.15 / EN 14148) should be replaced by the methods endorsed as a Type II methods for infant formula (i.e., AOAC 2015.09 / ISO 21446).

• refer the proposal for methods of analysis for gluten free as presented in CX/MAS 19/40/3 Add.2 to CCNFSDU for their consideration.

CCMAS40 further noted that there were questions about the applicability of ISO 8070 | IDF 119 to infant formula and whether typing as Type III or Type IV was appropriate, and that the CCMAS Physical Working Group (PWG) had retained the methods as Type III but concluded that this should be reviewed either during the establishment of method performance criteria by CCNFSDU or at CCMAS41 (May 2020). Similar questions arose on other methods for minerals (e.g., AOAC 985.35) and CCMAS40 agreed that the same approach would be followed as for ISO 8070 | IDF 119. U.S. Position: These referrals from CCMAS are under consideration. However, the United States supports the recommendation to endorse AOAC 2011.4/ISO 15151|IDF 229 methods as Type II so they can move to CAC for adoption. We are still developing our positions around items 2, 3, 4, and 5.

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AGENDA ITEM 3 – MATTERS OF INTEREST ARISING FROM FAO AND WHO Document: CX/NFSDU 19/41/3 Background: Matters included under this agenda item include progress reports from FAO/WHO on work being undertaken by the FAO/WHO Joint Expert Meetings on Nutrition (JEMNU), including those for CCNFSDU. Other information relating to FAO/WHO Expert Meetings and/or technical information may be included. The matters in this Agenda Item are usually for information only but action items may occur. We anticipate an update on the request to JEMNU for technical advice on nitrogen conversion factors. U.S. Position: The United States supports continuing to use JEMNU as a primary source of scientific advice for CCNFSDU and will be open to discussions regarding the current work on nitrogen conversion factors and consideration of for new work for JEMNU.

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AGENDA ITEM 4 – REVIEW OF THE STANDARD FOR FOLLOW-UP FORMULA (CODEX STAN 156-1987)

4A: Draft Scope, Description and labelling for follow-up formula for older infants (at Step 6)

Documents: CX/NFSDU 19/41/4 – Comments in reply to CL2019/77-NFSDU REP19/NFSDU, Appendix III Background: • At CCNFSDU39 (November 2017), the Committee agreed to finalize product definitions and

labeling requirements for older infants and young children, consider options for the structure of the standard, and develop proposals for the scope sections for older infants and young children.

• CCEXEC75 (June 2018) expressed its expectation that CCNFSDU would continue at its next session to complete the other elements, including scope, definitions and labeling, of the Standard for Follow-up formula.

• CAC42 (July 2019): o adopted the proposed draft text (scope, definition and labeling – as endorsed and

amended by CCFL), and noted that the last part of section 9.6.4 on cross-promotion would be further considered by CCNFSDU; and

o noted that CCEXEC77 (July 2019) had recalled and reaffirmed the advice given by CCEXEC75 regarding use of references to WHO documents and WHA resolutions.

U.S. Position: The United States supports the draft provided in the report of the last session (REP19/NFSDU Appendix III), Proposed Draft Revised Standard For Follow-Up Formula (CXS 156-1987), which was adopted by CAC42at Step 5. The United States provided the following responses and comments to the Codex Secretariat in response to Circular Letter (CL) 2019/77/OCS-NFSDU: Request for comments at Step 6 on the review of the Standard for follow-up formula: draft scope, description and labelling for FUF for older infants. Section 1 (Scope) and Section 2 (Description) Comment 1. The United States supports the Scope (Section 1) and the Description (Section 2) as written. The other definitions under 2.2 define the term infant. While we support these definitions, we note that it should be made clear that “no older than 12 months” includes the 12th month of life which aligns with the definition agreed as part of the work on NRVs. This will

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mean that the [name of product] for young children will be appropriate for children beginning at the 13th month of age and not starting at the 12th month of age. Section 9 (Labelling) Comment 2. The United States agrees that it is important to protect and support breastfeeding. We recognize the importance of distinctive labeling of Follow-Up Formula for Older Infants (FUF-OI) to assure the product is labeled in such a way that there is no confusion between FUF-OI, [name of product] for young children, and infant formula. The United States believes that the purpose of the label is to provide the consumer with clear statements of the product’s identity, composition and appropriate use. Specifically, the United States notes that the purpose of the Guidelines on Nutrition Labelling (CXG 2-1985) includes “to ensure that nutrition labelling is effective…in providing the consumer with information about a food so that a wise choice of food can be made” and “to ensure that nutrition labelling does not describe a product or present information about it which is in any way false, misleading, deceptive or insignificant in any manner.” Comment 3. The United States requests clarification on how the statement under “9. Labelling” regarding “prohibition on the use of nutrition and health claims” in the proposed Standard for FUF-OI impacts declaration of optional ingredients on the label. When optional ingredients are added (DHA/EPA for example) how is that fact to be disclosed on the label? For example, would the statement “contains 20 mg DHA/EPA” be a permitted factual statement? Comment 4. The United States supports Labelling (Section 9) if the amendments from CCFL are incorporated to Sections: 9.2.2, 9.3, 9.4.1 (i) and (ii), 9.4.2, and 9.6.1 as described in REP19/FL and provided as individual comments below, with changes inserted in pertinent text of the proposed Standard. Section 9.1 (Name of Product) Comment 5. The United States has no comments on Section 9.1(Name of Product) and its subparts. Section 9.2 (List of Ingredients) Comment 6. The amendment from CCFL states, “The second sentence of Section 9.2.2 should be revised by deletion of “these ingredients and” as functional classes were applicable food additives and not ingredients and as required by Section 4.2.3.3 of GSLPF.” This clarification is demonstrated in the following edit:

9.2.2 The specific name shall be declared for ingredients of animal or plant origin and for food additives. In addition, appropriate functional classes for these ingredients and additives may be included on the label. The food additives INS number may also be optionally declared.

Section 9.3 (Declaration of Nutritive Value) Comment 7. The amendment from CCFL states, “The units in Section 9.3 should be in the

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abbreviated form (e.g., ml) as more appropriate for labelling purposes and in line with the Guidelines on Nutrition Labelling (CXG 2-1985).” This clarification is demonstrated in the following edits:

9.3 Declaration of Nutritive Value The declaration of nutrition information [for follow-up formula for older infants] shall contain the following information which should be in the following order: a) the amount of energy, expressed in kilocalories (kcal) and/or kilojoules (kJ), and the number of grams of protein, carbohydrate and fat per 100 gramsg or per 100 millilitresml of the food as sold [as well as] [or] per 100 millilitresml of the food ready for use, when prepared according to the instructions on the label. b) the total quantity of each vitamin, and mineral as listed in paragraph 3.1.3 of Section A and any other ingredient as listed in paragraph 3.2 of Section A per 100 gramsg or per 100 millilitresml of the food as sold as well as per 100 millilitresml of the food ready for use, when prepared according to the instructions on the label. c) In addition, the declaration of nutrients in a) and b) per 100 kilocalories (kcal) (or per 100 kilojouleskJ) is permitted.

Section 9.4 (Date Marking and Storage Instructions) Comment 8. The amendment from CCFL states, “To assure the consistency of date marking and to allow for the use of “expiration date” or “use by date”, the Committee agreed to replace Section 9.4.1 (i) and (ii) and 9.4.2, except for the last sentence, with a reference to Section 4.7.1 of the GSLPF to allow countries to have a choice in using the appropriate date-marking to be declared on the label.” This clarification is demonstrated in the following edits:

9.4 Date Marking and Storage Instructions 9.4.1 (i) The “Best Before Date” or “Best Quality Before Date” shall be declared by the day, month and year except that for products with a shelf-life of more than three months, [at least] the month and year [shall be declared] [The day and year shall be declared by uncoded numbers with the year to be denoted by 2 or 4 digits, and the month shall be declared by letters or characters or numbers. Where only numbers are used to declare the date or where the year is expressed as only two digits, the competent authority should determine whether to require the sequence of the day, month, year, be given by appropriate abbreviations accompanying the date mark (e.g. DD/MM/YYYY or YYYY/DD/MM).] (ii) In the case of products requiring a declaration of month and year only, the date shall be introduced by the words “Best before end <insert date>; or “Best Quality before end <insert date>]. The date-marking and storage instructions shall be in accordance with Section 4.7.1 of the General Standard for the Labelling of Prepackaged Foods. 9.4.2 In addition to the date, any special conditions for the storage of the food shall be indicated if [where they are required to support the integrity of the food and, where] the validity of the date depends thereon. Where practicable, storage instructions shall be in close proximity to the date-marking.

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Section 9.5 (Information for Use) Comment 9. The United States has no comments on Section 9.1 (Name of Product) and its subparts. Section 9.6 (Additional Labelling Requirements) Section 9.6.1 Comment 10. The Unites States has no comments on subparts a, b, and d. For subpart c, the amendment from CCFL states, “9.6.1 c) to emphasize that health workers should be independent were not agreed to as CCNFSDU had already considered these proposals and the provisions were a result of extensive discussion and compromise in CCNFSDU.” No change is requested to the text here, and the United States continues to support that “independent” is not specified in 9.6.1.c. This clarification is demonstrated in maintaining the following text:

9.6 Additional Labelling Requirements 9.6.1 Labels should not discourage breastfeeding. Each container label shall have a clear, conspicuous and easily readable message which includes the following points:

a) the words "important notice" or their equivalent; b) the statement "Breast-milk is the best food for your baby" or a similar statement as to the superiority of breastfeeding or breast-milk; c) a statement that the product should only be used on advice of a health worker as to the need for its use and the proper method of use. d) the statement; ‘The use of this product should not lead to cessation of continued breastfeeding’.

Sections 9.6.2 - 9.6.3 Comment 11. The United States has no comments on the Additional Labelling Requirements in Sections 9.6.2 - 9.6.3. Section 9.6.4 Comment 12. The United States generally supports the Additional Labelling Requirements in Section 9.6.4. We appreciate the recommendations from CCFL and support the recommended changes including not including the final bullet on a prohibition of Cross Promotion. The United States appreciates the comments of CCFL and the CAC regarding the topic of cross promotion and will be prepared for the additional discussion of the term “cross-promotion” at the Plenary. The United States does not support a prohibition of “cross-promotion” on the label or in labeling.

• Specifically, the United States notes that unlike the current Follow-up Formula Standard, the proposed Standard identifies FUF-OI as a breastmilk substitute. Therefore, the requirements in the proposed Standard are subject to the prohibitions on the use of nutrition and health claims for breastmilk substitutes.

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• Comment 12.a. The United States supports the first sentence under 9.6.4 and requests that a period be added after “between them” to end the sentence.

• Comment 12.b. The United States supports the deletion of the sentence “Cross

promotion between product categories is not permitted on the [label/labelling] of the product.” as suggested by CCFL. In conjunction with the other proposed draft provisions, the first sentence achieves the purpose of avoiding consumer confusion among product categories.

9.6.4 Products shall be distinctly labelled in such a way as to avoid any risk of confusion between infant formula, follow-up formula for older infants, (name of product) for young children, and formula for special medical purposes, in particular as to the text, images and colours used, to enable consumers to make a clear distinction between them. Cross promotion between product categories is not permitted on the [label/labelling] of the product.

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4B: Essential composition requirements for follow-up formula for older infants and [product] for young children (held at Step 7)

Document: REP19/NFSDU, Appendix II Background: • CCNFSDU33 (2012) agreed to review the Follow-up Formula (FUF) standard. The

Committee in following years reviewed the nutrient composition of FUF compared to infant formula, cow’s milk, and nutrients of global concern.

• At CCNFSDU39 (2017), the Committee agreed to forward the essential composition requirements for older infants and young children at Step 5 for adoption by CAC41.

• CAC41 (2018) adopted the essential composition requirements for older infants and young

children of the Standard for Follow-Up Formula at Step 51 (CXS 156-1987).

• At CCNFSDU40 (2018), the Committee agreed to retain the essential requirements for follow-up formula for older infants and for [product] for young children at Step 7 (held short of final adoption pending completion of other parts of the standard) and to request the Electronic Working Group (EWG) on follow-up formula (see Agenda Item 4b) to consider the proposals on Dextrose Equivalence (DE) for products not based on milk protein and related to substances imparting or enhancing a sweet taste in section 3.2.1, and to provide further recommendations for comments and consideration by the next session of the Committee.

U.S. Position: The United States continues to support adoption of the essential composition requirements for older infants and young children of the standard to progress the completed work.

1 REP18/CAC, para 62, Appendix IV

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4C: Proposed draft product definition and labelling for [product] for young children (at Step 4)

Document: REP19/NFSDU, Appendix IV Background: • At CCNFSDU39 (2017), the Committee agreed to finalize product definitions and labelling

requirements for older infants and young children, consider options for the structure of the standard, and develop proposals for the scope sections for older infants and young children.

• CCEXEC75 (2018) expressed its expectation that CCNFSDU would continue at its next session to complete the other elements, including scope, definitions and labelling, of the Standard for Follow-up formula.

• At CCNFSDU40 (2018), the Committee agreed to defer discussion on Section B: product

definition and labelling of [product] for young children (Appendix IV), the structure of the Standard(s) and preamble(s) for discussion at CCNFSDU41.

U.S. Position: The United States supports the recommendation that the definition for [name of product] for young children, as follows:

[Name of product] for young children means a product manufactured for use as a liquid part of the diversified diet of young children to contribute to the nutritional needs of young children.

The United States is of the view that [Name of Product] for young children is not nutritionally adequate to be a breastmilk replacement and therefore should not be presented as such. To make it clear that these products should not replace breastmilk our view is that the definition should be modified as following:

[Name of Product] for young children means a product manufactured for use as a liquid part of the diversified diet of young children, the product is not nutritionally adequate to replace breast milk and therefore, is not a breast milk replacement and should not be presented as such.

The United States supports the recommendation for the introductory paragraph to the Labelling Section for [Name of product] for young children as follows:

The requirements of the General Standard for the Labelling of Pre-packaged Foods (CXS 1-1985), the Guidelines on Nutrition Labelling (CXG 2-1985), and the Guidelines for Use of Nutrition and Health Claims (CXG 23-1997) apply to [Name of Product] for Young Children.

The United States supports the recommendation that the following text for The Name of Product Section 9.1 for [Name of product] for Young Children and the deletion of “or regional” as follows:

9.1 The Name of the Product 9.1.1 The text of the label and all other information accompanying the product shall be written in the appropriate language(s). 9.1.2 The name of the product shall be [Name of Product] for Young Children as defined in Section 2.1, or any appropriate designation indicating the true nature of the product, in accordance with national usage. 9.1.3 The sources of protein in the product shall be clearly shown on the label.

a) If [name of animal] milk is the only source of protein [*], the product may be labelled ‘[Name of Product] for Young Children Based on [name of animal] milk [protein]’. b) If [name of plant] is the only source of protein [*], the product may be labelled ‘[Name of Product] for Young Children Based on [name of plant] [protein]’. c) if [name of animal] milk and [name of plant] are the sources of proteins*, the product may be labelled ‘[Name of Product] for Young Children Based on [name of animal] milk protein and [name of plant] protein’ or ‘[Name of Product] for Young Children Based on [name of plant] protein and [name of animal] milk protein’. [* For clarity, addition of individual amino acids where needed to improve protein quality does not preclude use of the above labelling options.]

9.1.4 A product which contains neither milk nor any milk derivative shall be labelled "contains no milk or milk products" or an equivalent phrase.

The United States supports further discussion regarding the recommendation for the Additional Labelling requirements for [name of product] for young children with the following comments for consideration. The United States notes that based on the nutritional composition of the product for young children, it important that [name of product] for young children be clearly identified as not being suitable as a breastmilk substitute. The [Name of product] for young children contains a limited number of essential nutrients and its use as drink in the diet of a young child is designed to address nutrients that may be insufficient. We consider it essential to point out to the consumer that the composition of this product is not the same as Infant formula (sole source of nutrition). The revised standard for [Name of product] for young children has mandatory requirements for only 8 micronutrients (Vitamin C, A, D, B2, B12, Iron, Calcium, Zinc) as compared to the infant formula standard and the proposed follow-up formula for older infants, which require a complete mandatory nutrient composition. We also find the words humanized or maternalized or other such terms unhelpful for label use to the consumer. However, the concepts should be considered as inappropriate for marketing

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purposes and the suggested edits address this in the recommendation regarding paragraph 9.6.3 of the Standard. We note that the bracketed phrase [including pictures of feeding bottles,] does not add clarity to the product’s use and suggest that this phrase be deleted. This product is nutritionally appropriate as a drink and not as a formula, another reason why there should be separate standard for this product for young children. We consider the text in paragraph 9.6.2 acceptable until the last phrase in the last sentence: “in particular as to the text, images and colours used” to represent a clear statement of the limitations of the product and propose the deletion of this wording. We are concerned about the subjective nature of text and the potential for different interpretations that could inadvertently create trade barriers. We suggest consideration be given to additional wording that provides for alternative packaging shapes to provide an easy and distinguishable differentiation among the products and graphics for product preparation so that consumers with low literacy could correctly prepare the product. We support the following wording for Section 9.6:

9.6 Additional Labelling Requirements 9.6.1 The label of [name of product] for young children shall have no image, text or representation that could undermine or discourage breastfeeding or which idealises the use of [name of product] for young children. 9.6.2 Products shall be labelled in such a way as to avoid any risk of confusion between infant formula, follow-up formula for older infants, [name of product] for young children, and formula for special medical purposes and to enable consumers to make a clear distinction between them.

The United States supports the recommendation for further discussion on the Name of Product (for young children) as the current name is not sufficiently descriptive. It is our view that the name should clearly differentiate this product from both infant formula and FUF-OI as a tool to prevent confusion and signal the appropriate age group for this product. The United States supports the recommendation to further discuss the structure of the standard(s) at the Committee meeting, noting the preference of the Electronic Working Group (EWG) for either one standard with two parts or two separate standards. However, in addition to our earlier comments under “General Comments,” the United States finds Option 2 that provides for separate standard as a practical option for several reasons:

• Two separate standards fit well within the terms of reference. • Addresses the differences in the physiological needs for the age ranges and associated

nutritional requirements for two separate products. • Clearly distinguishes the role in the diet between these two products. (We note that the

compositional requirements that have been developed over the last few years with a point of differentiation at 12 months, indicates that the Follow-Up Formula-Older Infants (FUF-OI) is a nutritionally complete product that is appropriate for the 6-12 month old whereas the product for the 12-36 month old is not nutritionally complete.)

• Allows for distinct label/labelling that would clearly differentiate the products’ uses for the intended populations.

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Preamble • The United States recalls that the Terms of Reference (ToR) agreed to by the Committee

prioritized finalizing the essential composition, product definitions, and labelling requirements as well as developing proposals for the scope and considering options for the structure of the standard. It is the view of the U.S. that the Committee should remain focused on completing the important work of finalizing the structure, scope, compositional and labelling parts of the standard during this year’s meeting. The U.S. suggests that the preamble discussion occur after finalizing other elements of the standards as the decisions on scope, labelling, definitions, and structure will impact the scope of the preamble. Thus, the U.S. supports finalizing the essential composition, labelling, scope, and product definition pieces of the standard to progress the work on this Standard. The U.S. is of the view that it is necessary to have robust discussion of the structure and deliberate consideration of the advice from CCEXEC75 before the discussing the Preamble text.

• The U.S. notes the advice from CCEXEC75 (2018) and CCEXEC77 (2019) and agrees that including references in standards should be considered on a case-by-case basis, as appropriate for providing context and supports inclusion of additional technical and science-based information to assist members in better understanding the basis and use of standards.

• The U.S. supports the CCEXEC advice that concepts and technical information can be

incorporated into the text of the standard itself, rather than referencing sources external to Codex; and references must be relevant to the scope of the standard itself, fall within the mandate of Codex, have a scientific basis, and have been developed through a transparent process.

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4D: Proposed draft follow up formula for older infants and [product] for young children (at Step 4)

Documents: CX/NFSDU 19/41/5 CX/NFSDU 19/41/5 Add.1 - Comments in reply to CL 2019-78-NFSDU Background: At CCNFSDU40 (2018), the Committee agreed to re-establish the Electronic Working Group (EWG) chaired by New Zealand and co-chaired by France and Indonesia and working in English to address the issue of Dextrose Equivalence (DE) and the sentence in square brackets in section 3.2.1 (See paragraph 33 of REP19/NFSDU) and to complete the remaining sections as follows

o purity requirements o vitamin compounds and mineral salts o consistency and particle size o specific prohibitions o food additives o contaminants o hygiene o packaging o fill of container o methods of analysis and sampling

U.S. Position: The United States provided the following responses and comments to the Codex Secretariat in response to Circular Letter (CL) 2019/78/OCS-NFSDU: Request for comments at Step 3 on the Review of the Standard for follow-up formula: proposed draft standard for follow-up formula for older infants and [product] for young children. Each comment below corresponds with a recommendation within CL 2019/78/OCS-NFSDU. For example, “Comment 1” below is the U.S. response to Recommendation 1 within the CL. In addition, the United States also requested clarification regarding “optional ingredients.” Specifically, the U.S. posed the following question: If a manufacturer includes an optional ingredient, how is the inclusion of that ingredient able to be communicated to the consumer? Comment 1. The United States agrees with the sentence in bold and brackets and supports the deletion of the brackets because purpose of the carbohydrate in the [Name of Product] for young children is to provide energy, regulate blood glucose, spare protein, and assist in the breakdown of fats to prevent ketosis. For non-milk-based products which tend to have a bitter taste, use of other mono and disaccharides and/or glucose polymers should be permitted within the carbohydrate level constraints. The constraint of 10% of total calories from sugars (2.5 g 100kcal) and the maximum carbohydrate level limits sweetness in the product and we are not aware of a scientific basis for the exclusion of sucrose and/or fructose.

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Footnote 4) Lactose should be the preferred carbohydrates in [Name of Product] based on milk protein. For products not based on milk protein glucose polymers should be the preferred carbohydrates used. Mono- and disaccharides, other than lactose, should not exceed 2.5 g/100kcal (0.60 g/100kJ). National and/or regional authorities may limit this level to 1.25 g/100 kcal (0.30 g/100 kJ). Comment 2. The constraints on total calories and the maximum carbohydrate level limits sweetness in the [Name of Product] for young children. The United States agrees that the where possible, future proofing the Standard is desirable. However, potential future optional non-caloric or artificial sweetener- type ingredients that could impart “sweet taste” would be constrained by the requirement that a particular nutritional purpose is needed for addition and imparting “sweet taste” is not a nutritional purpose. In addition, sweet taste is subjective, has no definition, and is not enforceable. The United States requests deleting the sentence in square brackets as it does not provide future proofing of the Standard. We also note that artificial sweeteners have not been adequately studied for use in children and should not form a significant part of a child’s diet according to the American Academy of Pediatrics as well as other associations. Comment 3a. The United States agrees with the Purity Requirements as they are identical to the those in the Infant Formula Standard, with the clarification of the age range for the older infant of 6-12 months and accepts the removal of the brackets[older] to retain the term “older” to differentiate the age range appropriately. Comment 3b. The United States agrees with the Purity Requirements as they are consistent other relevant Codex documents with the clarification of the age range for young children and the removal of the brackets [Name of Product] to differentiate the age range appropriately and insert the “name of product” once the name has been decided. Comment 4a. The United States agrees with Recommendation 4 to use the text found in the Infant Formula Standard regarding Vitamin Compounds and Mineral Salts as it is consistent with the committee’s agreement to use text from the Infant Formula Standard wherever appropriate. However, the United States requests clarification on what sections of the proposed Standard are being referred to by mention of “Sections 3.3.1 and 3.2.2.” Comment 4b. The United States agrees with recommendation 4 to use the text found in the Follow-up Formula Standard regarding “Vitamin Compounds and Mineral Salts.” . However, the United States requests clarification on what sections of the proposed Standard are being referred to by mention of “Sections 3.3.1 and 3.2.2.” In addition, the current draft Standard for [Name of Product] for young children includes a prohibition on the addition of sodium chloride; therefore, we also support the deletion of: “The amounts of sodium derived from vitamin and mineral ingredients shall be within the limit for sodium in Section 3.2.6 in the proposed Standard for [Name of Product] for young children” because the sodium content from vitamin and mineral salts is constrained by the limited number of required nutrients. Comment 5a. The United States agrees with recommendation 5 to have the product free of lumps and large coarse particles as proposed because such components can lead to gaggling, choking, and/or product refusal by the infant consuming follow- up formula for older infants..

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Comment 5b. The United States agrees with recommendation 5 to have the product free of lumps and large coarse particles as proposed because such components can lead to gaggling, choking, and/or product refusal by young children consuming [Name of Product] beverage. Comment 6a. The United States agrees with recommendation 6 that follow-up formula and its components for older infants be specifically prohibited from being treated by ionizing radiation consistent with other Codex Standards for foods for infants. Comment6b. The United States agrees with recommendation 6 that the [Name of Product] for young children and its components for young children be specifically prohibited from being treated by ionizing radiation consistent with other Codex Standards for foods for young children. However, we suggest consistency in the text for both follow up formula for older infants and [Name of Product] for young children copied below. Specific prohibitions The product and its components shall not have been treated by ionizing radiation unless such radiations were rendered safe for young children and permitted in other appropriate Codex Standard. Comment 7a. The United States agrees with recommendation 7 that follow-up formula for older infants retain the permissions for food additives as stated above: That CCNFSDU agree to retain the permissions for food additives (excluding flavourings) in the current Follow-up Formula Standard (CXS 156-1987), for follow-up formula for older infants, noting these will be replaced by a reference to the corresponding sections of the General Standard for Food Additives (GSFA) following the completion of the alignment work. Comment 7b. The United States agrees with recommendation 7 that the product for young children as stated above: That CCNFSDU agree to retain the permissions for food additives (excluding flavourings) in the current Follow-up Formula Standard (CXS 156-1987), for follow-up formula for older infants, noting these will be replaced by a reference to the corresponding sections of the GSFA following the completion of the alignment work. Comments 8a and 8b. The United States agrees with both part a and b under Recommendation 8 as stated.

a) That CCNFSDU agree to administrative changes i – iii, and to aligning the names of food additives in the current Follow-up Formula Standard with those in the GSFA (see Appendix II for administrative changes) b) That CCNFSDU consider if ‘Packaging gases’ should be included in the Food Additive section and listed under the appropriate functional class, noting also Recommendation 13 to retain them in Section 7 Packaging.

Comment 9a. The United States agrees with Recommendation 9 with support for Option 2 as recommended by the Chair. Option 2 which corrects the reference in the appropriate sections from the Preamble of the GSFA (Section 4 (CXS192-1995)) are included in the proposed Standard for Follow-up Formula for older infants. Comment9b. The United States agrees with Recommendation 9 with support for Option 1, as young children are already consuming foods for the general population.

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Comment 10a. The United States agrees with Recommendation 10 regarding section 4.5 Flavourings and supports the removal of the brackets and acceptance of the sentence as stated for inclusion in the proposed Standard for Follow-up Formula for Older Infants: The flavourings used in products covered by this standard should comply with the Guidelines for the Use of Flavourings (CXG 66-2008). The U.S. is not clear if the options for flavourings is limited to those listed or if other options are permitted. We do not understand the basis for limiting the types of flavors. Comment 10b. The United States agrees that the proposed Standard for [Name of Product] for young children should include: The flavourings used in products covered by this standard should comply with the Guidelines for the Use of Flavourings (CXG 66-2008), we question the need for the inclusion of the list of specific flavourings under 4.5 since young children are exposed to many other flavors in complementary foods that could be considered for the [Name of Product] for young children. Comment 11a. The United States agrees with the text provide under Recommendation 11 regarding “Contaminants” to be included in the proposed standard for Follow-up Formula for older infants. Comment11b. The United States agrees with the text provide under Recommendation 11 regarding “Contaminants” to be included in the proposed standard for [Name of Product] for young children. Comment 12a. The United States agrees with Recommendation 12 and supports the removal of the brackets so that the additional relevant processing and packaging hygienic practices are included (CXC-40-1993) and (CXC23-1979) in the proposed standard for Follow-up Formula for Older Infants. Comment 12b. The United States agrees with Recommendation 12 and supports the removal of the brackets so that the additional relevant processing and packaging hygienic practices are included (CXC-40-1993) and (CXC23-1979) in the proposed standard for [Name of Product] for young children. Comment 13a. The United States agrees with Recommendation 13 regarding the safeguarding of “packaging” for the proposed Standard for Follow up Formula for Older Infants. Comment13b. The product shall be packed in containers which will safeguard the hygienic and other qualities of the food. When in liquid form, the product shall be packed in hermetically sealed containers; nitrogen and carbon dioxide may be used as a packing media. The containers, include ng packaging materials, shall be made only of substances which are safe and suitable for their intended uses. Where the Codex Alimentarius Commission has established a standard for any such substance used as packaging materials, that standard shall apply. Comment 14a. The United States agrees with Recommendation 14 regarding the fill of containers for the proposed Standard for Follow-up Formula for Older Infants.

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Comment14b. The United States agrees with Recommendation 14 regarding the fill of containers for the proposed Standard for [Name of Product] for young children. We also note, that because the standards are planned to be separated, the numbering will need to be updated. Comment 15a. The United States agrees with Recommendation 15 regarding the Methods of analysis and sampling for the proposed Standard for Follow-up Formula for Older Infants. Comment 15b. The United States agrees with Recommendation 15 regarding the Methods of analysis and sampling for the proposed Standard for [Name of Product] for young children.

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AGENDA ITEM 5 – READY-TO-USE THERAPEUTIC FOODS (RUTF)

5A: Proposed Draft Guideline for RUTF

(at Step 4)

Documents: REP19/NFSDU, Appendix V Background: • At CCNFSDU36 (2014), the United Nations Children’s Fund (UNICEF) presented a

discussion paper and recommended that CCNFSDU consider the development of a Standard for Ready to Use Foods (RUF). UNICEF was asked by CCNFSDU to prepare a revised discussion paper and project document, with the support of Senegal for CCNFSDU37.

• At CCNFSDU37 (2015), the Representative from UNICEF presented a discussion paper for the development of a Guideline for use in the management of severe acute malnutrition. The Committee agreed to establish an Electronic Working Group (EWG), led by South Africa and co-chaired by Senegal and Uganda, working in English and French, to develop the proposed guideline for consideration at CCNFSDU38 (2016).

• At CCNFSDU38 (2016), CCNFSDU39 (2017), and CCNFSDU40 (2018), the Committee agreed on the following sections of the guideline: outline, purpose, scope, description, raw materials and ingredients. Sections regarding recommendations on the preamble, food additives, and quality of protein remain to be discussed during CCFNSDU41 (2019).

U.S. Position: Preamble: The United States continues to support a concise preamble that provides context for a technical guideline for RUTF. The United States prefers:

• In para. 1, the first sentence “RUTF is an option used to manage severe acute malnutrition (SAM)”. For some national authorities, the word treatment could imply that RUTF is used as a drug.

• In para. 2, use of the word ‘guidelines’ rather than ‘requirements’ because this is a Guideline not a Standard and notes that the purpose of the guideline is addressed in the ‘Purpose’ section;

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• In para. 2, delete the second and third sentences as the mission of Codex Alimentarius addressed in these sentences are implicitly inferred by the creation of a Codex text and dispute clauses are generally not included in Codex texts;

• In para. 2, language is included to explain that technical recommendations are based on transparent and rigorous scientific review of relevant scientific evidence;

• RUTF labelling states that RUTF is not a breastmilk substitute. The United States questions the need to include references pertaining to the marketing of breastmilk substitutes because RUTF is not a breastmilk substitute, not available for retail sale and only used in food aid. Further, WHA resolutions, both current and subsequent, are not specified making it unknown which resolutions are considered relevant. For footnote 1, the United States supports deletion of the “Code and subsequent and relevant WHA resolutions” as it is our view that they do not pertain to the relief and limited duration of use of RUTF in a severely malnourished population

US Proposed text: RUTF is an option used to manage severe acute malnutrition (SAM). The primary focus for these guidelines pertains to the use of RUTF for children with uncomplicated SAM from 6-59 months. However, RUTF may be given to other age groups with various forms of malnutrition at the implementation level. Since RUTF are prescribed according to weight, National Authorities may decide to include the provision of RUTF in their national protocols for use by other age groups. These guidelines should be used in accordance with technical recommendations based on transparent and rigorous review of relevant scientific evidence and related Codex texts2. Appendix V Item 4 Description The United States continues to have the position that RUTF are a food for special dietary use and does not support classification of these products as a food for special medical purposes.

• 5.1.2 Legumes and Seeds:

The United States questions the need to reduce phytoestrogens. Removal of these substances can substantially increase ingredient cost and decrease nutritional value and is technically complex. This requirement may limit local innovation and the use of locally sources legumes and seeds. We are not aware of evidence that intake of

2 A Joint Statement by the World Health Organization, the World Food Programme, the United Nations System Standing Committee on Nutrition and the United Nations Children’s Fund. 2007.

Community-Based Management of Severe Acute Malnutrition; A Joint Statement by the World Health Organization and the United Nations Children's Fund. 2009.

Child growth standards and the identification of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation. 2013. Guideline:

Updates on the management of severe acute malnutrition in infants and children, Geneva: World Health Organization; World Health Organisation. 2003.

Global Strategy for Infant and Young Child Feeding, Geneva: World Health Organization; World Health Organisation. 1981.

Code of Ethics for International Trade in Food including Concessional and Food Aid Transactions (CXC 20-1979);

Food and Agriculture Organisation and World Health Organisation. 2016. FAO/WHO Microbial safety of lipid-based ready-to-use foods for management of moderate acute malnutrition and severe acute malnutrition, Rome: Food and Agriculture Organisation.

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phytoestrogens from legumes and seeds for the relatively short time that RUTF will be used to manage SAM has any negative consequences to justify the proposed restriction.

• 5.2.1 Carbohydrates:

The United States supports the text as shown below. But notes that while they are an important source of energy, acknowledges that they are also used to improve palatability.

[Carbohydrates are used to achieve energy requirements in balance with proteins and lipids. Plant starch, lactose, maltodextrin, and sucrose are the preferred carbohydrates in RUTF. Free sugars should be limited and should not exceed 20% of total energy. Only pre-cooked and/or gelatinized starches may be added. Carbohydrates must adhere to the relevant Codex Alimentarius texts. Honey should not be used in RUTF due to the risk of infant botulism from clostridium botulinum.]

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5B: Section 5.2.2 (Food Additives) and Section 6.2 (Proteins) Documents: CX/NFSDU 19/41/6-Add.1 Comments in reply to CL 2019/79 NFSDU CX/NFSDU 19/41/6 Background: At CCNFSDU 40 (2018) the Committee made good progress on much of the Guideline but did not complete work. The terms of reference for the Committee’s continued work were to continue drafting the guideline based on the work at CCFNSDU39 (2017) and in particular for Section 5.5.2 (Food Additives) and Section 6.2 (Proteins). U.S. Position: The United States provided the following responses and comments to the Codex Secretariat in response to Circular Letter (CL) 2019/79/OCS-NFSDU: Request for comments at Step 3 on section 5.2.2 (food additives) and section 6.2 (proteins): proposed draft Guidelines for Ready-to-Use Therapeutic Foods (RUTF). Each comment below corresponds with a recommendation within CL 2019/79/OCS-NFSDU. Recommendation 1: That CCNFSDU agree to the proposed list of food additives and their functional class in Table I (in CL 2019/79/OCS-NFSDU) for use in RUTF and that the table be utilized as the basis for further discussions on additives in RUTF. Comment United States of America: We support Recommendation 1 as the preferred approach and can also support referencing other commodity standards as appropriate. Recommendation 2: Seeking advice from CCFA It is recommended that CCNFSDU agree to ask the Codex Committee on Food Additives (CCFA) to confirm if RUTF Guidelines belong to Food Category (FC) 13.3; and if FC 13.3 is the right FC, then CCFA should consider aligning the proposed food additives listed in Table I of this document with FC 13.3 of the General Standard for Food Additives (GSFA). Comment United States of America: As this document is a guideline rather than a formal standard we do not feel it is necessary to define a FC for RUTF and therefore there is no need to consult with CCFA. We prefer the approach of agreeing the technological justification for additive classes as per Table I. Consultation with CCFA will not add enough value and will create unnecessary delay in completing this work.

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Recommendation 3: That CCNFSDU agree to the following texts on “Carry-Over of Additives and Carriers” in RUTF Guidelines: Proposed Texts Only the food additives referenced in this Section or in the Advisory List of Nutrient Compounds for Use in Foods for Special Dietary Uses Intended for Infants and Children (CXG10-1979) may be present in the foods described in section 2.1 of this Standard, as a result of carry-over from a raw material or other ingredient (including food additive) used to produce the food, subject to the following conditions:

a) The additive is acceptable for use in the raw materials or other ingredients (including food additives) according to the General Standard for Food Additives (CXS 192-1995) b) The amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximum use level specified in the General Standard for Food Additives (CXS 192-1995); and c) The food into which the additive is carried over does not contain the additive in greater quantity than would be introduced by the use of the raw materials or ingredients under proper technological conditions or good manufacturing practice, consistent with the provisions on carry-over in the Preamble of the General Standard for Food Additives (CXS 192-1995).

Comment United States of America: We support recommendation 3 as a practical approach to carry over additive and feel this approach provides enough flexibility while being responsible. Recommendation 4: That CCNFSDU agree to the proposed texts on protein quality assessment in RUTF Guidelines.

Recommendation 4.1: That CCNFSDU agree to the proposed protein values of the Guidelines for RUTF.

Unit Minimum Maximum GUL g/100g 13 16.5 - g/100kcal 2.4 3.2 -

Recommendation 4.2

That CCNFSDU agree to the proposed texts on protein quality assessment in RUTF Guidelines.

Proposed texts

Protein should provide 10% to 12% of the total energy. Protein quality should be determined using protein digestibility-corrected amino acid score (PDCAAS), calculated according to the

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reference amino acid requirement and scoring patterns related to catch up growth of 10 g/kg/day in the target population of children 6 to 59 months for RUTF. The PDCAAS shall not be less than 90, when determined using PDCAAS methodology, appropriate fecal Digestibility values and the reference amino acid pattern in the Report of the FAO Expert Working Group: Protein quality assessment in follow- up formula for young children and ready to use therapeutic foods. High quality protein will be achieved with RUTF formulations containing a minimum of 50% of protein from milk products.

In formulations with lower scores, the quality and/or quantity of protein should be adjusted to achieve the de- sired value. The quality of protein can be achieved by adding the limiting amino acids. Any added amino acids should be solely in the L-form and included only in amounts necessary to improve the protein quality of the RUTF.

Comment United States of America: We support recommendations 4.1 and the Text in 4.2. These text provide the needed flexibility for selecting high quality proteins and that high quality proteins can be achieved with RTUF formulations containing a minimum of 50% protein from milk. Recommendation 5: That CCNFSDU agree to the proposed texts on “Processing Technologies in RUTF Guidelines. Proposed Texts Processing Technologies Processing technologies used for RUTF and their ingredients shall be validated to prove that they do not alter the nutritional value of RUTF and that they allow the reduction of anti-nutritive factors. Milling or grinding, roasting, toasting are examples of processing technologies that can be used on ingredients. Any technologies used should take into consideration the target group and any impact on the integrity of the nutrient content of the products. In addition to the practices described above, Good Hygiene Practices should be implemented for manufacturing of RUTF, according to the General Principles of Food Hygiene (CXC 1-1969) and Code of Hygienic Practices for Low Moisture Foods (CXC75-2015) to avoid cross contamination during the storage of raw materials and the manufacturing process. RUTF and/or their raw materials should be treated with a validated microbial reduction treatment in order to inactivate pathogens such as Salmonella, noting that some pathogens have increased heat resistance characteristics at reduced water activities in food matrices. Commonly used microbial reduction treatments that could be applied to RUTF and/or their raw materials include both thermal and non-thermal control measures. For additional information on validation of control measures, refer to the Guidelines for the Validation of Food Safety Control Measures (CXG 69-2008). Additionally, refer to the Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM) (CXG 63-2007). Comment United States of America: We support the text in recommendation 5. However, we note that some processing technologies may alter the nutritional quality of an ingredient such as

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those used to lower antinutritional factors. So long as the change in nutritional quality is corrected for by adding back those nutrients lost the ingredient may still be suitable for use in RUTF.

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AGENDA ITEM 6 – TRANS-FATTY ACIDS (TFAs)

6A: Proposed Draft Claim for ‘free’ of Trans Fatty Acids (held step 4)

Document: REP19/NFSDU, Appendix VII Background: • At the 41st Session of the Codex Committee on Food Labelling (CCFL41, 2013 2013), the

CCFL requested CCNFSDU to establish conditions for “free” of trans fat claims, to be included in in the Guidelines For Use of Nutrition and Health Claims (CAC/GL 23-1997). At the same time, CCFL also sought advice from the Codex Committee on Methods of Analysis and Sampling (CCMAS) concerning a method of analysis for TFAs.

• At CCNFSDU36 (2014), Canada, proposed conditions for a “free” of trans fatty acids (TFA) claim and reported that the WHO Nutrition Guidance Advisory Group (NUGAG) guidance was not yet available. Due to concerns about methodological issues, the Committee agreed to defer discussions until the outcome of the WHO NUGAG report and receipt of advice from CCMAS on whether current analytical methods can accurately and reliably detect TFAs at the proposed level of 0.1 g trans fat per 100 g or per 100 ml.

• At the 36th Session of the Committee on Methods of Analysis and Sampling (CCMAS36, 2015), CCMAS pointed out that it would not be possible to establish a single level for TFA for all foods, but that CCNFSDU would have to develop separate levels for different commodities.

• At CCNFSDU37 (2015), the Committee deferred discussion on this matter until the WHO NUGAG final results. Meanwhile, the WHO issued the technical report “Effect of trans-fatty acid intake on blood lipids and lipoproteins: a systematic review and meta-regression analysis” (Brouwer, I.A., Geneva, World Health Organization, 2016) although the WHO NUGAG draft guidelines had not yet been issued.

• At CCNFSDU 38 (2016) Canada presented a revised discussion paper on findings from two WHO systematic reviews on saturated fat and trans fatty acids. In the presentation, Canada noted the comments made at CCNFSDU36 (2014) and CCMAS36 (2015) that “the methods of analysis for determining TFAs should be practical and internationally accepted as well as being reliable and consistently reproducible.” Based on this, the Committee agreed to request advice from CCMAS on the three methods that could be applied to determine TFA as defined in the Guidelines on Nutrition Labelling (CAC/GL 2-1985) and the WHO definition, which specifies at least one double bond in the trans configuration at the level of 1 g per 100 g of fat. Based on the reply from CCMAS, the Committee will further consider the proposed claim.

• At CCMAS38 (2017), for trans fatty acids, the Committee agreed to forward information on the methods identified by CCNFSDU on the matrices and levels for which they had been validated for their consideration (Appendix II, part 3).

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• At CCNFSDU39 (2017), the Committee discussed the condition for low saturated fat, noted

the ingredient of concern was industrially produced trans fat and queried if other regulatory approaches rather than a free claim would be more effective.

U.S. Position: The United States recognizes the strong evidence in the relationship between trans fat intake and saturated fat and increased LDL-cholesterol concentration, a surrogate endpoint for coronary heart disease risk. The United States therefore recognizes the importance of declaring the amount of trans fat on the food label to assist consumers in maintaining health dietary practices, and when possible relevant nutrient content claims. The United States is of the view that:

• The three proposed analytical methods do not measure the proposed TFA level in all foods and are may not be globally applicable

• An accompanying condition for saturated fat is consistent with public health objectives but the U.S. queries whether the proposed condition for ‘low’ achieves its objective of helping consumers maintain healthy dietary practices because the condition would prevent claims on oils high in unsaturated fatty acids recommended in many national dietary guidelines.

The United States views that the proposed level of 1 g trans fat per 100 g of fat cannot be accurately and precisely measured based on the available collaborative study data on the analytical methods (Table 1). While the three proposed current analytical methods may detect the proposed level of trans fatty acids, the methods do not accurately and precisely measure the proposed level of 1g per 100 g of fat based on the available collaborative study data on limited food matrices. Moreover, the methods may not work well for all foods. Accurate determination can be achievable for specific foods and in specialized labs with highly trained and experienced analysts but may not be globally applicable. The findings from multi-lab validation studies, such as those discussed in Table 1, are a more appropriate source of information about the analytical method than what occurs with specific analysts within a specific lab. The United States is concerned that basing the claim on 100 g of fat versus 100 g of product could potentially limit trans fatty acids ‘free’ claims on products with low levels of total fat and exclude the use of oils containing low levels of trans fat when use of that oil in the product may be low. While we support inclusion of a condition for the saturated fatty acid (SFA) as part of a proposed “free” claim for trans fatty acids, the U.S. is concerned that the conditions for ‘low’ in saturated fats in the Guidelines for the Use of Nutrition and Health Claims (CXG 23-1997)3 may exclude products such as some vegetable oils that are important sources of unsaturated fatty acids, including the essential fatty acids recommended in national dietary guidelines. Modeling using the proposed trans fat level with various saturated fat thresholds would help to identify which products could bear the proposed claim, which would thereby assist consumers to maintain healthy dietary practices. 3 1.5 g of saturated fat per 100 g (solids); 0.75 g saturated fat per 100 mL (liquids) and 10% of energy from saturated fat

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6B: Discussion Paper on Risk Management possibilities for the reduction of TFAs

Documents: REP19/NFSDU, Appendix VII CX/NFSDU 19/41/7 Background:

• At CCNFSDU40 (2018), the Committee agreed to suspend the discussion on the proposed draft condition for a claim for “free” of TFAs (Appendix VII) and have Canada prepare a discussion paper on different risk management possibilities for the reduction of TFAs within the mandate of Codex for consideration by its next session.

U.S. Position: The United States supports the Committee finding an appropriate way of supporting the public health goal of limiting and/or eliminating the intake of industrial produced trans fatty acids.

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AGENDA ITEM 7 - PROPOSED DRAFT DEFINITION FOR BIOFORTIFICATION (AT STEP 4)

Document: REP19/NFSDU, Appendix VI Background:

• This agenda item was approved as new work at CAC38 (2015). Since CCNFSDU37 (2015), Zimbabwe and South Africa have co-chaired the EWG to develop a proposed draft definition.

• Work to date has considered criteria for necessary elements in a definition, a proposed definition, proposed use of the definition, and where it could reside in a Codex text.

• The 45th session of the Codex Committee on Food Labelling (CCFL45, 2019) acknowledged the tremendous work done by CCNFSDU but agreed that current labeling texts were adequate for CCFL purposes and there was no need for a definition of biofortification in the context of food labelling.

• CAC42 referred the matter to CCNFSDU for further discussion and possible discontinuation in light of CCFL’s conclusions.

U.S. Position: The United States supports the conclusions of the CCFL and CAC. Unless a clear need for a definition of biofortification is agreed at CCNFSDU41, our position would be to discontinue the work on biofortification and focus the Committee’s resources on completing work on other agenda items and considering proposals for new work. The United States notes that the World Health Organization (WHO) posted guidance and a definition of biofortified crops in 2019 (see https://www.who.int/elena/titles/biofortification/en/) which appears to be accepted and, therefore, it is our view that there is no need for Codex to develop a separate definition.

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AGENDA ITEM 8 – DISCUSSION PAPER ON NUTRIENT REFERENCE VALUE REQUIREMENT (NRV-R) FOR OLDER INFANTS AND YOUNG CHILDREN Document: CX/NFSDU 19/41/8 Background: • Within Codex, NRV-Rs for children (4 years and older) and adults have been established.

The recommended use of these values in both labeling and claims is covered in a variety of Codex texts.

• At CCNFSDU39 (2017), it was agreed to take on new work because NRV-Rs and their use

in labelling and claims for children under the age of 4 had not been covered by previous Codex work. An electronic working group (EWG) was established and chaired by Ireland and co-chaired by Mexico and the United States.

• At CCNFSDU40 (2018), the EWG presented its findings and the Committee agreed to

continue discussing several recommendations of the EWG. The Committee agreed to develop a list and prioritize vitamins and minerals for which NRV-Rs should be established. The Committee also agreed to consider the inclusion of protein for NRVs-R for older infants and young children required based on existing Codex texts. Lastly, the Committee also agree to determine which NRV-Rs were to be allocated/applied to which of the existing Codex texts.

U.S. Position: The United States supports new work: to develop science-based principles for establishing NRVs-R for older infants and young children; determine which nutrients require NRVs-R for a) older infants and b) young children; and consider how the list of nutrients may apply to relevant Codex texts. Recommendation 1 – standardization of age ranges The age ranges for older infants and young children should be standardised throughout all relevant Codex texts as follows:

Older infants are aged from 6 months to not more than 12 months Young children are from the age of more than 12 months up to the age of 3 years (36 months)

For the purposes of NRVs-R, this interpretation of when older infants become young children, is based on the point of differentiation being the end of the day on the 1stbirthday. If agreement on this is difficult to achieve, the current wording of the specific age boundaries in the Codex texts should continue to be used (even though these age

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boundaries are not exactly the same across all Codex FSDU texts, the meaning is generally understood). The United States supports a standardized age range that is used throughout Codex texts. Consistency in age range across relevant Codex texts would reduce confusion and assist with interpretation and implementation of Codex texts. The United States views the 6 to < 13 months and 6 to < 12 months ranges to reflect the same physiological development and nutrient needs. The United States prefers 6 to < 13 months (from 6 months up to, and including, 12 months) as it aligns more closely with the Institute of Medicine Dietary Reference Intakes. However, the United States also recognizes that RASBs vary how they delineate between older infants and young children. Recommendation 2 – Nutrient declaration and location of NRVs-R The NRVs-R for older infants and young children be located in the Guidelines on Nutrition Labelling and apply to foods for special dietary uses (FSDU). Application of these NRVs-R to general foods require further discussion at plenary. Note: While the majority of the Electronic Working Group (EWG) were in favour of applying these NRVs-R to general foods, a minority wanted these limited to FSDU only. One CM wanted application of NRVs-R to general foods for young children but not older infants. The United States supports housing NRV-Rs for older infants and young children in Guidelines on Nutrition Labelling (GNL). The GNL contains the definition for NRVs-R and lists values for NRVs-R that have been established for the general population. Putting the NRVs-R for older infants and young children in the GNL will allow for:

• revisions to one overarching Codex text instead of multiple FSDU texts • broader applicability and would include general foods as well as FSDU • flexibility for national authorities that permit claims on foods specifically labelled for older

infants and young children • nutrient declaration information to help parents make healthy and appropriate dietary

choices for their children. The United States agrees that NRVs-R for older infants and young children should also apply to all foods intended for older infants and young children. Establishing NRVs-R for these age groups would allow member countries flexibility to provide nutrient declaration on all foods directed to older infants and young children. The 2018 EWG (CX/NFSDU 18/40/10) reported that almost all member countries report having ‘general’ foods (foods intended for older infants and young children but are not covered by the FSDU texts discussed) for sale in their jurisdiction. Examples of such products sold in the United States are fortified baby cereals, pureed fruits, vegetables, pureed meats, and mixture of these baby foods, crackers, puffs. Having NRVs-R for general foods for this age group would provide information and help parents make choices for a healthy diet. While most foods could refer to one set of NRVs for older infants or young children, concerns about labelling for older infants and young children could be addressed by dual column labelling.

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Recommendation 3 – Guiding vitamin and mineral composition The decision on whether these NRVs-R should be used to guide vitamin and mineral composition in the Guideline on Formulated Complementary Foods for Older Infants and Young Children, should be deferred until the General Principles are established. This will also allow consideration of the potential use of these NRVs-R as reference criteria for the optional addition of vitamins and minerals in other relevant FSDU texts. The United States views nutrient requirements to underpin labelling reference values as well as guide vitamin mineral composition. The United States supports using one set of NRVs-R based on the most recent science to guide vitamin and mineral composition. Recommendation 4 – reference criteria for claims under national legislation NRVs-R for older infants and young children should be established in the Guidelines on Nutrition Label-ling and be used as reference criteria by jurisdictions where such claims are permitted. The United States supports establishing NRVs-R for older infants and young children in the Guidelines on Nutrition Labelling and using the NRVs-R as reference criteria for nutrition and health claims where provided for in national legislation. This approach aligns with the Guidelines on Use of Nutrition and Health claims (CAC/GL 23-1997). The United States view is that NRVs could provide the basis for some claims, particularly when a claim has a strong scientific and public health basis to support it. Recommendation 5 – NRVs-R for vitamins and minerals That NRVs-R for older infants and young children be established for all 13 vitamins (including folate instead of folic acid) and 9 minerals (excluding molybdenum). The United States supports setting NRVs-R for all 13 vitamins (vitamins C, A, D, E, K, B-6, B12, thiamin, riboflavin, niacin, pantothenic acid, folate, and biotin) and 10 minerals (calcium, iron, zinc, iodine, magnesium, phosphorus, selenium, copper manganese and molybdenum). These vitamins and minerals have NRVs-R already established in the Guidelines in Nutrition Labelling for the general populations and are essential for human health and play a vital role in growth and healthy development for older infants and young children. Each nutrient serves multiple functions. For example, vitamin C protects cells from damage; and is important for wound healing, iron absorption, and proper immune function. Examples of other nutrient functions are:

• Calcium, vitamin D, phosphorus and magnesium are essential for bone and muscle health.

• Vitamin A is important for vision, vitamin E for protecting cell membranes, and vitamin K for blood clotting.

• B vitamins (riboflavin, niacin, B-6, B-12, pantothenic acid, biotin and folic acid) assist in energy metabolism.

• Other minerals (i.e. iron, zinc, iodine, selenium, copper, manganese, molybdenum) function as components of enzymes that needed for healthy growth and development.

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Recommendation 6 – NRV-R for protein That an NRV-R be established for protein for older infants and young children separately and as a combined group. The United States supports setting a NRV-R for protein for older infants and young children separately. Protein is essential for the rapidly growing body of an infant and child, as well as for recovery from illness or injury. Infants and young children have different protein requirements. Establishing an NRV-R for protein will provide important information to parents and caregivers about protein needs in the context of a daily diet. Recommendation 7 – Prioritization when establishing NRV-Rs That the priority rankings provided by the eWG be used to inform and help direct the work when the General Principles are being established. The United States notes the Committee has not yet discussed the process for establishing NRVs-R for older infants and young children. NRVs-R for the general population were established based on dietary reference intake values set by recognized authoritative bodies. Should the same process be applied, the United States supports a general prioritization approach for both older infants and young children that:

• prioritizes nutrients that are listed as mandatory for product composition and labelling in Codex texts

• clusters nutrients that function similarly together for both infants and young children • acknowledges the nutrient’s role in growth and development

If NRVs-R are established de novo, the United States supports an approach that prioritizes nutrients of public health importance as determined by prevalence of inadequate intakes, status and/or deficiency or disease. Group 1 Nutrients Calcium, vitamin D, phosphorus, magnesium Protein, vitamin A, iron, zinc, iodine Group 2 Nutrients Vitamin E, vitamin C, vitamin K, copper Thiamin, niacin, riboflavin, vitamin B-6, vitamin B-12, folate Group 3 Nutrients Pantothenic acid, biotin, manganese, selenium, molydenum

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AGENDA ITEM 9 – FOOD ADDITIVES

9A: Mechanism/framework for considering technological justification of food additives

Document: REP19/NFSDU, Appendix VIII

Background: • At CCNFSDU37 (2015), the Committee agreed to cease using a working list of additives

(“wish list”) and discussed the future work to align CCNFSDU commodity standards with the Codex food additive standards. The Codex Secretariat informed the Committee of the procedures for entry of new substances and/or revision of adopted food additives provisions in the GSFA and discussed establishing a priority list of substances for evaluation by JECFA.

• At CCNFSDU (2016) the Electronic Working Group (EWG) chairs, European Union and the

Russian Federation, presented a framework for confirming the technological justification for food additives. The Chairs managed the EWG consultations, which the United States participated. The Committee continued to discuss the framework at plenary and at in session working groups.

• At CCNFSDU40 (2018), the Committee held an in-session Working Group chaired by the EU to review Annex A and Annex B of CX/NFSDU 18/40/11. Significant progress was made on the Mechanism/Framework for Considering Technological Justification of Food Additives (see Annex 1 and 2 of Appendix VIII of REP19/NFSDU). However, due to a lack of time, work was not completed on Question 3 of the framework, and the Committee was unable to appraise the technological need of xanthan gum (INS 415), pectin (INS 440) and gellan gum (INS 418). The Committee agreed to establish a PWG to meet immediately prior to CCNFSDU41, chaired by the European Union and co-chaired by the Russian Federation, working in English, French and Spanish, to further consider: i) the text in square brackets (Appendix VIII), ii) the questions under question Q3 in document CX/NFSDU 18/40/11; and iii) appraise the technological need for the proposed use of xanthan gum (INS 415), pectin (INS 440) and gellan gum (INS 418) taking into account the information submitted by the applicant (See CX/NFSDU 18/40/11 Annex D).

U.S. Position: PWG term of reference (i) “the text in square brackets (Appendix VIII)” Revisions to Question 3 in Annex 2 of Mechanism/Framework for Considering Technological Justification of Food Additives (see Appendix VIII of REP10/NFSDU). The following question (focused on text in brackets) will be discussed during the food additive PWG at CCNFSDU41:

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Q3. COMPLIANCE WITH THE APPROACH ON THE USE OF ADDITIVES IN FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN [Q3.1: Does the proposed food additive perform the same/similar technological purpose as other additives that have already been authorized for use in the same product category? If not, what is the justification for the need for an additive with a new functional class and/or technological purpose? If yes, what advantage(s) does the proposed additive provide over currently permitted options?] The United States does not support the last sentence of Q3.1: “If yes, what advantage(s) does the proposed additive provide over currently permitted options?”. The United States notes the apparent basis for this sentence is that if one food additive is already approved for a particular technological function, then another food additive performing the same technological function is not “needed”, or that, among additives found to be safe by JECFA certain additives are “safer” than others. The United States notes that this basis is in direct conflict with the dual mandate of Codex Alimentarius, which is to ensure both safe food and fair food trade practices. In order for a food additive provision to be adopted, it must have a relevant JECFA safety assessment, and for use in foods intended for infants that includes a risk assessment specific for infants less than 12 weeks of age. JECFA’s risk assessment for infants provides a specific maximum use level in infant foods below which the use of the additive is safe. JECFA does not determine if an additive is “safer” or “less safe” than another and using a JECFA assessment for this purpose is not appropriate. JECFA’s safety assessment specific to infants and its determination of the safe level of an additive in infant foods satisfy the “great caution” criteria for the use of an additive in foods intended for infants. Therefore, that another food additive may already be allowed for the same functional effect, is not relevant to safety and can only be used to promote unfair trade practices. PWG term of reference (ii): “ii) the questions under question Q3 in document CX/NFSDU 18/40/11” The US strongly opposes many of the other proposals suggested for Question 3 as described in CX/NFSDU 18/40/11. It is our hope that the focus of the discussion of Question 3 can be kept to the text in brackets as shown in Appendix VIII of REP19/NFSDU. In particular, the US does not agree with the implications in CX/NFSDU 18/40/11 that the Codex Committee on Food Additives (CCFA) endorsed an approach that certain food additives are “more suitable for use in baby foods” based on certain factors. This is not correct. The factors noted are taken from a discussion paper (CX/FA 11/43/5) authored by one Member delegation of CCFA. This discussion paper was a response to questions from CCNFSDU as to whether specific additives proposed for use in infant formula could be adopted into the infant standards without a JECFA assessment for infants under 12 weeks of age4 – any information from this discussion paper should only be considered in that context. The discussion paper proposed that it may be appropriate that additives that fell into certain groups could be adopted into standards for infant foods without a JECFA assessment specific to infants, but that additives that fell into other groups should have a JECFA assessment specific to infants prior to inclusion in those standards (CX/FA 11/43/5 paras 15 – 18). When CCFA43 (2011) considered the 4 It should be noted that, at that time, JECFA had recently revised its review paradigm for additives to be added to infant foods to include a specific review for infants.

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discussion paper it reiterated the current procedure, that proposals for inclusion of an additive in Codex standard for foods intended for infants below 12 weeks of age require a separate evaluation by JECFA (REP 11/FA, para 43). CCFA43 did not endorse an approach that additives that fall within certain groups are “more suitable for use in baby foods”. Rather, CCFA43 endorsed that the consideration for safety of new additives proposed for use in foods for infants is a JECFA evaluation for infants under 12 weeks of age. The United States supports the decision of CCFA43. PWG term of reference (iii): “appraise the technological need for the proposed use of xanthan gum (INS 415), pectin (INS 440) and gellan gum (INS 418) taking into account the information submitted by the applicant (See CX/NFSDU 18/40/11 Annex D)” The United States is of the opinion that sufficient information has been provided to demonstrate the technological need for the three additives under consideration. The three additives perform a technological function in the standardized food that CCNFSDU has already determined are needed in those foods.

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9B: Alignment of food additive provisions in CCFNSDU standards with the General Standard for Food Additives (GSFA)

Document: CX/NFSDU 19/41/9 Background: • At CCNFSDU40 (2018), the Committee noted that with the finalization of the CCFA

guidance document on the alignment of food additive provisions in commodity standards, CCNFSDU was now in a position to proceed with the alignment of food additive provisions in standards under its purview.

U.S. Position: The United States supports moving this work forward to align food additive provisions across CCNFSDU texts with the GSFA.

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AGENDA ITEM 10 – PRIORITIZATION MECHANISM TO BETTER MANAGE THE WORK OF CCNFSDU

Document: CX/NFSDU 19/41/10 Background: • At CCNFSDU40 (2019), in response to the request of CCEXEC75 (2018), the Committee

agreed to consider a forward work plan to prioritize and manage its overall work on a long-term basis. The Committee agreed that the host country would prepare a paper summarizing the work completed so far, some of the previously identified work that had not gone forward in the Committee, the currently ongoing work; and emerging issues to assist the Committee in prioritizing its future work. The paper would also incorporate the proposals for work on prebiotic guidelines and protein supplements for bodybuilding, which were not discussed at the current session due to time constraints.

U.S. Position: The United States strongly supports a process to prioritize work of the CCNFSDU. The United States agrees with the proposed criteria, not in order of importance (Revision of existing texts necessary due to new scientific findings and/or other developments; Request from CAC; Request from other Codex committees; Target group(s); Impact on public health; Impact on food safety; Impact on fair trade practices). The United States agrees proposals for new work should be provided in a discussion paper and reviewed by a standing ad hoc working group to evaluate new work proposals prior to the plenary session. The United States agrees with the terms of reference for the ad hoc working group to:

• conduct a case-by-case review of every proposal on the basis of a decision tree and the detailed rationale including the rating (high/medium/low impact) as presented in the discussion paper and to propose a list of work proposals ranked according to their priority.

• prepare a report to be presented to the plenary to enable CCNFSDU to evaluate and decide on the new work proposals.

The United States agrees that the Committee decides to submit a new work proposal and supports the use of the prioritization guideline drafted in Appendix A. Draft Guideline for the preliminary assessment and identification of work priorities for CCNFSDU. The United States strongly supports adherence to the Codex Procedural Manual. Proposals for new work should follow the process and criteria outlined in the Procedural Manual for Proposals to Undertake New Work or Revise a Standard, in addition to the following criteria specific to CCNFSDU.

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AGENDA ITEM 11 – DISCUSSION PAPER ON HARMONIZED PROBIOTIC GUIDELINES FOR USE IN FOODS AND DIETARY SUPPLEMENTS

Document: CX/NFSDU 19/41/11 Background: • At CCNFSDU39 (2017), an observer from the International Probiotics Association presented

a proposal to develop guidelines for a harmonized framework for probiotics to ensure and sustain the quality of probiotic products on a global scale. Argentina expressed their support and interest to lead this work.

• This work was discussed briefly at CCNFSDU40 (2018). The Committee requested that Argentina redraft the paper and elaborate further on the sections on scope, definition as well as health and trade concerns.

U.S. Position: The United States is still reviewing the discussion paper and has not formed a position at this time. We note however that in our view this work is lower in priority than proposed work on nutrient profiles.

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AGENDA ITEM 12 – DISCUSSION PAPER ON GENERAL GUIDELINES TO ESTABLISH NUTRITIONAL PROFILES

Document: CX/NFSDU 19/41/12 Background: • This work is at request of CCFL44 (2017) to establish general guidelines for the

development of nutrient profiles to complement CCFL electronic working group (EWG) work led by Costa Rica and New Zealand on front of pack labeling.

• At CCNFSDU39 (2017) and CCNFSDU40 (2018), Costa Rica, speaking also on behalf of Paraguay, presented a discussion paper with support of Paraguay. Costa Rica proposed to establish an EWG to further scope the new work and refine the project document; or to issue a circular letter to collect global information on models of nutritional profiles.

• At CCNFSDU40 (2018), the Committee agreed that it was premature to start new work and that Costa Rica will present a discussion paper at the next session that describes and evaluates the different existing nutrient profile models available.

U.S. Position: The United States appreciates the work of Costa Rica and Paraguay to develop the summary of nutrient profile models and offering a framework for further discussions. We support taking up new work on developing a guideline for establishing nutrient profiles as this is needed to complement the ongoing work at CCFL on front of package labeling.

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AGENDA ITEM 13 – OTHER BUSINESS AND FUTURE WORK

Document(s): Not yet posted to the CCNFSDU41 meeting website. Background: • At CCNFSDU30 (2008), the electronic working group (EWG) on methods of analysis for

infant formula recommended that the Committee periodically review the methods in the infant formula list in the Recommended Methods of Analysis and Sampling (CODEX STAN 234-1999) to keep them updated (ALINORM 09/03/26).

• To date, CCNFSDU has referred to Codex Committee on Methods of Analysis and Sampling

(CCMAS) methods for vitamin A, vitamin C, vitamin B12, vitamin D, vitamin E, biotin, pantothenic acid, myo-inositol, fatty acid profile, total nucleotides, iodine, chloride, chromium, selenium, and molybdenum and all have been adopted by CAC as Type II methods for the purpose of dispute resolution.

U.S. position: As noted earlier in this paper (Agenda Item 1), the United States anticipates submitting proposals via a Conference Room Document (CRD) to discuss under this Agenda Item regarding Methods of Analysis in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72-1981). The CRD will discuss proposed methods of analysis for Choline/Carnitine (AOAC 2015.10), B Vitamins (AOAC 2015.14), and Beta Carotene (AOAC 2016.13).