The 44th session of the Codex Alimentarius Committee on Nutrition and Special Dietary Uses (CCNFSDU44) finalized work on new General Principles for the Establishment of NRVs-R For Persons Aged 6 – 36 Months; a first set of NRV-Rs for that population group; a stepwise approach to develop new NRV-Rs; editorial amendments to the infant formula on energy conversion factors, no change to nitrogen to protein conversion factors but an important note added to the method. CCNFSDU44 advanced work on other NRV-Rs on Vitamins C, Vitamin B12, and Vitamin K, as well as on folate, etc.; it also sent four nutrient carriers for technological justification assessment as additives and embarked on its third batch of food additives justifications. CCNFSDU44 adjourned the decision to work on Guidelines on the Nutritional Equivalence of Plant-Based Foods, pending the availability of an FAO report. It discontinued work and kept the status quo on the current Codex definition of “Dietary Fibre,” stopped working on Guidelines on Probiotics by urging FAO and WHO to update 20+ years old documents, and proposed to revoke outdated methods of analysis (such as an old one on dietary fibre, replaced by a more modern one), and stop working on a sensory method on sweetness, by comparison with that of lactose (related to the Follow Up Formula Standard).

CCNFSDU44 was held in person in Dresden (Germany) from Wednesday, October 2nd to Sunday, October 6th, 2024, and was preceded by two pre-session working groups (PWG). The next CCNFSDU meeting (CCNFSDU45) will be held during Fall 2026 in a venue to be determined. More information about CCNFSDU44 supporting documents remains available[ii], and official proceedings are available[iii].

PRINCIPLES FOR THE DEVELOPMENT OF NUTRIENT REFERENCE VALUES (NRVs-R) RECOMMENDED FOR PEOPLE OF 6 TO 36 MONTHS OLD – General Principles Finalized and First Set of NRV-Rs agreed for final adoption at the forthcoming CAC47; and stepwise approach validated.

Based on the outcome of an intercessional work (via an electronic working group – EWG) and a pre-session preparatory discussion (via a physical working group – PWG), both led by Ireland, CCNFSDU44 discussed several aspects related to NRV-Rs, including General Principles for their elaboration, a stepwise review approach for the establishment of NRVs-R, and decisions on NRVs-R for some micronutrients. The Committee praised the tedious work and patient chairwomanship performed by Dr. Mary Flynn, Chief Specialist Public Health Nutrition, Food Safety Authority of Ireland (FSAI).

Guidelines on General Principles – Cleared for final approval by the Codex Alimentarius Commission
CCNFSDU44 finalized the development of new General principles for establishing nutrient reference values for persons aged 6 to 36 months and sent them for adoption by the upcoming 47th Codex Alimentarius Commission (CAC47) and for their future inclusion into CXG 2, Annex 1, Part B (see Appendix II Part A of CCNFSDU44 report).

CCNFSDU44 also completed its work on the Stepwise approach on how elaborating NRVs-R. CCNFSDU44 requested the Codex Secretariat to publish the Stepwise Process as an information document on the Codex website for internal use by CCNFSDU. (see Appendix III of CCNFSDU44 report).

NRVs-R values – First series adopted, others sent to EWG for further work
CCNFSDU44 agreed on the NRVs-R for Vitamins A, B6, and E, thiamin, riboflavin, niacin, pantothenic acid, copper, iodine, potassium, and protein for final adoption by CAC47, and future inclusion into CXG 2 (section 3.4.4.2). CCNFSDU44 also agreed with values for Vitamin D, Calcium, and Zinc, based on revised FAO and WHO DIRVs, for older infants, young children, combined group mean, and lowest UL for the combined group[iv] (see also Appendix II Part B of CCNFSDU44 report). CCNFSDU44 also agreed with consequential changes to CXG 2 (see Appendix II Part C of CCNFSDU44 report).

The Committee returned the remaining NRVs-R for Vitamins D, B12, and K, folate, biotin, selenium, manganese, magnesium, phosphorous, and iron for further development by using the stepwise process. For that purpose, a new EWG led by Ireland, and helped by the USA and Costa Rica was established to propose NRVs-R for persons aged 6-12 months, 12-36 months, and 6-36 months for these micronutrients. The Committee agreed to request the EWG to update the tables presented in Appendix II of CX/CNFSDU 24/44/4 (Part B Rev) with NIHN data and also to keep open the possibility to convene a PWG prior to the next session to review comments and prepare a revised proposal for CCNFSDU45 consideration. The CCEXEC/CAC would be informed of the deadline for completing the work should be extended to 2026 (since CCNFSDU will not be meeting in 2025).

METHOD TO “MEASURE” SWEETNESS OF CARBOHYDRATE SOURCES IN THE STANDARD FOR FOLLOW-UP FORMULA – long story, for an outcome falling short.

CCNFSDU44 agreed to discontinue consideration of the method of analysis for the assessment of sweetness of carbohydrate sources as it could not agree to forward any recommended sensory method to CCMAS for endorsement. CCNFSDU44 further encouraged countries and other institutions to develop more appropriate or better-validated methods. CCNFSDU44 also agreed that even if there was no internationally agreed method, it did not preclude Codex members to use of ISO 5495 method with or without the modifications discussed at the session about the reference quantity of lactose per 100 ml to serve as a baseline for the sensory method or any other available method. Those delegations not supporting the method (Canada, New Zealand, USA, etc.) emphasized that they were not looking at reopening the footnote four set in the follow-up formula standard but rather questioned the suitability of the method since the proposed method had not been validated for this specific measurement of the sweetness of other carbohydrate sources than lactose in non-milk protein based follow up products, as the standard (CXS 153, Section B, 3.1.3c) covering those products states that such sources should not be sweeter than lactose. Therefore, doubts remained about the use of the method for the purpose of enforcing that provision. It was questioned whether “perception” was a suitable criterion for enforcement purposes as well[v].

NEW WORK PROPOSALS – Dietary fibre, Probiotic, Plant-based nutritional equivalence, New Standard on (formulated complementary) foods for older infants and young children

New Standard For Foods for Older Infants and Young Children – Green lighted!
CCNSDU44 agreed with the proposal for new work and established an EWG, led by the USA with the help of the EU, Kenya and Panama to prepare a proposed draft standard for circulation for comments and consideration at CCNFSDU45, while keeping open the possibility of a PWG to meet prior to CCNFSDU45. CCNFSDU44 noted that the title of the standard could be further discussed and determined during the EWG discussions. The proposed new standard would incorporate the foods from the two existing standards (CXS 73) and (CXS 74). The main aspects that this proposed standard would consider are as follows:

• Relevant updates in light of current scientific findings and recommendations for complementary feeding for persons aged 6-36 months;
• Foods for older infants and young children comprised of basic food groups, including animal-source foods, fruits and vegetables, cereals and grains, pulses, nuts, and seeds as individual foods or in food group combinations;
• Essential compositional and safety factors, including food group requirements and nutritional composition;
• Additional food safety, quality, packaging, labeling, and analytical methods and sampling provisions, as appropriate;
• Name and structure of the standard.

Products to be covered by the future standard are not breast-milk substitutes (BMS), and some provisions will make clear they shall not be formulated or pre-sented as such (as BMS).

Dietary Fibre – No way to change definition, but greenlight to upgraded method
Definition of Dietary Fibre
CCNFSDU44 rejected the proposal from the observer organization Calorie Control Council to reopen and amend the definition of dietary fibre included in 2009 in the Guidelines on nutrition labelling (CXG 2). The proposal aimed at deleting the note referring to the decision left to Codex member competent authorities to decide whether the carbohydrate polymers with a degree of polymerization of 3 to 9 units could be included in the definition of dietary fibre or not. During the PWG, it should be noted that the representatives of FAO and WHO intervened very proactively on this topic to convince Codex members to maintain the status quo of the currently approved definition[vi].

Method of analysis for the determination of all types of dietary fibre sources
CCNFSDU44 agreed to request CCMAS to (a) endorse AOAC 2022.01/ICC Standard 191/AACC 3261.01 as Type I for the determination of insoluble and soluble dietary fibres of higher and lower molecular weight in food that may or may not contain resistant starches[vii]. CCNFSDU44 also agreed to revoke AOAC 2011.25/AACC 32-50.01 for use with the same provision[viii]. The EU stated that the improved method didn’t mean that all types of fibres covered by it would necessarily be considered as a “dietary fibre” according to its legislation. The EU also indicated that even when a substance was viewed as being a dietary fibre (for nutrition labeling purposes), it would not necessarily mean the substance health benefits would be automatically recognized (compared to that what is generally attributed to traditional dietary fibre (e.g., whole grain cereals). The EU indicated that health claim should be evaluated separately, according to specific scientific and legal requirements. (See also Appendix VII of CCNFSDU)

Plant-Based Protein Versus Animal-Based Protein Foods – put on hold and new work proposal to be re-submitted in the future.
CCNFSDU44 agreed to return the proposal to develop possible Codex Guidelines, including General Principles for the Nutritional Composition of Foods and Beverages made from Plant-based and other Alternative Protein Source to the submitters for further development, emphasizing the need to consider the forthcoming FAO publication; and noted the revised proposal should be submitted in response to the Circular Letter for new work proposals. During the PWG, there was a proposal to narrow further down the scope of the guidelines by removing references to bacteria, insects, and fungi and by removing references to labeling considerations to recenter the work on the macronutrients and micronutrients and differences in composition between animal and non-animal protein sources. Discussion was postponed until the next CCNFSDU session, to give enough time to FAO to publish its report on the systematic comparison work between plant-based foods and their animal-based counterparts, which is expected to be the case by end 2024.

Guidelines on Probiotics – No go. For now. Missed opportunity for Codex?
Malaysia made a long presentation of the issues that the electronic working group has overcome in proposing the revised discussion paper[ix].

Despite the substantial number of delegations that expressed their support to develop Codex-owned Guidelines on probiotics, CCNFSDU44 failed to agree to embark on this new work. CCNFSDU44 noted, however, the willingness of FAO and WHO to take over this task and encouraged Members to provide resources to support FAO and WHO to conduct this review; and that once the review of the two documents was completed, a new work proposal on probiotics could be reconsidered if a new work proposal is submitted in response to the Circular Letter — and then being screened according to the newly approved prioritization mechanism.

CCNFSDU44 therefore agreed, as what appears as least denominator found — keep status quo with no Codex text on that matter for at least the next 3 to 5 years — to request FAO and WHO to conduct a review of their respective documents, i.e., Joint FAO/WHO Expert Consultations (a) held in Argentina in 2001 (attended by eleven selected experts) entitled “Health and Nutrition Properties and Guidelines for Evaluation” and also including “Powder Milk with Live Lactic Acid Bacteria” and (b) held in Canada in 2002 (attended by five selected experts) entitled “Guidelines for the Evaluation of Probiotics in Food,” both published in 2002 the FAO Food and Nutrition Paper no 85 (FNP 85) and incorporating a literature review of the scientific evidence on probiotics available back then[x].

The representative of WHO also indicated that should WHO embark into this new work, it would follow the current guidance for developing Guidelines, which involved a review of the scientific literature and a systematic review of the weight of evidence related to each study. FAO and WHO agreed to incorporating new scientific evidence on probiotics when reviewing these two documents, and that could be performed in a properly organized joint FAO/WHO Expert Consultation or deferred to JEMNU. A representative of the International Probiotics Association later expressed her surprise: “Despite thirteen Codex Members representing nearly 75% of the human population, supporting the development of dedicated Codex guidelines for probiotics, Codex seems to have missed a unique opportunity to provide clarity for global consumers. The scientific knowledge on the functionality and safety of probiotics has been well established since the Joint FAO/WHO Expert Consultations held in 2001 and 2002, which have since then served as a global definition of what probiotics are. Does the CCNFSDU decision imply that the current definition would be outdated?”

Prioritization Mechanism on Emerging Issues / New Work Proposals – Guidelines adopted (to be published as information document)
CCNFSDU44 agreed to request the Codex Secretariat to issue a Circular Letter (CL) requesting for proposals for new work, including on emerging issues, for consideration at CCNFSDU45; and that an ad-hoc pre-session PWG, meeting either prior to CCNFSDU45 or in-between sessions, might be established to make recommendations for consideration by CCNFSDU45. Such PWG would be chaired by Germany (country hosting the CCNFSDU) and co-chaired by Canada (country hosting the CCFL) to “conduct a case-by-case review of every proposal for new work, including a review of the scope and rationale for clarity and the assessments submitted by the petitioning Member(s) and determine whether each proposal could be carried forward a new work by the Committee” and use the priority mechanism to score and rank the proposals amongst each other.

CCNFSDU44 also agreed to (i) use the existing procedures to review standards under the purview of CCNSFDU (as compiled and presented by the Codex secretariat at the session); (ii) encourage Members (and Observers) to propose revisions or amendments to existing standards, and to flag emerging issues in response to the CL requesting new work proposals; (iii) request the CCNFSDU host country secretariat to include the existing standards developed by CCNFSDU in the inventory of proposals and potential areas of new work as proposed in the “Process for compiling new work proposals” of the Guideline for the preliminary assessment to identify and prioritize new work for CCNFSDU. CCNFSDU44 further agreed to request the Codex Secretariat to publish the finalized Guidelines as an information document on the Codex website (See Appendix IV of CCNFSDU44 report), noting that the Guideline would continue to be used by CCNFDU to evaluate and prioritize new work proposals, as necessary. The next Codex Executive Committee (CCEXEC87) will also be informed accordingly. CCNFSDU44 noted that the Guideline document was a living document and could be amended in the future as experience is gained in its use for evaluating and prioritizing new work proposals. CCNFSDU44 also adopted the related Decision Tree for scoring and ranking such new proposals.

MISCELLANEOUS

Use of Food Additives
Batch #2 – Guar gum and some modified starches not justified for use in infant formulas and alike FSMPs
CCNFSDU44 agreed with the conclusions and recommendations resulting from an intersessional EWG chaired by EU. The review of the technological justifications for a technological need of guar gum (INS 412), distarch phosphate (INS 1412), phosphates distarch phosphate (INS 1413), acetylated distarch phosphate (INS 1414), and hydroxypropyl starch (INS 1440) (the second batch of additives considered so far) confirmed that these additives were not used in current products and there was no commitment to generate data for safety assessments.

The representative of ISDI (“baby food” manufacturers) supported such conclusion, noting that an internal survey from ISDI members found no current use of these additives included in this batch 2, but such conclusions may not be the same for future batches under consideration. ISDI highlighted the “baby food” industry’s efforts to minimize the use of food additives in infant formula, aligning with the principles outlined in the preamble of the General Standard for Food
Additives (GSFA) published in CXS 192.

Nutrient carriers as food additives in foods conforming to the Codex Standard on Canned “Baby Foods” (CXS 73)
CCNFSDU44 agreed with the recommendations made from the work of the EWG to inform CCFA that this standard does permit the use of food additives listed as nutrient carriers in the Codex Guidelines containing the Advisory Lists of Nutrient Compounds for Use in Foods for Special Dietary Uses intended for Infants and Young Children (CXG 10 – Part D). CCNFSDU44 agreed to include these four food additives (i.e., acacia gum, also known as gum arabic (INS 414), amorphous silicon dioxide or SAS (INS 551), mannitol (INS 421), and sodium ascorbate (INS 301)), as batch 6 of the future review of the technological need and justifications for using these food additives in infant formulas and alike FSMPs in the established work plan of the Committee and its re-established EWG on that matter, continued to be chaired by the EU. It was further agreed to request CCFA to take appropriate actions accordingly in the context of the one-to-one alignment between the GSFA (CXS 192) and the standard on infant formulas (CXS 72).

Technological need and justifications for using Basic Methacrylate Copolymer (BMC)
CCNFSDU44 agreed to refer that matter to the newly established EWG and discuss the future recommendations at CCNFSDU45. It was reiterated that vitamin A deficiency, along with other micronutrient deficiencies, remained a pressing challenge. Senegal emphasized that BMC was a critical tool and could significantly enhance the fortification and availability of essential nutrients for young children, especially Vitamin A.

Future work of the re-established EWG
CCNFSDU44 agreed to re-establish an EWG, led by the EU (under the acknowledged leadership of EU offcial Mr J. Sochor) to collect information from applicants on (a) use and use levels in infants formulas and alike FSMPs conforming to CXS 72 on L-, D-, and DL-lactic acid (INS 270), lecithins (INS 322i), citric acid and citrates (INS 330, 331(i), 331(iii), 332(I), 332(ii)), mono- and diglycerides of fatty acids (INS 471) and basic methacrylate copolymer or BMC (INS 1205), while confirming applicants readiness to provide data on the safety assessment for infants below 12 weeks of age (to JECFA), when requested to do so. The EWG will also use the framework for considering technological justification and uses in foods conforming to the Codex Standard for Infant Formulas and alike FSMPs (CXS 72) only for those additives for which use, use levels and commitment to provide data would be confirmed.

The same framework will be used for use and use levels and a commitment to provide data confirmed for basic methacrylate copolymer or BMC (INS 1205) in foods conforming to Codex Standards on products for older infants and young children (CXS 156); canned “baby foods” (CXS 73); Processed cereal-based foods for infants and young children (CXS 74); and Guidelines for ready-to-use therapeutic foods, or RUTF (CXG 95). The EWG will review the information provided and make recommendations to CCNFSDU45 on these technological justifications for each food additive.

Methods of Analysis
CCNFSDU44 agreed to send revised methods for several nutrients (Vit. E, Vit. D, Thiamine, riboflavin niacin, Vit. B6, Vit. B12, folic acid, Vit. C, biotin, iron, calcium, phosphorus, magnesium, sodium, chloride, potassium, manganese, selenium, copper, zinc, tot nucleotides, choline, myo-inositol, L-carnitine, total
amino acids, tryptophan, total fatty acids in IFs and FUFs) for endorsement by CCMAS, including one on Crude Protein in FUF whereby CCNFSDU44 agreed to send the titrimetric (Kjeldahl) method (ISO 8968-1 / IDF 20-1) as a Type I method to CCMAS for endorsement (and inclusion into CXS 234). Note that for Vitamin A, Iodine, and pantothenic acid, the methods were sent to CCMAS for revoking or retyping or both, for their determination in FUF and currently listed in CXS 234, (i.e., retype/revoke AOAC 992.24 for Iodine; retype/revoke AOAC 974.29, AOAC 992.04 and AOAC 992.06 for Vitamin A; and retype AOAC 992.07 for pantothenic acid).

CCNFSDU44 agreed that methods of analysis used for the determination of nutrient contents in standards under its preview deserved to be subject of a standing agenda item at future sessions, and be subject to a circular letter and an EWG, led by the USA, with the objective to consider existing methods of analysis in CXS 234 for the standards under the CCNFSDU purview to check their fitness for purpose, formulate recommendations to the Committee for adding new methods, replacing existing methods, revoking existing methods or make any other corrections found necessary. CCNFSDU44 also decided that any future proposal about methods of analysis should be strictly limited to nutrients and other substances only for products which are falling within the purview of CCNFSDU. Finally, CCNFSDU44 agreed that there was no rationale to justify the endorsement of the proposed methods for fructans, beta-carotene, lycopene in infant formulas and FSMPs for infants.

Nitrogen to Protein Conversion Factors
Despite the support of the USA to amend conversion factors in the standards under the purview of CCNFSDU, the chair agreed that no change should be made about the existing conversion factors in the commodity standards and noted that CCMAS had already agreed to ask for CAC47 to adopt the inclusion of these conversion factors attached to the Type I method for the determination of Nitrogen by the Kjeldahl method, as an annex to the General Standard
on Methods of Analysis (CXS 234) (amended version
reflected in Appendix VII – Part C)[xiii]

FAO Reporting – main focus on plant-based protein sourced foods and alternative to animal-sourced foods, including work on protein and individual amino-acid digestibility
FAO emphasized four main ongoing activities: (a) an FAO literature review to assess the nutritional composition of foods made from plant-based protein sources, which are intended to replace animal-based products, with comparison of the nutritional composition of these products to their animal-based counterparts, with a report expected to be released by the end of 2024 and aimed at providing evidence to inform the CCNFSDU on proposed work for related guidelines; (b) a background review of evidence on benefits and risks of Alternative Animal Source Foods (A-ASFs) looking into aspects including nutrition, environment, socio-economic considerations, and food safety; (c) Joint FAO/IAEA work on a database on ileal digestibility of protein and individual amino acids in
foods and (d) a new FAOSTAT domain on “Food and Diet”

WHO Reporting – Upcoming working definition of Ultra-Processed Foods
The Representative highlighted WHO activities on (1) four guidelines published on diet and health recently on total fat intake; saturated fatty acids and trans-fatty acids intake; carbohydrate intake; and the use of non-sugar sweeteners; (2) three guidelines underdevelopment on the use of lower-sodium salt substitute; polyunsaturated fat intake; and tropical oil consumption; (3) two new guidelines in the early stages on optimal intake of animal source foods; and on consumption of “Ultra-processed” foods (UPF); (4) two guidelines on nutrition policies on food marketing and on fiscal policies recently published; and (5) two more guidelines forthcoming on nutrition labelling policies; and on school food nutrition policies. The IFT representative made a statement on Ultra-Processed Foods, along the line of their CRD38[xv].

Joint FAO/WHO Reporting – Upcoming Joint Statement on Principles for a “Healthy Diet”

The Representative of WHO reported on several joint FAO/WHO scientific advice activities held in June 2024 (i.e., the Joint IAEA/FAO/WHO meeting on Human Energy Requirements and the Joint FAO/UNICEF/WHO Guidance on Healthy Diets Monitoring Initiative). She also expressed her hope for the release – thought imminent – of the Joint FAO/WHO Statement on the Principles of a Healthy Diet.

Endnotes:
[i] Food Production Systems Engineer, Food Standards & Food Safety Regulatory Specialist, Counsellor at Keller and Heckman LLP Brussels office

[ii] See https://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCNFSDU&session=44&

[iii] See REP24/NFSDU at https://www.fao.org/fao-who-codexalimentarius/meetings/en/

[iv]The following NRV-Rs are sent for final approval by CAC47:

* Conversion factors for niacin, vitamins A and E are presented in CXG 2-1985
*** The draft values are subject to a public consultation which is scheduled to be held in early 2025. They also need to go through internal FAO and WHO clearance processes.
**** FAO/WHO age brackets are 7-12 months, and 1-3 years inclusive, in line with reporting of age brackets in the 2004 documents, Vitamin and mineral requirements in human nutrition, 2nd edition (https://www.who.int/publications/i/item/9241546123)

[v] The table below reflects up to which point the CCNFSDU44 ended up in its discussions on this sweet matter:

* neutral, tasteless, still, odourless, and preferably with low mineral content
** ISO 8586 – Sensory analysis – General guidelines for the selection, training, and monitoring of selected assessors and expert sensory assessors; and ISO 3972
+ Cor. 1 – Sensory analysis – Methodology – Method of investigating sensitivity of taste shall be used for the selection, training and qualification of sensory assessors. For the implementation of the standard ISO 5495 the following default values for α-risk, β-risk and pd should be applied to achieve minimal statistical precision:

• α-risk: 0.05,
• β-risk: 0.05,
• pd: 50%.

Noting that:
If α-risk is 0.05, there is a 5% likelihood of inaccuracy
If β-risk is 0.05, there is a 5% likelihood of inaccuracy Pd, the proportion of the population of subjects who are able to distinguish between the two samples.

[vi]Canada, as EWG/PWG Chair, noted that: (i) there was no justification for changing the definition of dietary fibre based on current evidence; (ii) the existing definition represented a satisfactory compromise reached after extensive discussions in the Committee; and, (iii) the definition provides flexibility, and many authorities recommend increasing the consumption of fruits, vegetables, pulses, and whole grains to enhance fibre intake. The PWG concluded that there was no need to amend the definition of dietary fibre in the Guidelines on nutrition labeling (CXG 2). During the PWG, the WHO Representative stated that the current definition was satisfactory as it stands and should not be changed. WHO’s recommendation is to increase dietary fibre intake as to those naturally occurring in food, instead of changing the definition.CCNFSDU44 endorsed the PWG’s recommendation to reject the proposal.

[vii] Method proposed as Type I method for Dietary Fibre quantification: AOAC 2022.01/ AACC 32-61.01/ ICC Standard No. 191 (Enzymatic-Gravimetry High Pressure Liquid Chromatography), annotated to state that “isolated, purified, and/or synthetic fibres captured by AOAC 2022.01/ICC Standard 191/AACC 32-61.01 that do not meet the Codex definition of dietary fibre in the Guidelines on nutrition labelling (CXG 2-1985) should be subtracted from the final measurement, where deemed appropriate by competent authorities.” CCNFSDU44 acknowledged that this new AOAC method is more accurate and alleviates inaccuracies found with the older method (in endnote xii). It was clarified that the purpose of the new method was not to evaluate physiological benefits but to facilitate the separation of fibres by molecular weight into soluble and insoluble categories. In light of concerns (of the EU) regarding potential for the new method to capture fibres that did not conform to national definitions of dietary fibre or established criteria, the marked(*) footnote was added for clarification.

[viii] Method for the quantification of dietary fibre proposed to CCMAS for revocation: AACC Intl 32- 50.01 / AOAC 2011.25 (Enzymatic-Gravimetry High Pressure Liquid Chromatography).

[ix] Malaysia indicated that (i) there was no expectation that CCNFSDU would evaluate the safety and efficacy of specific strains or create positive or negative lists of approved strains; (ii) regarding the rationale for the guidelines, Members from various regions emphasized that numerous probiotic products were available in their markets, backed by scientific support for health benefits. However, concerns about dubious products that did not meet established definitions and might contain harmful organisms had been raised; (iii) regarding the development process, the guidelines would utilize the two FAO and WHO reports (i.e. “Health and Nutrition Properties of Probiotics in Food, including Powder Milk with Live Lactic Acid Bacteria” (2001) and “Guidelines for the Evaluation of Probiotics in Food” (2002) as a scientific basis. Given the recognition of the validity of these reports, they would be officially incorporated into Codex as guidelines to ensure harmonized use among Members; and (iv) regarding the utilization of the guidelines, the guidelines would be voluntary in nature and would assist many countries in developing national legislation, ensuring that probiotic products met safety criteria and were appropriately labelled so that consumers could make informed choices. China, as co-Chair of the EWG, added that the guidelines would be developed in line with FAO and WHO recommendations. It aimed to assist Members in effectively integrating these recommendations into their national regulations, thereby enhancing human health, food safety, consumer protection, and global trade in a cooperative and consistent manner. These points are included in CCNFSDU44 report, but strange enough were not followed by CCNFSDU44 pre-session WG nor the plenary despite large numbers of delegations in favor of the new work.

[x] See “Probiotics in foods” https://openknowledge.fao.org/server/api/core/bitstreams/382476b3-4d54-4175-803f-2f26f3526256/content and “Guidelines for the Evaluation of Probiotics in Food” available at https://isappscience.org/wp-content/uploads/2019/04/probiotic_guidelines.pdf

[xiii] Nitrogen to protein factors: amendment to CXS 234 for final approval by CAC47 (part in red added): “NITROGEN TO PROTEIN CONVERSION FACTORS FOR COMMODITIES APPROVES BY COMMODITY COMMITTEES (proposal to include the Nx for follow-up formula for older infants and product for young children in the annex in CXS 234)

Animal Protein Source
Milk and milk products – 6.38
Meat – 6.25
Cook cured ham – 6.25
Infant formula – The calculation of the protein content of products prepared ready for consumption may be based on N x 6.25 unless a scientific justification is provided for the use of a different conversion factor for a particular product. The value of 6.38 is generally established as a specific factor appropriate for conversion of nitrogen to protein in other milk products, and the value of 5.71 as a specific factor for conversion of nitrogen to protein in other soy products.
Follow-up formula for older infants and products for young children – The calculation of the protein content of the final product ready for consumption should be based on N x 6.25 unless a scientific justification is provided for the use for a different conversion factor for a particular product. The protein levels set in this standard are based on a nitrogen conversion factor of 6.25. For information, the value of 6.38 is used a s a specific factor appropriate for conversion of nitrogen to protein in other Codex standards for milk products.1

Fish and fishery products
Crackers from marine and freshwater fish, crustaceans, and molluscan shellfish – 6.25

Plant Protein Source
Wheat, wheat protein products – 5.71
Soya and non-ferment soybean products – 5.71
Maize – 6.25
Quinoa – 6.25
Sorghum – 6.25
Tempe – 5.71
Gochujang – 6.25
Products produced by separation from wheat and soya grains and flours of certain nonprotein constituents (starch, other carbohydrates) – 6.25.
1 Other equivalent names of this product are “Drink for young children with added nutrients,” or “Product for young children with added nutrients,” or “Drink for young children.”

[xv] IFT stated that « Present categorizations for UPFs are creating much confusion for all stakeholders, with widely varying interpretations. Many of these definitions, including NOVA, which is predominant in the literature, are subjective and ambiguous from a scientific research and implementation standpoint. As the WHO works on additional research and frameworks to provide greater clarity on the classification of foods as ultra-processed, we also suggest the following considerations for research:

• The concept of UPF overlaps many nutrients and food components, such as added sugars, sodium, and saturated fats. There is a greater body of evidence for these food components that enable greater confidence in recommendations. Future research should better tease apart the role of specific nutrients and food components within UPFs in relation to health.
• Due to the broad classification criteria utilized in many definitions, UPFs can include foods with nutrients that need to be increased, such as whole grains, fibre, vitamins, and minerals in many enriched and fortified grain products or dairy products, as well as nutrients and components that need to be decreased, such as added sugar, sodium, and saturated fat.

IFT also encourages WHO to seek global input focused on meaningful, science based guidance for the global community of stakeholders and encourages a thorough review of recent global scientific literature regarding UPFs.