Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses: CCNFSDU43

The 43rd meeting of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU43) successfully completed its entire agenda by meeting in person. In terms of accomplishments:

It fully revised the preamble and pending issue on the Codex Standard on Follow-Up Formulas[1], closing a 15-year loop;
It significantly progressed the text of General Principles for Establishing NRVs-R for Persons Aged 6-36 Months;
It agreed on a protocol and batches for reaffirming technological justifications for food additives[2] as well as for new uses in infant formulas and special medical purpose foods. An important discussion occurred on the determination of sweetness for infant formulas, with potential longer-term ramifications for other foods;
It improved its draft internal guidelines for prioritization of new work with enhanced focus on scope for new proposals, as the primary entry (or rejection) point;
It amended two existing texts by deleting a labelling warning against using canned beet root and spinach for infants below 12 weeks[3], and, aligning conditions for folic acid source from calcium-l-methyl folate with those set forth for n-pteroyl-l-glutamic acid in the advisory list of nutrient compounds for use in foods for special dietary uses intended for infants and young children[4];`
It sent back to submitters proposed new works on nutritional quality of plant-based foods compared to their animal-sourced analogues and more surprisingly on probiotics;
It dismissed completely a proposal for Codex guidelines on common principles to develop national nutrition profiling systems for FOP nutrition labelling purposes[5]; and
It also dismissed developing a NRV-NCD for trans-fatty acids.

The 43rd session of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses was held in person for the first time since 2019 from 6 to 15 March 2023 in Düsseldorf, Germany and was immediately preceded by two half-day working groups on general principles for the establishment of NRVs-R for persons aged 6 – 36 months and on its prioritization mechanism for new work or emerging issues proposals.

By Christophe Leprêtre[6] (Keller and Heckman LLP)

Adoption of new or revised Codex texts

Follow up formula
CCNFSDU43 devoted a significant part of its agenda to discussing the structure of the standard, the name of the standard and the presence and content of a Preamble to the standard. Ultimately, the Committee agreed to send to the next Codex alimentatius Commission the standard as a whole, while referring the new title of the standard to CCMAS for inclusion in the standard on methods of analysis (CXS 234). The Committee agreed to publish the future text as a single standard and separate the requirements in two parts: part A on follow up formulas for older infants (6-12 months of age) and part B on “products” for young children (12-36 months of age). The specifications for compositional requirements and labelling provisions were not revisited as they had already been agreed to at its last meeting.

The most contentious issue was linked to the consideration by some countries (and the WHO) that some of these products would be considered as breast-milk substitutes whereas other countries would not. A footnote allows all national models to coexist under the purview of this standard. Supporters of using breast-feeding until 3-years of age would have preferred those products not being covered by a Codex standard at all and viewed as breast-milk substitutes (which means they would also have agreed that those products remain regulated only at national level, as in their view all Codex standards unduly promote the consumption of such foods). On the other hand, it is difficult to dispute that Codex standards ensure also a safety net of globally approved and recognised minimum safeguards about the composition and labelling of such products.

With regards to the name of the standard, an asterisk note was added to describe “product for young children” mentioned in the title as “Other equivalent names for this product are Drink for young chilren with added nutrients, or Product for young children with added nutrients, or Drink for young children”. The title of the standard itself now reads as Standard for Follow-up Formulas for Older Infants and Products for Young Children.

With regards to the Preamble, arguments were shared on the role of adding a preamble in Codex texts in general. There was a general consensus on keeping a preamble. It was not as clear about the content. Most delegations were comfortable with the first paragraph describing the structure of the standard (i.e. that “This Standard is divided into two sections. Section A refers to Follow-up Formula for Older Infants, and Section B deals with Drink for Young Children with Added Nutrients, or Product for Young Children with Added Nutrients, or Drink for Young Children, or Product for Young Children”). Most delegations were also amenable to a general factual statement in the third paragraph that “Relevant World Health Organization (WHO) guidelines and policies and World Health Assembly (WHA) resolutions were considered in the development of this Standard and may provide further guidance to countries.”

However, there were reservations about references to national and/or regional “legislation” in the second paragraph referring to “The application of this Standard should be consistent with national/regional health and nutrition policies and relevant national/regional legislation and take into account the recommendations made in the International Code of Marketing of Breast-milk Substitutes, as per the national/regional context.” Given that not all countries consider products covered in particular by Part B of the standard as Breast-milk Substitutes, formal reservations on the second paragraph were raised by Argentina*, Colombia, Costa Rica*, Cuba*, Guatemala*, Panama, Morocco, USA, and Vietnam*, and some of these countries* expressed their reservation on the third paragraph as well.

The Codex Secretary confirmed that the name of the standard should be as clear and concise as possible, in accordance with the CAC Procedural Manual. To achieve this general objective, while keeping the other descriptors for products intended for persons of 12 to 36 months of age, the Committee agreed with the proposal to shorten the title and add an asterisked note equivalent names for the products as “Drink for Young Children with Added Nutrients or Product for Young Children with Added Nutrients or Drink for Young Children”. The title of the standard as adopted will read in its 2023 published version “Standard for Follow-up Formula for Older Infants and Product for Young Children”.

Canned beetroot and spinach
Dominican Republic proposed an amendment to a labelling provision set in the Canned baby food standard stating that those made of canned beetroot and spinach shall not be consumed below 12 weeks to bring that cut off to 12 months. This issue relates to the presence of nitrates in some vegetables. As reported by a WHO representative, the scientific literature notes some increased risk of a specific health condition affecting capacity of the blood to capture oxygen (methaemoglobinaemia) when infants and young children consume too many nitrates. He pointed out that such situations are rare and primarily linked to the consumption of well water with high concentrations of nitrates. Consumption of root vegetables and other green leafy vegetables could provide high nitrate intakes when grown in soil with high nitrate content and when infants consume very large quantities of such vegetables. Nutritional benefits of such vegetables are recognized and, in most cases, would outweigh potential problems related to nitrate intake. WHO representative noted that other dietary sources may bring high intakes of nitrates such as other root vegetables (e.g., carrots) or other green leafy vegetables (e.g. chard, kale) when grown in soils containing higher levels of nitrates. The Committee decided to send the amendment deleting completely that part of the standard for adoption by the next CAC (i.e., a step 0 to 8 type of approach but presented as an “amendment” to the standard).

Sources of folates in the advisory list
This amendment aims at adding the possible use of Calcium L-methyl-folate as a source of folate in the same standards and parts of standards in addition to N-Pteroyl-L-Glutamic acid. And, a reference to the US Pharmacopeia for its purity requirement was added. This amendment will be presented to direct adoption by CAC as an amendment to existing Codex text (i.e., a step 0 to 8 type of approach as well).

Advancement of pending, new or revised texts

General Principles for Establishing NRVs-R for Persons Aged 6-36 Months
CCNFSDU43 adopted the recommendation of the pre-session working group which added the draft text, especially its preamble, definitions and list of draft principles. The definition of recognized authoritative scientific bodies (RASB) is kept consistent with that introduced in existing Annex 1 to CXG 2 on nutrition labelling. The Committee also agreed to a definition for Adequate Intake which is synonym to the terms used by WHO as average intake which would be different from that of estimated average intake.

To avoid ambiguities in terms, the acronym AI was deleted. WHO informed that the nutrient intake values for adequate intakes of calcium, vitamin D, zinc for that age group was underway and it is possible that the definition for adequate intake and other related terms may need an update. As such, the definition of adequate intake in the General Principle will be discussed again. For the suitable basis, the Committee indicated that INL98 should be taken and reference to the 2021 FAO report should be deleted. The text as amended is therefore advanced in the step process and will be further elaborated by an inter-session EWG (included in Appendix III of the CCNFSDU43 report). An EWG is reestablished to finalise the discussion of the General Principles and revise the draft Stepwise Process and start applying it to the proposed NRV-Rs for persons of 6-12 months of age, 12-36 months of age and eventually for consolidated ones for 6-36 months of age.

Technological justifications for food additives
Building on past work of the committee on the general framework to appraise technological seeds for food additives[7], CCNFSDU43 considered several food additives for inclusion in standards on foods for special medical purpose FSMPs or other baby foods, noting the on-going work of the Codex Committee on Food Additives with regards aligning food additive provisions set in those commodity standards with those set in the General Standard on Food Additives (CXS 192) in the corresponding food categories. The Committee agreed to refer some issues to CCFA but in principle would agree with the proposal put forward on e.g., low acyl clarified gellan gum (INS 418). Ascorbyl Palmitate and tocopherols were cleared for adoption in the Infant formula standard (CXS 72) as well as phosphates. An inter-session EWG will review the technological justifications for using several other food additives, while safety assessment for their use in products for infants below 12 weeks of age, be subject to a discussion in CCFA for review by JECFA. Data mining for the food additives in future batches for review will be collected on intended uses, use levels and commitments on safety data to be provided.

Sweetness method and other methods of analysis

Sweetness
As part of the broader review of adequate methods of analysis and inherent sources of uncertainties presented by the AOCS delegation, CCNFSDU43 discussed the pertinence of referring to organoleptic method for the determination of sweetness in infant formulas to compare the sweetness brought by other carbohydrates sources permitted in the standard compared to that provided by lactose when lactose is used as a primary carbohydrate source in the product. It was agreed that the topic should be further discussed in the context of an EWG chaired by the EU and co-chaired by Switzerland to collect more information on scientifically available methods for use in sensory evaluation in the target age group (i.e.,12-36 months), noting that (a) such preferred methods would be those based on a comparison with the sweetness brought by lactose; (b) The ratio between lactose and glucose polymers in terms of how sweetness will be measured could be explored, (c) the impact of flavourings (i.e. vanillin and ethyl vanillin) on sweetness might also need some consideration. The EWG will review, identify and, as appropriate, recommend methods for referral to CCMAS for endorsement, in particular ISO 5495, for assessing the sweetness of carbohydrate sources in comparison to lactose in “Product for Young Children” in line with revised Section B, point 3.1.3c footnote 6 for those products based on non-milk protein of CXS 156 standard as per its 2023 version included in the Appendix II of CCFSDU43 report (i.e., “For products based on non-milk protein, carbohydrate sources that have no contribution to sweet taste should be preferred and in no case be sweeter than lactose”).

Methods of analysis
CCNFSDU43 considered several new methods submitted for the determinations of a couple of nutrients in infant formula specifically. It is sending them to CCMAS for endorsement as type II method for total amino-acids (excluding taurine and tryptophan) and tryptophan, both for use according to section 3.1.3 (a) footnotes 3 and 4 of the latest version of CXS 72; and type III method for Vitamin B12. The Committee reestablished an EWG to review the use of fructans, beta-carotene, lycopene as optional ingredients in the latest version of the infant formula standard (CXS 72) and develop recommendations to CCNFSDU44 regarding the safety and suitability of these ingredients.

Prioritization mechanism

While this topic seems to be reflecting only internal needs of the committee to establish a protocol to prioritize its work and also decide on which new work on which to embark, this is one of the most fundamental for the future of the Committee and its relevance in terms of impact on overall nutritional standards or remain strictly focusing on baby foods and foods for special dietary uses. The topic is managed by the German authorities as host country of the Committee and by the German secretariat. It developed comprehensive guidelines which sets principles “to filter proposals for new work” and ensure that “only proposals which fulfil all procedural requirements would be forwarded to the Committee”. As such the guidelines include a decision-tree composed of a stepwise approach and therefore cumulative selective criteria.

The process includes a self-assessment to be performed by the “applicant” for new work and that a future and more systematic pre-session PWG would be task to assess and prioritize all the requests against the criteria and rank them by order of importance. An EWG chaired by Canada is established to revise the decision-tree and possibly consider whether an additional step could ensure that the scope of the proposal for new work and the rationale are clear enough to the Committee before accepting such proposal. The increasing complexity of these rather administrative guidelines, initially aimed at simply ranking many proposals by order of importance to each other and offer some strategic planning to the Committee seems to render the task of applicant for any new proposal an impossible task to satisfy such all the desires of perfection and may end up with the Committee selecting only the need for a revision of existing standards, which in a way is more regressive than progressive. The Future may tell.

Disillusions for some proposed new work

Probiotics
Despite overwhelming support in favor of the proposal (e.g., China, India, Indonesia, Malaysia, and many African countries, as well the NHF), but with the notable formal opposition of the European Union and the food supplement industry global representative organization IADSA and the CRN, the report of the meeting presents the arguments in favor or against the proposal in a surprisingly 50-50 balance. Delegations in favor pointed out that the topic was of considerable relevance and tackled current challenges. Although the work may be challenging, this was not a reason to not proceed. It was also pointed out the proposed guidelines included important aspects not covered by other Codex texts, and that probiotics were already in use as food ingredients in many countries and a Codex guidance was required to help countries regulate the proliferation of probiotics uses in conventional foods but also in food supplements. As such a harmonized guideline for the age group above two years were much needed to protect consumers from unsafe or fraudulent probiotic products. Delegations not in favour of proceeding with the new work considered that Probiotics could represent a health concern, rather than a food safety concern. The term “probiotics” itself could be considered as a health claim, since it was proposed to be defined as live microorganisms which confer beneficial effects on health. As such those delegations had concerns on how the products were to be labelled and what kind of claims were being made for products for infants and young children in particular, and as such infant foods and foods for young children should be excluded from the scope. Regarding the scope, they were also of the view that considerations of a scientific or microbiological nature were beyond the mandate and resources of CCNFSDU and needed to be clarified regarding definition, minimum safety requirements and labelling parameters (and in conjunction with the upcoming new prioritization criterion!). Those delegations indicated that the work could go to the CCFH (microbiological safety and hygiene) or the CCFL (labelling) if the proposal was to be refined. They also questioned that if the work were to support countries with insufficient resources to evaluate probiotics and rule out microbial microorganisms that are not probiotics, would the work of CCNFSDU include the evaluation of individual strains and how would this work be kept updated?

CCNFSDU43 therefore agreed to establish an EWG chaired by Argentina and co-chaired by China and Malaysia to further refine and clarify the Discussion Paper on Harmonized Probiotic Guidelines for Use in Foods and Food Supplements, especially with regards to the scope, impact on food safety and need for scientific advice; and develop a revised version of that paper and its attached project document.

Plant-based and other alternative protein sources’ nutritional quality compared to their animal-based analogues
The USA presented the proposal prepared jointly with Canada on a general guidance on what nutrients replacement foods (such as plant or other alternative protein sources) might need to contain to assure that when consumers replace animal-based variants with an alternate protein-based variant, nutrient adequacy would not be compromised. The Committee was asked to comment on its scope and stated that for fully developing/refining the scope of this work, scientific advice from FAO and WHO would be helpful. ISO spokesperson clarified that ISO was working also on this topic aiming at identifying what could be defined as « plant-based » food and what type of ingredients could be used. They further clarified that the nutritional composition of such products was currently out of their scope and that the ISO draft text was expected to be available by the end 2023 and expected to be finalized in 2024.The EU recommended to limiting the scope to voluntary initiatives, where essential nutrients, adequacy or equivalency were required, to reflect also different attitudes in the world with regards to addition of nutrients to foods. It was further proposed that the Codex General Principles for the Addition of Essential Nutrients to Foods (CXG 9, latest version 2015) could be amended to address some of the concerns mentioned by the proponents of the new work. Other delegations expressed concern regarding the composition of plant-based and other alternative protein sources, including specific concerns about parasites and human allergic reactions to insect consumption, while the global problems of food waste needed to be also addressed. Singapore pointed out to their comments made at the last CAC and their preference for the Codex alimentarius for setting up a dedicated ad hoc International Task Force to develop specific guiding texts with regards to NFPS (new food protein sources and new food production systems). CCNFSDU43 agreed that Canada and USA would refine the scope of the new work proposal.

Nutrition Profiling Systems for FOPNL
The discussion fell short after a statement by the PAHO representative (speaking on behalf of WHO) about the development of existing regional WHO offices nutrition profiling systems and the upcoming publication towards end 2023 of a global WHO technical guidance on the health policy uses of nutrition profiling systems for FOP labelling (not restricted to nutrients in WHO view), restrictions for advertising or even marketing to children, fiscal incentives and disincentives to promote healthier options of foods and impose a price malus on foods with high content in sugar salt and fats (and in some cases non-sugar sweeteners). As such, no country expressed support for the work done by Costa-Rica over the past years to fulfil all the criteria for new work proposal in the restricted scope of FOP nutrition labelling. Clearly, it seems Codex CCNFSDU is not ceasing the opportunity to complete the existing adopted guidelines on FOPNL and WHO remains the only body to develop such guidance document, without the same levels of involvement, transparency, scientific-based and inclusive approach than those in force in Codex alimentari-us standard and related guidelines development.

All Codex texts adopted as final international food standards by the CAC all available at https://www.fao.org/fao-who-codexalimentarius/codex-texts/jp/

CCNFSDU43 official report will be available at https:// www.fao.org/fao-who-codexalimentarius/meetings/en/ and all its working documents and written comments at https://www.fao.org/fao-who-codexalimentarius/ meetings/detail/en/?meeting=CCNFSDU&session=43

This article was first published in the World Food Regulation Review March 2023 Issue.

[1] CXS 156, current version: 2017. See https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXS%2B156-1987%252FCXS_156e.pdf

[2] Acyl clarified gellan gum (INS 418), Ascorbyl palmi-tate (INS 304), Mixed tocopherol concentrates (INS 307b), some Phosphates (339(i), 339(ii) and 339(iii) and 340(i), 340(ii) and 340(iii)).

[3] CXS 73, current version 2017. See https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B10-1979%252FCXG_010e_2015.pdf

[4] CXG 10, 2015 version. See https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B10-1979%252FCXG_010e_2015.pdf

[5] Those profiles were not developed according to same science-based, transparency and inclusiveness playing field levels and approaches than those used for the development of Codex texts. Hence, creating an open-range for countries to use WHO Regional Offices nutrition profiles systems for policies going well beyond the scope FOP-NL, such as for restrictions on advertising, taxation, marketing to children, etc.

[6] Food safety standards regulatory specialist at Keller and Heckman LLP

[7] See https://www.fao.org/fileadmin/user_upload/codexalimentarius/committee/docs/INF_NFSDU20_e.pdf