FEATURE: CCNFSDU41 made good progresses

This article is written by Christophe Leprêtre and supported by Katia Merten-Lentz and is first published in the World Food Regulation Review January 2020, Vol. 29, Number 8.

This article explains the main topics discussed by 400+ global food safety and nutrition regulators during the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU41) in Düsseldorf from 24 to 29 November 2019.

CCNFSDU41(*) made good progresses and...

• finalized the revision of the standard on follow up formulas;
• advanced for finalization the standard on ready-to-use “therapeutic” foods;
• stopped to work on the condition of using any “free of” Trans Fatty Acids claims, while agreed to start considering risk management options for curbing down the presence of TFAs of concern in food supplies subject to international trade;
• considered what to do with the definition of “biofortification” after the CCFL U-turn on it;
• agreed to start working on NRVs for older infants and young children (labelling purpose);
• finalized the mechanism/framework for considering the technological justification of food additives in baby foods and other special dietary use foods while discussion new work on alignment of food additive provisions in CCNFSDU standards with the GSFA;
• considered a discussion paper on probiotics guidelines in foods and food supplements and postponed the decision to start new work to the next session;
• considered a discussion paper on nutrition profiling systems guidelines and agreed to refine again the scope of the work for a possible work start from the next session;
• considered the relevant feedbacks from other Codex bodies (especially the one on labelling or CCFL), FAO and WHO ; and,
• discussed further about a prioritization mechanism of the work of the committee.

(*) The 41st session of the Codex alimentarius Committee on Nutrition and Foods for Special Dietary Uses (“CCNFSDU41”) was held in Düsseldorf (Germany), from Sunday 24th to Friday 29th November 2019 and was preceded by (i) a half a day working group on food additives in “baby - and other special dietary uses - food” standards and (ii) a side-event about the outcome of the very first scientific opinion issued by the “newly” re-established Joint FAO/WHO Expert Meeting on Nutrition (JEMNU) on the nitrogen-based conversion factors to declare milk-based and plant-based protein content of a food.

Follow up formulas (FUF) for older infants and young children: “almost there, keep going”

CCNFSDU41 considered and reached consensus on three main outstanding issues related to mandatory and optional compositional requirements of the FUF products for young children (1-3 years old). One of them related to the restrictions to be applied with regards to the sweetness (or sweet taste) of those products when prepared based on non-milk protein. One may question whether sweetness is a compositional requirement in the meaning of Codex commodity standards. Beyond that issue, it is therefore the first time ever that a Codex text would contain a restriction reading as “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.”

In the same vein, another change was made to extend the coverage of the provision on sweetness from “substance” to “ingredients” and the sentence was moved to the end of the section on optional ingredients to read

“Ingredients shall not be added with the purpose of imparting or enhancing a sweet taste of the [name of the product] defined in Section 2.1. for young children.”

That proposal, mainly driven by a zealous and sharp European Commission official, is clearly targeting more types of ingredients than the classical mono- and di-glycerides coming from any carbohydrate food sources, such as fruit concentrates, honey or partially hydrolyzed starches. As a justification, the EC official referred to

“substances which are sweet but are not sugars or they enhance the sweet taste, and are not necessarily regulated as food additives (ndlr: she forgot to refer to novel foods… any intentional miss out here?). A lot of research and development is going on and extracts from some plants or protein-like products can have that sweet effect as well. To cover the future proof of the standard and also exclude these products, it is important to add such a statement to the standard.”

It is very disturbing to see such a proposal coming from an EC official, on behalf of the whole EU, whereas within the EU and the EU Member States there are many discordant positions about the concept/claim of “added sugars/with no added sugars”, especially strong legal disagreements to consider substances regulated as food additives such as intense sweeteners as covered by the scope of such a provision. Sugars are mono- and disaccharides. Intense sweeteners (neither polyols) are definitively not sugars and are not covered by “foods imparting a sweet taste” in the context of the definition of any “no added sugar(s)” claim. A lot of stakeholders are also a bit anxious to see this provision, currently specifically introduced to cover “follow up formula” products to young children (below 36 months of age), as it could potentially become a new trend (a precedent lawyers would say) that may be used in other existing Codex commodities standards, or in other more general Codex texts, to “regulate” in the longer run the sweetness of foods and drinks in general or extend the applicability of that provision to individuals (children) beyond 36 months of age.

Alongside this debate, the issue of measuring or characterizing sweetness was raised, and the issue of whether properly validated method(s) of “analysis” to measure sweetness of carbohydrate sources for these particular products was deferred to the Codex specialized committee on methods of analysis and sampling (CCMAS). With regards to the method of analysis, the representative of the AOAC recalled that there was some merit to ask CCMAS to review existing methods, even if they only were sensory methods on the understanding that relative sweetness to lactose was mainly based on a 2016 study (i.e. Functionality of sugars in foods and health. Comprehensive Reviews in Food Science and Food Safety 15:433-470).

CCNFSDU41 spent a significant part of its plenary session in reviewing the definitions and the labelling section of part of the standard related to the FUF products intended for young children (12 to 36 months old). The main issue and controversy was whether these products should be viewed as breast-milk substitute in the Codex standard (clearly a WHO’s services view, as well as set in many national regulations which are following the WHO recommendations to the letter without further discernment, as when the young child gets older the type of these product may change and a significant part of the diet is replaced by stapled food). As such, parts of those products would not arguably fall under the WHO umbrella as breast-milk substitute, because precisely they could not wholly replace any of the recommended continuation of breast-feeding beyond 12 months. CCNFSDU41 advanced the following text, although the USA made clear that they were reserved about the added footnote. So far, those FUF products for young children would ? mean[s] a product manufactured for use as a liquid part of the diversified diet of young children [which may contribute to the nutritional needs of young children] ? with the footnote referring to “In some countries, these products are regulated as breast-milk substitutes”. One may indeed argue that the footnote could eventually equally reads: “In some countries, these products are not viewed nor regulated as a breast-milk substitute”.

 The plenary also spent a significant amount of time and revisited it at several occasions, the name of such FUF products for young children. Finally, mainly due to a split in countries opinions, CCNFSDU41 decided to limit its own ambitions (and mandate) in harmonizing with a single descriptor those FUF products, and let countries to decide, when implementing the future revised standard, between “Drink/Product for young children with added nutrients” and “Drink for young children”. Probably CCNFSDU42 will have to revisit that part, as Codex standards should be forward looking, global and unambiguous.

The last main contentious part discussed was on additional labelling requirements, with a lot of back and forth proposals, finally ending with one worked out on the side of the plenary (reflected in CRD 50) while deleting the proposed footnotes and amending it to refer to a WHO recommendation to breast-feed young children up to two (yes 2…) years. The result is a largely expanded section 9.6 with many references to similar text found in some technical guidance from WHO services which in their views are cross-promotional practices to be discouraged.

Therefore, the main additional labelling requirements would provide that the label (and the labelling) of such products:

• shall have no image, text or representation, including pictures of feeding bottles, that could undermine or discourage breastfeeding or which idealises the use of the product(…). The terms ‘humanized’, ‘maternalized’ or other similar terms must not be used on the label.
• should not discourage breastfeeding. Each container label shall have a clear, conspicuous and easily readable message which includes the following points: a) the statement “Breastfeeding is recommended up to two years and beyond.” b) a statement that the mother/caregiver should seek advice of a health worker on proper feeding of the young child.
• shall have no pictures of infants, older infants, young children and women or any other picture, text, or representation that: a. undermines or discourages breastfeeding; or that makes a comparison to breast-milk, or suggests that the product is similar, equivalent to or superior to breast-milk; and b. might convey an endorsement or anything that may be construed as an endorsement by a professional or any other body, unless this has been specifically approved by relevant national or regional regulatory authorities.
• shall be distinctly labelled in such a way as to avoid any risk of confusion with infant formula, follow-up formula for older infants, and formula for special medical purposes intended for infants, in particular as to the text, images and colours used, to enable consumers to make a clear distinction between them.
• shall not refer to infant formula, follow-up formula for older infants, or formula for special medical purposes intended for infants, including numbers, text, statements, or images of these products.

Due to lack of time, all the remaining parts of the FUF standard (including the preamble) could not be discussed and CCNFSDU41 is therefore asking for another extra-time up to CAC45 in 2022, while the scope definition and labelling section for FUF products for young children is advanced into the step process, the labelling section is sent back to CCFL for endorsement, and a new inter-session electronic working group is re-established to finalize the definition of these FUF products (with particular focus of part in square brackets referring to nutritional needs) and assess its “linkages and impact”. That upcoming EWG will also consider the report and options presented by JEMNU on Nitrogen to protein conversion factors for soy-based and milk-based ingredient used in infants and follow –up formula, and to what extent it needs to be considered for the revision of the draft standard/s for follow up formula for older infants and ‘Drink/Product for young children with added nutrients’ and ‘Drink for young children.

To that regard, the Joint WHO/FAO secretariat of JEMNU did presented the results of this historical first JEMNU opinion in the recent history during a side-event held on the day before CCNFSDU41 started. CCNFSDU39 indeed had asked JEMNU experts whether the current and unique conversion factor of 6.25 to deduce the protein content from the Nitrogen Kjeldhal test (i.e. complete acid mineralization) could still be adapted depending on the dairy source or the plant (soy) source of the proteins as well as what would account for the total protein content (especially the non-protein source of nitrogen in complex foods). JEMNU experts answered the question in two main ways: firstly, the scientific evidences reviewed were named according to the GRADE scale from very low evidence to moderate evidence. Obviously, this low Grade of evidence did not please a lot of people in the room (as out of the 6000 publications reviewed, only 57 were retained by experts in their systematic review). JEMNU also made some review of the impact of non-protein nitrogen (e.g. nucleic acids, amines, urea, alkaloids, etc.) and prosthetic groups (e.g. phosphoryl groups and oligosaccharides)) on the overall protein count (a protein could be defined either as the sum of the amino-acids only or that sum plus the prosthetic groups). Secondly, depending on the definition chosen for a protein, JEMNU suggested two options to CCNFSDU to consider: 

1. where Protein would be viewed only as the sum of its amino-acids, then the 6.25 nitrogen conversion factor would be replaced by 6.1 for dairy source (with moderate certainty, which is the highest GRADE found in the systematic review) and 5.7 for non-dairy source (plant/soy source) (with low certainty); or
2. where Protein would viewed as the sum of all amino-acids and the prosthetic groups, then then the 6.25 nitrogen conversion factor would be replaced by 6.3 for dairy source (with moderate certainty, which is the highest GRADE found in the systematic review) and 5.7 for non-dairy source (plant/soy source) (with very low certainty).

Given the late arrival of the JEMNU report (and the potentially huge implications of the above proposed options it may have on infant and young children foods as well as many other foods (regardless whether food comes from a dairy source or not)), CCNFSDU41 agreed to postpone the regulatory discussion to change the current Nitrogen conversion factor of 6.25 in many Codex texts to its next session.

Guidelines on Ready-to-Use Therapeutic Foods: “one small step for a man…”

CCNFSDU41 dedicated the necessary amount of time to review all the main parts of this landmark piece of text and agreed to advance it for further consideration at the next session on only remaining parts in square brackets. This Codex text is very much needed to clarify the essential characteristics of these very particular type of foods which are used in emergency situations and provided to individuals suffering from severe acute malnutrition. These types of foods are generally subject to procurement calls issued by UN agencies such as UNICEF, UNHCR and the WFP to supply field operations and camps in areas where malnutrition is widespread.

This Codex text is very original in many different ways.

The first is that the text describes definitions, mandatory and voluntary compositional requirements, hygiene requirements, contaminants and additives/processing aids restrictions, labelling provisions, and methods of analysis exactly in the same manner as a Codex commodity standard would do, but it is still viewed and called a Codex Guidelines. At this point in time, only the labelling and additives/processing technologies provisions, so far, are foreseen to be shared respectively with the CCFL and CCFA for endorsement, but not the other provisions (e.g. on contaminants or hygiene).

This text is also original in a way that it covers a type of food which is called “therapeutic”. CCFL will certainly have to express some views on this title, definitions, and denomination, regardless whatever UNICEF or others are calling these types of food with a medical purpose, because of a possible inconsistency with the core definitions set in Codex guidelines and standards and the procedural manual about “food” and “claims”, including “health claims”. A food cannot be “therapeutic” as a food cannot cure a disease. However, a medicine can. It is not anecdotical at all.

Finally, the text is original because it contains a very unique provision in its “Packaging” section stating that, maybe as a premonition for future Codex work,

“the 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.”

So far (i.e. since 1963), the Codex alimentarius Commission -- strangely enough one may say -- has not developed any proper technical recommendations nor even any broader guiding principles about the nature and requirements applicable to packaging materials which are entering in direct (or indirect) contact with food, whether such a food is covered by any Codex commodity standard or not. There used to be one general text on “packing media” published in the early 2000s, as a miscellaneous document, no more available. It is clear that food contact materials are made of complex mixtures of chemicals (and sometimes carrying contaminants), whereby inevitably some of them would end up in migrating into foods (and drinks) at more or less low doses. The Codex alimentarius Commission may wish one day to send that broader issue on food contact materials to CCFA, CCFH and CCCF for further inputs from these committees.

Trans fatty acids: “the truth is elsewhere…”

CCNFSDU41 agreed to discontinue its work on possible conditions for the claim “Free of Trans Fatty Acids (TFAs)”. Equally, CCNFSDU41 agreed to inform the Codex committees on labelling (CCFL) and on fats and oils (CCFO) and ask them for considering to engage into developing risk management options to help reduce or eliminate TFAs from the diet, in the respective areas of their terms of reference and standards.

Canada tried to influence the CCNFSDU by issuing a revised set of recommendations in the CCNFSDU working document a couple of days before the meeting, by putting a specific emphasis on the mandatory labelling of TFA and cholesterol and warnings solutions (Canada is the host country of the Codex Committee on Labelling and their proposals are also the reflection of Canada national legislation). Canada seems to use Codex and her host country capacity to shape and revise Codex standards closer to Canada own labelling legislation, something they are very transparent about.

The WHO representative made a strong statement that WHO has already decided upon a global strategy to ban partially hydrogenated oils (i.e. the REPLACE initiative) worldwide, promote mandatory nutrition labelling of TFAs and establish very low limits for industrially induced TFAs, to aim at a complete phasing out from the food chain by 2023.

The EU recalled their own approach with a maximum limit in foods (on a fat basis) adopted recently and that a study made in the EU demonstrated the total lack of cost-effectiveness of extra-labelling measures against TFAs whereas other solutions gave better results (including voluntary phasing out by the industry to work on new processing techniques). EU was supported by Malaysia, Philippines, Brazil, while New Zealand was unhappy about the Canada attempted coup.

The USA did not intervene on this topic although they have already un-GRAS-ed PHOs as a food ingredient and did not consider useful nor acceptable the petition put forward by the US industry for allowing minor uses of PHOs in some technical B2B applications.

The German Vice-Chair of CCNFSDU chairing that part of the session expressed a form of frustration in stating that “at the level of CCNFSDU, there is no risk management options which are part of the terms of reference of the Committee”, a way to indicate that for her the only way forward is the mandatory labelling pathway (which from a EU-based perspective was fairly surprising).

Proposed draft definition for biofortification: “this is end, my friend…”

As expected, CCNFSDU41 decided to stop working on a definition of biofortification and not a single member country took the floor on that issue. CCFL already killed the process last May (see related WFRR article). The CAC also instructed last July the CCNSDFU to make a final choice about whether the definition - developed at the request of CCFL for labelling purpose - of “biofortification” (i.e. meaning a natural enhancement of presence of vitamins and minerals, or other nutritionally relevant substances through conventional – and advanced but not GMO - breeding techniques) would be useful for texts developed by the CCNFSDU.

WHO representative pointed out that they had been working with FAO and the New York Academy of Sciences on a series of technical documents posted on the WHO-ELENA database with regards to biofortification. WHO also considered that the 2006 technical guidance on food fortification strategies still fully applies (WHO forgot to mention the adopted of far more recent Codex guidelines on addition of essential nutrient to foods[3], CXG 9, in 2015).

IFPRI representative made a last chance intervention to express its sadness that the CCNFSDU would not take a second shot at the issue, which remains an important lever to reduce dietary unbalances by fortifying crops, e.g. Rice with Vitamin A in Asia. IFPRI tried to suggest innovative ways to move things forward again, such as (i) considering different definitions depending in the different mode of production of nutritionally enhanced crops, (ii) review of the Codex guidelines on the addition of essential nutrient to foods, (iii) seek from some commodity committees such as CCCPL (covering rice and wheat), CCFFV (covering papaya) to assess whether at least the concept of “biofortification” in relation to food nutrient composition could be introduced in some of their commodity standards .

Nutrition Profiling Guidelines: “not quite there yet, but it could have been worse…”

CCNFSDU agreed to continue working on the discussion paper and project document on Nutrition Profiles Guidelines in order to discuss it at the next CCNFSDU session as a specific agenda item. It will be further discussed whether CCNFSDU shall start a new work to develop dedicated Codex guidelines on how establishing nutrition profiling systems in the limited and strictly defined context of the Front-of-Pack Nutrition Labelling schemes, for countries and - possibly - private sector(s). The revised discussion paper is to be prepared by Costa Rica, Paraguay, the USA and the European Union (new co-chair) and will be discussed at the next session as a formal agenda item of the next session.

New Zealand indicated that the new work was “absolutely critical” for Codex CCNFSDU to start and pointing out the sequence of meetings of the next CCFL to be held just a couple of weeks before the next CCNFSDU. The EU (EC on behalf of the EU) also pointed out there was a need for further harmonization at Codex level to frame the work on existing and upcoming nutrition profiles which are definitively used in the context of FOPNL schemes. EU further insisted to become a co-chair of the revision of the discussion paper and that this work was a necessary complement about what CCFL is currently doing on the Codex future FOPNL guidelines. Other countries in favor of the proposal were Australia, Egypt, USA, Brazil, Argentina, Philippines, Panama, Paraguay, EU28.

WHO and the German Vice-Chair of that part of the session were apparently at unease to get this decision going through. The German Chair expressed some preference to have it parked along with the overall list of other new work proposals and subject to the priority setting proposed mechanism, whereas WHO representative clearly did not see the proposal as friendly to WHO’s own guidance on multipurpose nutrition profiles and why the Codex ones should be limited to FOP Nutrition Labelling. WHO referred to FOP labelling overall (skipping ‘nutrition’), pursuing many other objectives (shame-name/negative claim/health warnings/taxing/market restrictions/etc. of all kinds they want to promote within NUGAG).

Some US/Canada-based industry representative made an intervention to indicate their support to the new work and that such profiles should also take into account the presence of positive nutrients to foods, e.g. fibers, fruits, etc. Other soft drink industry representative expressed their support to nutrition profiles that shall be science-based.

WOF (World Obesity Federation) supported the work and pointed out the large body of scientific evidences to establish thresholds for nutrients of concerns (sugars, salt, saturated fats) while WPHNA (World Public Health Nutrition Association) did not intervene.

The Committee therefore agreed to establish a dedicated EWG (Costa Rica, Paraguay, EU, USA) to (i) analyse the document presented at NFSDU41 session and (ii) refine the discussion paper and the project document to define the scope for developing general guidelines for the establishment of nutrient profiles for use in front of pack nutrition labelling; and to inform CCFL of the ongoing discussion within CCNFSDU and ask CCFL to what extent the work concerning nutrient profiles in CCNFSDU can support the work of CCFL on FOPNL and to what extent it is taken into account.

Other issues and remarkable features

• Probiotics guidelines: “pushed back into the shopping list of new works… So long…”

CCNFSDU41 did not agree to develop new guidelines on probiotics and rather has rebuffed a revision of the discussion paper and sent it all to the overall framework for new priorities (to be decided next year as well, see further below).

The discussion Paper prepared and fast-track presented during the session by Argentina about a proposed possible new work (guidelines) on probiotics in foods and food supplements (i.e. dietary supplements) was considered by CCNFSDU41 as not clearly enough defined, for the second time in two years. The aim of the proposed new work was to support national legislative frameworks, provide a general understanding through setting definitions, as well as minimum characterization requirements, safety criteria, quality and labelling criteria.

Support to the new work was brought by Jordan, Colombia, Malaysia, and Egypt, highlighting the need for such a guideline, and noting that the guidelines could be established taking into account existing FAO and WHO definitions and guidelines to provide high level guidance and basic principles while focusing on the use of probiotics as ingredients and addressing the need for further international regulatory harmonization within the Codex alimentarius.

IADSA (food supplements industry) made a fairly strange statement about the lack of need for such Codex guidance on probiotics due to the absence of trade barriers to probiotics sold as food supplements, and it pleased the EU (16 Member States present in the room at the time of the discussion) and Turkey which favored postponing this new work. The EU representative argued that many proposed provisions were already addressed by other Codex standards and guidelines such as the horizontal principles and guidelines on labelling, claims, contaminants, safety and hygiene covering all foods, including food supplements. Undertaking new work on probiotics could create significant duplication by repeating in vertical guidelines what had already been agreed in those horizontal texts.

It was noted that FAO and WHO have already undertaken work in this area including establishing a definition for probiotics and that such a definition was already widely used as a basis for regulating probiotics and there was no need to use Codex resources to address these issues again.

While responding to the concern whether dietary supplements were covered under the scope of CCNFSDU, the Codex Secretariat clarified that Codex previously elaborated “Guidelines for Vitamin and Mineral Food Supplements (CXG 55) and such guidelines would then apply only in those jurisdictions where such products are regulated as foods (Section 2.1 of the Guidelines). Some delegations confirmed that dietary supplements including probiotics were regulated under food while others mentioned they were regulated as “medicines”.

Regional proverb: “Instead of pulling over the blanket for oneself, think rather about getting a larger bed (and blanket).”

• NRV-R for young children: “a major hint forward…”

CCNFSDU41 clarified that proceeding to such a new work would cover foods intended to individuals from 6 month old to not more than 12 months old and individuals from more than 12 month old up to 36 month old (i.e. from 1 day after the 1st (year) birthday to the day of its 3rd birthday) and be subject to a stepwise approach.

CCNFSDU41 therefore established a dedicated EWG (lead by Ireland, Costa Rica and USA) to develop first general principles to guide (i) the most appropriate approach to derive NRVs-R, based on an analysis of Dietary Intake Reference Values (DIRVs) from FAO/WHO and the 6 RASBs; and recall (ii) the purpose(s) of these NRVs-R for labelling. Then, it will suggest NRV-Rs, including for protein (but with lower priority), and, if appropriate, make recommendations to refine the (nutritional) composition of foods falling within the scope of the Codex Guidelines on Formulated Complementary Foods for Older Infants and Young Children. In that context, CCNFSDU may consider at a future stage the need for getting a dedicated scientific advice on how existing requirements for each of the 24 nutrients were derived by FAO/WHO and the 6 RASBs and how evaluating and ranking these nutrient requirements based on the quality of evidence.

• Mechanism/framework for considering the technological justification of food additives and alignment of food additive provisions in CCFSDU-developed standards with Codex GSFA: “mission accomplished…”

CCNFSDU41, helped with a one morning pre-session PWG, finalized the text of the mechanism in adopting the last piece as follows:

“(a) 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?

(b) If not, what is the justification for the need for an additive with a new functional class and/or technological purpose?

(c) If yes, what advantage(s) does the proposed additive provide over currently permitted options?”.

The named document “CCNFSDU framework for appraising the technological need” is to be published as an information document on the Codex website (see https://www.fao.org/fao-who-codexalimentarius/resources/inf-doc/en/, although for the time being is only available as Appendix VIII Part A of the CCNFSDU41 report).

In addition, CCNFSDU41 agreed to proposed for final adoption in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72) two new food additive provisions relating to xanthan gum and pectins as thickeners, which were tested through the decision-tree screening of the new above framework and passed successfully all the criteria. It was also agreed to request CCFA to include those provision accordingly in the 1-to-1 corresponding food category 13.1.3 “Formulae for special medical purposes for infants” of the General Standard for Food Additives (CXS 192).

Equally, the CXS 72 standard will be amended as follows: CCNFSDU41 agreed to establish an EWG (lead by European Union, Russian Federation) to collect further information from applicants about (i) low acyl clarified gellan gum, (ii) ascorbyl palmitate (INS 304), (iii) mixed tocopherol concentrates (INS307b) and (iv) phosphates (INS 339(i), 339 (ii) and 339(iii) and INS 340(i), 340(ii), and 340(iii)) and screen the responses to the reply form included in Annex II of the Framework through the decision-tree included in the Annex 1 of the Framework for considering and make recommendations to the next CCNFSDU as to whether they may be technologically justified for use in products conforming with the latest version of CXS 72.

• Discussion paper on a prioritization mechanism to better manage the work of CCNFSDU: “see you next year…”

Germany, as host country presented his discussion paper containing a list of criteria and a decision-tree to establish future priorities of the CCNFSDU. As part of this process, Germany also suggested that a pre-session working group (PWG) be held prior each future session of the Committee to screen the proposals for new work and make recommendations to the plenary in terms of ordering them from higher to lower priorities. Countries willing to submit new proposals for new work will be asked to do so in replying to a yearly circular letter to be issued by the Codex secretariat in advance to each future CCNFSDU session.

The Committee agreed to consider further the proposed prioritization mechanism; while starting to test it -- on a pilot basis -- to assess its usefulness at the next session PWG with the aim to finalize it at the next CCNFSDU session. It should be noted that, as currently drafted, the decision-tree would give always the highest priority to the revision of existing standards, compared to new work proposals, and then requests from the CAC, followed by requests from other Committees. Also, the decision-tree make a distinction between “public health” and “food safety”. Maybe the two criteria could be merged in one criteria referring to “consumer health”. A new proposal would be automatically be rejected if the information provided in the response form of the circular letter are incomplete or in the case it does not affect any target population group, and has low impact on consumer health and low impact on fair practices in the food trade (does not mislead the consumer).

As such, CCNFSDU41 requested that a Circular Letter (CL) be issued to seek from Codex members and observers their proposals for new work on emerging issues or otherwise. The next pre-session PWG will therefore (i) adjust as necessary the draft prioritization mechanism framework with a possible simplification of the criteria listed while streamlining the proposed process and (ii) carry out a case-by-case review of the proposals (to be submitted by Codex members and observers in response to the future CL). The future final prioritization mechanism (expected to be adopted at CCNFSDU42 in 2020) will be published as an information document and posted on the Codex website for internal use by the Committee.

• Last minute Korean proposal to develop Codex guidelines to member countries for the qualification of Nutrition and Health Claims on Foods (i.e. content of pre-market approval dossiers): “pushed back into the shopping list of new works… So long…”

Korea submitted as a CRD an comprehensive - but unsolicited - discussion paper and project document with the aim to develop harmonized Codex guidelines for the qualification of Nutrition and Health Claims on Foods. The purpose of this work would be to guide countries on how approving at national level case by case health claims based on sound scientific evidence. Due to lack of time the proposal was not considered, but Korea was invited to submit their proposal again in response to the circular letter mentioned in the context of the Mechanism for Establishing Priorities of CCNFSDU (see previous section).

• Issues coming from other Codex bodies and reporting of activities from WHO and FAO relevant to the work of CCNFSDU: “business as usual…”

From CCMAS, CCNFSDU41 agreed:

• to request CCMAS to develop performance criteria for Type III methods for determination of the nine minerals (calcium, copper, iron, magnesium, manganese, phosphorus, potassium, sodium and zinc) in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CXS 72), noting that this approach would provide flexibility to members to choose methods for general use; and to inform CCMAS that Type II methods should continue to be listed in CXS 234 as specific methods were preferred for dispute settlement purposes.
• that it was premature to consider the proposed alternative as research is still ongoing to determine the most appropriate method for determination of amount of gluten in foods and wait for the outcome of ring trial tests under way.
• to align section 5.2 with the wording from the Procedural Manual “For checking the compliance with this standard, the methods of analysis and sampling contained in the Recommended Methods of Analysis and Sampling (CXS 234 – 1999) relevant to the provisions in this standard, shall be used.”, noting that the method for determination of gluten by the enzyme-linked immunoassay (ELISA) R5 Mendez Method is already listed in CXS 234 and any change to the method related to the determination of gluten remained the responsibility of CCNFSDU and editorial amendment will be made accordingly to CXS 118, after being formally adopted by CAC43.

After further work during insession-WG and its plenary, CCNFSDU41 further agreed to:

• submit to CCMAS the method for dietary fibre, ICC Standard No. 185 / AOAC 2017.16 / as Type I method to replace AOAC 2009.01 / AACC Intl 32-45.01
• submit to CCMAS the following methods for review, endorsement as Type II and inclusion in CXS 234 (as applicable to CXS 72 on Infant formulas):

1. AOAC 2015.14 / ISO DIS 21470 for thiamine, riboflavin, niacin, vitamin B6;
2. AOAC 2015.10 / ISO DIS 21468 for choline and carnitine;
3. AOAC 2016.13 / ISO 23443 for beta-carotene and lycopene;
4. AOAC 2016 17 / ISO DIS 22579 | IDF 241 for fructans;
5. AOAC 2016.02 / ISO DIS 23305 for biotin.

• request to CCMAS to re-qualify the existing Type II methods for aforementioned nutrients as Type III in CXS 234-1999.
• inform CCMAS that it could include AOAC 2011.14 / ISO 15151 | IDF 229 for calcium, copper, iron, magnesium, manganese, phosphorous, potassium, sodium and zinc as Type III in CXS 234-1999.
• inform CCMAS that the microbiological methods for nicotinamide, niacin, pantothenic acid, pyridoxine, cobalamin, and Vitamin D were still in use and to retain these methods.
• inform CCMAS to replace AOAC 999.15 / EN 14148 for vitamin K with AOAC 2015.09 / ISO 21446 as Type II method of analysis in CXS 156 (FUF).

From FAO, CCNFSDU41 noted:

• the results of the Joint FAO/WHO Expert Meetings on Nutrition (JEMNU), to provide scientific advice for the establishment of nitrogen to protein conversion factors for soy-based and milk-based ingredients used in infant formula and follow-up formula, noting that the main outcomes of the report, along with the systematic review that had been presented during a CCNFSDU41 side event (see above under FUF);
• the report of the FAO Expert Working Group on Protein Quality Assessment in Follow-up Formula for Young Children and Ready to Use Therapeutic Foods, as published in 2018.

From WHO, CCNFSDU41 noted:

• NUGAG upcoming early December meetings of its Subgroup on Policy Actions back-to-back before the subgroup on Diet and Heath). The scope and purpose of the NUGAG Subgroup on Policy Action 9-13 December (Qingdao, China)[4] where final systematic reviews were to be considered and recommendations on nutrition labelling policies, policies to restrict marketing to children, fiscal and pricing policies to promote healthy diets, were to be drafted and/or finalized; through:
• Assessing the certainty of evidence;
• Determining the strength of respective recommendations, taking into consideration detailed criteria, such as the balance of evidence on benefits and harms, values and preferences, resource implications, priority of the problems, equity and human rights, acceptability and feasibility;
• Reviewing and identifying implications for future research, taking into account on- going research and any existing controversies; and
• Reviewing any possible challenges for implementation of the guidelines.

The NUGAG Subgroup on Diet and Health 16-19 December (Qingdao, China)[5] was expected to perform the following: (i) Finalization of any outstanding issues on the guidelines for polyunsaturated fatty acids (PUFA), non-sugar sweeteners and carbohydrates; and (ii) address PICO (Population, Intervention, Comparator, Outcome) questions and prioritized outcomes for low-sodium salt substitutes.

All CCNFSDU41 working documents are available at https://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCNFSDU&session=41 and the CCNFSDU41 official report and agenda are available at https://www.fao.org/fao-who-codexalimentarius/meetings-reports/en/  

[1] Food Engineer, Regulatory and Scientific Counsellor at Keller and Heckman LLP

[2] Food Law Attorney & Partner at Keller and Heckman LLP

[3] See https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FStandards%252FCXG%2B9-1987%252FCXG_009e_2015.pdf

[4] See https://www.who.int/docs/default-source/nutritionlibrary/events/2019-2nd-nugag-meeting-scopeandpurpoe-9to13dec.pdf?sfvrsn=b0638d88_7

[5] See https://www.who.int/docs/default-source/nutritionlibrary/events/2019-13th-nugag-meeting-16to19dec-scopeandpurpose.pdf?sfvrsn=1ba3aa3f_14