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This article originally appeared in WorldFoodRegulationReview.

Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to meet end November in Berlin (Germany) to complete the discussion on follow-up formulas (FUF), ready-to-use foods for nutritionally deprived people (RUTF), decide on the development of science-based Codex Nutrition Profiling System(s), possible new work on Codex guidelines on Probiotics, adoption of a biofortification definition, expected postponement on EPA/DHA with key scientific controversy and to discuss conditions for a “free from fatty acids” claim and new item on “bodybuilding foods”

The 40th session of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Used (CCNFSDU40, Berlin, Germany; 26-30 November 2018) has a heavy agenda again to cover this year. This specialised Codex Committee is one of the horizontal committees of the Codex Alimentarius Commission, although it is also one elaborating Codex vertical/commodity standards on very specific foods, generally called “baby foods” and “food for special dietary uses”. The Committee oversees nutrition labelling and claims (together with the Codex Committee on Labelling –

CCFL), specialised foods (e.g. foods for special medical purposes) and dietary supplements, foods for special consumer groups (e.g. gluten-free).


Towards a final revision of the current Codex Standard on Follow Up Formula

CCNFSDU40 is expected to complete the revision of the compositional requirements of the Codex standard on follow-up formulas (FUF) intended for older infants (6 to12 month-old) and young children (12 to 36 month-old). It is expected that the discussions within CCNFSDU40 will be tough with regard to outstanding matters, especially the sections on the scope and labelling of these products.

Early life nutrition food makers will focus on scientific substantiation of the nutrients and the level thereof to be finally included in the standard. Special attention should be given to the question of whether it is desirable to leave so much room of manoeuvre within the ranges in this important food standard as currently foreseen. Why are there so many references made to national and/or regional authorities in a Codex commodity standard of this kind? The presence of so many areas of possible deviations from the values of nutrients to be set in this standard seems completely at odds with what a Codex Alimentarius Food Standard should stand for, i.e. the standardization of norms and the reduction of national and/or regional deviations. One may also wonder whether such a standard would still be viewed as “deemed compatible” with World Trade Organization (WTO) Sanitary and Phytosanitary (SPS) and moreover Technical Barriers to Trade (TBT) Agreements, as Codex Alimentarius norms used to be and shall normally always be.

Technical discussions will focus on available criteria for carbohydrates, proteins, lauric and myristic fatty acids, DHA, vitamin A, vitamin D3. Some comments submitted suggest additional review of the correspondence of nutrient requirements between FUF for older infants (up to 12 months old) and those for young children (12 to 36 months old), where FUF use is decreased gradually and substituted with staple foods.

Breast-feeding promotion advocate organisations (such as the International Lactation Consul- tant Association (ILCA), International Baby Food Action Network (IBFAN), and International Association of Consumer Food Organizations (IACFO)) are very much expected to continue their battle to undermine this Codex standard, as a whole. They are expected to suggest adding a myriad of references to WHO resolutions. Those resolutions may represent the views of WHO member countries, but others may just be stamped as “WHO”, and originate from un-transparent working groups, the composition and reports of which are never made available publicly on the WHO website, or only years after they occur, which is not compatible with the objectives of the Codex Alimentarius to provide for transparent and scientifically substantiated guidelines . They are also likely to reiterate their unsubstantiated statement that these types of follow up formulas “kill” hundreds of thousands of babies by being at the source of all deficiencies later in their life (e.g., over- weight and obesity, noncommunicable diseases, psychological or affective disorders, etc., you name them). These organisations are also expected to continue to argue that marketing tools and possible claims on the proven benefits of compositional ingredients must be banned, as per what is already the case for infant formulas (i.e., breast-milk substitutes). These organisations are also likely to continue their fight against any visual representations of appealing babies on the labels of these products and claim that FUF products are not necessary for young children older than 12 months and should be regulated otherwise (i.e., in such a way as to convince parents not buying those FUF).

Of course, CCNFSDU40 is not expected to go that far as the decision-making process should be based on sound-scientific evidences.


Possible new work on Nutrient Reference Values Recommended (NRV-R) for labelling purposes on foods to older infants and young children

CCNFSDU40 will consider seven recommendations from an intersession electronic working

group on Nutrient Reference Values Recommended (NRV-R) which primarily concludes that new initiatives should be taken with regard to: (i) NRV-R for older infants;

(ii) NRV-R for young children, (iii) all age references in existing relevant Codex texts to be aligned to define older infants and young children in the same way as the Codex FUF standard (see above); (iv) NRVs-R to be established in those Codex texts (e.g. Canned baby foods; Vitamin and Mineral Food Supplements, etc.); (v) NRV-Rs for vitamins and minerals based on criteria included in vitamin and mineral supplements and formulated complementary foods for older infants and young children; (vi) NRVs will be introduced in the Guidelines on Nutrition Labelling; (vii) NRVs to be used also for nutrients subject to permitted nutrition and health claims in national and/or regional jurisdictions in food products intended for older infants and young children.

It is to be seen how the above recommendations may interact and/or interfere with those discussions to be held first on the composition and label- ling sections of the FUF standard under revision (see above).


Second time consideration of proposed Codex guidelines on ready-to-use (“therapeutic”) foods (so-called RUTFs) for nutritionally deprived people

WFRR readers may recall the two articles published last year on this topic. The content of such international guidelines aims at providing a very solid and detailed basis for guiding countries and international organisations to define essential com- position factors to characterize these foods used exclusively in emergency situations to save children – and even adults – in case of severe and acute malnutrition status, noting that RUTFs are not meant to be sold to consumers. The disastrous cur- rent famine in Yemen could benefit from the delivery of such RUTFs. The purpose of these future guidelines is to ease the production of standardised RUTFs and speed up the drafting of tenders by UNICEF, WFP, WHO and national authorities, as well as to benefit non-governmental organisations such as Médecins sans Frontières (MSF) also using such RUTFs to respond timely to emergency interventions in areas where famine is striking local populations.

It is critical for CCNFSDU40 to spend enough time to discuss the revised draft guidelines, which have been further elaborated since last year by an international electronic working group (EWG). It is worth noting that the recommendations coming out from the EWG will not serve as the basis for CCNFSDU40 decisions. There will be a physical working group in person (PWG), to be held on the whole Saturday immediately before the CCNFSDU40 session, which may provide the plenary committee with different recommendations. The report of that PWG and its recommendations on amending the draft guidelines will serve as the basis for the CCNFSDU40 plenary decisions. This is not ideal for those delegations attending only the plenary, but this is inherent to any PWG held immediately prior to Codex Committees. The document from the EWG contains 22 recommendations to amend the draft revised guidelines and the physical working group may be able to pre-digest hope- fully most of them – if not all – in issuing a simplified number of recommendations to the CCNFSDU40 plenary for advancing the text, possibly for final adoption at Step 5/8. Otherwise the text may be advanced only to step 5 and final adoption will occur only next year.

Let’s hope in that regard that the yet-to-be-appointed new expected co-chairpersons of the CCNFSDU40 will keep a very tight control over the discussion on the FUF standard – and possibly limit that one to a known-in-advance time count – so that the CCNFSDU40 could make significant progresses on the other agenda items of equal importance, such as these long-awaited “Guidelines” on RUTFs.


New Work on Nutrition Profiles: a “should-I-stay-or-should-I-go” dilemma?

As you may recall, last year CCFSDU39 was not able to discuss in detail this important (some say fundamental) proposal for new work on Nutrition Profiles due to a lack of time. So, the discussion paper has been further worked out by Costa Rica and Paraguay to define a path forward for CCNFSDU to develop Codex guidelines on Nutrition Profiles within the next 4 to 6 years.

It seems that the ambition for this year is more limited: to provide general guidance (to countries and organisations/companies) for establishing nutrient profiles for food labelling. It is a sort of wishy-washy approach between addressing the issue just from a general principles and smallest de- nominator level point of view and give a Codex stamp on existing national models.

The announced official objectives are:

nDevelopment of standardized general guidelines for establishing nutrient profiles for use in front-of-pack labelling systems, nutrition education programs and the food industry, in order to encourage the development of healthier foods and diets for consumers, based on solid scientific evidence;

n Revision of the Codex Alimentarius Guide- lines on Nutrition Labelling (CXG 2-1985, 2017 version), for the purpose of developing additional guidelines and facilitating the use of nutrient profiles, taking into account previous work undertaken by the World Health Organization (WHO) in this area.

The discussion paper authors suggest that this should be done through identifying and reviewing nutrient profile models developed in recent years, in order to create a global inventory (by a circular letter). It sounds like almost repeating what WHO claimed it already did a few years ago. WHO has already developed (questionable) nutrient profiling systems at regional levels and has been field testing them for quite a while. In some areas (e.g. South America and PAHO nutrition profiles), countries are already developing legislation on taxes, marketing restrictions and colour coded Front of Pack nutrition labelling based on such models.

The discussion paper authors suggest starting with asking governments, organisations and companies for ten basic questions:

Table 1
Country/ Region of application Implemented/ or proposed Voluntary or mandatory Who developed the profile? (government, industry, other) What critical nutrients does it include? Is it based on categories or groups of food?


Table 2
Nutrients that were considered/in- cluded in the system Foods that are considered important to the diet of your country Tools used to develop the nutrient pro- file

1. Does your country/ organization believe that the Codex Guidelines on Nutrition Labelling pro- vide general guidance for establishing nutrient profiles in food labelling? Yes or No. Please justify your answer. Please quote the specific paragraphs in the Codex Guidelines on Nutrition Labelling, to which you are referring.

  1. If the answer to question 1 is NO, which text, paragraph or section of the Codex Guidelines on Nutrition Labelling do you feel should be adjusted to address this issue? [Indicate text/ paragraph/ section]
  2. Has your country/ organization developed a nutrient profile? Mark with an X. Yes__ (proceed to question 4) No__ (to the end of the questionnaire)
  3. What are the general features of the profile that has been developed?

[See Table 1, above]

  1. What were the criteria used to develop your nutrient profile? Please justify your answer.

[See Table 2, above]

  1. How will your nutrient profile be used?
  2. Has the nutrient profile been validated? Yes/ No Justification (Please give details on the validation process).
  3. What benefits, difficulties and limitations have been observed in using the nutrient profiles that you have developed and implemented?
  4. Do you have statistical data on how your nutrient profile system has impacted the consumer?
  5. How often is your nutrient profile evaluated?”

If this is what it is all about, then it will be just a way for countries having already such nutrient pro- filing systems in place (and linked to color-coded mandatory Front of Pack nutrition labelling, and sometimes warnings/negative health claims), to escape any possibility for a trade dispute complaint in virtue of the rights and obligations set in the WTO/TBT Agreement. It would also raise the question of the legitimacy of Codex Alimentarius in food standardization aiming at facilitating trade by ensuring global harmonization of technical bar- riers to trade based on non-ambiguous Codex standards. Maybe this Codex Alimentarius work is coming quite late. But better late than never. The parallel CCFL discussions on Codex Guidelines on FOPNL will probably have to be slowed down to see how this CCNFSDU work is going to proceed with nutrition profiling guidelines (for use on FOP nutrition labelling!). Maybe ultimately, the two guidelines could be merged? Future may tell.


Probiotics in foods or as food supplements: possible new work on Codex guidelines

This topic on probiotics in foods or as food supplements was already discussed last year. Argen- tina has now worked out a much more advanced and substantiated discussion paper for CCNFSDU40 consideration. It includes thorough explanations of the worldwide growing use of probiotics bacteria added either to foods or sold as food supplements.

The purpose of the proposed new work is to “address the current lack of harmonization which leads to issues and concerns for the regulators, the probiotics industry, and even consumers, with regard to quality, safety and labelling of ‘probiotics’ through the development of a standard or guidelines for probiotics and food with probiotics in order to harmonize framework that includes essential requirements for ‘probiotics’.

But in practice, the discussion paper goes much beyond establishing a Codex definition of the term “probiotics”, and even suggests already a draft text for future Codex Guidelines on how Probiotics could be defined and even evaluated by national authorities. With regard to the definition, the proposed scope is sufficiently broad to cover vegetative microorganisms, spores, inactivated microorganisms, etc., also providing for some exclusions such as non-alive microorganisms, other microbial-based nonviable products.

The second objective is to develop internationally agreed requirements for the evaluation of a “probiotic” as a food ingredient, e.g. taxonomic characterization of the microorganism; characterization of the strain; demonstration of functional properties of the strain, safety of the microorganism for the intended use (through in vivo and in vitro tests; gut translocation of bacteria).

The guidelines would go also one step further in establishing “requirements for the evaluation of a ‘food with probiotics’” or at least criteria to cover at national level such as the amount of probiotic microorganisms; the proven living nature of the microorganism at the time of the food consumption, and, most controversially a demonstration of physiological and/or nutritional benefits of the food at Codex level.

Furthermore, the guidelines would contain a few other recommendations in terms of hygiene, contaminants, labelling and methods of analysis and sampling, as per any other Codex vertical food standard.

It is expected that this new proposal is going to raise a lot of questions which CCNFSDU40 may not be able to address at the forthcoming meeting, given the complexity of some issues included. Most likely CCNFSDU40 will discuss how narrowing down the scope of the proposed new work first (e.g. start with a definition, and then discuss either a standard or guidelines but not a mix of the two). The most controversial issue will probably be the related health claims demonstration. Should CCNFSDU40 be convinced of the need to start this new work, it is expected to be supported by an inter-session electronic working group to discuss a draft text. It will be interesting to see which man- date will be given to this EWG, and which countries may apply for being the chair and the co-chair(s) of it.


Food additives in baby foods – define a process to decide how and who defines the technological needs and CCNFSDU-CCFA interactions

CCNFSDU40 is to discuss the respective roles of CCNFSDU and CCFA. A modernized working flowchart (i.e. a “mechanism/framework”) has been drafted to establish clearer back-and-forth rules to determine which committee has the first and/or final say on the “technological justification” of food additives in foods for special dietary uses (primary focus being on foods for infants and young children).

For that purpose, CCNFSDU40 will consider a revised discussion paper (at the time of writing this discussion paper is still under preparation by the European Union (EU)). One may reasonably expect the discussion to float around a possible at- tempt – through the “technological needs/justification/purpose” criteria to be set up – to raise the issue of the evaluation of all currently

permitted food additives in baby foods for very early life risk assessment by the Joint Expert Committee for Food Additives (JECFA) (first 16 weeks of age), as per current work in the EU and recent data calls issued by the European Food Safety Authority (EFSA) on the same issues.

The discussion paper will probably discuss how the current decision-making process already established in the various sections of the CAC procedural manual may be amended, complemented or even substituted by the result of the proposed framework. Beyond the issue of the respective roles of CCNFSDU and CCFA, the discussion may also include the need to proceed to a full re-evaluation of the already permitted substance and a thorough update of their specifications, when the food additive in question was not evaluated recently enough by JECFA or where new emerging science would warrant such a thorough risk assessment, with therefore possible impact on all the other uses of the substance in foods. Next month, a WFRR article will describe the outcome of those discussions in detail.

Conditions of Use of claim on “Free of Trans Fatty Acids (TFAs)”

CCNFSDU40 is expected to discuss the same conditions of use which were reviewed last year. This year, the discussion will be more technical and around the following main issues:

nWhether the proposed concentration criterion of no more than 1 g per 100 g of fat is relevant compared to a concentration limiting trans fatty acid based on 100 g of foods

n Whether the proposed criterion can be adequately measured with precision with the three methods of analysis suggested; and

nWhether the additional required compliance with the criteria of “low” is met for all foods (especially vegetable oils and fats sold to consumers), as defined in the existing Codex guidelines on nutrition and health claims (i.e. 1.5 g saturated fat per 100 g (solids), 0.75 g saturated fat per 100 mL (liquids) and 10% of energy of saturated fat).

Some countries suggest performing simulations with various foods (especially vegetable oils and fats) to evaluate whether such foods containing essential fats and nutritionally interesting long chain unsaturated fatty acids may pass the proposed above cumulative criteria.

It may be argued that CCNFSDU40 should first request more scientific inputs from the newly activated FAO/WHO Joint Expert Meeting on Nutrition (JEMNU), a group of experts in nutritional risk assessment, before rushing through any conclusion of this matter.


Definition and associated criteria of “Biofortification”

CCNFSDU40 is expected to complete its work this year at defining the concept of “biofortification”. The definition has been further worked out by an international electronic working group since last year CCNFSDU39. The revised definition coming out from this intersession work reads as follows:

“Biofortification1 is any process2 other than conventional addition to food3 whereby nutrient4 content is increased or become more bioavailable in all potential food sources5 for the intended nutritional purposes6.

1 Some Member governments may prefer to use the equivalent term.

2 Process to be determined by the competent national/regional authority.

3 Conventional addition to food is covered by the General principles for the addition of essential nutrients to foods (CXG 9-1987).

4 Nutrient is defined by the Guidelines on nutrition labelling (CXG 2-1985).

5 e.g. animal, plant, fungi, yeasts, bacteria

6 Nutritional purpose:

  • preventing/reducing the risk of, or correcting, a demonstrated deficiency in the population;
  • reducing the risk of, or correcting, inadequate nutritional status or intakes in the population;
  • meeting requirements and/or recommended in- takes of one or more nutrients;
  • maintaining or improving health; and/or
  • maintaining or improving the nutritional quality of food.”

It is worth noting that the concept of “fortification” itself – i.e. foods fortified with minerals, vitamins or other biologically useful substances – is no longer of use in the full Codex Alimentarius, that is to say the compendium of all norms (i.e. all the standards, guidelines, recommendations and statements adopted by the CAC). The proposed definition of “biofortification” aims at covering new plant-growing technologies (other than through modern genetic change techniques), where the crops would be enhancing the production or con- centration of macro/micronutrients, or where antinutritional factors or nutrients “of concern” would be reduced, or where different nutritional composition and balance may be achieved, simply through the growing process of these crops.

During last year CCNFSDU39, some countries voiced up to change the term “biofortification” it- self, arguing that the prefix “bio-” could be con- fused with the concept of “organically grown and farmed products” (i.e. organic foods, translating into Latin languages as “bio(logic) foods”).

It seems that the EWG does not recommend any change to the term “biofortification”. Equally, the EWG is not making any concrete suggestion with regard to what CCNFSDU and CCFL may do next with that definition, or where it should be added (although it is suggested to make it simple and add it to the CAC Procedural Manual in the “definitions” section). The EWG also further recommends to the CCNFSDU40 to work with the CCFL to draw lines between “biofortified foods” and “non-biofortified foods” (i.e. conventional foods?).


NRV-NCD on EPA/DHA – Long way to go, rather towards an “we-agree-not-to-disagree” type of status quo

CCNFSDU40 is invited to consider four recommendations coming out from an intersession electronic working group. Indeed, due to lack of consensus at the last CCNFSDU39 (2017), this electronic working group was to review again scientific evidences available at national level and from the WHO-NUGAG (NUtrition Guidance Ex- pert Advisory Group) systematic review on long chain unsaturated fatty acids (trivially known as Omega 3 and Omega 6). On that aspect, the EWG was not able to reach a consensus on the grade of evidences with regards to the role of EPA/DHA dietary intakes on the reduction of risk factors linked to “fatal coronary heart disease” (called CHD).

Therefore, CCNFSDU40 has been asked to postpone any discussion on establishing a NRV-NCD until (i) new convincing/generally accepted evidences become available, (ii) WHO NUGAG clarifies the definition of risks related to cardiac death and coronary heart disease, (iii) new work is initiated to amend the Codex general principles for the establishment of NRVs to include opinions of the “Recognized Authoritative Scientific Body (RASB)” into the Codex decision-making process, when such RASBs have decided not to set reference values about nutrients reviewed for establishing a NRV-NCD (i.e. regarding nutrient’s positive or negative role on risk factors related to noncommunicable disease for labelling purposes).

The EWG also recommends CCNFSDU40 (i) to stick to the grading of scientific evidences/studies as “convincing, generally acceptable, probable, possible, or insufficient” set by a FAO/WHO ex- pert consultation (held in…2002!), and not necessarily to follow WHO NUGAG GRADE system; and,

(ii) to start a discussion on the criteria which define the set of scientific evidences to be considered as “convincing/generally accepted”.

Another way of approaching that issue would be for CCNFSDU40 to send this spiny and spicy scientific matter to the newly established permanent Joint FAO/WHO Expert Meeting on Nutritional risk assessment; named JEMNU. Indeed, according to Codex general procedures, when a Codex Committee is facing a risk assessment/scientific issue, it should ask the established risk assessment body attached to that committee (i.e. JEMNU is that risk assessment body for CCNFSDU). It could allow experts appointed in the JEMNU from a roster of experts publicly available on FAO and WHO websites, through a fully transparent nomination process, to offer a dialogue with those experts working for the WHO-NUGAG. As this is simply a scientific controversy, it should be first debated among scientists, before it comes back to nutritional risk managers in the CCNFSDU.


Proposal for new work on General Requirements For Protein Supplements Intended for “Bodybuilding”

CCNFSDU40 will consider under other business (last item on its agenda) a proposal put for- ward by Egypt to develop a Codex text to define the minimum requirements for foods appreciated by gym clubs’ practitioners and professional bodybuilders.

Those foods are generally sold as food supplements to increase lean body mass, muscle size and improve athletic performance for people practicing intensive sports. They are also used to simultaneously decrease the percentage body fat so as to create better muscle definition or allow faster recuperation after intensive work-out. Products targeted are high protein drinks (e.g. whey protein powders), branched-chain amino acids (BCAA), glutamine, arginine, essential fatty acids, creatine, ˜-hydroxy ˜-methylbutyrate (HMB) and weight loss products, sold in different forms such as pow- der, liquid or tablets.

Although the discussion paper refers to generic international Guidelines on general requirements for supplements intended for bodybuilding, the proposed structure of the “Guidelines” would refer clearly to a Codex Commodity/Food Standard (i.e. Purpose, Scope, Definitions, Essential Composition, General requirements for products of body- building supplements and quality criteria, labelling, hygiene, contaminants, pesticides, hormone (not clear whether it refers to veterinary drugs, steroids or other doping-listed forbidden substances?) residues, methods of analysis and sampling, with reference to pre-existing Codex documents). The document also refers to a cooperation with FAO, WHO and, more surprisingly, with ISO – while ISO does not generally establish food standards, Codex Alimentarius does.

For access to all detailed documents of the forthcoming CCNFSDU40, click here.