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Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to meet early December in Berlin

This article originally appeared in World Food Regulation Review, Vol. 27, Number 6, November 2017.

Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) to meet early December in Berlin (Germany) to resume work on follow-up formulas, ready-to-eat foods for nutritionally deprived people, a definition of biofortification, a nutritional reference value for EPA and DHA, possibly define the condition of using claims “free from fatty acids”, and respond to the Codex Committee on Food Labelling on Nutrition Profiling System(s), among other standardization works

The 39th session of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (Berlin, Germany; 4-8 December 2017) has a heavy agenda to cover. This specialised Codex Committee is one of the horizontal committees of the Codex Alimentarius Commission, however it also elaborates Codex vertical standards on very specific foods, generally called “baby foods”. The Committee oversees nutrition labelling and claims (with CCFL), food and dietary supplements, foods for special consumer groups (e.g. gluten-free, foods for special medical purposes).

The FAO and WHO report activities on nutrition policies, future possible Codex work on nutrition profiling system(s) as well as other issues from other committees (especially technical discussions on methods of analysis)

CCNFSDU39 will note the information from the last Codex Alimentarius Commission (CAC40) decisions, such as the agreement that the work on the nutrition labelling reference value (NRV-NCD) for EPA and DHA long-chain omega-3 fatty acids shall be completed by 2018. CAC also agreed to give one more year (until 2019) to complete CCNFSDU’s current work on follow up formula and biofortification, thus anticipating the difficulties CCNFSDU may face to cover all the work on those two items at this December session.

CCNFSDU39 will also note the decisions of the Codex Alimentarius Committee on methods of analysis (CCMAS38) to (i) include new methods of analysis for chromium, molybdenum and selenium as Type II, while retaining or retyping, where necessary, the older methods as Type III, (ii) endorse the AOAC 2012.13-ISO 16958-IDF 231 method for total fatty acids and (iii) endorse a couple of other methods, e.g. Vitamin C, E, B12, and Myo-Inositol, in infant formulas. CCNFSDU is to answer several questions from CCMAS on collaborative studies about methods of analysis on trans fatty acids in various food matrices.

CCNFSDU will also have to provide guidance back to CCMAS on several microbiological methods used for the determination of amounts of Vitamin B3 (nicotinamide and niacin), Vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), Vitamin B12 (cobalamin) and Vitamin D (ergocalciferol (D2) & cholecalciferol (D3), and others). It is likely that the detailed discussion on those methods may be handled under the other businesses agenda item (AOB) given that more information has been provided by the USA in a Discussion paper on Methods of analysis in the Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (CODEX STAN 72-1981) for Biotin, Vitamin D and Chloride.

In addition, CCNFSDU will observe the different works and events carried out by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO). The development of a new Global Food Consumption Database, which has been established in close collaboration with the European Food Safety Authority (EFSA) and based on the European Union (EU) FoodEx2.0 food categorization system (see www.fao.org/gift-individual-food-consumption/en/) will also be presented.

As you may recall from the report of the outcome of CCFL44 (see WFRR October 2017 issue), the CCFL tabled a question to CCNFSDU on what CCNFSDU could foresee to work on nutrition profiles, in relation to CCFL new work on Front-Of-Pack nutrition information labelling (FOPNL). However, the way it is set out in the CCNFSDU working document implies that CCNFSDU may decide upon potential new work to develop general guidelines to establish nutrient profiles, which would supplement the work on FOPNL. CCFL44 agreed to request that CCNFSDU should consider how it could contribute towards the new work on FOPNL. This is confirmed by the publication on 30th November (only five days before the plenary) of a Discussion Paper proposed by Costa Rica and Paraguay as a conference room document (CRD n°4), the title of which demonstrates no doubt or ambiguity in their minds on what CCNFSDU may work on: “General Guidelines to Establish Nutritional Profiles”. The future will tell if countries and observer delegations are ready for this last-minute proposal for new work. Probably the German Chair of CCNFSDU39 will suggest to move the detailed discussion under AOB on the last afternoon of the CCNFSDU39 plenary. According to food industry sources, this discussion may lead for a push to activate the FAO/WHO Joint Expert Meeting on Nutrition (JEMNU) which is now a recognised source of scientific advice to CCNFSDU, as per the revised “Nutritional Risk Analysis Principles and Guidelines for Application to the work of the CCNFSDU” (soon to be published in the 26th edition of the Codex Alimentarius Commission Procedural Manual). Indeed, while JEMNU terms of reference were adopted in 2012, this expert body remains for the time being a virtual one. JEMNU is viewed by many as a more transparent and inclusive process than the WHO Nutrition Guidance Expert Advisory Group (NUGAG), reviewing primarily the impact on health, and JEMNU would provide coherent scientific advice to CCNFSDU, consistent with how other Codex Committees risk analysis principles (JECFA to CCFA, CCRVDF and CCCF, JMPR to CCPR, and JEMRA to CCFH).

Revision of the Codex Standard on Follow up Formula: last discussion or lack of consensus?

Apart from the discussion on the proposed new work on Codex “General Guidelines to Establish Nutritional Profiles”, the continuation of the revision of the Codex standard on follow-up formulas (FUF) for older infants and young children is going to constitute the culmination of the forthcoming CCNFSDU39 session.

The plenary is asked to take no less than 37 decisions on 37 recommendations (consolidated into a 92 page-long working document) to amend the proposed draft revised standard on FUF, based on the outcome of an electronic working group (EWG). This electronic working group has tried to improve the redrafting work since the CCNFSDU 38th session held in December 2016.

Discussions are expected to be very technical and may involve many scientific controversial debates (e.g. protein quality; carbohydrates, sugars and energy contents; voluntary addition of DHA and ARA, Calcium-to-Phosphorus ratio, Vitamin D, etc.). On top of those expected lengthy debates among early-life nutrition specialists, the most crucial and sensitive part of the CCNFSDU39 plenary is definitively going to be on the labelling and preamble sections. Some elements relate to promotion and advertising of FUF products, and there will be a lot of attention for WHO guidelines and recent discussions on the definition of breast-milk substitutes. Watch out for the WFRR December issue to learn more about the outcome of CCNFSDU39.

First consideration of a text for a proposed draft Codex guidelines on ready-to-eat (“therapeutic”) foods (RUTFs) for nutritionally deprived people

This is definitively the third most important topic on the agenda of CCNFSDU39, as it is going to be the very first time the plenary will review, section-by-section, advanced proposed draft guidelines on specialised foods used in case of nutritional emergency situations – e.g. in refugee camps, countries at war and emergency centres for treating people in critical malnutrition status in regions where food supplies are scarce. The United Nations Children’s Emergency Fund (UNICEF) is primarily at the origin of this fundamental work to establish clear guidance (i.e. a food standard), but then, as a compromise, it was turned into Codex guidelines. Nevertheless, the content of such guidelines intends to provide a very solid and detailed basis for regulating these kinds of essential emergency foods to countries and having a good basis for UNICEF’s tenders.

The CCNFSDU39 plenary session has also been asked to consider changes made to revised draft guidelines elaborated since last year’s plenary by a dedicated electronic working group. CCNFSDU39 is expected, if time allows, to review 28 recommendations for further amending the text in a 51 page long working document. The proposed draft guidelines follow a very similar structure to any other Codex commodity standard but with some essential deviations – with Preamble, Purpose, Scope, Definitions, Essential Composition Factors (raw materials, ingredients and optional additions), nutritional and quality descriptors, contaminants, descriptive elements on processing, good manufacturing and hygiene practices, methods of analysis and sampling, packing media, labelling (including nutrition labelling and instructions of use). Watch out for the WFRR December issue to learn more about the outcome of CCNFSDU39.

Definition of a nutritional value of reference for labelling purpose on EPA/DHA

This issue is expected to end up with a lack of consensus. EPA/DHA are substances with recognised health benefits, whereas the larger family of fats they belong to, i.e. the long chain polyunsaturated fatty acids (Lc-PUFA), are considered by some competent authorities, and even by WHO NUGAG, as being potentially of nutritional health concern, with positive correlation with noncommunicable disease such as cardiovascular risks. Last year, the CCNFSDU tasked the Russian Federation to chair an electronic working group on the topic to try to develop some guidance to the CCNFSDU39 plenary as to whether (i) there is sufficient substantiation to establish a nutrition labelling health guidance value to limit the presence of Lc-PUFA in foods (i.e. a NRV-NCD value), (ii) whether EPA/DHA shall be characterised with a specified content in omega 3 and omega 6. The ratio of which may be rather seen with positive nutritional effects in the context of a balanced diet.

Otherwise, CCNFSDU may continue to have a debate on the grade of convincing evidence, on whether WHO NUGAG is taking the whole set of available scientific studies during their systematic reviews or solely the ones suggesting risks, thus occulting the fact that a population exposed to diets rich in fishes (e.g. Japan) may have a long-life expectancy and fewer NCDs, possibly because of the presence of Lc-n3-n6-PUFA in such diets.

Definition and associated criteria of “Biofortification”

CCFNSDU39 is to review the outcome of another electronic working group, to finalise the descriptors of the six criteria for using the working definition already agreed on Biofortification and, if finalised, to discuss CCNFSDU recommendations as to where the definition and criteria may be recorded in the Codex Alimentarius compendium of “norms”. The criteria are (i) the Source Organisms; (ii) Nutrient and Related Substance; (iii) the (nutritional) outcome of such biofortification; (iv) the Intended Purpose(s); (v) the measurability of the increased levels of nutrients in biofortified organisms (probably to be merged within criteria (iii)); and (vi) the method(s) of production (with the back-and-forth debate on whether it includes modern biotechnology (i.e. gene modifications) or even more powerful breeding techniques or genome replication/modifications/editing techniques).

Because it is unrealistic to think that CCNFSDU39 may reach a consensus on which production techniques may be included or excluded from criterion n°6, it is suggested to leave it to the national jurisdiction. But, wait, when Codex refers to national jurisdiction because it can’t agree on a common approach, isn’t Codex Alimentarius undermining itself and its core objective to offer a global benchmark for enhancing global harmonization of national sanitary measures and technical rules, and thus facilitate trade and fair practices in food trade as per its mandate? Or does it rather open the door to even further diverging national sanitary measures and technical rules? This is an even wider debate… and as some used to say “Future will tell”.

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

Canada has drafted a Discussion Paper and is suggesting to the CCNFSDU39 to amend the table of conditions for nutrient content claims in the current version of the Codex Guidelines for Use of Nutrition and Health Claims (CXG 23-1997), and agree on the following conditions of use of the claim “Free of TFAs”: the food should not contain more than 1 g per 100 g (1%) of fats and must meet the conditions set for “low” in saturated fats, as stated in the same Table. In fact, this is an indirect and maybe misleading way for the Codex Alimentarius to set a standard to limit the presence of TFAs at 1% in foods, but the CCNFSDU39 discussions may clarify that point and be further explained in the report of the meeting. Watch out for the WFFR December issue to learn more about the outcome of CCNFSDU39.

Discussion on a new and specific process by which CCNFSDU may consider food additives in the food standards it elaborates

Although many experts acquainted with Codex procedures would argue that there is no need to define any specific process for CCNFSDU on food additives, due to the fact that the current rules of procedures in the Codex Procedural Manual defining the relationship between commodity committees and the Codex Committee on Food Additives are very clear and self-explanatory, the 2016 CCNFSDU meeting tasked the European Union (i.e. the European Commission) to prepare a discussion paper on any need for new work to define a new procedure for CCNFSDU to manage its own work program on evaluation and re-evaluation of food additives permitted in foods for special dietary uses (i.e. infant formulas, follow-up formulas, foods for special medical purposed for these age groups and adults, etc.).

Industry proposal to develop a definition and applicable criteria for probiotics

Although, not on the agenda of the CCNFSDU39 session, it is quite interesting to note the conference room document produced by the International Probiotics Association (IPA) to develop a dedicated New Work on Harmonized Probiotic Guidelines for Use in Foods and Dietary Supplements. However, the document does not include any project document following the normal template to suggest new work. This topic may be discussed at the very end of the plenary under AOB and the only possible output is to have a further discussion paper prepared for the 2018 CCNFSDU, provided that a country would volunteer for following up on IPA’s document at this 2017 CCNFSDU session. Watch out for the WFRR December issue to learn more about the outcome of CCNFSDU39.