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Christophe Leprêtre is an experienced advisor to the firm’s clients on matters of national, regional, and international complexity. Having worked for public authorities, including the French government and United Nations Food and Agriculture Organization (UN FAO) and for private companies on a wide range of food issues, Mr. Leprêtre has a unique expertise in regulatory matters affecting the food industry. Read More

This article originally appeared in WorldFoodRegulationReview.

 

FEATURE

Last week of November, the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) reviewed most of the draft standards and guidelines on its agenda. However, only in part and to be further worked out (e.g. follow-up formulas; RUTFs), or sent back for further elaboration (e.g. NRV-R for older infants and young children; nutrient profiles; probiotics), or with a changed focus (i.e. “Free of TFA claim” conditions turned into a risk management options for reducing – if not phasing out – the presence of neo-formed TFA during edible oils and fats partial hydrogenation manufacturing process). Other proposals did not get through and the work was either stopped (e.g. NRV-NCD for EPA/DHA) or sent back to other Codex Committees (e.g. biofortification) or added to a priority list for possible new work (e.g. prebiotics; food supplements for bodybuilders).

Over 400 delegates from 73 countries, the European Union, and 41 NGOs attended the 40th session of the Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU40, Berlin, Germany; 26-30 November 2018). CCNFSDU40 covered all its agenda – and a bit more – this year. This specialised Codex Committee is one of the horizontal committees of the Codex Alimentarius Commission, dealing with nutrition, but not nutrition policies. It also elaborates Codex vertical/commodity standards and guidelines on specific foods, such as “baby foods” (e.g. infant formulas and follow up formulas for older infants and young children) and “food for special dietary uses” (e.g. gluten free foods, foods for special medical purposes (FSMPs) and food supplements). The Committee oversees nutrition labelling and nutrition claims together with the Codex Committee on Labelling (CCFL).

 

Revised Follow Up Formula Standard – progress made on composition, still a long way to go on labelling, the preamble and the structure of the standard

CCNFSDU40 went through the various parts of the revised follow up formula texts (i.e. composition requirements for both age groups, scope for both age groups, labelling requirements and definitions for older infants only) but, due to time constraints, it did not discuss the controversial preamble. In short, CCNFSDU40 agreed to:

  • retain the essential requirements for follow-up formula for older infants and for products for young children at Step 7, and to request the EWG on follow-up formula (see (v) below) to consider the proposal on dextrose equivalent for products not based on milk protein and to provide further recommendations for comments and consideration at the next session;
  • advance Section A: follow up formula for older infants to Step 5 for interim adoption by CAC42 (in Appendix III of CCNFSDU40 report) and a request for comments at Step 6;
  • send the labelling provisions for FUF for older infants to CCFL45 for endorsement;
  • defer the discussion on product definition and labelling of [product] for young children, the structure of the Standard (s) and preamble (s) for discussion at CCNFSDU41; and,
  • re-establish the EWG chaired by New Zealand and co-chaired by France and Indonesia, to address the issue of Dextrose Equivalent and the sentence in square bracket in section 3.2.1 on non-sugar substances conferring sweet taste (i.e. foods like honey), with the understanding stated in the report that this concept does not relate to intense sweeteners, regulated as food additives, given that such use is prohibited both by the FUF standard and the GSFA. CCFFSDU also agreed to complete the remaining sections as follows (a) purity requirements, (b) vitamin compounds and mineral salts, (c) consistency and particle size, (d) specific prohibitions, (e) food additives, (f) contaminants, (g) hygiene, (h) packaging, (i) fill of container, and (j) methods of analysis and sampling

One aspect requires some additional attention. During the discussion on composition requirements, it appears that many references to national and/or regional competent authorities have been retained or even added, in order (i) to help advance the provisions or (ii) provide flexibility to address local nutritional needs when countries are to implement the future revised standard or (iii) both. This is raising a fundamental question about Codex Alimentarius Commodity Standards. In the 20th century Codex’s and WTO/SPS and TBT agreements’ assumptions, Codex Alimentarius standards and related texts should provide precise enough standards to promote the reduction of non-tariff barriers to trade. As such, the fact that CCNFSDU introduces a range of values for a nutrient and its requirements, or references to different national/regional competent authorities de facto allowing national deviations from the international norm is of particular concern. Indeed, international Codex standards aim at serving as a non-ambiguous reference, i.e. set one value per criterion. But because consensus must be reached at all costs, these permitted deviations made their way even into commodity standards, which is clearly equivalent to a Note 161 added across the board.

Arguably, the purpose of internationally “standardized” foods is precisely to be… standardized. And in such a manner that it reduces to the maximum the margin of flexibility – such margin shall ideally be equal to zero, i.e. the international standard sets one value for one given nutrient. The overall purpose of the Codex Alimentarius since its creation in 1963, well before WTO was created, has been and is to promote harmonization of rules through non-ambiguous standards, and thus facilitate trade and fair practices in trade. If that trend continues, it would be hard to consider any longer Codex standards and related texts as core reference for judging non-tariff related trade disputes (especially in times where leading voices are announcing a reform of the WTO).

We can think of two out-of-the-box ideas to resolve this issue in the context of CCNFSDU work on this standard revision, regardless on whether the “norm” discussed falls under WTO/SPS or WTO/TBT.

In the first place, in order to address different nutritional needs of different target groups of consumers, several singled-out values could be set for those nutrients where certain composition formula should be labelled as intended for certain population groups.

After such acknowledgement, once the standard (e.g. the FUF standard) is advanced at Step 8 by the Committee (i.e. CCNFSDU), it could be referred to the six Codex Regional Coordinating Committees which could discuss regional differences and address those regional different nutritional needs. It would lead to the creation of six (or less) regional Codex standards on e.g. FUF, allowing at least some level of intra-regional harmonization and free trade based on one standard. The international level Codex standard on FUF would then cover only those areas and composition requirements where a full consensus about their relevant for all populations and regions would be reached out in the Committee, i.e. CCNFSDU. In doing so, it would then limit the number of deviations and still permit, at least on a regional basis, a relative stability of the standardization. And thus, references to national/regional competent authorities could be completely deleted from any Codex standards (both in international and regional ones)”.

Maybe the two above ideas could be explored also by other Codex Committees. It may help to reach consensus in a more expeditious manner on core international pieces of the standards, while increasing the role of regional standards to define their own level of flexibility where it is not feasible in the Committee in charge, and still minimize the risks of a multiplication of even more national standards with the current trend.

                To be continued…

 

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

CCNFSDU40 reviewed the recommendations included in the discussion paper prepared by Ireland for the plenary. The committee followed the recommendations to:

  • develop three sets for the future NRVs-R, one for older infants, one for young children and one combined for both age groups, depending on the actual values of nutrient requirements for those age groups;
  • harmonize all the age ranges referred to in existing relevant Codex standards and related text under the purview of the CCNFSDU (i.e. 6-12 months old and 12-36 months old), since WHO is aligning its own age groups with the Codex age ranges for nutritional requirements; and,
  • continue the development of NRVs-R for the 4 Codex Standards for the age groups identified above while excluding the Guidelines for Vitamin and Mineral Food Supplements (CXG 55-2015) from the list of Codex texts for which NRVs-R would be established for labelling of nutrient declaration as well as for which NRVs-R would be applied as reference criteria for vitamin and mineral composition.

As a next step, Ireland, with the help of Costa Rica and the USA, will chair and co-chair an inter-session electronic working group (EWG) tasked (i) to advance the work described above and to further discuss unresolved issues such as the place where the NRV-R for older infant and young children is to be added in the Codex texts, and (ii) to develop a prioritized list of NRV-R for vitamins and minerals adequate to these age groups, as well as for protein requirements.

To be continued…

 

Draft guidelines on ready-to-use (“therapeutic”) foods (so-called RUTFs) for nutritionally deprived people – progress made but still a long ride ahead

A pre-session Physical Working Group (PWG) reviewed the outcome of an inter-session electronic working group. The hope was that this doubled effort could help the CCNFSDU40 to make faster progresses on these guidelines for RUTFs by simply adopting an advanced revised text through a reduced set of recommendations from the PWG. Unfortunately, this was not exactly the case, and the plenary went through technical amendments to the text and left a large part uncovered due to the time constraints.

CCNFSDU40 established again an inter-session EWG, chaired by South Africa and co-chaired by Senegal and Uganda, to continue developing the section 5.2.2 on Food additives and Section 6.2 on Proteins, for circulation for comments and consideration at next year’s CCNFSDU plenary. CCNFSDU40 also agreed to keep on hold the rest of the text at Step 4, and to consider the remaining recommendations of this year’s PWG at next year’s Plenary session. Yes, it is a bit confusing: it simply means a lot remains to be addressed before the text can be moved to the next steps; either piece by piece or as a whole, starting at next year’s session.

To be continued…

 

Nutrition Profiles Guidelines – no new work, but existing systems compilation

The suspense was short. The Committee considered the discussion paper and decided to task again Costa Rica and Paraguay to revise the discussion paper and produce a stock-take of all existing nutrient profiles primarily used in the context of FOPNL systems, but also for other purposes, and further develop the discussion paper for consideration by the next session.

Particularly interesting was the statement of the representative of WHO that WHO is willing to share a similar catalogue of existing nutrient profile models developed for different applications already compiled at WHO level. The WHO representative reminded that WHO Regional Offices have also developed their own regional nutrient profile models for restricting marketing of foods and non-alcoholic beverages to children, and for multiple policy tools and in several regions, while countries are adapting or using those regionally-based nutrient profile models for multiple applications – such as regulating promotion and sales of food and beverages in and around schools and nutrition labelling. The WHO Representative suggested to add those nutrient profiles to the Codex process.

But WHO made clear that, in its view, it would be premature to develop Codex guidelines on nutrient profiling models for front-of-pack nutrition labelling (FOPNL) as proposed in this year’s discussion paper, since the CCFL had not yet determined how they would modify the section of supplementary information in the Guidelines on Nutrition Labelling to incorporate the guidance on FOPL. This issue is still under consideration by a CCFL inter-session EWG and its report, due early January, will be considered at the forthcoming CCFL(to be held early May 2019). As WHO is also working on policy documents to countries on FOPNL, the WHO representative expressed WHO’s interest in contributing to the stock-take exercise.

No electronic working group was formed. Note however that the USA offered its assistance to Costa Rica and Paraguay in their compiling work and the refinement of the scope of the future possible new work on specific Codex guidelines. What about the other countries? They will have to wait until the next CCNFSDU.

To be continued…

 

Technological Need and Food Additive: Mechanism and related alignment issue (CCNFDU texts and CCFA GSFA) – almost approved, but…

As reported in last month’s WFRR issue, the purpose of this work is to optimize the review of food additives used in the texts elaborated by CCNFSDU both from a technical need and from a safety perspective due to the target populations exposed to those foods (e.g. early life formulas and other baby foods, sometimes intended for children with diseases, i.e. foods for special medical purposes).

Although the relationship between Codex Committees elaborating food/commodity “standards” and the Codex Committee on food additives (CCFA) is laid down fairly clearly in the Codex Alimentarius Commission’s Procedural Manual, there was a need from a CCNFSDU point of view to develop a dedicated framework to make sure that CCNFSDU can confirm first and foremost that the technological needs, justifications and purpose(s) of a given additive in a given food for those vulnerable subsets of the population are duly provided by the applicants and duly checked and cleared by the CCNFSDU.

Two in-session working group sessions, chaired by the EU, were called upon by the CCNFSDU40 Chair to continue advancing the discussion on (i) the process by which technological needs are appraised and (ii) the list of questions to be answered on such technological needs for being counterchecked by CCNFSDU. They were included in two one-page documents, which came out from the intersession EWG which elaborated them since last year, also under the EU chairmanship.

The process itself describes the various action steps to be taken by the CCNFSDU to collect information on technological needs (e.g. by a Circular Letter (CL) issued by the Codex Secretariat) when JECFA assessment would be required or via an EWG when a new standard is under development by CCNFSDU. If CCNFSDU concludes that the needs are sufficiently substantiated, then there are two possibilities:

  • If a JECFA assessment is necessary, then the applicant must follow the CCFAprocess to seek inclusion of the substance for JECFA priority list (to be agreed at subsequent CCFA meeting), after which JECFA evaluates and return its conclusions to CCFA, which in return sends it back to CCNFSDU. Then GSFA and applicable standards (if this is in a standardized food) are amended based on use levels justified.
  • If a JECFA assessment is not necessary, then the normal endorsement procedure is followed with CCNFSDU sending the projected additive use level(s) in a given CCNFDSU food standard to CCFA for endorsement and inclusion in the GSFA, and if the food standard is not aligned with GSFA, for inclusion in that food standard.

The justification of the technological needs itself consists of a list of three main questions for the applicant to answer and for CCNFSDU to check the answers.

(1) Identification and Intended use: the applicant must provide detailed info on the International Numbering System (INS) (or in absence of INS its chemical registered name), foods and forms of that food, where additive is used, and – this is a real novelty – the range of the proposed use level of the food additive needed to accomplish the desired technological effect at the lowest possible use level.

(2) Compliance with section 3.2 of the GSFA preamble, while indicating also the functional class and the expected technological purpose(s) the food additive will exert in the targeted food(s)). Under (2), two additional criteria would apply as foreseen by the preamble of GSFA (and therefore should normally also apply to GSFA provision discussions): (a) Can the objectives be achieved by other economically and technologically practicable means? and (b) Would any characteristic of the food be modified in a way that might mislead the consumer?

(3) Compliance with the approach on use of food additives intended for infants (both new born and older) and young children: the objective is to determine whether other food additives with the same/similar technological purpose and level of performance are already authorized in the target food. If this is the case, further justification must be provided on the advantage that additive brings. If this is not the case, the need(s) for this additive with new functional class or other technological purpose must be made clear.

The plenary of CCNFSDU was very close to endorsing Question (3) after having discussed Question (1) and (2) and amended the outcome of the two successive in-session working groups. As the CCNFSDU Chair was fairly under time pressure to review other items on the agenda, the text of Question (3) remained unapproved.

In summary, CCNFSDU agreed to include the process and the framework in Annex 2 of its plenary report and to organize a physical working group immediately before next year’s CCNFSDU to (i) address the remaining parts still unapproved (such as question (3)) and (ii) test the future revised protocol and framework to appraise the technological needs for the proposed uses of xanthan gum (INS 415), pectin (INS 440) and gellan gum (INS 418) in infant formulas, as already submitted this year by manufacturers (International Special Dietary Food Industries; ISDI).

In addition, during the plenary the Chair tried to address the issue of alignment of food additive provisions between Codex texts (standards) already elaborated by CCNFSDU and the Codex GSFA. However, no-country-for-old-men on this topic, since delegates were a bit taken by surprise. Thus, the issue was postponed to next year. CCNFSDU40 official report refers to an information document prepared by CCFA to the attention of all Codex Commodity Committees on how such an alignment work has been conceived by CCFA (and drafted by Australia) and should be carried out by them.

Click here.. This document also includes a tentative workplan and priorities must be given by CCS, CCFO, CCPFV, and CCNFSDU to this important alignment task.

Next year, ISDI may use that opportunity to suggest a pilot review of the possible alignment e.g. on infant formula, in the same manner that IDF demonstrated their ability to help CCFA to perform such an alignment work on one dairy standard, as a test-case (see WFRR June 2018 feature article on the outcome of CCFA).

All delegates who attended the two in-session working groups and the follow up discussions during the CCNFSDU plenary highlighted and commended the fair and excellent chairmanship of the European Commission official in charge, Jiri Sochor, leading up to this unexpectedly good and consensual interim result by CCNFSDU. Well done J.S.!

To be continued…

 

Conditions of Use of claim on “Free of Trans Fatty Acids (TFAs)” – nope, again and new (expanded) focus on industrially neo-formed TFAs in PHOs

CCNFDSDU40 was supposed to reach a conclusion on the conditions for making the claim “free of TFAs”. However, opinions diverged on those conditions, given the uncertainty about the accuracy of the methods of analysis in different food matrices. In addition, not all TFAs are necessarily bad for health (IDF says dairy product contain good TFAs), so “free of TFA’s” claim could mislead the consumer and the focus on TFA alone as a nutrient of concern may not be the adequate message to help consumers to make healthier food choices. Also, technical relationship with other saturated fats was not necessarily well spelled out in the current suggested conditions of use of the claim.

The WHO representative also indicated that the NUGAG was finalising its guidance on saturated fats and TFAs, to be published during the first quarter of 2019. The WHO representative made clear that the WHO policy objective is to completely phase out “industrially” neo-formed TFAs during partial hydrogenation of vegetable oils and animal fats from the food chain supply, given the fact that these types of TFAs were clearly correlating with noncommunicable diseases (NCDs) due to dietary intake. WHO pointed out that their policy approach is to limit all TFAdaily intake to less than 1% of total energy in the daily diet while simultaneously limit saturated fatty acids (fats) to less than 10% of total energy in the daily diet.

CCNFSDU40 debated whether other risk management options could be considered, ranging from a ban of all partially hydrogenated oils (PHOs) to FOPlabelling warnings against the presence of such PHOs full of industrially neo-formed TFAs. CCNFSDU40 also discussed whether it could alternatively or in parallel refer the issue to the Codex Committee on Contaminants in Foods (CCCF) to develop (i) a maximum limit of industrially neo-formed TFAs in food ingredients or in foods where PHOs are used, or (ii) a Code of practice for their reduction in PHOs or (iii) both. The JECFA/FAO representative indicated that JECFA was totally capable to perform a risk assessment of the toxicological safety of industrially neo-formed TFAs from PHOs, should CCCF would require such a scientific advice. But that route was considered premature.

CCNFSDU40 therefore decided (i) to keep on hold the discussion on the current conditions for the claim “Free of TFA”; (ii) agreed that Canada will prepare a discussion paper for next CCNFSDU consideration to explore various risk management possibilities for reducing TFAs in the food supply chain; and, (iii) to inform the Codex Committees on fats and oils (CCFO meeting end of February 2019) and the CCCF (meeting end of April 2019) about this discussion.

To be continued…

 

Definition and associated criteria of “Biofortification” – sent back to CCFL

CCNFSDU40 discussed a further elaborated definition of “biofortification”, coming from a consensus outcome of an inter-session electronic working group. One NGO stated that, despite the overall consensus found in the EWG, the CCNFSDU has the power to override such a consensus. That statement created a large perplexity in the meeting room, as the purpose of Codex inter-session EWG is precisely to help building consensus in advance to Codex Committee plenary meeting and are generally recognized to achieve that goal.

The Committee slightly amended the definition as follows:

Biofortification[3] is any process[4] other than conventional nutrient addition to food[5] whereby nutrient content is increased or become more bioavailable in all potential food sources[6] for the intended nutritional purposes[7] .

Arguments put forward last year were reiterated. Most of the African, Asian and Latin American countries, where new genetic breeding technics plant (but not with GMO techniques) are already cultivated, were overwhelmingly in favor of the final adoption at Step 8 of such a definition. Other countries were unclear as to where such a definition should be used in the Codex system or added to existing Codex texts also expressed their opposition to proceed. These countries, including the EU and its member countries, reiterated the need to take the time to assess the impact on claims, labelling, classical food composition, and possible confusion caused by the prefix “BIO”, which is generally devoted to the organic farming products (e.g. issued from the “agriculture biologique” in French). The definition was found too broad as new genetic modification techniques could ultimately fall under a “GMO” definition. Also, the decision left to national authorities could result in a lack of necessary harmonization on such a WTO/SPS-related matter.

Countries in favor were Nigeria, Burkina Faso, Senegal, Mali, Ghana, Cuba, the Philippines, Costa Rica (requesting a cross-reference to the Codex Procedural Manual existing definition of bioavailability to be added), Uganda, and to some extent Malaysia, Chile, Brazil; and the USA which suggested to add a reference to an increase in sufficient amount of conventional nutrients, compared to the counterpart crop. Countries which expressed a fresh welcome to this work were the EU (including Belgium), Norway, Argentina, the Russian Federation, Nepal, and the observer of NHF.

In conclusion, without really coming up with a consensus over the proposed definition, the Chair concluded that the CCNFSDU40 decided to send the text as amended during this session back to the CCFL, to get further guidance from the Codex labelling experts, in a very apparent relief in passing on the very “hot” (e.g. beta-carotene-enriched-orange-flesh-sweet-)potato to Canada as CCFL’s host country.

Next CCFL meets in May 2019 and it is unclear what they may do, given that the initial request to CCNFSDU to work on a biofortification definition – and to indicate what to do with it in the Codex system – came originally from the CCFL.

To be continued…

 

Probiotics in foods or as food supplements – not quite yet, so play it again

Based on the discussion paper prepared by Argentina, CCNFSDU40 discussed the proposal to develop guidelines to define probiotics and lay out guidance and main common grounds on how countries could regulate their use and their labelling and assess their claimed health benefits at national and/or regional level.

Many country delegations who spoke out expressed some reservations about the scope of the document and the expected final output for the guidelines. They were in principle supportive of the idea to further discuss the probiotics topic, while noticing that this topic may be considered as a lower priority for the Committee to embark on. Those countries were Canada, USA, Malaysia, Vietnam, Norway, Russian Federation, and the European Union. The EU delegation had the strongest doubt about even the need to develop such guidelines at all. Just a few countries supported the proposal as presented, such as Iran, requesting an electronic working group to work on the document (with the Codex Regional Standard on Doogh where “probiotics” is mentioned), China (indicating its nationally regulated positive list of approved bacteria strains), Nepal, Nigeria, Egypt, Sudan (using this opportunity to promote prebiotics as well – see down below) and obviously the IPA (representing the probiotics manufacturers in Codex).

The CCNFSDU40 requested Argentina to revise the discussion paper for the second time in two years, especially to revisit the scope for the proposed future guidelines, to discuss it again at next year CCNFSDU plenary meeting as a plain agenda item.

To be continued…

 

NRV-NCD on EPA/DHA – Discontinued, ouch

CCNFSDU40 did not find a consensus on the way to make any further progresses for establishing a NRV-NCD for EPA/DHA. According to WHO NUGAG, there aren’t enough positive correlations between consumptions of EPA/DHA and reduction of NCDs (e.g. CVD, Heart attacks) or reduction of risk factors favoring the appearance of NCDs (LDL-cholesterol vs HDL-cholesterol in blood), at consumption levels compatible with food supplements.

CCNFSDU40 agreed to discontinue discussing the matter (i.e. to drop it off its agenda and work program), until new scientific evidences are reviewed again systematically by WHO NUGAG or eventually by JEMNU in the future, as recommended by EPA/DHA food supplements manufacturers. Future new work will have to follow the procedure and may also be considered within the broader context of priority setting announced by the German chair of CCNFSDU40.

 

Proposal for new work on Codex G

Based on late proposal tabled by Sudan as CRD, CCFSDU40 did not discuss this matter at all due to lack of time. Sudan’s discussion paper is interesting as it lays out the growing trend of prebiotics as a source of nutrients for the symbiotic bacteria living in human intestines and bowel. Obviously, the primary focus of Sudan is on Gum Arabic / Acacia Gum (also known as food additive INS/E 414, e.g. as an emulsifier or a carrier,), as clearly stated in their written comments to be found in CRD30. Such new work would also be of high interest of other prebiotic manufacturers (e.g. GOS, inulin, fructo-oligosaccharides, resistant starches, etc.).

Therefore, it is to be seen next year where this proposal may go. To know more about Sudan’s proposal, go to CRD4 at www.fao.org/faowho-codexalimentarius/meetings/detail/en/?meeting= CCNFSDU&session=40.

To be continued…

 

Proposal for new work on General Requirements For Protein Supplements Intended for “Bodybuilding” – sent to waiting list

Due to lack of time, this proposed new work submitted by Egypt was not discussed at all.

However, both proposals on (a) prebiotics and (b) bodybuilding foods will be retained and listed as part of the broader discussion paper on prioritization of the work of the Committee – to be prepared by Germany as the host country of CCNFSDU – and will be considered under a plain agenda item at the next year session (CCNFSDU41), to be held in Düsseldorf (Germany) from 25 to 29 November 2019.

To be continued…

 

To access CCNFSDU40 official report, click here.

To access to all CRDs and latest documents, click here.

 

[3] Some Member governments may prefer to use the equivalent term.

[4] Process to be determined by the competent national/regional authority.

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

[6] e.g. animal, plant, fungi, yeasts, bacteria.

[7] 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 intakes of one or more nutrients;

– maintaining or improving health; and/or

– maintaining or improving the nutritional quality of food.

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.

This article originally appeared in WorldFoodRegulationReview.

The 50th session of the Codex Alimentarius Committee on Food Additives (CCFA50) has completed its full agenda and found consensus on many new food additives provisions, which has reduced significantly the backlog from past years on miscellaneous food additives, with a good perspective to complete this task at its next session(almost two years ahead of schedule). And, against all odds, CCFA50 agreed for the first time since 2012 to work on a handful number of colour additive provisions in a limited number of confectionery categories for possible adoption as of the 2019 CCFA51 session (i.e. part of the GSFA mandate) as a test case for all the colour pending provisions. The Committee also modernised some of its internal procedures – and relations with JECFA – to speed up future work. CCFA50 seems to have slightly changed its mind about enzymes since last year and agreed to give a higher consideration to enzymes in the future, especially for their review by JECFA. The Committee also endorsed internal guidelines with other Codex Committees on the crucially important alignment between food additives provisions in the GSFAand those approved in Commodity Standards. As a good example, CCFA50 has completed the alignment work for fish and fishery products standards fully, and in the future, it will also rely more on active Codex commodity committees to perform such an alignment task. Last but not the least – and totally unexpectedly –CCFA50 agreed to start again the discussion on Note 161 related to some provisions on intense sweeteners, where left unanswered three years ago.

Mr. Christophe Leprêtre2
Mrs. Katia Merten-Lentz3

The 50th session of the Codex Alimentarius Committee on Food Additives was held in Xiamen (China) from 26 to 30 March 2018, preceded by a two-day pre-session working group in person (PWG) to advance recommendations to the CCFA50plenaryontheGSFA.CCFA50alsoheld3 in-session working groups to advance recommendations to CCFA50 plenary on Alignment, the INS and class names of food additives, and priorities assigned to JECFA for safety evaluation, specification reviews among other tasks.

“CCFA 2.0”: Yes indeed, but practical implementation should be tested

The discussion held on the last afternoon of the plenary was deliberately oriented to consider those recommendations only as a common pathway for future ways of working, rather than to make clear-cut choices between the various suggested different options under each recommendation.

Therefore, all the expected debates fell quite short and many written comments submitted were not raised in plenary, except for the key countries (China, EU, Australia, Canada, USA, New Zealand) and only from a handful number of observer organisations.

  • Note 161 – No battle, mainly due to an absence of willingness to fight, this time…

The suspense was carefully kept until the very end of the plenary of CCFA50, as in any very good movie. And bang! The CCFA 50 did not discuss the Note 161 issue. Like a couple of magicians pulling out a peaceful white rabbit from a hat on stage, the USA and the EUsuggested that the Committee shall resume its discussions exactly where it left them three years ago, in reutilizing the report of an old electronic working group, led at that time by the UK on three intense sweeteners. For sure, such a concerted solution must have been subject to intense informal discussions, day and night, during the whole CCFA50.

Therefore, CCFA50 tasked an electronic working group (EWG) to review the 2015 EWG recommendations which classified selected sweeteners provisions in six batches; each of them offering a possible dedicated solution to replace the Note 161 with other existing notes (i.e. with no added sugars; energy-reduced; or a combination) or new notes. It should be mentioned that the past work did not cover all intense sweeteners provisions, but only those for aspartame, acesulfame K and the salt of aspartame-acesulfame, both already adopted (i.e. included in the published GSFA, alias CXS 192) and draft provisions (i.e. provisions in the step process)5.

Smiling moment: when the CCFA50 Chairman asks, who would like to chair this new EWG, then both the USA and the EU were prompt to offer their support – but both as co-chairs – as none seemed to be truly prepared to take the lead on this “hot potato” issue. Alike the (lack of) outcome of the CCFA47 negotiation in 2015, the situation looks like “even” – starting with this chairmanship issue. As pointed out by Germany though, a new spirit seems to have emerged within the CCFA delegations, so maybe this time solutions matching all the contradicting and polarized positions (including within the various industry sectors) may be found… At least, one reassurance: Note 161 issue is like a CCFA type of phoenix… It resuscitates and rises from the ashes. It is the second time in the past 10 years it does so. Future may tell, “what about this time?”

  • Key factors to speed up the review process by the CCFA
  • Reducing the time-lapse between a draft entry in GSFA and final adoption

CCFA50 agreed that once it would agree to enter new (or revised) draft provisions for a food additive in the GSFA, such provisions would be immediately circulated to the CCFA community for comments and consideration at the immediate next session. At last! Indeed, this very simple solution is intended to alleviate the current uncertainty between entry into the GSFA of a draft provision and consideration by the CCFA for possible adoption.

Some provisions reviewed by CCFA50 this year have been waiting for 20 years before being considered. The new process flow may help to ensure more foreseeability, especially for new substances which were recently reviewed by JECFA. However, CCFA50 is somewhat conditioning the implementation of that decision to until after next year’s session. Who knows what may happen then…

  • Decisions to help with the work on Alignment (between GSFA and Food Standards)

CCFA50 took several decisions and anticipated a little bit ahead of the new working procedure. The new working procedure would involve organisations representing technical expertise in a defined food sector. As such, and in line with another CCFA50 decision to ask the International Dairy Federation (IDF) to prepare the future background alignment work on alignment of food additive provisions for all ripened cheese standards, CCFA50 agreed to use further Codex observers for preparatory work, nominated Japan as co-chair of the regular inter-session EWG on alignment (chaired by Australia) and agreed to enhance the partnership with and the delegation of the preparatory alignment work to other active Commodity Committees (see more details on Alignment below). The European Union delegation indicated that Codex observer’s preparatory work will need to be scrutinized very carefully by Codex members (all country and EC representatives) to avoid any mismatch.

  • Marginal decisions on the INS but important precisions a new policy rule

CCFA50 agreed to amend the general section of the INS (i.e. CAC/GL 36, now CXG 36) to add some precisions that the INS list may include names of substances not evaluated by JECFA (reminder) or that are not included in the GSFA (this is the newly added text). As a consequential change and other recommendations adopted by CCFA50, the yearly Codex Circular Letter requesting comments on the INS is amended. It will now specify that any proposal for deletion of INS entries cannot be submitted if there are existing provisions (adopted or in the Step Process) for the additive in the GSFA with the understanding that the CCFA must first take a formal decision to remove those provisions from the GSFA prior to the submission of proposals to delete a corresponding INS entry.

  • Prioritize new work for JECFA and other aspects

CCFA50 recognized almost unanimously that the primary key factor to review a substance (a food additive, including flavouring, and processing aids such as enzymes, all included in the Codex definition of “food additive”) was when it raises a food safety concern. Potential trade issues linked to “imperfect” specifications were also noted but the question may diverge about what “imperfect” is, as countries and industry groups may not have the same interpretation – nor the same needs – about that. But the discussion went in sequence: classical food additives (for inclusion in GSFA) and enzymes and flavourings (only covered by Codex Guidelines and where Codex only approved the specifications).

The Committee endorsed the recommendations included in the discussion paper but left open to give it a second thought soon. Therefore, the Committee is now giving the highest priority to re-evaluation of existing food additives should new safety concern(s) may arise. Then, it may consider on equal grounds the safety evaluation of new substances (including establishment of specifications) and the optimization of existing specifications.

Regarding food additives other than enzymes and flavourings, one observer reminded the Committee that the Committee already worked intensively – eight years ago – at a scoring screening system developed by Canada, with the help of multiple successive electronic working groups. This is based on a screening tool that the prioritization of colours for re-evaluation was established. It was pointed out that such a list was still the one used by JECFA to carry on with the re-evaluation program of such prioritized colours. It should be noted that many criteria were included in the screening score tool and that the date of the last JECFA evaluation was viewed as an important criterion, but not the only one to be considered and weighed. The tool was never further tested for other groups of food additives than colours.

Regarding the type of questions to be added to the Codex circular letter requesting comments for new JECFA work, the Committee tasked the JECFA secretariat and Codex secretariat to work on what improvement could be made for consideration at the next in-session WG on JECF A priorities (at the 2019 CCFA51). This work would certainly echo the decision already made by the Canada Chair during this session WG on JECFA priorities to populate more information about the various requests so that the information is not lost. It also echoes the JECFA/WHO statement about the additional requirements for naturally sources substances (e.g. plant extracts) in terms of chemical characterization and toxicological profiles. The two suggested options were retained as one covering flavourings and another one enzymes.

  • Processing aids: no clear decision on a dedicated standard on all types of processing aids

CCFA50 recognised and stated again that the current database on processing aids – which is maintained up-to-date by the Chinese government with technical support from New Zealand expert – is not a Codex text nor a recognition of any type of the list of substances but rather a simple inventory. CCFA50 did not agree to develop a dedicated Codex standard on processing aids, despite the heavy support by New Zealand and Australia for the idea.

At minima, CCFA50 conceded that the current Codex Guidelines on Substances used as Processing Aids (CAC/GL75, i.e. CXG 75) may be reviewed/amended, as a future priority and not to be completed at this point in time. At the same time, many enzymes have been added to the priority list for JECFA safety evaluation and establishment of specifications (see further below). Last year, CCFA49 concluded that priorities assigned to JECFA needed to go first and foremost to food additives. Well, well, well…

Regarding how the Committee would decide upon the order by which priorities are set, the recommendation was discarded. While the EU called upon a more inclusive and transparent process for qualitative evaluation of the new work, Australia encouraged the Committee not to lose the core principles underlined by the priority order settings and urged the committee to develop a mechanism to address prioritization. But the Committee simply decided not to. This means that the current status quo may prevail, with marginal other changes made. Therefore, there is no real innovative approach on the go. And it is still not clear how all the other decisions made on the other recommendations will work out together towards the objective of the “One CCFA approach”.

GSFA pending provisions: landmark progresses made by CCFA, despite The Voice’s extinction and controversial debates on several key provisions on “other fluid milks (plain)” and “water-based flavoured drinks” (i.e. soft drinks)

A two-day CCFA50 pre-session working group (PWG) went through all pending GSFA provisions on its agenda (see WFRR Vol. 27, Number 9, Feb. 2018) and reviewed new proposals for inclusion of other draft provisions at Step 2. Mostly, it suggested to CCFA50 plenary provisions for (i) adoption, (ii) revision, (iii) discontinuation and (iv) revocation. CCFA50 plenary endorsed most of them. It is a spectacular result obtained by the Chair of the PWG, Dr Paul Honigfort (USA-FDA) and a landmark performance, given a painful voice extinction which made him suffer during the full duration of the debates. That result is also the expression of a new spirit of compromise blowing throughout all delegations, except on a few issues reported below.

(i) Draft and proposed draft provisions in the GSFA regarding the second half of food categories (from fish products to prepared foods)6;
(ii) new provision for inclusion at step 2 in the GSFA or proposed revisions of already approved provisions in GSFA;
(iii) Proposed draft provisions related to fluid milk (plain); (iv) Proposed draft provisions related to the recently created new food category on other fluid milk (plain)7;
(v) Lutein esters from Tagetes erecta and octenyl succinic acid (OSA)-modified Gum Arabic proposed for inclusion in Table 3 of the GSFA (i.e. GMP use unless otherwise regulated);
(vi) Some provisions in food categories subject to standardized foods on processed fruits and vegetables and edible oils.

It is virtually impossible to report here about each individual decision taken by CCFA50 based on the 250+ pages long working document. All CCFA50 decisions about each draft provision proposed for final adoption and inclusion in the published GSFA (subject to formal approval by the next Codex alimentarius Commission (CAC41, July 2018)) are included in Appendix V-Part A of the CCFA50 report.

The one provision proposed for revocation (by a CAC41 approval decision)is included in Appendix VI. The quite few new draft provisions introduced in the GSFA (at Step 2 and 3) are reported in Appendix VII, and draft provisions discontinued and to be deleted from the step process (decision enacted immediately) are included in Appendix VIII.

However, it may be of interest to note that several provisions did lead to some very interesting debates. The following have been identified as the most remarkable ones.

  • Trisodium citrate in plain fluid milk

Although the pre-session working group on GSFA found compromise on permitting this food additive at GMP level in UHT milk from non-bovine species only, only as emulsifier and stabilizer, Brazil and New Zealand raised the need to add sterilized milk and maybe not add the restriction to other species then bovine (whereas the EU made clear that it is technologically justified in e.g. goat milk and not in bovine milk). Thus, the provision will be discussed again next year.

  • Emulsifiers, Thickeners, and Stabilizers in other types of plain fluid milks

This topic has led to harsh discussions both during the pre-session working group and the CCFA50 plenary. Members were split on the question whether the use of emulsifiers and stabilisers may be justified for use (i) in this full food category (i.e. all the fluids milks other than those covered by food category plain (unflavoured) fluid milk), or (ii) in recombined and reconstituted other fluid milk products only; and/or (iii) in non-flavoured other fluid milk fortified with vitamin and mineral only; and/or (iv) in other fluid milks such as protein-adjusted milk, lactose-low milk, etc.

Despite of the lack of consensus noted in the report on many of these issues, the provisions under consideration are proposed for adoption (by the next CAC41) with specific notes reflecting the debate additive by additive, “for use in non-flavoured vitamin and mineral fortified fluid milk only”9, “excluding lactose-reduced milk”10, of with more specific level set as “Except for use in lactose-reduced milks at 500mg/kg”11. Nitrogen was also approved as packaging gas only.

The debate on the use of other food additives as emulsifiers and stabilizers in this food category was even more animated both during the pre-session PWG. The CCFA50 could only conclude about to a lack of consensus and did not endorse the PWG recommendation to recognise that those substances would generally be technologically justified for use in these types of fluids milk. Hence, all the provisions are retained on hold and it means that they will be re-discussed again one by one next year12.

  • Soft drinks, “ADI” and a moment of palpable tension

Although most of the discussions went well on other provisions, one topic has led to vivid exchanges between delegations on some provisions considered both at the pre-session working group and the plenary.

Everything started badly with the consideration of a provision of 10 mg/kg of dioctyl sodium succinate (INS 480) in water-based flavoured drinks (i.e. soft drinks), including ‘sport’, ‘energy’ or ‘electrolyte’ drinks and ‘particulated’ drinks. The EU representative made clear that (i) with a low JECFA Acceptable Daily Intake (ADI) for that substance, (ii)with the current proposed maximum use level, (iii) and considering that if a 20 Kg-body-weight (very) young child would be drinking just a few centilitres of such soft drink containing that additive, it would easily lead to exceed the ADI13.

The same type of argument was used again by the EU for the provision for tocopherols (INS 307 a, b, c). But this time it triggered a chained reaction by USA, Canada, Australia and their allies of the day (Senegal, Chile, Colombia, South Africa, Kenya and Palestine, supported by ICBA and ICGMA) which denounced (i) a misleading argument as distorting what a proper exposure assessment should be, which would constitute a worrying precedent in CCFA proceedings; (ii) the concept of ADI (life-time exposure basis so focusing only on one age group is not relevant); and, (iii) that tocopherols were re-evaluated recently by the European Food Safety Authority and did not lead to safety concerns.

However, the EU representative indicated that the EFSA evaluation was referring to the use it as a vitamin and the health guidance value was a Tolerable Upper Limit but that, at the 95th percentile, the exposure to infants would lead to five times the ADI at the proposed 1000 mg/kg level. During the discussion, the JECFA secretariat was asked to check (i) when tocopherols (as well as other food additives considered for that food category) were reviewed for the last time and (ii) whether JECFA performed a dietary exposure assessment back then. The JECFA secretariat carefully indicated the last reviews were in 1986, 1975, 1976, 1973 depending on the food additives mentioned, and pointed that the JECFA role was limited to establish an ADI at that time and no exposure assessment was done by or requested to JECFA back then. (And let’s remember: GSFA started to be reviewed in its modern feature from the early 1990s only).

At another point of the discussion on the other provisions for this food category, the JECFA secretariat also indicated that if CCFA would decide to ask JECFA to performan exposure assessment for a given additive, it could be that JECFA experts will consider that the food additive in question may also deserve a re-evaluation (given the last date of review by JECFA) and they decide to revisit the food additive specifications to check new methods of production or simply put the specifications in line with others, adopted at national/regional level. That’s where the discussion was left in the PWG on GSFA before the plenary revisits the issue.

Hence, the CCFA50 report contains an unusually long paragraph (Para.91) which spells out very clearly the (still) divergent points of views expressed during the plenary.

In terms of the provisions, five are going through for final adoption (including the one on tocopherols but with a new note added to it referring to the fact that in this case tocopherols are secondary food additives – and wasn’t it the whole point of the EU to challenge the technological needs and justifications provided in the first place about the draft level proposed initially at 1000 mg/kg?)14, and 8 other provisions are discontinued (two at the express request of the soft drink industry as they are used as flavouring not flavour enhancers)15. Therefore, all ended up well. And CCFA50 finished its agenda smoothly.

  • GSFA work for 2018/2019: some colours are back on the work program

CCFA50 decided to establish a new EWG on GSFA to go overall the pending provisions for miscellaneous additives (except those subject to specific issues to be resolved such as adipic acid, nitrites, nitrates or feedbacks expected from other Codex commodity committees), but not only. The most astonishing breaking news is that the work program of the EWG on GSFA also includes, to the surprise of most of the participants, all pending provisions in the step process for colours in candies (hard and soft), marzipans and nougats, decorations to confectionery, and chewing gum, to start with. This is the first time in the past eight years, that CCFA has decided to place any colour provision on its work program, in the context of the GSFA itself. Indeed, discussions stopped on colour (and sweeteners) a couple of years ago, because of the growing use of Note 161 to get provisions approved. And then, the Committee focused primarily on Note 161itself, and then Note 161 on sweeteners (see above).

At that occasion and in the specific context of the new work on colours, an industry observer stated that it intended to “develop a constructive dialogue with all interested parties based on (i) sound science, (ii) state-of-the-art food technology, (iii) Codex Alimentarius procedures, and (iv) the Preamble of the GSFA”. The observer further pointed out that the recent progress made by the CCFA, not only at this 50th session but also the three last. In this industry observer’s view, such progress “were good for (i) consumer health protection, (ii) fair practices for foods in international trade and (iii) global harmonization of national and regional regulations and standards on food additives”. A round of applause concluded the statement and to thank the USA delegates (Chairing the EWG and PWG) and all the other delegations for their hard work in speeding up exponentially the progress to reduce – and soon complete – the backlog of all pending provisions in the GSFA.

Other, more classic, CCFA50 decisions on Alignment, INS and JECFA list of priorities

  • Alignment: great achievement and one of the most important ongoing pieces of work

The revised provisions for aligning food additives permitted in Annexes to the Commodity Standard for Canned Fruits (i.e. mangoes, pears, pineapples) and all the Commodity standards for fish and fish products16. Those provisions aligned between the related food categories of the GSFA and each of the Commodity standards are included

in Appendix IV-Part A & Part B; Appendix V – Part B1&B2 of the CCFA50 report (pending CAC41 approval decision). All those commodity standards will accordingly be modified and republished during the second half of 2018 to reflect the changes.

CCFA50 adopted a very important working guidance document on alignment, included in Appendix XI of CCFA50 report. This document will be published as an information document on the Codex Alimentarius website17. The working guidance also includes a flowchart decision-tree and further specific recommendations to the active Codex Commodity Committees to start thinking to help CCFA in the alignment process of food additives provisions in Codex food standards under their responsibility and the corresponding food categories in the GSFA. CCFA50, therefore, agreed that commodity committees shall be informed about that document as well as all FAO/WHO regional coordinating committees which have developed regional standards in the last decade. They will also be informed about the alignment plan that CCFA has adopted at its 50th session, and specially request CCSCH, CCFO, and CCPFV to consider prioritizing initial alignment of commodity standards within the scope of the next two years. The full plan includes all Codex food standards. The full completion of the work is expected by 202518.

CCFA50 also approved a revised approach on how listing the corresponding commodity standards in Table 3 of the GSFA after having verified its applicability for the GSFA-online posting and how the information could be managed in the GSFA overall database and published version of CXS 192.

CCFA50 also requested other Codex Committees to revoke the permitted use for some food additives with no JECFA specification (i.e. potassium hydrogen malate (INS 351(i)), potassium malate (INS 351(ii)), monosodium tartrate (INS 335(i)), monopotassium tartrate (INS 336(i)) and dipotassium tartrate (INS 336(ii)) in several Commodity Standards which they are responsible for.

Therefore, it can be concluded that the alignment work will be the most substantive part of the work of CCFA for the next years, with Australia and Japan as the leading countries, and with new help from specialised industry observer organisations, such as the International Dairy Federation (IDF) and the Codex Commodity Committees, now that the operating rules and working procedures have been approved by CCFA.

  • Review of JECFA past work, current recommendations for CCFA consideration and CCFA decisions on next priorities of work for JECFA in the next 2 years

As usual, CCFA reviewed the outcome of the most recent JECFA meeting on food additives (held in June 2017) and considered whether any action may be necessary. It is worth noting that JECFA has re-evaluated two colours (Brilliant Blue FCF and Fast Green FCF) and reaffirmed that both did not raise any safety concern in terms of exposure (even if the ADI has been lowered in one case). Meanwhile, CCFA50 agreed with JECFA recommendation that the Group ADI for all carotenoids may be re-evaluated in the light of the information provided about a new algal source of beta-carotene.

CCFA50 also adopted several new and revised JECFA specifications (i.e. adopted as “Full” by JECFA) for possible adoption as Codex specifications for food additives (i.e. as international standards)19. Two new specifications for Tamarind seeds polysaccharide (INS 437 – assigned by CCFA50 to be approved by CAC41) and Beta-Carotene-rich extract from Dunaliella salina (No INS assigned yet, but it is on the agenda of the EWG on INS – see below). CCFA50 also adopted full revised specifications for Brilliant blue FCF (INS 133); Fast Green FCF (INS 143); Silicon dioxide, amorphous (INS 551); Sucrose esters of fatty acids (INS 473); Microcrystalline cellulose (INS 460(i)); Gum ghatti (INS 419); Sodium aluminium silicate (INS 554) and Steviol Glycosides (INS 960). These changes are reflected in Appendix III of CCFA50 report.

CCFA noted – for information only – other specifications currently under JECFA review (i.e., called “Tentative” by JECFA), pending additional information is provided to JECFA for their finalisation (e.g. Jagua (Genipin–Glycine) Blue; Metatartaric acid (INS 353); and Yeast extracts containing mannoproteins).

Regarding JECFA list of priorities assigned at this CCFA50 session, the most remarkable change is the addition of many enzymes (used as processing aids) to the list of priorities. The other remarkable additions relate to several applicants request to consider new types of steviol glycosides obtained according to various techniques ranging from the use of genetically modified microorganisms to bioconversion and biosynthesis. A new natural pigment extract named Black carrot extract is also added All JECFA new priorities are reflected in Appendix X of the CCFA50 report. Moreover, it should be noted that the table has been populated with a more formalised list of information fields, at the initiative of the Canada chair, aiming at keeping records on details of the initial requests, previously only recorded in working documents uneasy to find back20. Those new fields will also be reflected in the Codex circular letter requesting comments on new JECFA priorities each January. In addition, a new Annex will be added to such circular letter to ask applicants/sponsor countries responsible for substances already under the review process by JECFA to confirm (i) the interest in pursuing with the application and (ii) they would comply with the announced deadline for data availability.

In that context, it is also worth noting that another very important amendment has been agreed to be added to the Codex circular letter at the request of the JECFA secretariat (WHO side). That amendmentisplacedundersection9ofthecircular letter about the “list of data available”. It reads as follows: “For substances obtained from natural sources, characterization of the products in commerce and a relevant set of biochemical and toxicological data on such products are essential for JECFA to develop a specifications monograph and the related safety, and such data/information could include: components of interest; all components of the final products; detailed manufacturing process; possible carry-over of substances; etc.

The addition of this paragraph primarily reflects the strong views of risk assessment scientific experts in JECFA that the safety evaluation and establishment of specifications for substances from natural sources shall not substantially differ from what is required for substances obtained by other methods. Indeed, “natural” does not mean necessarily “safe”. Some plants or organisms are indeed containing very toxic elements, sometimes deadly at low doses. And the soft methods used to extract other interesting parts of such plants or organisms (such as natural colouring pigments) may not necessarily phase out those natural toxicants.

This addition approved by CCFA may be viewed as anecdotal, however, it is a fundamental clarification. It should draw the attention of all companies having strategies or making ‘natural’ claims about concentrated colouring pigments, sold as “colouring foodstuffs” or “foods with colouring properties”. As a matter of fact, some of them exert a very similar colouring function in final foods than food additives (colors). And they are currently not subject to the same stringent risk assessment scrutiny and regulatory clearance as colour food additive (if any). Synthetic colours, on the other hand, have a known and constant composition. They have been re-evaluated and generally, no safety concerns based on their intended uses are generally concluded by JECFA or national competent risk assessment agencies.

  • CCFA50 followed all the recommendations prepared by its in-session EWG on the INS21, chaired by Belgium due to the absence of Iran representative

CCFA50 has adopted several changes to the Food Additive Class Names and International Numbering System (including functional classes and technological purposes) for food additives mostly based on the work done since the last session through an inter-session electronic working group and new proposals put forward. CCFA50 did set-up

an in-session physical working group which tuned up further those recommendations into concrete proposals to the CCFA50 plenary for adoption.

The most important CCFA50 decision relates to Steviol Glycosides (i) to change the way Steviol Glycosides are numbered in the INS; (ii) what it means with regards to the provisions adopted in the GSFA and (iii) consequential amendments to the relevant Codex document listing adopted JECFA specifications.

Changes to steviol glycosides listing in the INS are included in Table 3 of Appendix IX-Part.A2 of the CCFA50 report. The first change is that the entry corresponding to INS 960 becomes a parent category as “Steviol Glycosides” (therefore with no assigned functional class nor technological purpose for that parent category, as it becomes a “title” or class name of a broader family of food additives).

A new INS 960a is assigned to Steviol glycosides from Stevia rebaudiana Bertoni with possible synonym added in brackets “Steviol glycosides from Stevia”. That substance (which corresponds to the (only) one permitted in GSFA to date), is obviously a sweetener used for technological purpose as sweetener (i.e. for sweetening).

Another two new entries are introduced in the INS. INS 960b is now a sub-parent category of Steviol Glycosides to describe all steviol glycosides obtained “from fermentation”. That number has no functional class nor technological purpose consequently. Under this sub-parent category, a new entry as INS 960 b(i) Rebaudioside A from multiple gene donors expressed in Yorrowia lipolytica is created as sweetener and for the technological purpose of sweetener (i.e. for sweetening). That approach looks quite new and may raise consistency questions across the overall INS system. But that’s what is proposed for final adoption at the next CAC41 this July.

Furthermore, CCFA50 decided that in the Codex text listing the Codex-approved JECFA specifications for food additives (CAC/MISC 6 – CXM6), the two entries for INS960a and INS960b (i)would replace the current “Steviol glycosides” one. Consequential amendments are included in Appendix XI – Part B.

The other consequential decision taken by the CCFA50 is that all already approved provisions for Steviol Glycosides in the Codex GSFA will be applicable as a parent category entry into the GSFA to both new INS 960a and INS 960b (i), such as what is done for other food additives with a Group ADI and covered by a parent category (e.g. Phosphates). In concrete terms, it means that all the previously reviewed and approved use levels for Steviol Glycosides obtained by plant extraction from Stevia rebaudiana Bertoni will be also approved for Rebaudioside A from multiple gene donors expressed in Yorrowia lipolytica, as the maximum permitted use levels are expressed as steviol equivalent anyway.

Among other things, CCFA50 also approved other changes with a new functional class for (a) propylene glycol as a carrier and two corresponding technological purposes as carrier and carrier solvent, (b) mono- and diglycerides of fatty acids, as glazing agent and surface-finishing agent, (c) gellan gum as a gelling agent and (d) DL-malic acid as a sequestrant. Potassium poly aspartate has been added to the INS with number 456 as a stabilizer, with the technological purpose being also as a stabilizer. As mentioned earlier, Tamarind seed polysaccharide was also assigned a new INS number 437 as an emulsifier, stabilizer, thickener and gelling agents with corresponding technological purposes, plus as “foam stabilizer”.

All the adopted changes are reflected in Appendix IX Part. A2 and B.

  • CCFA50 endorsed provisions for food additives adopted in the Codex standard for dairy permeate powders but not for the Near East Regional standard on Doogh, thus delaying very much the publication of the standard approved by CAC40 in July 2017

CCFA50 endorsed with no difficulty the limited food additive provisions of the Codex Standard on Dairy Permeate Powders (developed by correspondence). It should be noted that the standard also contains a provision on processing aids.

However, CCFA50 was not able to find consensus on the food additives provisions enclosed in the Near East Regional Standard on Doogh based on the outcome of discussions held during the in-session working group on Endorsement and Alignment and the plenary. Indeed, this topic also led to very interesting discussions and a reminder about the relationship between Codex Committees elaborating commodity (i.e. food) standards and the GSFA when it comes to food additives.

Starting with the reminder, the USA reminded everyone, including the Codex Secretariat, that on page 50 of the English version of the CAC Procedural Manual, “Should the commodity committee consider that a general reference to the General Standard for Food Additives does not serve its purpose, a proposal should be prepared and forwarded to the Committee on Food Additives for consideration and endorsement. The commodity committee shall provide a justification for why a general reference to the General Standard for Food Additives would not be appropriate in light of the criteria for the use of food additives established in the Preamble of the General Standard for Food Additives, in particular, Section 3.” Based on this reminder, the CCFA did not get the technical inputs it needed to understand the technological needs for each of the individual provisions suggested in the standard.

It was recalled however that almost all food additives – but two (i.e. nisin and magnesium dihydrogen diphosphate) and the reference to national legislation were present also in the adopted international Codex Standard on Fermented Milk22, something that IDF tried to underline to the plenary.

IDF equally flagged out that there were transcription errors in the draft Regional Standard for Doogh, including in table 4.1 between heat-treated Doogh and heat-untreated Doogh compared to the Codex Standard on Fermented Milk. Japan also raised the issue of one type of Chlorophyllin which may need to be taken out from the list as not permitted in GSFA.

Finally, the USA indicated that the reference to national and/or regional competent authorities for the implementation of such provisions should not be present in such Codex standard and section on food additives unless duly justified as well. Indeed, that reference seems to close to the wording of Note 161 found in the GSFA.

As a consequence of all of the above, CCFA50 did not endorse the food additive provisions in the draft Near East Regional Standard for Doogh and requested that the CCNE consider at its next session (a) whether a general reference to the GSFA was possible in place food additive provisions in the draft Regional Standard and if not to provide a justification; (b) assess the detailed comments provided by Japan in CCFA50 CRD31 and (c) reconsider the reference to national legislation set in the footnote(a) of the Table of Section 4.1 of the draft regional standard. Given the time by which the next CCNE may convene its 10th session (especially if after next CCFA51 in March 2019), the finalization and publication of the Regional Doogh Standard may be postponed by one to two years, as CCFA is to give its final say on the food additive section again. Maybe that’s something which may be fixed before then perhaps through a discussion to be held on the side of – or during – a forthcoming CAC meeting.

Discussion on nitrates and nitrites

CCFA50 considered the outcome of an EWG on the matter led by the Netherlands which came back with more questions than definitive recommendations for consideration by the CCFA.

Based on several interventions and clarifications from the JECFA secretariat (both FAO and WHO sides) on this issue, it was clear that there is an obvious lack of clear-cut useful data, there is a thin line between what CCFA was doing on food additives and what CCCF was doing on contaminants regarding sources of dietary exposures to help JECFA refining all the aspects related to the risk(s) characterization, and a lack of visibility on the various risk management options. Based on that, CCFA50 agreed to task a new EWG chaired this time by the EU and co-chaired by the Netherlands to continue the investigation work and try to answer further some of the questions. More details are accurately reflected in paras. 94 to 104 of the CCFA50 report.

Discussion on further definitions of “plain”, “fresh”, “untreated”, “processed”, “unprocessed” (raw food or fresh food), “minimally processed (plain) foods”, “ultra-processed products” and possible related criteria for using food additives in them.

CCFA50 struggled a bit with the discussion paper prepared by the Russian Federation. Indeed, CCFA49 did ask the Russian Federation to prepare a document which would go into more details about Russia’s request to develop more precise Codex definitions about the terms “plain” and “unprocessed”, used and found in descriptors of the food categorization system included in the full GSFA (CXS 192). The discussion paper rather expanded the objective in trying to develop a set of new criteria to qualify, a priori, the suitability for the use of food additives in foods, depending on the level of processing they could have been subject to. Some countries were not in favour simply to continue working into that subjective direction, while others mentioned that what could be useful is to discuss the differences of concepts between “plain”, “fresh”, “unprocessed” and “untreated”.

CCFA50 tasked the Russian Federation to prepare a new discussion paper to review all existing Codex texts and identify where the terms “plain”, “fresh”, “unprocessed” and “untreated” were used and to what purpose to assess the feasibility and usefulness to develop definitions of these terms, for the purpose of allocating food additive provisions to those foods qualified with those terms.

Next CCFA session

CCFA51 will be held in China from 25 to 29 March 2019 and preceded by a physical working group on GSFA and maybe on Alignment.

More details about CCFA50 working documents and conference room documents (CRD) are available at www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFA&session=50 http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFA&session=50

Report of CCFA50 session is available at www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=ht tps%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcode x%252FMeetings%252FCX-711-50%252FReport%252FREP18_FAe.pdf

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1  The Codex GSFA is also known as CODEX STAN 192 (now CXS 192); it is composed of a preamble, several appendices (e.g. defining the hierarchic food categorizations system) and Tables 1 to 3 containing all adopted food additive provisions, as well as the list of Notes, specifying further conditions/restrictions of use for such provisions.
2  Food Engineer, Regulatory and Scientific Counsellor at Keller and Heckman LLP.
3  Food Law Attorney & Partner at Keller and Heckman LLP.
4  Both supported by many countries from Africa (Kenya, Senegal, Zimbabwe); the Americas and the Caribbean (Canada, Chile, Costa Rica, Colombia, Brazil, including Cuba); Europe and Asia Pacific (Russian Federation, UK, Germany, China, Australia).
5  Report of the 2015 UK-led EWG was gathered in CX/FA 15/47/13 working document of CCFA47 agenda item5g.
6  With the exception of those additives provisions with technological functions of colour or sweetener, adipates, nitrites and nitrates, and the provisions related to grape wines.
7  With the exception of food additives provisions with the function of colour and sweetener.
8  INS 474 provision currently approved at 10000 mg/kg in Sauces and sauce-like products.
9  INS 330, 472a, 472b, 472c, and 472e (each at GMP).

10  INS 300, 301, 322(i), 331(iii), 471, and 525 (each at GMP), 475 (at 1000mg/kg), 307a,b,c (at 200 mg/kg); 473, 473a and 474 (singly or in combination at 1000 mg/kg).
11  All phosphates (listed in GSFA) singly or in combination at 2200 mg/kg, expressed as Phosphorus.
12  INS 410, 407, 418, 412, 414*, 1440, 460(i), 440, 1200, 501(i)*, 466 and 415 (each at GMP), and 405 (at4000mg/kg) – those marked with * here are noted “For use in non-flavoured vitamin and mineral fortified fluid milk only”.
13  The EU representative showed what that amount would score on a small water bottle; Given his intervention was broadcasted on the meeting room screens, everyone could clearly see his dramaturgic illustrative gesture.http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FStandards%252FCODEX%2BSTAN%2B243-2003%252FCXS_243e.pdf . CRD31 (Japan comments) are available at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FMeetings%252FCX-711-50%252FCRDs%252Ffa50_CRD31x.pdf

14  INS 473, 473a, 474 (at 200 mg/kg singly or in combination, except for use in non-alcoholic aniseed-based, coconut-based, and almond-based drinks at 5000 mg/kg), INS 334, 335(ii), 337 at 800 mg/kg expressed as tartaric acid, and Tocopherols (INS 307 a, b, c) at 200 mg/kg as carry-over from use as an antioxidant in flavours, colours, juice ingredients and nutrient preparations.
15  INS 637*, 636*, 476, 430, 431, 405, 262(ii), 491 to 495 (* at the request of the soft drink industry).
16  Standard for Certain Canned Fruits (CXS 319-2015) and the Standards for Canned Salmon (CXS 3-1981); Canned Shrimps or Prawns (CXS 37-1991); Canned Tuna and Bonito (CXS 70-1981); Canned Crab Meat (CXS 90-1981); Canned Sardines and Sardine-Type Products (CXS 94-1981); Canned Finfish (CXS 119-1981); Salted Fish and Dried Salted Fish of the Gadidae Family of Fishes (CXS 167-1989); Dried Shark Fins (CXS 189-1993); Crackers from Marine and Freshwater Fish, Crustacean and Molluscan Shellfish (CXS 222-2001); Boiled Dried Salted Anchovies (CXS 236-2003); Salted Atlantic Herring and Salted Sprat (CXS 244-2004); Sturgeon Caviar (CXS 291-2010); Fish Sauce (CXS 302-2011) and Smoked Fish, Smoke-Flavoured Fish and Smoke-Dried Fish (CXS 311-2013).
17  Likely to be posted at http://www.fao.org/fao-who-codexalimentarius/resources/infodoc/en/
18  See page 148 and 149 of the CCFA50 report (English version).
19  For inclusion in a Codex standard called CAC/MISC 6 (i.e. CXM 6). See the March 2018 version at http://www.fao.org/fao-who-codexalimentarius/codex-texts/miscellaneous/en/. As such, CCFA does not develop its own specifications for food additives (and flavourings) but rather adopt those developed by JECFA.

20  Type of request, proposed by [sponsoring country], Year request was endorsed by CCFA, date of availability of required data in applicant dossier, data provider’s full name and details, basis for the request, Possible issues for Trade.
21  INS and Class names are published once a year as CAC/GL 36 (CXG 36). See the March 2018 version at http://www.fao.org/fao-who-codexalimentarius/codex-texts/guidelines/en/

World Food Regulation ReviewVol. 27, Number 10March 2018 —

This article reviews the outcome and decisions taken at last month’s session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods, about new international standard maximum limits for lead, cadmium, methylmercury and other contaminants and toxins in several types of foods (e.g. chocolate, fish products, salt, fat spreads, etc.). It also dropped working on other draft limits (e.g. total aflatoxins in ready-to-eat peanuts, lead in processed tomatoes)). It adopted and advanced work on Code of Practices for the reduction of some contaminants (e.g. Dioxins and Dioxin-like PCBs; 3-MCPDE and Glycidyl esters of fatty acids). It also advanced mid-way for final adoption future Codex Guidelines regarding the risk analysis principles about the inadvertent low-level presence of chemicals in foods

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International food safety leaders and experts on contaminants and toxins made significant progress in adopting and advancing most of the provisions that were discussed at the last meeting of the Codex Alimentarius Committee on Contaminants (and Toxins) in Foods (CCCF12)[1], held mid-March in Utrecht (The Netherlands). This article reviews those decisions and describes the pending and new work issues which will be addressed in the next 12 months through various electronic working groups or directly at the next CCCF session. CCCF12 has opened the door for Codex Alimentarius to develop guidelines which may provide – subject to confirmation – a common future backbone to help global harmonization on the ways countries may assess the migration of chemicals from food contact materials to foods. 

The 12th session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods (CCCF) was held in Utrecht (The Netherlands) from 12 to 16 March 2018. CCCF is the Codex Alimentarius horizontal committee in charge of the update of the General Standard on Contaminants and Toxins in Foods. Therefore, it is one of the most important Codex committees – which sets tolerable levels for environmentally and industrially-sourced contaminants in foods as low as reasonably (i.e. technically and economically) achievable to ensure an acceptable protection of consumer health, while ensuring fair practices in international trade of such foods. 

CCCF12 will take important decisions on regulatory limits for foods in international trade of lead, cadmium, methylmercury, aflatoxins, ochratoxin A

Lead 

CCCF12 agreed to suggest the adoption of lowered maximum tolerable levels for lead in several food categories in the Codex Alimentarius General Standard in Contaminants and Toxins in Food (GSCTF)[2] and, where appropriate, in the corresponding Codex Commodity Standard.

Quinoa

CCCF12 discussed the reasons why quinoa, a pseudo-cereal, was specifically excluded from the applicable MLs for lead and cadmium to cereals. CCCF12 concluded that a further background search would be needed and that there may be room to address the issue in the future (i) to include quinoa as a pseudocereal currently covered under “other cereal grain” in the context of the ongoing revisions of the Classification of Food and Feed (CAC/MISC (CXM) 4) and/or (ii) to develop specific MLs for lead and cadmium for quinoa.

Grape Juice

As announced (see WFFR February 2018 issue), CCCF12 agreed to cut the applicable ML for lead in grape juices by 20%, down to 0.04 mg/kg.

Processed tomatoes

CCCF12 took a very surprising decision in not following the recommendation of the intersession EWG to adopt a ML for lead of 0.08 mg/kg and even concluded to stop suggesting such a level (‘revoke the existing level and discontinue any further work’). It seems that the proposed ML would have had some significant impact on some specific types of processed tomatoes, especially those with a high natural soluble solids content (e.g. TSS = 28 – 38%). Given the fact that a ML of 0.05 mg/kg for lead is already established for fruiting vegetables (which includes fresh tomatoes), it could also be used to derive a ML for processed products, using the technique of concentration factors (leading to a higher endpoint ML for such processed products).

It is public knowledge that some large tomato producing areas intended for producing specific tomato concentrates – which are of high brand value for worldwide consumers and of strategic importance for the local economy and communities – may have been affected by decades of environmental contamination due to the fraudulent management of domestic and industrial waste via illegal landfilling disposal. Although this fact was not discussed as such during the session, CCCF took a wise approach in leaving countries a degree of liberty in establishing their own limits for tomato concentrates, while indicating a path forward by pointing out the Codex ML for fresh tomatoes.

In summary, this (non)decision is a perfectly illustrative example of pragmatism about “agreeing to not disagree” on an international standard. But the issue might be revisited in the future based on a better geographical representation when new occurrence data become available on more achievable levels. Future may tell.

Mango Chutney

The Committee did “cut the pear in two halves” and finally reached consensus on a half-way 35% reduction of the existing ML in suggesting to adopt a level of 0.4 mg/kg.

Wine

Despite an already established ML for lead in wines at 0.15 mg/kg established by the intergovernmental organization setting up standards for wines (i.e., the OIV) and noting that wider geographical occurrence data in some grape wines and liquor wines elaborated from fruits may be needed at Codex level, CCCF12 deferred the future ML discussion to the intersession electronic working group tasked to review lead limits in the GSCTF. CCCF12 further noted that the future ML would apply to wines produced only after the date of adoption (by the CAC) of the future Codex ML and therefore such a ML would not be applicable to any wine in current aging stages, which will be marketed after that future adoption date.

Food grade salt

CCCF12 reached a consensus to suggest cutting the current ML by a half, down to 1 mg/kg for final adoption. This level would also apply to standardized products conforming with the corresponding Codex commodity standard for food grade salt. However, it was noted that salt is (i) consumed in small daily quantities, (ii) a level of 1.5 mg/kg could have been protective and (iii) an exemption could have been granted for salt harvested from marshes. The Committee did not retain those comments, except for the exemption of salts from marches, and adopted the 1 mg/kg 50%-reduced ML for lead in all salts.

Fat spreads and blended spreads and edible fats and oils

As announced, the Committee agreed to a 60% reduction of the existing ML for lead in fat and blended spreads down to 0.04 mg/kg. For edible fats and oils, the Committee reached consensus on only a 20% reduction of the existing ML down to 0.08 mg/kg, although a more ambition reduction would have allowed 97% of current global products to be compliant with the new ML. However, it should be noted that the mitigation measures are difficult to put in place for some secular oils and the Committee took that aspect into account as well. Those levels are applicable to products conforming with the relevant Codex commodity standards covering fat spreads, blended spreads and edible fats and oils.

Fresh farmed mushrooms, i.e. common mushrooms (Agaricus bisporous), shiitake mushrooms (Lentinula edodes), and oyster mushrooms (Pleurotus)

CCCF12 agreed to move forward with suggesting the adoption of a new ML for lead in fresh farmed mushrooms at 0.3 mg/kg. This is less ambitious than the EWG recommended level of 0.2 mg/kg, but still allows 96% of global products to comply with the new ML, relevant to those mushrooms conforming with the corresponding Codex Commodity Standard. The ML applies to the whole commodity and not only the edible part. In this regard, this is a good achievement full of pragmatism.

Canned brassica vegetables

While agreeing that canned brassica vegetables were part of the vanned vegetables food category, CCCF12 agreed to establish a specific new ML for lead at 0.1 mg/kg, as planned and announced.

Fruit juices obtained exclusively from berries and other small fruits

CCCF12 also discussed and agreed to provide additional clarification to the scope of applicable existing ML for lead in this food category and whether it should be lowered. While confirming that the current ML of 0.05 mg/kg applies to the whole commodity (not the concentrated ones) or the commodity reconstituted to the original juice concentration, ready to drink (applicable also to nectars, ready to drink), CCCF12 agreed to suggest an adoption of a 20% reduced ML for lead to grape juices at 0.04 mg/kg, noting however that such a reduced level may cause a 15% negative impact on the global trade of grape juices. The current ML for the other types of fruit juices remained unchanged.

The Committee also agreed to continue working on further MLs in edible offal and some wines.

Cadmium in chocolates and other types of cocoa-based foods 

CCCF12 had some interesting discussion about the various proposals for establishing maximum tolerable levels (MLs) for cadmium in chocolate products and other cocoa products. The Committee finally agreed to support the adoption of two MLs for cadmium in chocolates, taking into consideration the total cocoa solids content on a dry matter basis as a criterion to apply the two different ML.

For chocolates with such cocoa solids above or equal to 70%, CCCF12 suggests the adoption of a 0.90 mg/kg ML, as a compromise between the EWG suggested 1.00 and the request for a lower value (0.80) by some large importers.

For chocolates with cocoa solids content below 70% and above or equal to 50%, a ML of 0.80 mg/kg was set for adoption, although a lower 0.60 value would have led to only a potential 4.3% global trade impact. A note has been added to both MLs making clear that they would also apply to sweet chocolate, Gianduja chocolate, semi-bitter table chocolate, vermicelli chocolate/chocolate flakes, bitter table chocolate, all subject to Codex commodity standards.

For chocolates with a solid matter level lower than 30%, CCCF12 was not able to achieve a compromise between the EWG suggested ML of 0.40 mg/kg and the suggestions for much lower levels (0.10 and 0.20), i.e. between the interests of producing countries where cocoa fields are located on volcanic soils (rich in cadmium) and the objective to protect further vulnerable groups of population, particularly keen to eat these types of chocolates.

For chocolate and chocolate products containing or declaring an amount of total cocoa solids below 50%, but above or equal to 30% (on a dry matter basis), (too) many different MLs were proposed, at values around the already suggested 0.50 mg/kg. Unable to find a middle-ground agreeable value, CCCF12 tasked a new EWG to continue working on this chocolate products type and assess whether it was feasible to merge two categories and derive only one ML for chocolate and chocolate products containing or declaring a total cocoa solids content below 50% (on a dry matter basis), taking into account the small dataset for this category versus datasets available for the chocolates below 30%.

For dry mixtures of cocoa and sugars that are sold for final consumption, the Committee was torn about whether the Committee should continue the work or not, as some of these products are regularly consumed by children. As a compromise, CCCF12 agreed to discontinue the work on dry mixtures of cocoa and sugars sold for final consumption (therefore leaving an international vacuum which may be filled by existing or upcoming – possibly even more trade disruptive – national limits), but to continue to work on cocoa powders with 100% total cocoa solids on a dry matter basis. They noted that consistency among all these kinds of chocolate and cocoa products is important and that such a level could allow countries to derive pertinent limit(s) for the dry mixtures of cocoa and sugars sold for final consumption.

Methyl mercury in fish including associated sampling plans 

CCCF12 made some progress in adopting MLs for methyl mercury in all types of tunas (1.2 mg/kg); alfonsinos (1.5 mg/kg); marlins (1.7 mg/kg) and sharks (1.6 mg/kg) based on less than 5% rejection (rather than the P95 approach) and equally applicable to whole fresh fish or frozen fish (including those intended for further processing). However, the EU28, Norway and Switzerland were unhappy with these decisions and their 5% rejection basis and officially expressed their reservations about all of them, while indicating that they won’t change the applicable MLs in the EU and EEA region. A further note provides the precisions on screening (relation with total mercury content) and national legislation for vulnerable groups, as follows: “Countries or importers may decide to use their own screening when applying the ML for methylmercury in fish by analysing total mercury in fish. If the total mercury concentration is below or equal to the ML for methylmercury, no further testing is required and the sample is determined to be compliant with the ML. If the total mercury concentration is above the ML for methylmercury, follow-up testing shall be conducted to determine if the methylmercury concentration is above the ML. The ML also applies to fresh or frozen fish intended for further processing. Countries should consider developing nationally relevant consumer advice for women of childbearing age and young children to supplement the ML.”

For Amberjack, the Committee recalled its policy about the target ML of 0.3 mg/kg and given the fact that occurrence data showed that both the average and median concentrations of total mercury and methylmercury were below that level, the Committee decided to discontinue the work on the ML for Amberjack. In doing so, the Committee also confirmed its policy that contaminant regulations and standards shall focus on those food categories which contribute the most to the exposure.

The Committee did not reach any consensus on how to make progress on a ML for swordfish and simply decided to discontinue and stop working on any ML. This decision was surprising, especially because the Committee noted that the methylmercury concentrations in swordfish were high, which was a health concern when consuming this fish. But at the same time, many delegations were unhappy with the ML itself and considered it as too high. Other delegations pointed out the role of selenium as a possible remedy to the presence of methylmercury, especially present in swordfish flesh. The reality is probably far more complex than this, with (i) developing countries highly dependent of catches of swordfish and (ii) the reluctance of the Committee to restart past discussion on Guideline Levels for special species of swordfish versus MLs, as the application of Codex GLs by official control authorities has been an issue in the past. There too, in the absence of any international standard (i.e. ML), the regulation of methylmercury for swordfish is therefore entirely left to the appreciation of national and/or regional competent authorities, which may develop their own sanitary measures, in due line with their rights (and obligations) to do so under the WTO/SPS Agreement, and necessarily with some level of impact to trade in the absence of Codex MLs.

Beyond the MLs discussion, the Committee agreed on an amended sampling plan for methylmercury contamination in fish, which is now to be reviewed by the next CCMAS[3] meeting (May 2018) for a possible endorsement.

Finally, the Committee agreed to establish a new EWG, chaired by New Zealand and co-chaired by Canada, to prepare a discussion paper on the establishment of other MLs in additional fish species, yet to be identified.

Total aflatoxin limit in ready-to-eat peanuts and associated sampling plan 

CCCF12 reviewed the recommendation for an ML of 10 micrograms per kilogram (μg/kg or ppb) total aflatoxins in ready-to-eat peanuts for the final consumer. As announced, the debate raged for hours based on arguments that have been used and raised for many years already. The Committee oscillated between those countries in favour of a lower level than the one suggested by the EWG at 10 μg/kg (based on exposure data) and a higher level than 10 μg/kg (to protect some supplying countries’ interests). Instead of completely phasing out the objective to develop a Codex ML, the Committee resolved all these inextricable expressed positions by suggesting that more occurrence data were needed specifically on (i) ready-to-eat peanuts (not intended for further oil processing) which are subject to international trade (i.e. not to domestic consumption from local producers).

Such a call for new data will therefore only be issued by JECFA as of three-years from now to grant an additional “grace” period for the main producing and exporting countries to implement the 2004 Codex Code of Practice for the prevention and reduction of aflatoxins in ready-to-eat peanuts. Indeed, it was pointed out that some confusion exists on some current occurrence data about peanuts intended for further processing (edible oil production). Thus, the Committee decided to keep but put on hold, the draft ML for total aflatoxins at 10 μg/kg in ready-to-eat peanuts, so that discussion will start again when JECFA reports on the new occurrence data collected in 4 or 5 years from now.

In other terms, opponents to such an international standard have bought extra time to avoid such an international ML, which then leaves the door fully open to national or regional competent authorities to set their own national limit due to this patent lack of global harmonization due to multiple diverging interests.

Total Aflatoxins and Ochratoxin A (OTA) limits in culinary herbs and spices 

Same symptoms, same remedy. In view of the diverging positions between countries and business operators on the various MLs, and despite some recommendations to make progress on OTA from the dedicated past intersession EWG, CCCF12 decided to hold at their current step the draft proposed MLs (i.e. total aflatoxins at 20 or 30 micrograms per kilogram (μg/kg or ppb) in Nutmeg, Chili and Paprika, Ginger, Pepper and Turmeric and Ochratoxin A at 20 μg/kg). Therefore, JECFA is now tasked to issue a call for new occurrence data in three years from now and then the Committee may start to discuss the MLs again. Buying time is of great value to avoid adopting an international standard (i.e. ML) that nobody can agree upon.

As some Codexians would say: ‘Better off with no norm rather than with a bad norm’. Maybe… Because, meanwhile, a lack of global harmonization prevails (i.e. national diverging limits coexist).

It should also be noted that this is to allow time for the Codex Committee on Spices and Culinary Herbs (CCSCH) to make progress on commodity standards on some of the above-mentioned categories, and maybe in that context, CCSCH may come up with its own views of possible MLs, which in any case must be subject to endorsement by the CCCF.

Codes of practice for the reduction of the presence of industrial or environmental contaminants 

Dioxins, PCB-like dioxins (DL-PCB), non-PCB dioxin-like substances (NDL-PCB)

CCCF12 went through a revised version of the draft Code of Practice text which was presented as the outcome of the EWG which worked on it in the past 12 months. Given that most of the recent amendments to the text were editorial and did not substantively change the core aspects of the Code, the Committee agreed to suggest its final adoption by the forthcoming Codex Alimentarius Commission (CAC41), which will be held this July. The final agreed text is to be found in Appendix V of the CCCF12 report[4].

It will be subject to a circular letter that will be issued soon in the context of the preparation of CAC41 and seeking comments on the adoption of the final text. The deadline is generally being set on May 15.

3-MCPDE and Glycidyl esters in refined vegetable oils and their products thereof, with a special focus on infant formulas

CCCF12 had a fair, plain and consensual discussion on this Code of Practice. Unlike the Code on PCBs, the Committee considered it required more work, especially because parts of the Code still include texts in square brackets (i.e. on specific practices on matters such as low lipase activity, irrigation water, polar solvents, degumming, bleaching clay and two-stage deodorization, or the inclusion of specific references to fish oils). Therefore, the Committee decided to move the proposed draft Code of Practice for adoption at Step 5 (out of 8) (thus becoming such a draft Code and with a WTO/TBT value) by the next CAC41.

The Title was changed to make sure the Code would not only cover vegetable oils, and a new paragraph to the introduction to further clarify that revised title. Thus, CCCF12 established a new EWG to revise the draft Code of Practice based on the comments and information to be submitted by Codex members and observers in response to a specific circular letter, after CAC41. The EWG is tasked to resolve all outstanding issues for possible final review at the next CCCF session in 2019 (CCCF13). Before CAC41, a specific other circular letter is expected to seek comments to support the adoption at step 5 and advancing to step 6. The text of the draft Code of Practice is already available in Appendix VI of the CCCF12 report4.

Proposed draft guidelines to define the risk analysis principles about the inadvertent low-level presence of chemicals in foods 

CCCF12 had to review a new version of the proposed draft guidelines, instead of the one which was published as the result of the EWG. Indeed, it seems that a handful number of delegations have had an informal meeting prior to the CCCF12 session and came up with revised version delivered to the CCCF12 plenary, as a conference room document[5]. Many improvements were brought to the text (e.g. revised title to avoid different interpretations of “emerging contaminants” or “inadvertently present”; shorter introduction; clearer scope (i.e. contaminants outside the normal regulatory framework); changes to definitions; new section on and to clarify how cut-off values should be derived with one illustrative example).

The discussion highlighted the need to clarify the scope even further to address anything else than “classical” residues or permitted addition of chemical substances to food (so food additives, pesticide residues, residues of veterinary drugs will be specifically excluded). The whole approach on how guidance levels (alert levels) are derived from values obtained by using the threshold of toxicological concern (TTC) will need to be further worked out and its applicability reassessed for the various cases considered on a case-by-case basis.

Despite the remaining work on the guidelines, the Committee considered that the text was ready for adoption at Step 5 (out of 8) by this July CAC41. The text as amended is available as appendix IX to the CCCF12 report4.

CCCF12, therefore, established a new EWG to further develop the guidelines with a focus on the texts in square brackets for consideration at the next session. Although not formally established by CCCF12, CCCF12 leaves the door open to the chairs from New Zealand and the Netherlands to organize a physical working group (PWG) to meet immediately prior to CCCF13 session to make further recommendations to the Committee, based on the text to be included in the EWG report.

It is worth noting that among the case study examples listed in Annex 3 of the draft guidelines, a clear reference and link is made to the “Occurrence and Risk Characterization of Migration of Packaging Chemicals in New Zealand Foods”, published by New Zealand Ministry for Primary Industries[6]. Therefore, it seems very clear that the intent is to provide to governments Codex guidelines to implement national policies in a harmonized fashion how they may regulate migration of those substances viewed as a contaminant (i.e. non-intentionally added substances) only, from the complex chemical-based food contact material matrices into foods. This move of Codex CCCF in the food contact material area is worth noting as quite significant and somewhat historical.

Discussion papers on possible future work 

Other Lead limits

The Committee agreed with the principle of three different priority groups for certain food categories (high, intermediate, low). CCCF12 established a new EWG to prepare a revised discussion paper and project document, also taking into consideration exposure data (in addition to other criteria for prioritization of commodities) in establishing the prioritization categories for MLs, and to propose, if feasible, MLs for the categories indicated with a focus on commodities identified as high in the priority list. In this context, it should be carefully noted that some of the comments were raised during the session to move the confectionery product category to that high priority group.

Certainly, an issue to be monitored during the EWG work, because not all confectionery products are intended to be marketed to children, nor are primarily consumed by children, and thus it would make no sense to move them to the high priority group at all, rather the opposite. Indeed, because Lead may not be present (even detectable) in many confectionery products, it would rather be more adequate to move that food category to the lowest priority list. But as always, future may tell.

The Committee also noted that JECFA would issue a call for occurrence data for lead in several categories listed in Table 4 of the working document[7]. It encouraged Codex member countries to submit data on national food consumption levels and on lead occurrence data to WHO GEMS/Foods to assist in the development of the discussion paper and a possible decision on any new work (new MLs) for lead in the categories identified in the high priority group.

Aflatoxins and sterigmatocystin in cereals

CCCF12 agreed that this issue was important and therefore assigned to a new EWG the task to update the discussion paper with proposals for new work and project documents.

The aim is to suggest specific MLs for total aflatoxins in (a) wheat, maize, sorghum and rice (specifying the categories) for grains for human consumption and (b) in flour and cereal-based foods for infants and young children. Regarding the issue of the method of analysis to identify and quantify the presence of sterigmatocystin in cereals, CCCF12 encouraged standard development organizations (such as AOAC, ISO, AOACC, etc.) to develop a duly validated method and submit it for consideration by CCMAS.

Regarding the specific Annex on sterigmatocystin, CCCF12 agreed that no action was required, at this point in time.

Prevention and reduction of cadmium in cocoa (beans)

CCCF12 also considered that a specific and new Code of Practice for the prevention and reduction of cadmium in cocoa would be useful. It tasked a new EWG to further elaborate the discussion paper to (a) determine whether mitigation measures available at present would support the development of a Code of Practice, noting that such measures should be proven to be cost-effective, applicable worldwide by both large and small-scale business operators, including farmers, and (b) identify the scope of such a code of practice (e.g. whether it would cover the whole production chain or only the primary production step), based on a survey.

Should those pre-conditions be met in time, then the EWG is to include a project document to define the scope and timeline of the new work and possibly append a first proposed draft of such a Code of Practice.

Hydrocyanic acid and mycotoxins in cassava and products thereof

The discussion was postponed to 2019 CCCF13 for an administrative reason.

CCCF12 Priorities for future work of JECFA on contaminants 

Based on the recommendations made by an in-session working group, CCCF12 reaffirmed the need for JECFA scientific evaluations/review of (i) dioxins, (ii) arsenic (inorganic), (iii) scopoletin (in relation to Noni Juice consumption), (iv) ergot alkaloids, (v) ciguatoxins, and (vi) an updated risk assessment, including exposure assessment, of mycotoxins trichothecenes (T2 and HT2). The full details are included in Appendix X of the CCCF12 report4.

Other Issues 

Forward Work Plan For The Committee On Contaminants In Foods

CCCF12 tasked the Codex Alimentarius Commission’s, JECFA’s and the Host Country’s secretariats, with the assistance of the EU, to continue the work on the discussion paper to focus on whether the Committee has now covered all main staple foods subject to international trade and of public health concern.

Proposal for the development of general guidance on data analysis for ML development

Based on the request of JECFA to develop a general guidance on data analysis for ML development to avoid different approaches applied by the various EWGs, e.g. on the handling of occurrence data without information on limit of quantification of method used and therefore established a new EWG to prepare such a discussion paper for further consideration by CCCF13 in 2019.

Revision of the Code of Practice for the Prevention and Reduction of Lead Contamination in Foods

Upon a proposal from the USA, CCCF12 agreed to establish a new EWG to prepare a discussion paper including a project document for a proposal for new work on the revision of the existing Code of Practice for consideration by CCCF13 in 2019.

The aim of such revision would be to add new information on lead reduction strategies in the areas of (i) agricultural production (e.g. techniques to address lead contamination in soil and water) and (ii) food processing (e.g. filtration aids for juice manufacture, measures to reduce lead in foods during cooking, and minimizing introduction of lead from food processing equipment).

More details on CCCF12 working documents, CRDs are available on the webpage of the session at http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCCF&session=12  

CCCF12 full official report is to be available at http://www.fao.org/fao-who-codexalimentarius/meetings/en/

 


[1]     CCCF does not regulate any specific or overall migration limit(s) for any chemical used as a technical ingredient in food contact materials (themselves largely unregulated at the Codex Alimentarius level), but this may change at one point in time in the future.

[3]     CCMAS is the Codex Alimentarius Committee on Methods of Analysis and Sampling. Next CCMAS webpage is available at http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCMAS&session=39

Forthcoming 12th session of the Codex alimentarius Committee on Contaminants and Toxins in Food (12-16 March 2018, Utrecht, The Netherlands) –  Many limits are expected to be lowered for heavy metals in several food categories and various discussions are foreseen on industrial and environmental contaminants and related codes of practices for their reduction, and the committee is to explore a new approach about low levels of  contamination of the food chain with various chemicals.

World Food Regulation Review, Vol. 27, Number 9, February 2018 — The forthcoming 12th meeting of the Codex Alimentarius Committee on Contaminants (and Toxins) in Foods (CCCF12) has a loaded agenda, including the adoption of new and revised maximum tolerable levels for contaminants and toxins, such as lead, cadmium, methyl mercury, total aflatoxins, and ochratoxin A in several foods. CCCF12 will also consider the adoption of two codes of practices concerning the reduction of (i) dioxins, PCB-like dioxins, and (ii) 3-MCPD and glycidyl esters in refined vegetable oils and derived products, especially in infant formulas. In addition, for the first time, CCCF12 will discuss a new guidance for risk analysis of the inadvertent low level presence of chemicals in food.

Furthermore, CCCF12 will review several discussion papers paving the way to continue working on other maximum levels (i.e. hydrocyanic acid, lead, aflatoxins and sterigmatocystin) as well as a code of practice for the prevention and reduction of cadmium in cocoa (beans). Last, CCCF12 will address possible actions, based on feedback from other Codex bodies, including the outcome of the last relevant FAO/WHO Joint Expert Meeting on Food Additives (JECFA).

______________________________

The 12th session of the Codex Alimentarius Committee on Contaminants (and Toxins) in foods (CCCF) will be held in Utrecht (The Netherlands) from 12 to 16 March 2018. CCCF is the Codex Alimentarius horizontal committee in charge of the update of the General Standard on Contaminants and Toxins in Foods and therefore one of the most important committees in establishing tolerable levels for environmentally and industrially-sourced contaminants in foods, as low as reasonably (i.e. technically and economically) achievable to ensure acceptable protection of consumer health while ensuring fair practices in international trade of such foods4.

CCCF12 will take important decisions on regulatory limits for foods in international trade of lead, cadmium, methyl mercury, aflatoxins, ochratoxin A

  • Lead

CCCF12 will consider the inclusion into the Codex Alimentarius General Standard in Contaminants and Toxins in Food (GSCTF)5 of new maximum tolerable limits (MLs) of lead in several foods: (a) lowering the ML for (i) grape juice from 0.05 mg/kg to 0.04 mg/kg (20% reduction), (ii) processed tomato concentrates from 1.5 mg/kg (currently 0.05 mg/kg at Step 5) to 0.08 mg/kg (about 47% reduction), (iii) mango chutney from 1 mg/kg to 0.3 mg/kg (70% reduction), (iv) wine from 0.2 mg/kg to 0.05 mg/kg (75% reduction), (v) food grade salt from 2 mg/kg to 1 mg/kg (50% reduction), (vi) fat spreads and blended spreads from 0.1 mg/kg to 0.04 mg/kg (60% reduction), (vii) edible fats and oils from 0.1 mg/kg to 0.07 mg/kg (30% reduction); and (b) to include canned brassica vegetables in the canned vegetables category with a ML of 0.1 mg/kg; and, (c) establishing an ML for fresh farmed mushrooms [common mushrooms (Agaricus bisporous), shiitake mushrooms (Lentinula edodes), and oyster mushrooms (Pleurotus)] of 0.2 mg/kg.

  • Cadmium

CCCF12 will also review various proposals for establishing maximum tolerable levels (MLs) for Cadmium in chocolate products and other cocoa products. Suggested levels range from 0.40 to 1.00 microgram per kilogram (µg/kg or ppb) in chocolate products, from 0.4 to 1.2 µg/kg in dry mixtures of cocoa and sugars, and 0.4 µg/kg in cocoa powder intended for the final consumer. Note that the number of significant figures after the comma for each level is very important in terms of methods of analysis robustness. Those MLs are meant to be applicable to both the GSCTF standard and Codex commodity standards regulating these foods.

  • Methyl mercury in fish including associated sampling plans

CCCF12 will reconsider the recommendations from an inter-session electronic working group (EWG) to adopt specific revised MLs for methyl mercury in fish – by far the primary source of methyl mercury responsible for the neurological Chisso-Minamata syndrome. The EWG recommends two different bases for the establishment of such MLs in various carnivore fish species (as these fishes are at the top of the food chain in oceans and are most likely to concentrate the highest levels of methyl mercury): either on the 95th percentile or on the immediate next higher amount leading to less than 5% rejection of lots. The two different bases though lead to quite negligible differences in the suggested ML values (thereafter the suggested levels are reported as [P95]/[<5%], as follows: (a) 1.1/1.2 mg/kg (i.e. ppm) for all tunas or 1.3/1.4 mg/kg for Bigeye and Bluefin tunas and 0.7/0.8 mg/kg for tuna other than Bigeye and Bluefin; (b) 1.5/1.5 mg/kg for Alfonsino, (c) 1.6/1.7 mg/kg for Marlin or 4.5/4.6 mg/kg for Marlin (based on Blue marlin, unspecified), (d) 0.7/0.8 mg/kg or no ML at all for Amberjack; (e) 1.5/1.6 mg/kg for Sharks; and, (f) 2.3/2.4 mg/kg for Swordfish. The working document also describes the associated sampling plans which are fundamental in terms on how the analytical results are obtained and compared to the future MLs.

  • Total aflatoxins limit in ready-to-eat peanuts and associated sampling plan

CCCF12 will again review this long-standing and contentious issue on the CCCF agenda. An inter-session EWG led by India recommends the adoption of an ML for total aflatoxins of 10 micrograms per kilogram (µg/kg or ppb) in ready-to-eat peanuts for the final consumer. This proposed maximum limit value remains a very sensitive issue for ready-to-eat peanuts producing countries, as various climate and prophylactic conditions may lead to different capacities to prevent growers from limiting the developments of the moulds producing those aflatoxins and matching that suggested limit (especially the B1 type, one of the most carcinogenic aflatoxins for human liver, especially for the vulnerable group of humans carrying hepatitis B virus). The other source of tension is linked to different limits set at national levels. Most of the producing countries (but not all and that’s where the competitive advantage may well be) are not ready to accept a lower level for total aflatoxins in ready-to-eat peanuts in the Codex Alimentarius, as it may force those countries to subsequently lower their national regulatory maximum level (this is a WTO/SPS issue, as for all contaminants) and put an extra-burden on their national producers wishing to export on the global market. Future will tell whether any compromise may be reached out on this economically very sensitive issue.

  • Total Aflatoxins and Ochratoxin Alimits in some culinary herbs and spices

CCCF12 is to review the recommendations of the inter-session EWG led by India on limits in Nutmeg, Chili and Paprika, Ginger, Pepper and Turmeric for (a) total aflatoxins at 20 or 30 micrograms per kilogram (µg/kg or ppb), whereby those values seem still open for negotiation and for (b) Ochratoxin Aat 20 µg/kg, where that value is a firm recommended level by the EWG. This is related also to the role of India as the host (and chairing) country of the Codex Committee on Culinary Herbs and Spices, developing vertical Codex commodity/food standards on these foods.

Codes of practices for the reduction of the presence of industrial or environmental contaminants
In addition, CCCF12 is exploring ways to develop two new Codex Codes of Practice for the prevention and reduction of the contamination of the food chain by substances, coming either from environmental sources (such as dioxins) or neo-formed chemicals during processing (such as 3-MCPD and refining of vegetable oils). The development of such codes may be a valuable risk management alternative to establishing maximum tolerable levels. These codes are also necessary complementary tools useful to comply with already existing and any future possible maximum tolerable levels.

  • Dioxins, PCB-like dioxins (DL-PCB), non-PCB dioxin like substances (NDL-PCB)

The working document is not yet available at the time of going to press. However, CCCF12 is going to review the recommendations of an inter-session EWG led by the European Union to update the existing recommended practices to prevent the contamination of the food chain with Dioxins and PCB-like dioxins. The document is expected to add new mitigation measures related to e.g. cooking practice and carry-over from feed to food, and to add new measures to those already detailed in the discussion paper discussed at the 11th session of CCCF. Those measures did include the following recommendations (quoted from CCCF11 corresponding working document):

(a) Inclusion of the outcome of the risk assessment performed by JECFA80 in 2015 on NDL-PCBs toxicity as well as the provisions derived from the Stockholm Convention related to PCBs under source directed measures.

(b) Reducing measures applicable to DL-PCBs also applicable to NDL-PCBs.

(c) If necessary, completion of the Code of Practice for the Prevention and Reduction of Dioxin and Dioxin-like PCB Contamination in Food and Feeds (CAC/RCP 62-2006) with specific measures for the prevention and reduction of NDL-PCBs in feed and food.

(d) Inclusion of information on specific analytical methods/requirements for NDL-PCBs.

(e) Inclusion of specific recommendations provided on (direct) drying techniques and traceability of the supply chain of fats and oils as experience has shown that these sources could result in unacceptable levels of dioxins and PCBs in feed and food.

(f) Inclusion of relevant recent information on the carry-over of dioxins and PCBs from feed into food of animal origin.

(g) Inclusion of cooking practices reducing the presence of dioxins and PCBs in food.

  • 3-MCPDE and Glycidyl esters in refined vegetable oils and their products thereof, with special focus on infant formulas.

CCCF12 will consider a series of mitigation measures developed by the edible vegetable oil industry in the past few years to minimize the presence of 3-MCPDE and glycidyl esters of fatty acids, which were recently further evaluated by the European Food Safety Authority6 .

The working document was elaborated by an inter-session EWG led by the USA and co-chaired by the EU and Malaysia. It contains the full text of a possible Codex Code of Practice which covers better agricultural practices, sourcing recommendations about raw edible oils, the processing and refining of such edible oils, and other recommendations for the controlled use of carefully selected fats and oils in infant formulas. The draft Code of Practice also includes two specific annexes, describing in detail the various mitigation measures for each important key steps of the oil refining processing and the adaptation thereof to each type of oil and fat manufacturing plant. It has yet to be seen how far the CCCF12 may review the document (in part, fully, or not at all due to lack of time). The recommendations for infant formulas primarily emphasize the need to select carefully edible oils not containing 3-MCPDE and glycidyl esters of fatty acids or in minimized amounts.

Proposed draft guidelines to define the risk analysis principles about the inadvertent low level presence of chemicals in foods: is it a way to change the paradigm of zero tolerance on presence of banned chemicals? Or a confession of a lack of capacity to control certain pollutants already in the food chain? Or simply to challenge the “below limit of analytical detection (LOD)” going lower and lower with analytical methods improvements? or a way to cover up or smoothen anything else not laid out clearly yet in the paper?
The working document contains a complete first draft of the future guidelines for risk analysis of chemicals inadvertently present in food at low levels. This text has been developed by an inter-session EWG led by New Zealand and the Netherlands. CCCF12 will consider (a) the establishment of a definition of an emerging contaminant, (b) the use of a cut-off value as an initial risk management step (i.e. a kind of alert guidance level triggering action), (c) internationally agreed rapid risk assessment methodology to be used by countries, (d) the exclusion of feed from the proposed draft guidelines scope, (e) the request to JECFA to propose appropriate cut-off values and specific questions for those risk assessment experts and (f) the definition of the role JECFA may play in the identification and review of the above-mentioned rapid risk assessment methodology.

As laid out into the working document, these guidelines are triggered by scientific progress on the automatic lowering of the limit of detection of analytical methods subject to constant technical improvements. These progresses in analytical chemistry have accelerated in the recent past in such a way that now presence of chemical residues and other chemicals can be demonstrated in the food supply chain at very low levels. These improved analytical methodologies may then show the presence of substances undesirable in the food chain, at much lower levels than the established (national, regional or international) regulatory limits or identify their presence whereas previously they were considered as “absent” with older methods having higher LODs.

The working document is emphasizing the concept of Threshold of Toxicological Concerns as a primary screening tool. It provides for several interesting examples of chemical types which may fall under the definition of emerging contaminant: e.g. (i) Greenhouse gas mitigation technology such as chemicals used to address specific environmental and climate change-related issues, including agriculture nitrification and urease inhibitors, which have not been anticipated to be present in food; (ii) Emerging contaminants from materials used during processing of food such as non-regulated packaging materials and printing inks; or oils/lubricants/resins used as manufacturing maintenance compounds; (iii) Emerging natural toxins such as newly characterised mycotoxins or food crop phytotoxins; (iv) Environmental contaminants such as corrosion inhibitors, flame retardants and musks/fragrances.

These draft guidelines may pave the way to address issues not covered by any specific Codex Committee regulations, such as issues related to food contact material migrations to food, presence of microplastics, wide spread mineral hydrocarbons from environmental or industrial sources, e.g. used as free-flow and anti-dust agent on grains crops in storage silos, ports, etc…). But these guidelines may also be relevant beyond the “contaminant” scope as it may cover the presence of residues of undesirable veterinary drugs, pesticide residues, or genetically modified transformation event at the level of traces as well. The document can be summarized with the decision-tree included in the Annex 1 of the proposed draft guidelines, reproduced in Figure 1, below.

For sure, this agenda item will constitute an important piece of the CCCF12 outcomes.

 Discussion papers on possible new work

  • Hydrocyanic acid and mycotoxins in cassava and products thereof

The discussion paper was not available at the time of going to press. This paper will review the recommendations of the inter-session EWG led by Nigeria regarding the need for including a specific maximum tolerance limit for hydrocyanic acid in cassava and products derived thereof (i.e. fermented cassava products and cassava flour) into the Codex GSCTF. Regarding mycotoxins in cassava and derived products thereof, the discussion paper will present the data available on the levels of presence of these mycotoxins throughout Africa so that CCCF12 may assess the level of risks and provide some guidance back to the Codex FAO/WHO Regional Coordinating Committee for Africa.

  • Other Lead limits

The final working document was also not available at the time of going to press of this article. This paper was prepared by an inter-session EWG led by Brazil to make priority recommendations to CCCF12 to develop new maximum tolerable levels to a wider scope of foods. However, based on the second-round draft document, it seemed clear that the intent is to cover a much wider scope of food products where maximum tolerable limits may be recommended as new work.

This discussion paper indicates a total shift in the paradigm for regulating lead limits in the food chain. For decades, the approach favored by CCCF and national regulators has been to focus on those foods contributing the most to the dietary exposure of lead, while the discussion paper aims at a code of practice for the reduction and prevention suggesting lead limit in a much wider range of foods, some of them arguably contributing insignificantly to lead dietary exposure.

The discussion paper suggests several prioritization criteria for approval by CCCF12. Based on those criteria, Brazil-led EWG recommends the tiered-approach for the development of new maximum tolerable levels for lead in three groups of food categories as follows (the presenting order also seems to matter)

High priority group: (i) cereal-based food for infants and young children; (ii) fruit juice and herbal tea for infants and young children; (iii) canned baby food, (iv) tea and herbs/fruits for infusions, (v) food supplements, (vi) Cocoa and cocoa products, (vii) seafood (except fish), (viii) dried fruits, (ix) processed fish.

Intermediate priority group: (i) eggs, (ii) algae and seaweeds, (iii) nuts and oilseeds, (iv) sugar and confectionery (excluding cocoa), (v) flours and starches, (vi) dried vegetables, (vii) spices and aromatic herbs (to be likely addressed jointly with the CCCHS), (viii) alcoholic beverages (except wine), (ix) coffee and coffee-based beverages.

Low priority group: (i) stalk vegetables, (ii) vegetable juice (likely to be addressed jointly with CCPFV), (iii) ice cream, and (iv) non-alcoholic beverages.

The discussion paper calls upon Codex Members to submit more data of lead occurrences in the above prioritized food categories to feed the WHO GEMS/Foods database. It also calls for Codex Members to flag up any other food category which may be relevant to be added to the priority lists based on data to be communicated to WHO (and FAO).

  • Aflatoxins and sterigmatocystin in cereals

The working document includes a project document for consideration by CCCF12 suggesting the development of specific maximum presence levels for aflatoxins (including aflatoxin B1) and sterigmatocystin, for e.g. sorghum, rice and wheat and their derived products thereof. More specifically, the discussion paper recommends to CCCF12 to develop (a) a maximum tolerable level for aflatoxins in cereal, cereal-based products and food for infants and small children; (b) specific maximum tolerable levels for other cereal food groups if data available at the time show it is essential to do so; (c) encourage standards development organizations to provide a validated method of analysis for sterigmatocystin; and, (d) discuss whether there are specific management practices for sterigmatocystin in cereals, intended to be included as an annex to the revised Code of practice for the prevention and reduction of mycotoxin contamination in cereals.

  • Prevention and reduction of cadmium in cocoa (beans)

An inter-session EWG led by Peru to revise the discussion paper on the development of a Code of Practice for the prevention and reduction of the presence of cadmium in cocoa and in cocoa-derived products. The code of practice aims at focusing primarily on good agriculture practices and identification of potential sources of cadmium, both naturally present in soils where cocoa plantations are located or due to industrial pollution. The discussion paper emphasizes the need to cost-benefit assessment before implementing any stringent risk management measures. The discussion paper insists also on accompanying the training of cocoa farmers, growers, collectors and traders to the issue of Cadmium. It insists on a progressive implementation of any available mitigation measure and further research on other possible mitigation measures. The discussion paper flags up the need to improve primary production and processing, in improving infrastructures and equipment used for the fermentation and the drying process with modules adapted to tropical environment conditions. The lack of laboratories officially accredited for cadmium testing is also underlined as a limiting factor for the good implementation of mitigation measures. CCCF12 is invited to consider a process whereby it would regularly survey validated best practices (i.e. “on farm assessments that gave good results and were profitable”) to improve the discussion on the future Codex Code of Practice, and ideally conduct such a preliminary survey prior to starting a new work on developing such a Code of Practice. It is expected that the guidelines and research on mitigation measures performed by the Food And Agriculture Organization of the United Nations (FAO) would be a great help in that regard.

CCCF12 to endorse provisions for contaminants included in Codex food standards elaborated by Codex Commodity Committees
CCCF12 is asked to respond to the Codex Alimentarius Commission on whether the maximum tolerable levels for the contaminants regulated in the Codex GSCTF applicable to cereals do or do not apply to Quinoa (as Quinoa is subject to a Codex commodity standard) and if not, what levels would apply then.

CCCF12 Priorities for future work of JECFA on contaminants
The CCCF12 will reconvene an in-session working group to discuss a list of further priorities for JECFA review and what type of work to be carried out. For example, CCCF11 last year asked JECFA to proceed to full evaluations of (i) dioxins, (ii) arsenic (inorganic), (iii) scopoletin (in relation to Noni Juice consumption), (iv) ergot alkaloids, (v) ciguatoxins, and (vi) an updated risk assessment, including exposure assessment, of mycotoxins trichothecenes (T2 and HT2).

More details on CCCF12 are available on the webpage of the session at www.fao.org/fao-who-codexalimentarius/meetings/detail/ en/?meeting=CCCF&session=12
More details about CCCF12 outcome will be present in WFRR’s March issue.

 

1 JECFA is the international risk assessment body dealing with contaminants and toxins (as well as veterinary drugs residues) in foods, in addition to food additives, but with different experts and meetings.

2 Food Engineer, Regulatory and Scientific Counsellor at Keller and Heckman LLP.

3 Food Law Attorney & Partner at Keller and Heckman LLP.

4 Neither CCCF nor CCFA regulate any specific and overall migration limit for any chemical used as technical ingredient in food contact materials (themselves largely unregulated at the Codex level). This has been a void area of work at the international level, and by the Codex alimentarius Commission, up to now.

5 See latest version of the GSCTF (i.e. CODEX STAN 193) at http://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252 Fsites%252Fcodex%252FStandards%252FCODEX%2BSTAN%2B193-1995%252FCXS_193e.pdf

6 EFSA opinion on MCPD and Glycidyl esters of fatty acids published in March 2016 and corrected in January 2018 available at https://www.efsa.europa.eu/en/efsajournal/pub/4426. EFSA also published in January 2018 a new risk assessment of these neo-formed chemicals, adopted in November 2017 and available at https://www.efsa.europa.eu/en/efsajournal/pub/5083

 

World Food Regulation ReviewVol. 27, Number 9February 2018 — 

The forthcoming 50th meeting of the Codex Alimentarius Committee on Food Additives (CCFA50) is expected to make significant progress in reducing the backlog on food additives other than sweeteners and colours, but will also discuss important changes to the ways the Committee is working to move towards a “CCFA 2.0”.

The meeting will also address the important suggested enhanced alignment of the food additive provisions included in the Codex General Standard on Food Additives (GSFA) with vertical food standards on fish and fishery products and is expected to continue that fundamental work on other standardized foods. CCFA50 will also address the regular points on its agenda regarding actions of other Codex bodies, the FAO/WHO Joint Expert Meeting on Food Additives (JECFA), revisions to the class names and international numbering system for food additives, and assignment of new priority items for review by JECFA.

The contentious issue on “Note 161” is back on the agenda of this CCFA meeting, but really is it an real issue? This article explores the views and forces in presence and tries to put the future discussion into perspective.
____________________________________________

The 50th session of the Codex Alimentarius Committee on Food Additives will be held in Xiamen (China) from 26 to 30 March 2018, preceded by an important pre-session working group in person (PWG) to advance recommendations to the CCFA50 plenary. These will especially include recommendations regarding the draft pending provisions discussed since last year by an electronic working group on GSFA and proposals on new or revised-adopted provisions. The session will celebrate the 50th anniversary of the CCFA. It will also be marked by a landmark leadership change as its historical chairman, the honourable Pr Junshi Chen3 , will pass on the relay to his talented protégé Dr Yongxiang Fan, who has already demonstrated the necessary skills as vice-chairperson at CCFA49 last year. Nostalgic “Codexians” already deeply regret the highly-recognized chairmanship of Pr Chen (one of the best in the Codex system to be frank) and all he has accomplished for the CCFA and the Codex Alimentarius standards in general in the past eleven years (and well before then); at the same time, newcoming “Codexians” already have great expectations about Dr Fan’s style and leadership.

CCFA50’s agenda Item 8 working document on Future Strategies, towards a “CCFA 2.0”: great hopes to see CCFA addressing differently outstanding issues and adopting new ways CCFA may operate to speed up new substances and provisions in the future and accelerating the completion of GSFA4

  • Relationship between CCFA and JECFA: speeding up the considerations of draft food additives provisions for inclusion, discussion and adoption into the GSFA, once JECFA safety evaluation has been completed to foster CCFA coping with food additive innovation

The working paper contains several recommendations to reduce the timespan between the final review of the safety of a given substance by JECFA and the consideration for final adoption by CCFA. Currently, there is no clear systematic guidance to the Committee as to when draft provisions may be discussed, once they are introduced at step two into the GSFA. That time-lapse varies from 3 up to 20 years. The proposals aim to minimize the time between the conclusions of the risk assessment performed by JECFA and the review by CCFA. By doing so, CCFA will be able to cope with food technology innovations found safe by JECFA and will ensure more secure planning for businesses intending to use new safe (and more naturally grown) food additives.

  • Way forward to address one of the most contentious issues in the past 10 years: the “Note 161” issue

Recommendation two is suggesting several pathways to reignite the sulfurous debate on Note 161, a note introduced to the GSFA more than 10 years ago. Note 161 aims at helping CCFA to adopt food additive provisions while recognising that countries may have some different views on how to implement such provisions at a national level. Note 161 refers to the principles for using food additives enshrined in the preamble of the GSFA, which applies at this moment to all food additive provisions included in and for inclusion into the GSFA.

Many countries are realising that referring to national authorities’ flexibility to implement Codex standards may impact their rights and obligations under the World Trade Organizations SPS and TBT Agreements. But it should be noted that the two are in fact disconnected. All Codex standards are in principle voluntary (i.e. country members of the Codex Alimentarius Commission have no obligation to implement Codex text, as this is non-binding international “soft law”). Nevertheless, it is an acceptable argument to consider that “additives” fall under the WTO SPS (for safety aspects) and TBT (for fair practices to consumers) and thus the issue of Note 161 is not solely a “Codex” issue.

The working document offers some pathways as a starting point for further discussion to consider whether this Note 161 glass is half-full or half-empty, or simply for recognising what any Codex text is. Note 161 may not be necessary at all, as it is simply repeating the nature of any Codex adopted provision. But its deletion from GSFA may be replaced by at least an overall common understanding about the next step “rules of the game” in future negotiations on pending provisions.

What food business operators fear the most from that discussion is to end up with some self-destructive battle (each opposing party may indeed stick to its own interpretation of Note 161). Food business operators do overall agree on one thing: CCFA should swiftly complete its work on GSFA and consider many 20+ year-old pending provisions, put on-hold for discussion because of more than 10 years of total misunderstanding – and probably mistrust – over the Note 161 genesis and ways it has been used by CCFA and its PWG on GSFA in the past. There too, there is hope that all new standard-making regulators in the various country delegations – bearing in mind the reasons for the recent failed attempt to resolve the issue of Note 161 to intense sweeteners – would lead to a more constructive and open-minded dialogue on the pending provisions for several colours. This includes natural colours which are desperately needed by food business operators for possible reformulation to serve consumer demand for “healthier” processed foods – whether real or perceived; that’s another debate – and for helping to ensure the Codex GSFAbecomes more and more an effective unique point of reference for global harmonization on food additives After all, examples of references to national and regional competent authorities added to the Codex commodity standards to deviate from them are legion (see WFRR Vol. 27, Number 7 issue, December 2017 – CCNFSDU39 Outcome – discussion on FUF composition) and relate to provisions with dual WTO SPS/TBT aspects embedded in them, and it does not create the same crispation. Future will tell but the “goodwill” to search for an agreeable solution(s) to all parties is going to be the key factor to gradually resolve the “Note 161” issue. But this will only be possible if those who have been putting oil on this fire would admit it may be in their best – long-run – interest to see this issue less passionately discussed.

  • Other recommendations to address more technical aspects of CCFA prioritization-setting process and suggest ways to modernize the INS

The working document also includes other recommendations to enhance the more automatic alignment of food additive provisions set by Codex Commodity Committees on food standards, together with the corresponding food categories de© Copyright 2018 Research Information Ltd. All rights reserved. ISSN 0963-4894 20 WORLD FOOD REGULATION REVIEW fined in the GSFA, and vice versa. It also suggests a scoring system to address emerging new issues, while advocating the status quo with the predominant role played by the chairs of the four key inter-session EWGs re-established at each CCFA session (i.e. on the (i) INS, (ii) Alignment, (iii) JECFA list of priorities and (iv) GSFA). More details will be provided in the next WFRR March 2018 issue.

Finally, it includes recommendations to address the presence in the international numbering systems (INS) of food additives which have never been reviewed by JECFA, or do not include draft provisions in the step process in GSFA, or both. These apparent discrepancies come predominantly from the genesis of the INS in the 1990s as a concatenation of lists of permitted food additives mainly in the EU, USA, Australia/New Zealand and Japan. It has yet to be determined to what extent those recommendations may lead to a comprehensive clean-up of the INS, i.e. the deletion those food additives never reviewed by JECFA and not yet in GSFA, and then subsequently may lead to the suppression of their permitted uses at national level, even in other countries than those at the origin of the INS. It might also result in a pledge to suppliers of these substances to take initiatives to have them reviewed – or reconsidered for review for a couple of them (e.g. paraffin) – by JECFA in the foreseeable future. Another issue may be addressed in the context of this thorough review of the INS, namely the role of a parent INS number versus sub-listed INS numbers such as (a) anthocyanins under INS 163, versus individual numberings of various botanical sources of anthocyanin extracts; (b) waxes, paraffin and petroleum oils under INS 905, etc.)

Pre-session PWG and recommendations on GSFA pending provisions already reviewed by an inter-session EWG on GSFA: the core work of CCFA to see significant outcome and progress this year
Like every year, the CCFA50 plenary will consider the recommendations for adopting, revoking, revising or further discussing GSFA provisions based on the work of the PWG on GSFA meeting on the Friday and Saturday before CCFA50. The PWG itself will review the recommendations resulting from the report of the inter-session EWG on GSFA, which included two rounds of discussions about the draft food additives provisions that CCFA49 assigned to it (see WFRR Vol. 26, Number 11, April 2017). Three main and landmark outputs (in terms of the number or importance) are expected this year:

  • Draft and proposed draft provisions in the GSFA regarding the second half of food categories (from fish products to prepared foods)5 ; this part constitutes the largest number of draft provisions still pending on the backlog of provisions on food additives other than sweeteners and colours (called sometimes “miscellaneous” food additives), with extra interpretative work on a specific note applicable to smoke fish;
  • Proposed draft provisions related to fluid milk (plain) with comments on the technological need for the specific additive, the specific type of food products within that food category where the food additive is used and the maximum level necessary to reach the function of stabilizer, including a specific review of technological purpose of trisodium citrate in fluid milk (plain) other than from cows and how GMP may be replaced with a numerical maximum level; Proposed draft provisions related to the recently created new food category on other fluid milk (plain)6 ;
  • Some provisions in food categories subject to standardized foods on processed fruits and vegetables and edible oils, as well as two food additives proposed for inclusion in Table 3 of the GSFA(i.e. GMP use unless otherwise regulated and not permitted) (i.e. lutein esters from Tagetes erecta and octenyl succinic acid (OSA)-modified gum arabic);
  • New provisions for inclusion at step 2 in the GSFA as draft provisions and proposed revisions of other provisions already approved in GSFA.

The CCFA50 plenary is also expected to review other aspects and provisions for possible adoption into GSFA, based on matters referred by other committees. It will discuss the revised discussion paper on nitrates and nitrites (raising more questions than suggesting solutions) as well as a new discussion paper drafted by the Russian Federation. That discussion paper is expected to be intensively debated because it is aiming at introducing new and variable principles (subject to interpretation) for the use of food additives in what is defined as “plain”, “fresh”, “untreated” and “processed”, while suggesting new definitions for “unprocessed food” (raw food or fresh food), “minimally processed (plain) foods” in contrast to “ultra-processed products”. It is likely that that discussion paper will be further discussed in 2019.

Other, more classic, CCFA discussion items (Alignment, INS, JECFA, Endorsement)

  • Alignment: very intense work performed by Australia chairing the inter-session EWG on Alignment

The CCFA50 plenary will review the future recommendations resulting from an expected in-session working group to be created at the start of CCFA50 plenary, itself based on the recommendations in the report of the inter-session electronic working group on Alignment chaired by Australia. These recommendations will aim at finalizing the complete alignment between the food additive provisions set in many Codex Alimentarius Commodity Standards on Fish and Fishery Products and those provisions included in the corresponding food categories in the GSFA (adopted and draft). Alignment is one of the most important consistency work undertaken by CCFA to ensure that in the long run, GSFA becomes the unique point of reference, including into all Codex Alimentarius Commodity/Food standards. For the moment, the dual system is a source of misinterpretation and similar discrepancies at national levels in case countries implement both those food standards and the GSFA, containing for the time being those inconsistencies.

  • Review of JECFA past work, current recommendations for CCFA consideration and CCFA decisions on next priorities of work for JECFA in the next two years

As usual, CCFA will review the outcome of the most recent JECFA meeting on food additives held in June 2017 and consider whether any action may be necessary. It is worth noting that JECFA has re-evaluated two colours (Brilliant Blue FCF and Fast Green FCF) and reaffirmed that both additives do not raise any safety concern in terms of dietary exposure. Meanwhile, JECFA is recommending that the Group ADI for all carotenoids may be re-evaluated in the light of the information provided about a new algal source of beta-carotene.

As part of a separate agenda item, CCFA50 will also consider the various revised and new specifications that JECFA considers as completed (i.e. named “Full”) for possible adoption as Codex revised of new specifications for food additives7 (e.g. silicon dioxide, sucrose esters of fatty acids, Tamarind seed polysaccharide, etc.). CCFA will also consider temporary specifications (named “tentative”), not yet finalized regarding certain substances under JECFA review (e.g. Yeast extracts containing mannoproteins, Oenological tannins, etc.).

  • CCFA50 to review proposed changes to the INS from the outcome of an inter-session EWG chaired by Iran and Belgium

As usual, CCFA50 will also review recommendations from an in-session PWG for be announced at the start of the plenary to review the proposed changes to the INS laid down in the report of the inter-session EWG on the INS8 . Among other things, it may include a new functional class for (a) propylene glycol as a carrier and two corresponding technological purposes, (b) mono- and di-glycerides of fatty acids, as glazing agent and surface-finishing agent, (c) gellan gum as a gelling agent and (d) DL-malic acid as a sequestrant.

At that occasion, CCFA50 in session PWG may also discuss whether it is time to distinguish the  source of a food additive (such as steviol glycosides) depending on its mode of production (by physical or chemical extraction and purification, by fermentation, by production with the help of genetically modified microorganisms, by chemical reaction synthesis, etc.), in the context of the INS. Therefore, it may also trigger questions on the JECFA specifications as well. For sure, any rushed decision into this matter may create a landmark precedent which may possibly lead to revisiting and requalifying other food additives, based on its production method (e.g. tartaric acid versus oenological tannins). This may be totally impact-less at the Codex Alimentarius level given that the INS is not viewed as relevant for labelling purposes – but only allocates a unique reference number to each food additive. However, it may directly influence the way food additives are required to be labelled at national or regional level where countries are using the INS for labelling purpose and even more impactful in those countries which imposes the INS number as a mandatory labelling provision based on the latest Codex INS list. It may also fuel – unintentionally – an undesirable debate on how Codex may revisit the labelling settlement reached on food or food ingredients obtained from recombinant DNA (after nearly 15 years of negotiations). INS and Class names are published once a year as CAC/GL 36 (CXG 36). See 2017 version at http://www.fao.org/fao-who-codexalimentarius/c odex-texts/guidelines/en/ It may also – and more likely – directly influence the way food additives are required to be labelled on marketed food’s lists of ingredients at national and/or regional level(s).

  • CCFA50 to endorse provisions for food additives adopted in Codex food standards elaborated by Codex Commodity Committees

The CCFA50 will review the various specific food additive (and processing aids) provisions for endorsement that the Codex Commodity Committees and Regional Coordinating Committees found technologically justified in the vertical food standards they have developed. As per its terms of reference, CCFA50 will review those provisions and possibly endorse them, so that the food additive section of those vertical standards would not impede any future publication or adoption of those food standards. So far, only the provisions for the Near East Regional Standard on Doogh and for the CCMMP Standard on Dairy Permeate Powders (developed by correspondence) are available for endorsement.

More details on CCFA50 are available on the webpage of the session at www.fao.org/fao-who-codexalimentarius/meetings/detail/ en/?meeting=CCFA&session=50

 

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

2 Food Law Attorney & Partner at Keller and Heckman LLP.

3 Pr Junshi Chen has been universally praised as an internationally and nationally well-known and respected expert on food additives – and more widely on food safety risk assessment and management – for decades and moreover as the Chairperson of the CCFA since 2007, when China became the host country of CCFA after the Netherlands and the split of former CCFAC into CCFA (food additives) and CCCF (contaminants).

4 The Codex GSFA is also known as CODEX STAN 192 (now CXS 192), and it is composed of a preamble, appendices, e.g. defining the hierarchic food categorizations system, and Tables 1 to 3 containing all adopted food additive provisions, as well as the list of Notes, specifying further conditions of use for such provisions.

5 With the exception of those additives provisions with technological functions of colour or sweetener, adipates, nitrites and nitrates, and the provisions related to grape wines.

6 With the exception of food additives provisions with the function of colour and sweetener.

7 For inclusion in a Codex standard called CAC/MISC 6. See the 2017 version at http://www.fao.org/fao-who-codexalimentarius/codex-texts/miscellaneous/en/. As such, CCFA does not develop its own specifications for food additives (and flavourings) but rather adopt those developed by JECFA.

8 Class Names and International Numbering System on Food Additives (including a unique number, list of functional classes and associated technological purposes)

Outcome of the last Codex alimentarius Committee setting standards in Nutrition and Food for Special Dietary Uses, including “baby foods” (5-9 December 2017; Berlin, Germany): the last CCNFSDU made significant progresses on the revision of the existing standard on follow up formula on its  compositional requirements and paved the way for new guidelines to regulate foods ready-to-use in case of severe malnutrition in emergency situations (i.e. RUTFs).  The committee also discussed the definition of Biofortification and pushed back to next year the possible future development of Codex-specific nutrition profiles.

The Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) (i) agreed upon and advanced important revised provisions of the Codex Standard on follow-up formulas on composition requirements and considered other amendments on labelling sections and the preamble for further discussion, including the first – and historical – request for scientific advice to the Food and Agriculture Organization (FAO)/World Health Organization WHO) Joint Expert Meetings on Nutrition (JEMNU) on nitrogen-to-protein factors (soy and milk only); (ii) revised a list of methods of analysis for testing amounts of three nutrients in infant formulas; (iii) sent back for redrafting a possible specific mechanism or framework on how CCNFSDU shall consider the technological justifications for food additives used in foods for infant and young children; (iv) reviewed half of the proposed draft guidelines on ready-to-use foods for nutritionally deprived people (i.e. RUTFs); (v) postponed by one more year the consideration of developing Codex guidelines on Nutrition Profiling System(s); (vi) amended the proposed draft definition of “biofortification”, while pointing out the term shall be revisited; (vii) agreed to consider next year possible future work on harmonized probiotic guidelines for use in foods, including food supplements; (viii) made significant progress on defining future conditions for making a “free” of fatty acids nutrition claim but postponed future decision by one year; (ix) sent back the proposed nutritional reference value (NRV) for EPA and DHA for more in-depth scientific review while expanding the scope in revising some sections to the Annex of the General Principles for establishing NRVs for the general population, and (x) adopted other decisions.

Four issues were added to the agenda: nutrition profiles, probiotics, methods of analysis for infant formulas, and a fourth one, conversion factors for soy and milk protein, discussed “on-the-side”, at the time of the discussion but separate from the “protein” section of the follow up formula for older infants.

The next CCNFSDU meeting will be held in December 2018 in Germany.

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