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Katia Merten-Lentz, partner resident in the Firm’s Brussels and Paris offices, is a leading practitioner in European food, feed, and agricultural law. Her practice also extends to Environmental Law, Biotechnologies (new breeding technologies) and Cosmetics Law.

Ms. Merten-Lentz assists clients throughout the food chain with issues ranging from marketing (food labeling, health and nutrition claims, organic labels etc.) to innovation (nanomaterials, genetically modified organisms, novel foods). She also helps clients in the food and feed area obtaining European authorization for new additives, enzymes and novel foods. 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.

Where does laboratory produced meat fit in the regulatory frameworks of the US and the European Union?

Meat produced in a laboratory is close to coming to market, raising questions about the regulatory hurdles the US and EU may put in place

Published 11 Dec 2018 at EU Food Law

ANALYSIS

On 16th November 2018, the US Department of Agriculture and the US Food and Drug Administration announced that they had reached an agreement on a joint regulatory framework on laboratory made, cultured meat, also called in vitro meat. The Agencies have not yet revealed which framework will apply to this new way of making meat, but their respective roles have been clarified, as Katia Merten-Lentz of international law firm, Keller & Heckman, reports.

Cultured meat, or in vitro meat, is a form of cellular agriculture allowing the growth of meat from animal cells. Over the last few years, the price of producing this meat has dropped drastically, raising the possibility of these meats hitting the market.

However, these developments have also raised questions about their regulatory status, safety and labelling issues.

The statement released by the USDA and the FDA in November is another step towards the setting up of a regulatory framework regarding in vitro meat. The agencies have decided to oversee jointly the production of in vitro meat , according to their regular competencies: the FDA will oversee the first stages regarding cell-culture technology, and USDA the production and labelling of in vitro-meat. The joint statement of USDA and FDA does not explain which regulatory status will be applied to lab meat. But this status – as well as labelling issues – will have to be settled before the meat is placed on the market.

 

Regulatory status and safety assessment of meat in vitro

The US and EU regulatory framework regarding meat in vitro will differ.Regarding the US, several hypotheses can be explored. The first important hurdle is that it is arguably difficult to consider that in vitro meat fits in the definition of “meat product” as defined in the Federal Meat Inspection Act (FMIA), since FMIA assumes a meat food product is derived from a carcass.

If FMIA is inapplicable to culture meat, the rules regarding conventional foods would probably apply, and the FDA’s Biotechnology Policy could provide some help  in analysing the status of cultured meat.

It is also possible that in vitro meat could be considered to be a food additive.

The current method for growing in vitro meat consists of using a cell culture medium or scaffold, which is a structure where the cells attach to in order to allow growth, and cellular growth factors.

As explained by the Food and Drug Law Institute , the FDA may consider that these substances are food additives, since they are intentionally added to a food.

If it is the case, they will have to be authorised, unless they meet the two so called GRAS criteria (generally recognized as safe) i.e.: there is a reasonable certainty of no harm; and the intended use of the substance in food must be recognised as safe by qualified experts based on publicly available scientific information (general recognition standard).

Moreover, the safety of the primary cells used would also have to be asserted, since they are genetically modified cell lines. This may pose a hurdle, as, according to the US Consumers Union, “these lines exhibit the characteristics of a cancerous cell”.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

Indeed, in vitro meat falls under a relevant category in the Novel Foods Regulation that explicitly refers to food produced from cell culture or tissue culture derived from animals.

In its answer to a parliamentary question on this topic in October, the European Commission confirmed that in vitro meat may fall in this category and must then be considered as a novel food.

In the EU, the regulatory status of in vitro meat has already been settled: it will have to be authorised as a novel food at the European level.

For being authorised as a novel food, the producers of in vitro meat will have to file an application which must include all relevant data.If the product is deemed safe after a scientific assessment by the European Food Safety Authority (EFSA), the Commission can enact a Regulation to authorise in vitro meat.  The Commission recently confirmed that no application for the authorisation of in vitro meat has been received so far.

Therefore, in vitro meat cannot yet be placed on the market, and any such meat would be seized by the authorities.

This is what happened in December 2017, when tasting experiments of cultured meat made by the company JUST were organized in the Netherlands, and the Dutch Safety Authority sealed the products to prevent them from being consumed.

Issues regarding labelling

The Novel Foods Regulation states that when novel foods are added to the Union list of authorized novel food, there can be requirements regarding labelling, in order to fully inform the consumer, for instance by describing the food or its composition. It is more than likely that specifications will be added for in vitro meat.

In any case the EU Regulation on Food Information to Consumers (also known as ‘the FIC Regulation’) will apply to in vitro meat once it is authorised, but its application may prove challenging.

For instance, there is an obligation to indicate on the label the denomination of a food, but there are unsolved issues regarding the denomination of in vitro meat.

Since this food is not on the market yet, there is no legal name and no customary name either. Many names already coexist (in vitro meat, cultured meat, clean meat, lab meat, etc.), and the choice of the name is quite touchy.

Since the FIC Regulation’s main objective is to ensure that fair, clear and precise information is provided to the consumers – for instance about the manufacturing or production method – it seems very likely that operators will have to ensure that the product name makes clear that the meat has been grown in a lab.

Moreover, in vitro meat does not comply with the current European definition of “meat”. According to the FIC Regulation, the definition of meat – for labelling purpose – is: ‘skeletal muscles of mammalian and bird species recognised as fit for human consumption with naturally included or adherent tissue (…)’.  In vitro meat neither consists of “skeletal muscles” (‘muscles under the voluntary control of the somatic nervous system’) nor of ‘naturally’ included or adherent tissues, so it would mean that the term ‘meat’ could not be used in the current state of the EU legislation.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

The exact same issue applies for the US as in vitro meat does not comply exactly with the definition of “meat food product” under FMIA. In the EU, there are also specific issues regarding the labelling of meat that will be difficult to apply to in vitro meat.

Several regulations make the indication of the country of origin or place of provenance of meat mandatory.  However, for in vitro meat, since there is no animal being born, reared or slaughtered, it will be virtually impossible to apply this disposition.

In the US, the public is given the opportunity to comment on the regulatory issues regarding lab meat until 26 December 2018. The expected statements that will follow from the public agencies will hopefully reveal for operators the first outlines for a regulatory framework for in vitro meat.

For the EU, probably only the submission of a novel food application to EFSA could start a process towards a regulatory framework.

Published 28 November 2018 at EG Policy and powered by EU Food Law.

 

In April 2018, the European Commission officially proposed a targeted revision of the General Food Law Regulation (EC 178/2002) to improve the transparency of scientific studies in the food safety area, writes Katia Merten-Lentz of international food law firm Keller & Heckman.

This proposal follows a European Citizens’ Initiative submitted in October 2017 focusing on pesticides and food safety.

However, the main principles of food safety in the EU, i.e. responsibility of the operator and traceability, will not be part of this revision.

The Commission recently explained in its answer to a parliamentary question that the current framework had resulted, globally, in positive outcomes and did not have to be amended for now.

 

Keeping the preventative approach

European food safety regulation is primarily based on a preventive approach, in which food business operators (FBOs) hold the primary legal responsibility for ensuring compliance with food law.

The legal framework results from two main instruments combined:

  • the General Food Law Regulation (GFL), which lays down the general principle that all operators in the supply chain may only place safe foods on the market; and
  • the EU Regulation (No 852/2004) on the hygiene of foodstuffs.

The EU Regulation on hygiene states that FBOs must implement a food safety management system, which prevents and reduces food-borne hazards, and which is based on the hazard analysis and critical control point (HACCP) principles.

These flexible principles are developed to enable operators to identify points during the production where potential hazards may occur (related to harmful microorganisms, chemical hazards, packaging or equipment quality, etc), analyse the probability of those hazards happening, and set up controls and corrective actions to tackle them, such as sampling the food to check microbiological criteria for instance.

The Regulation on hygiene also provides a set of rules on good hygiene practice, covering aspects like cleaning and disinfection, pest control, waste management, hygiene of the staff and transport.

Operators must also ensure that products comply with specific EU provisions on safety, such as the regulations setting up maximum levels for certain contaminants and residue levels of pesticides in food, beyond which a food may not be placed on the market.

If, despite the preventive measures, an unsafe product is placed on the market, the GFL Regulation provides for additional dispositions to protect the safety of consumers.

The GFL imposes general obligations on food business operators in terms of traceability, notification of food safety incidents and withdrawal and recall of unsafe food.

The obligation of ‘traceability’ means that the operator must be able to identify both their suppliers and customers through all stages of production, processing and distribution. Traceability is essential to facilitate withdrawal and recall of food.

Indeed, if an operator believes that a food that it has imported, manufactured or distributed is not in compliance with food safety requirements, he or she must withdraw it immediately, by removing it from the supply chain. If this product might have been already bought by consumers, it has to be recalled in addition. The FBO also has to notify the national authorities of the withdrawal as soon as possible.

When a serious health hazard is detected, the national authorities inform the European Commission and the other Member States via a platform called the Rapid Alert System for Food and Feed.  If deemed necessary, the Commission can adopt emergency measures – such as suspending the placing on the market of products – to mitigate the risks.

 

Reform on transparency of the risk assessments for food-related authorisations

After completing, in January 2018, the REFIT on the GFL Regulation, the Commission concluded that the core principles regarding risk analysis, primary responsibilities of FBO and traceability, have been successful in protecting public health.

However, the Commission noted a lack of trust from the citizens regarding transparency of risk analysis, particularly with regard to the authorisation dossiers.

While on the one hand the operators are responsible for the safety of the products they put on the market, on the other hand, the European Food Safety Authority (EFSA) plays a major part by assessing the dossiers submitted by operators seeking authorisation for novel foods, additives, plant protection products and food improvement agents.

The GFL Regulation lays down that EFSA’s assessment is primarily based on industry studies – therefore generated by the applicant. Moreover, EFSA is bound by strict confidentiality rules with regards to these studies. These elements have a negative impact on consumers’ trust. To tackle this issue, the Commission has made several proposals to ensure more transparency during the risk assessment process.

The reform proposes free access for citizens to all safety related information submitted by the industry, and the creation of an European Register of studies.

The proposal also includes consultation of stakeholders and public on studies submitted by the industry, as well as an increase in the EU member states’ involvement in EFSA. Finally, the Commission also wants to strengthen risk communication to citizens by promoting public awareness and better explaining scientific opinions.

The proposal is currently being examined by the European Parliament in first reading, and the main sticking point in the discussions relates to the level of confidentiality that must be granted to industry studies.

The first trilogues are expected late December and early January, which means that the reform will probably be adopted during the course of 2019, but certainly not under the current Parliament.

Food companies fail to agree on new nutrition label in Europe

Trials to highlight calories, fat, sugar and salt to be abandoned after two years

© The Financial Times Limited 2018

Five of the world’s biggest food companies have abandoned trials aimed at developing a new nutrition labelling scheme for Europe, dealing a blow to efforts to help consumers better understand what is in their food.

Coca-Cola, Mondelez, Nestlé, PepsiCo and Unilever have been working together for two years on an “Evolved Nutrition Label”, which would have replaced the monochrome labelling system in place in Europe.

The new label sought to use colours from red to green to indicate whether a portion of a given food was high in calories, fat, sugar or salt.

But after trials in several countries and consultation with academics and consumer groups, the companies could not gain consensus around the new portion-based, colour-based scheme, said Bart Vandewaetere, a Nestlé government affairs executive. […]

 

Click here to read full article and Katia’s expert opinion.

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 was published at Foodnavigator.com.

 

Edible insects are covered by the EU’s novel food regulation – but none have yet made it to the list of authorised novel foods. Legal experts from Keller and Heckman Katia Merten-Lentz and Caroline Commandeur weigh in on the the legal status of edible insects in Europe.

The importance of proteins in daily diet is now widely recognised across the world. At the same time, traditional animal sources of proteins like meat, containing all the nine essential amino acids necessary for the human diet, are becoming increasingly controversial, especially as a consequence of their big environmental footprint.

In this context, insect consumption could be an answer. Insects are complete proteins, comprising of all nine amino acids. They are also much more environmentally friendly than traditional meat production.

However, the marketing of edible insects within EU remained a sensitive issue for a long time. The legal gap on their status was only filled in 2015, with the adoption and update of the Novel Food Regulation, applicable since 2018.

 

Legal gap on insects’ status

In 1997, when the first Novel Food Regulation (EC) No 258/97 was adopted, it defined as ‘novel’ any food or food ingredient which had not been used for human consumption to a significant degree before 15 May 1997 and which fell under one of the categories listed by the regulation, including “food ingredients isolated from animals”.

However, it was silent regarding whole insects and ingredients from whole insects – such as whole insects flour, leading to diverging national interpretations on the legal status of these foods and ingredients.

For instance, the UK Food Standard Agency considered whole insects and their parts as not covered by Novel Food Regulation, while France, Spain and Sweden systematically considered insects, whichever their shape, as novel food requiring a pre-market authorization. The Belgium authorities adopted a tolerance policy in relation to ten insect species, and in Germany, no position was taken at federal level, leading to differentiated approaches among the different German ‘Länder’.

To fix and harmonize the legal status of edible insects across EU, the expanded definition of novel food since 2015 explicitly includes “food consisting of, isolated from or produced from animals or their parts” in the categories of food that may constitute a novel food. To dispel any doubts, recital 8 of the new novel food Regulation even states that “those categories should cover whole insects and their parts”.

Insects now clearly fall into the scope of the Novel Food Regulation, and for this reason must be specifically authorized and included in the Union list of authorized novel food, to be placed on the European market.

However, such list, established by Regulation (EU) No 2017/2470, does not contain any insects or food derived from such animals yet.

 

Transitional measures

The patchwork of legislation in Member States necessitated the introduction of transition arrangement to cover foods that had been legally sold prior to 2018.

Article 35(2) of Regulation (EU) No 2018/2283 details these transitional measures with respect to insects lawfully placed on the market before 1st January 2018 in Member States who previously permitted it such as Netherlands, UK, Finland or Denmark.

Such products may continue to be marketed until an Novel food authorization is granted in accordance with the new novel food rules. In other words, food business operators have to submit to the Commission either an application for authorization of a novel food (in accordance with articles 10 to 13 of the Novel Food Regulation), or a notification of a traditional food from a third country (as set out in articles 14 to 20 of the Novel Food Regulation).

There is a strict deadline for submitting their dossier: before 1 January 2019.

 

Strategic choice for applicants: notification and authorization procedure

Whether to seek approval via the authorization or notification procedure is an important strategic decision for food makers.

As insects are commonly part of the daily diet in other parts of the world and derived from primary production, they could theoretically fit with the definition of traditional foods from third country. If a food business operator is able to demonstrate a history of safe use for at least twenty-five years in a third country, he can opt for a simplified procedure of notification, instead of following the whole procedure of authorization.

However, this notification procedure does not prevent Member States and/or European Food Safety Authorities from making some duly reasoned safety objections to the placing on the market of the traditional food.

Taking into account recent EFSA’s publications on risk profile related to consumption of insects as food (2015) and for the house cricket (2018), which both highlighted the lack of data related to possible hazards when insects are used as food, this procedure is probably not suited for fast-track placing on the market of edible insects.

Moreover, the choice for this fast-track procedure would also prevent the applicant from requesting data protection, a possibility the standard authorization procedure normally offers.

To date, five novel foods applications regarding insects have been submitted to the European Commission: two species of crickets (acheta domesticus and gryllodes sigillatus), two types of mealworm (tenebrio molitor) and mealworm larvae products (alphitobius diaperinus).

None of EFSA’s scientific opinions on their safety have been published yet. However, the first two draft scientific opinions were discussed in early October 2018: it was considered that additional information from the applicant was needed to proceed with the scientific assessment of applications regarding dried mealworm.

In this context, even if the legal gap on their status was filled, insects will not be part of our European diet in the coming months.

This article is written by Katia Merten-Lentz and published at Food Manufacture

In a paper dated 6 September 2017, the European Commission (EC) stated that if IP rights – such as those for Protected Designation of Origin (PDO), Protected Geographical Indication (PGI), and Traditional Specialities Guaranteed (TSG) – were granted before Brexit, they should be enforceable in the EU and the UK afterwards. But to ensure recognition of these rights, the UK must put this legislation in place before the withdrawal date, and there is currently no UK legislation on PDO, PGI and TSG labels.

An official agreement regarding such marks has still to be reached. We also don’t know if applications made during the March 2019 and December 2020 transition will be protected.

The EC paper states that where applications have been submitted to an EU body before the withdrawal date and if the administrative procedure is ongoing on that date, applicants should be entitled to keep the benefit of any priority date in respect of such applications.

Marks from third countries can get EU protection, subject to agreement. If negotiations on this succeed and equivalent UK legislation is set up, there will be no need to reapply from scratch.

Companies should have  applied under current EU law before Brexit to have the best chance of securing such labels.

  • The Government has pledged to set up UK GI schemes and logos, compliant with World Trade Organisation rules, after Brexit. The 86 current EU GI holders would be included.

Veganism has soared in Europe over the past years but there is no legal definition either for “vegetarian” or “vegan” in EU law. Katia Merten-Lentz of international law firm, Keller & Heckman, looks at how regulatory clarity could come about.

03 october 2018

This article is written by Katia Merten-Lentz and published at EU Food Law

While there are no precise statistics on the number of vegans in Europe, it is estimated that 3.5 million British people and over 1.3 million Germans are now identifying themselves as such, as well as 5% of the French.

However, this increasing visibility of veganism in society contrasts with the slow pace of changes regarding the legal framework with respect to the labelling of vegan food.

Vegans try to avoid as much as possible all forms of exploitation of animals for food, clothing, or any other purpose.

In terms of food habits, it denotes the practice of staying clear from all products derived wholly or partly from animals. However, there is no legal definition of ‘vegetarian’ or ‘vegan’ in EU law, and as a result, there is no specific harmonised European legal framework for labelling vegan and vegetarian food either.

The Commission is supposed to adopt implementing acts on voluntary information related to the suitability of a food for vegetarians or vegans, but it recently stated that it will only start working on this issue in 2019. Setting up these definitions is sorely needed to ensure the validity of vegan claims and to provide for a better information of the consumer.

 

Absence of strict criteria regarding vegan food

As there is no specific dispositions on vegan or vegetarian food in EU law, the first issue regarding these labels is to determine which regulations apply to them.

Health claims and nutrition claims  are covered by an EU regulation. However, the indication ‘suitable for vegans’ on a product cannot fall within this regulation, since nutrition claims suggest or imply that a food has specific beneficial nutritional properties, which is not necessarily the case of vegan food.

This means that the general framework applies to vegan food, more specifically the provisions of Regulation 1169/2011 (also known as the “the FIC Regulation”) , which states that food information provided to the consumers must allow them to “make informed choices and to make safe use of food, with particular regard to health, economic, environmental, social and ethical considerations.” The main goal of this regulation is ensuring that the consumer is not mislead by the information provided on the labelling of products.

The FIC Regulation lays down the possibility of adding voluntary food information on the packaging , which means that operators can indicate on the product that it is vegan, if they respect some conditions.

The information must not be ambiguous nor confusing for the consumer, and must also be fair, particularly as to the composition and method of production . That is why the absence of a definition is problematic regarding vegan food. Due to the lack of harmonisation, private labels have multiplied, and they do not always set up the same criteria for a product to be labelled as “vegan”. Indeed, sometimes products are marketed as vegan or vegetarian while they used processing aids or additives obtained through processes involving animal products (For example xanthan gum, an additive, can be produced using a fermentation process involving whey, a dairy ingredient).

Moreover, some operators also indicate ‘vegan’ on the package while not even referring to a particular private label, therefore it is difficult for the consumer to know if the product was really obtained without any animal products.

On the other hand, the names of vegetarian and vegan food often refer to animal products – like “vegan milk” or “tofu steak” – while evidently not containing any milk or meat. This can be confusing for the consumers, and operators of the meat and dairy sectors have begun to complain about the use of these denominations.

Denominations of vegan products: the war regarding the name ‘steak’

In its judgement ‘TofuTown’ of 14 June 2017, the Court of Justice of the European Union considered that vegetal products cannot, in principle, be marketed under names such as ‘milk’, ‘cream ‘, ‘butter’, ‘cheese’, ‘yoghurt’, as EU law reserves these designations for animal products.

The Court expressly said that this helps protecting the consumers against any confusion as to the composition. It is thus now impossible to market a vegan product under the name ‘vegan cheese’ or ‘soya milk’.

The issue has never been raised before the Court regarding meat, but it has been brought up by members of the European Parliament. In May 2018, a MEP has asked the Commission what it was planning to do to prevent operators to use terms such as ‘meat’, ‘hamburger’ or ‘steak’ for referring to products that contain little or no meat.

The Commission replied that according to the FIC Regulation, food information shall not be misleading as to the nature and composition of the food, and that since term ‘meat’ was already defined in EU law , it could thus not be used for a product that does not contain any meat. However, the Commission did not say anything about fighting the use of other denominations.

Indeed, words like ‘nuggets’, ‘burger’, ‘steak’ or ‘sausage ’are not defined in EU law , so in principle they can be used for vegetal products as long as they do not mislead consumers about their nature and mode of production.

The Commission will not be able to stay silent on this issue for much longer because in an even more recent parliamentary question , Mara Bizzotto (ENF) asked if the Commission was considering granting special protection for sales denominations of meat-based products against the “growing unfair competition from vegetarian and vegan products which imitate their appearance and labelling”.

Ms Bizzotto stressed that more and more food products for vegetarians and vegans are marketed in such a way as to suggest that they are ‘substitutes’ for meat-based products, even though their ingredients and nutritional contents are completely different.

Therefore, it seems that the future discussions on the matter will have to determine if there is a real possibility of confusion in the mind of a consumers between a ‘soya steak’ and a normal beef steak.

The Commission has yet to reply to this latest parliamentary question, and its answer is becoming more and more necessary in order to harmonise this issue.

Indeed, Member States are starting to take the matter into their own hands, which could hinder the free movement of vegan products.

France recently passed an amendment to its agriculture bill that prohibits any product that is largely based on non-animal ingredients from being labelled like a traditional animal product. While the reform is not adopted yet, it is thus probable that names such as ‘vegetable steak’ or ‘soy sausage’ could be banned in French territory soon, making the need of a consensus at the EU level an even more pressing issue.

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/