51st Meeting of the Codex Alimentarius Committee on Food Additives (CCFA51) Finalizes Most of Its Backlog on Food Additives
They did it! During the last ten days of March 2019, about 350 food safety regulators from all over the world attended the 51st session of the Codex Alimentarius Committee on Food Additives (CCFA51) and found consensus on all issues on the session’s agenda, even faster than expected. The consensus included (i) the first colour provisions considered since 2011 and other GSFA provisions; (ii) the way forward on nitrites and nitrates; (iii) alternative notes to advance solutions on sweeteners by starting to phase out existing references to Note 161; clarification on parent names of food additives; (v) further alignment of the food additives provisions between the Codex Alimentarius General Standard for Food Additives (GSFA) and an impressive list of commodity standards; (vi) changes to the International Numbering System (INS); (vii) Codex Alimentarius-approved Joint FAO/WHO Expert Committee on Food Additives (JECFA) specifications; or the JECFA priority list. Here is an attempt to summarize what many delegates dared to describe as an “historical successful session”. “God speed” CCFA, for now, on and on!
The 51st session of the Codex Alimentarius Committee on Food Additives was held in Jinan (China, as the People’s Republic of China is the host country of CCFA) from 22 to 29 March 2019, preceded by two important pre-session working groups (PWG) to advance recommendations to the CCFA51 plenary. Both PWGs built on the recommendations from electronic working groups (EWG) respectively on (i) alignment between GSFA and several commodity standards and (ii) GSFA draft pending provisions. The CCFA51 also created two in-session Working Groups (inPWG) on the INS and JECFA priorities which also advanced recommendations that helped the plenary to find consensus. It demonstrates that Codex Alimentarius “working groups” in general do help Codex Committees to build consensus and take decisions in a more expeditious manner, at least this has been proven to be effective and efficient for the CCFA.
GSFA draft pending provisions: a giant step ahead drastically reducing the backlog, and more to come next year
Draft provisions for approval by CAC42 forthcoming July and inclusion in final GSFA 2019 version (inAppendix VI of CCFA51 report)
- Table 3: GMP additives
CCFA51 agreed to propose for adoption at the forthcoming Codex Alimentarius Commission session in July (CAC42) two new substances (i.e. Gum Ghatti (INS 419) and Tamarind seed polysaccharide (INS 437)) as food additives permitted according to GMP (Good manufacturing practice, i.e. quantum satis) levels in all food categories not listed in the Annex of Table 3 of the GSFA. For those food categories listed in the Annex of Table 3, industry can submit requests for new numerical uses for future inclusion in Table 1 and 2 by responding to the regular circular letter (by 15 January 2020) on new and revised uses. The two substances have also been added for permitted use at GMP in several Codex Alimentarius commodity standards (e.g. table olives (as a thickener only in table olives with stuffing), Bouillons and Consommés, Halwa Tehenia, Fermented Milks, Fat Spreads and Blended Spreads, Jams, Jellies and Marmalades, etc.)
- GSFA color provisions in some confectionery products
CCFA51 succeeded for the first time since 2011 to agree on all the proposed pending provisions for colors (including natural colors like curcumin, annatto extract, paprika extracts) in five food categories (i.e. hard candies, soft candies, nougats and marzipans, decorations, toppings and fillings, and chewing gum).
Some of those provisions were pending since 1999. CCFA51 followed most of the recommendations coming from the EWG on GSFA and made some marginal changes to increase some of the proposal levels often at the request of the delegation of India, willing to align GSFA levels to permitted uses in India in these food categories during the pre-session PWG on GSFA.
This CCFA51 consensus has proven totally wrong those commentators who believed – and have been heavily advocating – that there was an indefectible link between Note 161 and colors. Such link exists, but is nothing more than a statistical correlation due to the historical origin of note 161 and its use when some of those color provisions were discussed from 2005 to 2011. This CCFA51 constructive spirit on colors is paving the way for further progress on similar color provisions in other food categories for consideration next year by the committee (e.g. food supplements, non-alcoholic beverages, chocolate and cocoa products).
CCFA51 also decided to assign to the renewed EWG on GSFA an item on already adopted color provisions in the five food categories considered this year, where this time a note 161 is already allocated to such provisions. This item will serve as an-other “test case” for the CCFA community to see whether it is able to reach consensus to delete such a note by revising the current approved level in the GSFA or any other means through alternative note(s). It is primarily relating to adopted provisions for Iron Oxides (INS 172(i), (ii) and (iii)), Sunset Yellow FCF (INS 110), or Ponceau 4R (INS 124), among the five food categories reviewed this year.
The lack of approval of color provisions in the GSFA has been a source of difficulties in international trade of these confectionery products but also other foods. Countries having adopted the Codex Alimentarius GSFA by cross-reference, or aligning their national regulations or standards on the GSFA based on current version in force, considered products containing these colours as unlawful and refused containers at the border or even considered these products as a fraud. So, at least for these five confectionery food categories, the problem is going to be resolved once the CAC42 approves the CCFA51 advanced provisions and the GSFA (i.e. CXS 192) is republished in its 2019 version. How-ever, import control authorities at national level could try already to anticipate and, where legally feasible, offer flexibility by already smoothening border control rules and guidelines on products containing such colors.
- Fluid milk: the magic of notes
CCFA51 also found consensus on the very tricky question about the use of trisodium citrate (INS 331(iii)) in “fluid milk (plain)” at GMP level. It was only possible through the definition of strict conditions by the means of new notes stating it was (i) for use as emulsifier or stabilizer only, (ii) for use in UHT milk from non-bovine species, and (iii) for use in UHT milk from bovine species to compensate for citrate or calcium content to prevent sedimentation as a result of climatic conditions only.
CCFA51 also approved a series of natural gums (e.g. gellan gum) as well as pectin, polydextrose and potassium carbonate at GMP level in “other fluid milks”, with restrictions for use through notes (i) only as emulsifier or stabilizer and (ii) with the double exclusion of all fluid milks that are not vitamin or mineral fortified. The provision for propyl glycol alginate (INS 405) was put on hold and will be subject to a request for comments. Note also that sodium hydroxide is also proposed for approval at GMP level in “other fluid milks”, but with the specific exclusion of “lactose-reduced milks.
- Water-based flavoured drinks and coffee/tea-based ready-to-drink beverages: smoother than expected but…
CCFA51 followed to the letter the recommendation from the pre-session PWG on GSFA to allow polyglycerol esters of fatty acids (INS 475) at 5000 mg/kg on a “served to the consumer” basis. The other provisions for stearoyl lactylates were discontinued and the provision for dioctyl sodium sulfosuccinate (INS 480), which was subject to extensive debates at last year CCFA50, was sent to JECFA to review some exposure calculations performed according to the ‘Budget’ method. The EU and Russia reiterated their concerns about the low JECFA ADI of the substance and possible exceedance in terms of dietary exposure, but the CCFA51 atmosphere was much more constructive than last year discussions. Hence, CCFA51 moved forward.
The food additive propylene glycol (INS 1520) led to very interesting discussion for the provisions in three sub-food categories of food category 14.1.4. Water-based flavoured drinks, including “sport,” “energy,” or “electrolyte” drinks and particulated drinks. The proposal was to discuss maximum levels ranging from 3000 mg/kg to 200,000 mg/kg for use “as carrier only”. It revived the past intense debate that the CCFA had two to five years ago on secondary food additives (i.e. food additives used in preparations of food additives, flavorings and enzymes (when enzymes are food additives)), where CCFA concluded that secondary additive provisions should be addressed through specific notes. Many countries (Japan, Brazil, India, Australia) and the representative organization of producers (the International Council of Beverages Associations – ICBA) considered that those three provisions should be discontinued and be revisited when the CCFA considers any possible horizontal approach. The flavour industry representative organization (the International Organization of the Flavor Industry – IOFI) indicated that the issue was addressed properly in the Codex Alimentarius Guidelines for the Use of Flavourings (CXG 66-2008).
The EU and Russia noted several aspects why this use of propylene glycol should be regulated in GSFA such as exposure assessment and technolog-ical justifications. As a compromise, CCFA ple-nary agreed with the PWG recommendation to keep the provisions on hold. CCFA51 also agreed to revisit the issue at a later stage when conditions are again met for CCFA to discuss a dedicated “comprehensive approach” on food additives in “food additives” (i.e. in the Codex Alimentarius, flavorings are considered as “food additives”, un-like some jurisdictions like the EU and the UK).
CCFA51 also recalled the working definition of “secondary food additive” agreed five (5) years ago, as follows: “Secondary food additive means any food additive that: (i) is used in preparations of food additives, enzymes, flavourings, nutrients or sub-stances with physiological effect that are formulated particularly for commercial use; (ii) exerts a tech-nological function in those preparations (e.g. to facilitate their storage, standardisation, dispersion, dilution or dissolution); and (iii) does not have a technological function in the food in which those preparations have a function. The term does not in-clude processing aids which do not have any techno-logical function in the preparations or in the food in which the preparations have a function.”
- Other provisions about miscellaneous additives in all food categories
CCFA51 also had an easy job by just following the recommendations from the PWG to adopt pending provisions in all the proposed food categories. These provisions relate to emulsifiers or stabilizers (e.g. INS 470(i), 471, 472, 473, 473a, 474, 475, 491-495 in many food categories), acidity regulators or antioxidants (e.g. INS 334 tartaric acid in candies), or antioxidants (e.g. tocopherols in egg-based desserts), or flour treatment agent (i.e. calcium sulfate at GMP in flours).
Other provisions proposed for adoption, also as results of the “alignment process” both in GSFA and in Commodity Standards
- Mozzarella standard amended for high moisture content and use of preservatives and anticaking agent on their surface
The outcome of the work of the past EWG on GSFA served as the basis of the recommendation of the PWG on GSFA and the CCFA51 plenary decision without any discordance. This example may prove, to the CCGP or others, that working groups in Codex are not only useful, but they really help plenary meetings to save time which can be allocated to broader issues or strategic orientations of the work of the Committees. CCFA51 therefore concluded that the Codex Alimentarius Standard on Mozzarella (CXS 262, 2018 version) will be amended to allow preservatives to be used only in mozzarella with high moisture content not packaged in liquid and for surface treatment only, and anticaking agents in mozzarella with high moisture content which is shredded and/or diced only and for surface treatment only. Those types of mozzarella are commonly used as toppings on processed pizzas.
- Consequential changes to the work on alignment of Codex Commodity Standards with the GSFA and reversely (See Appendix V of CCFA51 report for specifics)
Alignment is one of the most important work pillars of CCFA. Indeed, Codex standardized foods have generally limited food additive uses defined. In the meantime, it often happens that the GSFA food categories are broader than the few foods subject to such a Codex Commodity Standard. Therefore, CCFA has been engaged for the past few years in a massive work of aligning provisions in commodity standards with the GSFA and ensuring that the GSFA in return does reflect the restrictions set in Commodity Standards. A lack of alignment is generally transposed at national level and leads to a lot of trade barriers and conflicts between the reading of the national horizontal legislation on food additives and the national food standards, given that the two regulatory areas are generally not governed by the same national control competent authorities. It poses also interpretative questions about the hierarchy of such conflicting national norms, especially by border inspection post officials and their delegated companies, responsible for compliance check (i.e. conformity assessment) of incoming consignments.
Based on a massive piece of work performed by Australia chairing an EWG in the past 12 months, and through the pre-digestive work of the pre-session PWG on Alignment, CCFA51 has adopted a huge set of changes to the corresponding food categories in GSFA to thirteen (13) standards on ripened cheeses (e.g. cheddar, edam, gouda, emmental, provolone, brie, camebert coulommiers, etc.) and GSFA food category 01.6.2, two (2) standards on sugars and honey, two (2) standards on natural mineral waters and bottled waters, three (3) standards on cereals and pulses (i.e. wheat flour; couscous; instant noodles) and three (3) standards on vegetable proteins, and a few amendments to notes to existing provisions for ascorbyl esters in baby food categories in the GSFA and the three corresponding commodity standards (responsible Codex Alimentarius committee is the active CCNFSDU). The alignment also amended the GSFA to exclude many food additives uses from the GSFA into Commodity Standards by the use of exclusion (or XS) notes, and also addresses the use of Table 3 GMP food additives, also with precising inclusions in tables attached to Part B of the Annex of Table 3 in the GSFA.
Consistent with the framework for further alignment, CCFA51 also agreed that the coming year EWG on alignment will develop guidance to CCFA and to all the Codex Commodity Committees to ad-dress how future divergence of the GSFA and the commodity standards could be avoided as the (active) Commodity Committees amend or develop new food additives provisions in such commodity standards. That EWG will also continue to work closely with IDF (International Dairy Federation) to finish the alignment work on nine (9) cheese and three (3) milk standards, as well as on ten (10) other standards (e.g. Edible Fats and Oils not Covered by Individual Standards, Olive Oils and Olive Pomace Oils, Named Vegetable Oils, Named Animal Fats, Fat Spreads and Blended Spreads, Fish Oils and three spices and herbs (Cumin, Dried Thyme, and Peppers)).
It seems that the Standard on Dairy Permeate Powders may have been forgotten in the final CCFA51 report list. It should be also noted that there are two active committees respectively in charge of fats and oils and spices and culinary herbs.The alignment work plan is scheduled to last until 2023 for those standards where there is no more an active commodity committee and the next expected batch will cover Codex standards on processed fruits and vegetables. CCFA51 also requested the CCNFSDU to start its alignment process with two (2) of the standards under its purview, i.e. CXS 181 on formula foods for use in weight control diets and CXS 203 on formula foods for use in very low energy diets for weight control.
Other issues related to the GSFA
- Parent categories for food additives with a JECFA’s “group ADI”
At the last CAC in July 2018, a request for clarification was put forward to CCFA to clarify the procedure by which the addition of a substance to a group of food additives with a “group” ADI set by JECFA and already permitted in GSFA, would automatically extend those approved uses to the new substance, without going through a review case by case (i.e. use level by use level).
Although the issue was raised in the context of “the inclusion of Rebaudioside A from multiple gene donors expressed in Yarrowia lipolytica (INS 960b(i)) in the GSFA”, the issue is of a general nature and was also relevant for (i) Sucroglycerides (INS 474), (ii) Sucrose esters of fatty acids (INS 473), and (iii) Sucro-oligosaccharides (SOE) of type I and II (INS 473a).
In response to the first question, CCFA51 noted that the CAC Procedural Manual provided specific considerations for the inclusion of individual food additives as group food additives in the GSFA. CCFA51 further clarified that in the future, when JECFA is to recommend to CCFA to include an additive in the GSFA, it shall be discussed under matters referred from FAO and WHO (including JECFA) to CCFA and that the decision of the CCFA will be captured both in the body of the re-port of the CCFA session as well as in the relevant Appendix.
CCFA51 also agreed that the Codex Secretariat is to update the compilation of food additives covered in the INS (upcoming 2019 versions of both CXG 36 and the online GSFA), already done for this session and for a discussion at CCFA52 in 2020.
With regard to the emulsifiers INS 474, 473, and 473a, the reestablished EWG on GSFA will be compiling all the adopted and draft provisions in the GSFA database for these three substances and circulating the compilation for comments. The EWG on GSFA will consider options for how to create a group heading for these three food additives.
- Possible new principles for the use of food additives in food categories with qualifiers such as “plain”, “fresh”, “unprocessed”, “untreated”
CCFA51 discussed briefly the discussion paper and its recommendations prepared and introduced by the Russian Federation. Kazakhstan, current host country of the Codex Committee for Europe and member of the Eurasian Customs Union (with Russia), supported the Russian Federation recommendation to develop a better definition of what may be regarded as “plain”, “unprocessed”, “fresh” or “untreated” foods in relation to food additive uses, as found in GSFA descriptors or commodity standards. The EU indicated that the issue may rather be the definition of strengthened criteria for the inclusion of new draft provisions for food additives, for example by amending the reply form to the circular letter requesting new uses once a year. The USA, supported by several other delegations (e.g. Australia, Brazil, Chile), pointed out the important role of Codex Commodity Committees in charge of some of those unprocessed foods in justifying the technological needs for food additives in standardized products. Russia somewhat acknowledged the US views on technological justifications from the Codex Committee on Fresh, Fruits and Vegetables, but also referred to food categories in the GSFA not subject to Codex Commodity Standards and active dedicated Committees.
The CAC Secretary made an attempt to elevate and broaden the debate on misleading the consumer, and food falsification or fraudulent practices linked to past misuse of food additives, by referring also to the previous failed attempt by Codex Alimentarius to define the claim “natural”. He suggested to refer CCFA51 discussion and the role of food additives, to the CAC, the CCFL or the CCGP (and he could also have added CCFICS on food fraud, but certainly he had this in mind as well).
However, based on Codex member interventions and acknowledging the lack of consensus, the CCFA51 Chair, supported by USA, Brazil, China, Australia, Chile, Thailand, Cameroon and to some extent the EU (i.e. on lack of consensus), concluded that the CCFA51 agreed to stop the work on this issue and on that discussion paper. The CCFA51 Chair thanked the Russian Federation for the quality of the information consolidated in the paper. It was interesting to note that this part of the CCFA51 draft report was one of the most amended parts during the report adoption session, which demonstrates the need for nuances and details, finally carefully reflected in the CCFA51 report.
- Nitrates and Nitrites
CCFA51 reviewed the outcome of an EWG led by the EU and the Netherlands and praised the quality of the well-balanced reporting of the diverging opinions on the various risk management measures on how nitrates and nitrites should be regulated when added to some foods as preservative, and all the scientific challenges which remain unresolved for the appropriate risk assessment of all sources of nitrates and nitrites in the diet, including potable tap water. Therefore, the discussion was held in two sequences, one on the need for further scientific advice from JECFA and how this advice could be better informed, and one on how risk management decisions could be reflected in the GSFA.
On risk assessment, CCFA51 agreed to task the Codex Alimentarius Secretariat and the JECFA secretariat to issue a circular letter to request countries to submit more general information on the availability of (i) occurrence data and/or dietary exposure assessment to nitrates and nitrites and (ii) surveys of natural occurrence levels and levels occurring from their use as food additives.
On risk management, the reestablished EWG on GSFA was tasked to circulate existing adopted and draft provisions for nitrites and nitrates to all Codex members for comment as well as the further input based on the information to be received in the context of the risk assessment circular letter, to suggest establishing both ingoing levels (i.e. levels added to foods as preservatives) and residue levels of nitrates and nitrites in foods for possible inclusion of all of them into the GSFA as draft provisions.
Special report on consensus found on Note 161 in the context of sweeteners: another win for this CCFA51
The topic of Note 161, referring to national legislation and the criteria for using food additives ac-cording to section 3.2. of the preamble of the GSFA has been one of the most high level contentious topics CCFA has been given to try to address in the past fifteen (15) years. When the CCFA last year decided to reactivate international discussions on alternative notes where the committee left the discussion unachieved in 2015, only a handful of people would have bet on the possibility for the CCFA to find any consensus.
The dedicated EWG on Note 161 which has worked since last year under the co-chairing of the USA and the EU has approached the negotiation in several phases. As perfectly presented by the delegate of the European Union during CCFA51, the first circular aimed at testing an alternative wording to Note 161 which would describe the variety of situations on how countries regulate the use of food additives used to replace sugars and confer a sweet taste to foods (i.e. functional class as “sweeteners”). The key contentious issues were the use of such “sweeteners” in (i) the whole category of the food products, (ii) in significantly energy-reduced and/or in foods with no added sugars. There was also a pending question about the cases where such a substance could also be used for other functional class and technological purposes as “flavour enhancer”, i.e. impact on sweet and/or flavor and taste release profiles.
The EU explained the diverging views which led to the second circular proposal which reinforced a proposal to establish specific provisions when the food additive is used as a flavor enhancer and also clarify that in such case, the conditions of significant energy reduction or no added sugars would not apply. The second circular offered options to address these aspects. There were diverging views on the level of prescription the proposed revised notes should be to address that issue and due to lack of time the EWG was not able to offer a third circular proposal.
The EU co-chair explained that the five recommendations suggested in the CCFA51 working document were the result of the two circulars and the comments submitted. They reflected the proposals from the two co-chairs, rather the final opinion of the EWG itself. The US co-chair added that these proposals for alternative notes in the context of sweeteners provisions were developed in a co-operative manner and provided a good compromise solution.
At that point in time, all participants in the CCFA51 plenary room were holding their breath: would the big battle start again? The suspense was cut short: it seems a lot of pre-plenary consultations among country delegations occurred, and all of the five recommendations were adopted by the CCFA51 plenary with a large level of consensus which was expressed by the large silence leading the CCFA51’s Chairperson to conclude that the committee agreed to:
(i) adopt the following two alternative replacement notes to Note 161:
- Note for provisions for additives with the function of sweetener but not the function of flavour enhancer:
“Some Codex members allow use of additives with sweetener function in all foods within this Food Category while others limit additives with sweetener function to those foods with significant energy reduction or no added sugars.”
- Note for provisions for additives with both sweetener and flavour enhancer functions:
“Some Codex members allow use of additives with sweetener function in all foods within this Food Category while others limit additives with sweetener function to those foods with significant energy reduction or no added sugars. This limita-tion may not apply to the appropriate use as a flavour enhancer.”
(ii) that the alternative notes be considered for both the adopted provisions and draft provisions and subject to the intended function of the additive (i.e. sweetener function only or sweetener and flavour enhancer functions).
As a consequence, CCFA51 agreed to review all the adopted and draft provisions for all “sweeteners” (and not only for aspartame, acesulfame K and the salt of aspartame-acesulfame) and apply the above notes instead of Note 161 currently attached to those provisions, depending on the nature of the technological purpose of those food additives (i.e. as a sweetener and/or as flavour enhancer).
The EU obtained that CCFA51 agreed to give special consideration to the use of “sweeteners” in (i) bread and ordinary bakery wares and mixes, (ii) seasonings and condiments, and (iii) vinegars. For those food categories, the EU believes in the absence of any technological justification for using sweeteners and also in risks of misleading the consumer, and is challenging any sweetener provision for those three food categories in the GSFA. The EU also obtained that a special focus is to be given to the use of (i) alitame in water-based flavoured drinks, including “sport,” “energy,” or “electrolyte” drinks and particulated drinks; (ii) saccharin and its salts for the same category and for coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa; and (iii) acesulfame K in general, due to the EU concerns that the adopted and draft maximum levels in the GSFA may raise dietary intake issues.
CCFA51 agreed also to adopt the following explanatory statement as the opinion of the CCFA: “The replacement notes provide information on the current use of sweeteners by Codex Members, and also provides information on the specific considerations of CCFA in adopting the provision. The proposed text does not place labelling requirements on food, nor put additional criteria on the use of sweeteners to that listed in Section 3.2 of the GSFA preamble, but rather provides information on where CCFA was able to reach consensus on the use of sweeteners within that criteria. Codex Members can take this information into account in determining the implementation of the provision at the national or regional level.”
Last but not least, CCFA51 agreed to reactivate the EWG on Note 161 to address specific cases where the replacement of Note 161 by the agreed alternative notes may require further consideration, either because they were not listed in the 2015 UK-led EWG report, or there are reservations expressed by the EU (as explained above), or those provisions may need to be revised, revoked or discontinued beyond the note 161 replacement discussion, or further discussion may be needed with regards to technological purposes (i.e. as “sweetener” and/or as “flavour enhancer”). The USA and the EU will continue to co-chair that EWG. The other aspects were assigned to the USA-led EWG on GSFA. CCFA51 finally agreed to exclude the chewing gum category from the scope of this EWG given that it would be addressed fully in the context of the EWG on GSFA, as reflected in the CCFA51 final report.
Heavy loaded mandate for the EWG on GSFA for the year to come
Based on all the discussions held at this session (e.g. endorsement, alignment, GSFA, Note 161), CCFA51 assigned the following mandate to a reestablished EWG on GSFA, still chaired by the USA, to consider:
- Replies from CCSCH on the technological justification for the use of anticaking agents where used in the powdered form of culinary herbs and that magnesium stearate (INS 470 (iii)) and amorphous silicon dioxide (INS 551) may be used in the powdered form and in accordance with GMP;
- Replies from CCFO26 on the technological justification for the use of emulsifiers in FC 02.1.2 of the GSFA;
- Draft and proposed draft provisions in Table 3 of the GSFA (which will include CCFA51 decisions on BMC as carrier and encapsulating agent, lutein from Tagetes erecta (INS 161b(i)), zeaxanthin (synthetic) (INS 161h(i)) as well as lecithin partially hydrolysed (INS322(ii)));
- Adopted provisions and provisions in the step process for sucrose esters of fatty acids (INS 473), sucrose oligoesters, type I and type II (INS 473a) and sucroglycerides (INS 474) in FCs 01.0 to 16.0 in the GSFA as a result of their group ADI and possibly create a group heading accordingly;
- Draft and proposed draft provisions in “Surface-treated fresh fruit” and “Surface-treated fresh vegetables, (including mushrooms, and fungi, roots and tubers, pulses and legumes (including soybeans), and aloe vera, seaweeds and nuts and seeds” for discussion on the technological justification for the use of additives as a glaze or in a glaze/coating or wax for surface treatment
- The provision for propylene glycol alginate (INS 405) in Other fluid milks (plain) for comment on the numeric use level;
- The provision for Magnesium carbonate (INS 504(i)) as a flour treatment agent in Flours and starches (including soybean powder);
- Provisions for nitrates (INS 251, 252) and nitrites (INS 249, 250) in step process or adopted (ingoing and residual use levels), where it was agreed that the EU would provide assistance to the USA on this topic;
- Adopted provisions for: alitame (INS 956) for discussion on actual use and use level; acesulfame potassium (INS 950) in Water-based flavoured drinks, including "sport," "energy," or "electrolyte" drinks and particulated drinks and Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa and saccharins (INS 954(i)-(iv)) in subcategories of Water-based flavoured drinks, including "sport," "energy," or "electrolyte" drinks and particulated drinks for discussion on use level;
- Draft and proposed draft provisions for sweeteners in several food categories listed in tables T, U, and Y of the 2015 UK-led EWG report with the exception of the three food categories mentioned by the EU where doubts were expressed on the technological need of sweeteners (i.e. bread, condiments, vinegars);
- Adopted provisions for colours in candies and chewing gum with Note 161 associated with them to consider options how replacing or deleting such references to the note 161;
- Adopted provisions for additives with the functional class of colours with Note 161 associated with them and draft and proposed draft provisions for additives with the functional class of colour, in chocolate and cocoa products, food supplements, and beverages and its subcategories (except FCs 14.1.2, 14.1.3, 14.2.3 and their subcategories); and
- Provisions entered into the step process as a result of CCFA51 decisions on new provisions for additives with technological function of colours and limited to provisions in confectionary products and its subcategories, food supplements, and beverages and its subcategories (except FCs 14.1.2, 14.1.3, 14.2.3 and their subcategories).
CCFA51 also approved the following “policy statement” as a result of an issue arising from discussions held in the context of the alignment working groups. CCFA51 agreed that the EWG on GSFA would consider consequential changes to food additive provisions in the GSFA, and relevant Commodity Committees should also consider consequential changes to their standards, whenever JECFA changes an ADI (whether numerical or ADI not specified or not allocated).
Technical (and underlying political) discussion on the GSFA online versus CXS 192 (the true and full GSFA), and overall management of the GSFA “database”
An interesting, although technical, discussion occurred on the current version of the GSFA placed online on the Codex Alimentarius website and the overall underlying GSFA database, versus the only official version of the GSFA published as the Codex Alimentarius General Standard on Food Additives (i.e. CXS 192, updated yearly). The CAC Secretary indicated that the current technology pertaining to the GSFA online does not allow the CAC Secretariat to implement the changes to the GSFA which are reflected in the CXS 192, especially with regards to the specific provisions in the Part B of the Annex to Table 3 of the GSFA with regard to the use of some GMP food additives in Commodity Standards. Behind those technicalities it was clear that the CAC Secretary wanted to raise other internal difficulties related to FAO-IT services and also question who is in charge of maintaining the overall database used for both the production of CXS 192 and the online GSFA database.
The Committee considered two options proposed by the CAC Secretary: (i) to implement the decisions of CCFA50 in the PDF version of CXS 192 now (which was feasible for the secretariat) and remove the online system to avoid any inconsistencies; or (ii) to grant the Codex Secretariat a further year to attempt finding a solution internally within the FAO. CCFA51 noted that for option (ii) the Secretariat would work with the FAO in-house IT department to create a realistic workplan for a more flexible GFSA system, allowing swift implementation of past and future CCFA decisions. Should such attempts to resolve the issue in-house fail, the Codex secretariat would make alternative proposals. CCFA51 stressed the urgent need to resolve these issues, underscoring the convenience and usefulness of the online version for countries and food business operators.
After several rounds of discussions involving the USA and EU delegations and the CAC Secretary, CCFA51 agreed to: (i) postpone the implementation of the CCFA50 decisions and a decision on the future of the GSFA online for another year to attempt to find a solution allowing to keep both the PDF and the online version of the GSFA; (ii) include this matter on the agenda of CCFA52 and request the Codex Secretariat report the progress on this matter in line with the discussion above; and (iii) bring the matter to the attention of the forthcoming Codex Alimentarius Executive Committee. In other words, “Whoever controls the information, controls the power”.To be continued...
Other CCFA “routine” issues (Endorsement, INS, JECFA priorities and specifications, other matters)
CCFA51 had some interesting discussions based on the discussions held during the pre-session PWG on endorsement/alignment. The question related to the proposed provisions of food additives used as anticaking agents in several commodity standards under developments by the Codex Alimentarius Committee on Spices and Culinary Herbs (CCSCH), and in particular whether these additives could be considered as processing aids (free-flow agents), and how CCSCH should ad-dress them. To cut a long and very technical story short, CCFA51 agreed to:
(i) amend the text for the food additive provisions in the SCH Standards as follows: “Anticaking agents listed in Table 3 of the General Standard for Food Additives (CXS 192-1995) are acceptable for use in powdered form of the foods con-forming to this standard.”
(ii) endorse in the food additive provisions in the pro-posed draft standards for dried or dehydrated garlic, dried oregano, dried leaves – dried basil, dried floral parts – dried cloves, and saffron; and
(iii) not endorse draft provisions in the proposed draft standard for dried roots, rhizomes and bulbs – dried or dehydrated ginger, noting that it was unclear whether the two substances (i.e. calcium oxide and sulphur dioxide) were food additives or processing aids and requested corresponding clarification from CCSCH.
CCFA51 also agreed to inform CCSCH, that when including processing aids in a commodity, a general reference should be made to the Guidelines on Substances used as Processing Aids (CXG 75, 2010 version).
Finally, on the question as to how CCFA could make a distinction whether the commodities belong to culinary herbs or spices, the Codex Alimentarius Secretariat clarified that CCSCH had developed a non-exhaustive list for these two groups; and that oregano and basil were listed under the culinary herbs while the remaining three commodities were listed under spices. It was proposed that in future such a differential approach is made when presenting standards for endorsement to the CCFA by the CCSCH.
Priority List of JECFA scientific advice to CCFA on food additives, flavourings and enzymes (specifics to be found in Appendix X of CCFA51 final report)
CCFA51 endorsed all the proposals for new work developed by an in-session WG on JECFA priorities. It will review the various requests received for revising the established list of JECFA priorities. Such request could deal with a full safety evaluation and establishment of specification (new or old substances) – generally highest priority, a change to existing specifications (e.g. a method of analysis) – generally lowest priority, or relate to existing pending requests already on the list and confirmation of dossier/data availability – generally normal priority.
New entries added by CCFA51 to the list relates to (i) azodicarbonamide (INS 927a) for safety evaluation; (ii) Sucroglycerides (INS 474), Sucrose esters of fatty acids (INS 473) and Sucrose oligoesters, type I and type II (INS 473a) for an exposure assessment (concerns expressed by the EU in relation to their use in chocolate products; (iii) ortho-Phenylphenol (INS 231) and sodium ortho-phenylphenol (INS 232) (high safety concerns) for a reevaluation of the ADI; (iv) nisin (INS234) and natamycin (INS 235) for a safety re-evaluation and a possible revision of specifications; (v) fulvic acid for a safety evaluation and establishment of specifications (new food additive proposed by South Africa); (vi) many new flavouring substances as per customary practice and promotion by IOFI.
It should be noted that for spirulina extract (INS 134), the June 2018 JECFA meeting assigned an ADI “not specified” but the specifications as “tentative” until further analytical data is provided. Data expected by JECFA by December 2019 relate to (a) full compositional characterization of commercial products in both liquid and powder forms; (b) full compositional characterization of the aqueous extract before formulation/standardization; (c) validated analytical methods for identification of the substance with a suitable specificity (including validation data and representative batch data); and,(d) validated analytical methods for the determination of the purity of the substance with a suitable specificity (including validation data and representative batch data).
It is worth noting that Appendix X of CCFA51 final report containing the JECFA priority list also contains a full table with a “waiting list” of enzymes (generally used as processing aids, not food additives) for their evaluation by JECFA. Responding to a question from ETA and AMFEP, the WHO JECFA secretariat representative indicated that the JECFA guidelines for the safety evaluation of enzyme preparations, under way since 2006, should be finalised soon enough to help future application dossiers and that JECFA was drafting up a dedicated work plan for an enzymes evaluation program.. The WHO JECFA Secretariat representative also announced important updates to the core WHO document for chemicals evaluation (known as EHC 240) with regard to (i) guidance on dose-response modelling and application of the benchmark-dose approach; (ii) more detailed guidance on the interpretation and evaluation of genotoxicity studies; (iii) the whole chapter on exposure assessment.
Codex approval as international norms of JECFA new and revised specifications of identity and purity (specifics in Appendix III of CCFA51 final report)
CCFA51 agreed to advance for final adoption as Codex standards and inclusion in CXM 6 (i.e. in the upcoming 2019 version), the specifications considered as fully developed (i.e. “Full”) by JECFA for (a) methacrylate copolymer, basic (BMC), (b) Cassia Gum, (c) Erythrosine, (d) Glycerol ester of wood rosin (INS 445(iii), (e) Indigotine; (f) Lutein from Tagetes erecta as well as several dozens of flavourings.
International number system and functional classes/technological purposes (specifics in Appendix IX of CCFA51 final report)
CCFA51 followed the recommendations of an in-session PWG on the INS, itself basing its recommendations on the outcome of the EWG on INS working since September 2018. There were reluctances from some parties to delete references to some food additives given the inventory nature of the INS list (i.e. CXG 36, 2018 version). CCFA51 plenary basically approved all the recommendations from that in-session PWG without a single additional comment. CCFA51 agreed to the deletion from the INS (i.e. in CXG 36 and as a con-sequence CXM 6 to be reflected in the 2019 versions of these two Codex norms) of the following food additives (a) Red 2G (INS 128); (b) Sodium sorbate (INS 201); (c) Potassium ascorbate (INS 303); and (d) Distarch glycerol (INS 1411). ß-carotene-rich extract from Dunaliella salina was assigned the same INS 160a(iv) as the previously described substance named “Carotenes, beta-, algae”.CCFA51 re-established an EWG on INS chaired by Belgium, praised for its chairmanship of previous EWG and the in session PWG, to address several issues raised during the alignment discussions (e.g. whether tricalcium and tripotassium citrates and lecithin could be an “antioxidant synergist”, whether magnesium carbonate and sodium ascorbate could be “flour treatment agents”, etc.). More importantly, the EWG on INS will consider the options for the establishment of a mechanism to keep track of the deleted INS numbers in CXG 36.
In response to the request from CCEXEC on CCFH activity on the development of Guidelinesfor the management of (micro)biological foodborne crises/outbreaks, CCFA51 noted that the existing risk-management tools currently used by CCFA (i.e. scientific advice from JECFA and associated guidelines on flavourings and processing aids) were adequate, and agreed that there was no need to develop separate guidelines for the management of foodborne crises/outbreaks caused by food additives at this time, but could consider this matter in future in case the need should arise.
This article was originally featured in World Food Regulation Review, April 2019, Vol. 28, Number 11.