This article was published in World Food Regulation Review, April 2023, p. 26-31.
The 53rd meeting of the Codex Alimentarius Committee on Food Additives (CCFA53) was held in Hong Kong from 24 to 31 March 2023. CCFA53 succeeded in covering the entirety of its agenda. CCFA53 adopted about 800 food additive provisions for adoption, revision, or inclusion into the Codex General Standard on Food Additives (GSFA). For the first time since 2015, a full set of color provisions were adopted in three staple food categories (dairy; fats and oils; edible ices; in addition to those which were adopted in 2019 in some confectionary categories used as “test case”). CCFA53 took decisions based on the outcome of four working groups held immediately before or during the plenary. CCFA53 reached a landmark consensus for recognising the use of substances in wine making and processing at GMP level in the GSFA corresponding food category, closing a 10-year loop and unlocking the deadlock the Committee had fallen into since 2015. The Committee also made significant progress on the necessary fundamental work on reflective alignment between the GSFA and the food additive provisions set in Codex food commodity standards. Spirulina extracts and Riboflavins are now considered as safe food additives at GMP level in many food categories, as per their inclusion in Table 3 of the GSFA. CCFA53 significantly reduced the permitted use levels for Carotenoids while reorganising completely the parent category as Beta-Carotenes and aligning max levels with those approved for vegetable Beta-Carotenes.
The 53rd session of the Codex Alimentarius Committee on Food Additives convened in person for the first time since 2019 and was preceded by one pre-session working group (PWG) on the GSFA provisions (including new or revised proposals) to consider the outcome of the intersession EWG on alignment. Two other inSession working groups were held on the JECFA priority list and on the INS and Class Names. Australia made a statement to support face-to-face adoption of Codex meetings’ reports when sessions are held in person, wherever possible and practical, so as to be more conducive to achieving consensus and more equitable for countries in different time zones, who otherwise had to attend the report adoption by virtual means at inconvenient times soon after travel.
Update of Food Additive Provisions in GSFA Tables 1, 2 AND 3 of CXS 192 (2021 version)
Newly adopted and revised provisions
CCFA53 considered the outcome of the WG on GSFA held immediately prior to its session. It generally endorsed most of the PWG recommendations as well as several individual provisions pending confirmation of technological justification provided in plenary or by other Codex Committees. It would be too cumbersome to describe all the provisions reviewed and proposed for adoption by CAC46 and final publication into the next version of the GSFA (CXS 192), likely to be published mid-2024. As such, the list provided below provides illustrative examples of the 800+ provisions reviewed and subject to a decision by the CCFA53.
Based upon the confirmation by the Codex Committee on Fats and Oils (CCFO27), CCFA53 agreed with final adoption of the provision for mono- and diglycerides of fatty acids (INS 471) in Food category (FC) 02.1.2, as an antifoaming agent in products conforming to the Codex Commodity Standard for Edible Fats and Oils and Named Vegetable Oils (CXS 16 and CXS 210), excluding virgin and cold pressed oils (Note 356 and XS 33) at max level of 1% “For use as an antifoaming agent in oils for deep frying”. For that FC, CCFA53 also amended several notes relating to provisions of three emulsifiers (INS 475, 491-495, 481(i)-482(i)).
Based on landmark generation of new scientific data and the JECFA conclusions of raising the upper bound of new ADI for Benzoates by 4 folds compared to previous evaluation (at 20 mg/kg body weight per day), CCFA53 therefore concluded its 10 years past discussions by deleting note 301 “an interim maximum level until CCFA53” without changing the existing maximum level of 250 mg/kg approved (as benzoic acid) in FC 14.1.4 “Water-based flavoured drinks, including “sport”, “energy”, or “electrolyte” drinks and particulated drinks” (i.e., soft drink beverages).
CCFA53 also approved the final inclusion of the Riboflavins group (to which CCFA53 also added new INS 101(iv) Riboflavin from Ashbya gossypii) into the Table 3 of the GSFA. CCFA53 decided the like for natural color Spirulina Extract (INS 134). It will open their use at GMP level in many (unstandardized) food categories (e.g., candies). Consequently, all numerical levels already adopted in food categories not listed in the Annex to Table 3 have also been proposed for final revocation (i.e., deletion from the GSFA) as they became automatically GMP with their inclusion in Table 3.
Given the result of the alignment work about fermented milks, the reference to the corresponding Commodity Standard (CS 243) was deleted from the Annex of Table 3 (i.e., opening the use of all GMP food additives listed in Table 3 in that food category, as per GSFA provisions in FC01.2.1).
As part of the pending issues from last years, CCFA53 reached consensus on the technological justification of the use of trisodium citrate (INS 331(iii)) in Plain Fluid Milk (FC 01.1.1). The Committee obtained this result by creating a new note to specify that the GMP permitted use level would be replaced by a maximum numerical level and only “for use in sterilized and UHT milk from bovine species at 1000 mg/kg expressed as citric acid, to compensate for low raw milk intrinsic citrate content, as a result of specific environmental conditions only”, in addition to two other existing notes specifying that it was “for use as emulsifier or stabilizer only” (Note 438) and “for use in sterilized and UHT treated milks only” (Note 227).
As part of other landmark pending issues, CCFA53 reached a consensus over a 15+ year-old controversy for the use of several substances in grape wine making processes (FC 14.2.3) and align them to those permitted by the OIV Code of Good Oenological Practices. Those substances relate to organic acidity regulators (such as malic, ascorbic, citric, fumaric, lactic, erythorbic acids), and to clearing agents such as gum arabic (acacia gum) (INS 414) or sodium carboxymethyl cellulose (INS 466), which will be permitted at GMP level. That result has been obtained with the addition of a new note stating “The maximum level of the additive in grape wine set as Good Manufacturing Practice must not result in (i) the modification of the natural and essential characteristics of the wine and (ii) a substantial change in the composition of the wine. Some Codex Members further specify the use to be consistent with the Code of Oenological Practice of the International Organisation of Vine and Wine (OIV)”. Calcium sulfate (INS 516) was also approved in fortified wines (FC 126.96.36.199). The role of OIV representative to Codex alimentarius for the past 20 years (Jean-Claude Ruf) and the spirit of consensus of some countries, in particular Brazil on this matter, enabled Codex alimentarius to fulfill its mandate taking into consideration standardization work done by other intergovernmental international organizations, on a case-by-case basis1.
Building upon the work achieved in 2019 at its last session in person (CCFA51), CCFA53 also went through many provisions for sweeteners (such as acesulfame potassium, aspartame, cyclamates, saccharins, sucralose, steviol glycosides) which have been revised by adding the horizontal notes 477 and 478 to replace completely throuhgout the GSFA the use of the Note 161 (referring to national legislation) for sweeteners. On sweeteners, CCFA53 also harmonized the applicable notes and provisions applicable to several food categories, between the existing and draft provisions for aspartame, acesulfame K and the “salt” of aspar-tame-acesulfame. All those revised or new provisions are proposed for final inclusions into the GSFA, closing a 20 year+ process.
For the first time since the 2015 deadlock created by the past extensive use of Note 161 associated with provisions for colors, CCFA53 succeeded in considering in one single attempt the adoption of pending provisions for colors in dairy products (FC 01); oils, fats and emulsions (FC 02) and Ice-creams (FC 03)2. It paved the way for the Committee to continue the review of existing and pending color provisions in other food categories (see below paragraph on the mandate of the newly created EWG on GSFA).
CCFA53 pre-session WG on GSFA also spent a significant amount of its time discussing the revision of provisions for “Carotenoids” and other beta-carotenes. CCFA53 largely endorsed the PWG recommendations. As such, CCFA53 agreed first and foremost to change the name and the composition of the parent category for these colors from “Carotenoids” to “Beta-Carotenes”. It is the result of the complete deletion from the GSFA of beta-apo-8’-ethyl ester of carotenoid acid (INS 160f), and the singling out of beta-apo-8’-Carotenal (INS 160e) as an individual additive. The new “Beta-Carotenes” group is therefore now put in full coherence by only containing beta-carotenes, beta-carotene extracts obtained using different type microorganisms (Blakeslea trispora; Dunaliella salina) or by chemical synthesis (Synthetic Beta-Carotene). CCFA53 also aligned existing maximum levels approved for Vegetable Beta-Carotenes with the new or revised provisions for this new group of “Beta-Car-otenes”, and via two new notes to express all of them “as beta-Carotene” and ensure all Carotenes are used singly or in combination. CCFA53 also reviewed all the individual existing provisions, and with a very few exceptions, largely reduced all the other existing permitted maximum levels to take into account on the ADIs for those substances (JECFA risk assessment outcome) indicating that the vulnerable group of smokers would particularly be at risk to consume such beta-carotenes and carotenoids. However, this issue may be revisited after 2025 when JECFA may receive updated data on real use levels once the new classification and the reduced maximum permitted levels in the GSFA would have been implemented at national level, or already anticipated by food business operators. JECFA will issue a call for data. CCFA53 also adopted other changes to the GSFA either because of alignment or based on technological justifications provided, such as to permit Tamarind Seed Polysaccharides (INS 437) in Codex standard for Pickled Cucumbers (See report of CCFA53).
Revocation of adopted provisions
In addition to the consequential revocation of numerical provisions for riboflavin and beta-carotenes and carotenoids, CCFA53 also determined that Ortho-phenyl phenols were not any longer suitable for their inclusion in the GSFA as food additive, by noting that MRLs had been established by the Codex Committee on Pesticide Residues (CCPR) for use of these substances as fungicides on some agriculture commodities. The existing single provision for use on “surface-treated fresh fruit” (FC 04.1.1.2) in the GSFA was therefore removed from the GSFA.
Discontinuation of draft provisions
CCFA53 discontinued several pending provisions, either as consequential changes of their inclusion in table 3 of the GSFA (e.g., synthetic zeaxanthin, Lutein from Tagetes erects, etc.) or the adoption of other provisions (such as for beta-carotenes) or the lack of support for those provisions in those food categories (e.g., several synthetic colors; phosphates, tartrates, pectins, or carboxymethyl cellulose in juices or nectars; several sweeteners or polyols in categories like beers, fine bakery wares (sucralose), grape wines and other food categories).
New provisions added and other provisions for further consideration
CCFA53 has agreed to consider inclusion of new provisions for Lauric arginate ethyl ester (ethyl lauroyl arginate – INS 243) to revisit some 2021 adopted provisions in unripened and ripened cheeses and fat or dairy spreads; two proposals for sorbates (INS 200, 202, 203) in some unripened and ripened cheeses; a new note to allow a reduced max use level for polydimethylsiloxanes (INS 900a) in standardized Jams, jellies and marmalades; an increased maximum level for polyglycerol esters of unesterified ricinoleic acid (INS 476) to allow use in emulsified sauces with more than 20% fat content; a new note to allow higher use at 1100 mg/kg for azorubine (carmoisine) (INS 122) in some food supplements in “effervescent forms as sold to the consumer only”; a full set of provisions in many food categories for the entry of a new natural color Jagua (genipin-glycine) blue (INS 183) in the GSFA.
Notes 488 and 502 were amended to take out reference to potassium silicate (INS 560) given that additive has no Codex-approved JECFA specification.
Descriptors for the food categories 12.2.1 and 12.2.2 were revised to provide clarifications on the fundamental differences betwen herbs and spices on the one hand and condiments on the other hand3.
CCFA53 praised the work of the Chair of the EWG and the PWG on GSFA, Dr Paul Honigfort from the US-FDA, and its team of colleagues who co-chaired the PWG, Dr Daniel Folmer and Dr LaShonda Cureton, with overall the support of USDA and the US Codex office.
New mandate for the GSFA EWG
CCFA53 agreed to reconvene the EWG on GSFA with the objective to consider (a) all the remaining draft and proposed draft provisions for sweeteners in the GSFA as well as adopted provisions for sweeteners with Note 161 in the GSFA; (b) all draft and proposed draft for colors as well as adopted provisions with note 161 in bakery wares (FC 07), in Salts, spices, soups, sauces, salads, protein products (FC 12), Foodstuffs intended for particular nutritional uses (FC 13), and Ready-to-eat savories (FC 15) and all their subcategories; (c) draft and proposed draft provisions in FCs 14.2 (alcoholic beverages, including alcohol-free and low-alcoholic counterparts) and subcategories; (d) provisions entered as draft in the GSFA by CCFA53; and (e) all the remaining draft and proposed draft provisions in the GSFA with the exception of colors not
addressed under (b) and (c), and provisions for which CCFA is awaiting guidance from other Codex Alimen-tarius Committees or from JECFA. The report of the EWG will be considered at a pre-session WG to be held immediately prior to CCFA54 (end April 2024).
Endorsement of Provisions Suggested by Other Committees in Codex Standards under Developments or Revisions
CCFA53 endorsed the proposed food additives provisions about draft regional and global commodity standards on dried meat (with editorial change to the general statement for the use of flavorings in this product to bring it in line with the approved wording in the procedural manual); dried and dehydrated chili pepper and paprika; spices derived from berries and fruits (allspice, juniper berry, and star anise); and small cardamom (with editorial changes to refer to ground/powdered form of the product conforming to that standard).
CCFA53 also endorsed the provisions for standards which were already adopted by the last CAC45 session, namely onions and shallots; berry fruits; fresh dates; soybean products fermented with Bacillus species; Lucuma; Culantro Coyote; cooked rice wrapped in plant leaves (with substantive change to restrict to colors and stabilizers only the uses allowed in FC 06.7 of the GSFA).
List of New or Revised or Revoked Specifications for some Food Additives and Flavourings
CCFA53 approved the specifications elaborated by JECFA for inclusion in Codex CXM 6:
– as new for (a) food additives — Spirulina extract (INS 134) and Riboflavin from Ashbya gossypii (INS 101(iv); (b) enzymes — Lipase from Thermo myces lanuginosus and Fusarium oxysporum expressed in Aspergillus oryzae (JECFA95-7), Collagenase from Streptomyces violaceoruber expressed in S. violaceoruber, β-Glucanase from Streptomyces violaceoruber expressed in S. violaceoruber; and (c) flavourings: Trans-4-tert-butylcyclohexanol and Caryophylla-3(4),8-dien-5-ol (Flav. 2263 and 2264);
– as revised for (a) food additives — Benzoic acid, its salts and derivatives (INS 200, 202, 203) an Modified Starches (INS 1400 to 1451) and (b) enzyme — Phospholipase A2 from Streptomyces violaceoruber expressed in S. violaceoruber.
Alignment of GSFA Provisions with Food Additive Provisions Set in Commodity Standards, and vice versa
Alignment is probably one of the most important pieces of the “One GSFA” approach and ensures the coherence of the Codex food additive provisions adopted in the GSFA and those considered acceptable to remain in the numerous Codex commodity/food standards. It is also a tedious work as it requires one to one, line by line check and addition of cross-references to such Codex standards in Table 3 of the GSFA while ending up with a full coherence with the maximum levels included in Tables 1 and 2 of the GSFA. However, as the discussion on fruit juices and nectars showed during the session, there may be some variations in the system that may result in the development of unstandardised type of foods not bearing the names of the standardized products and with specific food additives provisions.
The proposed changes to the GSFA and reversely to Commodity Standards are ensured by an inter-session EWG as well as a pre-session PWG chaired by Australia. The tedious work is therefore largely done by Australian representative and his team (Mark Fitzroy in particular). The ability to drive the committee through those changes was praised by CCFA53 which gave a standing ovation to Dr. Steve Crossley, announcing Australia’s decision to step down from supporting that work any longer, after 10 years of intense personal involvement and unvaluable contribution to that work for the CCFA. Canada indicated they would pursue that endeavor.
At this session, CCFA53 went through revised food additive provisions of the GSFA in relation to the alignment of seven dairy product standards4, three processed fruit and vegetable standards5, six standards on foods for special dietary uses6, two regional standards7, and one set of guidelines for food for special dietary uses8. We refer the reader to the CCFA53 report for the specific changes to these standards and the GSFA.
As a consequence of the CCFA53 decision made to the parent category of riboflavins and to carotenoids, all the relevant commodity standards are to be aligned with the changes to the provisions approved in the GSFA for them as well as remove 8’-ethyl ester of carotenoic acid (INS 160f) from all relevant commodity standards where it is mentioned.
CCFA53 also agreed to request China, Canada and the EU to prepare a discussion paper to identify any outstanding issues with respect to avoiding future divergence between the GSFA and the commodity standards/guidelines, to be discussed eventually at the next session. It was pointed out that in their views, current CCFA’s “Guideline on avoiding future divergence of food additive provisions in the GSFA with Commodity Standards” (see https://www.fao.org/filead-min/user_upload/codexalimentarius/committee/docs/ INF_CCFA_DIVe.pdf) could appear as insufficiently clear, complete or holistic enough to ensure that further divergence does not occur.
Alignment New Mandate
The Alignment work will continue with the help of a re-established EWG, chaired by Canada and co-chaired by the USA and Japan, with the aim to (a) Re-circulate the alignment of the following milk and milk products commodity standards (CXS 243, CXS 288); (b) initiate the development and maintenance of Table 3 notes in the GSFA, in consultation with the Codex Secretariat, until implementation into the GSFA database is achieved; (c) verify whether CXS 57 has been aligned, and if so to verify that the provisions in the corresponding FC in Table 1 & 2 accurately reflect the alignment; (d) align the following CCPFV commodity standards (CXS 66, CXS 260, CXS 320), and align the regional standards (CXS 308R, CXS 313R, CXS 314R, CXS 323R, CXS 324R).9
Priority List for JECFA Safety Assessment Revised List as it stands after CCFA53
CCFA53 updated the list of substances for review by JECFA for safety assessment or reevaluation, including establishment specifications or dietary exposure assessment. As such, JECFA will focus its next priorities among the following requests: adipates, butterfly pea flower extract, carob bean gum (in infant formula), dioctyl sodium sulfosuccinate (dietary exposure only), 16 new and 88 past flavourings plus 18 for revised specifications, natamycin and nisin, polysorbates (INS 432-436), sorbitan esters of fatty acids (INS 491-495), sucrose esters (INS 474, 473, 473a) (dietary exposure only, part of mapping), thaumatin II, glycolipids, rosemary extract, silicon dioxide, among others with lower priority or pending data availability confirmation at CCFA54.
Statement on use levels considered by JECFA and approved by CCFA
In light of the discussion held on carotenoids and the comparison provided by the EU delegation between the data used by JECFA in their safety assessment and proposed maximum use levels by CCFA53, it was noted that in cases where there would be a large discrepancy between the use levels submitted to JECFA and maximum use levels approved in the GSFA, the JECFA exposure assessment would become questionable. As such CCFA53 is sending to CAC46 for information the statement put into its report “emphasizing the importance that robust and globally applicable use data be provided to JECFA in response to a call for exposure data. Such data is necessary to ensure that JECFA’s assessment can be appropriately applied to the risk management decisions of CCFA when setting maximum use levels for food additive provisions in the GSFA.”
Proposal for Additions, Deletions or Other Changes to the Class Names and International Numbering System for Food Additives
Based on recommendations coming from the outcome of an EWG and an in-session PWG, CCFA53 agreed to (a) add the functional class and technological purpose of ‘carrier’ to gum ghatti (INS 419); (b) add the functional class ‘Humectant’ with technological purpose of ‘moisture-retention agent’ as well as add the technological purpose of ‘foam stabilizer’ to existing functional class ‘Stabilizer’ to cassia gum (INS 427); (c) delete the overall entry for INS 960b(i); (d) addition of technological purpose of ‘coating agent’ to the functional class ‘glazing agent’ for anionic methacrylate copolymer (INS 1207). Proposed changes, once adopted by CAC46, will be reflected in Codex Guidelines CXG 36.
Discussion Paper for the Possible Development of a Commodity Standard for Yeasts
China presented its proposal for CCFA to develop a commodity standard for yeasts for any application in food, food processing or sold as such. There was some confusion over the scope of the proposed standard and whether it should be focusing on fresh and dry baker yeasts (already covered by a German specifications standard – DIN 91473 – noting possible discussions at ISO level to develop a similar one) or on B2B industrial uses of yeasts only. China, with the help of France10, and other interested Codex Members will discuss and revise the project document for further consideration by CCFA54.
Other Issues of Interest
CCFA is also engaged in a mapping work for the further comparability, compatibility and operability of the food categorization systems used by JECFA (including possibly WHO GEMS/Foods), the foods caegories established in the GSFA and the one developed by EFSA (named FoodEx 2.0). Pilot will be tested in considering the dietary exposure assessment of sucrose esters.
More information about the CCFA53 meeting and its working documents are available here: https://www. fao.org/fao-who-codexalimentarius/meetings/detail/ en/?meeting=CCFA&session=53&
Final report of the session will be posted here: https:// www.fao.org/fao-who-codexalimentarius/sh-proxy/en /?lnk=1&url=https%253A%252F%252Fworkspace. fao.org%252Fsites%252Fcodex%252FMeetings%252F-CX-711-53%252FFinal%252520report%252FREP23_ FAe.pdf
1 The following statement is forwarded to CAC46: “ The compromise Note associated with the provisions for food additives in FC 14.2.3 represented an exceptional approach and should not be considered as a precedent in any other circumstances as it was specific to the unique situation involving use of these additives in grape wine”.
2 It should be noted that CCFA53 succeed to perform similar review of color provisions in the years 2018-2019 for some confectionery products (such as candies and chewing gums) with deletion of Note 161 associated to those provisions concluded in 2019 and 2021.
3 FC 12.2.1 (revised): « Herbs and spices are usually derived from botanical sources, and may be dehydrated, and either ground or whole. Examples of herbs include basil, oregano and thyme. Examples of spices include cumin and caraway seeds. Spices may also be found as blends in powder or paste form. »
FC 12.2.2 (revised): « Condiments and seasonings are mixtures of herbs and spices together with other food ingredients (such as salt, vinegar, lemon juice, molasses, honey or sugar, and sweeteners). Examples include meat tenderizers, onion salt, garlic salt, Oriental seasoning mix (dashi), topping to sprinkle on rice (furikake, containing, e.g. dried seaweed flakes, sesame seeds and seasoning), and seasoning for noodles. The term “condiments” as used in the Food Category System does not include condiment sauces (e.g. ketchup, mayonnaise, mustard) or relishes.
4 Milk powders and cream powders (CXS 207), Dairy Fat Spreads (CXS 253), Mozzarella (CXS 262), Evaporated milks (CXS 281), Sweetened condensed milks (CXS 282), Edible Casein Products (CXS 290), Dairy Permeate Powders (CXS 331).
5 Mango Chutney (CXS 160), Gochujang (CXS 294), Chili sauce (CXS 306).
6 Infant Formula And Formulas For Special Medical Purposes Intended For Infants (CXS 72), Canned baby Foods (CXS 73), Processed Cereal Based Foods For Infants And Young Children (CXS 74), Follow-Up Formula Standard (under revision – CXS 156), Formula Foods In Weight Control Diets (CXS 181), Formula For Use In Very Low Energy Diets For Weight Reduction (CXS 203)
7 Unrefined Shea Butter (CXS 325R-Africa) and Chan-terelles (CXS 40R-EURO)
8 Ready To Use Therapeutic Foods (CXG 92)
9 List of codex standards: see https://www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/en/
10 France is currently chairing the ISO/TC 34 on foods. Traditionally, ISO does not develop any food standard as per its historical memorandum of understanding with the Codex Alimentarius Commission. Only one ISO food standard was developed in recent past (2016) on royal jelly (a type of honey, as ISO 12824), mostly focusing on authenticity criteria and methods of analysis.