/>iAspartame and Titanium Dioxide are both safe for use as Food Additives
The 54th session of the Codex Alimentarius Committee on Food Additives, Flavorings, Enzymes, Yeasts, and Processing Aids (CCFA54) successfully concluded its assigned work ahead of schedule. As a landmark decision, CCFA54 reaffirmed the safety of both aspartame (INS 951) and titanium dioxide (INS 171) as well as relevance of their respective duly justified technical needs and as such CCFA54 considered that no change to their current intended uses and maximum permitted levels set in the GSFA (CXS 192) was warranted. CCFA54 adopted proposed, new, and revised provisions resulting from (a) the endorsement of provisions from Commodity Committees; (b) the alignment of provisions between GSFA food categories and corresponding Commodity Standards — in particular completing that review entirely for all Codex standards on dairy products; (c) the review of new and revised provisions for inclusion into the GSFA; (d) the revised INS catalogue of food additives and related specifications; and, (e) the amended list of priorities for JECFA future evaluations and reevaluations of food additives, flavorings, and enzymes. CCFA54 decisions were prepared with the support of four different working groups, held immediately before or during the plenary session.
CCFA54 was held in person in Chengdu (Sichuan, China) from 22 to 26 April 2024 and was preceded by two pre-session working groups (PWG), held on 19 and 20 April, on (a) pending draft, new or proposed revised provisions for adoption in the GSFA or inclusion in the step process and on (b) alignment between the Codex Commodity Standards and the GSFA. Two inSession working group (iWG) meetings advanced the proposed conclusions on (a) the revised JECFA priority list and (b) revisions to the INS list and to functional classes and technological purposes for some food additives. CCFA54 was attended by about 300 delegates from 41 Member Countries, one Member Organization, 23 Observer Organizations, FAO and WHO and was chaired by Pr Yongxiang Fan, Deputy Director of the National Centre for Food Safety Risk Assessment of the People’s Republic of China (C-CFSRA). The next CCFA meeting (CCFA55) would be held on 24-28 March 2025, and preceded by the PWG on Alignment and GSFA (21 and 22 March 2025). More information is available about the CCFA54 meeting and its working documents, as quoted in this article[ii], as well as in the official report of the CCFA54 meeting[iii].
UPDATED FOOD ADDITIVE PROVISIONS IN TABLES 1, 2 AND 3 OF THE GSFA CXS 192 (2024 version)
Newly adopted and revised provisions
CCFA54 considered the outcome of the PWG on GSFA held immediately prior to its session. It generally endorsed each of the PWG recommendations, as well as individual provisions pending confirmation of technological justification provided in plenary or by other Codex Committees. It would be too cumbersome to describe all provisions reviewed and proposed for adoption by CAC47 and final publication into the next version of the GSFA (CXS 192), likely to be published during the first quarter 2025, as those are included in Appendix VI-Part B of the official report. CCFA54 agreed to finalize all pending provisions for a few intense sweeteners in three food categories[iv]. The most controversial provisions were those approved in bread and ordinary bakery wares (food category (FC) 07.1) and all its subcategories. To achieve a consensus, CCFA54 agreed to adopt a new Note, as a variant of existing notes 477 and 478, which reads “Some Codex members allow the use of additives with sweetener and colour functions in this FC while others limit this FC to products without these additives.” It should be noted that the reference to colors aimed at covering other provisions for several colors in the subcategories to FC 07.1[v]. In that regard, it is worth noting that Chile, the EU27, and the Russian Federation highlighted that they did not (and will not) permit, within their respective jurisdictions, the use of sweeteners in products falling under FC 07.1 and its subcategories. CCFA54 couldn’t agree however on how revising the already adopted provision for aspartame in FC 07.1, and therefore it will be subject to an intersessional work until CCFA55 with a request for the bakery industry and countries to provide actual (real) use level of aspartame while taking into account the application of the new note referred to above. CCFA54 also concluded on all the pending color provisions in the subcategories of the remaining food categories from FC 12 to FC 15.
With regards to other types of food additives, CCFA54 discussed more particularly the provisions for Dimethyl dicarbonate (INS 242) in fruit and vegetable juices and nectars (respectively FC 14.1.2 and FC 14.1.3), as well as new provisions for BMC (Basic Methacrylate Copolymer) in sugars and moreover in rice, including rice regulated by the Codex standard. The EU27 did not support the provisions for dimethyl dicarbonate due to their own concern about the potential formation of significant amounts of methanol, which could pose health risks to consumers, and in their opinion, there was no technological need for using the substance in these food categories.
The EU while not objecting to the PWG recommendation, noted they did not permit the use of dimethyl dicarbonate (INS 242) in FCs 14.1.2 and 14.1.3. The International Fruit Juice Manufacturers Union (IFU), referring to their written comments included in CRD-22vi, expressed their disagreement with these proposed provisions. IFU pointed out that the use of Note XS 247 was an exception agreed upon to cover specific intended use of xanthan gum in standardized fruit
juices. IFU was not in favor of promoting the use of preservatives in standardized fruit juices, while pointing out that the use of various concentrates and mixes could also lead to multiple uses and perhaps cumulative concentrations in final products. CCFA54 noted that (i) JECFA did evaluate dimethyl dicarbonate (INS 242) for safety; (ii) there had been a deliberation on the classification of the substance as a food additive or as a processing aid, with consensus reached in favor of viewing it as a food additive, based on labelling requirements that would ensure consumers’ awareness; and (iii) the Note XS 247 was associated with these
provisions, to exclude use in products conforming to the Codex Alimentarius General Standard for Fruit Juices and Nectars (CXS 247, latest). CCFA54 agreed to adopt the controversed provisions[vii]. Some discussion occurred about the proposed provision of Jagua (genipin-glycine) blue (INS 183), as it was claimed
that the proposed uses in some food categories (e.g., soft drinks) had not been reviewed by JECFA at its 89th meeting during the dietary exposure assessment. A correction was made to Ribofavins (INS 101(i),(ii), (iii), (iv)) in Frozen battered fish, fish fillets, and fish products, including mollusks, crustaceans, and echinoderms (FC 09.2.2) and the Note 602 was revised to read as “Except for use as an antifoaming agent only in products conforming to the Standards for Jams, Jellies and Marmalades (CXS 296-2009) at a maximum level of 10 mg/kg.”.
Punctual Revision of Descriptors in Annex B and Annex C of GSFA (alignment work consequence)
As a result of the alignment work for dairy products covered by individual Codex Standards, CCFA54 agreed to revise to the descriptor for Clotted Cream (Plain) (FC 01.4.3) included in the Annex B of the preamble of the GSFA preamble as follows: “01.4.3 Clotted cream (plain): Thickened, viscous cream by fermenting and acidifying cream thus reducing the pH by means of fermentation with suitable microorganisms and/or by the use of suitable acidity regulators, with or without coagulation, and with or without the use of milk coagulating enzymes.
Based on similar changes made to the Codex Commodity Standard on Cream and Prepared Cream (CXS 288), CCFA54 amended the Annex C of the GSFA preamble to list the revised descriptors to the corresponding cream and prepared cream products to GSFA food categories 1.4.1, 1.4.2, and 1.4.3, respectively[viii].
Reaffirmed Policy on Maximum Use Levels
In the context of the specific discussion on jagua (genipin-glycine) blue (INS 183) described above, it was further clarified that (a) the technological justifcation for using colors in various food categories was well-established and Jagua (genipin-glycine) blue (INS 183) was not the first color proposed for these food categories, many of which already contained colors. Thus, the technological justification for the use of jagua (genipin-glycine) blue (INS 183) in the proposed applications was considered adequate; and regarding the use levels, the PWG maintained consistency with the use levels reviewed by JECFA89 for dietary exposure estimates.
Revocation of already adopted provisions
CCFA54 agreed to revoke only four provisions overall (Fast Green FCF in parent category Bakery wares (FC 07.0), Brilliant Blue FCF in sub-parent category Bread and ordinary bakery wares (FC 07.1), Caramel IV in sub-parent category Herbs, spices seasoning and condiments (FC 12.2), and the unique provision for Azodicarbonamide (INS 927a) in wheat flours (FC 06.2.1)). CCFA54 also agreed to revoke the approved provision for Azodicarbonamide (INS 927a) as a dough conditioner: if approved by the CAC47, it would mean that Azodicarbonamide (INS 927a) would be banned for that intended use, at the international Codex GSFA level.
Discontinuation of draft provisions
A bit less than one hundred draft and proposed draft food additive provisions of the GSFA were discontinued, either as a result of the adoption of other provisions or a revision of another similar provisions, or due to the lack of support to adopt such provisions in the GSFA.
New provisions added and other provisions for future consideration
CCFA54 accepted the inclusion of new provisions in the GSFA at proposed draft stage, in particular for the deletion of note XS294 currently attached to the provisions adopted for acetic acid, calcium lactate, citric acid, disodium 5’-guanlyate in most fermented vegetables (except several fermented soybean products) so that these substances would become also permitted in products conforming to the Codex Standard on Gochujang (CXS 294, adopted in 2023). CCFA54 also agreed with the recommendations from the presession PWG on the GSFA to include a couple of other new draft food additive provisions for consideration by the newly established EWG on the GSFA and future approval at CCFA55 in 2025[ix].
New mandate for the GSFA EWG
Hence, CCFA54 agreed to reestablish the EWG and the PWG on the GSFA. The EWG will also consider the replies from CCFO28 on the technological justification for the use of paprika extract (INS 160c (ii) in FC 02.2.2 of the GSFA; revocation of the adopted provision for annatto extracts, bixin based (INS 160b(i)) in FC 01.2.1; the adopted provision for aspartame (INS 951) in FC 07.1 for comment on the actual use level and application of the alternative Note; the draft, and proposed draft provisions, respectively, for colors in FCs 01.0 through to 08.0 and their subcategories as well as adopted provisions for colors with Note 161 in FC 01.0 through to FC 08.0 and their subcategories with the exception of colors addressed in bullet points i and ii above; and provisions entered at Step 2 of the GSFA by CCFA54. The PWG on GSFA will consider the report of the EWG on the GSFA; and responses to the circular letter containing proposals for new and/or revised provisions of the GSFA and it will be held immediately prior the CCFA55 session.
New process adopted when no sponsor or no supplier is identified or when no interest is expressed to JECFA secretariat for any substance placed on the list of JECFA priorities
In the context of discussion on Azodicarbonamide (INS 927a), CCFA54 discussed what CCFA shall do when a substance got its ADI withdrawn without any formal food safety risk assessment but just as a decision made by the JECFA Secretariat due to lack of support, data, or interest in such a substance. The JECFA Secretariat (from FAO) clarified that the establishment or the withdrawal of any health-based guidance values is exclusively a JECFA (the risk assessment body) decision, or in lieu of JECFA, the JECFA Secretariat itself. In the case of Azodicarbonamide (INS 927a), the issue was pending since 2019, but the discussion held in 2023 was not sufficiently captured in the report of the JECFA meeting to ensure a sufficient transparency in the CCFA decision making process.
The JECFA Secretariat (from WHO) suggested to CCFA54 to adopt a new procedure by which for each substance no longer supported by Codex Members
or sponsors (i.e. suppliers), the JECFA ADI would be systematically withdrawn upon the initiative of the JECFA secretariat and without a full risk assessment. JECFA Secretariat (from WHO) suggested that CCFA should include such substances in the JECFA Priority List with a note stating that « if no sponsor were to be identified to provide data at the future JECFA meeting, all provisions in the GSFA may be removed » so as to alert all Codex Members and sponsors (i.e. suppliers) that JECFA may formally withdraw an ADI without performing any full safety/risk assessment. CCFA54 agreed with a new proposed working mechanism: (1) CCFA shall inform JECFA of safety concerns about a food additive and request a re-evaluation by JECFA by adding the substance on the JECFA priority list, (2) JECFA shall review the data received and decide whether the ADI may be revised, including its possible withdrawal, noting that if no data were to be submitted to JECFA and/or no interest in using such substance would be expressed, the Secretariat of JEC-FA would address the issue directly (e.g., by deciding to withdraw the ADI); and (3) JECFA shall inform the CCFA of its decision on the review of the ADI and CCFA would then discuss the appropriate risk management approach under matters referred from FAO and WHO (noting that an ADI withdrawal often leads the Committee to revoke all existing approved provisions in the GSFA).
ENDORSEMENT OF PROVISIONS SUGGESTED BY OTHER COMMITTEES IN CODEX STANDARDS UNDER DEVELOPMENTS OR REVISIONS
CCFA54 endorsed the proposed food additives provisions set in the Codex Standard for dried or dehydrated roots, rhizomes, and bulbs – turmeric (CXS 343) as well as in the Codex General Standard for Dried Fruits and the Codex General Standard for Canned Mixed Fruits (not published yet as final standards). CCFA54 agreed to forward for adoption all revisions to the food additives provisions to the Standard for Pickled Cucumbers (Cucumber Pickles) (CXS 115) — with the late correction to add the GMP provision for ribofavins — and to the Standard for Jams, Jellies and Marmalades (CXS 296). CCFA54 requested CCASIA to (a) confirm the acceptability of deleting ribofavin, synthetic (INS 101(i)) from the table to Section 4 of CXS 298R-2009, acknowledging its use as a Table 3 additive and (b) clarify if other individual additives in the group of Ribofavins would be acceptable for use in foods conforming to CXS 298R, or if there is reason to limit use to Ribofavin, synthetic (INS 101(i)); and (c) provide justification and maximum use levels of beta carotenes- and carotenoid-related food additives (INS 160a(i), 160a(iii), 160a(iv), INS 160a(ii) and INS 160e) in the table to Section 4 of CXS 322R, acknowledging current CCFA approach regarding these substances. CCFA54 answered CCFO28 that CCFA54 agreed (a) to send to the EWG on Alignment the question on chlorophylls use (INS 140) in CXS 19 (noting corrections needed to reflect that no color is permitted for use in vegetable oils conforming to CXS 19); and (b) to send to the GSFA EWG established by CCFA54 for consideration re: the usage of paprika extract (INS 160c (ii)) in CXS 256 and CXS 253.
NEW, REVISED, OR REVOKED SPECIFICATIONS FOR FOOD ADDITIVES AND FLAVOURINGS AND OUTCOME OF JECFA MEETINGS HELD SINCE CCFA53 MEETING
CFA54 agreed to forward the full specifications for food additives and flavorings developed by JECFA96 and JECFA97 to CAC47 for final adoption and make the consequential amendment to the List of Codex Specifications for Food Additives (CXA 6). It was noted that some safety concerns were found for favoring substance 4,7-decadienal (mixture of isomers) (FL No. 2298) and that the evaluation of FL n°2299, 2303 and 2306 was not completed due to toxicological concerns, while the use of acetaldehyde (FL n°80) as a flavoring agent needed to be re-evaluated as acetaldehyde was a structural analogue to FL n°2299, 2303 and 2306. In addition to the review of these favoring substances, JECFA96 and JECFA97 meetings were mostly dedicated to the full reevaluation of aspartame (INS 951) and of titanium dioxide (TiO2, INS 171)[x].
Aspartame
WHO’s JECFA Secretariat made a comprehensive presentation of these reviewed, noting that aspartame had been evaluated at the same time by both the WHO/FAO JECFA and the WHO International Agency for Research on Cancer (IARC) but independently from each other. JECFA, which reviewed also the same studies than IARC did conclude in reaffirming the previously established Acceptable Daily Intake (ADI) for aspartame, up to 40 mg per Kg body weight per day.
Titanium dioxide (TiO2, INS 171)
WHO’s JECFA Secretariat reported that JECFA had reaffirmed the previously established ADI “not specified” for titanium dioxide (INS 171). The EU, noting that the full JECFA monograph had not yet been published, pointed out that the available information was indicating limitations and equivocal findings in the available evidence for genotoxicity and the lack of suitable testing methodologies for nanoparticles. In addition, the EU, referring to the latest scientific opinion of the European Food Safety Authority (EFSA), pointed out that titanium dioxide (INS 171) was not any longer authorized for use in foods in the twenty-seven member countries of the European Union[xi].
ALIGNMENT OF GSFA PROVISIONS WITH FOOD ADDITIVE PROVISIONS SET IN COMMODITY STANDARDS, AND REVERSELY
Alignment is probably one of the most important pieces of the “One GSFA” approach and ensures the coherence of between the food additive provisions
adopted in the GSFA and food additive provisions currently approved in Codex Commodity Standards. CCFA54 praised the work of Australia as previous chair if the EWG and PWG on alignment and Canada the new chair with the completion of the alignment process of all food additive provisions for all dairy standards and the support work of the dairy industry represented by the International Dairy Federation (IDF). Indeed, this year CCFA54 approved the proposed alignment and revised provisions for two food standards from CCMMP, one standard from CCPFV, one standard from CCASIA and one standard from CCLAC[xii].
Alignment – Main decisions
As such, CCFA54 approved the related proposed revisions of the food additives provisions set in the Codex Standard for Pickled Cucumbers (Cucumber Pickles) (CXS 115) and Codex Standard for Jams, Jellies and Marmalades (CXS 296). CCFA54 adopted editorial corrections to the General Standard for Cheese (CXS 283), and the consequential amendments to the Codex Standard for Aqueous Coconut Products – Coconut Milk and Coconut Cream (CXS 177) due to change made to the INS number of gellan gum as INS 418(i) (see section on INS below). CCFA54 therefore adopted revised provisions in the GSFA in relation to the two dairy standards, the alignment of four standards from CCPFV (Processed Tomato Concentrates (CXS 57); Table Olives (CXS 66); Pickled Fruits and Vegetables (CXS 260); and Quick-Frozen Vegetables (CXS 320)); and form the five regional standards (Harissa (Red Hot Pepper Paste) (CXS 308R) and Date Paste
(CXS 314R) for the Near East; Tempe (CXS 313R) Laver Products (CXS 323R) for Asia; and Yacon (CXS 324R) for Latin America and the Caribbean.
The Codex Secretariat noted that according to the proposed workplan for the next EWG on alignment, the Regional Standards under the purview of CCA-SIA were scheduled for alignment with GSFA and that CCASIA had also agreed to establish an EWG to undertake a similar exercise. It was proposed that CCASIA Members should be encouraged to join the CCFA-EWG with a view to ensure optimal resource utilization. CCFA54 endorsed the workplan on alignment and agreed to revise the workplan in the information document: Guidance to Commodity Committees on Alignment of Food Additive Provisions accordingly[xiii].
Alignment – New EWG Mandate
CCFA54 reestablished the PWG and the EWG on endorsement and alignment, to be chaired by Canada, and co-chaired by USA and Japan. The EWG was tasked to align the food additive provisions set in standards and regional standards under the purview of (a) CCASIA (i.e., CXS 298R; CXS 301R; CXS 322R; CXS 354R; CXS 355R); (b) CCNE (i.e., CXS 257R; CXS 258R; CXS 259R; CXS 341R); (c) CCSCH standards (i.e. CXS 342; CXS 343; CXS 344; CXS 345; CXS 347; CXS 351; CXS 352; CXS 353); and verify and update the provisions for colors in the GSFA for food category 02.1.2 given that, prior to the alignment exercise, colors were not permitted in vegetable oils covered by CXS 19. The EWG is also task to introduce the limited use of methacrylate copolymer, basic (BMC) (INS 1205) in fortified rice, by (i) introducing a food additive section in the Standard for Rice (CXS 198), including an appropriate reference to certain carriers in FC 06.1 of the GSFA; (ii) making consequential changes to the food additive provisions of FC 06.1, as necessary. The EWG was also asked for updating the list of Table 3 additives that should be migrated from Tables 1 and 2 of the GSFA, following the Table 3 Notes approach. The pre-CCFA55 PWG session will therefore consider the report of the EWG on alignment and all food additive provisions referred to CCFA for endorsement by Codex commodity committees.
Discussion paper to avoid further divergence between the GSFA and Commodity Standards
CCFA54 agreed with the proposal to develop a briefing document about good working practices together with an engagement plan to avoid future divergence between the GSFA, commodity standards and other related Codex texts, building up on existing information documents the Committee had developed previously[x]. This new briefing document would be co-drafted by Australia, Brazil, Canada, China, the EU, Senegal, and the USA. This decision resulted from thorough discussions (including an informal consultation the results of which were published in CRD 35)xiv, based on a discussion paper initially prepared by China with inputs from Canada and the EU identifying outstanding issues that may explain possible source of divergence between the GSFA, commodity standards and other texts in advance to CCFA54.
It was pointed out that (a) the CAC Procedural Manual did not explicitly recognize the GSFA as a single source of food additives; (b) the endorsement and alignment steps for food additives provisions were carried at different time; (c) the introduction of XS Notes in the GSFA at times which would not take into account an existing commodity standard; (d) the possible development of food additive provisions in commodity standards, without fully adhering to the requirements set in the CAC Procedural Manual when it comes to such food additives provisions. CCFA54 considered possible options to address these issues and would include i) developing working practices and guidance document for the endorsement and
incorporation of food additive provisions considered by Regional/Commodity Committees in order to ensure that the necessary timely changes are made to the GSFA (including information on how Commodity Committees make proposals to the CCFA and how the CCFA will incorporate these into the GSFA), ii) developing an engagement plan how CCFA may interact with Commodity/Regional Committees. CCFA54 noted that this might take two years period to
complete that plan, with a possible dedicated EWG on this matter to be decided at CCFA55 for completion of the work at CCFA56 (2026).
CCFA54 noted that the CAC Procedural Manual contained already helpful guidance to minimize the likelihood of divergence between food additives provisions in the commodity standards and those set in the GSFA such as (a) the requirement for all food additive provisions in commodity standards to be endorsed by the CCFA before publication of any commodity standard; and, (b) any Codex commodity standard (or alike guidelines) format would require the section on food additives to make a reference to the corresponding section of the GSFA such as “[Food additive functional class] used in accordance with Tables 1 and 2 of the General Standard of Food Additives in food category x.x.x.x [FC name] or listed in Table 3 of the GSFA are acceptable for use in foods conforming to this standard.” CCFA54 also noted that it should focus on how best to minimize divergency or misalignment of food additives provisions between the GSFA and commodity standards, as it would reduce significantly the burden of the alignment work.
PRIORITY LIST FOR JECFA SAFETY ASSESSMENT OF FOOD ADDITIVES, FLAVOURINGS, AND PROCESSING AIDS (ENZYMES)
CCFA54 considered the recommendation from an in-session physical working group (inSessionPWG) chaired this year by Kenya, which considered proposals and other information received and compiled in advance to CCFA54 agenda item 7 working document. CCFA54 agreed to (a) forward the amended Priority List of Substances Proposed for Evaluation by JECFA for endorsement by CAC47; and to FAO and WHO for follow-up; and (b) request the Codex Secretariat to issue a circular letter (CL) requesting information and comments on the Priority List of
substances proposed for evaluation by JECFA[xv].
Propylene glycol (INS 1520)
Despite the fact that this proposed addition was relating to diverging views about the approval of current draft GFA provisions for propylene glycol (INS 1520) for use in soft drink beverages (FC 14.1.4) as a carrier for favors, the mandate assigned to JECFA was changed to perform an updated safety evaluation of the food additive including an updated exposure estimate, to reflect all uses of that additive as a carrier. As a consequence, all draft provisions in the relevant sub-categories of FC 14.1.4 were held – while amended to include the Note131, “For use as a flavour carrier only,” until the JECFA review is fully completed.
Gellan gum, low-acyl clarifed (INS 418 (ii))
CCFA54 noted that JECFA87 already concluded on the safe use of low-acyl clarified gellan gum (INS 418 (ii)) and that the only work left to be done by JECFA was to finalize the establishment of specifications. For ascorbyl palmitate (INS 304), it was recalled that the request to JECFA was the result from CCNFSDU43 discussions to perform a safety evaluation for its intended uses in foods for special purposes falling under food category 13.0. However, the WHO’s JECFA Secretariat representative clarified that JECFA should aim at a full re-assessment of ascorbyl palmitate (i.e., for any intended use), given that the latest JECFA safety assessment was more than 50 years old and did not include an exposure assessment. It was agreed that JECFA review for ascorbyl palmitate (INS 304) would be a full evaluation, with special focus on the consumption by infants under 12 weeks of age.
Sucroglycerides (INS 474)
CCFA54 agreed to extend the date for providing all the needed information about the sponsor and data availability from December 2024 to December 2027, also to align with the two other food additives belonging to the same parent category of “sucrose esters” (i.e., sucrose esters of fatty acids (INS 473) and sucrose oligo-esters of type I and type II (INS 473a), sharing the same group ADI (up to 30 mg per Kg body weight per day)). Echoing the earlier discussion on Azodicarbonamide, it is clear that if no support is provided or interest further expressed for sucroglycerides, there is a high likelihood that WHO’s JECFA Secretariat may suggest in the future to withdraw the ADI for sucroglycerides (without any safety assessment).
PROPOSAL FOR ADDITIONS, DELETIONS OR OTHER CHANGES TO THE CLASS NAMES AND INTERNATIONAL NUMBERING SYSTEM FOR FOOD ADDITIVES
CCFA54 considered the recommendations from an in-session working groups (IWG) chaired by Belgium, building up on those of an intersessional EWG and comments received on that report to amend the International Numbering System for Food Additives (CXG 36). Proposed changes, once adopted by CAC47, will be reflected in these Codex Guidelines CXG 36. CCFA54 also reestablished a new EWG on the INS, chaired by Belgium and co-chaired by Iran, to consider future replies to a circular letter requesting proposals for change and/or addition to Section 3 of the Class Names and International Numbering System for Food Additives (CXG 36) and prepare a proposal for circulation for comments at Step 3; deleting azodicarbonamide (INS 927a) from the INS list; and assessing the information provided by Chile on phycocyanin produced by bacteria for use as a blue color, including information about local authorization for use at national and/or regional level[xvi].
NEW WORK ON A COMMODITY STANDARD FOR BAKER’S YEAST
CCFA54 agreed to establish a dedicated EWG, chaired by China and co-chaired by France and Türkiye, to develop the text of the proposed draft standard for baker’s yeast, for further consideration by CCFA55 in 2025. The observer of COFALEC made an intervention to remind the committee about some parallel work which has been initiated by ISO to develop a standard on fresh and dry baker’s yeasts building up on the specifications existing in German standard DIN 91473. The development of that ISO standard was under the purview of its Technical Committee n°34 (TC 34) for foods, currently chaired by France (AFNOR). COFALEC questioned the need necessity for developing a similar Codex standard.
CCFA54 encouraged further cooperation between ISO and Codex so as to avoid any inconsistencies and added that both organizations were differing in membership and that their respective standards may be differing in use. CCFA was confirmed as the competent Codex Committee by the fact that CAC assigned that work to CCFA and CCFA had an history of developing commodity standards, such as the Standard for Food Grade Salt (CXS 53). CCFA54 agreed to amend the product definition in the project document by deleting the words “as example,” which could be construed to mean that other species than of yeast Saccharomyces Cerevisiae were to be covered by this standard.
OTHER ISSUES OF INTEREST
CCFA54 endorsed the recommendation that “XS Notes” be added to the GSFA during alignment, even if their absence would not affect the current understanding of the food additive provisions.
With regards to the Notes of Table 3 of the GSFA, CCFA54 agreed to pause work on the Table 3 Notes to the GSFA until the functionality of the new GSFA database is better understood; and that the WG on Alignment should maintain a list of Table 3 additives that will subsequently be migrated from Tables 1 and 2 when the functionality of the GFSA database allows the incorporation of Table 3 Notes. During a side event, FAO presented an ongoing work to update the Codex alimentarius website as well as the online GSFA database and its current technical difficulties to overcome and it was recognized that the current GSFA online is not fully consistent with the content of the GSFA standard published as CXS 192. CCFA54 noted the importance of making significant progress on these updates of the GSFA database and its online version.
Endnotes
[i] Food Production Systems Engineer, Food Standards & Food Safety Regulatory Specialist., Counsellor at Keller and Heckman LLP Brussels office
[ii] See https://www.fao.org/fao-who-codexalimentarius/
meetings/detail/en/?meeting=CCFA&session=54&
[iv] Steviol glycosides in cocoa mixes (syrups) at 350 mg/kg (with note 477); Saccharins in seasonings and condiments (with note 477) at 150 mg/kg; and, sucralose (revised at 650 mg/kg), steviol glycosides (new at 165 mg/kg), neotame (revised at 70 mg/kg), advantame (new at 10 mg/kg), acesulfame K (revised at 1000 mg/kg), an the salt of aspartame-acesulfame (new at 1000 mg/kg, expressed as acesulfame K equivalent), in bread and ordinary bakery wares, with a new overarching note reading as “Some Codex members allow the use of additives with sweetener and colour functions in this food category while others limit this food category to products without these additives”
[v] As examples, the following new color provisions were approved in the food subcategory covering the most “traditional” yeast-leavened breads and specialty breads: Tartrazine at 300 mg/kg, Fast Green FCF at 100 mg/kg, curcumin at 200 mg/kg, Caramel II at 15000 mg/kg (i.e., 1.5%), Brilliant Blue FCF at 100 mg/kg, all with the new note referred in above endnote ii. The provision for Caramel II is conditioned by another new note “For use in pumpernickel bread at 15,000 mg/kg and for use in malt bread at 3,000 mg/kg.”
[vii] 250 mg/kg in Fruit and vegetable juices (FC 14.1.2) and the same in nectars (FC 14.1.3), both with Note XS247
[viii] Cream and Prepared Creams (reconstituted cream, recombined cream, prepackaged pasteurized liquid cream, including those made from reconstituted or recombined cream) (corresponding to FC 01.4.1); Cream and Prepared Creams (prepackaged sterilized and UHT cream, whipping cream, cream packaged under pressure, whipped cream, including those made from reconstituted or recombined cream) (corresponding to FC 01.4.2); and Cream and Prepared Creams (fermented cream, acidified cream, including those made from reconstituted or recombined cream) (corresponding to FC 01.4.3);
[ix] Other provisions included at Step 2 were several food additives in various types of formulas for infant or for older infant and young children, or formulas for specific medical purpose (acetylated distarch adipate, acetylated distarch phosphate, distarch phosphate, hy-droxypropyl starch, starch sodium octenyl succinate, L-ascorbic acid, L-, D- and DL-lactic acid, ascorbyl esters, calcium and sodium ascorbates, sodium and calcium hydroxides, sodium carbonate, carob bean gum, guar gum, gum arabic, citric acid, trisodium and tripotassium citrates, sodium dihydrogen citrate, citric and fatty acid esters of glycerol, lecithin, mannitol, mono- and di-glycerides of fatty acids, tocopherols, pectins, xhantan gum) for the deletion of note 381 from already adopted provisions in the GSFA (Note 381 reads “as consumed”) as it is a basic principle from the preamble that when there are no specified conditions for applying the use level, it would apply by default to the product “as consumed”. Provisions for 4-Hexylresorcinol in processed fish and shellfish categories, limited to crustaceans only. Two proposed draft provisions were added in wines (mannoproteins from yeast cell walls at 400 mg/L, metatartaric acid at 100 mg/L). Two draft provisions for Annatto Extracts for use in bread specialties (FC 7.2.1 and FC 7.2.2) were also returned to Step 2. The new proposed draft provisions for methacrylate copolymer, basic (BMC) in dried pastas and noodles and like products, herbs and spices (excluding products conforming to commodity standards for certains herbs and spices through relevant XS notes), and complementary foods for infants and young children were added at GMP level, noting that CCFA54 also requested CCNFSDU to appraise the technological need and justification of using BMC (INS 1205) in commodity standards corresponding to the GSFA food categories 13.1, 13.2, and 13.3 (i.e., CXS 72, CXS 156, CXS 73, CXS 74, and Codex Guideline CXG 95).
[x] JECFA revised specifications approved for Aspartame (INS 951) and Titanium Dioxide (TiO2, INS 171), as well as for flavouring substances FL n°1383, 1170, 1233, 1166, 1411, 1416, 808, and 810. JECFA adopted new specifications and approval for use for flavouring substances FL n°2271 to 2285; 2300 to 2305; 2308 to 2311; and 2286 to 2297. Specifications for the favoring substance “ethyl levulinate propyleneglycol ketal (FL n°1973)” were withdrawn, as information to allow the completion of the safety review of the flavouring agent has not been provided to the Committee in a timely manner (meaning that this substance is no more viewed as a Codex-approved flavouring substance). Specifications established for flavouring substances FL n°2303, 2306, and 2299 are qualified as “Tentative” due to an incomplete safety evaluation by JECFA to date.
[xi] It should be noted that the full JECFA Toxicological Monograph for aspartame (INS 951) was made available on June 18, 2024, on the WHO website at https://www.who.int/publications/i/item/9789240092549. It should also be noted that the Chemical Technical Assessment (CTA) of Titanium Dioxide (TiO2, INS 171) is available on FAO website at https://www.fao.org/3/cc9664en/cc9664en.pdf. The full JECFA Toxicological monograph for Titanium Dioxide (TiO2, INS 171)) was not available (up to 30 June 2024). No CTA was prepared for aspartame. EU27 ban of titanium dioxide was adopted by Commission Regulation (EU) 2022/63 of 14 January 2022 published on 18 January 2022, based on EFSA opinion of 25 March 2021, published in 6 May 2021 (https://www.efsa.europa.eu/en/efsajournal/
pub/6585).
[xii] CCMMP: Standard for Fermented Milks (CXS 243) and for Cream and Prepared Creams (CXS 288). CCPFV: Standard for Table Olives (CXS 66). CCASIA: Regional Standard for Laver Products (CXS 323R). CCLAC: Yacon (CXS 324R).
[xiii] The revised guidance will be posted on the Codex Information Documents webpage at https://www.fao.org/fao-who-codexalimentarius/resources/inf-doc/en/ once the revised work plan is formally adopted by CAC47 in Dec. 2024.
[xv] See CL 2024/59-FA (deadline 15 January 2025) at https://www.fao.org/fao-who-codexalimentarius/resources/circular-letters/en/.
[xvi] CCFA54 agreed to amend Section 3 and Section 4 of CXG 36 in (a) adding glycolipids (INS 246), buffered vinegar (INS 267), oat lecithin (INS 322a), gellan (INS 418), low-acyl clarified gellan gum (INS 418(ii)), and carbomer (INS 1210) and (b) amending the INS for gellan gum from 418 to INS 418(i). CCFA54 also agreed to amend respective functional class and technological purpose(s) for carob bean
gum (INS 410), mannitol (INS 421), sodium sesqui-carbonate (INS 500(iii)), calcium sulfate (INS 516), sodium thiosulfate (INS 539), starch sodium octenyl succinate (INS 1450), and technological purpose as “carrier” was added to sodium ascorbate (INS 301). CCFA54 agreed to forward these proposed changes to the Class Names and International Numbering System for Food Additives (CXG 36) for final adoption by
CAC47. The new INS number for gellan gum (INS 418(i)) would be reflected in all standards and related texts where it appeared. Chile questioned about what to do when a national approval of a new food additive is preconditioned to the assignment of a Codex INS number. Chile sought clarification, noting that
their country only allowed those substances for use as food additives if they have suitable provisions in the GSFA. They further noted that this substance has neither an INS number nor a provision in the GSFA and therefore it cannot be authorized for use as an additive in their country. Consequently, complying with the requirement of an existing national approval for this substance is not feasible. CCFA54 recognized the complexity of the situation but agreed to keep
the current process to request new INS for inclusion into CXG 36, however, Chile request for phycocyanin would be assigned to the newly established EWG on INS, on an exceptional basis.
