This article was published in World Food Regulation Review, October 2021, p.29-34.
Early September, food additive risk managers from record-breaking 85 participating countries attended the 52nd session of the Codex Alimentarius Committee on Food Additives (CCFA52) through electronic means (called “virtual meeting”), after three successive postponements in 2020 and 2021 due to the Covid-19 pandemic outbreak. Under such exceptional circumstances, regulators have succeeded to exhaust fully the agenda and reaching out consensus on (i) the before last batch of pending provisions for sweeteners and colors for adoption in the GSFA; (ii) replacement of Note 161 with alternative notes for almost all provisions; (iii) new category names to distinguish steviol glycosides based on their method of production (extraction, fermentation, bioconversion, glycosylation); (iv) alignment of food additives provisions on a further impressive list of commodity standards (e.g. cheeses; spreads; oils; fats; culinary herbs and spices) and the GSFA; (v) embarking on a new review work about carotenoids and carotenes; (vi) request to JECFA risk assessors to re-evaluate fully aspartame and titanium dioxide, as a matter of high priority; (vii) Codex-approved JECFA specifications (new and revised) on food additives and flavourings.
The 52nd session of the Codex Alimentarius Committee on Food Additives initially planned to be held in Lanzhou (Gansu Province, China) in March 2020 was finally held by ‘virtual’ means (i.e., by videoconference) split in several sessions of 3 hours from 1st to 10 September 2021.
It was preceded by two important pre-session virtual working groups (VWG) held end June 2021 preparing recommendations for CCFA52 plenary approval on ‘GSFA’ and ‘Alignment’.
The postponement of the session allowed important issues to be further resolved thanks to further comments responding to additional circular letters and the prolongation of EWGs created by CCFA51.
GSFA pending provisions: backlog finally largely dissolved, and much more serein discussions foreseen ahead
- Draft provisions for approval by the CAC44 (to be held in November) for final inclusion in 2021/2022 GSFA3
- Colors and Sweeteners provisions with Note 161 and other food additive provisions into GSFA – nearly 600 new permitted uses proposed for final adoption or revision by CCFA52, while about 100 for revocation, and about 70 for discontinuation, and 2 new provisions added as draft
Building on the great success obtained at its last session (see WFRR Vol. 28, Number 10, March 2019), CCFA52 demonstrated once more the willingness of major countries (USA, EU, Australia, China, Kenya, Uganda, Nigeria, Malaysia, Thailand, Indonesia, India, Japan, South Africa, and so many others) to resolve the replacement of the Note 161 referring to national legislation by other notes dedicated to sweeteners (i.e. Note 477 and 478) or no note at all by decreasing or revoking some already approved use levels, sometimes with more specific restriction notes.
CCFA52 therefore completed the work on alitame (by restricting drastically its use in only three remaining categories), salt of aspartame-acesulfame, (new sweetener) advantame, neotame, aspartame, and a few on cyclamates and saccharin and three sweeteners (maltitol, thaumatin and maltitol syrup) in coffee and coffee substitutes, tea, herbal infusions, etc. (excluding cocoa).
CCFA52 also completed the review on pending color provisions (e.g., azorubine, tartrazine, sunset yellow, curcumin, paprika extracts, etc.) in soft drinks, cocoa products, food supplements, beer, ciders, non-grape wines, and other alcoholic beverages, as well as for iron oxides in confectionery.
CCFA52 approved new provisions for tamarind seed polysaccharide in a few aligned categories; BMC in salt and flours; Nisin in clear sauce and other sauces like ketchup and gravies; Magnesium carbonate in flours; among others (e.g., alginates and other natural gums as well as a few emulsifiers in surface treatment preparations for fruits and vegetables). The use of pectin and xanthan gum in Formulae for special medical purposes for infants has also been endorsed based on the request coming from the Codex committee dealing with infant foods (i.e., the CCNFSDU).
- Table 3: GMP additives
CCFA52 agreed to include Zeaxanthin, synthetic; Lutein from Tagetes Erecta; Lecithin, partially hydrolyzed and Basic Methacrylate Copolymer (BMC) to Table 3 food additives, opening their use in a wide number of food categories at GMP level. They will be subject to specific request for comments on possible use levels in those food categories listed in Annex to Table 3 for which numerical use level are generally required. CCFA52 also amended a large number of entries in the Table 3 as a consequence of the alignment work to allow their use in some standardized food categories.
JECFA clarified that for food additive provisions included in Table 3 — which generally have an acceptable daily amount (ADI) “not specified” – that the “term [is] applicable to a food substance of very low toxicity that, based on the available chemical, biochemical and toxicological data as well as the total dietary intake of the substance (from its use at the levels necessary to achieve the desired effect and from its acceptable background in food), [and] does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual evaluations, the establishment of an ADI expressed in numerical form is not deemed necessary. An additive meeting this criterion must be used within the bounds of Good Manufacturing Practice: that is, it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal inferior food quality or adulteration, and it should not create a nutritional imbalance” — and one may also add that “it should not mislead the consumer”.
CCFA52 also noted that the technical issues related to the implementation of the Committee decisions on tables included in Annex II of Table 3 relating to restricted uses of food additives included in Table 3 in Commodity Standards (standardized foods) have been resolved. As such, the future new Codex interface supporting the online Codex database on the GSFA will soon reflect fully the content of the GSFA which is published as CXS 192. That upgrade of the online GSFA database will ensure further clarity for the implementation of the Codex alimentarius food additive provisions at national and regional levels and help ensure more coherence for the use of such food additives in foods which are subject to national standards and take fully into account the CCFA work on alignment between GSFA and mirror Codex commodity standards. Hence, it is expected that national commodity standards may gradually be also harmonized with both the GSFA and the amended Codex alimentarius Commodity Standards (starting with the dairy standards now fully aligned after CCFA52).
- Parent category for Sucrose esters and future work to refine exposure assessment by JECFA
CCFA52 followed the recommendations of the June VWG to move away from individual permitted uses for three emulsifiers (sucro-glycerides (INS 474), sucrose esters of fatty acids (INS 473) and sucro-oligoesters of type I and II (INS 473a)) and address them as a group under a new header “Sucrose esters”. CCFA52 also agreed with a JECFA recommendation to use that opportunity to compare those permitted uses by using both food categorization systems (i.e., the GSFA one and FoodEx2.0 (that of the EU27/ EFSA). CCFA52 agreed that future data on use levels would be collected for categories where these additives are known to be used and identifying food categories where such uses are not that frequent would help to refine the exposure assessment. That work is expected to be completed by end 2023 and Japan, as an historical sponsor, will ensure coordination with the applicant and sectors. At that occasion, Japan may also assess the specific theorical contribution of the food category 5.1.4 Chocolates to that exposure, as the whole debate came from that specific proposal, which is now held in the GSFA as a draft provision pending the outcome of that JECFA review.
- Contentious issue about the use of trisodium citrate (INS 331(iii)) in “Fluid milk (plain)”, especially some kinds of UHT milk
CCFA52 tried again to find a consensus between those countries (led by Brazil) which consider that extensive body of work and technological justification for using this additive was provided during the EWG and VWG on GSFA; and those countries (led by Costa Rica) considering that milk covered by this food category shall not contain such a food additive as it may lead to potential changes on the nature of the product and in their view could mask poor quality of the incoming milk and mislead the consumer, while some among them also pointed out that similar products were traded in Africa without using trisodium citrate and in their view that use could conflict with the definition of plain fluid milk set in the General Standard for the Use of Dairy Terms (CXS 206).
Although the contentious issue may be linked to the proposed GMP level (instead of suggesting a proper technologically justified maximum limit for this very ‘sensitive’ food category), one may also recall past discussions on associated notes, e.g., (a) for use as emulsifier or stabilizer only, (b) for use in UHT milk from non-bovine species, and (c) 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. A new specific circular letter will, again, request more information on scientifically-sound substantiated technological justifications and related adequate use level(s) in this food category (or some sub-type of the category) and Brazil was tasked to prepare a discussion paper based on such responses.
- Specific discussion on the delineation between processing aid and food additive
In the context of the endorsement of food additive provisions for the standard for dried roots, rhizomes and bulbs (in particular the dried or dehydrated ginger), CCFA52 members had vigorous exchanges about whether the use of calcium oxide should be considered as a food additive use or rather as a processing aid use, especially when the invoked technological purpose (i.e., as a bleaching agent) is viewed by the Codex Guidelines on the INS and Class names as a food additive purpose. It was in particular noted that the delineation between processing aids and food additives has always been blurry and has never been clearly defined. Therefore, determination of the technological purpose for use of substances is the responsibility of the concerned commodity committee (in this case the Committee on spices and culinary herbs, hosted by India); and such a commodity committee is responsible for determining whether a substance is a processing aid or not. It was noted that, although the international inventory for processing aids (IPA) had no official status in Codex alimentarius, calcium oxide was included in it. CCFA52 finally agreed to endorse the recommendation, while transferring the other entry for sulfur dioxide from the processing aids section to the food additives section. Chile and the European Union expressed their reservation on that endorsement about calcium oxide as a processing aid in that specific standard.
- Specific new work for the coming year: carotenes/carotenoids in the spotlight
CCFA52 noted that JECFA had withdrawn the two group ADIs of 0–5 mg/kg bw for: (1) the sum of carotenoids including Beta-carotene, Beta-apo-8’- carotenal and Beta-apo-8’-carotenoic acid methyl and ethyl esters of Beta-apo-8’-carotenoic acid and (originally applicable to INS 160e, INS 160f); (2) Beta-carotene (synthetic) and Beta-carotene derived from Blakeslea trisporae (originally applicable to INS 160a(i) and INS 160a(iii)), because a group ADI is applicable to the general population, which includes heavy smokers. CCFA52 further noted that JECFA had established an ADI of 0-0.3 mg/kg bw for INS 160e and no data was submitted for INS 160f.
As a consequence, CCFA52 agreed that the next inter-session EWG on GSFA should address this fairly complex issue from a risk management viewpoint in the absence of clear guidance on substances for which JECFA has withdrawn the ADI and review existing approved provisions for carotenoids, as well as for beta-carotenes from vegetable, to adapt GSFA MLs to JECFA risk assessment and possibly rearrange the groupings under which carotenes and carotenoids are currently listed. The basis for expressing permitted use levels (on a carotenoids basis) shall also be reviewed once more. It was noted that section 1.1 of the preamble of the GSFA does foresee the case where food additive provisions are included in the GSFA despite the absence of an ADI, based on the general assumption of lack of safety concern in relation to the (limited) intended uses; (also when a much more significant source of exposure comes from the diet directly and that such intended food additive uses are negligible compared to that mainstream dietary intake). The future work should not be limited to carotenoids currently covered by the group header category but also vegetable beta-carotene provisions.
- New mandate for the inter-session electronic working group on the GSFA
CCFA52 agreed to re-establish the EWG on GSFA, chaired by the USA (as usual) to consider:
- all Carotenoids and Carotenes in the light of JECFA conclusions and some clarification needed on existing provisions reporting basis;
- CCPFV future technical inputs on technological needs on a few additives in a few standards4;
- proposed amendments prepared by the Codex secretariat to several notes associated with food additives contained under group headers for cyclamates, saccharins, iron oxides, polyethylene stearate, polysorbates, riboflavins, and sorbitan esters of fatty acids;
- whether technical notes linked to the way to express approved GSFA approved MLs for aspartame, acesulfame potassium and the salt of aspartame-acesulfame are aligned and adapt relevant provisions as warranted;
- technological justifications and specific (real) use level to be provided for propylene glycol alginate in Other fluid milk (plain);
- further inputs expected on actual (real) use level and their reporting basis for any provision (including draft and proposed draft) for sweeteners in Coffee, coffee substitutes, tea, herbal infusions, and other hot cereal and grain beverages, excluding cocoa;
- all remaining draft and proposed draft sweetener provisions;
- remaining provisions with Note 161 in Cocoa mixes (powders) and cocoa mass/cake; Bread and ordinary bakery wares and in Herbs, spices, seasonings and condiments (e.g. seasoning for instant noodles) and their respective sub-categories;
- all remaining draft and proposed draft provisions for sweeteners in all FCs of the GSFA not already covered above ; and,
- provisions entered at Step 2 of the GSFA by CCFA52 for sucralose in fine bakery wares (in wafer paper only) and for ethyl lauroyl arginate (i.e., lauric arginate ethyl ester) in Ripened Cheese, including rind (deletion of exclusion notes (XS263 to XS272) of individual cheese commodities in that food category). The CCFA53 pre-session physical (or ‘virtual’) WG on GSFA will also consider any outstanding provisions for colors in food categories 1.0 to 3.0 and all the other pending draft provisions. As such, after CCFA53 completes its work, it means that the GSFA will be largely completed (save the on-going work on alignment and new provisions for new substances).
- Other issues related to the GSFA
- Nitrates and Nitrites
This topic is complex and uneasy to apprehend from a food additive or ‘contaminant’ point of view. In order to address individual provisions for the use of nitrates and nitrites in specific foods (as food preservatives), the past two year intersession EWG reached consensus on the fact that 1) provisions would have to report the ingoing amount as the ML with a footnote designating the residual level, and that the ingoing level would be set on the corresponding ion basis (Nitrate: “as NO3 ion”; Nitrites: “As NO2 ion”) as well as the residual level for nitrites (“As NO2 ion”); 2) discussion on linking nitrate and nitrite use in a given food category should be postponed until consensus is reached on a reporting basis for the nitrate provisions; 3) MLs should be based on the product as marketed, and not on a “meat basis”; 4) the use of additional food additives used in conjunction with nitrates and nitrites should be the subject of separate food additive provisions (i.e., through the use of new notes as per past committee discussion on secondary food additives); and 5) specifying testing timeframes for residual levels is not necessary.
CCFA52 therefore endorsed the recommendations to request the Codex Committee on Methods of Analysis and Sampling (CCMAS) to (i) establish criteria for the detection of nitrate and nitrite ions in a variety of food matrices specifically dairy (cheese), meat, and seafood; and (ii) provide information on available methods for detection that meet the established criteria, and in addition whether the method can detect both ions and if so whether the method detects each ion separately or only in combination. In support to CCMAS analysis, CCFA52 agreed to forward to CCMAS all past information that CCFA had compiled on (a) test method(s) and (b) relevant background discussion in part of the related CCFA52 working document; (c) GSFA-adopted maximum use levels for nitrates in “Ripened cheese” and for nitrites in “Heat treated processed meat, poultry, and game products in whole pieces of cuts” and in “Processed comminuted meat, poultry, and game products”; and (d) the lowest proposed residual levels for representative provisions in dairy (cheese), meat, and seafood.
- Alignment process between GSFA and Commodity Standards (See Appendix V of the CCFA52 final report)
The purpose of alignment is to make sure that provisions set in a given food category in the horizontal GSFA are consistent with those provisions which have been approved by the Codex Committees specialized in products foods standardized (subject to a CXS standard – or CXG guideline) covered by that GSFA food category (generally broader or 1-to-1 corresponding). Especially, restrictions are often foreseen for Table 3 food additives, for which a general approach by functional class is now in application. It requires therefore a very meticulous work carried out by intersession EWG and a pre-session VWG held in June under an unprecedent and widely recognized leadership and support by Australia and in particular Steve Crossley and his team.
Based on those recommendations, CFA52 agreed to forward to CAC44 for adoption revised food additive sections for nine standards for milk and milk products5; six standards for fats and oils6; and three standards for spices and culinary herbs7. It also sent for approval related revised provisions for inclusion into the GSFA in the corresponding food categories, including the standard for Soups and Broths and related provisions in 12.5.
Interestingly, and in order to prevent the Committee from future deviations between subsequent revisions of commodity standards and GSFA or reversely, CCFA52 agreed to publish on the Codex website as an information document the “Guideline on avoiding future divergence of food additive provisions in the GSFA with Commodity Standards” and corresponding Commodity Committees will be informed about it (and presumably also kindly requested to follow that guidance). The future alignment work plan has been amended accordingly and is available in Appendix XIII of CCFA52 report as well as will be further included in a revised version of the Guidance to Commodity Committees on the Alignment of Food Additive Provisions Information Document.
Australia, helped by the US and Japan will continue to work through a dedicated EWG to further cross-check dairy standards, CCNFDU standards, and CCAFRICA and CCEURO regional standards, and remaining technical issues on Mango Chutney; Standard for Gochujang; and Standard for Chilli Sauce. The EWG will also provide further guidance on the implementation of notes in Table 3 on the GSFA online (compared to CXS 192) and foresee whether current section on food additive alignment described in the Procedural Manual could be upgraded in the light of the work progress made and need to keep the system as coherent as possible in the future.
CCFA52 agreed to endorse the food additive provisions in a) the draft regional standards for: “fermented cooked cassava-based products”, “fermented noni fruit juice”, “kava products for use as a beverage when mixed with water”, and “mixed zaatar”; b) the proposed draft standard for dried seeds – nutmeg, draft standard for dried roots, rhizomes and bulbs – dried or dehydrated ginger as amended i.e. i) the units for the maximum level of calcium oxide (INS 529) from “mg/kg” to “on dry basis by mass, %; and ii) transferring the original provision for sulfur dioxide (INS 220) as a processing aid to a provision as a food additive; and c) in the proposed draft guidelines for ready to use therapeutic foods (RUTF). CCFA52 also agreed to include the guidelines for RUTF in the list of CCNFSDU standards awaiting future alignment work and that this work will also undertake the determination of the appropriate GSFA food category. CCFA52 also agreed to refer the food additive provisions in the standards for processed fruits and vegetables to the CCFA’s EWG on Alignment with a view to resolve the technical issues identified by the last June VWG.
- Priority List of JECFA scientific advice to CCFA on food additives, flavourings and enzymes (specifics to be found in Appendix XI of CCFA52 final report)
CCFA52 took a landmark decision to ask JECFA to re-evaluate fully and that with a high priority both aspartame and titanium dioxide, two substances regularly put to the question although largely viewed of no safety concern globally and still in use an overwhelming number of countries around the world.
JECFA is also tasked to refine its exposure assessment for acesulfame potassium and saccharin due to its use in soft drinks in particular. JECFA is tasked with a first evaluation of black carrot extract and butterfly pea flower extract (two anthocyanins), the review of pending data (to be provided by suppliers) on gellan gum, carob gum, nisin, natamycin.
JECFA is also urged to carry out a full re-evaluation for polysorbates, sorbitan esters of fatty acids, and two polyglycerol esters (INS 475 and 476). JECFA is tasked to complete its work on the first evaluation of spirulina extract and consider starting that of Thaumatin II. Rosemary extracts suppliers were kindly reminded to provide missing information about the substance by the next JECFA meeting, otherwise its ADI is likely to be withdrawn which could lead to full deletion from the GSFA at once by a subsequent CCFA.
JECFA is asked to review also a series of 61 new flavourings, in addition to previous 68 ones and revise the specifications for 21 others. A series of 25 enzymes is also on the list (as processing aids). Specifications for lead in Bentonites (used as food additive) and in Diatomaceous Earths and Activated carbon (charcoal) (used as filtering and decolouring processing aids) are also subject to review.
Ultimately, it remains under the sole control of the Joint FAO/WHO Secretariat(s) of JECFA to prioritize the work and related calls for data for substances assigned to it by CCFA.
- Codex approval as international norms of JECFA new and revised specifications of identity and purity (specifics in Appendix III of CCFA51 final report)
CCFA52 endorsed for final approval new or revised specifications of identify and purity for eleven food additives (e.g., Steviol glycosides, Brilliant Black, a few beta-Carotenes and carotenoids, Citrem, Potassium polyaspartate, Rosemary extract) and 36 flavourings, (e.g., vanillin, ethyl vanillin, glutamate-types, phenol-based derivatives, dcarvone, pentylfuran and other furan-based).
- International number system and functional classes/technological purposes (specifics in Appendix IX of CCFA51 final report)
CCFA52 amended the international nomenclature of food additive by allocating new INS numbers to a new type of riboflavin (from Ashbya gossypii), a new anthocyanin (Butterfly pea flower extract), a new color (Jagua genipin-glycine blue), and two new numberings for two new types of steviol glycosides to better reflect the various production methods (to add enzymatically-produced and glucosylated to existing ‘from fermentation’ or by extraction/purification from Stevia rebaudiania bertoni), as reflected in the revised specifications elaborated by JECFA and approved by the Committee at the same session (see previous paragraph). New technological purposes were also added for (i) tripotassium citrate and tricalcium citrate as as antioxidant synergist; (ii) magnesium carbonate and sodium ascorbate as a flour treatment agent; (iii) isomalt (hydrogenated isomaltulose) as a flavour enhancer and as a flavour synergist and (iv) lecithin as a flour treatment agent and antioxidant synergist.
CCFA52 report can be accessed at: http://www.fao.org/fao-who-codexalimentarius/meetings/en/
All CCFA52 working documents are available at: http://www.fao.org/fao-who-codexalimentarius/meetings/detail/en/?meeting=CCFA&session=52
1 Food Safety Specialist, Senior Regulatory and Scientific Counsellor – Keller and Heckman LLP.
2 Food Law Attorney, Partner – Keller and Heckman LLP.
3 Codex alimentarius General Standard on Food Additives (CXS 192 http://www.fao.org/fao-who-codexalimentarius/codex-texts/list-standards/en/)
4 Tartrates in Fruit based spreads (e.g. chutney), excluding products in FC 04.1.2.5); b) acidity regulators in general, and tartrates specifically in Dried fruit; c) emulsifiers, stabilizers, thickeners in general, and xanthan gum specifically, in Fruit and vegetable juices and in Fruit and vegetable nectar (including tamarind seed polysaccharide in some subcategories); d) colours in French fried potatoes included in the Standard for Quick Frozen Vegetables; e) acidity regulators in general, and calcium lactate specifically, in Fruit juice generally, and in Chinese plum juice specifically; f) acidity regulators in general, and phosphates and tartrates specifically in Vegetable juice, Concentrates for vegetable juice, Vegetable nectar, and in Concentrates for vegetable nectar and the maximum use levels needed to achieve the intended technological effect; g) tamarind seed polysaccharide in the Standard for Pickled Cucumbers.
5 Cheeses, Cheeses in Brine; Cottage Cheese; Cream Cheese; Extra Hard Grating Cheese; Unripened Cheese including Fresh Cheese, as well as for Blend of Evaporated Skimmed Milk and Vegetable Fat; Blend of Skimmed Milk and Vegetable Fat in Powdered Form; Blend of Sweetened Condensed Skimmed Milk and Vegetable Fat.
6 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; and, Fish oils.
7 Black, White and Green – BWG – Peppers; Cumin; and, Dried Thyme.