This article was published in World Food Regulation Review, January 2024, p. 25-34.
While celebrating its 60th anniversary, the 46th CAC meeting has seen several historical decisions taken.
First and foremost, it has closed the long-standing controversy about Zilpaterol hydrochloride by adopting through two successive votes by advancing and adopting the proposed maximum residue limits (MRLs) in several animal tissues, despite the firm and definitive opposition by the European Union and several associated countries (e.g., China, Thailand, Norway, etc.).
Second, CAC46 adopted all the other proposed standards, guidelines, codes of practices, maximum levels and residue limits by covering its whole agenda during allocated time, paving the way for the publication of the entirely revised Codex standard on “Follow Up Formulas,” after more than 10 years of bitter-sweet discussions about these “baby-foods” by the CCNFSDU.
Third, CAC46 created an Electronic Working Group directly under its own purview to fix a very technical amendment to the Codex standard on fruit juices and nectars, which is a real first but is meant to be exceptional and not creating any precedent.
Fourth, CAC46 agreed to collect for the very first time in its entire existence a stockpile of information on possible food safety issues that may be related to the use of recycled materials in food contact materials (FCMs) surrounding prepackaged foods and to inform CAC whether it may wish to embark onto any proposed new work in that very technical and legally complicated area.
Fifth, CAC46 agreed that any future concrete proposals for Codex texts on new food protein sources (i.e., cell-based and bio-mass technologies; precision fermentation; enhanced plant, algae, microbial, fungi’s proteins or fats, etc.) may be put forward by respecting all existing procedures and prioritization mechanisms, via all the existing Codex Alimentarius bodies (Committees, CCEXEC, and CAC).
Sixth, CAC46 agreed to give a pause to the finalization of its internal draft operationalization guidance (and its decision-tree) on the application of the Statement of Principles on the Role of Science, Taking Into Account Other Legitimate Factors until further experience is gained by the chairpersons of the CAC and CAC’s subsidiary bodies.
Last but not the least, CAC46 also projected itself with a blueprint about the “Future of Codex” as the main building blocks for setting future goals within the next CAC Strategic Plan (2026-2030), and praising the consensual work achieved by CAC’s Vice-Chairperson Allan Azegele (Kenya), in that regard.
By Christophe Leprêtre(*)
(*) Food Production Systems Engineer, Food Standards & Food Safety Regulatory Specialist.
From 27 November to December 2, 2023, more than 500 delegates, with 160 others attending remotely, from 158 countries (and 39 observer organisations) met during CAC46th meeting and approved all the food safety and quality standization work performed by the Codex Alimentarius Committees held in the past 12 months (since CAC45th meeting).
CAC46 also celebrated the 60th anniversary of this unique international UN food ‘standard’-setting programme.
The meeting was held in the plenary hall room at the FAO Headquarters, Rome (Italy). Everyone appreciated the leadership of Mr. Steve Wearne, CAC Chairperson, and the harmony by which even the most controversial debates were conducted, handled, and concluded. In return, Pr Guilherme da Costa, former CAC Chairperson, commanded the work of Steve Wearne (United Kingdom), and his three Vice-Chairpersons, Allan Azegele (Kenya), Raj Rajasekar (New Zealand), and Diego Varela (Chile), for their contributions to the Codex Alimentarius, that Corinna Hawkes, Codex Secretary ad interim (Director at FAO’s Division of Agrifood Systems and Food Safety), qualified as “an extraordinary piece of team work.”
Steve Wearne noted in his concluding remarks that “it is an honor and a privilege, together with the three vice-chairs, to serve this Commission for one more year,” while giving a rendez-vous to the Codex Alimentarius community for CAC47, to be held in Geneva (Switzerland), end November 2024.
CAC46 also notably honored the memory of Richard Boyd (USA, and last Chair of CCPFV), Hajime Toyofuku (Japan, former WHO-JEMRA staff), Suzan McLennon-Miguel (Jamaica Veterinary Services), and Modesto Perez (longstanding Dominican Republic’s Codex Contact Point).
Zilpaterol Hydrochloride: Different Perspectives on Animal-Food Production Systems for its Final Clap
Steve Wearne, CAC Chairperson, recalled all the efforts deployed since the already historical votes held at CAC45 meeting (to advance the standard at step 5) in consulting nearly 90 Codex members from all regions and hopefully find a consensus for a final adoption of the proposed maximum residue limits (MRLs) for Ziltpaterol Hydrochloride (a β2-adrenoceptor agonist, leading to animal growth promotion and higher milk production volumes) in Cattle organs and some offals, i.e., muscle (i.e., leading to meat) at 0,5 micrograms/kg, kidney at 3,3 micrograms/kg, and liver at 3,5 micrograms/kg. He also clearly indicated the process flow by which he suggested to CAC47 to discuss in sequence this topic, i.e., start with CAC47 views on (i) the outcome of the JECFA risk assessment (which led to the proposed MRLs), (ii) the risk management options for CAC47, and (iii) the ways to come to a final conclusion.
JECFA assessment fully endorsed
CAC46 agreed almost unanimously that the JECFA review of the scientific facts related to the intended purpose and uses of that substance in cattle (and milk) productions and therefore the proposed MRLs values (derived from the established acceptable daily intake (ADI) and the Acccute Reference Dose (ARfD)) was robust and sound. Thailand and other countries, while not disagreeing with the robustness of such JECFA risk assessment in relation to the proposed MRLs in cattle’s liver, kidney, and muscle, expressed concerns to the limited number of animal tissues considered in the risk assessment, as it did not reflect the range of animal tissues highly consumed in some countries, and hence the MRLs proposed would not be sufficient to protect consumers health. It was recalled that any proposal in that regard could be put forward to the Committee in charge of veterinary ‘drugs’ (CCRVDF) for future review by JECFA and establishment of MRLs in other tissues, offals, or lactative secretions.
Risk management options – and (same) arguments repeated again
The UK, supported by several delegation including notably China, made a ‘last hour’ proposal for adding a footnote aimed to be attached to the proposed MRLs; reach consensus at the session, and avoid dissenssions leading to vote on the proposals, and would read as “any trade in meat produced with zilpaterol hydrochloride should only be on the basis of mutual agreement between the countries concerned, and without prejudice to trade with other countries.” The Chairperson noted observations he had received from the FAO and WHO Legal Offices regarding footnotes, generally advising against the use of notes or footnotes that would reflect the process of adoption of a standard, rather than the content of a standard or its application, noting that the proposed option would refer to the application of the standard.
Views among Members on this footnote were also mixed: it was noted that it could be a way for possibly reaching a consensus or that the proposed footnote might allow more Members to abstain from acceptance. While some pointed out the late arrival of such a proposal, others indicated their preference for an adoption without any footnote, because in their view such a footnote could devalue or lead to “second class standards.” Last but not least, it was noted that trade between countries was always based on mutual agreements by the two parties and as that CAC procedural manual recognized the voluntary nature of Codex standards (and the possibility to abstain from acceptance), was defeating the need for any footnote. The UAE made a strong intervention to refer to the “One Health” approach, prohibition in their country of growth promoting substances in meat production, intention to ban imports of animal production containing such substances, and recalled the WTO SPS Agreement rights and obligations.
Other countries, especially developing countries with a fast-growing human population, recalled that, while the substance may not be permitted in their country, they were looking for Codex adopted MRLs to be able to control imported animal food product and protect their own consumers. Other countries in that situation argued that precisely with such Codex MRLs, they could also foresee the use of Zilpaterol Hydrochloride for their own domestic productions or exports.
Another batch of countries (sometimes the same as prevously mentioned) possibly viewed as “Codex legistimists,” reiterated explicitly or implicitly their positions expressed at CAC45 that national regulatory frameworks not allowing the use of growth promoters were outside the purview of the discussion on MRLs per se and beyond the Codex mandate. They also reemphasized that a due process (all procedures) had been followed for the establishment of the MRLs; no safety concerns associated with the use of zilpaterol hydrochloride were identified by JECFA based on available data/information; no additional scientific evidence had been made available to CCRVDF or JECFA since the most recent JECFA evaluation. So, that in their view, not only the MRLs could be advanced at Step 8 but approved as final standards as well. It was also recalled that countries not supportive of the MRLs could “abstain from acceptance” as outlined in the Procedural Manual.
Last Act: two votes in sequence and two large support to the advancement and adoption
Advancement to Step 8
A series of countries expressed their reservations to such an advancement (sometimes for divergent rationale) and even formal objections against CAC decision to advance step 8 were expressed. Noting the range of views, the Chairperson had no other choice than to conclude to a lack of consensus on the advancement of the MRLs to the final step of the uniform step-process adoption procedure. Therefore, a vote by show of hands and simple majority ballot (of the votes expressed minus abstention) was triggered and 137 countries voted, among which 86 in favor, 51 against, 11 abstained. As a conclusion, the MRLs were advanced to Step 8.
Adoption at Step 8
Several Codex Members objected to the proposed final adoption and stated their sustained opposition (interestingly largely but not exacly matching the list of those opposing to advancement). Noting the range of views, the Chairperson had no other choice than to conclude to a lack of consensus on the advancement of the MRLs to the final step of the uniform step-process adoption procedure. Therefore, a vote by show of hands and simple majority ballot (of the votes expressed minus abstention) was triggered and 137 countries voted, among which 88 in favor, 49 against, 11 abstained. As a conclusion, the three MRLs in Cattle were adopted as final Codex standards. This conclusion led to a round of rather modest applauses, as every single delegate in the meeting room, while being relieved to see the end of an epic battle, were all totally aware of the exceptional nature of this way of adopting Codex standards and could measure some fundamental differences among countries around the world about their appreciation of animal food producing methods and the use of growth promoters.
The Chairperson invited members willing to make a statement to provide them in writing and would be consolidated in the CAC46 report.
CAC46 Main Decisions on Adopted Standards (see also Annex)
The Zilpaterol discussions shouldn’t shadow the other overall tremendous successes of the CAC46, which has not returned to any Committee a single proposal for final adoption. As such, while not being so exceptional, it shows the overall – still intact hopefully– willingness of the overall Codex Community to develop and adopt Codex standards by consensus and through multilateral negotiations.
MRLs Veterinary Drugs
Among all the notable approvals, it is also worth mentioning the approval of the following MRLs for other veterinary drugs, including for the first time in history, by extrapolation:
- existing MRLs were extrapolated to ruminants and finfishes, as follows:
- for all ruminant on a. Amoxicillin (muscle, fat, liver, kidney, milk) b. Benzylpenicillin (muscle, liver, kidney, milk) c. Tetracyclines (muscle, liver, kidney, milk) d. Cyhalothrin (muscle, fat, liver, kidney, milk) e. Cypermethrin (muscle, fat, liver, kidney) f. Deltamethrin (muscle, fat, liver, kidney) g. Moxidectin (muscle, fat, liver, kidney) h. Spectinomycin (muscle, fat, liver, kidney, milk) i. Levamisole (muscle, fat, liver, kidney) j. Tilmicosin (muscle, fat, liver, kidney)
- for all other finfishes on a. Deltamethrin (muscle) b. Flumequine (muscle)
- New MRLs for ivermectin (sheep, pigs, and goats – fat, kidney, liver, and muscle) and for nicarbazin (chicken).
Nutrition and Foods for Special Dietary Uses
- Completely revised standard on follow-up formula (currently CXS 156) will be also renamed as the Standard for Follow-up Formula for Older Infants and Product for Young Children; with the reservations of Costa Rica, EU27, Norway, Panama, Switzerland, and USA for reasons mainly relating to the preamble and cross-references to texts adopted by the WHO’s World Health Assembly or the status of these products, as breast-milk substitute or not, or some other issues related to levels set for Vitamin A (and seen too high).
- It should be noted that this is a landmark finalization, given that the overall revision of such a standard had started roughly more than 10 years ago.
- Guidelines for the Control of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef, Fresh Leafy Vegetables, Raw Milk and Raw Milk Cheeses, and Sprouts (General Section, Annex I on raw beef and Annex III on raw milk and raw milk cheeses)
- Guidelines for the Safe Use and Reuse of Water in Food Production and Processing (General Section and Annex I on Fresh Produce)
Food Import Control and Export Certification Systems
- Guidelines on Recognition and Maintenance of Equivalence of National Food Control Systems (NFCS)
- Principles and Guidelines on the Use of Remote Audit and Inspection in Regulatory Frameworks
MRLs Pesticide Residues
- Historical final completion of the revision of the Classification of Foods and Animal Feeds (to be published in CXA 4 document) with adoption of changes to the Revised Class B – Primary commodities of animal origin and to the Class E – Processed foods of animal origin with
- Consequential amendments of the above revision to the:
- Principles and Guidance on the Selection of Representative Commodities for the Extrapolation of MRLs for Pesticides to Commodity Groups (CXG 84): a. Tables of representative commodities for Class B and Class E. b. Revised Subgroup 12C: Eggplant and eggplant-like commodities, Table 2.
- Classification of Foods and Animal Feeds (CXA 4): a. Revised definitions for the portion of the commodity to which MRLs apply and which is analysed for Group 006 – Assorted tropical and subtropical fruits of inedible peel, and Group 023 – Oilseeds and oilfruits. b. Additional commodity groups in Class A – Primary food commodities of plant origin, and Class D – Processed foods of plant origin.
- New/revised MRLs for different combinations of pesticides/commodities in/on foods and animal feeds
- New (and therefore historical) Code of Practice for Prevention and Reduction of Mycotoxin Contamination in Cassava and cassava-based product
- Maximum level (ML) for lead in ready-to-eat meals for infants and young children
- ML for lead in soft brown, raw, and non-centrifugal sugars
- ML for total aflatoxins in dried chili and nutmeg
- ML for ochratoxin A in dried chili, paprika, and nutmeg
Food Additives (this is a non-exhaustive list of all approved provisions) for inclusion in the GSFA
- Historical approval of food additives provisions at GMP level in “Grape wines” (food category 14.2.3) with an explanatory note (to be used only on an exceptional basis and not meant to create any precedent in any other circumstances) to read: “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)” – reservation by Tanzania;
- Trisodium citrate (INS 331(iii)) approved at GMP level in “fluid milk (plain)” (food category 01.1.1), with three substantive notes, including a new one agreed by consensus at the March CCFA53 meeting, and as self-limiting factor, which read: (a) “For use as emulsifier or stabilizer only” (Note 438); (b) “For use in sterilized and UHT treated milks only” (Note 227), (c) “Except 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” (New Note)
- New and revised provisions for all riboflavins (riboflavin, synthetic (INS 101(i)), riboflavin 5′-phosphate sodium (INS 101(ii)), riboflavin from Bacillus subtilis (INS 101(iii), including the addition in the parent category of riboflavin from Ashbya gossypii (INS 101(iv)) in particular those added to in Table 3 for use at GMP levels in all foods not listed in Annex of Table 3 of the GSFA.
- New Provision for spirulina extract (INS 134) added to in Table 3 for use at GMP levels in all foods not listed in Annex of Table 3 of the GSFA.
- Overall revision (significant reduction) of all existing provisions for carotenoids (especially beta-apo-8’-carotenal (INS 160e) and ban of beta-apo-8’-carotenoic acid ethyl ester (INS 160f)), whereas all synthetic beta-carotenes (including produced by Blakeslea trispora or extracted from Dunaliella salina were regrouped into a parent category). The EU27, represented by the European Commission on this agenda item, highlighted the importance of an upcoming new call for data by JECFA on carotenoids (still in preparation by the JECFA secretariat) and that this call for data would ensure that JECFA’s update of the exposure assessment rely on the actual uses of these food additives, and that this information should enable CCFA to review as soon as possible the GSFA provisions on carotenoids.
- Provisions for mono- and diglycerides of fatty acids (INS 471); polyglycerol esters of fatty acids (INS 475), sorbitan esters of fatty acids (INS 491- 495), and stearoyl lactylates (INS 481(i), 482(i)) in vegetable oils and fats (food category 02.1.2)
- Deletion of the limiting Note 301 about benzoates in non-alcoholic beverages (FC 14.1.4)
- Revision and alignments of applicable notes related to several sweeteners (aspartame, acesulfame K, and salt of aspartame-acesulfame)
- Alignment between GSFA and Food/Commodity Standards; leading to (a) revised food additive sections in seven standards for CCMMP, three standards for CCPFV, six standards for CCNFSDU, one standard for CCAFRICA, one standard for CCEURO, and one set of guidelines for CCNFSDU and (b) related food additive provisions in the GSFA in corresponding food categories covering those standards foods.
- Revision to the descriptors to herbs and spices and seasonings (i.e., food categories 12.2.1 and 12.2.2)
- All the above new and revised provisions just approved by CAC46 at global level will only be visible once the revised GSFA (CXS 192) is published which is expected to happen towards the end of the first half of 2024. For countries adopting or accepting all the GSFA provisions by a simple cross-reference in their legislation, it therefore means those new provisions would only become effective when the 2023 version of CXS 192 in published. For all the other countries, the new GSFA will need to be introduced in their own national legislation through an amending national modifying text, which would take a couple of months, if not years. As such, revisiting such provisions (e.g., on beta-carotenes, sweeteners) before they are implemented would be a source of confusion.
- CAC46 also noted the statement contained in the CCFA53 report, emphasizing the importance that robust and globally applicable data on use levels should 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. CAC46 therefore encouraged all stakeholders to provide JECFA with precise and reliable data and information relating to food additives and their uses.
Regional standards adopted
- Asia: Standards on Soybean Products Fermented with Bacillus species and Cooked Rice Wrapped in Plant Leaves. Latin America and the Caribbeans: food additive provisions in Standards for Culantro Coyote and Lucuma. North America and the South West Pacific: Fermented Noni Fruit Juice.
New work (and its committee in charge)
CAC46 endorsed the proposals for new work as follows:
- Guidelines for food hygiene control measures in traditional markets for food and consider its relationship between the proposed new text with the General Principles of Food Hygiene (CXC 1) and the 4 regional texts on street-vended foods — CCFH
- Revision of the Guidelines on the Application of the General Principles of Food Hygiene to the Control of Pathogenic Vibrio Species in Seafood (CXG 73) — CCFH
- New food additive proposed draft provisions for future inclusion into the GSFA — CCFA
- Priority List of food additives, flavorings and enzymes proposed for evaluation by JECFA – CCFA
- Priority List of contaminant substances proposed for evaluation by JECFA – CCCF
- Code of Practice/Guidelines for the prevention or reduction of ciguatera poisoning – CCCF
- Priority list of veterinary drugs for evaluation or re-evaluation by JECFA – CCRVDF
- Consolidation of Codex guidelines related to equivalence — CCFICS
- Reviewing and updating of the existing Principles for Inspection and Certification System (CXG 60) — CCFICS
- Amendment to the General Standard for the Labelling of Pre-packaged Foods (CXS 1) re: the labelling of pre-packaged foods in joint presentation and multipack formats — CCFL
- Priority list of pesticides for evaluation by JMPR — CCPR
- Development of Guidance for monitoring the stability and purity of reference materials and related stock solutions of pesticides during prolonged storage — CCPR
- Amendment of the General Standard for Fruit Juices and Nectars (CXS 247), via an historical innovation by setting up a dedicated EWG under the direct purview of the CAC (see below).
New Electronic Working Group under the Direct Purview of CAC to address a very technical issue
CAC46 has taken another historical decision to agree with Brazil’s proposal to amend the existing General Standard for Fruit Juices and Nectars (CXS 247), by setting up a dedicated electronic working group (EWG), chaired by Brazil and opened to all Codex members and observers, and under the direct purview of the CAC.
The technical issue at stake concerns the establishment of a lower Brix level for juices and nectars obtained from Vitis labrusca and its hybrids at 14° (instead of 16° for those obtained from grapes obtained from Vitis vinifera L.), while suggesting the addition of an explanatory note rather than a stratification of the table set in the Annex of CXS 247 by stating that “It is recognized that in different countries, the Brix level may naturally differ from this value. In cases where the Brix level is consistently lower than this value, reconstituted juice of lower Brix from these countries introduced into international trade will be acceptable, provided it meets the authenticity methodology listed in the General Standard for Fruit Juices and Nectars and the level will not be below 14ºBrix for grape juice from Vitis labrusca and hybrids thereof. Such an approach was considered to better align with other food commodities in the table such as apple and pineapple.”
This issue was largely debated because, in the case of a future lack of consensus on such a technical matter, CAC47 will not be able to resolve that issue at all and the work to be done may be lost. The issue also entails not only technical questions, but also procedural questions which may be used as a precedent, although the CAC46 report states clearly that this EWG pathway was due to “exceptional circumstances.”
Food Safety Issues that may be related to the use of recycled materials in food contact materials
CAC46 agreed with a USA proposal to issue a circular letter (CL) to gauge whether there would be any need for a possible future new work to provide some guidance about food safety considerations related to the use of recycled material in food contact materials/packaging. The proposed CL will contain specific questions for Codex Members (e.g., to share information on existing relevant regulatory programs or mandates, as well as programs currently under development) and for Codex Observers (e.g., to share information on voluntary programs already undertaken or currently under development, as well as any issues experienced or expected related to availability of appropriate recycled material or trade impacts). Responses will be compiled into a discussion paper for further consideration by the CCEXEC and CAC and identify potential next steps. China indicated that Codex Alimentarius aims at addressing food safety and fair practice in trade and insisted that China has not seen evidence yet demonstrating that recycling materials could raise any food safety concerns. China also pointed out that Codex Alimentarius had no existing framework text about food contact materials in general. China was not seeing this area as a priority for Codex. China further emphasized the need for a solid scientific basis for assessing the food safety risks related to food contact materials (e.g., migration of substances from the packaging to the food). This new – informational – workstream can clearly be qualified as another historical feature of this CAC46, although for now it is only an exploratory compilation of information.
Next year, CAC47 might discuss and address interests, needs, and values or benefits for the Codex Alimentarius to develop such guidelines on food safety-related issues to the use of recycled materials in food contact materials and packaging; or, as suggested by Indonesia, Thailand, and Botswana, to embark on a more ad libidum project to develop a “general standard on food packaging or on food contact materials.” Resources and timeline implications would not be exactly the same.
CAC47 will also have to decide which existing committee (or committees) could such a work be carried out singly (or jointly, e.g., CCFA and CCCF, and/or as suggested by Iraq CCFH), or whether a totally new Codex body would be warranted (i.e., an ad hoc Intergovernmental Task Force working on a limited scope and time-limited output as indirectly suggested by Egypt) and in such case, which Codex Member may be willing to host (and chair) such a new body. It will also depend largely on the competing interests of food packaging and food and drink producing industries, as well countries possible diverging views on how they wish Codex to address this recycled material safety matter specifically or more holistically (as suggested by Cuba to cover outer wrapping as well). As also mentioned by Costa Rica, other ongoing international (UN) discussions about plastics, plastic materials, and recycling targets may also be taken into due consideration.
New food protein sources and food production systems
CAC’s vice-chair, Mr. Diego Varela (Chile), served as CAC46 Chairperson on this topic, given its role in coordinating the activity of a CCEXEC sub-committee on this matter since CAC44 (2021).
CAC46: (a) highlighted the importance of addressing challenges posed by NFPS and the important role Codex can play in this; (b) noted that the current working mechanisms were adequate to address any new work on NFPS that Members may propose; (c) noted the range of issues expressed by Members and Observers and encouraged Members to submit discussion papers or new work proposals, either to active Codex committees or to the Executive Committee through the Codex Secretariat; (d) thanked FAO and WHO for their continuing work relevant to this issue (FAO work: referred to series of meeting as part of the FAO Food Safety Foresight Programme relevant to NFPS (see overall report on the FAO programme), including a recently held expert meeting on plant-based foodstuffs, precision fermentation, and 3-D printing mid-November (see report), as well as a stakeholder technical meeting held on cell-based foods and precisions fermentation earlier in November (see press news), as presented in CRD 2. WHO work: NFPS placed in the context of healthy diets); and (e) Whatever mechanism was used, ensuring inclusivity as well as ongoing efforts to gather accurate and up to date information about this dynamic and changing field was considered paramount.
The discussion focused on (a) how Codex as an international standard setting body could contribute to addressing the issues related to NFPS, and (b) the possible mechanisms by which to undertake such work, as follows:
- Recognition of the importance and relevance of NFPS among Members and Observers and the key role that Codex could play in this area.
- Importance of scientific data and risk assessment as a basis for any work Codex might do in this area, was highlighted with the valuable work FAO and WHO had done to date and could do in the future, recognized.
- Members and Observers shared a range of views about the types of work Codex might undertake on NFPS, as follows:
- developing a definition of NFPS since the term was very broad and there was a need for Codex to define the areas in which it could add value;
- focusing on cell-based meat and seafood and precision fermentation to promote consistent regulatory approaches and risk management measures to these new foods across countries and regions;
- developing general principles on risk analysis of NFPS to support national authorities in the management of NFPS;
- addressing food safety aspects of seaweed as there is an increase in global trade and an absence of standards;
- developing food hygiene guidelines and a code of practice on the production of new foods; reviewing existing horizontal texts to identify gaps that may need to be addressed to ensure they are also applicable to NFPS;
- addressing novel risks introduced by NFPS;
- the need to consider halal requirements in any discussions regarding NFPS;
- using an analysis of the national legislation, regulation, and risk management measures to determine key work areas; and
- identifying those products that have a history of consumption in some countries compared to those that don’t to better define work areas and approaches.
- One Member highlighted the challenges arising due to cell-based technology leading to alternative production methods of traditional products or derivatives thereof, noting that the concerns went beyond food safety and related to food trade. Several Members were of the view that a horizontal approach to NFPS would be more appropriate. Other Members noted the role NFPS may play in the transition towards more sustainable agrifood systems and the related need for Codex standards.
- Several Members recalled that CCEXEC had requested the Codex Secretariat to develop guidance on new work proposals which was planned for 2024, and considered that it would be a useful future resource also for Members planning to submit new work proposals in the area of NFPS.
- Many Members were of the view that the existing working mechanisms in Codex were sufficient to address new work proposals in NFPS. The breath of topics covered by Codex General subject committees as well as commodity committees provided a lot of flexibility and the revision of TORs of these committees, or the establishment of an ad hoc intergovernmental task force, remained options if needed.
- Several Members considered that a new mechanism such as a task force that focused on the unique food safety aspects of NFPS, including, but not limited to, media used in cultured food, would be valuable and fill an existing gap. Others considered that in the absence of concrete work proposals it was premature to consider such a mechanism. A Member urged pragmatism and flexibility in terms of the approach and encouraged CAC46 to fully avail of the range of working modalities Codex had available to it.
- A concern was expressed regarding prioritization of work on NFPS, particularly within existing subsidiary bodies.
CAC46 agreed that any future concrete proposals for Codex texts on new food protein sources (i.e., cell-based and bio-mass technologies; precision fermentation obtained by microorganisms or enzymes more or less genetically modified or even synthetically gene-edited; enhanced plant, algae, microbial, fungi’s proteins or fats, etc.) may be put forward by respecting all existing procedures and prioritization mechanisms, via all the existing Codex Alimentarius bodies (Committees, CCEXEC, and CAC).
Draft guidance (and its decision-tree) for the Operationalization of the consistent and sound application of the Statement of Principles on the Role of Science, Taking Into Account Other Legitimate Factors (the “SOP”)
CAC’s vice-chair, Mr. Raj Rajasekar (New Zealand), served as CAC46 Chairperson on this topic, given his role in coordinating the activity of a CCEXEC sub-committee on this matter since CAC44 (2021).
CAC46 (a) noted the further comments in response to CL 2023/32/OCS-CAC on the draft guidance on the application of the Codex Alimentarius Commission’s Statements of Principle concerning the role of science in the Codex decision making process and the extent to which other factors are taken into account (thereafter ‘SOP’); (b) reiterated its previous conclusion that the draft guidance remained serviceable and available as practical guidance for Chairpersons of Codex Commission and its subsidiary bodies and for Members in situations when there is agreement on science but differing views on other factors/considerations; (c) noted the ongoing differences among Members on the outstanding issue regarding the use of footnotes in the context of the operationalization of the Statements of Principle; (d) noted the ongoing concern among Members about the lack of clarity around the meaning of ‘abstention from acceptance’ and ‘reservation’; (e) confirmed that the scope of developing the draft guidance excluded revision of the SOP in the PM; (f) agreed on the need to gain more experience on application of the draft guidance; and, (g) agreed to revisit the draft guidance in the light of experience gained.
Codex members commented that (i) the draft guidance, while not finalized, was a serviceable and useful practical tool for operationalization of the SOP that could be applied by Chairpersons of subsidiary bodies and Members; (ii) the draft guidance could help in promoting consistent application across Codex committees and gaining experience on its application to inform future discussions on the application of the SOP; (iii) the flow chart included in the draft guidance was useful to guide discussions and assist Chairpersons of subsidiary bodies; (iv) the scope of the work was to develop practical guidance to operationalize the SOP and excluded reopening or changing the SOP in the PM; (v) further work on the draft guidance, while important, should await further experience on its application; (vi) concerns regarding the inclusion of the option of using footnotes, which alluded to the manner in which the standard was adopted, were expressed by several Members, noting that this might devalue the standard and create the perception of second-class standards; (vii) the PM already contained all guidance for Members to either abstain from acceptance or express reservations without preventing adoption of standards; (viii) support for including the option of using footnotes in standards were expressed by other Members who noted that footnotes were already on some occasions used in Codex standards; (ix) the text in square brackets could remain for now while gaining experience on the application of the draft guidance before revisiting it; (x) some Members highlighted the need to provide further clarity on the terms “other legitimate factors,” “abstention from acceptance,” and “reservation”; and, (xi) the possibility of including the practical guidance to operationalize the SoP, once finalized, in the Handbook for Chairpersons.
Diversity of views was largely recognized, and it was noted that the draft guidance was considered useful in its current state to be shared with Members and Chairpersons of subsidiary bodies. It was further noted that additional experience needed to be gained on the application of the draft guidance to inform future discussions on this issue. One Member highlighted the need for clarity on the preliminary and voluntary nature of the guidance.
Future of Codex and Codex Strategic Plan 2026-2031
CAC’s vice-chair, Mr. Allan Azegele (Kenya), served as CAC46 Chairperson on this topic, given his role in coordinating the activity of a CCEXEC sub-committee on this matter since CAC44 (2021). The Chairperson recalled that what had begun as a blueprint for the future of Codex had branched into two separate pathways, with one section of the document now being considered in the context of the Codex Strategic Plan 2026-2031, while the other key element on the Model for Future Codex Work had been subject to CAC46’s discussion. Codex Members shared a range of views as follows: the Model for Future Codex work remained a living document which could continue to capture experiences and developments in the area of working modalities and meeting formats, and the benefits of virtual and hybrid meeting formats in terms of increased transparency, participation and inclusivity in Codex work. There was a need to codify procedural guidance related to these different meeting modalities (in person, virtual, in person with virtual participation). It was noted that Codex members had provided their inputs via a CL (CL 2023/82/OCS-EXEC).
The Codex Secretariat was tasked to present to the CCEXEC86 the data and information on participation, working practices and costs linked to the various meeting formats. CCEXEC86 will therefore work on an updated Model for Future CodexWork, based on information compiled by the Codex Secretariat and Codex members responses to the CL. CCEXEC86 was tasked to discuss the opportunity of developing guidelines and criteria on the use of digital tools. The timely availability of documents supported effective participation in Codex meetings in all official languages remained of high importance in that regard.
Members also took this opportunity to express their appreciation about the process under which the Codex Strategic Plan 2026-2031 was developing so far, and indicated that they looked forward to further consultations foreseen on the future Strategic Plan’s goals and outcomes and the way to formulate them. Several Members highlighted that Codex should focus on matters falling strictly within its statutory purpose/mandate. Other Members highlighted the opportunity of the future Strategic Plan to articulate how Codex Alimentarius could contribute to the transformation of the global agri-food production systems.
 Statements of principle concerning the role of science in the Codex decision-making process and the extent to which other factors are taken into account. (Adopted in 1995. Amended in 2001). In CAC Procedural Manual, 28th edition. FAO, 2023 (ISSN 2520-243X online). See pages 195-196. See https://www.fao.org/fao-who-codexalimentarius/publications/procedural-manual/en/.
 Algeria, Botswana, Iraq, Iran, Qatar, Syria, Thailand, Tunisia, while the United Kingdom noted their intention to abstain from acceptance. Members who formally objected and stated their sustained opposition to advance the draft MRLs: Belarus, China, the European Union (26 countries at the time of the vote), Kyrgyzstan, North Macedonia, Norway, Russian Federation, Switzerland, Türkiye, and the UAE.
 Belarus, China, European Union, Iraq, Iran, Kazakhstan, Kyrgyzstan, North Macedonia, Norway, Moldova, Russian Federation, Switzerland, Syria, Thailand, Türkiye, the UAE, and Uzbekistan.
 Statements provided after the adoption of the MRLs for Zilpaterol hydrochloride: Algeria, Azerbaijan, Belarus, Bosnia Herzegovina, Botswana, Cameroon (abstained from approval), China, the EU27, Georgia, Indonesia (ban it domestically but OK with Codex MRLs), Jordan, Egypt, Oman, Kazakhstan, Kyrgyzstan, Malta, Mauritania, Mauritius, Norway, Qatar, Moldova, Russian Federation, San Marino, Saudi Arabia, South Africa, Switzerland, Thailand, Tunisia, Türkiye, UAE, UK (abstained from approval), Tanzania, USA, Uzbekistan, and joint statement by countries of the CCLAC region (Antigua and Barbuda, Argentina, Belize, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominica, Dominican Republic, Ecuador, El Salvador, Grenada, Guatemala, Guyana, Haiti, Honduras, Jamaica, Mexico, Nicaragua, Panama, Paraguay, Peru, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Suriname, Trinidad and Tobago, Uruguay, and Venezuela).
 Reservations expressed by the EU27 (also on tetracyclines, spectomycin, tilmicosin), supported by Georgia, North Macedonia, Norway, Switzerland, Tunisia, Türkiye, and the United Kingdom; other reservations by Colombia; Russian Federation (CRD 58), Syria.
 With the reservations of:
Egypt and the United Arab Emirates, on MRLs for Broflanilide (326) due to the lack of available toxicological data on this pesticide at national level. It was noted that according to USA-EPA evaluation report from 2022, this compound was likely to be carcinogenic in humans. But it was also equally noted that the FAO/WHO JMPR considered those issues and noted that “tumours were observed at the lowest observed adverse effect level (LOAEL) of 95 mg/kg bw per day in rats” and that by establishing an ADI at 0.02 mg/kg body weight per day, it would allow for a margin of safety of at least 4750 which led JMPR to conclude that such an ADI was “adequately protective.”
The European Union, North Macedonia, Norway, and Switzerland, on the MRLs for different combinations of pesticides and commodities as listed and for the reasons explained in CRD23 and in particular that, in their view, several of these Codex limits (CXLs) were not acceptable to the EU “with respect to areas such as consumer protection, supporting data and extrapolations, as well as environmental issues of global nature (such as the decline of pollinators or the accumulation of persistent bio-accumulative and toxic substances in the environment) in conformity with WTO rules and as announced in the Farm to Fork Strategy and the EU Green Deal.”
 See Feature article in WFRR Vol. 32, Number 11 (ISSN: 1752-7449 (Online))
 Ibid footnote 10.
 It should be noted that the fruits and vegetable juices and nectars are specifically now part of the CCPFV terms of reference, and that CCPFV is adjourned sine die (i.e., dormant) and used to be hosted by the USA until now. But originally, the standard was developed by a dedicated ad hoc Intergovermental Task Force, dismissed upon completion of its work. The representative of the OIV indicated that OIV member countries were committed to provide data to this Codex EWG process, noting that the OIV own standard-setting work on this very same issue had been put on hold pending the CAC decision as to avoid any inconsistencies between international standards, set on the one hand by the OIV and on the other hand by the Codex alimentarius Commission.
 See CRD 36. During the discussion, the proposal was formally supported by: Brazil, Cameroon, Cuba, Ecuador, Egypt, Gambia, Haiti, Indonesia, Jordan, Mexico, Nigeria, Panama, Peru, The Philippines, Thailand, Türkiye, Vanuatu, Zambia.
 Three dimensional (3D-) food printing is not obviously a source of new food protein as such, but a technology which covers new ways to approach ‘extrusion’ – ‘mixing’ – ‘cooking’ techniques
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