This article was published in World Food Regulation Review, January 2023, p. 29-34.
By Christophe Leprêtre1 (Keller and Heckman LLP)
The once-a-year Codex Alimentarius Commission session (CAC45) recently adopted eleven (11) new international norms in various areas ranging from national food law template to new limits for heavy metals, pesticides, new standards on dried meat and ready-to-use “therapeutic” foods in case of severe malnutrition. Five (5) Codex texts were adopted as revised, including the fundamental norm about food hygiene general principles (CXC 1), as well as some amendment to the essential composition for sunflower seed oils. Eight (8) new work items were approved.
Finally, CAC45 revoked one text of methods of analysis and a few existing MRLs for pesticide residues2. CAC45 also noted the conclusions about the draft operationalization scheme for Codex bodies’ Chairpersons – and for Codex members – to handle “other (legitimate) factors” (in addition to risk assessment conclusions) when such factors may be raised within the dual mandate of the Codex Alimentarius Commission. On new food (protein) sources and “new” food production systems (NFPS), CAC45 referred to current Codex procedures for new work and asked FAO and WHO to report about their activities, where relevant, within existing Codex bodies.
The 45th CAC session was held in hybrid format during successive daily sessions. For the second time in a row, CAC45 did not complete the adoption of its report within an 8 hour deliberation. Codex members have used a written process to review the remaining sections of the final report via a Codex forum online. Mr Tom Hei-landt, CAC’s Secretary, took this opportunity to make a proposal for changing the method of adoption of Codex sessions report3.
Adoption and Advancement of new food ‘norms’
New regional and international standards, guidelines, or codes of practices
CAC45 has adopted the following two (2) new regional standards for the African region on:
• a regional template for national food safety legislation; and,
• a regional standard on dried meat (having the potential to become an international standard in the future).
CAC45 also adopted the internationally applicable norms regarding:
• Management of biological foodborne outbreaks,
• Emergency ready-to-use “therapeutic” foods (in case of severe and acute malnutrition);
• Onions and Shallots;
• Berry fruits;
• Dried or dehydrated chilli pepper and paprika;
• Cadmium reduction and prevention in cocoa beans; and,
• Guidelines for the recognition of active substances or authorized uses of active substances of low public health concern that are considered exempted from the establishment of an MRL or do not give rise to residues.
New maximum levels for contaminants and residues of agro-chemical or veterinary treatments in foods CAC45 also adopted:
• four hundred seventy six (476) new protective maximum limits for pesticide residue (MRLs) and
• thirteen (13) limits for contaminants (MLs) for:
– cadmium in cocoa powder with 100% cocoa solids on a dry matter basis;
– lead in cereal-based foods for infants and young children, white and refined sugar, corn and maple syrups, honey and some sugar-based candies; total aflatoxins in maize grain, destined for further processing; flour meal, semolina and flakes derived from maize; husked rice; polished rice; sorghum grain, destined for further processing; and two for cereal-based food for infants and young children, including once for food aid programs; and,
• methylmercury in orange roughy and pink cusk eel.
Amendments to existing standards
CAC45 adopted several proposed amendments to:
(a) the standard on named vegetable oils and fish oils;
(b) Latin American regional standard for Castilla Lulo (“small orange” from Solanum quitoense Lam.);
(c) global standard on fresh curry leaves;
(d) an alignment of all food hygiene texts with the CAC45’s revised general principles on food hygiene; and
(e) the development of principles and guidelines on the use of remote audit and verification in regulatory frameworks.
Advancement subject to further discussion in Codex Committees or the CAC
It also advanced to next step of discussion other important texts and MRLs, including a highly disputed text on veterinary substance zilpaterol hydrochloride4 in kidney, liver, and muscles (but not in fat, because no residue traces are found in that tissue, so MRL is not applicable to animal fat).
“Operationalization” of the 1997 Statements of Principle Concerning the Role of Science in the Codex Decision-Making Process and the Extent to which other [legitimate and international] Factors are taken into Account5 (thereafter “Role of Science, including OLFs”) See figure 1.
This matter is at the heart of the most animated Codex alimentarius debates, controversies, and misunderstandings around the second part of Statement which is referring to “other legitimate factors”. Those factors are those that food safety risk managers may take into account when establishing a maximum limit for e.g., agrochemical or veterinary treatment substances or a specific technical restriction (such as quality grades for some vegetables e.g., Extra Class vs Normal Class) when adopting a mandatory requirement at national level.
The concept relates to similar wording found in the 1995 WTO Agreements on Sanitary and Phytosanitary (SPS) measures, relating to protection of plant, animal, or human health6 and on Technical Barrier to Trade (TBT) on product quality and other aspects relating to product integrity and authenticity (referring to non-directly health related “technical norms)7. It is also intimately linked to the sovereign right of any country to determine the appropriate level of sanitary or phytosanitary protection it wants to set at national level, while taking into account the objective of minimizing negative trade effects (as per Article 5.§4 of SPS Agreement) and if it deviates from international standards, it should be based on a proper analysis of the risks (Article 3.§1 to §3 and Articles 5.§1 to 5.§3 of SPS Agreement)8.
One of the principal goals for the Codex alimentarius Commission and its members is to develop and reach consensus on a set of international standards which includes food standards and general standards; guidelines; recommendations (code of recommended practices, including good hygiene practices) and statements. They all have the same legal level of applicability from a WTO standpoint, to ensure the objective of harmonization (Article 3 of SPS Agreement) and thus aim at reducing non-tariff (e.g., not linked to customs duties or fees) burdens, limit the possibility that national measures taken by a country or a group of countries are in fact a means of arbitrary or unjustifiable discrimination (between Members where the same conditions prevail) or be a disguised restriction on international trade (i.e., protectionism).
Codex texts are deemed to be compatible with the conditions set in the WTO SPS and TBT agreements9 and national measures consistent with international standards are also deemed to be compliant with these multilateral trade agreements requirements. Of course, Codex alimentarius tries to remain self-standing and does not refer to those trade considerations managed under the WTO SPS and TBT committees.
To avoid the continuation of endless debates on the interpretations that Codex members may have on the Statement of Principle on The Role of Science including OLFs itself and that of the Statement of Principle on Risk Assessment10 and related Working Principles for Risk Analysis set in the Procedural Manual11 , a dedicated sub-group of the Executive Committee (CCEXEC) has developed with a decision-tree (see Figure 2).
The decision-tree is intended to apply the two Statements Principles in a sequential manner to take all aspects into account before adopting a Codex normative text, including by a vote when warranted. The decision-tree is aiming at guiding all Codex stakeholders, including the Chairs of the CAC and related Committees, Task Forces and, where appropriate, Working Groups. Indeed, CAC45 noted that although the text annexed to the CCEXEC83 report was not final (square brackets remaining), CCEXEC83 considered it as a serviceable document; fairly reflecting the comments made and considered by the subcommittee.
Codex Members expressed a range of views about the draft guidance, noting that it was serviceable and useful, in particular the flowchart, and had been already applied to a certain extent during CAC45 (e.g., on Zil-paterol, MRL for pesticides for adoption and discontinuation or on ML for mycotoxins). Although CAC45 was unanimous about the current draft Guidance, there were diverging views as to whether it should be used as such by Chairpersons to gain experience and learn lessons out of such use or being further elaborated before being used.
As noted by the Chair of the CXEXEC subcommittee, the option of using a footnote in a standard in square brackets remained an outstanding issue, with some arguing the option should be deleted and others supporting its retention. Those delegations supporting the deletions were concerned that such a footnote would create a precedent and devalue the whole Codex. Those delegations supporting the footnote retention reminded that the use of footnotes has been useful in other Codex texts to add clarity and transparency. It was also noted that some members believe that more guidance was needed on the difference between abstention from acceptance and reservation.
One delegation noted that it was important not just to focus on the risks of different foods, but to also consider their potential benefits to health noting that WHO had defined health as a state of complete physical, mental and social well-being and not merely the absence of disease and infirmity.
While commending the progress made on such Guidance, CAC45 acknowledged that the draft guidance attached to the report of CCEXEC83 was neither final nor agreed but noted that through the process of developing the draft guidance, Members had been sensitized to the practical application of the SOP on Role of Science including OLFs.
CAC45 agreed with the proposal to refer the draft guidance to the Chairpersons of Codex subsidiary bodies to facilitate deliberations on matters that fell within the scope of the SOP and urged members to take it into account during standards development and advancement processes.
A circular letter (CL) will be prepared by the Codex secretariat inviting Members and Observers to provide specific suggestions to improve the draft guidance, its finalization, and its possible incorporation into guidance documents for Chairpersons and Members. These comments will be reviewed at CAC46.
New Food Production Systems and New Food Protein Sources (NFPS)
CAC45 agreed that the work done by the CCEXEC subcommittee and the information collected on NFPS had sensitized Codex to their challenges and opportunities. CAC45 recognized the importance of Codex working in a flexible and timely manner to consider NFPS as an important topic in the development of international standards aimed at protecting public health and promoting fair practices in the food trade. CAC45 also acknowledged the role of CCEXEC in ensuring cross-committee coordination as part of the critical review.
Mostly, CAC45 strongly encouraged FAO and WHO to continue sharing information on NFPS with all Codex bodies through the typical agenda item 3 “Matters arising from FAO and WHO”, to ensure full awareness of upcoming issues in this area and which could be considered by members for possible new work.
As such, CAC45 encouraged Codex Members to submit proposals related to NFPS using the existing Codex mechanisms and Codex subsidiary bodies to consider these proposals on NFPS in their own program of work and priority-setting deliberations. Views expressed by members are summarized.
CAC45 didn’t reach a consensus on the need for a new cross-cutting coordination mechanism for NFPS and requested the Codex Secretariat to send a circular letter (CL) to all Codex members and observers to identify possible issues related to NFPS that the current structure and procedures could not address and options to address them, for a possible further discussion at CAC46 (Nov. 2023).
All Codex texts adopted as final international food standards by the CAC are available at https://www.fao.org/fao-who-codexalimentarius/codex-texts/jp/ All working documents for the preparation of CAC45 are available at https://www.fao.org/fao-who-codex-alimentarius/meetings/detail/en/?meeting=CAC&ses-sion=45
1 Food Safety Specialist, i.e., Senior Regulatory and Scientific Affairs Counsellor at Keller and Heckman LLP Brussels office.
2 Guidelines on the use of mass spectrometry for the identification, confirmation and quantitative determination of residues (CXG 56) as well as a few existing MRLs pesticide residues.
3 It was suggested that CAC members may consider other report adoption methods, such as having a drafting committee of Members to agree on the summaries and conclusions, or report only main conclusions in such reports while publishing an appended verbatim transcript of the session, a system already operated by FAO.
He also suggested whether it should be a written, virtual, hybrid or in-person (physical) adoption process. See also Codex News at https://www.fao.org/ fao-who-codexalimentarius/news-and-events/news-de-tails/en/c/1626947/
4 See WFRR November 2022 issue
5 See 27th edition Codex Alimentarius Commission’s Procedural Manual https://www.fao.org/fao-who-co-dexalimentarius/sh-proxy/en/?lnk=1&url=https:// workspace.fao.org/sites/codex/Shared%20Documents/Publications/Procedural%20Manual/Manual_27/ PM27_2019e.pdf
6 Article 5.3 “In assessing the risk to (…) health and determining the measure to be applied for achieving the appropriate level of sanitary or phytosanitary protection from such risk, Members shall take into account as relevant economic factors: (…) the relative cost-effectiveness of alternative approaches to limiting risks.” and to a certain extent 5.5. and Annex 3 F “Where international standards exist or their completion is imminent, the standardizing body shall use them, or the relevant parts of them, as a basis for the standards it develops, except where such international standards or relevant parts would be ineffective or inappropriate, for instance, because of an insufficient level of protection or funda-mental climatic or geographical factors or fundamental technological problems.” Echoed by Article 3.3.
7 Article 2.2. “(…) for instance because of fundamental climatic or geographical factors or fundamental technological problems.”
8 Article 3.3 “Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on the relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a Member determines to be appropriate in accordance with the relevant provisions of paragraphs 1 through 8 of Article 5. Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement.”
9 Note of the drafter: that this is quite disputable and is only based on the assumption that contributors to the elaboration of Codex texts pay due attention to the absolute need for such a compatibility/consistency point, given that there is no formal authority – or body – in charge (yet) to check such compatibility or consistency before a Codex text is finally adopted by the CAC, be it within Codex (perhaps another task to think for the CCEXEC in the future) or outside Codex (e.g., WTO). One may question whether Codex guidelines forstering the development of national and or regional voluntary schemes or mandatory legislation or technical regulations (e.g. FOP-NL schemes) are duly compatible with SPS – and moreover – TBT requirements.
10 Adopted in 1997. “STATEMENTS OF PRINCIPLE RELATING TO THE ROLE OF FOOD SAFETY RISK ASSESSMENT:
1. Health and safety aspects of Codex decisions and recommendations should be based on a risk assessment, as appropriate to the circumstances.
2. Food safety risk assessment should be soundly based on science, should incorporate the four steps of the risk assessment process, and should be documented in a transparent manner.
3. There should be a functional separation of risk assessment and risk management, while recognizing that some interactions are essential for a pragmatic approach.
4. Risk assessment should use available quantitative information to the greatest extent possible and risk characterizations should be presented in a readily understandable and useful form.”
11 Section entire Section 4 of CAC Procedural Manual 27th edition (2019). Working Principles For Risk Analysis For Application In The Framework Of The Codex Alimentarius and the dedicated Working Principles for CCFA (food additives, flavourings and processing aids), CCCF (contaminants and toxins), CCRVDF (veterinary ddrugs), CCPR (pesticide residues), CCNFSDU (nutrition, baby foods, food supplements and other foods for special population groups or dietary requirements or nutritional needs), CCFH (hygiene, microorganisms and viruses) and, where their exist, related policies thereof.
12 See in particular CCEXEC82 agenda item 4 working document: interim report https://www.fao.org/fao-who-codexalimentarius/sh-proxy/en/?lnk=1&url=https%253A%252F%252Fworkspace.fao.org%252Fsites%252Fcodex%252FMeetings%252F-CX-702-82%252FWD%252FEx82_04e.pdf
13 As part of the views expressed by delegation (and reflected in CAC45 report), it is interesting to note that (a) NFPS were complex and required an inclusive interdisciplinary approach; (b) NFPS were of increasing importance and due to lack of international guidance, harmonization would be more difficult in the future if Codex did not take timely action, including proper definitions ; (c) NFPS might encompass areas such as (i) plant, animal, or microbial based foods that were part of the traditional diet in some countries but not yet widely consumed elsewhere; (ii) new ways in which existing foods were processed; and (iii) foods produced by various new technologies, such as (animal) cell-based protein (meat). It was also noted that some of these areas could be addressed using existing approaches while for others which were still in the research and development stage, standard setting would be premature. Views were expressed claiming that NFPS would be key to adapting food systems capable of feeding a growing population and could significantly contribute to more sustainable and healthy diets; while international guidance could help minimizing trade barriers. As such, the development of risk analysis principles for new food may need to be further explored and it should rather focus on how to evaluate NFPS and guide Members on the related risk identification and options for prevention and control, while expert groups or scientific advice could be provided by FAO and WHO, as needed.
Figure 1. CAC Procedural Manual Statement of Principles
Figure 2. Flowchart for decision-making process and taking into account other legitimate factors Flowchart