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This article was published in World Food Regulation Review, November 2022, p. 33-34.

By Christophe Leprêtre1 (Keller and Heckman LLP)

The 45th plenary session of the Codex alimentarius Commission (CAC45) was held on the week of 21 to 25 November 2022. It generally made expected progresses on important standards such as heavy metals and mycotoxins maximum limits in key foods, with a controversy about different levels on infant formulas intended for food aid vs placing on the market. CAC45 reached again a climax of unbearable suspense – and controversy – on which and how other legitimate factors should – or should not – be taken into account in setting new work, or in advancing and adopting new standards, especially for the adoption of a MRL for the growth promoting synthetic chemical zilpaterol hydrochloride for bovine animal production (currently in use in a limited number of countries or banned in major countries such as China), which was subject to an epic two round-voting unfinished epilogue. CAC45 has also seen intense exchanges on some pesticide residues discussion, as well as on a couple of commodity standards, such as moisture content for fresh dates, level of defects for the “Extra class” quality for e.g., onions, shallots or berry fruits; or the country of harvest vs origin for saffron.

The 45th CAC session was held for the first time in person since the Covid-19 worldwide outbreak spread in March 2020, as well as in hybrid format allowing remote attendance by key delegates such as Thailand or Iran. The session was also streamed live online for the public.

Pending further reporting on the session in the next WFRR issue, it is fair to say that this CAC45 meeting could be seen, in many aspects, as a transition towards a new Codex alimentarius, in times of global challenges – and diverging views – about the way this Joint FAO/WHO food standard program is working, while maintaining untouched its dual mandate of protecting the health of consumer of foods and ensuring the continuous application of fair practices in international trade of foods (which includes labelling and conformity assessment aspects), and at the same time respond to growing consumer and developing countries aspirations legitimate contemporaneous expectations about their foods, the way they are produced and the ways information are conveyed to them, and the possible negative externalities that food production systems which are driven by such standards may have, despite those standards may ensure safety and quality of those foods. The session has also acutely demonstrated how much countries may be divided and how difficult it has become to chair a plenary CAC session to adopt such international standards by consensus.

First example: zilpaterol hydrochloride.

Long story short, CAC45 has had to develop a specific voting mechanism (see Figure 1) to make sure countries would accept any ultimate decision on the proposed MRLs for Zilpaterol hydrochloride, a synthetic substance used for growth promotion in bovine production permitted in some countries, while being fully banned and not considered as a necessary veterinary treatment in others since 20132 . The first CAC45 vote cast ended up with agreeing to advance the proposed MRL at the next step by a large majority, indicating to those countries banning the substance that there was a recognition of the JECFA work and that in the absence of food safety concern, then the MRL should be progressing in the adoption step process.

The second CAC45 vote cast failed short by only 3 country ballots to reach the 2/3 required majority to advance the MRL to its final step prior to final adoption. As such, the MRL will be subject to another round of comments and those comments will be considered directly at the next CAC46 next year. A first. In other terms, it was somehow a draw, and ren-dez-vous is taken at the next CAC meeting for another – dramatic – vote (by simple majority).

The heart of this controversy is also different views about the common understanding and the application 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 Account3 (factors that some argue shall only fall within the dual mandate of Codex, others being strongly in favor to enlarge them to other aspects such as environment protection, sustainability of food production systems, socio-economic consideration or even ethical matters). On that point, CAC45 commanded the work coordinated by CAC Vice-Chairperson Raj Rajasekar (New Zealand) with a draft operationalization of the Statement of Principles. That approach, although still a draft, will be tested by CAC and other Codex committee’s Chairpersons. (To be expanded upon in the next issue.)

Figure 1. Flowchart on CAC45 specific decision-making process on Zilpaterol MRL

Flowchart on CAC45 specific decision-making process on Zilpaterol MRL

Second example: total aflatoxins in infant formula and young children intended for the general population or for food aid.

Almost all African countries and some Near East countries (e.g., Syria) express a strong discontent to see that the proposed ML for total aflatoxins for foods intended to infant and young children destined to food aid be proposed at 33% higher level than those commercial foods marketed for the normal population (i.e., 15 ppb vs 10 ppb). Most of them representing 50+ countries expressed their reservation. Despite this, the levels were pushed through for final adoption, without a vote, considering that adopting such MLs would constitute an important safety net for food aid and sourcing to the WFP or MSFs. From a risk communication point of view though (the third pillar of risk analysis with risk assessment and risk management), the perceived message was that food aid could be allowed to contain more “nasty stuff” than foods going to developed markets. The truth is both levels are protective enough from a public health perspective, as pointed out by JECFA secretariat, while keeping food aid in sufficient and affordable quantities for donor and emergency organizations.

Third example: commodity standards have been at the heart of Codex work.

Codex is to celebrate its 60th anniversary next year and it is important to note that it started with various cheese standards development (from 1963 to 1966). So, when it is suggested that the Extra Class for onions and shallots could be subject to a higher presence of defects such as mold. Here too, two visions are in opposition. One considers that it is safe because the defects are only on a part of the commodity, which is generally not consumed, and therefore it is safe and could be permitted. Another considers that the Extra class defines a premium category of products for which no defect tolerance shall be permitted because it is a higher value for growers. Reservations were noted for the second vision and the revised standards were adopted. Whereas the other way round could have been suggested, or a vote could have been proposed.

Fourth example: Saffron.

The Committee in charge of spices and culinary herbs suggested that the declaration of the country of harvest could remain voluntary in the standard. The labelling provision would be reviewed for endorsement by the next CCFL. Given the cases of food fraud and misbranding entailed for this very high value spice, producing countries were of the view that the country of harvest should be mandatory (in addition of the country of origin) to make sure that traders and consumers would be reassured about the standards of production in those countries and the identity of the product. There too, two visions of what should prevail in international trade for such foods, with regards to conformity assessment, consumer legitimate expectations and protection of traditional ways of producing Saffron, or a mass production of such products according to other techniques.

All Codex texts adopted as final international food standards by the CAC all available at

All working documents for the preparation of CAC45 are available at 

1 Food Safety Specialist, i.e., Senior Regulatory and Scientific Affairs Counsellor at Keller and Heckman LLP Brussels office

2 See JECFA specifications at

3 See new Codex webpages on the Codex Procedural Manual at