Top: QU Dongyu, Director-General of FAO, far left, opens the CAC45. The UK’s Steve Wearne, centre, in the Chair for the first time. Below: Member states watch the screen for the controversial vote on Zilpaterol, the drug used to promote growth in livestock. Photo credit: ©FAO/Roberto Sciotti
CAC45: RUTF Guidelines adopted but still no Zilpaterol conclusion
Rome, 21-25th November 2022
The 45th Codex Alimentarius Commission, a hybrid meeting in Rome with over 350 participants online and 400 in person, ended on Friday 25th November.
A key agenda item for IBFAN and its partners ENCA, ILCA and WPHNA was the Draft Guidelines for Ready to Use Therapeutic Foods (RUTF) that UNICEF first proposed in 2014. IBFAN considers that it was a big risk to hold such sensitive discussions in the Codex Committee on foods for Special Dietary Uses (CNFSDU), a particularly problematic Committee, where typically over 40% of participants represent the food and agri-industry, many sitting on government delegations. IBFAN’s advocacy succeeded in improving the Guideline’s safeguards on ingredients, labelling and the conditions for use, with continued breastfeeding and nutritious family food highlighted and a ban on promotional claims and the general sale of RUTF. However, our concerns about the high levels for sugar, pesticides and contaminants such as aflotoxins remain. Our call for support for wet-nursing and re-lactation was not taken up. Another key worry is that an imported, expensive, Codex-approved RUTF, will be seen as the first and best line of treatment, instead of continued breastfeeding () and culturally appropriate diverse home or locally produced treatments. (1) The Guidelines were finally adopted at CAC45, with only minor editorial changes .
The debate on Zilpaterol (the drug made by Merck used to promote growth in livestock) illustrated the dilemma policy makers face when trying to protect both health and the environment in a corporate-driven food system. CAC45 tried to ignore these pressing wider issues and focused instead on the narrow issues of whether Maximum Residue Limits (MRLs) should be officially approved by Codex for use in world trade. Many countries, including the UK, the EU, China and Russia ban the use of this drug and few countries except the USA and Argentina admit to using it. It seemed that the countries that wanted an MRL were doing so to protect their populations from residues in imported meat. The majority of consumers in Europe are also opposed to its use for health, environment and animal welfare reasons. Not surprisingly, Codex has been unable to reach consensus on this matter, and after two votes, the work will remain with the CAC and not move to the final step 8 this year. We warned that a Codex MRL based on narrow criteria, for the commercial use of a drug, would accelerate its global use and misuse (as the Follow-up Formula standard did), taking us in entirely the wrong direction, undermining bio-diverse, traditional food cultures. We called for mandatory labelling if Zilpaterol is used.
See HERE and below for our interventions
The debate on the maximum levels for contaminants such as Cadmium, Lead and Aflotoxins was also troubling. Many African and some of the Arab countries raised concerns about the proposed high levels for Aflotoxin in baby foods and especially the even higher levels for baby foods as food aid – something defended by Medicines sans Frontiere (MSF)and UNICEF on the basis of economics (and that children are only fed these products for a short while). Eventually a small compromise was made – that there could be a review of evidence in 3 years time instead of 5 years. We remain very worried about this issue.
IBFAN and ENCA made 13 interventions in all, including interventions on RUTF, Aflotoxins, Pesticides, science, the Use of Codex standards, Matters arising from WHO and FAO, the Codex Trust Fund and the 60th Anniversary of Codex.
What happened Day by Day
DAY 1 Monday 21st November
The UK’s Steve Wearne, as the new Chairperson of the Commission, opened the meeting and, after the addresses from FAO and WHO, gave thanks to WHO’s Dr Chizuru Nishida, who has been the WHO representative at Codex for 29 of her 36 years at WHO. The IBFAN Codex team is acutely aware of the enormous difference that Dr Nishida has made to our work, providing strong and consistent support for policy coherence with WHO’s recommendations throughout that time. She will be hugely missed.
QU Dongyu, Director-General of FAO began his welcome address saying that he was born in 1963, the same year as Codex. He stressed food security, efficiency, professionalism, the critical role of science, technology and innovation, and said that Codex standards help provide health, prosperity and healthy planet. He also pledged full transparency and that no one would be left behind.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, followed via video, with a bleak and honest message, welcoming the fact that everyone could meet face-to-face again:
“But you meet at at time of unprecedented challenges. Conflicts and climate change are exacerbating food insecurity and malnutrition. Most people around the world who have access to food can not afford healthy diets. Deforestation and habitat loss are increasing the risk of zoonotic pathogens. Anti Microbial Resistance, environmental contamination and degradation, occupational hazards, unsafe and adulterated foods – the list goes on. A transformation of the world’s food systems is needed urgently, based on a One Health approach that protects and promotes the health of humans, animals and the planet. The Codex Alimentarius has a critical role to play in guiding country regulations that promote health, while facilitating fair trade. WHO remains committed to working with FAO to develop and deliver high quality scientific advice and evidence-based global food food safety guidelines and standards.”
IBFAN/ ENCA STATEMENTS
The Philippines commented on the need to ensure that local foods are not undermined. Brazil spoke but did not read out the excellent written comments it had submitted. No-one objected to the adoption.
Alison Fleet, UNICEF Thanks the UNICEF to the working groups, Senegal and South Africa. This Guidelines will enable the most vulnerable consumers to have access to therapeutic foods that are safe and nutritious and will restore them to health in just under 4-6 weeks. Now we look forward to the implementation of these GL so more children can gain access to treatment. Thank all the Member States for the finalisation of this work.
Patti Rundall (ENCA). We had some concerns about these Guidelines in the very beginning but we are pleased that some, many of our comments have been taken on board and removed. The products will not be on general sale which is a huge relief to us, because we have to be aware that there is a commercial agenda to push products for malnourished children, so I am quite pleased that we managed to get that in. However, there are still some concerns with this document. There should be more about relactation and breastfeeding that can be the lifesaver for children in these dreadful situations. And the sugar levels have been mentioned by many member states – they are too high. So there are things that we hope that governments will pick up when they use these Guidelines and that they will actually make sure that the safest possible foods are given to these children. And also, ideally, they should be locally made nutritious foods, not replacing family foods that are there. There is a great danger that that can happen that the imported food can look so much better and more effective than real family foods that are not processed.
Scott Tipps, NHS – expresses concern about the low magnesium level. 15mg per day is insufficient, especially for malnourished children.
Elisabeth Sterken (IBFAN) Thank you. Yes, we have a few suggestions for improving the guidelines, in particular the Preamble. We would like it to include wording that would strengthen the support for breastfeeding – which we all recognise is the life-saving provision, particularly for the immune capacity as well as the appropriate nutrients for healing the gut and other areas of concern for malnourished children. We also would like that instead of saying ‘promoting’ breastfeeding it should say ‘supports’ breastfeeding. There’s a big difference between supporting and promoting. Support means providing help to mothers in order to breastfeed. As well, there should be mention of support for wet-nursing and support for re-lactation. These are very important components for the rehabilitation of malnourished children. Additionally we are concerned about the carbohydrate levels. 20% remains very high for sugars to be added to these products. These are empty calories when malnourished children need nutrient-dense foods as much as high energy foods so we feel the sugar levels should be reduced to 10%. In the recommendations for use we would like to see the provision of potable water because the density of these products means that thirst is a big concern.
WHO Chizuru Nishida. WHO supports but wants a few editorial comments to ensure it is aligned with updated WHO guidelines , particularly on the definition of SAM.
Anja Bronstrup: Chair of Codex Commission for Foods for Special Dietary Uses (CNFSDU) This was first proposed by UNICEF in 2014 – and approved by CAC in 2016. We agree the text is not perfect – and agree with WHO and EU to make these few changes that will improve the readability but not change the meaning.
Day 1 Afternoon and Tuesday
Patti Rundall: This is a horrible problem, and we recognise the difficult balancing act you have here. One problem is that Codex Standards are so often used as the ideal and promoted as such. We need to be honest about the risks of those products – especially when they are promoted as the healthier option. We faced all these problems in the debate about RUTF. Food security is also a very tricky thing to address. Its very important that the import of foods for aid does not undermine national agriculture and the production of healthier biodiverse family foods and of course breastfeeding, which is the safest of all. So we are very, very concerned about this but I can see that there are real problems. Whatever is decided it must be made very clear that this is a Minimum [safeguard], not a Maximum.
DAY2 Tuesday Agenda Item 4.8
Tuesday afternoon: Patti Rundall (on the JECFA question). Thankyou Mr Chair. This is a worrying part of the corporate-driven food system and the JECFA analysis does not touch on the wider questions that are so important. The use of growth enhancing drugs for purely commercial reasons is a complex cross-cutting issue that involves health, veterinary medicine, ecology, food systems and the political control of resources. Having a Codex standard based on narrow criteria will accelerate its global use and misuse and will take us in entirely the wrong direction, undermining bio-diverse, traditional food cultures. Did JECFA explore whether resistant bacteria and resistance genes might emerge and spread from food animals to humans through the food chain? Or whether such use would increase the risk of antimicrobial resistance (AMR) – now recognised to be one of the greatest global threats to public health, leading to 5 million deaths every year.We believe this standard could have a devastating impact on human and planetary health. And that Codex must move to a One Health approach (as WHO and others are attempting to do) and address veterinary and environmental concerns not just human health. Countries will certainly be under pressure to allow this product to be used.
DAY 3 Wednesday Elisabeth Sterken (IBFAN) (on MRLs) Thank you chair. IBFAN supports the position of the European Union, Norway, Switzerland and others who do not support the advance of the MRLs for zilpaterol. Clearly there is no consensus to move this item forward. IBFAN is of the opinion that there are many questions remain regarding human health, animal health, the lack of information about the interaction of growth promoters with other chemical and biologically active food additives and contaminants as well as other concerns brought up in this meeting. We are not in doubt about the science provided by JECFA, However we are particularly concerned about the lack of rigourous convincing evidence relating to the health impact on pregnant women, breastfeeding mothers, older infants young children . What impact does it have on the growth and development of children – does it contribute to the huge burden of overweight and obesity? The impact on the microbiome? Mr chair, the evidence for safety is only as good as what has been researched which is no doubt valid but far too many gaps exist. It is our opinion that any setting of global policy must protect the most vulnerable of our global community and so we take the position that the only safe MRL is no MRL. Thank you Mr Chair.
Patti Rundall: Finding evidence of harm on animals, the environment or anti microbial resistance – should not be the responsibility of countries who worry about Zilpaterol. The corporations and countries now using Codex MRLs to promote and expand the use of this product should first take a precautionary approach and investigate the wider questions that THOSE OUTSIDE this building are rightly worried about. In this context setting MRLs is an empty safety assurance – there is no safe MRL.From our experience we know how weak standards – once set – are used to challenge government regulations on marketing, labelling and safety. There have been 245 such challenges – many behind the scenes – on formulas for babies – a major factor in the undermining of safeguards over the years.Before it is too late. Please let’s wind these risky processes DOWN not speed them UP. Please listen to WHO and other warnings. Show that Codex is aware of what is actually happening in our world. Most countries here do not use this product themselves and many consumers have no idea if they are consuming it because its not declared on the food. This is a violation of their rights.
AFTERNOON after the vote.
This is such a worrying development – for all the reasons expressed. But I wonder in the meantime, while thought is given to future work to assess risks, could countries take steps to limit inform the public and limit the promotion of these products – I realise that at present business to business – but there must be some way to do this. Perhaps there could be mandatory product information or labelling? It seems to me that many countries do not want to use the product, but they believe that having an MRL is some sort of safeguard if they do have to import meat grown in this way. Few seem to realise that a Codex standard will boost the sale enormously. We had this with the follow on Formula standard – a totally unnecessary product but one whose sale was hugely boosted by a bad Codex standard.
DAY 3 Wednesday afternoon: Agenda Item 4.6 Pesticides Residues
Elisabeth Sterken:Thank you, Mr Chairman, IBFAN is aligned with the European Union, Finland, Germany and the issues raised by countries who are opposed to moving this agenda item forward. IBFAN wishes to express our concern regarding the ever increasing burden of exposure to pesticides. We wish to note that the safety of the levels of pesticide as expressed in the MRLs cannot be taken out of the broader context of all the other contaminants and food additives, heavy metals packaging materials growth enhancement chemicals, hormones, polychlorinated bisphenols, dioxins, pthalates and many more. The total burden and their synergistic impact from diet, water, air and all sources must be taken into account. Children start life with a greater body chemical burden than ever before with an exponential increase year after year and face a lifetime of ever increasing levels of exposure and its subsequent health risks. The evidence of prenatal and early childhood exposure and its harms, demonstrates the urgent need to reduce exposure. The causal relationship of the chemical burden on fetal death, birth defects, prematurity, cancers, asthma, auto-immmune disorders, neurological disorders, the human suffering is of great concern.In response to this item we wish to state the urgency of reducing maternal and childhood and environmental exposures and therefore we object to moving this item forward.
DAY 4 Thursday Morning. Novel foods
Patti Rundall: While these innovations could help break down food taboos about insects etc and have some advantages, there are also serious concerns about any move away from bio-diverse minimally processed foods to ultra-processed foods. Evidence is mounting about the disastrous impact of Ultra Processing on human health – UPF consumption is a significant cause of premature death in Brazil – increasing the risk of NCDs as well as all-cause mortality.
Innovation will definitely be controlled by corporations and will open the door to misleading marketing, excess packaging and an enormous increase in the use of flavors, colors, emulsifiers, and other additives for cosmetic purposes. If Codex is going to go down this track it will need to strengthen its conflict of interest safeguards – to make sure that these processes are properly evaluated and that at national level governance is protected to prevent harmful marketing.
There must be much greater investment in agriculture and support for small farmers and fisherfolk to produce the whole bio-diverse natural food the world so urgent needs.
DAY5 Friday Morning
Agenda item 7. 2022 Survey on the Use and Impact of Codex Texts
Patti Rundall: This is important because there is no use reminding governments to adopt laws at national level, when they come under pressure from powerful corporations and exporting countries. There have been 245 challenges(2) to regulations via the WTO process. Until Codex standards meet the WHO recommendations such pressure will continue and this will lead to weaker safeguards and harm to child health.
Patti Rundall: Thanks to Chizuru – especially for her work on Infant Feeding. She will be very much missed. We mustn’t forget her call to prioritise NCDs in standard setting.
As Dr Tedros said on Monday, we need to meet the challenge of emergencies. But there needs to be care in humanitarian appeals – RUTF should not be promoted as the first line of action ahead of support for life saving breastfeeding and culturally appropriate and nutritious family foods. There are reports of healthy children consuming RUTF.
On Food Safety Strategies it is important to highlight the need for safeguards from commercial influence and the serious problem of intrinsic bacterial contamination of formula that this year caused infant deaths and widespread shortages of formula in the USA.
Thanks to WHO for mentioning the importance of WARNINGs on labels. These have been shown to be so much more effective than other methods, yet they are so often challenged.
We support the extension of Codex Trust fund but not please with Private Funding. This would be inappropriate and undermine its good work. Thank you.
60th Anniversary of Codex Codex Members were invited to describe their plans for celebrating the 60th Anniversary in 2023. Patti Rundall, explained that she had attended Codex since 1997, wearing different hats – IACFO and ENCA but always as IBFAN, with the aim of bringing Codex standards into line with the recommendations of the World Health Assembly while advocating more transparency and stricter conflict of interest safeguards. She appealed to members to be frank in their assessments of Codex achievements, acknowledging its successes, failures and risks. Good assessments need good archives, so it is important that the CAC webcasts stay on line. It is highly problematic that other Committees, and in particular the CCNFSDU do not permit recordings of proceedings.
(1)“Effectiveness of home-based Egg Suji Diet in management of Severe acute malnutrition of Rohingya Refugee children” Journal of Health, Population, and Nutrition, Roy et al. Journal of Health, Population and Nutrition (2022) 41:53. https://doi.org/10.1186/s41043-022-00321-x “We conclude that family-made local, diverse and nutrient-dense food can completely eliminate and cure SAM children in refugee camps by their own caretakers. The result of this study encourages to apply such simple and cost-effective solution for treatment of uncomplicated SAM children.”
“…RUTF is extremely expensive compared to egg-suji feeding (USD 5 vs 0.22, i.e., 23 times more expensive) . SAM children are abundant in resourcepoor countries of the world; therefore, the cost of treatmentis a major concern where other competing needs are not met.”
(2) Russ K, Baker P, Byrd M, et al. What you don’t know about the Codex can hurt you: how trade policy trumps global health governance in infant and young child nutrition. International Journal of Health Policy and Management 2021; 10(12): 983-97. Baker et al. Globalization and Health (2021) 17:58. Advocacy at Work During the Codex Committee on Food Labelling Meeting