Codex Alimentarius Commission meeting in July 2019 (CAC42).
Rough transcript of the debate about the additive Trisodium Citrate in liquid milk . (Page down for the report of the debate on the follow on formula standard and cross promotion.)
At the end of the debate the EU said: We would like to support the proposal just made and make clarifications. This is a sensitive discussion since it relates to food additives in plain milk. We agree it should NOT be used in plain milk. Indeed nitrogen Trisodium Citrate is NOT authorised in EU and will not be. [The EU position] is related to the risks of deceiving the consumer and related to other legitimate factors that consumers do not expect milk to contain additives. There needs to be further discussion on this issue to find a way forward.
Monday 8th – Plenary session 2 – Afternoon
Zimbabwe (1.50) expresses concern that the additive Trisodium Citrate was being proposed as an additive to liquid milks, and that milks are fed to babies. [Even if they are not specifically marketed for them.] Kenya (1.54) agrees with Zimbabwe, as does Cameroon (1.58).
IBFAN (Patti): “How many countries can express reservations and it not lead to anything – how will this work out?”
Tom Heilandt (Codex Sec) There is no numerical limitation on the numbers, but if there were more reservations than approvals it would be very strange. But this is not the case here. In this case the reservations will be noted in the report.
Zimbabwe (2.02): Echo the concerns of the previous speaker. Since there is no consensus why consider adopting this?
Burkina Faso (2.02) and Senegal endorse the reservations expressed by African countries.
Ethiopia: Why are we here if we don’t have consensus, if most countries don’t agree?
Ghana: (2.04) I agree with concerns expressed by other countries.
ECOWAS (Economic Community of West African States):Echo the concerns of others i the region. We should apply consensus throughout and not adopt anything without consensus.
IDF (International Dairy Industry – global dairy industry) (2.05) Deeply involved in the preparation of the proposals. Happy to explain how and why these are used and consider them perfectly safe.
Guinea (2.07): aligns with other African countries.
Nigeria (2.08): also not comfortable of this additive to milk.
Brazil (2.08) supports the measure. Its a very important matter for us. CCFA is the correct place to evaluate the scientific evidence and we had many opportunities to raise concerns. We urge that the provisions are adopted so we can move forward.
China, Chair of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (2.09.31):This has been discussed many times and some members want to use this additive. There was a long discussion on how to use the note. From the document you can see we use the 3 notes. To reflect that we limit the use to particular climatic conditions. Sorry to see several reservations – but as Chair of Committee I don’t think we can find a better solution. The Committee finally agreed to forward it to the CAC for adoption.
Guilherme Antonio Da Costa, Codex Chair (2.13 ) After our discussions we should take into account what we had in the technical committee which is based on a sound scientific basis. I understand the concerns but taking into account the discussions already we should adopt the standard and register the reservations in the report. Does the Commission accept that?
Zimbabwe (2.13.43): I appreciate your comments on this matter – however – this is not the first time a standard has been agreed in a subsidiary committee, and then it comes to CAC and there is not consensus. We don’t have consensus because the evidence is not considered exhaustive. We want to express a similar concern on food category 01.1.1 and ‘other fluid milks – where there are provisions for emulsifiers and stabilisers’. I think we should add another reservation on the provisions.
Costa Rica (2.15): It was not our intention to be in opposition of the standard – we want to make sure that its clear – in Costa Rica the additives are not permitted and this is set out in the handbook. (need to check)
Mauritania (2.16): Is not convinced. UHT can spoil with just a tiny bit so there is no need to add Trisodium Citrate.
Cameroon (2.19): We spent a whole morning the fundamental values of transparency, and consensus and here we see that we have to accept this, despite reservations. Our discussions this morning – where we spent the whole morning trying to satify the reservations from a few countries. So we cannot ignore the reservations of african countries.
Chair (2.18): I understand your concern but this is two different issues. What we are discussing now is something that came from a technical committee where there was consensus. He refers to the ‘scientific base’ and was decided in the committee.
ECOWAS (2.21) Adds voice to Cameroon. All the African countries here today expressed their concerns, we are a big number. This is not the first time this has happened. All African countries here feel the same.
Chair: The doubts raised here in terms of science in relation to additives – based on decisions on science – it’s different. We are in one environment that’s different.
IBFAN (2.22) I wonder – because the report is hardly seen – could a line of caution be added to the standard – particularly when these products are used for children. It seems to me that all the African countries have concerns. I’ve been watching Codex for many years and have seen countries objections so often relegated to the report. I doubt whether law makers look at the report. Basically Codex gives an aura of safety to all the products and I think it needs to be really careful before it does that.
Tom Heilandt (Codex Sec): This seems to be a question of science and I understand that the safety of this additive at the amounts specified was not question.
Markus Lipp (Food and Agriculture (FAO), Secretariat of JECFA (2.25): Questions the criticisms and said there is no reason that JECFA is aware of to doubt the safety of the additive. He is unclear what is missing and why it is not technologically needed. If there is knowledge it should be brought to JECFA so it can be re-evaluated.
Benin (2.27): Expresses reservations and says its our duty to say this.
Codex Secretariat: Reads the notes about climatic conditions and the necessity for the additive.
Peru: Has no doubts about additives in milk.
Chile: Is happy to go ahead.
Cameroon (2.32): Several cases where JECFA provided all the cases – if the evaluation took into account of the concerns of the African countries….
Markus Lipp: Takes into account the global issue – different conditions – different diets. In this particular case the only function is for proteins not to settle in certain climatic conditions…merely an additive to prevent sedimentations. Where are the scientific questions? What convincing needs to happen?
Zimbabwe: The 3 notes alluded to bring even more doubt to the adoption of the standard. Sect 4.2 – the same milk remains even with the additives.
ECOWAS 2.37: This product is intended for many categories of people in the document we want to adopt now. understanding GMP – it can be used at any level. We are creating a lot of problems for developing countries in terms of Public Health.
Chair: everything from JECFA is concerned with safety. Good manufacturing practices – used for a long time. Based on Codex elements.
Mauritania (2.41). There are more worries relating to children.
Paraguay: Supports the adoption.
Cuba also supports adoption. No problem. If fortifiers are used they must not cause bad effects – industry needs to use good manuals and practice.
Kenya: 2.57. Reserve comment on this. Not clear which climatic conditions this note would apply. Additives may have thickening properties. Can JECFA say climatic conditions?
Markus Lipp, Sec. JECFA: There was uncertainty in the Committee on how to describe climatic conditions. The additive has multiple functions in food – not explicitly mentioned, except as a stabiliser.
China: Chair CCFA (2.49): Technical discussions should take place in the technical committee. I didn’t hear so many different voices before. It is up to the Commission to decide or take it back to CCFA. As Chair of committee I’m quite open.
Chair persists in saying it should be adopted with reservations mentioned in the report.
National Health Federation (NHF):
…pause while they elect 3 vice chairs. After the session closes – at the reception I talked to the Chair and others and about the implications of being seen not to take the concerns seriously and not taking the issue back for another year.
Tuesday – Plenary session 3
Chair: 4.47: Before we start any further exchange of views I want to recall the helpful intervention of the Chair of CCFA.
CHINA Chair of CCFA: Notes the concerns about Trisodium Citrate. Proposes that as the TC has different properties and is only stabiliser, when we look at the use proposed, CCFA can try to work on a numerical limit for its use – or more discussion on the notes to reduce the potential for its misuse. This would reduce concerns about Para 1.1.1. Para 1.1.2 concerns other fluid milks and is a newly created food category with two different food additives. There is a technical justification for additives for this food category.
EU: We would like to support the proposal just made and make clarifications. This is a sensitive discussion since it relates to food additives in plain milk. We agree it should NOT be used in plain milk – Indeed nitrogen Trisodium Citrate is NOT authorised in EU and will not be. [The EU position] is related to the risks of deceiving the consumer and related to other legitimate factors that consumers do not expect milk to contain additives. There needs to be further discussion on this issue to find a way forward.
Zimbabwe says bit more
Outcome. African and EU concerns were heard. The issue is taken back for another year.
Draft provision for trisodium citrate (INS 331(iii)) in FC 01.1.1 “Fluid milk (plain)”
21.The Codex Secretariat introduced the item and explained that the use of trisodium citrate (INS 331(iii)) in FC 01.1.1 “Fluid milk (plain)” had been extensively discussed at several CCFA sessions, and that CCFA had decided to associate the provision with notes 438, 439 and B25, to facilitate its application.
22.CAC42noted the following views expressed by delegations not supporting the provision:
i.The use of trisodium citrate (INS331 (iii)) was not technologically justified and could result in changing the nature of the product and cause in consistencies with the General Standard for the Use of Dairy Terms(CXS 206-1999);
ii.Scientific studies had demonstrated that there was no need to use additives in UHT milk and that currently nitrogen (INS 941) and the food additive group PHOSPHATES were the only additives authorised for use in FC 01.1.1;
iii.Permitting the use of this food additive under conditions of GMP could create public health concerns in infants fed with UHT milk; and
iv.This issue was related to the application of section 3.2 of the preamble to the GSFA and therefore the use of food additives in this FC would mislead consumers as they did not expect milk to contain additives.
23.Delegations supporting the adoption of the provision recognised the scientific advice provided by FAO and WHO and were of the opinion that the use of trisodium citrate in FC 01.1.1 did not constitute any food safety concerns and was technologically justified only under certain climatic conditions.
24.One delegation that supported the use of this food additive considered it necessary to insist on good practices in the food chain bearing in mind risk factors.
25.The Representative of FAO clarified that, taking into account the global diet exposure data, the safety of trisodium citrate had been confirmed by JECFA. Should new information become available, a JECFA re-evaluation could be requested by CCFA.
26.One member stated that it was unclear under which “climatic conditions” Note B25 reading “For use in UHT milk from bovine species to compensate for citrate or calcium content to prevent sedimentation as a result of climatic conditions only” would apply and that further explanation would be needed.
27.In view of the lengthy discussions and difficulty in reaching consensus, the CCFA Chairperson proposed that CAC42 recommend to CCFA to further consider possible solutions, e.g. setting numeric use levels and/or clarifying the notes further.
28. CAC42 encouraged members to actively participate in CCFA meetings so that technical issues could be fully deliberated there.Conclusion29.CAC42 agreed to return the draft food-additive provision for the use of trisodium citratein FC 01.1.1 to CCFA for further consideration.Proposed draft provisions related to FC 01.1.2 “Other fluid milks (plain)” with the technological functions of emulsifier and stabilizer30.CAC42was informed that FC 01.1.2 was a new food category adopted by CAC39 in 2016 aimed at differentiating the use of food additives used in fluid milks other than those specified in FC 01.1.1.
31.Delegations not supporting the adoption of the proposed draft provisions pointed out that:
i.Addition of food additives in FC 01.1.2 with the technological functions of emulsifier and stabilizer could mislead consumers as these additives could also have other technological functions, such as thickener which, for this category, was not justified in accordance with Section 3.2 of the preamble of the GSFA; and
ii.Food products covered under FC 01.1.2 may be used in production of food for children and therefore the use of food additives in FC 01.1.2 should be addressed together with the provisions relating to FC 01.1.1.
32.Delegations supporting the adoption of these provisions were of the view that:
i.These food additives had been evaluated by JECFA with Acceptable Daily Intakes (ADIs)of “not specified” and there had been consensus after extensive discussions at several sessions of CCFA; and
ii.The use of these food additives in this food category is limited to emulsifier or stabilizer only, which was technologically justified and would not mislead consumers.
33.CAC42adopted the proposed draft provisions related to FC 01.1.2 with the technological functions of emulsifier and stabilizer only, at Step 5/8.34.
Costa Rica expressed their reservation to this decision.
Review of the Standard on Follow-up Formula (CXS 156-1987): Proposed draft Scope, Description and Labelling for follow-up formula for older infants – Debate about Cross Promotion
81.A delegation could not support adoption of the text as there were unresolved issues on the scope and labelling, and requested that reference to the WHO International Code of Marketing of Breast-milk Substitutes, other relevant WHO documents and relevant WHA resolutions should be included in the scope similar to the Standard on Infant Formula and Formulas for Special Medical Purposes Intended for Infants(CXS 72 –1981).
82.Other delegations supported adoption, while also noting that the issue of cross-promotion required further consideration in CCNFSDU,including from the perspective of determining if such a concept was fully consistent with the international trade rules established by WTO and WIPO. CAC42 noted that all technical comments, including those related to cross-promotion,should be resubmitted at Step 6 in reply to a Circular Letter, for consideration by the next session of CCNFSDU.
83.An observer stated that there was no need for follow-up formula and noted that because of marketing of these products, a provision on cross-promotion was needed
i.adopted the proposed draft text (scope, definition and labelling –as endorsed and amended by CCFL), and noted that the last part of section 9.6.4 on cross-promotion would be further considered by CCNFSDU;
ii.noted that CCEXEC77 had recalled and reaffirmed the advice given by CCEXEC75 regarding use of references to WHO documents and WHA resolutions.