American Holistic Health Association (AHHA) - Codex Suzan Walter Report 2002
AHHA Attends Berlin Codex Session
What did we learn?

Report from Suzan Walter, president of American Holistic Health Association, on her attendance at November 4-8, 2002 session of Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) in Berlin, Germany.

Some things have to be experienced to be believed. A Codex Committee session is one of these. This report is to share my experience with you.

The Codex document "Guidelines for Vitamin and Mineral Supplements" and the potential for negative impact on access to nutritional supplements in the US sparked my interest in Codex matters. After researching this in order to develop the website www.codexinfo.org, I felt a strong sense that I needed to be at the CCNFSDU session in-person to share some of my concerns. I was able to arrange permission to attend with media observer status.

The 223 people attending this CCNFSDU session represented countries from every continent plus international special interest organizations. The Committee agenda had 10 items related to international trade standards. This report will focus on Agenda Item #6 - development of the document "Guidelines for Vitamin and Mineral Supplements."

General Impressions

The polarization on issues is dramatic. Picture a situation where groups with opposing positions each insist that their way is the only way. Issues involve the very different needs of developed and developing countries. Delegations come from both democratic and dictator led governments. Regarding use of vitamin and mineral supplements - Some groups are convinced that a normal diet is sufficient, and nutritional supplements are rarely necessary. Others stress the value of supplements and remind us of existing science validating how dietary supplements can enhance health and reduce the risk of disease. Regarding the issue of how much is "too much" - One side passionately insists any more than an established daily requirement of a nutrient is dangerous. The opposing side asserts that maximum safe limits must be established by scientific risk assessment research.

The Chairman controls what happens. Professor Rolf Grossklaus, the German Chairman of CCNFSDU, determines who can speak, how long discussions on an agenda item will last, and the consensus of the assembly. Delegations may submit written Comments prior to the session. However, during the session, they are ignored and a delegation must have permission from the Chair to present their written "Comments" verbally. In order to be recognized each delegation has a mic with a request button they hit when they want to speak. This lights up on a board in front of the Chair. The Chair directs which mics are opened for comments. No votes are taken. The Chair normally listens to what is said by various delegations, then states what he views the consensus of the whole assembly to be. If people speak up that they disagree with that, the "decision" may or may not be changed. A summary report of what took place at the session is presented on the last day. Delegations can request corrections, but the Chair has the final say as to what is put into the report as approved changes.

Progress is painfully slow. With the combination of the divergent positions on issues and the way that the session deliberates, it is not surprising that hours can be spent on the wording of one sentence. There is no mediator working to negotiate a middle position or something that can gain general consensus. Note - the Guidelines document has been developing since 1988.

Press exposure is discouraged. My admittance to the Codex session was with a badge marked Press. When I asked where the press section of the auditorium was located, I was informed that there was none. The press had not been invited to cover this event. Others with Press badges were, like myself, interested individuals who were not part of any delegation. One individual with a press badge told me he had arranged for a video crew, but the crew was denied permission to enter the building where the meeting was held. Another day a man seated near the back of the auditorium was observed using a camcorder. The Chair announced that the filming must stop or the meeting would be adjourned. Obviously, they do not wish media exposure.

Actions on Guidelines

With the background of these general impressions I now relate what I observed during the CCNFSDU session in regards to Agenda Item #6 - Guidelines for Vitamin and Mineral Supplements. (If you aren't into details, jump to the Summary at the end of this section.)

Discussion on all of the agenda items was scheduled for Monday (9am-6pm), Tuesday (9am-6pm) and Wednesday (9am-8:30pm). The Chair allowed one agenda item to take up most of two days. At 7:15pm on Wednesday evening the Chair finally started discussion on Agenda Item #6.

The lead delegate from South Africa read a statement reminding the assembly of the scientific research supporting the value of vitamin and mineral supplements, including research quoted from a recent Journal of the American Medical Association article that recommends that adults take a multi-vitamin daily. There was actually applause from the assembly after her statement.

The lead delegate from the United States suggested that all decisions should be based on data grounded in science. She also recommended that all Guidelines statements be changed from "shall" to "should", as this document is to be suggested Guidelines.

The lead delegate from the European Union suggested that the title of the document be changed to add the word "Food", making it "Guidelines for Vitamin and Mineral Food Supplements."

The lead delegate from South Africa proposed replacing the current Guidelines Preamble with a totally new version.
Current Preamble:

    Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet. Because foods contain many substances that promote health, people should therefore be encouraged to select a balanced diet from food before considering any vitamin and mineral supplement. In cases where the intake from the diet is insufficient or where consumers consider their diet requires supplementation, vitamin and mineral supplements serve to supplement the daily diet.
Suggested revised Preamble:
    People should be encouraged to select a balanced diet. However, vitamin and mineral supplements are useful in cases where dietary intake of vitamins and minerals is inadequate to either correct nutrient deficiencies or to supply prevention such as to reduce the risk of disease.
Somehow the discussion became about supplements as defined by the Guidelines are not to be used to treat disease. Comments were cut off on a procedural technicality that South Africa had not included this in their published Comments. The Chair did agree to include the suggested new Preamble in the final Committee report.

Note that all of these discussions involved suggestions or statements of support (or lack of support) for the matter being addressed. No mention was made of actual changes being finalized.

The next matter addressed was Guidelines section 1.0 Scope. There were a number of suggested changes for section 1.1:
Current:

    1.1 These guidelines apply to vitamin and mineral supplements intended for use in supplementing the daily diet [if and where necessary] with vitamins and/or minerals. These Guidelines apply to vitamin and mineral supplements which are regulated as foods.
Numerous delegations supported deletion of the phrase [if and where necessary] in the first sentence. The two sentences in 1.1 were addressed individually, with suggestions involving deletion or moving to another section.

One delegate suggested that the scope of the Guidelines be expanded to apply to food supplements with other ingredients.

Finally, attention was focused on what most of us considered the most important issue to be addressed - Maximum Levels - 3.2.2 (option #1) and 2.3.3 (option #2):
Current:

    3.2.2 [The maximum level of each vitamin and/or mineral contained in a vitamin and mineral and mineral supplement per daily portion of consumption as suggested by the manufacturer should not exceed [100%] of the recommended daily intake as determined by FAO/WHO.]

    3.2.3 [Maximum amounts of vitamins and minerals in vitamin and mineral supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following criteria into account. (a) upper safe levels of vitamins and mineral established by scientific risk assessment based on generally accepted scientific data, taking into consideration, as appropriate, the varying degrees of sensitivity of different consumer groups; (b) the daily intake of vitamins and minerals from other dietary sources.

    Setting the maximum levels, the reference intake values of vitamins and minerals for the population should also be taken into account.]

Comments from delegations fell into three groups. Understand that this was NOT a vote. Of the 83 delegations, only a very small number were recognized by the Chair and had an opportunity to state which option they supported. The following is offered to give you a general idea of positions and is not a complete list:
Supporting Option #1 - 3.2.2 - Maximum levels not to exceed RDI.
    Norway, Brazil, Indonesia, Thailand, Malaysia, Nigeria
Supporting Option #2a - 3.2.3 - Maximum levels based on risk assessment
    European Union (representing 15 countries), Japan, Korea, United Kingdom
Supporting Option #2b - 3.2.3 - Maximum levels based on risk assessment, but deleting the final sentence.
    United States, Switzerland, Canada, Peru
The lead delegate for the National Health Federation commented that research on the safety of vitamins has already been established. NHF did register support of Option #2a, but only as a very last resort.

By now the 8:30pm closing hour was fast approaching, and there were still two other important agenda items to be addressed. Discussion on Agenda Item #6 was closed, but first the Chair seemed to me to lecture the Option #1 RDI group. He stated very strongly that this is about safety (so consumers are not harmed), not needs. In addition, he commented that upper safe limits are not dosages.

On Friday we assembled to review the draft report that outlined what transpired at this session. This report is not structured as detailed minutes, and does not list which countries were for or against a position. From 8-9:30am Friday morning the delegates scrutinized the report looking for errors and/or omissions. When we assembled at 9:30am, one by one the Chair allowed comments on each item in the report. When Agenda Item #6 was reached, I was very surprised to see that the Chair had incorporated three suggestions into the Guidelines as official changes. During the Wednesday evening discussions I had never heard him state that consensus had been reached. This would have allowed opposing delegations to speak out. Apparently I was not the only one surprised. Numerous delegates disagreed with the Chair's decisions. One delegate stated that her delegation's request light was on, but not honored. The Chair responded that she should have registered a complaint at that time. (How was she to know to complain?)

------------------ Summary ------------------

When the dust settled, the following were the official changes.

Title - Guidelines for Vitamin and Mineral Food Supplements

Section 1.1 These guidelines apply to vitamin and mineral supplements intended for use in supplementing the daily diet [if and where necessary] with vitamins and/or minerals. These Guidelines apply to vitamin and mineral supplements which are regulated as foods.

These changes do not appear to be significant. So, this year no real progress has been made toward revising the Guidelines into a document that all can support. Long time participants are encouraged that several countries have switched to supporting Option #2 - Risk Assessment. Another indication that Option #2 will be the ultimate choice is that the governing body of Codex has officially adopted a preference for risk assessment.

CLICK HERE to review the official report from this 24th Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses that will be submitted to the Codex Alimentarius Commission for review June 30-July 5, 2003. Agenda Item #6 is on pages 11-12 (paragraphs 87-100). The current draft of the Guidelines for Vitamin and Mineral Food Supplements is in Appendix IV on pages 56-57.

Personal Activities at Codex

As I was not part of a government delegation nor an NGO (non-governmental organization) delegation, I was free to focus on networking with whomever I wished.

I initially focused on surveying delegates as to their understanding of how, once the Guidelines are finalized, this document would be enforced. Everyone I spoke with erroneously believed that individual countries would be free to use the Guidelines as suggestions and adapt them as they wished. Further, none were aware that the World Trade Organization (WTO) has the actual enforcement power, and the WTO does not view a "guideline" document as optional. I found this extremely disturbing, as this indicated to me that the people responsible for creating the document did not understand how it would be used.

The next new awareness for me was related to an apparent conflict of interest. I was already aware that some countries designate nutritional supplements as drugs and others as food, and that the Guidelines are drafted to only apply when supplements are regulated as food. This means that a number of countries who regulate supplements as drugs are drafting the Guidelines but will never have to abide by them. During my conversations at the Berlin session, I discovered that a number of countries use both designations. At lower levels of "dosage" supplements are treated as food, while at higher levels they are handled as drugs. Now I realize that the number of exempt countries is even larger than I thought. My reactions to this... Why are the countries who are exempt fighting so hard to have the rules set up "their way"? How many countries on the CCNFSDU are exempt? Will the exemption be honored by the WTO?

By day two of the session I had become aware that no one was integrating the Comments submitted by a number of the delegations prior to the start of the session. I selected the first three sections of the Guidelines (Preamble, Scope, and Definition) and drafted a summary of input that incorporated those ideas that worked well together. I added a bit under the Scope section that would protect the document from WTO misuse. This sheet was shared with a number of delegations, resulting in some positive impact. However, the Codex procedural requirement that new ideas must be submitted in writing before the Committee session starts really hampers this type of mediating integration. No wonder it takes years to negotiate progress.

The opportunities I had to discuss various Codex issues at length with a number of the attendees was an exceptional privilege. There are a number of people who have been following Guidelines developments for a number of years. Some are still optimistic, while others throw up their hands and voice expectations that this will be going on for another five years or more. I look forward to staying in touch with these individuals from all over the world.

Now What?

Now that the politics of how Codex committees operate is better understood, the AHHA Board of Directors can strategize where we should put our efforts to enhance Guidelines activities between now and the November 2003 CCNFSDU session in Germany.

We might consider compiling data on WTO enforcement procedures and document how WTO expects to apply them to Codex standards and guidelines. Codex headquarters had informed us that enforcement will not be known until there have been a number of trade disputes processed by WTO - providing precedents for future decisions. This seems too important an issue to be left so undefined. Isn't it vital that those drafting the Guidelines are fully informed of how they will be used?

We might also consider reviewing past delegation Comments that have been overlooked. In Berlin I learned that many, many excellent ideas have been proposed, but ignored. Perhaps AHHA can resurrect some of these ideas for consideration in 2003.

AHHA is not a lobbying group. We will not be contacting delegations around the globe and trying to influence them to our way of thinking. AHHA is a 501(3)(c) educational nonprofit organization. It would be appropriate for us to research and document facts and share through our website at codexinfo.org, particularly areas where delegates are not currently fully informed.

If you have ideas or feedback, send us an e-mail codex@ahha.org.