History of CODEX




Suzanne Harris, J.D.

Copyright © 2004 The Law Loft



Ÿ         November 1st, Dr Christine Taylor announced the launch of the new Joint FAO/WHO framework project. It will build a new overarching international model for the evaluation of the safe upper levels of nutrients and maybe even model one or two vitamins or minerals all the way through to final conclusion on safe upper levels.

Ÿ         November 2nd, the Nutrition and Foods for Special Dietary Uses Committee of the Codex Alimentarius Commission reached agreement on the final language for the guideline on vitamins and minerals as food supplements paving the way for its adoption in July 2005 in Rome.

Ÿ         November 10th, the General Principles Committee of the Codex Alimentarius Commission agreed to recommend deletion of the notification and acceptance procedures in the Codex Procedural Manual as ‘obsolete’ and ‘irrelevant.’


Dr. Taylor made the announcement. The official FAO/WHO project to create, for the first time, an overarching framework for the establishment of safe upper levels for nutrients has been launched:


Dr. Christine Taylor, of the FDA, now on special assignment to the World Health Organization, announced at Codex NFSDU the formal launch of the Joint FAO/WHO Development of a Scientific Collaboration to Create a Framework for Risk Assessment of Nutrients and Related Substances on day one of the meeting in Bonn. The project represents the first major collaboration at an international level to create an overarching framework through which the upper levels for vitamins and minerals and ‘related substances’ can be formally established.[1] “We should have communality and overarching principles where possible” explained Dr. Wim Van Eck, senior nutrition adviser to WHO’s Food Safety Department, to the Law Loft at the CCGP meeting in Paris.


The launch of this project is terribly important to the fate of health freedom and nutritional therapies for several reasons. One reason is that under paragraph 5.1 of the

Sanitary Phytosanitary Agreement (SPS)[2], member nations of the WTO are required to take into account risk assessment techniques developed by the relevant international organizations in establishing their own food safety measures to protect human health. Up to now, there have been few international risk assessment techniques that bear directly on the use of vitamin, mineral and other nutritional supplements. What is happening now, both inside and alongside the Codex Alimentarius Commission, is a rush to create such international risk assessment techniques.


This exercise is not academic. Ever since the WTO’s appellate panel’s decision in the sardine case brought against the European Union by Peru, international law experts have seen the relevance and applicability of the standard setting activities at Codex and at other relevant international organizations in a new light. What before the sardines case was seen as unlikely to be binding on national authorities, is now seen as either absolutely binding or very likely to be binding on national authorities. Before the sardines case, many authorities thought that technical regulations promulgated by Codex (and other international standard setting organizations) that fell within the jurisdiction of  the Technical Barriers to Trade Agreement (TBT), were unlikely to have binding impact on national regulators. A kind of ‘SPS, you are bound, TBT you are not bound,’ mentality developed. Since in actual practice is could be very, very difficult to tell which measures fell under which agreement, regulators functioned at Codex in a kind of fog of misunderstanding believing that what they were writing was never going to bind their own countries. Today that picture has changed dramatically. “The TBT is mandating use of international standards when they are appropriate,” explained international trade law professor Dr. James Mathis to an audience of Codex attendees at a Consumers International/Ford Foundation funded seminar in Paris on November 9th.


So now that we see the importance of it all, the question naturally arises: What direction have the FAO and WHO taken in their framework for risk assessment for nutrients project? The answer is grim and short. The worst possible direction. The project design as outlined so far includes: massive amounts of guesswork (all guesses to be in the wrong direction, that is, away from the scientific principle that higher levels of nutrient intake can prevent chronic disease), use of intake assumptions based on estimates of nutrient values obtained from ordinary foods coupled with estimates of high-end supplementation intake, and final ULs, upper level settings, based on protection of the most sensitive consumer from the risks, both real and imagined, of over supplementation.



Codex Nutrition and Foods for Special Dietary Uses Committee reached final agreement on the last key paragraph of the Draft Guidelines for Vitamin and Mineral Food Supplements on November 2nd paving the way for final adoption at the Codex Alimentarius Commission meeting in Rome in July 2005:


Last year at CCNFSDU, the USA and the EU staked out seemingly irreconcilable positions on a key paragraph (3.2.2) within the proposed draft guidelines for vitamin and mineral supplements. Their dispute centered around the content of vitamins and minerals, that is, upper limits/ maximum amounts, of vitamins and minerals in dietary supplements as set forth in manufacturers’ recommended daily portions. At last year’s CCNFSDU, it was agreed that scientific risk assessment would form a part of the decision establishing upper limits for daily portions. But how big a part was left to decide at this year’s meeting. The EU, which had already gotten language into 3.2.2 mandating reference to daily intake from other dietary sources into the text, had wanted to add language saying when the maximum levels are set, due account should be taken to the reference intake values of vitamins and minerals for the population.


So this year both sides went into the CCNFSDU meeting seemingly prepared to duke it out over whether that language in italics above would go into the text as the EU wanted or stay out as the USA wanted. The end result: a compromise of sorts. The final text as agreed reads, When the maximum levels are set, due account may be taken of the reference intake values of vitamins and minerals for the population. This provision should not lead to setting of maximum levels that are solely based on recommended nutrient intakes (e.g., Population Reference Intake or Recommended Daily Allowance values).


So, who won here? There were a number of comments but few answers offered after the fact. “We are pleased that we were able to come to a resolution,” Basil Mathioudakis, the EU delegate, told the Law Loft in a post session interview. One member of the US government delegation said to the Law Loft in passing, “It was important to change the language from ‘should’ to ‘may.’ I was surprised that Basil agreed to that.” James Roza, the director of external affairs at NOW Foods, was perhaps the most frank of all, “We had to compromise. To get something through, there was no choice.”


But who really won? While opinions differ considerably here, we at the Law Loft think the Europeans did - and big time. Why? While one can agree that CRN’s announced strategy of ‘expanding the disputed language into meaninglessness’ helped weaken the offensive language in disputed text, when one compares the Codex text as advanced for adoption by CCNFSDU and the European Union’s directive, one sees that the two are almost identical in key areas.  Similarly, looking at the net effect of the agreed to language in the context of the new joint FAO/WHO framework setting project described above (which will be circumscribed to a degree by the Codex text), one can see a number of serious problems that the text either does not solve or actually exacerbates. Under the Codex guideline, it will be possible for the joint FAO/WHO framework project to: establish a nutrient risk assessment framework that; uses risk assessment but conflates it with lots of guesswork, thus pushing upper levels in a downward direction, compounds that error with the addition of postulated (read that as imaginary) supplement nutrient intake added to  estimates of nutrient intake drawn from the daily diet and then lastly adds into the mix reference daily intake values that may not be as low as they were in World War II when they were first designed to prevent overt vitamin and mineral deficiency in soldiers, but remain even as revised upwards in more recent decades, very low.


And in the end, a kind of macabre piece of good news:

Putting a final end to the folly of thinking, we are not bound by what happens at Codex:


Incredibly, several apparently well meaning lawyers with no experience in WTO/Codex law or politics have touted the notion recently that it doesn’t matter what happens at Codex, since no nation is bound in its domestic law to what happens at Codex unless that nation files a notification and acceptance of Codex standards or guidelines with the Codex Alimentarius Commission. While even to suggest such a thing in the post WTO world seems like the height of folly, nevertheless, these positions, however off the cuff and/or misquoted, have gained a certain traction within portions of the dietary supplement industry and alternative health community in North America.


Fortunately amid all this bad news coming out of Bonn and Paris, there is at least an end to this absurd folly. Let us be clear here, with the acceptance and ratification of the results of the Uruguay Round in 1995 that formally created the WTO and introduced both the SPS and TBT into international trade law, it is absolutely irrelevant whether a WTO member country formally accepts a Codex standard or guideline or not. The member country is bound by whatever legal interpretation of a Codex standard or guideline the WTO’s Dispute Settlement Body’s Appellate panel applies to that standard or guideline. This is, in effect, exactly what the WTO’s representative had told CCGP prior to last week‘s meeting. So, on November 10th, a number of key players came to the CCGP meeting in Paris with the express idea of ending the obsolete reporting procedures to Codex once and for all. “These acceptance procedures have never worked. Countries ignored them,” US delegation chief Dr. Edward Scarborough told members of the US delegation at a pre-session meeting. “The appellate bodies of the WTO have said quite clearly that whether we, at Codex, vote for or against notification within Codex has no bearing on enforceability,” European Union delegate Henri Belveze told the GP meeting.


So, in the end, the delegates at this year’s meeting of the Codex Committee on General Principles agreed without dissent to recommend the total abolition of both the Codex notification and acceptance procedures. Hopefully this long overdue decision will end the mistaken perception that Codex standards and guidelines have to be individually accepted by WTO member countries in order to become binding upon them.


Why is this good news? Because in order to react to where you are, you have to first see where you are.


So where are we in the end? Engaged in a battle for global dietary supplement regulation, a battle that means life or death for some of us, a battle that we are losing, to a Europe that doesn’t really believe in supplementation except on doctor’s orders:


While we are aware that a number of analysts see all of this in terms of good versus evil and conspiracy theory, we at the Law Loft see it in much simpler terms. We think that the high end of industry seeing far enough down the road to see international regulations coming, wants to have something to sell, especially in the expanding, open European market. They want to have something to sell even if the product they sell is not much more than cotton wadding in a bottle containing modest amounts of nutrients amidst a lot of filler. Their goal is, as it must be, to survive and prosper. On the European side, there seems to be a real push coming out of the silent but powerful Switzerland to see as they said last year that ‘these products (dietary supplements) are never going to carry health claims because they are never going to exist in high enough potencies to merit them.’ And within the European Union itself, we see not only a blend of bureaucratic intransigence and hostility to vitamins and minerals on the market as foods, but also a fundamentally different mindset toward who should control specialized nutrition. Dr. Rolf Grossklaus, chairman of the CCNFSDU and a medical doctor specializing in nutrition, said it best when he told the Law Loft in a post session interview, “We need clarification that food supplements are foods not drugs. But what is the scope of the food class? It is not to prevent disease or to heal but rather the scope is to optimize nutrition. Consumers should know that a balanced diet is best.”


So, what we face here is the fundamental fact that Europe thinks differently. They believe, especially in Germany, the founder of the regulatory concept of medical foods, that doctors should prescribe the meaningful products. So here we are in a global contest.  On one side is Europe that believes in strict regulation and doctors’ prescriptions for the really useful products. On the other side is a North American populace that believes in freedom of choice but where many of the staunchest believers in freedom of choice and companies, most likely to be extinguished by the end results of that battle, do not even know that a global battle is raging. And at the center of the mix, we have powerful commercial interests allied with whatever side they think will produce the best market opening opportunities.


Is there anything left that we can do here? Yes, but time is short and only an intelligent, well-crafted, concerted effort has any chance of success. Those interested in taking serious action, not just playing at it, are invited to contact the Law Loft at [email protected].



[1][1] The scientifically established upper safe levels may in turn be lowered by risk managers taking into account other dietary intakes from conventional foods, thus creating even lower ‘maximum permitted levels’ when the products finally reach the consumer.

[2][2] The WTO international agreement that gives Codex international reference standard setting authority in specified areas of food safety while leaving the designation of other areas of food safety standard setting to unspecified ‘other relevant international organizations’.