Guidelines Completed. Now What?

Report from Suzan Walter, president of American Holistic Health Association, on her attendance November 1-3, 2004 at the session of the Codex Committee on Nutrition and Foods for Special Dietary Uses in Bonn, Germany.

It’s over. After more than a decade of wrangling, the Guidelines for Vitamin and Mineral Food Supplements as drafted by CCNFSDU have been completed and sent on for final adoption by the Codex Alimentarius Commission (CAC) at its summer 2005 session. While governments may submit comments to the CAC by March 31, 2005, the formal finalization is expected to be merely a formality. International “harmonization” of regulations continues.

The completion of debate on the Guidelines this year was not surprising, as the last of the major areas of disagreement were addressed at the 2003 session. What is significant is that because there are so many related matters that remain to unfold, it is not possible to state with assurance exactly how the Guidelines will impact us in future years.

The official Codex position, according to what was stated from the podium at the CCNFSDU session, is that Codex documents are not mandatory. Member countries decide how they wish to use them. The error of omission from this public position is that Codex signed agreements with the World Trade Organization (WTO). These agreements give the WTO the right to use any Codex document as an international trade standard. Therefore, the Guidelines can be used as a mandatory international trade standard by the WTO dispute resolution system. This is definitely not the impression that the CCNFSDU chair was giving to the assembled 280 assembled delegates from 62 countries and 25 non-governmental international organizations.

It will be important to watch the progress of the Codex project to update international Nutrient Reference Values (NRVs) from what was developed by the Helsinki Consultation in 1988. NRVs determine what can be put on labels for all foods, not just dietary supplement labels. The discussions have revealed that a number of countries are against any indication that nutrition can prevent disease.

The Guidelines rely upon safe upper levels established by scientific risk assessment to determine the maximum amount of a vitamin or mineral allowed in a supplement product. Exactly which organizational body (FAO, WHO, or Codex) ends up developing the risk assessment protocol could be vitally important. Also, the level of integrity of the experts who are selected to apply this protocol will determine the quality of the outcome. Science can be pure, or it can be manipulated to a desired end result. The individuals who hold the power to select the experts to serve on the decision-making bodies may determine our future access to dietary supplements.

The issue is more than what will be allowed in a supplement product. There are Codex committees dealing with what nutrient claims can be made about a product, what educational information can be provided to consumers, and what nutrient information can be placed on a supplement product label. These matters will impact our free access to nutritional information in the future.

For those who want more information about what happened at the 2004 CCNFSDU session, the next section of my report includes what was stated in the official Codex session report, plus my comments based on my notes and personal observations.

A few clarifications:
* Codex session participants are either in delegations of member countries or in delegations of non-governmental international organizations. The former have voting power, whereas the latter may speak at the session to influence, but have no decision-making clout.
* While member country delegations have voting power, decisions at Codex sessions are made by consensus. The perception that consensus has been reached is at the sole discretion of the chair of the committee.
* References are made only to the name of a country or an organization, not to the name of the head delegate, who serves as the voice for that delegation.
* Codex documents are called texts. Development of a text is an eight-step process.
* Codex texts may take many years to be drafted. Sections where consensus has not yet been reached are left in place, but surrounded by square brackets [ ].

* The CCNFSDU working session takes place on Monday, Tuesday, and Wednesday. The committee draft report is reviewed on Friday. If something is incorrect or omitted, the report contents can be challenged by delegations. The colored sections below are text omission challenges that were accepted by the chair. The chair did not accept a number of other challenges.

There were twelve agenda items. This report addresses only one.
You may find it helpful to follow along with the actual text of the Guidelines.
New text is underlined. Deleted text has a line through.

Agenda Item 4 – Draft Guidelines for Vitamins and Mineral Food Supplements

    23. The Committee recalled that the last 27th session of the Codex Alimentarius Commission adopted the Proposed Draft Guidelines at Step 5 and advanced it to Step 6 for further comments and consideration by the Committee. The Committee decided to consider the text of the Guidelines focusing its discussions on sections containing square brackets and made the following amendments and comments.

Despite this statement, the chair did allow a few matters that were outside of square brackets. This appeared to occur when the change was something the chair could support.

    General comments
    24. The Committee noted that at its last session it was agreed to refer to vitamins and mineral “food” supplements not only in the title but also in relevant parts and therefore made editorial amendments where necessary throughout the text.

At the 2002 session, the European Community (EC) delegate requested that food be added to the title of the text. With no other discussion, the chair announced that consensus had been reached and the title was changed. In 2003, several delegations tried to get the word food removed from the title. The chair resisted and the official report for that year included the following sentence: “After an exchange of views it was however agreed to retain the current title and to refer to ‘food supplements’ where necessary throughout the text.” However, the addition of food in front of supplement throughout the text was not incorporated. Perhaps because this was not what was agreed upon.

At this 2004 session, the EC delegate requested that the word food be added throughout the text, based on the reference in the 2003 report. The U.S. and the National Health Federation (NHF) pointed out that with the food reference in the title, it was not necessary to repeat the word throughout the text. The chair deemed that consensus was to add food in front of supplement throughout the text.

    25. The Committee discussed how to address the wording in relation to reference to small unit quantities in Section 2.1. Some delegations were of the view that this last sentence was necessary to reflect that vitamins and minerals were provided in dose form and should be taken in small unit quantities, to reflect the difference with ordinary foods. Other delegations expressed the view that this was not necessary as the text already indicated that these products were not in a conventional food form and the type of product concerned was illustrated by the examples therefore this text should be deleted. The Committee agreed to amend the second sentence clarifying that vitamins and mineral supplement sources are designed to be taken in measured small-unit quantities and added a footnote to clarify that the small-unit quantities referred to physical forms of vitamin and mineral supplements and to their potency of supplements.

In section 2.1 there was a final sentence: They are designed to be taken as measured [small unit quantities]. This sentence led to heated discussion in 2003 and did so again in 2004. EC strongly supported retaining the full sentence. New Zealand and U.S. felt the sentence was not needed. NHF pointed out that small unit quantities had no meaning. Then there was a long period in the discussion where various delegations asked for the floor to state a pro or con opinion. Supporters of retaining the sentence included Switzerland, Australia, Malaysia, and Thailand. South Africa, Zimbabwe, Costa Rica, Tanzania, and Brazil supported deleting the sentence. At this point the discussion focused on clarifying the other wording in 2.1 that included the following: …marketed in forms such as capsules, tablets, powers, solutions etc., not in a conventional food form…. There were some who wanted the etc. removed. Others were concerned about confusion with food substitutes in powered form. The chair asked Australia, as a native speaker of English, to assist in clarification of terms.

The discussion continued, with delegations stating their positions.
Venezuela, Turkey, India, and Cuba supported deleting the sentence. EC, supported by France, again urged keeping the sentence.

The chair commented that the issue was not worth quarreling about. The Council for Responsible Nutrition (CRN) commented that the physical form was already in the definition and the potency was addressed at the lower and upper level limits. Thus, CRN said, the sentence should be deleted. NHF suggested that supplements contain micronutrients rather than macronutrients, and this could be used in place of small unit quantities. The chair asked EC if this was acceptable. EC stated that there was “no valid reason to strike” the sentence, that the sentence was helpful. CRN commented that parts of the definition could be interpreted two ways, and it would be better to be specific and more direct.

At this point, the chair called for a break and requested that EC, U.S. and Australia talk during the break to find a solution. After the break Australia offered a compromise: retain etc. and add measured to the definition in 2.1. U.S. requested that it be noted in the session report that the statement refers to the physical form, not the potency. More discussion followed. Tanzania suggested adding a footnote to the text with the statement the U.S. had requested for the report. EC stated that it could support this.

At this time, EC said that because he represented a large block of countries, his position should be strongly noted. India asked what the chair’s role is when the group cannot get consensus. The chair stated that consensus is when participants are given time to give pros and cons and everyone has been listened to and can live with position. The chair’s role, the chair added, is to be helpful and direct discussion.

The chair then asked the assembly who still had concerns. Tanzania insisted the footnote was needed. The chair then determined that EC, U.S., and Australia could all support the wording with the footnote added. After more discussion about the exact wording of the footnote, the final sentence was removed, some of the wording was moved to the main definition in 2.1, and a footnote of clarification was added. The result is as follows: Vitamin and mineral food supplements for the purpose of these guidelines derive their nutritional relevance primarily from the minerals and/or vitamins they contain. Vitamin and mineral food supplements are sources in concentrated forms of those nutrients alone or in combinations, marketed in forms such as capsules, tablets, powders, solutions etc., that are designed to be taken in measured small-unit quantities 1 but are not in a conventional food form and whose purpose is to supplement the intake of vitamins and/or minerals from the normal diet. The footnote states, 1 This refers to the physical forms of the vitamin and mineral food supplements not to the potency of the supplements.

It should be noted here that the 27th session of the CAC in June/July, 2004, passed a clarification of consensus: The chairpersons should always try to arrive at a consensus and should not ask the Committee to proceed to voting if agreement on the Committee’s decision can be secured by consensus. There should be full discussion and exchange of views on the issue under consideration, in order to ensure the transparency of the process and arrive at compromises that would facilitate consensus. This clarification statement did not, however, include any actual definition of how the chair determines if there is general agreement. Thus by default decisions end up at the discretion of the chair.

    Section 3.1 Selection of vitamins and minerals
    26. The Committee agreed to amend the first sentence in Section 3.1.2 to clarify that not only sources of vitamins and minerals may be natural or synthetic but also their selection should be based on considerations of safety and bioavailability.

The square brackets were around natural or synthetic sources. There was no objection to removing these brackets.

There was considerable discussion on the sentence with 3.1.2: In addition, purity criteria should take into account FAO/WHO standards, or if FAO/WHO standards are not available, international Pharmacopoeias or recognized international standards. Some asked what recognized international standards are?

Discussion focused next on the sentence, The sources of vitamins and minerals may be from natural or synthetic sources and should be based on consideration such as safety and bioavailability. EC wanted to remove the word sources. The chair suggested using preparations. Some wanted to change the wording to include provitamins and vitamin-like substances. The chair stated that trace elements were not included in vitamins and minerals addressed in these Guidelines. South Africa pointed out that provitamins were referenced in 3.1.1., but the chair did not acknowledge this statement.

At this point South Africa pointed out that the CAC had issued directives for drawing up Codex standards that required that all standards and related texts should have a preface containing a brief description of the purpose of the text. South Africa noted, and NHF supported, that there was not a stated purpose for the Guidelines in the text’s Preamble. The chair stated that there would be no discussion about the Preamble. Later, South Africa again referenced the CAC Procedural Manual change and noted the need to add a statement of purpose to the Guidelines text. The chair responded that a guideline had lower priority than a standard. (I checked at the break with the chair that I had a correct translation of that statement. He verified that that was what he said.) Later, South Africa questioned the chair for clarification that a guideline was a “related text” as defined by CAC. After several attempts by South Africa the chair turned to Dr. Jeronimas Maskeliunas, of the Codex Secretariat (incorrectly identifying him as the FAO Secretariat), who acknowledged that this was a true statement. Dr. Maskeliunas stated that the Guidelines had a scope section that says who this applies to, so this covers “purpose.” No action was taken and no mention was made of this issue in the official report.

The discussion on 3.1.2 continued during the discussion of the scope. The chair stated that secondary plant substances would be addressed in the future. It was pointed out that there are forms of calcium with no bioavailability. A final compromise sentence was drafted to read as follows: The sources of vitamins and minerals may be either natural or synthetic and their selection should be based on considerations such as safety and bioavailability.

    27. The Committee also clarified the last sentence of this paragraph to emphasize that in the absence of international purity criteria, national legislation may be used.

This discussion merely involved removing an and from the sentence.

    28. It was proposed to include provitamin and vitamin-like substances in the guidelines, however the Committee recalled that it had agreed earlier to limit guidelines to vitamins and minerals for which the Recommended Daily Intake was established by FAO/WHO. The Delegation of South Africa pointed out that provitamins were already included in Section 3.1.1.

See previous comments. Note that NHF successfully challenged the chair to add South Africa’s comment, which had not been included in the initial draft, to the report.

    Section 3.2 Contents of vitamins and minerals
    29. The Committee had quite a lengthy discussion regarding the last paragraph containing additional explanation of conditions when maximum levels of vitamins and minerals are set.

After extensive discussion in 2003, the 3.2.2 section was selected which had maximum amounts of vitamins and minerals in vitamin and mineral food supplements per daily portion of consumption as recommended by the manufacturer set by scientific risk assessment. There remained a sentence in square brackets at the end of this section: When the maximum levels are set, due account should be taken to the reference intake values of vitamins and minerals for the population.

Again, in 2004 there was extensive discussion about whether to keep or delete this sentence. Venezuela, Brazil, Bolivia, EC, India, Norway, and Philippines supported keeping the sentence. U.S., South Africa, and Turkey supported deleting the sentence. The chair deemed that there was consensus to retain the sentence.

    30. Some delegations proposed to convert this paragraph into criterion “c” since it clarified requirements for setting maximum levels, while other delegations were of the view that this provision was already covered by criterion “a” dealing with establishment of upper safe levels of vitamins and minerals based on scientific risk assessment it should be deleted from the document.

U.S. pointed out that by changing the retained sentence to a “c” designation, it could look like you could choose between a, b, or c. This was definitely not the intention. The U.S.’ position was accepted. While the sentence was retained, however, it was not designated as “c.”

    31. The Committee agreed to add an additional sentence to this paragraph to clarify that maximum levels should not be solely based on recommended nutrient intakes.

There was still considerable dissention about the retention of the sentence at the end of 3.2.2. The International Alliance of Dietary/Food Supplement Association (IADSA) recommended adding text to ensure that individuals are not placed at the risk of deficiency. U.S. insisted that the intent needed to be added. EC would not support the suggested additions. There was concern that this final sentence might lead to maximum upper levels that were PRI (Population Reference Intake) or RDA (Recommended Daily Allowance)-based. I was now late in the day and the chair requested that the delegates “digest” their positions over night.

The next day, U.S. noted that while the U.S. preference was to delete the sentence, U.S. could offer as a compromise an additional statement to cover the concerns, plus change should to may in the first sentence of 3.2.2. NHF supported U.S.’s suggested change to may, noting that this was more appropriate, as sometimes the statement was not applicable. The chair declared consensus to be 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).

    Section 5. Labelling
    32. The Committee amended the first sentence of section 5.1 as recommended by the Codex Committee on Food Labelling in order to be consistent with general labelling requirements.

This change, dictated by another Codex committee, changed the word are to should be.

    33. In section 5.4 the Committee inserted an additional wording at the end of sentence to clarify that in addition to the amounts of the vitamins and minerals declared per portion of the product as recommended for daily consumption, the amount per unit for single use may also be given.

In 5.4 the section in square brackets was and if different, the amount per single use. EC supported removing or making a second option. NHF suggested new wording. Brazil wanted single unit rather than single use. EC did not support the suggested changes. U.S. suggested single unit of measurement. NHF supported Brazil’s idea for single unit. IADSA supported single use as offering greater flexibility. U.S. suggested amount per unit for single use. South Africa supported an and/or option for daily consumption. EC supported U.S. NHF supported South Africa’s and/or. EC could not accept the and/or option, but wanted the daily consumption wording. Brazil again supported per unit. The chair here presented himself as a nutritional expert and lectured about daily intake, single dose, and single use nutritional reference to daily intake. EC noted that daily portion could be single unit or daily portion could be two to three units for a single use. U.S. noted that the statement should also recommend how many units for daily consumption, which may be single or several units. EC pointed out that section 5.6 addresses quantity references on labels. The chair accepted the sentence with some revisions as follows: The amounts of the vitamins and minerals declared should be those per portion of the product as recommended for daily consumption and if different, the amount per unit for single use may also be given.

    34. The Committee made some editorial changes to section 5.6 for simplification and clarification purposes.

The original wording, The label must indicate the recommendations on how to take the product (quantity, frequency, special conditions), was changed to The label should indicate how the product should be used (quantity, frequency, special conditions).

    Status of the Draft Guidelines for Vitamins and Mineral Food Supplements
    35. The Committee, recognizing that considerable progress had been made on the text, agreed to advance the Draft Guidelines for adoption at Step 8 by the 28th Session of the Codex Alimentarius Commission

At this point, the chair declared that the matter under discussion was a guideline and added that all open questions had been solved. He recommended that the text be proposed to the CAC at Step 8. A number of editorial points were brought up and incorporated, including correcting the numbering sequence.

There was a final attempt to have a statement in the text that indicated whether the intent of the Guidelines was to be optional or mandatory. This would be for the benefit of future readers. The chair turned to Dr. Maskeliunas, of the Codex Secretariat (again incorrectly identifying him as the FAO Secretariat). Dr. Maskeliunas stated that all documents are not mandatory. Member countries decide how to use them. NHF stated that this needed to be specified in the document or in the report. U.S. stated that as the FAO had clarified the issue, that should be sufficient. EC agreed with U.S. Nothing was added. (Editorial Comment: When I privately questioned Dr. Maskeliunas, he admitted that the WTO could use Codex documents as an international trade standard to settle trade disputes.)

Tanzania tried again to have a purpose stated in the Preamble. Chair stated that there had been a comprehensive discussion on this matter. Nothing was added.

There was reference again that some countries designate vitamin and mineral supplements as drugs. It was also mentioned again that the use of the Guidelines was up to the individual countries.

The chair ended all discussion and declared that the Draft Guidelines for Vitamin and Mineral Food Supplements would be submitted to the CAC at Step 8.

The final version incorporating all changes can be viewed online.

Governments and international organizations wishing to comment on the Guidelines text should do so in writing, preferably by e-mail, before March 31, 2005. Send to:
The Secretary, Codex Alimentarius Commission, FAO
Viale delle Terme di Caracalla, 00100 Rome, Italy
fax: +39 06 5705 4593

This author’s primary personal concern has been how the WTO can use the Guidelines. This year I expanded my research to better understand the agreements signed by Codex Alimentarius and the WTO. It is very clear that any Codex document can be used as a mandatory international trade standard by the WTO to settle international trade disputes.

I composed an open letter to the CCNFSDU members and posted it in the website. I sent an e-mail to the delegation for each country on the committee and invited them to review this letter. In addition, I took copies of the letter and distributed them among the sixty-two country delegations at the session in Bonn. I personally handed the chair a copy of my letter. As you read in my comments, above, the chair was very deliberate in conveying a very different impression to the delegates.

This website was originally designed to educate the American public about the Draft Guidelines for Vitamin and Mineral Food Supplements. Now that this text has been completed, the site will be converted to following how the Guidelines are implemented and the development of related matters. Your input for what needs to be included would be welcomed.

The American Holistic Health Association (AHHA) is a 501(3)(c) educational nonprofit organization, not a lobbying group. AHHA president, Suzan Walter, researched and compiled information on Codex and the WTO in order to explain these matters to the U.S. public through the website. AHHA is careful to share only facts and encourages all readers to review the various positions and make up their own minds about which positions to support.

Suzan researched Codex procedural manuals and other documents, and then compared them with what Codex delegates and the nutritional supplement industry reported. It became apparent that there are a number of areas with conflicting interpretations. This has motivated Suzan to continue to research the agreements between Codex and WTO and how Codex standards and guidelines are used. Feeling a responsibility to bring these facts to the attention of CCNFSDU delegates, Suzan attended the CCNFSDU sessions as an observer in 2002, 2003, and 2004.